NACDS applauds FDA decision on side-effects rule

ALEXANDRIA, Va. The National Association of Chain Drug Stores is hailing a decision by the Food and Drug Administration to give pharmacies some breathing room in their efforts to comply with a new patient-information mandate.

In an interim final rule published last week, the FDA is giving 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. Beginning on that date, pharmacy operators must also provide patients with a statement to contact their doctors for medical 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 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 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 for their patients,” said association president and chief executive officer Steven Anderson. “We look forward to continuing to work with the FDA over the next year 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.