E-DRUG: World TB Day 2016: Celebrating Successes & Lessons Learned in Swaziland
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In 2012, bedaquiline was conditionally approved by U.S. Food and Drug
Administration for the treatment of drug-resistant tuberculosis (TB),
making it the first new TB drug to enter the market in more than 40 years.
With the rise of multidrug-resistant and extensively drug-resistant TB
leaving patients with fewer treatment options, the approval of bedaquiline
gave new hope to health professionals and TB sufferers around the world.
However, uptake of bedaquiline has been slow for many reasons. Chief among
these is the high cost of bedaquiline and accompanying medicines. A full
treatment course of bedaquiline is estimated to be $900 in low-income
countries - well beyond the reach of much of the population in these
countries.
In March 2015, USAID partnered with Johnson & Johnson affiliate Janssen to
increase access to bedaquiline for people in low-income countries. By
establishing a global bedaquiline donation program, the organizations are
aiming to provide treatment to 30,000 MDR- and XDR-TB patients over four
years.
Releasing new medicines, however, requires a strong health system to ensure
proper medicine use, monitor adverse medicine reactions, and optimize
patient safety. To establish local capacity in the management of
bedaquiline, the USAID-funded Systems for Improved Access to
Pharmaceuticals and Services (SIAPS) Program is providing technical
assistance to countries involved in the donation program.
Swaziland: Steps Toward Stronger Systems
Swaziland is one of the countries benefiting from the bedaquiline donation
program. With a high TB/HIV co-infection rate, increasing numbers of
confirmed XDR-TB patients, and some patients experiencing severe adverse
reactions to existing TB medicines, Swaziland demonstrated a clear need for
bedaquiline. SIAPS Program worked extensively with Swaziland to ensure the
country's health and pharmaceutical systems were prepared to accept the
first shipment of donated bedaquiline, which arrived in December 2015.
As a first step, USAID and SIAPS worked with the Swaziland National
Tuberculosis Control Programme (NTP) to identify areas within the health
system that needed capacity building or support. The identified areas for
technical assistance were broadly classified under pharmacovigilance,
clinical capacity building, and monitoring and evaluation, which aligned
with WHO recommendations for bedaquiline use.
The NTP then established a technical working group, which developed and
approved a national implementation plan for bedaquiline. This made it
possible for the NTP to define a centralized distribution pathway, develop
a pharmacovigilance process for new TB medicines, and establish other
interventions that would effectively address gaps within the pharmaceutical
system.
Noting that pharmacy and clinical staff in Swaziland had limited experience
working with bedaquiline, SIAPS led a clinical training workshop on
bedaquiline use in September 2015. The workshop was attended by more than
70 health care workers, implementing partners, and Ministry of Health and
NTP staff. These staff members are now able to provide ongoing trainings on
bedaquiline use at their respective facilities, aided by clinical
guidelines for bedaquiline use, job aids on adverse event management, and
standard operating procedures developed by SIAPS Program and the NTP.
Lessons Learned
SIAPS staff learned some important lessons during the process of preparing
Swaziland's health system for bedaquiline implementation:
- Stakeholder coordination is incredibly important: With multiple
stakeholders (NGOs, Ministry of Health, NTP, donors, etc.) involved in
providing health care to TB patients, SIAPS staff had to contend with many
different approaches and funding sources to improve TB care and services in
country. As such, the implementation of new TB medicines was a challenge
for Swaziland, as stakeholders were working to obtain and use bedaquiline
in different ways. This resulted in parallel systems and a duplication of
efforts, despite having similar objectives and a shared pool of patients.
SIAPS staff found that this could be prevented by working with the NTP to
coordinate activities and responsibilities of in-country stakeholders to
keep everyone on track to reaching common goals.
- Build upon existing systems rather than establishing new ones:
Before adopting bedaquiline, Swaziland had an established active
surveillance system for antiretroviral and anti-TB medicines. SIAPS Program
worked with the National Pharmacovigilance Unit to modify the system to
address the additional reporting needs for bedaquiline including a process
for reporting the occurrence of serious adverse events (SAEs) within 24
hours amongst others. Additionally, the NTP selected the most experienced
TB treatment sites to serve as focal points and referral centers for
bedaquiline treatment. The NTP increased laboratory capacity and
prioritized the training of health care workers from those sites, sending
them to the initial clinical training workshop with the aim of enabling
them to act as trainers for workers in surrounding facilities.
SIAPS Program's experience in Swaziland brought to light many key factors
to bear in mind while implementing bedaquiline and other new TB medicines
in low-resource settings. It is important to manage the process carefully,
working with key stakeholders to review the country's health system for
gaps and leverage existing strengths. By employing an approach that works
to strengthen health and pharmaceutical systems as a whole, SIAPS is laying
the foundation for a future free from TB.
Read more here:
http://siapsprogram.org/2016/03/24/world-tb-day-2016-celebrating-successes-and-lessons-learned-in-swaziland/
Kelly Sawyer, MPH
Technical Associate, TB
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Management Sciences for Health
4301 North Fairfax Drive
Arlington, VA 22203
United States
Direct: +1-703-310-3401
E-mail: ksawyer@msh.org