Most patients these days can be treated with commercially available pharmacy medications. These are drugs that are mass-produced, marketed and sold to the public and approved by the Food and Drug Administration (FDA). However, in certain circumstances, patients may require medications to be customized to meet special needs. This process of altering or customizing medications is known as compounding. Although compounded prescriptions make up just a small percentage of all medications—one to three percent—their use is gradually increasing. In this article, we’ll take a closer look at compounded medications, exploring what they are, when they’re needed and the risks they carry.
What are compounded medications?
Compounded medications are drugs created by mixing, altering or combining ingredients to tailor a medication to a patient’s specific needs. This is typically done by a licensed pharmacist or physician when a commercially available drug doesn’t meet the patient’s requirements. Medications like these can offer greater flexibility and personalization in treatment. However, it’s important to note that compounded drugs are not approved by the FDA. This means the FDA does not evaluate their safety, effectiveness or quality before they are dispensed.
When might a patient need a compounded medication?
Compounded medications may be necessary in specialized situations to account for:
- Allergies. Some people are allergic to dyes found in certain drugs. When this happens, a new version of the medication needs to be created without the dye.
- Alternative dosage forms. Sometimes, children or elderly patients can’t easily swallow pills or capsules. In these cases, a liquid dosage form of a medication may be needed instead.
- Drug shortages. If an FDA-approved drugs experiences a shortage, a compounded version may be created under specific guidelines.
What are the risks associated with compounded medications?
Because compounded drugs are not FDA-approved, they carry certain risks for patients. These can include things like contamination during preparation or using incorrect amounts of an active ingredient. For these reasons, FDA-approved, commercially manufactured medications should always be considered first when available and appropriate.
Can you get a compounded drug at your local pharmacy?
Yes, but it depends on the complexity of the medication. Simple compounded drugs—like an amoxicillin suspension—are often available at local pharmacies. More complex compounds, however, are typically prepared at specialized compounding pharmacies or hospital pharmacies.
Does insurance typically cover compounded drugs?
Coverage for compounded medications varies by insurance plan. For example, at Meritain Health Pharmacy Solutions (MPS):
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- Compounded drugs must meet standard utilization management criteria.
- They cannot include bulk compounding powders that lack FDA approval or an indication for treating specific conditions.
Patients should always check their plan summary before filling a compounded prescription.
Conclusion
Understanding what compounded medications are can help patients make informed decisions about their treatment options. While these medications offer valuable flexibility, they also come with unique risks and limitations. Make sure to always consult with your health care provider or local pharmacist to determine the best course of treatment.
Sources:
- National Institute of Health, The Role of Pharmaceutical Compounding in Promoting Medication Adherence
- 2. Compounding and the FDA, Questions and Answers
