Controlled Drugs Policy Clinical Policy CL060 - NHS County Durham

Version Number:
Controlled Drugs Policy
Clinical Policy CL060
Version 3, 13 th November 2009
Issued date: 9 December 2009
Review date: 9 December 2011
Sponsoring Director: Director of Clinical Quality
Prepared by: Senior Pharmaceutical Advisor
Consultation Process: Drugs & Therapeutics Committee
Policy Development Group
Formally approved: December 2009
Policy adopted from: National Prescribing Centre Guide to Good
Practice in the Management of Controlled Drugs
in Primary Care (England)
Approval given by: Director of Clinical Quality
Drugs & Therapeutics Committee
Policy Development Group
POLICY VALIDITY STATEMENT
This policy is due for review on the latest date shown above.
After this date, policy and process documents may become invalid.
Policy users should ensure that they are consulting the currently valid
version of the documentation.

Document Information
Document Title: Controlled Drugs Policy
Initial Issue: Version 1: 13 March 2008
Document history
Version Date Significant Changes
2 30 June 2009 Policy has been significantly re-drafted
3 13 Nov 2009 Contact names, SOPs and Audits updated
Equality impact assessments:
Date Issues
18 August 2009
There are no specific equality and diversity issues which arise within this policy
document.

Controlled Drugs Policy
Contents
Section Title Page
1
2
3
4
5
6
7
8
9
INTRODUCTION
DEFINITIONS
POLICY DETAIL
DUTIES AND RESPONSIBILITIES
IMPLEMENTATION
TRAINING
DOCUMENTATION
MONITORING, REVIEW AND ARCHIVING
IMPACT ASSESSMENTS
Appendices to the Policy
1
2
3
4
5
Relevant acts of parliament and regulations
Accountable officer
Monitoring and auditing the management and use of controlled
drugs
Possession of controlled drugs
Purchasing and supply of controlled drugs
6
7
7
8
9
9
9
10
11
14
18
20
24
25
2

6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Preparation and administration of controlled drugs
Prescribing of controlled drugs
Prescribing in instalments
Private prescriptions
Prescriptions for prisoners and other agency agreements for NHS
services
Storage of controlled drugs
Dispensing of controlled drugs
Recording of controlled drugs
Transportation of controlled drugs
Administration of controlled drugs
Nurses working in the community
Palliative care
Self-medication
Patients travelling overseas
Destruction of controlled drugs 56
Standard Operating Procedures 59
Patient information
28
30
35
37
39
40
43
47
50
51
52
53
54
55
60
3

A
B
C
D
E
F
G
H
I
J
K
L
M
N
Appendices of Procedures
List of Controlled Drugs and Their Schedules 61
Summary of legal requirements of the possession and supply of
Controlled Drugs.
Relevant Contact Details regarding Controlled Drugs
Information Sharing Code in respect of the operation of the County
Durham and Darlington Local Intelligence Network for Controlled
Drugs governance
Controlled Drugs Practice Declaration and Self Assessment Audit
for GP Practices 2009/10
Controlled Drug Personal Declaration and Self Assessment Audit
for GP‘s 2009/10
Controlled Drugs Practice Declaration and Self Assessment Audit
for Dental Practices 2009/10
Controlled Drug Personal Declaration and Self Assessment Audit
for Dentist‘s 2009/10
Controlled Drug : Practice Audit by PCT Pharmacist
Controlled Drug : Personal Audit by PCT Pharmacist
Controlled Drug : OOH/UCC/Dispensing Doctor Audit
Controlled Drug : Community Hospital Audit
Controlled Drug : Prison Audit
Useful External Contacts
62
64
66
82
92
103
113
124
133
140
148
155
172
4

O
P
Q
R
S
T
Table of Controlled Drugs and Indications allowed to be prescribed
by Nurse Independent Prescriber‘s
Methods of Destruction of Controlled Drugs
Standard Operating Procedure for witnessing destruction of
Controlled drugs by a delegated PCT Pharmacist
Controlled Drug Destruction Record Form
Summary of Controlled Drug guidance for GP‘s
Guidance on Standard Operating Procedures
176
177
180
189
190
194
5

1. Introduction
Controlled Drugs Policy
NHS County Durham and NHS Darlington aspires to the highest standards of
corporate behaviour and clinical competence, to ensure that safe, fair and equitable
procedures are applied to all organisational transactions, including relationships
with patients their carers, public, staff, stakeholders and the use of public resources.
In order to provide clear and consistent guidance, NHS County Durham and NHS
Darlington will develop documents to fulfil all statutory, organisational and best
practice requirements and support the principles of equal opportunity for all.
This document gives guidance on the requirements of The Misuse of Drugs Act
1971, the Misuse of Drugs Safe Custody Regulations 1973, and the
recommendations resulting from the Fourth Report of the Shipman Inquiry and
associated amendments to the Misuse of Drugs Regulations 2001.
The Misuse of Drugs Act and Misuse of Drugs Regulations govern the
circumstances under which controlled drugs (CDs) may be manufactured,
possessed, supplied, imported and exported. Full details of the relevant legislation
are in Appendix 1.
1.1 Status
This policy is a Clinical policy.
1.2 Purpose and scope
This document aims to
� Develop good practice in the management of controlled drugs in primary care in line
with current legislation.
� Identify robust systems for obtaining, storing, supplying, recording, monitoring and
safe disposal of CDs, whilst at the same time ensuring appropriate and convenient
access for those patients that require them.
This policy is applicable to Health Care Providers within Co Durham and Darlington
PCT‘s, including independent contractors and directly managed services and staff
where controlled drugs are handled, prescribed or used, including: -
GP and Dental Practices
Pharmacies
Midwifery Services
Out of Hours/ Urgent Care/Walk in Centre Services
Patients own homes
Care Homes
Community Hospitals
6

Community Nursing Services
Community Palliative Care Services
Substance Misuse Services
Hospices
Prison Services
2. Definitions
There are no specific definitions applicable to this policy
3. General Policy Statement
Co Durham and Darlington PCT‘s have an obligation to comply with legislation
outlined in Appendix 1 and with the Health Care Commission Standards for Better
Health: Core Standard : C4 D in that organisations keep patients, staff and visitors
safe by having systems to ensure that medicines are handled safely.
Each practice (GP, Dental etc), pharmacies, services and PCT directly managed
services and staff, are required to have clear practice standard operating
procedures (SOP‘s) covering issues relating to the prescribing, receipt, storage,
supply, recording, monitoring, administration and disposal of controlled drugs.
These SOPs should provide a full audit trail to track the movement of CDs in
primary care from acquisition to administration.
As designated bodies Co Durham and Darlington PCT‘s have a duty under the
Health Act 2006 to : -
Appoint an Accountable Officer and describe the duties and responsibilities of
the officer to improve the safe management of CDs. The regulations specify who
may be appointed as an Accountable Officer.
Share intelligence on CD issues with other local and national agencies.
Have the power of entry and inspection for the police and other nominated
people to enter premises to inspect stocks and records of CDs.
Specific procedures applicable to this policy are shown in Appendices 3-22
The Care Quality Commission is responsible for overseeing the Regulation of the
management of CDs by the PCT.
7

4. Duties and Responsibilities
Trust board:
The Trust Board has overall responsibility within each Trust for setting the strategic
context in which organisational process documents are developed, and for
establishing a scheme of governance for the formal review and approval of such
documents.
Chief Executive
The Chief Executive has overall responsibility for the strategic direction and
operational management, including ensuring that Trust process documents comply
with all legal, statutory and good practice guidance requirements.
Director of Clinical Quality
The director of clinical quality is the sponsoring director for this document and is
responsible for ensuring that:
The document is drafted, approved and disseminated in accordance with the
Policy for the Development and Approval of Policies.
The necessary training or education needs and methods required to
implement this policy are identified and resourced or built into the delivery
planning process.
Mechanisms are in place for the regular evaluation of the implementation
and effectiveness of this policy.
Controlled Drugs Accountable Officer
The duties of the Accountable Officer are shown in Appendix 2
All staff
All staff, including temporary and agency staff, are responsible for:
Compliance with relevant process documents. Failure to comply may
result in disciplinary action being taken.
Co-operating with the development and implementation of policies and
procedures and as part of their normal duties and responsibilities.
Identifying the need for a change in policy or procedure as a result of
becoming aware of changes in practice, changes to statutory requirements,
revised professional or clinical standards and local/national directives, and
advising their line manager accordingly.
Identifying training needs in respect of policies and procedures and bringing
them to the attention of their line manager.
Attending training / awareness sessions when provided.
8

5. Implementation
This policy will be available to all Staff, in particular the staff listed in Section 1.2 of
the policy for the circumstances described there.
All directors and managers are responsible for ensuring that relevant staff within
their own directorates and departments have read and understood this document
and are competent to carry out their duties in accordance with the procedures
described.
It may be necessary to develop specific implementation plans.
6. Training Implications
The sponsoring director will ensure that the necessary training or education needs
and methods required implementing the policy or procedure(s) are identified and
resourced or built into the delivery planning process. This may include identification
of external training providers or development of an internal training process.
It has been determined that there are no specific training requirements associated
with this policy/procedure.
7. Documentation
7.1 Other related policy documents.
Safe and Secure Handling of Medicines (2008)
7.2 Legislation and statutory requirements
Misuse of Drugs Act 1971
Misuse of Drug Regulations 2001 (2001 Regulations)
Misuse of Drugs (Safe Custody) Regulations 1973
Misuse of Drugs (Supply to Addicts) Regulations 1997
Medicines Act 1968
Health Act 2006
Dangerous Drugs, England, Scotland: The Controlled Drugs
(Supervision of Management and Use) Regulations Health Act 2006
7.3 Best practice recommendations
National Prescribing Centre Guide to Good Practice in the Management of
Controlled Drugs in Primary Care (England) 2 nd Edition February 2007
9

7.4 References
The major references consulted in preparing this document are described above.
8. Monitoring, Review and Archiving
Monitoring
The director of clinical quality as sponsor director, will agree with the policy
manager a method for monitoring the dissemination and implementation of this
policy. Monitoring information will be recorded in the policy database.
Review
The sponsoring director will ensure that each policy document is reviewed in
accordance with the timescale specified at the time of approval. No policy or
procedure will remain operational for a period exceeding three years without
a review taking place.
Staff who become aware of changes in practice, changes to statutory requirements,
revised professional or clinical standards and local/national directives that affect, or
could potentially affect policy documents, should advise the sponsoring director as
soon as possible, via line management arrangements. The sponsoring director will
then consider the need to review the policy or procedure outside of the agreed
timescale for revision.
If the review results in changes to the document, then the initiator should inform the
policy manager who will renew the approval and re-issue under the next ―version‖
number. If, however, the review confirms that no changes are required, the title
page should be renewed indicating the date of the review and date for the next
review and the title page only should be re-issued.
For ease of reference for reviewers or approval bodies, changes should be noted
on the ―Document history‖ table on page 2 of this document.
NB: If the review consists of a change to an appendix or procedure document,
approval may be given by the sponsor director and a revised document may be
issued. Review to the main body of the policy must always follow the original
approval process.
Archiving
The Policy Manager will ensure that archived copies of superseded policy
documents are retained in accordance with Records Management: NHS Code of
Practice 2006.
10

9 Audit / Impact Assessment Statements
EQUALITY IMPACT ASSESSMENT FORM
Please refer to the corporate checklist for further information.
Name of function/strategy/policy/service: Controlled Drugs Policy
Date of Review: 18 August 2009
a) Please provide a brief description of the function/strategy/policy/service:
This document gives guidance on the requirements of The Misuse of Drugs Act
1971, the Misuse of Drugs Safe Custody Regulations 1973, and the
recommendations resulting from the Fourth Report of the Shipman Inquiry and
associated amendments to the Misuse of Drugs Regulations 2001.
The Misuse of Drugs Act and Misuse of Drugs Regulations govern the
circumstances under which controlled drugs (CDs) may be manufactured,
possessed, supplied, imported and exported.
b) What Type of positive and negative equality & diversity implications are you
aware of that arise from your function/strategy/policy/service?
There are no specific equality and diversity issues which arise within this policy document.
c) In line with our statutory duty under equality legislation do your
functions/strategies/policies/services make reference to equality wherever relevant?
In line with the Race Equality Duty to
eliminate discrimination, harassment,
promoting equality of opportunity and good
relations between people of different racial
groups
In line with the Disability Equality Duty to
promote positive attitudes towards
disabled persons and encourage
participation by disabled people
NHS County Durham aspires to the highest
standards of corporate behaviour and clinical
competence, to ensure that safe, fair and
equitable procedures are applied to all
organisational transactions, including relationships
with patients their carers, public, staff,
stakeholders and the use of public resources. In
order to provide clear and consistent guidance,
NHS County Durham will develop documents to
fulfil all statutory, organisational and best practice
requirements and support the principles of equal
opportunity for all.
Applied equally to all employees
11

In line with the Gender Equality Duty to
eliminate unlawful discrimination and
harassment & promote equality of
opportunity between men and women
Other relevant equality legislation/best
practice?
Applied equally to all employees
d) What relevant groups have a legitimate interest in the
function/strategy/policy/service?
Does it impact differently on particular minority groups?
If Yes – Which Groups are affected, and how are they affected?
Group Impact
All Trust
employees
This policy is appropriate and applicable to those staff identified in Section
1.2.
e) Please outline below any work you have carried out to assess, monitor, address and review
the equality implications of your function/strategy/policy/service and identify additional work
that needs to be carried out to meet requirements of our statutory duties.
Area of Work
Consultation
Monitoring & Target
Setting
Access to
Information/Services
Marketing &
promotion
Work already
carried out /
Measures in Place
Drugs &
Therapeutics
Committee
Work Required Timescales
Management Group
to approve
Review June 2011
Available to staff via
the Intranet and hard
copy of policy.
Signpost access to
services and support.
All staff informed of
approval and
publication of the
policy.
June 2011
Following approval
Following approval
12

Training/Briefing
staff
Employment Issues
Review and
Evaluation
N/A
Review June 2011
June 2011
WHERE APPROPRIATE, ACTIONS AND TARGETS DESCRIBED HERE SHOULD BE
EVIDENT IN SERVICE AREA PLANS
13

RELEVANT ACTS OF PARLIAMENT AND REGULATIONS
1.1 Misuse of Drugs Act 1971
Appendix 1
The Act establishes a series of criminal offences for the unauthorised use, possession,
supply, importation and unlawful production of drugs considered ‗dangerous or
otherwise harmful‘, with potential for diversion and misuse.
Drugs controlled under this act are divided into 3 classes – A, B & C in order to
determine the penalties for offences committed under the act. The class of drug
reflects its relative harm when misused. The maximum penalties for offences of
possession and supply of the main CDs within each class are outlined in the table
below.
Drug Class Penalties for Penalties for
Class A
possession supply
Diamorphine (heroin), Cocaine (Crack), Up to seven years Up to life
MDA (Ecstasy, lysergic acid diethylamide imprisonment or an imprisonment or an
(LSD), methamphetamine, cocaine, more unlimited fine or unlimited fine or
potent opioid analgesics e.g. methadone both
both
Class B
Up to five years Up to 14 years
Amphetamine, barbiturates, Cannabis *, less imprisonment or an imprisonment or an
potent opioids e.g. codeine
unlimited fine or unlimited fine or
both
both
Class C
Up to two years Up to 14 years
Benzodiazepines (and zolpidem), ketamine, imprisonment or an imprisonment or an
anabolic steroids and gamma-
unlimited fine or unlimited fine or
hydroxybutyrate (GBH)
both
both
NB: Any class B drug in an injectable form is treated as Class A.
* The Advisory Council on the Misuse of Drugs reviews and advises Ministers in
the United Kingdom on measures that deal with social problems caused by drug
misuse. Therefore the above summary may change, for up to date and detailed
information contact The Home Office.
1.2 Misuse of Drug Regulations 2001 (2001 Regulations)
These regulations
Authorise and govern certain activities which would otherwise be illegal under
the Misuse of Drugs Act.
Identify those Health Care Professionals who may legitimately posses and
supply CDs.
Establish a regime of control around prescribing, administration, safe custody,
dispensing, record keeping and destruction or disposal.
The 2001 regulations divide CDs into 5 schedules, which dictate the degree to
which a CDs use is regulated, which in turn depends upon the therapeutic
benefit versus harm when misused.
Schedule 1 CDs are subject to the highest level of control whereas Schedule 5
CDs are subject to a much lower level of control.
Regulations are subject to amendments: full details are available from the Home
Office and the Office of Public Sector information website. www.opsi.gov.uk

1.2.1 Schedule 1 (CD Licence)
These drugs have no recognised medicinal use, although Sativex® (a cannabis based
product) can be supplied on a named patient basis under Home Office Licence.
Examples: cannabis, coca leaf, mescaline, ecstasy, hallucinogens (e.g. LSD) and raw
opium.
Only certain people licensed by the Home Office may possess Sch 1 drugs for
research or other special purposes Practitioners and pharmacists may not lawfully
possess Sch 1 drugs except under licence from the home office.
1.2.3 Schedule 2 (CD)
Includes more than 100 drugs such as the opiates, the major stimulants, secobarbital
and amphetamine.
Sch 2 CDs (except quinalbarbitone) are subject to safe custody requirements (under
the Misuse of Drugs Safe Custody Regulations 1973).They must be stored in a locked
receptacle, such as an appropriate CD cabinet or approved safe, which can be opened
by the person in lawful possession of the CD or a person authorised by them.
Quinalbarbitone is exempt from safe custody requirements but is it considered good
practice to store with other CDs.
A licence is required to import and export drugs in Sch 2. They may be manufactured
or compounded by a licence holder, a practitioner, a pharmacist or a person lawfully
conducting a retail pharmacy business acting in their capacity as such.
A pharmacist may only supply Sch 2 CDs to a patient only on the authority of a
prescription in the required form issued by an appropriate prescriber.
A pharmacist may only supply Sch 2 CDs for the purpose of stock in primary care on
the authority of a requisition in the required form issued by an appropriate person.
SCH2 CDs may be administered to a patient by a doctor or dentist or by any person
acting in accordance with the directions of an appropriately qualified prescriber.
Nurse independent prescriber‘s are permitted to prescribe, administer or direct anyone
to administer some CDS for specific conditions and routes of administration. Full
details are given at www.doh.gov.uk/nonmedicalprescribing
A CD register must be kept for Sch 2 CDs and this must comply with the requirements
of the 2001 regulations.
The destruction of Sch 2 CDs stock must only take place in the presence of an
appropriately authorised person. Patient returns do not currently have to be witnessed
but good practice would deem that another person should witness their destruction.
1.2.4 Schedule 3 (CD No Register)
Sch 3 includes a small number of minor stimulant drugs and others which are less
likely to be misused than Sch 2.
The majority of Sch 3 drugs are exempt from safe custody requirements. Exceptions
are: Flunitrazepam, Temazepam, Buprenorphine, Diethylpropion, which must be
stored in a locked receptacle, such as an appropriate CD cabinet or approved safe,
which can be opened by the person in lawful possession of the CD or a person
authorised by them.
A pharmacist may only supply Sch 3 CDs for the purpose of stock in primary care on
the authority of a requisition in the required form issued by an appropriate person.
Page 15 of 196

Certain prescription requirements apply.
There is no legal requirement to record transactions of Sch 3 CDs in a CD register
The requirements for destruction do not apply unless the CDs are manufactured by the
individual.
Sch 3 drugs are subject to full import and export control.
1.2.5 Schedule 4 (CD Benzodiazepines and CD Anabolic steroids)
Sch 4 is split into 2 parts
Part 1 (CD Benzodiazepines) contains most of the benzodiazepines, plus eight
other substances including zolpidem, fencamfamin and mesocarb.
Part 2 (CD Anabolic steroids) contains most of the anabolic and androgenic
steroids such as testosterone, together with clenbuterol and growth hormones.
There is no restriction on the possession of a Sch 4 Part 2 (CD Anabolic
steroids) drug when it is in the form of a medicinal product.
Possession of a drug from Sch 4 Part 1 (CD Benzodiazepines) is an offence without
the authority of a prescription in the required form. Possession, by practitioners and
pharmacists acting in their professional capacities, is authorised.
Drugs in Part 1 (CD Benzodiazepines) are subject to full import and export control and
a Home Office licence is also required for importation and exportation of Part 2
Anabolic Steroids unless the substance is in the form of a medicinal product and is for
personal use/ administration.
All substances from Sch 4 are exempt from safe custody requirements with destruction
only applying to importers, exporters and manufacturers.
Prescription-writing requirements set out in the 2001 Regulations for these CDs do not
apply, except those requirements laid down in the Medicines Act 1968.
CD registers do not need to be kept for Sch 4 drugs, although records should be kept if
such CDs are compounded.
1.2.6 Schedule 5 (CD Invoice)
Schedule 5 contains preparations of certain CDs e.g. codeine, pholcodine, morphine,
which are exempt from full control when present in medicinal products of low strength,
as their risk of misuse is reduced.
There is no restriction on the import, export, possession, administration or destruction
of these preparations and safe custody Regulations do not apply.
The Misuse of Drugs Regulations have been amended so that preparations containing
more than 0.1% cocaine are no longer exempt from prohibitions on import, export and
possession.
A practitioner or pharmacist acting in his capacity as such, or a person holding an
appropriate licence, may manufacture or compound any CD in schedule 5.
Appendix A contains a list of the most commonly used controlled drugs and their
Schedules.
Appendix B contains a summary of the legal requirements, possession and supply.
Page 16 of 196

1.3 Misuse of Drugs (Safe Custody) Regulations 1973
These regulations impose controls on the storage of CDs. The degree of control
depends on the premises where the drugs are stored.
All Schedule 2 and some Schedule 3 CDs should be stored securely in accordance
with the safe custody regulations. These regulations state that such CDs must be
stored in a cabinet or safe, locked with a key. It should be made from metal, with
suitable hinges and fixed to a wall or floor with rag bolts that are not accessible from
outside the cabinet.
1.4 Misuse of Drugs (Supply to Addicts) Regulations 1997
These regulations prohibit doctors from prescribing, administering or supplying
diamorphine, cocaine or dipipanone for the treatment of addiction or suspected
addiction except under a Home Office Licence. A licence is not required with such
drugs for the treatment of organic disease or injury.
1.5 Medicines Act 1968
This Act sets out the requirements for a valid prescription. It also allows Midwives to
possess and administer diamorphine, morphine, pethidine or pentazocine.
A number of Health Care Professionals are permitted to supply or administer
medicines in accordance with a patient group direction under medicines act legislation.
Some of these professional groups, but not all, are permitted to supply or administer
CDs in accordance with a PGD under Misuse of Drugs legislation.
1.6 Health Act 2006
See section 2.2
1.7 Dangerous Drugs, England, Scotland: The Controlled Drugs
(Supervision of Management and Use) Regulations 2006 Health Act 2006
These regulations set out the requirements for certain NHS bodies and independent
health care bodies to appoint an Accountable Officer and describe the duties and
responsibilities of Accountable Officers to improve the safe management and use of
CDs.
The regulation requires specific bodies to co-operate with each other, including with
regard to sharing of information, about concerns about the use and management of
CDs, and set out arrangements relating to powers of entry and inspection.
Page 17 of 196

ACCOUNTABLE OFFICER
Page 18 of 196
Appendix 2
2.1 Appointment of Accountable Officer
As designated bodies, Co Durham NHS and Darlington NHS have a duty to appoint an
Accountable Officer. The Health Act 2006 specifies who may be appointed as an
Accountable Officer.
The Accountable Officer cannot be a person who routinely supplies, administers or
disposes Controlled Drugs as part of their duties.
The PCT must notify the Head of Operations at the Care Quality Commission of the
nomination or appointment of their Accountable Officer, and also the removal or
change of an Accountable Officer.
These notifications can be made via the Accountable Officer notification form available
via the Care Quality Commission Website.
www.cqc.org.uk/guidanceforprofessionals/healthcare/allhealthcarestaff/managingrisk/c
ontrolleddrugs/accountabl/accountableofficernotificationform.cfm
The Care Quality Commission is required to publish a list of Accountable Officers in
England and an up to date list is available via their website.
Contact details for Co Durham NHS and Darlington NHS Accountable Officer see
Appendix C
2.2 Roles and Responsibilities of the Accountable Officer
The Accountable Officer is responsible for ensuring the safe and effective use and
management of controlled drugs within Co Durham and Darlington PCT.
The Accountable Officer must have regard to best practice in relation to the
management of controlled drugs;-
Secure the safe management and use of CDs in particular
Establish and ensure appropriate arrangements to comply with Misuse of Drugs
Legislation.
Ensure adequate and up to date Standard Operating Procedures are in place in
relation to the management of CDs.
Ensure adequate destruction and disposal arrangements for CDs
Ensure monitoring and auditing of the management and use of CDs
Ensure relevant individuals receive appropriate training
Maintain a record of concerns regarding relevant individuals
Assess and investigate concerns
To take appropriate action if there are well founded concerns
To establish arrangements for sharing information
The PCT Accountable Officer has the authority to inspect CD registers, premises and
general drug control procedures in practices and nominate certain designated PCT
personnel to facilitate this or perform inspection on their behalf.
The PCT Accountable Officer is responsible for arranging periodic inspections of
premises which are used in connection with controlled drugs and are not subject to

inspection by the Care Quality Commission or the Royal Pharmaceutical Society
Inspectors (RPSGB). Advanced notification of the inspection does not have to be
provided.
2.3 Local Intelligence Network
Local Agencies required by legislation to share information include: Health Care
organisations, the police, social services and relevant inspectorates, Care Quality
Commission and RPSGB.
Responsibility for establishing the Local Intelligence Network lies with the PCT
Accountable Officer. The network will enable agencies that have cause for concern
about the activities of any Healthcare professional to share them as soon as possible
with other local agencies who may be affected or who may have complimentary
information.
Full details can be found in the Information Sharing Code for Durham and Darlington
Local Intelligence Network. Appendix D
Page 19 of 196

Page 20 of 196
Appendix 3
MONITORING AND AUDITING THE MANAGEMENT AND USE OF CONTROLLED
DRUGS
3.1 Controlled drugs declaration statement and self assessment
All organisations providing clinical services are required to complete a declaration (at
least every two years) on whether or not their organisation keeps stocks of CDs.
Those that do hold stocks of CDs will be required to complete a self assessment of
their management of CDs.
The self assessment will inform other monitoring and inspection activities.
A declaration and self assessment questionnaire will be sent by the PCT Medicines
Management Team to GPs on Co Durham and Darlington performers list, registered
dentists on Co Durham and Darlington performers lists and PCT /CHS services.
Appendix E, F, G, H for details of the forms.
The forms should be returned to Co Durham and Darlington PCT Medicines
Management Team.
Co Durham and Darlington PCTs will be required to complete the Health Care
Commission Annual Health Check Core Standards Assessment.
3.2 Routine Inspections
Inspection remains a useful tool to check physical arrangements for the storage,
record keeping and management of CDs, to support individual and organisational
development and to identify and investigate concerns.
The Health Act has created power of entry and inspection for the police and other
nominated people to enter premises to inspect stocks and records of CDs. See table
below
The PCT Accountable Officer is responsible for authorising PCT personnel, as a
nominated person, to carry out these duties on his behalf, completing the PCT Audit
Tool. See Appendix I, J, K, L and M.
This delegation excludes premises subject to inspection by the Care Quality
Commission or the Royal Pharmaceutical Society Inspectors (RPharmSGB).
The PCT inspecting body is the Care Quality Commission, however, routine
inspections of PCT /CHS services will also be performed by authorised PCT staff in
order to support development and identify concerns.
3.3 Inspection Responsibilities
Area Inspecting Body
GP Practices
PCTs. Inspection will be announced and
NHS dentists
may be combined with other visits.
Community Pharmacies The Royal Pharmaceutical Society
PCTs Care Quality Commission

PCT Prisons
PCT Community Hospitals
PCT Services/clinics etc.
PCT
PCT
PCT
NHS Trusts Care Quality Commission
Independent Healthcare sector
including GPs in private practice
Care Quality Commission
Care Homes Care Quality Commission
3.3.1 Standards for Inspection
A small number of routine inspections of a random sample (about 10%) must be
performed on an annual basis. The Head of Medicines Management or the
Accountable Officer for the PCT will determine the number and frequency of routine
monitoring visits.
Routine inspections will be performed by designated PCT pharmacists. Pharmacists
who perform monitoring must not do so in practices or services where they work or are
registered as a patient.
To ensure consistency common guidelines will be followed: -
Controlled drugs: Monitoring and inspection guidelines - Core activities for CD
monitoring and inspection work - Primary care : Department of Health - Publications
Inspections will comply with the ten principles of inspection set out in the government‘s
policy on Inspection of Public Services.
http://archive.cabinetoffice.gov.uk/opsr/documents/pdf/policy.pdf
Those involved in monitoring and inspection are required to complete the mandatory
PCT training and the National Prescribing Centre competency framework.
http://www.npc.co.uk/pdf/CDI_Competency_Framework.pdf
Notification will be given prior to a routine inspection. Unannounced inspections may
only be carried out under specific directions from the Accountable Officer.
3.4 Monitoring Controlled Drug Prescribing and Requisitions
The PCT Medicines Management team will monitor NHS and private prescribing and
requisitions of Schedule2 and 3 controlled drugs via ePACT data on a quarterly basis.
These reports will inform other monitoring and inspection activities to determine
whether any further action is needed. Currently there is no facility to monitor NHS
dentist prescribing by this method.
ePACT data is available for a rolling 60-month historical period only therefore local
historical data will be archived and stored securely and via designated spread sheets,
as this information may be required as evidence by other bodies.
The PCT Pharmaceutical Advisers will use the reports generated to:
Identify GP practices, private practice, non medical prescriber‘s and services,
with a higher than average cost or frequency of CD prescribing/requisitions
compared with the PCT average.
Prescribing/ordering of excessive quantities.
Prescribing for drug addicts
Identify where prescriptions/ requisitions were dispensed or supplied from.
Page 21 of 196

This will enable monitoring of prescribing and ordering patterns to determine
specific medicines and quantities prescribed.
These techniques do not detect inappropriate, fraudulent or criminal behaviour or
identify individual patients; it identifies prescriber‘s/services with unusual
prescribing/requisition patterns for these drugs.
When unusual and/or excessive prescribing or ordering is identified from these reports
the PCT Pharmaceutical Advisers may contact the prescriber or service lead. The
prescriber or service lead may use this information to identify patients receiving
unusual or excessive quantities and take action or identify a legitimate reason or raise
concerns. Where a legitimate reason is identified the advisers should be informed so
this can be logged onto the database.
If anomalies or abnormal prescribing patterns are picked up and no legitimate reason
is identified, the PCT Pharmaceutical Advisers will seek guidance and expert help via
the Clinical Governance Leads and the Accountable Officer will be notified.
If concerns are raised about controlled drugs, by any Healthcare Professional, from the
ePACT data, these should be reported. There are a number of mechanisms for this –
See Reporting concerns section 13.6
3.5 Information Sharing
In sharing information the PCT will have regard to the Data Protection Act 1998 and
the codes of practice on confidentiality, in particular the Caldecott principles.
The Local Intelligence Network code of conduct on information sharing will be followed.
Wherever possible, information will be anonymous. In exceptional circumstances the
PCT may determine that it is in the public interest to share patient/ practitioner
identifiable information or that they are required to do so by statute. The patients/
practitioners consent should be sought or they should be notified of the disclosure
unless such action would prejudice an investigation.
3.6 Reporting Concerns
In addition to concerns arising from routine monitoring and inspection, concerns may
be raised by individuals.
The Public Interest Disclosure Act 1998 protects employees who are worried about
wrongdoing in their place of work and want to raise concerns,
The Act applies to all NHS employees and includes all self-employed NHS
Professionals (i.e. doctors, dentists, opticians, optometrists, and pharmacists).
For the purpose of the Act, the employer of a self employed NHS Professional is
deemed to be the relevant PCT or Strategic Health Authority.
Other relevant policies are the
PCT Whistleblower Policy
PCT Incidents Reporting Policy
Concerns may be raised by following the above policies or reporting direct to any of
the relevant personnel or regulatory authorities listed in Appendix C and N.
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3.7 Controlled Drug Review
Information from declaration and self assessment, routine monitoring and other
sources will be reviewed to decide whether any further action is needed
The review will assess the organisation/practitioners clinical standards in the
prescribing, supply, administration, storage, record keeping and disposal of CDs and
assure compliance with the Misuse of Drugs Act 2001 and associated Regulations,
medicines legislation and any relevant professional codes of practice.
Page 23 of 196

POSSESSION OF CONTROLLED DRUGS
Page 24 of 196
Appendix 4
Unlawful possession of any CD in Schedule 2 to 4 (part1) is a criminal offence.
Persons who can legally possess CDs include:-
Medical Practitioners (this includes doctors and dentists)
Pharmacists or a person lawfully conducting a retail pharmacy business
Supplementary Prescriber‘s where CDs form part of a clinical management plan
Nurse Independent prescriber‘s, but restricted to specific CDs for specific
indications
Any person administering under the directions of a doctor or dentist
Midwives acting in their capacity as such (restrictions apply)
Paramedics acting in their capacity as such (restrictions apply)
Health Professionals supplying or administering CDs under a PGD (restrictions
apply)
Persons in charge of a hospital or care home with nursing
Someone who is transferring, with permission, a CD to another person who is
lawfully allowed to have it in their possession. This permission may be granted
by the person authorised to possess and should be in writing
Someone who has legally been prescribed a CD
Someone who has found a CD and is immediately taking it to a person who may
lawfully possess it. E.g. a pharmacist for a medicinal product, a police officer for
illicit drugs
Someone who has removed a CD from someone else to stop them offending
and is immediately taking it to a person who may lawfully possess it.
Other categories (not applicable to primary care) are allowed, for full details refer to the
Misuse of Drugs Act.

