Pharmacy Site Visits & Inspections
Pharmacy Connection, January/February 2003

This article summarizes the current Ontario pharmacy inspection process and serves as an update to “The OCP Inspection Process” that was previously published in Pharmacy Connection (March/April 1999).

The following protocol reflects key modifications that were introduced to reflect changes in requirements as a result of the revised Standards of Practice. (The protocol will be modified as the practice of pharmacy changes.)

The report highlights some of the major areas of inspection, and is not complete checklist. It is also important to note that, while College pharmacy inspections must review necessary operational regulations and requirements, the College has broadened its inspection philosophy to include a greater emphasis on providing education and guidance to pharmacists operating pharmacies.

Highlights of the Inspection Protocol

I. Accredited Pharmacy Area
Looks at the physical location and some of the requirements that should be visible to the public such as:

• Is the most current accreditation certificate publicly displayed?
• Is the license of the designated manager displayed?
• Are both black and yellow OCP signs prominently displayed and do they meet regulation size?
• Is the pharmacy set up as a lock and leave operation? & Does the barrier comply with current guidelines?
• Are all pharmacy-related drugs located behind barriers in the absence of pharmacist? [ DPRA Reg 551 s78]
• Is there clear counter space of 12 sq. ft. available for efficient prescription filling?
• Are there provisions for an acoustically/visually private consultation area? (Policy Handbook)

II. Compounding Equipment and Consumable Materials [DPRA Reg 551 s 73 (1)]
These are the requirements required for the safe practice of pharmacy and act as quality assurance checks.

• Are the torsion/electronic balances properly calibrated and defect-free?
• Are all areas and equipment kept in a clean, sanitary and clutter-free condition?
• Does a pharmacy performing sterile dispensing comply with guidelines?
• Does the pharmacy use either dossette or blisterpak compliance packs? If so, does the pharmacy’s compliance and package labelling comply with OCP policy (Policy Handbook)
• Are the pegged blisterpaks containing "light-sensitive" drugs protected?
• Are the automatic drug dispensers properly labelled in accordance with federal regulations? (drug/manuf./lot #/expiry date)

III. Pharmacy Maintenance [DPRA Reg 551 s72, s73]
Again, this is to ensure that the pharmacy is in a clean and sanitary condition. This is also to ensure that drugs being sold in a pharmacy are safe for the public.

• Are the dispensary shelves regularly cleaned?
• Are all floors/carpets/mats regularly swept & cleaned?
• Is there a system in place to monitor and remove any expired drugs in the dispensary? (Pharmacy Connection November/December 1995)
• Are front shop shelves regularly monitored for cleanliness, and is all inventory regularly checked for expired drugs?

IV. Labels: [(DPRA : s 156 (3]

• Does the prescription labels display all required information as required by the regulations?

In cases where there has been an acquisition or relocation, does the information reflect the changes made either to the corporate name, trading name address of pharmacy or telephone number? New amended prescription labels must be used immediately upon receipt of same.

V: Non-Prescription Sales Control

• Are all Schedule II drugs located in a non-public access area?
• Are all Schedule II narcotics located in non-public view area?
• Are all Schedule III drugs located in an area that allows pharmacist audio-visual control?

VI: Pharmacy Library [DPRA Reg 551 s 73 (k) & Library Guide]:

• The most current library guide can be found at www.ocpinfo.com. It lists all current and/or required editions.
• Pharmacies (with Internet access in the professional area that can access the ocpinfo.com website online) may rely on the online OCP Manual in lieu of having a physical hard copy of the Manual in the dispensary. Pharmacists should also research whether other library requirements can be accessed online.

VII. Prescription Processing: Systems & Procedures

• Is important information relating to the patient being gathered by the receiving pharmacist?
• Are dispensed prescriptions being compared to their originals for accuracy?
• Are auxiliary labels available and affixed to containers when deemed necessary?
• Is it the pharmacist or intern that is making the final check of filled prescriptions?
• Is documentation of dialogue being recorded on all new prescriptions that clearly indicate:

- The patient’s name
- identification of agent acting in behalf of patient
- contact person on delivered prescriptions
- any reason for non-dialogue (Policy handbook)

• Documentation must also be recorded, indicating reasons, whenever counselling does not occur. Pharmacies should not use pre-programmed defaults for the dialogue function.
• Is there a system in place to flag new prescriptions that require counselling?

VIII. Prescription Records: (Regular & Narcotic/Control drugs)
Inspectors check prescriptions to ensure compliance with the regulations. Some of the areas checked are: filing and retrieval, retention of records, prescription transfers, verbal and written orders, and recording and labeling. Accuracy of directions and documentation regarding any changes to prescriptions are also checked. Following are some of the items on the inspection report:

• Is all information on transferred prescriptions being recorded as per regulations, particularly the date that the prescription was originally issued by the prescriber?
• Are single ingredient drugs being labelled generically? (Policy Handbook)
• Are prescriptions being dispensed in the quantity prescribed?
• Is documentation being recorded for:

- Reduced quantity or quantities (Patient or agent must sign)
- "No sub requests" by patient
- Modifications or interventions conducted by the pharmacist

• Are receipts indicating "Cost, fee, total" being provided to ALL PATIENTS? [DIDFA: s(10), DIDFA Reg 205/96 s 4(1)]
• Are all prescriptions dispensed, logged or inputted into the computer for later dispensing being signed by the pharmacist? [ DPRA: s 156 (1) (g)]
• Are all faxed prescriptions received on "thermal paper" subsequently photocopied onto plain paper for image retention? [Policy Handbook]

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.
On 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.

The inspectors respect the time and effort that many pharmacists have made in preparing the actions taken to address any issues and deficiencies noted during the visit. However, it is incumbent upon pharmacists to ensure that all such action plans submitted be completed with sufficient detail, and include any required documentation or invoice(s). (When submitting action plans, please include copies of invoices as proof of purchase for texts or material previously cited as missing.)

As always, if you ever have questions about your inspection or general practice issues, please feel free to contact your inspector.

Ronald Kyniski, B.Sc. Phm.
Field Inspector