National Council on Patient Information and Education (NCPIE)

Additional Statement, Submitted by N. Lee Rucker, M.S.P.H. Senior Vice President, Policy and Public Affairs National Council on Patient Information and Education, Bethesda, MD

On behalf of the National Council on Patient Information and Education (NCPIE), we appreciate the opportunity to testify today at the National Summit on Medical Errors and Patient Safety Research. I am N. Lee Rucker, M.S.P.H., Senior Vice President, Policy and Public Affairs. NCPIE is a 501(c)(3) coalition of nearly 200 organizations, including: health care professional associations, national consumer and patient advocacy groups, health care delivery and academic institutions, pharmaceutical manufacturers and their trade associations, managed care organizations, and government agencies (e.g., Food and Drug Administration). These comments may not necessarily reflect the opinions of each NCPIE member.

Since our founding in 1982, NCPIE has focused on improving patient safety related to medication use. Specifically, as a coalition, we are committed to improving communication between health care professionals and patients about the appropriate use of medicines. We sponsor public affairs campaigns, such as the national health observance of "Talk About Prescriptions" Month each October; produce educational resources for health care professionals and consumers such as Prescription Medicines and You: A Consumer Guide (produced jointly in 1996 with AHCPR, and now under revision at AHRQ); and the National Medication Check-Up Kit, whose original version (early 1990’s) was produced with the U.S. Administration on Aging. In October 1999, NCPIE launched www.talkaboutrx.org

Having organized and sponsored educational conferences on improving medication compliance; on patient responsibility in medication management; and on the role of medicine communication in ensuring safe, appropriate medicine use, NCPIE is well-versed in many dimensions of the patient safety issue. Thus, it is with this backdrop that we present the following key environmental parameters framing the discussion of medication safety.

Environmental Parameters of Medication Safety

The total number of retail (outpatient) prescriptions dispensed in 2000 is expected to reach 3.15 billion. Over 65% of physician office visits ended with a prescription being written, making medication therapy the most commonly-mentioned therapeutic service. As noted in the Institute of Medicine’s To Err is Human (1999), medication errors accounted for a substantial proportion of all medical errors and deaths.

By far, the majority of medicines (both prescription and non-prescription) are used by ambulatory patients, yet the majority of research on medication-related errors has been conducted in hospital/health-system/long-term care environments. This research focus may stem primarily from better access to inpatient records that include drug utilization data, than from researchers’ deliberate oversight of the ambulatory setting. Fortunately, the paucity of ambulatory data about medicine utilization seems to be lessening, albeit slowly. However, it remains a serious deterrent to analyzing the issue of medication errors in the ambulatory setting, and to proposing practical solutions.

For nearly two decades, public policy objectives and private sector initiatives have focused on improving communication about safe, appropriate medicine use. These include, but are not limited to:

1. Medicine: Before You Take It…Talk About It – 10 Important Questions to Help You Use Medicines Safely. Bethesda, MD: Natl. Council on Patient Information and Ed., 2000.
2. Recommendations to Advance Medication Compliance, Washington, DC: NCPIE, 1994.
3. Prescription Medicine Compliance: A Review of the Baseline of Knowledge, Washington, DC: NCPIE, 1995 (reprinted in Journal of Pharmacoepidemiology, Vol. 3, No. 2, 1995).
4. Issuance on Aug. 24, 2000 of the first FDA-mandated "Medication Guide" for the prescription medicine Lotronex, per Federal Register, Vol. 63, No. 230, Dec. 1, 1998, pps. 66378-66400.
5. National FDA consumer surveys, conducted periodically since 1982, assessing the delivery of written and oral information about prescription medicines – accessible at: www.fda.gov/cder/ddmac/Y2KTITLE.HTM
6. Action Plan for the Provision of Useful Prescription Medicine Information, developed by the private sector (including NCPIE) per P.L. 104-180; approved by HHS Secretary D. Shalala in January 1997.
7. Healthy People 2000, Chapter 12, "Food and Drug Safety," objectives #12-6, 12-18.
8. Healthy People 2010, Chapter 17, "Medical Product Safety," objectives #17-3, 17-4, 17-5.
9. Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting, Chicago, IL: American Medical Association, Sept. 1996.
10. Guiding Principles for Enhancing the Likelihood of Positive Medication Use Outcomes in Geriatric Patients (position statement draft, June 2000); Standards for Written Prescription Medicine Information (draft, August 2000); Ten Guiding Principles for Teaching Children and Adolescents About Medicines (1999), Rockville, MD: United States Pharmacopeia, www.usp.org (click on "Drug Information").

