Transcript Proposed steps to adopt new TB regimens at country

NEED FOR NEW TB DRUG REGIMEN –
PERSPECTIVE FROM TANZANIA
A presentation for the TB drug Forum
Arlington, Virginia: 6-7 Dec. 2005
Dr. S. M. Egwaga
NTLP - Tanzania
NTLP - MoH
Burden of Tuberculosis
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WHO estimated 8.8 million new cases and 1.7 million deaths in
2003 –98% of these in the developing world
80% of all cases in 22 high-burden countries in Africa, South
East Asia and Western Pacific regions
12 out of the 15 countries with the highest estimated TB
incidence rates per capita are in Africa
Underlying cause of the increase is the HIV/AIDS pandemic
WHO reports indicates that 102 of 109 countries surveyed from
1994-2003 have Multi-drug resistance (MDRTB)
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Policy Environment for TB control
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Most countries have responded to the TB epidemic by scaling up
the WHO recommended DOTS strategy in an environment of
Health Sector Reforms and decentralization
There is often little dialogue between those responsible for health
systems policy and those responsible for delivering specific
programmes like TB control to ensure ownership and informed
decision making
There is an acute shortage of human resource – both in quantity
and quality to adequately supervise TB control
TB control may be higher on the political agenda after emergency
declaration by African Health Ministers in August 2005
The lost productivity due to prolonged TB treatment may affect the
whole family and the country at large
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Health system challenges
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TB diagnosis among suspects is often subjected to user-fees
charges even after declaring it free of charge
TB treatment is provided free of charge but the cost to patient to
access treatment sometimes is equal or more than the cost of the
drugs
TB drug logistics demand detailed planning to ensure uninterrupted
supply
Pharmacy storage facilities are generally small and often without air
conditioning
Adherence to treatment regimens especially after the intensive
phase is problematic and requires special support
Follow-up of patients who are out of control is often expensive and
often not done
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TB regimen challenges
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TB treatment is complicated - depends on a multi-drug
treatment regimen not easily understood by the average
health worker and majority of patients
TB treatment requires daily monitoring by health workers
or treatment supporters
The treatment duration is long: 6-8 months
The number of tablets swallowed a day is big especially if
accompanied with ARVs too.
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Meeting the challenges
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The Stop TB partnership has established the Global Drug Facility
(GDF) to support countries access high quality drugs at an
affordable price
WHO with partners has revised TB treatment guidelines to
accommodate the HIV/AIDS pandemic to minimize failure and
relapses after treatment
New 4-fixed dose combination drugs are now available to patients
through GDF grant
The new STOP TB strategy recognises and empowers patients and
communities to take active role in supervising treatment and
fostering adherence
The Global Alliance for TB drug development is spearheading the
development of new treatment regimens which could be shorter
and simpler for the patients and service providers.
NTLP - MoH
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Desired characteristics of new TB drugs
regimens -1
New TB regimens should have the following
characteristics:
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More effective – reducing treatment duration to a
couple of months or weeks
Ideally should be provided once a day
Ideally effective even for MDR-TB
The number of pills to be swallowed – not more two
They should be compatible with ARVs currently used or
to be used in future
Well tolerated even on an empty stomach
Few serious side effects
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Desired characteristics new TB regimen -2
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The drugs should not require air-conditioning or a cold
chain system
They should have a long shelf life (not less than two
years) under room temperature and high humidity
They should be affordable by the government of the
country – ideally equal to or below the price of current
products (about $10 per patient)
The packaging should be robust, waterproof, light but not
bulky
The drugs should also be safe for children use
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Proposed steps to adopt new TB
regimens at country level -1
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Advocacy at all levels by NTP
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Orienting key decision makers at national, regional and
district levels on new regimens
Advocacy to include the new regimen into the essential
drug list
Ensure new regimen is reflected in government budget
Sensitise key private providers and other stakeholders
on the need to change drug regimen
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Proposed steps to adopt new TB regimens
at country level - 2
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Strengthening public – private mix to improve
coverage
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Involve faith-based providers and private for profit
Ensure same regimens in private sector as in public to
minimise resistance by providing them with drugs
Same TB drug management policy guidelines in public
and private sectors
Training health care workers – in public and private
sectors
Reinforce prescription of anti-TB regimen by trained
personnel
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Proposed steps to adopt new TB
regimens at country level - 3
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Logistics and drug management issues
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Strengthen NTP capacity to estimate drug
requirements: running and buffer stocks
Availability of a modern drug procurement, storage and
distribution system from national to district levels
Effective clearance and forwarding system to avoid
unnecessary delays at port of entry
Decentralised and appropriate storage at district level
Monitoring and accountability at all levels – stocks,
ledgers, security
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Proposed steps to adopt new TB
regimens at country level - 4
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Quality of new regimen
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All new drugs have to be registered with the National
Drug Regulatory Authority to ensure that the source of
drugs is GMP compliant
Checking quality of drugs after entering into the country
Having a mechanism for continuous market
surveillance of the circulating products
Having capacity to track information relating to the
products - batch number, expiry dates, manufacturer
and place of issue
Establish mechanism for surveillance of side effects
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Proposed steps to adopt new TB
regimens at country level - 5
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Orienting health care providers and patients:
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There should be appropriate national policy manuals,
guidelines and training manuals for health providers
Updated tools for recording: registers and forms
Training health care workers on new regimens
Establish mechanism for supportive supervision and
on-job training on new regimens
Provide opportunity for health workers to share
experiences
Document best practices
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Proposed steps to adopt new TB regimens
at country level - 6
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Patient education and community awareness
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Raise community awareness on new regimen
through mass media, world TB day, local theatres
Educate patients on change of regimen and
advantages – mass media, IEC materials for patients
and treatment supporters
Establish peer support groups at community level
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In conclusion
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New TB treatment regimens are overdue
The Global Alliance for TB drug development provides a
unique opportunity to usher in newer drugs and regimens
through public private mix
Resource-limited countries especially in Africa should
start creating conducive environment for the proper use of
the new TB regimens
Encourage production of generic drugs to reduce prices
There should be mechanism to support local production
of new regimens as part of technology transfer
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Thank you all for your attention
NTLP - MoH