A pilot study to evaluate a community pharmacy-based monitoring system to identify adverse drug reactions associated with paediatric medicines use

Mansour Tobaiqy, Derek Stewart, Peter J. Helms, Christine Bond, Amanda Jane Lee, Nick Bateman, Dorothy McCaig, James McLay

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

INTRODUCTION: Current pharmacovigilance systems are limited by spontaneous reporting of adverse drug reactions (ADRs), lack of a denominator, and lower than expected reporting rates. The aim of our study was to undertake a formal pilot evaluation of a community pharmacy-led ADR monitoring system. METHODS: The setting was community pharmacies in five Health Boards areas of Scotland. Subjects were parents, guardians, or children presenting prescriptions for children 16 years and under prescribed serotonin specific reuptake inhibitors (SSRI), anticonvulsants, or medicines for the treatment of attention deficit hyperactivity disorder (ADHD). All pharmacies (n = 827) were invited to participate. Over a 3-month period they were asked to identify prescriptions for targeted medicines and give out an ADR questionnaire. Questionnaire content included child demography, duration of medicine use, indication, perceived ADRs, and their description and severity. The study was approved by the North of Scotland Research Ethics Committee. RESULTS: Seventy-two community pharmacists (8.7%) agreed to take part. Two hundred and twenty-nine questionnaires were distributed and 55 (24%) completed and returned by parents. Forty-one questionnaires related to ADHD medications, 13 to anticonvulsants, and 1 to an SSRI. Thirty questionnaires reported 44 possible ADRs, 19 of which were related to methylphenidate. CONCLUSIONS: The proposed ADR monitoring system identified expected ADRs thus demonstrating face and content validity for our approach. However the process was limited by low community pharmacist participation rates and low questionnaire return rates.
Original languageEnglish
Pages (from-to)627-632
Number of pages6
JournalEuropean Journal of Clinical Pharmacology
Volume66
Issue number6
Early online date2 Mar 2010
DOIs
Publication statusPublished - Jun 2010

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Pharmacies
Drug-Related Side Effects and Adverse Reactions
Pediatrics
Drug Monitoring
Serotonin Uptake Inhibitors
Scotland
Attention Deficit Disorder with Hyperactivity
Pharmacists
Anticonvulsants
Prescriptions
Parents
Pharmacovigilance
Methylphenidate
Research Ethics Committees
Reproducibility of Results
Surveys and Questionnaires
Medicine
Demography
Health

Keywords

  • Adverse drug reactions
  • Pharmacovigilance
  • Children
  • Questionnaire

Cite this

A pilot study to evaluate a community pharmacy-based monitoring system to identify adverse drug reactions associated with paediatric medicines use. / Tobaiqy, Mansour; Stewart, Derek; Helms, Peter J.; Bond, Christine; Lee, Amanda Jane; Bateman, Nick; McCaig, Dorothy; McLay, James.

In: European Journal of Clinical Pharmacology, Vol. 66, No. 6, 06.2010, p. 627-632.

Research output: Contribution to journalArticle

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