The private-sector Consumer Medicine Information Coalition plans to develop prototypes for written patient prescription information by therapeutic class.

The CMI initiative, formed by the National Council on Patient Information and Education, will translate the Keystone criteria for "useful" written consumer drug information into "concrete requirements," NCPIE representative and Medical Care & Outcomes Managing Director David Blair told an FDA public meeting on the status of useful CMI July 31.

NCPIE will invite FDA input "into design and acceptability of criteria," Blair said. "Whatever criteria applications are developed must be acceptable to FDA."

NCPIE's CMI initiative aims to mobilize the private sector to ensure 95% of patients obtaining new scripts receive "useful" written Rx information by 2006, as mandated by a 1996 law. NCPIE was represented on the committee that drafted the Keystone Group action plan, which laid out usefulness criteria in conjunction with the legislation.

The FDA public meeting and the CMI initiative were prompted by an FDA-commissioned survey that found that only 50% of written Rx information provided to patients in 2000 was "useful," 25% short of a statutory target (¹ [A#00640250017], p. 25).

In July 2002, FDA's Drug Safety & Risk Management Advisory Committee recommended the establishment of an oversight group to ensure 2006 goals are met (² Also see "FDA Should Create Oversight Body For Consumer Rx Information, Cmte Says" - Pink Sheet, 22 July, 2002., p. 28). NCPIE's CMI initiative, which involves multiple stakeholders and FDA, appears to be a private-sector attempt to fulfill the oversight role.

The CMI initiative comprises committees on the subjects of criteria, education and implementation. Most committee members represent pharmacy organizations and data vendors/publishers.

The National Association of Chain Drug Stores will participate in both the education and implementation committees; the American Society of Health-System Pharmacists and National Community Pharmacists Association are members of the criteria committee. Data vendor First DataBank is represented on both the criteria and education committees.

The single drug industry rep is Merck Research Labs, which is on the implementation committee.

The criteria committee's role is to refine Keystone usefulness criteria and "ensure patients receive truly 'useful' CMI." The committee is charged with developing the CMI principles and prototypes for specific medications and therapeutic classes, and will "rely on consumer research to assess variety of CMI formats' effect on consumer understanding" Blair said.

The education committee will work to "raise awareness of Keystone criteria" and "motivate audiences to achieve year 2006 goals," NCPIE representative and APhA VP-Policy & Communications Susan Winckler said.

Educational campaigns will target CMI vendors, purchasing managers, health care professionals, industry and consumers. The committee will also oversee publication of an NACDS "CMI assessment guide," and will launch a CMI website.

The implementation committee's role will be to provide "coordination and feedback, and monitor progress" of the other two committees, NCPIE Senior VP-Policy & Public Affairs N. Lee Rucker explained. The committee's work "must be faithful" to the Keystone process and "to FDA's scoring system used to assess success at the end of 2006," she said.

FDA used a Keystone-based scoring system for the 2000 survey, and indicated it may do an interim assessment of CMI usefulness before 2006.

Not all meeting participants were pleased with the NCPIE CMI initiative. Some maintained the process would be too lengthy and would essentially repeat work already done by the Keystone group (see ³ Also see "“MedGuide” Regulation Advocates Urge FDA To Take First Steps" - Pink Sheet, 11 August, 2003. ).

However, FDA pledged support for the initiative. Commissioner McClellan declared in a July 31 memo that consumer information improvement is one of his "highest public health priorities." The agency is "confident that...goals for the distribution of useful information about prescription drugs to patients will be met," he said.

FDA's support for private sector initiatives over regulation should please groups like the Pharmaceutical Research & Manufacturers of America, which requested that FDA publish a CMI guidance.

Patient Rx Info Coalition Will Develop Prototype Consumer Drug Leaflets

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