PURCHASING AND SUPPLY OF CONTROLLED DRUGS
Page 25 of 196
Appendix 5
A requisition is required for purchase of Schedule 2 and 3 controlled drugs.
The requisition must contain the following information
Name and address and profession or occupation of the recipient
Purpose for which drug supplied
Name form and strength of the drug and quantity to be supplied
Date on which supplied
Faxed or other electronically transmitted requisitions are not currently permitted.
Invoices should be retained for a minimum of two years. It is good practice to keep
records for longer as any investigations take longer than 2 years.
5.1 Supply from community pharmacy (FP10CDF forms)
Controlled drugs ordered from a community pharmacy should be made using the
dedicated CD Requisition Form (FP10CDF).
FP10CDF forms are available from the service which supplies other controlled
stationary e.g. prescription forms.
PCT shared services office which supplies other controlled stationery (i.e.FP10).
Contact: -
The Office Services Manager
John Snow House
Telephone 0191 3011300
Independent Hospitals, Out of Hours, Community Hospitals etc will be provided with an
organisation code and/or a practice code for the purpose of ordering controlled drugs
from a community pharmacy. Please contact the PCT Medicines Management Team
for more details.
FP10CD forms are controlled stationery, with unique numbers, and should be stored
securely with access limited to authorised personnel. The minimum number of forms
should be held (i.e. 1 form per GP at any one time).To order controlled drugs all fields
of the form Part B to D should be completed. The person ordering the CDs should sign
the requisition by hand, all other parts of the form may be printed or completed by
another designated person.
If a messenger is sent to collect the CD they must carry a bearer‘s note, signed and
dated by the prescriber, stating that they are authorised to collect the CD. The
pharmacy may retain the bearers note for a minimum of 2 years.
Dispensing Doctors should not supply controlled drugs ordered on a requisition as they
are not permitted to carry out a wholesale function unless they have a wholesalers
licence.
Pharmacies who supply the CD must record their name and address on the forms and
submit these to the Prescription Pricing Division (PPD) of the NHS Business Services
Authority (BSA).
5.2 Supply of controlled drugs from a wholesaler or NHS Hospital Trust
Supply of controlled drugs from a wholesaler or NHS Trust should be made via a
written requisition, containing all the details as per the FP10CDF.
Pharmacists and doctors may order controlled drugs, for their dispensary,
electronically from wholesalers; however, doctors must provide a written requisition on

eceipt of the controlled drugs. Pharmacists do not need to issue a signed order when
purchasing from a pharmaceutical wholesaler, however, this does not apply to support
pharmacist prescriber function.
5.3 GP Practices
Previous recommendations were that the practice holds a central stock under the care
of a designated person for distribution to individual GP for their bags.
The introduction of designated controlled drug requisition forms in 2008 and the
subsequent monitoring of these now make this recommendation obsolete.
GP practices who wish to continue to hold a central stock of CDs should ensure a full
auditable trail is available from ordering to administration and overseen by a
designated member of staff.
The FP10CDF requisition to replenish bags or stock should be completed by the
doctor who requires the stock for their bag.
There is a distinction between supplies of CDs prescribed for individual patients on a
prescription and those obtained by practitioners for stock or bags for home visits etc.
Medicines prescribed for an individual patient must be supplied to, and used by, that
patient only.
Practitioners must NOT use patient specific CD prescriptions to replace or top up their
bags for home visits, etc, or practice stock, even if the stock was used for that patient
initially. This could be considered as a potential offence under the Theft Act 1968 and
might be seen as a means of obtaining CDs by deception.
GPs can claim the cost of injectable controlled drugs, purchased by the practice, which
have been administered to patients. To do this the GP should generate an FP10 and
submit this to the Prescription Pricing Division (PPD) of the NHS Business Services
Authority (BSA) at the end of the month along with other personally administered
claims on form FP34D or FP34PD for dispensing doctors. For more information
contact the PPD on 0845 6101171.
5.4 Urgent Supplies (GPs)
A practitioner who requires a Sch 2 or 3 CD urgently and who is unable to supply a
signed requisition (FP10CDF) can request the drugs to be supplied in an emergency.
The practitioner may be supplied with the CD provided he/she gives an undertaking to
supply the completed requisition (FP10CDF) within 24 hours. Failure to do this is a
criminal offence on the part of the practitioner.
5.5 ACQUISITION OF CONTROLLED DRUGS BY OTHER HEALTHCARE
PROFESSIONALS
In addition to the legal requirements and good practice described previously, the
following applies when other healthcare professionals acquire CDs.
5.5.1 Midwives
Community Midwives should obtain controlled drugs for stock in accordance with their
employing authority policies and procedures. For more details on the regulations and
midwives refer to the National Prescribing Centre Guidance : - NPC - Home Page
Alternatively, a prescription can be written by a doctor e.g. a GP if that patient is under
their care. The patient obtains the prescribed CD from a pharmacy and keeps it in their
home until it is required for administration by the midwife.
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5.5.2 Paramedics
Ambulance paramedics can supply and / or administer under PGD all drugs listed in
schedule 4 and 5. Under separate exemptions and a group authority, NHS ambulance
paramedics serving at any approved ambulance station are able to administer
diazepam and/or morphine sulphate injection (to a max of 20mg) for immediate
necessary treatment of sick or injured persons.
Out of Hours, Urgent Care, Walk in Centres etc. are not approved ambulance stations
therefore registered paramedics who are required to administer diazepam or
midazolam in the course of their duties must do so under an approved Patient Group
Direction (PGD). Currently administration of schedule 2 controlled drugs (i.e. morphine,
diamorphine) are not allowed via PGD for use in trauma.
5.5.3 Hospices, community hospitals and independent hospitals
Where a hospice, community hospital or private hospital does not employ a
pharmacist, the person or acting person in charge may obtain CDs via a requisition
signed by a doctor or dentist employed or engaged there.
If supplies are obtained from a community pharmacy the FP10CDF requisition form
must be used. A designated organisation code and/or practice code will be issued by
the PCT and PPD for the specific purpose of ordering controlled drugs from community
pharmacies via FP10CDF requisitions.
If supplies are requested via a wholesaler or the pharmacy department of an NHS
Trust with whom a service level agreement (SLA) is in place a written requisition form
should be used which complies with the regulations set out above. (FP10CDF forms
do not apply).
5.5.4 Out of Hours premises
At out of hour‘s premises, as long as the ordering, supply or dispensing of CDs is
undertaken by a doctor or pharmacist, CD stock can be ordered as in section15.5.3
above.
Acquisition may be undertaken by anyone else i.e. office manager of the Out of Hours
Provider – under these circumstances a Home Office licence is required.
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PREPARATION AND ADMINISTRATION OF CONTROLLED DRUGS
6.1 Legal Framework
Any person may legally administer a schedule 5 CD to any other person
Page 28 of 196
Appendix 6
Administration of CDs via PGD applies to the specified healthcare professional in the
PGD, this cannot be delegated to another person.
Doctors and dentists and any person acting in accordance with the directions of a
doctor or dentist may administer Sch 2, 3 or 4 CD from stock.
Nurse independent prescriber‘s or any person acting in accordance with their
directions can administer a limited range of controlled drugs. See Appendix O
Some professional groups, not all, are permitted to supply or administer controlled
drugs in accordance with a PGD.
A carer/relative, can, with consent, administer a CD that has been individually
prescribed for a third party. As CDs are included within the legal category of
prescription only medicines (POM), home carers who are competent to administer
medicines should also be competent to administer CDs.
Midwives may possess those CDs which they may also lawfully administer (i.e.
diamorphine, morphine, pethidine and pentazocine)
Ambulance paramedics see section 15 above
6.2 Good Practice
Except in exceptional circumstances, the person prescribing the CD should not also
personally undertake all of the following tasks: preparation, dispensing, transportation
and administration of the CD.
A record of each administration should be kept in the relevant patient clinical notes.
This record should specify the date, time, strength, presentation and form of
administration, dose administered as well as the name and occupation of the person
administering it.
There should be policies and procedures that define safe medicine practice for the
preparation and administration of injections including CDs that comply with the
National Patient Safety Alerts: Promoting safer use of injectable medicines. Further
details can also be found in the PCT Safe and Secure Handling of Medicines Policy
and the PCT Syringe driver policy.
6.3 Naloxone
Naloxone injection, an antidote to opiate-induced respiratory depression, should be
available in all clinical locations where diamorphine and morphine injections are stored
and administered, including GPs bags; as per the National Patient Safety Agency
alerts NHS to risks with high dose morphine and diamorphine injections
6.4 Extemporaneous preparation of methadone
If a licensed product is available, methadone mixture should only be prepared
extemporaneously if the quantity of methadone dispensed on a regular basis is large
enough to preclude storage of sufficient quantities of the licensed product.
SOPs must be in place for the extemporaneous preparation of methadone

It is essential that robust standards and systems are in place to ensure the quality of
the prepared methadone so that patient care is not compromised.
Full guidance can be found at http://www.rpsgb.org/pdfs/coepsgssmeds.pdf
Page 29 of 196

7.1 Medical practitioners
PRESCRIBING OF CONTROLLED DRUGS
Page 30 of 196
Appendix 7
Doctors and dentists may prescribe all CDs in Schedules 2 to 5 for organic disease.
Doctors are only able to prescribe diamorphine, dipipanone and cocaine to substance
misusers for the treatment of addiction if they hold a licence issued by the Home Office. All
doctors may prescribe such drugs for patients, including substance misusers, for the relief
of pain due to organic disease or injury without a specific licence.
(Note: supplementary prescriber‘s working within agreed patient specific management plans
who prescribe for substance misusers for the treatment of addiction are not currently able to
apply for a licence from the Home Office: currently licences are restricted to doctors; this
may be subject to change in the future).
7.2 Non-medical prescriber‟s
7.2.1 Community practitioner nurse prescriber‟s
Community practitioner nurse prescriber‘s may only prescribe those products and
medicines specified in the Nurses Prescriber‘s‘ Formulary for community practitioners. No
CDs are included in this formulary.
7.2.2 Nurse independent prescriber‟s
Nurse independent prescriber‘s are permitted to prescribe, administer, or direct anyone to
administer certain CDs solely for specific medical conditions.
7.2.3 Pharmacist independent prescriber‟s
Pharmacist independent prescriber‘s cannot currently prescribe CDs, although community
pharmacists can advise on and sell Schedule 5 CDs from a pharmacy.
7.2.4 Supplementary prescriber‟s
Registered nurses, pharmacists and Registered midwives, chiropodist / podiatrist, physio-
therapist, radiographer and optometrist supplementary prescriber‘s may now prescribe any
CD as long as it is within the Clinical Management Plan specific to that patient and agreed
between the independent prescriber (doctor or dentist), supplementary prescriber and the
patient.
7.2.5 Midwives
Midwives may also train as nurse independent prescriber‘s. Midwives who are not trained
as nurse independent prescriber‘s may administer CDs under Exemption Orders under
medicines regulations.
7.3 Patient Group Directions
The supply and administration of the following CDs is currently allowed under PGDs:
Diamorphine, but only for the treatment of cardiac pain by nurses working in
coronary care units or hospital accident and emergency departments.
Midazolam. (This is the only Sch 3 CD allowed under a PGD)
All drugs listed in Schedule 4 of the Regulations except:
The anabolic steroids in part 2 of that Schedule
Injectable formulations for the purpose of treating a person who is addicted to a
drug

All drugs listed in Schedule 5 of the Regulations.
The amended Regulations allow nurses, midwives, pharmacists, optometrists, chiropodists,
radiographers, orthoptists, physiotherapists, ambulance paramedics, occupational
therapists, orthotists and prosthetists to supply or administer CDs in Schedule 4 and 5.
7.4 Exemptions
Midwives, who are not trained as nurse independent prescriber‘s may administer some
specific named CDs under Exemption Orders under medicines legislation.
7.5 PRESCRIPTION REQUIREMENTS
7.5.1 Schedule 2 and 3 controlled drugs (except temazepam)
A prescription for Schedule 2 and 3 CDs (with the exception of temazepam and
preparations containing it) must:
Contain the following details, written so as to be indelible, e.g. written by hand,
typed or computer-generated:
The patient‘s full name, address and, where appropriate, age
The name and form of the drug, even if only one form exists
The strength of the preparation, where appropriate
The dose to be taken (Take as directed or as required are not acceptable)
The total quantity of the preparation, or the number of dose units, to be
supplied in both words and figure
Be signed by the prescriber with their usual signature (this must be handwritten)
and dated by them (the date does not have to be handwritten)
The address of the prescriber must be stated on the prescription and must be within
the UK. (NB: the UK does NOT include the Channel Islands or the Isle of Man)
Dentists: prescriptions issued by a dentist must contain the words ‗for dental
treatment only‘.
7.5.2 Temazepam and Schedule 4 and 5 controlled drugs
Prescriptions for temazepam and for Schedule 4 and 5 CDs are exempt from the specific
prescription requirements, however, they must still comply with the general prescription
requirements.
7.5.3 Quantity supplied on prescription
The quantity of drug prescribed on each prescription should be appropriate for the clinical
need of the patient. Careful consideration should be given to the quantities prescribed, both
to anticipate requirements, e.g. over a weekend, and to reduce the amount of excess CDs
stored in the patient‘s home.
Although not a legal requirement, there is a strong recommendation that prescriptions for
Schedule 1, 2, 3 and 4 CDs are limited to a quantity necessary for up to 30 days clinical
need.
7.5.4 Prescribing more than 30 days supply
In exceptional circumstances where the prescriber believes a supply of more than 30 days
medication is clinically indicated and would not pose an unacceptable threat to patient
safety the prescriber:
Should make a note of the reasons for this in the patient‘s notes
Be ready to justify his / her decision if required
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7.5.5 Repeat prescribing
Current legislation does not allow Schedule 2 and 3 CDs to be prescribed as repeat
prescriptions (i.e. to be part of the repeat prescribing system within a practice, or part of a
repeat dispensing system).
7.5.6 NHS repeat dispensing scheme
Schedule 4 and 5 CDs may be ordered on prescriptions issued under the repeat dispensing
scheme. For Schedule 4 CDs, the first prescription must be dispensed within 28 days.
Currently Schedule 2 and 3 CDs are not permitted on prescriptions issues under repeat
dispensing schemes.
7.5.7 Dispensing more than 30 days supply
It is not illegal for a pharmacist to dispense a prescription for more than 30 days
supply, but they must satisfy themselves as to the clinical appropriateness of the
prescription before doing so
A pharmacist does not need to contact the prescriber each time they receive a prescription
requesting a supply in excess of 30 days of a Schedule 2-4CD. There may be
circumstances where there is a genuine need to prescribe more than 30 days supply and
pharmacists should exercise their professional judgement and assess both the prescription
and the situation to check the suitability for the patient. Where there is concern that the
prescription is not appropriate the prescriber should be contacted.
7.5.8 Good practice (general)
All prescriptions for Schedule 2 and 3 CDs should include the patients NHS number where
possible so that the usage of CDs by individual patients can be audited.
The professional registration number and the profession of the person who signs the
prescription should be added to the CD prescriptions they write, to assist with any future
audit. The prescriber‘s full name, address, telephone number and the PCT in which they are
working should also be included on the prescription. This information is generally preprinted
on the prescription.
Dosages and frequencies for all CDs should normally be presented in full by the prescriber,
to aid administration by nurses and carers. (i.e. Take one tablet up to four times a day when
required for pain relief). Particular care should be taken to ensure clarity of dosage
instructions where systems such as syringe drivers are being used.
Any space on the prescription form that has not been written on must be blanked off,
e.g. by drawing a line through it to reduce the opportunity for fraud.
CDs have the potential to be diverted to the illicit market. For this reason, when a patient
presents a CD prescription for an acute condition, more than two/three weeks after the
prescription was issued, it would be prudent to check with the patient and/or prescriber that
the supply of the CD is still warranted before dispensing the item.
Computer systems should be used, wherever feasible, as an additional method to record
and audit the prescribing of CDs. If a prescriber makes a domiciliary visit, and a CD is
administered or a handwritten prescription for a CD is issued, it is good practice to make a
note of this on the patient‘s computer record as soon as possible after the event. The doctor
should also record the administration of a CD to a patient
Page 32 of 196

7.5.9 Validity of prescriptions
The validity period of NHS and private prescriptions for Schedule 1, 2, 3 and 4 CDs has
been restricted to 28 days. This means that the prescription should not be dispensed if
more than 28 days have elapsed since it was signed and dated by the prescriber, or if the
prescription has a later start date, not more than 28 days from this date.
In the case of a prescription containing a Schedule 2 or 3 CD, which directs that specified
instalments of the total amount may be supplied at stated intervals, the first instalment must
be supplied no later than 28 days after the ‗appropriate date‘.
See the following website for further details The Misuse of Drugs (Amendment No. 2)
Regulations 2006
7.5.10 Technical errors on a prescription
Pharmacists are able to supply Schedule 2 and 3 CDs except temazepam (which is exempt
from CD prescription requirements), against some prescriptions that have a minor technical
error but where the prescriber‘s intention is clear.
The only errors that pharmacists may amend are:
Minor typographical errors or spelling mistakes
Where the total quantity of the preparation of the CD or the number of dosage units
as the case may be is specified in either words or figures but not both (i.e. they may
add the words or the figures to the CD prescription if they have been omitted).
As a safeguard to these changes the pharmacist must satisfy two pre-conditions before
amending the prescription and supplying the CD:
He must be satisfied on reasonable grounds, having exercised due diligence that the
prescription is genuine and that he is supplying the drug in accordance with the
intention of the prescriber
Any correction must be marked so as to be attributable to the pharmacist to ensure it
is readily identifiable, for the purpose of the audit.
Additional guidance is available at www.rpsgb.org.uk
7.5.12 Prescribing to self and family
Other than in emergencies, no prescriber should prescribe any drug for themselves
or anyone with whom they have a close personal or emotional relationship.
There may be some cases, such as in an emergency situation in which prescribing for
family, friends or self is immediately necessary to:
Save life
Avoid significant deterioration in the patients health
Alleviate uncontrollable pain
And that no other person with the legal right to prescribe is available to assess the patient‘s
clinical condition and to delay prescribing would put the patient‘s health at risk, or cause
unacceptable pain.
The British Medical Association (BMA) and the General Medical Council (GMC) advise
doctors against prescribing for themselves, family, friends and colleagues. There is a risk
that doctors who self-treat may ignore or deny serious health problems. There is also a risk
that self-prescribing could lead to drug abuse or addiction.
Page 33 of 196

The RPSGB and Nursing and Midwifery Council (NMC) also advise against self prescribing,
and prescribing for friends, family and colleagues. See NMC ‗Standards of Proficiency to
prescribe‘ www.nmc-uk.org and RPSGB ‗Code of Ethics‘ www.rpsgb.org.uk
7.5.13 Security of Prescription pads
There are regulations covering security measures to prevent users unlawfully obtaining
supplies of drugs and syringes; prescription pads; and headed notepaper from
premises.
NHS Security Management Service; Security of Prescription Forms Guidance 2008
and the PCT Guidance on security of prescriptions pads must be followed.
Do not leave blank prescription pads lying around unattended.
Blank prescription pads should never be pre-signed
Pads should always be locked away at night in case of unlawful entry
Prescriber‘s must never use blank or out of date prescription pads as spare notepads
Prescription forms for Schedule 2 & 3 CDs should not routinely be sent to the patient‘s
pharmacy via the postal system, but should be collected by a healthcare professional,
a member of their staff, the patient or their representative.
Prescriptions for the treatment of drug addiction may be sent to pharmacies when it is
not practical for the pharmacists to collect prescriptions from the premises i.e. due to
distance and it is not always desirable for the patient to be handed the prescription.
It is good practice to keep a record of controlled drug prescription forms awaiting
collection in the practice (including prescriptions for drug addiction). Also for the
person collecting the prescription to date and sign for receipt of the prescription form.
Care must be taken to ensure other prescriptions for the patient are also collected at
the same time.
Page 34 of 196

PRESCRIBING IN INSTALMENTS
Page 35 of 196
Appendix 8
Some CDs can be dispensed to substance misusers in instalments providing they are
prescribed using specific NHS prescription forms. FP10 (MDA)
A prescriber writing a private prescription can also ask for the prescription to be dispensed
in instalments.
8.1 FP10 (MDA)
The form FP10 (MDA) is used to prescribe in instalments Schedule 2 CDs, buprenorphine
(Schedule 3) or diazepam (Schedule 4) for drug addiction. This form must not be used for
any other purpose. E.g. when the total quantity needs to be dispensed at one time – in this
case the normal FP10 form must be used.
Hospital or clinical-based prescriber‘s use a variation of this form – FP10 (MDA) SS that is
overprinted with the words ‗HOSPITAL PRESCRIBER‘. The SS forms are intended to be
used for computer-generated prescriptions although they can be handwritten as well.
8.1.2 Details to be specified
If a CD prescription is to be dispensed in instalments, e.g. daily, then the prescription must
specify the following details:
1. The number of instalments
2. The intervals to be observed between instalments; if necessary, instructions for
supplies at weekends or bank holidays should be included
3. The total quantity of CD that will provide treatment for a period not exceeding
14 days.
4. The quantity to be supplied in each instalment
Points 1, 2 and 3 are required by the NHS (General Medical Services Contract) Regulations
2004. Points 2 and 4 are required under the Misuse of Drugs Regulations 2001, Regulation
15.
8.2 Collection of instalments
The prescription must be dispensed on the date on which it is due. If the client does not
collect an instalment when it is due that supply is no longer valid. The client cannot collect
that supply the following day.
If a prescriber has ordered several days‘ instalments to be collected on one day and the
client does not come in on the specified day, then he loses the complete instalment; he
cannot have the remainder of the instalment. Pharmacists should endorse the prescription
‗NOT DISPENSED‘ for that instalment and, if possible, notify the prescriber.
However, guidance from the Home Office has indicated that the use of specific wording will
enable those supplying CDs to issue the remainder of an instalment prescription when the
person has failed to collect the instalment on the specified day. The wording below can be
used if a prescription does not contain such wording the Regulations only permit the supply
to be made in accordance with the prescriber‘s instalment direction. Further guidance can
be found at:-
www.pharmj.com/Editorial/20050430/society/ethics.hmtl.
‗Supervised consumption of daily dose specified days; the remainder of supply
to take home. If an instalment prescription covers more than one day and is not
collected on the specified day, the total amount prescribed less the amount
prescribed for the days used may be supplied‘

‗Unsupervised consumption; instalment prescriptions covering more than one day
should be collected on the specified day; if this collection is missed the remainder of
the instalment (i.e. the instalment less the amount prescribed for the days missed)
may be supplied.‘
8.3 NHS forms issued to substance misusers
Issued by / in Type of form Region What is allowed
GPs
Hospital or clinic
based prescriber‘s
Nurse independent
prescriber‘s
Supplementary prescriber‘s
FP10(MDA) or
FP10(MDA) SS
FP10(MDA) SS
FP10(MDA) or
FP10(MDA) SS
FP10(MDA) SS
FP10(MDA) SP
England
England
England
England
Schedule 2 CDs, buprenorphine,
diazepam, plus single supplies of
water for injection as necessary
Schedule 2 CDs, buprenorphine,
diazepam, plus single supplies of
any other medication allowed on
FP10
Diazepam for treatment of initial
or acute withdrawal symptoms
caused by the withdrawal of
alcohol from persons habituated
to it.
Schedule 2 CDs, provided this is
agreed by a doctor in the patient‘s
Clinical Management Plan.
8.4 Good Practice
On FP10 (MDA) prescriptions, it is good practice for the duration of the instalments to be
set out on the prescription, e.g. dispense daily for five days starting on x date.
The client should collect the CD in person. If he or she is unable to collect prescriptions
personally, the client may arrange for a representative to collect it. The representative
should bring a suitable note on each occasion to ensure they have authority to collect.
The requirements to see identification on collection only apply to the first dispensing of an
instalment prescription.
8.5 Prescribing controlled drugs for addiction
Only doctors are able to prescribe diamorphine, dipipanone or cocaine to substance
misusers for treatment of addiction, but only if they hold a licence, issued by the Home
Office. Prescriber‘s can prescribe such drugs for patients, including substance misusers, for
relief of pain due to organic disease or injury, without a specific licence.
Page 36 of 196

PRIVATE PRESCRIBING
Page 37 of 196
Appendix 9
Besides reviewing the current legal framework, this document helps to establish good
practice for the management of CDs. Although this is presented in the form of guidance for
the NHS, this is equally applicable to professionals providing health care in non-NHS
settings. The law relating to prescribing applies to all NHS and non-NHS settings and good
governance is equally applicable to Non NHS organisations.
The term ‗private prescriber‘ is used to describe the situation when a private prescription is
written, either by NHS or non-NHS practitioners, in either NHS or non-NHS settings.
9.1 Legal framework
When writing private prescriptions, prescriber‘s must comply with all legal requirements,
including appropriate record keeping, when ordering, prescribing, dispensing, administering
and destroying CDs.
Registerable private doctors and independent clinics, as defined under section 2 of the
Care Standards Act 2000, are required to be registered with the Healthcare Commission, as
laid out in the Health and Social Care (Community Health and Standards) Act (2003) and
Private and Voluntary Health Care (England) Regulations 2001. *There is a need to
demonstrate safe systems of handling and prescribing CDs in meeting the National
Minimum Standards for Independent Healthcare
www.dh.gov.uk/assetRoot/04/07/83/67/04078367.pdf
Normally, private prescriptions can allow a prescriber to request that the prescription is
repeatable ** for a specified number of times. However, this is not permitted for Schedule 2
and 3 CDs. It is possible to prescribe Schedule 4 and 5 CDs on a repeat basis, both
privately and under NHS repeat dispensing arrangements.
* It is an offence under the Care Standards Act 2000 section 11 to carry on or manage a
registerable service without first being registered to do so. Failure to apply for registration
could render the practitioner liable to prosecution and could lead to the refusal of the
application to register.
** The repeat method is where a private prescription is written for a specified quantity of
drugs and the prescriber endorses the prescription with the number of times the prescription
should be repeated. The pharmacist is then able to make the specified number of
dispensing transactions from that prescription.
9.2 Standardised private prescription form
All private prescriptions for human use of Schedule 1, 2 and 3 CDs (including temazepam)
that are presented for dispensing in the community (not the hospital) must be written on a
standard prescription form which must include the private prescriber‘s unique (six digit)
identification number issued specifically for the private prescribing activity.
There are two types of forms available:
Personalised FP10 (PDC) NC – These contain the prescriber‘s details already printed.
Non personalised forms FP10 (PCD) SS – These allow private prescriber‘s to print private
CD prescriptions, including their private prescriber details, using their practice computer
systems.

Private prescriber‘s should obtain stocks of private prescription forms via their designated
PCT.
9.3 Private prescriber identification number
Prescriber‘s who issue private prescriptions for Schedule 2 and 3 CDs that will be
dispensed by community pharmacists must have a unique prescriber identification number.
Any prescriber requiring a private prescriber identification number should apply via local
PCT. A number will be then issued by the PPD of the NHS Business Services Authority. It
will be different from the prescriber‘s NHS prescriber code if they have one. A prescriber
who practices in the NHS and privately will, therefore have two identifier numbers (one NHS
and one private).
Prescriber‘s working in private practice in a hospital should inform patients that private
prescriptions not written on the standard form can only be dispensed in a hospital
pharmacy.
9.4 Submission of prescription
The original or a copy of each prescription for a Schedule 1, 2 or 3 CD should be submitted
after dispensing (community pharmacists or dispensing doctors) to the relevant National
Health Service Agency (NHS Business Services Authority for England) along with a CD
submission form (FP34PCD). Until the Miscellaneous Provisions Regulations are amended
a copy needs to be submitted.
9.5 Good practice
The National Clinical Assessment Service (NCAS) and the NHS Clinical Governance
Support Team have suggested the following good practice for private prescriber‘s:
Private prescriber‘s should produce their own guidance for use in their services with respect
to:
Treatment, prescribing and review policies
Clinical governance systems
Training and continuing professional development (CPD)
This guidance should be rooted in any relevant national good practice guidance,
Including ‗Drug misuse and dependence: guidelines on clinical management‘
published by DH.
Private prescriber‘s should, in most circumstances and with the patient‘s agreement,
contact the patient‘s private or NHS GP before initiating treatment and during the course of
treatment.
Private prescriber‘s should, in most circumstances, liaise as appropriate with other health
care professionals involved in the care of the patient. This should include the pharmacist/
dispensing doctor.
Private prescriber‘s should indicate on the prescription when prescribing for a non-UK
resident. Several of the points here are included in Regulation under the Health and Social
Care (Community Health and Standards) Act (2003), and private and Voluntary Health Care
(England) Regulations 2001.
Page 38 of 196

Page 39 of 196
Appendix 10
Prescriptions for prisoners and other agency agreements for NHS services
In England, the NHS provides prescriptions for prisoners and some other patients under
SLA‘s with other organisations. Traditionally, this has been treated for administrative
convenience in the same way as private work in order to prevent submission to and
reimbursement by the relevant NHS agency. However, the new standardised private
prescription forms should not be used for such patients as this is classed as NHS activity.

