IJOPP Vol.2(1), Jan-Mar, 2009 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy Practice
ijopp
Vol.1(2), Jan-Mar, 2009
EDITOR-IN-CHIEF
A
Dr. Shobha Rani R. Hiremath
shobha24@yahoo.com
P
ASSOCIATE EDITORS
Dr. G. Parthasarathi
Dr. Pramil Tiwari
partha18@airtelmail.in ptiwari@niper.ac.in
T
ASSISTANT EDITORS
Mr. Jaiprakash S. Vastrad
Mr. Ramjan Shaik
jsvastrad@gmail.com
ramjanshaik@gmail.com
I
EDITORIAL OFFICE
INDIAN JOURNAL OF PHARMACY PRACTICE
An Official Publication of Association of Pharmaceutical Teachers of India
H.Q.: Al-Ameen College of Pharmacy,
Opp. Lalbagh Main Gate, Hosur Road, Bangalore 560 027, INDIA
Mobile: +91 9845399431 | +91 9845659585 | +91 9878488050 | +91 9972588878
+91 9916069842 | Ph: +91 80 32712981; Fax: +91 80 22225834
www.ijopp.org || ijopp@rediffmail.com

Indian Journal of
Pharmacy Practice
Indian Journal of Pharmacy Practice
ijopp
Vol.1(2), Jan-Mar, 2009
EDITORIAL ADVISORY BOARD
Dr. Atmaram P. Pawar, Pune
Dr. Claire Anderson, Nottingham, UK.
Dr. Dhanalakshmi Iyer, Mumbai
Prof. Ganachari M S, Belgaum
Dr. Geeta.S, Bangalore
Dr. Hukkeri V.I, Ratnagiri (Dist)
Dr. Krathish Bopanna, Bangalore
Prof. Mahendra Setty C.R, Bangalore
Dr. Miglani B D, New Delhi
Dr. Mohanta G.P., Annamalai Nagar
Dr. Nagavi B.G, Ras Al-Khaimah, UAE
Dr. Nalini Pais, Bangalore
Dr. Rajendran S.D, Hyderabad
Dr. Ramananda S.Nadig, Bangalore
Dr. Revikumar K G, Cochin
Dr. Sampada Patawardhan, Mumbai
Dr. Sriram. S, Coimbatore
Dr. Sreekant Murthy, Philadelphia, USA
Dr. Sunitha C. Srinivas, Grahamstown, RSA
Dr. Suresh B, Mysore
Dr. Tipnis H.P, Mumbai
Disclaimer: The editor-in-chief does not claim any responsibility, liability for
statements made and opinions expressed by authors
EDITORIAL OFFICE
INDIAN JOURNAL OF PHARMACY PRACTICE
An Official Publication of Association of Pharmaceutical Teachers of India
H.Q.: Al-Ameen College of Pharmacy,
Opp. Lalbagh Main Gate, Hosur Road, Bangalore 560 027, INDIA
Mobile: +91 9845399431 | +91 9845659585 | +91 9878488050 | +91 9972588878
+91 9916069842 | Ph: +91 80 32712981; Fax: +91 80 22225834
www.ijopp.org || ijopp@rediffmail.com

Indian Journal of
Pharmacy Practice
Indian Journal of Pharmacy Practice
ijopp
Vol.1(2), Jan-Mar, 2009
CONTENTS
Editorial
Review Articles
Clinical Pharmacy Practice in Psychiatry
Christopher P Alderman -----------------------------------------------------------------------------------------------1-7
Genesis, Development and Popularization of Doctor of Pharmacy (PharmD) Education Program at the
Global level -A study based on the story from 1955 to 2009.
Sonal Sekhar M, Suja Abraham, Revikumar KG--------------------------------------------------------------------8-17
Good Pharmacy Practices in Chronic Disease Management
Neelam Mahajan-----------------------------------------------------------------------------------------------------18-20
Drug Information Centre (DIC)-An Indian Scenario
Nitesh S Chauhan, Firdous, R Raveendra, Geetha J, B Gopalakrishna,Roopa Karki-------------------------21-27
Research Articles
A prospective study comparing Total Lymphocyte Count (TLC) and CD4 counts in HIV patients in a
resource limited setting in India
Lincy Lal, Cijo George, Anitha Yesoda, Jayakumar.B-------------------------------------------------------------28-35
A Study of Clinical Pharmacist Initiated Changes in Drug Therapy in a Teaching Hospital
Bhupathy Alagiriswami,Madhan Ramesh, Gurumurthy Parthasarathi, Hatthur Basavanagowdappa----36 -45
Pharmacy and Therapeutics Committee in Bangalore Institute of Oncology - Promoting Rational
Pharmaceutical Management
Divya Hariharaputhran, Sunitha C. Srinivas, Ramesh S. Billimaga, Ajai Kumar B.S------------------------46-52

Indian Journal of Pharmacy Practice
ijopp
Vol.1(2), Jan-Mar, 2009
Efficacy and Safety of Azithromycin with Various Cephalosporins Used in Treatment of Lower
Respiratory Tract Infection
1 2
Imran Ahmad Khan , Shobha Rani. R.H .-------------------------------------------------------------------------53 - 61
Evaluation of Drug Information Service provided by Clinical Pharmacy Department based on
Provider and Enquirers' Perspective
1 2 3 4 5
Kuchake V.G , Maheshwari O.D , Surana S.J , Patil P.H , Dighore P.N .--------------------------------------62-68
Short Communications
Preliminary Clinical Study of a Polyherbal Formulation (Wh1) in the Treatment of Vaginitis
Vishnu Bapat, Leena Alfred, Shobha Rani R.Hiremath, Pushpa. T Ksheerasagar,
Geetha Hegde, Soumya. K. Lund.----------------------------------------------------------------------------------69-74
Prevalence of Diseases and Observation of Drug Utilization Pattern in Geriatric Patients: A Home
Medication Review
Pandey Awanish,Tripathi Poonam,Pandey Rishabh Dev.-------------------------------------------------------75-80
Case Reports
L-Asparaginase Induced Central Venous Thrombosis in Acute Lymphoblastic Leukemia
Lavanya S, Vijayan K, Abhay Dharamsi, Rajasekaran A Vijayakumar A-------------------------------------81-84
Instructions to Authors -------------------------------------------------------------------------------------------85-88

Editorial
Dear Readers,
We are indeed very delighted at the warm and overwhelming response that we have received
for our first issue of the journal. Thanks to all the authors for their contribution and
reviewers for their timely co-operation. we look forward for the continued support.
With Pharm.D course started in many Institutions and about to start in many more, we have
greater responsibility in choosing and publishing the right articles so that it can make an
impression on the collaborating hospitals and clinicians on the role of pharmacist in patient
care.
Our objective is to publish those articles which highlight the role of pharmacist as an
important member of healthcare team in bringing about better patient care.
So once again, on behalf of the entire editorial team, I request all
academicians/researchers/practising pharmacists/students to contribute meaningful
articles that enrich the content of our journal and make it on par with any indexed
international journals.
Your feedback is most welcome for the improvement of our journal.
Dr. Shobha Rani R.Hiremath
Editor-in-chief

APTI
Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Clinical pharmacy practice in psychiatry
Christopher P Alderman
Director, Pharmacy Department and Clinical Pharmacist (Psychiatry)
Repatriation General Hospital, Daw Park, SOUTH AUSTRALIA
Address for Correspondence: chris.alderman@rgh.sa.gov.au
Invited Article
ijopp
An evolution of pharmacy practice
patients. The movement to 're-professionalisation' of
In an evolutionary process that has spanned several pharmacy involved practitioners accepting
1
decades, many pharmacists in primary and secondary responsibility and accountability for their input into the
care settings have shifted their focus from medication patient care process. 8
supply functions (largely in the form of compounding A concept that is gaining increasing currency and
and dispensing) to assisting other clinical staff with the credibility in relation to the role of clinical pharmacists in
management of patients and their drug therapy. This promoting optimal outcomes for patients is the
clinical pharmacy practice began in the 1960s, when contribution of these practitioners in the facilitation of
9
hospital pharmacists began visiting the wards of quality use of medicines (QUM). QUM has been defined
hospitals to check drug charts and proactively initiate as exhibiting three key components
medication supply without the need for prescriptions to judicious selection of therapeutic management options
2,3
be sent to the pharmacy. This practice allowed
(considering the place of medicines in treating illness
pharmacists to establish a presence at the point of patient
and maintaining health, and recognising the possibility
care, in daily contact with doctors and nurses, and
that there may be better ways than medicine to manage
a particular situation)
position themselves to offer advice and assistance with
selection of a suitable medication, if a medicine is
3, 4
matters relating to drug therapy.
considered necessary. This will involve consideration
In the context of ward pharmacy, pharmacists soon
of the characteristics of the individual patient, the
became involved in roles that included activities such as
5
clinical condition, risks and benefits associated with
recording patients' medication history and the
treatment options, the dosage and duration of
qualitative review of orders on patients' medication
treatment, co-existing conditions, other therapies,
6
charts. These practitioners were starting to assume a role
monitoring considerations, and costs for the
that helped to guide and inform prescribing, allowing
individual, the community and the health system as a
7
them to function as a part of a multidisciplinary team. whole.
Although the re-engineering of pharmacy practice to a safe and effective use of medications to
ward-based model facilitated these changes, other achieve optimal health outcomes through monitoring,
drivers also contributed. Rationing of public health funds minimizing misuse, over-use and under-use of medicreated
changes for the hospital sector, so that only the cations, and ensuring that the patient or their carer have
most acutely ill patients were admitted to hospital, for the knowledge and skills to solve problems related to
example. This in turn meant that the acuity and the use of their medication(s).
complexity of inpatient care progressively increased. The QUM framework extends the pharmaceutical care
Advances in pharmacotherapy led to the discovery and model and provides a mechanism for integrating clinical
widespread implementation of entirely new drug pharmacists into the broader health care environment.
treatment approaches for many clinical problems,
It has the potential to address the issues that the more
profession-specific pharmaceutical care model raised
creating a rapid expansion in the scope of information
in terms of the integration of pharmacists into the
about the clinical applications for these drugs, their
healthcare team. It also facilitates the routine
adverse effects and drug interactions and the need for
incorporation of pharmaceutical care as a component of
individualisation of dosage to accommodate the needs of
emerging service delivery programs in hospitals, agedcare
and primary health care settings and health care
Indian Journal of Pharmacy Practice
teams. It is important, therefore, that the unique
Received on 12/03/2009
Accepted on 12/03/2009 © APTI All rights reserved
contribution of clinical pharmacists that results from the
1

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
training and skills developed in practice should be widely
13
Table 1. Perhaps the most noteworthy aspect of this
understood.
comparison is that, although the data have been drawn
More than 30 years ago, it was already clear that the basis from a range of disparate sources such as North America,
for pharmacy specialisation is related to a specialised Western Europe, Asia and Australia, there are several
knowledge of pharmacy-related sciences (biological and common themes that emerge. Importantly, each study
10
behavioural), rather than a particular practice setting. validates the early findings from the work initiated by the
Pharmacists practising in specialised roles have the WHO, confirming the high prevalence of mental illness
opportunity to provide a highly refined and effective type in various settings and providing a basis for a conclusion
of pharmaceutical care in a context where a generalist that this area has justifiably been selected by health
practitioner may not have the opportunity to do so, policy makers as a high priority for the development of
providing a unique avenue to a high quality and strategies that might be used to reduce the associated
distinctive contribution to the advancement of quality harm.
use of medicines for highly vulnerable patients. A range It is clear that mental illnesses are very common. Those
of pharmaceutical specialities have now been who are affected, experience significant disadvantages
acknowledged and are flourishing, including highly that are evident in terms of poorer health outcomes,
focused areas such as oncology pharmacy, higher rates of premature death and enduring disability,
radiopharmacy and psychiatric pharmacy. The role of socioeconomic disadvantage and poor quality of life.
psychiatric pharmacists in patient care has been People with mental illness are significant users of health
11
extensively advocated, and this type of practice model services, having frequent and lengthy hospitalisations
has been shown to improve clinical outcomes and reduce and requiring extensive medication therapy.
psychotropic medication-related morbidity. 12 Polypharmacy is common amongst those with
Rationale for clinical pharmacy in psychiatry
psychiatric illnesses, and the drugs that are used are often
Extensive previous research has addressed the of low therapeutic index and with considerable potential
prevalence of MRPs in hospitals and the community, and to cause significant medication-related problems.
the utility of clinical pharmacy services as a means to Fundamentally, it is also clear that pharmacists, by nature
mitigate medication-related harm: a detailed discussion of their training, experience and skills developed through
of this research is beyond the scope of discussion here. ongoing clinical practice, bring a unique perspective to
The potential impact of the implementation of specialist the care of patients with mental illnesses, in this way
clinical pharmacy services would be expected to be enhancing health outcomes through the prevention,
influenced not only by the utility of the service delivery detection and resolution of medication-related problems.
model, but also the prevalence of mental illnesses and the The integration of specialist pharmacists into a
disability associated with them. With respect to quality multidisciplinary team caring for patients with complex
use of medicines initiatives in a public health sense, psychotropic pharmacotherapy needs allows the
priority must be given to areas in which adverse health application of the unique skills and experience of these
outcomes and medication-related harm have the greatest practitioners in situations where that positive impact of
potential to cause death, disability, compromised quality the services can be expected to be highest. It is desirable
of life and adverse societal consequences, including for pharmacists to have distinctive role in
increased treatment costs, increased health service multidisciplinary mental health treatment teams,
utilisation and other unfavourable economic outcomes working in cooperation with consumers and clinicians as
such as loss of productivity.
brokers of specialised knowledge in clinical pharmacy
There has been a rapid growth in information about the
and therapeutics, and integrating this with insight into
epidemiology, severity, and social and economic influpathophysiology
and an understanding of life challenges
ences of mental disorders around the world. The faced by patients with severe and chronic psychiatric
compelling and consistent nature of the information that illnesses.
is available to guide policy and to influence directions in Evidence for the benefits of clinical pharmacy in
health service delivery demands that the detection, psychiatry
prevention, early management and follow-up of mental Research into the use of psychotropic drugs has
disorders rate as concerns that equal other major health identified important roles for clinical pharmacists in the
priorities. Key research in this area has summarised in
14
management of psychiatric illness. Polypharmacy is
2

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
common amongst patients with psychiatric illnesses, and rehabilitation ward resulted in the improvement in
15
the drugs involved are often of low therapeutic index. patients' mental state, a reduction in the range of drugs
Medical co-morbidity is common, particularly in the used, a reduction in the number of drugs prescribed per
elderly, creating increased potential for drug-disease and
21
patient and a reduction in drug costs. Lobeck et al.
drug-drug interactions. Psychosocial problems and established that the involvement of clinical pharmacists
difficulties with patient compliance also contribute to the in the care of patients with mental illnesses can decrease
potential for drug-related problems in this patient the number of prescriptions written for these patients,
population. 15 also decreasing the cost per prescription and the total cost
Nearly 20 years ago, Stimmel identified the need for
22
of care.
clinical input by pharmacy staff caring for patients with Another study examined the effects of participating
16
psychiatric illnesses. Early work in this area focused clinical pharmacists using a standard data collection
upon a role for clinical pharmacists in non-acute settings, form, documentinga total of 229 recommendations made
such as long-term care facilities for intellectually disrecommendations
23
for 109 patients. In 130 cases (57.6%), there were
abled patients. Berchou demonstrated that pharmacy
for adding a new drug or discontinuing
input in the multidisciplinary care of intellectually a current one; in 67 cases (29.3%), the recommendations
disabled patients was associated with a significant were for increasing or decreasing the dose of a
increase in the use of antipsychotic and anticonvulsant medication; and in 21 cases (9.2%), recommendations
17
monotherapy. The implementation of clinical pharmacy
were for requesting laboratory tests or monitoring.
Ewan and Greene performed a study that provides insight
services in an acute-care, adult psychiatric facility was
to the input that can be provided by pharmacists in the
examined by Saklad et al. in a study using retrospective
18
care of patients with psychiatric illnesses in a community
longitudinal drug utilisation review methods. Saklad
setting, studying interventions by three community pharfound
that the introduction of clinical pharmacy services
macists in the care of 30 long-term mentally ill patients in
was associated with a significant decrease in the total
24
the UK. There were 94 medication-related problems
number of drugs prescribed per patient, the number of
identified involving 30 patients; and review by an expert
antipsychotic drugs prescribed per patient and the
panel found that in the case of 84 problems there were
re-admission rate for patients during a one year follow-up
24
18
appropriate interventions.
period. Stanislav et al. retrospectively examined the
Haw and Stubbs studied the nature, frequency and
effects of a psychopharmacy consultation service on potential severity of prescribing errors detected by
patient outcomes in a psychiatric hospital, finding that pharmacists working in a psychiatric hospital, detecting
the majority of consultations resulted in a positive
25
311 errors in approximately 2.2% of prescribed items.
19
outcome for patients.
Prescription writing errors (87.5%) were more common
Other research has also explored the role of clinical
than decision making errors (12.5%), but potentially
pharmacy services in the mental health setting. Canales
serious errors were relatively infrequently encountered
12
et al. compared patients receiving standard pharmacy
25
(8.7 % of all errors detected). A subsequent study
services with a group of patients who received intensive
involved pharmacists checking 22 036 prescription items
psychiatric pharmacy services. Those in the intervention
in nine hospitals, with 523 errors meeting the study
group showed significant improvements in clinical definition detected (2.4% of prescription items
response and drug-induced extrapyramidal symptoms,
26
checked). Prescription writing errors (77.4%) were
and were highly satisfied with the pharmaceutical
most common, while decision-making errors accounted
services they received. Medication costs and length of
26
for 22.6% of errors.
stay were similar for the two groups. Baigent used a Another study analysed qualitative data relating to
survey to assess the opinions of medical staff on the clinical pharmacy interventions for an acute-care, adult
clinical pharmacy service provided to a mental health psychiatric inpatient population in an Australian hospital,
unit, finding a high level of acceptance of key services finding that a significant proportion of clinical pharmacy
including prescription monitoring, costing of alternative interventions in the study related to non-psychotropic
drug therapy, advising on therapeutic drug monitoring
27
drug therapy. This finding was in keeping with those of
20
teaching roles. Cloete et al. found that the work of a an analysis of drug information enquiries to pharmacy
multidisciplinary team (consultant psychiatrist, registrar, staff at a large psychiatric hospital, where O'Hare et al.
senior nurse and pharmacist) on a longstay psychiatric found that two-thirds of all queries related to the use of
3

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Overall, there now appears to be ample evidence that the
provision of clinical pharmacy services in the psychiatric
context is justifiable, both form an economic point of
view, and more important, to help assure safe and
effective drug therapy for patients affected by mental
illness. The challenge is for practitioners to develop and
sustain a practice model that can allow the delivery of
these services, both in hospitals and in the community
sector. Inherent to this challenge is the need to devise
persuasive business cases that can be used in influence
payors and governmental bodies, so that these services
can eventually become routinely available where needed.
A framework for the delivery of clinical pharmacy
services in psychiatry
Although other systems have been proposed, the
conceptual framework that had its foundations in the
work relating to the pharmaceutical care model has been
widely embraced as a basis for the work of clinical
pharmacists in many settings. Strand et al. define a
medication-related problem as 'any undesirable event
experienced by the patientthat involves or is suspected to
involve drug therapy and that actually or potentially
29
interferes with a desired patient outcome'. Using this
model, pharmacists can base their clinical practice
around the prevention, detection, documentation and
resolution of drug-related problems (DRPs). The
original eight categories of DRP proposed in this system
are outlined with examples in Table 2.
The current and active set of clinical pharmacy practice
standard from the Society of Hospital Pharmacists of
30
Australia (SHPA) was disseminated in 2004, and
describes clinical pharmacy practice as the practice of
pharmacy in the context of multidisciplinary healthcare
team, directed at achieving quality use of medicines.
Each of the clinical pharmacy functions outlined in the
SHPA practice standards are directly applicable in the
context of psychiatry, and include, but are not limited to:
active participation in the management of individual
patients
assistance with the application of the best available
evidence in daily clinical practice
contribution of clinical knowledge and skills to the
healthcare team
identification and reduction in risks associated with
medicines use
involvement in the education of patients, carers, and
other health professionals and involvement in
research.
The guidelines provide information about a range of
activities that are components of contemporary clinical
pharmacy practice. These include those activities that are
oriented towards the management of DRPs for the
individual patients – measures such as obtaining an
accurate medication history, assessment of current
medication management, clinical review, therapeutic
drug monitoring, ward round participation, provision of
medicines information to health professionals and
patients, adverse drug reaction management and others.
In addition, the guidelines outline other aspects of
clinical pharmacy practice that although not focused
upon individual patient outcomes, still have direct
relevance for psychiatric pharmacy practice. These
include clinical research, teaching and quality assurance
activities.
Practical implementation of clinical pharmacy
services in psychiatry
Particularly, if a practitioner has not had experience in the
field of psychiatry, the implementation of clinical
pharmacy services in a psychiatric unit can prove to be a
daunting task. If there is no existing base to build upon,
the best advice would be to start with modest aims, and
work steadily to build relationships with clinicians and
patients. Take every opportunity to participate in
interdisciplinary meetings, and to learn from the
experience and wisdom of medical, nursing and
paramedical colleagues. Listen actively and carefully to
information presented in multidisciplinary meetings, and
understand that a holistic approach to patient care must
be used to underpin the provision of clinical pharmacy
services. It is important to be able to acknowledge that in
some cases, drug therapy (although possibly important)
is not the only way to approach the management of
psychiatric illnesses: psychological therapy, community
based support, counselling, and the provision of practical
assistance in difficult times can be vital to the success of
overall treatment.
In some cases, it may be necessary to prioritise and
progressively implement clinical pharmacy services in a
way that is commensurate with the resources available.
Under these circumstances, it is vital to ensure that basic
functions with high impact upon patient outcomes are
afforded the highest priority. Medication chart review,
assistance through the provision of high quality drug
information, adverse drug reaction and drug interaction
screening, and work directly at ensuring the patients have
an adequate understanding of their medications are the
most important functions,as well as making sure that
there are adequate supplies of medication available to the
patient, and that the patient has the insight and motivation
4

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
In many cases, enlisting the support of family or close
friends of the patient can assist with these objectives. As
practitioners begin to accumulate increasing experience
in psychiatric clinical pharmacy practice, they develop
greater understanding of the special challenges involved:
these include communicating with the mentally impaired
patient, recognising a patient who might be a danger to
themself or to others, dealing with issues relating to
substance abuse (more common amongst patients with
severe psychiatric illness), and problems in helping
patients to adhere to the prescribed therapy. Although
clinical pharmacy practice in psychiatry is challenging,
it is certainly rewarding in equal measure. In choosing to
work in this field, a pharmacist chooses to deal with
patients who are often both chronically and severely
physically and mentally unwell. There is extensive
polypharmacy with drugs of low therapeutic index.
Serious adverse drug reactions and drug interactions are
common. Mentally ill patients are amongst the
vulnerable and underprivileged in any society: arguably
there is no higher calling in clinical pharmacy than
working for the protection and assistance of these people.
Table 4.1
Key findings of epidemiological studies of mental illness
Study Setting Key findings
Global Burden of Disease Worldwide Unipolar depression leading cause of disability
Burden of Disease & Injury in
Australia
National Survey of Mental Health
and Wellbeing of Adults
Mental Health Disorders in
Australian Veterans
Mental Health: Report of the
Surgeon General
Mental Health Supplement to the
Ontario Health Survey
National Psychiatric Morbidity
Netherlands Mental Health Survey
and incidence study
Taiwan Psychiatric
Epidemiological Project
Australia
Australia
Australia
USA
Canada
Britain
Netherlands
Taiwan
Mental disorders account for 30% of non-fatal
disease in Australia. Depression and dementias
foremost causes of disability caused by mental
illness
18% of Australians affected by key mental
illnesses Health and during the preceding 12
months. 34.5% Wellbeing of adults experienced
disability.
GAD, PTSD, Depression and alcohol abuse most
Veteran Community (Veterans) common. PTSD
accounts for > 50% of accepted mental health
claims.
One-year prevalence of diagnosable mental illness
approximately 22-23%. Prevalence for anxiety
disorders and mood disorders 16.4% and 7.1%
respectively.
18.6% affected, 14.2% with one disorder, 4.5%
two or more disorders. Anxiety disorders (12.2%),
affective disorders (4.5%) and substance use
disorders (5.2%) most prevalent.
16% of subjects met screening criteria for mental
disorders Surveys of Great Britain. No differences
amongst geographical regions of Great Britain
Lifetime prevalence of 41.2% and 12-month
prevalence 23.3% for psychiatric disorders
Lifetime prevalence estimates of 16-28%
depending upon setting.
5

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table 2. Categorisation of medication-related problems (after Strand et al.)
Indication without drug therapy
The patient has a medical problem that requires medication therapy (an indication for
medication use) but is not receiving a medication for that indication.
Patient with heavy alcohol abuse but no thiamine has been ordered.
Drug use without indication
The patient is taking a medication for which there is no medically valid indication.
Patient with acute agitation in hospital that has resolved post-discharge continues
treatment with tranquillisers initiated as an inpatient.
Improper drug selection
The patient has a medication indication but is taking the wrong drug.
Delirium due to a urinary tract infection has been diagnosed, and antibiotic therapy has
been prescribed, but the organism involved is not sensitive to the antibiotic that has been
chosen.
Sub-therapeutic dosage
The patient has a medical problem that is being treated with too little of the correct
medication.
After initiation of an antipsychotic drug, blood glucose concentrations remain
unacceptably elevated despite the use of insulin; dosage must be increased to achieve
desired control.
Over-dosage
The patient has a medical problem that is being treated with too much of the correct
medication.
A patient is prescribed a very large dose of an antipsychotic drug: the magnitude of the
dosage does not create additional antipsychotic benefit but generates severe
extrapyramidal side effects.
Adverse drug reaction (ADR)
The patient has a medical problem that is the result of an ADR or adverse effect.
The patient develops nausea, vomiting and diarrhoea as a result of treatment with an
antidepressant.
Drug interaction
The patient has a medical problem that is the result of a medication-medication,
medication-laboratory, or medication-food interaction.
Elevated serum haloperidol concentration with toxicity secondary to hepatic enzyme
inhibition arising from SSRI treatment.
Failure to receive a drug
The patient has a medical problem that is the result of not receiving a medication that
was intended as a part of the designed treatment regimen.
Patient is prescribed an expensive, non-subsidised drug therapy and has not received any
counselling about the expected benefits of therapy. The patient does not have the
prescription filled and does not adhere to the established treatment plan.
6

