Implementation status of recommendations
All recomendations
| Recommendations | Status | Implementation | Institution responsible for implementation | Deadlines |
| Case-finding and diagnosis | ||||
Специальные рекомендации
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14. A collaborative agreement should be established between the Ministry of Health and the State Department for the Enforcement of Sentences, including who will pay for what, and supervision of the prison level III laboratories ensured by the Ministry of Health oblast level III laboratory. |
Implemented
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13. Certification of the appropriate functioning of biosafety cabinets should be carried out urgently and repeated annually. Sanitary–epidemiological service units should be included in training in biosafety principles. |
Not implemented
|
For the regular certification of appropriate functioning of laminar flow biosafety cabinets, legal framework should be accordingly amended by Ukrmedderzhstandart (State medical standard of Ukraine) which would regulate this process. |
UCDC
|
On an ongoing basis |
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12. Supportive supervision and quality assurance in the laboratory network should be improved by the establishment of strong level III laboratories in each oblast and the provision of transport for regular supervisory visits. |
Partially
|
a) Efficient laboratories of level III were opened in civilian sector in all 27 regions of Ukraine and successfully passed the external quality control in 2012 and 2013. However, 50% (5 of 10) laboratories of level ІІІ which are subordinated to the penitentiary system successfully passed external quality control in 2013. b) Under “Stop Tuberculosis in Ukraine” program (GF), starting 2012 monitoring visits from the national level (reference laboratory) to the regional level and from the regional level to the district level have been financed (since 2013 monitoring visits in 17 regions have been financed with the round 9 grant of the Global Fund, 10 regions have been financed with Chemonics project). |
UCDC
Regional healthcare departments
|
On an ongoing basis |
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11. The National Tuberculosis Reference Laboratory should be officially tasked to: (i) prepare national manuals with standard operating procedures for bacteriology and biosafety; (ii) prepare and coordinate the implementation of a training plan and training materials for laboratory procedures; and (iii) provide consultation and supervision on standard operating procedures. |
Implemented
|
The applicable Order of the Ministry of Health of Ukraine and the National Academy of Medical Sciences of Ukraine dated November 22, 2013 N 995/102 “On Ensuring Operation of the Central Reference Laboratory for Microbiological Tuberculosis Diagnosis of the Ministry of Health of Ukraine” sets forth that the national reference laboratory is authorized to perform all functions listed in this recommendation. The administrative and maintenance support (equipment and consumables) is not provided from the state-budget of the National Reference Laboratory. Starting January 2013, under the project named “Support to the National Reference Laboratory, the Charity Foundation “Development of Ukraine” finances administrative costs, approbation of new methods. In September 2013, the Foundation supplied equipment to the training room and in July 2013 supplied equipment for rapid TB diagnosis and other laboratory equipment. |
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10. Sputum smear microscopy should be improved by: (i) teaching patients how to expectorate better; (ii) organizing the transport of sputum samples in rayons and oblasts; and (iii) implementing the front-load method (two sputum samples on the spot) to ensure that at least two samples are available for investigation. |
Partially
|
a) Under the awareness campaign of “Stop Tuberculosis in Ukraine” program, awareness-raising posters “Sputum Sampling Rules” (interlinking) were developed and distributed in 2011-2013 among first aid facilities and specialized TB institutions. b) Unified guidelines on development of local treatment protocols for healthcare facilities in Ukraine clearly specify how the patient’s clinical route should be specified. In accordance with these guidelines the patient’s route, sputum smear transportation routes and schedules should be specified in each local protocol. Considering that the percentage of bacteriologically-confirmed new cases of TB in 2011 totalled 34, in 2012 (cohort 1-3) - 39, such low rate may witness of incompliance with the protocol requirements and with sputum smear transportation pattern and conditions. c) Recommendation is not valid, whereas the divisibility of sputum smear sampling according to the unified clinical protocol should total 2. |
UCDC
|
On an ongoing basis |
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9. The criteria for defining a TB suspect should be improved and promoted widely. |
Implemented
|
In accordance with the applicable Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091, the unified protocol sets forth the criteria for the identification of TB-suspects and such criteria comply with the WHO recommendations (Section А.3.1.1, page 55). The diagnosis pattern and criteria by which a TB-suspect is identified are also reflected in local protocols on regional and district levels. Since 2012, outreach activities are being carried out, within the framework of All-Ukrainian Awareness Campaign of “Stop Tuberculosis in Ukraine” program (GF) among the population masses and risk groups, concerning major TB symptoms and importance of timely visit to a doctor. Community awareness is ensured with public service announcements (interlinking) broadcast by the national and regional TV-channels and radio stations, awareness-raising posters (interlinking) in public places, distribution of specialized materials among the risk groups etc. |
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8. New tools should only be introduced, such as the rapid diagnosis of TB, when testing results are proven reliable and all new cases detected can be treated with a full course of second-line TB drugs. |
Implemented
|
