State board says it can regulate compounding pharmacies

Board beefed up standards in recent years

November 18, 2012|By Andrea K. Walker, The Baltimore Sun

The state board that regulates Maryland pharmacies like the Massachusetts firm under investigation in a national fungal meningitis outbreak said it can adequately oversee so-called compounding pharmacies, despite cries from critics that the federal government should have more authority.

The Maryland Board of Pharmacy said last week that in the last four years it has beefed up oversight of compounding pharmacies, which make drugs not sold commercially. New safeguards including random, annual inspections would make it hard for a Maryland facility to reach the level of contamination problems found at the New England Compounding Center, said Laverne Naesea, the board's executive director.

The 19-state fungal meningitis outbreak that sickened 438 and killed 32 is linked to three lots of steroids mixed at the New England Compounding Center. In Maryland, 23 people have been sickened and 1 has died. Federal investigators found mold, bacteria and other contamination problems at the facility.

The case prompted calls to give the Food and Drug Administration more authority over the regulation of the facilities, which are now under the jurisdiction of state boards. Some lawmakers and advocacy groups have argued the state boards don't have the resources to guarantee the safety of compounding pharmacies.

While no place is totally immune from harm, what happened in Massachusetts is unlikely to occur in Maryland facilities because of the safeguards that are in place, Naesea said. New England Compounding acted more as a large manufacturer, which is against state law, she said. Investigators in Maryland would be able to see signs of a company becoming too large, she said.

Inspections should also catch problems with cleanliness and sanitation at the state's 99 compounding pharmacies, Naesea added.

"It could happen anywhere depending on how deviant the practitioner is," Naesea said of the meningitis contamination. "But here in Maryland, compounding facilities are monitored fairly closely.

At least one board member said increased FDA oversight also would come with complications.

"There are so many of them [compounding pharmacies] and they are so small, oversight would be difficult," said David Ross Chason, a commissioner with the Maryland Board of Pharmacy.

Maryland was among 34 states that Massachusetts Rep. Edward J. Markey said in a recent report had "problematic" compounding practices and lax oversight.

The report listed four incidents in which Maryland was confronted with tainted drugs from compounding pharmacies. In one case, 16 patients contracted hepatitis C from a contaminated drug used for heart imaging, and in another an Annapolis pharmacy was using drugs with an ingredient that caused cardiac problems in patients in other countries.

The FDA also cited a Lanham company for distributing a drug that causes sterility to Maryland hospitals and clinics and a Minnesota company for selling drugs to Maryland hospitals and clinics that could lead to blindness.

All those incidents happened in 2004 and 2005, and members of the pharmacy board pointed out the FDA hasn't issued any more warning letters since the state strengthened oversight of the facilities in 2008.

That year, the state began using standards it adopted from the U.S. Pharmacopeial Convention, a group that sets voluntary drug safety standards. Under the new guidelines, Maryland's compounding pharmacies must meet requirements of general pharmacies, as well as separate ones for compounding facilities.

The requirements for compounding facilities fall under 11 categories that include proper training of employees in sterile preparation procedures, cleaning standards for rooms where drugs are made and proper disposal of waste.

In October, the board strengthened the laws even further by requiring out-of-state compounding facilities selling to Maryland hospitals and clinics to meet Maryland laws and have at least one pharmacist licensed in the state. Before that Maryland could only investigate a complaint if the home state didn't take action.

"The board is extremely proactive in trying to prevent problems from occurring," Naesea said.

Still, in light of the meningitis incident, the pharmacy board said it is looking at other ways it can boost oversight. It is exploring requiring additional data from compounding pharmacies about their volume and credentials and whether to conduct additional inspections. It also is looking to further increase oversight of out-of-state boards.

But proponents of more government oversight said even the strongest state programs could use more support from the federal government. Congressman Markey said the meningitis case shows that state boards can't control cases that don't originate locally.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.