After the New England Compounding Center meningitis outbreak incident that killed 64 and injured and sickened 751 people, the Massachusetts State Pharmacy Board has gone from almost having inexistent pharmacy inspections to unveiling a new plan to monitor all pharmacies across the state.
As we know, most states don’t have the funding or enough inspectors to regulate pharmacies like they should. Additionally, most inspectors that are sent to monitor compounding pharmacies don’t have the training they need to know how to regulate compounding pharmacies. In fact, according to a Boston Globe article, some state inspectors testified at a public hearing after the meningitis outbreak that they didn’t have the experience needed to be able to effectively monitor compounding pharmacies.
Because compounding is the riskiest type of pharmacy practice since pharmacists mix and customize drugs, those who inspect compounding pharmacies in Massachusetts will now be required to have specialized training. “If they aren’t trained properly, they don’t know what they are looking at,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association.
How the New Legislation Will Benefit the Public
The new law that will require inspectors who monitor compounding pharmacies to have some training also requires that one pharmacist with experience in compounding will join the state’s pharmacy board. By giving inspectors special training and having someone on the board with compounding experience should help the board regulate compounding pharmacies better.
Not only will better regulation of compounding pharmacies help protect the public, but the new plan also includes monitoring hospital pharmacies—which have never before been subjected to regulation by the state’s pharmacy board. The Massachusetts State Pharmacy Board is hopeful that through the regulation of hospital pharmacies plus better regulation of compounding pharmacies, patients will be better protected. “This potentially can be a model for the rest of the country,” said Todd Brown.
The new law also established:
- Expanding the board from 11 to 13 members, and 8 of the members will be pharmacists.
- Inspectors to conduct planned and unplanned inspections of compounding pharmacies.
- New fines for pharmacies not in compliance with the law.
- Reporting adverse drug events to the FDA.
Although many state pharmacy boards across this nation are looking to strengthen patient safety, pharmacy errors still occur. If you have been the victim of a pharmacy mistake, you should order a free copy of our report, How to Make Pharmacies Pay for Injuries Caused by Medication Errors.