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Medical Product Safety

Goal

Introduction

Modifications to Objectives and Subobjectives

Progress Toward Healthy People 2010 Targets

Progress Toward Elimination of Health Disparities

Opportunities and Challenges

Emerging Issues

Progress Quotient Chart

Disparities Table (See below)

Race and Ethnicity

Gender, Education, and Disability

Objectives and Subobjectives

References

Related Objectives From Other Focus Areas

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Midcourse Review  >  Table of Contents  >  Focus Area 17: Medical Product Safety  >  Progress Toward Healthy People 2010 Targets
Midcourse Review Healthy People 2010 logo
Medical Product Safety Focus Area 17

Progress Toward Healthy People 2010 Targets


The following discussion highlights objectives that met or exceeded their 2010 targets; moved toward the targets, demonstrated no change, or moved away from the targets; and those that lacked data to assess progress. Progress is illustrated in the Progress Quotient bar chart (see Figure 17-1), which displays the percent of targeted change achieved for objectives and subobjectives with sufficient data to assess progress.

Progress was made in the Medical Product Safety focus area. Two subobjectives met or exceeded their targets (17-2a and c). Two subobjectives made progress toward their targets (17-1a and 17-2b). One objective and one subobjective showed no movement toward or away from their targets (17-6 and 17-5a), and one subobjective moved away from its target (17-5b). Trends could not be assessed for one objective and one subobjective at the time of the midcourse review (17-4 and 17-2d).

Objectives that met or exceeded their targets. Two subobjectives met their 2010 targets. The proportion of providers in health care organizations using electronic medical records (17-2a) increased from 12 percent in 2000 to 19 percent in 2004, surpassing its target. The proportion of general and children's hospitals using computerized prescriber order entry (17-2c) increased from 4 percent in 2001 to 6 percent in 2003, achieving the target.

Achieving and moving beyond these targets involves the entire health care system. Practices such as using electronic medical records and computerized prescriber order entry, if adopted, can enhance the quality of care by reducing potential errors.1, 2 Information technology use in health care organizations is linked to financial resources. Accordingly, influencing organizations to allocate resources to implement information technology is a challenge. Large organizations, however, are beginning to implement electronic medical records and computerized prescriber order entry systems. For example, the U.S. Department of Veterans Affairs intends to have all of its acute care facilities equipped with bar-coding technology. However, financial and other incentives are probably needed to address smaller organizations, ambulatory settings, and physician offices.

The Food and Drug Administration (FDA) is encouraging health care providers to adopt information technologies and is working with the National Library of Medicine to establish a publicly accessible electronic repository of current prescription drug labeling. This repository can be used by decision support systems throughout the health care community to inform prescribing decisions.

Other activities encompass collaboration among organizations to establish standards for electronic recording, submission, and dissemination of approved product labeling to improve use by providers and patients.1 In addition, standard vocabularies and taxonomies to facilitate the seamless exchange of electronic data submissions between different operating systems are being developed by FDA, the National Cancer Institute, the U.S. Pharmacopeial Convention, and others. These collaborations offer opportunities for outside groups to contribute to developing the information technology standards necessary for more universal data exchange.

Objectives that moved toward their targets. One objective and one subobjective moved toward their targets. Pharmacists using electronic medical records (17-2b) achieved 13 percent of the targeted change between 1999 and 2001 (see earlier discussion). The proportion of health care organizations monitoring and analyzing adverse events associated with their medical therapies (17-1a) increased between 1998 and 2003, achieving 25 percent of the targeted change.

FDA's approval process includes a rigorous review of science-based clinical trials to identify clinically important safety issues in the population studied. However, the more rarely occurring safety issues may only become evident with wider use. To identify early signals of patient harm, FDA relies on required reporting by product manufacturers and on health care providers' voluntarily reporting suspected serious adverse events. To move the subobjective for monitoring and analyzing adverse events (17-1a) toward its target, FDA, the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality are collaborating to broaden the ability to capture adverse event and medication information. Collaborations such as Connecting for Health3 have been founded to facilitate automated data collection by devising tools for health information networks and by partnering to support development of health information exchange between different localities.

