Recruitment of a cohort of lamotrigine users through community pharmacists: differences between patients who gave informed consent and those who did not

Pharmacoepidemiol Drug Saf. 2005 Feb;14(2):107-12. doi: 10.1002/pds.992.

Abstract

Objective: Community pharmacists may function as intermediaries in the recruitment of a population-based cohort of patients using specific drugs. In this study, baseline characteristics and the retention rate of patients that gave informed consent, refused and did not answer were compared.

Methods: A total of 1819 patients using the new antiepileptic drug (AED) lamotrigine were asked to provide informed consent for a retrospective chart study via their individual pharmacist. Four possible reactions resulted from the consent question: active consent, active refusal, passive refusal and non-informed. Patient characteristics and lamotrigine retention rate of the different groups were compared.

Results: Pharmacists did not inform a total of 183 patients (10%). Of the remaining patients, a total of 968 (59%) gave consent; 101 (6%) actively refused and 567 (35%) did not respond. Age, burden of illness, psychotropic co-medication and continuation of lamotrigine therapy were related to active consent. Lamotrigine retention rate in patients that gave consent was higher than in other patients.

Conclusions: Patient recruitment with community pharmacists as intermediaries for observational studies on the effects of (new) drugs is feasible, and allows access to a broad population of patients. The recruitment procedure, however, may lead to selection bias.

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • Anticonvulsants / administration & dosage*
  • Anticonvulsants / therapeutic use
  • Cohort Studies
  • Community Pharmacy Services*
  • Epilepsy / drug therapy
  • Female
  • Health Status
  • Humans
  • Informed Consent*
  • Lamotrigine
  • Male
  • Middle Aged
  • Patient Selection*
  • Pharmacists / statistics & numerical data*
  • Retrospective Studies
  • Socioeconomic Factors
  • Triazines / administration & dosage*
  • Triazines / therapeutic use

Substances

  • Anticonvulsants
  • Triazines
  • Lamotrigine