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
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24 Ewan MA, Greene RJ. Evaluation of mental health
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Richards AL, Levin GM. Psychiatric pharmacists.
25 Haw C, Stubbs J. Prescribing errors at a psychiatric
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16 Stimmel GL. Clinical pharmacy services in mental 122 – 146.
7

APTI
ijopp
Genesis, Development and Popularization of Doctor of Pharmacy
(PharmD) Education Program at the Global level - A study based on
the story from 1955 to 2009.
1 2 3 4
Revikumar K.G , Mohanta. G.P , Veena.R , Sonal Sekhar
1. Principal, Amrita School of Pharmacy, Amrita University, AIMS, Edappally, Kochi, Kerala. 682 026
2. Professor of Pharmacy Practice, Annamalai University, Chidambaram, T.Nadu,
3. Sr.Lecturer, College of Pharmaceutical Sciences, M.G.university, Ettumannoor, Kottayam. Kerala
4. Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita University, Kochi. Kerala
Address for Correspondence: kg.revikumar@gmail.com
Abstract
The concept of clinical pharmacy was introduced in pharmacy profession by the American Hospital pharmacists
during the period 1920-1940, though the term 'clinical pharmacy' as such was not coined during those days.
Clinical pharmacy as discipline evolved in USA from a combination of factors that contributed for the
development and achievements in the area of hospital pharmacy. The introduction of PharmD in the University
of California at San Francisco in 1955 contributed for the overall growth and popularization of clinical
pharmacy. By 1980s the PharmD became a sought after course in the US. The American Association of College
of Pharmacy (AACP) and the Accreditation Council for Pharmaceutical Education adopted PharmD as the
essential and basic qualification required for the practice of pharmacy. Along with the regular PharmD, other
non-traditional programs like post baccalaureate PharmD were also introduced and PharmD got migrated to
other parts of the world. When the Foreign Pharmacy Graduation Equivalency Committee (FPGEC) in the US
mandated a 5 year pharmacy graduation program to be eligible to the Foreign Pharmacy Graduation Equivalency
Examination ( FPGEE), pharmacists from other countries particularly Asian countries including India got upset.
All this prompted Indian authorities too to think of introducing PharmD. Finally the PharmD program was
initiated in India in 2008 in few selected institutions approved by the Pharmacy Council of India. In spite of the
limitations of the Indian PharmD structure and the curriculum, the program will develop to one of the best such
programs in the world in the years to come.
Key words: PharmD, Doctor of Pharmacy, Pharmacy Practice, PharmDr.
INTRODUCTION
th
Though public pharmacies started during the 12 century needs of pharmacists.
in Italy, France and other parts of the world, the first The concept of clinical pharmacy was first developed in
pharmacy college was established in 1777 in Paris. In America. From the period of Jonathan Roberts in 1752
1803 six schools of pharmacy were started in France and (when he was appointed as the first hospital pharmacist
private pharmacy education institutions arose in 1808 in in Pennsylvania hospital in North America) to 1920,
Bavaria in Germany. It was in 1821 that the Philadelphia
hospital pharmacy did not make significant
College of Pharmacy admitted the first batch of
developments or achievements in USA, that warrants
pharmacy students in America. With the starting of
special mention. The post-1920 period, particularly the
pharmacy institutions like Philadelphia College of
Pharmacy, Massachusetts College of Pharmacy ( 1823)
1940 to 1970s, witnessed many scientific developments
and New York College of Pharmacy (1829) the global and achievements in the area of American Hospital
focus of pharmacy eduction took an orientation towards Pharmacy. It was during this golden era of the American
America. They could initiate time and again many Hospital Pharmacy that the clinical pharmacy originated
innovative programs aimed at the future prospects and as a superspeciality of hospital pharmacy.In fact, Clinical
Indian Journal of Pharmacy Practice
Received on 11/03/2009
Accepted on 11/03/2009 © APTI All rights reserved
Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Invited Article
Pharmacy as a discipline, evolved in America from a
combination of factors like innovations in the discipline
of hospital pharmacy since 1920s, growth of clinical
8

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
pharmacology since 1940s, formation of the American By 1980s, the authorities in US adopted PharmD as a
Society of Hospital Pharmacists(ASHP) in 1942, national professional degree program and by 1992, the
innovative teaching programs introduced in 1940s and AACP and the various pharmacy professional
50s, and the decline of pharmacology instructions in organizations in America took a joint decision to make
medical schools. The introduction of PharmD program Pharm D as the minimum requirement for practice of
contributed effectively for the development and Pharmacy in USA. Since the graduating class of 2006,
popularisation of clinical pharmacy as a speciality of the BS Pharm degree has been completely replaced by
pharmaceutical sciences. More over, the distributive PharmD degree in USA(Carrie 2008). All these
aspects of the pharmacy profession was entrusted to the developments have positively influenced the pharmacy
pharmacy technicians (Tse CS 2007).
educational institutions and authorities throughout the
Genesis of PharmD
world to take proper precautions at their countries.
Hospital pharmacy attained new status at the University Influence of American system in other countries.
of Michigam under the chief of their hospital pharmacy In 1992, the American Association of Colleges of
services Harvey AK Whitney Sr in the late 1920s and Pharmacy (AACP) house of delegates voted to support
early 1930s. In 1942 when he started the ASHP, his vision a single entry level educational program at the doctoral
of pharmacy got percolated into the pharmacy level (PharmD). The national organisation that accredits
community of USA and other parts of the world pharmacy degree programs the Accreditation Council for
(Mc Leod 2006). However, it was a surprise to many Pharmaceutical Education (ACPE) endorsed the
pharmacy professionals in various parts of the world, decision of the AACP. However, till 1998, the American
when a pharmacy program of study leading to the Universities and Pharmacy Schools were running
professional degree, Doctor of Pharmacy (Pharm.D.), programs like B.S (Pharmacy) / B.Pharm and PharmD
was initiated in the University of California at San simultaneously. In 1998, orders were issued to all
Francisco (UCSF), USA in 1955. Though the clinical American Universities to replace their B.S (Pharmacy)
pharmacy concepts were discussed and debated in the and B.Pharm programs with PharmD to make the
country from 1940s itself, the take-off of the PharmD in prospective pharmacists eligible for practice of
UCSF was not smooth and resistance free. The program pharmacy. The adoption of PharmD as the national
had to face some unfriendly reactions and resistances pharmacy education program to practice pharmacy in
from certain corners within the country. But many other USA was the result of the success story of practice
universities started to adopt the PharmD in the 1960s. oriented, service based and patient focused model of
Some other Universities including the University of pharmacy practice at the community and hospital levels.
Kentucky had also taken leading roles in developing Advantages of PharmD program
PharmD helps to develop abilities and skills required
Clinical Pharmacy programs in the world. Due to the
i) To practice pharmaceutical care, the concept of
innovative thinking of people like Paul F Parker, many
which is based on sharing the responsibility for the
clinical pharmacy activities were introduced in
out comes of drug and related therapy.
pharmacy in the 1960s. Inspired from the success of ii) To effectively communicate with patients and
Whitney's experiment of Drug Information center in health care professionals.
Michigan University, Paul F Parker opened the first iii) To scientifically conduct patient interview with the
Drug Information Center at a Pharmacy School in 1962. objective of developing patient data base.
The first hospital wide unit dose distribution program in iv) To be competent to conduct research studies on
the country was also initiated at the University of drugs and patients in specific areas of interest.
Kentucky in 1965. In 1968, the pharmacy residency
v) To be able to design, implement and evaluate
program was started that awarded both PharmD degree
various research projects in health care.
vi) To refine pharmacy practice skills through
and residency certificate.
evidence-based concepts.
It took about two decades for getting PharmD
vii) To inculcate problem solving skills.
popularised in USA and other parts of the world. In 1973 viii) To be able to take up projects and programs in the
UCSF started Department of Clinical Pharmacy as an area of health sciences with special focus on
independent unit, which was responsible for the pharmacoeconomics, medication error and phardevelopment
of the first clinical pharmacy curriculum macovigilance.
in the world. Today, the clinical pharmacy residency ix) To promote and practice prudent and rational use
program of UCSF is the largest in USA.
of medicines aimed at patient care.
9

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
PharmD follows a multi-disciplinary curriculum that pharmacist profession in Portugal called, "Pharmacists
can produce pharmacists with sufficient mental acuity to Order" or in Portuguese "Ordem dos Farmacêuticos". It
differentiate their position from that of the traditional and is equivalent to the residency of Indian programs. After
orthodox role of dispensers of medicines.
the enrollment the title of Doctor of Pharmacy is issued.
Increasing emphasis on improving quality of medication Afterwards, Pharmacists can pursue their career in a
use and enhancing medication safety have dramatically limitless number of professional areas that range from
increased the demand for clinical pharmacy and the community pharmacies, drug development, health
PharmD program in the US. This is the reason why they research, biotechnology to areas such as forensic
had initiated a well planned project in the early 1980s sciences, food analysis and toxicology. The student can
itself for introducing PharmD as the basic qualification also choose to become a specialist in activities like
st
for practice by the beginnig of the 21 century. They had Pharmaceutical Industry, Pharmaceutical Regulation,
given sufficient opportunities and facilities, like Hospital Pharmacy, and Clinical Analysis. Each one of
introduction of non-traditional PharmD programs, for them require an additional 5 year professional study
all the existing pharmacists to get themselves converted program guided by a tutor in the respective area of
as doctors of pharmacy. The Universities framed their knowledge. This specialization is composed of regular
own modules with practical approach for part-time and e- evaluations performed by the professional order, which
learning process of PharmD for existing licensed at the end of the 5 years performs an exam. After the
pharmacists. Many colleges througout USA offered post- success at the exam, the Pharmacist then becomes a
baccalaureate PharmD as an additional degree that specialist, respectively, an Industrial Pharmacist,
offered clinical course work and practical training in Regulations Pharmacist, Hospital Pharmacist, and
clinics and hospitals.
Clinical Analyst.
PharmD in other countries
In the Czech Republic, the title is known as PharmDr.
The first Canadian PharmD was initiated at the
(Pharmaciae doctor). The Pharm Dr is in fact a diploma
University of British Columbia (U.B.C.) in 1991. The
which is different form the Indiana diplomas. The PhD is
Canadian PharmD program is a post-baccalaureate
also a diploma in Czech. The PharmDr. can be obtained
program of two years ( academic period of 20 months)
by pharmacists who had graduated in pharmacy
duration. The PharmD programs in Canada are to be
(Magister, Mgr.) and students have to study for a
accredited by the Canadian Council for the Accreditation
minimum period of 5 years. Applicants must defend a
of Pharmacy Programs (CCAPP). Students enrolled in
research or experimental thesis, and pass a rigorous
the program are required to have graduated from a
examination. The PharmDr. title is predominantly a
Canadian Council for Accreditation of Pharmacy
prestigious thing.
Programs (CCAPP) or an American Council of In France students are admitted to pharmacy education
Pharmaceutical Education (ACPE) School with an programs (like medicine) through a competitive
accredited teaching program. Those who have passed examination held at the end of the first year. The duration
the Pharmacy Examining Board of Canada (PEBC) of pharmacy education extends from a minimum of
Evaluating and Qualifying examinations can also join for 6 years to 9 years depending upon the options taken. The
the Canadian PharmD. In Canada interestingly the maximum period of education is for students choosing
PharmD program is offered in both English and French. hospital pharmacy or clinical pharmacy. Students must
Pharm D is today very much popular in Europe. In specialize when entering the 5th year, and choose
Portugal, Pharmacy studies can be chosen after between dispensing pharmacy, pharmaceutical industry
completing 4 years of basic school, 5 years of preparatory or hospital internship. State diploma for the Doctorate of
school, and three years of high school education. The Pharmacy, PharmD., is granted to pharmacists after they
process of admission is the same for all degrees from have completed a short thesis (experimental or
medicine to engineering. The student takes the Master's bibliographic). It is also possible to defend a "real"
degree in Pharmaceutical Sciences which is equivalent research thesis for preparing à Ph.D.
to the PharmD program in one of the many Pharmacy In Italy, the course of study leading to the Doctor of
faculties. The masters program comprises a six year Pharmacy ( Dottore in farmacia) is of 5 year duration
rigorous study. After completing the degree program and includes a guided professional apprenticeship in a
the students enroll in the regulatory institution for the pharmacy.
10

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
The education of pharmacists in the Netherlands requires duration of the program as seven years.
a minimum of six years of university study. The Dutch In the Philippines, Pharm D was first started in 2005 at
consider the educational level of their current (M.Sc.) the Centro Escolar University (CEU) as a two year post
Degree in Pharmacy to be comparable to the PharmD title baccalaureate program open to licensed pharmacists.
in use in the United States. To become a hospital The CEU had started the College of Pharmacy in 1921.
pharmacist,a 4-year residency program has to completed. Thailand is one among the few countries that had taken
In the United Kingdom, the PharmD is a relatively new early steps to make their national pharmacy education
postgraduate program. It is considered as a doctorate program ready to adopt the American PharmD program.
degree open to qualified pharmacists. It is offered by the Thailand signed an MOU with 9 American Universities
University of Bradford, taking place over 3 years of paying a sum of 15 million US $ in 1984-85 to train
clinical practice followed by 2 years of research. It is also their teachers in pharmacy schools in USA. They had
offered by the University of Portsmouth and the sent their pharmacy teachers to the American
University of Derby.
Universities for getting on the site exposure and
Iran Universities like the Tehran University, changed the experience in running PharmD program including its
Pharmacy degree from Masters to doctorate (Pharm.D) various components. The first PharmD in Thailand was
and the duration of the study was increased to 5 years. initiated at Naresuan University in 1992.
Graduates need to present and defend their theses in In Pakistan, traditionally the bachelor's degree in
different fields of pharmacy and this adds another year to pharmacy was the first-professional degree for pharmacy
their studies and generally after 6 years students can practice. In 2003, the Pakistan Pharmacy Council
graduate as Doctor in Pharmacy.
mandated that a doctorate in pharmacy (Pharm D) would
In Lebanon, the first Doctor of Pharmacy (Pharm D) be the new first-professional degree. PharmD degree is
degree was awarded by the Lebanese University Faculty a professional degree that prepares the graduate for
of Pharmacy (upon a decree by the Lebanese pharmacy practice with a duration of 5 years. Most
government) to its graduating class of 19 students in universities in Pakistan are offering the PharmD program
1992. The program was first established by Dr. Anwar such as Karachi University, Dow College of Pharmacy,
Bikhazi, a Pharmacy graduate of the American Hamdard University, Baqai University, Federal Urdu
University of Beirut with a PhD from the prestigious University, the University of Punjab, the University of
University of Michigan. The 6-year entry level PharmD Lahore, Gomal University, the Islamia University of
program at the Lebanese University adopted the US Bhawalpur, etc. The qualified institutes are recognized
PharmD curriculum and training. Enrollment into the by the Pakistan Pharmacy Council. Provincial Pharmacy
program is highly competitive with an average admission councils of Punjab, Sindh, NWFP and Balochistan issue
rate of 20% of applicants. This was the leading PharmD Pharmacist Licenses (RPh). In all the countries where
program in the Middle East, which was followed by other PharmD is in existence, the PharmD curriculum is
mirror copies of similar programs in Lebanon and similar but not identical. However, it is true that certain
neighboring countries, such as the ones provided by the institutions/ universities give more emphasis to certain
University of Saint-Joseph (USJ) in Beirut and the subjects, and place less emphasis on others.
Lebanese American University.
Curriculum contents and goals- global scenario.
Saudi Arabia started first Pharm D in 2001 at King The PharmD program has three main components.
Abdualziz University (KAU) and later other institutions Didactic curriculum, laboratory works based on the
and Universities like Ibn-Sina University, KFU, theory papers and the clinical rotations including clinical
Qassim University, KSU College of Pharmacy at Riyadh, clerkship and residency. The didactic curriculum
College of Pharmacy at Kharj, and Taif University also ensures a strong educational base for the clinical
started PharmD. Pharm D in Saudi is of six years component of the program. Unlike the other pharmacy
duration including one year clinical rotations. According education programs, the didactic component of PharmD
to the Saudi Commission for Health Specialties gives emphasis on pharmacotherapeutics,
(SCFHS), if a student has taken PharmD within a pharmacokinetics and pathophysiology. The laboratory
minimum six years period, the graduate has a chance to works of the PharmD is very much similar to the
further develop himself by taking Accredited Residency traditional B.Pharm program in the case of the general
Training Program for one year duration, making the total and common subjects.
11

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Throughout the curriculum, students apply what they practice, clinical pharmacy practice, or other speciality
learn to the practice of pharmacy in the health care of areas depending upon the personal interests, preferences
patients. In the first and second years, students master and specific career requirements of the students.
important concepts in science, study mechanisms of drug Completion of a pharmacy residency is sometimes a
action and the fate of drugs in the body, and begin to requirement for employment in hospital pharmacy
explore the dimensions of pharmacy practice. During the practice or as clinical faculties at pharmacy schools.
third year, students shift their attention to clinical focused Through experiences in a variety of practice settings,
courses and, increasingly, to courses in their chosen students strengthen their clinical skills as active members
pathway and elective courses. The population-based and of a health care team. The program also helps students
research-focused course contents of the PharmD provide develop skills required for clinical and basic sciences
sufficient emphasis on the principles of health policy, research.
economics, and the application of management The characteristic feature of the PharmD is its
techniques. Direct patient care experiences, called components of clinical postings, ward rounds, clerkship
advanced pharmacy practice experiences (APPEs), and residency. Hospital pharmacists in France have
allow students to begin to hone their clinical skills. The initiated medical rounds with physicians since 1815.
fourth year combines APPEs with pathway specific After the internship in hospital pharmacy was introduced
experiences and electives.
in 1815, the municipal hospital of Paris had become more
The PharmD curriculum helps to produce scientifically effective than it had been, and the pharmacy interns were
and technically competent pharmacists who can apply directed to make hospital rounds with physicians and
their education to provide maximum health care surgeons. By 1829, the responsibility of the pharmacistservices
to patients. Students are provided with the intern to make hospital rounds with physicians and
opportunity to gain greater experience in patient care in surgeons was explicitly stipulated in the Regulations of
close cooperative relationships with health practitioners. Paris hospitals. Kenneth Fitch, a former Editor of the
It is the goal of all pharmacy schools to prepare Journal, 'Mondial de Pharmacie', and a contemporary
pharmacists who can assume expanded responsibilities and an associate of William Martindale, went to the
in the care of patients and assure the provision of rational hospital to examine patients with amoebic dysentery and
drug therapy.
to note the effects of drugs, synthesised by Martindale,
Clerkship, Residency and Clinical rotations.
against the disease.
The first pharmacy scientific residency program in the Length of Study
US was developed by Whitney at University of Michigan In USA, the Pharm.D degree program requires at least
hospital in 1927. The ward rounds, clinical postings and 2-years of specific pre-professional or pre-pharmacy
clerkship and the residency are the core components of undergraduate coursework followed by 4-academic
the PharmD program. It is through these, the students get years ( to the extend of 3 calendar years) of professional
accustomed to real hospital practice situation and get study. Pharmacy colleges and schools accept students
oriented to the evidence based therapy concepts. The directly from high school for both the pre-pharmacy and
clinical rotations provide students the opportunity to pharmacy curriculum, or after completion of the college
apply knowledge acquired in the classroom to the course prerequisites. Majority of students enter a
practice of pharmacy in a variety of patient care settings. pharmacy program with 3 or more years of college
In addition to refining advanced pharmacy practice experience. College graduates who enroll in a pharmacy
skills, students gain confidence in applying evidence- program shall have to complete the full 4-academic
based principles to drug treatment decisions.
years of professional study to earn the Pharm.D degree.
Core rotations in adult internal medicine, The AACP does not track the availability of accelerated
ambulatory/primary care, cardiology, critical care, programs of study for individuals with a baccalaureate
emergency medicine etc, are essential for the students. degree in a related health career or science field.
They are also given the options for elective clinical Though the duration of PharmD is 4 academic years
rotations as per their choice in other areas like oncology, (three years) in USA after two years of pre-professional
nephrology, neurology, pediatrics, infectious diseases, program at the University level, in other countries, it
psychiatry, dermatology, endocrinology and urology. varies from 5 to 6 or even more years. In most of the
The residency programs can be in general pharmacy countries, the PharmD is a 5 year program.
12

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Arab countries like Egypt, Syria, Jordan, Saudi Arabia early 1980s. However, clinical pharmacy could make an
were intuitively conducting 5yr degree course impact in the pharmacy profession and the practice in
(B.Pharm) since early 1990s and some of their India only in the 1990s. In the beginning, clinical
pharmacy colleges just changed the name of the course pharmacy was restricted to hospitals in India, but later
from B.Pharm to PharmD. Pakistan very smartly took spread to community settings. Today, Indian clinical
the inadvisable shortcut by upgrading their degree to pharmacy also addresses industry-based issues like
new nomenclature of Pharm.D and increased 4 year to drug information, clinical trials, pharmacy journalism
5 year duration. In some countries, including Pakistan and pharmacovigilance activities.
the post-baccalaureate PharmD is of only one year The area of pharmaceutical sciences in India is
duration and in most other countries, it is a two year developing day by day and the role of pharmacist is also
program.
undergoing major changes. The pharmaceutical
Genesis of Pharm D in India.
industry in India has attained tremendous growth and
The pharmacy education in India is not much old. It was
development during the last three or four decades.
initiated in Banaras Hindu University in 1932 by a thirty
With growing internationalization of the pharma
year old youth, Mahadeva Lal Schroff popularly known
industry and the globilization of the pharmacy
as M.L. Schroff. He could start pharmacy education in
education program, the standards of pharmacy
the country just because of the encouragement and
education need to be world class and the country is no
support he got from Pandit Madan Mohan Malaviya, a
doubt moving in that direction. The first effort in
national figure and Vice chancellor of the Banaras
introducing PharmD in India was initiated in
Hindu University.
In 1940, April the first M.Pharm course was started in
Trivandrum Government Medical College in the 1990s
the Banaras Hindu University (BHU). Later, Schroff
itself and in 1999 Dr.Revikumar K.G., Head of
worked as Principal of Birla College, Pilani during
Hospital and Clinical Pharmacy, framed a curriculum
(1949- 52) and was the Professor of pharmacy at
for starting PharmD in the University of Kerala,
Saugar University (1958-60). In 1964, based on the Trivandrum with the help of some some American
invitation from Dr. Triguna Sen he organized the Universities (Fig1) and took it ahead. Though the
department of pharmacy at Jadavpur University, Board of Studies and the Faculty of Medicine cleared
Calcutta. However, the growth of pharmacy education the proposal, it could not materialise due to some
was in the 'bonsai style' in the beginning. Even at the reasons at that time.
time of independence there were only five pharmacy
When the Foreign Pharmacy Graduation Equivalency
colleges in the country and it increased to 16 by 1967.
Committee (FPGEC) in US mandated a 5 year pharmacy
During the period 2000-2008 hundreds of new
graduation programme to be eligible to take the Foreign
pharmacy degree colleges started in the country. The
Pharmacy Graduation Equivalency Examination
number of degree colleges increased to around 900 by
(FPGEE), quite naturally pharmacists from South
2009. Only about 15 percent of the Indian Pharmacy Asian countries including India have got upset. Many
Colleges are situated in the health care campus Indian Bachelor of Pharmacy graduates who had
attached to the hospitals or medical colleges.
undergone the 4year B.Pharm course and went to US
In India, the post graduate pharmacists working in the for a job since 2003 were put in quandary. All this
hospital pharmacies were engaged in different teaching prompted Indian authorities to think seriously about the
positions in the department of pharmacology of various introduction of PharmD in India.
medical colleges. They were well respected and The Indian authorities could introduce the six year
accepted by the medical students. Some academicians regular PharmD and the three year post baccalaureate
in India, like Dr.P.C.Dandiya, Professors Gode and PharmD in 2008 in the country. The Gazette of
th
Gambir (Department of Pharmacology, Institute of Government of India, dated 16 May 2008 notified the
Medical Sciences, BHU), Prof. R.D. Kulkarni norms for PharmD program. The current syllabus of the
(Department of Pharmacology, Grant Medical College, PharmD include regular Pharmacy subjects and specific
Bombay) and Dr.B.D.Miglani (Delhi University) tried subjects like therapeutics and clinical pharmacy.
to bring this evolution of clinical pharmacy in the West, Orientation and exposure in clinical, hospital and
into the Indian pharmacy profession in the 1970s and community pharmacy practices is also incorporated.
13

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table1. Pharmacy Colleges approved by PCI for starting regular PharmD in 2008
Sl.No Name of College University
1. Department of Pharmacy Practice, Annamalai
University , T.N.
Annamalai University, Annamalai Nagar
Chidambaram, Tamil Nadu.
2. Visveswarapura Institute of Pharmaceutical
Sciences, Bangalore
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
3. J.S.S College of Pharmacy, Mysore J.S.S University, Mysore, Karnataka
4. K.L.E College of Pharmacy, Belgaum K.L.E University, Belgaum, Karnataka
5. M.S Ramaiah College of Pharmacy, Bangalore Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
6. Navodaya Education Trust’s N.E.T Pharmacy
college ,Raichur
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
7. Hyderabad Karnataka Education Society’s
College of Pharmacy,Gulbarga
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
8. Sri.Jagadguru Mallikarjuna Murugharajendra
College of Pharmacy,Chitradurga
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
9. B.V.V Sangha’s Hanagal Shri Kumareshwar
College of Pharmacy, Bagalkot
Rajiv Gandhi University of Health Sciences,
Bangalore, Karnataka
10. J.S.S College of Pharmacy,Ootacamud J.S.S University, Mysore, Karnataka
11. Sri Ramachandra College of Pharmacy,Chennai Sri Ramachandra University,Chennai, Tamil
Nadu
12. Sri.Ramakrishna Institute of Paramedical
Sciences,Coimbatore
The Tamil Nadu Dr.MGR Medical University,
Chennai,Tamil Nadu
13. Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka.
Manipal
14. Smt.Sarojini Ramulamma College of Pharmacy, Osmania University, Hyderabad, Andhra Pradesh
Mahabubnagar
15. Raghavendra Institute of Pharmaceutical
Education & Research,Anantapur
Jawaharlal Nehru Technological
Kukatpally,Hyderabad, Andhra Pradesh
16. Deccan School of Pharmacy, Hyderabad Osmania University, Hyderabad, Andhra Pradesh
17. Talla Padmavathi College of Pharmacy, Kakatiya University, Andhra Pradesh
Warangal
18. Bharat Institute of Technology,
RangaReddy(Disst.)
Jawaharlal Nehru Technological
Kukatpally,Hyderabad, Andhra Pradesh
19. St.Peter’s Institute of Pharmaceutical
Kakatiya University, Andhra Pradesh
Sciences,Vidyanagar
20. Sri.Venkateshwara College of Pharmacy, Osmania University,Hyderabad, Andhra Pradesh
Hyderabad
21. GIET School of Pharmacy,Rajahmundry Andhra University, Visakhapatnam, Andhra
Pradesh
22. Malla Reddy College of Pharmacy,
Osmania University,Hyderabad, Andhra Pradesh
Secunderabad
23. Shri Vishnu College of Pharmacy,West Andhra University, Visakhapatnam, Andhra
Pradesh
24. Vaagdevi College of Pharmacy,Warangal Kakatiya University, Andhra Pradesh
25. P.Rami Reddy Memorial College of
Pharmacy,Kadapa
Jawaharlal Nehru Technological
Kukatpally,Hyderabad, Andhra Pradesh
26. Shri.Ramnath Singh Institute of Pharmaceutical
Sciences & Technology,Gwalior
Rajiv Gandhi Proudyogiki Vishwavidyalaya,
Bhopal, Madhya pradesh
27. Poona College of Pharmacy, Pune Bhari Vidyapeeth University,Maharashtra
14

