As a self governing profession, the College regulates the practice of pharmacy in Ontario. The College is unique in that it is given the authority under the Pharmacy Act to regulate both the member as well as the practice site. The practice site is regulated mainly through the Drug and Pharmacies Regulation Act (DPRA).
In addition to licencing pharmacies and regulating the storage, dispensing and distribution of drugs in Ontario, the DPRA provides the College with the authority to inspect pharmacies.
The inspection process can be compared to the Quality Assurance Program used by the College to assess pharmacists. It is a form of practice review that focuses on the operation of the pharmacy. The inspections are designed to be educational in nature to assist members to comply proactively with legislative requirements, as well as to maintain professional and operational standards of practice.
The goal of inspections is compliance as opposed to enforcement of the legislation, policies and guidelines of the College.
New Pharmacy Accreditation (Licencing) Inspection
Once the application to open a new pharmacy has been satisfied, the inspector for that district is informed and a pre-opening inspection date is arranged. The visit is normally done 3-7 days prior to the actual opening date. This inspection reviews the legislative requirements, lay-out, physical condition of the pharmacy and operational readiness of the pharmacy. Where the proposed pharmacy meets the requirements, the accreditation is approved and the pharmacy is allowed to open on the date requested.
Once opened, the new pharmacy is subject to a call-back inspection in 6-12 months. At this time, pharmacists’ standards of practice, operational standards, record keeping and systems and procedures are reviewed. Where the inspection is satisfactory, the pharmacy is then placed into the regular inspection process.
Inspection Process
Every pharmacy receives a prior notice letter informing them that an inspection will take place within the following 3-6 months providing them ample time to prepare. A pharmacy is normally inspected every 3-4 years. This provides every pharmacy with one routine inspection (Level I) and a follow up re-inspection (Level II) at no cost if required. Any additional inspections (Level III and above) will result in a cost recovery charge, paid by the pharmacy. The authority to direct an inspection at cost lies with the Accreditation Committee. In addition, inspections at cost can be ordered by the Discipline or Complaints Committee as part of the decisions.
The province is divided into specific geographic areas and each inspector is assigned to a particular area or areas. In addition to routine inspections, the inspectors are responsible for inspecting new pharmacies before the pharmacy opens, call backs, acquisitions, relocations and inspections as a result of Complaints or Discipline decisions. This translates into 300 to 350 site visits per inspector per year. The detail of the inspection reports, assessments of compliance to the Standards of Practice and the ever-increasing complexity of pharmacy operation have increased the time required by College field staff to conduct basic inspections.
Role of the Inspector
The role of the inspector is to observe and report their findings, not to judge the pharmacist or the pharmacy.
The role of the compliance officer is primarily reinspections (Level II and above) that have been initiated by an unsuccessful routine inspection or the submission by the Designated Manager of incomplete or unsatisfactory action plans. The Compliance Officers prepare the cases for presentation to the Accreditation Committee and carry out any additional inspections as directed by the Committee
Upon completion of an inspection the inspector or compliance officer can do one of the following:
- Conclude
- Conclude with a satisfactory action plan
- Order a re-inspection (Level II)
- Request an action and refer the pharmacy to the Accreditation Committee (compliance officer only)
On rare occasions when patient safety is at risk, a matter may be brought to the attention of the Registrar following a Level I inspection, who may forward his/her concern to the Accreditation Committee for a decision.
The Inspection
The inspection is divided into 8 basic sections with additional sections depending on the type of practice.
1. Accredited Pharmacy Area
2. Compounding Equipment and Consumable Materials [DPRA Reg 551 s 73 (1)]
3. Pharmacy Maintenance [DPRA Reg 551 s72, s73]
4. Labels: [(DPRA : s 156 (3)]
5. Non-Prescription Sales Control
6. Pharmacy Library [DPRA Reg 551 s. 73 (k) & Library Guide]:
7. Prescription Processing: Systems & Procedures
8. Prescription Records: (Regular & Narcotic/Control drugs)
There are also supplementary portions of the inspection process that address different practice settings such as long-term care, methadone dispensing or sterile compounding. Specific checklists have been designed to reflect these particular practice settings.
Upon completion of the inspection, the inspector will leave a computer printout of his/her report and indicate to the pharmacist on duty any deficiencies noted, comments, and/or corrections that need to be made. An action plan will also be left with the pharmacist for completion.
Additional links on our website regarding inspections:
- Opening a new Pharmacy
- Update to the Inspection Process
- The Inspection Process
- Understanding the Inspection Process
- Action Plans
- Maintaining a Professional Workplace Environment
Frequently Asked Questions
I understand that pharmacies may be charged for re-inspections. Please clarify.
The College regularly inspects all Ontario pharmacies. This is an aspect of quality assurance that ensures that each community pharmacy location is in compliance with all legislation and that the Standards of Practice are being met. Inspections also serve as an opportunity for pharmacists and owners to meet and discuss operational issues with College field staff.
All pharmacies and pharmacists, through their accreditation and membership fees, share the cost of this program. While the majority of pharmacies in Ontario are compliant and meet the standards, there are, unfortunately, a few pharmacies that fail to meet the standards and continue to have problems, even after several visits.
The Accreditation Committee considered this issue and felt that it was unfair for the majority of pharmacies to bear the cost of re-inspections for just a few pharmacies. Council therefore approved a recommendation by the Committee to implement cost-recovery fees for sites requiring further inspections after the initial inspection and one re-inspection.
Currently, all pharmacies receive one regular inspection and, if there are deficiencies, a possible second inspection. Pharmacies failing this second inspection are referred to the Accreditation Committee. If the Committee decides that a future inspection is warranted, a cost recovery fee is charged to the pharmacy prior to the next inspection. This policy has been in effect since January, 1, 2002. (PC Sept/Oct 2002)
I'm thinking of renovating my pharmacy, do I have to notify the College?
We advise you to notify us in writing by letter or fax, with supporting information, on any significant renovations that you intend, including expansion or reduction of the accredited premises. You should also submit a set of floor plans that illustrate the existing accredited premises along with the new proposed area. These plans will be forwarded to your inspector who will then visit your pharmacy the next time they are in your area. (Please also clearly mark your pharmacy's permanent walls (brick or concrete) on all drawings.) (PC Jan/Feb 2004)
When will the inspector contact me about my new pharmacy opening?
An inspector will contact you to arrange an appointment as soon as all paperwork is complete and your new pharmacy accreditation fee is received.
Alternatively, you may contact the Pharmacy Practice administrative assistant to leave a message for your inspector to contact you. We recommend that you arrange to have the inspection completed at least one week prior to opening so that you have enough time to receive pharmaceutical shipments and to set up third-party accounts. (PC Jan/Feb 2004)
Do I have to notify the College when I relocate the dispensary within my pharmacy?
Although this is not a legal requirement, the Pharmacy Practice Department should be notified, in writing by letter or fax to ensure your pharmacy is meeting all legal requirements and standards in advance of undergoing renovations. If possible, please also submit a floor plan indicating current and proposed changes. (PC Jan/Feb 2004)
Do I need to include a floor plan with my application to open a new pharmacy?
Although there is no regulatory requirement to submit floor plans, there is a minimum area requirement for a pharmacy, so it would be beneficial for the inspector to see your pharmacy's plan(s) prior to the accreditation inspection. (PC Jan/Feb 2004)