A pilot study to evaluate a community pharmacy-based monitoring system to identify adverse drug reactions associated with paediatric medicines use.
BACKGROUND
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.
Tobaiqy
Mansour
M
Division of Applied Health Sciences, The Aberdeen Medical School, The University of Aberdeen, Abeerden, UK. m.tobaiqy@abdn.ac.uk
Stewart
Derek
D
Helms
Peter J
PJ
Bond
Christine
C
Lee
Amanda Jane
AJ
Bateman
Nick
N
McCaig
Dorothy
D
McLay
James
J
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000927:Anticonvulsants / Q000009:adverse effects*; D000069445:Atomoxetine Hydrochloride; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008550:Melatonin / Q000009:adverse effects; D008774:Methylphenidate / Q000009:adverse effects*; D010594:Pharmacies / Q000706:statistics & numerical data*; D010865:Pilot Projects; D011437:Propylamines / Q000009:adverse effects; D011446:Prospective Studies; D018401:Sample Size; D012606:Scotland; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
D000927:Anticonvulsants; D000069445:Atomoxetine Hydrochloride; D008550:Melatonin; D008774:Methylphenidate; D011437:Propylamines; D017367:Selective Serotonin Reuptake Inhibitors