STORAGE OF CONTROLLED DRUGS
Page 40 of 196
Appendix 11
This section covers the legal and good practice issues for the storage of CDs. It does not
cover any clinical or drug stability issues, which should be addressed separately.
All Schedule 2 (except quinalbarbitone) and Schedule 3 CDs (except Buprenorphine,
Diethylpropion, Flunitrazepam and Temazepam) are subject to safe custody requirements
and must be kept in a locked receptacle, which is so constructed and maintained to prevent
unauthorised access to drugs.
In residential and healthcare settings it is recommended that the specifications of cabinets
and safes set out in Schedule 2 of the Safe Custody Regulations should be regarded as a
minimum standard for the storage of CDs.
11.1 Controlled drug cabinets/safes
Requirements and/or recommendations are that:
The receptacle should consist of a locked safe/cabinet preferably of steel, with
suitable hinges, fixed to a wall or the floor with rag bolts (these bolts should not be
accessible from outside the cabinet)
Ideally the safe/cabinet should be within a cupboard or in such a position as to avoid
easy detection by intruders.
Nothing should be displayed outside to indicate that CDs are kept within the
container.
The room containing the safe/cabinet should be lockable and tidy to avoid drugs
being misplaced.
This room should not normally be accessible to patients, nor should the keys
required for access. However, if patients do have to enter the area where CDs are
stored, it is good practice that they should be continuously supervised until such time
as they leave the area.
The walls of the room should be constructed to a suitable thickness using suitable
materials.
The locked receptacle must only be opened by the person in lawful possession of the
CDs or a person authorised by him/her.
Stock should be kept to a minimum and the cabinet should not contain anything other than
the drugs, or the drugs and register. (The register does not have to be kept locked with the
drugs).
The CD register should be stored safely outside the CD container but near to it but not
easily visible or accessible.
Items such as money should not be stored in the CD cabinet.
Tamper evident manufacturer seals must be left in tact on receipt of the CD and only
opened at time of administration/supply.
All services/practices must have SOP in place for management of CD stock held on the
premises.
One designated person within the premises should take overall responsibility for the
management of controlled drugs including keys/codes. The number of sets of keys to the
container, and who holds them, or who has access to the codes for digital key pads, must

e known at all times by the designated person. The keys should always be kept separate
from the container and should never be accessible to unauthorised persons. The container
should only be opened by the designated person, or by the person authorised by them, e.g.
a locum. The designated person remains ultimately accountable for the management of the
CDs.
Other drugs that are liable to misuse can be locked in the container if this is deemed
appropriate by the relevant health care professional.
Drugs in Schedules 4 and 5 can also be a target for substance misusers. Dispensary areas
are required to be secure enough to prevent unauthorised access, but additional
precautions, such as keeping these items out of sight of patients, may be advisable.
All CDs should be stored out of sight and reach of children
11.2 Controlled drugs in a „doctor‟s bag‟
A‘ doctor‘s bag‘ is a locked bag, box or case for home visits, etc. which should be kept
locked at all times, except when in immediate use. The person in lawful possession of this
bag, or an individual authorised by them, must always retain the keys.
Legal precedent holds that such a bag is regarded, once locked, as a suitable receptacle for
storing CDs, but a locked car is not. Bags containing CDs should not be left in a vehicle
overnight, or in a vehicle left unattended for long periods of time.
For a bag for home visits, etc. a digital combination lock on a case is often the most
practical and convenient solution and avoids problems with keys.
The stock levels held in this bag should be kept to a minimum and informed by previous
requirements.
Normally, only one strength of each CD should be kept in a bag for home visits, etc. in order
to minimise the risk of confusion, error and inappropriate administration.
Oral preparations of CDs would not routinely be considered essential items to be carried in
such a bag.
The doctor, or a delegated member of staff, should undertake a monthly stock check of CDs
held within each bag for home visits and a record made that this has been done. This
process also provides a good opportunity to check for any out-of-date (or ‗soon to expire‘)
stock. This needs to be included in an SOP.
When a bag for home visits, etc. containing CDs is in the practice, it should be stored in a
safe place away from patient areas in a locked room. This location should be determined by
carrying out a risk assessment.
A separate CD register should be kept for the CD stock held within the bag and a running
balance maintained.
Restocking of a bag for home visits, etc. from FP10CDF or practice stock should be
witnessed by another member of the practice staff, as should the appropriate entries into
the CD register.
Where a prescription is written by a doctor following administration of a CD to a patient, the
doctor should endorse the form with the words ‗administered‘ and then date it. This process
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aims to avoid unauthorised individuals attempting to reuse such prescriptions to obtain CDs
illegally
When a drug from the doctor‘s bag is administered to a patient, an entry must be made in
the CD register for that bag. Personal administration should also be recorded in the
patient‘s notes/computer record.
Each professional should also assess the risks and benefits in relation to where they store
CDs and registers in relation to each other. A balance has to be achieved between having
the CD register readily available to make an entry at the time of administration, and the
possibility of the bag and the register both being stolen, with the consequent loss of both
the CDs and the audit trail.
If CDs kept in a bag for home visits, etc. expire, they should be returned to the central
practice stock for future destruction in the presence of an authorised individual. If the
practice does not hold central stock, then the CDs need to be destroyed directly from the
bag, witnessed by an authorised individual and appropriate records made in the CD
register.
A small number of GPs continue to provide their own personal service in the out-of-hours
period, and would therefore use their own bag in the same way as they do during normal
hours. However, the majority of GPs delegate responsibility to an organised provider of outof-hours
services e.g. a GP Co-operative or a deputising service.
In terms of good practice when managing CDs out-of-hours, reference should be made to
the following DH guidance ‗Securing proper access to medicines in the out-of-hours period‘
www.out-of-hours.info/downloads/short_medicines_guidance.pdf and the accompanying
practical guide:
www.out-of-hours.info/downloads/medicines_supply_guidance_a_practical_guide.pdf.
Page 42 of 196

DISPENSING OF CONTROLLED DRUGS
Page 43 of 196
Appendix 12
12.1. General
In this context, the term ‗dispense‘ means to assemble and to supply a medicine
(please note ‗dispense‘ is not defined in legislation).
A second person should check the quantity/volume and strength of a CD being
dispensed, although this may not be practiced in all situations.
All CDs should normally be dispensed in child-resistant containers, or with childresistant
closures.
As with all dispensed medicinal products (except unlicensed medicines), it is a legal
requirement to provide a manufacturer‘s patient information leaflet.
Details of supplies of Schedule 2 CDs must be entered into the CD register as soon as
possible and at the latest the next day following the day of supply.
The date entered in the CD register should be the date of supply (i.e. the date on
which the CD is handed to the patient/carer/representative) and not the date when it is
assembled.
The pharmacist/dispensing doctor must endorse prescriptions for Schedule 2 and 3
CDs with the date of supply to the patient.
Advice to patients, their representatives or carers should include safe and secure
storage at home, especially out of sight and reach of children, and safe disposal by
returning any unused CDs to a pharmacy.
If a prescription for a CD is handed in for dispensing, but is not due to be collected until
a future date or time, the prescription can be assembled in advance. However, details
should not be entered in the CD register until after the CD has been supplied to the
patient/carer/representative.
Patients, or other people collecting Schedule 2 and 3 drugs on their behalf, should sign
for them. This applies to both NHS and private prescriptions; there is space on the
back of the form for this purpose. See below for details on proof of identity for
Schedule 2 CDs.
12.2 Dispensing against instalment prescriptions FP10 (MDA)
For instalment prescriptions of Schedule 2 CDs, each supply must be entered, on the
day of supply, into the relevant section of the CD register. This task must not be left
until the end of the prescription period or carried out in advance.
Instalments must only be supplied on the day that they are due, as specified on the
prescription.
Medical Services Contract) Regulations 2004 specify only a sufficient quantity of
drugs as will provide treatment for not more than 14 days can be prescribed on NHS
instalment prescriptions.

Prescriptions are valid for 28 days. The 28 day period starts on the applicable date
entered on the prescription form. This date will be the date of signing or a start date
specified by the prescriber on the form. The first instalment must be dispensed within
the 28-day limit, with the remainder instalments dispensed in accordance with
instructions.
Where appropriate, shared care arrangements for the prescribing and dispensing of
CDs for substance misusers, should be developed
If an instalment prescription for a CD is presented, then it should be stamped with the
pharmacy/dispensing practice address at the time of the first dispensing. This is to
prevent the possibility of future misdirection of the prescription.
In practice, methadone prescriptions are often made up in advance, to ensure
substance misusers can be dealt with in a proactive and timely manner when they
present for their medicine. The pre-assembled methadone must be stored in a cabinet
which meets the legal requirements, or be under the direct personal supervision of the
pharmacist/doctor.
If the patient does not collect the instalment, it can be returned to stock, provided it is
labelled appropriately as stock, e.g. with batch number and expiry date. Where CDs
are assembled in advance for instalment dispensing and not collected, the patient
medication record should be amended and the prescription annotated to reflect the fact
that the supply was not collected.
Guidance on instalments prescribing and pharmacy closures can be found at
www.rpsgb.org.uk/pdfs/LEBapprovwordinginstalprescs.pdf
Pharmacists dispensing CDs to substance misusers should liaise with the prescriber
regarding collection/non-collection of the CDs by these clients
Patients receiving methadone, diazepam and buprenorphine may require supervision
of consumption by a pharmacist. This should ideally be carried out in a quiet area of
the pharmacy. This area should not normally be the dispensary, or involve taking the
patient through the dispensary.
Particular care should be exercised when a third party collects a CD for a patient being
treated for addiction. RPSGB guidance states that third party collection of CDs for addicts
should only occur in exceptional circumstances. A letter of authority from the patient should
be obtained on every occasion that the representative collects the prescription and this
letter should be retained in the pharmacy. If a patient regularly sends a third party to collect
a supply, it may be necessary for the pharmacist to notify either the clinic where the
substance misuser is being treated, or the prescriber.
12.3 „Owing‟ prescriptions for controlled drugs
If the pharmacist/dispensing doctor are unable to supply the total quantity of the drug
requested, the entry made in the CD register must only be for the quantity of the drug
actually supplied. A further entry must be made when the balance is supplied. If the patient
no longer requires the balance of the prescription, the prescription should be endorsed with
the amount dispensed. It is good practice to record the reason why the remainder was not
dispensed, e.g. the patient has died.
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Dispensed items or Owings for Schedule 2, 3 or 4 CDs cannot be supplied more than 28
days after the appropriate date on the prescription.
Where the prescriber has written on the prescription that it must be supplied on a specific
date, as in the case for instalment prescriptions, those instructions must be complied with.
Where a prescription requires a specific quantity of CDs to be dispensed on a specific date,
the dispenser may not dispense a part of this quantity and then rest at a later date, as this
would deviate from the prescriber‘s instructions. The stock initially held in the dispensary,
plus the balance remaining, can be dispensed to the patient, as long as it is done during the
same calendar day.
12.4 Emergency supplies to patients
Under no circumstances may an emergency supply of a schedule 2 or 3 CD be made to a
patient. The only exception to this rule is phenobarbital for the treatment of epilepsy. An
emergency supply of Schedule 4 or 5 CDs may be made as long as the other conditions for
the supply of a POM medicine are satisfied, taking into consideration the abuse potential of
these drugs.
12.5 Dispensing doctors
It is lawful for a dispensing doctor to delegate the act of dispensing medicines for their
patients to employed staff.
Practice and partners carry vicarious liability for errors made, or for the breach of the law. A
dispenser or other dispensing doctor employee would not normally be expected to dispense
a Schedule 2 or 3 CD without first checking the dispensed items with a doctor. The
Dispensing Doctor‘s Association‘s Guidelines for dispensing doctors state that ‗the doctor
should check all prescriptions for CDs‘.
Updated guidance on managing the use of CDs is available from the Dispensing Doctor‘s
Association www.dispensingdoctor.org/.
12.6 Proof of Identity; Prescriptions for Schedule 2 controlled drugs
Patients or their representatives may require evidence of identity when collecting Schedule
2 CDs.
Persons asked to supply Schedule 2 CDs on prescription must seek to establish whether
the person collecting the drug is the patient, the patient‘s representative or a health care
professional acting in his professional capacity on behalf of the patient.
Where the person is the patient or the patient‘s representative, e.g. a friend, neighbour, etc.,
the dispenser
May request evidence of that person‘s identity, and
May refuse to supply the drug if he is not satisfied as to the identity of that person
Where the person collecting the prescription is a health care professional acting in his
professional capacity on behalf of the patient, the dispenser:
Must obtain the person‘s name and address
Must, unless he is acquainted with that person, request evidence of that person‘s
identity; but
May supply the drug even if he is not satisfied as to the identity of that person.
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Any strengthening of controls has been balanced with ensuring that patients have access to
medicines they need and have been prescribed for them. The new requirement placed on
the dispenser therefore allows them:
Discretion not to ask patients or patient representatives for proof of identity if for
example they have concerns that to do so may compromise patient confidentiality or
deter patients from having their medicine dispensed.
It is a requirement to record the following information in the CD register for Schedule 2 CDs
supplied on prescription:
Whether the person who collected the drug was the patient, the patient‘s
representative or a health care professional acting on behalf of the patient.
If the person who collected the drug was a health care professional acting on behalf
of the patient, that person‘s name and address.
If the person collected the drug was the patient or their representative, whether
evidence of identity was requested (as a matter of good practice a note as to why the
dispenser did not ask may be included but this is not mandatory).
And whether evidence of identity was provided by the person collecting the drug.
RPSGB have issued professional guidance ‗Changes in the management of CDs affecting
pharmacists (England, Scotland and Wales)‘ for their members on what forms of
identification may be considered suitable and advice on circumstances where discretion
should be exercised. This guidance is available from the following website:
www.rpsgb.org.uk/pdfs/cdmanagechguid.pdf
It is good practice to record information to support the proof of identity requirements
outlined.
As a matter of good practice, the form of identification for health care professionals should
be their professional registration number.
Page 46 of 196

RECORDING OF CONTROLLED DRUGS
Page 47 of 196
Appendix 13
This section applies to all CD registers, whether held by a doctor, a pharmacist or other
health care professional (personally or as part of the activities of an organisation).
Records for Schedule 2 CDs must be kept in a CD register. This is not a legal requirement
for Schedule 3, 4 or 5 CDs.
All health care professionals who hold personal CD stock must keep their own CD register,
and they are personally responsible for keeping this accurate and up-to-date.
13.1 Controlled Drug Registers
Currently the register must:
Be bound (not loose-leaved) or a computerised system which is in accordance with best
practice guidance
Contain class sections for each individual drug
Have the name of the drug specified at the top of each page
Have the entries in chronological order and made on the day of the transaction or
the next day
Have the entries made in ink or otherwise so as to be indelible or in a computerised
form in which every such entry is attributable and capable of being audited and is in
accordance with the best practice guidance endorsed by the Secretary of State
under Section 2 of the NHS Act 1977.
Not have cancellations, obliterations or alterations: corrections must be made by a
signed and dated entry in the margin or at the bottom of the page.
Be kept at the premises to which it relates and be available for inspection at any
time. A separate register must be kept for each set of premises (for example, not just
the main surgery)
Be kept for a minimum of two years after the date of the last entry, once completed
Not be used for any other purpose
13.2 Computerised controlled drug registers
If the CD register is held in computerised form it must be attributable and capable of being
audited the following should be put in place:
Safeguards should be incorporated in the software to ensure the author of each entry
is identifiable
Entries cannot be altered at a later date
A log of all data entered is kept and can be recalled for audit purposes
Full details see www.opsi.gov.uk/si/si2005/20052864.htm
13.4 Record keeping requirements
For CDs received into stock the following details must be recorded in the CD register:
The date on which the CD was received
The name and address of the supplier, e.g. wholesaler, pharmacy
The quantity received
The name, form and strength of the CD
For CDs supplied to patients (via prescriptions), or to practitioners (via requisitions),
or personally administered the following details must be recorded in the CD register
The date on which the supply/ administration was made

The name and address of the patient or practitioner receiving the CD
Particulars of the authority of person who prescribed or ordered or administered the
CD
The quantity supplied/administered
The name, form and strength in which the CD was supplied/administered
The 2001 Regulations were amended in July 2006 to make clear that the record keeping
requirements of the CD Regulations are a minimum and do not prevent any person required
to keep a CD register from including additional related information.
It is good practice to record the batch number and expiry date of the CD, time of
administration and maintain a running balance.
13.5 Prescriber and dispenser details
CD registers are allowed but not required to include:
The prescriber identification number (six digit private prescriber code or the NHS
prescriber code) and or professional registration number of the prescriber where
known
The name and professional registration number of the pharmacist or dispensing
doctor
As the dispensing of a prescription can involve several pharmacists, it should be the
pharmacist who makes the supply of CDs to a patient or his/her representative whose name
and professional number are entered in the CD register.
13.6 Maintaining a running balance of stock
Pharmacists and other health care professionals who supply CDs should maintain a running
balance of stock in their CD registers as a matter of good practice. The aim of maintaining
running balances in CD registers is to ensure irregularities are identified as quickly as
possible.
The running balance of drug remaining should be calculated and recorded after each
transaction and balances should be checked with the physical amount of stock at regular
intervals. Guidance on this can be found on the RPSGB website
www.rpsgb.org.uk/pdfs/cdrunningbalanceguid.pdf
Accountability for maintaining the running balance of CD stock and dealing with any
discrepancies lies with the health care professional in charge and not with the person to
whom they may delegate day-to-day responsibility under defined SOPs.
13.7 Physical reconciliation with stock levels
The running balance recorded in the CD register should be checked with the physical
amounts of stock at regular intervals, at least once a month is recommended for infrequent
users (i.e. GP practices) or weekly where there is a high usage or turnover of staff (i.e.
OOH)
Wherever possible, two members of staff should check all stock received or removed, and
both individuals should initial the entry in the CD registers, or a record made that the stock
balance has been checked.
It is good practice for a health care professional/registered manager or registered provider,
when first taking over accountability for premises that hold CD stock, and where they will be
in regular attendance, to ensure the CD stock levels are correct. This primarily applies to:-
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GP practices holding CD stock in the surgery
Pharmacies
Dispensing doctor practices
Care homes, community hospitals and hospices
Independent health care establishments, hospitals and community hospitals without
a pharmacy.
Where changeover of responsibility occurs very frequently, e.g. when multiple locums are
required within community pharmacies, out-of-hours providers or GP practices, it would be
impractical to carry out stock checks at every changeover. SOPs for the reconciliation of
physical stock with balances should define how often this task takes place; as a minimum it
should take place weekly. If usage of CDs is high, e.g. in drug and alcohol units, palliative
care establishments, etc., then stock checks should be carried out more frequently and by
different, suitably trained members of staff. The day-to-day responsibility for this task can be
delegated under SOPs, to another appropriate, suitably trained, member of staff who is
routinely present at the premises.
The accountability for maintaining the correct balance of CD stock lies with the professional
in charge and not with the person to whom they may delegate the day-today responsibility.
13.8 Preservation of records
Registers, requisitions and orders for CDs must be preserved for two years. It is
recommended that records are preserved for longer as this may be required as evidence if
an untoward incident occurs and investigations may take longer than 2 years
13.9 Dealing with discrepancies
SOPs should clearly define the action to be taken if a discrepancy arises. Once resolved,
a note should be made in the CD register correcting the discrepancy in the balance. It is
also advisable to keep appropriate records of the action taken when discrepancies arise.
If the source of the discrepancy cannot be identified during the stock check, then a
nominated member of the relevant organisation should be informed and a formal internal
investigation undertaken. This process may include discussion with the relevant
professional body, or other inspectors. If this still does not resolve the issue satisfactorily
then the police should be informed. The Accountable Officer should be informed of any
concerns in relation to the management and use of CDs.
Page 49 of 196

TRANSPORTATION OF CONTROLLED DRUGS
Page 50 of 196
Appendix 14
All health care professionals in legal possession of a CD have a professional duty of care to
take all reasonable steps to maintain safe custody of that CD at all times.
Nurses, midwives, doctors, pharmacists, pharmacy staff and other health care
professionals, plus formal carers and patients‘ representatives, are legally allowed to
transport CDs to a patient, provided the CDs have been prescribed, by an appropriate
prescriber, for the patient.
Any nominated individual is also allowed to return CDs from the patient to the pharmacy, or
the practice for destruction.
The person authorised to possess may grant permission, and it should be in writing.
Community pharmacies and GP practices must not accept waste medicines, including CDs,
from care homes providing nursing care.
Health care professionals involved in the delivery of patient care should not routinely
transport a patient‘s own CDs to and from the patient‘s home. Where this is essential, part
of an organised service, or where pharmacies operate collection and delivery schemes to
the household and other needy patients, it is good practice to keep the CDs out of view
during transit.
CDs should not generally be transported via mail, taxi services or equivalent. However, in
exceptional circumstances, where urgent clinical need dictates, dispensed CDs can be sent
to a patient, or stock CDs to premises, via such routes. Where the mail route is used, the
CD should always be sent as a special delivery item to ensure the pathway is auditable.
If transport of CDs or CD prescriptions via mail, taxi services or equivalent has to be used
an SOP should be developed which reflects a risk management assessment.

ADMINISTRATION OF CONTROLLED DRUGS
Page 51 of 196
Appendix 15
A record of administration should be made in the patient‘s records which detail dose, form
and route, site of injection, expiry date, time of administration and if records require this the
batch number and expiry date.
If the patient has nursing records for administration of medicines, (i.e. palliative care,
residential care homes and hospices) these should be completed by the person
administering the medicine, (this also applies to the patient, carer, visiting doctor etc) so a
full record is made to avoid accidental overdose.
Also, if the patients nursing records have a running balance of the patients own controlled
drugs this should be maintained by all visiting healthcare professionals.

NURSES WORKING IN THE COMMUNITY
Page 52 of 196
Appendix 16
16.1 Transportation
Nurses should not routinely transport CDs. This should only be undertaken in
circumstances where there is no other reasonable mechanism available. CDs should be
kept out of sight during transportation.
16.2 Administration
Nurse may administer CDs to a patient in their care, as long as they are acting in
accordance with the directions of a doctor or dentist or in accordance with an approved
Patient Group Direction.
Nurse independent prescriber‘s, or nurses acting under the directions of a nurse
independent prescriber, can administer the CDs listed in the table in Appendix O but solely
for the medical conditions specified.
Midwives may administer diamorphine, morphine, pentazocine and pethidine to their
patients, acting on their own professional judgement.
Any CD that is administered by a nurse must be recorded in the nurse‘s and patient‘s notes,
stating the medicine and dose administered, the date of administration, the method of
administration and the person who administered it.
For CDs stored in a patient‘s home, the nurse should keep a running balance. Any
discrepancy must be investigated and reported to the nurse manager, the Head of
Medicines Management and an incident form completed.
16.3 Administration on a verbal instruction
The NMC has published ‗Guidelines for the administration of medicines‘, which includes
guidance on CDs, and is available at:
www.nmc-uk.org/aFrameDisplay.aspx?DocumentID=610
16.4 Disposal of controlled drugs
Prescribed drugs including CDs are the property of the patient and remain so even after
death. However, it is illegal to possess CDs that have not been prescribed for you. In the
first instance the patient/patient‘s relatives should be advised that all CDs no longer
required should be returned to a pharmacy for safe destruction.
It should not normally be the responsibility of the community nurses to become involved in
the disposal of unwanted CDs. However, there may be occasions when it is appropriate for
nursing staff to become involved in recovery/disposal of CDs.
A possible staged approach would be:
If return by relatives/next of kin is not practical or possible then the following action
could be taken
Nurse with another member of the nursing team acting as a witness disposes of CD
in an appropriate and safe manner. This should be within an agreed local SOP and
should include appropriate record keeping in patient‘s notes. See Appendix P and Q
for details on safe disposal of controlled drugs.
Or
Nurse could take CDs to local community pharmacy who would be asked to
countersign patient nursing record.
Appendix 17

PALLIATIVE CARE
17.1 Good Practice
It is good practice to only prescribe quantities of CDs that are needed by the patient for
effective symptom control. This can include CDs for regular dosage, plus a quick-acting CD
at an appropriate dose for breakthrough pain. The good practice principles for managing
CDs described earlier in these guidelines apply equally to the palliative care situation.
Where prescriber‘s are prescribing high doses CDs for palliative care, it is recommended
that the specialist palliative care team are contacted for advice and support, wherever
feasible. Any actions resulting from such a contact should be recorded in the patient‘s
notes.
If a prescriber is prescribing high doses of CDs for a patient, particularly where prolonged
use is expected, then it is recommended that this is reported to the Medicines Management
team at the PCT to aid the interpretation of routine ePACT data.
Palliative care patients may obtain CD prescriptions from more than one source, e.g. GPs,
hospices, hospitals, out-of-hours services and specialist palliative care teams. In such
circumstances, one professional in the locality, could take on a co-ordinating role to avoid
over-supply and to help maintain patient and public safety.
Additional sources of information:
Cancer Care Alliance www.cancernorth.nhs.uk or www.cancercarealliance.nhs.uk
Liverpool Care Pathway www.lep-mariecurie.org.uk
NHS End of Life Programme www.endoflifecare.nhs.uk
National Council for Palliative Care www.ncpc.org.uk
PCT Syringe Driver Policy http://intranet/PCTServices/2041.htm
17.2 Out-of-hours palliative care
There are sometimes problems encountered with the availability of medicines for palliative
care patients in the community during the out-of-hours period. To maintain effective
symptom control in patients choosing to be treated at home, or in other care environments,
it is important that health care professionals ensure sufficient quantities of appropriate
palliative care drugs, including CDs, are available to anticipate deterioration in the patient‘s
condition. The potential needs of deteriorating conditions need to be balanced with the
safety risk of increased quantities of CDs left in the domiciliary/care setting.
For specific recommendations about the manner in which a patient-centred, high quality
palliative care service can be provided out-of-hours, please refer to ‗Securing proper access
to medicines in the out-of-hours period‘
www.out-of-hours.info/downloads/short_medicines_guidance.pdf
and the accompanying practical guide
www.out-of-hours.info/downloads/medicines_supply_guidance_a_practical_guide.pdf.
And the
PCT Syringe Driver Policy – http://intranet/PCTServices/2041.htm
Page 53 of 196

SELF-MEDICATION
Page 54 of 196
Appendix 18
If patients are self-medicating, whether in a hospice or hospital, their CDs should be kept in
a locked metal receptacle immediately adjacent to their bed, or in their bedside locker. The
receptacle should not be readily portable. In order to prevent unauthorised access, each
receptacle should have an individual key, with a master key kept by the person in charge
(on duty).
Where a patient is being treated in their own home, professional advice and supporting
information should be provided in a timely way, by the most appropriate professional, to
ensure safety and efficacy is maintained.

PATIENTS TRAVELLING OVERSEAS
Page 55 of 196
Appendix 19
Travellers carrying prescribed drugs controlled under Schedules 1, 2, 3 and 4 Part I to The
Misuse of Drugs Regulations 2001 may require a personal licence.
Persons travelling for over three months either abroad or to the United Kingdom
will need to have a personal licence.
If a person is staying outside their resident country for a period exceeding 3 months
they are advised to register with a doctor in the country they are visiting for the
purpose of receiving further prescriptions.
Persons travelling for three months or fewer will not need a personal export/import
licence.
Applications should be made at least 10 days prior to travel.
Licences are normally issued with an expiry date of one week after the expected return to
the UK.
A personal licence has no legal standing outside the UK and is intended to allow travellers
to pass through the UK customs unhindered.
Other countries may have their own import regulations for controlled drugs.
Travellers should check this with the UK-based representative(s) of the
country/countries to which they are travelling.
Further details and Personal licence application forms can be downloaded from Personal
licences | Home Office - Tackling Drugs Changing Lives
It is good practice for CDs to be carried in original packaging in hand luggage with a letter
from the prescribing doctor confirming the carriers name, destination, drug details and
amount.

DESTRUCTION OF CONTROLLED DRUGS
20.1 Stock controlled drugs (including doctor‟s bags)
Stock refers to CDs that have not been issued/dispensed to a patient.
Page 56 of 196
Appendix 20
When Schedule 2 CDs plus temazepam, flunitrazepam, buprenorphine and diethylpropion
pass their expiry date, they should be stored in the CD cabinet/safe or doctors bag (if no
central stock held in practice) until destruction. They should be segregated and clearly
marked as ‗date-expired‘ stock to prevent them being issued in error to patients.
20.1.1 Authorised witnesses
Destruction of obsolete, expired and unwanted Schedule 2 CD stock must be witnessed by
an authorised person.
The following classes of people are currently authorised by the Secretary of State for Health
and the Home Secretary to witness the destruction of CDs: -
Chief dental officer of the DH or a senior dental officer to whom authority has been
delegated
Supervisors of midwives appointed by the Local Supervising Authority
Senior officers in an NHS Trust who report directly to the Trust Chief Executive and
who have responsibility for health and safety, security or risk management matters in
the Trust
Chief Executives of NHS Trusts
A PCT chief pharmacist or pharmaceutical/prescribing adviser who reports directly to
the chief executive or to a director of the PCT
A registered medical practitioner who has been appointed to the PCT Professional
Executive Committee or equivalent
The PCT board executive member with responsibility for clinical governance or risk
management
Medical director of a PCT
Inspectors of the RPSGB
Police constables
Holders of specific roles within the independent health care sector, for example,
registered managers of independent hospitals.
Public limited companies operating retail pharmacies nominated persons for their
own stock of CDs
Persons in charge or acting person in charge of private hospitals providing palliative
care or hospices wholly or mainly maintained by a public authority out of public funds
or by a charity or by voluntary subscription.
Persons or class of persons authorised by the Accountable Officer
For County Durham and Darlington PCTs Authorised persons see Appendix Q.
Stock CDs from GP practices, dentists, vets, midwives, community hospitals, Out of
Hours/Urgent Care centres or nursing homes should not be sent to a pharmacy for
destruction. Practices should contact an authorised witness.
An authorised person cannot witness the destruction of CDs that have been supplied to
them or by them – there must be an appropriate separation of roles and responsibilities.