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
th
th
Hospital rounds, clinical postings, training in 4 and 5
year and the one complete year residency in the hospital
during the last year of the course (sixth year ) can help
the PharmD students get familiar with actual hospital
and clinical practice set-ups. However the curriculum for
the PharmD course as finalized by the Pharmacy Council
of India (PCI) require drastic changes taking into
consideration the global and national scenario to make it
more effective and result oriented.
The PCI in July 2008 invited applications for starting
PharmD in India. Though it was done in a comparatively
hasty manner giving only minimum period to apply, they
had received about 50 applications from states like
Andhra Pradesh, Karnataka, Tamil Nadu, Kerala,
Maharashtra, Madhya Pradesh and Orissa and
conducted the inspection in August. In September 2008,
the PCI approved about twenty pharmacy institutions
from states like Tamil Nadu, Andhra Pradesh,
Karnataka, Maharashtra and Kerala for starting
PharmD course from the academic year 2008- 09.
Subsequently few more institutions were approved for
starting the program. Some of these were given the
permission to start both PharmD and PharmD post
baccalaureate (See Table 1 and II).
The pharmacy colleges have to fulfill the requirements
as fixed by the PCI like sufficient number of qualified
faculty, class rooms laboratories etc. Along with hospital
facility (300 bed hospital) for starting the PharmD. In
2008, the University Grants Commission (UGC) has
sanctioned Rs.50 lakh to Annamalai University in Tamil
Nadu to start PharmD program. They are the first to
launch the PharmD in India. Immediately after starting
the PharmD, the Annamalai University initiated steps for
having a tie-up with some American Universities. In
2009 February Dr.James Scott from Western Universtity,
California visited Annamalai University to study the
situation and the facilities available at the University for
running the program. In that connection, Dr. Scott has
visited and studied the facilities in some other centers in
south India like Amrita School of Pharmacy (Amrita
University, Kochi, Kerala), Alshifa College of Pharmacy
(Calicut University, Kerala), KLE College of Pharmacy (
KLE University, Belgaum) and Sri Ramachandra
University, Chennai. In the years to come, the PharmD
program in India will develop to one of the best such
programs in the world as the country has the potential and
facility for the same.
PharmD Tuition Fee
The tuition fee for PharmD varies from country to
country, state to state, university to university and
institution to institution. The tuition fee is highest in
countries like USA. In Idaho State University (ISU) it is
$12000 (about Rs 6 lakhs) per semester for non-residents
and 5000$ for Idaho residents. In Pakistan the fee is
almost uniform and is about Rs. 50000 per semester. In
India the tuition fee on average rupees one lakh per year
in private sector. However, depending upon the facilities,
infrastructure and other amenities the fee may increase or
decrease. In government institutions the fee is very less.
Unfortunately, very few government institutions have
taken steps to start PharmD in India.
Table.2. Pharmacy Colleges approved by PCI for starting Pharm.D (post baccalaureate) program.
Sl.No Name of College University
1. Dept. of Pharmacy Practice, Annamalai Annamalai University, Chidambaram,Tamil Nadu
University T.N.
2. Visveswarapura Institute of Pharmaceutical
Sciences,Bangalore
Rajiv Gandi University of Health Sciences, Bangalore,
Karnataka
3. J.S.S College of Pharmacy, Mysore J.S.S University, Mysore, Karnataka
4. K.L.E College of Pharmacy, Belgaum K.L.E University, Belgaum, Karnataka
5. J.S.S College of Pharmacy, Ootacamud J.S.S University,Mysore,Karnataka
6. Sri Ramachandra College of
Sri Ramachandra University,Channai,Tamil Nadu
Pharmacy,Chennai
7. Sri. Ramakrishna Institute of Paramedical The Tamil Nadu Medical University, Chennai, Tamil
Sciences, Coimbatore
8. Manipal College of Pharmaceutical Sciences,
Manipal
Nadu
Manipal University, Manipal, Karnataka
15

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Fig1. PharmD syllabus of University of Kerala framed in 1999 for starting the program in Trivandrum
Medical College in 2000
16

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Future prospects.
ASHP in 2003 issued a vision statement for pharmacy education, an idea or a necessity. Iranian J Pharm Res.
practice in American hospitals and health systems. It Available at: http://www.ijpr-online.com/ Docs/
prescribes 6 goals and 31 objectives to be attained by 20021/IJPRe001.htm. September 5, 2007
2015. It motivates the ASHP members to advance the 12. Parthasarathi G, Ramesh M, Nyfort-Hansen K,
profession to higher levels. In 2004, another visionary Nagavi BG. Clinical pharmacy in a South Indian
statement was launched by the Joint Commission of teaching hospital. Ann Pharmacother.
Pharmacy Practitioners(JCPP). It ensures that 2002;36(5):927–932.
pharmacists will be the health care professionals 13. Pedersen CA, Schneider PJ, Santell JP. ASHP
responsible for providing patient care that ensures national survey of pharmacy practice in hospital
optimal medication therapy outcomes by 2015. Both settings: prescribing and transcribing 2001. Am J
these position statements envisage that all clinical Health Syst. Pharm 2001;58:2251-2272.
pharmacists and practicing pharmacists will have 14. Revikumar KG,Veena R. Clinical Pharmacy –A
completed at least one year of residency training by the sought-after specialty: Chronicle Pharmabiz: Nov
year 2020. The Indian PharmD has to be planned and 30, 2006. 65- 68.
developed as a program giving sufficient opportunities 15. Salamzadeh J. Clinical pharmacy in Iran: where do
for residency and other hospital and clinical postings we stand. Iranian J Pharm Res. 2004;3:1–2.
promoting evidence based practice culture. The practice 16. Singh H. History of Pharmacy in India and Related
and education have to move ahead in tandem. It is Aspects. Pharmacy Practice. Vallabh Prakashan,
essential to provide sufficient opportunities for carrying Delhi. 2002;3.
out real and innovative practice experiences in the 17. Smith WE. Clinical Pharmacy: Reflections and
PharmD program. Experiences and lessons form other Forecasts. The Annals of Pharmacotherapy: 2007;
countries show that prospects for the PharmD are much 41:325-328.
better in India.
18. Tse CS. Clinical Pharmacy Practice 30 years later.
References The Annals of Pharmacotherapy. 2007;41: 116-118.
1. Babar ZU. Pharmacy education and practice in 19. Yang E, Shin TJ, Kim S, Go Y, Lee S. The
Pakistan. Am.J.PharmEduc. 2005;69(5).
pedagogical validity for a six years curriculum in
2. Babar ZU. Defining clinical pharmacy in Asia.
E s s e n t i a l D r u g s 2 0 0 7 . Av a i l a b l e a t : pharmacy education. Korean J Med Educ.
http://www.essentialdrugs.org/edrug/archive/2007 17(3):225–238.
06/ Accessed September 5, 2007
3. Calvert RT. Clinical pharmacy- a hospital
perspective. Br J Clin Pharmacol 1998; 47: 231-238
4. Carrie N, James GS. The development of clinical
pharmacy practice in the United States. IJHP 2008;
45: 116-118.
5. Department of Hospital & Clinical Pharmacy
S e r v i c e s M e d i c a l C o l l e g e H o s p i t a l ,
Thiruvananthapuram. IJHP 1997 Sept-Oct XXXIV,
5 175- 178.
6. Jean FB, Patricia L. Hospital Pharmacy Practice: a
Canadian Perspective, International Pharmacy
Journal 2002:16(1); 11- 13.
7. Joint Commission of Pharmacy Practitioners..
Future vision of pharmacy practice. Washington
DC. 2008.
8. Ghilzai K, Naushad M, Arjun DP. India to introduce
five-year Pharm D program. Am J Pharm Educ.
2007;71(2).
9. Mc Leod DC. Contribution of the Annals of
Pharmacotherapy in the development of clinical
pharmacy. The Annals of Pharmacotherapy 2006;
40:109-111.
10. Merchant SH. Clinical Pharmacy and Ward
Pharmacy- Need of developing these services in
Indian hospitals. The Indian Journal of Hospital
Pharmacy 1983. May June XX, 3 127-129.
11. Mosaddegh M. Revision of Iranian pharmacy
17

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
Abstract
Good Pharmacy Practice in Chronic Disease Management
Neelam Mahajan
lecturer, MSIP C-4 Janakpuri, Delhi-58
*Address for correspondence: neelam_4247@yahoo.com
Key words: Chronic diseases, pharmaceutical care, Quality of life.
ijopp
Chronic diseases have been reported to be leading cause of death in world. The WHO report had proposed the global
goal to reduce the projected trend of chronic disease death rates by 2% by 2015. Various individual, institutional &
organizational healthcare interventions in academic, hospital and community settings are required and have been
reported to achieve this aim. Ironically, the provision of pharmaceutical care to the patient of chronic diseases by
community pharmacist in community settings had remained a far reality on one hand and on the other hand the
escalating healthcare costs, unstable disease state, changing disease patterns, multiple complications requiring
administration of multiple drugs ,complex dosage regimens, non compliance to therapy, associated multiple psycho
social problems make chronic disease and chronic disease therapy management problematic. Quality of life of the
chronic disease patients and reduction of chronic disease death rates depends not only on the quality of drugs
supplied by community pharmacies but also on the necessary psycho social support and pharmaceutical care of
pharmacist. It is proposed that, community pharmacies should be projected as places where the chronic disease
patients can get pharmaceutical care. Adherence to good pharmacy practices by community pharmacies is viable
intervention required to maintain the quality of therapy received by the patients of chronic diseases.
INTRODUCTION
Chronic diseases have been reported to be leading cause tions due to adverse drug reactions leading to reduction in
of death in world. The WHO report had proposed the overall healthcare cost and agony of chronic disease
global goal to reduce the projected trend of chronic patients. In other words, the focus of the community
disease death rates by 2% until 2015. Various individual, pharmacy practice should be oriented towards quality
institutional & organizational healthcare interventions pharmaceutical products first, then to a well informed
are required and have been reported to achieve this aim. patient equipped with necessary knowledge of
To achieve this aim;
medication prescribed by him/her & lastly to provision
1. Good manufacturing practices are required to be of pharmaceutical care.
followed to produce cost effective quality drugs for Ironically, the provision of pharmaceutical care to the
this segment.
patient of chronic disease by community pharmacist had
2. Adherence to good pharmacy practices in community remained a far reality. It is because of the minimum
pharmacies is required to maintain the quality of eligibility of qualification for a registered pharmacist is
therapy received by the patient. It is because D.Pharma and Diploma Holders in India receive
community pharmacy is the end point of the channel of practical training which is inadequate to train them in the
distribution & a vital link between suppliers of quality provision of pharmaceutical care to the patients. They are
drugs & the patients. If the pharmacist in-charge of the theoretically ill equipped due to teaching of obsolete
Community Pharmacy follows Good Pharmacy subjects in the light of slow curricula revisions. Majority
Practices, then the benefits of the medication therapy of the retail pharmacy outlets are either owned by
received by the patients are maximized while the diploma holders or run by diploma holders. Hence, it is
adverse side effects are minimized. This is followed common practice to witness the absence of two vital
by reduction in the number of unnecessary hospitalizaelements
of pharmacy practice i.e. patient and
professional practice.
Traditionally, retail pharmacies are the community
Indian Journal of Pharmacy Practice
Received on 06/09/2008 Modified on 11/09/2008
pharmacies where OTC and non OTC products for
Accepted on 14/09/2008 © APTI All rights reserved
chronic disease are sold.The pharmacist in-charge of
18

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
community pharmacies, though theoretically well versed
lack the necessary competencies and skills to educate the
patient about the therapy received for the chronic disease
and to provide pharmaceutical care through services like
pharmacovigilance. Even if the retail pharma
outlets/community pharmacies are manned by pharma
graduates, the situation remains more or less the same.
It is because though theoretically better equipped then
diploma holders, they show total lack of clinical
orientation due to industrial orientation of B.Pharm
syllabi & lack of clinical training. Though introduction of
Ph.D. programme is heartening yet it is required to give
clinical training to the large pool of existing registered
Pharmacists running community pharmacies.
Good community pharmacy practices
Since Chronic Disease Management is problematic due
to the administration of multiple drugs to the patients, it
requires speciality pharmacies dedicated to various
chronic diseases like Cancer, AIDS, Diabetes etc.. This
highlights the need of having super special community
pharmacies. Such Pharmacies will demand pharmacist
with clinical training in super-specialities of chronic
diseases. Though a structured continuing educative
programme for registered pharmacists in India is missing
yet by attending various workshops in clinical training,
symposia, conferences etc. and by means of internet, the
registered pharmacist can stay in touch with latest
advancement in chronic disease management. The superspeciality
pharmacies catering to particular chronic
disease patients should provide the related medicines and
information to the patients. The patients should get
individualized information on therapy. Such pharmacies
should have the element of professional pharmaceutical
are where pharmacist can act as a warrior and keep under
check the unwanted adverse drug reactions due to
polypharmacy in chronic diseases. These pharmacies
should cater to the disease specific pharmaceutical needs
of chronic disease patients, should have A to Z of the
requirement of all drugs, diagnostics and other
accessories for routine and emergency management of
chronic diseases.
All chronic diseases lead to psycho-social problems like
anxiety about hospitalization, restricted diet, disease
progression, financial problems, anger, depression,
restricted movements etc. These psycho-social problems
and the complex dosage regimens of the drugs
administered, the unstable/serious disease state, non
adherence to therapy highlight the need of
pharmaceutical care and psycho social support of
pharmacist. The community pharmacies should be
projected as places where the chronic disease patients can
get the necessary psycho-social support and
pharmaceutical care. The Pharmacist should identify
and mobilize the strength and resources of patient to
endure and manage their health concerns. This requires a
vigorous training of such pharmacist for patient
counseling. The retail pharma outlets should put up
posters or distribute pamphlets to patients of chronic
disease to inform them about special patient counseling
services of the pharmacy. Such pharmacies should build
the public opinion on the accessibility and
approachability of the community pharmacist as a well
informed health care professional. These should also act
as platform to spread awareness about the significance of
the super-speciality pharmacies in provision of
professional pharmaceutical care in chronic diseases like
health care screening services in detection and
prevention of chronic diseases at early stages by referring
them to referral services.
The patients should be given computer generated
information on the medications and the therapy received
by the patients. The pharmacist should give spontaneous
or planned detailed individualized medication
information and answer the queries of the patients of
chronic diseases related to prescribed therapy and the
drug product as per individual requirement. The
pharmacist should do value addition to the knowledge of
the patient regarding proper and safe use of medicines for
specific chronic disease. The pharmacy should impart
planned education to chronic disease patients on the
medications received in groups. The education of the
groups of Patients of such diseases can take place through
an interactive learning experience between the
pharmacist & patients. Besides, the pharmacist should
be groomed to carry out detailed discussions to guide the
patients in management of their disease state and the
therapy prescribed for the same.
The focus of counseling to the patients of chronic
diseases should be on active participation of the patients
in safe and proper use of medications & management of
specific disease states rather than passive participation. It
is very important because of the agony suffered by
chronic disease patients and the huge healthcare costs
involved. This shifting of foci can lend to tremendous
reduction in their agony and healthcare cost involved.
The Pharmacist should encourage the filling of self
reporting forms of adverse drug reactions of drugs
prescribed to chronic disease patient so that these can be
19

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
checked in time & unnecessary hospitalizations can be global goals (proposed by WHO) of reduction of death
avoided. These forms should form an essential tool for rates due to chronic diseases by 2% until 2015.
providing pharmaceutical care to such patients along References
with medication cards issued to the patient. The
1. Preventing chronic diseases: a vital investment,
Medication cards should contain the information on
WHO
2. Chronic trouble: 60m Indians at risk over next ten
medications taken by these patients and their dosage
years, The Times of India, 19-02-06
regimen. This can help the patient in recovering the
3. Pharmacy practice changing times, new roles,
medication. The physicians in the area of super-speciality
Chronicle Pharmabiz, p.31, 13-12-2007
pharmacies should be contacted to publicize their 4. Playing pivotal in patient care, Chronicle Pharmabiz,
professional services of patient counseling on disease p.33, 13-12-2007
state and medication management of chronic disease 5. Patient counseling the magic spell for better
patients. The advice of physicians can be used for further healthcare, Scientific Abstracts, p.512, 60th IPC,
improvement of the counseling services of the Pharmacy. 2008
Further, the Community Pharmacies should adopt the 6. Patient awareness in cardiac diseases-today's need,
nearby community where the chronic diseases are more Scientific Abstracts, p.504, 60th IPC, 2008
prevalent. The Pharmacist should educate the patients 7. A study of interventions made by clinical
and susceptible patients of chronic disease on the various pharmacists, Scientific Abstracts, p.509,, 60th
aspects of these diseases. A host variety of activities IPC,2008
can be stated by the pharmacy to promote healthy life
8. The cancer pharmacist, p.505, Scientific Abstracts,
styles and curb unhealthy practices in the community, to
p.527, 60thIPC, 2008
9. Shaping Pharmacy Profession, B.Suresh, Chronicle
screen masses for early detection of diseases and to give
Pharmabiz, p.20, 13-12-2007.
psychosocial reassurance to the patients of chronic
diseases. A to Z of pharmaceutical care should be
provided to the patients of chronic diseases in adopted
community. The Pharmacist should help the patient to
develop understanding on the role of medicines to
promote good health, to take suitable decisions related to
the medications (their dosage regimen) prescribed, to
manage adverse side effects and drug interactions and to
become a well informed partner in the management of
his/her chronic disease state.
Conclusion
If these good pharmacy practices are adopted in
Community Pharmacy settings, then the mortality rate
due to Adverse Drug Reactions of the drugs administered
to patients of chronic diseases will be reduced. It is
because, the community pharmacist by virtue of good
counseling skills will ensure proper and safe use of drugs
by patients of such diseases. This in turn, will maximize
the benefits of therapy and quality of life of chronic
disease patients will improve. The added benefits will
include public recognition of the role of the pharmacist in
the management of their diseases and medication.
Moreover, due to health promotion and health screening
activities, the spread of chronic disease in susceptible
masses can be brought under control. The net result of
these good pharmacy practices in community
pharmacies will be reduction in death rates due to chronic
diseases in India, achievement of national goals and
20

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
Drug Information Centre (DIC)-An Indian Scenario
1 1 1 1 1 2
Nitesh S Chauhan , Firdous , R Raveendra , Geetha J , B Gopalakrishna , Roopa Karki
1
R R College of Pharmacy, Bangalore-560090, India
2
Acharya & B.M.Reddy College of Pharmacy
Address for correspondence: nikki_srms@rediffmail.com
ijopp
Abstract
Drug information centre refer to facility specially set aside for, and specializing in the provision of drug information
& related issues. The purpose of drug information centre is to provide authentic individualized, accurate, relevant
and unbiased drug information to the consumers and healthcare professionals regarding medication related
inquiries to the nation for health care & drug safety aspects by answering their call regarding the all critical
problems on dug information, their uses and their side effects. Apart from that the centre also provides in-depth,
impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and other
health care professionals to safeguard the health, financial and legal interests of the patient & to broaden the
pharmacist role visible in the society & community. Number of drug information centers are being opened with the
prospective of safe health care & drug safety which will surely serve the community & enhanced the role of
community pharmacist. Information present in the current paper will not only enlighten the role of drug information
centre but also focused on the rational use of drug.
Key words: Drug information, health care
INTRODUCTION
Drug information is the provision of a written and/ or catering to the information needs of nursing staff. The
verbal information about drugs and drug therapy in staffs of the drug information center were expected to
response to a request from other healthcare provider, take an active role in the education of health
organizations, committees, patients, public or professionals within the institution. In 1973, the first
community.
formal survey identified 54 drug information centers in
Drug information service refers the activities undertaken
the USA. According to a report published in 1995, there
by pharmacists in providing information to optimized
are about 120 full-fledged pharmacist-operated drug
drug use. Drug information centre provides in-depth,
information centers in the United States, which accept a
unbiased source of crucial drug information to meet the 1
broad scope of requests from health care professionals .
needs of the practicing physicians, pharmacists and other
Indian scenario
health care professionals. In the country like India where Recognizing the need to provide organized drug
the national polices are industry focused rather than information to health care professionals as well as
health focused, it became crucial to enlighten the role of consumers, the WHO India Country Office in
drug information centre to spread the awareness about
collaboration with the Karnataka State Pharmacy
drug information services & rational use of drug.
Council (KSPC) is supporting the establishment of 5
Global scenario
In 1962, the first drug information center was opened at drug information centres. These centers have been
the University of Kentucky Medical Center and was established in Haryana (Sirsa), Chhattisgarh (Raipur),
intended to be utilized as a source of selected, comprehe- Rajasthan (Jaipur), Assam (Dibrugarh), and Goa
2
nsive drug information for staff physicians and dentists to (Panaji) .
allow them to evaluate and compare drugs besides The Karnataka State Pharmacy Council established its
Drug Information Centre (DIC) in August 1997 to
disseminate unbiased drug information to healthcare
Indian Journal of Pharmacy Practice
professionals. In India, this was the first independent DIC
Received on 09/09/2008 Modified on 19/09/2008
Accepted on 23/09/2008 © APTI All rights reserved
started by Karnataka State Pharmacy Council to
21

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
provide unbiased drug information to healthcare from FDA and other agencies.
professionals. The centre is registered with IRDIS, an Drug Information Centre works towards in
2
International Register of Drug Information Services promotion of safe, effective, rational and economic use
2
Drug Information Services
The centre provides in-depth, unbiased source of of drugs by the health professionals and patients.
crucial drug information to meet the needs of the Structure of Drug Information Centre
practicing physicians, pharmacists and other health Framework of drug information centre is a crucial task
care professionals in following areas:
which will determine the efficacy of work & service.
Adverse Drug Reactions - Suspected adverse drug 3
Setup & Equipment
reactions are assessed. Specific information regarding
The centre should equipped with computer terminals
predisposing factors, relationship to dose or duration of
therapy, incidence, clinical manifestations, and with printer & printed material (current periodical,
management are provided.
bound journal volume, references texts) and has
Evaluation of Drug Reactions - The significance of a
access to Medline, the internet and various other
drug-drug, drug-food, drug-disease or drug laboratory
test interaction is evaluated. The data of drug-drug, drugonline
drug and medical references.
food and drug-disease obtained from the hospitals and The centre should maintain subscription to nationally
medical institutes.
recognized journal and text of Pharmacy and Medline.
Foreign Drug Identification - The DIC attempts to Centre should have direct access to computerized on
identify drugs in other countries. When possible the DIC
provides product composition and US equivalent. An
line data searching CD ROM database and access to
assessment of the efficacy and potential hazards of the
product are also given. Data for foreign can be obtained
the world wide web (www) should be
available.(Table1)
Table 1 The Framework of Drug Information Centre 1
Books, Journals
Formularies
Computer Database
Drug Information Service
World Wide Web
(www)
Poison Centre
Access
Callers
Physicians
Pharmacists
Nurses
Researchers
Students
Pharmacy & therapeutic Communities
Legal aids
Dr ug industries
Marketing firm
Dissemination
Information
Reprint
Answer to telephone call
Computer retrieval system
Internet Search
Publication & Education
Drug Policy & Decision
Cost Benefits Analysis
Sharing & Debating on Information
Information to Patients
22

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Staff, Student & Scheduling
530(1997) (mean 654.0, range 531-773), respectively.
DIC requires one full time director, one full time resident In august 1997, the Karnataka state pharmacy council
and six pharmacy students.
established its drug information centre. The centre
The state pharmacy council (Department of Pharmacy) received 1002 calls for the period from august 1997 to
provides the secretarial support. This centre also serves
July 2000. the queries from doctors were only 132
as training site for undergraduate & post graduate student
(13.2%). rest the all queries were from patients,
of pharmacy.
1,3,6
pharmacists and drug regulatory authorities. after the
Evaluation of the performance of DIC
The evaluation of the drug centre at university of awareness program the total numbers of queries received
Kentucky medical center revealed that there was a steady fro the period of August 2000 to January 2002 was 1592
increase number of call from the year of 1994 to 1997. and 658 (41.3) were from doctors. Rest 59% of the
The average and range of calls per month form January enquiries was from patient, pharmacist and drug
1994 to December 1997 also documented a steady regulatory authorities. The majorities of queries (75%)
increase form>350 (1994) (mean 421.7, range 351-548) were received from Bangalore. Response time was
to >400(1995) (mean 467.4, range 416-604) to recorded and about 80% of enquiries were answered
>520(1996) (mean 608.3, range 523-704) and to > within 30 minutes.
Table 2. List of the Indian Drug Centre & Clinical Pharmacy Department. 2
Independent drug information centre
CDMU Documentation Centre,
Calcutta
Drug information centre, Maharashtra
State Pharmacy council, Maharashtra
Andra Pradesh State Pharmacy
Council, Andra Pradesh
Karnataka State Pharmacy Council,
Karnataka
JSS, Ooty
Tamilnadu Pharma Information Centre,
Chennai
Hospital attached drug information centre with clinical
pharmacy service
Christian Medical College Hospital, Vellore Talimnadu
Drug information centre(KSPC), Bowring & Lady Curzon
Hospital, Bangalore, Karnataka
Department of Pharmacy Practice, Chidambaram, Tamilnadu
Department of Pharmacy Practice, National Institute of
Pharmaceutical Education & Research (NIPER), Chandighar
Jawaharlal Nehru Medical Hospital, Belguam, Karnataka
JSS, Mysore, Karnataka
JSS, Ooty, Tamilnadu
N.R.S Medical Hospital, Calcutta
Kempagowda Institute Medical Sciences (KIMS), Bangalore
Karnataka
Kasturba medical college, Manipal, Karnataka
Poison Information Centre, AIIMS, Delhi
Poison Information Centre, National Institute of
Occupational Health, Ahemdabad
Department of toxicology, Amrita Institute Medical Science
& Research, Cochin
Toxicology & IMCU Unit, Government General Hospital,
Chennai
Sri Ramachandra hospital, Porur, Chennai
Sri Ramachandra Mission Hospital, Coimbotore, Tamilnadu
Trivandrum medical college, Trivandrum, Kerela
23

