Healthy People Consortium Meeting and Public Hearing
"Building the Next Generation of Healthy People"
November 12 and 13, 1998
Capital Hilton, Washington, D.C.

Medical Product Safety


The Draft Healthy People 2010 document is open for public comment until December 15, 1998. This session of the Consortium meeting was to provide those individuals/organizations an opportunity to discuss their comments with the Work Group coordinator(s) of the various chapters of particular interest. The input of the participants in the Chapter 13 breakout session is summarized below:

Objective 13.1: As currently worded this objective is process oriented and that rewording this statement should include a public health outcome. Recommended rewording: By the year 2010, adverse events associated with medical therapies will be reduced by (50%).

Objective 13.2: The breakout session group agreed that this objective is confusing. They suggested that FDA look to specific regulatory or legislative solutions to address this issue. They recommended deleting this objective.

Objective 13.3: Managed Care Organizations (MCO) have extra administrative layers. The pharmaceutical companies, therefore, do not receive the adverse events directly from the treating physician or pharmacist but second hand from the MCO's RiskManager. According to industry representatives, this interferes with information necessary to provide accurate information to FDA and others. There apparently is also a liability concern for MCOs to share this information.
Recommendation: The group recommended deleting this objective.

Objective 13.4 and 13.5: Both objectives are process focused. Recommended rewording for 13.4: Reduce the number of ADEs associated with misinformation and miscommunications by percent the proportion of pharmacies and other dispensers within integrated health care systems that use linked automated information systems to facilitate information sharing between different components of health care.
Recommended similar rewording in Objective 13.5 as in Objective 13.4.

The problem with these objectives is that there is no way to measure the number of ADEs. That is the reason why it was not accepted as a MedWatch goal.

Objective 13.6: There was discussion as to whether this is included in the HEDIS Performance Measures. There was also a question as to if or when the data source, the Primary Care Providers Survey, has been repeated. This was added to Healthy People 2000 as a pharmacy initiated objective, but the pharmacy organizations would not do the surveys.
Recommendation per the representatives from APhA: removal of the words "and dispenser" and replace with "and pharmacist".

Objective 13.7: There was a discussion with the APhA representatives that the logistics for entry into a system and the time involved may be a problem for the primary care providers and the dispensers. The discussion included possibly developing an incentive toaddress this issue. According to APhA correspondence, the most significant comments where from the National Community Pharmacists Association who have a concern about the additional time necessary to obtain this information. However, other pharmacy associations view this objective as important in the delivery of pharmaceutical care.

There was also a discussion that providers need to be aware of the range of the potential drug-drug interactions. There is a need for an outcomes oriented safety objective for this area.
Recommendation: Clem Bezold will submit a proposed safety objective.

Change wording of "dispenser" as in #6. Reword objective to be more outcomes oriented. Include more emphasis on the reason why tracking alternative therapy use is important.

Objective 13.8: This should be an incentive for continuing education. Some concerns regarding liability.
Recommended rewording: To be more health outcome oriented.

Objective 13.9: The participants felt this objective was the same as objective 13.5.
Recommendation: Deleting this objective.

Clem Bezold discussed that Genotype/Phenotype technology will be available so that the potential to experience an ADR(s) will be targeted before it develops. There will be significant privacy issues associated with this technology.

Objective 13.1: The APhA representatives recommended the following: A suggestion regarding a data source for this objective was consistent with the development of privacy protected electronic surveillance system with a population base of 20,000,000, baseline data will be assessed in the year 2004. Out years data will be obtained through the year 2010.

Objective 13.3: Concerns were expressed that access to this information may be difficult because of MCOs issues surrounding liability and confidentiality.


Objective 13.8: There was a discussion that there is a need for access to new accurate information and the application of that information.

CLOSING REMARKS included participants statements that they will send written comments for the Draft Healthy people 2010 document.


Joseph Schulman, Vagaretti and Harris
Douglas Hoey, National Community Pharmacy Association
Evonne Carroll, Clinical Lab News
Clem Bezold, Institute for Alternative Futures
Mark Boesen, American Association of Colleges of Pharmacy
Leslie Jaggers, American Society of Health System Pharmacists
N. Lee Rucker, National Council on Patient Information and Education
Peter Rheinstein, Food and Drug Administration
Eileen Parish, Food and Drug Administration
Marean Duarte, National Coalition of Hispanic Health and Human Services Organization
Ellis Davis, Office of Disease Prevention and Health Promotion
Bill Harlan, National Institutes of Health


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