Unplanned medication discontinuation as a potential pharmacovigilance signal: a nested young person cohort study

Angela Peichen Sun, Bradley Kirby, Corri Black, Peter John Helms, Marion Bennie, James Stuart McLay*

*Corresponding author for this work

Research output: Contribution to journalArticle

8 Citations (Scopus)
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Abstract

Background: Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people.

Methods: Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation.

Results: During the study period, 79 patients were prescribed orlistat (81% female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52% and 77% at 1 and 3-months. Almost 20% of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1-2 compared to SIMD 9-10 OR 0.09 (95% CI0.01 - 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (>= 17 yr versus, OR 3.07 (95% CI1.03 - 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24% of patients. Urinary retention was reported for 7.6% of patients.

Conclusions: Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people.

Original languageEnglish
Article number11
Number of pages9
JournalBMC Pharmacology
Volume15
DOIs
Publication statusPublished - 4 Mar 2014

Keywords

  • pharmacovigilance
  • pharmacoepidemiology
  • obesity
  • child
  • Orlistat
  • adverse drug reaction
  • medical records systems
  • computerized
  • young people
  • adverse drug-reactions
  • body-mass index
  • obese adolescents
  • general-practice
  • pediatric outpatients
  • insulin-resistance
  • glucose-tolerance
  • controlled-trial
  • children

Cite this

@article{3037332169594e1582c2d98e594a4cfc,
title = "Unplanned medication discontinuation as a potential pharmacovigilance signal: a nested young person cohort study",
abstract = "Background: Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people.Methods: Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation.Results: During the study period, 79 patients were prescribed orlistat (81{\%} female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52{\%} and 77{\%} at 1 and 3-months. Almost 20{\%} of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1-2 compared to SIMD 9-10 OR 0.09 (95{\%} CI0.01 - 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (>= 17 yr versus, OR 3.07 (95{\%} CI1.03 - 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24{\%} of patients. Urinary retention was reported for 7.6{\%} of patients.Conclusions: Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people.",
keywords = "pharmacovigilance, pharmacoepidemiology, obesity, child, Orlistat, adverse drug reaction, medical records systems, computerized, young people, adverse drug-reactions, body-mass index, obese adolescents, general-practice, pediatric outpatients, insulin-resistance, glucose-tolerance, controlled-trial, children",
author = "Sun, {Angela Peichen} and Bradley Kirby and Corri Black and Helms, {Peter John} and Marion Bennie and McLay, {James Stuart}",
note = "This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.",
year = "2014",
month = "3",
day = "4",
doi = "10.1186/2050-6511-15-11",
language = "English",
volume = "15",
journal = "BMC Pharmacology",
issn = "1471-2210",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Unplanned medication discontinuation as a potential pharmacovigilance signal

T2 - a nested young person cohort study

AU - Sun, Angela Peichen

AU - Kirby, Bradley

AU - Black, Corri

AU - Helms, Peter John

AU - Bennie, Marion

AU - McLay, James Stuart

N1 - This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

PY - 2014/3/4

Y1 - 2014/3/4

N2 - Background: Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people.Methods: Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation.Results: During the study period, 79 patients were prescribed orlistat (81% female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52% and 77% at 1 and 3-months. Almost 20% of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1-2 compared to SIMD 9-10 OR 0.09 (95% CI0.01 - 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (>= 17 yr versus, OR 3.07 (95% CI1.03 - 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24% of patients. Urinary retention was reported for 7.6% of patients.Conclusions: Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people.

AB - Background: Because of relatively small treatment numbers together with low adverse drug reaction (ADR) reporting rates the timely identification of ADRs affecting children and young people is problematic. The primary objective of this study was to assess the utility of unplanned medication discontinuation as a signal for possible ADRs in children and young people.Methods: Using orlistat as an exemplar, all orlistat prescriptions issued to patients up to 18 years of age together with patient characteristics, prescription duration, co-prescribed medicines and recorded clinical (Read) codes were identified from the Primary Care Informatics Unit database between 1st Jan 2006-30th Nov 2009. Binary logistic regression was used to assess association between characteristics and discontinuation.Results: During the study period, 79 patients were prescribed orlistat (81% female, median age 17 years). Unplanned medication discontinuation rates for orlistat were 52% and 77% at 1 and 3-months. Almost 20% of patients were co-prescribed an anti-depressant. One month unplanned medication discontinuation was significantly lower in the least deprived group (SIMD 1-2 compared to SIMD 9-10 OR 0.09 (95% CI0.01 - 0.83)) and those co-prescribed at least one other medication. At 3 months, discontinuation was higher in young people (>= 17 yr versus, OR 3.07 (95% CI1.03 - 9.14)). Read codes were recorded for digestive, respiratory and urinary symptoms around the time of discontinuation for 24% of patients. Urinary retention was reported for 7.6% of patients.Conclusions: Identification of unplanned medication discontinuation using large primary care datasets may be a useful tool for pharmacovigilance signal generation and detection of potential ADRs in children and young people.

KW - pharmacovigilance

KW - pharmacoepidemiology

KW - obesity

KW - child

KW - Orlistat

KW - adverse drug reaction

KW - medical records systems

KW - computerized

KW - young people

KW - adverse drug-reactions

KW - body-mass index

KW - obese adolescents

KW - general-practice

KW - pediatric outpatients

KW - insulin-resistance

KW - glucose-tolerance

KW - controlled-trial

KW - children

U2 - 10.1186/2050-6511-15-11

DO - 10.1186/2050-6511-15-11

M3 - Article

VL - 15

JO - BMC Pharmacology

JF - BMC Pharmacology

SN - 1471-2210

M1 - 11

ER -