Legal issues associated with pharmacokinetic software

• Published in: American journal of hospital pharmacy Vol. 46; no. 1; p. 120
• Main Authors: Schwartz, J I, Fink, 3rd, J L
• Format: Journal Article
• Language: English
• Published: United States 01-01-1989
• Subjects: Drug Therapy, Computer-Assisted - legislation & jurisprudence; Pharmacokinetics; Pharmacy Service, Hospital - legislation & jurisprudence; Physicians; Sepsis - drug therapy; Sepsis - microbiology; Software - legislation & jurisprudence; Therapy, Computer-Assisted - legislation & jurisprudence; United States; United States Food and Drug Administration; United States
• ISSN: 0002-9289
• DOI: 10.1093/ajhp/46.1.120

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.