At it’s February 2019 meeting, the College Board approved amendments to Professional Practice Policy 68 – Cold Chain Management of Biologicals (PPP-68), including broadening its scope and renaming it ‘PPP-68 – Cold Chain Management.’
#CPBCBoard approves amendments to PPP-68 Cold Chain Management of Biologicals effective immediately.
— BC Pharmacists (@BCPharmacists) February 14, 2020
PPP-68 was originally approved in 2011,adopting the BC Centre for Disease Control (BCCDC) guidelines on the Management of Biologicals (BCCDC Vaccine Guideline), to address the concerns with larger volumes of vaccines being stored at pharmacies as a result of pharmacists’ injection authority, but lack of storage standards for vaccines and other biologicals that require refrigeration.
Recognizing that there are drugs other than biologicals and vaccines that require refrigeration, it was recommended that PPP-68 be broadened to include any drug requiring cold chain management, and revised to better align with current pharmacy practices.
All drugs requiring refrigeration must be stored and maintained in accordance with all applicable requirements, including but not limited to:
- Manufacturer’s requirements,
- BCCDC Vaccine Guideline, and
- NAPRA Compounding Standards.
Refrigerators, Freezers and Other Storage Equipment
The BCCDC Vaccine Guideline provides guidance for refrigerators and freezers specific for vaccine storage. However, some of the recommendations are not applicable to pharmacies or drugs other than vaccines.
To address this, a set of principle-based requirements have been included in the amended policy for refrigerators, freezers, and other storage equipment (collectively defined in the policy as “cold storage equipment”).
Temperature Recording and Monitoring
In recognition of modern technology, the amended policy permits temperatures to be recorded either manually or automatically.
Pharmacies must now 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.
Pharmacy Specific Policies and Procedures and Staff Training
To provide more flexibility, the policy now includes requirements for pharmacy managers to establish policies and procedures specific to their pharmacy’s practices.
In addition, the pharmacy manager must ensure staff are trained on these policies and procedures in accordance with PODSA Bylaws.