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Safety & Neglected Tropical Diseases

Together with our colleagues at the World Health Organization, the Pan American Health Organization, the NTD NGO Network (NNN), RTI International, Fred Hollows Foundation, the International Trachoma Initiative (ITI), USAID, and other organizations, we have advanced a global initiative to ensure the safety of mass drug administration (MDA) for control and elimination of neglected tropical diseases (NTDs), which reaches 1 billion people each year.

 

The Challenge

 

Preventing harm to individuals while delivering health benefits to populations is an ethical responsibility of all public health programs. The medicines to prevent and control NTDs have excellent safety profiles, and MDA is a safe, effective intervention for NTD control and elimination. Although the technical components of drug safety have largely been addressed and serious adverse reactions (SAEs) such as choking rarely occur, we need to take further steps to ensure safety and fulfill the ethical mandate to ‘do no harm.’

 

Our Approach

 

Advocacy

With our collaborators, we organized workshops and participated in safety reviews to raise awareness of challenges surrounding safety and NTDs.

Research

We collaborated on research projects to better understand the incidence, risk factors, and preventive strategies for SAEs, particularly choking, during MDA for soil-transmitted helminthiasis and trachoma.

Guidance

Building on the momentum generated by advocacy and informed by research findings, we worked with partners to develop guidance and resources.

Training

To disseminate this guidance and address practical issues, FACE collaborated with several partners, including PAHO, WPRO, IZUMI Foundation, RTI and Fred Hollows Foundation on national and regional training for NTD safety in Ethiopia, Nigeria, Vanuatu, Haiti, Colombia, Dominican Republic, Paraguay, and Honduras. 

 

 

Lessons Learned

 
MDA Safety Consultation Addis Ababa, Ethiopia February 12-15, 2019
Gail Davies, Chair of NNN, signs NNN Commitment to safety, 17 September 2019

Advocacy: Advances in advocating for NTD safety came from linking it to the broader patient safety movement and building on the work of many partners to ensure the pharmacological safety of mass drug administrations (MDA) to prevent and control NTDs. 

Research: Operational research on incidence and risk factors for choking during MDA provided the evidence base for preventive strategies. This research also revealed systemic barriers to improved NTD safety, such as weak collaboration between NTD programs and national pharmacovigilance agencies.

Guidance: Leadership by the World Health Organization, including its regional offices in Africa, the Americas, and the Western Pacific, was essential for developing normative guidance, providing training, and raising awareness.

Training: The training workshops provided a unique opportunity for frank dialogue and exchange of ideas between NTD programs and pharmacovigilance agencies, which, in many cases, set the stage for joint planning and further collaboration. Program managers in countries that had experienced SAEs were highly attuned to the need for clear communication and pharmacovigilance support, and the majority of workshops led to the development of joint NTD safety roadmaps or communiqués.

Further improvement in the safety of MDA for the control and elimination of NTDs requires:

  • Weaving safety into the culture of all MDA programs

  • Addressing programmatic aspects and capacity

  • Improved SAE reporting and investigation

  • Closer coordination between NTD programs and national pharmacovigilance agencies

  • Safety training for community drug distributors

  • More effective risk communication

 

Resources and Tools

 

In five short years, NTD safety has advanced significantly, building on effective advocacy, research, guidance, and training. Our NTD Safety Resources Page includes safety guidelines, educational and training materials, examples from our workshops, published research, and more. 

Awareness, Planning, and Readiness

WHO Guidance

  • WHO guidance document, 2021, Safety in administering medicines for neglected tropical diseases, available in EnglishFrenchPortuguese, and Spanish.

  • Other WHO guidance on NTD safety and adverse event management: WHO has published several guidelines and documents related to the safe administration of drugs given for NTDs, as well as guidance on assessing and reporting serious adverse events.

Training

Peer-reviewed Publications Related to NTD Safety and Pharmacovigilance

Other Resources on NTD Safety

NTD Workshops

To support the adoption of new safety tools and guidance developed by WHO, NGOs have collaborated with WHO, USAID, and Ministries of Health on a series of regional and national workshops.  These workshops have focused on three priority areas:

1. Coordination with pharmacovigilance agencies to identify, manage, report, and prevent MDA-associated SAEs

2. Communication exercises and readiness preparation to address SAEs or rumors of adverse events

3. Prevention of MDA-associated choking-related deaths in children

The workshops included didactic sessions, small-group exercises, role-play, and group discussion. The workshop format and content were adapted to address the needs of the participants.

National workshops were held in Ethiopia, Nigeria, and Haiti in 2021 with support from USAID’s Act to End NTDs | East program. A national workshop was also hosted in Vanuatu in 2021. In June 2022, the Pan American Health Organization (PAHO) hosted a regional workshop for NTD Programme Managers and pharmacovigilance agencies from Colombia, the Dominican Republic, Guyana, Honduras, Nicaragua, and Paraguay.  This was followed by a Training of Trainers workshop in November 2022 and national-level Training of Trainers workshops in 2023.

Partners

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