3Qs: Many questions remain in meningitis outbreak

October 18, 2012 by Angela Herring
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.

Explore further: 3Qs: New clues to unlocking the genome

Related Stories

3Qs: New clues to unlocking the genome

September 19, 2012
Last week, Nature Mag­a­zine, Genome Research and Genome Biology pub­lished 30 papers on break­through research that will change the face of genetics. After nearly a decade of searching, the Ency­clo­pedia of DNA Ele­ments ...

Mental illness and limited literacy

October 8, 2012
(Medical Xpress)—Approx­i­mately 47 per­cent of the U.S. pop­u­la­tion reads below an eighth-​​grade level, but the per­centage is sig­nif­i­cantly greater among people using public mental-​​health ser­vices, ...

3Qs: When painkillers kill

August 3, 2012
The U.S. Food and Drug Admin­is­tra­tion recently intro­duced a series of safety mea­sures designed to reduce the risk of extended-​​release and long-​​acting opioid med­ica­tions, ...

Chipping away at cancer

June 25, 2012
(Medical Xpress) -- In the last two decades, the number of deaths from col­orectal cancer has steadily declined, according to the Amer­ican Cancer Society. While some of the decrease can be attrib­uted to better ...

Recommended for you

Google searches can be used to track dengue in underdeveloped countries

July 20, 2017
An analytical tool that combines Google search data with government-provided clinical data can quickly and accurately track dengue fever in less-developed countries, according to new research published in PLOS Computational ...

MRSA emerged years before methicillin was even discovered

July 19, 2017
Methicillin resistant Staphylococcus aureus (MRSA) emerged long before the introduction of the antibiotic methicillin into clinical practice, according to a study published in the open access journal Genome Biology. It was ...

New test distinguishes Zika from similar viral infections

July 18, 2017
A new test is the best-to-date in differentiating Zika virus infections from infections caused by similar viruses. The antibody-based assay, developed by researchers at UC Berkeley and Humabs BioMed, a private biotechnology ...

'Superbugs' study reveals complex picture of E. coli bloodstream infections

July 18, 2017
The first large-scale genetic study of Escherichia coli (E. coli) cultured from patients with bloodstream infections in England showed that drug resistant 'superbugs' are not always out-competing other strains. Research by ...

Ebola virus can persist in monkeys that survived disease, even after symptoms disappear

July 17, 2017
Ebola virus infection can be detected in rhesus monkeys that survive the disease and no longer show symptoms, according to research published by Army scientists in today's online edition of the journal Nature Microbiology. ...

Mountain gorillas have herpes virus similar to that found in humans

July 13, 2017
Scientists from the University of California, Davis, have detected a herpes virus in wild mountain gorillas that is very similar to the Epstein-Barr virus in humans, according to a study published today in the journal Scientific ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.