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Controlled Substances and Pain Management: Regulatory Oversight, Formularies, and Cost Decisions

Published online by Cambridge University Press:  01 January 2021

Douglas J. Pisano
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Extract

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies (product selection), and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to pain management generally.

All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA). CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 24 , Issue 4 , Winter 1996 , pp. 310 - 316
Copyright
Copyright © American Society of Law, Medicine and Ethics 1996

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References

21 U.S.C. §§ 801 et seq. (1970).Google Scholar
Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1242 (1970).Google Scholar
Fink, J.L. Marquardt, K.W. Simonsmeir, L.M., Pharmacy Law Digest (St. Louis: Facts and Comparisons, 26th ed., Nov. 1995): At CS-1.Google Scholar
Id. at CS-2.Google Scholar
Mass. Gen. L. ch. 94c, § 1 (1984).Google Scholar
Fink, Marquardt, Simonsmeir, , supra note 3, at CS-2.Google Scholar
21 C.F.R. § 1301.21 (1992).CrossRefGoogle Scholar
Id. at §§ 1305 et seq.Google Scholar
Mass. Gen. L. ch. 94c, § 23(b).Google Scholar
Id. at § 23(b)(d). Massachusetts law limits the filling of prescriptions for Schedule II drugs for no more than a thirty-day supply. However, dextroamphetamine and methylphenidate are exceptions and are fillable in Massachusetts for up to a sixty-day supply on any single filling. Id. at § 23(d).Google Scholar
Id. at § 2(a).Google Scholar
Fink, Marquardt, Simonsmeir, , supra note 3, at CS-4.Google Scholar
21 C.F.R. § 1306.21.Google Scholar
Id. at § 1306.11.Google Scholar
Id. at § 1306.13.Google Scholar
Id. at § 1306.11(d)Google Scholar
21 C.F.R. § 1306.11(e)(f) (1994).CrossRefGoogle Scholar
21 C.F.R. § 1306.22 (1992).Google Scholar
Id. at § 1306.21.Google Scholar
Id. at § 1306.04.Google Scholar
United States Pharmacopea, USP/Dispensing Information (Alexandria: United States Pharmacopea, Vol. III, 13th ed., 1993): At v.Google Scholar
Id. at I/7.Google Scholar
Id. at I/9.Google Scholar
Id. at I/10.Google Scholar
Id. at I/12.Google Scholar
Mass. Regs. Code tit. 105 § 720.050(b)(1994).Google Scholar
National Association of Boards of Pharmacy, Survey of Pharmacy Law (Park Ridge: National Association of Boards of Pharmacy, June 1995): At 50.Google Scholar
Bootman, J.L. Townsend, R.J. McGhan, W., Principles of Pharmacoeconomics (Cincinnati: Harvey Whitney Books, 1991): At 4 (defining pharmacoeconomics as “the description and analysis of the costs of drug therapy to healthcare systems and society”).Google Scholar
Id. at 5.Google Scholar
Id. at 6.Google Scholar
Id. at 6–7.Google Scholar
Id. at 78–79.Google Scholar
A fentanyl patch is a transdermal patch containing the Schedule II drug fentanyl, which is applied to the skin and used in pain management.Google Scholar