The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

R A Charlton, V Bettoli, H J Bos, A Engeland, E Garne, R Gini, A V Hansen, L T W de Jong-van den Berg, S Jordan, K Klungsøyr, A J Neville, A Pierini, A Puccini, M Sinclair, D Thayer, H Dolk

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

PURPOSE: Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases.

METHODS: An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs.

RESULTS: Data availability varied between databases. All databases could be used to identify the frequency and duration of prescriptions to women of childbearing age from primary care, but there were specific issues with availability of data from secondary care and private care. To estimate the frequency of exposed pregnancies, all databases could be linked to pregnancy data, but the accuracy of timing of the start of pregnancy was variable, and data on pregnancies ending in induced abortions were often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests.

CONCLUSION: Current electronic healthcare databases do not contain all the data necessary to fully monitor the effectiveness of PPP implementation, and thus, special data collection measures need to be instituted.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Clinical Pharmacology
Vol/bind74
Udgave nummer4
Sider (fra-til)513-520
ISSN0031-6970
DOI
StatusUdgivet - 2018

Fingeraftryk

Databases
Delivery of Health Care
Prescriptions
Wales
Denmark
Norway
Netherlands
Italy
Primary Health Care
Equipment and Supplies

Citer dette

Charlton, R A ; Bettoli, V ; Bos, H J ; Engeland, A ; Garne, E ; Gini, R ; Hansen, A V ; de Jong-van den Berg, L T W ; Jordan, S ; Klungsøyr, K ; Neville, A J ; Pierini, A ; Puccini, A ; Sinclair, M ; Thayer, D ; Dolk, H. / The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures. I: European Journal of Clinical Pharmacology. 2018 ; Bind 74, Nr. 4. s. 513-520.
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abstract = "PURPOSE: Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases.METHODS: An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs.RESULTS: Data availability varied between databases. All databases could be used to identify the frequency and duration of prescriptions to women of childbearing age from primary care, but there were specific issues with availability of data from secondary care and private care. To estimate the frequency of exposed pregnancies, all databases could be linked to pregnancy data, but the accuracy of timing of the start of pregnancy was variable, and data on pregnancies ending in induced abortions were often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests.CONCLUSION: Current electronic healthcare databases do not contain all the data necessary to fully monitor the effectiveness of PPP implementation, and thus, special data collection measures need to be instituted.",
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Charlton, RA, Bettoli, V, Bos, HJ, Engeland, A, Garne, E, Gini, R, Hansen, AV, de Jong-van den Berg, LTW, Jordan, S, Klungsøyr, K, Neville, AJ, Pierini, A, Puccini, A, Sinclair, M, Thayer, D & Dolk, H 2018, 'The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures', European Journal of Clinical Pharmacology, bind 74, nr. 4, s. 513-520. https://doi.org/10.1007/s00228-017-2398-9

The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures. / Charlton, R A; Bettoli, V; Bos, H J; Engeland, A; Garne, E; Gini, R; Hansen, A V; de Jong-van den Berg, L T W; Jordan, S; Klungsøyr, K; Neville, A J; Pierini, A; Puccini, A; Sinclair, M; Thayer, D; Dolk, H.

I: European Journal of Clinical Pharmacology, Bind 74, Nr. 4, 2018, s. 513-520.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - The limitations of some European healthcare databases for monitoring the effectiveness of pregnancy prevention programmes as risk minimisation measures

AU - Charlton, R A

AU - Bettoli, V

AU - Bos, H J

AU - Engeland, A

AU - Garne, E

AU - Gini, R

AU - Hansen, A V

AU - de Jong-van den Berg, L T W

AU - Jordan, S

AU - Klungsøyr, K

AU - Neville, A J

AU - Pierini, A

AU - Puccini, A

AU - Sinclair, M

AU - Thayer, D

AU - Dolk, H

PY - 2018

Y1 - 2018

N2 - PURPOSE: Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases.METHODS: An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs.RESULTS: Data availability varied between databases. All databases could be used to identify the frequency and duration of prescriptions to women of childbearing age from primary care, but there were specific issues with availability of data from secondary care and private care. To estimate the frequency of exposed pregnancies, all databases could be linked to pregnancy data, but the accuracy of timing of the start of pregnancy was variable, and data on pregnancies ending in induced abortions were often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests.CONCLUSION: Current electronic healthcare databases do not contain all the data necessary to fully monitor the effectiveness of PPP implementation, and thus, special data collection measures need to be instituted.

AB - PURPOSE: Pregnancy prevention programmes (PPPs) exist for some medicines known to be highly teratogenic. It is increasingly recognised that the impact of these risk minimisation measures requires periodic evaluation. This study aimed to assess the extent to which some of the data needed to monitor the effectiveness of PPPs may be present in European healthcare databases.METHODS: An inventory was completed for databases contributing to EUROmediCAT capturing pregnancy and prescription data in Denmark, Norway, the Netherlands, Italy (Tuscany/Emilia Romagna), Wales and the rest of the UK, to determine the extent of data collected that could be used to evaluate the impact of PPPs.RESULTS: Data availability varied between databases. All databases could be used to identify the frequency and duration of prescriptions to women of childbearing age from primary care, but there were specific issues with availability of data from secondary care and private care. To estimate the frequency of exposed pregnancies, all databases could be linked to pregnancy data, but the accuracy of timing of the start of pregnancy was variable, and data on pregnancies ending in induced abortions were often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests.CONCLUSION: Current electronic healthcare databases do not contain all the data necessary to fully monitor the effectiveness of PPP implementation, and thus, special data collection measures need to be instituted.

KW - Journal Article

U2 - 10.1007/s00228-017-2398-9

DO - 10.1007/s00228-017-2398-9

M3 - Journal article

VL - 74

SP - 513

EP - 520

JO - European Journal of Clinical Pharmacology

JF - European Journal of Clinical Pharmacology

SN - 0031-6970

IS - 4

ER -