PRP Annual Report 2019/2020: What We Learned Part 3 – Pharmacies
Findings from the Pharmacy Review
The Practice Review Program conducts a comprehensive review of pharmacy and pharmacy professional practice, to ensure compliance with College standards. Practice reviews play an important role in identifying areas of non-compliance and ensuring consistent delivery of pharmacy services across BC.
This is the third and final article in our series discussing the top areas of non-compliance noted during both Pharmacy Professionals’ Reviews and Pharmacy Reviews, as outlined in the 2019/2020 PRP Annual Report.
Read the first two articles:
- Findings from the Pharmacy Professionals Review – Part 1: Pharmacists
- Findings from the Pharmacy Professionals Review – Part 2: Pharmacy Technicians
Top Areas of Non-Compliance for Pharmacies During the 2019/2020 Fiscal Year
Community pharmacies are evaluated on 12 mandatory and 4 non-mandatory categories for sites that provide sterile compounding, residential care, opioid agonist treatment, and/or injectable opioid agonist treatment.
Hospital pharmacies are evaluated on 12 mandatory categories and 5 non-mandatory categories. The 5 non-mandatory categories are reviewed if the service is provided at the hospital pharmacy.
The top non-compliance categories for both hospital and community are as follows:
|Community Pharmacy||Hospital Pharmacy|
Equipment and References
While not the top non-compliance area for either practice setting, Compliance Officers have noted recurring instances in both community and hospital pharmacies, of non-compliance with the requirements for temperature monitoring and storage of drugs requiring cold chain management found in Professional Practice Policy – 68: Cold Chain Management.
The most common instances of non-compliance noticed by Compliance Officers were the following:
- Registrants failing to record the current temperature and the minimum and maximum temperatures reached since the last temperature recording, at least twice daily
- Pharmacy cold storage equipment failing to maintain appropriate temperatures
- Pharmacy cold chain storage equipment not equipped with an appropriate temperature monitoring device
- Standard bar fridges (small volume with one exterior door) being used to store vaccine or biologicals in pharmacies
Key Requirements for Cold Chain Management
Pharmacy managers are reminded that all drugs requiring cold chain management must be maintained in accordance with the manufacturer’s requirements and any other applicable requirements. PPP-68 sets out the requirements for pharmacy managers on cold chain management and their responsibilities under PODSA Bylaws.
Refrigerators, Freezers and other storage equipment
PPP-68 was amended in February 2020 to include a set of principle-based requirements for refrigerators, freezers, and other storage equipment (collectively defined in the policy as “cold storage equipment”):
- The cold storage equipment must be purposed for drug storage only (e.g. storage of food in the same equipment is not permitted);
- The cold storage equipment must maintain only one temperature range enclosed by a door with an air-tight seal (e.g. a bar fridge that contains both refrigerator and freezer compartments with only one exterior door is not acceptable as it does not maintain even temperatures).
- The cold storage equipment must be equipped with a digital thermometer or temperature monitoring system.
Temperature Recording and Monitoring
The policy permits temperatures to be recorded either manually or automatically.
If the temperature is recorded and monitored manually, it must be done at least twice each working day, documenting the current temperature, and minimum and maximum temperatures reached since the last recording.
If the temperature is recorded automatically, the system must record temperature at a frequency that can determine current temperature and minimum, maximum temperature reached at least twice a day and an alarm must be in place to alert staff of temperature excursions.
Pharmacies must ensure that temperature records, equipment maintenance records, and documentation of actions taken in the event of temperature excursions, be retained and made easily retrievable for a period of at least 3 years.
For additional practice insights from the 2019/2020 review cycle, please read the Full Report.