What Can Go Wrong with Compounded Drugs

There is some controversy concerning compounding pharmacies-especially in that they seem to escape some of the safeguards in place that large drug companies have to conform to regarding drug testing for uniform potency, uniform dosages, safety to consumers, and being free of contaminants. Drug dosages that are pre made by pharmaceutical companies have to be tested and approved for use by the Food and Drug administration. Compounded prescriptions have thus far escaped such rigorous safety measures. Drug companies are required to send samples to independent labs for quality and quantity analysis. Compounded items are exempt from this. Experimental safety trials were done on drugs and generics when they came out, but human error can result in doses varying quite widely as far as active ingredient quantity and potency are concerned. Some consider compounded drugs to be unapproved new drugs.
 
Because of the lack of independent testing on compounded items, there is the chance that the active ingredients in drugs will be adversely affected by the other ingredients they are mixed with. Another concern is the bulk ingredients obtained by compounders. Are they from reputable sources? Are they pure and free of bacterial and fungal agents? Do they have uniform, consistent potency throughout the batch if it is the active ingredient? When independent tests are done on compounded pharmaceuticals versus their standardized counterparts, dosage and absorption characteristics are found to vary widely in about half of the samples tested.

In the case of slow release pharmaceuticals, these should not be compounded. Compounded items are best made for drugs that work in an all or none fashion.

Lastly, compounding pharmacies can make drugs available at cheaper prices especially if the dosage prepared is smaller than a conventional dosage. Also, generic drugs are often utilized to make up compounded prescriptions. some pharmacies do not pass these savings along to their customers. While this is not a safety concern, it still can affect consumers negatively.

If you or a loved one were harmed by botched or contaminated prescriptions from a compounding pharmacy, you may be eligible for monetary damages. Call the Sweeney Law Firm and let us review the facts. You may have a personal injury case. If we take your case, we work on a contingency fee basis- meaning there is no charge for representation unless a settlement or recovery of funds is made on your behalf.

 

To read related articles on this site, click the links: What is a Compounding Pharmacy, Inactive Ingredients of Pharmaceuticals and Adverse Reactions They Can Cause, Bill Would Make Compounders Register with FDA, Meningitis Outbreak Toll: 23 Deaths, New England's Compounding Center's Other Drugs may be Causing Illness, FDA Warns