As a physician, I assume the medications I prescribe and administer are safe. However, the recent fungal meningitis outbreak has made me, my fellow physicians, hospitals, legislatures and the public concerned. The Centers for Disease Control and Prevention have reported a total of 39 deaths and 656 cases 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 extremely tragic (and unnecessary), we were fortunate that these numbers were not significantly higher.
Compounding pharmacies have served a special and important patient service 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, mixes or alters various drug ingredients in order accommodate a patient allergy, need for a liquid form, or flavoring. Some pharmacies, however, have metamorphosed into manufacturing drugs. They function as miniature drug companies and no longer specifically formulate a medication to a specific patient's need. Doctors and hospitals have turned to these "manufacturing" or "non-traditional" pharmacies because of drug shortages or lower prices compared to major manufacturers.
In 2012, a study showed that 98 percent of anesthesiologists experienced drug shortages in the past year. When a particular drug is not available, we have one of three options: Stop providing anesthesia services, utilize alternative medications that may have dangerous side effects, or attain medications from compounding pharmacies. The last option is the most logical.
However, after the fungal meningitis outbreak, a glaring light has been shined on compounding pharmacies and revealed that they fall into a regulatory and legal loophole. Trade associations that represent the sector have sidetracked attempts at regulation on the federal level. As it currently stands, regulation of compounding pharmacies fall under state boards 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, Cumberland, Atlantic, recently introduced the "Compounding Pharmacy Quality Assurance Act (S2365)," which would require all traditional compounding pharmacies in the state of New Jersey to receive accreditation from the Pharmacy Compounding Accreditation Board, or PCAB.
Even as a physician, I was not aware of the PCAB accreditation until the fungal meningitis outbreak.
PCAB accreditation is currently the "gold standard" to ensure that a compounding pharmacy meets nationally accepted quality-assurance, quality-control and quality-improvement standards.
It serves as a form of external validation. The process involves a review of facilities, equipment, records and procedures required to prepare quality compounded medications, and the program for testing compounded preparations.
It also involves verification that the pharmacy uses ingredients from sources registered with and/or licensed by the Food and Drug Administration, is not on probation for issues related to compounding quality, public safety or controlled substances, and is properly licensed in each state it does business in.
Additionally, the bill would require that any traditional compounding pharmacy in another state be PCAB accredited in order to provide medications to residents of New Jersey. Nontraditional or manufacturing pharmacies are not included in the bill because the FDA is requesting Congress to grant it powers to regulate them.
The American Medical Association has called on state pharmacy boards to require all compounding pharmacies to be accredited by the PCAB. However, until Van Drew's bill, no state legislature has attempted to enforce this.
Physicians, patients and hospitals should be able to expect and demand the drugs they prescribe or receive are sterile, stored appropriately, not expired and appropriately labeled. This bill would enhance the safety of residents in New Jersey without increasing the size of government or government spending. It is just plain common sense.
Dr. Nina Radcliff, of Galloway Township, is a member of the American Society of Anesthesiologists.