The limitations of some European healthcare databases for monitoring the effectiveness of Pregnancy Prevention Programmes as risk minimisation measures.Concise title – Healthcare data to evaluate pregnancy prevention programmes

Research output: Contribution to journalArticle

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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 require 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.MethodsAn 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.ResultsData 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 often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests. ConclusionCurrent 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.
LanguageEnglish
JournalEuropean Journal of Pharmacology
Volume55
Early online date11 Dec 2017
DOIs
Publication statusE-pub ahead of print - 11 Dec 2017

Fingerprint

Databases
Delivery of Health Care
Pregnancy
Contraception
Prescriptions
Pregnancy Tests
Secondary Care
Induced Abortion
Wales
Denmark
Norway
Netherlands
Italy
Primary Health Care
Equipment and Supplies

Keywords

  • pregnancy
  • teratogen
  • pregnancy prevention programme
  • electronic health records
  • isotretinoin

Cite this

@article{9d6457c3f6c84183a167184f47b948b7,
title = "The limitations of some European healthcare databases for monitoring the effectiveness of Pregnancy Prevention Programmes as risk minimisation measures.Concise title – Healthcare data to evaluate pregnancy prevention programmes",
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 require 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.MethodsAn 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.ResultsData 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 often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests. ConclusionCurrent 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.",
keywords = "pregnancy, teratogen, pregnancy prevention programme, electronic health records, isotretinoin",
author = "Sinclair, {Marlene .} and Helen Dolk",
note = "Reference text: References 1. European Medicine Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2). 2017 [cited 2017 05 July]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. 2. European Medicines Agency. (2015) Towards optimising risk minimisation measures. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Report/2015/12/WC500198810.pdf [Accessed on 07.05.2017]. 3. Whitley L, Knight C, Gabbay F. Risk minimisation and measuring effectiveness - the evolving challenge. Available from www.transcrip-partners.com/files/download/78 [Accessed on 07.07.2017]. 4. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, Braun JT, et al. Retinoic Acid Embryopathy. New England Journal of Medicine. 1985;313(14):837-41. 5. McBride W. Thalidomide and congenital abnormalities. Lancet. 1961;2:1358. 6. Howard WB, Willhite CC. Toxicity of Retinoids in Humans and Animals. Journal of Toxicology: Toxin Reviews. 1986;5(1):55-94. 7. Bonebrake R, Casey MJ, Huerter C, Ngo B, O'Brien R, Rendell M. Ethical challenges of pregnancy prevention programs. Cutis. 2008;81(6):494-500. 8. Roche Products (Ireland) Limited. 2016. Roaccutane: Pregnancy Prevention Programme. Physician's guide to prescribing Isotretinoin (Roaccutane) Available from https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/roaccutane-prescriber-guide.pdf?sfvrsn=2. Accessed on 08/06/2016. 9. Acitretin Summary of Prouct Characteristics. 