Legislation introduced in Massachusetts will address the reform of compounded drugs. Compounded drugs are readily available but are not subject to the approval of the Food and Drug Administration (FDA). Compounded drugs are theoretically designed for the special needs of a particular patient and are usually mixed by specially trained pharmacists. For example, compounded medications are used when small doses are required for babies and children, or for patients who are allergic to some of the ingredients found in regular medicines.
However, because they are not subject to the same level of scrutiny as most prescription medications, compounded drugs are often used in place of other medications. Additionally, compounded drugs are not usually associated with the same price limits for workers’ compensation so there is a financial incentive to use them.
In light of the recent meningitis outbreak, and the apparent errors by the New England company that produced the tainted compounded drugs, the Massachusetts governor, Deval Patrick, announced that he is filing legislation to both reform the Pharmacy Board and to improve oversight of the compounding industry within the state.
Proposed Legislative Reforms Addressing Compounded Drugs
- requires companies that compound drugs to have a special license,
- authorizes the Pharmacy Board to assess fines against Massachusetts licensed pharmacies,
- requires licensure for out of state pharmacies that do business in Massachusetts, and
- establishes a process for restructuring the Pharmacy Board.
The Governor also announced his support for a bill that raises the fine from $1,000 to $250,000 when a company is found to be guilty of wrongdoing. In addition, he will direct the Department of Public Health (DPH) to increase its’ inspection staff at the Board of Pharmacy. Inspectors will be required to be pharmacists with at least five years of experience, and to have additional training in sterile compounding practices.
The outbreak of meningitis was the result of tainted vials of medication that were used in epidural steroid injections. The injections were given primarily to patients with back pain. The New England Compounding Center (NECC) was ultimately blamed for the outbreak and has since filed for bankruptcy. According to the Centers for Disease Control and Prevention’s (CDC) latest figures, there have been 620 cases of meningitis that have been tied to the outbreak, which began in September. The cases were found in nineteen states with the highest case count (223) in Michigan.
Although the CDC did not identify patients that were on workers’ compensation, undoubtedly they were included in some of the individuals that were affected.