Pharmacy board looks to tighten regulations -- Gazette.Net


In response to an outbreak of meningitis linked to tainted drugs, the Maryland Board of Pharmacy is looking to strengthen its regulations on out-of-state facilities permitted to do business in the state.

The recent outbreak originated in such a facility in Massachusetts.

At a hearing Wednesday before the House Health and Government Operations Committee, board executive director LaVerne Naesea said she is weighing options to prevent future outbreaks in Maryland.

“These problems are going to occur,” said Naesea, noting that 660 pharmacies that operate outside the state hold Maryland permits. “Our job is to prevent them, to protect patients in Maryland.”

As of Nov. 5, 23 cases in Maryland had been linked to contaminated steroid injections, including one fatality. Nationwide, 30 have died and more than 400 in 19 states have been infected, according to the U.S. Centers for Disease Control and Prevention.

Meningitis is an inflammation of the tissue surrounding the spinal cord. The source of the outbreak has been tracked to contaminated steroid injections from a compounding pharmacy in Massachusetts, called the New England Compounding Center. A compounding pharmacy alters pharmaceutical products to fit patient needs.

As it concerns compounding by facilities inside the state, the board has a comprehensive set of regulations, said Anna Jeffers, legislation and regulations manager for the pharmacy board.

“Since 2008, [when regulations were implemented], we have not had any major issues as those that you read in the newspaper like this outbreak we’re dealing with now,” Naesea said. “The gap that has to be filled is making sure that we have oversight of out of state [compounding facilities.]”

Currently, the Board of Pharmacy does not inspect facilities outside the state, but is looking at ways to do that.

One way would be to send inspectors out to those compounding facilities that hold Maryland permits on a routine basis, Naesea said. Another would be to make stricter reporting requirements of problems in those facilities.

The board also may recommend that the General Assembly tie compounding centers into a law that was passed in the 2012 legislative session that strengthened requirements for out-of-state pharmacies, but did not include compounding centers.

The board will review its options at a Nov. 28 meeting and then make recommendations to the committee about strengthening regulations.

Seven Maryland medical facilities have been identified as having received contaminated products from the New England Compounding Center, and the Maryland Department of Health and Mental Hygiene estimates that as many as 1,100 patients may have been injected with contaminated steroids.

Since becoming aware of the outbreak in September, the facilities and DHMH have notified about 1,700 patients.

A major source of the problem is a lack of regulation from state and federal agencies, according to a report by Maryland Department of Health and Mental Hygiene doctors. Of the 7,500 compounding facilities in the U.S., only 2 percent participate in voluntary accreditation programs.

The department plans to advocate for stronger regulation of compounding pharmacies from the U.S. Food and Drug Administration. FDA officials did not return calls for comment.

“There have been some concerns about what authority the FDA has and does not have, and that will hopefully be clarified quickly,” said David Blythe, an epidemiologist with DHMH.