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table 3. State-wise List of Contact Address of Drug Information Centres
24

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Figure 1 Network of Drug Information Centre (DIC) in India
Ahemdabad
One Hospital
Attached DIC
Andhra Pradesh
One Independent DIC
Cochin
One Hospital
Attached DIC
Kerela
One Independent
Maharashtra
One independent
DIC
Drug
Information
Centre
Delhi
Two Hospital
Attached DIC
Karnataka
One Independent &
Five Hospital
Attached DIC
Punjab
One Independent &
One Hospital
Attached DIC
West Bengal
One Independent &
one Hospital
Attached DIC
Tamilnadu
One Independent
& Five Hospital
Attached DIC
New Selected Centre in
Haryana, Chhattisgarh,
Jaipur, Goa & Assam
1,3,6
Evaluation of the performance of DIC
The evaluation of the drug centre at university of In august 1997, the Karnataka state pharmacy council
Kentucky medical center revealed that there was a steady established its drug information centre. The centre
increase number of call from the year of 1994 to 1997. received 1002 calls for the period from august 1997 to
The average and range of calls per month form January July 2000. the queries from doctors were only 132
1994 to December 1997 also documented a steady (13.2%). rest the all queries were from patients,
increase form>350 (1994) (mean 421.7, range 351-548) pharmacists and drug regulatory authorities. after the
to >400(1995) (mean 467.4, range 416-604) to awareness program the total numbers of queries received
>520(1996) (mean 608.3, range 523-704) and to > fro the period of August 2000 to January 2002 was 1592
530(1997) (mean 654.0, range 531-773), respectively. and 658 (41.3) were from doctors. Rest 59% of the
25

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Figure 2. Statistical Evaluation Data of DIC in Karnataka
Statistic data of DIC
Number of calls
1800
1600
1400
1200
1000
800
600
400
200
0
1997-2000 2000-2002
Year
Series1
enquiries was from patient, pharmacist and drug very important for drug information centre to frame
regulatory authorities. The majorities of queries (75%) guidelines on ethical issues.
were received from Bangalore. Response time was Quality of information
recorded and about 80% of enquiries were answered Providing quality information is one of the crucial task of
within 30 minutes.
DIC. In order to maintain the flow of quality information
Competency of Drug Information Centre
the staff should be well trained & comprehensive about
Competent evaluation of drug information service and
the quality framework provided by DIC is very the new trends in drug discoveries. It is also highlighted
important. The development of DIC is the beginning of that information is not knowledge and knowledge comes
the clinical pharmacy concept to provide adequate
7
from the interpretation of information .
information for those who consume, prescribe, dispense Conclusion
& administer drug. Factors like information technology Drug Information Centres are regarded as a gateway of
changes, sophistication of drug therapy, changing drug information. The future of drug information centres
philosophies of pharmacy practices, the education of in India lies in the quality of service, credibility among
pharmacist in the field of drug information and the more
users and the evaluation of its progress. The future of
knowledgeable patient are very influential in the
clinical pharmacy and drug information centre is very
evolution of pharmacist's role in drug information
bright so the government, private hospitals and
provider. To maintain the competency in DIC time to
time assessment program is mandatory.
regulatory bodies should come forward to establish more
Ethical Facet
number of DIC in future time so that clinical pharmacist
At present, drug information centres are confronted with and drug information centre can work to locate the
questions from public that pose ethical dilemmas. The
quality in community.
truthful answer to drug information question may
Acknowledgement
compete with values such as privacy, interference in the The author is thankful to Karnataka State Pharmacy
patient-physician relationship and social respons-
Council (KSPC), Karnataka, Dr. B Gopalakrishna,
4
ibilities .
New drug like sildenafil used in male erectile
Principal, R R College of Pharmacy, Bangalore for
dysfunction may cause social problem such as abuse by providing useful Information. The author also owe to the
healthy men and indiscriminate prescription by the PKM Educational Trust Management for providing
primary care physician s.For ethical aspect it becomes excellent facility.
26

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
References
1. Pradhan SC. The Performance of drug information 1990;47:2245-50.
centre at the university of Kansas medical center,
5. Vernon GM, Woods DJ. Development of an
Kansas city, USA-Experiences and Evaluation. Ind J
Pharmacol 2002;34:123-129.
International Network of drug Information Center
2. Karnataka state pharmacy council. Available from (indices). Aust J Hosp Pharm 1998;28:115-6
URL:www.kspcdic.com 6. Lakshmi PK, Gundu Rao DA, Gore SB, Shyamala
3. Rajesh DH, Kudagi BL, kamadod MA, S S Biradara. Bhaskaran. Drug information service to doctors of
Drug information Center-Is the window that lets us
Karnataka, India. Ind J Pharmacol 2003;35:245-247
see the world. The Pharma Review April 2008.
4. Kelly WN, Krause EC, Krowiniski WJ, Small TR,
7. Malone PM, Mosdell KW, Kier KL, Stanovich JE.
Drana JF. National survey of ethical issues presented Drug information: A guide for pharmacists.
to drug information centre. Am J Hosp Pharm Stamford ct: Appleton & Lange; 1996.
27

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
ijopp
A prospective study comparing Total Lymphocyte Count (TLC) and
CD4 counts in HIV patients in a resource limited setting in India
1 2 3 4
Lincy Lal , Cijo George , Anitha Yesoda , Jayakumar.B
1. Pharmcoeconomic Research Specialist, Drug Use Policy and Pharmacoeconomics, UT MD Anderson Cancer
Center, 1515 Holcombe Blvd, Unit 706, Houston, Texas 77030
2. Manager-Clinical Pharmacy, HCG Towers, P.Kalinga Rao Road, Bangalore-27, Karnataka, India
3. Asso. Professor, College of Pharmaceutical sciences, Medical college, Thiruvananthapuram, Kerala, India
4. Prof & Head, Dept. Of Medicine, Medical college Hospital, Thiruvananthapuram, Kerala, India
*Address for correspondence: llal@mdanderson.org
INTRODUCTION
Even after 25 years of the first detection of Acquired goals of HAART are given in table 1.
Immunodeficiency Syndrome (AIDS), it remains a major Various guidelines have been published on HAART to
1
health care problem without any cure. Extensive make sure that the therapy is appropriate. These
research around the world and the subsequent guidelines give clear information on indications to start
4, 5
introduction of highly active antiretroviral therapy HAART
(HAART) has produced dramatic reduction on Test for CD4 count is too costly for resource poor
morbidity, mortality and health care utilization. HAART countries. As highly active antiretroviral therapy
regimens have revolutionized the treatment of human (HAART) is now becoming available to large
immunodeficiency virus (HIV), which consistently populations of HIV-infected patients in resource-poor
results in sustained suppression of HIV-1 RNA countries, resource-appropriate markers need to be
replication, resulting in gradual increases in CD4 T- identified for clinicians to use in deciding when to initiate
lymphocyte count, sometimes to normal levels. Durable HAART. Also, monitoring individuals with HIV
suppression of viral replication and the accompanying infection/AIDS involves the use of expensive tools,
increases in CD4 count, reverse HIV disease progression, including CD4, which are not readily available in
even in persons with advanced HIV infection.
resource- limited settings. Previous studies suggested the
Despite these great advancements, HAART poses a absolute lymphocyte count (ALC) or total lymphocyte
number of challenges. Many of the effective regimens are count (TLC, i.e. ALC plus all large lymphocytes such as
complex and have major adverse effects leading to lymphoblast or reactive lymphocytes) might be useful in
problems with patient compliance and drug resistance. identifying patients who would benefit from initiating
These problems continue to limit the effectiveness of prophylaxis for AIDS-related opportunistic infections.
HAART and present major challenges in managing HIV
6,7,8
Due to the lack of enough financial as well as qualified
infection. Further, cost and intellectual property personnel support, initiation and monitoring of HAART
protections effectively limit access to antiretroviral drugs based on CD4count becomes a significant challenge in
2 TM
in countries most heavily affected by HIV. Atripla , India. Patients may have to wait for more than two
(efavirenz 600mg, emtricitabine 200mg, tenofovir months to get the CD4 count results even in National
disoproxil 245 mg) a fixed dose, once a day tablet for AIDS Control Organization (NACO) supported centers.
treating HIV-1 infection in adults is a promising step to This is a major obstacle in the proper management of
3
improve patient compliance.
HAART in a country like India where the HIV estimate
A HAART regimen should be able to delay disease for the year 2005 is 5.21 million infections and it is
progression, prolong survival and maintain quality of life growing at a rapid scale. 9
through maximal viral suppression. Considering the Initiation and monitoring of HAART based on TLC
conditions and challenges of a resource poor country, the instead of CD4 count is particularly significant in a
developing country like India. In India the cost of CD4
count by flow cytometry is approximately1500 Indian
Indian Journal of Pharmacy Practice
Received on 09/09/2008 Modified on 19/09/2008
Accepted on 23/09/2008 © APTI All rights reserved
Rupees (INR) ($30.00 US) while the cost for TLC is less
than 40 INR (

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
per capita income is 34,825 Indian Rupees ($820.00 National AIDS Control Organization (NACO) of India
10,11
US) and the per capita expenditure for health by and subsequently, NACO is funded by various programs
12
government is about $27.00 US , this cost difference has under WHO. All patients attending ART clinic gets
a significant impact in treating AIDS patients.
treatment and related tests including CD4 count test free
WHO recommends CD4 count to monitor the patient's of cost.
clinical status in AIDS cases; but in resource limited Study data was collected from patients who satisfied the
setting where there is no data on CD4 is available, TLC inclusion and exclusion criteria and gave consent for the
can be used as a substitute for symptomatic patients. study. The inclusion criteria consisted of patients who
According to the guideline by WHO for scaling up are 18-65 years of age and patients who are receiving
antiretroviral therapy in 2003, CD4 testing is the tool for triple regimen of HAART from the clinic during the
making decision on HAART therapy and monitoring; study period. Exclusion criteria were pediatric patients
however if this is not available, one can use TLC count less than 18years of age and pregnant patients. Perm-
3
less than 1200 /mm as surrogate marker for CD4 count ission to conduct the study in the ART unit was given by
3 13
less than 200 cells/mm .
the Head of the Department of Medicine. The study was
This recommendation was based on rigorous evaluation approved by the Human Ethical Committee of
of data obtained almost exclusively from developed Government Medical College, Thiruvananthapuram. An
6, 7,8,14
countries.
informed consent form, approved by the Human Ethical
However, there are also studies indicating that Committee, was signed by all patients and this process
substitution of TLC for CD4 count monitoring might not was in accordance with Good Clinical Practice (GCP).
be a good clinical decision. A study conducted in Nigeria The following demographics of the study patients were
evaluating the reliability of total lymphocyte count as a collected: HAART regimen, age, sex, urban/rural, place
substitute for CD4 cell count found that total lymphocyte and source of infection, disability status, employment
count is not suitable for CD4 cell count in a resource status, marital status, and income. CD4 count was
limited setting. The sensitivity of total lymphocyte count recorded from the report from the department of
as a predictor of CD4 cell count was 45.5% and the dermatology (CD4 count was ordered from this
specificity was 62.2%. The study's author concluded that department). WBC and Total lymphocyte count were
3
if WHO recommendation of 1200 cells/ mm were used to obtained from medical laboratory report. (Both CD4
determine treatment, 1 in 3 individuals would have been count and TLC count were done on same day).
deprived of needed treatment. So in that particular setting Statistical analysis
TLC is not a reliable predictor of CD4 cell count in Sensitivity, specificity, positive predictive value (PPV),
HIV-infected individuals. 14 and negative predictive value (NPV) were calculated to
Based on these differing evidence accounts, this study's establish the relationship between TLC and CD4 counts.
primary aim was to analyze the reliability and clinical A receiver operator characteristic (ROC) curve was also
utility of total lymphocyte count as a surrogate marker for drawn to determine the best cut-off points. Statistical
CD4 count and to check the reliability of WHO significance was calculated utilizing linear regression.
recommendation in resource limited setting in India. The Paired t-test was utilized to determine statistical
main objective was to calculate the sensitivity and significance of pre and post treatment CD4 counts. For
specificity values of using total lymphocyte count as a all tests, p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
patients taking ART enrolled for the study was 142. The that this was a significant difference at p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Though these methods are under intensive research, we analyzed various combinations of paired
WHO recognizes the immediate need for a low cost observations of CD4 count and TLC. Based on the
method for scaling up of antiretroviral therapy in clinical utility and best descriptive analysis value we
countries where spreading rate of HIV infection is came to the most suitable CD4 count TLC combination.
startling. Monitoring of HAART is a must to minimize The best estimate appears to be that if the TLC count is
the more dangerous possibility of developing drug
3 3
= 3000cells/mm , the CD4 count will be = 400cells/mm
resistant which may cause a catastrophe to the already which is also seen in the ROC curve. Though the
less than optimal HAART program in developing and
3
combination of CD4 count = 200cells/mm & TLC count
17,18
3
poor countries.
=2500cells/mm is most clinically relevant in the view of
This study was conducted in the ART unit (in the WHO recommendation, it lacks reasonable sensitivity
Department of Medicine) of Government Medical and specificity (56.7 & 76.7 respectively).
College Hospital, Thiruvanathapuram, Kerala, India. In this study we had 39 patients with CD4 count less than
This hospital is funded by NACO in support of WHO.
3
200cells/mm . When the TLC was compared (those
3
Even in such a center CD4 testing is irregular for the having 1500 cells/mm or less and more than 1500 cells/
patients. Because of the high patient load they may have
3
mm ,close to the WHO recommendation.) only 6 patients
to wait up to 3 months to get their CD4 count done. This
3
had less than 1500 cells/mm TLC count. Though WHO
shows the importance of a reliable surrogate marker for
3
recommends TLC less than 1200 cells/mm can be used
CD4 count for the better administration of HAART. This
3
as a predictive for CD4 count less than 200 cells/mm , in
study was designed to check the reliability and clinical this study population, it does not seem to be predictive.
utility of TLC as a surrogate marker for CD4 count. Had the WHO recommendation followed, only 15.4% of
Along with this we also compared out results with WHO patients would have got treated and the rest 84.6% of
recommendation.
patients were left untreated. This result could be due to
In this study, from 68 patients we collected 69 paired the small sample size of the study. But the positive
observations of CD4 counts and TLC. From this data we correlation of CD4 count with TLC promises further
find out the direction of change of TLC count with investigation for appropriate levels of TLC which would
increase in CD4 count is positive. In addition to predict more precisely the CD4 level less than
correlating direction of change between TLC and CD4
3
200 cells/mm . Further more this study was conducted for
count, this study also examined the average change in 6 months which is not enough to recruit more number of
TLC per unit change in CD4 count. In this study patients for the study. Total number of paired
population, the average individual specific mean change observations of CD4 count and TLC in this study is 69,
3 3
in TLC per 1 CD4 cell/mm was 4.6 cells/mm . a nd on ly 26 pati en ts h ad a pre and post treatment CD4
To find out the best sensitivity and specificity correlation count.
Table – 1: Goals of HAART 4 *
Goals of HAART 4
Maximal and durable suppression of viral r eplication (measured by viral load assays)
Restor ation and/or preservation of immune function
Reduced human immunodeficiency virus (HIV)-related morbidity and mortality
Improved quality of life
Limit the likelihood of viral resistance to preserve future treatment options
Provide maximum access to HAART regimens
31

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table –2: Study Population Demographics
Figure 1: Linear Regression of Lymphocytes versus CD4 counts (p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
33

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Figure 2: Receiver Operator Curve (ROC) for CD4 Values
Receiver Operator Curve (ROC) for CD4 Values
1
Sensitivity
0.8
0.6
0.4
0.2
CD4= 400
CD4= 350
CD4= 300
CD4= 250
CD4= 200
0
0 0.1 0.2 0.3 0.4 0.5
1- Specificity
References
1. Fletcher V, Kakuda NK, Collier AC. Human Mehta K, Solomon S. et.al. Changes in Total
immunodeficiency virus infection. In: Dipiro TJ, Lymphocyte Count (TLC) as a surrogate for changes
Tallbert LR , Yee CG, Matzke RG, Wells GB, Posey
in CD4 count following initiation of HAART:
LM, editors. Pharmacotherapy: A Pathophysiolo-
Implications for monitoring in resource – limited
th
gical approach. 5 ed. United States of America:
settings. J Acquir Immune Defic Syndr 2004; 36:
McGraw-Hill Medical publishing division; 2002:
567-575.
2151-2174.
2. Kojic EM, Carpenter CJ. Initiating antiretroviral
9. National AIDS control organization (India)
therapy. Available from University of California, HIV/AIDS epidemiological surveillance &
San Francisco, CA, (US); hivinsite; 2006.
estimation report. New Delhi:2005
3. U.S Food and drug administration (US).FDA 10. World Bank (US).World development indicators,
approves the First Once-a-Day Three-Drug India- data and statistics. Washington: Data
Combination Tablet for Treatment of HIV-1. Silver profile; 2008
Spring: FDA news;2006.
11. Reserve bank of India (India).RBI reference rate on
4. New York State Department of health (US). Anti-
31/07/08.Mumbai:Exchange rate; 2008
retroviral therapy. New York :2008.
12. World heath organization (Switzerland).Selected
5. Guidelines for the Use of Antiretroviral Agents in
national health accounts indicators. Geneva: The
HIV-1-Infected Adults and Adolescents. National
Institute of Health, Maryland, (US); aidsinfo; world health report; 2006.
October 10, 2006.
13. World heath organization (Switzerland).Scaling up
6. Jacobson MA, Liu L, Bashi HK , Deeks S, Hecht of Antiretroviral Therapy in resource limited setting.
FM, Kahn J. Absolute or total lymphocyte count as a Geneva: Guidelines for a public health
marker for the CD4 T lymphocyte criterion for approach;2002
initiating antiretroviral therapy. AIDS 2003;17: 917- 14. Akinola N O, Olasode O, Adediran I. A, Onayemi O,
919. Murainah A, Irinoye O. et.al. The Search for a
7. Spacek LA, Griswold M, Quinn TC, Moore RD.
Predictor of CD4 Cell Count Continues: Total
Total lymphocyte count and hemoglobin combined
Lymphocyte Count Is Not a Substitute for CD4 Cell
in an algorithm to initiate the use of highly active
antiretroviral therapy in resource-limited settings.
Count in the Management of HIV-Infected
AIDS 2003; 17:1311–1317.
Individuals in a Resource-Limited Setting. Clin
8. Mahajan AP, Hogan JW, Snyder B, Kumarasamy N, Infec Diseases. 2004; 39:579–581.
34

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15. Farmer P, Léandre F, Mukherjee JS, Claude M, Nevil 2002;34:984-990.
P, Smith-Fawzi MC. et.al. Community-based 17.Harries AD, Nyangulu DS, Hargreaves NJ, Kaluwa
approaches to HIV treatment in resource–poor O, Salaniponi FM. Preventing antiretroviral anarchy
setting. Lancet 2001;358:404-409
in Sub-Saharan Africa. Lancet 2001; 358:410-414.
16. Mitty JA, Stone VE, Sands M, Macalino G, Flanigan
18. Weidle PJ, Mastro TD, Grant AD, Nkengasong J,
T. Directly observed therapy for the treatment of
people with human immunodeficiency virus Macharia D. HIV/AIDS treatment and HIV vaccines
infection: a work in progress. Clin infec diseases for AFRICA. Lancet 2002; 359: 2261-67.
35

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
ijopp
A Study of Clinical Pharmacist Initiated Changes in Drug Therapy
in a Teaching Hospital
Bhupathy Alagiriswami, *Madhan Ramesh, Gurumurthy Parthasarathi and Hatthur Basavanagowdappa
Department of Pharmacy Practice, JSS College of Pharmacy, Mysore -15
1
Professor and Head, Department of Medicine, JSS Medical College Hospital, Mysore - 15
Address for correspondence: madhanramesh@hotmail.com
Abstract
This study was aimed to assess and quantify the pharmacist-initiated changes in drug therapy and its cost savings at
a tertiary care South Indian Hospital. The medication details of all patients enrolled to the study was collected
prospectively and reviewed independently by the intervening pharmacist to identify any Drug Related Problems
(DRPs). Where an DRP was identified, it was discussed with physician and suitable suggestion was provided.
Clinical significance of each intervention was graded based on the expected clinical outcome. An independent panel
consisting of clinician and academic clinical pharmacists reviewed all the interventions made by the intervening
pharmacist for potential cost savings relating to length of stay, readmission, drugs, medical procedures and
laboratory monitoring. A total of 261 DRPs were identified from 189 patients. The incidence of DRPs was found to be
7.9 per 100 patients. The most common DRP was found to be drug use without indication (18%) followed by improper
drug selection (14%). Seventeen percent of the DRPs observed were in patients suffering from cardiovascular
disorders followed by respiratory disorders (15%). The average time spent for each intervention was 12.5 minutes.
The most frequent change initiated by the intervening pharmacist was cessation of the drug (20%). The annualized
cost savings incurred by the pharmacist-initiated changes in drug therapy was Rs: 46,686 /=.
In our study, pharmacist initiated change in drug therapy was well accepted by the physicians. The study
demonstrates that routine clinical pharmacist review of in-patient drug therapy can improve patient outcome and
reduce patients' healthcare cost.
Key words: Pharmacist, Intervention, Drug therapy, Drug related problems, Cost.
INTRODUCTION
Drug therapy enhances health related quality of life
4,5
likelihood of similar events occurring in the future . In
1
(QoL) for most of the diseases . Despite excellent clinical medicine, a wide range of drug related problems
benefits and safety profile of most medications, drug
3,6
might arise due to various causes. Various factors
related problems pose a significant risk to patients, which encountered in medical practice lead to DRPs. Medical
adversely affect quality of life, increases hospitalization prescribing errors, improper dosage, improper drug
2,3
and overall healthcare costs. However, optimization of selection, drug-drug interaction, drug without indication,
drug therapy may, by preventing Drug Related Problems untreated indication are the most commonly encountered
(DRPs), influence health expenses, potentially save lives
6
DRPs. The cause of DRPs also includes those that are
1, 2, 3
and enhance patient's quality of life. Increased use of iatrogenic and idiosyncratic in nature. In addition, factors
medication and availability of new drug therapies like increased use of medications, polypharmacy and
potentially increase the risks of patient for iatrogenic
availability of new drug therapies will potentially
3, 6
4,5
adverse drug events in hospitals. Iatrogenic adverse
increase the risk of drug-induced illness.
Studies on the prevalence of DRPs in hospitals and a
events are important for consideration because it can not
closer characterization of all DRPs are lacking and the
only prolong hospital stay but also increase the patient
bedside clinical approach evaluation of patients' DRPs is
healthcare expenditure. Therefore, it is important that all 1
applied. However, studies carried out to assess and
drug related problems resulting in serious injury or death 6
minimize DRPs in hospitals are reported. It is reported
are evaluated to assess whether improvement in the
that medication errors occur in 3-6.9 % of in-patients and
healthcare delivery system can be made to reduce the
the error rate for in-patients' medication orders was
reported to be 0.03-16.9 % with each hospital
Indian Journal of Pharmacy Practice
Received on 24/10/2008 Modified on 17/02/2009
Accepted on 19/02/2009 © APTI All rights reserved
7
experienced a medication error every 22.7 hours. An
Indian study reported that the incidence of DRPs was
1
36

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
found to be greater than quoted as an average in in our study. The exclusion criterion was patients
3
developed countries . High incidence of inappropriate receiving treatments on out-patient basis. The
dosage and improper drug selection observed in the study intervening pharmacist was a postgraduate pharmacy
was attributed to lack of standard treatment protocols or a practice student. All the interventions made by the
formulary for hospital and the differing treatment intervening pharmacist were preceded by consultation
patterns between the medical wards in each Indian with the academic clinical pharmacist. The medication
3
hospital .
details of all those patients who were admitted to medical
Drug therapy has become so difficult that no one wards were collected and documented in a suitably
professional is expected to optimize the drug therapy and designed data collection form. The intervening
7,8
control DRPs alone . Today there exist a due problem in pharmacist, to identify the drug related problems,
medical care that urgently requires expert attention reviewed collected data independently. Nature of the
namely that of preventable drug related morbidity and drug related problem of each case that was identified was
3,9
mortality . These problems could be well preventable / categorized based on categories described by Helper and
9
minimized by initiating changes in drug therapy through Strand.
3
clinical pharmacy services . Also, reduction in healthcare Drug related problem identified was brought to the notice
cost and improved patient care may be attained through of the concerned physician for the remedial action and
clinical pharmacy services by ensuring the rational use of the primary reason(s) for initiating the intervention was
medications, and improving patient compliance with recorded. In addition, appropriate suggestions were
10
medications .
provided to the concerned physician at the earliest
A study in the United States estimated that the cost of possible time. The clinical significance of each
treating conditions caused by inappropriate medication intervention was assessed by the intervening pharmacist,
8
was US $177.4 billion in 2000. It is reported that due to and later reviewed and verified by an academic clinical
high expenditure towards medical expense patients tend pharmacy practitioner for accuracy. The acceptance level
to skip the medication or nonadherence to the medication of physician for the particular intervention was also
that will worsen the disease condition. Pharmacist can recorded as either accepted or not accepted. Similarly,
ensure appropriate drug use, decrease out of pocket whether or not there was a change in drug therapy was
11
expenditures, and improves access to needed drugs by noted. After the interventions, further details such as
providing consultation at the point of care. In a recent suggestions provided, its category and resources or
study it is reported that the annualized cost savings references consulted were documented. In addition, the
relating to length of stay, readmission, drugs, medical total time taken by the intervening pharmacist in
procedures and laboratory monitoring as a result of preparing and undertaking the intervention was recorded.
clinical pharmacist initiated changes to hospitalized At the time of patient discharge, the intervening
patient management or therapy was $ 4 444 794 for eight pharmacist documented the actual changes to drug
major acute care government funded teaching hospitals therapy and patients' outcomes relating to the
2
in Australia. Studies exploring cost savings achieved intervention. The involvement of pharmacist in
through the provision of clinical pharmacy services to therapeutic decision - making was rated according to
hospitalized patients in major acute care teaching Campagna's decision- making model, but for
hospital are limited. Moreover, in Indian setup, studies simplification.
assessing the pharmacist interventions and its cost saving
An independent clinical panel was convened which
has not been well demonstrated. Hence, this study was
consisted of a consultant physician, final year
intended to assess and quantify the clinical pharmacistpharmacist.
All those interventions, which were accepted
postgraduate medical student and an academic clinical
initiated changes to drug therapy and its cost savings at
JSS Medical College Hospital, Mysore.
and changed by the physician, were assessed by the panel
METHODS
for any possible impact on the following: length of stay
This prospective study was conducted at a 1000 bed (LOS), readmission probability, medical procedures and
multispeciality tertiary care teaching hospital (JSS laboratory monitoring. The independent clinical panel
Medical College Hospital, Mysore) over a period of reviewed only those interventions perceived by the
seven months. In-patients of either sex of any age intervening pharmacist as having an impact on either
undergoing treatment in medicine wards were included length of stay, readmission probability, medical
37

