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9
Creating a Blueprint for Action
In the final session of the workshop, moderators and speakers from ear-
lier sessions summarized the major themes that emerged from their sessions
and the actions recommended by speakers. This chapter draws on those
remarks and on previous chapters in this summary to outline a blueprint for
action to guide future decisions, organized by major topics discussed at the
workshop. The conclusions and recommendations presented in this chapter
were offered by the speakers identified in parentheses in the text and do not
represent the consensus of the group or of the conveners of the workshop.
DRUG-RESISTANT TB IN INDIA
India has been conducting an “amazing” expansion of MDR TB treat-
ment with the goal of achieving universal access to treatment, said Salmaan
Keshavjee, Harvard Medical School. The country is using primarily an
ambulatory model of care delivery with very short hospital stays. Keshavjee
emphasized that achieving national goals in India will require strengthening
the health care system. Important steps are to build laboratory capacity,
recruit and continually train staff, and reorganize the system to deliver care
to MDR TB patients.
Initial results from Gujarat discussed at the workshop were “worri-
some,” according to Keshavjee. Resistance to the fluoroquinolones was high
at 24 percent. High death rates among some patients suggest late case detec-
tion, and high default rates suggest problems with the delivery of treatment.
On the other hand, Vishwa Mohan Katoch, ICMR, noted that India has
in the past had success in tackling major diseases, such as leprosy, despite
113
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114 DRUG-RESISTANT TUBERCULOSIS IN INDIA
its large population and socioeconomic disparities. With regard to leprosy,
there was not only success in reducing the numbers of affected people, but
also a reduction and near elimination of drug resistance through implemen-
tation of a regimented program.
Conclusions and recommendations offered by individual workshop
participants regarding drug-resistant TB in India included the following:
• The overall public health care system in India needs to be strength-
ened to support a strong anti-TB program. (K. Srinath Reddy,
Public Health Foundation of India)
• All TB patients should have equitable access to care, and their
interests and needs should be protected. (Reddy)
• The basic TB program in India needs to reach out to unnotified
and missed cases and to poor and highly vulnerable populations.
(Reddy)
• TB medicines should be sold by prescription only and should be
prescribed and dispensed by accredited public and private provid-
ers. (Reddy)
• A catalog of TB-related activities in India should be undertaken to
take stock of the quality and quantity of these activities. Unproduc-
tive or ineffective activities should be rejected to make room for
innovative new approaches. (Several workshop participants)
PREVENTING TRANSMISSION OF DRUG-RESISTANT TB
As long as people with drug-resistant TB remain untreated or inad-
equately treated, they have the potential to transmit the disease to others.
Infection control in health care facilities and in the community is essential
to stop the spread of the epidemic.
Much remains unknown about both the evolution of drug resistance
in M.tb. and the transmission of drug-resistant strains among individuals.
Certain strains of MDR TB predominate in different countries and regions.
An interesting question, said Keshavjee, is whether these strains are more
or less fit than other strains in these regions.
Conclusions and recommendations offered by individual workshop
participants in the area of preventing transmission of drug-resistant TB
included the following:
• Infection control and patient management remain inadequate in
many countries. (Keshavjee)
• Treatment should start as early as possible to reduce transmission.
(Edward Nardell, Harvard Medical School)
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CREATING A BLUEPRINT FOR ACTION
• The potential of surgery to reduce the transmission of TB should be
explored. (Rohit Sarin, LRS Institute of Tuberculosis and Respira-
tory Diseases)
• More research is needed on the fitness and potential for transmis-
sion of drug-resistant strains of M.tb. (Sébastien Gagneux, Swiss
Tropical and Public Health Institute and University of Basel)
STRENGTHENING LABORATORY CAPACITY
The ability to combat drug-resistant TB is limited by the lack of reli-
able, quality-assured laboratory tests capable of detecting drug resistance
rapidly to support patient management decisions, said Thomas Shinnick,
CDC. As Prakash N. Tandon, INSA, observed, a 100 percent sensitive and
specific test for TB in general and MDR TB in particular still does not exist,
and current tests are cumbersome, costly, and difficult to use widely. Some
workshop participants also suggested that although the ideal diagnostic
test has yet to be developed, more focused and effective efforts should be
undertaken to identify MDR TB using current diagnostics.
India is making good progress in improving laboratory capacity by
expanding access to quality-assured conventional and molecular testing,
and it is taking advantage of new technologies that are being developed,
said Shinnick. But much more work needs to be done to expand the ability
of patients to access laboratory services. Rapid tests are promising, but are
not yet sufficient to address the problem. The time between ordering a test
and implementing a patient management decision based on that test must
be minimized. To this end, close communication and coordination among
clinicians, TB program managers, laboratory managers, and others will be
necessary.