2015 Available from http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1463720374780.pdf Accessed on 09.06/2016. 10. Crijns I, Zomerdijk I, Sturkenboom M, de Jong-van den Berg L, Straus S. A comparison of pregnancy prevention programmes in Europe. Expert Opinion on Drug Safety. 2014;13(4):411-20. 11. Crijns HJ, Straus SM, Gispen-de Wied C, de Jong-van den Berg LT. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. 2011;164(2):238-44. 12. Raguideau F, Mezzarobba M, Zureik M, Weill A, Ricordeau P, Alla F. Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin. Pharmacoepidemiology and Drug Safety. 2015;24(5):526-33. 13. Henry D, Dormuth C, Winquist B, Carney G, Bugden S, Teare G, et al. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ : Canadian Medical Association Journal. 2016;188(10):723-30. 14. EUROmediCAT. Safety of medication use in pregnancy (2011) Available from http://euromedicat.eu/. 15. Charlton RA, Neville AJ, Jordan S, Pierini A, Damase-Michel C, Klungs{\o}yr K, et al. Healthcare databases in Europe for studying medicine use and safety during pregnancy. Pharmacoepidemiol Drug Saf. 2014;23(6):586-94. 16. Dolk H. EUROCAT: 25 years of European surveillance of congenital anomalies. Arch Dis Child Fetal Neonatal Ed. 2005;90:F355-F8. 17. Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011;39(7 suppl):30-3. 18. Wallach Kildemoes H, Toft S{\o}rensen H, Hallas J. The Danish National Prescription Registry. Scand J Public Health. 2011;39(7 suppl):38-41. 19. Thygesen LC, Daasnes C, Thaulow I, Br{\o}nnum-Hansen H. Introduction to Danish (nationwide) registers on health and social issues: Structure, access, legislation, and archiving. Scand J Public Health. 2011;39(7 suppl):12-6. 20. Schirm E, Tobi H, de Jong-van den Berg LTW. Identifying parents in pharmacy data: a tool for the continuous monitoring of drug exposure to unborn children. J Clin Epidemiol. 2004;57(7):737-41. 21. Bakker MK, Jentink J, Vroom F, Van Den Berg PB, De Walle HE, De Jong-Van Den Berg LT. Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands. BJOG. 2006;113(5):559-68. 22. Espnes MG, Bj{\o}rge T, Engeland A. Comparison of recorded medication use in the Medical Birth Registry of Norway with prescribed medicines registered in the Norwegian Prescription Database. Pharmacoepidemiol Drug Saf. 2011;20(3):243-8. 23. Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, S{\o}rensen HT. The Nordic Countries as a Cohort for Pharmacoepidemiological Research. Basic Clin Pharmacol Toxicol. 2010;106(2):86-94. 24. Klungs{\o}yr K, Morken NH, Irgens L, Vollset SE, Skj{\ae}rven R. Secular trends in the epidemiology of pre-eclampsia throughout 40 years in Norway: prevalence, risk factors and perinatal survival. Paediatr Perinat Epidemiol. 2012;26(3):190-8. 25. Coloma PM, Schuemie MJ, Trifir{\`o} G, Gini R, Herings R, Hippisley-Cox J, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 2011;20(1):1-11. 26. Coloma PM, Trifir{\`o} G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, et al. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf. 2012;21(6):611-21. 27. Gagne JJ, Maio V, Berghella V, Louis DZ, Gonnella JS. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol. 2008;64(11):1125-32. 28. Ford D, Jones K, Verplancke J-P, Lyons R, John G, Brown G, et al. The SAIL Databank: building a national architecture for e-health research and evaluation. BMC Health Serv Res. 2009;9(1):157. 