The Ontario College of Pharmacists regulates both the practice of members and the practice site or pharmacy. Members are regulated through the Regulated Health Professions Act and the Pharmacy Act. Practice sites or pharmacies are regulated through the Drug and Pharmacies Regulation Act.

Background

The authority for the College to appoint inspectors and inspect pharmacies is given through the Drug and Pharmacies Regulation Act (DPRA) s. 148, 148.1, 148.2, 148.3, 148.4. These sections also include the powers and activities given to inspectors. In addition, provisions in the regulations require inspections for “remote dispensing locations” (O.Reg.58/11 s.36) and “lock and leave” installations (O.Reg.58/11 s.38).

Holders of Certificate of Accreditation, directors and designated managers are advised to review the DPRA, Ontario Regulation 58/11, Part III “Certificates of Accreditation: Issuance and Renewal” as the deficiencies in the operation of a pharmacy may impact the ability to renew the Certificate of Accreditation (DPRA, O.Reg. 58/11 s.16 (4).

Inspections are identified by the categories and levels:

• Level 0 – opening inspection
• Level I – call back, regular practice review, acquisition or relocation
• Level II – re-inspection ordered by inspector
• Level III (and above) – inspections ordered by the Accreditation Committee

The inspection process is comparable to the Quality Assurance Program (QA) currently being used by the College to assess members. Focusing on the operational requirements of the pharmacy, the inspection is a form of practice review to ensure that the operation is safe and the public is protected. The expectation of the College is that the inspections are educational to assist members to comply with legislative requirements, in order to meet and maintain professional and operational standards of practice.

Regular inspections are cyclical usually occurring within a 4-5 year period. Cycle times may vary depending on the strategic plan of the College or need for information regarding emerging practices.

Options that are available to the inspector at the conclusion of the inspection are:

• Satisfactory – inspection concluded
• Issues identified - action plan required, inspection not concluded
• Re-inspection ordered – action plan required, inspection not concluded
• Referral to Accreditation Committee – action plan required, Committee decision
• Report to Accreditation Committee – action plan required, Committee decision.

Prior to a Level I routine inspection, the Designated Manager (DM) will receive a letter informing them that an inspector will visit their pharmacy within the next eight months. The visit is intended to not only review the pharmacy practice for compliance to legislation but also to provide an opportunity to discuss issues relevant to current pharmacy practice. All pharmacy staff, pharmacists and technicians are encouraged to ask any questions they may have.
Although appointments are not made for routine inspections, the DM may contact the inspector in advance with any special requests about timing of the visit.

Practice Review, New Openings, Call Backs, Acquisitions, Relocations

During a regular cycle, each pharmacy is entitled to one routine inspection (Level I) and a re-inspection (Level II), if necessary, at no cost. Provided wireless internet connection is available, the inspection is done on-line and in real time. The results of the inspection and issues are discussed with the pharmacists on duty or Designated Manager (DM) if available. An e-mail is sent to the DM at the conclusion of the inspection and the DM can access the inspection and complete any Action Plan required on-line at the College website.

Re-inspection

At a Level 1 inspection, where a pharmacy has a large number of issues that are not in compliance with legislative requirements or there are issues which may pose a risk to the public, a re-inspection (Level II) may be ordered. This is done at no cost to the operator usually within 12 months of the first inspection. A notification will be sent from the Professional Practice Department to the DM and the Director Liaison, informing them that a Level II inspection will take place and the implications should compliance not be achieved as the pharmacy may be referred to the Accreditation Committee.

The purpose of this inspection is not only to determine whether the pharmacy is in compliance with legislative requirements but also to provide support and guidance to ensure continued success in achieving the required standards of operation.

The inspector conducting the re-inspection focuses mainly on the issues from the previous inspection, however if other issues are observed these will be reported as additional issues not observed during the previous inspection. At the conclusion of the inspection, the issues will be discussed with the DM or pharmacist present. At this time, if the inspection was satisfactory, the inspection will be concluded provided the action plan (if required), addresses the issue(s) and compliance can be achieved.

Referral to Accreditation

Where the re-inspection (Level II) continues to be unsatisfactory, the inspector will advise the DM of the seriousness of the non compliance and refer the pharmacy to the Accreditation Committee for a decision. The DM and Director Liaison will receive a notice from the Professional Practice Department advising the member of the findings of the inspection and that the Accreditation Committee will be reviewing the pharmacy file at the next committee meeting. The DM will be given 30 days to make a submission to the Committee which submission should include an Action Plan as well as any other issues they may wish the Committee to consider. Before reaching a decision, the Committee will review the inspector’s report (which has been copied to the DM/Director Liaison), inspection history as well as the action plans and submissions provided by the DM.

Report to Accreditation Committee

At the completion of a Level III or higher inspection, the inspector will create a report regarding the inspection of the pharmacy. A copy of this report will be provided to the DM and the Director Liaison. They will also receive a notification informing them that the Committee will review their pharmacy file at the next scheduled meeting and the requirement to submit their completed Action Plan within 30 days along with any additional information they may wish the Committee to consider. The notification will again outline the authority of the Committee.


Committee Decisions

The committee may:

• Conclude the matter if they feel compliance has been achieved
• Order another inspection at cost to the pharmacy (OCP By-laws, Article 14.5) (Currently the cost to the pharmacy is $1000.00)
• Refer to the Discipline Committee, the certificate holder, DM or Directors of the corporation.

Decisions are communicated in writing and detail the factors the Committee considered to arrive at the decision. Sample decision letters are provided in this guide. Decision letters are structured in such a way as to provide information regarding the issues the Committee considered, as well as often providing guidelines, regulations and standards as to what is expected and required.