Published: 10/29/2012 2:24 AM
Last Modified: 10/29/2012 6:13 AM
Sterile compounding pharmacies in the state, similar to the one in Massachusetts that has been linked to an outbreak of fungal meningitis, are regulated by the Oklahoma State Board of Pharmacy, which has seen few complaints against them in recent years.
There are about a dozen sterile compounding pharmacies in Oklahoma and the pharmacy board has seen five complaint cases since 2006.
Twenty-five people have died and more than 300 have been sickened in 18 states from potentially contaminated steroid injections that caused fungal meningitis, according to the Centers for Disease Control.
As many as 14,000 people in 23 states have been exposed through the shots meant to ease back pain. The injections came from New England Compounding Center of Framingham, Mass.
None of them was shipped to Oklahoma, although other products from the pharmacy were sent to Oklahoma and have been recalled, according to the U.S. Food and Drug Administration.
The most serious complaint for sterile compounding pharmacies in Oklahoma in the past six years was from a 2008 prescription that was improperly mixed and caused a Paul's Valley man to go into intensive care with respiratory failure, drug overdose and aspiration pneumonia.
The state pharmacy board tries to inspect pharmacies on an annual basis. A pharmacy that creates any compound that will be injected into the body is independently tested for sterility and documentation is checked for the proper calculation of medicines, said Cindy Hamilton, chief compliance officer with the pharmacy board.
"We are here to protect the public, we're not here to protect the pharmacies," she said.
Alyssa Lees-Sanders, co-owner of The Apothecary Shoppe, a compounding pharmacy in Tulsa, said her pharmacy does not ship products to residents of other states and doesn't produce at the level of the Massachusetts pharmacy.
At The Apothecary Shoppe, batches are tested by an independent source, as well as in-house. Equipment is checked every time it is used, surfaces and air are tested and staff are qualified regularly, she said.
The workers can be seen from the front of the shop through large windows as they work. In that front room, the air is as clean as the air in an operating room, she said.
Numerous steps are taken to ensure a sterile environment where one is necessary, she said.
"We take every measure and every precaution," she said.
The company is working on accreditation through the Pharmacy Compounding Accreditation Board. It meets all the qualifications but is still going through the paperwork, she said.
The Apothecary Shoppe had one complaint from 2006 for what the pharmacy board said was filling prescriptions at higher quantities than authorized by a physician.
Lees-Sanders said they did fill some prescriptions at higher rates but it was always approved by a physician. The pharmacists, who no longer work there, didn't properly note the approval.
For example, they might have given two or three suckers to someone who had a prescription for one sucker to be refilled six times but needed extra to make it through the weekend. They would always call the physician for authorization before doing so but didn't always fill out the proper documentation of that authorization, she said.
Other complaints against pharmacies in recent years have included improper supervision of pharmacy technicians and a lack of written records.
A pharmacist in Broken Bow was placed on probation in 2006 after misfilling a prescription, submitting fraudulent billing reports, improperly labeling prescriptions and allowing a non-pharmacist to operate the pharmacy in the absence of a pharmacist.
Original Print Headline: Compounding pharmacies checked often
Shannon Muchmore 918-581-8378
shannon.muchmore@tulsaworld.com
1 comment:
It would be interesting to know how many inspections of compounding pharmacies Oklahoma Board of Pharmacy Inspectors actually conducts each year, how many complaints they receive but refer on to the FDA, and how many it refers to other state pharmacy boards.
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