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Lawmakers seek more oversight of compound drugs after meningitis outbreak

Posted On: Oct. 10, 2012 12:00 AM CST

A couple of U.S. lawmakers say they will introduce legislation aimed at increasing the oversight of compound pharmaceuticals, which have been linked to the deadly meningitis outbreak.

In the workers compensation industry, compound drugs have faced scrutiny for driving up prescription drug expenses. Compounding refers to the preparation of prescription medications by doctors and pharmacies to meet unique needs patients may have for customized drugs.

According to the U.S. Centers for Disease Control and Prevention, at least 11 deaths and 119 cases of meningitis across 10 states are possibly linked to a compounding facility in Framingham, Mass., that distributed epidural steroid injections used to treat back pain.

Some of the 76 health care facilities across 23 states that received the potentially contaminated drugs from New England Compounding Pharmacy Inc. treat workers comp claimants among other patients.

On Tuesday, Rep. Rosa DeLauro, D-Conn., announced she will introduce legislation to strengthen the U.S. Food and Drug Administration's authority to ensure the safety of drugs from compounding pharmacies

“These pharmacies are intended to create customized versions of medicine for specific patients, not bulk production of medications, such as the estimated 17,000 steroid injections tied to the outbreak,” the congresswoman said in a statement. “Currently the pharmacies are licensed and overseen by a patchwork of state agencies and the FDA's guidance to states on licensing such pharmacies was last updated in 2002.”

Also on Tuesday, Rep. Edward J. Markey, D-Mass., criticized compounding pharmacies and said he, too, will introduce legislation calling for increased oversight.

But the Missouri City, Texas-based International Academy of Compounding Pharmacists said in a statement that compounding is a valuable part of traditional pharmacy practices that is regulated by organizations such as the FDA and state pharmacy boards. The IACP represents more than 2,700 pharmacists, technicians and members of the compounding community.

Several reports have tied doctor-dispensed or compound drugs to rising workers compensation pharmaceutical costs.

Some states have taken action to curb those expenses. California Gov. Jerry Brown, for example, recently signed a measure that will bring compound drugs under the state pharmacy fee schedule for workers compensation claims.