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rating across disciplines are all mechanisms that will contribute to creating a culture of safety.

RECOMMENDATION 7.3 The Food and Drug Administration (FDA) should increase attention to the safe use of drugs in both preand post-marketing processes through the following actions:

• develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use;

• require pharmaceutical companies to test (using FDA-approved methods) proposed drug names to identify and remedy potential sound-alike and look-alike confusion with existing drug names; and

• work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through postmarketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients.

The FDA's role is to regulate manufacturers for the safety and effectiveness of their drugs and devices. However, even approved products can present safety problems in practice. For example, different drugs with similar sounding names can create confusion for both patients and providers. Attention to the safety of products in actual use should be increased during approval processes and in post-marketing monitoring systems. The FDA should also work with drug manufacturers, distributors, pharmacy benefit managers, health plans and other organizations to assist clinicians in identifying and preventing problems in the use of drugs.

Implementing Safety Systems in Health Care Organizations

Experience in other high-risk industries has provided well-understood illustrations that can be used to improve health care safety. However, health care management and professionals have rarely provided specific, clear, high-level, organization-wide incentives to apply what has been learned in other industries about ways to prevent error and reduce harm within their own organizations. Chief Executive Officers and Boards of Trustees should be held accountable for making a serious, visible and on-going commitment to creating safe systems of care.

Front Matter (R1-R24)

Executive Summary (1-16)

1 A Comprehensive Approach to Improving Patient Safety (17-25)

2 Errors in Health Care: A Leading Cause of Death and Injury (26-48)

3 Why Do Errors Happen? (49-68)

4 Building Leadership and Knowledge for Patient Safety (69-85)

5 Error Reporting Systems (86-108)

6 Protecting Voluntary Reporting Systems from Legal Discovery (109-131)

7 Setting Performance Standards and Expectations for Patient Safety (132-154)

8 Creating Safety Systems in Health Care Organizations (155-204)

A Background and Methodology (205-209)

B Glossary and Acronyms (210-214)

C Literature Summary (215-253)

D Characteristics of State Adverse Event Reporting Systems (254-265)

E Safety Activities in Health Care Organizations (266-272)

Index (273-287)