How to report a suspected ADR

Clinical description

• Who: any health workers must report suspected ADRs.
• What: any of the following conditions must be reported to the National Pharmacovigilance Centre:

o Well-known side effect or ADR of the medicine given. This allows the DHA and PMRA to compare the incidence rate of the reaction to the documented rate by the manufacturer.

o Non-serious ADRs: a change in the incidence rate, distribution or clinical presentation of the reaction may constitute a safety signal.

o Rare ADRs: rare ADRs are commonly not documented as they were not seen in clinical trials. A rare ARD may constitute a safety signal.

• How: Fill the standard paper reporting form (Suspected ADR Reporting Form, version 1.1).

Whenever possible, also submit the report via cell-phone to the Medisafe-360 USSD platform.

o Send the paper ADR reporting form to the district pharmacovigilance focal person for submission to the National Pharmacovigilance Centre o The pharmacovigilance focal person is responsible for collecting and summarising all ADRs to the District Health Management Team (DHMT). S/He collaborates with district program coordinators (ART, TB, Malaria, Family planning, etc.)

118 Pharmacovigilance Using the paper ADR Reporting Form

• Fill all mandatory fields for each section:

Section Details 1 Patient name, age, birth date, gender, etc.

2 AE description, date of onset, action, lab results, outcome + date (e.g. death)

3 Suspected medicine generic and brand name, batch number 4 Other medicines taken, incl. herbal remedies 5 Reporters name and contact details Using the Medsafe-360 USSD platform

• Can be accessed toll-free from any basic or smart-phone (Airtel or TNM) by dialling *360#
• Mirrors the paper ADR reporting form
• Respond to the questions in sequence using the number-pad or keyboard of your phone