The lack of comprehensive regulations regarding compounding pharmacies is cause for great concern. For example, records and other documents show that grave safety lapses, such as that which occurred at a Massachusetts pharmacy last fall linked to a deadly meningitis outbreak, was not an isolated occurrence. Alarming revelations predate the New England Compounding Center’s contaminated steroid shots, which were linked to 45 deaths and 651 illnesses.
Compound pharmacies are entities which compound certain drugs for use in hospitals and the like, which are then used to treat patients. Examples of such compounds include intravenous fluids used to treat various conditions. Compound pharmacies evolved out of the need for hospitals to have readily available intravenous drugs, that couldn’t conveniently and accurately be compounded on site.
A Washington Post analysis reveals unsanitary and loose practices at large specialty pharmacies that have in turn been linked to illnesses and deaths over the past 10 years. The Post reviewed hundreds of documents, including lawsuits and FDA documents, and found serious issues with at least three of the fifteen large scale compounding pharmacies that dominate the industry.
Safety concerns have not been adequately addressed by regulators because these compounding pharmacies can fall in a precarious legal limbo between state pharmacy boards and the FDA. These companies, which supply about 40% of all intravenous medications used in American hospitals, are not subject to the same stringent requirements as drug makers, meaning they cannot be compelled to test each lot or batch for sterility and proper potency.
Among the recorded complications were several related serious bacterial infections, believed to have been caused by contaminated water that was used in the cleaning process. Additionally compounds were too concentrated in several cases. Batches that were too strong are believed to be the cause of death for several patients who underwent heart surgery, also believed to be responsible for causing a brain bleed and severe injuries in a two year old girl. At least eighteen people in five states became ill as a result of contamination.
Even though individuals cannot necessarily purchase these compounded solutions on the open market, as with other pharmaceuticals drugs, these products are considered consumer products, meaning that they are subject to product liability protections. Eventhough these compounding pharmacies cannot be required by the FDA to test their products, the fact that there is evidence of recurring bacterial infections and problems with drug concentration are potentially actionable. The end product should meet the sterility and concentration requirements necessary to keep patients safe and alive.
The pharmacy error attorneys at Lebowitz & Mzhen can assist Maryland victims who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule your free and confidential consultation, contact us today through our website, or by calling us at (800) 654-1949.
More Blog Posts:
Check Your Pills Twice: Pharmacist Gives Woman Incorrect Pills,Pharmacy Error Injury Blog, published February 19, 2013
Fosamax Plaintiff Receives $285,000 Verdict After Jury Trial, Pharmacy Error Injury Blog, published February 12, 2013
Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies, Pharmacy Error Injury Lawyer Blog, published January 26, 2013