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What Nurses Should Know About Administering “New Drugs”

Published online by Cambridge University Press:  20 January 2021

William R. Rollins
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Extract

Nurses often administer drugs to patients for treatment and research purposes, at the direction of physicians, without knowing their legal responsibilities. Following a doctor's orders is not an adequate defense for a nurse against a lawsuit based on the administration of a drug not approved by the Food and Drug Administration (FDA); administration of a drug approved by the FDA, but approved only for a different purpose; or administration of a drug without the informed consent of a patient. Considerable confusion exists about a nurse's legal obligations in administering “new drugs,” and the purpose of this article is to provide some clarity.

Type
Research Article
Information
Nursing Law & Ethics , Volume 1 , Issue 6 , July 1980 , pp. 1 - 11
Copyright
Copyright © American Society of Law, Medicine and Ethics 1980

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References

1. N.Y. Educ. Law (McKinney) Art. 139, §6902.Google Scholar
2. Mass. Gen. Laws Ann. Ch. 112, 580B.Google Scholar
3. Mass. Gen. Laws Ann. Ch. 94C, 51.Google Scholar
4. 21 U.S.C. § 321(g) and (p) (Federal Food, Drug, and Cosmetic Act, § 201(p) and (g)(l).Google Scholar
5. 21 C.F.R. 310.3(h).Google Scholar
6. Mundy, GR, Flechenstein, L, Mazzullo, JM, Current Medical Practice and the Food and Drug Administration: Some Evidence for the Existing Gap, Journal of the American Medical Association 229(13):1744 (September 23, 1974).Google ScholarPubMed
7. Erichson, SH, Bergman JJ, , Schneeweis, R, Cherkin, DC, The Uses of Drugs for Unlabeled Indications, Journal of the American Medical Association 243(15):1543 (April 18,1980).Google Scholar
8. See Jotkowitz, S, Package Inserts and FDA Policy, New England Journal of Medicine 298(15):856 (April 13,1978).Google ScholarPubMed
9. 37 Fed. Reg. 16503,16504 (Aug. 15, 1972) Notice of Proposed Rule Making by the FDA.Google Scholar
10. 42 U.S.C. § 2891-3(a) (National Research Act of 1974); 45 C.F.R. 46; 21 U.S.C. § 505(i); 21 C.F.R. 312.Google Scholar
11. N.Y. Controlled Substances Act, N.Y. Pub. Health Law (McKinney) Article 33, §3304.Google Scholar
12. Mass. Gen. Laws Ann. Ch. 94C, § 8(i).Google Scholar

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