Consortium Meeting and Public Hearing
Medical Product Safety
|PURPOSE OF BREAKOUT SESSION
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:
I. SUGGESTIONS TO REWORD ADD OR
DELETE AN OBJECTIVE
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.
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.
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.
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.
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.
Objective 13.9: The participants felt this objective was
the same as objective 13.5.
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
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