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2/6/2002

One Report Can Make a Difference in Product Quality

Cheryl A. Thompson

One pharmacist, one safety report. That's all it may take to trigger a federal investigation that results in a company recalling its poor-quality drug product from the marketplace.

Roger Gregorio, program coordinator for the Food and Drug Administration (FDA) Drug Quality Reporting System (DQRS), likes to tell the tale of a pharmacist who reported a loose cap on a vial of an injectable drug product. Investigation of the report confirmed the agency's suspicion: a problem at the manufacturing plant. The company had been improperly crimping the metal seal on vials, a defect that prevented the plastic cap from fitting tightly. To FDA, the improper crimp meant that the company could not ensure the sterility of the vial's contents.

Some 20 products had to be recalled by the company, he said.

"Pharmacists are really our bread and butter in terms of reporting problems with drug products," said Gregorio.

From October 2000 through September 2001, 60 percent of the 2,469 reports received by the DQRS came from pharmacists, according to program records. One percent came from pharmacy technicians.

The DQRS assigns one of three priority levels to each report. A "priority 1" classification means that Gregorio or a colleague perceives an imminent or serious health hazard from the problem.

For example, the report from a Los Angeles physician of four patients who spiked a fever after receiving a drug injection was classified as a priority 1, Gregorio said. FDA found that the manufacturer had used contaminated water to make the supposedly pyrogen-free drug product. Also assigned to the highest priority was a narcotic product that had been packaged two tablets, instead of one tablet, to a blister—a defect that could have killed a patient, he said.

A "priority 2" classification means a company may be deviating drastically from FDA's manufacturing standards for the industry. Gregorio cited as an example syringes with needles that are always dull before their first use.

Blurred labels would be considered a "priority 3," he said.

The DQRS maintains a database of reports dating back to 1988, Gregorio said. Various FDA groups, such as the one that investigates reports of therapeutic inequivalence between generic and brand-name drug products, use the database in their work.

Information about defects in drug products should be sent on the MedWatch form, an all-purpose one-page document used by FDA to collect reports on safety and adverse events. MedWatch personnel will give reports on product-related problems to the DQRS office. The United States Pharmacopeia stopped running its long-standing Drug Product Problem Reporting program in September 2000.

"We may call you if we need some sort of verification," Gregorio said, adding that not every report is followed up with a phone call. If the defective product might have caused an adverse event, someone from the MedWatch office will also investigate, he said.

MedWatch accepts reports by telephone (800-332-1088), fax (800-332-0178), Internet (www.fda.gov/medwatch), or mail (see the Internet address for access to the form).