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Risk management of teratogenic medicines: a systematic review
  • Wejdan Shroukh,
  • Douglas Steinke,
  • Sarah WillisOrcid
Wejdan Shroukh
The University of Manchester
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Douglas Steinke
University of Manchester
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Sarah Willis
Orcid
The University of Manchester
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Abstract

Aim: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of child bearing age and studies reporting risk perceptions of teratogenic medications. Methods: MEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counselling, contraceptive counselling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value. Results: Fifty-five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counselling (9.5-99.3%), contraceptive counselling (6.1-98%), pregnancy testing before starting treatment (0-95.1%), pregnancy testing during treatment (12.7-100%), contraception use before starting treatment (15.7-94%), and contraception use during treatment (1.7-100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynaecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and non-pregnant women). An under-estimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynaecologists). And over-estimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations. Conclusion: Considerable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of child bearing age is reported in the literature. A common tendency to over-estimate the risk of teratogenic medications was evident.