Conclusions and recommendations offered by individual workshop
participants with regard to strengthening laboratory capacity included the
following:
• In resource-limited settings, standardized treatment regimens rather
than individualized regimens may be necessary. (Sarin)
• India needs to strengthen its laboratory capacity with a tiered net-
work at the subdistrict, district, regional, and reference laboratory
levels. (Camilla Rodrigues, Hinduja Hospital)
• Validation, quality assurance, and quality control all are essential
for DST. (Shinnick)
• Supranational reference laboratories must have the resources and
expertise to survey drug resistance and conduct external qual-
ity testing for drug susceptibility tests. (Nagamiah Selvakumar,
National Institute for Research in Tuberculosis)
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116 DRUG-RESISTANT TUBERCULOSIS IN INDIA
• DST laboratories in India need to maintain their proficiency despite
shortages of second-line drugs. (Neeraj Raizada, FIND)
ADDRESSING TB AND DRUG-RESISTANT TB
IN VULNERABLE POPULATIONS
Children, people infected with HIV, and migrant and refugee popula-
tions all are especially vulnerable to drug-resistant TB and can contribute to
its spread. The incidence of drug-resistant TB in these populations remains
unknown, especially among children, and this lack of information obscures
the extent of the problem. But contact tracing has revealed large numbers
of TB and MDR TB cases arising within and from these populations.
Another important vulnerable population, noted Gary Filerman, Atlas
Health Foundation, is the prison population. Although the incarcerated
and others in congregate settings were not discussed extensively at the
workshop, Filerman and Keshavjee noted that the prison populations in
almost every country have higher rates of TB and MDR TB than the general
population and deserve special attention.
Conclusions and recommendations offered by individual workshop
participants in the area of addressing TB and MDR TB in vulnerable popu-
lations included the following:
• The burden of drug-resistant TB in vulnerable populations needs
to be documented. (Soumya Swaminathan, National Institute for
Research in Tuberculosis)
• Better diagnostics are especially important for pediatric popula-
tions. (Swaminathan)
• New technologies that can deliver results of DST rapidly for
children and people coinfected with HIV are a particular need.
(Keshavjee)
• Shorter treatment regimens for MDR TB may be possible in chil-
dren because of their lower bacillary burden, but clinical trials are
needed to test this hypothesis. (Swaminathan)
• New drugs being developed for adult TB patients should be stud-
ied in children early in the development process so that pediatric
populations can have access to these drugs as quickly as possible.
(Swaminathan)
• The possibility of using first- and second-line drugs prophylacti-
cally to prevent TB infection in children and other vulnerable
populations needs to be studied. (Swaminathan)
• Vulnerable populations and their contacts should be eligible for
more aggressive testing. (Mercedes Becerra, Harvard Medical
School)
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CREATING A BLUEPRINT FOR ACTION
• A global project on pediatric MDR TB could produce much more
information about a population that also acts as a sentinel popula-
tion for infection and treatment issues. (Becerra)1
COMBATING DRUG-RESISTANT TB THROUGH PUBLIC–
PRIVATE COLLABORATION AND INNOVATIVE APPROACHES
The majority of people in India access private-sector health care ser-
vices, which means that engaging private health care providers in the fight
against MDR TB is essential. In addition, the volume of anti-TB drugs being
disseminated by the private sector suggests that many people being treated
for TB are not being recorded by public-sector providers. Some second-line
drugs are widely available outside the public-sector program. Conclusions
and recommendations offered by individual workshop participants on this
subject included the following:
• Private-sector laboratories need to be incorporated into the public
health laboratory network so they will become an integral part of
the national TB control program. (Puneet Dewan, WHO)
• Opportunities to subsidize private laboratories for the early detec-
tion of drug-resistant TB should be explored. (Dewan)
• The quality of the case management performed by private provid-
ers needs to be improved. (Dewan)
• Private laboratories should be reimbursed, at cost, for drug-suscep-
tibility testing so that these savings can be passed on to patients.
(Rodrigues)
Strengthening the Workforce
Human resources to carry out drug-susceptibility testing, MDR TB
treatment, and other activities associated with drug-resistant TB are severely
limited in India. Coordination of training between the public and private
sectors could ease shortages and improve skills. Speakers offered the fol-
lowing conclusions and recommendations on strengthening the workforce:
1 Since the workshop, Mercedes Becerra, Assistant Professor, Department of Global Health
and Social Medicine, Harvard Medical School, and Soumya Swaminathan, Head, Division of
Clinical Research, National Institute for Research in Tuberculosis, collaborated to launch a
research network on pediatric drug-resistant TB. As of April 2012, more than 140 individuals
from more than 30 countries had come together to collaborate on joint projects through the
network, titled The Sentinel Project on Pediatric Drug-Resistant Tuberculosis. More informa-
tion is available at http://sentinel-project.org/ (accessed April 30, 2012).
