Pharmacy gets reprieve in side-effects rules

ALEXANDRIA, Va. —Pharmacy leaders are breathing easier after the Food and Drug Administration agreed last month to postpone a new patient-information mandate.

The National Association of Chain Drug Stores hailed the FDA’s decision, which effectively gives pharmacies some breathing room in their efforts to comply with the regulation.

In an interim final rule published Jan. 3, 2008, in the Federal Register, the FDA reported it will give pharmacies until Jan. 1, 2009, to comply with a requirement to provide patients with an FDA-maintained toll-free number to report drug side effects. Pharmacies also will have to provide patients with a statement to contact their doctors for advice about side effects.

The newly published rules also give pharmacies some flexibility as to how they distribute the side-effects statement to patients.

The original rule, as proposed by the agency, required that information on a medication’s side effects be included in FDA-approved Medication Guides. “We also proposed that the side-effects statement be distributed with each prescription drug product…and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting,” the agency noted.

However, the FDA acknowledged the difficulties pharmacies and other health stakeholders would have implementing the new rule, and said it would hold off on the mandate until Jan. 1, 2009. “The FDA continues to anticipate that affected entities, including manufacturers of drug products, authorized dispensers and pharmacies, will need time to comply with the new requirements,” the agency reported last month. “Therefore…the agency does not intend to take enforcement action with regard to this interim final rule before that date.”

The FDA’s change of course perhaps reflects an improved climate for more effective dialogue between the chain pharmacy organization and federal health agencies. “NACDS worked closely with the FDA on the impact of this rule, and we are very appreciative of the agency’s sensitivity to pharmacies in complying with a measure that would impact the millions of prescriptions they fill each year,” said association president and chief executive officer Steve Anderson. “We look forward to continuing to work with the FDA to help chain pharmacies meet the requirements by next January.

“We also emphasize the need to raise awareness among patients that the toll-free number is for the sole purpose of reporting side effects, and that it provides no mechanism for patients to obtain medical advice,” Anderson added.