Congress’ consideration of, and the policy spotlight afforded to Vice President Al Gore’s and Governor George W. Bush’s proposals for, expanding Medicare coverage to include outpatient prescription medicines. Persons aged 65 and older make up 13% of the U.S. population, but account for 34% of all prescription medicines dispensed, and for 42% of retail prescription expenditures. Each of these plans would dramatically increase seniors’ access to pharmaceuticals. Consequently, their risk of medication-related errors may also increase. Thus far, there has been only limited public policy discussion about, or private sector support for, programs to empower seniors (and all consumers) in their own medication management.

Key Research Questions

Given these environmental factors, let us now examine some key research questions: U.S. demographics and market forces dictate that medication use in the ambulatory setting will continue exceeding use in inpatient settings. (By the year 2004, the number of retail prescriptions is estimated to reach four billion.) This is driven by:

• An aging population (through 2010, the fastest-growing age cohort will be those aged 45-64; after 2010, those aged 65 and up will be the fastest-growing cohort).
• An increase in expenditures on pharmaceutical direct-to-consumer advertising of 50% per year since Aug. 1997, when FDA relaxed guidelines for broadcast ads.
• Rapidly-expanding self-care market, particularly for "alternative" medicines such as dietary supplements (when taken in combination with prescription medicines, non-prescription medicines and supplements can increase the chance for dangerous drug-drug interactions and other adverse drug events).
• Broader range of outlets providing medications, such as: on-line pharmacies, mail-order, and community retail pharmacies. Frequenting just one pharmacy for all medicine needs is often advocated as one simple step to reducing medication errors.
• Advent of managed care, resulting in more frequent switching among health care plans, providers, and pharmacies. Such switching may negatively impact a patient’s continuity of care, thus impairing optimal medicine communication between all of the patient’s health care providers and caregivers.

Barriers to Ambulatory-Based Research in Medication Safety

With these realities, what barriers are facing researchers who choose to examine patient medication safety within ambulatory settings?

• Fragmented patient medical records – computerized patient records that include pharmaceutical products (prescription and OTC), laboratory results, and medical diagnosis remain the exception rather than the rule.
• Variable follow-up by health care professionals who are actually involved in the patient’s care to determine a patient’s medicine compliance.
• Prioritization of research objectives based on existing hospital-based research on medication errors (e.g., retrospective analysis of adverse drug events), and not necessarily on objectives that could maximize patient health outcomes (e.g., concurrent and prospective interventions by the primary care provider, pharmacist and patient to encourage appropriate medicine use).
• Lack of uniformity in methodology when consumer recall about medicines is involved. For example, FDA’s national consumer surveys on the receipt of written medicine information, and of oral counseling from providers, only uses households where the respondent has received a prescription within the past four weeks. For other consumer surveys with a similar focus, the allowable recall period may be 6-12 months or longer. This lack of uniformity has resulted in dramatically different results, despite similar questions in the survey instruments.

Potential Partnership Organizations

As a first step to defining a research agenda to promote medication safety in ambulatory settings, it will be important to identify leading organizations with whom researchers could partner, who have demonstrated a clear commitment to patient safety. These might include:

• NCPIE health professional members, including the American Medical Association ; state medical societies; nursing professional societies and nursing education organizations; and pharmacist professional societies, pharmacy education organizations and related trade groups (a complete NCPIE membership roster is attached).
• American Medical Group Association, Alexandria, VA – www.amga.org
• Medical Group Management Association, Englewood, CO – www.mgma.com
• Group and staff-model health maintenance organizations that are active in health services research related to patient safety, such as Kaiser Permanente and Group Health Cooperative of Puget Sound (WA).

This is not meant to be a comprehensive list, but rather is representative of a starting point for researchers eager to pursue partnerships.

