State pharmacy regulators across the country are moving to strengthen their oversight of compounding pharmacies like the one in Framingham that has been blamed for a deadly outbreak of fungal meningitis in 19 states.
The Massachusetts pharmacy board, whose failure to ensure safe practices at New England Compounding Center was highlighted in two days of legislative hearings this week, has enacted emergency regulations and begun surprise inspections. Ohio and Texas have stepped up inspections in their states, Florida pulled the license of a pharmacy with a history of past problems, and several states have created task forces to revamp their rules.
Comments
To have each of the 50 states investigate, discuss, craft legislation potentially setting different guidelines and upholding different standards bodies, get it passed (or not), form or upgrade regulatory boards, investigate, intermediate, sanction, is nuts. This cries out for federal legislation and regulation -- to ensure safety, and also efficiency.
Federal (CMS) legislation and regulation already exists!!!!!!!!!!!!!!
Mr. Wallack got past the Globe's wall of silence--to make some phone calls outside Greater Boston. He has written one of the Globe's few soundly researched articles in years on an issue of national scope. Other news sources have reported that about 3,000 state-licensed pharmacies in the U.S. are performing large amounts of compounding and are shipping products across state lines.
Mr. Wallack could have helped by asking the pharmacy boards he contacted in California, Texas, Florida, Ohio, Virginia and Massachusetts how many such pharmacies they license and how many of those they have inspected in the past year and the past three months. Our guesses would be that most state pharmacy boards lack accurate information about compounding pharmacies and that few have been inspecting more that tiny fractions of those pharmacies.
Mr. Wallack might have done even better by comparing the stringency of federal standards and inspections with those of the states on which he reported. Stories from other news sources suggest that many states resemble Massachusetts in tolerating unapproved and unsanitary practices, For such an investigation, Mr. Wallack would need help from someone expert with pharmaceutical laboratories and their regulation--another knowledge barrier at the Globe.
Bolons - you are both right & wrong: Mr. Wallack could have obtained and reviewed many, many CMS studies with statistical proof of Massachusetts DPH record of poor regulatory supervison in comparison with other states:
- The Globe reported CMS statistics of MA having the highest number of Psychotrophic medications administered in MA nursing home, compared with other states,
- The CMS provided statistics that showed MA regulators of nursing homes documented fewer resident pressure sores, than the Nursing Homes self-reported to CMS (makes no sense).
However, the state employment system is complicated with Administrators who have risen far above their level of competence, don't understand their job, & want to avoid 'rocking the boat.'
Look, you could add ten new agencies and twenty new laws to address this problem but the simple fact of the matter is that there are laws and agencies ALREADY in place to deal with this. The problem (and always will be) is that people charged with performing this task ARE NOT DOING THEIR JOB. Adding another layer of beaurocracy to an already existing layer of waste is not going to help one bit (except cost more taxpayer monies). Holding "public servants", and I use that term loosly, accountable for doing what they are paid to do would help in many many ways. Oh well, I can dream can't I after all I do live in Mass. where incompetance and corruption is a way of life.
These regulators are not doing their jobs because they have been captured by the industry they regulate (a far too common event in general). As indicated in the article, the industry group for compounding pharmacies has worked very hard to prevent additional regulation. These two facts are not unrelated.
And I thought regulation was a bad thing!
The issue here in Massachusetts is, the DPH ignored their responsibility to follow the LAW and the Regulatory Requirements provided by the Centers for Medicare & Medicaid.
This begs the question, are the Massachusetts DPH Administrators "qualified?" Do they understand that if a tainted, unsanitary, substance is injected into a person - that this is not a good thing?
States have regulations which were developed by CMS & the state itself! BUT- DPH ignored complaints, and letters of warning.
In the U.S. there are 30 deaths and 419 persons diagnosed with Meningitis.
There is talk of civil action with possible jail term for state employee Annie Dookhum: What about the DPH administrators who chose to ignore their responsibilities to protect the health of the public?
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