Meningitis Outbreak could spark new legislationThe catastrophic meningitis outbreak has brought on efforts to enact new legislation regarding the inspection and regulation of compounding pharmacies. Although the states have the ultimate authority in the matter of policing compounding pharmacy practices, the FDA has been called upon to review the pharmacies that have, in the past, violated best practices.
The watchdog group, Public Citizen, sent a letter to the FDA asking that agents be sent to six compounding pharmacies that have received warning letters from the years 2003 to 2012. The violations that caused the issuance of the warning letters included:
- Creating and distributing vast quantities of drugs
- Creating and distributing drugs without individual patient prescriptions
- Fabricating copies of drugs that are commercially available
- Manufacturing drugs using ingredients that are not FDA approved
- Maintaining improperly sanitized facilities and equipment
- Employing improperly trained staff
According to the letters issued by the FDA to the offending pharmacies, there have been examples of patients being sickened or even killed by solutions of dextrose that had been contaminated by microorganisms, and one inspection uncovered a pharmacy using an ingredient found in industrial cleaners in an injectable drug.
The letter also requests that all documentation and reports concerning the inspection of compounding pharmacies be released to the public for review. This includes not only the pharmacies that have received warning letters, but all 483 reports since 2003.
There are other areas that might merit further investigation, namely Medicaid and Medicare coverage policies. Public Citizen, a nonprofit organization that acts as a people’s advocate, sent a letter earlier in November, 2012, suggesting that reimbursement policies for compounding pharmacies created by Medicare and Medicaid were actually financial incentives. Because the Centers for Medicare and Medicaid services routinely cover compounded drugs, compounding pharmacies were able to create large scale manufacturing operations that might not have been otherwise possible. According to the letter, the following areas warrant examination:
- The fact that the Centers for Medicare and Medicaid services (CMS) guidance documents prohibit covering compounded medications that have not been approved by or in violation of the FDA, yet later state that Medicare and Medicaid can continue coverage until either the FDA or CMS specifically take action against reimbursement.
- The fact that the CMS denies coverage of compounded inhalation drugs but not other large scale compounded drugs.
- The fact that some CMS carriers have approved coverage for compounded drugs that are administered near the spine by an implanted pump.
According to Dr. Michael Carome, the deputy director of Public Citizen’s Health Research Group, the CMS policies have actually encouraged compounding pharmacies to produce large quantities of dangerous drugs. “An independent investigation is necessary to determine exactly how these policies contributed to the current meningitis outbreak and to prevent a similar tragedy from happening in the future,” he says.