Implementation of the Harmonized EU Isotretinoin Pregnancy Prevention Programme

Crijns, Ineke; Straus, Sabine M. J. M.; Luteijn, Michiel; Wied, Christine Gispen-de; Raine, June; Berg, Lolkje Jong-van den de

doi:10.2165/11595570-000000000-00000

Cited by 19 publications

(25 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite the introduction of this prevention programme, exposed pregnancies have continued to occur since 2003 and recommendations do not seem to have been applied by health care professionals and patients . A Dutch study reported 143 cases of exposed pregnancies in 22 countries in the European Union between 2003 and 2004 . In France, 147 exposed pregnancies were reported between 2003 and 2006 .…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of compliance with isotretinoin PPP recommendations and exploration of reasons for non‐compliance: Survey among French‐speaking health care professionals and patients in Belgium

Lelubre

Hamdani²,

Senterre

et al. 2018

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

“…5 A Dutch study reported 143 cases of exposed pregnancies in 22 countries in the European Union between 2003 and 2004. 6 In France, 147 exposed pregnancies were reported between 2003 and 2006. 7 In Switzerland, Swissmedic reported in 2017 that approximately 4 to 9 cases occur per year and 6% of exposed pregnancies lead to birth defects.…”

mentioning

confidence: 99%

Evaluation of compliance with isotretinoin PPP recommendations and exploration of reasons for non‐compliance: Survey among French‐speaking health care professionals and patients in Belgium

Lelubre

Hamdani²,

Senterre

et al. 2018

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

show abstract

“…Crijns et al [14] reviewed the pregnancy prevention programs (PPP) in European countries. Pregnancy incidence was reported as 0.02-0.1 percent in women of childbearing age using isotretinoin.…”

Section: Discussionmentioning

confidence: 99%

Systemic Isotretinoin Treatment and Pregnancy: A Longitudinal Cohort Study from Turkey

Özyurt¹,

Kaptanoğlu²

2015

Eurasian J Med

View full text Add to dashboard Cite

Objective: Isotretinoin is known to be the most effective treatment of severe and persistent acne. However, one of the most important adverse effects of this drug is known to be teratogenicity. In this regard, tests are administered before initiating the treatment, to assure that an unknown pregnancy is not present and accordingly, patients are advised to take contraceptive precautions during their systemic isotretinoin treatments. On the contrary, many cases of unwanted pregnancies and relevant abortuses have been reported all over the world. In the Turkish literature, only a few reports have been identified about foetal exposure to isotretinoin. Materials and Methods:In this respect, a study was carried out on fifty-seven female patients, aiming to fulfil the gap of information mentioned above. Female patients, with ages ranging between 14 and 35 years, were recruited to the study and they were administered isotretinoin treatments (cumulative dose of 120 mg/kg) for an average period of 6 months. The patients were followed up during and after the treatment for a total period of 18 months. Results:As a result, it has been observed that none of the patients got pregnant during the treatment period and relevantly, no abortuses or foetal abnormalities were recorded. Moreover, none of the patients got pregnant 12 months after the termination of the treatment. Additionally, the socio-demographic analysis of the patients indicates that most of the patients were single and 81% of the patients were sexually inactive. Conclusion:Our findings suggest that the low reportage of teratogenicity due to isotretinoin usage in Turkey could be due to several reasons, such as the sociocultural profile of the female patients undertaking the isotretinoin treatment, and strict adherence to contraceptive methods, and/or underreporting of teratogenic incidents due to lack of studies held in cooperation with obstetricians.Keywords: Acne, isotretinoin, pregnancy, contraception, teratogenicity Özet Amaç: İzotretinoin şiddetli ve inatçı aknenin bilinen en etkili tedavisidir. Ancak bu ilacın en önemli yan etkilerinden biri teratojenik olmasıdır. Bu sebepten tedavi öncesinde bilinmeyen bir gebelik durumu olup olmadığını ortaya çıkarmak için testler yapılmakta ve beraberinde hastaların sistemik izotretinoin tedavileri boyunca kontraseptif önlemler almaları önerilmektedir. Buna rağmen dünyanın pek çok ülkesinden istenmeyen gebelikler ve bununla ilişkili düşükler bildirilmektedir. Ancak Türk literatüründe fetal izotretinoin maruziyeti ile ilgili yalnızca birkaç bildiri tespit edilmiştir. Gereç ve Yöntem:Yukarıda belirtilen bu veri eksikliğini gidermeye yönelik olarak 57 kadın hasta geriye dönük olarak değerlendirilmiştir. 14-35 yaş arası kadın hastalar ortalama 6 ay boyunca total kümülatif doz olarak 120 mg/kg izotretinoin tedavisi almıştı. Bu hastalar tedavi süresinde ve sonrasında toplam 18 ay boyunca izlenmişti. Bulgular: Sonuç olarak hiçbir hastanın tedavi sürecinde gebelik yaşamadığı ve dolayısıyla herhangi bir düşük ya da fetal ano...

show abstract

“…There is an increased risk of spontaneous abortion as well; however, an accurate estimation is not available [9]. Finally, studies show that compliance to the PPP is limited and isotretinoin pregnancies still occur [10,11]. Recently a Dutch study estimated that 2 per 10,000 pregnancies were exposed to isotretinoin during pregnancy [7].…”

Section: Which Actions Are Possible?mentioning

confidence: 99%

To dispense or not to dispense? Ethical case decision-making in pharmacy practice

et al. 2015

View full text Add to dashboard Cite

In daily practice, pharmacists are regularly confronted with moral problems in which deciding what to do is not always a straightforward decision. In this contribution we show how the use of a specific method for moral deliberation can (in retrospect or prospective) aid moral judgements. We use the case of dispensing isotretinoin to demonstrate one ethical reflection method, namely the Utrecht Method.

show abstract

Implementation of the Harmonized EU Isotretinoin Pregnancy Prevention Programme

Cited by 19 publications

References 13 publications

Evaluation of compliance with isotretinoin PPP recommendations and exploration of reasons for non‐compliance: Survey among French‐speaking health care professionals and patients in Belgium

Evaluation of compliance with isotretinoin PPP recommendations and exploration of reasons for non‐compliance: Survey among French‐speaking health care professionals and patients in Belgium

Systemic Isotretinoin Treatment and Pregnancy: A Longitudinal Cohort Study from Turkey

To dispense or not to dispense? Ethical case decision-making in pharmacy practice

Contact Info

Product

Resources

About