Category: Reviews & Views

Procedure and Substance

One of the most frustrating aspects of litigation is the almost endless procedures and complicated court rules that the parties must endure on the way to seeking justice. Procedures sometimes get in the way of substance, much like misplaced focus on a single tree prevents us from seeing a whole forest. A recent case, Burkes v. Fred’s Stores of Tennessee, demonstrates the problems that can occur when too much emphasis is placed on following court rules and scant attention is paid to the facts at hand. A suit that has taken four years to move to trial illustrates the problem of paying more attention to court procedures than the facts …

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Mistake or Wanton Disregard?

The standard for showing wanton disregard is much higher than for a negligent mistake. T here should be no doubt that pharmacists and pharmacies will be held liable in a civil lawsuit when a dispensing error causes patients to be harmed. The damages usually awarded to the patient are for compensation of the injuries actually suffered and may include an amount for pain and suffering. In some states, patient-plaintiffs may also seek punitive damages if there is evidence that the defendant did something willful or wanton in reckless disregard for the plaintiff’s safety. Two recent cases demonstrate the distinction. Case #1 The plaintiff entered a weight-loss treatment program in …

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Two-Tier Pricing: Unequal Protection

Many third-party prescription drug benefit programs use two-tier pricing schemes that differentiate between “chain” and “independent” pharmacies. In almost all situations, discounts off the Average Wholesale Price (AWP) of drugs are smaller for the independents and larger for the chains. For example, the independents may be reimbursed using a formula of AWP minus 10% (plus a “dispensing fee” minus any co-pay). The formula for a chain in the same program might be AWP minus 15%. The rationale given for the dichotomy is a belief that the chains have the ability to secure larger discounts from the wholesalers and manufacturers by virtue of volume purchases. Independents are viewed as not …

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Refusal to Fill

The Court concluded that the duty to consult with a patient arises only when the pharmacist receives a prescription order—but is it that simple? Should a pharmacist be held liable when a patient is harmed because the pharmacist does not assist the patient in obtaining a prescription? Does it make any difference if the pharmacist has never seen the patient before? These are the questions faced by the court in a recent case. Facts On October 1, 1994, the patient entered a pharmacy that she had never been in before. She had a history of severe asthma and she believed she was suffering an attack when she went to the pharmacy. …

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Legal Considerations: 'Drugstore' or 'Pharmacy'?

A recent opinion reveals how the words “drugstore” and “pharmacy” may be interpreted in different ways. It also shows just how valuable the terms may be in conducting pharmacy (or drugstore) business. Facts A pharmacy signed a 20-year lease in 1977 with a commercial landlord, for occupancy of a 15,000-square-foot space in a shopping center. The pharmacy negotiated several exclusive rights in the lease, including an obligation by the landlord not to lease space in the shopping center to any other “drugstore” or any other store whose “primary business is the sale of patent medicines, health and beauty aids, cosmetics” or other specific items. A similar clause gave the pharmacy an …

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Off-Label Promotion Approved to Limited Extent

How far will the FDA go in separating promotional activity from free speech? Before marketing any drug in the United States, a manufacturer must obtain permission from the Food and Drug Administration (FDA) in the form of an approved New Drug Application (NDA). As part of this process, the FDA approves the labeling for the new drug. The labeling indicates the purposes for which the drug has been found to be safe and effective. In many situations, after the drug is initially marketed, new indications are discovered that are not referred to in the labeling. In most cases, the manufacturer will seek to amend the labeling …

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Book: The Facts about Drug Use

The Facts about Drug Use Dr Barry Stimmel, The Haworth Medical Press, 10 Alice St, Binghamton, NT 13904-1580, USA, 1993, 366pp Family physicians often see patients who misuse drugs. This widespread problem is the source of much hidden morbidity and mortality for patients and much frustration for doctors. Family doctors are likely to have had little formal training in identifying and intervening in this area. Their attitudes toward problem drug use probably differ little from those held by the public. This book was written “to enable those with little or no background in science or health care to understand the often complex issues of drug use” and “is presented clearly, concisely, …

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Book: A quick reference for drug information

Essentials f Drug Therapy Gordon E. Johnson, PHD W.B. Sounders Company, 55 Homer Ave, Toronto, ON M8Z 4X6, 1991, 425 pp Essentials of Drug Therapy is a clearly written book, summarizing information on drugs that are commonly used. It is not a reference text in pharmacology or an exhaustive detailed volume, such as the Compendium of Pharmaceuticals and Specialties, but is a practical source of information for the medical student and practitioner. The chapters are organized according to therapeutic categories and are introduced by a brief overview of the therapeutic rationale for use of pharmacologie agents. Most drug groups are included, even those used for symptomatic relief, such as antitussives and …

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Drug-induced hepatotoxicity

Drug-induced hepatotoxicity Ed by RG Cameron, G Feuer, FA de la Iglesia, 681 pp, ISBN 3 540 60201 1, Berlin: Springer Verlag 1996 The editors of this splendid volume have invited an international array of contributors to cover its 26 chapters on all aspects of hepatotoxicity due to drugs — adverse effects that mimic acute fulminant hepatitis, chronic active hepatitis, cirrhosis and even malignancy. Turn to one of these chapters for an update on molecular aspects of hepatic drug reactions, in vitro models, cytochrome P450, drug-induced cholestasis, choline deficiency, the fatty liver, immune mechanisms, encephalopathy, pregnancy, Reye syndrome, or hepatotoxicity in infants and the elderly; and, of course, for separate information …

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Complete Guide To Women's Health

Author: American Medical Association Random House of Canada, Ltd, 1265 Aerowood Dr, Mississauga, ON L4W1B9 1996/759 pp Good starter guide to women’s health Strengths Well formatted, easy to read, practical approaches to common problems, focus on wellness and preventive health Audience General public This comprehensive reference volume for women contains common-sense approaches to a number of important health issues. Its target audience is middle-class American women with a moderately high level of literacy. The book aims to provide women with up-to-date medical information to guide decision making and to facilitate communication with their physicians. Its four main sections cover health maintenance, sexual and reproductive health, pregnancy, and the common health …

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