Anyone directly involved with a GP practice, or who is authorised to supply CDs from the
GP practice, e.g. a PCT clinical governance lead working in their own practice, or practice
based pharmacists, must not be asked to witness the destruction of CDs in that GP
practice, even if they are included within the authorised groups.
Home Office Drugs Licensing is responsible for the processing of applications for
authorisation to witness the destruction of CDs under Regulation 27(1) of the Misuse of
Drugs Regulations 2001. These authorisations cover the holders of specified jobs and
locations within the private sector, e.g. regional managers of major retail pharmacy chains.
For further information, contact the Home Office Drugs Licensing on 0207 035 0483 or
email Licensing enquiry. aadu@homeoffice.gsi.gov.uk.
Accountable Officers should not be designated as authorised people to witness destruction
as one of the criteria for Accountable Officers is their independence from day-to-day
management of CDs.
20.1.2 Recording
When a CD is destroyed, details of the drug must be entered into the CD register. This
should include: the name of the drug; form; strength and quantity; the date it was destroyed;
and the signature of the authorised person who witnessed the destruction and the
professional destroying it (i.e. two signatures)
20.2 „Patient-returned‟ controlled drugs
‗Patient-returned‘ CDs are those that have been prescribed for, and dispensed to, a named
patient and then returned unused or part-used for destruction.
Controlled Drugs (Supervision of Management and Use) Regulations 2006 require SOPs to
be in place for maintaining a record of Schedule 2 drugs that have been returned by the
patients.
It is good practice for pharmacists and doctors to keep a separate book to record all CDs
returned by patients. Although it is not a legal requirement to witness destruction of ‗patientreturned‘
CDs by an authorised witness, good practice would recommend that they are
witnessed by another member of staff and the signature of both the person witnessing and
the person destroying should be entered in a separate book set aside for this purpose
Medicines returned from patient stocks should NOT be re-issued or used to treat other
patients.
For pharmacists, the RPSGB Code of Ethics prevents pharmacists reusing patient returns.
A breach of this requirement could form the basis of disciplinary action.
Community pharmacies can accept CDs returned by patients from their own homes and
from care homes (personal care) for safe destruction and onward disposal even if they did
not originally dispense them.
Pharmacists are not able to accept waste medicines, including CDs, from care homes
(nursing), unless the pharmacy holds a waste management licence. It should be noted
that the definition of ―care services‖ may exclude certain NHS premises.
Under the Waste Management Regulations, a pharmacy does not require a Waste
Management Licence to store its own unwanted expired stock, pending disposal. There is
also an exemption in the Waste Management Licence Regulations for the secure storage at
a pharmacy, pending disposal, of waste medicines, which have been returned to the
Page 57 of 196

pharmacy from households or by individuals. This includes waste medicines from a
patient‘s own home or a care home providing residential care, but NOT from a care home
providing nursing care (this is classed as industrial waste).
20.3 Methods of destruction
CDs can be placed into waste containers only after the CD has been rendered irretrievable
(i.e. by denaturing). See Appendix P and Q.
The RPSGB issues guidance on the methods of destruction/denaturing that meet the
requirements of the Misuse of Drugs Regulations 2001 and the health and safety needs of
people undertaking the role.
20.4 Environment Agency Regulations and permissions on waste
The destruction and disposal of CDs are also subject to Waste Management Licensing
Regulations 1994. Having considered the risks posed by destruction of CDs in a pharmacy,
the Environment Agency (EA). Which covers England and Wales, has decided that it does
not believe it is in the public interest to expect pharmacies to obtain a waste management
licence for denaturing CDs and this is seen by the EA as a ‗low risk‘ activity. The EA
emphasises, however, that it may amend or revoke its position at any time and will continue
enforcement in all circumstances where activity has or is likely to cause pollution or harm to
health.
For further information on Waste Management Regulation visit the following website:
www.environmentagency.gov.uk.
Guidance on The Hazardous Waste Regulations 2005 can be found on the RPSGB
website:
www.rpsgb.org/pdfs/hazwastehospphguid.pdf. Since the guidance was published, the EA
has agreed that pharmacists may de-blister and otherwise treat waste CDs in a pharmacy
without the need to obtain a licence. Further information on this may be found on the EA
website: www.environment-agency.gov.uk
Page 58 of 196

STANDARD OPERATING PROCEDURES
Page 59 of 196
Appendix 21
Standards for Better Health Core Standard 4d requires each service and practice to have
clear practice policy covering issues relating to the prescribing, ordering, receipt, storage,
monitoring and disposal of controlled drugs. This policy should ensure that there is a full
audit trail for the movement of controlled drugs in primary care form acquisition to
administration and disposal.
Standard operating procedures must be developed which describes the responsibilities and
procedures to provide clarity and consistency for all staff handling controlled drugs within
agreed working practices and current legislation.
Each service should have a designated person responsible for the management of
controlled drugs on the premises.
Each Nursing team should have procedures in place to ensure the safe handling of
controlled drugs in the domiciliary and educational setting.
Baseline information which should be contained in an SOP can be found in Appendix T.

Page 60 of 196
Appendix 22
PATIENT INFORMATION
NHS Direct
The NHS direct website has developed a Common Health Question about CDs specifically
to inform the public and is available from What is a controlled drug (medicine)? - Health
Questions - NHS Direct
Medicines Guides for patients
Medicines guides provide a source of information for members of the public who are looking
for information about individual medicines. Guides for CDs that have been published can be
found at Medicine Guides - Welcome

Appendix A – List of Controlled Drugs and their Schedules
This list is not exhaustive: it covers the most common drugs encountered in general
practice. Practice computer system may be able to help for specific examples not listed
below. Brand names are not listed except where no generic name exists, or is not
commonly used.
Schedule 1 CDs are drugs with virtually no medical uses, such as cannabis and
hallucinogens. Possession and supply of these drugs is limited to persons granted a special
licence by the Home Office except for Sativex spray. It is not a requirement for a prescribing
doctor or dispensing pharmacist to contact the Home Office in relation to obtaining a licence
to prescribe or supply Sativex spray. The Home Office has also lifted the record-keeping
requirements and, therefore, pharmacists do not need to record Sativex in their CD
registers.
Controlled drug
Schedule
Controlled drug
Schedule
Amobarbital (Sodium
Amytal
3 Fentanyl 2
Anabolic Steroids 4 (part 2) Flunitrazepam 3
Benzodiazepines
Hydromorphone 2
(Except temazepam,
midazolam,
flunitrazepam)
4 (part 1)
Buprenorphine 3 Kaolin & Morphine
Mixture & tablets
5
Chlordiazepoxide 4 (part 1) Meprobamate 3
Cocaine 2 Methadone 2
Co-codamol 5 Midazolam 3
Codeine
2
Morphine * 2
Oral codeine max
strength

Appendix B Summary of Legal Requirements of the Possession and Supply of CDs
Prescription requirements
Handwriting requirements
Requisitions necessary
Records to be kept in CD register
Emergency supplies allowed
Safe Custody
Date of supply to marked on
prescription
Address of prescriber to be within
the UK
Stock destruction to be witnessed
Validity of prescription
Invoices to be kept for 2 years
Import / export licence required
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
28 days
No
Yes
Schedule 2: CD
Secobarbital
Yes
No
Yes
Yes
No
No
Yes
Yes
Yes
28 days
No
Yes
Yes
No
Yes
No
No
No
Yes
Yes
No
28 days
Yes
Yes
Phenobarbital
Yes
No
Yes
No
Yes
No
Yes
Yes
No
28 days
Yes
Yes
Schedule 3: CD No Reg
Temazepam
No
No
Yes
No
No
Yes
Yes
Yes
No
28 days
Yes
Yes
Diethylpropion
Flunitrazepam
(Rohypnol)
Yes
No
Yes
No
No
Yes
Yes
Yes
No
28 days
Yes
Yes
Buprenorphine
(Subutex)
Yes
No
Yes
No
No
Yes
Yes
Yes
No
28 days
Yes
Yes
Schedule 4:
CD Benz and
CD Anab
No
No
No
No
Yes
No
No
No
No
28 days
Yes
Yes
Schedule 5:
CD Inv
No
No
No
No
Yes
No
No
No
No
6 months
Yes
Yes

Appendix C
Relevant Contact Details Re: Controlled Drugs
Contact Title Email Telephone
Dr. Hilton Accountable hilton.dixon@nhs.net
0191 3011300
Dixon Officer for
County Durham
and Darlington
PCTs
Kate
Huddart
Vicki
Vardy
Alison
Hopkins
Paul
Errington
Senior
Pharmaceutical
Adviser for
County Durham
and Darlington
PCTs
Controlled Drug
Accountable
Officer Support
and Data
Manager for
County Durham
and Darlington
PCTs
RPSGB
Professional
Standards
Inspector
Controlled Drug
and Chemical
Liaison Officer
Kate.huddart@nhs.net 01388 825687
Vicki.vardy@nhs.net 01388 825680
Alison.hopkins@rpsgb.org
020 75722557
Paul.errington@durham.pnn.police.uk 0191 3752626

Appendix D
Information Sharing Code in respect of the operation of the County Durham and
Darlington Local Intelligence Network for controlled drugs governance
Disclaimer
The contents should not be used as expert opinion, legal or otherwise.
Professional advice should be sought where appropriate. Any liability arising
from action taken in relation to the contents of the Protocol is excluded.
Version 3 November 2009
Page 64 of 196

Information Sharing Code in respect of the operation of the County Durham and
Darlington Local Intelligence Network for controlled drugs governance
Contents
Section 1 – Background and scope of the Code
Section 2 – Purposes for sharing information
Section 3 – Information to be shared
Section 4 – Arrangements for sharing information
Section 5 – Access and security
Section 6 – Dissemination, monitoring and review
Section 7 – Advice and guidance
Appendices
Appendix 1 – Data Protection and Caldicott principles
Appendix 2 –County Durham and Darlington Local Intelligence Network
Appendix 3 – Specialist advice and guidance
Page 65 of 196

Section 1
Background and scope of the Code
1.1 Background
Legislation, guidance and Government policy all emphasise the importance of
confidentiality and the protection of personal information. Strong emphasis is also
placed on the need to share information in order to provide effective, integrated
services.
The Heath Act 2006 includes a legal duty of collaboration for local agencies to share
information, within certain constraints, about the use of controlled drugs in the health
and social care sectors. The active duty of collaboration should be manifested through
the operation of a Local Intelligence Network (LIN) through which information can be
shared, analysed and acted upon.
Within the Department of Health Safer Management of controlled drugs: (1) guidance
on strengthened governance arrangements published in January 2007 it states:-
Care should also be taken with sharing information about identifiable health and social
care professional and where possible, they should be made aware of concerns raised
about them. Intelligence networks may wish to agree a code on information-sharing
and nominate a person to be responsible for ensuring the code is followed.
This Information Sharing Code (ISC) has been drawn up by the LIN to assist the
appropriate sharing of information, some of which may be personal information, about
the use of controlled drugs.
The code is intended to reinforce current working practices, give guidance to staff and
be a training resource for new members of staff. It defines the information which will be
transferred between the organisations listed and arrangements for assisting
compliance with relevant legislation and guidance including the Data Protection Act,
1998.
1.2 Framework for confidentiality and information sharing
Four key documents provide the main national framework for information sharing:
Data Protection Act 1998 – This Act provides the main legislative framework for
confidentiality and information sharing issues. The Act stipulates eight principles
(see Appendix 1) that must be followed when personal information is ―processed‖
by organisations. (“Processing” refers to any work done with personal information
including obtaining, recording, viewing, listing, disclosing and destroying.) The Act
stipulates the conditions under which information may be shared i.e. the legal
justifications.
Human Rights Act 1998 – This Act incorporates Article 8 of the European
Convention of Human Rights which provides that everyone has the right to respect
for their private and family life, home and correspondence.
Caldicott Guidance – The Caldicott Committee produced their report on the
―Review of Patient Identifiable Information‖ in December 1997. Caldicott guidance
applies to all NHS organisations and local authority Social Services Departments.
Guidance is based on six key principles (see Appendix 1). Organisations are
required to appoint Caldicott Guardians to oversee the confidentiality / information
sharing process.
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The NHS Confidentiality Code of Practice – The Code of Practice was issued in
July 2003 and applies to all NHS organisations. It is a guide to required practice on
confidentiality, security and disclosure of personal information.
The health and social care agencies in County Durham and Darlington have developed
this Information Sharing Agreement to formalise good practice guidelines for sharing
information with regard to controlled drugs.
1.3 Members of LIN that will work within the code
� County Durham Primary Care Trust
� Darlington Primary Care Trust
� County Durham and Darlington Foundation Trust
� Tees, Esk and Wear Valley NHS Trust
� Woodlands Hospital, Darlington
� St Cuthbert‘s Hospice
� St Theresa‘s Hospice
� Willowburn Hospice
� The Inspectorate of the Royal Pharmaceutical Society of Great Britain (RPSGB)
� Care Quality Commission
� Durham Constabulary
� County Durham Social Services.
� Darlington Social Services
� North East NHS (Strategic Health Authority)
� North East Ambulance Service (NEAS)
� NHS Counter Fraud and Security Management
� Durham DAAT
� Darlington DAAT
� Prison Cluster representation
As the Local Intelligence Network matures it may be necessary to include any other
responsible body (as defined within the CD regulations) located in County Durham and
Darlington with a legal obligation to appoint an Accountable Officer and associated
duty to collaborate on issues relating to controlled drugs.
1.4 Approval of the Code
The local intelligence network member‘s representative of the list in Para 1.3 will be
asked to approve the final draft of the code at a LIN meeting, in particular to:
Facilitate the sharing of information on the basis detailed in the code;
Support staff and new members of the local intelligence network in the
implementation of the code through the provision of training, advice and guidance;
Provide relevant information to facilitate monitoring and review.
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Section 2
Purposes for sharing information
The purpose of this code is to provide a framework for the sharing of data,
information and knowledge relating to the use, handling, prescribing or
management of controlled drugs (CD) in order to achieve the following:
Section 3
Review or analysis of trends in CD use
Interpretation of CD data in relation to local influences
Identification of persons or groups of people who are managing, using,
prescribing or handling CDs inappropriately or illegally
Identifying “best practice” in the management of CDs (with the exception
of best clinical practice)
Identifying poor systems of control for the management of CDs
Raising concerns relating to any of the above.
Information to be shared
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 state
that there is an active duty to share any information that
―[An organisation that is party to this agreement] may disclose to any other
[organisation that is party to this agreement] any information in its possession or
control which it reasonably considers it should share with that body for the purposes
of—
(a) identifying cases in which action may need to be taken in respect of matters arising
in relation to the management or use of controlled drugs by a relevant person;
(b) the consideration of issues relating to the taking of action in respect of such
matters;
(c) the taking of action in respect of such matters.‖
Such information may include but is not restricted to data extracted from:
Prescribing reports (e-PACT) for GPs, Dentists, Nurse prescribers and private
prescribers of CDs
Records of ordering , receipt and dispensing of CD‘s
Records of administration of CDs within hospitals and hospices
Records of the destruction of CDs in any setting
e-PACT reports generated that detail the dispensing of controlled drugs by
pharmacies
Records of the supply of ward CD stationary
Records of supply of FP10PCD prescriptions to private prescribers
Records of supply of CDs from wholesalers
Records of issues to wards and departments from the JAC system or similar
stock management system in hospitals
Routine stock checks of CDs held in wards and departments in hospitals and
hospices
Records of Drug Testing and Treatment Orders
Records of arrests for drug related crime
Information discerned from any of the above that will provide:
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Patterns or trends in the prescribing, ordering, receipt, dispensing,
administration or destruction of controlled drugs on an individual practitioner,
collection of practitioners or population basis.
Details of anomalies within the prescribing, ordering, receipt, dispensing,
administration or destruction of controlled drugs on an individual practitioner,
collection of practitioners or population basis.
Details of CDs, the whereabouts of which cannot be ascertained.
Identification of areas or activities for which record keeping is not adequate
Patterns or trends in activities relating to the enforcement of controlled drugs
legislation.
Information or knowledge regarding causes for concern relating to CD use or
management, actual or suspected, derived from:
A complaint or the analysis of complaints
An incident report or the analysis of incident reports
The conduction or results of an investigation into an incident or complaint
―Whistle-blowing‖ or other report of a concern relating to professional conduct or
performance.
Confiscation of controlled drugs that have been possessed illegally.
The report or investigation of an alleged or actual criminal act relating to
controlled drugs
A report resulting from an inspection carried out by the RPSGB, CSCI, HCC or
PCT.
Communications from NHS Counter Fraud & Security Management Services
(NHS CF&SMS).
Where a concern has been raised information may be shared that includes any of the
above in addition to or contained within the following:
―Occurrence Reports‖ (as defined in the 2006 regulations)
Reports of a concern where evidence or information has been collated.
The agenda, minutes and reports of a LIN incident panel.
Letters of referral to regulatory, indemnifying or representative bodies.
Referrals to the police or NHS CF&SMS
Minutes of meetings of the LIN
Personal information may include:
The person‘s name, and or any aliases they live under
The person‘s address(s)
The person‘s occupation
The person‘s age and date of birth.
The person‘s sex
Information about the person‘s social circumstances (which may include
references to ethnicity)
Information about the person‘s health or healthcare
Information relating to the person‘s alleged or proven, past or present criminal
offences
The person‘s movements, habits, conduct or practises.
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Section 4
Arrangements for sharing information
4.1 Provision of information
Information which is not personally identifiable information will be shared in any
of the following formats:
Face to face & telephone conversation
Post
Fax
e-mail
Where information identifies an organisation or practice (or similar collective)
information will be shared in the following ways:
Face to face & telephone conversation
Post using recorded/special delivery
Secure fax (or secure faxing method)
e-mail using a password protected file
Where information identifies an individual or could be used to identify an
individual the following methods will be used:
Face to face & telephone conversation conducted in privacy
Post using recorded delivery
Safe Haven Fax or secure faxing method
4.2 Consent from service users
4.2.1 Sharing with Consent
If an organisation wishes to disclose information under this code that contains person
identifiable information but this information is not required for the purposes of
identifying cases in which action may need to be taken, the organisation must remove
the person identifiable information. If this is not possible or the organisation considers it
necessary to disclose person identifiable information, the organisation must, where
practicable, obtain the consent of the patient to whom the information relates. In such
cases only the minimum amount of person identifiable information will be disclosed.
4.2.2 Other Justifications for Sharing
Where it is not appropriate to use consent as the basis for sharing information, the
following justifications may be applicable:
Information shared for medical purposes between health professionals
Information can be shared if it is for medical purposes and is shared between
health professionals. The terms ―medical purposes‖ and ―health professionals‖
are defined in the Data Protection Act.
Serious harm
It may be justified to share information where there is evidence that serious
harm would be caused to the service user, (or another person) if this was not
Page 70 of 196

done. This may arise for example in relation to child, adult or public protection
issues.
Vital interests
Information may be shared where this is in the ―vital interests‖ of the service
user or another person. This refers to life or death circumstances.
Prevention or detection of crime
Personal information may be provided to the Police where this is necessary for
the prevention or detection of crime. This is a power not an obligation. A
judgement needs to be made in each case as to whether it is appropriate to
release information taking into account the following criteria. Advice should be
sought if there is uncertainty about interpreting these criteria. Information should
only be disclosed where:
- without disclosure the task of preventing or detecting crime would be
prejudiced;
- information shared is limited to what is strictly relevant to a specific
investigation;
- there are satisfactory undertakings that the information will not be used for
any other purpose than the specific investigation.
It may also be appropriate to disclose information under Section 29 of the Data
Protection Act in response to investigations by the NHS Counter Fraud and
Security Management Service (CF&SMS). Service Users should not be
informed about information disclosed unless the appropriate officer of the
CF&SMS concurs.
Court Order
Information must be shared where the service is instructed to do so by a Court
(including a Coroner‘s Court.)
Wherever possible and appropriate service users should be informed if their
information is to be shared without consent.
4.2.3 Confidentiality
The right to confidentiality is extended to all persons including clinicians, unless an
organisation considers that disclosure is necessary for:
(a) identifying cases in which action may need to be taken in respect of matters arising
in relation to the management or use of controlled drugs by a relevant person;
(b) the consideration of issues relating to the taking of action in respect of such
matters;
(c) the taking of action in respect of such matters
The sharing of information relating to the management of controlled drugs is facilitated
by the operation of the Local Intelligence Network. The framework under which the LIN
operates is provided in Appendix 2
Page 71 of 196

Section 5
Access and security
5.1 Need to know
All the members of the LIN may be privy to information as detailed in section 3.
Sharing of the information detailed in section 3 that has been made available to the
LIN within a recipient organisation will be restricted to those persons who need the
information to carry out their duties in relation to the investigation of a concern. In such
circumstances the organization will be bound by its own information governance or
confidentiality policy as well as the Data Protection Act 1998.
5.2 Secure storage and transfer of personal information
Steps should be taken by all members of LIN to ensure that personal information is
held and transmitted securely. Organisations should ensure that their staff have
access to their policies on Confidentiality and Information Security and NHS staff have
access to the NHS Confidentiality Code of Practice. (See Appendix 3 for details).
Guidance on security issues is given in the Procedures Section B of the Information
Sharing Protocol.
5.3 Retention of records
Files relating to an individual‘s controlled drugs management will remain active for the
duration of time practitioners continue to practice within the County Durham and
Darlington LIN area. The files will be archived once practitioners cease to practice in
the County Durham and Darlington LIN area and retained for a period of 25 years to
provide evidence if required in any future litigation which may be brought.
Each organisation that is party to this agreement has responsibility for retaining
information that relates to practitioners within their scope of responsibility.
Files of information that arise from an investigation of a LIN incident panel will be
retained by the PCT Accountable Officer or his/her deputy until such time as the
concern is resolved. Once resolution is achieved the files will be transferred to the
most appropriate organisation to be kept with the practitioner‘s individual file.
CD files relating to individual practitioners may be passed on to other Accountable
Officers at their request should a practitioner move from the area covered by the LIN
into another LIN area.
The Accountable Officer of each organisation or for organisations without an
Accountable Officer the LIN member will act as the data controller for shared data
originating in their respective organisation.
Section 6
Dissemination, monitoring and review of the Code
LIN Members will make copies of the code and the protocol available to all
relevant staff and on request to service users. Partners will ensure that
appropriate training is provided to all relevant staff.
LIN Members should ensure they are familiar with the requirements of The
Controlled Drugs (Supervision of Management and Use) Regulations 2006 and
with their internal policies relating to the implementation of these regulations.
Page 72 of 196

Section 7
LIN Members should investigate any breaches of the code and ensure that
problems are addressed as promptly as possible within their partner
organisations.
The code will be reviewed every twelve months. Changes to the code will not be
considered during this period unless they are required urgently.
As part of the review process all LIN members will be asked about use of the
code, any proposals they may have for addressing specific problems and any
amendments they feel are necessary.
Advice and guidance
Sources of advice about confidentiality and information sharing issues are included in
Appendix 3 of the agreement.
Details of relevant additional guidance are given in Appendix 3.
Page 73 of 196

Appendix 1 of Information sharing Code - Key principles
The eight principles of the Data Protection Act:
1.Fair and lawful: Personal data shall be processed fairly and lawfully and, in
particular, shall not be processed unless certain conditions are met, also the
processing must adhere to the fair processing code.
2. Use for specified purposes: Personal data shall be obtained only for one or more
specified purposes, and shall not be further processed in any manner incompatible
with that purpose or purposes.
3. Adequate, relevant and not excessive: Personal data shall be adequate, relevant
and not excessive in relation to the purpose.
4. Accurate and up to date: Personal data shall be accurate and, where necessary,
kept up to date.
5. Don‟t keep longer than necessary: Personal data processed for any purpose or
purposes shall not be kept longer than is necessary for that purpose or those
purposes.
6. Rights given under the act: Personal data shall be processed in accordance with
the rights of the data subject under this act‖.
7. Security: Appropriate and organisational measures shall be taken against
unauthorised or unlawful processing of personal data and against accidental loss or
destruction of, or damage to, personal data.
8. Disclosure outside Europe: Personal data shall not be transferred to a country
outside the European Economic area, without adequate protection.
The six Caldicott Principles:
1. Define Purposes: Every proposed use or transfer of patient-identifiable information
within or from an organisation should be clearly defined and scrutinised, with
continuing uses regularly reviewed, by an appropriate guardian.
2. Use anonymised information if possible: Patient-identifiable information items
should not be included unless it is essential for the specified purpose. The need for
patients to be identified should be considered at each stage of satisfying the purpose.
3. Use the minimum information necessary: The minimum amount of identifiable
information should be transferred or made accessible that is necessary for a given
function to be carried out.
4. Access to personal information on a need to know basis: Only those individuals
who need access to patient-identifiable information should have access to it, and they
should only have access to the information items that
they need to see. This may mean introducing access controls or splitting information
flows where one information flow is used for several purposes.
5. Staff must be aware of their responsibilities: Action should be taken to ensure
that those handling patient-identifiable information – both clinical and non-clinical staff
– are made fully aware of their responsibilities and obligations to respect patient
confidentiality.
6. Use only when lawful: Every use of patient-identifiable information must be lawful.
Page 74 of 196

Appendix 2 of Information Sharing Code
Framework for a Controlled Drugs Local Intelligence
Network.
Introduction
The Heath Act 2006 includes a legal duty of collaboration for local agencies to share
information, within certain constraints, about the use of controlled drugs in the health
and social care sectors. The duty of collaboration should be manifested through the
operation of a local intelligence network through which information can be shared,
analysed and acted upon.
Remit
The remit of the group is twofold:
1. To comply with the duty of collaboration as defined by the Health Act 2006 (and
related regulations) with regard to identifying and resolving issues of
a. poor management of controlled drugs
b. poor clinical/professional handling or use of controlled drugs.
2. To act as a forum for the dissemination of best practice in the 2006 (and related
regulations) with regard to identifying and resolving management of controlled
drugs.
Area of operation
The local intelligence network covers the people living or working in the geographical
area of County Durham and Darlington
Membership of the network
The Accountable Officers of healthcare organisations within the defined boundaries. (A
named and fully informed deputy of the accountable officer may be nominated in place
of the organisations Accountable Officer)
Named representatives from the organisations below:
� Care Quality Commission (CQC)
� The inspectorate of the Royal Pharmaceutical Society of Great Britain (RPSGB)
� The Healthcare Commission
� The Police
� Local Authority provided Social Services Department
� North East NHS (Strategic Health Authority)
A non-executive director who will offer lay representation.
In addition the network should include input from the following where such expertise is
not already found in the group:
� Chief pharmacists
� Medical directors
� Nursing directors,
� Social care providers and
� Clinical governance leads of the healthcare organisations
� Representatives of local wholesale dealers
The network will be chaired by the PCT Accountable Officer who will have the
additional responsibility of liaising with representatives of neighbouring local
intelligence networks.
Page 75 of 196

It remains the duty of each organisation to ensure full clinical engagement in the
management of controlled drugs within its area of responsibility.
Meeting Arrangements
Regular communication will be necessary to share information of non-specific trends
(for example an increase or decrease in the number of patients receiving palliative
care) and to advise the network of any issues relating the quality or effectiveness of
the information that is available for monitoring purposes. This will predominantly be
done using teleconferencing or e-mail.
Initially the members of the network will meet formally four times a year.
On occasions where concerns are raised ad-hoc meetings are to be called, by the
responsible Accountable Officer, that includes only those members of the network on
whom the concern will impact. It will remain the duty of the responsible accountable
officer to escalate the concern to the full network if they consider this to be necessary
and co-ordinate the necessary meetings.
Contact Management
For use when causes of concern require rapid sharing of information to safeguard the
public, the network maintains a list of emergency contacts for each organisation which
can be used when the member of the group (or the relevant accountable officer) is not
contactable (e.g. during annual leave). Wherever possible an out-of-hours contact will
also be maintained.
The PCT Accountable Officer is responsible for maintaining this list and testing its
operation.
Information sharing
An information sharing agreement will be developed and subsequently adopted by
each responsible organisation that will enable collaboration as outlined below.
Each organisation should decide what information is shared routinely and the
frequency in which this information is produced or updated based upon the validity and
reliability of the data.
Only information that is useful to partner organisations should be shared. Such
information may be useful by means of providing context to the interpretation of other
data, complimenting other data, direct addition to other data or increasing the pool of
collective knowledge.
Data may include:
� Complaints
� Incident reports
� Whistle blowing
� Reports from visits or inspections
� Self declarations from CD holders
And where there is good validity and reliability:
� Concerns raised during performance review
� Analysis of prescribing trends
� Analysis of dispensing trends
And in the future
� Wholesaler/supply chain reports
� Records of administration
Page 76 of 196

Other information or knowledge may include:
� Interpretation of data
� Changes to clinical practice
� Police activity
� Reasonable suspicion, conjecture, speculation and predictions.
The network recognises that in the course of implementing better management of
controlled drugs areas of practice which do not comply with the letter of the law will be
uncovered. Where an undertaking is made by the professional concerned to remedy
the problems and such problems are considered not to be due to an unsafe disregard
for the law or to malicious intent, such discrepancies do not automatically require
raising as a concern to the network.
The body of data to be routinely collated will be developed over time as systems are
devised that allow the production of a consistent data set. A centralised secure
repository of information will be established once a technological solution can be
found. It will remain the responsibility of the producing organisation to securely store
and archive the information it produces.
During the course of responding to a concern each organisation will make available
data or information in an open and timely manner on the request of a member of the
network.
In the process for raising a concern to the local intelligence network each organisation
continues to be responsible for monitoring use of controlled drugs by its staff, patients
and clients. The tools that the organisations use should be operated in such a manner
that the threshold that any anomaly has to cross before an enquiry is made is very low.
This low threshold will trigger enquiries that in the most part will be explained by the
normal variation in practice. Any anomalies that are not sufficiently accounted for, or
leave room for doubt will be highlighted to the local intelligence network. When an
anomaly is first highlighted to the local intelligence network it should be anonymous
unless the cause for concern is proven and serious. Anonymous reports will be
compared for patterns or similarities and only if a pattern or similarity is observed will
identifying details be exchanged.
Confidentiality rules should be maintained at all times and this is the responsibility of
the organisational lead. When sharing this becomes essential to take an investigation
further then all other parties are bound by the same rules.
Where concerns have been dealt with without the need to involve the whole network
the responsible accountable officer should circulate a report of the concern and its
subsequent resolution to inform the whole network.
Administrative Support
The PCT hosts administrative support that:
� Co-ordinates the meetings and activities of the network,
� Acts as a librarian for shared data and information and
� Collates and analyses data and information in response to a concern being
raised and elevated to include the whole network.
All other administrative support remains the responsibility of the organisations within
the network.
Page 77 of 196

Appendix 3
Additional guidance and key contacts
Guidance
The Controlled Drugs (Supervision of Management and Use) Regulations 2006:
www.opsi.gov.uk/si/si2006/20063148.htm
The Data Protection Act 1998 can be accessed via the Information
Commissioner‘s website at www.informationcommissioner.gov.uk
The NHS Confidentiality Code of Practice is available at
www.dh.gov.uk/ipu/confiden
Caldicott requirements are available at www.dh.gov.uk
Specialist advice: contact details
In relation to controlled drugs governance and management:
Kate Huddart
Senior Pharmaceutical Adviser
Medicines Management (Commissioning)
County Durham and Darlington Primary Care Trusts
Merrington House
Merrington Lane Industrial Estate
Spennymoor
County Durham
DL16 7UT
Tel: 01388 82 5687
Email: kate.huddart@nhs.net
In relation to information sharing and the Data Protection Act
Kevin Garrigan
Information Governance Manager
Tel: 0191 301 3820
Email: kevin.garrigan@nhs.net
Page 78 of 196