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
procedures or laboratory monitoring. The panel then mentioned in Indian Drug Review (IDR) was considered.
confirmed or rejected the intervening pharmacist's All those changes made in drug therapy were noted from
assessment and quantified the resultant changes. The patients' medication administration records. The total
criteria for assessment and quantification of these drug cost was calculated by considering only the actual
changes were based solely on review of the individual drug cost based on drug, dose administered, frequency
case and the collective decision of the panel. The panel and duration of therapy. Administration charges, syringes
did not assess the interventions perceived to result only in and reconstitution solutions, and discharge medications
a change in drugs but instead intervening pharmacist were excluded from the cost assessment procedure. Cost
calculated the impact on drugs-costs. Actual cost at the of injections was calculated as whole vials. If a dose
study site was considered for the purpose of analysis of range was prescribed, cost was based on the average dose
impact on cost savings on length of stay, probability of
2
administered.
readmission and evaluation of changes to lab monitoring. Annualized Cost Savings
Cost Evaluation of Probability of Readmission and Annualized cost savings were calculated by
Length of stay
extrapolating the seven months' data and their associated
The probabilities of readmission were estimated based cost saving over a year.
on the probability (expressed as percentage likelihood) RESULTS
of a readmission event occurring without the intervention
A total of 3315 cases were followed and reviewed in the
compared with the probability of a readmission after the
medical ward over seven months period. Of the cases
2
reviewed, 261 drug related problems were identified
intervention has occurred. Costs were then calculated by
multiplying this probability with the average cost of the from 189 patients. The incidence of DRPs was found to
treatment for specific disease costing at study site.
be 7.9 per 100 patients followed. Average DRPs per
The panel quantified the impact of each intervention on prescription was 1.4 (range: 1 to 5). Majority [57.8 %
LOS by estimating the change in the number of days in (n=109)] of patients were male. The average age of the
either a general medical ward or high dependency wards patients was 49.8 + 13 (Mean +SD) years (range: 19 to 80
(Incentive Care Unit, Coronary care unit, Emergency years). Majority (52.8%) of DRPs occurred in the age
wards). The change in LOS was based on likelihood of group of 41- 60 years. The demographic details of the
changes in LOS occurring if the intervention was not study patients are summarized in Table 1.
2
done. The local independent clinical panel decided as to The most common drug related problem was drug use
sub-classification of the wards based on individual case. without indication, which accounted for 18% (n=47) of
The cost impact of changes in LOS was then calculated total DRPs followed by improper drug selection [14%
based on average ward costs for the particular ward as (n=36)] and subtherapeutic dose [14% (n=36)].The types
existed at the study site.
of drug related problems are summarized in Table 2.
Laboratory Monitoring Changes and Medical Of the total interventions, the significance level
Procedures
'moderate' was found to be high (60%) followed by
The independent clinical panel examined the changes to significance level 'minor' (29%). The significance level
laboratory monitoring or medical procedures and of drug related problems is represented in Table 3.
allocated a probability of the event being changed as a The most frequent suggestion provided by the
result of the intervention. The cost impact was then intervening pharmacist was cessation of drug [20 %
calculated by multiplying this probability by the study (n=53)] followed by addition of drug [14% (n=37)].
site's costs for the particular medical procedure or Change in drug dose accounted for 13% (n=33) of total
laboratory test.
suggestions provided. Suggestion related to
Evaluation of Drug Cost
pharmaceutical aid was found to be least [2% (n=4)].
The impact of pharmacist intervention on drug cost was Various suggestions provided by the intervening
assessed by considering change in the medication orders pharmacist are summarized in Table 4.
that occurred during hospital stay. The discharge The acceptance rate of intervening pharmacist's
medications of the patient were not considered for cost suggestions was found to be 87 % (n=227). Of these,
2
evaluation. For the analysis of drug costs, intervening changes in drug therapy was observed in 81% (n=183) of
pharmacist referred latest issue of Current Index of accepted suggestions. The total time spent by the
Medical Specialities (CIMS). If the drug costs for the intervening pharmacist in preparing, undertaking and
particular drug was not available in CIMS, then cost documenting all interventions was 106 and 25 minutes
38

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
[average 12.5 minutes; range: 2 to 60 minutes].
gastritis associated with use of antibiotics and NSAIDs.
Of the total interventions, 46% (n=118) of interventions However, where appropriate, after intervening
belonged to drug therapy decision-making level 1 pharmacist's intervention rabeprazole was withdrawn
(Corrective) followed by level 4 (Proactive) accounting from the patient's therapy.
to 30% (n=79). The Pharmacist's involvement in drug Improper drug selection [14%] was the second most
therapy decision making is presented in Table 5.
common DRP observed. This finding coincides with the
A total of 128 interventions resulted in decrease in cost of
3
study conducted by Gurumurthy Parthasarthi et al
therapy while 33 interventions incurred additional cost. wherein, it reported improper drug selection [17%] as the
The total net cost savings was Indian Rupees (INR) second most common DRP that occurs in medicine
27,233.55/=. This included savings of INR 5590.50/= for
wards. The high incidence of improper drug selection
reduction in length of stay, INR 9079.85/= for
may be attributed to lack of standard treatment protocol
readmission reduction, INR 476.20/= for laboratory
in the hospital, poor history taking etc. In one incidence,
monitoring and INR 12,087.00/= for drugs. The impact
hypertensive patient with a history of diabetes was
of pharmacist-initiated changes to drug therapy and their
administrated with Beta-blocker owing to lack of
associated cost savings is presented in Table 6.
documentation of patient's medical history. Later, when
DISCUSSION
In India, clinical pharmacy service is an emerging
intervening pharmacist reviewed the case, it was
3
discipline . Clinical pharmacy service is to optimize
observed that the patient was also diabetic and
patient outcomes by working to achieve the best
appropriate intervention was made as beta blockers may
12
possiblequality use of medicines. It has been shown that
mask the hypoglycemic side effect of anti-diabetics.
the clinical pharmacy activities reduce the drug related
Failure to receive drug was accounted for 5% (n=14) of
problems related hospitalization, probability of readthe
total DRPs. In few cases, it was due to economic
2,3 constraints of the patients that led to non-procurement of
mission and total cost of drug therapy. This prospective
prescribed medicines while in few other cases it was due
study was carried out to assess and quantify the
pharmacist-initiated changes in drug therapy of into
take the medications for unknown reasons. Other types
to shift change of nursing staff and reluctance of patients
patients of a tertiary care teaching hospital.
In our study, DRPs were high (52.8%) in patients aged of DRPs including drug duplication and class duplication
between 41and 60 years. Of the 189 patients, DRPs were majority due to availability of more than 80,000
commonly observed in male patients (57.8%). This formulations of drugs in Indian market with different
3
finding might be due to increased medication use owing brand names leading to confusion. This error can be
to their multiple co-morbidities. Majority (71.4%) of minimized by prescribing generic names and also by
patients received more than six drugs per day and hence reviewing and re-checking of medication order regularly
increased risk of occurrence of drug related problems. prior to drug administration.
Regular review of patients' medication use may Of the 261 DRPs, 29% (n=75) were rated to be 'minor',
potentially decrease the drug related problem. 13 60% (n=157) were 'moderate' and 11% (n=29) were
Drug use without indication [18% (n=47)] was the most 'major' significance of interventions. This finding
3
common DRP observed followed by improper drug correlates with a study that reported 49% of
selection [14% (n=36)]. This observation is in contrast interventions as 'moderate' significance. The 'moderate'
with the study carried out by Gurumurthi Parthasarthi et significance level is the level of problems requiring
3
al , in which inappropriate dosing accounted for highest adjustments, which are expected to enhance
(31%) followed by improper drug selection (17%). Few effectiveness of drug therapy producing minor reduction
drugs often used without indication included in patient morbidity or treatment costs. In our study, for
Rabeprazole, Paracetamol and Ranitidine. Although anti example, patient experienced severe diarrhea [presence
secretory agents often used as prophylaxis, especially in of signs of dehydration with abdominal pain and cramps]
patients with previous history of acid peptic ulcer after receiving Clindamycin. After having assessed the
disease, the agents were prescribed while there was no ADR, the intervening pharmacist informed physician
such indication. A study conducted by David L. Whaley about the possible Clindamycin induced diarrhoea and
14
et al reported that gastrointestinal agents were the major sought for the cessation of drug. Thus the timely
class of drug prescribed in a hospital. In our study, the use intervention by intervening pharmacist might have
of proton pump inhibitor was to prevent the possible resulted in reduction in hospital stay and hence the cost
39

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
involved in the management of adverse drug reaction. the suggestions provided. In few cases, experienced
Antibiotics (21%) was the most commonly implicated physician did not change their routine prescribing pattern
drug class in DRPs. This observation was coinciding despite the presence of DRP, especially, DRP of 'minor'
15,16
with observations made by different studies. Ahuva significance. For example, a suggestion for use of
15
Lusting found antibiotics (38.7%) as the most prevalent domperidone instead of ondansetron for vomiting was
class of drugs prescribed in hospital. Inappropriate
rejected.
antibiotic usage may provoke the emergence of bacterial The total time spent by the pharmacist in preparing,
resistance and increased healthcare cost. Similar finding undertaking and documenting all interventions was 106
was reported in a study conducted by Carlos Bantar et
hours and 25 minutes. The average time spent for each
16
al . In our study, patients were either receiving high dose
intervention was 12.5 minutes (range: 2 to 60 minutes).
of antibiotics or antibiotics were prescribed without any 2
This observation is in contrast to Michael J. Dooley et al
valid indication. Of the 261 DRPs, 17% and 15% of the
study wherein 9.6 minutes (range: 0-60 minutes) was
DRPs were found in patients treated for cardiovascular
spent for each intervention. This difference may be
disorders and respiratory disorders respectively. These
2 attributed to the fact that unlike India, drug information
observations correlated with the Michael J. Dooley et al
services and patient medication history were available
study conducted in Australia. In our study, it may be
17
perhaps due to high occupancy rate of patients with
online in developed countries like Australia . In addition,
cardiovascular disorders and respiratory disorder in unlike our study, involvement of experienced clinical
medical ward resulting in use of more medication in these pharmacist would have led to the high acceptance rate
patients, thus leading to potential DRPs. and also reduction in time spent for each intervention.
Cessation of drug (20%) and addition of drug (14%) were Textbooks were found to be the most frequently (56%)
the suggestions most frequently provided. This finding consulted references followed by the personal
2
differs from observation made in an Indian study knowledge of the intervening pharmacist in providing
wherein change in drug dose was reported as the most various suggestions. As majority of DRPs were of 'minor'
common suggestion made. Other suggestions made in significance, most of DRPs were managed with the
our study included change in drug dose, duration of amount of information available in various textbooks.
therapy, frequency of administration and substitution of The information available in textbooks is very
drug etc. Addition of drug was suggested in case of comprehensive and also covers wide ranges of diseases
untreated indications that required treatment. Few of the and their treatment aspect. Also, since the department of
untreated conditions included anemia, cough and cold. In clinical pharmacy located at JSS hospital is well
most cases, the change in drug dose was sought in
equipped with drug information resources including the
patients with renal/hepatic impairment requiring dosage
latest resources of textbooks, it was possible to obtain
reduction. In our study, the major reasons for cessation of
latest information required to address the DRPs.
drug were due to drug use without indication and
All the 183 interventions which were accepted and
improper drug selection. Few examples that warranted
changed by the physicians were allocated for cost
the cessation of drugs in our study included use of betaanalysis.
Of these, 163 interventions had impact on the
blockers in asthma patient, steroids in diabetes and
cost and the remaining interventions did not have any
paracetamol in afebrile condition. These findings of our
impact on cost savings. Of the 163 interventions, 126
study indicate that there is a scope for pharmacist to
interventions had impact on drug cost alone and hence
suggest issues related to rational drug therapy and
emphasise the importance of involvement of pharmacist
only 37 interventions were assessed by the independent
in healthcare delivery.
panel for quantification of length of stay, readmission,
The acceptance rate of intervening pharmacist's medical procedures and laboratory monitoring. As
suggestions was found to be high (87%). This decided by the clinical panel, 33 interventions had
3,10
observation correlates with other published studies . Of resulted in cost-savings but two interventions resulted in
the 87% of interventions accepted, 81% of interventions increase in cost of therapy. However, two interventions
led to the changes in drug therapy. The remaining 19% of were excluded as there was no impact on cost savings.
interventions that did not lead to changes in drug therapy The net cost savings made through interventions was
might perhaps be due to lack of information to strengthen Indian Rupees (INR): 27,233/=. In our study, the
40

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.1 - Demographic details of the study patients
Characteristics Number (%) (n= 189)
Age (years) 18-29 10 (5.3)
30-40 31(16.4)
41-50 50 (26.4)
51-60 50 (26.4)
61-70 42 (22.2)
71-80 6 (3.2)
Sex Male 109 (57.8)
Female 80 (42.3)
Number of drugs received
per patient
1-5 drugs 54 (28.6)
6-10 drugs 116 (61.4)
>10 drugs 19 (10)
Co-morbidities Nil 56 (30)
1-2 95 (50)
3-4 31 (16)
>4 7 (4)
Table No.2 - Types of drug related problems
Drug related problems
Number (%) (n=261)
Drug use without indication 47 (18)
Improper drug selection 36 (14)
Sub therapeutic dose 36 (14)
Drug interaction 31 (12)
Over dose 28 (11)
Adverse drug reaction 21 (8)
Untreated indication 19 (7)
Failure to receive drug 14 (5)
Others* 29 (11)
* Class duplication (n=12), Drug duplication (n=9), Dispensing errors (n=6) and Drug use
without prescription (n=2).
41

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.3 - Significance level of drug related problems
Significance level*
Number (%) (n=261)
Minor 75 (29)
Moderate 157 (60)
Major 29 (11)
* Minor: Problems requiring small adjustments and optimization to therapy, which are not
expected to significantly alter hospital stay, resource utilization or clinical outcome.
Moderate: Problems requiring adjustments, which are expected to enhance effectiveness of
drug therapy producing minor reductions in patient morbidity or treatment costs.
Major: Problems requiring intervention, expected to prevent or address very serious drug
related problems, with a minimum estimated effect on reducing hospital stay by no less than
24 hours.
Table No. 4 - Suggestions provided by the intervening pharmacist
Su ggestion provid ed
N umb er (%)
(n =261)
Cessation of drug 53 (20)
Addit ion of drug 37 (14)
Cha nge in drug dos e 33 (13)
Cha nge in durat ion of therapy 31 (12)
Cha nge in frequency of ad ministration 23 (9)
Substit ution of drug 22 (8)
Cha nge in cost of therapy 18 (7)
Cha nge in route of adm inistration 13 (5)
Cha nge in dosage form 12 (5)
Pharmaceutica l a id 4 (2)
Others * 15 (6)
* Need for laboratory investigation (n=1), need for patient counseling (n=6), annotation
changes (n=7) and availability of drugs (n=1).
42

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.5 - Pharmacist’s involvement in drug therapy decision making
D ecision m ak ing lev el* T o ta l (% ) (n= 2 61 )
Lev el 1 4 2 (1 6 )
Lev el 2 1 1 8 (4 6)
Lev el 3 2 2 (8 )
Lev el 4 7 9 (3 0 )
* Level 1 (Annotative): The pharmacist is clarifying a prescription and/or the interventions of a
prescriber. The prescriber makes no changes.
* Level 2 (Corrective): The pharmacist is actively questioning a prescription to try to get it changed
or corrected. His advice may be accepted or rejected. The prescription may or may not be
changed.
* Level 3 (Consultative): The pharmacist is making an active contribution to a discussion. He is
asked for or offers his advice before a decision is made. His advice may be accepted or rejected.
The prescription may or may not be written or changed.
* Level 4 (Proactive): The pharmacist suggests something, which has not been previously
considered. He may also initiate and/ or start a discussion. His advice may be accepted or rejected.
The prescription may or may not be written or changed.
Table No.6 - The impact of pharmacist initiated changes to drug therapy and their associated
cost savings.
Number of intervention
Cost incurred (INR)
Increase in
Cost of
Therapy
Decrease
in Cost of
Therapy
Increase in
Cost of
Therapy
Decrease
in Cost of
Therapy
Length of Stay
General ward bed 2 12 315.00 3176.05
High dependency bed 0 4 0 2729.45
Readmission 0 13 0 9079.85
Laboratory Monitoring 0 4 0 476.20
Medical Procedures 0 0 0 0
Drugs 31 95 1621.75 13708.75
Total 33 128 1936.75 29170.30
Overall Savings (net savings) 27233.55
Annualized Savings 46686.08
43

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
potential cost savings quantified arose only from the This findings correlates with the multicentre prospective
intervening pharmacist-initiated interventions. The
2
study conducted in Australia which showed a reduction
potential cost savings arose from other activities carried of $1 50 307 due to decrease in length of stay as a result of
out by the intervening pharmacist such as drug
their intervention in eight major acute care hospitals. The
information, patient medication counseling, monitoring
difference in the magnitude of reduction in healthcare
and managing adverse drug events were not considered
expenditure due to reduced length of stay may be
and quantified. In addition, the total time spent by the
explained by the fact that their study was conducted on a
intervening clinical pharmacist to address the DRPs was
106 hours and 25 minutes. If the intervening clinical large-scale population in eight acute care government
pharmacist had spent more time in reviewing patients' funded hospitals.
drug therapy, it would have resulted increased potential The potential for probability of readmission was
cost savings. Moreover, the cost savings due to prevented in 13 cases and that resulted in cost savings of
intervention quantified in our study were a direct link to INR: 9079.85. This finding differs with the Michael J.
2
utilization of specific health resources. Although some Dooley et al study wherein the cost saving was found to
patients experienced other health outcome benefits from be $111848. There were no interventions on medical
the interventions done by the intervening clinical procedures that resulted in cost savings and only four
pharmacist, these outcomes were not quantified in
interventions had impact on laboratory monitoring that
economic terms. Reduction in drug cost accounted for
resulted in cost savings amounting to INR: 476.20. In
the majority of the cost-benefit measured. It is obvious
2
Michael J. Dooley et al study the expenditure on
that increased number of drug use without indication and
improper drug selection increases the unnecessary drug
laboratory monitoring was $ 4558 and cost savings on
cost. Therefore, by intervening in these types of DRPs laboratory monitoring was accounted for $ 4 213.
clinical pharmacist can contribute to reduction in
In our study, the annualized cost savings due to clinical
unnecessary healthcare expenditure arising due to use of pharmacist-initiated changes to drug therapy was found
2
unnecessary medications. The total drug cost saved due to be Rs: 46,686.08. In Michael J. Dooley et al study, the
to clinical pharmacist interventions was INR: 13,708.75 reported annualized saving was $ 4 444 794. The
while increase in drug cost accounted for Rs: 1621.75. difference in the annualized cost savings between these
This increased drug cost observed in our study was two studies is due to fact that variation in the study
majority due to untreated indication such as anemia,
population and number of hospitals included in the study.
cough and vomiting. Although, addition of drug in these 2
Michael J. Dooley et al study was conducted at eight
cases led to increase in treatment cost, patient would have
major acute care hospital with well trained and
benefited in terms of therapeutic outcome. However, the
net drug cost savings was INR: 12,087. Savings of drug
experienced pharmacist. But, our study was conduced in
2
cost was also observed in Michael J. Dooley et al study
a single tertiary care teaching hospital and also the
wherein the cost savings accounted for $8 279 while the intervening pharmacist was a postgraduate clinical
increased drug cost accounted for $ 7964. Our study pharmacy student with minimal experience on drug
findings reveal that the clinical pharmacist's intervention therapy reviewing and managing DRPs. Other reasons
is one of the effective cost saving measures, and clinical might be due to differences in the cost of drugs,
pharmacists should enforce their attitude towards cost laboratory tests, hospital stay charges etc between the
effective patient management.
study sites.
Increased length of stay has been consistently associated
Nevertheless, clinical pharmacist initiated changes to
with drug related problems like inappropriate drug
drug therapy resulted not only the cost savings but also
selection and subtherapeutic dose. Interventions of these
associated with improved patient outcome. The overall
DRPs would certainly result in reduction in the patients'
observation made from this study was that pharmacists
healthcare expenditure. In our study, the reduction of
treatment cost due to reduction in length of stay was have greater responsibility in healthcare team in
estimated to be INR: 5905.50 while two of the minimizing and/or preventing drug related problems and
interventions had increased the length of stay thereby thereby can potentially reduce the unnecessary hospital
increasing the healthcare expenditure by INR: 315.00. stay, readmission, laboratory monitoring and drug cost.
44

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
CONCLUSION
Our study demonstrates that the physicians' acceptance
rate of pharmacist-initiated changes in drug therapy is
high. Clinical pharmacist's review of in-patients drug
therapy can positively influence the patient outcomes
and reduce healthcare costs. This proves the fact that
clinical pharmacist has an enormous role to play in the
healthcare management through quality use of
medicines.
ACKNOWLEDGEMENT
We would like to thank the Principal, Staff and
Postgraduate students of Department of Pharmacy
Practice, JSS College of Pharmacy, Mysore, and the Staff
of Department of Internal Medicine and Administrative
Staff of JSS Medical College Hospital, Mysore for their
support and encouragement.
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45

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
INTRODUCTION
Growing expenditure on pharmaceuticals is one of the
driving factors that resulted in initiating Pharmacy and
Therapeutics Committee (PTCs) in developed countries
like Germany, Australia, Canada, Ireland, and Holland,
along with other countries that have utilized PTCs
effectively to optimise therapeutic health outcomes for
patients as well as economic benefits for hospitals
(Thurmann et al, 1997; Weekes and Brooks, 1996; Feld,
1986; Ferrando and Henman, 1986; Mannebach in Fijn et
al, 1994). Developed countries have traditionally used
PTCs to initiate and maintain rational use of medicines
programs at hospitals. Internationally, hospitals in
developed countries have had PTCs for over 70 years
with built-in methods to monitor and evaluate their
performance (Thurmann et al, 1997; Summers and
Szeinbach,1993; Bochner et al, 1994; Rucker, 1988;
Mehr 2006). The individual activities of PTCs differ
while maintaining a common theme and approach of
advisory and educational activities to maximize the
rational use of medicines. The beneficial effect of
hospital PTCs in monitoring and promoting quality use
of medicines and containing costs in hospitals and other
institutional settings has been generally well-accepted in
Indian Journal of Pharmacy Practice
Received on 02/03/2009 Modified on 13/03/2009
Accepted on 16/03/2009 © APTI All rights reserved
ijopp
Pharmacy and Therapeutics Committee in Bangalore Institute of
Oncology - Promoting Rational Pharmaceutical Management
Divya Hariharaputhran, Sunitha C. Srinivas, Ramesh S. Billimaga, Ajai Kumar B.S
1, 3
Bangalore Institute of Oncology, Bangalore, India
2
Rhodes University, South Africa
4
HealthCare Global Enterprises Ltd, Bangalore, India
*Address for correspondence: s.srinivas@ru.ac.za
Abstract
Bangalore Institute of Oncology (BIO), a Comprehensive Cancer Center operating since 1989 has initiated
Pharmacy and Therapeutics Committee (PTC) in 2007 as a forward looking step in promoting rational use of
medicines. The first step in establishing role of PTC was to carry out ABC Analysis of Anti-Cancer Drugs procured at
BIO for the period of October 2006 to September 2007, according to Management Sciences for Health (MSH) and
World Health Organization (WHO) guidelines. ABC Analysis provided a comprehensive and clear picture of
consumption of chemotherapy medicines. The number of brand names procured for individual medicines were also
collated. Constructive debate amongst PTC members resulted in making the decision to streamline the procurement
of only three brand names for each medicine that had numerous brands procured earlier. PTC members of BIO have
constructively utilized the forum in further improvising the pharmaceutical management as a first step in
establishing PTC as a decision making body for rational use of medicines.
Key words: Pharmacy and Therapeutics Committee; ABC analysis; Rational use of medicines
developed countries. Unfortunately, there has been little
critical evaluation of the clinical or economic impact of
this approach in developing countries.
PTCs have been mandated standards in hospital settings
in the USA even before 1960s (Bagozzi, 2005) for safe
and cost effective use of medicines in hospitals. In this
context there is a need to highlight an important concept
that maximum expenditure is not necessarily the only
method to achieve optimal health benefits. Developed
countries use the concept of balancing therapeutic
efficacy with cost and not just striving for cost
effectiveness. Formularies are updated by using different
approaches to evolve decision-making methods
(Bagozzi, 2005). These include inventory management
approach, cost accounting approach and criteria based
approach, to develop and manage an effective formulary.
The WHO in promoting the rational selection of
medicines has used the same concept by highlighting
four paramount features to be considered, which are:
efficacy, safety, quality and cost of medicines (WHO,
2001) . The rich countries have used the same concepts
despite lack of financial constraints in order to balance
the expenditure without subrogating the quality of care
provided to patients. Hence the policies in developed
countries have supported PTCs for many years, by using
PTCs as mandated standards in health care organisations
(Hochla and Tuason, 1992). Australia considers PTCs
46

