Exercising professional judgment in such areas as counseling drug product selection raises new liability issues for pharmacists

1995 ◽  
Vol 35 (12) ◽  
pp. 14-24
Author(s):  
Nicholas J. Lynn ◽  
Robert E. Kamm
Keyword(s):  
Drug Product ◽  
Professional Judgment ◽  
Product Selection

scholarly journals Drug product selection: the Florida experience.

1980 ◽  
Vol 70 (5) ◽  
pp. 479-484 ◽  
Author(s):  
G J Vuturo ◽  
J P Krischer ◽  
W C McCormick
Keyword(s):  
Drug Product ◽  
Product Selection

The Pharmacist's Dilemma—Drug Product Selection Using Bioavailability Data

1973 ◽  
Vol 7 (10) ◽  
pp. 444-450
Author(s):  
George Kennedy Cawthorne ◽  
Fred M. Eckel
Keyword(s):  
Blood Level ◽  
Drug Product ◽  
Potential Usefulness ◽  
Product Selection ◽  
Wide Applicability ◽  
Drug Products ◽  
Drug Companies ◽  
Selection Decisions

One hundred fifty-six U.S. drug companies were surveyed to determine whether or not they would supply bioavailability data on 147 drugs marketed as 1894 drug products. The submitted data were analyzed for completeness, validity and potential usefulness to the pharmacist in making drug product selection decisions. Ninety (57.7 percent) companies responded to the survey. Thirty-eight (24.4 percent) sent data of which that from 29 (18.6 percent) was judged acceptable for use in drug product selection. Acceptable data were submitted on 59 drugs. Data on 46 drugs were considered blood-level bioavailability data while the data on 13 drugs were considered clinical bioavailability data. The results, though relatively limited in number of drugs, represented drugs in a number of different pharmacologic classes, so were judged to be of relatively wide applicability.

A Practical Guide to Drug Product Selection: Getting to Know the Food and Drug Administration's (FDA's) Approved Drug Products List (Orange Book) With Therapeutic Equivalence Evaluations

1995 ◽  
Vol 8 (3) ◽  
pp. 115-120
Author(s):  
David L. Rosen
Keyword(s):  
Health Professionals ◽  
Drug Product ◽  
Therapeutic Equivalence ◽  
Product Selection ◽  
Drug Products ◽  
Practical Guide ◽  
Orange Book

This article provides pharmacists and other health professionals with a practical guide to using FDA's Orange Book, the authoritative source for FDA approved products and their respective therapeutic equivalence ratings. Copyright © 1995 by W.B. Saunders Company

Product Hopping

2017 ◽  
Vol 23 (2) ◽  
Author(s):  
Michael Carrier
Keyword(s):  
Drug Product ◽  
Patent Law ◽  
Decision Makers ◽  
Insurance Companies ◽  
Antitrust Law ◽  
Brand Name ◽  
Product Selection ◽  
Regulatory Frameworks ◽  
Antitrust Analysis ◽  
The U.S

One of the most pressing issues in antitrust law involves “product hopping.” A brand-name pharmaceutical company switches from one version of a drug (say, capsule) to another (say, tablet). The concern with this conduct is that some of these switches offer only a trivial medical benefit but significantly impair generic competition.The antitrust analysis of product hopping is nuanced. In the U.S., it implicates the intersection of antitrust law, patent law, the Hatch-Waxman Act, and state drug product selection laws. In fact, the behavior is even more complex because it involves uniquely complicated markets characterized by buyers (insurance companies, patients) who are different from the decision-makers (physicians).This article introduces the relevant U.S. laws and regulatory frameworks before exploring the five litigated cases.

Bioequivalence and drug product selection

1974 ◽  
Vol 31 (10) ◽  
pp. 931-931
Author(s):  
William A. Zellmer
Keyword(s):  
Drug Product ◽  
Product Selection
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