Oklahoma Protects the Public with Strict Regulations for Pharmacies
Loyd Allen, editor-in-chief of the International Journal of Pharmaceutical Compounding headquartered in Edmond, Okla., and a pharmacist of 50 years duration, has been active in helping the state's legislators develop policy and regulations for pharmacies over the years. Regulations have been in place for 40 years requiring pharmacists practicing in Oklahoma to take continuing education classes in order to renew their licenses, long before most other states put the mandate into practice.
Air quality must be monitored in the state's compounding pharmacies, and monitor specific parts of a facility for microorganisms. Allen explained to NewsOK.com that all the regulations would mean nothing if there weren't inspectors to monitor facilities' adherence to the standards. Allen also told the news source that had the U.S. Food and Drug Administration had closed the NECC in 2006 when poor adherence to sanitation standards was present, the current fungal meningitis outbreak would have been averted.Why Do We Have Compounding Pharmacies?
In the 18th and 19th centuries, all pharmacies were compounding pharmacies; there were no pharmaceutical manufacturers. But as the population grew and the demand for prescription medications increased, pharmaceutical companies emerged and grew, reducing the need for the corner druggist to compound all his customer's prescription drugs.
Allen explains though that as the big pharmaceutical companies grew and merged, there were some drugs still needed but no longer manufactured. Couple that with the growing number of medications for which there is a shortage each year, and you can see the continued need for compounding pharmacies.
A compounding pharmacy is regulated to manufacture, package and distribute medications prescribed by a physician for a particular patient. What NECC was doing, in addition to having unsanitary conditions, was manufacturing and distributing medications in mass quantities, overriding its licensure requirements.Fungal Meningitis Outbreak 2012 Victim Count Continues to Rise Oklahoma is not one of the 19 states that received shipments of NECC's tainted drug to its outpatient facilities. Meanwhile, in states such as Michigan, Tennessee, Virginia and Florida, nearly 14,000 people exposed to potentially tainted spinal and joint injections wait and watch for symptoms that may or may not develop.
The case count for fungal meningitis is now 490, with 34 resultant deaths and 11 cases of peripheral joint infection.
A number of people who have developed the fungal infection are considering, or have already filed lawsuits, according to PRweb . Congress continues to delve into exactly how this public health disaster occurred and the FDA has asked for additional regulations to increase its authority over compounding pharmacies nationally. ~yahoo.com~