3Qs: Many questions remain in meningitis outbreak

October 18, 2012 by Angela Herring, Northeastern University
Jack Reynolds, dean of the School of Pharmacy, discusses the recent outbreak of fungal meningitis, which was traced back to a compounding pharmacy in Framingham, Mass. Credit: Brooks Canaday.

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. Northeastern University news office 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.

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