Appendix E
Controlled Drugs Practice Declaration & Self Assessment audit for
GP Practices 2009/2010
Please complete the form below:
Name of organisation/Practice
Address of organisation/Practice
Telephone Number
Name of person completing form (Please
print name)
PPA Practice Code i.e. A12345
Please indicate which applies to you: (please tick box)
GP Nurse Practice Manager Other
Please complete the relevant parts of the questionnaire below. This questionnaire relates to activities,
since October 2008 and relates to schedule 2 and 3 Controlled Drugs (CDs) including Midazolam &
Temazepam, as they are subject to a higher level of control.
Area of activity Yes/No If answer is YES
Question 1 Does the practice write/print
prescriptions for CDs?
Question 2 Does the practice supply or
dispense CDs?
Question 3 (i) a. Are CDs stocked either on the
premises or off site? E.g. in
doctor‘s bag/Emergency box.
(ii)
Question 4 Do you destroy or dispose of CDs
(patient returns/stock) in the
practice?
Page 79 of 196
Please complete
TABLE A and
SECTION 1
Please complete
TABLE A and
SECTION 2
Please complete
TABLE A and
SECTION 3
Please complete
TABLE A and
SECTION 4

Controlled Drugs Practice Declaration Statement for GP Practices 2009/2010
In ALL cases please delete as applicable and sign the declaration below:
a) I declare to the best of my knowledge and belief that the organisation/practice does not handle,
use or manage Schedule 2 or 3 CDs on any premises from which I provide clinical services.
OR
b) I declare that to the best of my knowledge and belief that I do/do not comply (please delete as
appropriate) with the provisions of the Misuse of Drugs Act 1971 and the associated Regulations in its
handling, use, prescribing and management of schedule 2 and 3 CDs.
Signature*
Name and registration number
Date of Signing
* This form must be signed by appropriately authorised personnel, who have responsibility for the management
and use of CDs within the organisation/Practice.
Please note that you must notify us of any material changes to the answers to questions 1 to 4 within 14
days of change.
Please return your completed Controlled Drug Declaration to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone number; 01388 285680
Vicki.vardy@nhs.net
Page 80 of 196

TABLE A: General Information; Please complete in ALL cases
Does the practice have written standard
operating procedures or written policies
covering the handling and management
of CDs, appropriate to the activities
carried out at the premises?
Does the practice have in place a local
procedure for dealing with a significant
event* involving CDs?
Does the practice have appropriate
procedures for the initial and continuing
training or development of all staff
involved in the prescribing, handling,
supply and administration of CDs?
Are there any specific restrictions (iii) that
have been applied that would affect the
handling/prescribing/supply/administration
of CDs by any of the healthcare
professionals involved with your practice?
Yes/No Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 81 of 196

Section one:
Prescribing of CDs
Have there been any patient or carer
complaints* involving the prescribing of
CDs by your practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about unusual,
excessive or inappropriate prescribing of
CDs by your practice?
Have there been any significant events (iv) **
involving the prescribing of CDs within
your practice?
Yes/No or
N/A
Details
* This includes complaints about failing to prescribe appropriate doses and/or appropriate medicines
** Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 82 of 196

Section Two:
Supply/Dispensing of CDs
Does the practice supply/dispense CDs
as part of substance misuse treatment?
If so, are the drugs checked against the
prescription by a GP when
supplying/dispensing?
Does the practice supply/dispense CDs
against private prescriptions:
a) For or from substance misuse
services?
b) Elsewhere?
Does the practice supply CDs against (v) a
signed order:
a) To doctors?
b) To others (not including patients)?
From where does your practice obtain (vi)
stocks of CDs?
Does your practice provide advice (vii) to
patients on the safekeeping and disposal
of unwanted CDs within your practice?
Are patient returned medicines ever (viii) reused
in the practice?
Are patient information leaflets supplied (ix)
to all patients supplied/dispensed CDs by
the practice?
Have there been any patient or carer
complaints involving the
supply/dispensing of CDs in your
practice?
(x)
Have there been any concerns expressed (xi)
by colleagues, police, drugs misuse
service or others about CDs
supply/dispensed from the organisation
/practice?
Have there been any significant events* (xii)
involving the supply/dispensing of CDs
from your practice?
Yes/No or
N/A
Details
Page 83 of 196

Section Three:
3.1) Security and safe custody of CDs on premises
Does the practice store CDs in:
a) A central store? (e.g. A single
cupboard that holds all CD stocks for the
practice)
b) Doctors bags?
c) Other places (please details)?
Are all CDs (including patient returned
CDs or unwanted/obsolete CDs) are kept
locked in a cupboard that complies with
BS2881 (a metal cupboard with an
internal locking system)?
Is access to CDs controlled within (xiii) your
practice?
e.g. Keys held only by appropriate staff
If yes, then who?
Do you utilise the CD storage facilities (xiv)
for storage of anything other than CDs?
If so, please state
How often does date checking of (xv) CD
stock take place in your practice?
Give details of date checking procedures
How often does date checking of (xvi) CD
stock in Doctors bags take place?
(where applicable)
Please give details of date checking
procedures
Are all stock CDs kept in the original (xvii)
manufacturers pack within the practice?
Yes/No or
N/A
Details
Page 84 of 196

If a dispensing practice,are dispensed
patients medicines appropriately labelled
in the practice?
Are different strengths of the same
medicine segregated in any way?
Do you have out of date or obsolete
stock CDs currently stored in the
practice?
Are out of date/obsolete/patient returned (xviii)
CDs segregated from other in date CDs
in the practice?
If Yes, where?
Are patient returned medicines (xix) ever
reused in the practice?
Yes/No or
N/A
Details
3.2) Security and Safe custody of CDs in transport
Do you transport or are you responsible
for the transport of CDs (this includes
sending CDs using third party carriers
such as delivery drivers and postal
system) to other sites?
If NO, please move on to section 3.3
What procedure do you have in place for
the transport of CDs in the practice?
Are CDs routinely kept under lock and
key during transport?
If No, then please provide details.
What records are maintained of CDs in
transport?
Yes/No or
N/A
Details
Page 85 of 196

3.3) Security and Safe custody of CD registers
Yes/No or Details
N/A
Do you keep an up to date CD register in
the practice?
Do you keep running balances of stock
CDs held?
If yes:
a) Do you audit your running totals?
(state how often and date of last
audit)
b) Are the running totals audited by
an independent 3 rd party (i.e. PCT
staff)? (state how often and date of
last audit)
Have you identified any discrepancies
between running totals and actual CD
balances, since October 2008 in the
practice?
If yes:
a) What was the explanation for the
discrepancy?
b) What action was taken?
Do you maintain records of all receipts
and supplies of CDs within your practice?
If yes, for how long do you keep records?
Have there been any patient or carer
complaints involving the storage,
transport or record keeping of CDs in the
practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the storage,
transport or record keeping of CDs in the
practice?
Have there been any significant events*
involving the storage, transport or
recording keeping of CDs?
Page 86 of 196

Section Four:
Destruction and Disposal of CDs
Patients Returned CDs
What records do you keep of CDs
returned to you by patients for disposal
within the practice? (Where applicable)
Do you routinely destroy patients old or
obsolete CDs in the practice?
What arrangements do you have in place
to dispose of patients old or obsolete CDs
in the practice?
Is the destruction of patients old or
obsolete CDs witnessed in the practice?
If yes, by whom?
Do you keep records of the destruction of
patients old or obsolete CDs in the
practice?
Stock CDs (if applicable)
How often do you aim to destroy out of
date or obsolete stock CDs in the
practice?
Do you have any out of date or obsolete
stock CDs currently awaiting destruction?
Who usually witnesses your stock CDs
destruction?
When was the last witnessed CD stock
destroyed?
Are records of stock destruction kept in
the CD register within the practice?
Yes/No or
N/A
Details
Page 87 of 196

Have there been any patient or carer
complaints involving the destruction or
disposal of CDs in the practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the destruction
or disposal of CDs in the practice?
Have there been any significant events*
involving the destruction or disposal of
CDs in the practice?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Please return your completed self assessment audit to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 88 of 196

Appendix F
Controlled Drugs Personal Declaration & Self Assessment audit for
individual GPs 2009/2010
Please complete the form below:
Name of Clinician
Address of main workplace
Telephone Number
Name (Please print name)
GMC Number
Please indicate which applies to you: (please tick box)
Partner GP Salaried GP Locum GP Other
Please complete the relevant parts of the questionnaire below. This questionnaire relates to activities
since October 2008 and relates to schedule 2 and 3 Controlled Drugs (CDs) including Midazolam &
Temazepam, as they are subject to a higher level of control.
Question 1
Question 2
Question 3
Area of activity Yes/No If the answer is YES
Do you prescribe CDs? Please complete TABLE A
and SECTION 1
Do you supply CDs? Please complete TABLE A
and SECTION 2
Do you administer CDs (or
supervise or assist patients own
administration)?
Question 4 (xx) a. Do you keep a stock of CDs?
(xxi) e.g. In doctor‘s bag.
(xxii) b. Do you keep patients CDs?
Question 5 Do you destroy or dispose of CDs
(patient returns/stock)?
Please complete TABLE A
and SECTION 3
Please complete TABLE A
and SECTION 4
Please complete TABLE A
and SECTION 5
Page 89 of 196

Controlled Drugs Personal Declaration Statement for individual GPs
2009/2010
In ALL cases please delete as applicable and sign the declaration below:
c) I declare to the best of my knowledge and belief that I do not handle, use or manage
Schedule 2 or 3 CDs.
OR
d) I declare that to the best of my knowledge and belief that I do/do not comply (please delete as
appropriate) with the provisions of the Misuse of Drugs Act 1971 and the associated Regulations in its
handling, use, prescribing and management of schedule 2 and 3 CDs.
Signature*
Name and registration number
Date of Signing
Please note that you must notify us of any material changes to the answers to questions 1 to 5 within 14
days of change.
Please return your completed declaration to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 90 of 196

TABLE A: General Information; Please complete in ALL cases
Do you have written standard operating
procedures or written policies covering
the handling and management of CDs,
appropriate to the activities carried out at
the premises?
Do you have in place a procedure for
dealing with a significant event* involving
CDs?
Do you have appropriate arrangements in
place, for ongoing personal
development/training
CDs?
with regards to
Are there any specific restrictions (xxiii) that
have been applied that would affect the
handling/prescribing/supply/administration
of CDs by yourself?
Yes/No Details
* Significant event include any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 91 of 196

Section one:
Prescribing of CDs
Have there been any patient or carer
complaints* involving the prescribing of
CDs by you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about unusual,
excessive or inappropriate prescribing of
CDs by you?
Have there been any significant events (xxiv) **
involving the prescribing of CDs by you?
Yes/No or
N/A
Details
* This includes complaints about failing to prescribe appropriate doses and/or appropriate medicines
** Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 92 of 196

Section Two:
Supply of CDs
Do you supply CDs as part of substance
misuse treatment?
If so, are the drugs checked against your
prescription by someone other than
yourself, when being supplied?
Do you supply CDs to patients against
private prescriptions written by:
c) Other doctors?
d) Yourself?
Do you supply CDs against a signed (xxv)
order:
c) Other doctors?
d) To others (not including patients)?
e) Yourself?
From where do you obtain your stocks (xxvi) of
CDs?
Do you provide advice to patients on (xxvii) the
safekeeping and disposal of unwanted
CDs?
Are patient returned medicines ever (xxviii) reused
by you?
Are patient information leaflets supplied (xxix)
to all patients receiving CDs directly from
you?
Have there been any patient or carer (xxx)
complaints involving the supply of CDs by
you?
Have there been any concerns expressed (xxxi)
by colleagues, police, drugs misuse
service or others about the supply of CDs
by you?
Have there been any significant events* (xxxii)
involving the supply of CDs by you?
Yes/No or
N/A
Details
Page 93 of 196

Section Three:
Administration of CDs (This excludes supervision of CDs consumed by addicts)
The CDs used for administration are:
a) Stock CDs?
b) Patients own CDs?
c) Both a) and b)
Do you maintain records of
administration:
If Yes, where? (Register, MAR charts etc)
Is administration of CDs witnessed?
If not, what risk management policies are
in place to cover administration?
Have there been any patient or carer (xxxiii)
complaints involving the administration of
CDs by you?
Have there been any concerns expressed (xxxiv)
by colleagues, police, drugs misuse
service or others about the administration
of CDs by you?
Have there been any significant events* (xxxv)
involving the administration of CDs by
you?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 94 of 196

Section Four:
4.1) Security and safe custody of CDs on premises
Do you store CDs in:
d) A central store (e.g. a single cupboard
that holds all CD stocks for your use)?
e) Doctors bags?
f) Other places (please details)?
Are all CDs (including patient returned
CDs or unwanted/obsolete CDs) are kept
locked in a cupboard that complies with
BS2881 (a metal cupboard with an
internal locking system)?
Is access to CDs controlled? (xxxvi)
E.g. keys held by appropriate staff?
If yes, then how?
Do you utilise the CD storage facilities (xxxvii)
for storage of anything other than CDs?
If so, please state
How often does date checking of (xxxviii) CD
stock take place?
Give details of date checking procedures
How often does date checking of (xxxix) CD
stock in Doctors bags take place?
(where applicable)
Please give details of date checking
procedures
Are all stock CDs kept in the original (xl)
manufacturers pack?
Yes/No or
N/A
Details
Page 95 of 196

Are dispensed patients medicines
appropriately labelled by you?
Are different strengths of the same
medicine segregated in any way?
Do you have out of date or obsolete
stock CDs currently stored?
Are out of date/obsolete/patient returned (xli)
CDs segregated from other in date CDs?
Are patient returned medicines (xlii) ever
reused by you?
Yes/No or
N/A
Details
4.2) Security and Safe custody of CDs in transport
Do you transport or are you responsible
for the transport of CDs (this includes
sending CDs using third party carriers
such as delivery drivers and postal
system)?
If NO, please move on to section 4.3
What procedure do you have in place for
the transport of CDs?
Are CDs routinely kept under lock and
key during transport?
If No, then please provide details.
What records are maintained of CDs in
transport?
Yes/No or
N/A
Details
Page 96 of 196

4.3) Security and Safe custody of CD registers
Yes/No or Details
N/A
Do you keep an up to date CD register by
yourself?
Do you keep running balances of stock
CDs held?
If yes:
c) Do you audit your running totals?
(state how often and date of last
audit)
d) Are the running totals audited by
an independent 3 rd party (i.e. PCT
staff)? (state how often and date of
last audit)
Have you identified any discrepancies
between running totals and actual CDs
held in the last 12 months?
If yes:
a) What was the explanation for the
discrepancy?
b) What action was taken?
Do you maintain records of all receipts
and supplies of CDs?
If yes, for how long do you keep records?
Have there been any patient or carer
complaints involving the storage,
transport or record keeping of CDs by
you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the storage,
transport or record keeping of CDs by
you?
Have there been any significant events*
involving the storage, transport or
recording keeping of CDs by you?
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 97 of 196

Section Five:
Destruction and Dispose of CDs
Patient returned CDs
What records do you keep of CDs
returned to you by patients for disposal
(where applicable)?
Do you routinely destroy patients old or
obsolete CDs?
What arrangements do you have in place
to dispose of patients old or obsolete
CDs?
Is the destruction of patients old or
obsolete CDs witnessed?
If yes, by whom?
Do you keep records of the destruction of
patients old or obsolete CDs?
Stock CDs (if applicable)
How often do you aim to destroy out of
date or obsolete stock CDs?
Do you have any out of date or obsolete
stock CDs currently awaiting destruction?
Who usually witnesses your stock CDs
destruction?
When was the last witnessed CD stock
destroyed?
Are records of stock destruction kept in
the CD register by you?
Yes/No or
N/A
Details
Page 98 of 196

Have there been any patient or carer
complaints involving the destruction or
disposal of CDs by you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the destruction
or disposal of CDs by you?
Have there been any significant events*
involving the destruction or disposal of
CDs by you?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Please return your completed CD Declaration & self assessment audit to:
Vicki Vardy
Controlled Drug Accountable support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 99 of 196

Appendix G
Controlled Drugs Practice Declaration & Self Assessment for Dental
Practices 2009/2010
Please complete the form below:
Name of organisation/Practice
Address of organisation/Practice
Telephone Number
Name of person completing form (Please
print name)
Please indicate which applies to you: (please tick box)
Dentist Nurse Practice Manager Other
Please complete the relevant parts of the questionnaire below. This questionnaire relates to activities
since October 2008 and relates to schedule 2 and 3 Controlled Drugs (CDs) including Midazolam &
Temazepam, as they are subject to a higher level of control.
Area of activity Yes/No If the answer is YES
Question 1 Does the practice write/print
prescriptions for CDs?
Question 2 Does the practice supply or
dispense CDs?
Question 3 (xliii) a. Are CDs stocked either on the
premises or off site? E.g. in
dentist‘s bag/emergency box.
(xliv)
Question 4 Do you destroy or dispose of CDs
(patient returns/stock) in the
practice?
Page 100 of 196
Please complete TABLE
A and SECTION 1
Please complete TABLE
A and SECTION 2
Please complete TABLE
A and SECTION 3
Please complete TABLE
A and SECTION 4

Controlled Drugs Practice Declaration Statement for Dental Practice 2009/2010
In ALL cases please delete as applicable and sign the declaration below:
e) I declare to the best of my knowledge and belief that the organisation/practice does not handle,
use or manage Schedule 2 or 3 CDs on any premises from which I provide clinical services.
OR
f) I declare that to the best of my knowledge and belief that I do/do not comply (please delete as
appropriate) with the provisions of the Misuse of Drugs Act 1971 and the associated Regulations in its
handling, use, prescribing and management of schedule 2 and 3 CDs.
Signature*
Name and registration number
Date of Signing
* This form must be signed by appropriately authorised personnel, who have responsibility for the management
and use of CDs within the organisation/practice.
Please note that you must notify us of any material changes to the answers to questions 1-4 within 14
days of change.
Please return your completed Controlled Drug Declaration to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone number; 01388 285680
Vicki.vardy@nhs.net
Page 101 of 196

TABLE A: General Information; Please complete in ALL cases
Does the practice have written standard
operating procedures or written policies
covering the handling and management
of CDs, appropriate to the activities
carried out at the premises?
Does the practice have in place a local
procedure for dealing with a significant
event* involving CDs?
Does the practice have appropriate
procedures for the initial and continuing
training or development of all staff
involved in the prescribing, handling,
supply and administration of CDs?
Are there any specific restrictions (xlv) that
have been applied that would affect the
handling/prescribing/supply/administration
of CDs by any of the healthcare
professionals involved in your practice?
Yes/No Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 102 of 196

Section one:
Prescribing of CDs
Have there been any patient or carer
complaints* involving the prescribing of
CDs by your practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about unusual,
excessive or inappropriate prescribing of
CDs by your practice?
Have there been any significant events (xlvi) **
involving the prescribing of CDs within
your practice?
Yes/No or
N/A
Details
* This includes complaints about failing to prescribe appropriate doses and/or appropriate medicines
** Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 103 of 196

Section Two:
Supply/Dispensing of CDs
Are drugs checked against your
prescription by someone other than
yourself, when being supplied?
Does the practice supply/dispense CDs
against private prescriptions:
e) For or from substance misuse
services?
f) Elsewhere?
Does the practice supply CDs against (xlvii) a
signed order:
f) To doctors?
g) To others (not including patients)?
From where does your practice obtain (xlviii)
stocks of CDs?
Does your practice provide advice (xlix) to
patients on the safekeeping and disposal
of unwanted CDs within your practice?
Are patient returned medicines ever (l) reused
in the practice?
Are patient information leaflets supplied (li)
to all patients supplied/dispensed CDs by
the practice?
Have there been any patient or carer
complaints involving the
supply/dispensing of CDs in your
practice?
(lii)
Have there been any concerns expressed (liii)
by colleagues, police, drugs misuse
service or others about CDs
supply/dispensed from the
organisation/practice?
Have there been any significant events* (liv)
involving the supply/dispensing of CDs
from your practice?
Yes/No or
N/A
Details
Page 104 of 196

Section Three:
3.1) Security and safe custody of CDs on premises
Does the practice store CDs in:
g) A central store?(e.g. a single
cupboard that holds all CD stocks for the
practice)
h) Dentist bags?
i) Other places (please details)?
Are all CDs (including patient returned
CDs or unwanted/obsolete CDs) are kept
locked in a cupboard that complies with
BS2881 (a metal cupboard with an
internal locking system)?
Is access to CDs controlled within (lv) your
practice?
E.g. keys held only by appropriate staff
If yes, then how?
Do you utilise the CD storage facilities (lvi)
for storage of anything other than CDs?
If so, please state
How often does date checking of (lvii) CD
stock take place in your practice?
Give details of date checking procedures
How often does date checking of (lviii) CD
stock in medical bags take place?
(where applicable)
Please give details of date checking
procedures
Are all stock CDs kept in the original (lix)
manufacturers pack within the practice?
Yes/No or
N/A
Details
Page 105 of 196

Are dispensed patients medicines
appropriately labelled in the practice?
Are different strengths of the same
medicine segregated in any way?
Do you have out of date or obsolete
stock CDs currently stored in the
practice?
Are out of date/obsolete/patient returned (lx)
CDs segregated from other in date CDs
in the practice?
Are patient returned medicines (lxi) ever
reused in the practice?
Yes/No or
N/A
Details
3.2) Security and Safe custody of CDs in transport
Do you transport or are you responsible
for the transport of CDs (this includes
sending CDs using third party carriers
such as delivery drivers and postal
system)?
If NO, please move on to section 3.3
What procedure do you have in place for
the transport of CDs in the practice?
Are CDs routinely kept under lock and
key during transport?
If No, then please provide details.
What records are maintained of CDs in
transport?
Yes/No or
N/A
Details
Page 106 of 196

3.3) Security and Safe custody of CD registers
Yes/No or Details
N/A
Do you keep an up to date CD register in
the practice?
Do you keep running balances of stock
CDs held?
If yes:
e) Do you audit your running totals?
(state how often and date of last
audit)
f) Are the running totals audited by
an independent 3 rd party (i.e. PCT
staff)? (state how often and date of
last audit)
Have you identified any discrepancies
between running totals and actual CD
balance since October 2008 in the
practice?
If yes:
a) What was the explanation for the
discrepancy?
b) What action was taken?
Do you maintain records of all receipts
and supplies of CDs within your practice?
If yes, for how long do you keep records?
Have there been any patient or carer
complaints involving the storage,
transport or record keeping of CDs in the
practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the storage,
transport or record keeping of CDs in the
practice?
Have there been any significant events*
involving the storage, transport or
recording keeping of CDs?
Page 107 of 196

Section Four:
Destruction and Dispose of CDs
Patient returned CDs
What records do you keep of CDs
returned to you by patients for disposal
within the practice? (Where applicable)
Do you routinely destroy patients old or
obsolete CDs in the practice?
What arrangements do you have in place
to dispose of patients old or obsolete CDs
in the practice?
Is the destruction of patients old or
obsolete CDs witnessed in the practice?
If yes, by whom?
Do you keep records of the destruction of
patients old or obsolete CDs in the
practice?
Stock CDs (if applicable)
How often do you aim to destroy out of
date or obsolete stock CDs in the
practice?
Do you have any out of date or obsolete
stock CDs currently awaiting destruction?
Who usually witnesses your stock CDs
destruction?
When was the last witnessed CD stock
destroyed?
Are records of stock destruction kept in
the CD register within the practice?
Yes/No or
N/A
Details
Page 108 of 196

Have there been any patient or carer
complaints involving the destruction or
disposal of CDs in the practice?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the destruction
or disposal of CDs in the practice?
Have there been any significant events*
involving the destruction or disposal of
CDs in the practice?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Please return your completed CD Declaration & self assessment audit to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 109 of 196

Appendix H
Controlled Drugs Personal Declaration & Self-Assessment Audit for
Dentists 2009/2010
Please complete the form below:
Name of Clinician
Address of main workplace
Telephone Number
Name (Please print name)
GDC Number
Please indicate which applies to you: (please tick box)
Dentist Other
Please complete the relevant parts of the questionnaire below. This questionnaire relates to activities
since October 2008 and relates to schedule 2 and 3 Controlled Drugs (CDs) including Midazolam &
Temazepam, as they are subject to a higher level of control.
Area of activity Yes/No If the answer
is YES
Question 1 Do you prescribe CDs? Please complete
TABLE A and
Question 2 Do you supply CDs?
SECTION 1
Please complete
TABLE A and
SECTION 2
Question 3 Do you administer CDs (or supervise or
Please complete
assist patients own administration)?
TABLE A and
SECTION 3
Question 4 (lxii) a. Do you keep a stock of CDs? E.g. in
Please complete
dentist‘s bag/Emergency box.
TABLE A and
(lxiii) b. Do you keep patients CDs?
SECTION 4
Question 5 Do you destroy or dispose of CDs (patient
Please complete
returns/stock)?
TABLE A and
SECTION 5
Page 110 of 196

Controlled Drugs Personal Declaration Statement for Dentist‟s
2009/2010
In ALL cases please delete as applicable and sign the declaration below:
g) I declare to the best of my knowledge and belief that I do not handle, use or manage
Schedule 2 or 3 CDs.
OR
h) I declare that to the best of my knowledge and belief that I do/do not comply (please delete as
appropriate) with the provisions of the Misuse of Drugs Act 1971 and the associated Regulations in its
handling, use, prescribing and management of schedule 2 and 3 CDs.
Signature*
Name and registration number
Date of Signing
Please note that you must notify us of any material changes to the answers to questions 1-5 within 14
days of change.
Please return your completed declaration to:
Vicki Vardy
Controlled Drug Accountable Support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 111 of 196

TABLE A: General Information; Please complete in ALL cases
Do you have written standard operating
procedures or written policies covering
the handling and management of CDs,
appropriate to the activities carried out at
the premises?
Do you have in place a procedure for
dealing with a significant event* involving
CDs?
Do you have appropriate arrangements in
place for ongoing personal
development/training with regards CDs?
Are there any specific restrictions (lxiv) that
have been applied that would affect the
handling/prescribing/supply/administration
of CDs by yourself?
Yes/No Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 112 of 196

Section one:
Prescribing of CDs
Have there been any patient or carer
complaints* involving the prescribing of
CDs by you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about unusual,
excessive or inappropriate prescribing of
CDs by you?
Have there been any significant events (lxv) **
involving the prescribing of CDs by you?
Yes/No or
N/A
Details
* This includes complaints about failing to prescribe appropriate doses and/or appropriate medicines
** Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 113 of 196

Section Two:
Supply of CDs
Are drugs checked against your
prescription by someone other than
yourself, when being supplied?
Do you supply CDs to patients against
private prescriptions written by:
g) Other dentist‘s?
h) Yourself?
Do you supply CDs against a signed (lxvi)
order:
h) Other dentist‘s?
i) To others (not including patients)?
j) Yourself
From where do you obtain your stocks (lxvii) of
CDs?
Do you provide advice to patients on (lxviii) the
safekeeping and disposal of unwanted
CDs?
Are patient returned medicines ever (lxix) reused
by you?
Are patient information leaflets supplied (lxx)
to all patients receiving CDs directly from
you?
Have there been any patient or carer (lxxi)
complaints involving the supply of CDs by
you?
Have there been any concerns expressed (lxxii)
by colleagues, police, drugs misuse
service or others about the supply of CDs
by you?
Have there been any significant events* (lxxiii)
involving the supply of CDs by you?
Yes/No or
N/A
Details
Page 114 of 196

Section Three:
Administration of CDs (This excludes supervision of CDs consumed by addicts)
Are the CDs used for administration:
d) Stock CDs?
e) Patients own CDs?
f) Both a) and b)
Do you maintain records of
administration:
If Yes, where? (Register, MAR charts etc)
Is administration of CDs witnessed?
If not, what risk management policies are
in place to cover administration?
Have there been any patient or carer (lxxiv)
complaints involving the administration of
CDs by you?
Have there been any concerns expressed (lxxv)
by colleagues, police, drugs misuse
service or others about the administration
of CDs by you?
Have there been any significant events* (lxxvi)
involving the administration of CDs by
you?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 115 of 196

Section Four:
3.1) Security and safe custody of CDs on premises
Do you store CDs in:
j) A central store?(e.g. a single
cupboard that holds all CDs)
k) Dentist‘s bags?
l) Other places (please details)?
Are all CDs (including patient returned
CDs or unwanted/obsolete CDs) are kept
locked in a cupboard that complies with
BS2881 (a metal cupboard with an
internal locking system)?
Is access to CDs controlled? (lxxvii)
E.g. Keys held only by appropriate staff
If yes, then how?
Do you utilise the CD storage facilities (lxxviii)
for storage of anything other than CDs?
If so, please state
How often does date checking of (lxxix) CD
stock take place?
Give details of date checking procedures
How often does date checking of (lxxx) CD
stock in medical bags take place?
(where applicable)
Please give details of date checking
procedures
Are all stock CDs kept in the original (lxxxi)
manufacturers pack?
Yes/No or
N/A
Details
Page 116 of 196

Are dispensed patients medicines
appropriately labelled by you?
Are different strengths of the same
medicine segregated in any way?
Do you have out of date or obsolete
stock CDs currently stored?
Are out of date/obsolete/patient returned (lxxxii)
CDs segregated from other in date CDs?
Are patient returned medicines (lxxxiii) ever
reused?
Yes/No or
N/A
Details
3.2) Security and Safe custody of CDs in transport
Do you transport or are you responsible
for the transport of CDs (this includes
sending CDs using third party carriers
such as delivery drivers and postal
system)?
If NO, please move on to section 3.3
What procedure do you have in place for
the transport of CDs?
Are CDs routinely kept under lock and
key during transport?
If No, then please provide details.
What records are maintained of CDs in
transport?
Yes/No or
N/A
Details
Page 117 of 196

3.3) Security and Safe custody of CD registers
Do you keep an up to date CD register?
Do you keep running balances of stock
CDs held?
If yes:
g) Do you audit your running totals?
(state how often and date of last
audit)
h) Are the running totals audited by
an independent 3 rd party (i.e. PCT
staff)? (state how often and date of
last audit)
Have you identified any discrepancies
between running totals and actual CD
balances since October 2008?
If yes:
a) What was the explanation for the
discrepancy?
b) What action was taken?
Do you maintain records of all receipts
and supplies of CDs?
If yes, for how long do you keep records?
Have there been any patient or carer
complaints involving the storage,
transport or record keeping of CDs by
you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the storage,
transport or record keeping of CDs by
you?
Have there been any significant events*
involving the storage, transport or
recording keeping of CDs by you?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Page 118 of 196

