Drug product selection: Legal issues

Thomas P. Christensen, Duane M. Kirking, Frank J. Ascione, Lynda S. Welage, Caroline A. Gaither

Research output: Contribution to journalReview articlepeer-review

15 Scopus citations

Abstract

OBJECTIVE: To review the potential legal liability of the pharmacist in the drug product selection process. DATA SOURCES: Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions. DATA SYNTHESIS: Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation. CONCLUSION: Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

Original languageEnglish (US)
Pages (from-to)868-874
Number of pages7
JournalJournal of the American Pharmaceutical Association (Washington, D.C. : 1996)
Volume41
Issue number6
DOIs
StatePublished - 2001

Bibliographical note

Funding Information:
This study was supported by the Blue Cross Blue Shield of Michigan Foundation.

Funding Information:
Dr. Asci one has received research grants from Amgen, Upjohn (now Phar-acia), and Glaxo-Wellcome (now GlaxoSmithKiine). Dr. Welage is a consultant for AstraZeneca, Wyeth-Ayerst, and Pharmacia, and has received nding from Eli Lilly, AstraZeneca, Wyeth-Ayerst (pending), Pfizer, and GlaxoWellcome. She is on the speakers bureau for Pfizer, AstraZeneca, r P, Wyeth-Ayerst, Pharmacia, Eli Lilly, and Aventis. The other authors '.ieclare no conflicts of interests or financial interests in any product or ser-.;ice mentioned in this article, including grants, gifts, employment, stock .:oldings, or honoraria.

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