In 2012, rapid molecular DNA diagnostic methods recommended by WHO were implemented in 12 regions of Ukraine. Since 2013, all 27 regions of Ukraine are provided with access to rapid diagnostic methods. In the course of equipment installation across the regions, installation trainings were held by a maintenance engineer at all laboratories. The responsible experts made two monitoring visits to each region in the course of launching rapid diagnostic methods in order to ensure on-the-job training. In 2011 patients with sensitive TB had the limited access to the first-line TB drugs. In 2012-2013, availability of first-line drugs was 100%. In 2011 patients with MDR-TB were provided with second-line drugs for 79%, in 2012 – for 95%, in 2013 – for 102%.* |
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7. The quality of laboratory services should be ensured by external quality assurance. |
Partially
|
Until 2012, the system of external quality assurance for II level laboratories had not been implemented in Ukraine. In 2012 and 2013, all 27 civilian sector laboratories of the III level successfully passed external quality control (100%). Laboratories subordinating to the penitentiary system had not been included to external quality control until 2013. In 2013, 50% (5 of 10) penitentiary laboratories successfully passed external quality control. Draft Order of the Ministry of Health of Ukraine “On Assurance of Bacteriological Assays Quality Control” is pending approval with the structural divisions of the Ministry of Health of Ukraine. The schedule for quality control assurance in 2014 for microbiological TB laboratories of level III were developed and coordinated with the head of Central Reference Laboratory of the Ministry of Health of Ukraine, including the laboratories subordinated to Penitentiary Service Department of Ukraine. Pursuant to latest update from the Ukrainian Centre for Socially Dangerous Diseases Control, 663 of 777 microbiological TB laboratories of level 1 were subject to external quality control in 2013, which accounts for 85.3%. |
UCDC
|
On an ongoing basis |
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6. The National Tuberculosis Reference Laboratory should be officially designated, with clear responsibilities and dedicated human and financial resources and located within the National Institute of Tuberculosis and Pulmonology (under a contract with the Ministry of Health) or in another facility. |
Implemented
|
The Order of the Ministry of Health of Ukraine dated 02.08.2011 No. 457/70 “On Ensuring Operation of the Central Reference Laboratory of the Ministry of Health and Laboratory Network for Microbiological TB Diagnosis”. |
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5. A working group should be set up to develop a strategy for optimizing the national laboratory network, based on a countrywide analysis of the needs of: (i) laboratory services according to population coverage, geographic access and the epidemiological burden of TB; (ii) an upgrading of the laboratories (civil work renovation, purchase of new equipment); (iii) human resources. |
Implemented
|
Interagency working group on improvement of laboratory network activity in microbiological TB diagnosis was organized in 2012 and, based on its work results, guidelines “Ways to Optimize Laboratory Network Activity in Bacterioscopic TB Diagnosis in Ukraine” were issued the same year. Developing institution: state-owned institution “F.G. Yanovsky National Institute of Phthisiology and Pulmonology of the National Academy of Medical Sciences of Ukraine”. |
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4. In the absence of a rapid molecular test, the diagnosis of TB should always be confirmed with bacteriological investigation. |
Partially
|
Percentage of lung TB diagnosis (category 1-3) confirmed with bacteriological technique totalled: |
UCDC
|
On an ongoing basis |
|
3. A proper diagnostic algorithm should be followed for sputum smear-negative patients, including the use of a broad-spectrum antibiotic and excluding any fluoroquinolone. |
Partially
|
In accordance with the applicable Order of the Ministry of Health of Ukraine dated 03.07.2006 No. 433 the protocol of medical aid to patients with community-acquired pneumonia stipulates that fluoroquinolones therapy may be prescribed as an alternative treatment regimen. Proper diagnostic pattern is specified in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”, which is approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091. (Section А 3, Diagnosis and Treatment Stages, page 55). This pattern, in its turn, must be reflected in local protocols in all regions across Ukraine. |
MOH
|
31.12.14
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2. TB screening should be optimized by: (i) analysing the yield for each group screened, and (ii) identifying the risk groups to screen based on the higher yields. |
Implemented
|
The recommendation is taken into account in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”, which is approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091. (Annex 1., page 118) |
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Общие рекомендации
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1. Only defined risk groups should be targeted for TB case-finding by fluorography, and the funds saved should be redirected towards other needs of the NTP. TB screening with fluorography is done extensively and includes population groups that are not at special risk of TB disease. The criteria for TB screening should be revised based on their cost-effectiveness and documented by quality-checked data. Financial incentives for TB screening should be carefully reconsidered. |
Not implemented
|
In accordance with the applicable Order of the Ministry of Health of Ukraine dated 17.05.2008 No. 254 ”On Approving of the Guidance for Periodicity of Chest X-Ray Examinations for Certain Population Categories in Ukraine”, preventive X-ray examinations are made twice a year starting the age of 18. Screening examinations, pursuant to this Order, are carried out on a large scale and include those social groups which do not join any groups of TB high risk. |
State Service
|
31.12.14
|
| Treatment and case management | ||||
Специальные рекомендации
|
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7. Support should be given to patients in order to enhance their adherence to, and improve the outcomes of, treatment through: (i) transport and food/hygiene packages; (ii) prescription of fixed-dose combination drugs; and (iii) broader involvement of the general health services for DOT. |
Partially
|