Section Five:
Destruction and Dispose of CDs
Patient returned CDs
What records do you keep of CDs
returned to you by patients for disposal
(where applicable)?
Do you routinely destroy patients old or
obsolete CDs?
What arrangements do you have in place
to dispose of patients old or obsolete
CDs?
Is the destruction of patients old or
obsolete CDs witnessed?
If yes, by whom?
Do you keep records of the destruction of
patients old or obsolete CDs?
Stock CDs (if applicable)
How often do you aim to destroy out of
date or obsolete stock CDs?
Do you have any out of date or obsolete
stock CDs currently awaiting destruction?
Who usually witnesses your stock CDs
destruction?
When was the last witnessed CD stock
destroyed?
Are records of stock destruction kept in
the CD register?
Yes/No or
N/A
Details
Page 119 of 196

Have there been any patient or carer
complaints involving the destruction or
disposal of CDs by you?
Have there been any concerns expressed
by colleagues, police, drugs misuse
services or others about the destruction
or disposal of CDs by you?
Have there been any significant events*
involving the destruction or disposal of
CDs by you?
Yes/No or
N/A
Details
* Significant event includes any action or omission resulting in patient(s) being harmed or any action or
omission that nearly happened but did not (near miss)
Please return your completed CD Declaration & self assessment audit to:
Vicki Vardy
Controlled Drug Accountable support & Data Manager
NHS County Durham
Merrington House
Merrington Lane Ind estate
Spennymoor
CO. Durham
DL16 7UT
Telephone Number; 01388 825680
Vicki.vardy@nhs.net
Page 120 of 196

Appendix I
Practice Name
Practice Address
Controlled Drugs: Practice Audit by PCT Pharmacist
Practice Representative (Print
Name)
Practice Representative
(Signature)
PCT Pharmacist (Print Name)
PCT Pharmacist (Signature)
Date of Visit
Personnel Prescribing CDs
1.
2.
3.
4.
5.
6.
Personnel with access to CD
receptacle
1.
2.
3.
4.
Overall responsibility for CDs rests
with:
7.
8.
9.
10.
11.
12.
5.
6.
7.
8.
Page 121 of 196

Section 1: Obtaining Controlled Drugs
Main Supplier of CDs:
Orders authorised by:
Person authorised to receive
CDs at premises:
Is there a written standard operating procedure in place for
ordering CDs?
Is a record of orders kept for a minimum of 2 years?
Are CD orders authorised?
Is there a written standard operating procedure in place for
the receipt of CDs?
Is there a written standard operating procedure in place for
the receipt of CDs delivered via transport systems?
Is the level of stock held to a minimum and reviewed
annually?
YES NO
Page 122 of 196

Section 2: Supply of Controlled Drugs
Do you supply CDs to addicts?
Do you supply CDs against private
prescriptions:
(a) From addiction services?
(b) Elsewhere?
Do you supply CDs:
(a) To doctors?
(b) To others (excluding patients)
Do you provide advice to patients on the
safekeeping and disposal of unwanted CDs?
Are patient information leaflets supplied to all
patients receiving CDs?
Are patient returned medicines ever reused?
Have there been any patient or carer
complaints involving the supply of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the supply of CDs from the
organisation?
Have there been any significant events
involving the supply of CDs relating to the
organisation?
Yes No Details
Page 123 of 196

Section 3: Administration of Controlled Drugs
Are CDs which are administered:
(a) Stock CDs?
(b) Patient‘s own CDs?
Do you maintain records of administration?
(If yes, where? E.g. Register, MAR chart etc.)
Is the administration of CDs witnessed?
If administration is not witnessed, do you have
risk management policies in place?
Have there been any patient or carer
complaints involving the administration of
CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the administration of CDs from
the organisation?
Have there been any significant events
involving the administration of CDs relating to
the organisation?
Yes No Details
Yes No Details
Page 124 of 196

Section 4a: Storage of Controlled Drugs
Do you have any current Chief Constable
exemption certificates in operation for your
CD storage facilities?
Are Schedule 2 CDs stored in a locked,
secure, non-portable receptacle?
Is the receptacle permanently affixed to an
internal wall?
Is the receptacle used only for CDs?
Are all stock CDs kept in their original
containers?
Are different strengths of the same medicines
segregated?
Are there any patient‘s own medicines stored
in the CD receptacle?
Are out of date/returned medicines/out of date
stock segregated?
Are patient returned medicines ever reused?
Is there a written standard operating
procedure which details routine date checking
of stock CDs?
How often does routine date checking take
place?
Is the room containing the CD receptacle
lockable?
Is the room containing the CD receptacle kept
locked?
Does the room containing the CD receptacle
have limited access?
Is there a named person detailed in a written
standard operating procedure, with
responsibility for the CD receptacle and a list
of the current key holder(s)?
Is there a clear daily audit trail for key holders
(i.e. keys signed in and out, and not stored in
a drawer)?
Do you store naloxone in the practice?
Yes No Details
Page 125 of 196

Section 4b: Security and safe custody of Controlled Drugs in transport
Do you transport or are you responsible for
the transport of CDs (this includes sending
CDs using third party carriers)?
Do you have written standard operating
procedures in place for the transport of CDs?
Are CDs kept in a locked receptacle during
transport?
Are records maintained of CDs in transport?
Section 4c: Register of Controlled Drugs
Do you maintain a controlled drug register?
Are the controlled drugs kept at more than
one surgery site?
Is there a separate register for each area
where the CDs are stored?
Is the CD register stored safely, near to, but
outside the CD receptacle?
Are all records, registers and invoices kept for
a minimum of 2 years?
Have there been any patient or carer
complaints involving the storage, transport or
record keeping of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the storage, transport or
record keeping of CDs?
Have there been any significant events
involving the storage, transport or record
keeping of CDs?
Yes No Details
Yes No Details
Page 126 of 196

Section 4c: Paper based CD registers
The following table may be used to identify which procedures are being followed and the number of
registers in current use. Tick the box to indicate whether the criteria are being followed in the practice.
Criterion Register Comments
1. Format of register
1.1 Bound book
1.2 Separate section per drug
1.3 Separate section per presentation with
name and strength at top of each page
2. Entries
2.1 In ink
2.2 Chronological order
2.3 Entries within 24 hours
3. Errors and corrections
3.1 As margin/foot notes
3.2 Corrections dated
3.3 Corrections initialled
4. Record of receipt
4.1 Date of receipt
4.2 Name and address of supplier
4.3 Amount obtained
4.4 Form and strength obtained
4.5 Running balance
4.6 Signature
4.7 Process for discrepancies
5. Record of supply
5.1 Date of supply
5.2 Name and address of person supplied
5.3 Authority to supply
5.4 Amount supplied
5.5 Form and strength supplied
5.6 Running balance
5.7 Signature
Criterion Register Comments
5.8 Collected by
6. Record of administration
6.1 Date of administration
6.2 Name and address of person
administered to (where appropriate)
6.3 Name and authority of person
administering
6.4 Amount administered
6.5 Form administered
6.6 Time of administration
6.7 Running balance
6.8 Signature and witness where appropriate
6.9 Procedure if pack contents incorrect
7. Stock check
7.1 Evidence of appropriate stock check e.g.
monthly
7.2 Stock checked and correct
7.3 Different people carrying out stock check
Page 127 of 196

Section 5: Destruction of Controlled Drugs
Are CDs destroyed using recommended
methods?
Are there any CDs awaiting destruction in the
CD receptacle?
Is date expired CD stock clearly labelled?
Is date expired CD stock clearly segregated?
Have there been any patient or carer
complaints involving the destruction of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the destruction of CDs?
Have there been any significant events
involving the destruction of CDs?
Destruction of stock controlled drugs
Is there a written standard operating
procedure for the destruction of controlled
drugs?
Is destruction of stock CDs witnessed by an
authorised person?
Is the authorised person NOT directly involved
with CD supply in the practice?
Is the name, form, strength and quantity of the
drug destroyed, entered into the CD register?
Is the date of destruction entered into the
register?
Is the signature of the witness entered into the
register?
Is there a written standard operating
procedure for the destruction of expired stock
from doctor‘s bags?
Destruction of patient returned controlled
drugs
Are records made of patient returned CDs in a
separate book (not the CD register)?
Does this book record:
The date received?
Name and address of the patient prescribed
CD?
Pharmacy/practice where originally
dispensed?
Name, quantity, form of CD?
Role of person returning CD?
Name and signature of staff receiving CD?
Name and signature of staff destroying CD
and date?
Destruction of patient returned controlled
drugs
Does this book record:
Name and signature of witness to destruction
and date?
Yes No Details
Yes No Details
Page 128 of 196

Are patient returned CDs destroyed as soon
as possible?
Is the patient returns process audited?
Page 129 of 196

Section 6: General
Do all staff know who to contact at the
Primary Care Organisation regarding
concerns about other colleagues in relation to
CDs?
Comments
Yes No Details
It is good practice to keep all audit records for 7 years
Revision Date: August 2010
Page 130 of 196

Appendix J
GP Name
GP Address
GP Signature
Controlled Drugs: Personal Audit by PCT Pharmacist
PCT Pharmacist (Print Name)
PCT Pharmacist (Signature)
Date of Visit
Section 1: Obtaining Controlled Drugs
Do you obtain controlled drugs from your local pharmacist?
Do you obtain controlled drugs by signed requisition?
Do you use practice headed paper for your signed
requisition?
Do you obtain controlled drugs using an FP10
Do you obtain controlled drugs from patients who have died?
Is there a written standard operating procedure in place for
ordering CDs?
Is a record of orders kept for a minimum of 2 years?
Is there a written standard operating procedure in place for
the receipt of CDs?
Is there a written standard operating procedure in place for
the receipt of CDs delivered via transport systems?
Is the level of stock in your bag held to a minimum and
reviewed annually?
Section 2: Supply of Controlled Drugs
Do you supply CDs to addicts?
Do you supply CDs against private
prescriptions:
(c) From addiction services?
(d) Elsewhere?
Do you supply CDs:
(c) To doctors?
(d) To others (excluding patients)
Do you provide advice to patients on the
YES NO
Yes No Details
Page 131 of 196

safekeeping and disposal of unwanted CDs?
Are patient information leaflets supplied to all
patients receiving CDs?
Are patient returned medicines ever reused?
Have there been any patient or carer
complaints relating to you involving the supply
of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others relating to you about the supply of
CDs from the organisation?
Have there been any significant events
involving the supply of CDs relating to you?
Section 3: Administration of Controlled Drugs
Are CDs which are administered:
(c) Stock CDs?
(d) Patient‘s own CDs?
Do you maintain records of administration?
(If yes, where? E.g. Register, MAR chart etc.)
Is the administration of CDs witnessed?
If administration is not witnessed, do you have
risk management policies in place?
Have there been any patient or carer
complaints involving the administration of CDs
by you?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the administration of CDs by
you?
Have there been any significant events
involving the administration of CDs relating to
you?
Section 4a: Storage of Controlled Drugs
Do you store controlled drugs in a locked
doctors‘ bag?
Do you store controlled drugs in your car?
If you store controlled drugs in your car are
they stored in a locked container?
If you store controlled drugs in your car, is the
car locked?
If you store controlled drugs in your car, are
they stored in a locked boot?
When would you store controlled drugs in
your car?
Yes No Details
Yes No Details
Page 132 of 196

Would controlled drugs be left overnight in
your car?
Are out of date/returned medicines/out of date
stock segregated?
Are patient returned medicines ever reused?
Is there a written standard operating
procedure which details routine date checking
of stock CDs?
How often does routine date checking take
place?
Where is your bag, containing controlled
drugs stored out of hours?
Is the room containing the CDs kept locked?
Does the room containing the CDs have
limited access?
Do you carry naloxone in your bag?
Do you store naloxone in your practice?
Section 4b: Security and safe custody of Controlled Drugs in transport
Do you transport or are you responsible for
the transport of CDs (this includes sending
CDs using third party carriers)?
Do you have written standard operating
procedures in place for the transport of CDs?
Are CDs kept in a locked receptacle during
transport?
Are records maintained of CDs in transport?
Section 4c: Register of Controlled Drugs
Do you maintain a controlled drug register?
Is the CD register kept with the controlled
drugs?
Are all records, registers and invoices kept for
a minimum of 2 years?
Have there been any patient or carer
complaints involving the storage, transport or
record keeping of CDs regarding you?
Have there been any concerns regarding you
expressed by colleagues, police, substance
Yes No Details
Yes No Details
Page 133 of 196

misuse services or others about the storage,
transport or record keeping of CDs?
Have there been any significant events
regarding you involving the storage, transport
or record keeping of CDs?
Section 4c: Paper based CD registers
The following table may be used to identify which procedures are being followed and
the number of registers in current use. Tick the box to indicate whether the criteria are
being followed in the practice.
Criterion Register Comments
1. Format of register
1.1 Bound book
1.2 Separate section per drug
1.3 Separate section per presentation with
name and strength at top of each page
2. Entries
2.1 In ink
2.2 Chronological order
2.3 Entries within 24 hours
3. Errors and corrections
3.1 As margin/foot notes
3.2 Corrections dated
3.3 Corrections initialled
4. Record of receipt
4.1 Date of receipt
4.2 Name and address of supplier
4.3 Amount obtained
4.4 Form and strength obtained
4.5 Running balance
4.6 Signature
4.7 Process for discrepancies
Criterion Register Comments
5. Record of supply
5.1 Date of supply
5.2 Name and address of person supplied
5.3 Authority to supply
5.4 Amount supplied
5.5 Form and strength supplied
5.6 Running balance
5.7 Signature
5.8 Collected by
6. Record of administration
6.1 Date of administration
6.2 Name and address of person
administered to (where appropriate)
6.3 Name and authority of person
administering
6.4 Amount administered
6.5 Form administered
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6.6 Time of administration
6.7 Running balance
6.8 Signature and witness where appropriate
6.9 Procedure if pack contents incorrect
7. Stock check
7.1 Evidence of appropriate stock check e.g.
monthly
7.2 Stock checked and correct
Section 5: Destruction of Controlled Drugs
Are CDs destroyed using recommended
methods?
Are there any CDs awaiting destruction in the
GP bag
Is date expired CD stock clearly labelled?
Is date expired CD stock clearly segregated?
Have there been any patient or carer
complaints involving the destruction of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the destruction of CDs?
Have there been any significant events
involving the destruction of CDs?
Destruction of stock controlled drugs
Is the out of date stock from your emergency
bag destroyed by a GP?
Is destruction of stock CDs witnessed by an
authorised person?
Is the authorised person NOT directly involved
with CD supply in the practice?
Is the name, form, strength and quantity of the
drug destroyed, entered into the CD register?
Is the date of destruction entered into the
register?
Is the signature of the witness entered into the
register?
Is there a written standard operating
procedure for the destruction of expired stock
from doctor‘s bags?
Destruction of patient returned controlled
drugs
What do you do when Sch 2 controlled drugs
that are no longer required by your patient for
use in their home e.g. terminal care? Are the
Yes No Details
Yes No Details
Page 135 of 196

drugs:
Returned by you to a community
pharmacy?
Returned by others to a community
pharmacy?
Added to your own emergency bag
stock?
Destroyed by you?
Destroyed by a District Nurse?
Destroyed by patient‘s relatives?
Destroyed by an authorised person?
Are records made of patient returned CDs in a
separate book (not the CD register)?
Does this book record:
The date received?
Name and address of the patient prescribed
CD?
Pharmacy/practice where originally
dispensed?
Name, quantity, form of CD?
Role of person returning CD?
Name and signature of staff receiving CD?
Name and signature of staff destroying CD
and date?
Name and signature of witness to destruction
and date?
Are patient returned CDs destroyed as soon
as possible?
Is the patient returns process audited?
Section 6: General
Do all staff know who to contact at the
Primary Care Organisation regarding
concerns about other colleagues in relation to
CDs?
Comments
Yes No Details
It is good practice to keep all audit records for 7 years
Revision Date: August 2010
Page 136 of 196

Appendix K
OOH/UCC/Practice Name
Controlled Drugs: OOH/UCC/Dispensing Doctors Audit
OOH/UCC/Practice Address
OOH/UCC/Practice
Representative (Print Name)
OOH/UCC/Practice
Representative (Signature)
PCT Pharmacist (Print Name)
PCT Pharmacist (Signature)
Date of Visit
Personnel Prescribing CDs
1.
2.
3.
4.
5.
6.
Personnel with access to CD
receptacle
1.
2.
3.
4.
Overall responsibility for CDs rests
with:
7.
8.
9.
10.
11.
12.
5.
6.
7.
8.
Page 137 of 196

Section 1: Obtaining Controlled Drugs
Main Supplier of CDs:
Orders authorised by:
Person authorised to receive
CDs at premises:
Is there a written standard operating procedure in place for
ordering CDs?
Is a record of orders kept for a minimum of 2 years?
Are CD orders authorised?
Is there a written standard operating procedure in place for
the receipt of CDs?
Is there a written standard operating procedure in place for
the receipt of CDs delivered via transport systems?
Is the level of stock held to a minimum and reviewed
annually?
Section 2: Supply of Controlled Drugs
Do you supply CDs to addicts?
Do you supply CDs against private
prescriptions:
(e) From addiction services?
(f) Elsewhere?
Do you supply CDs:
(e) To doctors?
(f) To others (excluding patients)
Are the drugs checked against the
prescription by a GP when dispensing
schedule 2 and 3 controlled drugs?
Do you provide advice to patients on the
safekeeping and disposal of unwanted CDs?
Are patient information leaflets supplied to all
patients receiving CDs?
Are patient returned medicines ever reused?
Have there been any patient or carer
complaints involving the supply of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the supply of CDs from the
organisation?
Have there been any significant events
involving the supply of CDs relating to the
organisation?
YES NO
Yes No Details
Page 138 of 196

Section 3: Administration of Controlled Drugs
Are CDs which are administered:
(e) Stock CDs?
(f) Patient‘s own CDs?
Do you maintain records of administration?
(If yes, where? E.g. Register, MAR chart etc.)
Is the administration of CDs witnessed?
If administration is not witnessed, do you have
risk management policies in place?
Have there been any patient or carer
complaints involving the administration of
CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the administration of CDs from
the organisation?
Have there been any significant events
involving the administration of CDs relating to
the organisation?
Section 4a: Storage of Controlled Drugs
Do you have any current Chief Constable
exemption certificates in operation for your
CD storage facilities?
Are Schedule 2 CDs stored in a locked,
secure, non-portable receptacle?
Are Schedule 3 CDs stored in a locked,
secure, non-portable receptacle?
Is the receptacle permanently affixed to an
internal wall?
Is the receptacle used only for CDs? (i.e. is
there a separate CD cupboard?)
Are all stock CDs kept in their original
containers?
Are different strengths of the same medicines
segregated?
Are there any patient‘s own medicines stored
in the CD receptacle?
Are out of date/returned medicines/out of date
stock segregated?
How are out of date/returned medicines/out of
date stock segregated?
Are patient returned medicines ever reused?
Is there a written standard operating
Yes No Details
Yes No Details
Yes No Details
Page 139 of 196

procedure which details routine date checking
of stock CDs?
How often does routine date checking take
place?
Is the room containing the CD receptacle
lockable?
Is the room containing the CD receptacle kept
locked?
Does the room containing the CD receptacle
have limited access?
Is there a named person detailed in a written
standard operating procedure, with
responsibility for the CD receptacle and a list
of the current key holder(s)?
Is there a clear daily audit trail for key holders
(i.e. keys signed in and out, and not stored in
a drawer)?
Do you store naloxone in the practice?
Section 4b: Security and safe custody of Controlled Drugs in transport
Do you transport or are you responsible for
the transport of CDs (this includes sending
CDs using third party carriers)?
Do you have written standard operating
procedures in place for the transport of CDs?
Are CDs kept in a locked receptacle during
transport?
Are records maintained of CDs in transport?
Section 4c: Register of Controlled Drugs
Do you maintain a controlled drug register?
Are the controlled drugs kept at more than
one surgery site?
Is there a separate register for each area
where the CDs are stored?
Is the CD register stored safely, near to, but
outside the CD receptacle?
Are all records, registers and invoices kept for
a minimum of 2 years?
Have there been any patient or carer
complaints involving the storage, transport or
record keeping of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
Yes No Details
Yes No Details
Page 140 of 196

or others about the storage, transport or
record keeping of CDs?
Have there been any significant events
involving the storage, transport or record
keeping of CDs?
Section 4c: Paper based CD registers
The following table may be used to identify which procedures are being followed and
the number of registers in current use. Tick the box to indicate whether the criteria are
being followed in the practice.
Criterion Register Comments
1. Format of register
1.1 Bound book
1.2 Separate section per drug
1.3 Separate section per presentation with
name and strength at top of each page
2. Entries
2.1 In ink
2.2 Chronological order
2.3 Entries within 24 hours
2.4 Are entries dated, timed and signed by
two practitioners
3. Errors and corrections
3.1 As margin/foot notes
3.2 Corrections dated
3.3 Corrections initialled
4. Record of receipt
4.1 Date of receipt
4.2 Name and address of supplier
4.3 Amount obtained
4.4 Form and strength obtained
4.5 Running balance
4.6 Signature
4.7 Process for discrepancies
5. Record of supply
5.1 Date of supply
5.2 Name and address of person supplied
5.3 Authority to supply
5.4 Amount supplied
5.5 Form and strength supplied
5.6 Running balance
5.7 Signature
Criterion Register Comments
5.8 Collected by
6. Record of administration
6.1 Date of administration
6.2 Name and address of person
administered to (where appropriate)
6.3 Name and authority of person
administering
6.4 Amount administered
Page 141 of 196

6.5 Form administered
6.6 Time of administration
6.7 Running balance
6.8 Signature and witness where appropriate
6.9 Procedure if pack contents incorrect
7. Stock check
7.1 Evidence of appropriate stock check e.g.
monthly
7.2 Stock checked and correct
7.3 Different people carrying out stock check
Section 5: Destruction of Controlled Drugs
Are CDs destroyed using recommended
methods?
Are there any CDs awaiting destruction in the
CD receptacle?
Is date expired CD stock clearly labelled?
Is date expired CD stock clearly segregated?
Have there been any patient or carer
complaints involving the destruction of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the destruction of CDs?
Have there been any significant events
involving the destruction of CDs?
Destruction of stock controlled drugs
Is there a written standard operating
procedure for the destruction of controlled
drugs?
Is destruction of stock CDs witnessed by an
authorised person?
Is the authorised person NOT directly involved
with CD supply in the practice?
Is the name, form, strength and quantity of the
drug destroyed, entered into the CD register?
Is the date of destruction entered into the
register?
Is the signature of the witness entered into the
register?
Is there a written standard operating
procedure for the destruction of expired stock
from doctor‘s bags?
Destruction of patient returned controlled
drugs
Are records made of patient returned CDs in a
separate book (not the CD register)?
Does this book record:
The date received?
Name and address of the patient prescribed
CD?
Destruction of patient returned controlled
Yes No Details
Page 142 of 196

drugs
Does this book record:
Pharmacy/practice where originally
dispensed?
Name, quantity, form of CD?
Role of person returning CD?
Name and signature of staff receiving CD?
Name and signature of staff destroying CD
and date?
Name and signature of witness to destruction
and date?
Are patient returned CDs destroyed as soon
as possible?
What methods are used to destroy patient
returned controlled drugs? (Dispensing
Doctors)
Is the patient returns process audited?
Section 6: General
Do all staff know who to contact at the
Primary Care Organisation regarding
concerns about other colleagues in relation to
CDs?
Can the nurse/ECP/dispenser in charge
explain protocol/policy if a vial/tablet is:
Broken
Unaccounted for
Out of date
No longer required by the patient after
dispensing
Yes No Details
Page 143 of 196

Comments
It is good practice to keep all audit records for 7 years
Revision Date: August 2010
Page 144 of 196

Appendix L
Community Hospital Name
Community Hospital Address
Community Hospital
Representative (Print Name)
Community Hospital
Representative (Signature)
PCT Pharmacist (Print Name)
PCT Pharmacist (Signature)
Date of Visit
Personnel Prescribing CDs
Personnel with access to CD
receptacle
Controlled Drugs: Community Hospital Audit
Page 145 of 196

Overall responsibility for CDs rests
with:
Section 1: Obtaining Controlled Drugs
Main Supplier of CDs:
Orders authorised by:
Person(s) authorised to receive
CDs at premises:
Is there a written standard operating procedure in place for
ordering CDs?
Is a record of orders kept for a minimum of 2 years?
Are CD orders authorised?
Is there a written standard operating procedure in place for
the receipt of CDs?
Is there a written standard operating procedure in place for
the receipt of CDs delivered via transport systems?
Is the level of stock held to a minimum and reviewed
annually?
Section 2: Supply of Controlled Drugs
Do you provide advice to patients on the
safekeeping and disposal of unwanted CDs?
Are patient information leaflets supplied to all
patients receiving CDs?
Are patient returned medicines ever reused?
Have there been any patient or carer
complaints involving the supply of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the supply of CDs from the
organisation?
Have there been any significant events
involving the supply of CDs relating to the
organisation?
Section 3: Administration of Controlled Drugs
Are CDs which are administered:
(g) Stock CDs?
(h) Patient‘s own CDs?
Do you maintain records of administration?
(If yes, where? E.g. Register, drug cardex
YES NO
Yes No Details
Yes No Details
Page 146 of 196

etc.)
Is the administration of CDs witnessed?
If administration is not witnessed, do you have
risk management policies in place?
Have there been any patient or carer
complaints involving the administration of
CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the administration of CDs from
the organisation?
Have there been any significant events
involving the administration of CDs relating to
the organisation?
Section 4a: Storage of Controlled Drugs
Are Schedule 2 CDs stored in a locked,
secure, non-portable receptacle?
Is the receptacle permanently affixed to an
internal wall?
Is the receptacle used only for CDs?
Are all stock CDs kept in their original
containers?
Are different strengths of the same medicines
segregated?
Are there any patient‘s own medicines stored
in the CD receptacle?
Are out of date/returned medicines/out of date
stock segregated?
Are patient returned medicines ever reused?
Is there a written standard operating
procedure which details routine date checking
of stock CDs?
How often does routine date checking take
place?
Is the room containing the CD receptacle
lockable?
Is the room containing the CD receptacle kept
locked?
Does the room containing the CD receptacle
have limited access?
Is there a named person detailed in a written
standard operating procedure, with
Yes No Details
Page 147 of 196

esponsibility for the CD receptacle and a list
of the current key holder(s)?
Is there a clear daily audit trail for key holders
(i.e. keys signed in and out, and not stored in
a drawer)?
Do you store naloxone in the department?
Section 4b: Security and safe custody of Controlled Drugs in transport
Do you have written standard operating
procedures in place for the transport of CDs?
Are CDs kept in a locked receptacle during
transport?
Are records maintained of CDs in transport?
Section 4c: Register of Controlled Drugs
Do you maintain a controlled drug register?
Is the CD register stored safely, near to, but
outside the CD receptacle?
Are all records, registers and invoices kept for
a minimum of 2 years?
Have there been any patient or carer
complaints involving the storage, transport or
record keeping of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the storage, transport or
record keeping of CDs?
Have there been any significant events
involving the storage, transport or record
keeping of CDs?
Section 4c: Paper based CD registers
Yes No Details
Yes No Details
Yes No Details
The following table may be used to identify which procedures are being followed and
the number of registers in current use. Tick the box to indicate whether the criteria are
being followed in the practice.
Criterion Register Comments
1. Format of register
1.1 Bound book
1.2 Separate section per drug
1.3 Separate section per presentation with
name and strength at top of each page
2. Entries
2.1 In ink
Page 148 of 196

2.2 Chronological order
2.3 Entries within 24 hours
3. Errors and corrections
3.1 As margin/foot notes
3.2 Corrections dated
3.3 Corrections initialled
4. Record of receipt
4.1 Date of receipt
4.2 Name and address of supplier
4.3 Amount obtained
4.4 Form and strength obtained
4.5 Running balance
4.6 Signature
4.7 Process for discrepancies
5. Record of supply (discharge/return of
patient‟s own drugs)
5.1 Date of supply
5.2 Name and address of person supplied
5.3 Authority to supply
5.4 Amount supplied
5.5 Form and strength supplied
5.6 Running balance
5.7 Signature
5.8 Collected by
6. Record of administration
6.1 Date of administration
6.2 Name of person administered to (where
appropriate)
6.3 Name and authority of person
administering
6.4 Amount administered
6.5 Form administered
6.6 Time of administration
6.7 Running balance
6.8 Signature and witness where appropriate
6.9 Procedure if pack contents incorrect
7. Stock check
7.1 Evidence of appropriate stock check e.g.
monthly
7.2 Stock checked and correct
7.3 Different people carrying out stock check
Section 5: Destruction of Controlled Drugs
Are CDs destroyed using recommended
methods?
Are there any CDs awaiting destruction in the
CD receptacle?
Is date expired CD stock clearly labelled?
Is date expired CD stock clearly segregated?
Yes No Details
Page 149 of 196

Have there been any patient or carer
complaints involving the destruction of CDs?
Have there been any concerns expressed by
colleagues, police, substance misuse services
or others about the destruction of CDs?
Have there been any significant events
involving the destruction of CDs?
Destruction of stock controlled drugs
Is there a written standard operating
procedure for the destruction of controlled
drugs?
Is destruction of stock CDs witnessed by an
authorised person?
Is the authorised person NOT directly involved
with CD supply in the practice?
Is the name, form, strength and quantity of the
drug destroyed, entered into the CD register?
Is the date of destruction entered into the
register?
Is the signature of the witness entered into the
register?
Destruction of patient returned controlled
drugs
Are records made of patient‘s own CDs in a
separate book (not the stock CD register)?
Does this book record:
The date received?
Name and address of the patient prescribed
CD?
Pharmacy where originally dispensed?
Name, quantity, form of CD?
Role of person returning CD?
Name and signature of staff receiving CD?
Name and signature of staff destroying CD
and date?
Name and signature of witness to destruction
and date?
Are patient‘s own CDs destroyed as soon as
possible?
Is the patient‘s own returns process audited?
Page 150 of 196

Section 6: General
Do all staff know who to contact at the
Primary Care Organisation regarding
concerns about other colleagues in relation to
CDs?
Comments
Yes No Details
It is good practice to keep all audit records for 7 years
Revision Date: August 2010
Page 151 of 196

Appendix M Controlled Drugs: Prison Audit
Medicines Handling Audit for use in IDTS Implementation and CD Management
Criterion 1 There are clear lines of accountability
throughout the organisation…
1.1 Job description of lead Pharmacist /pharmacy
technician describes clear managerial and
professional accountability to the PCT and/or
Healthcare Manager
1.2 Terms of reference of responsible committee(s)
include medicines management and
involvement of a Pharmacist in advising on IDTS
e.g. DTC; IDTS steering & implementation
groups
1.3 An Organisational chart shows the relevant links
to medicines management in IDTS ( clinical and
medicines supply)
1.4 A strategy exists for ensuring the safe & secure
handling of medicines and this includes CDs
1.5 There is an index of medicines policies relating
to CDs and these are accessible and up to date
& available in healthcare and pharmacy dept
Criterion 2 Suitable controls are in place that ensure the
principles of the NPC primary Care CD
Guidance and Duthie report are met
Wings, clinics & wards
Yes No IDTS Toolkit
Reference
Section
Planning for
Delivery (1)
Planning for
Delivery (1)
Planning for
Delivery (1)
Planning for
Delivery (1)
IDTS Delivery
(22-
Pharmacy)
Comments Relating to Interpretation for
CDs in Prisons

2.1 Designated staff check items received against
requisition/delivery note
2.2 Goods are signed for at wing level by
designated staff
2.3 Designated staff return requisition/delivery note
to confirm delivery
Pharmacy/Healthcare Centre (HCC)
2.4 There is a schedule for rolling stock checks that
is adhered to and SOPs must reflect the checks
and frequency of checks
2.5 Ad hoc orders are in writing and meet the legal
requirements
IDTS Delivery
(22 -
Pharmacy)
Yes No IDTS Toolkit
Reference
Section
Page 153 of 196
Comments Relating to Interpretation for
CDs in Prisons
Where administration/supply occurs on a
designated wing or area/clinic room: official
CD Requisition book is needed (carbonated
and sequentially numbered)
Usually the top (white) copy of the requisition
book mentioned in 2.2
CD Stocks checked regularly in Healthcare on
wings/areas/clinic rooms. An overall prison
stock reconciliation check by designated staff
(e.g.by pharmacist on clinical visit) will be
required at least once a month. This monthly
check to be recorded in a different colour ink
for ease of reconciliation/audit (e.g. green/red
pen). In an on-site pharmacy dept, a rolling
stock check of pharmacy stocks should be
performed at least weekly.
If discrepancies arise, or if volume of use
necessitates, more frequent checks would be
needed.Records of checks must be kept for
as long as legislation dictates. (see section
2.9 - soon to be 11 years, as for registers)
For wings/wards/treatment rooms, requisition
books as in 2.2 are required.