29. Lyons R, Jones K, John G, Brooks C, Verplancke J-P, Ford D, et al. The SAIL databank: linking multiple health and social care datasets. BMC Med Inform Decis Mak. 2009;9(1):3. 30. Wood L, Martinez C. The General Practice Research Database: Role in pharmacovigilance. Drug Saf. 2004;27(12):871-81. 31. Charlton RA, Snowball J, Sammon CJ, de Vries CS. The Clinical Practice Research Datalink for drug safety in Pregnancy Research: an overview. Therapie. 2013;69(1):83-9. 32. Goodfield MJ, Cox NH, Bowser A, McMillan JC, Millard LG, Simpson NB, et al. Advice on the safe introduction and continued use of isotretinoin in acne in the U.K. 2010. Br J Dermatol. 2010;162(6):1172-9. 33. Medicines Healthcare products Regulatory Agency. 2014. Guidance - Isotretinoin for severe acne:uses and effects. Available from https://www.gov.uk/government/publications/isotretinoin-for-severe-acne-uses-and-effects/isotretinoin-for-severe-acne-uses-and-effects [Accessed 19.07.2017]. 34. Schaefer C, Meister R, Weber-Schoendorfer C. Isotretinoin exposure and pregnancy outcome: an observational study of the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy. Arch Gynecol Obstet. 2010;281(2):221-7. 35. de Jonge L, Garne E, Gini R, Jordan SE, Klungsoyr K, Loane M, et al. Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study. Drug Safety. 2015;38(11):1083-93. 36. Lagan BM, Dolk H, White B, Uges DRA, Sinclair M. Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies. Pharmacoepidemiology and Drug Safety. 2014;23(4):411-8. 37. Holmes, Bankowska, Mackie. The prescription of isotretinoin to women: is every precaution taken? Br J Dermatol. 1998;138(3):450-5. 38. Wildfang I, Nielsen N, Jemec G, Ibsen H, Avnstorp C. Isotretinoin in Denmark - 20 years on. J Dermatolog Treat. 2002;13(3):151-2. 39. Crijns I, Mantel-Teeuwisse A, Bloemberg R, Pinas E, Straus S, de Jong-van den Berg L. Healthcare professional surveys to investigate the implementation of the isotretinoin Pregnancy Prevention Programme: a descriptive study. Expert Opinion on Drug Safety. 2013;12(1):29-38. 40. K{\"a}ll{\'e}n B. Restriction of the use of drugs with teratogenic properties: Swedish experiences with isotretinoin. Teratology. 1999;60(2):53-. 41. De Santis M, Straface G, Cavaliere A, Nobili E, Caruso A. The need for restricted prescription of retinoic acid derivative isotretinoin to prevent retinoid teratogenicity. Prev Med. 2007;45(2-3):243-4. 42. Crijns HJMJ, van Rein N, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LTW. Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study. Pharmacoepidemiol Drug Saf. 2012;21(10):1060-6. 43. Teichert M, Visser L, Dufour M, Rodenburg E, Straus SJM, Smet PGM, et al. Isotretinoin Use and Compliance with the Dutch Pregnancy Prevention Programme. Drug Saf. 2010;33(4):315-26. 44. Zomerdijk IM, Ruiter R, Houweling LMA, Herings RMC, Sturkenboom MCJM, Straus SMJM, et al. Isotretinoin exposure during pregnancy: a population-based study in The Netherlands. BMJ Open. 2014;4(11). 45. European Medicines Agency. Valproate and related substances and their use in pregnant women. [Cited 08/07/2016] Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Valproate_and_related_substances_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500175214.pdf [Accessed 07.07.2017].",
year = "2017",
month = "12",
day = "11",
doi = "10.1007/s00228-017-2398-9",
language = "English",
volume = "55",
journal = "European Journal of Pharmacology",
issn = "0014-2999",
publisher = "Elsevier",

