State legislation would tighten controls on compounding pharmacies

Compounding pharmacies in Michigan may soon operate under a system of tighter controls and regulations, and employees could face felony charges and prison sentences if patients are injured or die because the new rules are not followed.

The aim behind Senate bills 704 and 904, sponsored by Sen. Joe Hune, R-Hamburg, is to prevent the kind of injuries and deaths suffered in the state two years ago when the Framingham, Mass.-based New England Compounding Center allegedly sent tainted medicine to clinics around the country.

Michigan was the hardest hit when the tainted steroids were delivered to clinics in the state, resulting in 264 infections and 19 deaths. Nationwide, the death count hit 64 with 751 cases of fungal infections or meningitis, according to the Centers for Disease Control and Prevention.

"Hearing from constituents that have been so adversely impacted by these tainted steroids, it's the least we can do," Hune said.

Compounding pharmacies mix and assemble pharmaceuticals to create a drug or form of medicine needed by a patient.

Hune's bills would add a series of requirements for these businesses, including that accurate records of its procedures are maintained, that the pharmacies are subject to a physical state inspection once every two years and that all compounding pharmacies designate a "pharmacist-in-charge" responsible for making sure the business follows the state regulations.

The criminal penalties for violating the rules that result in personal injury include a maximum of a four-year prison sentence. A violation that resulted in a patient death would carry a maximum 15-year sentence.

The legislation would also give the state the ability to immediately suspend the pharmacy license of the business if notice was received by the CDC or the Food and Drug Administration of imminent risk to public health or safety.

Attorney General Bill Schuette's office has been working with Hune on the bill, and supports the legislation he says will protect patients and hold pharmacists accountable.

"We can never undo the damage experienced by the victims of this meningitis tragedy, but we have a responsibility to find justice and ensure this never happens again," Schuette said in a statement to Crain's. "There is nothing more important than patient safety, and our laws should reflect that commitment."

The bill received its first hearing Thursday before the Senate Health Policy committee, and several organizations testified in support of it. No one voiced opposition.

Kelly Elizondo, state assistant attorney general, said she has handled a half-dozen licensing actions involving compounding pharmacies, and the legislation could save lives.

Compounding pharmacies currently do not have to create or keep records of the calculations or formula used to fill a prescription, she said. A recent case she worked on involved a pharmacist at a compounding pharmacy who made an error when mixing components of the medication.

The pharmacist was supposed to include 0.6 grams of the active ingredient of the drug, and instead included 6 grams of the ingredient, resulting in great harm to the patient, who had to be hospitalized, she said.

The record-keeping requirements in Hune's bills would have made a difference, she said, because it would require the pharmacist to record the strength, quantity and dosage of the compounded pharmaceutical, the formula used and the mixing instructions, all ingredients, the date of preparation and the name of the person who conducted the compounding.

"If that pharmacist had the formula and had been writing down what he was doing, I firmly believe he would have caught his error, and this gentleman would have been spared hospitalization," Elizondo said. "This is a very good bill that could save patient lives."

The record keeping also would assist investigators if there was an outbreak of illness, so that it could be traced back easily to the source. Part of the problem with the tainted steroid case in 2012 was that the company in Massachusetts was allegedly acting as a manufacturer of compounded pharmaceuticals -- making batches of steroids and selling them to clinics across the country -- rather than making a specific drug linked to a prescription for a specific patient.

That practice was also found to be going on in Michigan after the Department of Licensing and Regulatory Affairs inspected every compounding facility in the state after the news came out about the tainted steroids.

Those pharmacies changed their practices, and many compounding facilities updated their facilities to make sure they were compliant with state and federal laws following the inspections, according to LARA, which supports Hune's bill.

Larry Wagenknecht, chief executive officer of the Michigan Pharmacists Association, whose organization includes those working in compounding pharmacies, said he supports the bill as do the vast majority of compounding pharmacies.

However, he said there could be unintended consequences, if some of the compounders feel the penalties are not worth the risk of operating in the state, and may get out of the business.

Sen. James Marleau, R-Lake Orion, chairman of the Health Policy Committee, said the legislation could be approved and sent to the full Senate at next week's hearing.

http://www.crainsdetroit.com/article/20140427/NEWS/304279971/state-legislation-would-tighten-controls-on-compounding-pharmacies#