a) Motivational sets of food products have been provided by the Ukrainian Red Cross Society under the round 9 grant of the Global Fund since 2011. The project aims to ensure medical and social support to TB patients with a risk of treatment interruption (10% of general number of TB patients of categories 1-3) and all MDR-TB patients who are treated for money of the Global Fund (2012 - 800 patients (nearly 12% of all registered MDR-TB patients), 2013 - 960 patients, 2014 - 3136 patients, 2015 - 3810 patients). In 2011, the project was launched in the first 6 regions of Ukraine (Dnipropetrovsk, Donetsk, Lviv, Mykolaiv, Kharkiv regions and the City of Kyiv), in 2012 the project was expanded to include 8 regions more (the Autonomous Republic of Crimea, Zaporizhzhia, Kyiv, Luhansk, Odesa, Kherson Regions and the City of Sevastopol), in 2013 the project was again expanded to include the remaining 13 regions (Vinnytsia, Volyn, Zhytomyr, Zakarpattia, Ivano-Frankivsk, Poltava, Rivne, Sumy, Ternopil, Khmelnytskyi, Cherkasy, Chernivtsi, Chernihiv regions). Social support to MDR-TB patients was commenced in 2013. Social support to the rest of patients not complying with the project criteria, within the framework of the Global Fund grant, must be realized with the financial support of local budgets and must be organized by the social welfare authorities. This component of treatment is not fully implemented. |
UCDC
|
31.12.14
|
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6. Patient-centred care should be provided with different options for treatment (in both the intensive and continuation phases), such as ambulatory care (in the closest primary health care facility available), hospital day care, home care (with DOT provided by visiting nurses) or hospital care. |
Partially
|
All mentioned options of treatment provision are specified in the unified protocol; however, not all patients in practice are subject to DOT services. This may be connected with the fact that the clinical protocol also provides a 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 (article 17). Handing over of drugs to a patient contradicts the definition of DOT services according to the WHO (WHO: Implementing the WHO Stop TB Strategy: a handbook for national tuberculosis control programmes. 2008 (page 32)). |
UCDC
|
31.12.14
|
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5. Surgery should be limited to MDR-TB and other conditions clearly described in the national guidelines. |
Partially
|
The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care ”Tuberculosis” clearly sets forth recommendations for surgical treatment (page 93), however, they are somewhat broader that the WHO recommendations (WHO: TB treatment: recommendations. Fourth edition, 2009 (page 105)). |
UCDC
|
31.12.14
|
|
4. The criteria for hospitalization should be reviewed, and it should be limited to severe and advanced forms of TB, MDR-TB in the intensive phase of treatment and sputum smearpositive TB if ambulatory DOT is not possible. |
Partially
|
The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care ”Tuberculosis” sets forth that TB patients without bacterioexcretion may be treated outpatiently (DOT) from the very beginning of therapy (article 75), if the patient`s clinical status allows that. However, in cases of bacterioexcretion, a patient is subject to mandatory hospitalization, which contradicts the latest WHO recommendations (WHO: TB treatment: recommendations. Fourth edition, 2009 (page 105)). |
UCDC
|
31.12.14
|
Общие рекомендации
|
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3. Seasonal treatment should be stopped. |
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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2. Standardized regimens should be consistently used and directly observed treatment (DOT) should be ensured throughout treatment. |
Implemented
|
Standard treatment regimens are clearly specified in the 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. (Section А.3.3 Pharmaceutical treatment regimen, pages 74-93). |
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1. Outpatient treatment should be promoted in place of inpatient treatment. Prolonged and unnecessary hospital care should be avoided. Patients without severe clinical conditions and those that are sputum smear-negative should be treated outside hospitals. Ethical principles recognized internationally should be adopted and promoted actively. |
Partially
|
The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care ”Tuberculosis” sets forth that TB patients without bacterioexcretion may be treated outpatiently (DOT) from the very beginning of therapy (article 75), if the patient`s clinical status allows that. 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” was developed and approved upon the initiative of the Charity Foundation for Development of Ukraine. The trend of bed capacity reduction for TB patients at health care facilities of the Ministry of Health of Ukraine is the following (per 10 ths. of population): |
MOH
UCDC
|
31.12.14
|
| Childhood TB | ||||
Специальные рекомендации
|
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7. Inpatient treatment should be limited and inpatient preventive chemotherapy in sanatoria should be stopped. |
Implemented
|
Preventive chemotherapy is restricted under in-patient conditions, in accordance with the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (article 141). It may be received under conditions of a health resort, in general secondary and specialized schools for children under control exercised by a doctor or a nurse; or under out-patient conditions under control of a paediatric phthisiatrician, if certain guarantees of continuity and completion of prescribed chemoprophylaxis are available. |
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6. Isoniazid preventive chemotherapy schemes should be prolonged to six-month regimens and provided under ambulatory conditions. |
Partially
|
The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 140) stipulates that regimens for chemoprophylaxis (basic) in children must be designed for 3-6 months. |
UCDC
|
31.12.14
|
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5. Dosage of basic anti-TB drugs should be revised in line with WHO recommendations. Ethambutol should be used rather than streptomycin in the first-line regimen. |
Implemented
|
Dosing of major anti-tuberculosis drugs was revised and Ethambutol was provided as a first-line therapy instead of Streptomycin, which is reflected in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 151). |
