Compounding Pharmacy Myths
Written by Angelo Maida, PharmD, FACA
With any profession there arises misconceptions about how it’s practiced. Too often, the media and those not involved in the practice heavily influence public opinion. Compounding is no exception to this. Here are 4 common misconceptions I come across regularly.
Myth #1: We’re unregulated.
Quite the contrary. The FDA has jurisdiction over all compounding pharmacies. Though, it is almost always the case regular inspections are carried out by state boards of pharmacy. Twice a year a thorough inspection will take place. The Massachusetts Board of Pharmacy assesses for compliance of relevant chapters in the United States Pharmacopeia (USP). The USP is an independent organization whose mission is to improve global health. They have put in place strict standards for compounding pharmacies to follow. These standards were recently updated and will be enforced starting December 2019.
Often, the media and other healthcare professionals will candidly say, “but compounded medications are not FDA approved.” This is true, compounded medications are not FDA approved. However, to stop the conversation here and dismiss the practice of compounding pharmacy as a hazard is unfair to the profession, and the patients who rely on compounded medications. I’d like to put this statement into perspective. Consider the fact that many medications are prescribed off-label for conditions they weren’t originally approved for. In other words, although FDA approval is immensely reassuring, the lack of FDA approval doesn’t stop a sound treatment from being prescribed to patients. Comparable situations arise in the world of compounding. We’ll use FDA approved medications in an innovative way, combining them with other substances (also on a regulated list), to give a uniquely formulated medication. This is always done by prescription, often preceded by an extensive conversation between a compounding pharmacist and a provider.
Maida Pharmacy Compounding and Wellness has taken a voluntary step to go above what is required by law by becoming PCAB certified. The Pharmacy Compounding Accreditation Board (PCAB) is an independent organization providing accreditation to compounding pharmacies conducting quality assurance measures at the state-of-the-art level. PCAB certified pharmacies are the trusted leaders in the profession.
Myth #2: We’re “alternative medicine.”
A common misconception of compounding pharmacies is that we’re an alternative form of healthcare. It’s difficult to pinpoint how this notion came about. One possible reason is our collaboration with providers practicing integrative medicine. Integrative medicine – sometimes considered “alternative” – work closely with compounding pharmacies in-part because of common interest, but also because integrative practitioners tend to be collaborative to begin with. Another explanation for the association of compounding and alternative medicine may be compounding pharmacies marketing themselves as a such. Now, there may be some overlap between compounding pharmacy practice and what some might call “alternative.” Especially in the areas of herbal medicine. Consider the herb Arnica montana. Incorporated into an ointment, it’s effective for treating hemorrhoids. Some European countries even have an official
monograph in their pharmacopeias for the use of arnica in treating hemorrhoids. Let’s consider a pregnant woman, who like many pregnant women, is suffering from a hemorrhoid. Conventional treatment with a locally applied steroid such as hydrocortisone is concerning because of the potential for it to be absorbed and harm the developing baby. In this scenario, what may be originally dismissed as “alternative” is a sound treatment option.
Compounding pharmacists’ find themselves working with conventional medicine just as often. Western conventional medicine is practiced in an evidenced-based manner with double-blind, placebo controlled-clinical trials considered the most influential, and expert opinion the least. The medical literature is constantly gathering, and practitioners are improving their treatment plans as it does. Often, a compounding pharmacy is a tremendous asset for a practitioner up to date on the latest evidence relevant to their field. Take an old drug shown effective for a new condition it wasn’t originally studied to treat, and say this drug is effective for this condition at a dose is much lower than what’s commercially available. This is a perfect example of how a compounding pharmacist fits into an evidenced-based approach to healthcare. With a compounding pharmacist knowledge of formulating medications on a patient by patient basis, the practitioner’s treatment can be compounded, and the patient may be treated.
Terms like alternative, integrative, and conventional medicine are somewhat ambiguous. The point is compounding pharmacists find themselves working with a number of different providers whose philosophies may differ. Whether their approach is “alternative” or not doesn’t matter as much as the patient, the scenario, and credible scientific and clinical literature.
Myth #3: We just mix things together.
Any compounding pharmacist will passionately say that compounding medications is a science and an art. At its best, the formulating process begins with a conversation between a pharmacist, a patient, and a practitioner. After a treatment plan is decided, the compounding pharmacist is responsible for preparing the medication. Many things must be considered: the patient case, the dosage form, the properties of the drug, its compatibility with other ingredients, and patient-cost (to name a few). Several resources such as peer-review stability studies, time-tested formulations, or pharmaceutical science texts will be consulted. Next, a formulation record will be typed making sure to document items like the calculation, procedure, and any quality assurance measures that must be done. Formulations can be adjusted on a patient-by-patient basis or improved upon for any future scenario that might present. This process combines an age-old practice with the latest science and technology.
Myth #4: Only a select group of people need a compounding pharmacy.
All too often I hear that compounding is for patients who can’t swallow pills or for those who have allergies. Sure, compounding is a lifesaver for these people, but there are countless scenarios where a compounding pharmacist can be a tremendous asset! Even I’m regularly surprised at how versatile this specialty is. Here’s a hypothetical work week: Monday – progesterone suppositories for maintaining a pregnancy; Tuesday – formulate an ointment for a stubborn wart; Wednesday – prepare a customized acne cream; Thursday – flavor a nasty tasting seizure medication; Friday – a monkey at a local zoo need’s an antibiotic at a personalized dose. Don’t be surprised if a prescription of yours or a family member arrives at Maida Pharmacy!