When people get sick or feel ill, occasionally prescription drugs are necessary to combat the illness. Patients and doctors expect medication to have undergone rigorous regulatory oversight to ensure that they are safe for human ingestion and to have been manufactured in sanitary conditions. However, last year, this trust was shattered when a contaminated drug from a compounding pharmacy seriously injured and sickened nearly 50 New Jersey residents and killed 55 people across the U.S.
According to a report recently released by experts in New Jersey, the contaminated drug that caused the fungal meningitis outbreak is only a symptom of a larger problem. In general, compounding pharmacies are not drug manufacturers. They are in the business of customizing medications for patients who, for instance, cannot swallow a pill. However, larger compounding companies now manufacture drugs in bulk but do not perform the same rigorous testing or follow the same safety protocols that pharmaceutical companies do.
The report looked at over 40 FDA warning letters issued to compounding pharmacies between 2002 and 2012, and noted that several compounding pharmacies were cited for multiple violations. Specifically, violations included drugs being made in unsanitary conditions, and new, untested drugs being manufactured without authority. Further, one pharmacy was found using an industrial solvent not approved by the FDA for drug manufacturing. Another pharmacy was found producing a drug which had been withdrawn from the U.S. market in 1973. Currently, the New Jersey Attorney General is seeking revocation of the licenses of two of these pharmacies, as well as the pharmacists in charge of them.
Anyone who believes they have been seriously injured or sickened by the ingestion of a contaminated drug from a compounding pharmacy should, first and foremost, contact their doctors. Additionally, they may find it helpful to consult with a serious injury attorney to explore their legal recourse.
Source: NJ Today, “New report documents a decade of safety violations by compounding pharmacies,” May 24, 2013