Oklahoma Compounding Pharmacy Laws Some of Strictest in NPeople, Not Compounding, Real Issue Behind Meningitis Outbreak ation;

By L.L. Woodard | Yahoo! Contributor Network – 15 hrs ago

Jerrod Roberts, owner of Flourish Integrative Pharmacy, wants people to know that it is not the science of compounding that is behind the current U.S. meningitis outbreak, but some of the people working in the industry who are not following protocol, such as at the New England Compounding Center, NECC, at the center of the outbreak, reported NewsOK.com .

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.

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.

Source found here

Oklahoma has strict regulations for its compounding pharmacies

The topic of medical compounding has been at the center of a debate over a U.S. meningitis outbreak that has killed 33 people and sickened 480.

Compounding pharmacy technicians Jenny Brooks, left, and Estella Marler prepare medicines Friday at Sherry’s Drug in Edmond. Photo By Paul Hellstern, The Oklahoman

Lack of oversight and action have been said to be reasons why the U.S. is experiencing the worst fungal meningitis outbreak in the nation’s history.
Oklahoma pharmacy officials suggest...
View full article on Oklahoman.com
Read more: http://newsok.com/oklahoma-has-strict-regulations-for-its-compounding-pharmacies/article/3729689#ixzz2CbRSNGYT

Oklahoma Board of Pharmacy Discusses NECC at Board Meeting Today (November 7, 2012)

FOR REVIEW, DISCUSSION AND POSSIBLE BOARD ACTION:
Evidentiary Hearing on Complaints OSBP vs. New England Compounding Center, #99-722 – Case No. 1143
Proposed Executive Session pursuant to 25 O.S. Supp 2008, § 307 (B), (8); possible Board action.

To view entire agenda click here

Oklahoma gets few complaints about compounding pharmacies

By SHANNON MUCHMORE World Staff Writer 
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

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Shannon Muchmore 918-581-8378
shannon.muchmore@tulsaworld.com

Oklahoma Pharmacy Association 2012 Law Seminar

2012 OPhA Law Seminar

Please join us for our annual 2012 Law Seminar to be held on Sunday, December the 2nd from 8:00 am - 5:00pm at the OU College of Pharmacy in Oklahoma City. This program is intended for pharmacists, regardless of their practice setting who wish to increase and enhance their knowledge and skills as they relate to their knowledge of Oklahoma law. Our guest speakers include professionals from an array of law related backgrounds. I believe you'll find this eight hour program greatly informative. 

 

For more information cleck here.

Oklahoma State Board of Pharmacy Expects Compliance with USP 795 and 797

Oklahoma's State Board of Pharmacy April 2012 Newsletter has the following notice regarding compliance with 795 and 797:

12.07. USP 795/797: Compounding pharmacies are now expected to be in full compliance with United States Pharmacopeia (USP) Guidelines 795 (nonsterile products) and 797 (sterile products). These rules may be found in Section OAC 535:15-10 of the Oklahoma Pharmacy Lawbook.
Compounding pharmacists should be familiar with these regulations and act accordingly. Hazardous chemicals (which may include hormones)  must be prepared in a Class 1 biological safety cabinet.

Click here to view entire newsletter.