title: Notification of undesirable effects of cosmetics and toiletries.
abstract: An undesirable effect (UE) of a cosmetic product is a harmful reaction attributable to its normal or reasonably foreseeable use. However, the knowledge of UEs, at the population level, is limited by the absence of formal and reliable cosmetovigilance systems, which nevertheless are characterized by underreporting. To test the feasibility of the collection of UEs in our territory we have carried out a pilot project aimed to assess either the notification procedures or the validation/evaluation of the collected forms in our territory. As reporting categories, we have chosen dermatologists and community pharmacists who were asked to notify UEs to cosmetics through a reporting form we have set up. During the period July 2006-December 2007, we have registered 76 reporting forms. Dermatologists who have sent 47 reporting forms represented the main reporting category, followed by community pharmacists (15 reports), other health professionals (9 reports) and consumers (5 reports). Several drawbacks, mainly represented by the incompleteness and inaccuracy of the filled in forms, affected the validation process. Thus, on receipt, we could validate only 34 forms and only after a careful check with each single reporter, we could include in the study other 36 forms. The validation of the collected reports has stressed the importance of a well-structured reporting form, an easy access to notification procedures as well as education and training programme. The evaluation of the validated forms has revealed the need of a controlled term vocabulary for the classification of the observed events and diagnosis, especially with regard to cutaneous reactions that represented almost the totality of the reported events (95.7%). Among the events (n=45) reported by dermatologists, 22 were diagnosed as allergic contact dermatitis (ACD) and 18 as irritant contact dermatitis (ICD). Facial care products (19.7%), followed by body care products (16.9%), perfumes (12.7%) and eye care products (11.3%) were the cosmetics mainly suspected to be responsible for the observed events. Correspondingly, face (n=37), including periorbital and perioral area, forehead, ocular mucous membrane and lips, followed by entire body (n=9) were the body sites reported as more involved. In conclusions, our experience allowed us to identify the main pitfalls of the system we have experienced. These are setting/formulation of the reporting form, notification step, description of the event and diagnosis. A careful settlement of these aspects could substantially contribute to the establishment of an efficient reporting system, although the bias due to underreporting is difficult to eliminate.
authors.affiliation: Department of Experimental Pharmacology, University of Naples Federico II, Naples, Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.forename: Simona
authors.initials: S
authors.lastname: Cammarota
authors.forename: Simona
authors.initials: S
authors.lastname: de Portu
authors.forename: Lidia
authors.initials: L
authors.lastname: Sautebin
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003358:Cosmetics / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D003358:Cosmetics