The state has determined that none of the Connecticut patients who got injections of a recalled medication linked to a multi-state outbreak of fungal meningitis have the disease.
Officials with the state’s Department of Public Health said they are working with the only medical practice in Connecticut that received shipments of the tainted medication – Interventional Spine & Sports Medicine, PC in Middlebury – and that the 39 patients there who were injected with it are being monitored. So far, none of them show signs of the illness.
The facility is one of approximately 75 in 23 states that received the recalled medication. Click here for a detailed listing from the Centers for Disease Control and Prevention.
Fungal meningitis is not contagious but can be fatal. Several people have fallen ill with the disease since being injected with the tainted epidural steroid prepared by a New England facility and five have died, the CDC reports. Some have also suffered strokes that are believed to have been caused by the medication.
Click here for more information about the multistate outbreak.
Compounding of drugs always has been recognized as being most appropriately regulated by the triad of doctor, patient and pharmacist, with pharmacist practice overseen by the state. When a pharmacy compounds a product in mass quantities unrelated to the traditional prescriber/patient/pharmacist triad central to compounding, its activity is more akin to that of a drug manufacturer and the traditional justifications for exempting compounding from new drug regulation become less persuasive. Unfortunately such mass production is precisely what happened in the recent meningitis outbreak. The issue was NOT a lack of legislation; the issue was that the state of Massachusetts and the FDA did not enforce EXISTING laws, guidelines and inspections. The FDA's existing guidelines for regulating compounding are here: http://www.fda.gov/OHRMS/DOCKETS/98fr/02D-0242_gdl0001.pdf Perhaps the next time a crisis hits, before shooting off her mouth, DeLauro should take a break from the Georgetown cocktail party circuit and actually study our existing laws: something our paid-for-with-your-taxes legislator is SUPPOSED to be doing. Better yet, in November voters should replace this multimillionaire, party-going careerist with Wayne Winsley—so we have a Representative who actually will work for a living.
Thus compounding is a professional practice most appropriately regulated at the state and professional level. Doctors and pharmacists are licensed by state regulatory bodies and must follow state regulations in order to maintain licensure and good standing. These regulatory authorities can discipline at a professional level or at a criminal level based on the type of violation at issue. These professionals are also guided by professional organizations such as the American Medical Association and the American Pharmacists Association. Likewise, pharmacists traditionally have been regulated by the states that license them. State pharmacy boards have the power to discipline by fine, license revocation, or criminal prosecution. Do your job, Rosa--and study the law.