pivotal to the rational use of medicines (Weekes and This article describes initiatives in rational
Brooks, 1996) and it has been shown that effective PTCs pharmaceutical management as a part of the newly
play a very active part in educational, communication initiated PTC's activities of Bangalore Institute of
and advisory roles when clinicians, pharmacists and Oncology (BIO). BIO was founded in 1989 as the
nursing representatives work together with flagship unit of Banashankari Medical and Oncology
administrative personnel on PTCs. Based on this proven Research Center Ltd (BMORC). BMORC, initially
evidence from developed countries, some developing incorporated as a Private limited Company on 13
countries such as Brazil (Cruz and Paola, 2006) and Laos November 1986, became a public limited company in
(Vang, 2006) have actively adopted the concept of PTCs 1992. It was the first private Comprehensive Cancer
in their hospitals to advocate rational therapeutics that Hospital in Bangalore and Karnataka. The idea for such a
promote evidence-based medicine along with clinical hospital was initiated and is managed, by like-minded
effectiveness and not just cost effectiveness.
and dedicated cancer specialists who realized that the
Pharmaceutical management as proposed by the
existing facilities in the government hospitals were not
Management Sciences for Health (MSH) (Quick et al,
sufficient to meet the demands and the private sector
1997) and the World Health Organization (WHO)
needed to step in. BMORC manages and operates BIO, a
involves four functions: Selection, Procurement,
comprehensive cancer center which started its services in
Distribution and Use. This cycle requires support of legal
1989 with 5 consultants and 30 beds. It is now a 145-bed
and policy framework as well as management support
hospital with over 60 consultant physicians and a staff
that comprise financing, information management,
strength of 546 people. BIO treats nearly 3000 new
human resources and organization. Analytical techniques
cancer patients every year, and around 110 patients
are designed in developed countries and cost-conscious
receive radiotherapy every day. Besides, the daily
countries to identify and control excess costs in
outpatient attendance exceeds 300. Nearly 1800 major
pharmaceutical management. Even by the 1980s,
operations are performed every year. These numbers are
developed countries spent about 100 times as much on
ever increasing.
health and 20 times as much on pharmaceuticals, on a per
BIO's PTC was initiated in October 2007, with the
capita basis, when compared to developing countries
objective of promoting rational use of medicines. The
(Patel, 1983) and this trend continues to be predominant.
PTC is a standing hospital committee responsible,
Hence, industrialized countries have adopted techniques
through its chairman, to the Hospital executive board. It
to contain costs. This resulted in techniques such as ABC
is a policy recommending body to the medical staff and
analysis and Therapeutic Category analysis to quantify
administration of the hospital on matters related to the
costs and identify areas where costs could be reduced
therapeutic use of drugs. Improved health and economic
(Quick et al, 1997; Quick 1982). Cost reducing strategies
outcome of the hospital care, particularly those related to
are aimed at increasing the effectiveness and efficiency
the medication remains the core objective of the PTC.
of pharmaceutical supply.
Methodology
ABC analysis is also known as Pareto analysis. It is a
Pharmacy and Therapeutics Committee of BIO decided
well-known method in inventory management, and is a
to use the concept of ABC Analysis for rationalizing the
useful tool in analyzing consumption patterns and the
decisions of pharmaceutical procurement of
value of total consumption. A Canadian study highlights
Antineoplastic medicines to start with.
the extent to which cost effectiveness evaluation is a
ABC analysis ranks a set of pharmaceuticals by
useful input in decision-making moving beyond
calculating the expenditure on each medicine as a
examining budgets and towards broader balanced
percentage of the total expenditure on all medicines in the
benefits of therapeutic outcomes with economic
set. It is a method advocated by WHO and MSH for
outcomes (Dugal et al, 2002). This approach is a direct
assembling data to determine where money is being spent
consequence of growing concern about rising health care
(Quick et al, 1997).
costs due to pharmaceuticals as the main component of a. All items purchased are listed according to year and
expenditure (Levy and Gagnon, 2002; Fernandes, 2002). unit cost.
Cost-cutting strategies from policy makers, hospital b. Consumption quantities for each are entered.
administrators, and health care professionals generally c. Value of consumption is calculated for each by
targeted pharmaceutical expenditures first.
multiplying the unit cost by the number of units
47

consumed or purchased to obtain the total value for medicines to all their citizens.
each item.
Developed countries such as New Zealand resorted to
d. The values of all items is then totaled at the bottom of intervention in pharmaceutical management by
the column.
highlighting the need for better information to make
e. The percentage of total value represented by each item effective medicines available without bankrupting the
is calculated by dividing the value of each item by the health care system (Brougham, 2002). One of the first
total value of all items.
steps most developed countries adopted is computerising
f. The list is rearranged to rank the items in descending
the procurement process and documenting the usage of
order by percentage of total value, starting at the top
medicines. Studies reports the extent to which their
with the highest value.
purchasing and inventory control of pharmaceuticals
g. The cumulative percentage of total value of each item
improved by initiating computerised inventory control,
is calculated
Results
which progressed into formulary management and other
Concept of ABC Analysis was used for Anti-Cancer related interventions in pharmaceutical management
st
medicines procured for the period from 1 October 2006- (Rubin and Keller, 1983; McAllister, 1985). On similar
th
30 September 2007.The percentage value of procured lines BIO has been operating with the computerised
medicines with the highest, second highest and least inventory for procurement which made it easy to have
number of brand names were tabulated. Docetaxel ready access to the data for ABC Analysis. Based on ABC
(18.91%), Gemcitabine (9.37%) and Paclitaxel (8.87%) analysis and decisions taken to promote rational use of
were in the list of percentage value of ABC Analysis for medicines, formulary management is in the process of
medicines with the highest number of brand names. Table being initiated at BIO.
ABC analysis in conjunction with computerisation is one
1 shows the percentage value of ABC analysis for
of the common methods adopted to optimise inventory.
medicines with second highest number of brand names
The reason for the majority of health institutions to
and the least number of brands is shown in Table 2.
ABC Analysis which was done for the first time in the initiate inventory management techniques is due to the
institution gave a comprehensive and clear picture of recognition of raising pharmaceutical budgets and the
overall consumption of chemotherapy medicines for a realisation by hospital administrators that reducing the
period of one year. The complete details of individual pharmacy budget is an effective method of containing
consumption of chemotherapy medicines and number of institutional costs (Hutchinson et al, 1989).
brand names procured for individual medicines were Consequently ABC analysis has become a popular
obtained. This helped in making decisions to streamline method of quantitative measurement of inventory control
the procurement of only three brand names for each (Noel, 1984). Thus, an efficient and productive
medicine that had numerous brands procured earlier. purchasing system results in cost savings (Bair and Lee,
Discussion
1984) leading to ABC analysis becoming one of the
The constant monitoring of programs in developed management techniques. Similarly in BIO, PTC decided
countries helped in identifying increasing pharma- to list only three brand names based on criteria like cost
ceutical expenditures. A Canadian study reports growth and extent to which they are prescribed instead of
of pharmaceutical expenditure as being close to double procuring all available brands or brands based on
the rate of growth in other health care expenditure clinicians' choices, which is increasing the cost of
(Willison, 2002). Similarly, a study in Italy reports inventory. It was decided there should also be the option
growth of 11% per year in the last five years resulting in of two more additional brand names in the list and for
pharmaceutical expenditure becoming a challenge in the those additional item the clinicians will have to wait till
health care system (Rocchi et al, 2004). In response to the medicine is procured.
constant increases in pharmaceutical budgets, developed PTCs have been widely accepted both in the developed
countries faced the challenge by introducing various and developing countries as these represent a voluntary
interventions. It required them to make hard decisions and advisory control strategy with physicians in a central
about fundamental values in their health care systems position (WHO, 2004). Many PTCs report their activities
(Laupacis, 2004). The need to balance benefits of and one of them reported the important feature required
medicines with costs was the prime issue in order to for PTCs to be successful, as “a well-prepared agenda,
provide accessibility, equity, and affordability of good educational material, active members and strong
48

.
leadership” (Cohen, 1984). A study reported the reason
for success of their PTC as an 'evolution' rather than a
'revolution' and an 'educational' rather than
'confrontational' approach. Their members view their
involvement in the PTC as a forum of “valuable
interaction that helped them stay at the forefront of
important therapeutic advancements”(Hinthorn and
Godwin, 1989). Unless physicians see the benefit of their
interaction in PTC and perceive that benefit as important
for their clinical decisions, it is difficult to expect
ownership of a PTC concept. The profile of the
committee and mechanics of its functioning strengthen
PTCs. BIO's PTC has adopted these principles to the best
possible extent by providing a central role for clinicians
to make decisions in an evolutionary manner.
Constructive debate followed by buy-in of clinicians to
allow procurement of only three brand names for
chemotherapeutic agents instead of all brand names,
demonstrates the steps taken in the direction of rational
pharmaceutical management.
National Health Services hospitals in the UK use PTCs
effectively to control the introduction of new medicines
by applying principles of evidence-based medicine
(Jenkings and Barber, 2004). Overall, the traditional
roles of PTCs have been in advisory capacity and as
policy-recommending committees within health care
systems, for promoting rational use of medicines. These
roles expanded to incorporate Drug Utilization
evaluations, medical staff education, continuous quality
improvement, formulary restrictions and therapeutic
interchange (Wade, 1996). Evidence from developed
countries has shown that unless the PTC has wide
representation from all key stakeholder departments, the
focus simply remains on cost containment rather than
clinical efficacy, which would defeat the purpose of a
PTC (Woodhouse,1994; Borreson, 1986). On similar
lines BIO's PTC is well represented by all key stake
holders under the strong leadership resulting in
evolutionary steps taken towards implementing
institutional rational use of medicines.
Traditionally, PTCs have been used to steer the process of
maintaining updated formularies at hospitals. A study in
Malaga, Spain, shows how hospital policies operating
their formulary can be used to maintain the optimal
balance of using new medicines while considering cost
containment. The hospital reports potential therapeutic
and economic benefits as well as educational benefits
resulting in uniformity of pharmaceutical use. A study
reports their PTC as instrumental in establishing a
“flexible and dynamic formulary in an ever changing
health care environment”(Zoloth, 1989). Another study
stresses the importance of communicating updated
formulary decisions to medical staff. This educational
intervention plays a vital role in advocating rational
therapeutics (Dreyfus and Bender, 1987). These
principles are being adopted in decision making for
initiating and maintaining a formulary at BIO.
PTCs have been known to achieve objectives such as
availability of safe, efficacious, and quality medicines at
an affordable price (WHO, 2004). The shift in the
decision-making authority from the physicians to the
PTCs is likely to be resisted especially since physicians
traditionally hold an influential profession with
extensive freedom to prescribe. The negative attitude
towards a control body could be reduced by projecting a
need for information and the rationalization of drug
therapy and by advocating economic prescribing, which
is being adequately addressed in BIO.
Table No. 1: Percentage value of ABC Analysis for Medicines with second highest number of Brand Names
Names of Medicines % Value from ABC Analysis
Doxorubicin
7.138%
Oxaliplatin 6.453%
Carboplatin 2.630%
Temozolamide 1.535%
49

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.2: Percentage value of ABC Analysis for Medicines with least number of Brand Names
Names of Medicines
% Value from ABC Analysis
Rituximab 15.951%
Cetuximab 6.194%
Traztuzumab 2.649%
Bevacizumab 2.135%
Epirubicin 1.981%
Gefitinib 1.795%
Capecitabine 1.481%
Cisplatin 1.458%
Vinorelbine 1.309%
Fludarabine 1.205%
Irinotecan 1.196%
Ifosfamide 1.020%
Goserelin 0.735%
Letrozole 0.733%
Thalidomide 0.726%
Dacarbazine 0.617%
Bleomycin 0.390%
Cytarabine 0.382%
Exemestane 0.312%
Cyclophosphamide 0.296%
Erlotinib 0.255%
Etoposide 0.201%
Asparginase 0.173%
Anastrazole 0.158%
Tamoxifen 0.153%
Melphalan 0.132%
Chlorambucil 0.132%
5-Fluorouracil 0.107%
Vinblastine 0.104%
Daunorubicin 0.095%
Bortezomib 0.094%
Dactinomycin -D 0.086%
Lenalidomide 0.083%
Leuprolide 0.078%
Arsenic Trioxide 0.062%
Vincristine 0.057%
Imatinib 0.048%
Methotrexate 0.047%
Hydroxy Urea 0.040%
Megesterol 0.028%
Altretamine 0.025%
Lomustine 0.018%
Mitoxantrone 0.007%
Mitomycin 0.005%
Interferon 0.002%
50

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Conclusion
14. Hochla PK, Tuason VB. Pharmacy and Therapeutics
Pharmacy and Therapeutics committee in BIO has been
committee. Cost containment considerations. Arch
used effectively in initiating the rational inventory and
Intern Med 1992; 152(9):1773-1775.
procurement of chemotherapy medicines to start with.
15. Hutchinson RA, Hatoum HT, Kolinski R, Riley DW.
The advisory and educational objectives of the PTC are
being initiated to promote rational use of medicines. The The use of pharmacy personnel to positively impact
economic spin offs of rational inventory management not hospital finances. Hosp Formul 1989; 24(8):450-453.
only results in effective pharmaceutical procurement but 16. Jenkings KN, Barber N. What constitutes evidence in
it also paves the path in a stronger a role for PTC in hospital new drug decision making Soc Sci Med
rational use of medicines. 2004; 58:1757-1766.
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52

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
Abstract
Both macrolides as well as cephalosporins are widely used in the treatment of various lower respiratory tract
infections either alone or in combination. The most commonly prescribed macrolide is azithromycin, generally in
combination with different cephalosporins. The objectives of the present study were to find out the different
combinations of azithromycin and cephalosporins generally prescribed, compare their efficacy, safety (adverse drug
reactions) and cost. A prospective study was conducted in the medicine ward at St. Martha's Hospital, Bangalore.
The data was analyzed to interpret different parameters of the study. Efficacy was determined based upon the clinical
response (reduction in symptoms) and length of hospital stay. Safety was determined by assessing the occurrence of
ADR and their severity. Cost of treatment was calculated by cost effective analysis. In the study period, 88 patients
were included based on the inclusion criteria. Results revealed that different combinations prescribed were
azithromycin + cefotaxime, azithromycin + ceftriaxone and azithromycin + cefuroxime. The most commonly
prescribed combination was found to be cefotaxime with azithromycin. The cefotaxime group showed statistically
significant difference in the reduction of clinical symptoms thereby indicating greater efficacy. 18% of the patients
experienced ADRs which were mild in nature with none severe indicating that all the combinations were safe. The
cost effective analysis showed that combination of azithromyin and cefotaxime is most economical.
Key words: Antibiotics, Organisms, Antibiotic use, Pediatrics
INTRODUCTION
Respiratory tract infections (RTI) are very common in the budgets. In most of the adults with LRTI, the illness is
community and are one of the major reasons for visiting self-limiting and its course will not be modified by
1
to primary care physicians . The broad diagnosis of RTI antibiotic therapy, representing viral or clinically nonincludes
the two principal sub-diagnoses of lower
relevant bacterial diseases. However, failure to initiate
respiratory tract infection (LRTI) and upper respiratory
antibiotic therapy within four hours in cases of
2
tract infection (URTI) . Community-acquired lower
community acquired pneumonia is already associated
respiratory tract infection is a common cause of acute
6
with an increased mortality. The major problem in the
illness in adults. The spectrum of disease ranges from
mild mucosal colonization or infection, to acute
management of the LRTI is the inability to determine the
7
bronchitis or acute exacerbation of chronic bronchitis causative micro-organism in majority of patients .
(AECB) or chronic obstructive pulmonary disease There are great systematic differences in the prescription
(COPD), to overwhelming parenchymal infection in of antibiotics, both overall and for LRTI, between
3
patients with community-acquired pneumonia (CAP) . countries and between different healthcare providers in
8
The term LRTI includes a wide range of diseases which the same country . The "first generation" of guidelines
have different underlying pathologies and etiologies, e.g. was mostly consensus-based, whereas those published in
4, 5
acute bronchitis and pneumonia . In the out-patient 2000/2001 are at least partly evidence-based. However,
setting, LRTI account for the majority of all antibiotics there is still a lack of evidence in many areas of the LRTI
p r e s c r i b e d , b u r d e n i n g h e a l t h c a r e d r u g field, and, in addition, interpretation of the available
Indian Journal of Pharmacy Practice
Received on 05/02/2009 Modified on 13/03/2009
Accepted on 16/03/2009 © APTI All rights reserved
ijopp
Efficacy and Safety of Azithromycin with Various Cephalosporins
Used in Treatment of Lower Respiratory Tract Infection
1 2 3
Imran Ahmad Khan , Shobha Rani. R.H , Geetha Subramanyam
1. Sr. DSA, Quintiles, Bangalore
2. Department of Pharmacy practice, Al-Ameen college of Pharmacy, Bangalore-560027
3. Dept. of Medicine, St. Martha’s Hospital, Bangalore
*Address for correspondence: iamkhan@quintiles.com
9
evidence is variable in some cases .
MATERIALS AND METHODS
The present study was conducted at medicine wards of
St. Martha's Hospital, Bangalore which is 850 bedded
53

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
tertiary care teaching hospital providing specialized
health care services. Ethical clearance was obtained from
the Institutional review board, St. Martha's Hospital, and
an Informed consent was taken from the patients before
starting the study. The period of study was 8 months. All
adult and geriatric hospitalized patients of medicine
department who were diagnosed with lower respiratory
tract infection being prescribed with combination of
azithromycin and cephalosporin during the study period
and who were willing to participate in the study were
included. Out patients, Pregnant/lactating patients,
Pediatric patients, Non consenting patients were
categorized under exclusion group.
In this prospective study, data was collected from case
sheets of in-patients diagnosed with LRTI. A detailed
description of demographic details, Presenting
complaints, Past History, Personal History, Family
History, Drug history, Laboratory parameters was taken.
Patient follow up was carried out until discharge.
Efficacy was determined based upon the clinical
response i.e. reduction in the symptoms such as sputum
production, cough, wheezing, dyspnoea, fever,
discolored sputum and length of hospital stay. The
patients were monitored throughout till discharge and the
symptoms were noted at regular intervals of three days.
The patients were also monitored for any adverse drug
reactions during the treatment.
Table No.1
Gender n %
Male
Female
52
Table No.2
59
36 41
Age n %
20-29 4 5
30-39 16 18
40-49 19 22
50-59 29 33
60-69 10 11
= 70 10 11
Cost of treatment was calculated by “cost effective
analysis”. It is an economic evaluation method of
pharmacoeconomics where cost is measured in monetary
terms and consequences are measured in non-monetary
units. Cost effective analysis is used when there is single
measurable dimension of effectiveness for both
treatments. This method is used when it is necessary to
measure both cost and clinical outcomes of drugs.
The cost effective ratio for each treatment option is
calculated. This ratio is total cost of the drug divided by
the number of units of output (benefit). In this case, the
output is reduction in the symptoms on the seventh day of
the treatment. Preferred drug is the one with lower cost
per unit of output or health improvement. The difference
in the reduction of symptoms in different treatment
groups was statistically analyzed by Chi- square test.
RESULTS
After appropriate scrutiny 88 patients met the inclusion
criteria and were enrolled for the study during a period of
July 2007 to February 2008. Among the 88 patients that
were included, 52 (41%) were male and 36 (59%) were
female. The range of age of patients was between 23 to 88
years. Maximum number of patients 29 (33%) were in the
age group of 50-59 years, depicted in table nos 1 & 2.
Patients were addicted to different habits such as
smoking, alcohol and tobacco which affect the state of
disease. Smoking was found to be the commonest among
all the patients who accounted for 51.14% followed by
tobacco 29.55% and alcohol consumption 26.13%.
Different LRTI diagnosed are given in table no.3 of
which pneumonia was the form of illness in 40% of
patients making it highest among others.
Diagnosis
Pneumonia
Table No.3
Co-Morbid conditions were accounted for the use of
different combinations of antibiotics, of which
hypertension was the most common followed by
Diabetes Mellitus. Table no.4 gives the details of the
different combinations used for different co-morbidities.
n
35
AECOPD 20
AEBA 13
BRONCHITIS 20
%
40
23
14
23
54

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table.No.4
No. of Patients
Co-Morbid Conditions
Azithromycin +
Ceftriaxone
Azithromycin +
Cefotaxime
Azithromycin +
Cefuroxime
Total
HTN 16 21 7 44
DM 14 13 6 33
BA 5 9 2 16
ANAEMIA 4 5 1 10
COPD 3 8 1 12
UTI 6 5 4 15
RD 7 11 3 21
FEVER 7 13 3 23
The complaints presented by the patients are listed in table no.5, Majority of the patient (84.09%) complained of
cough followed by sputum production (82.95%). The other symptoms observed were discolored sputum (73.86%),
wheezing (53.40%), headache (43.18%), myalgia (39.77%) fever (36.36%), nausea (35.22%) and vomiting
(23.86%).
Table No.5
No. of Patients (%)
C linical Symptoms
Azithromycin +
Ceftriaxone
Azithromycin +
Cefotaxime
Azithromycin +
Cefuroxime
Total
sputum pr oduction 84.37 83.72 76.92 82.95
cough 81.25 88.37 76.92 84.09
wheezing 46.87 62.79 38.46 53.40
dyspnoea 25 30.23 23.08 27.27
headache 43.75 44.19 38.46 43.18
myalgia 37.5 39.53 46.15 39.77
fever 37.5 37.21 30.77 36.36
na usea 34.37 34.88 38.46 35.22
vomiting 25 23.25 76.92 23.86
oxygen used 21.87 20.93 30.77 22.72
discolored sputum 75 79.06 53.85 73.86
The various laboratory parameters which were evaluated were WBC, ESR, Platelet count, PaO2, PaCO2, HCO3,
and SaO2. The combinations of Macrolide and cephalosporin therapy prescribed to the patients for the treatment of
their relevant conditions are given in Table No.6.
Table No.6
COM BINATIONS
n
(% )
A zithromyc in + Ceftriaxone 32 36
A zithromyc in + Cefotaxime 43 49
A zithromyc in + Cefuroxime 13 15
55

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Treatment details based on the type of ailment are listed in table no 7.
Table No.7
No. of Patients (%)
Diagnosis
Azithromycin +
Ceftriaxone
Azithromycin +
Cefotaxime
Azithromycin +
Cefuroxime
Total
PNEUMONIA 37 43 20 40
AECOPD 40 45 15 23
AEBA 38 54 8 14
BRONCHITIS 30 60 10 23
The length of hospital stay of patients ranged from 2 to 12 days as shown in Table No.8, minimum stay was
observed in azithromycin + ceftriaxone combination.
Table No.8
No. of Patients (%)
No. of Days
Azithromycin +
Ceftriaxone
Azithromycin +
Cefotaxime
Azithromycin +
Cefuroxime
Total
1 - 4 0 4.65 7.7 3.4
5 - 8 56.25 69.77 15.38 56.82
9 - 12 43.75 25.58 76.92 39.78
Further evaluation of symptoms was done individually to assess their severity. The results are depicted in the
following table no 9, 10, 11, 12, 13 & 14
Table No. 9 CHANGE IN SPUTUM PRODUCTION
PAT IE NTS (% )
T RE ATM E NT
Day 0 (B ase line) Day 7
Severe
M ild/
M oder ate
Ab sent Disch ar ged Severe M ild/M oderate Absent
Azi th romyci n +
Ce ftriaxone
Azi th romyci n +
C efotaxime
84.4 12.5 3.1 21.9 43.8 9.4 25.0
83.7 9.3 7.0 34.9 25.6 0 39.5
Azi th romyci n +
Ce furoxime
84.6 0 15.4 7.7 46.2 30.8 15.4
2 = 3.635 P = 0.458 2 = 19.844 P = 0.003
56

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No. 10 CHANGE IN COUGH
2 = 2.901 P = 0.574 2 = 9.892 P = 0.129
Table No. 11 CHANGE IN WHEEZING
PATIEN TS (% )
TREATMENT
Day 0 (Base line) D ay 7
Severe
Mild
/Moderate
Absent Disc harged Severe
Mild/
Moderate
A bsent
Azithromycin +
Ceftriaxone
Azithromycin +
Cefotaxime
Azithromycin +
Cefuroxim e
46.9 12.5 40.6 21.9 9.4 18.8 50.0
62.8 11.6 25.6 34.9 0 14.0 51.2
61.5 23.1 15.4 7.7 23.1 23.1 46.2
2 = 4.325 P = 0.364 2 = 12.075 P = 0.060
57

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No. 12 CHANGE IN DYSPNOEA
PATIENTS (% )
TREATMEN T
Day 0 (Base line) Visit 2
Severe
Mild/
Moderate
Absent Discharged Severe
Mild/
Moderate
Absent
Az ithrom ycin +
Ceftriaxone
Az ithrom ycin +
Cefotaxime
Az ithrom ycin +
Cefuroxim e
25.0 50.0 25.0 21.9 6.2 31.2 40.6
30.2 39.5 30.2 34.9 0 16.3 48.8
53.8 30.8 15.4 7.7 23.1 46.2 23.1
2 = 4.290 P = 0.368 2 = 18.069 P = 0.006
Table No. 13 CHANGE IN FEVER
PA TIENTS (%)
TREATMEN T
Day 0 (Base line) Day 7
No Yes Disc harged No Y es
A zithromycin + Ceftriaxone 62.5 37.5 21.9 56.2 21.9
Azithromycin + Cefotaxime 62.8 37.2 34.9 53.5 11.6
A zithromycin + Cefuroxime 38.5 61.5 7.7 53.8 38.5
2 = 2.686 P = 0.261 2 = 7.091 P = 0.131
58

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No. 14 Change in color of sputum
TREATMENT
PATIENTS (%)
Day 0 (Base line) Day 7
No Yes Discharged No Yes
Azithromycin + Ceftriaxone 25.0 75.0 21.9 40.6 37.5
Azithromycin + Cefotaxime 20.9 79.1 34.9 46.5 18.6
Azithromycin + Cefuroxime 23.1 76.9 7.7 30.8 61.5
2 = 0.174 P = 0.917 2 = 10.079 P = 0.039
Table No. 15 Cost Effectiveness ratio
Cost Effective ratio = Cost of treatment for 7 days / Reduction of sym ptom s by 100%
Cost of Treatment = Cost of Drug + O ther associated costs (Syringe)
Cost Effective Ratio*
TREATMENT
Sputum
Production
Cough Wheezing Dyspnoea Fever
Discoloured
Sputum
Average
Azithromycin
+ Ceftriaxone
Azithromycin
+ Cefotaxime
Azithromycin
+ Cefuroxime
1497 1497 1621 3234 3897 1621 2230
1251 1042 1158 2408 2841 1202 1650
1822 2272 1822 2280 3043 4545 2631
*in Rs for 100% decrease in symptoms
Azithromycin + Cefotaxime has least cost effective ratio and is therefore most cost effective
59