FDA also has programs to improve the safe use of regulated products by facilitating reporting of serious adverse events related to the use of these products to FDA. MedWatch,4 FDA's Safety Information and Adverse Event Reporting Program, is one such program. MedWatch also disseminates updated drug safety information to inform providers of the most recent safety information. Furthermore, FDA's Medical Device Safety Network (MedSun) program is intended to improve the safe use of medical devices by the following actions:

  • Reducing barriers to reporting medical device-related adverse events by device-user facilities (such as hospitals and outpatient clinics).
  • Training device-user facilities to recognize and report adverse events.
  • Sharing information between device-user facilities about the identification, understanding, and resolution of device problems.

Other opportunities for meeting the target include taking advantage of adverse event recording and reporting systems that are linked between organizations, including FDA.

Preventing adverse events before they occur is the ideal solution. Accordingly, FDA is working on several projects to help identify the potential for an adverse event before it happens to a patient. For example, FDA continues to implement postmarketing risk management programs with active surveillance and is furthering its efforts to reduce medication errors by implementing a universal bar-coding system for prescription medicines and blood products.

Objectives that demonstrated no change. One objective and one subobjective remained static. No change was noted for the receipt of oral counseling about medications from prescribers (17-5a). Between 1998 and 2000, 24 percent of patients received counseling about their new prescription medicines.

National organizations are encouraging prescriber counseling with consumer-focused campaigns. Examples are the Partnership for Clear Health Communication's "Ask Me 3"5 and the National Council on Patient Information and Education's "Talk About Prescriptions."6 FDA participates in forums designed to influence health care professionals' behavior and emphasize the importance of counseling. FDA has finalized changes to prescription drug labeling for health care professionals. These revisions are expected to facilitate oral counseling by making clearer what information FDA and product manufacturers believe patients should be told.

Blood donations (17-6) also showed no change relative to the target. Between 1998 and 2003, the overall proportion of people in the United States who donated blood each year remained static at 6 percent.

Donor recruitment and retention are two major challenges in meeting the target. In the past, recruitment has not fulfilled demands. Blood and blood components have a limited shelf life and must be continually replenished. Further transfusion-transmitted diseases and various exclusionary behaviors have decreased the pool of eligible donors.

Through FDA, HHS is working to support industry efforts to recruit and retain new blood donors. The HHS Advisory Committee on Blood Safety and Availability works to ensure an adequate blood supply. FDA provides guidance on donor incentives and participates in workshops7, 8, 9 on donor incentives, donor suitability, and best practices in donor recruitment. In addition, FDA has actively worked with the blood community to improve the donation process by developing improved, tested donor-screening materials and computer-assisted donor interviews.

Objectives that moved away from their targets. One subobjective, receipt of oral counseling about medications by pharmacists (17-5b), moved away from its target. In 2000, 12 percent of patients received oral counseling about their prescription medicines from their pharmacists, compared with 14 percent who received such counseling during the baseline year of 1998.

Remaining challenges include the limited time and incentives for pharmacists to counsel patients. FDA has identified several opportunities for advancing this subobjective. These include collaborating with CMS in its oversight role for the Omnibus Budget Reconciliation Act of 1990 (OBRA 90), as well as working with State pharmacy boards to encourage oral counseling.

Objectives that could not be assessed. As discussed previously, provider review of medications taken by patients (17-3) was deleted due to lack of an identifiable data source. Receipt of useful information about prescriptions (17-4) remained developmental. Although FDA sponsored the collection of national data in 2001 to measure the usefulness of written information about prescription drugs, a single valid baseline measure could not be established. Furthermore, overall usefulness varied depending on what medication information was being assessed.

According to Public Law 104-180, FDA will not require the distribution of written medication information uniform in content and format as long as, by 2006, 95 percent of patients getting new prescriptions also get useful written information about the dispensed medicine. The specific requirements defining useful written information are detailed in a long-range action plan agreed on by a consortium of stakeholders and accepted by the Secretary of HHS.10 FDA is working with various private-sector stakeholders to meet this target, including recent guidance to the publishers of medication information.11

The use of computerized prescriber order entry by urban acute care facilities (17-2d) became measurable on the basis of data acquired from the Leapfrog Group. The baseline data from 2003 showed that 5 percent of urban acute care facilities used computerized prescriber order entry. The second evaluation occurred in 2005, and data analysis is under way.


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