The American College of Obstetricians and Gynecologists (ACOG), one of the leading organizations of OB/Gyn’s in the country, recently came out with a position statement telling their members not to use compounded medications for their patients. Their statement includes factual inaccuracies about the quality and validity of compounded medications.
Compounded (or customized) medications are an important part of the host of therapeutic options available for an individual patient, and unfortunately, the ACOG position limits doctors’ ability to treat their patients’ conditions by suggesting that they solely rely on medications provided by the pharmaceutical industry.
One of ACOG’s key criticisms of bioidentical hormones from compounding pharmacies is the lack of quality control when it comes to purity and potency of the finished medications. They mention an often cited FDA survey from 2001 (mistakenly referenced as being from 2009 in the ACOG paper, p. 4), that found a 34% potency failure rate from compounded prescriptions obtained over the internet.
Importantly, this FDA study (2001) about the potency of compounded products predates the founding of the Pharmacy Compounding Accreditation Board (PCAB), which created in 2006 “a system of standards by which each compounding pharmacy can test its quality processes.” PCAB is a not-for-profit organization founded and directed by eight leading national pharmacy organizations: The American College of Apothecaries, the National Community Pharmacists Association, the American Pharmacists Association, the National Alliance of State Pharmacy Associations, the International Academy of Compounding Pharmacists, the National Home Infusion Association, the National Association of State Boards of Pharmacy, and the United States Pharmacopeia.
The ACOG paper states, “the purity, potency and quality of compounded preparations are a concern” (pg. 3). They are clearly unaware of the rigorous quality control measures required in PCAB accredited compounding pharmacies, including the testing of multiple finished products as a way of ensuring quality and validating the processes used to make the compounded medications.
Compounded medications may not be right for all patients in all situations, but they are an important therapeutic tool for situations where a manufactured pharmaceutical does not meet a patient’s needs. ACOG’s position perpetuates factual inaccuracies about these customized medications at the expense of a patient’s ability to obtain the best possible treatment for her/his specific condition.
For patients and doctors who want to ensure that they are working with a pharmacy whose compounded products have reliable potency and purity, they can check to see if the pharmacy is accredited by PCAB. In addition, both patients and doctors can ask to see a pharmacy’s certificates of analysis of the products that they routinely test.
For 6 concise questions to ask a compounding pharmacy to evaluate the quality of its compounded medications, see Koshland Pharm’s “How to Evaluate a Compounding Pharmacy” hand-out.
I welcome your comments and feedback.
Peter Koshland, Pharm.D