| Risk communication method | |||
---|---|---|---|---|
MADRAC Bulletin | Safety Alert | DHPC | Educational material | |
Author | NPRA | NPRA | Product registration holder, reviewed by NPRA | Product registration holder, NPRA, MOH |
Target audience | Healthcare professionals | Healthcare professionals | Healthcare professionals | Healthcare professionals or patients |
Dissemination method | • Email to healthcare professionals in NPRA mailing list, administrative heads of healthcare facilities, professional associations • NPRA website | By product registration holder directly to healthcare professionals who use the product mentioned in DHPC | • By product registration holder or MOH directly to healthcare professionals • By healthcare professionals to patients | |
Content | • Local ADR case reports • MADRAC activities • Latest pharmacovigilance activities | • Latest or emerging safety issues • Summary of DHPCs | Important changes to medicinal product information. | Additional information to minimize risk of using the product, in addition to package insert information. |
Frequency of publication | Every four months | As required, depending on emerging safety issues. |