Monitoring Adverse Drug reactions in children using community pharmacies

a pilot study

D. stewart, Peter Joseph Benedict Helms, D. mccaig, Christine Margaret Bond, James Stuart McLay

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Aims

To determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children.

Design

Prospective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0-11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension.

Setting

Seven community pharmacies in Grampian, Scotland.

Results

During a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5%) agreed to participate in the study. One hundred and six participants (40%) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9%) and tiredness (31.6%) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15% and 20%, 7.4% and 18.5%, and 20% and 0%, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3%). Eight children (21.2%) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n = )]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age.

Conclusions

The prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible.

Original languageEnglish
Pages (from-to)677-683
Number of pages7
JournalBritish Journal of Clinical Pharmacology
Volume59
Issue number6
DOIs
Publication statusPublished - Jun 2005

Keywords

  • adverse drug reactions
  • children
  • community
  • parental
  • pharmacy
  • questionnaire
  • pediatric wards
  • general-practice
  • pharmacovigilance
  • outpatients

Cite this

Monitoring Adverse Drug reactions in children using community pharmacies : a pilot study . / stewart, D.; Helms, Peter Joseph Benedict; mccaig, D.; Bond, Christine Margaret; McLay, James Stuart.

In: British Journal of Clinical Pharmacology, Vol. 59, No. 6, 06.2005, p. 677-683.

Research output: Contribution to journalArticle

@article{6ffb34a392594675afcfa59471b3349f,
title = "Monitoring Adverse Drug reactions in children using community pharmacies: a pilot study",
abstract = "AimsTo determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children.DesignProspective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0-11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension.SettingSeven community pharmacies in Grampian, Scotland.ResultsDuring a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5{\%}) agreed to participate in the study. One hundred and six participants (40{\%}) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9{\%}) and tiredness (31.6{\%}) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15{\%} and 20{\%}, 7.4{\%} and 18.5{\%}, and 20{\%} and 0{\%}, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3{\%}). Eight children (21.2{\%}) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n = )]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age.ConclusionsThe prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible.",
keywords = "adverse drug reactions, children, community, parental, pharmacy, questionnaire, pediatric wards, general-practice, pharmacovigilance, outpatients",
author = "D. stewart and Helms, {Peter Joseph Benedict} and D. mccaig and Bond, {Christine Margaret} and McLay, {James Stuart}",
year = "2005",
month = "6",
doi = "10.1111/j.1365-2125.2005.02424.x",
language = "English",
volume = "59",
pages = "677--683",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
publisher = "Wiley-Blackwell",
number = "6",

}

TY - JOUR

T1 - Monitoring Adverse Drug reactions in children using community pharmacies

T2 - a pilot study

AU - stewart, D.

AU - Helms, Peter Joseph Benedict

AU - mccaig, D.

AU - Bond, Christine Margaret

AU - McLay, James Stuart

PY - 2005/6

Y1 - 2005/6

N2 - AimsTo determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children.DesignProspective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0-11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension.SettingSeven community pharmacies in Grampian, Scotland.ResultsDuring a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5%) agreed to participate in the study. One hundred and six participants (40%) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9%) and tiredness (31.6%) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15% and 20%, 7.4% and 18.5%, and 20% and 0%, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3%). Eight children (21.2%) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n = )]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age.ConclusionsThe prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible.

AB - AimsTo determine the feasibility of a community pharmacy-based parental adverse drug reaction (ADR) reporting system for children.DesignProspective study of parent-reported ADRs using a questionnaire issued to the parent or guardians of children 0-11 years of age collecting prescribed medicine for amoxicillin, and/or salbutamol, and collecting prescribed medicine for, or purchasing, paracetamol or ibuprofen suspension.SettingSeven community pharmacies in Grampian, Scotland.ResultsDuring a 4-week period 360 prescriptions or purchases for the study medications occurred. Two hundred and sixty-seven parents (85.5%) agreed to participate in the study. One hundred and six participants (40%) returned a total of 122 questionnaires. The demographics of responders and nonresponders including medication, age of child, and social status as assessed by the Depcat score were similar. There was no evidence of under-representation of any socio-economic group. Possible adverse events were detected using a symptom tick list and perceived ADRs using free text entry. Using the symptom tick list approach the most commonly reported symptoms were diarrhoea (28.9%) and tiredness (31.6%) for amoxicillin. The levels of diarrhoea and tiredness reported for ibuprofen, paracetamol and salbutamol were 15% and 20%, 7.4% and 18.5%, and 20% and 0%, respectively. Using the freehand section of the questionnaire 15 specific ADRs were reported by parents (12.3%). Eight children (21.2%) reported ADRs attributed to amoxicilin [diarrhoea (n = 4), fever (n = 1), anorexia (n = 1), hyperactivity (n = 1) and nonspecific (n = 1)], five to paracetamol [diarrhoea (n = 3), anorexia, irritability, crying and very angry (n = 1) and not stated (n = 1)], two to ibuprofen [diarrhoea (n = 1), not stated (n = )]. Only one off-label prescription was identified and this was for salbutamol syrup prescribed to a child under 2 years of age.ConclusionsThe prospective monitoring of paediatric ADRs, using a questionnaire issued to parents or guardians in the community pharmacies, is feasible.

KW - adverse drug reactions

KW - children

KW - community

KW - parental

KW - pharmacy

KW - questionnaire

KW - pediatric wards

KW - general-practice

KW - pharmacovigilance

KW - outpatients

U2 - 10.1111/j.1365-2125.2005.02424.x

DO - 10.1111/j.1365-2125.2005.02424.x

M3 - Article

VL - 59

SP - 677

EP - 683

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

IS - 6

ER -