Md. Pharmacy Board Asks for More Control to Beef Up Inspections

By EMILY HAILE, Capital News Service

WASHINGTON - After nearly two-thirds of the state's pharmacies went without required annual inspections last year, the Maryland Board of Pharmacy is hoping to change what some argue is a broken regulatory system.

Insiders say that the board lacks the resources and clout to carry out its regulatory duties.

The board is an independent agency ultimately responsible for regulating pharmacies, but inspections are carried out by the Division of Drug Control, an arm of the Maryland Department of Health and Mental Hygiene.

Board members are pushing for more control over inspections, a change that would need approval from DHMH before going to the Maryland General Assembly.

"We anticipate that by early next year the board will be performing some of the duties that were previously assigned to the Division of Drug Control," pending approval from the state, said Naesea.

The health department has a proposal from the board and is considering it, said DHMH spokesman John Hammond. He declined to comment further.

"We have been working to upgrade the process," said Naesea. "It takes a while to realize, 'Hey, this still is not working.' We did make a plan and now it's being addressed."

Current and former board members say that with no authority over the Division of Drug Control, the board's hands are tied.

"They are our agent," said Jeanne Furman, a board member and pharmacist at Mercy Medical Center in Baltimore. "They are not directly under the board. That's kind of a dilemma . . . we can't totally control them."

Others point to a lack of resources provided by the state to carry out the inspections in a timely manner.

Drug inspections performed by the Division of Drug Control declined in 2005 due to budget reductions, including insufficient staffing and computer problems, according to a 2006 budget analysis conducted by the Laboratories Administration, a division of the DHMH.

Inspections are lagging, partly because so many other things come up, said Georgette Zoltani, chief of the Division of Drug Control, but the division's troubles are largely a thing of the past.

The computer system received a major overhaul in the spring, which is making record-keeping more efficient, she said.

Yet, the division has five licensed pharmacists carrying out inspections, and each employee would have to work every day all year—no weekends, vacations or holidays—and inspect at least four pharmacies each day to meet the state's mandate.

Four additional employees, including Zoltani, are assigned to license approximately 26,000 Maryland businesses that handle controlled substances.

Zoltani has been with Drug Control for about a year. Several people retired in the past few years and it has been tough hiring new pharmacists, she said.

One position has been vacant for several months.

The biggest issue is inadequate resources, said Raymond Love, a professor at University of Maryland School of Pharmacy.

"State government pays pharmacists very poorly," said Love.

The state pays entry-level salaries of about $27,000 for pharmacy technicians and $47,000 for licensed pharmacists, according to the DHMH human resources Web site.

"These should be people with a lot of expertise and if you're going to pay less than any other employer of pharmacists in the entire region," recruiting is going to be difficult, he said.

Lawmakers say they would like to learn more about the issue of annual inspections.

Sen. Andrew P. Harris, R-Baltimore County, a practicing physician on the Education, Health, and Environmental Affairs Committee, was open to a hearing, but said that financial decisions would have to come from the Budget Committee.

Harris wondered whether certified pharmacists are needed to perform inspections or if other trained professionals could do just as well.

The pharmacy board is self-sustaining and may have to increase licensing fees to defray costs, he said.

"It's always a problem of funding," said outgoing State Sen. Paula Hollinger, D-Baltimore County.

"I think it puts the state at risk by not doing it because if there's a problem in a pharmacy the state could ultimately be responsible," said Hollinger, chairwoman of the Education, Health and Environmental Affairs Committee.

Even if the Board of Pharmacy controlled inspections it would face many of the same problems in recruiting, said Love.

But shifting the task of inspecting to the board would eliminate some bureaucracy and give the board more control over the process, he said.

"There were some changes made and the state is in the process of making adjustment . . . all of it is aimed at enhancement," said Naesea.

"But you know how life is...probably not going as quickly as expected."

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