The American Academy of Anti-Aging Medicine has issued an urgent call for action regarding the right for patients to choose their form of medical therapy when it comes to compounded pharmaceuticals. Why is this important? Because bioidentical hormones, among many other important life-saving treatments, are most often administered as compounded pharmaceuticals.
Senate Bill s.959 will be voted on in the next two weeks and I’d like to ask you to consider taking action now to contact your Senators and Congress representatives to re-work this ill-conceived Bill: Pharmaceutical Compounding Quality and Accountability Act. The provisions contained in S.959 give the FDA the authority to restrict and eliminate the bioidentical hormones upon which millions of women and men depend. Let me explain:
Physician’s View of Compounding Medications
I have been a physician for over 25 years, first in emergency medicine/trauma, then this past decade in integrative age-management medicine. In both practices, the use of compounded medications is a daily occurrence. Physicians understand that medications have risks and benefits, including unwanted and potentially dangerous side effects. But most physicians assume that medications ordered for patients are safe, effective, high quality, and free of dangerous infectious agents. Most physicians, however, are not aware of the compounding of medications, of US Pharmacopeia regulations 795 and 797, or of independent voluntary organizations like the Pharmacy Compounding Accreditation Board (PCAB). Often, physicians do not know what a compounding pharmacy does, even when they order medication from the compounding pharmacy.
Compounding Medications vs. Manufacturing Medications
Compounding of medications is different from commercial manufacturing. Compounding pharmacies (“compounders”) take commercially manufactured products and produce (or “compound”) that medication in an alternate form or size. Compounding provides individualized and customized therapy that does not meet the definition of manufacturing as described by state boards of pharmacy, the FDA, the US Drug Enforcement Administration (DEA), and the US Supreme Court.
Compounding is an essential component of health care because commercially manufactured medications cannot account for the specific needs of every individual patient or meet the demand of the nation. Compounding is a component of the profession of pharmacy that is and has always been regulated by individual state boards of pharmacy.
Compounding exists in every hospital across the United States. Hospital pharmacies are responsible for preparing intravenous (IV) solutions that contain antibiotics, chemotherapy, and parental nutrition, to name only a few examples. Compounders can produce medications like natural bioidentical hormones, such as estrogens, testosterone, and progesterone, which a physician may desire to treat patients with hormone imbalances like menopause and male low testosterone. Even though many natural hormones are produced by Big Pharma (Vivelle-dot, Testim, Androgel, Prometrium), a physician may request a hormone to be compounded due to cost, availability, dosage, or when judged by the doctor to be in the best interest of the patient.
Compounding Is Already Regulated
US Pharmacopeia regulation 795 requires compounding pharmacies to follow guidelines in the compounding of non-sterile products (like creams and tablets), while US Pharmacopeia regulation 797 requires compounding pharmacies to follow guidelines in the compounding of sterile products (like eye drops and injections).
Pharmacy Compounding Accreditation Board (PCAB) accreditation gives patients, prescribers, and third-party payers a way to select a pharmacy that meets or exceeds US Pharmacopeia’s high quality standards. Eight of the nation’s leading pharmacy organizations joined together, contributing their time, money and leadership, to create PCAB: a voluntary quality accreditation designation for the compounding industry.
Organizations that founded PCAB and that make up the PCAB Board of Directors include:
• American College of Apothecaries
• National Community Pharmacists Association
• American Pharmacists Association
• National Alliance of State Pharmacy Associations
• International Academy of Compounding Pharmacists
• National Home Infusion Association
• National Association of Boards of Pharmacy
• United States Pharmacopeia
The main issue is that PCAB is a voluntary accreditation, process and to date only 163 of the more than 7000 US compounding pharmacies have gone the extra mile to achieve this accreditation. With greater participation in accreditation, no further regulations need to be enacted and no watchdog group needs to be founded. What ought to happen, all things considered, is a push by the government, physicians, compounding pharmacies, third-party payers, the media, and most importantly the patients to require accreditation by PCAB for all compounding pharmacies
This goal cannot be accomplished immediately, since there is a limit to the rate at which new applicants can be evaluated by PCAB. Requiring immediate accreditation would eliminate the majority of compounding pharmacies, causing a shortage of compounded medications—a situation that would compromise the care of thousands of patients.
I urge you to let Congress know that they can fix the real problem without violating the rights of Patients. Please take action now.