GLC application

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GLC application
Fuad Mirzayev, Medical Officer Stop TB/THD, WHO
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http//whqlibdoc.who.int/publications/2006/9241546
956_eng.pdf
3
http//whqlibdoc.who.int/hq/2006/WHO_HTM_TB_2006.3
69_eng.pdf
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Body of the application

• Background
• Existing TB control programme
• Information on drug resistant TB in the area and
  past use of second line drugs
• Government commitment and partnerships
• Organization, management, and coordination
• Case finding, diagnosis and definitions
• Laboratory aspects
• Treatment and follow-up strategy
• Side effects monitoring and management
• Treatment delivery and adherence
• Drug management
• Information systems and data management

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Background

• General information on the country/region
• Epidemiology of TB in the country/region
• Epidemiology of HIV/AIDS if it is a significant
  problem
• Description of the current healthcare system with
  a focus on the TB control
• Applicant's assessment of the DR-TB in the
  country/region including reasons for emergence
• Regulations in relation to the import of SLD

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Existing TB control programme

• TB control performance report backed by the
  statistical data (basic DOTS)
• Current case-finding and treatment strategies
• Treatment delivery policies
• Drug supply mechanisms

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Information on drug resistant TB in the area and
past use of second line drugs

• All the relevant drug resistance data DRS or
  cohort profile
• Full description of the current management of
  drug-resistant TB cases.
• Use of second-line drugs in the past.

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Government Commitment and Partnerships

• Evidence of commitment to TB control (budget,
  legislation, social support, free of charge
  treatment, etc..)
• Partners (national, international)
• SLD procurement and distribution.
• Long-term strategy to manage drug-resistant TB.

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Organization, Management and Coordination

• Number of patients, start date and duration of
  the project.
• Facilities for drug-resistant TB.
• Personnel in the TB control system in charge of
  patients affected by the drug-resistant TB, and
  their training/experience in the management of
  such cases and use of second-line anti-TB drugs.
• Local facilities outside the TB control system
  that will be involved in the management of
  patients with drug-resistant TB, (e.g., prisons,
  general medical services, social services,
  psychiatric facilities, alcohol and drug abuse
  treatment programmes, social services, etc.).
• Infection control measures.
• Plan for implementation.

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Case finding, diagnosis and definitions

• Case finding methods employed/to be used.
  Policies for use of the DST.
• Inclusion/exclusion criteria
• Case definitions and treatment outcomes.

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Laboratory Aspects

• Laboratory network and main laboratories in the
  country/region of the project. Lab network
  capacity (in number and types of specimens
  processed) the techniques used for
  smear-microscopy, culture and DST bio-safety
  procedures for laboratory workers structure of
  the laboratory supervision
• Schedule, frequency, results delay and extent of
  bacteriological evaluation of patients on various
  stages of treatment and follow up
• Quality assurance/proficiency testing
• Collaboration with an international reference
  laboratory and the quality assurance system
  associated with this laboratory

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Treatment and Follow-up Strategy

• Treatment regimens ( empiric, standardized or
  individualized) and algorithms for their design
  for both initial and continuation phases
  (including length of treatment).
• Criteria used for change of the treatment regimen
  from initial to continuation and other
  modifications in the regimen.
• Transfer of patients and patient information from
  in-patient settings to out-patient setting, and
  in the reverse direction if necessary.
  Bacteriological (and other) monitoring schedule
  of treatment response for patients and
  evaluations/tests (and their frequency) to be
  performed.
• Management of patients with alcohol problems and
  narcotic drug users.

13
Side effects monitoring and management

• Scheme for monitoring of adverse reactions and
  collection of adverse reaction data. Tests
  performed at the baseline and regularly to watch
  over possible adverse reactions.
• Experience of the medical staff in using
  second-line anti-TB drugs, managing side-effects
  of these drugs or training activities planned.
• Ancillary drugs that will be available (free of
  charge or at the cost for the patient?) for the
  management of side effects of second-line anti-TB
  drugs.
• Strategy and algorithms for the management of the
  most frequently occurring/expected side effects.

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Treatment delivery and adherence

• Model of treatment delivery.
• Provision of social services and support needed
  by patients.
• Plan for follow up of patients defaulting
  treatment.

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Drug management

• Management system for second-line anti-TB drugs
  to be procured as a result of this application,
  storage, distribution, monitoring, reporting, and
  accountability
• Regulations on anti-TB drugs distribution/sale in
  the country/region. Anti-TB drugs (first- and
  second-line) registered in the country (name,
  form, generic name, and manufacturer).
• Interaction of the drug management for the
  project with existing drug regulations in the
  country.

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Information Systems and Data Management

• System of data recording and management in the
  hospital, dispensary, out-patient setting for the
  clinical management of each patient
• Laboratory data recording and reporting system.
• Format for aggregate quarterly and annual
  reporting.