Compliance with Pregnancy Prevention Recommendations for Isotretinoin in Estonia in 2012–2016

Uusküla, Anneli; Pisarev, Heti; Kurvits, Katrin; Laius, Ott; Laanpere, Made; Uusküla, Maia

doi:10.1007/s40801-018-0135-z

Cited by 11 publications

(38 citation statements)

References 12 publications

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“…Since 2007, implementation of REMS with ETASU have been required by the FDA for medications with serious safety issues like teratogenic medications to ensure that the benefits of a medication outweigh the risks to patients (Leiderman, 2009). Isotretinoin was the most commonly prescribed teratogenic medication covered by the studies included in this review (n = 16; 29.1%) (Algoblan, Bakhsh, Alharithy, 2019;Boucher & Beaulac-Baillargeon, 2006;Brinker et al, 2005;Cheetham et al, 2006;Crijns et al, 2012;Entezari-Maleki et al, 2012;Hogan et al, 1988 Ozyurt & Kaptanoglu, 2015; Pinheiro et al, 2013;Rao et al, 2000;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014). This may be because of two reasons.…”

Section: Risk Managementmentioning

confidence: 99%

“…Characteristics of the included studies are shown in Table 2 and summarized in Appendix B. (Chave et al, 2001;Mulryan et al, 2018) to 95.1% (Cheetham et al, 2006), pregnancy testing during treatment from 12.7% (Raguideau et al, 2015) to 100% (Hayward et al, 2016), contraception use before starting treatment from 15.7% (Uuskula et al, 2018) to 94% (Brandenburg et al, 2017), and contraception use during treatment from 1.7% (Tsur et al, 2008) to 100% (Ozyurt & Kaptanoglu, 2015).…”

Section: Risk Managementmentioning

confidence: 99%

“…B. Schwarz, Parisi, Williams, Shevchik, & Hess, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Steinkellner et al, 2010;Teichert et al, 2010;Uuskula et al, 2018;Wieck et al, 2007), while others used patients surveys (Algoblan et al, 2019;Banas et al, 2014;Bell et al, 2002;Boucher & Beaulac-Baillargeon, 2006;Brandenburg et al, 2017;Brinker et al, 2005;Castaneda et al, 2008;Chang et al, 2018;Ferguson et al, 2016;Goyal et al, 2015;Lelubre et al, 2018;Leverenz et al, 2019;Mitchell et al, 1995;Ozyurt & Kaptanoglu, 2015;Rao et al, 2000;E. B. Schwarz, Mattocks, et al, 2013;Shilalukey et al, 1997;Tsur et al, 2008;Valle et al, 1998;Werner et al, 2014;Yazdany et al, 2011), a combination of medical records and patient surveys (Bosak et al, 2019;Entezari-Maleki et al, 2012;Hogan et al, 1988;E.…”

Section: Risk Managementmentioning

confidence: 99%

“…B. Schwarz, Parisi, Williams, et al, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Steinkellner et al, 2010) Isotretinoin 16 (29.1%) (Algoblan et al, 2019;Boucher & Beaulac-Baillargeon, 2006;Brinker et al, 2005;Cheetham et al, 2006;Crijns et al, 2012;Entezari-Maleki et al, 2012;Hogan et al, 1988;Lelubre et al, 2018;Mitchell et al, 1995;Ozyurt & Kaptanoglu, 2015;Pinheiro et al, 2013;Rao et al, 2000;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014) Antiepileptic or anticonvulsant medications 5 (9.1%) (Bell et al, 2002;Bhakta et al, 2015;Bosak et al, 2019;Langan et al, 2013;Wieck et al, 2007) Arthritis or lupus medications 4 (7.3%) (Banas et al, 2014;Ferguson et al, 2016;Leverenz et al, 2019;Yazdany et al, 2011) Valproate/valproic acid 4 (7.3%) (Atturu & Odelola, 2015;Gotlib et al, 2016;Mulryan et al, 2018;Paton et al, 2018) Thalidomide or lenalidomide 3 (5.5%) (Brandenburg et al, 2017;Castaneda et al, 2008;Chave et al, 2001) Acitretin 1 (1.8%) (Raguideau et al, 2015) Chemotherapy for breast cancer 1 (1.8%) (Valle et al, 1998) Deferoxamine a...…”

Section: Data Availability Statementmentioning

confidence: 99%

“…B. Schwarz, Parisi, Williams, et al, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014;Yazdany et al, 2011)…”

Section: Data Availability Statementunclassified

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Risk management of teratogenic medicines: A systematic review

Shroukh

Steinke

Willis

2020

Birth Defects Research

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Aim: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing 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 counseling, contraceptive counseling, 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 counseling (9.5%-99.3%), contraceptive counseling (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/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An underestimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And overestimation 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 childbearing age is reported in the literature. A common tendency to overestimate the risk of teratogenic medications was evident.

