Isotretinoin use and compliance with the dutch pregnancy prevention programme: A retrospective cohort study in females of reproductive age using pharmacy dispensing data

Drug Safety

Volumn 33, Issue 4, 2010, Pages 315-326

  Teichert, Martina ^a,b   Visser, Loes E ^a   Dufour, Mark ^c   Rodenburg, Eline ^d   Straus, Sabine M J M ^a,e   De Smet, Peter A G M ^b,f   Stricker, Bruno H Ch ^a,d  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b Scientific Institute Dutch Pharmacists   (Netherlands)

^c Foundation for Pharmaceutical Statistics   (Netherlands)

^d Drug Safety Unit   (Netherlands)

^e MEDICINES EVALUATION BOARD   (Netherlands)

^f RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANDROGEN; ANTIINFECTIVE AGENT; BENZOYL PEROXIDE; ISOTRETINOIN; MACROLIDE; ORAL CONTRACEPTIVE AGENT; TETRACYCLINE DERIVATIVE; TOPICAL AGENT;

ACNE; ARTICLE; GENERAL PRACTITIONER; HORMONAL CONTRACEPTION; HUMAN; INTRAUTERINE CONTRACEPTIVE DEVICE; PATIENT COMPLIANCE; PHARMACY; PREGNANCY; PRESCRIPTION; PRIORITY JOURNAL; PROGNOSIS;

ABNORMALITIES, DRUG-INDUCED; ACNE VULGARIS; ADOLESCENT; ADULT; COHORT STUDIES; CONTRACEPTIVE AGENTS; DRUG PRESCRIPTIONS; FEMALE; GUIDELINE ADHERENCE; HUMANS; ISOTRETINOIN; MIDDLE AGED; NETHERLANDS; PHARMACEUTICAL SERVICES; RETROSPECTIVE STUDIES; TERATOGENS;

EID: 77949603272     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11319190-000000000-00000     Document Type: Article

References (35)

