July â¢ August 2003 - Ontario College of Pharmacists

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COLUMN INSPECTORS’ CORNER: INSPECTORS’ CORNER: THE INSPECTION PROCESS Rose Fitzgerald, B.Sc.Phm. “Inspection is not a game of "catch as catch can". Rather, as I noted, it is a process of verification for the purpose of creating confidence. It is not built upon the premise of trust. Rather, it is designed to lead to trust…” – Hans Blix, United Nations Weapons Inspector, January, 2003 Each year, the College’s Pharmacy Practice Department receives many calls, and inspectors and staff are also approached by many pharmacists, all asking questions about the process and details of pharmacy site visits/inspections. While past articles have focused on the details of the inspections, this article provides an overview to provide you with a greater understanding of the inspection process; starting from the Prior Notice letter informing the designated manager of an upcoming inspection through to the possible outcomes of that visit. Future articles will discuss specific aspects of the inspection process such as “action plans”. There are over 2700 accredited pharmacies in Ontario. Each pharmacy receives a routine inspection once every three years. The College employs four inspectors and one compliance officer who are responsible for all inspections 24 Pharmacy Connection July • August 2003
COLUMN which include routine, re-inspections, new openings, acquisitions and relocations. Inspections should not be confused with investigations. Inspections fall under the jurisdiction of the Accreditation program area whereas investigations are the responsibility of the Investigations and Resolutions Department. The Drug and Pharmacies Regulations Act (DPRA) provides the College with the authority to appoint inspectors and the authority to inspect pharmacies and examine records. The Inspection process for a pharmacy is similar to the Quality Assurance Program for pharmacists. It is a form of practice review. The inspections are primarily educational and conducted to assist members in complying with legislative requirements for maintaining a practice site that allows for the safe distribution of drugs and for pharmacists to maintain professional and operational standards of practice. The College has also worked over the years to revise the inspection process so that it becomes a more positive experience by shifting the inspection focus from “checking the nuts and bolts” of a pharmacy to a broad review of how members practice in the pharmacy site. Unfortunately identifying deficiencies is viewed by some pharmacists as criticism or enforcement. While some pharmacists view the inspection as adversarial or negative, the underlying role of the inspector is to accurately and professionally identify deficiencies in the pharmacy and/or in its members’ practice. These deficiencies are brought to the attention of the designated manager and/or the owner. The inspectors are also available to answer questions about pharmacy practice, clarify issues and to make recommendations. The College and its inspectors work to provide the most suitable and constructive way to achieve the ultimate goal of inspection, namely, to ensure that every pharmacy complies with the legislation and standards and that pharmacists meet the Standards of Practice. Routine Inspections Every accredited pharmacy receives, at no cost, one inspection and one follow-up re-inspection (if required). Cost Recovery In the past, pharmacies that did not achieve compliance were re-inspected until compliance was achieved or until the pharmacy was referred to the Accreditation Committee for review and a possible further referral to the Discipline Committee for resolution. This process led to many delays from initial visit to a final resolution, and in some cases, it resulted in four or five pharmacy visits over a period of years. It was also found that, in most cases, the same pharmacies were responsible for several re-inspections and a more expeditious process was needed. In 2002, the Accreditation Committee believed that it was unfair for the majority of compliant pharmacies to pay for the few non-compliant locations and recommended that cost recovery charges be imposed on non-compliant locations. Effective January 2003, pharmacies that the Committee decides require an inspection beyond their original inspection and one re-inspection will now be required to pay $500 (plus GST) for all future visits. Costs can also be charged for inspections determined through an undertaking as a result of a Complaints hearing or can be ordered as part of a Discipline decision. Pharmacy Connection July • August 2003 25
Page 1 and 2: July/August 2003 New Precursor Cont
Page 3 and 4: Ontario College of Pharmacists 483
Page 5 and 6: Come out and vote in Districts 2, 6
Page 7 and 8: COUNCIL this goal by helping the Fa
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: HEALTH CANADA Advisories & Notices
Page 27 and 28: COLUMN deficiency is extreme, the i
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