PAVIA’s strategy aims at strengthening national PV systems in a collaborative effort with Public Health Programmes (PHPs) starting with the National Tuberculosis Programme (NTP) and building up medicines’ safety surveillance activities in the context/on the platform of the new drugs introduced for Multidrug-Resistant Tuberculosis.

The main aim of this project is to improve the readiness of Sub-Saharan Africa (SSA) health system to effectively deliver new medical products and to monitor their post-market safety. The annual consortium meeting was held at Elily Hotel in Addis Ababa for five (5) days from 1-5 April 2019. Participants from the Ethiopia, Tanzania, Eswatini and Nigeria from various institutions such as Public Health Programs, Ministry of Health, Medical Research Institute and Regulatory Authorities were invited. Other participants came from the Coordination Office, the Advisory Board, the Executive Board and KNCV. FMHCA was the main host of this event.

The main objective of the Annual Supranational Consortium Meetings was to provide a forum for discussing project progress with international stakeholders and Advisory Board members. The forum’s discussions were grouped into work packages (WP1 to WP5). WP1 dealt with breakouts and back-to-backs for cross-WP activities relating to legal and policy framework and financial sustainability. For WP2 issues related to PV process, training and infrastructure.  WP3 was responsible for discussing outcomes and impact relating to PV signals. Whereas WP4 engaged much on stakeholder engagement and WP5 discussed on communication and dissemination of PAVIA issues. These meetings serve as monitoring and evaluation moments to adjust the roadmaps where needed. In addition, they will be an important training opportunity for the master trainers from the four countries who will work together intensively with international experts on various elements of the PV process.

Besides discussions based on WPs, other meeting objectives were covered:

  1. To bring together all PAVIA partners from the participating institutions to foster and engagement of its members.
  2. To discuss PAVIA alignment with related initiatives on the continent and beyond.
  3. To ensure clarity of the project objectives and activities among PAVIA members and stakeholders.
  4. To ensure the overall project plan and set strategies for successful implementation of the activities.
  5. To build up synergies in strategies and technical capacity between PAVIA and PROFORMA consortia.

6.To hold face –to –face meetings among the governance bodies of the PAVIA consortium.

Country (‘triangle’) terms in each of the 4 project countries supported by a country project coordinator.

Among the four partner countries, Nigeria is more advanced on PV activities and they even  have a standalone PV policy. Tanzania presentation impressed and provoked a more detailed discussion and was able to show to other partners how they have expanded their activities to reach out to more people in the society by:

  • Establishment of regional PV units at Regional hospitals
  • Revival of 7 regional PV Centers and capacitate 8 zonal PV centers
  • Introducing PV postgraduate programs
  • Strengthening use of the electronic tools in reporting ADR.

The Tanzania’s FDA is intensifying advocacy and sensitization on Pharmacovigilance by establishing several channels for dissemination of safety related information                                                 to the community including social media handles, mobile app, television, radio, drug safety bulletin and printed messages. Ethiopia’s presentation concluded mainly on intensifying capacity building of healthcare providers at different levels and allocating available resources and mapping for potential funds need to be done. Eswatini concluded that in the healthcare workers capacity development should increase staff and ensure staff training for new drugs and novel regimens before patient enrollment.  And to make sure that roles and responsibilities for data collection and reporting is well defined

Several challenges have been identified:

  • Lack of awareness
  • Poor connectivity between MDR PV team and general hospital PV team i.e. PV working better than MDR clinic.
  • System of risk management not well established.
  • Lacking PV Focal person for coordination of PV activities.
  • Poor transfer of knowledge from trained staff. All members who were previously trained have all retired.
  • Pharmacovigilance is not stand-alone module in medical training institutions (Not well structured)

Suggested Recommendations

  • To be visiting PAVIA website, social media regularly and put some information
  • To consider a sustainability mechanism when the project is gone.
  • Some people use excel sheet as their ADR database. This was found not to be very reliable and it was advised to opt for vigiflow database in case there is access to it.
  • To consider Zoom training as it is more cost effective than classroom training

Way Forward

  • The roadmap plan to be finalized by May 2019
  • Tanzania to prepare for blended training in October2019
  • Tool for monitoring and evaluation to be prepared by WP4