Recent Developments Suitable for Additional Research

For reasons noted previously, there is a paucity of research on the effect on health outcomes of improved health care professional / patient communication about medicines. However, two recent developments – one a research study, the other implementation of FDA policy – may open the door to additional research.

First, "Discrepancies in the Use of Medicines" (S. Bedell et. al.) was published in the Archives of Internal Medicine, Vol. 160, July 24, 2000. Set in a private practice affiliated with an academic medical center, the researchers found a 76% discrepancy rate between what medicines patients were actually taking, and what medicines had been recorded in their charts. "Older age and polypharmacy were the most significant correlates of discrepancy," they noted. Pervasiveness of the discrepancies "can have significant health care implications, and action is urgently needed to address their causes," Bedell and her colleagues observed. "Such action would likely have a positive impact on patient care, patient-physician relationships, and long-term outcomes," they concluded.

Second, the FDA’s issuance of its first "Medication Guide" for the prescription medicine Lotronex (alosetron hydrochloride) suggests an ideal research topic: assessing the Guide’s effect on patients’ health outcomes and avoidance of adverse effects. The FDA has the authority to issue Medication Guides for up to 10 prescription medicines per year. That authority is restricted to medicines where (1) patient labeling could help prevent serious adverse effects, (2) serious risks relative to benefits could affect patients’ beginning or continuing use of the medicine, and/or (3) patient adherence to directions for use is crucial to the medicine’s effectiveness.

In addition, a growing body of supplemental patient information presents itself in the media with direct-to-consumer advertising. Researchers are just beginning to assess its impact on the doctor-patient relationship, and consumers’ attitudes toward such advertising. However, its effect on medicine adherence and health outcomes remains to be judged "under the microscope."

NCPIE's Role as Clearinghouse for Medication Research in Ambulatory Settings

The National Council on Patient Information and Education has nearly two decades of experience in patient safety issues related to medication use. To advance "new knowledge in a manner most capable of immediate application," NCPIE proposes to serve as a clearinghouse for medication-related safety research in ambulatory settings. Development and implementation of this clearinghouse would be predicated on securing grant support from the Agency for Healthcare Research and Quality and other sponsors.

The functions of the clearinghouse would include, but not be limited to:

• Identification of researchers working in this area who have either published since 1999 and/or expect to be published in 2000-2002.
• Maintaining abstracts of published research; providing direct website links if possible.
• Maintaining an inventory of researchers who are searching for funding partners and/or ambulatory care organizations where the research could be conducted.
• Identification of potential funders and of organizations interested in participating in research studies.
• Maintaining a roster of private and public-sector sponsored medicine communication public affairs campaigns since 2000.
• Development/ maintenance of a dedicated website to incorporate the above functions; initially, it would be based at NCPIE’s website, www.talkaboutrx.org

NCPIE looks forward to fulfilling this vital clearinghouse function to promote the rapid collection and dissemination of knowledge in medication safety-related research. We welcome discussion of this proposal, and further collaboration with stakeholder organizations in the public, private and non-profit sectors to ensure its implementation.

Supplemental Documents

1.Educate Before You Medicate: Knowledge is the Best Medicine, "Talk About Prescriptions" Planning Kit 2000-2001, Bethesda, MD: National Council on Patient Information and Education, August 2000.

2. NCPIE Members by Advisory Council (roster), August 31, 2000

3.Healthy People 2000 Review, Food and Drug Safety Objectives (Ch. 12), 1997.

4.Healthy People 2010 (Conference Edition), Medical Product Safety Objectives (Ch. 17), Jan. 2000.

5. Guidelines for Physicians for Counseling Patients About Prescription Medications in the Ambulatory Setting (pamphlet), Chicago, IL: American Medical Association, Sept. 1996.

6. "Physician Education of Their Patients About Prescription Medicines", Report 2 of the Council on Scientific Affairs (I-98)," Chicago, IL: AMA, 1998, 14 pps.

7. Discrepancies in the Use of Medications: Their Extent and Predictors in an Outpatient Practice, S. Bedell, S. Jabbour, R. Goldberg, et. al., Archives of Internal Medicine, Vol. 160, July 24, 2000, pps. 2129-2134.

Current as of September 2000

Internet Citation:

National Council on Patient Information and Education. Additional Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/ancpie.htm

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