Compounding has been making headlines in the national news lately as a result of a compounding pharmacy in Massachusetts that has been linked to a serious meningitis outbreak—and 29 subsequent deaths—and the firestorm shows no signs of slowing down. On November 1, USA Today published "Harsh Punishments Rare for Compounding Mistakes" and the article gives all of pharmacy a black eye. Even though the details of this particular case reflect a specific company that has been seriously derelict, the media coverage paints pharmacy in a negative light and creates repercussions for the entire industry.
Many independent pharmacies around the country have developed compounding into a business that supports the needs of their community. These entrepreneurs are filling a market niche with specialized local service. But when a compounding pharmacy, such as the New England Compounding Center (NECC), acts as a drug manufacturer, producing drugs on a large scale, the story can change dramatically. This high-volume compounding operation endangered the public.
What kind of oversight has there been to regulate compounding pharmacies? This is done on the state level, but compared with other states, the Massachusetts pharmacy board has "suffered from a lack of transparency and efficiency," according an editorial appearing in the Boston Globe. The newspaper reported that while the state has now issued emergency regulations that tighten the oversight of compounding pharmacies, the governor has also appointed a commission to review the problem.
Already, there is a call for the federal government to step in because the state did not react appropriately or quickly enough to avert this disaster. But one must ask if this is really the best plan, especially in light of the fact that more government intervention can result in making the situation worse, not better. What about the many compounding pharmacists who are serving their patients very well with their compounding services? Just because this New England company aggressively sought to expand under extremely lax oversight, does it mean that all compounding pharmacies should pay the price with federal intervention?
Pharmacy must step up and regain the public trust with more information, more transparency, and better responses to violators. If this is not done by the states and individual pharmacists, with support from the national pharmacy associations, we can expect the situation to create policy that can only threaten the entrepreneurs in the industry. The new bill just announced by US Representative Edward Markey (D-Mass) is a case in point.
The National Community Pharmacists Association (NCPA) has weighed in on the situation, and it is worthwhile to read the association's stance. Although the NCPA acknowledges that the bill represents an identified problem, they say, "The proposed legislation also appears to create new overly board requirements on traditional pharmacy compounding that could negatively impact both patients' access to essential medications and the community pharmacists who provide them. As currently drafted, the legislation would grant powers to an already stretched Food and Drug Administration to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications they have been making safely and effectively for decades."
No doubt, pharmacists across the country will be watching the Massachusetts story closely.
Thank you for reading!
Chairman/Chief Executive Officer/President