TY - JOUR
T1 - The limitations of some European healthcare databases for monitoring the effectiveness of Pregnancy Prevention Programmes as risk minimisation measures
AU - Charlton, Rachel
AU - Bettoli, Vincenzo
AU - Bos, H Jens
AU - Engeland, Anders
AU - Garne, Ester
AU - Gini, Rosa
AU - Hansen, Anne
AU - de Jong-van den Berg, Lolkje
AU - Jordan, Sue
AU - Klungsøyr, Kari
AU - Neville, Amanda
AU - Pierini, Anna
AU - Puccini, Aurora
AU - Sinclair, Marlene
AU - Thayer, Daniel
AU - Dolk, Helen
PY - 2018/4/1
Y1 - 2018/4/1
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 - Electronic health records
KW - Isotretinoin
KW - Pregnancy
KW - Pregnancy prevention programme
KW - Teratogen
UR - http://www.scopus.com/inward/record.url?scp=85037681665&partnerID=8YFLogxK
U2 - 10.1007/s00228-017-2398-9
DO - 10.1007/s00228-017-2398-9
M3 - Article
SN - 0031-6970
VL - 74
SP - 513
EP - 520
JO - European Journal of Clinical Pharmacology
JF - European Journal of Clinical Pharmacology
IS - 4
ER -