MainSurveillance and monitoringImplementation of international recommendations on NTP (2007-2011)Drug-resistant TB

Drug-resistant TB

Status of implementation of recommendations for section Drug-resistant TB

Institution responsible for implementation

Status

Deadlines

Month

Day

Year

Deadlines

Recommendations	Status	Implementation	Institution responsible for implementation	Deadlines
Drug-resistant TB
General recommendations
1. A working group of key specialists from the main national and international stakeholders should be established to revise the existing Ministry of Health order on MDR-TB management in accordance with WHO guidelines and recommendations.	Partially	In 2012 a working group was made up which united professionals of the key national and international stakeholders (in particular, WHO representatives). Results of its work were used as a basis to develop and approve of the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”. However, not all provisions contained therein comply with the WHO recommendations.	UCDC	31.12.14
2. A standardized regimen IV should be used to treat all cases that fail treatment on regimen II, as long as drug susceptibility testing results are not fully reliable.	Implemented	This recomendation is not relevant any more. Reliability of drug sensitivity test results is now ensured in all laboratories of level 3 in the civil sector. All laboratories of level 3 successfully passed external quality control in 2013.
Special recommendations
3. An MDR-TB management expert team should be established at oblast level to be responsible for diagnosis, treatment, consultation assistance on case management and outcome evaluation.	Implemented	Councils of the Central Medical Consultative Board for Chemoresistant TB work on the regional level in accordance with the recommendations given in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 77 and further).
4. A systematic approach should be established in every oblast for MDR-TB case management according to the availability of quality-assured bacteriological diagnostics, and/or based on the medical history and clinical patterns using an established standard (regimen IV) or empiric treatment regimen.	Implemented	The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” provides the system-based approach to manage MDR-TB cases which is also reflected in local protocols on regional and district levels.
5. DOT should be carried out for all patients, in hospitals as well ambulatory, to prevent the development of MDR-TB.	Not implemented	The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” provides the possibility to hand over the drugs to a patient for a term of up to 10 days in case of very positive attitude to treatment (page 17). Handing over drugs to a patient contradicts the definition of DOT services according to WHO (WHO: Implementing WHO Stop TB Strategy: a handbook for national tuberculosis control programmes. 2008 (page 32). Within the framework of the Global Fund grant, in 2011 the project was launched on social support to TB patients with a risk of treatment interruption (10% of general number of TB patients of category 1-3). The project is being implemented by the Ukrainian Red Cross Society.	UCDC	31.12.14
6. An uninterrupted second-line TB drug supply should be ensured for all drug-resistant TB patients (including poly- and multidrug-resistant cases). Second-line drug procurement must also include those drugs used during the ambulatory phase for the treatment of adverse reactions. These drugs should all be given free.	Not implemented	Due to the absence of the unified state procedure for procurement of the second line drugs for the treatment regimens, drugs are procured individually; frequent delays by the drug suppliers lead to the interruption of treatment regimens by the patients. Thus, periodic delays of anti-TB drugs of the second line occurred in 2012 and 2013 in the regions of Ukraine. Under the round 9 grant of the Global Fund, second-line drugs have been procured since 2012 under complete schemes, which since 2013has ensured treatment to all MDR-TB patients involved in the project across Ukraine (nearly 12% of all MDR-TB patients across the country). The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” provides monitoring of treatment of the patients of category 4 (page 72), and also monitoring and treatment of any side effects. Drugs preventing and removing side effects must be procured for the funds of local budgets and must be handed over to patients free of charge. However, currently drugs are not provided in full. Ukrainian Centre for Socially Dangerous Diseases Control regularly monitors compliance with the above mentioned requirement during the monitoring visits.	MOH Regional healthcare departments	On an ongoing basis
7. Infection control should be implemented in MDR-TB departments and all TB health care facilities, including the full separation between infectious and non-infectious patients, drugresistant and susceptible patients, and patients with chronic MDR-TB who are not eligible for treatment.	Not implemented	The applicable Standard for TB infection control at health care centres, places of long stay of people and residence of TB patients approved with the Order of the Ministry of Health of Ukraine No. 684 dated 18.08.2010 sets forth the infection control requirements for MDR-TB departments. However, the departments that comply with all such requirements are only available in Donetsk and Kharkiv regions in fact.	UCDC Regional healthcare departments	31.12.14
8. Facilities should be established for chronic MDR-TB patients (non-eligible for treatment) where palliative care can be provided under proper infection control measures.	Not implemented	The Order of the Ministry of Health of Ukraine No. 584 dated 10.07.2013 “On Approval of Guidelines on Calculation of Bed Capacity at TB Facilities” provides a formula to calculate the need for facilities providing palliative care to chemoresistant tuberculosis patients. In some regions there are individual departments of palliative care at TB dispensaries. Within the framework of health care system reorganization and complying with the Order of the Ministry of Health of Ukraine No. 584 dated 10.07.2013, such facilities are planned to be established. Ukrainian Centre for Socially Dangerous Diseases Control regularly monitors compliance with the above mentioned requirement during the monitoring visits.	UCDC Regional healthcare departments	31.12.14
9. Training should be ensured for all levels of health personnel in implementation of the Stop TB Strategy, including all aspects of MDR-TB case management. MDR-TBmanagement should be included in under- and postgraduate training curricula.	Implemented	At the premises of P.L. Shupyk Kyiv Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine, MDR-TB trainings are held on a regular basis (Phthisiology and Pulmonology Chair). MDR-TB and TB/HIV trainings are scheduled to be held in 2015 at the Phthisiology and Pulmonology Chair of P.L. Shupyk Kyiv Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine, during two-week advanced courses for phthisiatricians. Starting from the phase II of the Global Fund grant (2014) and with its financial support, MDR-TB trainings are held at the Phthisiology and Pulmonology Chair of P.L. Shupyk Kyiv Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine; however such training modules are not approved by the mentioned educational establishment. In 2011-2013, under the phase I of the Global Fund grant, the following trainings were held: Training of trainers (ТОТ) “Management of MDR-TB case in accordance with the international and national standards and protocols” (9 national specialists were trained); International standards of MDR-TB case management (24 doctors from various regions of Ukraine were trained); Management of MDR-TB case in accordance with the international and national standards and protocols (301 doctors were trained whose functional responsibilities include identification, diagnosis and management of MDR-TB case); Management of MDR-TB case in accordance with the international and national standards and protocols (168 representatives of nursing staff were trained). In 2012-2013, under the USAID project “Enhanced TB Control in Ukraine”, the following trainings were held concerning MDR-TB: Management of MDR-TB case for phthisiatricians (74 specialists from various regions of Ukraine were trained); Role of a nurse at primary health care facilities in management of TB and MDR-TB cases (26 representatives of nursing staff were trained); Modern approaches to management of TB and MDR-TB cases (56 doctors were trained).
10. Patients should be supported during the ambulatory phase of daily DOT by the reimbursement of transport expenses on a daily basis.	Not implemented	Transport costs incurred by the patients within the outpatient treatment of daily DOT are not subject to indemnification. Other kinds of social support provided under the Global Fund grant are specified in the section 2. Treatment and Case Management (special recommendations, item 7).	Regional healthcare departments	On an ongoing basis
11. Seasonal preventive treatment of TB patients and contacts of MDR-TB patients should be discontinued.	Implemented	Seasonal treatment is not set forth in the applicable unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care ”Tuberculosis” approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091.

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