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How many more deaths is it going totake to convince our congressional leaders to do what should havebeen done about a decade ago. Compounding pharmacies have lobbied solong and hard on Capitol Hill that they have been able to remainunregulated. This is a little-known fact about the pharmaceuticalindustry and how they have been able to operate without supervisionfor so many years and out of sight of the public. The pharmaceuticalindustry through their compounders has been able to lobby againstregulation oversight and impress the politicians and their staffersfor the need of compounding.
If congress does not act, some groupsmay be able to if they follow actions by Sandra Fusco, director ofpatient advocacy at Allergy & Asthma Network Mothers ofAsthmatics. She took on the Compounding Industry and succeeded inforcing them out of the nebulizer drug business. When the nebulizerswere found out to have contamination and poor potency, she and hersupporters succeeded in getting insurers not to reimburse forcompounded nebulizer drugs. This may be one way to force compoundersto correct their errors. Don't take this to the bank as thecompounders are well established on Capital Hill and know how tobring in people to plead their case for drugs not otherwise availablein regular channels.
Even some of our well-known hospitalsare not ordering medications from certified pharmacies. John HopkinsUniversity had scientists investigate bacterial infections in sixintensive care unit patients. They traced the infection tocontaminated fentanyl from a compounding pharmacy. The trouble isthey assumed any drug bought in large quantities by a healthcarefacility comes from an FDA-approved and licensed manufacturer. Whenthis information was shared with the hospital pharmacists, they saidthey could not stop ordering from compounders: they were the onlysource of the fentanyl doses the ICU needed.
Even with deaths from medicationsreceived from compounding pharmacies, only 162 of several thousandcompounding pharmacies have become accredited. In order to obtainaccreditation, an on-site inspection is made to assess workers'competence, equipment, record keeping, air quality and clean-roomqualities meet certain standards. Even this has not made the marketdemanding accreditation. Who pays the price for this lack ofoversight – the patients of course!
“Now, as thedeaths and illnesses mount from fungal meningitis linked to acontaminated steroid injection, the question of why early concernsabout pharmacy compounding did not change U.S. law is a top focus forpatients, regulators and lawmakers.”
The FDA has traced the steroidinjections to New England Compounding Center, or NECC, a Framingham,Massachusetts compounding pharmacy founded in 1998. Unfortunately,this is just the tip of the problem with much wider implications. Itis highly doubtful that this will bring about actions necessary tobring these compounding pharmacies under FDA control or evenoversight. We don't know how much is being funneled into campaignsto insure no legislation will result.
You can be sure that once the electionsare over, lobbying will begin in earnest and these compoundingpharmacies will go to their people that rely on their compounds tolobby on their behalf. This problem with the compounding pharmaciesis one that I hope Congress will finally do something to bring themunder supervision and closer regulation. I nothing more stiffpenalties need to be imposed and I am not suggesting a few thousands,but a minimum of half a million since these compounding pharmacies akilling people because keeping equipment sterile seems to take secondplace to profits.
Other information can be read hereabout a congressional representative calling on the Department ofJustice to conduct an investigation into whether NECC violatedfederal laws designed to stem illegal activity in controlled drugs. Then this article discusses some of the other compounds involved inthe meningitis outbreak by NECC.
And now there is new information about the sister compounding pharmacy in Westborough,Massachusetts. This compounding pharmacy, Ameridose, has issued a recall of all its products in cooperation with the FDA investigation because of sterility issues.
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