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Biomedical subjects

J L Fink

Publications and source records attributed to J L Fink.

At least 19 recordsLinked to original sources

Legal issues associated with pharmacokinetic software.

Legal issues associated with the use of pharmacokinetic computer software are discussed. One issue involves the physician's reliance on the pharmacist, as a drug therapy expert, to provide consultation on drug dosages. Another issue is the problem of liability associated with the software and how this relates to the physician, the pharmacist, and those who designed, manufactured, and sold the software. The legal concept of negligence as it relates to medical computer software is discussed. Although the programmer and the manufacturer are responsible for verifying that the program does what it purports to do, the user must exercise due care in identifying any program limitations that might influence the accuracy of a consultation. Clinical perspective, effective validation techniques, and critical selection will help to ensure that pharmacokinetic computer software is developed, purchased, and used safely and effectively.

Drug Therapy, Computer-Assisted

Testing for drug use, Part 1: Analytical methods.

Issues surrounding the screening and testing of individuals for drug use, including analytical and legal aspects of the procedures and social, political, and ethical problems and concerns, are reviewed. Historically, professional and societal debate regarding drug taking, drug-use problems, and the utility of drug testing programs occurs in cycles. Analytical methods commonly used to test for drug use include breath analysis for alcohol and urine drug assays. Blood alcohol concentrations are determined by laboratory assay methods or by portable devices used in the field. While poor laboratory procedures can invalidate test results for both breath and urine tests, urine screening test results can be further invalidated by improper handling of specimens or by tampering on the part of the subject. Also, test results are meaningful only if they are correlated with a clinical state. Legal issues have been raised concerning the validity of testing procedures used and the reliability of evidence obtained, especially in relation to pre-employment drug screening. From an ethical standpoint, drug testing tends to focus efforts to combat drug abuse on the drugs themselves instead of on the social context of the problem. With a recycled interest in drug-use testing and screening, primarily attributable to technological advances, little attention is being given to other approaches to controlling drug use. Additional research is needed to better describe the nature and extent of our drug-use problems and their impact on society.

Humans

Patient package inserts and the pharmacist's responsibility.

Patient package insert regulations by the Food and Drug Administration are discussed, emphasizing the pharmacist's responsibility. The possible criminal and civil liability problems the pharmacist may face under the regulations are considered. Legal implications of alternatives to using PPIs provided by the manufacturer are presented. The prudent pharmacist will examine the alternatives, weighing the administrative, clinical and legal implications of the various approaches.

Legislation, Drug

Antisubstitution law changes and the hospital formulary system.

The effects of amendments to state antisubstitution laws on the hospital formulary system are discussed. The approaches of four states--California, Michigan, Minnesota and Delaware--are reviewed. It is concluded that the legal basis of the hospital formulary system remains intact regardless of the changes in state antisubstitution laws.

California