Enhancing pharmacosurveillance with systematic collection of treatment indication in electronic prescribing: a validation study in Canada

Drug Saf. 2010 Jul 1;33(7):559-67. doi: 10.2165/11534580-000000000-00000.


Background: Adverse drug reaction reports used in pharmacosurveillance often lack complete information on treatment indication that is important for benefit-risk analyses and clinical and regulatory decision making. A systematic documentation of treatment indication using electronic prescribing applications provides an opportunity to develop new pharmacosurveillance tools that will allow evaluation of drugs by weighing benefits and risks for specific indications, and evaluate off-label prescribing. In addition, interfacing indications with reminders and clinical guidelines can enhance clinical decision making. We investigated the validity of treatment indications documented using an electronic prescribing system at the time of prescribing.

Objectives: To determine the sensitivity and positive predictive value (PPV) of an electronic prescribing system in documenting treatment indications at the time of drug prescribing, and to investigate the use of treatment indication data to evaluate off-label prescribing in primary-care practice.

Study design and setting: We prospectively assessed the validity of documenting treatment indication using an electronic prescribing system by comparing it with treatment indications documented by physician-facilitated medical chart review ('gold standard'). Sensitivity and PPV were evaluated in 338 patients of 22 community-based primary-care physicians in Quebec, Canada, in 2006.

Results: The sensitivity of the electronic prescribing system in documenting treatment indication was 98.5% (95% CI 96.5, 99.5) and the PPV of the system in accurately identifying the treatment indication was 97.0% (95% CI 94.2, 98.6). The treatment indication data collected using this system allowed assessment of off-label prescribing.

Conclusions: The electronic prescribing system offers a valid method for documenting treatment indication at the time of prescribing. Our results provide strong evidence to support incorporating mandatory recording of treatment indication in integrated electronic prescribing systems to provide a critical piece of information for the evaluation of safety and effectiveness of drugs.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Drug Prescriptions* / standards
  • Electronic Prescribing* / standards
  • Female
  • Humans
  • Male
  • Medical Records Systems, Computerized / organization & administration
  • Medical Records Systems, Computerized / standards*
  • Medical Records Systems, Computerized / trends
  • Middle Aged
  • Off-Label Use / standards
  • Prospective Studies
  • Quebec