Understanding the adverse effects of cosmetics: a pilot project in cosmetovigilance.
Currently, cosmetics and toiletries are very popular and their use continues to increase because consumers consider physical appearance important and, at the same time, these products are considered to be safe. However, in spite of their safety and tolerability, during recent decades, we have become aware that adverse effects can occur. The number of adverse effects known so far is very low indeed. This is partly because such adverse effects are underestimated as a result of self-diagnosis and self-medication, which are common behaviours in the presence of mild-to-moderate reactions, as in the case of cosmetics. Moreover, such effects are underestimated because of the absence of formal and reliable monitoring systems ('cosmetovigilance'). This requires the creation of a standard reporting form, as well as resolution concerning professional categories authorized to report and the subsequent validation/evaluation of the collected forms. All these items are of great importance, not only to investigate but also to prevent risks caused by cosmetic use. A pilot project was undertaken to test the effectiveness of a notification system by the validation of either a reporting form or the role of dermatologists and community pharmacists as reporting categories. Collection of reporting forms began in July 2006 and it is still in progress; the preliminary data reported here refer to the period July 2006-June 2007 and mainly concern the recording and validation of the collected reporting forms. During this period, we have received 40 reporting forms (32 by dermatologists and 8 by pharmacists). The validation process of the recorded forms revealed several drawbacks, such as incompleteness (19 forms), inadequacy of the description of the suspected undesirable effect and its location (2), illegible handwriting (6) and mistaken statements (3). Six forms reported a misuse of a cosmetic product: four of these were related to the site of application while two were related to time. In one case, instructions for use were not followed. In conclusion, our experience regarding the notification of adverse effects of cosmetics, although limited to a restricted geographical area, suggests that for an efficient and reliable monitoring system to be in place, which includes all the necessary measures to protect public health, an education and training programme for all stakeholders (health professionals, consumers and appropriate authorities) is required.
Sautebin
Lidia
L
Department of Experimental Pharmacology, University of Naples Federico II, Naples, Italy. sautebin@unina.it
D003358:Cosmetics / Q000009:adverse effects*; D003880:Dermatology; D005062:European Union; D006266:Health Education; D006801:Humans; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011634:Public Health; D015203:Reproducibility of Results
D003358:Cosmetics