NEED FOR NEW TB DRUG REGIMEN

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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

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Burden 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)

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Policy 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

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Health 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

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TB 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.

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Meeting 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.

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Desired characteristics of new TB drugs regimens
-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

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Desired 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

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Proposed steps to adopt new TB regimens 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

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Proposed steps to adopt new TB regimens at
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

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Proposed steps to adopt new TB regimens 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

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Proposed steps to adopt new TB regimens 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

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Proposed steps to adopt new TB regimens 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

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Proposed steps to adopt new TB regimens at
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

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In 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

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Thank you all for your attention