As of yesterday, the meningitis outbreak linked to tainted drugs from New England Compounding Center (NECC) in Massachusetts has reached a total of 233 cases with 15 deaths in 15 states, according to MedPage Today. In response to the tragedy, many physicians are rethinking their use of compounding pharmacies, which create specialized forms of medicines, such as liquid forms of pills, The Wall Street Journal reported.
There are currently about 3,000 compounding pharmacies in the United States, up from almost none in 2000. Operating largely outside FDA regulation, compounding pharmacies have grown in popularity in response to severe drug shortages, as well as their ability to supply smaller dosages of medications than would be available from a drug company.
Laxmaiah Manchikanti, a pain physician in Paducah, Ky., told the WSJ that he had bought NECC-made vials of betamethasone, an anti-inflammatory steroid, since 2008 because the FDA-approved version was available only in single-use vials with dosages larger than the 12 milligrams he needed. By getting the smaller vials from NECC, Manchikanti said he was able to cut costs per patient. But after the meningitis outbreak, Manchikanti stopped using compounding pharmacies. "My trust was just borderline before. But personally, I won't be using a compounding pharmacy for, I guess, 20 more years," he said.
However, insiders from the compounding industry have spoken out in defense on their niche, pointing out that NECC was operating outside of its intended scope by preparing drugs for bulk, nationwide distribution, The Boston Globe reported. For the most part, compounders serve small geographic regions, preparing medications from raw ingredients to leave out potential allergens, create custom doses or prepare treatments not otherwise available.
In the wake of the meningitis outbreak, Massachusetts announced a new order requiring all compounders in the state to sign an affidavit, stating that they abide by state regulations, prohibiting compounders from mass-producing medications. Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, told the Globe that members are worried the entire field of compounding will be tainted by NECC.
The International Academy of Compounding Pharmacists (IACP) shared similar concerns, releasing a statement on Oct. 4 to raise awareness of the stringent policies and procedures employed in compounding and introduce its Compounding Pharmacy Assessment Questionnaire, a comprehensive tool for the medical community to help assess and select a compounding pharmacy.
Indeed, Tim Smyth, an anesthesiologist in the state hardest-hit by the outbreak, told the Tennessean that after receiving reassurance from its drug supplier in Arkansas that it had proper quality assurance controls in place, he would probably continue to rely on compounding to reduce costs. According to the newspaper, Smyth's practice typically pays between $15 and $20 for a multidose vial of the compounded version of the steroid, roughly half the cost for a name brand. "If you're going to lose money every time you do a procedure, you're going to stop doing it," he said.
To learn more:
- read the article from MedPage Today
- see the story from The Wall Street Journal
- here's the story from the Tennessean
- check out the story from The Boston Globe
- read the statement from IAPC