Compounding Pharmacy Won't Recall Contaminated Drugs

Med 4 Home Pharmacy Issued Restraining Order

Med 4 Homes, a mail order compounding pharmacy, was issued a restraining order effective through March 21, 2003 because it may have sent contaminated prescription drugs to over 19,000 people. The Missouri pharmacy was forced to stop compounding drugs after denying a state pharmacy board inspector access.

The drugs in question are Albuterol/Ipratropium and Budesonide, both of which are inhalant solutions used to treat chronic lung diseases such as emphysema and asthma. A routine state inspection of Med 4 Home Pharmacy revealed Burkholderia cepacia, a bacterial contaminant which, according to the Centers for Disease Control, is especially dangerous for patients suffering from cystic fibrosis. The bacteria can cause an infection that can spread quickly and become fatal. This puts people in nursing home settings at particular risk if they develop pneumonia, since they would be much more susceptible to bacteria from contaminated inhalants used to treat lung problems.

When notified of the contaminant, Med 4 Home recalled parts of the batches of compounded Albuterol/Ipratripium and Budesonide, but according to Steven Kinkade, Director for the Missouri State Board of Pharmacy, the pharmacy had not properly notified patients of the potential problem. The issue, according to Kinkade, is that "a patient on these drugs may already be in a compromised state, and if you introduce an organism into their lungs, it could become pathogenic. Anytime something is contaminated with an organism, we'll be highly concerned."

Compounded drugs are customized medications mixed by pharmacists in independent pharmacies. Sometimes the compounded drugs are just a combination of mixed brand-name prescription drugs customized at different levels for a patient's needs.