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4. The national policy on annual skin testing screening should be revised. Such testing should be limited to risk groups of children. |
Not implemented
|
In accordance with the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”, the annual screening with skin tuberculine test is performed on an annual basis to all children aged 4-14 (first of all, children from TB risk groups). Pursuant to the information of Ukrainian Centre for Socially Dangerous Diseases Control, the draft Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091 was amended as recommended by WHO. |
UCDC
|
31.12.14
|
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3. BCG should be limited to one vaccination at birth. |
Not implemented
|
As provided with the applicable Order of the Ministry of Health of Ukraine dated 16.09.2011 No. 595 “On Procedure of Prophylactic Immunization in Ukraine and Quality and Circulation Control of Medicinal Immunobiological Products”, BCG revaccination is made at the age of 7. Pursuant to the information of Ukrainian Centre for Socially Dangerous Diseases Control, the draft Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091 was amended as recommended by WHO. |
UCDC
|
31.12.14
|
Общие рекомендации
|
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2. Inpatient treatment should be limited to complicated and drug-resistant cases of TB. |
Not implemented
|
Inpatient treatment is also prescribed in other cases. The protocol does not specify that only severe TB and MDR-TB are subject to the hospitalization. |
UCDC
|
31.12.14
|
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1. The national guidelines on management of TB in children should be revised according to the international standards. |
Implemented
|
National recommendations were revised in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” and comply with the International Standards (page 151). |
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| HIV-related TB | ||||
Специальные рекомендации
|
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14. Co-trimoxazole preventive therapy should be introduced and rapidly expanded to include all co-infected individuals. |
Partially
|
The standard for preventive treatment with Co-trimoxazole of all persons with co-infection is specified in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 145). In 2012, 47% of TB/HIV co-infection patients received preventive treatment with Co-trimoxazole. Currently, it is impossible to achieve 100% coverage due to shortage in regional budgets, whereas preventive treatment with Co-trimoxazole must be financed from local budgets. Execution is being monitored on a regular basis during monitoring visits to the regions of Ukraine. |
UCDC
|
On an ongoing basis |
|
13. Voluntary HIV counselling and testing should be made available to all TB patients. |
Partially
|
Consultancy and HIV-testing of patients of TB facilities is performed under clearly defined criteria which comply with WHO recommendations and are specified in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 145-150). Based on updates from all regions of Ukraine, 86.4% of TB patients (category 1-3) received results of HIV-test in 2012. Execution is being monitored on a regular basis during monitoring visits to the regions of Ukraine. |
UCDC
|
On an ongoing basis |
|
12. Recommendations regarding TB infection control and biosafety should be incorporated into the construction of new, and renovation of existing, health facilities for TB, AIDS-related care and general health care. |
Partially
|
The standard for TB infection control at health care centres, places of long stay of people and residence of TB patients, which is approved with the applicable Order of the Ministry of Health of Ukraine dated 18.08.2010 No. 684 provides the mandatory list of departments in TB hospital of level III for distribution of TB patient flow, which should be provided with special departments/wards for HIV-infected persons (page 6-7). This document must be used in the course of designing and constructing of new health care facilities or repair of existing ones. State Building Code (SanPiN) for construction and repair of existing healthcare facilities are pending approval after being revised as required by the Standard for infection control. |
Regional healthcare departments
Sanitary Epidemiological Service
|
31.12.14
|
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11. Isoniazid preventive treatment should be provided to HIV-infected individuals (in whom TB has been excluded) at non-TB facilities to reduce their progression to active TB. |
Partially
|
The standard for preventive treatment with Isoniazid is specified in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 166). The responsibility for providing such preventive treatment is imposed to AIDS service. The Draft National Plan for TB/HIV Co-infection Monitoring and Assessment in Ukraine for 2013-2016 provides the collection of information for the indicator “Percentage and number of new patients with HIV-infection and indications for preventive treatment with Isoniazid, who started such treatment within the reporting period”, which enables to exercise control over preventive treatment with Isoniazid of HIV-positive persons. Moreover, pursuant to the information of Ukrainian Centre for Socially Dangerous Diseases Control, the draft amendments to the TB Protocol approved with the Order of the Ministry of Health of Ukraine dated 21.12.2013 No. 1091 provides the mentioned. |
UCDC
|
31.12.14
|
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10. The potential for transmission of TB to HIV-infected individuals should be reduced by ensuring that TB infection control measures are in place in all sites where TB screening and evaluation is carried out, including AIDS centres. |
Partially
|
The Standard for TB infection control at health care centres, places of long stay of people and residence of TB patients, which is approved with the applicable Order of the Ministry of Health of Ukraine, dated 18.08.2010 No. 684, sets forth basic elements of TB infection control at the centres for AIDS prevention and fight (page 16-17). |
UCDC
|
31.12.14
|
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9. All HIV-infected individuals should be screened for TB at regular intervals (quarterly, for example) and as clinically indicated. |
Partially
|
