The Question Everyone’s Asking: What are Compounding Pharmacies?
Lately, health news has been exploding with articles about the products, inter-workings and politics of compounding pharmacies. Whether it’s KV Pharmaceuticals and a compounding pharmacy competing for the sale of a drug that prevents premature births or the the recent meningitis outbreak, pharmacies that compound drugs are in the spotlight. Before I started this internship I had never heard of compounding pharmacies, so I’ve decided to do some research on what constitutes a compounding pharmacy, and would like to share it with you!
I learned that compounding pharmacies are intended to operate on a one-patient, one-prescription basis to alter a product to the unique needs of an individual. So say a patient can’t swallow pills and needs their prescription converted into a liquid- who is authorized to do this?... a compounding pharmacy. Say a child needs a medication that only comes in adult dosages and needs the drug dosage altered- compounding pharmacy. Say a patient is allergic to a non-essential ingredient in their medication and needs it extracted- compounding pharmacy.
Pharmacists at compounding pharmacies develop and test different chemical formulations for new medications so that the ingredients are safe, effective and appropriate for a specific patient. Many of the drugs manufactured by compounding pharmacies are cheaper than those produced by major pharmaceutical manufacturers. Generally, compounding is a safe practice as long as the medication was made with FDA approved ingredients and has been made specifically for one patient and their prescription. However, some of these pharmacies are going beyond compounding medications on a one-patient, one prescription level and are instead increasing their production to a larger market scale. An FDA representative states, "the methods of these companies seem far more consistent with those of drug manufacturers than with those of retail pharmacies. Some firms make large amounts of compounded drugs that are copies or near copies of FDA-approved, commercially available drugs. Other firms sell to physicians and patients with whom they have only a remote professional relationship."
The problem: compounded drugs are not FDA-approved and the FDA lacks the authority to adequately regulate compounding pharmacies. Instead they are regulated by state agencies, which do not have the same standard of safety and effectiveness as the FDA. Also, compounding pharmacies aren’t required to report adverse side effects and events associated with their drugs like commercial drug manufacturers are. So when compounding pharmacies start acting like unregulated pharmaceutical companies, there aren’t strong regulations or enforcement mechanisms in place to guide and oversee them. This means that issues such as the expiration date, potency, quantity and quality are not strictly regulated and may have negative effects on patients.
Here at the NWHN we urge for stronger regulations to ensure the safety of drugs and devices marketed to women. It will take advocacy by patients and consumers to ensure that Congress and the FDA work together to establish strong regulation and oversight of compounding pharmacies and pharmaceutical companies alike. As a patient what can you do to ensure you are receiving safe and effective medication? Ask questions! This New York Times article raises areas of concern and has a great list of detailed questions to ask when receiving medication. Be an advocate for your own health and strive to make informed health decisions!