Less than half of Maryland’s pharmacies were inspected in the past two years, and just a third in the past year, a situation that health care advocates say puts the public at risk of getting outdated or improper medication.
About one-third of the state’s 1,630 registered pharmacies were inspected in 2006, up from fewer than one-quarter in 2005, even though the state requires annual inspections of all pharmacies, according to a Capital News Service review of data from the Maryland health department’s Division of Drug Control.
Many say that the change in regulations, shared responsibility among agencies and a lack of funding are prohibiting the board from inspecting pharmacies on time.
But health care advocates say that inspections are a basic public health measure and worry that patients face risks when filling prescriptions at pharmacies operating with insufficient oversight.
“It’s a life-and-death issue,” said Bill Vaughan, a senior policy analyst with the watchdog group Consumers Union.
The average senior these days is taking five to six medications — a potential “witches brew” of pills that should be closely monitored, said Vaughan.
A pharmacy is often the front line in preventing harm to patients, and state inspections are especially important because federal guidelines are less clear, he said.
Inspections evaluate pharmacies on compliance with 51 measures including the labeling and dispensing of quality drugs, the number of pharmacists on duty, the cleanliness and organization of the pharmacy area and the adherence to procedures for record-keeping and counseling patients.
About half of the 524 pharmacies inspected in 2006 had at least one violation, and 12 percent of inspected pharmacies had five violations or more. About 8 percent of the pharmacies inspected had misbranded products and more than 20 percent were cited for having outdated products.
Misbranding a bottle of medicine can be very, very serious, said Vaughan, adding that the importance of a drug’s label is not to be taken for granted.
“It’s a 100-year battle on behalf of consumers about what’s in that bottle,” he said, adding that branding was one of the first laws the Food and Drug Administration created back in 1906.
“The people of Maryland deserve the assurance that they’re getting the right (drug) at the right time from the right person,” said Darrin Brown, chief lobbyist for the American Association of Retired Persons in Maryland.
“We can get that assurance by doing exactly what the law says.”
The Maryland General Assembly has required that all pharmacies in the state must inspected annually since 2002, when the Maryland Board of Pharmacy was reauthorized.
The board is aware of the inspection problems and is working to fix them, said LaVerne Naesea, executive director of the Maryland Board of Pharmacy.
“I’ve been working with the department and the Division of Drug Control to make substantial changes in the entire inspection process,” she said.
One of the problems in executing timely inspections, she said, is that the board is required to inspect, but it is the Division of Drug Control that actually conducts the inspections. That dual responsibility has meant bureaucratic problems.
Naesea said the board is attempting to get more control over inspection
