In 2012, a fungal meningitis outbreak was linked to the New England Compounding Center in Framingham, Mass., where a steroid produced by the facility became contaminated. The Centers for Disease Control and Prevention identified 751 individuals in 20 states sickened by the contaminated injections, including 64 who died.
The lack of medication safety and quality control at this particular compounding center created a public health concern. More than 31 violations were discovered, including mold growing in the compounding room, an air intake vent located 100 feet from a recycling plant and other unsanitary practices. Employees discussed creating thousands of fake prescriptions so that more medication could be made. Approximately 17,000 vials of the fungus-contaminated steroid were produced for distribution.
According to the Food and Drug Administration, “Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. Pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.” About 30 million prescription medications are compounded annually. In the old days, the neighborhood pharmacist mixed medications ordered by a doctor for his patient. Today, compounding has moved to free-standing compounding companies.
The practice of compounding drugs expanded since the 1990s due to the costs and budget constraints of hospitals and medical and surgical practices, many of which now outsource large parts of their drug mixing. While all pharmacies and pharmacists are licensed and regulated by State Boards of Pharmacy, the FDA and CDC have limited power over compounding pharmacies, as they are not required to register with or report problems to the FDA.
The FDA does regulate drug compounding by pharmacies to a degree, requiring a prescription for each patient receiving compounded medication, adherence to pharmacy standards detailed in The National Formulary and the U.S. Pharmacopeia, and the preparation of medications in limited amounts. Compounding pharmacies cannot legally produce drugs for the mass market, which requires FDA oversight, but a growing number of them manufacture specialized drugs that they distribute widely across state lines.
There are risks and benefits to drug compounding. Mixing drugs together changes their composition, and excellent quality control measures need to be in place. Compounded medications often have not been tested for safety and effectiveness in clinical trials. A pharmacist or a compounding facility prepares the product according to a doctor’s prescription. Ideally, the pharmacist evaluates the product to ensure the correct medications have been compounded with the correct dose and concentration for the individual patient.
The U.S. Pharmacopeia Convention sets the standards for customized products for individual patients. Procedures must be in place to maintain sterility (washing hands; wearing gloves; using masks and hair covers; and cleaning all surfaces and implements with bleach, alcohol or high heat). Equipment required includes laminar airflow laboratory hoods, biological containment chambers, nuclear material glove boxes and clean rooms. Storage requires refrigeration, cabinets with air circulation and humidity controls. Pharmacies that compound a large volume of drugs can be accredited through national standards developed by the Pharmacy Compounding Accreditation Board.
It may be difficult to recognize if you are taking a drug made by a pharmacy compounder. Ask your doctor and pharmacist whether the prescribed drug is compounded, why it is being compounded, where it is being compounded and the possible side effects and safety concerns. If you receive a compounded drug, ask the pharmacist if your doctor asked for it to be compounded and find out if an FDA-approved drug is available and appropriate for your treatment. Ask if the pharmacist is familiar with compounding the product in your prescription, and whether he or she has the training, equipment and processes in place to compound it. Many pharmacists are certified in compounding drugs; ask to see the certificate. Find out if it is an accredited compounding facility. Ask about state inspections of the facility, inspection results and the quality control and safety of the product.
Obtain information about proper use and storage of the compounded product. If you experience any problems or adverse events, contact your doctor or pharmacist immediately. Medication compounding risks include particulate, chemical or microbiological contamination; medication dosage or concentration error; and drug incompatibility. Inspect the medication and do not use it if it looks suspicious or if it tastes or smells strange. Report it to the pharmacy and the FDA MedWatch program.
In November 2013, Congress passed the Drug Quality and Security Act, a bill which gives the FDA more power to police compounding pharmacies but which stops short of granting complete authority over pharmacies that mix drugs for individual patients. The bill provides new safeguards regarding quality control and the ability to track medications given to patients, which will be phased in over a decade.
Many of the pharmacists in drug compounding facilities are devoted clinicians who follow the practices set in place by the USP or the Pharmacy Compounding Accreditation Board. You should feel comfortable asking the necessary questions of health care providers prior to the administration of any compounded medication.
The content of this article is for informational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition.
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