BLANCHARD — A few months after a nationwide fungal meningitis outbreak linked to contaminated drugs, the U.S. Food and Drug Administration launched an investigation into several compounding pharmacies, including one in Oklahoma.
Lowlyn Pharmacies, a Blanchard pharmacy that operates under the name Red Cross Drug, is one of about 30 pharmacies across the U.S. that were cited in an FDA investigation of facilities that the federal regulatory agency says are operating outside the realm of traditional compounding pharmacies.
“The recent tragic fungal meningitis outbreak linked to a contaminated compounded drug has shed a harsh but important light on an area that state and federal regulatory authorities have struggled to effectively oversee for years,” FDA spokesman Christopher Kelly said in a statement. “In light of the outbreak and other past events involving compounders, the FDA will continue to use its existing authorities we have to protect consumers.”
Kelly could not comment specifically on Lowlyn Pharmacies, for the FDA's investigation is still pending. Employees at the pharmacy declined to comment.
Compounding pharmacies provide specialized drugs for patients, who among other reasons, might have an allergy to a certain ingredient in a drug or need a drug that's unavailable because of a drug shortage.
Kelly said the FDA does not want to limit traditional compounding pharmacies but rather “nontraditional” compounding pharmacies that produce large amounts of drugs that aren't created for a specific patient.
This was the case in the compounding pharmacy behind the outbreak.
In September, the New England Compounding Center began its recall of steroid injections that were determined contaminated and causing patients to develop fungal meningitis. The compounding center was producing large amounts of compounded drugs and shipping them out of state.
The first lot of contaminated steroid injections was produced from the New England Compounding Center in May, according to the Centers for Disease Control and Prevention. Nineteen Oklahoma medical facilities were customers of the New England Compounding Center, according to FDA records.
The outbreak has sickened at least 720 people and killed 48. No one in Oklahoma has been reported sick or to have died because of the outbreak.
Earlier this year, the FDA investigated about 30 pharmacies nationwide in what Kelly said is the first round of this type of investigation. Depending on the result of these investigations, the FDA could expand its list of pharmacies to check into.
Red Cross Drug's compounding practice was founded by Harvey Ahl, who was a pharmacist for several years, and is now owned and operated by his son, Jeff Ahl, according to the company's website.
In their report on the Blanchard pharmacy, FDA investigators made 12 observations, noting the pharmacy's staff lacked proper training, did not wear proper gowning while at work and did not use proper sterilization techniques, according to the report.
Cindy Hamilton, at the state Board of Pharmacy, said Lowlyn Pharmacy has not come before the board and is not scheduled to be disciplined on Thursday at the board's April meeting.
Larry Kirkpatrick is listed in the state Board of Pharmacy's online database as the pharmacist in charge at Red Cross Drug. He is in good standing with the board and has no disciplinary actions listed against him, according to the database.
Lowell J. Ahl is listed in the FDA's report as the president of Lowlyn Pharmacy. He is a pharmacy technician and in good standing with no prior disciplinary actions, according to the state Board of Pharmacy's database.
In 2004, the FDA investigated the pharmacy and cited “significant violations of the Federal Food, Drug and Cosmetic Act.” The FDA's letter to Lowlyn Pharmacies cites concern over veterinary drugs compounded without an animal identified to receive treatment and drugs compounded that duplicate drugs available on the market.
Kelly said the pharmacy was operating outside the realm of services a compounding pharmacy is supposed to provide.
“What we view as nontraditional compounding occurs when a compounded product is intended to be sterile and the compounding is done in advance or without receiving a prescription and when (the pharmacy) ships compounded product across state lines,” he said.
A debate currently exists among pharmacists about whether the FDA investigated these pharmacies to be more comprehensive in their approach or because the agency needs to show the public it's doing something in light of the fungal meningitis outbreak.
Loyd Allen, the editor of the International Journal of Pharmaceutical Compounding, said he believes a large part of it is the latter.
One of the important services that compounding pharmacies provide is producing drugs that are not available because of a drug shortage, he said.
“What has really complicated the system of health care is the drug shortage issue, and so you've got hospitals all over the U.S. trying to buy medications for their patients, and they're not available,” Allen said.
In 2011, there were about 270 drugs facing shortages. Whenever there's a drug shortage, a compounding pharmacy is allowed to make that drug to help increase access.
But a gray area exists around what a compounding pharmacy can and cannot do when there's a shortage for a drug, he said.
“Pharmacies have tried to fill the void, and most of them are doing a great job, no question, but what we hear mostly about is those that don't, and for those that don't, there are some issues because they're either not properly trained or not abiding by the standards that are set,” he said.