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NTLP - MoH
NEED FOR NEW TB DRUG REGIMEN – PERSPECTIVE FROM TANZANIA
A presentation for the TB drug ForumArlington, Virginia: 6-7 Dec. 2005
Dr. S. M. Egwaga
NTLP - Tanzania
NTLP - MoH
Burden of TuberculosisBurden of Tuberculosis
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)
NTLP - MoH
Policy Environment for TB controlPolicy Environment for TB control
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
NTLP - MoH
Health system challengesHealth system challenges
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
NTLP - MoH
TB regimen challengesTB regimen challenges
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.
NTLP - MoH
Meeting the challengesMeeting the challenges
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
Desired characteristics of new TB drugs Desired characteristics of new TB drugs regimens -1regimens -1
New TB regimens should have the following characteristics: 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
NTLP - MoH
Desired characteristics new TB regimen -2Desired characteristics new TB regimen -2
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
NTLP - MoH
Proposed steps to adopt new TB Proposed steps to adopt new TB regimens at country level -1regimens at country level -1
Advocacy at all levels by NTP 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
NTLP - MoH
Proposed steps to adopt new TB regimens Proposed steps to adopt new TB regimens at country level - 2at country level - 2
Strengthening public – private mix to improve coverage 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
NTLP - MoH
Proposed steps to adopt new TB Proposed steps to adopt new TB regimens at country level - 3regimens at country level - 3
Logistics and drug management issues 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
NTLP - MoH
Proposed steps to adopt new TB Proposed steps to adopt new TB regimens at country level - 4regimens at country level - 4
Quality of new regimen 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
NTLP - MoH
Proposed steps to adopt new TB Proposed steps to adopt new TB regimens at country level - 5regimens at country level - 5
Orienting health care providers and patients: 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
NTLP - MoH
Proposed steps to adopt new TB regimens Proposed steps to adopt new TB regimens at country level - 6at country level - 6
Patient education and community awareness 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
NTLP - MoH
In conclusionIn conclusion
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
NTLP - MoH
Thank you all for your attention