Pilot to facilitate the reporting of ADRs in hospitals

ADRs in patients admitted to the hospital or in outpatients can easily report an ADR with only the patient identification number, the suspected drug and the ADR by sending an e-mail to a dedicated e-mail address. Clinical pharmacologists (in training) collect the ADRs from the e-mail inbox and complete the ADRs with information from the Electronic Medical Record of the hospital. After completion, the ADRs are sent hard copy to the pharmacovigilance centre where the reports are anonymized and follow the same processes as other spontaneous reports. The reports from the JBZ are marked in the Lareb-database.

The pilot with the facilitated reporting lasted for 6 weeks in the Department of Geriatric Medicine. Forty-five mails with ADRs were sent during the pilot which is close to what physicians and pharmacists in that particular hospital report in a year. So far, most of the reported ADRs are known and included in the summary of product characteristics, but the level of detail (electrolyte levels, additional diagnostic procedures and so on) is higher than in the average spontaneous report.

Currently, the pilot is finished and the project expands slowly throughout the hospital. The e-mail address is introduced to the Department of Internal Medicine and the number of reported ADRs is increasing. The received reports will also be discussed internally in an expert group with help of the Netherlands Pharmacovigilance Centre Lareb and will be used as much as possible to spread knowledge on ADRs for educational purposes in the hospital and the pharmacovigilance centre.