Compounding problems with health and safety oversight

A growing opinion -- 

OUR VIEW: Compounding problems with health and safety oversight
GateHouse News Service Posted Oct 13, 2012

  

This week, David Miller, executive vice president of the International Academy of Compounding Pharmacists, asked the question on everyone’s mind: “Who the heck at the government level was asleep at the switch?”

As of press time, 14 are dead, 184 sickened and nearly 14,000 were believed to have been exposed to fungal meningitis via spinal steroid injections developed at a Massachusetts compounding pharmacy.

What we do know is that Framingham-based New England Compounding Center was regulated by the Food and Drug Administration, but overseen by the Massachusetts Department of Public Health. DPH is the same agency which last month came under fire for its lack of oversight of a state crime lab where a chemist reportedly admitted to tampering with drug-related evidence. Numerous prisoners have already been freed and as many as 34,000 drug-related cases are in jeopardy.

As the overseer of the state Board of Pharmacy, DPH is responsible for maintaining safety standards at such facilities as compounding pharmacies. In fact, it’s responsible for oversight of well over 100 bureaus and programs across the state, including emergency preparedness and licensing of health professionals.

That’s an enormous responsibility for an agency which has seen its budgets slashed more than $3 million over five years.

Yet, budget crises or not, DPH has a moral contract with the more than 6 1/2 million residents of Massachusetts to ensure the highest standards of care.

It’s alarming that for the second time in as many weeks we are compelled to point out that it’s reasonable to expect the people we entrust to govern our state agencies to do so in a professional, conscientious and ethical manner. The deaths of 12 people and the potential for many more clearly demonstrate a failure of leadership at multiple levels.

We don’t have time to wait for a full investigation into the New England Compounding Center crisis to determine blame. Our state leaders need to act swiftly and openly to evaluate every function of DPH to ensure the standards already in place are being followed. Gov. Deval Patrick, Auditor Suzanne Bump and perhaps Attorney General Martha Coakley must move decisively and immediately.

This is a matter of public trust, now waning in light of the Patrick administration’s seeming lack of strict oversight of DPH.

It doesn’t appear as if anyone at the state level has publicly taken command of this latest investigation, but perhaps that’s because no one is in charge at DPH. In fact, on its website it still lists John Auerbach as commissioner, nearly four weeks after he resigned amid the crime lab scandal.

The public deserves reasonable assurance that something as simple as the medicines prescribed to us and the food we put into our bodies are safe. Because if everyday preparedness isn’t being met by DPH, the public can’t be expected to put much stock in DPH’s ability to protect in a natural disaster requiring emergency preparedness.

On the national level, U.S. Rep. Ed Markey, D-Mass., has written to the commissioner of the Food and Drug Administration requesting clarification on the role of the federal government in overseeing compounding pharmacies.

It’s important to know what the standards are and if they’re being met. We ask the same of the governor, Secretary of Health and Human Services JudyAnn Bigby and others at the state level when it comes to the Department of Public Health.

What processes should be followed regarding compounding pharmacies, and were they? What other public health oversight responsibilities need to be reviewed or revamped? Who is in charge?

All of this should be done with urgency and as much transparency as possible to assure the public that the integrity of the system can be relied upon.

Without such minimal assurances, we’ll know who was — and is — asleep at the switch.


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