“At some point in your life,” says LIUNA General Secretary Treasurer and LHSFNA Labor Co-Chairman Armand E. Sabitoni, “your health care provider may write you a prescription for a compounded drug. Although these made-to-order medications are specially formulated for you, they are not subject to Food and Drug Administration (FDA) approval. Instead, oversight is through the pharmacy board in the state where the compounded medication is prepared.”
While state supervision is usually sufficient for ensuring safety, occasionally the management of some customized medication threatens public health. This fall, a compounded steroid – manufactured under unsanitary conditions without adequate quality control and, then, injected as a pain reliever – was responsible for an outbreak of fungal meningitis that continues to sicken and kill growing numbers of patients.
“When errors like this occur, your only protection is fast action,” says Sabitoni, noting that it is important to know exactly what to expect from your compound. “Should you experience a reaction, you need to know if it is an expected side effect or if it is something potentially life-threatening, and you need to consult your doctor immediately.”
Utility of compounded medication
Medication is not one size fits all. For a variety of reasons, what works for one person may not be suitable for another. Compounded medication can address some concerns.
- Stomach upset when taking oral medication
- Allergy or sensitivity to ingredients such as flavors or dyes, lactose, sugar, alcohol, gluten
- Reluctance to take the medication due to its taste
- Issues with the route of administration, such as difficulty swallowing pills
- Requiring a different dose of medication than that which is available from a manufacturer
- Difficulty keeping track of multiple medications
- Patients who do not want to take medication at all, especially children
By removing or adding ingredients and changing formulations, pharmacists specializing in compounded medications help resolve many of these problems. For example, a drug commercially manufactured as a choke-size tablet can be prepared in easy-to-swallow liquid form.
In addition to meeting the special needs of particular patients, however, the work of compounding pharmacists has become increasingly vital to larger segments of the population. This is due to escalating drug shortages and discontinuations. In the United States alone, medication stockpiles of more than 200 drugs that treat serious conditions including leukemia, cancers of the breast and colon as well as anesthetics and antibiotics are severely depleted. According to a National of Institutes of Health (NIH) report, most of these drugs are generics that do not produce much profit. While the need for these medications may be ongoing, manufacturers have little financial incentive to sustain their production. Increasingly, compounding pharmacists are called on to fill this void.
“Unfortunately, most patients do not know whether the medication they take is compounded or not,” says Sabitoni. “While oversight needs to improve, you can reduce your risk for exposure to unsafe compounding practices by following these FDA recommendations:”
- Ask your doctor if an FDA approved drug is available and appropriate for your treatment.
- Check with your pharmacist to see if he or she is familiar with compounding the product in your prescription.
- Get information from your doctor or pharmacist about proper use and storage of the compounded product.
- If you knowingly receive a compounded product, ask the pharmacist if your doctor asked for it to be compounded.
- If you experience any problems or adverse events, contact your doctor or pharmacist immediately and stop using the product.
- Report any adverse events experienced while using the product to FDA’s MedWatch program at http://www.fda.gov/medwatch/.
[Janet Lubman Rathner]