Document Detail

Understanding the adverse effects of cosmetics: a pilot project in cosmetovigilance.
MedLine Citation:
PMID:  18422386     Owner:  NLM     Status:  MEDLINE    
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.
Lidia Sautebin
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Drug safety     Volume:  31     ISSN:  0114-5916     ISO Abbreviation:  Drug Saf     Publication Date:  2008  
Date Detail:
Created Date:  2008-04-21     Completed Date:  2008-09-19     Revised Date:  2014-11-17    
Medline Journal Info:
Nlm Unique ID:  9002928     Medline TA:  Drug Saf     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  433-6     Citation Subset:  IM    
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MeSH Terms
Cosmetics / adverse effects*
European Union
Health Education
Pilot Projects
Product Surveillance, Postmarketing / methods*
Public Health
Reproducibility of Results
Reg. No./Substance:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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