Monday, December 10, 2012

Massachusetts Department of Public Health conducting inspection of pharmacies in wake of meningitis outbreak;on December 10, 2012 at 7:40 PM

By Jim Kinney, The Republican 




SPRINGFIELD – Thirty-five pharmacies around Massachusetts say they prepare injectable medications under sterile conditions according to responses generated by stateDepartment of Public Health’s recent efforts to get its arms around the state’s compounding pharmacy industry.

Dirty conditions at the New England Compounding Center in Framingham are blamed for a nationaloutbreak of meningitis that that killed 36 patients and sickened more than 500 others.

But before the New England Compounding Center debacle became public, the state didn’t know which pharmacies were making injectables and had no good way of finding out.

“That isn’t data they ever collected before,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association. “I’m not sure why that data was never collected. but they just didn’t have it.”

The Department of Public Health released the list of 35 Monday in response to a freedom of information request filed by The Republican Nov. 14. The list includes four local pharmacies: Baystate Home Infusion, located in Springfield and part of Baystate Health, IntegriScript Pharmacy, McClelland Health System and Western Massachusetts Compounding which are located in West Springfield.

IntegriScript is part of Berkshire Healthcare and exclusively serves Berkshire Healthcare’s network of nursing homes and senior living communities, according to its website.

The state has conducted unannounced inspections at about half the 35 pharmacies on the list, said David Kibbe, a spokesman for the Department of Public Health. but Kibbe wouldn’t say Monday which pharmacies had been inspected and which have not.

Last week, the state took action against three of the 35 pharmacies on the list for having failed those inspections. OncoMed Pharmaceuticals in Waltham Pallimed Solutions Pharmacy in Boston and The Whittier Pharmacist in Bradford.

Kibbe said that the state is, at least for now, relying on voluntary statements from pharmacies who responded to a state request for information after New England Compounding’s role in the he outbreak became known.

“That’s not to say that if we find out that someone is doing the injectables and not telling us we wouldn’t do an unannounced inspection,” he said.

Kibbe wouldn’t say if that was something that actually happened or just a hypothetical.

Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said the inspections are talking longer than the state had expected. At the outset, the state said every pharmacy doing sterile injectables would be inspected by the end of this month. Now, he said the estimate is that the inspections will be done in sometime before March.

Clark E. “Skip” Matthews, president of Louis & Clark , a compounding pharmacy in Springfield that doesn’t do injectable drugs said the state can inspect any pharmacy at any time. It is part of the pharmacists license.

“My understanding is they don’t have many inspectors and that’s been part of the problem,” Matthews said.

As it stands now, pharmacies are only inspected at three points in time: when they open, when they expand and if there is a complaint.

Louis & Clark makes custom medications to meet patient specifications, often placing drugs in a lozenge form so someone who can’t swallow pills can get the medicine. Or a compounding pharmacy might make a medication without a dye to which the patient is allergic.
By contract, New England Compounding Center was making multiple doses and shipping them out of state.

Dr. Lauren A. Smith, interim state commissioner of public health said most states inspect on the same frequency, but more inspections is one of the reforms that state is considering.

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