Guidelines for submitting adverse event reports for publication.

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

Intranasally administered corticosteroids and neuropsychiatric disturbances: a review of the international pharmacovigilance programme of the World Health Organization.

BACKGROUND: The systemic use of corticosteroids is connected with a variety of psychiatric and neurologic effects. Corticosteroids for intranasal administration (INCs) are considered to act locally and to exert minimal systemic effects. An unexpected cluster of case reports of neuropsychiatric disorders during intranasal corticosteroid use was reported to the World Health Organization Uppsala Monitoring Centre. OBJECTIVE: To investigate the possible connection between intranasal corticosteroid use and the development of neuropsychiatric disorders, as reported to the International Pharmacovigilance Programme. METHODS: All reports containing adverse event terms indicating neuropsychiatric disturbances in suspected connection with intranasal corticosteroids were retrieved from Vigibase and evaluated (April 2006). The case reports are heterogeneous and vary regarding source, documentation quality, and relationship likelihood. RESULTS: A total of 429 reports were received from 16 countries (1980-April 2006), of neuropsychiatric events occurring in patients using INCs, representing 7.6% of the total of reports regarding these drugs in the same period. Frequently reported events were nervousness, anxiety, agitation, insomnia, emotional lability, depression, somnolence, confusion, convulsions, and migraine. Most reports concerned fluticasone propionate, beclometasone dipropionate, mometasone furoate, or budesonide. In 370 reports (86.2%), the INC was the sole suspect drug and in 220 (51.3%) it was the only drug used. In 97 of 108 patients who had discontinued use of the intranasal corticosteroid, the reaction abated. Of 41 patients, 32 had a relapse when the drug was reintroduced. CONCLUSIONS: The data collected by the International Pharmacovigilance Programme suggest that the intranasal use of corticosteroids can be complicated by neuropsychiatric adverse reactions. Further study is needed to confirm the connection and to determine the frequency and risk factors of such reactions.