Compounding Scrutinized After Large-Scale Meningitis Outbreak

A recent outbreak of meningitis tied to a compounded drug raises concerns about the scope of the practice of pharmacy compounding and prompts legislators to push for increased FDA authority over these products.

A national meningitis outbreak linked to contaminated drugs from a specialty pharmacy in Massachusetts called The New England Compounding Center (NECC) has reportedly caused a total of 19 deaths in 15 states, with most of the cases occurring in Tennessee.

The steroid associated with the outbreak—a preservative-free methylprednisone acetate—was used as an epidural injection to treat back pain or neck pain. The pathogen responsible for many of the cases is reportedly a rare fungus called Exserohilum, although initially, the infection was thought to be caused by another fungus, Aspergillus. The meningitis involved in the outbreak is not contagious, according to health officials.

MedPage Today reports that 3 lots of nearly 17,700 vials of the steroid were shipped to 75 clinics in 23 states. These products, along with all other products made by the specialty pharmacy, have since been recalled. The center has been shut down and has surrendered its license—but according to the Centers for Disease Control & Prevention, 247 people have already been affected by the contaminated vials. At least one of the sealed vials from the compounding pharmacy contained a particulate that was visible to the naked eye, according to reports. State and federal officials have been faced with the task of alerting the nearly 14,000 people who may have been given the drug. Tennessee health commissioner John Dreyzehner, MD, told reporters in a press conference that patients treated between June 27 and September 28 with the steroid should be alert for the symptoms of meningitis, including fever, headache, nausea, and slurred speech.

On Monday, October 15, 2012, the FDA announced that 2 more drugs manufactured by the NECC are suspected to have caused meningitis infections. One of the patients who contracted meningitis had an epidural injection of triamcinolone acetonide and there was 1 report of fungal infection with Aspergillus fumigatus in a transplant patient who was given a cardioplegic solution made by the company.

The negative news coverage surrounding the outbreak has led many to question the lack of regulation surrounding the practice of compounding. "The incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," stated a letter from Reps Henry A. Waxman (D, CA), Diana DeGette (D, CO), and Frank Pallone, Jr (D, NJ) to Energy and Commerce Committee Chairman Fred Upton (R, MI), Health Subcommittee Chairman Joseph Pitts (R, PA), and Oversight and Investigations Subcommittee Chairman Cliff Stearns (R, FL).

The federal officials acknowledge the value of the practice of compounding later in their letter to the Energy and Commerce Committee, writing, “Compounding pharmacies can serve an important public health function by mixing or altering medications designed to fulfill special needs of individual patients—such as when compounders create new dosage forms for children or others who cannot tolerate the FDA-approved dosage forms.” However, they also request an investigation and hearings on the meningitis outbreak. A full list of the questions the representatives feel deserve investigation is available here.

Reps Waxman, DeGette, and Pallone wrote that while prior court cases have raised questions about the FDA’s authority to regulate compounded drugs, pharmacy compounding is a practice that should only be used in limited instances.Congress "did not intend for a compounding pharmacy to be permitted to operate as a small drug manufacturer," they wrote. Citing figures from The New York Times, the representatives allege that providers may have had a "significant profit motive" to use the compounded product from NECC, as the pharmacy was selling the drug at a price as much as 45% lower than the FDA-approved manufacturer version, even though the reimbursement rates for both the compounded and FDA-approved version were the same. Two of the manufacturers of the generic version of the drug had stopped making the drug, according to a separate article from The New York Times, so there were few options available besides the branded and compounded versions.

States currently oversee compounding pharmacies, but Rep Edward J. Markey (D, MA) said he plans to introduce legislation that would ban the use of ingredients not approved by the FDA and require pharmacies that send products across state lines to register with the agency. In addition, a provision of the legislation would warn patients that compounded pharmaceuticals have not been approved as safe and effective by the FDA, according to reports from the Associated Press.

The International Academy of Compounding Pharmacists estimates that 2% to 3% of prescriptions in the United States are compounded prescriptions for individual patients. The Pharmacy Compounding Accreditation Board (PCAB) provides an additional level of quality assurance recognition for sterile and nonsterile compounded preparations, but of the nearly 3000 sterile pharmacies in existence, only 162 of them are accredited with this organization, according to reports. In an official statement from The International Academy of Compounding Pharmacists, NECC was identified as not being a PCAB-accredited pharmacy.

To address questions about the safety of compounded medications, the medical community can use IACB’s comprehensive tool, the Compounding Pharmacy Assessment Questionnaire (CPAQ). The checklist is available here. For expert advice about compounding from Cynthia Reilly, director of the practice development division for the American Society of Health-System Pharmacists, see this list from The New York Times.

Watch the below video from MSNBC for details about the outbreak:

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