}

TY - JOUR

T1 - The limitations of some European healthcare databases for monitoring the effectiveness of Pregnancy Prevention Programmes as risk minimisation measures.Concise title – Healthcare data to evaluate pregnancy prevention programmes

AU - Sinclair, Marlene .

AU - Dolk, Helen

N1 - Reference text: References 1. European Medicine Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2). 2017 [cited 2017 05 July]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. 2. European Medicines Agency. (2015) Towards optimising risk minimisation measures. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Report/2015/12/WC500198810.pdf [Accessed on 07.05.2017]. 3. Whitley L, Knight C, Gabbay F. Risk minimisation and measuring effectiveness - the evolving challenge. Available from www.transcrip-partners.com/files/download/78 [Accessed on 07.07.2017]. 4. Lammer EJ, Chen DT, Hoar RM, Agnish ND, Benke PJ, Braun JT, et al. Retinoic Acid Embryopathy. New England Journal of Medicine. 1985;313(14):837-41. 5. McBride W. Thalidomide and congenital abnormalities. Lancet. 1961;2:1358. 6. Howard WB, Willhite CC. Toxicity of Retinoids in Humans and Animals. Journal of Toxicology: Toxin Reviews. 1986;5(1):55-94. 7. Bonebrake R, Casey MJ, Huerter C, Ngo B, O'Brien R, Rendell M. Ethical challenges of pregnancy prevention programs. Cutis. 2008;81(6):494-500. 8. Roche Products (Ireland) Limited. 2016. Roaccutane: Pregnancy Prevention Programme. Physician's guide to prescribing Isotretinoin (Roaccutane) Available from https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/roaccutane-prescriber-guide.pdf?sfvrsn=2. Accessed on 08/06/2016. 9. Acitretin Summary of Prouct Characteristics. 2015 Available from http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1463720374780.pdf Accessed on 09.06/2016. 10. Crijns I, Zomerdijk I, Sturkenboom M, de Jong-van den Berg L, Straus S. A comparison of pregnancy prevention programmes in Europe. Expert Opinion on Drug Safety. 2014;13(4):411-20. 11. Crijns HJ, Straus SM, Gispen-de Wied C, de Jong-van den Berg LT. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol. 2011;164(2):238-44. 12. Raguideau F, Mezzarobba M, Zureik M, Weill A, Ricordeau P, Alla F. Compliance with pregnancy prevention plan recommendations in 8672 French women of childbearing potential exposed to acitretin. Pharmacoepidemiology and Drug Safety. 2015;24(5):526-33. 13. Henry D, Dormuth C, Winquist B, Carney G, Bugden S, Teare G, et al. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ : Canadian Medical Association Journal. 2016;188(10):723-30. 14. EUROmediCAT. Safety of medication use in pregnancy (2011) Available from http://euromedicat.eu/. 15. Charlton RA, Neville AJ, Jordan S, Pierini A, Damase-Michel C, Klungsøyr K, et al. Healthcare databases in Europe for studying medicine use and safety during pregnancy. Pharmacoepidemiol Drug Saf. 2014;23(6):586-94. 16. Dolk H. EUROCAT: 25 years of European surveillance of congenital anomalies. Arch Dis Child Fetal Neonatal Ed. 2005;90:F355-F8. 17. Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011;39(7 suppl):30-3. 18. Wallach Kildemoes H, Toft Sørensen H, Hallas J. The Danish National Prescription Registry. Scand J Public Health. 2011;39(7 suppl):38-41. 19. Thygesen LC, Daasnes C, Thaulow I, Brønnum-Hansen H. Introduction to Danish (nationwide) registers on health and social issues: Structure, access, legislation, and archiving. Scand J Public Health. 2011;39(7 suppl):12-6. 20. Schirm E, Tobi H, de Jong-van den Berg LTW. Identifying parents in pharmacy data: a tool for the continuous monitoring of drug exposure to unborn children. J Clin Epidemiol. 2004;57(7):737-41. 21. Bakker MK, Jentink J, Vroom F, Van Den Berg PB, De Walle HE, De Jong-Van Den Berg LT. Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands. BJOG. 2006;113(5):559-68. 22. Espnes MG, Bjørge T, Engeland A. Comparison of recorded medication use in the Medical Birth Registry of Norway with prescribed medicines registered in the Norwegian Prescription Database. Pharmacoepidemiol Drug Saf. 2011;20(3):243-8. 23. Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, Sørensen HT. The Nordic Countries as a Cohort for Pharmacoepidemiological Research. Basic Clin Pharmacol Toxicol. 2010;106(2):86-94. 24. Klungsøyr K, Morken NH, Irgens L, Vollset SE, Skjærven R. Secular trends in the epidemiology of pre-eclampsia throughout 40 years in Norway: prevalence, risk factors and perinatal survival. Paediatr Perinat Epidemiol. 2012;26(3):190-8. 25. Coloma PM, Schuemie MJ, Trifirò G, Gini R, Herings R, Hippisley-Cox J, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 2011;20(1):1-11. 26. Coloma PM, Trifirò G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, et al. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf. 2012;21(6):611-21. 