In a world where office visits grow shorter and doctors draw diagnoses from behind computer screens, finding a practitioner who wants to truly LOOK, LISTEN, and TEST in order to uncover and treat health concerns is not always easy. For many patients, even after finding a quality practitioner, the next challenge can surface when trying to gain access to the most specialized treatment options for their individual care.
One way practitioners can provide specialized treatment for a patient is by utilizing specialty compounding pharmacies. A compounding pharmacy has the ability to formulate prescriptions that are not available commercially. Compounding of specialized medications is important for numerous reasons. It allows for patients with allergies to dyes or other ingredients in commercial products to receive the medication they need without the additives. In pediatrics, compounding can have many applications: preparation of a liquid dosage form when a commercial liquid product is not available, flavoring of commercial liquid dosage forms to improve taste and administration, and medications that are gluten-free, sugar-free or casein-free.
COMPOUNDING UNDER ATTACK
In the last 5 years, compounding pharmacies have come under intense scrutiny from the federal government. In fall 2012, an outbreak of fungal meningitis linked to an injectable steroid medication from a Massachusetts compounding pharmacy gained the attention of the Centers for Disease Control and Prevention and the FDA. After the incident, the push toward regulating compounded medications gained momentum. By 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened federal control over compounding pharmacies. As a part of the legislation, the FDA approves what can and cannot be compounded which puts several alternative treatments at risk for being banned. It may also decrease affordability, availability, and may even influence patient access to supplements.
If you have been a patient of this practice, then you are probably quite familiar with many of the services that the Alliance for Natural Health USA predicts may be affected by this legislation. Here is their list:
Bioidentical Hormones—Estriol, progesterone, testosterone, and other hormones have been nominated to the “Demonstrably Difficult to Compound” list. This could make access to these hormones much more difficult.
Supplements—The FDA has stated that supplements must be pre-approved to be legally compounded. Many supplements and natural ingredients that have been nominated have been rejected, such as curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
Chelation and IV Nutrients—Compounded chelation drugs like CalEDTA, Disodium EDTA, and DMSA may be at risk. It is unclear whether the FDA will allow the compounding of nutrient IV bags—especially due to the threats to compounded supplements.
Office Use— The FDA has made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has not only increased the cost of these medications, it has also created more hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by such facilities will be limited.
Affordability—Due to the above-mentioned restrictions, and the threat of more to come, it has become extremely difficult for doctors to obtain medications. For example, the price of injectable B-12 has climbed just under 700% from the mid-2000’s.
Interstate Commerce—New legislation limits the amount of interstate shipments that facilities can make to 5% of total sales. This is extremely problematic given that certain pharmacies specialize in specific preparations. A memorandum of understanding released by the FDA increases this amount to 30%, but then states must take over regulatory responsibility over these facilities. Since it is likely that many states will not elect to take on this additional burden, the upshot is facilities will only be able to ship a small portion of their medications out of state, which could create shortages and increase the price of compounded medications further.
Loss of access to these services and treatments will disproportionately affect patients like ours who believe in an individualized, integrative, and often a holistic approach to healthcare. It is important to know your rights as a patient and stay up-to-date on important issues politically that may impact your healthcare. The Alliance for Natural Health has many resources that aim to encourage both patients and practitioners to speak out about these growing concerns.
Here is what you can do!
- Follow the developments regarding compounding at www.ANH-USA.org.
- Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to compounded medications.
- Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/
- Support ANH-USA in its efforts to rein in these excessive, burdensome, and costly regulations at http://www.anh-usa.org/donate/
- International Academy of Compounding Pharmacists http://www.iacprx.org/