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Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry - PharmaFacts
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Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry

Safety Considerations for Product Design to Minimize Medication Errors

Guidance for Industry

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

April 2016 Drug Safety

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Safety Considerations for Product Design to Minimize Medication Errors

Guidance for Industry

Additional copies are available from: Office of Communications Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research

April 2016 Drug Safety

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I. II.

A.

B. III.

A.

B. IV.

A. B.

Table of Contents

INTRODUCTION .............................................................................................................. 1 BACKGROUND ................................................................................................................ 2 Recommendations to Minimize Medication Errors ............................................................ 3 Safety by Design: A Systems Approach to Medication Error Prevention......................... 4 WHAT TO CONSIDER AT EARLY STAGE OF DRUG PRODUCT DESIGN TO MINIMIZE MEDICATION ERRORS............................................................................... 4 End Users and Environments of Use .................................................................................. 6 Drug Product-User Interface ............................................................................................... 8 PROACTIVE RISK ASSESSMENTS ............................................................................. 15 Failure Mode and Effects Analysis ................................................................................... 16 Simulated Use Testing ...................................................................................................... 17 CONCLUSION................................................................................................................. 17

Contains Nonbinding Recommendations

V.
GLOSSARY ......................................................................................................................... 19

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