Closing the barn door after the horse has escaped doesn’t help those it might encounter, but it does protect people from the many other horses that remain in the barn. This is analogous to what’s going on with compounding pharmacies in Florida and Massachusetts, now that the unsanitary conditions of the New England Compounding Center , NECC, have been linked to the current fungal meningitis outbreak.
Massachusetts Takes Action Against Compounding Pharmacies
The New York Times reported that after Massachusetts’ health officials performed surprise inspections at some of the compounding pharmacies located in the state, the Waltham, Massachusetts-based Infusion Resource voluntarily surrendered its license over the weekend. The license surrender followed an Oct. 23 inspection that found the environment in which medications were being made revealed sanitation issues and perhaps as importantly, this pharmacy had been administering intravenous medications to patients, a clear violation of their license.
Infusion Resource is the third compounding pharmacy in the state to have its license suspended.
Florida Takes Action Against Compounding Pharmacy
Rejuvi Pharmaceuticals was the first compounding pharmacy in Florida to have its operations suspended after an inspection of the facility by the Florida Department of Health, according to Reuters . State officials visited Rejuvi Pharmaceuticals on Oct. 26 as part of a routine inspection rotation and found a number of violations, ranging from cleanliness of areas related to medications to record keeping issues.
Role of Compounding Pharmacies
A compounding pharmacy’s main role is to make a drug or drugs as prescribed by a physician for a specific patient. These prescriptions may call for formulations or dosages of medications not available through the usual route from drug manufacturers.
As WebMD explained, perhaps a person is allergic to an ingredient in a manufactured medication. The compounding pharmacy would create the needed medication absent the allergy-causing ingredient. When a specific strength or dose is not available in manufactured medications, a compounding pharmacy is called upon to create what is necessary for that prescription, for that patient.
Where NECC Fell Short
In addition to the unsanitary conditions at NECC, in addition to the pharmacy violating its own regulations of awaiting test results on purity of product before that product is shipped, the NECC erred in manufacturing and distributing vials of medication that were not patient-specific in nature, such as the three lots of recalled methylprednisolone acetate linked to the fungal meningitis outbreak.
Bottom Line
No one is suggesting that compounding pharmacies shutter their doors, because the role their products play in health care is an important one. Compounding pharmacies have thus far escaped the same scrutiny and standards to which standard pharmaceutical companies are held. In Massachusetts, for instance, according to the Associated Press, a compounding pharmacy is inspected when it opens, if it moves, or if a complaint is received about it.
More inspections and improved regulations may prevent another public health dilemma, but improved vigilance will also cost more money. That may be the sore point with taxpayers/consumers.
Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of “The Red Man” state. With what he hopes is an everyman’s view of life’s concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.
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Compounding Pharmacies Feeling the Effects of NECC’s Errors
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Compounding Pharmacies Feeling the Effects of NECC’s Errors
