In recent weeks, an outbreak of fungal meningitis has infected more than 200 people and killed 15. The infection was traced back to a steroidal injection prepared at a compounding pharmacy based in Framingham, Mass., and on Tuesday criminal investigators from the Food and Drug Administration were reportedly at the facility as part of the ongoing investigation. We asked Jack Reynolds, dean of the School of Pharmacy, to explain the symptoms of the rare disease and to address the future regulation of compounding pharmacies.
What is fungal meningitis and how is it different from the more common bacterial version? How does it affect the body, both in terms of symptoms and biochemical mechanisms?
Meningitis is a condition marked by inflammation of the membranes surrounding the brain and spinal cord. Common symptoms include headache, fever, stiff neck, weakness, slurred speech and confusion. Bacteria and viruses are the most typical causes of meningitis and symptoms often come on very quickly. By contrast, fungal meningitis is rare — seen most often in individuals with compromised immune systems — and symptoms are slower to appear following exposure.
What is a compounding pharmacy? How is it different from a standard pharmacy or pharmaceutical company? Why would doctors chose drugs from a compounding pharmacy over drugs from a more mainstream pharmaceutical company?
Compounding pharmacies are licensed by individual states, as with all pharmacies. Using approved standards of practice and following state-based regulations, licensed pharmacists in such pharmacies prepare customized medications for patients based on special needs, and in response to individual physician prescriptions. For example, some patients have allergies to the inactive ingredients in commercially-manufactured medications, such as preservatives, dyes, or need medications that are not available in the desired formulation or dose. Before the widespread availability of mass-produced pharmaceuticals, it was common for pharmacists to prepare formulations using raw materials. Even now, custom-made medications, requiring the use of special flavoring agents for pediatric prescriptions, for example, are prepared for individual patients. Because needs for compounded medications still exist, though much less so than in the past, pharmacy students are still trained to compound solid and liquid dosage forms. Additionally, some pharmacists receive specialty training to prepare injectable solutions using aseptic (sterile) techniques and under strict conditions for quality assurance.
By contrast, pharmaceutical companies are considered manufacturers and are highly regulated by the FDA. They mass-produce medications for distribution to hospitals, clinics and pharmacies.
How will this meningitis outbreak affect the federal regulation of drugs and pharmaceutical companies?
New legislation will almost certainly be advanced in response to the recent fungal meningitis outbreak. The distinction between compounding and manufacturing has not always been clear, and new regulations will likely address the differences with very specific criteria. Based upon discussions in the professional associations it is still too soon to speculate as to what the outcome will be.