Accreditation standards buttress compounding pharmacy

May 15, 2012

Accreditation standards guarantee reputation and high safety standards for compounding pharmacies.

We cannot know for certain why he killed himself, but there are some facts we do know. Because of a compounding error committed at Doc's Pharmacy in Walnut Creek, Calif., the pharmacy where he worked, the batch of betamethasone injection prepared at the pharmacy was not properly sterilized; 13 people became ill and three people died. Unfortunately, this story is not unique.

People trust pharmacists. And the pharmacies that appear most worthy of trust are compounding pharmacies. In the course of their professional careers, many physicians, nurses, and other pharmacists will recommend a compounding pharmacy to people who trust their judgment.

When we select a compounding pharmacy or recommend it to others, how do we know that the one we recommend or select meets high and exacting standards?

Most of us are not in a position to make such a judgment. We base our choices upon reputation and the perception of high quality. But how can we know? To know, we need an assurance based upon professionally designed standards against which this healthcare organization has been tested.

For a hospital, the evidence is provided by Joint Commission accreditation. For a compounding pharmacy, it is provided by the seal of the Pharmacy Compounding Accreditation Board (PCAB).

Compounding pharmacy provides special challenges. It requires certain skills and knowledge. Warfarin errors account for a large number of claims filed against pharmacies each year, as attested to by the Pharmacists Mutual Insurance Co. Claims Study. When an error with warfarin is made, it usually involves one patient.

Many times, however, a pharmacy-compounded prescription is prepared in a batch of 5, 10, 25, or more prescriptions. One mistake may result in injury to several patients. There is nothing wrong with batch compounding. It improves quality as well as productivity. It means, however, that in compounding, quality standards must be higher.

Every compounding pharmacy must be tested against tough standards and must be willing to provide evidence that it has been tested and passed. Just as every hospital should be accredited by the Joint Commission, every compounding pharmacy should be accredited by the PCAB.