November 23, 2012

Bay State loosens rule on compounded drugs

In an emergency drug shortage, hospitals may share the medications they prepare for in-house use.

The Associated Press

BOSTON - Hospitals in Massachusetts would be allowed to share compounded medications in the event of future drug shortages under an emergency rule approved Wednesday by state health regulators.

The new regulation adopted by the Massachusetts Public Health Council stems from the deadly fungal meningitis outbreak that has been linked to a tainted steroid produced by the Framingham-based New England Compounding Center.

The specialty pharmacy has been shut down and Westborough-based Ameridose, a sister company with the same founders as the NECC, has voluntarily recalled its produces and closed through the end of the year for inspection. Those actions have prompted concerns about potential drug shortages.

Currently, hospitals that compound drugs can only do so for use by their own patients. Under the new regulation, the medications could be shared with other hospitals if state health officials determine that a severe shortage exists. Officials stressed that no such crisis has been declared at this time.

Nationally, 490 patients have been sickened and 34 have died since the fungal meningitis outbreak started. There have been no confirmed reports of illnesses in Massachusetts.

Compounding pharmacies mix customized medications based on prescriptions.

In an unrelated action on Wednesday, the Public Health Council -- at the direction of lawmakers -- moved to modify a 2008 state law and allow pharmaceutical companies and medical device makers to treat doctors to "modest meals" at restaurants.

The gift ban had barred those companies from buying meals for health care providers, except within hospitals or other health care settings and as part of an educational or training session. Backers of the law said expensive restaurant meals and other gifts could entice doctors to prescribe more expensive name-brand drugs or make unnecessary equipment purchases.

Critics who pushed to relax the gift ban said the pharmaceutical and medical device industries should have the freedom to market products in Massachusetts. Restaurant owners also objected to the law, saying it hurt their businesses.

The Legislature approved a measure in June ordering state health regulators to ease the restrictions. In doing so on Wednesday, the council voted to allow modestly-priced restaurant meals but declined to give a specific dollar limit. The rule only states that a meal shouldn't cost more than what a doctor might otherwise pay if dining at his or her own expense.

Groups worried about rising health care costs expressed disappointment that the council did not provide a specific definition of what constitutes a so-called modest meal.


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