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
DISCUSSION
significant difference in the symptoms namely cough,
During the study period, a total of 143 LRTI patients were wheezing and fever with different combinations.
admitted to the medicine units. Out of these, 88 patients The length of hospital stay ranged from 2 days to 12 days,
(61.5%) met the inclusion criteria and were included in according to Table No.8, maximum patients (56.82%)
the study. Out of total 88 patients, 52 (59%) were male got discharge between 5 – 8 days. In case of cefotaxime
and 36 (41%) were female as shown in Table No. 1.The and ceftriaxone group maximum patients i.e. 69.77% and
age of patients ranged from 23 to 88 years. Maximum 56.25% respectively got discharge between 5 – 8 days
number of patients 29 (33%) were in the age group of 50- whereas in case of cefuroxime group maximum patients
59 years whereas 4 (5%) patients belonged to the age (76.92%) got discharged between 9 – 12 days. Based on
group of 20-29 years as shown in Table No. 2.Out of 88 the number of days for discharge, the patients of
patients 35 (40%) were diagnosed with Pneumonia cefotaxime group were found to have improved and
followed by 20 patients with AECOPD (23%), 20 discharged earlier compared to the other two groups.
patients with bronchitis (23%) and 13 patients with Thus the combination of azithromycin and cefotaxime
AEBA (14%). The subjects were presented with different seemed most effective.
co-morbid conditions such as hypertension, diabetes Safety of the treatment was evaluated by monitoring the
mellitus, fever, bronchial asthma, renal disorder, chronic adverse drug reactions of the treatment groups
obstructive pulmonary disease, urinary tract infection throughout the study period. 21.59% of patients had
and anemia. Among these co-morbid conditions, the complaints of ADRs. Cefotaxime group of patient
most common conditions were hypertension (44 experienced lesser number of ADRs compared to the
patients) and diabetes (33 patients).
ceftriaxone and cefuroxime group. In case of patients
From Table No.6, it was observed that maximum patients given the combination of azithromycin with cefotaxime,
(43 patients and 49 %) were prescribed with the there was no complaint of arthralgia, gingivitis,
combination of azithromycin + cefotaxime followed by abdominal pain and heart burn, but CNS side effects such
azithromycin + ceftriaxone (32 patients and 36 %) and as agitation and dizziness were found. However, none of
azithromycin + cefuroxime axetil (13 patients and 15%). the ADRs were severe and life threatening. Hence, we
EFFICACY
can say that all the three combinations were safe.
Azithromycin was the common antibiotic prescribed
The cost of the therapy was calculated by cost effective
along with the cephalosporin to the enrolled patients at a
analysis. According to the Table No. 15, cefotaxime
dose of 500mg O.D. The minimum dose of cefotaxime
combination was found to be more economic compared
prescribed to the patients was 1g B.I.D and the maximum
to the ceftriaxone and cefuroxime combination. The
dose was 2g Q.I.D. In case of ceftriaxone, the minimum
average cost effective ratio of the cefotaxime
dose was 1g B.I.D and the maximum dose was 2g T.I.D.
combination was found to be Rs. 1650.00, whereas in
In case of cefuroxime, the minimum dose prescribed to
case of ceftriaxone and cefuroxime combination the
the patients was 1g B.D and the maximum dose
average cost per treatment for 100 % reduction in
prescribed was 2g Q.I.D.
symptoms was found to be Rs. 2230.33 and Rs. 2631.27
The efficacy of medications was evaluated mainly by
respectively.
observing the reduction of symptoms from the time of
CONCLUSION
th
admission up to the 7 day of treatment. According to the
The various cephalosporins used along with the
Table Nos. 9,10,11,12,13 & 14, it was found that
azithromycin for the treatment of LRTI in the medicine
reduction in symptoms was greater in case of the
wards of the hospital were cefotaxime (3rd generation),
combination of azithromycin with cefotaxime group
ceftriaxone (3rd generation) and cefuroxime axetil (2nd
compared to the other two groups. As the percentage of
generation). The combinations prescribed were
reduction in severe symptoms was greater in
appropriate with respect to the diagnosis. All the three
combination of Azithromycin with cefotaxime (58%),
combinations showed a decrease in the clinical
compared to ceftriaxone (40.6%) and cefuroxime
(36.9%) group of patients, cefotaxime combination
symptoms of the patients, but cefotaxime group of
seems more effective in reducing the symptoms.
patients showed a faster decrease compared to the other
Statistically there was a significant difference found in two groups. Length of the hospital stay was also less in
the reduction of sputum production and dyspnea between
the treatment groups. However, there was no statistically
the patients treated with cefotaxime and azithromycin
combination.
60

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Thus it can be concluded that combination of
azithromycin with cefotaxime was more efficacious than
azithromycin with ceftriaxone and azithromycin with
cefuroxime axetil.
Azithromycin with cefotaxime showed a lesser number
of adverse drug reactions than the other two
combinations. However, ADRs observed in patients
taking all the three different combination were mild in
nature and none of them were serious and life
threatening.
From the cost effective analysis azithromycin with
cefotaxime combination was found to be more cost
effective.
Thus, it can be concluded that combination of
azithromycin with cefotaxime was the best among the
three combinations in treating the LRTI.
REFERENCES
1. Lower respiratory Tract infections. Available from:
URL:http://www.nhsdirect.nhs.uk/articles/article.asp
xarticleId=316&sectionId=9.
2. Liberman D, Korsonsky I. A comparative study of the
etiology of adult upper and lowert respiratory tract
infections in the community. Diag Microb Infec
Disesa 2002; 42:21-28.
3. Schouten JA, Hulscher MEJL, Grol RPTM. Quality of
antibiotic use of lower respiratory tract infections at
hospitals: (How) can we measure it Clin Infec Diseas
2005;41:450-460.
4. Seppa Y, Bloigu A, Honkanen PO. Severity
assessment of lower respiratory tract infection in
elderly patients in primary care. Arch Intern Med
2001; 161: 2709-2713.
5. Simpson JCG, Hulse P. Do radiographic features of
acute infection influence management of lower
respiratory tract infections in the community Eur
Respir J 1998; 12:1384-1387.
6. Liberman D, Shvartzman P. Diagnosis of ambulatory
community aquired pneumonia. Scand J Prim Health
Care 2003; 21:57-60.
7. Stolz D, Crain MC, Gencay MM. Diagnostic values of
signs, symptoms and laboratory values in lower
respiratory tract infection. Swiss Med Wkly 2006;
136:434-440.
8. PlouffeJ, Schwartz DB. Clinical efficacy of
Intravenous followed by oral azithromycin
monotherpy in hospitalized patients with communityaquired
pneumonia. Anti Microb. Agents chemother
200;44:1796-1802.
9. Ortqvist A. Treatment of community aquired lower
respiratory tract infections in adults. Eur Respir J
2002; 20:40s-50s.
61

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
ijopp
Evaluation of Drug Information Service provided by Clinical
Pharmacy Department based on Provider and Enquirers' Perspective
1 2 3
Kuchake V.G , Maheshwari O.D , Surana S.J ,
4 5
Patil P.H , Dighore P.N .
1,2,3,4. Department of Clinical Pharmacy, R.C.Patel Institute of Pharmaceutical Education & Research, Shirpur,
Dist: Dhule (M.S.), India – 425405
5. M.D.(Medicine), Department of Clinical pharmacy, Indira Gandhi Memorial Hospital, Shirpur, Dhule,
Maharashra-425405
*Address for correspondence: msvragavrajan@yahoo.com
Abstract
Hypertension is not a disease but an important risk factor for cardiovascular complication. This type of medical
audit and appropriate feedback on usage of antihypertensive medications may greatly assist the health care
providers in rational use of medications.The objective of this study was to evaluate the prescribing pattern and drug
utilisation of antihypertensive medications in uncomplicated hypertension. Observational and Prospective study
was performed at Indira Gandhi Memorial Hospital, Shirpur, Maharashtra in India. Total 5025 patients visited the
medicine ward of Indira Gandhi Memorial Hospital. Among them 244 patients had uncomplicated hypertension.
st
st
From 1 July, 2008 to 31 December, 2008 Hypertensive medications were divided into 2 main categories;
Monotherapy and Combination therapy was defined and discussed separately. During 6 months study period, 510
prescriptions were collected, among them 244 including (132) female & (112) male patients were as per inclusion
criteria. Among them, 150 patients were on mono therapy which included 78 female & 72 male patients, comprising
54%(81) on Calcium Channel Blockers, 24.67%(37) on â-Blockers, 11.33%(17) on Angiotensin Receptor
Blockers, 6%(9) on Angiotensin Converting Enzyme Inhibitors, 4%(6) on Diuretics respectively, and 38.52% (94)
patients on combination therapy. In the view of drug utilisation, it was observed that, the diuretics are less
prescribed and calcium channel blockers are frequently prescribed medications in management of hypertension.
So, it requires further improvement of prescription pattern of antihypertensive medication for better patient health
care.
Key Words: Anti-hypertensive drugs, drug utilisation, hypertension, prescribing pattern
INTRODUCTION
Hypertension, a major risk factor for cardiovascular Socio-economic, behavioral, nutritional and public
(CV) disease and stroke and one-quarter of the adult health issues can lead to increase in CV disease
population of Western societies suffer from throughout the world. A plethora of new drugs are now
(1)
hypertension. Increasing awareness and diagnosis of available, and the quality of life of such people can be
hypertension, and improving control of blood pressure improved considerably. A number of drugs in various
with appropriate treatment, are considered critical public
(4-5)
combinations are generally used for effective long-
health initiatives to reduce cardiovascular morbidity and term management. Therefore, drug utilisation studies,
(2)
mortality. The Seventh Report of the Joint National
which evaluate, analyze the medical, social and
Committee on the Detection, Evaluation, and Treatment
economic outcomes of the drug therapy, are more
meaningful and observe the prescribing attitude of
of High Blood Pressure (JNC VII) is the most prominent
(6,7)
physicians with the aim to provide drugs rationally .
evidence-based clinical guideline for the management of
(3)
The present prescribing study for antihypertensive drugs
hypertension. Poor control on hypertension can lead to
was undertaken in the outpatient department (OPD) at
the development of ischemic heart disease, heart failure,
Indira Gandhi Memorial (IGM) hospital, Shirpur (rural
stroke & chronic renal insufficiency.
area) Maharashtra for the purpose of assessing the
current trend of prescribing pattern of anti-hypertensive
Indian Journal of Pharmacy Practice
Received on 06/01/2009 Modified on 13/02//2009
drugs. This kind of medical audit can help to make the
Accepted on 17/02/2009 © APTI All rights reserved
prescribing practice of physicians more rational and
62

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
prudent and thereby help in improving the patient health
care.
characteristic of all 244 uncomplicated hypertensive
patients is seen in Table No. 1.
MATERIALS AND METHOD
Figure No. 1 and 2 shows the social history of patients
The observational and prospective study was carried out like their occupation and education. The data suggested
at IGM hospital to collect the information of the patients.
The Protocol was prepared as per World Health
that elderly patients having more hypertension among
more patients were rest. Illiterates are more prevalence
(8)
Organization (WHO) guidelines and study was than literates.
approved by Institutional Human Ethical Committee Overall, 150 (61.48%) patients were treated with a single
(IHEC) of R.C.Patel Institute of Pharmaceutical anti-hypertensive drug and 94 (38.52%) patients were
Education & Research, Shirpur.
treated with anti-hypertensive drug combinations
Study design: This study was observational and suggesting that mono-therapies to be dominant in this
prospective conducted over the 6 months periods from type of rural area.
st st
1 July 2008 to 31 December 2008 for assessing Table No 2 shows the details of patients, who were
prescribing pattern and drug utilisation of
antihypertensive drugs in the management of
treated with monotherapy. Among them, 81 (54.0%)
patients were treated with Calcium Channel Blockers
uncomplicated hypertension
(CCBs), 37 (24.67%) were treated with â-blockers,
Study site: The study was carried out at the Medicine 17 (11.33%) with Angiotensin receptor blockers(ARBs),
ward of IGM hospital of Shirpur for collection of data. 9(6.0%) were treated with Angiotensin Converting
Study setting: The study was carried out on out patients Enzyme Inhibitors(ACEIs), and 6(4.0.%) treated with
of medicine ward, who were currently following the diuretic. Calcium channel blockers were the most
treatment of uncomplicated hypertension in IGM frequently prescribed antihypertensive drugs as
hospital, Shirpur.
monotherapy.
Source of data: All necccesary & relevant information Figure No.3 show details of patients treated with
were collected from out patient department cards, combination therapy. Among them 59, (62.78%) were
laboratory data report, treatment chart and verbal treated with two drugs, 31(32.98%) with three drugs and
communication with patients.
4 (4.25%) were treated with 4 drugs.
Collection of data: The format for the collection of the It was observed that eight different two-drug antithe
data is prepared as per WHO based guidelines and
hypertensive combinations, were prescribed to hyp-
Institutional Human Ethical Committee of R.C.Patel ertensive patients (Table no.3), namely: , â –blocker with
Institute of Pharmaceutical Education & Research, CCB 23 (32.98%), ARB with diuretic 18(30.51%), CCB
Shirpur which involved patient as well as medication with diuretic 6(10.17%), â-blocker with diuretic
information.
4(6.78%), ARB with CCB 4(6.78%), ACEI with CCB
Inclusion criteria: Patients either male or female with
2(3.38%), ACEI with diuretics 1 (1.69%) and ARB with
age more than 18 years, with History of hypertension or
â-blocker1 (1.69%).
currently diagnosed with hypertension and prescribed The CCB with â-blocker was the most frequentlyprescribed
two-drug combination in overall population
with antihypertensive medication.
Exclusion criteria: Patients with other comorbidities
followed by ARB with Diuretic. The CCB with â-blocker
like diabetes, other cardiovascular disorders, stroke,
were less prescribed in male than female patients due to
asthma, Chronic Obstructive Pulmonary Disease
(9)
side effect of â-blockers in male patients.
(COPD), arthritis, and other infectious disease.
DISCUSSION
Statatical Data Analysis
A Prescription-based survey is considered to be one of
The t- tests (Unpaired, Two tailed) were used for
the most effective methods to assess and evaluate drug
evaluation of mean S.E.M. (Standard Error Mean) of age
utilization of medication. It is also important to consider
and blood pressure of patients. A value of P0.05 (twothe
recommendations of international bodies on
tailed test) was declared as statistically significant.
hypertension that help to improve prescribing practice of
RESULTS
st st
During 6 months study from 1 July 2008 to 31 the physicians and ultimately, the clinical standards. A
December 2008, total 5025 out patients visited the continuous supervision is therefore required through
medicine ward of hospital, among them, 510 patients such kinds of systematic audit that provide feedback
were diagnosed with hypertension of which 244 had from the physician and help to promote rational use of
uncomplicated hypertension. The demographic drugs.
63

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.1: Demographic characteristics of 244 uncomplicated hypertensive patients visited at Medicine
ward of Hospital during 6 months study
Age (in years)
Male
(n =112)
Female
(n=132)
All patients
(n=244)
18-30 3 2 5 (2.05%)
31-40 9 17 26 (10.66%)
41-50 23 39 62 (25.41%)
51-60 37 30 67 (27.46%)
61-70 24 33 57 (23.36%)
71-80 16 11 27 (11.06%)
Age (year)
Mean± S.E.M.
56.57± 1.18
(P< 0.0001)
54.92±1.07
(P< 0.0011)
55.68 ± 0.79
(P< 0.0001)
Blood Pressure
Systolic (mmHg)
Mean ± S.E.M.
Diastolic (mmHg)
Mean ± S.E.M.
151.2 ± 2.56
(P

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table No.3: The Pattern of use of antihypertensive drugs in patients treated with two drugs combination
therapy with different classes.
Two drugs combination
Male
n=23
Female
n=36
Total n=59
% Utilisation
B + C 6 17 23 38.98
D + E 10 8 18 30.51
C + D 2 4 6 10.17
B + D 2 2 4 6.78
C + E 2 2 4 6.78
A + C 1 1 2 3.38
A + D 0 1 1 1.69
B + E 0 1 1 1.69
n = number of patients A: Angiotensin Converting Enzyme Inhibitors, B: â-blockers, C: Calcium Channel
Blockers, D: Diuretics, E: Angiotensin Receptor Blockers
Figure no. 1: Education of Patients.
Education of Patients
120
100
102
No of patients
80
60
40
20
35
67
29 29
58
18
12
30
34
24
10 12
8
20
Male
Female
Total
0
Illterate Primary S.S.C. H.S.C. Univercity
Level
Education
65

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Figure no.2: Occupation of Patients.
Occupation of Patients
No. of patients
90
80
70
60
50
40
30
20
10
0
Rest House wife Business Worker Farmer
Male 33 0 30 33 5 11
Female 51 70 0 3 2 6
Total 84 70 30 36 7 17
Occupation
Professiona
ls
Male
Female
Total
Figure no. 3: The Pattern of use of antihypertensive drugs in patient treated with combination therapy
(i.e. 2 drugs, 3 drugs and 4 drugs) with different classes.
Combiantion Therapy
70
60
59 (62.77%)
No . of Patients
50
40
30
20
31 (32.98%)
10
0
4 (4.25%)
2 drugs 3 drugs 4 drugs
Combination of Drugs
*** In this study we collected all details of patients such as his/her name, age, sex, address, phone number,
occupation, education, social history, family history, date of check up, present details and also medication
details which are medicine name, dose, frequency, route and duration. complaints, blood pressure, disease
diagnosed, associated diseases, medical, past history & past medication
66

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
The present prospective study observed that combination and in addition to its favorable
hypertension was more prevalent in females than in complementary synergistic effects, â-blockers tend to
males. Monotherapy and combination therapy were both blunt the troublesome complementary reflex tachycardia
more used in females at rates of 59.1% and 40.9% induced by the short-acting dihydropyridine (DHP) class
respectively. Further more, combination therapy seems of calcium channel blockers. The latter may additionally
to be a rational approach to reduce the cardiovascular counteract any peripheral vasoconstriction caused by the
(10)
mortality . The present study revealed that calcium former. Their combined efficacy has been confirmed
channel blockers were the drugs of choice for without causing adverse drug interaction or poor
hypertensive patients as a single drug therapy and overall tolerability. The fixed combination of â-blocker and
utilization, followed by â blocker which was less calcium channel blocker provides efficiency and
prescribed as a monotherapy. Diuretics are generally tolerability in the treatment of arterial hypertension.
recommended as first-line therapy for treatment of Pharmacists play an important role in educating the
hypertension as per Joint National committee VII. patient about the drugs and dosage schedule. It was
Utilization of diuretics in the present study was 4.0% as noticed that pharmacists who distribute the medicines
monotherapy. Lesser use of diuretics in the present study did not give adequate written or oral instructions.
may be due to adverse effect of diuretics on glucose CONCLUSION
(11)
Prescription pattern varies with age, gender and other
homeostasis and lipid profile .
The efficacy of ACE inhibitors and ARB on blood complications associated with hypertension. In view of
pressure was reported to be marked in patients with an often costly drugs for long term treatment, it is necessary
(12)
activated renin-angiotensin-aldosterone system . This that monitoring of their use, its co-relationship with
study showed that overall drug utilization of and clinical out comes and quality of life is essential to ensure
Angiotensin receptor blockers and ACE inhibitors was the optimal use of health care resources. It is found from
11.33% and 6.0% respectively, as monotherapy, which the study that the prescription of diuretics in hypertension
was lesser in number as compared to other drugs such as is comparatively low whereas the calcium channel
calcium channel blockers and â-blockers (Table no.2) but blockers are widely prescribed. The overall findings of
increasing prescription rate of angiotensin receptor the study show that there is need for further improvement
blockers now days than earlier studies.
in the prescription pattern of anti-hypertensives
Tiwari et al. suggested that an ideal combination must ACKNOWLEDGEMENT
include anti-hypertensive drugs possessing
The authors appreciate the co-operation of all the health
complementary modes of action that provide a
care providers of Indira Gandhi Memorial Hospital and
synergistic anti-hypertensive effect without any
patients who participated in this study.
REFERENCES
significant adverse effects, at low doses. Furthermore,
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the anti-hypertensive drug combination therapy should
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compensatory mechanisms that often limit the fall in Posey LM. A pharmacotherapy physiological
(13)
blood pressure . In the present study, two-drug approach. 7th ed, McGraw-Hill Companies. 2008:
combinations were mostly prescribed (62.78%), 172-3.
followed by three-drug combinations (32.98%) and four 3.Hedley AA, Ogden CL, Johnson CL, Carroll MD,
drug combination (4.25%) (Figure no.3).
Curtin LR, Flegal KM. Prevalence of overweight and
In two-drug combinations, a â-blocker with a calcium obesity among US children, adolescents, and adults.
channel blocker (Tablet Amlopin AT combination of JAMA 2004; 291(23):2847–2850.
Atenolol 50 mg and Amlodipine 5 mg) were most often 4. Kjeldsen SE, Farsang C, Sleigh P, Mancia G. World
prescribed (38.98%), Table no.3), followed by a ARB Health Organization; International society of
with diuretics (Tablet LoasrH50 combination of losartan hypertension. WHO/ISH hypertension guidelines-
50 mg and hydrochlorothiazide 12.5 mg) (30.51 %). A â- highlights. Journal of Hypertension 2001; 19:2285-
blocker with a calcium channel blocker was prescribed 2288.
more in females than males. The more likely reason for 5. Ramsay LE. British Hypertension Society Guideline
this gender difference may be related to the adverse effect for hypertension management: summary. Brit Med J
(14)
of â-blockers on sexual function in men .In this form of 1999; 319:630-635.
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6. Kapoor B, Raina RK, Kapoor S. Drug prescribing
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7. Pradhan SC, Shewade DG, Shashindran CH, Bapna
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Mabadeje B. In: How to investigate drug use in health
facilities (selected drug use indicator) action
programme on essential drugs. WHO official
publication 1995;68.
9. Tiwari H, Kumar A, Kulkarni SK. Prescription
monitoring of antihypertensive drug utilisation at the
Panjab University Health Centre in India. Original
Article. Singapore Med J 2004; 45(3): 117.
10. Mancia G, Grassi G. Antihypertensive treatment:
past, present and future. J Hypertens 1998; 16:S1-7.
11. Prisant LM, Beall SP, Nicholads GE, Feldman EB,
Carr AA, Feldman DS. Biochemical, endocrine, and
mineral effects of indapamide in black women. J Clin
Pharmacol 1990; 30:121-126.
12. Hansson L. The place of beta-blockers in the
treatment of hypertension . Clin Exp Hypertens 1993;
15:1257-1262.
13. Chalmers J. The place of combination therapy in the
treatment of hypertension. Clin Exp Hypertens 1993;
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68

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
INTRODUCTION
Vaginitis is described medically as an irritation and/or
inflammation of the vagina. It is a very common disease
affecting millions of women each year. The three most
common vaginal infections reported each year are
bacterial vaginosis (30-40%), candidiasis due to yeast
infection (20-25%) and trichomoniasis caused by
protozoal infection (15-20%). Vaginal infections can
produce a variety of symptoms, such as abnormal or
increased discharge, itching, fishy odor, irritation,
painful urination or vaginal bleeding(1,2,3).
Though the infections are not serious in nature, they can
become chronic and the eradication of such infections is
often difficult. If left untreated, bacterial vaginosis may
result in increased risk of pelvic inflammatory disease
(PID), infertility, pre-term birth, premature rupture of
membranes, low birth weight, intra-amniotic infections,
endometritis, cervical intra-epithelial neoplasia (CIN),
post-gynecological surgery infections and increased risk
of sexually transmitted diseases (4,5).
Indian Journal of Pharmacy Practice
Received on 10/02/2009 Modified on 19/02/2009
Accepted on 19/02/2009 © APTI All rights reserved
ijopp
Preliminary Clinical Study of a Polyherbal Formulation (Wh1) in
the Treatment of Vaginitis
1 2 3
4
Vishnu Bapat *, Leena Alfred , Shobha Rani R.H , Pushpa. T. Ksheerasagar ,
5 6
Geetha Hegde , Soumya. K. Lund ,
1. Vaidya Visharad, # 375 First B Main, First Phase, Girinagar, Bangalore 560 085
2,3,6. Department of Pharmacy Practice, Al-Ameen College of Pharmacy, Bangalore.
4. Retired Professor of Gynaecology, Bangalore Medical College, Bangalore.
5. Shreyas Poly Clinic & Laboratory , Chamarajpet, Bangalore.
*Address for correspondence: vrbapat@yahoo.co.in
Abstract
Vaginitis is a very common disease affecting millions of women each year with multifactorial etiology. If left
untreated it can lead to various complications. Current medical therapy may temporarily reduce infection but tend
to disrupt the normal vaginal flora. Hence, herbal therapy is gaining popularity in women on account of its reduced
side effects and restoration of the normal vaginal flora. With this in view, a preliminary clinical study was conducted
using a polyherbal formulation (WH I), containing herbs with antifungal, antibacterial, antiseptic and astringent
properties. In this prospective clinical study, 36 patients presented with the symptoms of vaginitis of varying
etiology were treated successfully with the polyherbal formulation (WH I) and was found to be safe and effective
(83%). The results of this study were found to be significant, thus this study will be extended on a large patient
population in future.
Key Words: Vaginitis, Polyherbal preparation (WH 1), Clinical Study, Female, bacterial vaginosis,
candidiasis,richomoniasis, leucorrhoea.
Vaginitis is identified by checking vaginal fluid
appearance, vaginal pH and presence of volatile amines
(the odor causing gas) and microscopic detection of clue
cells 2 (6).
Current medical therapy for vaginitis includes the use of
systemic or topical antibiotic and antifungal
preparations. Vaginitis being a disorder of multifactorial
etiology, a single-line therapy is often inadequate and
recurrence is a common complication. Though these
medications may temporarily reduce infection, they
often disrupt the balance of good bacteria and frequently
lead to recurrent infection. Studies shows that
vulvovaginal candiasis(VVC) affects three-quarters of
women during their lifetimes and use of antibiotics is an
acknowledged trigger for VVC, which adversely affects
women's physical and emotional health (7, 8, 9).
Therefore, as an alternative to these medications herbal
therapy is gaining popularity in women on account of its
reduced side effects and restoration of the normal vaginal
flora (10,11,12).
Ayurvedic herbs are available, which have been listed in
ayurvedic literatures like Dhanwanthri Nighantu,
Bhavaprakash Nighandu, Ashtanga Hrdaya, Sushruta
69