The draft Order “Clinical Protocol of Medical Care to Patients with Tuberculosis and HIV co-infection” which is now at the stage of public discussion sets forth that identification of TB patients is carried out during examination of HIV-infected patients in each case of seeking medical assistance at the regional AIDS centre or any facility of primary, secondary (non-specialized) medical care with complaints and/or symptoms resembling tuberculosis irrespective of their duration (page 12). The Draft National Plan for TB/HIV Co-infection Monitoring and Assessment in Ukraine for 2013-2016 provides the collection of information for the indicator “Percentage and number of HIV-infected patients screened for TB at the facilities providing assistance or treatment in case of HIV-infection within the reporting period”; this will enable to control execution of regular examinations of TB HIV-positive persons. |
UCDC
|
On an ongoing basis |
|
8. Counselling about TB should be provided to all HIV-infected individuals and those who present for HIV evaluation at every encounter. |
Partially
|
The draft Order “Clinical Protocol of Medical Care to Patients with Tuberculosis and HIV co-infection” which is now at the stage of public discussion includes a screening questionnaire to identify persons requiring examination for TB (page 83). |
UCDC
|
On an ongoing basis |
|
7. The WHO guide to monitoring and evaluating collaborative TB/HIV activities should be implemented. |
Partially
|
Under the Phase I of the Global Fund grant, a draft plan for TB/HIV M&E was developed in 2013 and was positively estimated by WHO experts. This document is scheduled for approval in the first half of 2014. State institution “Ukrainian Centre for Socially Dangerous Diseases Control” is responsible for the process of approval. |
UCDC
|
31.12.14
|
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6. Patient education should be expanded and enhanced on issues related to both TB and HIV (such as infection control issues, HIV prevention methods, optimal screening, diagnosis, and treatment regimens, outreach and patients’ rights). |
Implemented
|
Under the grants of the Global Fund and International Charitable Foundation “International HIV/AIDS Alliance in Ukraine”, the following awareness-raising materials were developed and distributed: |
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5. There should be a better culture of service to patients among health care workers in order to improve community involvement and enhance adherence with treatment. |
Partially
|
Under the Phase I of the Global Fund grant, the trainings were held which were devoted to “Formation of Positive Attitude in Patients to TB treatment and Reducing Stigma of TB Patients through Methods of Effective Communication and Consultancy” (339 healthcare professionals and social workers who are engaged in treatment of HIV-positive patients were trained). Standards of consultancy and testing of HIV patients at TB facilities are described in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 145-150). |
UCDC
|
31.12.14
|
|
4. TB and HIV physicians should be cross-trained on guidelines for diagnosis and treatment of each disease in those who are co-infected, and they should work together to coordinate the continuum of care. In high TB/HIV-prevalence settings, positions should be created for physicians who are responsible for co-infected individuals in both TB and HIV services. |
Partially
|
Under the Phase I of the Global Fund grant, the following trainings were held focusing on: |
UCDC
Regional healthcare departments
|
31.12.14
|
Общие рекомендации
|
||||
|
3. Outreach services provided by nongovernmental organizations should be promoted by revising existing laws and regulations and allowing non-medical workers to dispense isoniazid preventive treatment, co-trimoxazole preventive therapy and anti-TB drugs under DOT. |
Partially
|
Outreach services were revised and now comply with WHO recommendations and described in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (page 145) and the clinical protocol for medical assistance to patients with co-infections of TB and HIV. 47% of patients with TB/HIV co-infection received preventive therapy with Co-trimoxazole in 2012. |
State Service
|
On an ongoing basis |
|
2. National TB/HIV guidelines should be updated and completed to include the responsibilities of each service, the frequency and location of screening, infection control procedures, drug management, timing of co-treatment initiation and monitoring of side-effects. |
Not implemented
|
The Order of the Ministry of Health of Ukraine on approval of the clinical protocol for medical assistance to patients with co-infections of TB and HIV dated 28.05.2008 No.276 is still effective. Pursuant to the information of Ukrainian Centre for Socially Dangerous Diseases Control, the draft Order of Ministry of Health of Ukraine was developed on approval of HIV/TB protocol. |
MOH
Regional healthcare departments
|
31.12.14
|
|
1. Existing coordination bodies (oblast TB/HIV coordination councils) should be revived and focus on improving TB/HIV collaborative interventions and monitoring implementation. At local (rayon, city) level, multidisciplinary teams should be established composed of specialists in TB, HIV and support for injecting drug users, to discuss the management of TB/HIV cases and optimize treatment outcomes and support for patients. |
Implemented
|
Activity of HIV/TB coordination councils is regularly controlled through monitoring visits (relevant issues are included to checklists). The draft Order of the Ministry of Health of Ukraine was developed on approval of HIV/TB protocol. Responsibilities of TB and AIDS services must be specified in common orders of these two services for TB/HIV/AIDS Co-infection. |
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| Drug-resistant TB | ||||
Специальные рекомендации
|
||||
|
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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|
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 |
|
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 2012-2013, under the USAID project “Enhanced TB Control in Ukraine”, the following trainings were held concerning MDR-TB:
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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
|
|
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
|
|
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 |
|
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
|
|
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. |
||
|
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). |
||
Общие рекомендации
|
||||
