ALEXANDRIA, Va. — The National Association of Chain Drug Stores has sent a letter to the Food and Drug Administration outlining the need to improve the usefulness of patient medication information that consumers receive with their prescription drugs.
NACDS said Monday that the letter to the FDA is a supplement to testimony offered by the association to agency at a public hearing in September.
The message is the latest step in NACDS’ ongoing effort to advance a "one-document solution."
NACDS and seven other pharmacy and consumer organizations in June 2008 submitted a Citizen Petition to FDA, which called for a move to a concise, plain-language document for patients that would consolidate and replace the multiple written communications pharmacies are now required to distribute to patients. NACDS said it has maintained a proactive footing in advancing policy that is consistent with this Citizen Petition.
In the letter, NACDS stressed the importance of FDA-approved information "to ensure that all patient medication information meets FDA standards of accuracy and comprehensibility, and that the information is properly balanced to communicate risks and benefits" for patients.
The association also urged that if FDA approval was not feasible, that it conduct pilot programs to determine the best way to achieve a one-document solution that would provide the most useful and accurate information for patients about their medications.
"FDA’s limited resources must not serve as a barrier to moving forward with the ‘one-document solution.’ To address concerns about limited resources, we believe the best overall approach would be for FDA to pilot numerous approaches. The goals of the pilot programs should be to assess whether the patient medication information’s content and format meet FDA standards, as well as whether distribution is adequate, although current distribution of written consumer information is not considered to be problematic," the letter stated.
"The key to success for patient medication information will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups," NACDS continued in the letter. "Our membership is pleased with FDA’s recognition of this and looks forward to participation in FDA-developed pilot programs."
