WASHINGTON – 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years, and just a third in the past year, a situation that health care advocates say puts the public at risk of getting outdated or improper medication.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 About 8 percent of the pharmacies inspected had misbranded products and more than 20 percent were cited for having outdated products.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 inspections.
Drug quality and proper storage are of particular concern to consumer advocates.
While outdated drugs are generally not extremely dangerous to patients, professionals argue that they can carry risks.
The biggest risk in patients receiving outdated drugs is efficacy, said Dr. Fadia T. Shaya, associate director of the Center on Drugs and Public Policy at the University of Maryland School of Pharmacy.
“The first concern when you’re taking a drug is that it works,” said Shaya.
Expired antibiotics, for example, might have limited or partial therapeutic effects and could allow a condition to worsen, said Shaya.
But other professionals suggested that some violations are to be expected.
“With the number of laws, with the number of products, it’s almost impossible not to have a violation,” said Raymond Love, a pharmacist who served on the pharmacy board for eight years until 2005.
Descriptions on the standard inspection report are vague and compliance is often in the eye of the beholder, said Love, adding that an expired tube of toothpaste could mean the difference between a passing grade and a violation.
Many of the violations were described by pharmacists as technical and insignificant.
An example of a typical inspection is Medicine Plus Pharmacy in Thurmont, which had seven violations after its inspection in August, including misbranded products and no hot water. All of the problems have been corrected, said Sarah Jacobson, a pharmacist who has worked at Medicine Plus for nine years.
The violation for misbranded products amounted to the absence of manufacturing information on “a couple of labels,” she said.
The hot water heater wasn’t working on the day of the inspection, she acknowledged, and said she did not know how long it had been broken. It has since been replaced, she said.
“Most every store will have something,” said Jacobson, adding that the infractions were minor.
Pharmacists argued that they self-regulate, especially larger chain stores with their own compliance inspectors.
CVS pharmacies are regularly visited by company supervisors who review compliance, said company spokesman Mike DeAngelis.
Of the CVS pharmacies inspected in Maryland, 51 had at least one violation.
The problems are easily rectified, DeAngelis said in a statement, though he declined to address violations at specific pharmacies.
Most of the time, pharmacies cited during inspection are advised to fix any problems and are later reinspected, said Naesea.
A pharmacy may be reprimanded, placed on probation, or have its license suspended or revoked by the board if dangerous conditions are found that threaten public safety, she said.
The board has taken action against 11 pharmacies in the past three years, according to documents received from DHMH.
Still the delay in inspections is troubling to health care advocates like Darrin Brown.
“Ultimately the most important thing is that the inspections get done,” he said. “That has to be the bottom line.”
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