Somewhat overlooked in the flurry of events surrounding the implementation of Medicare Part D was the U.S. Pharmacopeia release of General Chapter <1079> “Good Storage and Shipping Practices” in November 2005.
And just as many pharmacists, particularly in hospital practice, began to become comfortable with the incorporation of cGMP into the practice environment, we now need to absorb the impact of GCCMP: good cold chain management practices.
Implementation of this General Chapter at the individual Pharmacy level has implications for personnel training, standard procedures and work instructions, environmental profiling and qualification, SOP development, documentation of deviation, record maintenance [and retention], return goods policies and auditable return receipt documentation, general patient packaging information and product storage information.
For obvious reasons, the greatest impact will occur in those facilities that deliver medications to their clients through the postal service or by common carriers or integrators: “mail-order”, “specialty” and “infusion” pharmacies.
What this General Chapter does is to raise the level of expectation for “basic” customer service. If a manufacturer or a distributor has to demonstrably present evidence that their product storage, transport, and delivery procedures preserve the integrity of a compendial item, it is not unreasonable to suppose that the end-user(s) will expect an individual pharmacy to provide the same level of assurance. And it is not unreasonable that we, as pharmacists, should provide this level of service to our clients.
How we package and ship sophisticated device-medication combinations, or “simple” dosage forms have a direct impact on our client’s health. Improperly packaged/transported biomolecular medications or “standard” dosage forms like tablets or capsules – subjected to temperature or humidity excursions, or shipped in a manner that negates their therapeutic or physical integrity not only injects unnecessary costs into the healthcare “system”, it can delay, impede, or negate a good outcome for our patients.
At this time, most pharmacists/pharmacies produce no documentation that their storage and shipping methods are “qualified” to deliver a finished pharmaceutical to a patient that preserves the integrity of that product.
If “mean kinetic temperature” or “cold chain management” are currently unfamiliar terms to you, at least you know what you need to learn….
James Sourcey, RPh
 U Langer, I Kramer, EHP, October 2001, Volume 7, Number 3, pp. 97-107.