|
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. |
||
|
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
|
| TB control in prisons | ||||
Специальные рекомендации
|
||||
|
6. Barriers to the continuation of treatment after release from prison should be removed by: (i) providing proper health education in prison; (ii) informing the Ministry of Health well in advance of a release from prison and allowing a Ministry of Health nurse or nongovernmental organization worker to visit the TB patient before release; (iii) allowing TB patients to receive treatment at the nearest health facility to their places of residence after release from prison, independently from their places of registration; (iv) not forcing exprisoners to register at police stations. |
Partially
|
a) Under the project “Mobilization of Non-Governmental Organizations and Immediate Representatives of TB-Vulnerable Groups for Ensuring TB Prevention, Early Identification and Positive Attitude to Treatment”, since October 2011 the All-Ukrainian Charity Foundation “Coalition of HIV Service NGOs” has been ensuring the social escort of prisoners from penitentiary TB hospitals to a civilian sector in 8 regions of Ukraine (Zaporizhzhia, Mykolaiv, Poltava, Kherson, Dnipropetrovsk, Luhansk, Ternopil and Kharkiv regions), for the grant provided by the Global Fund. Effectiveness of this project in 2012 accounted for 63%, and in 2013 – 64% (percentage of former prisoners who were supported and who proceeded with TB treatment in a civilian sector). |
The State Penitentiary Service of Ukraine
|
On an ongoing basis |
|
5. An agreement should be made with the Ministry of Health that allows the pooling of anti-TB drugs procurement and savings of scale. |
Not implemented
|
Agreement with the Ministry of Health of Ukraine on co-procurement of anti-TB drugs has not been concluded. It is impossible due to various budgets for the State Penitentiary System of Ukraine and the Ministry of Health of Ukraine. In accordance with the expert report drawn up in 2012 after the evaluation of needs of the State Penitentiary System of Ukraine for the resources intended to ensure effective TB fight at penitentiary and detention facilities, the patients failed to comply with full treatment regimens at the penitentiary facilities due to the lack of first-line and second-line drugs. |
The State Penitentiary Service of Ukraine
|
|
|
4. The use of standard regimens for TB should be enforced. |
Implemented
|
For prescription of treatment regimens, standardized regimens are applied in accordance with the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”. |
||
|
3. TB diagnoses should be strengthened, including the provision of rapid testing equipment and drug susceptibility testing. An increased budget and training of personnel are preconditions, as is the availability of all drugs to treat every case identified. |
Not implemented
|
In 2012 and cohort 1-3 of 2013, TB diagnosis in the penitentiary service was on the level of 41%. Under the World Bank project titled “TB and HIV/AIDS control in Ukraine”, BACTEC TB mycobacterium analyzers, consumables and other laboratory equipment were supplied to some penitentiary TB hospitals. Under the Global Fund grant, during 2011-2013, over 215 laboratory specialists, doctors and nursing staff of the penitentiary service were trained, who are involved in diagnosis and treatment of patients with sensitive and chemoresistant tuberculosis. Since 01.07.2014 MDR-TB patients in the penitentiary facilities will be involved into treatment under the Global Fund grant. Ceaseless and full availability of anti-TB drugs for all patients in the penitentiary system has not been achieved. |
The State Penitentiary Service of Ukraine
|
On an ongoing basis |
|
2. Case-finding based on symptoms arising during imprisonment should be strengthened. Staff should receive in-service training through cooperation and coordination with the Ministry of Health. |
Not implemented
|
Identification of new and relapsing TB cases in the penitentiary system is still very poor in predetention centers and other penitentiary facilities, except for specialized TB facilities within the system. TB identification is mostly carried out with fluorography. Bacterioscopically identified cases are not reported by the penitentiary facilities despite the recommendations of the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”. This issue is not solved with any regulations. Under the Global Fund grant, during 2011-2013, over 215 laboratory specialists, doctors and nursing staff of the penitentiary service were trained, who are involved in diagnosis and treatment of patients with sensitive and chemoresistant tuberculosis. |
The State Penitentiary Service of Ukraine
|
On an ongoing basis |
Общие рекомендации
|
||||
|
1. The financial resources for TB control in the State Department for the Enforcement ofSentences should be increased. Apart from ethical and equivalence issues, the current underfunding seriously contributes to the increased transmission of TB among detainees, personnel working in penal institutions and the population at large. |
Implemented
|
In accordance with the National Targeted Social Program on Combating Tuberculosis for 2012-2016, for the State Penitentiary Department it was planned to spend 22,405.56 ths. UAH for TB control in 2013 (for the purposes of comparison – this sum in 2012 totaled only 17,935.59 ths. UAH). In fact, financing (from various sources) in 2013 totaled 23,833.70 ths. UAH, which is a bit higher than it was planned. Financing is planned to be increased within the subsequent years of the Program implementation –27,979.06 ths. UAH for 2014 and 34,983.93 ths. UAH for 2015. |
||
| Other vulnerable populations and social determinants | ||||
Специальные рекомендации
|
||||
|
4. Nongovernmental organizations should be supported, including with advocacy, to work with TB vulnerable groups. |
Implemented
|
The National Targeted Social Program on Combating Tuberculosis for 2012-2016 provides complying with the indicator “Number of regions where non-governmental organizations cooperate with TB facilities”, which aims to improve access to hard-to-contact or vulnerable population groups with the participation of non-governmental organizations. Within the framework of Global Fund grant, active TB identification among risk groups, social support and persuading persons inclined to interrupt treatment to proceed with it (in particular, former prisoners as well) are carried out by the grant sub-recipients, such as All-Ukrainian Charity Fund “Coalition of HIV Service NGOs”, International Charitable Foundation “International HIV/AIDS Alliance in Ukraine”, Ukrainian Red Cross Society and other regional non-governmental organizations. |
