Compound pharmacy errors: what you should know

Sometimes getting your medication right can be a bit of a guessing game for your doctor and pharmacist. They need to balance out the benefits of a drug with potential side effects while dealing with other obstacles that are more patient specific, such as difficulty swallowing pills or being prone to allergies. In most cases the drugs that are ultimately prescribed are the same ones that were approved by the FDA and are used by thousands every day. For some people, the FDA drug doesn’t seem to be the right choice, and they wind up working with their doctor and pharmacist on possible alternatives. One option they explore is compounded medication from a compounded pharmacy.

What Is A Compound Pharmacy?

A compound pharmacy is a pharmacy that mixes medications with regards to the specific needs of a patient. Since they don’t carry a major brand label, some people confuse them with generic drugs, but they are actually far different. Generic drugs are produced on a large scale and are subject to the same testing and reporting requirements as comparable brand name drugs. A compound drug is made in a smaller batch, and compound pharmacies aren’t subject to as much oversight by the FDA when making these tailor made drugs as they do when making other drugs. There are some mainstream pharmacies that offer compounding services, and there are also pharmacies that specialize in making compound medications.

Good Manufacturing Practices

One of the reasons why approval of the the FDA is sought is that FDA drugs are monitored to assure that they are made following good manufacturing practices (GMP) which includes following various industry standards for quality and sterility and are verified as effective. This is not something that is done with compounded drugs, which opens up the possibility that errors can be made in the manufacturing process. It is more likely that bacteria may contaminate a batch of drugs, or even that dosing may not be consistent. It is also less likely that these drugs will come with clear instructions for safe use. For some this may mean the drugs are misused, and with no specific standard, it also may be more difficult to medically treat someone who has had an adverse reaction. Although many compound drugs are made on a small scale, some actually do get distributed to large groups of people. In just over a decade a failure to maintain proper sterilization led to at least three meningitis outbreaks.

Because there have been problems, some oversight has begun — such as a requirement to report and registered non FDA approved drugs to the FDA so that medications overall can be monitored.

While compounded drugs can sometimes help in ways that traditional drugs can’t, they can be dangerous in unpredictable ways and can potentially cause long term health problems or even death. If you or a loved one has been injured, has fallen ill, or has died from complications suffered after taking compounded drugs, a qualified medication error attorney may be able to help you hold the appropriate people responsible and pursue the compensation you need to move forward with your life.


FindLaw Network