Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK

D. Layton, Hazel Kathryn Sinclair, Christine Margaret Bond, Philip Christopher Hannaford, S. A. Shakir

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

Purpose The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies.

Method Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization.

Results A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p=0.0006 and 8.8 vs. 5.8%, p=0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms.

Conclusion Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-ups rates. Copyright (C) 2002 John Wiley Sons, Ltd.

Original languageEnglish
Pages (from-to)503-513
Number of pages10
JournalPharmacoepidemiology and Drug Safety
Volume11
Issue number6
DOIs
Publication statusPublished - 2002

Keywords

  • pharmacovigilance
  • non-prescription medicines
  • pharmacists
  • ibuprofen
  • DRUG-INTERACTIONS
  • MEDICATION

Cite this

@article{f751821e510540a383342d7c35d63c46,
title = "Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK",
abstract = "Purpose The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies.Method Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization.Results A total of 1021 eligible customers were recruited, 6.4{\%} (466/7320) and 48.2{\%} (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5{\%}), asthma (7.2 and 10.5{\%}), stomach/peptic ulcer (3.5 and 2.1{\%}), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2{\%}, p=0.0006 and 8.8 vs. 5.8{\%}, p=0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9{\%}, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1{\%}, respectively. Most participants did not seek medical advice for their symptoms.Conclusion Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-ups rates. Copyright (C) 2002 John Wiley Sons, Ltd.",
keywords = "pharmacovigilance, non-prescription medicines, pharmacists, ibuprofen, DRUG-INTERACTIONS, MEDICATION",
author = "D. Layton and Sinclair, {Hazel Kathryn} and Bond, {Christine Margaret} and Hannaford, {Philip Christopher} and Shakir, {S. A.}",
year = "2002",
doi = "10.1002/pds.734",
language = "English",
volume = "11",
pages = "503--513",
journal = "Pharmacoepidemiology and Drug Safety",
issn = "1053-8569",
publisher = "John Wiley and Sons Ltd",
number = "6",

}

TY - JOUR

T1 - Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK

AU - Layton, D.

AU - Sinclair, Hazel Kathryn

AU - Bond, Christine Margaret

AU - Hannaford, Philip Christopher

AU - Shakir, S. A.

PY - 2002

Y1 - 2002

N2 - Purpose The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies.Method Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization.Results A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p=0.0006 and 8.8 vs. 5.8%, p=0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms.Conclusion Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-ups rates. Copyright (C) 2002 John Wiley Sons, Ltd.

AB - Purpose The incidence of serious adverse events from non-prescription medicines remains to be established. The aim of this initial pilot work, using an observational cohort design, was to determine the feasibility of conducting a pharmacovigilance study of a non-prescription medicine, based in community pharmacies.Method Community pharmacists from Grampian, Scotland, and Hampshire, England, recruited user-purchasers of ibuprofen. Exposure data were collected from a series of self-completed questionnaires. Outcome data were any new symptoms, use of concomitant medication and subsequent health-care utilization.Results A total of 1021 eligible customers were recruited, 6.4% (466/7320) and 48.2% (555/1152) by the Hampshire and Grampian networks respectively. The cohorts differed with regard to age, smoking and socio-economic status, reason for purchase and recommendation, and duration of use. The two cohorts reported different use of concomitant medication (46.0 and 65.5%), asthma (7.2 and 10.5%), stomach/peptic ulcer (3.5 and 2.1%), a higher prevalence of gastrointestinal symptoms post-compared to pre-purchase (12.9 vs. 7.2%, p=0.0006 and 8.8 vs. 5.8%, p=0.034), ingestion of doses in excess of the licensed non-prescription dose by 5.1 and 3.9%, and discontinuation of treatment because the medicine upset them by 4.5 and 3.1%, respectively. Most participants did not seek medical advice for their symptoms.Conclusion Greater vigilance is required for adverse events that may be attributable to non-prescription product use. Development of pharmacovigilance models using community pharmacies is one means of systematically collecting information regarding drug safety. Further work is needed to identify a method which maximizes patient recruitment whilst maintaining acceptable follow-ups rates. Copyright (C) 2002 John Wiley Sons, Ltd.

KW - pharmacovigilance

KW - non-prescription medicines

KW - pharmacists

KW - ibuprofen

KW - DRUG-INTERACTIONS

KW - MEDICATION

U2 - 10.1002/pds.734

DO - 10.1002/pds.734

M3 - Article

VL - 11

SP - 503

EP - 513

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

SN - 1053-8569

IS - 6

ER -