July â¢ August 2003 - Ontario College of Pharmacists

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COLUMN INSPECTORS’ CORNER: INSPECTORS’ CORNER: By better preparing for an inspection, the designated manager / owner will have more time to discuss any inspection or practice-related issues with the inspector. Some designated managers/owners like to be present during an inspection. Although inspectors do not schedule appointments, a request for the inspection to be held on a specific day of the week can be arranged when the inspector’s schedule permits it. Pharmacy Site Visit / Inspection* Inspectors try to avoid interfering with a pharmacy’s daily routine and usually request the use of an office or an area close to the main dispensing area. Once the inspection is completed, the inspector will generate a report for the designated manager to discuss any deficiencies identified. The Inspection Process The Prior Notice Letter Begins the Inspection Process When three years has elapsed from the last inspection, a Prior Notice letter is sent to the designated manager/owner advising him/her that an inspection will take place within the next 3 months. This allows ample time for the pharmacy to prepare for the inspection by: - Reviewing the inspection checklist - Reviewing library requirements - Checking record keeping (*The Pharmacy Site Visit is discussed in detail in the January/February 2003 issue.) Action Plan* When deficiencies are identified, the inspector will request an action plan, with a deadline, from the designated manager/owner. Any questions concerning the action plan should be discussed at that time with the inspector. You can also call the inspector with any followup questions. Action plans are filed and recorded at the College and become part of the pharmacy’s inspection record. (While the pharmacy will be reminded if the action plan is not submitted on time, failure to submit an action plan may result in a referral to the Accreditation Committee.) The inspector reviews the action plans and can either accept or deem the plan incomplete. In some instances, when a number of deficiencies are identified or a particular 26 Pharmacy Connection July • August 2003
COLUMN deficiency is extreme, the inspector may request a re-inspection of the pharmacy in addition to an action plan. *An article detailing the Action Plan will be published in a future edition. Pharmacy Re-inspection The goal of a re-inspection is to ensure that the pharmacy has achieved compliance. The re-inspection is handled much like a regular inspection with special attention being paid to the issues/deficiencies identified in the prior inspection. Re-inspections normally occur within one to six months (after the College receives the action plan) and are performed by the compliance officer. Re-inspections are not usually done by the original inspector so as to allow the pharmacy to be reviewed without bias. Pharmacies that fail to achieve compliance upon this reinspection are then referred to the Accreditation Committee for a decision. The designated manager will be asked to provide a detailed action plan for the compliance officer that is then forwarded to the Accreditation Committee, along with the pharmacy’s previous inspection history, for review and decision. Accreditation Committee The Accreditation Committee is a statutory committee under the Pharmacy Act comprising of pharmacist members of Council, non-Council pharmacist members and public members appointed to Council. One of the Committee’s duties is to address issues related to the Certificates of Accreditation of pharmacies that have failed to achieve compliance. In reviewing the inspection reports and any information provided by a pharmacy, the Committee can make the following decisions: 1. Conclude the matter 2. Request another re-inspection with costs 3. Refer the pharmacy to the Discipline Committee 4. Refer the pharmacy to the Discipline Committee and request an Interim Suspension of the Certificate of Accreditation 5. Refer the owner/designated manager to the Executive Committee to recommend action Helping Pharmacists Achieve the Accreditation Standards For most pharmacies, the inspection process results in a successful report that the pharmacy has met the accreditation standards. Some pharmacies require multiple visits before compliance is achieved. Very few re-inspections result in a pharmacy being referred to the Accreditation Committee. The ultimate goal of the College is to provide advice and feedback to the designated manager and/or owner in order to achieve compliance for the pharmacy. If you have questions about a past or upcoming inspection, please feel free to contact your inspector. They will be pleased to assist you. Pharmacy Connection July • August 2003 27
Page 1 and 2: July/August 2003 New Precursor Cont
Page 3 and 4: Ontario College of Pharmacists 483
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Page 9 and 10: NOTICE Don’t Forget….. The next
Page 11 and 12: COVER STORY Greg Ujiye, B.Sc.Phm. M
Page 13 and 14: COVER STORY Information Office of C
Page 15 and 16: CLASS A PRECURSORS INDIVIDUAL EXEMP
Page 17 and 18: Q&A • Ensure that all relevant do
Page 19 and 20: FEATURE currently 15 weeks versus 1
Page 21 and 22: Q&A Q A& Q A Stephanie Edwards, B.S
Page 23 and 24: HEALTH CANADA Advisories & Notices
Page 25: COLUMN which include routine, re-in
Page 29 and 30: COMPLAINTS Reasons The Complaints C
Page 31 and 32: REPORT Recommendation #9 to the Gov
Page 33 and 34: DISCIPLINE DISCIPLINE CASE 2 Failur
Page 35 and 36: DISCIPLINE DISCIPLINE Order 1. A re
Page 37 and 38: DISCIPLINE DISCIPLINE regulations t
Page 39 and 40: COLUMN scription Renewals/Changes C
Page 41 and 42: B U L L E T I N B O A R D Class 7T3
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July â¢ August 2003 - Ontario College of Pharmacists