Patient details Health number: this may be a national identifier (preferred), hospital, clinic, or program number Name: full name is preferable as an accurate identifier, for follow up purposes and to avoid duplication Address and telephone number: to allow for follow up and accurate identification. Sex Date of birth (DOB) (preferred) or age, if DOB is unknown (add “est” if age is estimated). Weight and height 26 December 2018 Habab K Elkheir

Patient details Patient medical history of significance This section may include any relevant medical history. The information could include end-organ disease (e.g. of the lung, kidney, or liver), malnutrition. Any other medication OTC, prescription or herbal 26 December 2018 Habab K Elkheir

Details of medicines All medicines that were taken at the time preceding the reaction should be listed. Each suspect medicine can be indicated by an asterisk. Name(s) of medicines: (this may be the brand and generic name) and formulation (e.g. tablets, syrup, or injection). Recording the brand name gives valuable information. Standard abbreviations for TB do simplify recording. 26 December 2018 Habab K Elkheir

Details of medicines • Mode of administration (e.g. oral or injection). • Indication(s) • Dose: e.g. for most medicines with fixed dosing, recording the total daily dose is appropriate. It is important to simplify recording as much as possible without sacrificing accuracy. • Date treatment was started. • Date treatment was stopped. • Duration of use, if “start” and “stop” dates are not available. 26 December 2018 Habab K Elkheir

C. Reaction details • Date of onset. • Reporters should be asked to give a brief clinical description. They should not be asked to give the official pharmacovigilance reaction term. • Laboratory test results if available, together with units of measurement. • Outcome of event: resolved, resolving, no change, disabling, worsening, death (with date), or congenital anomaly. • Effect of re-challenge 26 December 2018 Habab K Elkheir

D. Reporter details The reporter details should include the name, contact details and profession: e.g. physician, nurse, or pharmacist. This information will be kept confidential but is important to include in case it is necessary to contact the reporter for additional information on the case. 26 December 2018 Habab K Elkheir

E. Date and place of report 26 December 2018 Habab K Elkheir

When to report A report should be completed IMMEDIATELY after the reaction is recognized. 26 December 2018 Habab K Elkheir

Who should report Reporters include physicians, pharmacists, and nurses. Other reporters include public health professionals, staff in medical laboratories and pathology departments, and pharmaceutical companies. Health and community workers (who are literate) should be encouraged to report, preferably to the clinician who prescribed the treatment, or directly to the PVC. Patients or patient representatives may also report. 26 December 2018 Habab K Elkheir

Follow-up All reports of serious events should be followed up if details are incomplete. This may require the involvement of health professionals in a clinical setting who have been trained and appointed for this type of work 26 December 2018 Habab K Elkheir

Who should write the report Responsibilities of writing report As agreed by the PV committee, NTP Medical doctors 26 December 2018 Habab K Elkheir

Sharing the results Anyone who sends in a report should, as a minimum, receive an acknowledgement and thanks from the PVC and additional reporting forms to encourage further reporting. 26 December 2018 Habab K Elkheir

Sharing the results If resources allow, the PVC should also provide some brief information about the reaction reported, such as, but not necessarily including all, of the following: 26 December 2018 Habab K Elkheir

Sharing the results number of reports of the reaction in the centers' database; • number of reports of the reaction in the WHO database; information from the literature; • The importance of the reaction in the treatment of patients condition(TB;HIV/AIDS, Malaria) • the safety or risk of further administration to the patient; • the possibility of preventing the reaction in other patients by indicating potential risk factors. 26 December 2018 Habab K Elkheir

Thanks for your attention 26 December 2018 Habab K Elkheir