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118 DRUG-RESISTANT TUBERCULOSIS IN INDIA
• Health workers at all levels need training, retraining, on-the-
job training, continuing education, and advanced management
training. (Aleyamma Thomas, National Institute for Research in
Tuberculosis)
• Training should be followed by in-service monitoring and supervi-
sion to detect performance deficiencies, identify new staff in need of
training, and identify additional staff needed for current and new
interventions. (Thomas)
Using Innovative Technologies
Technology—whether cell phones, electronic medical records, laptops,
or biometric identification systems—can facilitate better MDR TB treat-
ment, said Janet Tobias, President, Sierra/Tango Productions, Ikana Media.
These technologies can connect health care providers, laboratories, and
patients so that treatment can start earlier and be more effective. These
technologies also make it possible to offer incentives to private providers
and CHWs for identifying MDR TB patients and ensuring that they receive
treatment. In addition, technologies make it possible to collect and analyze
data that can shape policy decisions and improve patient outcomes. Con-
clusions and recommendations offered by individual workshop participants
regarding the use of technology included the following:
• Pilot programs involving technology should be carried out with
health care providers and TB patients to explore ways of expanding
treatment. (Tobias)
• Technological interventions in TB care are needed and can go
beyond data collection to increase the number of patients identified
and improve patient outcomes. (Several workshop participants)
• Economic analyses of the costs of MDR TB and the value of treat-
ment could help make the case to governments for the need to
invest in efforts to combat drug-resistant TB. (Tobias)
• Patients should be full partners in drug-resistant TB programs.
(Tobias)
• Low-cost, high-impact community-driven models are needed to
deliver testing and treatment in difficult-to-reach areas. (Shelly
Batra, Operation ASHA)
Creating Partnerships
A recurring sentiment expressed at the workshop was that, given the
incidence of MDR TB in India and elsewhere, partnerships are essential
to bring the combined resources of multiple organizations to bear on the
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CREATING A BLUEPRINT FOR ACTION
problem. Partnerships are needed among various government levels within
India, between the public and private sectors, and among international
organizations. Finally, patients must become partners with health care pro-
viders and governments to win the battle against MDR TB. Conclusions
and recommendations offered by individual workshop participants with
respect to creating partnerships to combat MDR TB included the following:
• International partnerships and assistance are essential to address
MDR TB in resource-limited settings. (Keshavjee)
• INSA should continue to collaborate with other national science
academies, including the IOM and National Academy of Sciences,
to reduce the threat of drug-resistant TB. (Krishan Lal, INSA)
• Science academies from around the world should convene to
develop consensus around actions needed to combat drug-resistant
TB. (Tandon)
STRENGTHENING THE SECOND-LINE DRUG SUPPLY CHAIN
Demand for second-line drugs remains too low to sustain multiple
suppliers, observed Owen Robinson, Partners In Health. As a result, the
prices for these drugs are too high, which is an obstacle to treatment, as
are today’s long lead times for the production of drugs. Volume needs to
rise to spur competition and lower prices. Financial guarantees or other
mechanisms could bring additional suppliers into the market.
Conclusions and recommendations offered by individual workshop
participants in the area of strengthening the second-line drug supply chain
included the following:
• More manufacturers of quality-assured second-line drugs are
needed to lower prices and ensure availability. (Keshavjee)
• Demand for quality second-line drugs needs to be adequately fore-
cast and then aggregated to generate the necessary investments by
suppliers. (Robinson)
• Risks need to be aggregated and shared throughout the drug supply
chain. (Robinson)
• Prequalification procedures and standards need to be harmonized
among countries to reduce barriers to entry into the second-line
drug market. (Robinson)
• A working group should be formed to explore challenges to the
drug supply chain, ways of overcoming current problems, and pos-
sible revolutionary rather than evolutionary changes in the drug
supply system. (Robinson)
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120 DRUG-RESISTANT TUBERCULOSIS IN INDIA
• Best practices from the retail industry could be adapted to man-
age the inventory and distribution of second-line drugs. (Prashant
Yadav, University of Michigan)
• Drug logistics guidelines are needed for the drug distribution net-
work. (Pradeep Saxena, Government of India)
