Good regulation means good health
The death toll from the recent meningitis outbreak caused by contaminated drug products from the New England Compounding Center has called into question the current regulations governing pharmacy compounding of drugs.
Pharmacy compounding generally involves preparing a formulation using various commercially available U.S. Food and Drug Administration-approved products. These products are required to be made by a licensed pharmacist in a state-licensed pharmacy or a federal facility as per a legitimate prescription for an individual patient by a licensed prescriber.
Compounding pharmacies are regulated by individual states’ boards of pharmacy. Safety of compounded drugs becomes a significant issue when regulations pertaining to compounding are not followed, which, as seen by the current outbreak, may have a significant impact on public health. But if the guidelines and regulations are enforced, the risk to patient safety is minimal.
In Massachusetts, state board inspections only occur when a pharmacy first opens, if the location is moved or if a complaint is filed against the pharmacy. Even when a complaint was filed against the NECC a few years ago, the Massachusetts BOP did not withdraw its license.
In California, the state has both instituted state compounding regulations and been diligent in enforcing those regulations. California is one of the few states that implemented its own regulations for compounding in 2002 in order to prevent incidents of patient harm. By state mandate, compounding pharmacies in California have a separate license that must be renewed annually; renewal is contingent upon a thorough inspection. These regulations were enacted as a result of a 2001 local tragedy, when several patients were harmed due to contaminated compounds from a neighborhood pharmacy.
The majority of compounding pharmacies follow standards very closely, including regular testing of the facilities and equipment, and deliver safe and effective products to patients.
However, as apparent from this recent event, some state’s BOPs may need to take a more proactive role in inspections and enforcement actions to ensure safety, efficacy and quality of product.
We are fortunate in California to have a diligent BOP and highly reputable compounding pharmacies to deliver these highly specialized products.