Posts Tagged 'regulations'

Ensuring Quality and Safety in Compounded Medications

As a compounding pharmacist, I have been saddened by recent unfolding news about a meningitis outbreak in southern and eastern states tied to injectable medications made at a compounding pharmacy in Massachusetts. As this news is shining a national spotlight on compounding, I would like to highlight two key issues this situation raises:

1) Accreditation by the Pharmacy Compounding Accreditation Board (PCAB) is essential in the compounding profession. Although new facts continue to be uncovered in the investigation of the pharmacy in question in Massachusetts, it has been established that it was not PCAB accredited. There are currently 165 compounding pharmacies nation-wide (and  21 in the state of California) that are PCAB accredited.

Although every compounding pharmacy is regulated by its state board of pharmacy, variation does exist state to state in practice requirements. Being PCAB accredited ensures that a pharmacy has passed the highest standards for safety and quality in the profession. The Pharmacy Compounding Accreditation Board was founded and is governed by eight leading national pharmacy organizations, including the United States Pharmacopeia (USP), and it requires pharmacies to adhere to strict policies and procedures that include rigorous and consistent testing of their finished products.

2) Sterile and non-sterile compounding are two different kinds of compounding a pharmacy can specialize in. Of the approximate 7,500 pharmacies nation-wide that specialize in compounding, 3,000 provide sterile compounding.  Sterile compounding requires additional equipment and procedures to ensure the sterility of the finished products that are injected directly into the body.  The medications that are under current investigation from the Massachusetts compounding pharmacy were sterile injections.

I, along with thousands of my compounding pharmacist colleagues, am dedicated to providing patients with the valuable option of using high-quality, customized medications when standard treatments are not working for their particular situation.  To read six key questions for a patient to keep in mind when evaluating a compounding pharmacy (particularly one that makes non-sterile products), see  Koshland Pharm’s “Understanding Compounding” webpage.  To read extensive questions a doctor can ask of a compounding pharmacy (particularly one that makes sterile products), see this questionairre created by the International Academy of Compounding Pharmacists. To read another recent blog about how the Massachusetts compounding pharmacy in question appears to differ from traditional pharmacy compounding, see the National Community Pharmacists Association blog.

Your comments and questions on this important topic are welcome.

~Peter

www.koshlandpharm.com

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