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Table 1 The major challenges encountered during the PV enhancement pilot project and solutions to these

From: Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

Country

Challenge

Solution

All three countries

Delayed transmission of AE reports from all levels of healthcare system to national PV center

• PV coordinator and focal points to be pro-active in ensuring reports are collected and reach national PV center

• PV coordinator to update focal points regularly on reports received by national PV center

• Partner with established organizations to assist with transmission from remote HCFs

• Continuous mentoring to maintain motivation

• Recognize achievements e.g. certificates to focal points with > 5 AEs reported from district

• Enable electronic reporting of AEs via mobile phone messenger applications

ADR reporting form not standard among countries and not as user-friendly as 1-page WHO AEFI reporting form

• Following consultation with national experts, 1-page ADR form introduced in Malawi, in line with 1-page and 1.5-page forms in Côte d’Ivoire and DRC

Perceptions among HCPs toward AE reporting

• Emphasize importance of reporting procedure

• Reassure HCPs that AEs can occur even when medicine has been used correctly

• Engage hospital management and involve senior staff in PV training

Delayed data entry into VigiBase

• Engage data manager within national PV center with clear roles and responsibilities

PV-related activities ongoing within public health programs without knowledge of key PV stakeholders and PV coordinator; full collaboration with EPI not established

• Present PV enhancement plan to program directors

• Gain participation of PV coordinator in PV trainings organized by health programs

ERC not sufficiently trained (Malawi) and no regular causality assessment meetings following signal detection (all three countries)

• Allocate funding to ensure routine functioning of ERC on causality assessment

• PV coordinator to ensure safety concerns are submitted to ERC and that meetings are organized promptly

Malawi

No official PV coordinator until six months into implementation; replaced after one year

• Plan for and engage PV coordinator ahead of implementation to allow for continuity

• Train the national PV center personnel in AE data entry into VigiFlow for sharing into VigiBase

EPI coordinators engaged as focal points: tended to become less concerned with PV during vaccination campaigns or epidemics; regularly transferred to other functions

• Engage clinicians and pharmacists as focal points

• Engage back-ups to PV coordinator and focal points

Initial training focused on HSAs who had limited medical knowledge to complete AE reports

• Train wide range of HCPs: HSAs, clinicians, nurses, pharmacists, etc.

Côte d’Ivoire and DRC

Delayed project implementation because of administrative complexities

• Anticipate delays in project timelines

• Examine all possible constraints with approving legal agreement

• Address issues that may delay implementation

• Re-present project to newly appointed PV stakeholders in country

  1. ADR Adverse drug reaction, AE Adverse event, AEFI Adverse event following immunization, DRC Democratic Republic of Congo, EPI Expanded Program on Immunization, ERC Expert review committee, HCF Healthcare facility, HCP Healthcare professional, HSA Health surveillance agent, PV Pharmacovigilance, WHO World Health Organization