||
|
3. Treatment procedures and access to disability benefits schemes should be coordinated so as to avoid perverse incentives to interruption of treatment and overall prolongation of the duration of treatment. |
Partially
|
TB patients may be given a disability status if such patients comply with the criteria set forth in the applicable guidelines on disability status approved with the Order of the Ministry of Health of Ukraine dated 05.09.2011 No. 561. However, a disability status does not solve, in practice, the issue of social vulnerability of TB patients. In particular, it would be more efficient to develop a system of material compensation for the patient`s treatment period (this may be motivational sets of food or personal hygiene products, reimbursement for transport costs, social and psychological support during the treatment, incentive payments for positive attitude to treatment or any other social guarantees). |
State Service
|
On an ongoing basis |
|
2. Each intervention adopted to improve TB case detection and treatment outcome should be analysed for effectiveness and cost–effectiveness. |
Partially
|
The 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 was developed with the consideration of international recommendations relying on an evidential basis (page 117). Moreover, implementation of only TB diagnosis and treatment measures with proved efficacy must be reflected in the regional local protocols. There is a vital need for calculation of economic effectiveness of measures being implemented on the national level and for regulatory approval of procedures for such analytical calculations. |
State Service
|
On an ongoing basis |
Общие рекомендации
|
||||
|
1. Vulnerable populations should be defined by level of TB risk and type of vulnerability. Based on this analysis, adequate interventions should be designed and implemented. |
Implemented
|
The 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, sets forth the categories of adults and children with increased TB risk (Annex 1, page 118, Annex 6, page 127). However, no analysis which could identify additional risk groups, specific for TB epidemics in Ukraine, has been carried out. |
||
| Infection Control | ||||
Специальные рекомендации
|
||||
|
12. Surgical masks should be provided, together with education in how and when to use them, to all potentially contagious patients (sputum smear-positive TB patients, TB suspects, people coughing and those with other respiratory symptoms). |
Partially
|
Procurement of surgical masks must be envisaged in TB Infection Control Plan. However, due to the lack of financing, it is impossible to achieve 100% availability of surgical masks for all potentially infectious patients. Therefore, masks are provided, as a rule, to those patients who cannot afford to buy them. Provision and use of surgical masks by the patients are inspected during monitoring visits to a health care facility. |
UCDC
|
On an ongoing basis |
|
11. A personal respiratory protection programme should be established for staff at high risk in settings where the use of administrative and environmental controls is not sufficient to reduce the risk of TB transmission. This should include education and the procurement and distribution of certified FFP2 or N95 respirators and annual testing for their fit. |
Partially
|
Section 8.2. “Criteria of Infection Control Quality” (page 22 and further) in the 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 following criteria of infection control effectiveness: |
UCDC
Regional healthcare departments
|
On an ongoing basis |
|
10. One or more engineers should be hired for the NTP who have appropriate education in ventilation, ultraviolet germinal irradiation and biosafety equipment issues, essential for the use, sustainability and cost–effectiveness of equipment. |
Implemented
|
On July 22, 2013, pursuant to the Order No. 145 and Resolution of the State Sanitary Epidemiological Service of Ukraine with the technical support by USAID project “Enhanced TB Control in Ukraine”, TB IC expert group of the State Sanitary Epidemiological Service of Ukraine was organized. |
||
|
9. Appropriate funding (5–10% of capital cost per year) should be allocated for the maintenance of sustainable and professionally designed, commissioned and maintained mechanical ventilation and laboratory biosafety equipment. Certification of the biosafety cabinets according to EN 12469 standard by appropriately trained and certified specialists should be sought. |
Partially
|
Funds for technical maintenance of mechanical ventilation and equipment at biosafety laboratory must be envisaged in local TB infection control plans at each health care facility. Compliance with this requirement is inspected in the course of monitoring visits. However, funds are provided partially due to limitations of the facilities` budgets. |
State Service
Regional healthcare departments
|
31.12.14
|
|
8. Local mechanical ventilation and/or upper room ultraviolet germinal irradiation fixtures should be installed and regularly maintained, and arranged so that they are present in highload sputum smear preparation rooms, waiting areas, medical examination offices, bronchoscopy rooms, autopsy rooms, common rooms and other high-risk settings where natural ventilation cannot be used effectively. |
Partially
|
Requirements to installation and maintenance of local ventilation and/or UF irradiators are set forth in the 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. Practical implementation of these requirements is inspected in the course of monitoring visits by the respective specialist. The most significant reason for incompliance with the requirements to installation and maintenance of local ventilation and/or UF irradiators is insufficient financing. Under the Global Fund grant, the mechanical ventilation system with negative pressure was installed in 2013 in the laboratory of level III in Kharkiv region. Similar ventilation systems were installed in laboratories of level III in Donetsk and Mykolaiv regions for the money granted by the Charity Foundation “Development of Ukraine”. |
UCDC
|
On an ongoing basis |
|
