Original article
Effective monitoring of isotretinoin safety in a pediatric dermatology population: A novel “patient symptom survey” approach

https://doi.org/10.1016/j.jaad.2010.06.040Get rights and content

Background

Assessment of adverse effects in pediatric patients on oral isotretinoin has not been standardized and the exact incidence is unknown.

Objective

Our goal was to determine the usefulness of an isotretinoin symptom survey as a screening tool for assessment and quantification of adverse effects, including psychiatric symptoms, during isotretinoin treatment in a pediatric population of different age groups.

Methods

We performed a retrospective chart review on a random sample of patients treated with isotretinoin at a tertiary pediatric dermatology clinic where patients completed an isotretinoin symptom survey at each visit. Responses were stratified by age group and psychiatric history.

Results

The charts of 102 patients, representing 123 courses of isotretinoin and 760 treatment-months, were reviewed. A total of 722 (95.0%) symptom surveys were complete and 38 (5.0%) were incomplete/missing. Recorded side effects were similar to published adult data; dry lips/dry skin were reported in 94.25% and 72.13% of treatment-months of isotretinoin, respectively. Psychiatric symptoms were reported in 1.65%, with no statistical difference between patients with or without a mental health history. Patients aged 11 to 15 years had similar side-effect profiles to those aged 16 to 21 years. Impaired night vision, nosebleeds, and dry/bloodshot eyes were more common in the older age group.

Limitations

This was a retrospective chart review, with known limitations. The study was performed at a tertiary referral center for pediatric dermatology, possibly allowing patient selection bias.

Conclusions

The isotretinoin symptom survey appears to be an effective screening tool to standardize monitoring of isotretinoin side effects in the pediatric population.

Section snippets

Methods

A retrospective chart review was conducted on a random sample of patients, who were prescribed isotretinoin at the pediatric dermatology clinic between February 2003 and August 2007. The study was approved by the institutional review board of Rady Children's Hospital/University of California, San Diego (protocol #070858).

The ISS (Fig 1) was designed to assess the presence or absence of 13 possible adverse effects: dry lips, dry/bloodshot eyes, dry skin, muscle aches/pains, nosebleeds, frequent

Results

The sample size was 102 individual patients, with 123 courses of isotretinoin. There were 760 patient-months of collected data. Of the 123 documented courses of isotretinoin, 73 (59.3%) patients were male and 50 (40.7%) were female. The age range was 11 to 21 years, with an average age of 15.26 years and SD of 1.62. There were 722 (95.0%) complete symptom surveys, 30 (3.95%) with incomplete data entry, and only 8 (1.05%) unsubmitted surveys (Table I).

The incidence of symptoms is demonstrated in

Discussion

We found that the ISS was used in 98.95% of isotretinoin visits and 95.0% of these surveys recorded a complete data set. We included both complete and incomplete surveys, because we believed that responses should not be invalidated simply because the patient failed to circle a response to one question on the survey. Calculations reflect only the reported data, without modification for answers omitted by the patient.

The ISS presents individualized patient-reported information, providing a

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    Supported in part by a grant from the National Institutes of Health.

    Conflicts of interest: None declared.

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