| A pilot study to evaluate a community pharmacy-based monitoring system to identify adverse drug reactions associated with paediatric medicines use. | |
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MedLine Citation:
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PMID: 20195588 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Mansour Tobaiqy; Derek Stewart; Peter J Helms; Christine Bond; Amanda Jane Lee; Nick Bateman; Dorothy McCaig; James McLay |
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Publication Detail:
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Type: Journal Article Date: 2010-03-02 |
Journal Detail:
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Title: European journal of clinical pharmacology Volume: 66 ISSN: 1432-1041 ISO Abbreviation: Eur. J. Clin. Pharmacol. Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-05-13 Completed Date: 2010-07-26 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 1256165 Medline TA: Eur J Clin Pharmacol Country: Germany |
Other Details:
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Languages: eng Pagination: 627-32 Citation Subset: IM |
Affiliation:
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Division of Applied Health Sciences, The Aberdeen Medical School, The University of Aberdeen, Abeerden, UK. m.tobaiqy@abdn.ac.uk |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adverse Drug Reaction Reporting Systems / organization & administration* Anticonvulsants / adverse effects* Child Child, Preschool Drug Toxicity / chemically induced, epidemiology* Humans Incidence Infant Infant, Newborn Melatonin / adverse effects Methylphenidate / adverse effects* Pharmacies / statistics & numerical data* Pilot Projects Propylamines / adverse effects Prospective Studies Questionnaires Sample Size Scotland Serotonin Uptake Inhibitors / adverse effects* Severity of Illness Index |
| Chemical | |
Reg. No./Substance:
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0/Anticonvulsants; 0/Propylamines; 0/Serotonin Uptake Inhibitors; 113-45-1/Methylphenidate; 73-31-4/Melatonin; 83015-26-3/atomoxetine |
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