As reported in the November 17 & 18 Board Highlights and current issue of ReadLinks, the College Board, in response to concerns raised by College inspectors regarding the lack of standardization related to refrigerated pharmaceuticals, especially given the increased volume of vaccines stored at pharmacies, approved Professional Practice Policy #68 (PPP-68) - Cold Chain Management of Biologicals.

'Cold Chain' refers to the process used to maintain optimal temperature conditions during the transport, storage and handling of vaccines and other refrigerated pharmaceuticals, starting at the manufacturer and ending with the administration of the product to the patient.  Vaccines are sensitive biological products and may be inactivated by exposure to excess light, heat or freezing, depending on the nature of the product, the temperature reached and the duration of exposure.  The recommended temperature for vaccine storage is, at all times, +2°C to +8°C.

PPP-68 essentially adopts the BC Centre for Disease Control's (BCCDC) Guidelines on the Cold Chain Management of Biologicals as the BC Standard of Practice and requires all pharmacy managers to be in compliance with these new standards by July 1, 2012.  The policy (PPP-68), which includes a link to BCCDC's Guidelines, is available on the College website (click here).

To assist with compliance and implementation the key requirements are listed below:

Type of Refrigerator:

• Although the Guidelines specify that a standard 'bar' fridge is not acceptable because they are not able to maintain even temperatures, the reference is to a small, under the counter fridge that has a combination fridge/freezer with one exterior door.  A domestic 'frost free' refrigerator, which could be under the counter size, may be acceptable as long as it is able to maintain the required temperature range of +2°C to +8°C, at all times.

 Monitoring of Temperature:

• Each pharmacy is required to have a traceable memory refrigerator/freezer thermometer and to maintain a temperature log, at least two times daily, to ensure that the temperature inside the refrigerator is kept within the acceptable range of +2°C to +8°C, at all times.