A 2012 outbreak of fungal meningitis that was traced to a compounding pharmacy in Massachusetts has made tighter regulation of those facilities – where different pharmaceuticals are mixed to create medication for specific patient needs – a major issue publicly, politically and in the world of pharmacy technology.1
Poll finds that public is concerned about compounding pharmacies
Currently, there is very little in the way of state or federal oversight of compounding pharmacies, but the public, as well as state and federal legislators, appear to be turning the corner on the issue. A recent poll conducted by the Working Group on Pharmaceutical Safety2 found that a large majority of the populace is concerned about the safety of drugs that come from these under-regulated facilities.
Nearly all of the respondents to the poll – 87 percent – said that it is very important for their doctor to inform them when they are prescribed drugs that haven’t been approved by the Food and Drug Administration. A similar majority (83 percent) wants to be notified by their doctors or certified pharmacy technicians if there is an FDA-approved alternative.
People also appear to be very worried about general oversight issues. Of the respondents, 86 percent expressed concern about the fact that not every prescription drug sold in the United States is FDA-approved, and 77 percent find it troubling that the FDA does not verify the safety, effectiveness or manufacturing quality of drugs produced in compounding facilities.
Therefore, it’s not surprising that 77 percent of the people surveyed also support legislation that would give the FDA greater authority in regulating those drugs and the facilities where they are manufactured.
“These results show overwhelming support among Americans that the federal government should provide oversight to ensure the safety of the medications that doctors prescribe,” former Wisconsin Gov. Tommy Thompson, co-leader of the Working Group, said in a statement. “Last year’s meningitis outbreak and recent troubling findings following inspections of compounding pharmacies underscore the need for legislation that meets the simple and straightforward expectations of voters.”
States taking the lead
In response to that kind of public reaction, several states – including Michigan, which was hit the hardest by last year’s outbreak3 – are exploring laws that would add another layer of oversight to compounding pharmacies.
Bill Schuette, Michigan’s attorney general, is currently working with legislators and state officials, “to ensure compounding pharmacies operating in Michigan prioritize patient health, safety and welfare,” according to a statement from Joy Yearout, a spokeswoman for Schuette.
With both government officials and a large majority of the public showing increased skepticism of the compound pharmacy industry, it looks like it will only be a matter of time before laws and standards governing them and, in turn, pharmacy technician training, experience major changes.
1 Martin, Timothy W., “Dangers From Compounding Pharmacies Persist,” Wall Street Journal, Sept. 9, 2013. http://online.wsj.com/article/SB10001424127887324324404579041001254487312.html
2 “New Poll Finds Strong Support for Effective FDA Regulation of Compounding Pharmacies,” PR Newswire, Sept. 18, 2013. http://www.prnewswire.com/news-releases/new-poll-finds-strong-support-for-effective-fda-regulation-of-compounding-pharmacies-224236631.html
3 Zaniewski, Ann, “State Officials Plan to Announce Compounding Pharmacy Legislation,” The Detroit Free Press, Sept. 19, 2013. http://www.freep.com/article/20130919/NEWS06/309190039/meningitis-compounding-pharmacies-state-regulations-Michigan