Detection of adverse drug reactions among ordinary users of liraglutide on the occasion of drug dispensing in the community pharmacy setting.

OBJECTIVES

Postmarketing studies of drugs forms an essential part of safety surveillance. In particular, this concerns new drugs as safety information of these by large rests on randomized clinical studies conducted on a limited number of subjects before licensing. Pharmacists in community pharmacies are in a unique position for detection of user experienced adverse drug reactions (ADRs) in relation to drug dispensing. The study reports from a research initiative exploring prompt and proactive ADR detection of liraglutide and reporting facilitated by pharmacy students undertaking internship in a community pharmacy in Denmark.

METHODS

Nineteen pharmacy students undertaking regular 6 months' internship--eighth semester--in a Danish community pharmacy participated in the data collection. Before the data collection, students attended an interactive training seminar addressing ADRs in general, organ symptoms, diagnostic classification, and pharmacovigilance systems. Pharmacy students approached recurrent drug users purchasing liraglutide. Participating users were asked about experienced ADRs linked to liraglutide use. Reported ADRs were collected and analyzed.

RESULTS

Sixty-two liraglutide users participated in the study, of whom, 38 reported 84 ADRs possibly linked to liraglutide usage. Nausea was by far the most reported ADR followed by decreased appetite, diarrhea, fatigue, and abdominal pain (upper). The reported ADRs are in accordance with previously reported ADRs.

CONCLUSIONS

The study has demonstrated the feasibility of community pharmacy driven pharmacovigilance. The study supports the thesis that community pharmacists in the future may play a proactive and prominent role in patient-centered pharmacovigilance.