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Massachusetts Law About Prescription Medication

Massachusetts Laws

Massachusetts Regulations

Federal Laws

21 U.S.C. Chapter 9: Federal Food, Drug & Cosmetic Act (FD&C). U.S. Food and Drug Administration - Portal to the various subchapters and significant amendments of FD&C.

Federal Regulations

Other Web Sources

General

Drug Approvals and Databases, U.S. Food and Drug Administration

Drug Safety and Availability, U.S. Food and Drug Administration - Portal to information on safety, shortages and recalls.

Massachusetts Board of Registration in Pharmacy: Policies. The Board of Registration in Pharmacy publishes these policies in an attempt to clarify statutes and/or regulations which may appear unclear, or which may not lend themselves to varying practice settings.

Massachusetts Board of Registration in Medicine's Prescribing Practices Policy and Guidelines (adopted 8/1/1989, amended 11/17/2010) is a comprehensive overview of the physician's responsibilities related to physicians' prescribing practices.

Massachusetts Controlled Substances Registration (MCSR) Overview. The Drug Control Program issues the Massachusetts Controlled Substances Registration (MCSR) to health care facilities, manufacturers, distributors, community-based programs and other entities as well as to individual health care providers and researchers. The MCSR provides accountability for the manufacture, distribution, dispensing, possession, prescribing and administering of controlled substances which, in Massachusetts, includes all prescription drugs.

Multistate Outbreak of Fungal Meningitis and Other Infections. U.S. Food and Drug Administration, updated 11/2/12

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration, current through September, 2012

Prescription Drug Advertising. U.S. Food and Drug Administration.

Drugged Driving

Massachusetts Laws

MGL c.90, s.24: Drunk/Drugged Driving

Select Cases

Commonwealth v. Bishop, 78 Mass.App.Ct. 70 (2010), review denied 458 Mass. 1110. On the issue of involuntary intoxication, a judge should instruct the jury that a defendant is entitled to an acquittal if her intoxication was caused solely by her prescription medication, taken as prescribed, and she did not know or have reason to know of the possible effects of the drug on her driving abilities, but the jury can find the defendant guilty if they find that alcohol contributed to her intoxication.

Commonwealth v. Reynolds, 67 Mass.App.Ct. 215 (2006), review denied 447 Mass. 1112. Court correctly denied defendant's motion for required finding of not guilty of felony vehicular homicide where there was evidence on the essential element of intoxication that the defendant knew the consequences of taking the prescription drugs she consumed.

Web Sources

Drugs and Human Performance Fact Sheets. National Highway Traffic Safety Administration, 2004. Describes the effects of illegal and prescription drugs, including the drugs' effects on driving.

Print Sources

Trying OUI Cases in Massachusetts, MCLE, 2004 (w/supplements). Volume 1, Chapter 1: Trial Preparation, sections 1.6.5 - OUI of Prescription Drugs, and 1.6.6 - OUI of Alcohol and Prescription Drugs.

Medical-Legal Aspects of Drugs, 2nd ed. Lawyers & Judges Pub., 2007. Chapter 12: "Prosecuting Drugged Driving Cases" (p. 168 addresses prescription drugs); Chapter 16: "The Study of Drug Effects on Driving"

Massachusetts Practice v. 12 (Motor Vehicle Law and Practice, 4th ed.), ThomsonWest, 2008 with supplement. Section 28:36 - Operating under the influence of drugs or alcohol--M.G.L.A. c.90, s.24

Drug Liability

Select Cases

Cottam v. CVS Pharmacy, 436 Mass. 316 (2002): Court described the "learned intermediary doctrine" wherein a physician acts as a "learned intermediary" between the drug manufacturer or distributor and the consuming patient. As a result, a pharmacy has the duty only to fill the prescription correctly. Only a physician, not a pharmacy or a drug manufacturer, has a duty to warn a customer about a drug's side effects. A pharmacy which voluntarily assumes the duty to warn, however, such as by providing a list of a drug's side effects, must exercise reasonable care. In addition, a pharmacy may have a duty to warn if it has specific knowledge of increased danger to a particular customer such as filling two prescriptions which adversely interact with each other. See, for example, Brienze v. Casserly, 17 Mass.L.Rep. 214 (2003) : Court held that the CVS pharmacist had a duty to warn the plaintiff that taking Ciproflaxin and Theophylline together could potentially result in adverse effects.

Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Court set the standard for admitting expert scientific testimony in a federal trial. There was conflicting expert evidence offered as to whether the ingestion of the prescription antinausea drug, Bendectin, by a mother during her pregnancy caused the adverse effects of limb reduction birth defects suffered by her children.

Commonweath v. Lanigan, 419 Mass. 15 (1994) . Massachusetts accepted the basic reasoning of Daubert, above, concerning admissibility of scientific evidence.

Web Sources

Product Liability Claims Involving Pharmaceutical Drugs. Nolo.com.

Print Sources

Drug injury: Liability, Analysis, and Prevention, 2nd ed. Lawyers & Judges Pub. Co., 2005

Drug Product Liability. Matthew Bender, loose-leaf.

Drugs in Litigation: Damage Awards Involving Prescription and Nonprescription Drugs. Lexis Law Publ., 2002

Litigating the Nursing Home Case. American Bar Association, 2009. Chapter 13: Liability for Prescription Drug Problems.

Massachusetts Practice v. 10A (Procedural Forms Annotated, 6th ed.), ThomsonWest, 2009 with supplement. Section 43:12 - Action against pharmacist - Negligent prescription; Section 43:24 - Action against psychiatrist - Negligent prescription of drugs

Massachusetts Practice v. 51 (Professional Malpractice), ThomsonWest, 2007 with supplement. Section 12.14 - Pharmacists; Section 13.2 - The learned intermediary doctrine.

Massachusetts Practice v. 52 (The Law of Chapter 93A, 2nd ed.), ThomsonWest, 2007 with supplement. Section 9.29 - Torts --Pharmacist malpractice, pharmacies and pharmaceutical companies

Pharmaceutical Litigation: Cutting Edge Issues, Principles and Tactics. MCLE, 2005

Physicians' Desk Reference (PDR). Thomson PDR, 2004-

PDR Guide to Drug Interactions, Side Effects, and Indications. Thomson PDR, 2006-

Prescription Drugs. Oceana Pub., 2005

Medical Marijuana

Massachusetts Law

St.2012, c.369: Allows use of marijuana for medical purposes. Effective January 1, 2013.

Regulations

105 CMR 725 Implementation of an Act for the Humanitarian Medical Use of Marijuana

801 CMR 4 Establishes fees to implement the Dept. of Public Health's program for the medical use of marijuana.

Web Sources

Medical Marijuana in Massachusetts, Mass. Dept. of Public Health. Includes regulations, frequently asked questions, and more.

Medical Use of Marijuana, Mass. Medical Society. Links to information on issues for physicians regarding medical marijuana.

Questions Remain About Medical Marijuana, Leonardo Angiulo, Go Local Worcester, November 19, 2012. Explains the significant challenges in implementing the new law, and clarifies the timetable for various events.

Proper Disposal

Web Sources

Disposal of Unused Medicines: What You Should Know. U.S. Food and Drug Administration

Got Drugs? National Take-Back Initiative. U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control

Pharmaceuticals and Personal Care Products. Massachusetts Department of Environmental Protection. Includes information on safely discarding waste medications.