The Future of Drug Safety: Promoting and Protecting the Health of the Public

BOX 6-1

Recommendations Pertaining to Consumers from Preventing Medication Errors

Recommendation 1: To improve the quality and safety of the medication-use process, specific measures should be instituted to strengthen patients’ capacities for sound medication self-management. Specifically:

Patients’ rights regarding safety and quality in health care and medication use should be formalized at the state and/or federal levels and ensured at every point of care.
Patients (or their surrogates) should maintain an active list of all prescription drugs, over-the-counter (OTC) drugs, and dietary supplements they are taking; the reasons for taking them; and any known drug allergies. Every provider involved in the medication-use process for a patient should have access to this list.
Providers should take definitive action to educate patients (or their surrogates) about the safe and effective use of medications. They should provide information about side effects, contraindications, and how to handle adverse reactions, as well as where to obtain additional objective, high-quality information.
Consultation on their medications should be available to patients at key points along the medication-use process (during clinical decision making in ambulatory and inpatient care, at hospital discharge, and at the pharmacy).

Recommendation 2: Government agencies (i.e., the Agency for Healthcare Research and Quality [AHRQ], the Centers for Medicare and Medicaid Services [CMS], FDA, and the National Library of Medicine [NLM]) should enhance the resource base for consumer-oriented drug information and

The Role of Other Government Agencies

Other agencies in the Department of Health and Human Services (DHHS), such as the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services play a role in public communication about drug risk and benefit. For example, AHRQ’s Effective Health Care Program develops consumer summaries of reports prepared by its DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) network—prescription drug outcomes are one focus of the network—and other material on evidence-based practice. NIH conducts or sponsors clinical trials and does make

Table of Contents

Front Matter R1-R14

Summary 1-14

1 Introduction 15-30

2 Natural History of a Drug 31-64

3 A Culture of Safety 65-104

4 The Science of Safety 105-150

5 Regulatory Authorities for Drug Safety 151-176

6 Communicating About Safety 177-192

7 Resources for the Drug Safety System 193-204

Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States 205-216

Appendix B Acronyms 217-220

Appendix C PDUFA Performance Goals—All Years 221-254

Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas 255-266

Appendix E Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine 267-308

Appendix F Committee Biographies 309-318

Index 319-332

The Role of Other Government Agencies