Having FDA approval for a drug is how it is known to be safe for doctors who prescribe it and patients who use it. Without it, the drug’s safety, efficiency, and quality are not verified, which means people take the non-approved drugs at their risk.
However, some drugs are not FDA-approved but could be the only choice for individual patients. Drug compounds are both risky and necessary, but a lot depends on how and where the patient got them. Let’s have a closer look at drug compounding — what it is, why it’s needed and what are the risks of using compounded drugs:
What Is Compounding?
Compounding is most often for cases where the patient has allergies to a specific component of a drug. The process of compounding involves combining and mixing ingredients to create a medication that would be suitable for an individual patient’s needs. Usually, it’s two or more drugs combined, and the elements can often be altered to avoid any components that cause an allergy or a reaction with a patient.
Who Are the Compounders?
Pharmacies are the ones who usually do compounding, but that doesn’t mean that it doesn’t happen in other settings, even at the compounder’s home lab. According to the federal law, compounding can be performed by a licensed pharmacist in a state-licensed pharmacy, but it also allows for compounding by a physician or a central facility, as well as compounding done in the presence of a licensed physician.
Answering a Patient’s Unique Needs
Some patients can’t be treated with an FDA approved medication, either because of an allergy to a specific component or because of an inability to take that medication as designed. It could be as simple as an elderly patient who needs medicine in liquid form as opposed to a capsule or a tablet. In these cases, health professionals resort to using drug compounds. If an FDA-approved drug isn’t suitable to treat a specific patient for whatever reason, healthcare professionals in hospitals and clinics can provide them with compounded drugs.
FDA Approval for Compounded Drugs
FDA does not test or approve compounded drugs, even though the components used in the compounds are often standard medications which are FDA-approved. However, the safety and effectiveness of each compound are not verified by the FDA, which leaves compounded drugs in somewhat of a gray area that dishonest compounders can exploit.
Compounders Can Mislead, So Caution Is Advised
Despite it being an established medical practice, it doesn’t mean that using compounded drugs is always safe. According to the FDA, there are drug compounders who are consciously putting patients at risk and undermining the drug approval process by misleading them or outright lying. For example, stating that the drug meets the FDA approval standards and is therefore safe to use and effective against an array of diseases, some of them quite serious. It puts patients at risk and significantly undermines the trust that patients have in compounders.
Risks of Using Compounded Drugs
Even though compounded drugs have their place in serving the unique needs of patients, there are risks associated with using a drug that isn’t verified as safe and effective by the FDA. Unfortunately, there are frequent cases of FDA finding out about poor compounding practices which can cause problems that might even put lives at risk.
Some of those poor practices include improper sterilization (using toaster ovens), lack of a sterile environment where the drug compounding is taking place, or inappropriate and unsanitary handling of the pure drug products. It is often in the case of compounders manufacturing the drug on a large scale, without regard for any individual patient’s needs. Unsanitary conditions during the drug compounding process can have severe consequences for the health and well-being of patients.
Outbreaks Related to Contaminated Compounded Drugs
Unfortunately, the US has already seen just how dangerous compounded drugs can be. There has been a series of events with adverse effects on patient health and safety that are linked to poorly made compounded drugs that were still widely distributed. One of the most serious ones was the 2012 outbreak of fungal meningitis. A shipment of compounded drugs from a pharmacy in Massachusetts ended up infecting over 750 people in 20 states with the fungus that contaminated the drug, and more than 60 people died as a consequence. The effects could have been even more severe because around 14,000 patients injected these contaminated drugs into their spines and joints.
The situation is even more dangerous once you consider that compounders rarely report these adverse events to the FDA unless they’re on the scale of the 2012 outbreak. It means that we may not even be aware of all the potentially harmful effects the drugs have had on the US population relating to the mislabeling, contaminated, or overly strong compounded drugs.
FDA inspects the outsourcing facilities for compounding, and they have to meet strict quality standards to stay operational. However, other entities may also examine the facilities that carry out drug compounding, such as state boards of pharmacy. They have to take care of the day-to-day oversight of these facilities, especially of the state-licensed pharmacies that haven’t registered with the FDA as outsourcing facilities. If they do sign up, they become the responsibility of the FDA, which will oversee them and inspect them on a risk-based schedule. If they don’t register, the FDA will only conduct surveillance and for-cause inspections.
Compounded Drugs Quality Standards
Compounded drugs that are subject to current good manufacturing practice (CGMP) requirements are the ones produced and manufactured by the outsourcing facilities. However, some compounded drugs are subject to less strict quality laws, depending on state and manufacturer. In any case, whether the drug is compounded by an outsourcing facility, a licensed physician, state-licensed pharmacy or a federal facility, it still must fulfill the requirement of fulfilling sanitary conditions for the drug preparation, packing, and distribution.
Compounded drugs serve an urgent patient need, but caution is advised when using them. You don’t get the FDA guarantee that the drug is safe, so you should research the manufacturer and distributor of the drug to ensure that you can trust them with your health.
Author: Kirill Vesselov
Kirill Vesslov is our resident writer about health and wellness as well as our pharmacy services.