Assessment and Reporting of Cutaneous ADRS

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Chapter: Pharmacovigilance: Dermatological ADRs

Case assessment should begin with an accurate description of the skin lesions.


Case assessment should begin with an accurate description of the skin lesions. If a specific diagnosis is proposed, then it is important to know if it has been made or confirmed by a dermatologist. The use of lay words is often more informative than the use of ‘specific’ terms when the accuracy of these terms is not certain.

Relevant clinical information includes:

Distribution of lesions

Face, hands, feet vs. thorax and abdomen

Photoexposed vs. covered areas

Number of lesions

Pattern of individual lesions (macules, purpura, blisters, pustules, etc.)

Mucous membrane involvement.

It is important to distinguish whether the cutaneous part of an orifice of the body is involved or if there are lesions of mucous membranes (e.g. lips vs. mouth, scrotum vs. glans on genitalia, etc.). Only mucous membrane lesions indicate a severe reaction.

•   Duration of the eruption

•   Associated symptoms/signs



Lymph node enlargement.

The documentation of cases should be completed by photographic pictures. Cheap disposable cameras and digital cameras can provide both easy and adequate documentation. This will be of major help for the retrospective assessment of cases by experts.

A skin biopsy is not useful in mild eruptions, but is mandatory for all severe reactions. It will allow a retrospective validation of the diagnosis and in some cases may help to exclude non-drug causes of a reaction pattern.

Information should be obtained on the presence of factors that increase the risk of drug eruptions: HIV infection, acute EBV infection, collagen-vascular disease.

The attribution to a newly released drug of a few cases of severe cutaneous reactions may lead to restrictions in the use of this drug, with important medical and economic impacts. This underlines the importance of a good assessment of cases, which should be proportional to the seriousness of the reaction.

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