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Sanhita, Chakradatta and Nighandu Ratnakara which are simultaneously. Patients were encouraged to report any
of use in treating this condition.
adverse reaction to the physician during the course of
Common herbs such as Dhataki Flower, Musta, treatment.
Mocharas, Lodhra, Lata Karanja have actions that RESULTS & DISCUSSION
include antifungal, antimicrobial, antiseptic, astringent, 36 patients completed the preliminary clinical study with
and demulcents(13). Herbs with astringent activity may the polyherbal preparation (WH1). WH1 reduced the
produce a protective coating on the tissue surface. amount of vaginal discharge significantly in all the
Therapeutically, these herbs may reduce irritation, patients both symptomatically and clinically. Significant
inflammation, and excessive fluid secretion, and provide results were seen microbiologically in 30 patients (83%).
a barrier against infection. Antiseptic and antimicrobial During the study period, 58 patients were enrolled; only
herbs may work to eliminate bacterial and viral 36 patients completed the study. 22 patients were
infections, and antifungal herbs may help fight fungal therefore excluded from the study as per the protocol
infections. A list of herbs containing these qualities for design. Hence, statistics of only 36 patients who
the treatment of vaginitis is shown in Table-1.
completed the trial has been presented here and the
Traditionally, a mixture of powder of the herbs listed in
results were summarized as percentages. Age of patients
Table-1 in the medium of ghee as “Anupana” [vehicle of
ranged between 18 and 55 years (Fig.1) which explains
administration] has been used effectively in the treatment
incidences of risk factors such as child birth, abortions,
of vaginitis. However, there has been no documentation
passage of infective organism by infected semen etc in
regarding its efficacy and safety.
this age group (14). Maximum patients belonged to low
Hence, the objective of this work was to take up a
preliminary clinical study in a small patient group to
income group. Poor hygienic conditions, ignorance
confirm the efficacy and safety of this poly herbal
about the proper cleaning and toilet habits and bad
preparation (WH1). Therefore, this mixture of powders
nutritional status explains the higher incidence of this
in ghee base was formulated as soft gelatin capsules. The condition amongst this group (14). Duration of
formula of this preparation is given in Table 2.
complaints varied from less than 1 month (4 days) to 8
METHOD
years (Fig.2) which further confirms that women are
Institutional Ethical committee clearance was obtained busy in managing the household work without taking
from Sri Sai Charitable Dispensary, Girinagar, Bangalore sufficient care regarding their own health. 25 patients
and Shreyas Poly Clinic & Laboratory, Chamarajpet, improved with the first course of 10 days treatment
Bangalore, where the study was conducted for a period (69%). 7 patients received 2 courses of medicine and 2
of six months, from November 2006 to April 2007. patients 3 courses of medicine. 2 patients received more
Informed consent was taken from all patients included in
than 4 courses of medicine without benefit (Fig.3). The
the study after explaining to them the purpose of the
etiology of patients observed by microbiological
study.
examination is given in (Fig.4). 17 patients were
Inclusion Criteria: All patients presented with
symptoms of vaginitis at the clinic during the study
diagnosed as non specific vaginitis (47%), 14 as
period of 6 months.
Bacterial Vaginitis (39%), 3 as vaginal candidiasis (8%)
Exclusion Criteria: Patients with white discharge due to and 1 each as atrophic vaginitis and senile vaginitis (3%).
any other clinical condition like fibroid, malignancy etc The swabs taken after 15 days and after one month, which
and pregnant women.
assessed the effectiveness of the treatment
All patients who met the inclusion criteria were recruited microbiologically, showed 83% (30/36) patients
for the study. These patients were clinically examined improved with treatment and no improvement was seen
and a swab was taken from the vaginal discharge and sent in 17% (6/36) of patients (Fig.5). None of the patients in
to pathological laboratory. All patients were prescribed this series experienced any adverse reactions. Thus, the
the poly herbal formulation (WH 1) thrice a day for 10 polyherbal preparation (WH1) effectively produced
days after food. Two fortnightly follow ups were clinical and microbiological relief in women with
conducted and progress was assessed by clinical vaginitis of varied etiology.
improvements and confirmed by swab test. If the CONCLUSION
condition was not improved, another course of treatment The polyherbal formulation (WH1) has shown
was repeated and the sexual partner also treated significant results in the treatment of vaginitis. But this
70

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table -1: List of herbs used in the treatment of vaginitis
List of herbs Botanical name Action & uses
Dhataki Flower
Musta
Mocharas
Lodhra
Lata Karanja
Woodfordia Floribunda flower
Cyperus scariosus root
Bombax malabaricum gum
Symplecos recemosus root
Caesalpinia bonduc seed
Stimulant Astringent and Tonic used in
leukorrhea, mennorhagia
Pungent, Bitter, Astringent with Carminative,
antibacterial, antifungal and Stimulating
properties used in treatment of inflammation,
tumor and infection
Astringent, tonic, demulcent, contains tannic
acid and gallic acid. Used in dysentery,
leukorrhea and menorrhagia
Astringent used in wound healing to reduce the
bleeding, swelling and leukorrhea
Antiseptic, Anti parasitic and Cleansing action
used in treatment of pain and skin diseases
Table -2: Formula of the soft gel capsules * .
Ingredients
Ext. Dhataki Flower
Ext Musta
Ext. Mocharas
Pulv.Lodhra
Pulv. Lata Karanja
Ghee
Total weight of each capsule
Quantity/capsule
eq. to 20mg
eq.to 40mg
eq. to 22.5mg
100mg
50mg
q.s
650mg
* Poly herbal formula code : (WH 1)
Fig.1: Age distribution of patients in the study population
Age distribution of patients (yrs)
41-50
10%
51-60
5%
= 20
3%
21-30
38%
= 20
21-30
31-40
41-50
51-60
31-40
44%
71

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Fig.2: Duration of complaints reported by the patients.
Duration of complaints
UNKNOWN
32%
> 1 year
22%
< 1 month
10%
1-6 month
24%
7-12 month
12%
< 1 month
1-6 month
7-12 month
> 1 year
UNKNOWN
Fig.3: Number of medication courses given to the patients for the treatment of vaginitis.
Number of course of treatment
50
40
41
No.of patients
30
20
10
9
2 2
No. of Patients
0
1 2 3 4
72

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Fig.4: Conditions diagnosed in the patients included in this study
Diagnosis of patients
2%
2%
2%
Vaginal Candidiasis
13%
Trichomoniasis
Vaginal Candidiasis
Bacterial Vaginosis
33%
Non specific Vaginitis
Bacterial Vaginosis
Atropic Vaginitis
Senile Vaginitis
Non specific
Vaginitis
48%
Fig.5: Outcome of therapy using a polyherbal formulation (WH 1) in vaginitis
30
Therapy Outcome
30
25
18
No.of patients
20
15
10
6
4
5
0
Improved Not Improved Failed to
follow up
Exluded from
study
73

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
clinical study throws up a gamut of questions regarding vaginitis and bacterial vaginosis: a systematic
the specificity and sensitivity to each type of infection. review. Obstet Gynecol Surv 2003; 58(5):351-358.
Probably sensitivity and cultural studies may throw more 12. Neri A, Rabinerson , Kaplan B. Bacterial vaginosis:
light on the subject. Our observations are similar to some drugs versus alternative treatment. Obstet Gynecol
(15,16, 17)
of the trials published earlier. In conclusion, the Surv 1994; 49(12):809-813.
13. Available from:URL:www.holisticonline.com/
results of this study were found to be significant. Thus,
Herbal-Med/-Herbs/h143.htm.
this study will be extended in larger number of patients in
14. Loknath S, Shirpa A. Aetiopathological and
future.
therapeutic study on shleshmaja yonivyapada w.s.r.
ACKNOWLEDGMENT
We thank the Heads of Sri Sai Charitable Dispensary, to infective vaginitis. Suchitr Ayurved 2006; 49-55.
15. Renuka K, Nandita K, Vinita S, Vanita R, Urmila T,
Bangalore and Shreyas Polyclinic, Bangalore for their
Sharadini D. Clinical evaluation of PD-959 vaginal
help in this clinical study. We are thankful to the Principal
gel: An open trial. The Antiseptic; 97(11): 400-401.
and management of Al-Ameen College of Pharmacy for
16. Umadevi K, Swarup Asha. Efficacy of PD 959 gel in
their support. We also thank Dr. V. R. Bapat for
abnormal vaginal discharge. Asian J. Obstet.
suggesting the formulation, free supply of the Polyherbal
Gynecol. Practice 1999; 3(1): 68 .
capsules (WH1) and for sponsoring this clinical study. 17. Narmada B. Efficacy of V-gel in Vaginitis. Obstet &
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3. Allsworth JE, Peipert JF. Prevalence of bacterial
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4. Mitra SK, Sunitha A, Kumar VV, Pooranesan R,
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10.Boskey ER. Alternative therapies for bacterial
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43.
11. Van KK, Assefi N, Marrazzo J, Eckert L. Common
complementary and alternative therapies for yeast
74

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
INTRODUCTION
Home Medication Review is a concept where a likely to be present. A number of factors are believed to
pharmacist has the opportunity to visit a patient in the increase the risk of drug related problems in the elderly,
familiar surroundings of the latter's home and questions including suboptimal prescribing (e.g. overuse of
that no one has been able to confidently answer can be medications or polypharmacy, inappropriate use, and
answered. Medication review takes the pharmacist out of under use), medication errors (both by dispensing and
the shop into the community. Home medication review is administration problems) and patient medication, nonan
exciting opportunity for Indian pharmacist to adherence (both intentional and unintentional) [2].
contribute further to the health care of their communities. A number of studies have investigated medications and
The human body is in a state of change as the years go by. [3,4]
medication-related risk factors in patients' homes
There is a progressive functional decline in many organ however,the medication-related problems found in those
systems with advancing age. Age-associated physiologic studies werenot linked to patients health outcomes.
changes may cause reduction in functional reserve Other studies have sought to investigate the relationships
capacity (i.e. the ability to respond physiologic between a limited number of medication-related risk
challenges or stresses). The cardiovascular, factors that might be identified by a home visit and
musculoskeletal and central nervous system appears to adverse health outcomes. Hospital admission secondary
be most affected. The elderly have multiple and often to adverse drug reactions was found to be related to the
chronic diseases. It is not surprising therefore that they use of two or more pharmacies, while drug side effects
[1].
are the major consumers of drugs There has been a were reported as the reason for non-adherence in 35% of
steady increase in the number of elderly people, defined patients whose admission was related to non-adherence [5].
as those over 65 years of age. Several conditions are Non-adherence also precipitated about 5% of hospital
readmissions in geriatric patients previously discharged
on three or more drugs prescribed for chronic
Indian Journal of Pharmacy Practice
Received on 03/02/2009 Modified on 13/02/2009
Accepted on 17/03/2009 © APTI All rights reserved
ijopp
Prevalence of Diseases and Observation of Drug Utilization Pattern
in Geriatric Patients: A Home Medication Review
1 2 3
Pandey Awanish ,Tripathi Poonam ,Pandey Rishabh Dev
M.Pharm, Institute of technology and Management, Gorakhpur
Address for correspondence: awanishpandey@rediffmail.com
Abstract
Geriatric patients may have medication-related risk factors only identified by home visits, but the extent to which
thoserisk factors are associated with poor health outcomes remainsunclear. To observe the drug utilization pattern
and prevalence of chronic diseases in elderly by visiting them in their community. A door-to-door survey was
conducted in an area of 2 sq. km surrounding Shri Mahant Indiresh Hospital of Dehradun, to identify geriatric
residents, diseases prevalent in them and prescription pattern. The study was primarily targeted at the elderly
because, as a group they take more drugs than their younger counterparts and are known to be at risk of the side
effects of many of the drugs they consume. The result of this study showed that 34 % geriatric patients were suffering
from cardiac disorder while 22% from diabetes and 18% from osteoarthritis among elderly population. 40%
patients were non-compliant due to poor economic status, difficulty in swallowing of the prescribed dosage forms,
and disturbing side effects. Self-medication (38%) was a prevalent phenomenon among the elderly. The study
conclude that cardiac disorders, diabetes and rheumatism were the most prevalent diseases and self-medication
was the prevalent phenomenon responsible for the adverse drug reactions in geriatric patients. The study suggests
that elderly patient education through home medication review can significantly improve patient knowledge and
compliance with medication.
Keywords: Home medication review, Noncompliance, Selfmedication, Geriatrics, Polypharmacy
[6].
conditions Similarly, poor adherence was associated
75

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
with increased risk of adverse drugevents (ADEs) in the prescribed to the elderly patients (Table-2), out of which
[7],
elderly and hospital admission due to drug-related Antihypertensive drugs (31%), Anti-diabetic drugs
problems can result in patient morbidity, mortality and (22%), Antiplatelet agents (16%), Anti-rheumatic drugs
[8].
increased health costs It is possible that other (24%), Bronchodilators (7%), Hypolipidemic drugs
medication-related risk factors identified at home visits (2%), Anti-tubercular drugs (1%), and drugs acting on
could be associated with poor health outcomes, but Thyroid gland (1%) were prescribed. This survey also
these medication-related risk factors have not, to date, revealed that 38% of the elderly does self-medication,
been extensively studied.
out of which 32% take allopathic medicines and 6% take
This study has been conducted to observe the drug Ayurvedic and homeopathic medicines. Reasons for selfutilization
pattern and prevalence of chronic diseases in medication are listed in Table-3. Drugs like
elderly by visiting them in their community.
Multivitamins, Iron and Calcium supplements were
METHODOLOGY
taken by the elderly as Over the Counter preparation
A Door to door survey was conducted to identify the
(Table-4). Analgesics and Antipyretics were commonly
residents of age 65 years and above from May 2008 to
taken by the elderly for self medication (Table-5).
July 2008. 100 subjects were included for the study DISCUSSION
after informing them about the purpose of the study and The results from present study demonstrate that cardiac
prior consent. A questionnaire was prepared, many disorders, diabetes and rheumatism were the most
practical questions regarding diseases, medication prevalent diseases in geriatric patients of considered
prescribed, health status involving socioeconomic area. This study suggests that Difficulty in swallowing
[9].
status, family support, were included The geriatric tablets and economic factors are the majorly responsible
subjects were quite cooperative and confident in for non-compliance of geriatric patients so alternative
answering the questions since it was their familiar dosages form other than tablet may enhance the
surrounding i.e. home. Table-1 shows the questions, compliance of the geriatric patients and economic factor
which were asked during medication review of elderly should be considered by general practitioners at the time
patients. Questionnaire was analyzed by using SPSS of prescribing. In our study, we found that self-
Microsoft Excel.
medication was the prevalent phenomenon for drugs,
INCLUSION CRITERIA
which may be responsible for the adverse drug reactions
Patients were included in this study if they satisfied one
of drugs in geriatric patients. The study provides some
or more of the following criteria: (i) on five or more
indication that the home medication review by a trained
regularmedications; (ii) taking twelve or more doses of
pharmacist may help to rationalize prescribing by general
medication per day; (iii) three or more medical
practioners. The study also suggests that elderly patient
conditions; (iv) suspected to be non-adherent with their
education through home medication review can
medication regimen (v)on medication(s) with a narrow
significantly improve patient knowledge and compliance
therapeutic index or requiring therapeutic monitoring;
with medication. The teamwork of general practioners
(vi) had significant changes made to their medication
and pharmacist is needed. The public health system needs
regimen in the previous three months; (vii) had signs or
more specialists in this field. “We cannot heal the old
symptoms suggestive of possible medication induced
age, but let us protect it, promote it and prolong it,”Sir J
problems; (viii) had an inadequate response to [9]
Ros
medication treatment; (ix) admitted to hospital in
Table 1 – Questionnaire
preceding four weeks; (x) at riskin managing their own
medications due to language difficulties, dexterity
Questions were asked regarding
problems or impaired sight.
1. Disease of patient and medicines prescribed.
RESULTS
This community based survey included 100 elderly 2. Patient compliance for medication. If no, then reason.
patient.49% was males and 51% was females. Fig1
3.Any other medications (ayurvedic, allopathic, homeopathic)
shows prevelance of numerous chronic disorders in
concerned elderly population. The reasons for noncompliance
taken by the patient which neither pharmacist nor doctor knew.
are shown in Fig 2.Difficulty in swallowing
tablets (24%) was the most common cause of patient
4. Risks associated with the structure of house and furnishing
(such as poor lightning, stairs obstacles etc).
non-compliance. A Total of 120 individual drugs were
76

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table-2 Classification of drugs prescribed to the elderly.
Table 3-Reasons for Self-medication
S.N REASONS %PATIENTS %MALE %FEMALE
1.
Lack of time
23%
15%
8%
2.
High consultation fee
29%
14%
15%
3.
Quick relief
18%
18%
0%
4.
Believes in Ayurveda
16%
3%
13%
5.
Family members are not supportive
5%
0%
5%
6.
Unable to walk
9%
0%
9%
77

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Table 4 -Over the counter drugs used by the elderly
S.N DRUGS DOSE DOSAGE FORM
1.
Becosule(vit.B complex)
500mg o.d
Capsule
2.
Evion(vit.E)
500mg o.d
Capsule
3.
Dexorange(iron prep.)
50ml 2tsf b.d
Syrup
4.
Benadon(pyridoxine)
40mg o.d
Tablet
5.
Supracal(calcium citrate+magnesium hydroxide)
100mg b.d
Tablet
6.
Solbala plus(Methylcobalamine+lipoic acid)
10 mg b.d
Capsule
Table 5 - Drugs taken by the elderly as Self-medication
78

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Fig-1 Prevalence of chronic disorders among elderly
O steoarthritis
18%
C.N .S
disorders
6%
Cardiac
disorders
34%
D iabetes
22%
G .I.disorders
4%
M iscellaneous
disorders
6%
Resp iratory
disorders
10%
Fig.2 Reasons for non-compliance among elderly
Believes in home
remedies
8%
Family members
are not
supportive
8%
Forget to take
their medicines
20%
Side effects of
the drug
20%
Faces difficulty in
swallowing
24%
Due to poor
economic status
20%
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80

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
APTI
ijopp
L-ASPARAGINASE INDUCED CENTRAL VENOUS THROMBOSIS IN ACUTE
LYMPHOBLASTIC LEUKEMIA
1 2 1 1 1
Lavanya S , Vijayan K , Abhay Dharamsi , Rajasekaran A Vijayakumar A
1,3 .
1. Drug and Poison information Center, Department of Pharmacy Practice,KMCH College of Pharmacy,
Kalapatti road, Kovai Estate, Coimbatore - 641048
2. Consultant, Department of Neurology, Kovai Medical Center and Hospital, Coimbatore- 641014
Address for Correspondence: vijayspharm@gmail.com
Background
To report a case of central venous thrombosis following treatment of acute lymphoblastic leukemia with
L-asparaginase. A 13-year-old master presented with an acute lymphoblastic leukemia associated with three
episodes of focal onset convulsions with secondary generalization, headache and altered sensorium. He was
2 2
initially treated with 5000 u/m of L-asparaginase followed by 10,000 u/m every third day for 4 weeks. After a
week’s course of L-Asparaginase, the patient experienced central venous thrombosis. MRI showed thrombosis of
the sagittal, transverse and straight sinuses on the right side with partial recanalisation, suggesting a drug induced
neurotoxic reaction. According to the Naranjo probability scale, the central venous thrombosis was probably
caused by L-Asparaginase. L-Asparaginase-induced central venous thrombosis is rarely reported shortly after
beginning L-asparaginase therapy in patientswith acute lymphoblastic leukemia. However, bleeding or thrombosis
occurring as a direct result of changes in coagulation factors has not been frequently reported. The purpose is to
evaluate the current knowledge of central venous thrombosis in association with ALL in children. Health care
professionals should be aware of this potential adverse reaction and monitor the patients regularly during
L-asparaginase therapy.
Key Words: L-asparaginase, Central Venous Thrombosis, Acute Lymphoblastic Leukemia.
INTRODUCTION
CASE REPORT
Acute lymphoblastic leukemia (ALL) is more frequent in A 13-year-old boy was presented to Kovai Medical
children than in adults; indeed, two thirds of all cases Center and Hospital, India in January 2005, with
1
occur at pediatric age . The risk of thrombosis is complaints of three episodes of focal onset convulsions
increased in ALL patients, and its occurrence may
with secondary generalization. History revealed head
complicate the treatment course with a negative
turning to left follow by generalized tonic-clonic
2
prognostic impact . L-asparaginase hydrolyses L-
convulsions. Hemoglobin was 10.6 g/dl, leukocytes 1700
asparagine which is a non essential aminoacid. L-
cells/cumm, and the platelet count 1, 07,700 cells/cumm.
asparaginase is used particularly in acute lymphoblastic
The differential count revealed 16% lymphocytes, 81%
leukemia (ALL) and in other hematological
malignancies such as acute myeloblastic leukemia
neutrophils, and 3% monocytes. The patient's bone
(3,4)
(AML) and lymphoma . Therapy has been associated marrow aspiration showed 90% blasts (L1 type
with various forms of toxicity, including according to French-American-British (FAB)
hypersensitivity, coagulation abnormalities and classification) with Periodic acid Schiff reaction (PAS),
(5,6)
others . L-asparaginase shows this effect by decreasing sudan Black and myeloperoxidase stains negative. The
(7,8)
the synthesis of coagulation proteins . In literature, patient was on prednisolone, vincristine, daunorubicin, l-
thrombosis is emphasized more than hemorrhagic asparaginase, methotrexate and cytosine. Computed
complications due to L-asparaginase. This report Tomography (computerized type of x-ray that gives very
describes a case who developed central venous detailed images of internal organs such as the brain) scan
thrombosis confirmed by Magnetic Resonance Imaging
of the brain was normal but during the next 48 hours, he
(MRI) during L-asparaginase therapy.
developed weakness of the left upper limb.
The prothrombin time was 29 seconds, the partial
Indian Journal of Pharmacy Practice
Received on 12/01/2009 Modified on 11/02/2009
thromboplastin time 48 seconds fibrinogen, protein C,
Accepted on 24/02/2009 © APTI All rights reserved
protein S, antithrombin III levels were normal. Serum
81

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
ammonia was 443 ìg /dl (normal value 25-94 ìg/dl). L- normal coagulation factors-especially fibrinogen-and
asparaginase toxicity was suspected. Throat swab and thrombotic cases developing by decreased Antithrombin
urine cultures were negative. As cerebral venous sinus III (AT Ill) and Plasminogen or decreased fibrinogen
thrombosis was suspected a MRI and Magnetic level and hemorrhagic cases developing by normal AT III
Resonance Venography (MRV) of the brain were done,
(9,10)
and plasminogen concentration .
which revealed thrombosis of the sagittal, transverse AI-Mondhiry reported that, in two of the four patients
and straight sinuses on the right side with partial whom vincristine and prednisone treatment applied,
recanalisation. Low dose subcutaneous heparin 2500 fibrinogen level decreased but Prothrombin time (PT),
th
I.U 8 hourly was started and continued for 10 days. The Partial thromboplastin time (PTT) and Thrombin time
patient regained normal power in the left upper limb and
(11)
(TT) remain in normal limits . Ramsay et al used
did not have any further convulsions. Acetyl salicylic vincristine, prednisone, and L- asparaginase in 26 ALL
acid 150 mg/day orally was given for 7 to 10 days and cases. In these cases, after cessation of L-asparaginase
the patient was discharged.
coagulation tests were turned to normal limits.
Anterioposterior (AP) view of MRV showing absence
Consequently those coagulation abnormality were found
of filling of sagittal sinus and right transverse and (12)
to be due to L-asparaginase .
sigmoid sinuses is shown in picture 1. Lateral view of In the study of Miniero et al., when the patients are treated
MRV showing venous filling defects as noted above are by prednisone, vincristine and L-asparaginase, compared
shown in picture 2.
with patients treated by only L-asparaginase more
DISCUSSION
(13)
L-asparaginase enzyme has a molecular weight of
common coagulopathy was observed . In the
133.000 daltons and hydrolyses L- asparagine. L-
previously treated ALL cases, some hemorrhagic and
asparagine is synthesised by transamination of L- thrombotic complications due to L-asparaginase have
(14,15,16,17)
aspartic acid. In tumor cells, lacking of L-asparagine been reported .
synthase, the L-asparagine can be obtained from the
Hemorrhagic complications due to L-asparaginase are
circulating pool of amino acids. As the L-asparaginase
seen rarely and important for morbidity, once in 2 or 3
will decrease the amount of extracellular L-asparagine,
days the coagulation parameters (PT,PTT, Fibrinogen,
tumor cells use this amino acid which is necessary for
Plasminogen,and AT III levels) must be measured and
protein synthesis. But in normal cells, this synthesis when necessary, fresh frozen plasma, AT III and
may be re-done because of enzyme existence.
thrombolytic therapy must be given. However, bleeding
Cerebrovascular symptoms dependent on or thrombosis occurring as a direct result of changes in
L-asparaginase appear in two forms; either increased or
(18)
coagulation factors has not been frequently reported .
Table No 1: Treatment Schedule for Induction Therapy
Variables Mg/m2 Day
vincristin 1.5 8,15,22,29
prednisolone 60 1-28
daunorubicin 30 8,15,22,29
L-asparaginase 10,000 19,22,25,28,31,34,37,40
methotrexate BY AGE 1
82

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
Figure no.1: AP view of MR Venogram showing absence of filling of Sagittal sinus and
right transverse and sigmoid sinuses.
Figure no.2: Lateral view of MR venogram showing venous filling defects as noted above.
83

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009
CONCLUSION
L-asparaginase studies of fibrinogen survival using
Treatment related to thrombotic complications during autologus 1-131fibrinogen. Blood 1970; 35:195-
the induction therapy and recent evidence indicates that 200.
concomitant administration of L-asparaginase is likely 8. Peterson RC, Handschumacher RF, Mitchell MS.
to be associated with higher incidence of central venous Immunological responses to Lasparaginase. J Clin
thrombosis, especially in children with atleast one Invest 1971; 50:1080-1090.
prothrombotic risk factor. This result in prolongation of 9. Gugliotta L, Augelo A, Mattioli-Belmonte M,
the prothrombin time (PT), activated partial Vigano-O'Angelo S, Colombo G, Catoni L, et al.
thromboplastin time (aPTT) and hypofibrinogenimia. Hypercoagulability during L-asparaginase
These coagulation abnormalities resolve within 1-2 treatment the effect of antithrombin III
weeks after cessation of the drug.
supplemantation in vivo. Br J Haematol 1990; 74
At present, there is no general agreement on the need to (4):465-470.
monitor the coagulation/fibrinolytic systems in patients 10. Kingma A, Tammnga RY, Kamps WA, Le-ceultre R,
treated with L-asparaginase. There are also no Saan RJ. Cerebrovascular complications of
guidelines on ways to avoid either the haemorrhagic or L-asparaginase therapy in children with leukemia:
the thrombotic complications. It is suggested to replace aphasia andother neuropsychological deficits.
the coagulation factors with fresh frozen plasma and at Pediatr Hematol Onco1 1990; 10(4):303-309.
the same time, give AT III and heparin; but the 11. AI-Mondhiry H. Hypofibrinogenemia associated
consensus is to treat expectantly.
with vincristine and prednisone therapy in
ACKNOWLEDGMENT lymphoblastic leukemia. Cancer 1975; 35:144-147
The authors are thankful to Dr.Nalla G Palaniswami, 12. Ramsay NKC, Coccia PF, Krivit W, Nesbit ME,
Chairman and Managing Director of Kovai Medical Edson JR. The effect of Lasparaginase on plasma
Center and Hospital, Coimbatore and Dr.Thavamani D coagulation in acute lymphoblastic leukemia.
Palaniswami, Trustee, Kovai Medical Center Research
Cancer 1977; 40:1398-1401.
and Educational Trust, Coimbatore for providing 13. Kucuk 0, Kwaan HC, Gunnar W, Vazguez M.
necessary facilities and continuous encouragement. Thromboembolic complications associated with L-
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