Safety monitoring How the PV system should work Roles of partners Training needs Practical steps to improve the system Workshop Feb 10-12: NMCP/PNLP, PV centre, research groups, MC+CRS

Detection of cases of adverse drug reactions 1. Families, community aware of side effects and need to report 2. At the health facility: Side effects severe enough for the child to come to clinic. All suspected cases are reported. Clear definition of targetted symptoms helps HFW know when to report. (3. Frequency of mild symptoms, not bad enough to seek care, monitored through EOC surveys) Role of the CHW: Balanced message to the family Check for severe problems last time and refer Refer in (very unlikely) case of immediate severe side effect Refer if the child is unwell (at time of SMC or if seen later)

Key points 1 All suspected cases at health facilities should be reported Cases severe enough for the child to be brought to the clinic Common minor events ◦all cases should be reported ◦an increase may indicate a problem - need to be able to respond quickly ◦if communities lose confidence in SMC children will not be protected ◦cases of vomitting will be seen, reporting them shows the system is working Rare serious events ◦understand why some children are affected to be able to reduce the risk ◦to be able to respond to false rumours

Key points 2 When SMC is administered Message to families ◦all medicines can cause side effects ◦bad effects are rare ◦if your child is sick after SMC go to health worker ◦if your child has fever at any time, it could be malaria - see a health worker to get tested Ask about any serious side effects of previous SMC treatment ◦death ◦rash over all body or with oedema Child is unwell ◦Refer to the nearest clinic History of allergy to SMC drugs ◦Ever told by health worker to avoid a medicine ◦Any history of allergy to SP, other sulfa drugs, AQ Other medicines in the last month - SP, AQAS, AQ, Bactrim/Septrin/Cotrimoxazole Mark on the register/tally sheet and inform the supervisor

What should CHWs ask about previous side effects? The CHW should ask if the child has been well since the last treatment. In general, CHWs should not withhold SMC because of mild or moderate side effects experienced previously. Doing so would prevent many children from receiving SMC. Vomiting is a common side effect of SMC, the mother or carer should be advised to bring the child to see a health worker if there is severe vomiting (three times per day or persisting for more than one day), for rehydration. SMC should not be with-held next month. Often the vomiting is less severe in successive months. Extra-pyramidal syndrome (likely to be reported by the family as the child moved strangely and appeared drunk) is a very rare and most health workers will not see cases. Although unpleasant it is not life threatening and the child should be eligible to receive SMC in future. Mild rash or itching is also common and not a reason to with-hold SMC. There is no known link between a history of minor rash and risk of SJ syndrome. If the child had a severe rash (over the whole body, or associated with oedema) with a previous SMC treatment then it is advisable not to give SMC but refer the child to the nurse for assessment.

Make sure health facility staff in SMC areas: ◦are aware of the signs and symptoms of side effects ◦understand the importance of reporting ◦know when immediate notification of a case is required and who to notify ◦have SMC PV guidelines ◦have reporting forms and know how to complete them ◦(know how to treat and when to refer) Key points 3 Reporting

Key points 4 Follow-up of severe cases Response plan by district/regional health team: ◦care of the patient ◦immediate referral if required ◦support for the family ◦reassurance to the community ◦follow-up of patient MC/CRS aware (how?) research groups aware and arrange follow-up

Key points 5 Forwarding and processing of completed forms Forms forwarded directly to the PV centre Immediate processing and entry into Vigiflow Technical committee review

Role of NMCP/PV centre/district health teams 1.case detection and reporting via PV forms (health facility staff) 2.patient care (health facility staff, district medical officer) 3.notification (serious cases) (health staff; designated PV focal person) 4.response (for serious cases, and where high frequency of events reported) (regional medical team?) 5.any reimbursement of costs to patient family? (NMCP?) 6.assessment of causality, entry in Vigiflow (PV centre) 7.technical committee review (PV centre) 8.(drug QC) (PV centre or PNLP)

Role of CRS/MC country teams 1.Organise SMC cascade training. Liaise with LSHTM to contribute to master trainer training (and PV focal persons, + DMOs, to be present at country level trainings). 2.Liaise with PNLP/PV centre to ensure printing and distribution of PV report forms 3.Arrange printing and distribution of SMC AE job aid, after adding contact name and number agreed with PV centre and PNLP 4.Ensure collection and forwarding of completed PV report forms to PV centre each month 5.Liaise with PV centres/PNLP to receive timely updates on adverse event reports 6.Provide funds to cover costs incurred for care of severe cases, if necessary and agreed 7.Monitoring of PV via the EOC form 8.Complete monthly rapid assessment survey (after each cycle) 9.Contribute to country SMC working group meetings

Role of research groups/LSHTM/UCAD/TDR 1.contribute to development of SMC training materials, job aids 2.contribute to training of master trainers 3.participate in technical committee meetings 4.data entry of PV report forms into a database if there are delays in Vigiflow entry 5.follow-up visit to all severe cases 6.contribute to country SMC working group meetings 7.strengthened PV in sentinel surveillance facilities 8.Review of hospital data 9.technical support to PV centres and PNLP 10.facilitate country’s full membership of WHO safety monitoring 11.contribute to PV coordination costs – not foreseen in original budget, agreed to make available small budget for staff for data entry in Vigiflow, costs of technical cttee meetings, etc. 12.coordinate SMS message reminders to health staff 13.analysis of data 14.convene meetings of regional safety panel and reporting to WHO

Steps to improve the system 1: Revise/improve PV aspects of SMC training tools Add to job aid: guidance on completing PV report form PV focal persons nominated in each region/district/facility PV focal person participate in delivering training Visit facilities not involved in SMC training, for PV training, + ensure they have reporting forms and guidelines Print guidelines poster-size Support technical advisor visit Gambia and Chad Provide funds to PV centre

Steps to improve the system 2: Review notification process Review system for distribution and collection of PV forms to facilities Review system for forwarding of completed forms direct to PV centre Review EOC form data capture Nigeria: SMS reminders through NAFDAC. Free reporting number displayed on SMC guidelines and on back of child’s SMC card. Promote use of the free number for reporting. SMS message reminders Hold regular meetings of SMC working groups in each country, members to include PNLP, MC/CRS and other implementers, PV centre, researchers.

Essential aspects of the PV system Raise awareness among health staff Balanced message for community PV forms available at all health facilities PV forms collected regularly, acknowledged and processed Staff at all levels trained in PV PV guidelines available at all health facilities PV part of routine monthly reporting Clear channels of notification Response plan to ensure patient care and reassure communities

Guide for health facilities