An exploratory study of drug abuse and dependence information in package inserts

J Addict Dis. 2007;26(2):25-34. doi: 10.1300/J069v26n02_04.

Abstract

Information about drug abuse and dependence from package inserts of centrally acting drugs was evaluated for content. Of the 77 labels reviewed, 40 were opiate agonists, 18 were stimulants, and the remainder fell into other selected categories. The amount of information ranged from 0-66 sentences, with greatest variability found in the opiate agonists (range 9-66). Information amount was significantly correlated with the year of drug approval (p < 0.001) but not with the latest label revision (p = 0.749). Information amount did not differ significantly with warning strength or schedule. While most package inserts explain physical dependence, tolerance, and withdrawal, there is a lack of information about psychological dependence. Variability in information about abuse and dependence potential is high and can affect prescribing by physicians and counseling by pharmacists, underscoring the need for further studies.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Central Nervous System Stimulants* / adverse effects
  • Central Nervous System Stimulants* / therapeutic use
  • Drug Labeling* / standards
  • Drug-Related Side Effects and Adverse Reactions
  • Health Services Needs and Demand
  • Humans
  • Illicit Drugs*
  • Narcotics* / adverse effects
  • Narcotics* / therapeutic use
  • Patient Education as Topic / standards
  • Psychotropic Drugs* / adverse effects
  • Psychotropic Drugs* / therapeutic use
  • Substance-Related Disorders / prevention & control*
  • United States
  • United States Food and Drug Administration

Substances

  • Central Nervous System Stimulants
  • Illicit Drugs
  • Narcotics
  • Psychotropic Drugs