2.6 Copies of orders are kept for 2 years at least see 2.9 below
Yes No IDTS Toolkit
Reference
Section
Page 154 of 196
Comments Relating to Interpretation for
CDs in Prisons
2.7 Job descriptions identify responsible staff Legally the doctor is responsible for CD
ordering in Healthcare. The Head of
Healthcare (principal healthcare professional)
should be the designated person responsible
for the possession/handling of CDs in the
prison. The Principal Pharmacist is
responsible for the possession/handling of
CDs in the Pharmacy. Job Descriptions
should include delegated responsibilities of
other prison and healthcare staff relating to
medicines, including CDs.
2.8 Duties of purchasing and receipt are separated Where ever practical, duties should be
separated. All receipts of stock must be
witnessed and checked against the order
2.9 Records are held for periods of time identified by
the CD Regulations e.g. CD Register, CD
Prescriptions and Requisitions/Orders
/requisition and signed as such.
Currently all Registers, requisitions and
orders (and invoices) for controlled drugs
must be preserved for 2 years. The 2001
Regulations have been amended to allow the
information in these records to be preserved
in the original paper form or in computerised
form (as long as secure). Once
computerised recording is in common use,
The Government intends that secure
computerised copies be kept for 11 years.

2.10 An audit trail exists for the ordering, receipt and
supply of medicines
Criterion 3 Medicines are stored and handled in a safe
and secure manner
HCC, wings, clinics & wards
3.1 Medicines are locked away immediately on
Yes No IDTS Toolkit
Reference
Section
Page 155 of 196
Essential for CDs as every tablet or ml of
liquid must be accounted for and there must
be a robust audit trail in place.
Comments Relating to Interpretation for
CDs in Prisons
receipt
IDTS Delivery
(22-Pharmacy)
3.2 CD Medicine storage cabinets meet standards
Facilities see the Silver level of the 'Sold Secure'
of the Misuse of Drugs Regulations
Required (7 & standard SS304 (domestic safes).Currently
8)
exceed the Misuse of Drug regulations but
advised by the Home Office as being more
effective and appropriate for prisons.
Stationery is kept secure: Facilities Must be kept secure and only available to
Required (7 & designated authorised persons. Their security
8) & IDTS must be dealt with in the relevant Standard
Delivery (22 - Operating Procedures
Pharmacy)
3.3 CD requisition books and Registers
3.4 Prescription pads & charts
3.5 Order Pads
Transport of medicines:

3.6 There is a Standard Operating Procedure for the
secure transport of CDs into and within the
prison
3.7 Ward/wing/clinic area CD's are sealed in a
designated bag/box before delivery to them
Page 156 of 196
Facilities
Required (7&8)
IDTS Delivery
(22 -
Pharmacy)
Yes No IDTS Toolkit
Reference
Section
3.8 All stock medicines are sent in sealable
container
Security: Facilities
Required (7&8)
This should be considered in the prison Risk
Management procedure. The messenger
transporting drugs must be aware of the
security issues and the audit trail in 2.9.
Authorised signatory must ensure they sign to
confirm exactly what is received i.e. quantity
and strength of drug. (Gate staff are NOT
authorised signatories). There must be a
robust audit trail from receipt of CD at the
Gate to Healthcare/Pharmacy.
Comments Relating to Interpretation for
CDs in Prisons
Must be considered in prison's CD policy,
including all places in the prison where the
CDs are stored and administered.
Recommended that benzodiazepines are
stored and managed as for all other CDs
3.9 Pharmacy/HCC is secure Gated room; walls floors and ceilings solid.
3.10 Access to Pharmacy/HCC areas is restricted
3.11 Entrances to Pharmacy/HCC have secure solid
doors & security locks
Other:
Adhere to Prison security guidelines

3.12 Lists of CDs that are stocked are available,
maintained and updated regularly for healthcare,
all areas, wings, clinics & wards
3.13 Medicines etc for emergency use are available
in a suitable presentation and regularly checked
for expiry dates and stock levels maintained
3.14 Policies and procedures in place that describe
the actions to be taken with CDs if prison
security is breached or if discrepancies in CD
stock levels are identified
Page 157 of 196
IDTS Delivery
(22-
Pharmacy)
Yes No IDTS Toolkit
Reference
Section
IDTS Delivery
(22- Pharmacy
and 24)
IDTS Delivery (
22- Pharmacy)
Facilities
Required (7&8)
Comments Relating to Interpretation for
CDs in Prisons
Naloxone must be available for use in opiate
toxicity (in Emergency Bags?). Consider
availability where opiates are administered
AND where toxicity likely to be identified (on
wings?). Staff training and administration
procedures must also be completed.
This relates to when either
Healthcare/Pharmacy security is breached or
when there is "loss of control" in the prison or
a prison area. Risks to the security of CDs
must be considered in such cases.
Discrepancies and security breaches should
be recorded as critical incidents and a
procedure for reporting these incidents should
be in place. This would include the escalation
of the incident to high risk/ investigation
should more than one incident occur in a
given area over a specified time period,
especially if the same practitioner is involved.

Criterion 4 Prescription, supply and administration
conform to the requirements of relevant
legislation. Prescription, supply and
administration of medicines is undertaken
only by appropriately qualified staff.
Page 158 of 196
IDTS Delivery
(22 -
Pharmacy)
Facilities
Required (
7&8)
Yes No IDTS Toolkit
Reference
Section
4.1 All prescriptions are written by a doctor IDTS Delivery
(21)
4.2 All issues of CDs, including benzodiazepines,
are administered by supervised consumption
underpinned by an SOP
4.3 Administration charts are always available to
record all transactions with prisoners including
issues of 'canteen list' medicines
IDTS Delivery
(21 and 22 -
Pharmacy)
Recommend that all Methadone is
administered via automated pumps (manual
or computerised depending on frequency)
NOT by measuring out doses in conical
measures unless methadone is used
infrequently. Pharmacists should advise about
use, maintenance and calibration of these.
SOPs must specify these details.
Administration of CDs requires 2 staff, one of
whom should be a Healthcare Professional
Comments Relating to Interpretation for
CDs in Prisons
Nurse and pharmacist prescribers can
prescribe CDs for substance misuse via
Supplementary Prescribing ONLY
currently.
For IDTS programme
If CDs are administered using a computerised
record, then any written Drug Administration
charts and patient medical notes should
clearly state that the patient is receiving
treatment for substance misuse and what they
are prescribed. This allows for any clinical
review (e.g. for a pharmacist checking the
appropriateness of another prescribed/OTC
medicine or another prescriber) to take into
account this therapy.

4.4 All prescriptions are clinically checked by a
pharmacist
4.5 All relevant policies are in place and up to date
(including PGDs)
4.6 Proof of registration of all pharmacists &
Pharmacy Technicians is checked annually
4.7 Pharmacy services are in place to monitor and
review prescription writing against locally agreed
standards e.g. administration charts handwritten
by Docs/nurse prescribers are clear and
legible
4.8 Prisoners have access to advice and
counselling re their medicines from a
pharmacist/technician or if not available, other
member of the HC staff
4.9 Prisoners are supplied with written information
leaflets ideally each time a medicine is
dispensed (in accordance with EU regulations)
Page 159 of 196
The prescriber is responsible until the
pharmacist check is made
see 4.12 below
Workforce (14) Pharmacy technicians should be registered if
they are managing the supply/administration
of CDs.
Yes No IDTS Toolkit
Reference
Section
IDTS Delivery
(22 -
Pharmacy)
Comments Relating to Interpretation for
CDs in Prisons
Prescription writing for CDs must comply with
the Misuse of Drugs Regulations.(latest
guidance Jul 06) i.e. quantity must still be in
words & figures etc but Dr does not now need
to handwrite whole prescription
CARAT staff should be able to signpost
prisoners for medicines advice, so this advice
can be part of the advice and counselling
available to prisoners receiving treatment for
substance misuse (including treatment for
benzodiazepines, alcohol as well as opiate
misuse).
Because the CDs will be administered under
supervision (NIP) Healthcare/ pharmacy
should make any patient information leaflets
available during initial stabilisation as well as
later during treatment

4.10 There is a procedure for correctly identifying
prisoners when administering medication
4.11 Prisoners are observed taking/using their NIP
medicines by HC staff
4.12 Supply and administration of drugs is covered
by a Patient Group Direction where appropriate
4.13 Any CDs issued to prisoners directly from stock
are issued under the directions of a doctor and
recorded
Criterion 5 The prescribing, supply, administration, safe
custody and destruction of controlled
medicines complies with the appropriate
legislation.
Yes No IDTS Toolkit
Reference
Section
Page 160 of 196
Some IT systems will provide for iris or
fingerprint recognition. In the absence of
these, there must be a clearly stated means
of confirming prisoner ID as part of the SOPs
for administration of methadone.
This should be the case for all CDs used in
Substance Misuse, including benzodiazepines
and SOPs should specify this. Prison
procedures and protocols should mirror those
in primary care/ community pharmacy.
Comments Relating to Interpretation for
CDs in Prisons
Not applicable for CDs for Substance
Misuse as these cannot be supplied under
PGDs. Naloxone is able to be administered,
exempt from the Medicines Act, in an
emergency however.
As all doses will be administered under
supervision (NIP), the CDs should be
administered from stock supplies. There must
be set protocols for administration by
supervised consumption.

5.1 All relevant policies are in place and up to date
5.2 Prescriptions for CDs comply with Legislation
5.3 Pharmacy CD registers are stored for 2 years Likely to be eleven years when regulations
amended
5.4 CD requisitions and registers are completed
correctly
5.5 CD levels checked by the auditor are correct
5.6 CD checks are up to date
5.7 Only authorised personnel order, supply,
possess, prescribe & administer CDs
5.8 The destruction and disposal of CDs complies
with legislation
Yes No IDTS Toolkit
Reference
Section
Page 161 of 196
Comments Relating to Interpretation for
CDs in Prisons
Legally only the doctor or pharmacist can
order CDs and so must countersign any
Requisitions but the Head of Healthcare
(healthcare professional) should have
designated overall authority and
accountability for the management of CDs
within the prison. Responsibilities in this
section should be delegated to appropriate
named staff only.
Advice from the PCTs Accountable Officer
should be sought. It is important that there is
an efficient mechanism for arranging for CD
destruction to prevent excess stocks being
stored.

Criterion 6 All medicines no longer required are
destroyed or otherwise disposed of in
accordance with safety, legal and
environmental requirements
6.1 The Pharmacy/HCC procedure is in place and
up to date
6.2 The prison's policy for the management of
pharmaceutical waste is in line with that of the
PCT
6.3 An audit trail exists that can be used to follow
the handling of pharmaceutical waste
Criterion 7 The organisation reports adverse incidents
involving medicinal products and devices to
the relevant agency, and appropriately
manages any subsequent required action.
7.1 Procedure is in place and up to date and
pharmacy/HCC responsibilities are documented
7.2 Staff are aware of incident/ADR/defective
product recall procedures
7.3 There is evidence that recalls are effectively
implemented
Page 162 of 196
IDTS Delivery
(22 -
Pharmacy)
Yes No IDTS Toolkit
Reference
Section
IDTS Delivery
(22 -
Pharmacy)
Note the destruction of CDs stock must be
witnessed by an authorised person (check
with Accountable Officer at PCT) and
rendered irretrievable. An SOP is needed.
See 5.8 above
Comments Relating to Interpretation for
CDs in Prisons
Incidents involving CDs are a high priority for
identifying, reporting, investigating and
actioning any follow-up. There should be an
SOP specifying a clear cascade of
alerts/recalls to relevant staff.

7.4 Errors are reported through a risk management
framework
7.5 Medication incidents are investigated and
reported locally
7.6 All NPSA alerts and safety notices are
implemented
Criterion 8 Supervision of pharmaceutical dispensing
processes is undertaken in accordance with
relevant legislation and current professional
standards.
8.1 Procedures are in place and up to date IDTS Delivery
(22-Pharmacy)
Yes No IDTS Toolkit
Reference
8.2 Staff rotas are in place to ensure adequate
cover
Page 163 of 196
Section
Workforce
(15,18)
Comments Relating to Interpretation for
CDs in Prisons
There will always need to be 2 people ( one of
which must be a registered nurse or
registered pharmacy technician or doctor or
pharmacist, plus another competent person)
involved in administering CDs to patients
8.3 Checking technicians are externally accredited Registered Pharmacy Technicians should
complete the ACT course, especially if there
8.4 All prescriptions are clinically checked by a
pharmacist
IDTS Delivery
(22-Pharmacy)
is not an on-site pharmacist.
This should be incorporated into the supply
process, as for patients receiving other
medication, to ensure quality of care. Initial
supplies may not have been checked by a
pharmacist if they have not dispensed the CD.
In this case responsibility rests with the
prescriber until the clinical check has been

8.5 Medication-related errors are recorded and
reviewed
8.6 Policies and procedures are in place if
extemporaneous preparations are needed
8.7 Extemps are only prepared where no equivalent
licensed product is available
Criterion 9 The risk management process contained
within the Risk Management standard is
applied to the safe and secure handling of
medicines.
19.1 All identified risks are documented, assessed
and prioritised
19.2 Action plans are developed and implemented
9.3 The PCT Board or equivalent is informed and
updated on significant risks
Page 164 of 196
Planning for
Delivery (5)
Yes No IDTS Toolkit
Reference
Section
made by the pharmacist.
See section 7
Prison Pharmacies should not be
reconstituting Methadone Mixture from the
powder and diluents or using the concentrate.
All supplies should be made using the 1mg/ml
Methadone Mixture that is commercially
available.
Comments Relating to Interpretation for
CDs in Prisons
The IDTS implementation group within the
establishment (in partnership with the D&T /
Medicines Committee) should identify any
risks associated with the medicines storage
and handling of CDs. These should be
included in the PCT/Prison Risk Register.

9.4 Staff are aware of systems in place to minimise
risk e.g. protocols for dispensing and supply of
medicines
Criterion 10 All healthcare staff involved with medicines
undertakes continuing professional
development to ensure that there are safe
and secure handling processes in place.
Page 165 of 196
Workforce (14,
15,16, 17 &
19)
All staff involved in medicines storage and
handling of CDs should have read and signed
the relevant SOPs
Pharmacy Pharmacists: All pharmacists involved in IDTS
should have completed the CPPE course
'Substance Use & Misuse' and the viva day to
attain the RCGP Part 1 certificate in
Substance Misuse. Pharmacy Technicians
should all be registered and have completed
the CPPE course 'Substance Use and
Misuse- fundamentals and practicalities for
the pharmacy technician‘ (modules 1-3) and
the viva day to attain the RCGP Part 1
certificate in Substance Misuse. Pharmacists
involved in clinical services should have
10.1 Training and development plans are in place
10.2 All pharmacy staff maintain CPD records
Yes No IDTS Toolkit
Reference
Section
completed RCGP part 2 training.
Comments Relating to Interpretation for
CDs in Prisons
10.3 Staff are aware of local policies
Other healthcare staff / Prison Officers Medicines Management training required by
these groups should be identified, prioritised
and needs met prior to approval of statement
of readiness. This includes training for staff
not directly involved in medicines handling

10.4 Training and development plans are in place
10.5 Healthcare staff maintain CPD records
10.6 Staff are aware of local policies
Criterion 11 The organisation, through the Lead
Pharmacist/Technician, has access to up-todate
legislation and guidance relating to the
safe and secure handling of medicines.
11.1 Can demonstrate access to relevant information
and means of update
11.2 Can demonstrate mechanism for cascading
information to appropriate prison staff
Criterion 12 Adequate resources support the safe and
secure handling of medicines.
12.1 A development plan that includes Controlled
Drugs is in place & there is a planned review
process
Page 166 of 196
Facilities
Required (7&
8)
Yes No IDTS Toolkit
Reference
Section
Planning for
Delivery (1 &
6) Workforce
(14,15 20)
and storage.
The registered pharmacy practitioner and
Head of Healthcare will be responsible for
ensuring that developments/requirements in
the management of CDs are identified and
cascaded to other staff as necessary.
Comments Relating to Interpretation for
CDs in Prisons

12.2 The pharmacy service & medicines
administration is safely resourced in terms of
staffing, equipment and facilities
12.3 If resources are not adequate, key areas where
funding is required are identified in the
development plan
Criterion 13 The system in place is monitored and
reviewed by management and the Board in
order to make improvements to the system
13.1 Internal audits reports are seen by the Board
13.2 Minutes of relevant meetings are seen by the
Board
13.3 The PCT Accountable Officer for Controlled
Drugs is also included in IDTS implementation,
as appropriate, and has access to
documentation in 13.1. & 13.2 above
Yes No IDTS Toolkit
Reference
Section
Page 167 of 196
It is essential that, as well as the medical and
nursing workforce needs identified by IDTS
implementation, the growth needed in
pharmacy staff (Pharmacy technicians,
Pharmacy Assistants and Pharmacist clinical
input) is included in the IDTS workforce
requirements.
Comments Relating to Interpretation for
CDs in Prisons
N.B. CD Regulations & The Health Act require
appointment of an Accountable Officer to
ensure there are robust arrangements for safe
& effective handling of CDs. The PCT
Accountable Officer will have jurisdiction over
prisons in their area.

Criterion 14 The PCT Board seeks independent
assurance that an appropriate and effective
system is in place.
14.1 External audit reports reviewed
Page 168 of 196
Commissioning
(11)
Future external audits are likely to include the
management of CDs. A duty of Collaboration
is placed on responsible bodies (Healthcare
organisations, police forces, Healthcare
Commission, Prison Inspectorate etc) under
the Health Act 2006 to share information on
CDs.

Appendix N
USEFUL EXTERNAL CONTACTS
British Medical Association
BMA House Tel: 0207 387 4499
Tavistock Square Fax: 0207 383 6400
London Website: www.bma.org.uk
WC1H 9JP
Care Quality Commission
Citygate Tel: 03000 616 161
Gallowgate
Newcastle upon Tyne Website: www.cqc.org.uk
NE1 4PA
Community practitioners‘ and Health Visitors Association
33-37 Moreland Street Tel: 0207 505 3000
London
EC1V 8HA Website: www.amicustheunion.org/cphva/
Council for Healthcare Regulatory Excellence
1 st Floor, Kierran Cross Tel: 0207 389 8030
11 Strand Fax: 0207 389 8040
London Website: www.chre.org.uk
WC2N 5HR
Department of Health
Richmond House Tel: 0207 210 4850
79 Whitehall Website: www.dh.gov.uk
London
SW1A 2NS
Dispensing Doctors‘ Association
Low Hagg Farm Tel: 01751 430835
Starfitts Lane Fax: 01751 430836
Kirbymoorside Website: www.dispensing doctor.org
North Yorkshire
YO62 7JF
Environment Agency
Millbank Tower Tel: 08708 506 506
25 th Floor Website: www.environment-agency.gov.uk
21/24 Millbank
London
SW1P 4XL

General Medical Council
Regent‘s Place Tel: 0845 357 3456
350 Euston Road Website: www.gmc-uk.org
London
NW1 3JN
Home Office Drugs Licensing Branch
2 Marsham Street Tel: 0207 035 0483
London Website: www.homeoffice.gov.uk
SW1P 4DF
Home Office Drugs Legislation and Enforcement Unit
2 Marsham Street Tel: 0207 035 0464
London Website: www.homeoffice.gov.uk
SW1P 4DF
Medicines and Healthcare products Regulatory Agency
Market Towers Tel: 0207 084 2000
1 Nine Elms lane Fax: 0207 084 2353
London Website: www.mhra .gov.uk
SW8 5NQ
National Clinical Assessment Service (part of the National Patient Safety Agency)
Market Towers Tel: 0207 062 1620
1 Nine Elms Lane Fax: 0207 084 3851
London Website: www.ncas.npsa.nhs.uk
SW8 5NQ
National Patient Safety Agency
4-8 Maple Street Tel: 0207 927 9500
London Website: www.npsa.nhs.uk
W1T 5HD
National Pharmacy Association
Mallinson House Tel: 01727 832161
38-42 St Peter‘s Street Fax: 01727 840858
St Albans Website: www.npa.co.uk
Hertfordshire
AL1 3NP
National Prescribing Centre
The Infirmary Tel: 0151 794 8134
70 Pembroke Place Fax: 0151 794 8139
Liverpool Website: www.npc.co.uk (Internet)
L69 3GF www.npc.nhs.uk (NHSNet)
National Treatment Agency
8 th Floor Tel: 020 7261 8801
Hercules House Fax: 020 7261 8883
Hercules Road Website: www.nta.nhs.uk
London
SE1 7DU
Page 170 of 196

NHS Clinical Governance Support Team
1 st Floor Tel: 0116 295 2000
St. Johns House Fax: 0116 295 2001
30 East Street Website: www.egsupport.nhs.uk
Leicester
LE1 6NB
NHS Direct
Headquarters Tel: 0207 599 4200
207 Old Street Fax: 0207 599 4299
London Website: www.nhsdirect.nhs.uk
EC1V 9PS
Nursing and Midwifery Council
23 Portland Place Tel: 020 7637 7181
London Fax: 020 7436 2924
W1B 1PZ Website: www.nmc-uk.org
Pharmaceutical Services Negotiating Committee
59 Buckingham Street Tel: 01296 432 823
Aylesbury Fax: 01296 438 427
Buckinghamshire Website: www.psnc.org.uk
HP20 2PJ
Prescription Pricing Divisions of the NHS Business Services Authority
Bridge House Tel: 0191 232 5371
152 Pilgrim Street Fax: 0191 232 2480
Newcastle-upon-Tyne Website: www.ppa.org.uk
NE1 6SN
Prescribing Support Unit
The Health and Social Care Information Centre Tel: 0113 254 7041
1 Trevelyan Square Fax: 0113 254 7097
Boar lane Website: www.psu.nhs.uk
Leeds
LS1 6AE
Royal College of General Practitioners
RCGP Substance Misuse Unit Tel: 0845 4564041 Ext. 217
14 Princess Gate Fax: 0207 225 3047
Hyde Park Website: www.regp.org.uk/substance
London
SW7 1PU
Royal College of Nursing
Head Office Tel: 0207 409 3333
20 Cavendish Square Website: www.ren.org.uk
London
W1G 0RN
Royal Pharmaceutical Society of Great Britain
1 Lambeth High Street Tel: 0207 735 9141
London Fax: 0207 735 7629
SE1 7JN Website: www.rpsgb.org.uk
Page 171 of 196

UK Home Care Association
42b Banstead Road Tel: 0208 288 1551
Carshalton Beeches Fax: 0208 288 1550
Surrey Website: www.ukhca.co.uk
SM5 3NW
Page 172 of 196

Drug
Appendix O
Table of Controlled drugs and indications allowed to be prescribed by Nurse
Independent Prescriber‟s
Schedule*
Indication
Page 173 of 196
Route of administration
Buprenorphine 3 Transdermal use in palliative care Transdermal
Chlordiazepoxide
Hydrochloride
4
Treatment of initial or acute
withdrawal symptoms caused by
the withdrawal of alcohol from
persons habituated to it
Codeine phosphate 5 N/A Oral
Co-phenotrope 5 N/A
Use in palliative care, pain relief
Oral
Diamorphine
2 in respect of suspected myocardial Oral or parenteral
Hydrochloride
infarction of for relief of acute or
severe pain of trauma, including
in either case post-operative pain
relief
Use in palliative care, treatment
of initial or acute withdrawal
Diazepam
4 symptoms caused by the withdrawal
of alcohol from persons
habituated to it, tonic-clonic
seizures
Oral, parenteral or rectal
Dihydrocodeine tartrate 5 N/A Oral
Fentanyl 2 Transdermal use in palliative care Transdermal
Lorazepam 4 Use in palliative care, tonic-clonic
seizures
Oral or parenteral
Midazolam 3 Use in palliative care, tonic-clonic
seizures
Use in palliative care, pain relief in
respect of suspected myocardial
Parenteral or buccal
Morphine hydrochloride 2 infarction or for relief of acute or
severe pain after trauma, including
in either case post-operative pain
relief
Use in palliative care, pain relief
Rectal
Morphine sulphate 2 in respect of suspected myocardial
infarction or for relief of acute or
severe pain after trauma, including
in either case post-operative pain
relief
Oral, parenteral or rectal
Oral or parenteral
Oxycodone
2 Use in palliative care
administration in
Hydrochloride
palliative care
*Schedule 1-5 of the Misuse of Drugs Regulations 2001
For the purposes of nurse independent prescribing, palliative care means the care of patients with advanced progressive
illness.
Oral

