Opinion: Oversight of N.J. compounding pharmacies would assure medical safety

By Dr. Nina Singh-Radcliff
As a physician, I assume that the medications I prescribe and administer are safe. However, last October’s fungal meningitis outbreak has greatly concerned me, my fellow physicians, hospitals, state legislatures and the public.
The Centers for Disease Control and Prevention has reported a total of 39 deaths and 656 cases in the country due to contaminated vials of steroids that were manufactured by the New England Compounding Center. There were 46 reported cases in the state of New Jersey. Approximately 17,500 vials that potentially harbored Exserohilum rostratum were shipped by the NECC to 76 health-care facilities in 24 states. Although it was extremely tragic (and unnecessary), we were fortunate that these numbers were not significantly higher.
Compounding pharmacies have served a special and important service for patients during drug shortages and for patient-specific needs. “Traditional” compounding pharmacies provide medications for an individual patient in response to a practitioner’s prescription. The pharmacist combines or alters various drug ingredients in order to accommodate a patient allergy or a need for a liquid form or flavoring.
Some pharmacies, however, have metamorphosed into drug manufacturers. They function as miniature drug companies and no longer specifically formulate a medication to a specific patient’s needs. Doctors and hospitals have turned to these “manufacturing” or “nontraditional” pharmacies because of drug shortages or their prices, which can be lower, compared to those of major manufacturers.
In 2012, a study showed that 98 percent of anesthesiologists came up against drug shortages in the past year. When a particular drug is not available, we have one of three options: Stop providing anesthesia services, use alternative medications that may have dangerous side effects or obtain medications from compounding pharmacies. The last option is the most logical.
However, after the fungal meningitis outbreak, the glaring light that has been shone on compounding pharmacies has revealed that they fall into a regulatory and legal loophole. Trade associations that represent the sector have sidetracked attempts to be regulated at the federal level. As it stands now, regulation of compounding pharmacies in New Jersey falls under the New Jersey State Board of Pharmacy. Although some state boards have strong requirements for compliance with quality standards, they can vary considerably.
New Jersey has become the first state to take a positive step toward enhancing patient safety by requiring oversight of traditional compounding pharmacies. Sen. Jeff Van Drew (D-Cape May Court House) recently introduced the Compounding Pharmacy Quality Assurance Act (S2365), which would require all traditional compounding pharmacies in the state to receive accreditation from the Pharmacy Compounding Accreditation Board (PCAB), a national organization.
Even I, as a physician, was not aware of PCAB accreditation until the fungal meningitis outbreak. PCAB accreditation, which is now voluntary, is currently the “gold standard” by which a compounding pharmacy can be ensured to meet nationally accepted quality assurance, quality control and quality improvement standards. It serves as a form of external validation. The accreditation process involves a review of the compounding pharmacy’s facilities, equipment and records and the procedures it requires to prepare quality compounded medications, as well as its program for testing compounded preparations. It also involves verification that the pharmacy uses ingredients from FDA-registered and/or licensed sources, is not on probation for issues related to compounding quality, public safety or controlled substances and is properly licensed in each state in which it does business.
Additionally, S2365 would require that any traditional compounding pharmacy in another state must be PCAB-accredited in order to provide medications to residents of New Jersey. Nontraditional or manufacturing pharmacies are not included in S2365, because the FDA is requesting Congress to grant it the powers to regulate them.
The American Medical Association has issued a policy that states that pharmacy boards should require all compounding pharmacies to be accredited by the PCAB. However, until Sen. Van Drew’s bill, no state legislature has attempted to enforce this.
Physicians, patients and hospitals should be able to expect and demand that the drugs they prescribe or receive are sterile, stored appropriately, not expired and appropriately labeled. S2365 would enhance the safety of New Jersey residents without increasing the size of government or government spending. Enacting it just makes plain common sense.
Dr. Nina Singh-Radcliff is a member of the American Society of Anesthesiologists.
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