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Section: Risk Managementmentioning

confidence: 99%

Section: Risk Managementmentioning

confidence: 99%

Section: Risk Managementmentioning

confidence: 99%

Section: Data Availability Statementmentioning

confidence: 99%

“…B. Schwarz, Parisi, Williams, et al, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014;Yazdany et al, 2011)…”

Section: Data Availability Statementunclassified

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Risk management of teratogenic medicines: A systematic review

Shroukh

Steinke

Willis

2020

Birth Defects Research

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Evaluating awareness, knowledge and practice of healthcare professionals following implementation of a revised pregnancy prevention programme for isotretinoin in Ireland: A multi‐stakeholder cross‐sectional study

Hughes¹,

Buckley

Looney

et al. 2022

Pharmacoepidemiology and Drug

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Purpose: In 2018, following an EU-wide safety review, a revised pregnancy prevention programme (PPP) was introduced for isotretinoin (Roaccutane ® ). This study aimed to examine awareness, knowledge, and experience implementing the revised isotretinoin PPP in clinical practice across three healthcare professional (HCP) groups in Ireland.Methods: A cross-sectional study using anonymous online surveys among general practitioners (GPs), community pharmacists, and specialist consultants was undertaken. Descriptive analyses are presented.Results: Across all HCP groups there was high (≥87%) awareness that oral isotretinoin is contraindicated in women of childbearing potential (WCBP) unless the conditions of the PPP are fulfilled, but varying awareness among GPs (54.9%) and community pharmacists (45.9%) that exposure during pregnancy can cause both severe fetal malformations and spontaneous abortions. Implementation of the PPP in clinical practice varied across HCP groups. When initiating isotretinoin in WCBP, 66.7% of specialists and 40.8% of GPs indicated they had considered alternative treatment options, and 71.4% of specialists and 31.6% of GPs reported they first requested a pregnancy test. There was limited provision of the patient reminder card to WCBP, where 26.1% of community pharmacists provide this at each dispensing, while 47.6% of specialists and 11.8% of GPs ensured WCBP had a copy of the card when initiating treatment. Across all HCP groups, there was high (≥81.6%) awareness of the need for urgent consultation and immediate cessation of isotretinoin in the event of an unplanned or suspected pregnancy.Conclusions: Reinforcement of the provision and utilisation of the isotretinoin patient reminder card may be required, and further targeted education on specific elements of the PPP should be considered for GPs and community pharmacists.

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Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015

et al. 2021

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Introduction Several studies have evaluated the effects of changes in isotretinoin risk mitigation programs, but little is known about actual fetal exposure rates in the context of other acne treatments. Objective Our objective was to quantify fetal exposure rates during the use of common acne treatments. Methods Employing the insurance claims data of > 100,000 acne treatment users between 2006 and 2015, we created three user cohorts: (1) isotretinoin (strong teratogen/mandatory risk mitigation program), (2) doxycycline/minocycline (mild teratogen, label warning), and (3) topical clindamycin/erythromycin (no fetal risk). Fetal exposure rates overall and stratified by age were compared after adjusting for potential confounders. Results Contraceptive use during acne treatment was < 50% in isotretinoin users and < 30% in the other study groups. Long-acting contraceptives contributed to 1% of all contraceptives used, with 90% being oral contraceptives. Isotretinoin users had 19.2 (95% confidence interval [CI] 20.3 to 17.9) fewer fetal exposures per 1000 person-years of use compared with doxycycline/minocycline users, which in turn had 28.8 (95% CI 31.2 to 26.3) fewer pregnancies compared with clindamycin/erythromycin users. Stratification by age showed attenuated differences in fetal exposure among acne treatment groups for teenagers. Conclusion Fetal exposure to acne treatments varied according to levels of teratogenicity, with reduced rates among users of isotretinoin and to a lesser extent doxycycline/minocycline. Teenagers had low pregnancy rates but less pronounced differences in fetal exposure across acne treatments.

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Compliance with Pregnancy Prevention Recommendations for Isotretinoin in Estonia in 2012–2016

Cited by 11 publications

References 12 publications

Risk management of teratogenic medicines: A systematic review

Risk management of teratogenic medicines: A systematic review

Evaluating awareness, knowledge and practice of healthcare professionals following implementation of a revised pregnancy prevention programme for isotretinoin in Ireland: A multi‐stakeholder cross‐sectional study

Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015

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