27. Gagne JJ, Maio V, Berghella V, Louis DZ, Gonnella JS. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol. 2008;64(11):1125-32. 28. Ford D, Jones K, Verplancke J-P, Lyons R, John G, Brown G, et al. The SAIL Databank: building a national architecture for e-health research and evaluation. BMC Health Serv Res. 2009;9(1):157. 29. Lyons R, Jones K, John G, Brooks C, Verplancke J-P, Ford D, et al. The SAIL databank: linking multiple health and social care datasets. BMC Med Inform Decis Mak. 2009;9(1):3. 30. Wood L, Martinez C. The General Practice Research Database: Role in pharmacovigilance. Drug Saf. 2004;27(12):871-81. 31. Charlton RA, Snowball J, Sammon CJ, de Vries CS. The Clinical Practice Research Datalink for drug safety in Pregnancy Research: an overview. Therapie. 2013;69(1):83-9. 32. Goodfield MJ, Cox NH, Bowser A, McMillan JC, Millard LG, Simpson NB, et al. Advice on the safe introduction and continued use of isotretinoin in acne in the U.K. 2010. Br J Dermatol. 2010;162(6):1172-9. 33. Medicines Healthcare products Regulatory Agency. 2014. Guidance - Isotretinoin for severe acne:uses and effects. Available from https://www.gov.uk/government/publications/isotretinoin-for-severe-acne-uses-and-effects/isotretinoin-for-severe-acne-uses-and-effects [Accessed 19.07.2017]. 34. Schaefer C, Meister R, Weber-Schoendorfer C. Isotretinoin exposure and pregnancy outcome: an observational study of the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy. Arch Gynecol Obstet. 2010;281(2):221-7. 35. de Jonge L, Garne E, Gini R, Jordan SE, Klungsoyr K, Loane M, et al. Improving Information on Maternal Medication Use by Linking Prescription Data to Congenital Anomaly Registers: A EUROmediCAT Study. Drug Safety. 2015;38(11):1083-93. 36. Lagan BM, Dolk H, White B, Uges DRA, Sinclair M. Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies. Pharmacoepidemiology and Drug Safety. 2014;23(4):411-8. 37. Holmes, Bankowska, Mackie. The prescription of isotretinoin to women: is every precaution taken? Br J Dermatol. 1998;138(3):450-5. 38. Wildfang I, Nielsen N, Jemec G, Ibsen H, Avnstorp C. Isotretinoin in Denmark - 20 years on. J Dermatolog Treat. 2002;13(3):151-2. 39. Crijns I, Mantel-Teeuwisse A, Bloemberg R, Pinas E, Straus S, de Jong-van den Berg L. Healthcare professional surveys to investigate the implementation of the isotretinoin Pregnancy Prevention Programme: a descriptive study. Expert Opinion on Drug Safety. 2013;12(1):29-38. 40. Källén B. Restriction of the use of drugs with teratogenic properties: Swedish experiences with isotretinoin. Teratology. 1999;60(2):53-. 41. De Santis M, Straface G, Cavaliere A, Nobili E, Caruso A. The need for restricted prescription of retinoic acid derivative isotretinoin to prevent retinoid teratogenicity. Prev Med. 2007;45(2-3):243-4. 42. Crijns HJMJ, van Rein N, Gispen-de Wied CC, Straus SM, de Jong-van den Berg LTW. Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study. Pharmacoepidemiol Drug Saf. 2012;21(10):1060-6. 43. Teichert M, Visser L, Dufour M, Rodenburg E, Straus SJM, Smet PGM, et al. Isotretinoin Use and Compliance with the Dutch Pregnancy Prevention Programme. Drug Saf. 2010;33(4):315-26. 44. Zomerdijk IM, Ruiter R, Houweling LMA, Herings RMC, Sturkenboom MCJM, Straus SMJM, et al. Isotretinoin exposure during pregnancy: a population-based study in The Netherlands. BMJ Open. 2014;4(11). 45. European Medicines Agency. Valproate and related substances and their use in pregnant women. [Cited 08/07/2016] Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Valproate_and_related_substances_31/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500175214.pdf [Accessed 07.07.2017].

PY - 2017/12/11

Y1 - 2017/12/11

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 require 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.MethodsAn 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.ResultsData 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 often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests. ConclusionCurrent 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 require 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.MethodsAn 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.ResultsData 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 often not available. Data availability on contraception to estimate compliance with contraception requirements was variable and no data were available on pregnancy tests. ConclusionCurrent 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 - pregnancy

KW - teratogen

KW - pregnancy prevention programme

KW - electronic health records

KW - isotretinoin

U2 - 10.1007/s00228-017-2398-9

DO - 10.1007/s00228-017-2398-9

M3 - Article

VL - 55

JO - European Journal of Pharmacology

T2 - European Journal of Pharmacology

JF - European Journal of Pharmacology

SN - 0014-2999

ER -