Appendix P
Methods of Destruction of Controlled Drugs
All medicines should be disposed of in a safe and appropriate manner. Medicines
should be disposed of in relevant waste containers which are then sent for incineration
and should not be disposed of in the sewerage system.
All CDs in Schedule 2, 3 and 4 (part I) can be placed into waste containers only after
the controlled drug has been rendered irretrievable (i.e. by denaturing).
Wherever practicable, CD denaturing kits should be used in order to denature CDs.
Where this is not possible or practical other methods of denaturing may be used. In the
past, various methods have been used to denature controlled drugs, including grinding
together with other waste medicines, and / or dissolving in soapy water or adsorbing
onto cat litter.
Having considered the risks posed by destruction of CDs in a pharmacy, the
Environment Agency (EA), which covers England and Wales, has decided that it does
not believe it is in the public interest to expect pharmacies to obtain a waste
management license for denaturing CDs and this is seen by the EA as a ‗low risk‘
activity. The EA emphasises, however, that it may amend or revoke its position at any
time and will continue enforcement in all circumstances where activity has or is likely to
cause pollution or harm to health. So, pharmacists must ensure that the activities they
undertake to denature CDs protect the environment and workers and others within the
pharmacy. These guidelines may transfer to other Healthcare settings e.g. Community
Nursing.
Solid dose formulations
Tablets and capsules can be removed from their outer packaging, removed from blister
packaging and placed in a CD denaturing kit. If a person is removing tablets / capsules
from blister packs they should wear gloves.
CD denaturing kits can be obtained from some PCTs, waste contractors, NHS
Supplies and the National Pharmacy Association.
Best practice would be to grind* or crush* the solid dose formulation before adding to
the CD denaturing kit to ensure that whole tablets or capsules are not readily
recoverable.
An alternative method of denaturing is to crush or grind the solid dose formulation and
place it into a small amount of hot, soapy water stirring sufficiently to ensure the drug
has been dissolved or dispersed. The resulting mixture may then be added to an
appropriate waste disposal bin supplied by the waste contractor.
*If grinding or crushing of tablets or capsules takes place, steps must be taken to
ensure that particles of CD dust are not released into the air or that this is minimised.
The use of a small amount of water whilst grinding or crushing may assist. It may also
be necessary for the person involved in the grinding or crushing to wear a suitable face
mask for protection, suitable gloves and ensure that the area is well ventilated.
Liquid dose formulations
A CD liquid can be poured from its container and added to the normal CD denaturing
kit where it will mix with the other waste materials, thus rendering it irretrievable.
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An alternative method of disposing of a large quantity of a liquid controlled drug is by
adding and adsorbing it into an appropriate amount of cat litter, or similar product.
However, this activity would need to take account of health and safety regulations so
that the person destroying the CDs and the environment are safeguarded from harm
and pollution. The cat litter or similar product should be disposed of for incineration via
the usual waste disposal methods for medicines.
Parenteral formulations
Liquid ampoules should be opened and as much of the content as possible emptied
into the CD denaturing kit or disposed of in the same manner as disposing of liquids
outlined above.
The ampoule should be disposed off in the sharps bin. The sharps bin should be
labelled ―contains mixed pharmaceutical waste and sharps – for incineration‖.
Ampoules containing the CD in a powder form can be opened, water added to dissolve
the powder and the resultant mixture poured into the CD denaturing kit or the bin that
is used for disposal of liquid medicines. The ampoule can then be disposed of in the
sharps bin. The sharps bin should be labelled ―contains mixed pharmaceutical waste
and sharps – for incineration‖. These are the ideal methods of denaturing ampoules.
Suitable gloves should be worn by the person breaking open glass ampoules as a
safety measure and to minimise the risk of injury from sharps.
An alternative but less preferable, disposal method is where the ampoules are crushed
with a pestle inside an empty plastic container. Once broken, a small quantity of hot
soapy water (for powder ampoules) or cat litter (for liquid ampoules) is added. If these
methods are used, care should be taken to ensure that the glass does not harm the
person destroying the CD. The resulting liquid mixture should then be disposed of in a
CD denaturing kit or in the bin that is used for disposal of liquid medicines.
Fentanyl and buprenorphine patches
The active ingredient in the patches can be rendered irretrievable by removing the
backing and folding the patch over on itself and then placing it in a waste disposal bin
or preferably a CD denaturing kit. Gloves must be worn by the person destroying the
CD.
Aerosol formulations
Aerosol formulations should be expelled into water (to prevent droplets of drug
entering the air). As a further precaution, it would be advisable for a facemask to be
worn by staff undertaking the activity and to ensure that the area where the destruction
takes place is well ventilated. The resulting solution can then be disposed of in
accordance with the above guidance on destruction of liquid formulations.
Controlled Drug Denaturing Kit
Shake container to loosen granules.
Fill container with one filling. (I.e. even if only one tablet/ampoule to destroy &
complete the process below)
Add the controlled drug as above to half the capacity of the jar.
Fill to capacity with water.
Replace lid securely.
Shake thoroughly to disperse.
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Contents congeal in 3 - 5 minute
Dispose of the denaturing kit in the designated medicines waste bins
immediately do not keep for further use.
Dispose of denaturing container by secure incineration service.
Controlled drug denaturing kits should not be used for the destruction of non CD
medicines.
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Appendix Q
Standard Operating Procedure for witnessing the destruction of Controlled
Drugs by a delegated PCT Pharmacist.
Version: 2
Date produced: 16/9/07, Updated November 2009
Revision Date: November 2012
Produced By: Kate Huddart (Senior Pharmaceutical Adviser)
Purpose: To ensure a standardised approach to controlled drug destruction by
delegated PCT Pharmacists across County Durham and Darlington.
1. Authorisation.
1.1 PCT staff that destroys controlled drugs must have delegated authority from the
Accountable Officer in writing. Currently delegated authority rests with the 7
pharmacists employed within the Medical Directorate:-
Kate Huddart
Sharron Kebbell
Linda Neely
Joan Sutherland
Ian Morris
Hazel Betteney
Stephen Purdy
1.2 The above named delegated PCT Pharmacists are directly accountable to the
Accountable Officer for controlled drugs destruction.
2. Destruction of Controlled Drugs in a G.P Practice / Dispensing Doctors
2.1 Delegated PCT Pharmacist should take their own CD Destruction Log and a
CD Denaturing kit with them to the practice.
2.2 Delegated PCT Pharmacist inspects CD cupboard to ensure that it is of the
correct standard and mounted in a secure way.
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2.3 Delegated PCT Pharmacist, along with Practice Witness (G.P, Practice
Manager or Practice Nurse) ensures keys are stored in a secure way.
2.4 Delegated PCT Pharmacist makes an entry in the practice CD register giving
the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Batch Number and date of expiry
Quantity to be destroyed
Signature of the delegated PCT Pharmacist
RPSGB number of the delegated Pharmacist
e.g. 18/9/07 Morphine Sulphate 10mg (Sevredol) 24 tablets BN 213AB Expired
20/06/07. Destroyed by PCT Pharmacist K E Huddart MRPharm Reg No 91749
2.5 Practice Witness also signs the entry in the CD register.
2.6 Prior to destruction check that any remaining in date stock balances with the
running balance of stock.
2.7 Amend running balance of stock
2.8 Delegated PCT Pharmacist then makes an entry in their own CD Destruction
Log Book giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Quantity destroyed
Signature of Pharmacist
Printed name of Pharmacist
2.9 Practice Witness also signs and prints their name against the entry in the
delegated PCT Pharmacist‘s CD Destruction Log Book.
2.10 The delegated PCT Pharmacist then carries out the destruction of the CD in the
presence of the Practice Witness.
2.11 The controlled drug must be destroyed as outlined in the RPSGB guidance for
pharmacists on the Safe Destruction of Controlled Drugs in England, Scotland and
Wales.
2.12 The process from 2.4 to 2.11 is repeated for each different strength and
presentation of controlled drug that is out of date.
2.13 The used CD Denaturing kit is then placed in the yellow medicines waste bin.
2.14 The delegated PCT Pharmacist conducts a spot check on 2 other CD‘s running
balances of stock. The delegated pharmacist makes an entry within the practice CD
register on the relevant page of the stock check, noting any discrepancies or
amendments to the running total
E.g. 18/09/07 Stock check of Morphine Sulphate 10mg (Sevredol) tablets by PCT
Pharmacist. K E Huddart MRPharm Reg. No. 91749. Stock check correct.
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2.15 The delegated PCT Pharmacist conducts a CD Practice Audit (Appendix I within
CD Policy) or a G.P. Dispensing Practice Audit (Appendix K within CD Policy), if the
practice has not had a previous audit conducted during that financial year.
2.16 If a previous CD Practice Audit has been completed then the delegated PCT
Pharmacist must complete a CD Destruction Form (Appendix R within CD Policy)
and forward this form to the Prescribing Support Technician as a record of the visit.
2.17 Any discrepancies or any other concerns must be notified to the Head of
Medicines Management and the PCT‘s Accountable Officer immediately.
3 Destruction of Controlled Drugs in GP individual stocks
3.1 Delegated PCT Pharmacist should take their own CD Destruction Log and a
CD Denaturing kit with them to the practice.
3.2 Delegated PCT Pharmacist inspects CDs are stored in a secure way by the
G.P.
3.3 Delegated PCT Pharmacist makes an entry in the G.P. CD register giving the
following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Batch Number and date of expiry
Quantity to be destroyed
Signature of the delegated PCT Pharmacist
RPSGB number of the delegated Pharmacist
3.4 GP must also sign the entry in his/her CD register.
3.5 Prior to destruction check that any remaining in date stock balances with the
running balance of stock.
3.6 Amend running balance of stock
3.7 Delegated PCT Pharmacist then makes an entry in their own CD Destruction
Log Book giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Quantity destroyed
Signature of Pharmacist
Printed name of Pharmacist
3.8 GP must sign and print their name against the entry in the delegated PCT
Pharmacist‘s CD Destruction Log Book.
3.9 The delegated PCT Pharmacist then carries out the destruction of the CD in the
presence of the GP.
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3.10 The controlled drug must be destroyed as outlined in the RPSGB guidance for
pharmacists on the Safe Destruction of Controlled Drugs in England, Scotland and
Wales.
3.11 The process from 3.3 to 3.10 is repeated for each different strength and
presentation of controlled drug that is out of date.
3.12 The used CD Denaturing kit is then placed in the yellow Medicines Waste bin.
3.13 The delegated PCT Pharmacist conducts a spot check on 2 other CD‘s running
balances of stock. The delegated pharmacist makes an entry within the practice CD
register on the relevant page of the stock check, noting any discrepancies or
amendments to the running total
E.g. 18/09/07 Stock check of Morphine Sulphate 10mg (Sevredol) tablets by PCT
Pharmacist. K E Huddart MRPharm Reg. No. 91749. Stock check correct.
3.14 The delegated PCT Pharmacist conducts a GP CD audit if the GP has not had
a previous CD audit in that financial year.
3.15 If a previous GP CD Audit has been completed then the delegated PCT
Pharmacist must complete a CD Destruction Form (Appendix R within CD Policy) and
forward this form to the Prescribing Support Technician as a record of the visit.
3.16 Any discrepancies or any other concerns must be notified to the Head of
Medicines Management and the PCT‘s Accountable Officer immediately.
4 Destruction of Controlled Drugs in a Community Pharmacy
4.1 Delegated PCT Pharmacist should take their own CD Destruction Log and a CD
Denaturing kit with them to the practice.
4.2 Delegated PCT Pharmacist inspects CD cupboard to ensure that it is of the
correct standard and mounted in a secure way
4.3 Delegated PCT Pharmacist, along with community pharmacist ensures keys are
stored in a secure way.
4.4 Delegated PCT Pharmacist to ensure that any patient returned controlled drugs
are separated and inform the community pharmacist that they need to be destroyed by
the community pharmacist as soon as possible in line with RPSGB guidance for
pharmacists on the safe destruction of Controlled drugs in England, Scotland and
Wales.
4.5 Delegated PCT Pharmacist to ensure that all out of date stock is clearly marked
‗out of date‘ on packaging and has been segregated from other stock. The RPSGB
inspector currently recommends out of date stock is placed in a clear bag,
appropriately labelled, stating ‗out of date stock‘ and also the quantity enclosed within.
4.6 Delegated PCT Pharmacist makes an entry in the community pharmacy CD
register giving the following details of the Controlled Drug destruction:-
Date
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Drug, Formulation and Strength
Batch Number and date of expiry
Quantity to be destroyed
Signature of the delegated PCT Pharmacist
RPSGB number of the delegated Pharmacist
E.g. 18/9/07 Morphine Sulphate 10mg (Sevredol) 24 tablets BN213AB Expired
20/06/07. Destroyed by PCT Pharmacist K E Huddart MRPharm Reg No 91749
4.7 The community pharmacist must also sign and add their RPSGB number to the
entry in the CD register.
4.8 Prior to destruction the delegated PCT pharmacist must check that any
remaining in date stock balances with running balance of stock. Please Note that out of
date CDs should be included in the running balance until they are destroyed.
4.9 Delegated PCT Pharmacist then makes an entry in their own CD
Destruction Log Book giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Quantity destroyed
Signature of Pharmacist
Printed name of Pharmacist
4.10 Community Pharmacist also signs and prints their name against the entry in the
delegated PCT Pharmacist‘s CD Destruction Log Book.
4.11 The delegated PCT Pharmacist then carries out the destruction of the CD in the
presence of the community pharmacist.
4.12 The controlled drug must be destroyed as outlined in the RPSGB guidance for
pharmacists on the Safe Destruction of Controlled Drugs in England, Scotland and
Wales.
4.13 The process from 4.6 to 4.12 is repeated for each different strength and
presentation of controlled drug that is out of date.
4.14 The used CD Denaturing kit should then be placed in the yellow Medicines
Waste bin within the department.
4.15 The delegated PCT Pharmacist conducts a spot check on 2 other CD‘s running
balances of stock. The delegated pharmacist makes an entry within the practice CD
register on the relevant page of the stock check, noting any discrepancies or
amendments to the running total
E.g. 18/09/07 Stock check of Morphine Sulphate 10mg (Sevredol) tablets by PCT
Pharmacist. K E Huddart MRPharm Reg. No. 91749. Stock check correct.
4.16 The delegated PCT Pharmacist completes a CD destruction form for community
pharmacy (Appendix R within CD Policy) and forwards this to the Prescribing Support
Technician as a record of the visit.
4.17 Any discrepancies or any other concerns must be notified to the Head of
Medicines Management and the PCT‘s Accountable Officer immediately.
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4.18 The Head of Medicines Management will discuss any discrepancy or other
concern with the relevant parties e.g. RPSGB Inspector.
5 Destruction of Controlled Drugs in the OOH‟s Centres
5.1 All stock within UCC/OOH CD cupboard expiring within the week is highlighted
to the UCC/OOH manager when a spot check is carried out.
5.2 If the stock has not been used within that month, the UCC/OOH manager then
contacts the delegated PCT Pharmacist and organises a date for destruction.
5.3 Delegated PCT Pharmacist should take their own CD Destruction Log and a CD
Denaturing kit with them to the practice.
5.4 Delegated PCT Pharmacist inspects CD cupboard to ensure that it is of the
correct standard and mounted in a secure way.
5.5 Delegated PCT Pharmacist, along with ECP/Clinical Lead ensures keys are
stored in a secure way.
5.6 Delegated PCT Pharmacist makes an entry in the UCC/OOH Centre CD
register giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Batch Number and date of expiry
Quantity to be destroyed
Signature of the delegated PCT Pharmacist
RPSGB number of the delegated Pharmacist
E.g. 18/9/07 Morphine Sulphate 10mg (Sevredol) 24 tablets BN 213AB Expired
20/06/07. Destroyed by PCT Pharmacist K E Huddart MRPharm Reg No 91749
5.7 Emergency Care Practitioner/ Clinical Lead must also sign the entry in the CD
register.
5.8 Prior to destruction check that any remaining in date stock balances with the
running balance of stock.
5.9 Amend running balance of stock.
5.10 Delegated PCT Pharmacist then makes an entry in their own CD Destruction
Log Book giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Quantity destroyed
Signature of Pharmacist
Printed name of Pharmacist
5.11 ECP/Clinical Lead also signs and prints their name against the entry in the
delegated PCT Pharmacist‘s CD Destruction Log Book.
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5.12 The UCC/OOH Centre stock control book should be amended accordingly by
the ECP /Clinical Lead witnessing the destruction and initialled by the delegated PCT
Pharmacist.
5.13 The delegated PCT Pharmacist then carries out the destruction of the CD in the
presence of the ECP or Clinical Lead.
5.14 The controlled drug must be destroyed as outlined in the RPSGB guidance for
pharmacists on the Safe Destruction of Controlled Drugs in England, Scotland and
Wales.
5.15 The process from 5.6 to 5.14 is repeated for each different strength and
presentation of controlled drug that is out of date.
5.16 The used CD Denaturing kit is then placed in the yellow medicines waste bin at
the UCC. Please Note: If the UCC/OOH centre does not have a medicines waste bin
for out of date medicines then take the used CD Denaturing kit to the nearest available
GP practice or community pharmacy and place in their yellow medicines waste bin.
5.17 The delegated PCT Pharmacist conducts a spot check on 2 other CD‘s running
balances of stock. The delegated pharmacist makes an entry within the practice CD
register on the relevant page of the stock check, noting any discrepancies or
amendments to the running total
E.g. 18/09/07 Stock check of Morphine Sulphate 10mg (Sevredol) tablets by PCT
Pharmacist. K E Huddart MRPharm Reg. No. 91749. Stock check correct.
5.18 The delegated PCT Pharmacist should conduct an UCC/OOH centre CD audit
(Appendix K within CD Policy) if the UCC/OOH centre has not had a previous audit
conducted in that financial year.
5.19 If a previous CD UCC/OOH centre audit has been completed then the
delegated PCT Pharmacist must complete a CD destruction form (Appendix R within
CD Policy) and forward it to the Prescribing Support Technician as a record of the visit.
5.20 Any discrepancies or any other concerns must be notified to the Head of
Medicines Management and the PCT‘s Accountable Officer immediately.
5.21
6 Destruction of Controlled Drugs in Prisons.
6.1 Delegated PCT Pharmacist should take their own CD Destruction Log and a CD
Denaturing kit with them to the prison.
6.2 Delegated PCT Pharmacist inspects CD cupboard to ensure that it is of the
correct standard and mounted in a secure way.
6.3 Delegated PCT Pharmacist, along with Prison Pharmacist ensures keys are
stored in a secure way.
6.4 Delegated PCT Pharmacist to ensure that any patient returned controlled drugs
are separated and inform the prison pharmacist that they need to be destroyed by the
community pharmacist as soon as possible in line with RPSGB guidance for
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pharmacists on the safe destruction of Controlled drugs in England, Scotland and
Wales.
6.5 Delegated PCT Pharmacist to ensure that all out of date stock is clearly marked
‗out of date‘ on packaging and has been segregated from other stock. The RPSGB
inspector currently recommends out of date stock is placed in a clear bag,
appropriately labelled, stating ‗out of date stock‘ and also the quantity enclosed within.
6.6 Delegated PCT Pharmacist makes an entry in the prison pharmacy CD register
giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Batch Number and date of expiry
Quantity to be destroyed
Signature of the delegated PCT Pharmacist
RPSGB number of the delegated Pharmacist
E.g. 18/9/07 Morphine Sulphate 10mg (Sevredol) 24 tablets BN 213AB Expired
20/06/07. Destroyed by PCT Pharmacist K E Huddart MRPharm Reg No 91749
6.7 The prison pharmacist must also sign and add their RPSGB number to the entry
in the CD register.
6.8 Prior to destruction the delegated PCT pharmacist must check that any
remaining in date stock balances with running balance of stock. Please Note that out of
date CDs should be included in the running balance until they are destroyed.
6.9 Delegated PCT Pharmacist then makes an entry in their own CD Destruction Log
Book giving the following details of the Controlled Drug destruction:-
Date
Drug, Formulation and Strength
Quantity destroyed
Signature of Pharmacist
Printed name of Pharmacist
6.10 Prison Pharmacist also signs and prints their name against the entry in the
delegated PCT Pharmacist‘s CD Destruction Log Book.
6.11 The delegated PCT Pharmacist then carries out the destruction of the CD in the
presence of the Prison Pharmacist.
6.12 The controlled drug must be destroyed as outlined in the RPSGB guidance for
pharmacists on the Safe Destruction of Controlled Drugs in England, Scotland and
Wales.
6.13 The process from 6.6 to 6.12 is repeated for each different strength and
presentation of controlled drug that is out of date.
6.14 The used CD Denaturing kit should then be placed in the yellow medicines
waste bin within the department.
6.15 The delegated PCT Pharmacist conducts a spot check on 2 other CD‘s running
balances of stock. The delegated pharmacist makes an entry within the prison
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pharmacy CD register on the relevant page of the stock check, noting any
discrepancies or amendments to the running total
E.g. 18/09/07 Stock check of Morphine Sulphate 10mg (Sevredol) tablets by PCT
Pharmacist. K E Huddart MRPharm Reg. No. 91749. Stock check correct.
6.16 The delegated PCT Pharmacist should conduct a CD Prison Audit (Appendix M
within CD policy), if the prison has not had a previous audit conducted in that financial
year.
6.17 If a previous CD Prison Pharmacy Audit has been completed then the delegated
PCT Pharmacist must complete a CD Destruction Form (Appendix R within CD Policy)
and forward this form to the Prescribing Support Technician as a record of the visit.
6.18 Any discrepancies or any other concerns must be notified to the Head of
Medicines Management and the PCT‘s Accountable Officer immediately.
6.19 The Head of Medicines Management will discuss any discrepancy or other
concern with the relevant parties e.g. RPSGB Inspector.
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Appendix R Controlled Drug Destruction Record
Location (please circle) Name and Address of location
General Practice
Community Pharmacy
Community Hospital
Other – please give detail
Details of Controlled drugs destroyed
Drug name /strength / formulation Quantity Reason for destruction
Comments/advice given
Authorised witness
(name and designation)
Second witness
(name and designation)
Date
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Appendix S – SUMMARY OF CONTROLLED DRUGS GUIDANCE FOR GPs
1.0 INTRODUCTION
1.1 Medicines Legislation governs the purchase, prescribing, storage, record
keeping, monitoring and destruction of Controlled Drugs.
1.2 The PCT Accountable Officer and the Police have the right of entry into
premises for the purpose of Controlled Drugs Monitoring and Inspection. This
authority can be delegated to suitably trained personnel such as the PCT
Commissioning Pharmaceutical Advisers.
1.3 Refer to the PCT Controlled Drug Policy for more detailed guidance and be
aware that legislation around CDs is subject to change.
2.0 GOVERNANCE, INSPECTION AND MONITORING
2.1 All practices and GPs are required to complete an annual declaration stating
whether or not they keep a stock of CDs.
2.2 Practices and GPs holding stock will be required to complete a self assessment
of their management of CDs
2.3 PCT will arrange for a small number of routine inspections from a random
sample of GPs, annually.
2.4 Controlled drug prescribing and purchases are monitored by the PCT via ePACT
and GPs may periodically be requested to review their prescribing.
3.0 STANDARD OPERATING PROCEDURES (SOPs) Appendix T of CD Policy
3.1 These should ensure there is a full audit trail for movement of CDs from
acquisition to administration and disposal and record keeping.
3.2 SOPs should also include how to deal with discrepancies in CD stock and
register; how and to whom staff can raise any concerns relating to CDs.
4.0 PURCHASING CONTROLLED DRUGS
4.1 A requisition form FP10CDF should be completed to purchase Schedule 2 & 3
CDs
4.2 FP10CDF forms are available from the service that provides prescription forms.
4.3 FP10CDF forms are controlled stationary and should be stored securely with
restricted access.
4.4 GPs must not use FP10 prescriptions to top up their personal or practice stock
CDs.
4.5 A system should be put in place for completing the FP10CDF forms as these are
monitored to individual GPs via ePACT.
4.6 The pharmacy will record the name of the person collecting the CDs in their
registers.
4.7 If a member of staff is sent to collect the CD they must carry a bearer‘s note,
signed and dated by the prescriber, stating they are authorised to carry the CD;
the pharmacy may retain the note.
5.0 STORAGE IN THE PRACTICE
5.1 CDs requiring safe custody must be stored in a designated locked CD cabinet or
safe.
5.2 The cabinet should be metal and fixed to the wall or floor with rag bolts and
within a lockable room with restricted access.
5.3 Ideally no other items should be stored in the CD cupboard/ safe; if this isn‘t
possible the CDs should be segregated from other items stored in the
cabinet/safe.
5.4 A designated person should be responsible for the safe custody of the keys and
records of who has access to keys or security code numbers. It is recommended
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that key codes are changed regularly to maintain security.
5.5 A designated person should be responsible for accepting stock into the practice,
transfer of stock to individual GPs and maintaining the stock CD register.
6.0 STORAGE IN GP HOME VISIT BAGS
6.1 Bags should be lockable and kept locked at all times except when in use.
6.2 Controlled drugs should not be left unattended in a car for prolonged periods of
time.
6.3 When on annual leave the Dr should consider handing over their controlled
drugs to the practice for safekeeping.
6.4 Controlled drug stock should be kept to a minimum and only one strength kept to
reduce the likelihood of an error.
6.5 Each ‗bag‘ must have its own designated CD register, which should ideally be
kept separate from the bag, in case the bag is lost or stolen.
6.6 Each GP is personally responsible for making entries into their bag register.
6.7 Supplies into a doctor‘s bag should be witnessed; this is considered essential if
top up is made from the practice central store.
6.8 SHARED BAGS: A full audit of the date and time of bags being handed to and
from each person should be made in a hard bound book. The stock balance and
CD register should be checked at each handover. The bag should be locked in a
cupboard with restricted access when not in use. A record should be made of
who has access to the bag and who is responsible for handing over and
receiving the bag.
7.0 STOCK CHECKS
Designated person(s) should be responsible for checking the CD stock and
expiry dates on at least a monthly basis and a record made that this has been
done.
8.0 CONTROLLED DRUG REGISTERS
8.1 The registers must be bound or computerised.
8.2 Entries in hard copy must be made in ink and in chronological order;
computerised records must be fully attributable and auditable.
8.3 A separate page is required for each controlled drug and presentation and
strength.
8.4 A running balance should be maintained.
8.5 All receipts and issues should be made within 24 hours of transaction
8.6 There should be no gaps between each line in the register
8.7 If an error is made then do not obliterate. Bracket entry in a manner that details
can still be seen, mark ‗error‘ and next to or in margin write the correct details
8.8 Drugs received; All register entries must show: -
Date received
Name and address of person or firm from whom they are received
Name and signature of person making the CD entry.
The amount received
Form and strength in which supplied
Running balance
8.9 Drugs administered/ supplied
Date and time administration/ supply made
Name and address of person for whom it was administered/supplied.
Name and authority of person who supplied/administered the item.
Amount administered/supplied
Running balance.
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Reimbursement should be made via a personally administered claim via FP10
for the practice.
9.0 OUT OF DATE STOCK or STOCK NO LONGER REQUIRED
9.1 The PCT Commissioning Medicines Management Team should be contacted to
make arrangements for disposal of stock CDs as this can only be performed by
an authorised person.
9.2 If the practice hold a central stock out of date CDs can be returned to the central
store; a record of this should be made in the CD registers.
9.3 If the practice does not hold central stock the destruction should take place
directly from the doctor‘s bag.
9.4 Out of date stock should be clearly marked and segregated from in date stock.
10.0 PATIENTS OWN CONTROLLED DRUGS
10.1 Medicines dispensed for one patient must not be used to treat another patient.
10.2 Patients should be encouraged to return their unwanted CDs to a pharmacy for
destruction.
10.3 Nursing and practice staff should not accept patients controlled drugs for
destruction except in exceptional circumstances.
10.4 If handed to a GP they cannot in theory be passed on to a pharmacy for
destruction.
10.5 The CDs should be recorded in a book specifically kept for this purpose.
10.6 Strict environment legislation covers the handling of all waste in the UK;
medicines should never be disposed of in household waste, sinks or flushing
down toilets.
10.7 CDs should be denatured before destruction. ‗DOOP‘ kits specifically designed
for this purpose are available from the waste company or the PCT; the DOOP kit
should be disposed of in the pharmaceutical waste bins.
10.7 Destruction should be witnessed.
10.8 ONLY in exceptional circumstances, district/community nursing staff can
destroy, with consent, patients controlled drugs and a record must be made and
witnessed if possible.
10.9 If a GP administers a patients own CDs during a home visit a record of this must
be made on the patient held nursing records or administration chart if available
and the practice computerised medical records. This should include drug, dose,
form, date and time of administration and if applicable running balance.
11.0 PRESCRIPTIONS
11.1 It is a criminal offence for a pharmacist to dispense a controlled drug against a
prescription which does not fully comply with legislation.
11.2 Prescriptions for CDs should be limited to 30 days supply.
11.3 Instalment prescriptions for drug addiction must be limited to a maximum of 14
days supply.
11.3 If more than 30 days supply is considered clinically appropriate a note should be
made in the patient‘s records stating the reason why.
11.4 Prescriptions for CDs are valid for 28 days; a later start date can be added; for
instalment prescriptions, the first instalment must be made within 28 days of the
start date.
11.5 A Home Office licence is required to prescribe diamorphine, dipipanone and
cocaine to substance misusers; GPs can prescribe these drugs for the relief of
pain due to organic disease or injury without a licence.
11.6 Other than in emergencies practitioners should not prescribe for themselves or
anyone they have a close personal relationship with including friends, family and
colleagues.
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12.0 PRIVATE PRESCRIPTIONS
12.1 A unique private prescriber code is required for a practitioner wishing to issue
private prescriptions.
12.2 Requests for a private prescriber code should be made to the PCT.
12.3 Private prescriptions must be written on designated private prescription forms
FP10 (PDC) NC.
12.4 FP10(PDC) NC private prescriptions are available from the PCT.
13.0 PATIENTS TRAVELLING OVERSEAS
13.1 Persons travelling for over three months either abroad or to the UK will need a
personal export/import licence.
13.2 If travelling for 3 months or less a Home Office licence is not required.
13.3 A personal licence has no authority outside the UK; it allows unhindered
passage through UK customs.
13.4 Personal licence application forms can be downloaded from the Home Office
web site.
13.5 Applications should be made at least 10 days prior to travel.
13.6 Licences are normally issued with an expiry date of one week after the expected
return to the UK.
13.7 It is good practice for CDs to be carried in their original container in hand
luggage with a letter from the prescribing doctor confirming the carriers name,
destination, drug details and amount.
13.8 If a person is staying outside their resident country for a period exceeding 3
months they should be advised to register with a doctor in the country they are
visiting for the purpose of receiving further prescriptions.
13.9 Other countries have their own import regulations for controlled drugs; travellers
should check this with UK based representative of country they are travelling to.
Issued by PCT Commissioning Medicines Management Team September 2008. Valid until 2010 or
sooner if newlegislation. To be read in conjunction with full PCT Controlled Drug Policy.
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APPENDIX T – GUIDANCE ON STANDARD OPERATING POLICY
This is intended as a guide for areas to consider when completing an SOP. Not all
areas but most will apply to each setting and more details may need to be added; refer
to full policy.
Designated person with overall
responsibility for controlled drugs
List of personnel allowed to prescribe
controlled drugs
List of personnel allowed to
supply/administer controlled drugs via
PGD
List of personnel allowed access to
controlled drug cabinet/safe/Drs bag
Prescriptions for controlled drugs
generated by (hand/computer/both)
A maximum of 30 days supply will be
prescribed.
Who is allowed to generate
prescriptions for CDs via computer
Prescription for controlled drugs
awaiting doctor‘s signature are placed
separately – where.
Details of where records are made for
CD prescriptions awaiting collection
Where are CD prescriptions awaiting
collection stored?
Details of where records are made of
person collecting the CD prescription
Procedure for missing CD
prescriptions
Name and Address of where CDs are
ordered from
Persons authorised to order
controlled drugs
Requisition forms used
Requisition forms are stored securely,
where
How is the requisition form sent to the
supplier
How are the CDs transferred from
supplier to the premises and by whom
The level of stock required is
If more than 30 days supply of a CD
is required on a prescription the
prescribing doctor will make a note in
the patient‘s clinical records.
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eviewed annually by
Who is authorised to receive
controlled drugs onto the premises
Where are the CDs placed when they
arrive at premises
The CDs received into the premises
are recorded in the controlled drug
register immediately on receipt by?
A running balance is maintained and
the stock checked on receipt.
The record of order and invoices
stored for 7 years, where?
Supply
Statement if CDs are supplied or not
Who is allowed to supply CDs
Including supply from central store to
doctors bags
What is the procedure for supplying
CDs
Administration
Are patients own CDs administered
Are stock CDs administered to
patients
Records of administration include
patients name, address, Drug, dose,
route and time of administration.
This record is made where
CD register
Patients clinical records
If patient has medicines chart/nursing
record or similar a record is also
made there.
The administration of CDs is
witnessed by.
If administration is not witnessed
state circumstances where this is
allowed.
Storage
Where are controlled drugs stored
List all places including each
individual doctors bag
Is a Home Office Licence required
Are there keys? What is procedure for
access and storing keys?
Who is allowed access to keys/ codes
and how is this regulated?
Doctors/Home visit bag (lockable
how?)
Points to consider
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Where is the bag stored
Whilst in practice
When on a home visit
When car unattended
Overnight
When on holiday
Transport
Who is allowed to transport CDs
Under what circumstances
What records are made
Stock Checks
List of CDs allowed to be stocked in
each area
The stock balance is checked by
This check is performed (state
intervals)
A record of the check is made (in the
CD register/on computer)
Destruction - Stock
Out of date/obsolete and CDs no
longer required are segregated by
placing in a bag (preferably clear
plastic) clearly labelled out of date
stock not for use.
Where CDs awaiting destruction are
stored)
Out of date CDs should remain in
running balance in register until time
of destruction.
Contact authorised person list names
and contact email/phone number.
Who is responsible for overseeing
this
Destruction Patients Own
Patients own medicines are not
reused for the treatment of any other
patient
Do you advise Patients to return CDs
to community pharmacy for
destruction
Under what circumstances do you
receive or are responsible for
destruction of patients own CDs
CD denaturing kits must be used
Enter details of how this is done
Where to obtain kits and where to
dispose of
Records must be kept, how is this
done and where
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Patients Own CDs - residential
Is the patient self medicating
Is there a policy/procedure for
patients who self medicate?
All above may apply & help complete
SOP
Record Keeping, including CD
registers
Where will records be stored
Should be kept for minimum of 7
years or longer if other NHS record
keeping policies apply
Dealing with discrepancies and
concerns
How are discrepancies in the running
balance dealt with
If stock/patients own CDs are missing
who should this be reported to
Give details of incident reporting
system
Give details of who else staff may
contact if they have concerns
How will staff reporting concerns be
protected
How would you deal with member of
staff about whom concerns have
been raised? May refer to other
policies about fitness to practice,
regulatory authority and codes of
conduct etc
National Patient Safety Alerts
Different strengths of injectable
opiates should be stored separately.
High dose injectable opiates i.e.
diamorphine 30mg and over should
be clearly marked and stored
separately from lower strengths. How
is this achieved in organisation?
Naloxone should be kept in each
clinical area including Drs bags where
injectable opiates are stored/
administered.
How is this done in the organisation?
There should be clear SOPs for
administration of injections including
how to prepare an injection i.e.
reconstitute
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Staff should be made aware of any SOPs applicable in the organisation and a record
made that they have read and understood them including the consequences of not
complying with the SOP.
SOPs should be reviewed on a regular basis to ensure they are practical and reflect
current practice and legislation. If training or competency is required in order to
implement an SOP a record should be made of when, how, what and to whom this was
completed.
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