1. European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Summary information on a referral opinion following an arbitration pursuant to article 29 of directive 2001/83/EG, for isotretinoin/lurantal/trivane/rexidal/scheritonin [online]. Available from URL: http://www.emea.europa.eu/ pdfs/human/referral/isotretinoin/281103en1pdf [Accessed 2009 Apr 20].
2. Brelsford M, Beute TC. Preventing and managing the side effects of isotretinoin. Semin Cutan Med Surg 2008; 27 (3): 197-206
3. Azoulay L, Oraichi D, Berard A. Patterns and utilization of isotretinoin for acne from 1984 to 2003: is there need for concern? Eur J Clin Pharmacol 2006; 62: 667-674
4. Berard A, Azoulay L, Koren G, et al. Isotretinoin, preg-nancies, abortions and birth defects: a population-based perspective. Br J Clin Pharmacol 2007; 63 (2): 196-205
5. Stern R, Rosa F, Baum C. Isotretinoin and pregnancy. J Am Acad Dermatol 1984; 10 (5): 851-854
6. Dai W, LaBraico J, Stern R. Epidemiology of isotretinoin exposure during pregnancy. J Am Acad Dermatol 1992; 26 (4): 599-606
7. Sladden MJ, Harman KE. What is the chance of a normal pregnancy in a woman whose fetus has been exposed to isotretinoin? Arch Dermatol 2007; 143 (9): 1187-1188
8. Lammer E, Flannery D, Barr M. Does isotretinoin cause limb reduction defects? Lancet 1985; II (8450): 328
9. Atanackovic G, Koren G. Young women taking isotretinoin still conceive: role of physicians in preventing disaster. Can Fam Physician 1999; 45: 289-292
10. Cragan J, Friedman J, Holmes L, et al. Ensuring the safe and effective use of medications during pregnancy: planning and prevention through preconception care. Matern Child Health J 2006; 10 (5 Suppl.): S129-35
11. Mitchell AA, Van Bennekom CM, Louik C. A pregnancy-prevention program in women of childbearing age receiving isotretinoin. N Engl J Med 1995; 333 (2): 101-106
12. Stern RS. Isotretinoin prescribing: finding a balance be-tween benefit and risk. Pharmacoepidemiol Drug Saf 2005; 14: 611-613
13. Schonfeld T, Amoura N, Kartochvil C. iPLEDGE alle-giance to the pill: evaluation of year 1 of a birth defect prevention and monitoring system. J Law Med Ethics 2009; 37 (1): 104-117
14. European Medicines Agency, Committee for Proprietary Medicinal Products (CPMP). Summary information on a referral opinion following an arbitration pursant to article 29 of directive 2001/83/EC, for isotretinoin/lurantal/ trivane/rexidal/scheritonin [online]. Available from URL: http://www.ema.europa. eu/pdfs/human/referral/isotretinoin/ 281103en1.pdf [Accessed 2010 Feb 19]
15. Merck. The Merck manual: isotretinoin drug information [online]. Available from URL: http://www.merck.com/ mmpe/lexicomp/isotretinoin. html#N1065CB [Accessed 2010 Feb 19].
16. Sandoz. Isotreinoine sandoz 10/20mg [online]. Available from URL: http://www.sandoz.nl/assets/content/nl/Assortiment/ Isotretinoine- Richtlijnen&waarschuwingen-arts.pdf [Accessed 2010 Feb 19].
17. Ratiofarm product information. Zwangerschaps preventie programma isotretinoine actavis [online]. Available from URL: http://db.cbg-meb.nl/ Bijsluiters/h29163.pdf [Accessed 2010 Feb 19].
18. Roche product information. Pregnancy prevention program: a risk management program to reduce pregnancies during accutane treatment [online]. Available from URL: http://www.fda.gov/ohrms/dockets/ac/00/backgrd/ 3639b1c-06.pdf [Accessed 2010 Feb 19].
19. Smeets JG, Grooten SJ, Bruinsma M, et al. NHG-standard acne. Huisarts Wet 2007; 50: 259-268
20. College ter Beoordeling van Geneesmiddelen. IB1 tekst [online]. Available from URL: http://www.cbg-meb.nl/CBG/ nl/humane-geneesmiddelen/ geneesmiddeleninformatiebank/ default.htm [Accessed 2010 Feb 19].
21. Drug Information Center. Compendium of drug informa-tion. The Hague: The Royal Dutch Association of Pharmacists (KNMP), 2008: 312
22. Commissie Farmaceutische Hulp. Isotretinoine: waarschu-wingen en voorzorgen. Amstelveen: Farmacotherapeutisch kompas. College voor Zorgverzekeringen, 2007
23. Mantel-Teeuwisse AK, Straus SMJM, Lekkerkerker JFF, et al. Community pharmacists' adherence to the isotretinoin pregnancy prevention program in the Netherlands. Drug Saf 2007; 30 (10): 919-990
24. World Health Organization Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment. Oslo: WHO, 2004
25. Dutch Foundation of Pharmaceutical Statistics (SFK). Rem op groei apotheken door sluitingen [online]. Available from URL: http://www.sfk.nl/ publicaties/farmacie-in-cijfers/2009/ 2009-08.html [Accessed 2010 Feb 19].
26. Garcia-Bournissen F, Tsur L, Goldstein LH, et al. Fetal exposure to isotretinoin: an international problem. Reprod Toxicol 2008; 25 (1): 124-128
27. Bensouda-Grimaldi L, Jonville-Bera AP, Mouret E, et al. Isotretinoin: compliance with recommendations in child-bearing women. Ann Dermatol Venereol 2005; 132 (5): 415-423
28. Cheetham TC, Wagner RA, Chiu G, et al. A risk manage-ment program aimed at preventing fetal exposure to iso-tretinoin: retrospective cohort study. J Am Acad Dermatol 2006; 55 (3): 442-448
29. Nava-Ocampo A, Koren G. Human teratogens and evi-dence-based teratogen risk counseling: the motherisk approach. Clin Obstet Gynecol 2007; 50 (1): 123-131
30. NationMaster. Health statistics: age of women at first child-birth (most recent) by country [online]. Available from URL: http://www.nationmaster.com/ graph/hea-age-of-wom-at-fir-chi-health-age-women-first-childbirth [Accessed 2010 Feb 19].
31. Wikipedia. Vasectomie [online]. Available from URL: http:// nl.wikipedia.org/wiki/Vasectomie [Accessed 2009 Sep 14]
32. GIPdatabank: informatie over genees-en hulpmiddelen [online]. Available from URL: http://www.gipdatabank.nl/ [Accessed 2010 Feb 19].
33. Robertson J, Polifka JE, Avner M, et al. A survey of preg-nant women using isotretinoin. Birth Defects Res A Clin Mol Teratol 2005; 73 (11): 881-887
34. Brinker A, Kornegay C, Nourjah P. Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program. Arch Dermatol 2005; 141 (5): 563-569
35. iPLEDGE: committed to pregnancy prevention [online]. Avail-able from URL: http://www.ipledgeprogram.com [Accessed 2009 Feb 13].