title: Implementation of the harmonized EU isotretinoin Pregnancy Prevention Programme: a questionnaire survey among European regulatory agencies.
abstract: BACKGROUND
  There is little information on the status of the implementation of the isotretinoin Pregnancy Prevention Programme (PPP) in the EU, and on compliance with this programme by the regulatory agencies.
  
  
  OBJECTIVE
  The aim of the study was to obtain information on implementation of the harmonized PPP of isotretinoin in the EU member states plus Norway and Iceland.
  
  
  METHODS
  In January 2009, a questionnaire (request for non-urgent information [NUI]) was sent to all 25 EU member states, plus Norway and Iceland, to collect information on the implementation status of the PPP and its effectiveness.
  
  
  RESULTS
  The response rate was 82% (22 of the 27 countries). In 21 of the 27 member states, isotretinoin is marketed and the PPP is in force, and in 18 of the 22 responding countries, the total required elements (seven) following a formal EU review are incorporated in the PPP. Seven member states had additional measures in place. In spite of implementation of the PPP and additional measures, a total of 143 isotretinoin-exposed pregnancies have been reported in 16 of the 22 responding member states since implementation of the harmonized PPP.
  
  
  CONCLUSIONS
  Despite implementation of the isotretinoin PPP in most member states, isotretinoin-exposed pregnancies were reported. This has led some member states to implement additional measures to the PPP, resulting in inconsistency with the approach agreed in 2003 following the European-wide review. It has been further suggested that common elements should be developed for PPPs for all medicines that are known to carry a high teratogenic risk.
authors: Medicines Evaluation Board, The Hague, the Netherlands. hj.crijns@cbg-meb.nl
authors: Ineke
authors: I
authors: Crijns
authors: Sabine
authors: S
authors: Straus
authors: Michiel
authors: M
authors: Luteijn
authors: Christine
authors: C
authors: Gispen-de Wied
authors: June
authors: J
authors: Raine
authors: Lolkje
authors: L
authors: de Jong-van den Berg
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D003267:Contraception / Q000379:methods* / Q000592:standards; D003879:Dermatologic Agents / Q000009:adverse effects; D005062:European Union; D005260:Female; D006077:Government Agencies; D019983:Guideline Adherence; D006284:Health Plan Implementation; D006306:Health Surveys; D006801:Humans; D007055:Iceland; D015474:Isotretinoin / Q000009:adverse effects*; D009664:Norway; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D013723:Teratogens; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D013723:Teratogens; D015474:Isotretinoin