Article

Causality methods in Cosmetovigilance: Comparison of Colipa and PLM versus global introspection

Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH 's-Hertogenbosch, The Netherlands.
Regulatory Toxicology and Pharmacology (Impact Factor: 2.14). 05/2012; 63(3):409-17. DOI: 10.1016/j.yrtph.2012.05.005
Source: PubMed

ABSTRACT The European Cosmetics Regulation requires a post-marketing system for detection of undesirable effects on human health of cosmetic products. Colipa, the European Cosmetic, toiletry and perfumery association, provided guidelines for causality assessment of these effects. In addition another causality method originally designed for causality rating in Post Launch Monitoring (PLM) of novel foods has been employed to assess causality of cosmetic products. In this study these two causality schemes for consumer cosmetic products were validated against clinical assessment, using the method of global introspection (GI) in 100 reported cases. Causality assessments were performed by three experienced assessors in pharmacovigilance. In the event of discordance between the assessors, an adapted Delphi method was used. The overall Spearman correlation coefficient was 0.74 for comparison of Colipa versus GI, whereas this was 0.50 for PLM versus GI. According to current guidelines, the sensitivity was 0.95 for both the Colipa and PLM method, specificity was 0.84 for Colipa and 0.40 for PLM. From these results it can be concluded the performance of the Colipa causality method yielded better correlation to GI than PLM causality method. The factor identified from comparison of these two schemes as having greatest impact was the course of the reaction.

Download full-text

Full-text

Available from: Paul Anthony Hepburn, May 24, 2014
0 Followers
 · 
140 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance (Revidal-Gerda), whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigilance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories. Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market.
    European journal of dermatology: EJD 12/2014; 24(6):643-9. DOI:10.1684/ejd.2014.2493 · 1.95 Impact Factor