7. Sputum should be collected in the open air in a well-designated area that is also usable in the winter. If this not feasible, a special room should be assigned to the collection of sputum with proper ventilation, either natural (open window) or mechanical (negative pressure room with at least 12 air changes per hour). |
Implemented
|
The 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 requirements to equipment of special sites and rooms for sputum sampling. Compliance with these requirements is inspected in the course of monitoring visits to all health care facilities. |
||
|
6. There should be appropriate triage of respiratory symptomatic patients, separation of patients and specimen flows with signage and reallocation of facilities (if needed), and isolation of smear-positive and M/XDR-TB patients. |
Partially
|
In accordance with the section 3.11. “Distribution of Patient Flow” (page 12 and further) of the 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, all TB facilities must distribute patient flows based on results of sputum smear microscopy for acid-resistant bacteria and based on data of anti-TB drug sensitivity. During the monitoring visits, distribution of patient flow is subject to inspection, though in practice it is not always possible to comply with all rules due to inappropriate design of old TB facilities. Moreover, risk zone distribution is depicted in colours (red, yellow, green) on all department schemes. |
UCDC
|
31.12.14
|
|
5. TB suspects, outpatients and hospitalized patients should be separated according to their symptoms, the results of sputum smear microscopy and drug susceptibility testing (or the risk of drug-resistant TB) and their HIV status, in both the outpatient and inpatient departments. Shortening the overall length of stay in hospitals and adhering to the national requirement for floor area per patient bed (to reduce overcrowding) are contributory factors in the reduction of transmission. This recommendation also applies to penal facilities. |
Partially
|
Section 3.11. “Distribution of Patient Flow” (page 12 and further) of the 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 specifies that all TB facilities must distribute patient flows based on results of sputum smear microscopy for acid-resistant bacteria and based on data of anti-TB drug sensitivity. Control over the compliance with this condition is exercised in the course of monitoring visits to TB facilities. However, in practice it is not always possible to distribute patient flow as required by the Standard due to the architectural inconformity of TB facility to infection control requirements. For the purposes of reducing in-patient TB transmission, the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” was amended, with which TB patients without bacterioexcretion may be treated outpatiently (DOT) from the very beginning of therapy (page 75), if the patient’s clinical status allows that. However, in cases of bacterioexcretion, a patient is subject to mandatory hospitalization, which contradicts the latest WHO recommendations (WHO: TB treatment: recommendations. Fourth edition, 2009 (page 105). |
UCDC
|
31.12.14
|
|
4. Risk assessments should be organized and TB infection control plans developed for each health care facility, integrated with general infection control measures and taking the available resources into account. These plans need to be updated annually to take account of new evidence-based procedures. |
Implemented
|
All health care centres must outline the structure of infection control measures management, draw up on an annual basis an implementation plan and control its fulfilment in accordance to the 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. During the monitoring visits, quality of plans and their fulfilment are inspected, and calculation of budget required for infection control measures and their actual volume of financing are analysed for correctness. |
||
|
3. An educational programme should be established on the prevention of TB transmission and cough etiquette for TB patients, their relatives and other close contacts, as well as for the general population. Infection control policies, a high-risk standard of operations and infection control educational programmes should be developed and implemented for health care workers, patients and the general population. |
Partially
|
Education program on TB transmission and “cough etiquette” for TB patients, their relatives and other close contacts has not been developed yet. However, some measures in this direction have been taken. In particular, under the awareness-raising campaign of “Stop TB in Ukraine” program, in 2011-2013 awareness-raising posters “Prevention of TB Infection at Hospitals” (interlinking), which provide visual representation of cough etiquette, were developed and distributed among primary care facilities and specialized TB hospitals. Moreover, in 2011 a sub-recipient in “communication” direction – International Non-Governmental Organization “Labor and Health Social Initiatives” (LHSI) – developed and distributed a brochure for patients and their family members titled “What You Should Know about Tuberculosis” (interlinking), which focuses on basic provisions of TB prevention for family members and hygiene of premises where a TB patient stayed or stays. Operational standards under conditions of high risk at TB facilities are provided in the 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. |
UCDC
|
31.12.14
|
|
2. Annual training courses on TB infection control should be organized at national, oblast, rayon and facility levels for hospital administrators, doctors, chief nurses, epidemiologists, laboratory managers and technicians. It is vital to include epidemiologists from the sanitary–epidemiological services in national and international training. There is a good training centre for infection control in Donetsk. |
Partially
|
Under the Global Fund grant, during 2012-2013, trainings in Planning and Arrangement of TB Infection Control were held for 95 specialists (with chief doctors, doctors, medical nurses, laboratory specialists, engineers and other specialists responsible for infection control at tuberculosis facilities among them). Moreover, in 2012-2013, under USAID project “Enhanced TB Control in Ukraine”, trainings in the following directions of the infection control were held:
|
UCDC
|
On an ongoing basis |
Общие рекомендации
|
||||
|
1. TB infection control measures should be urgently implemented in the civilian and penal TB, HIV/AIDS and general health care services. The high level of nosocomial TB transmission and the growing epidemic of drug-resistant TB in high-HIV-prevalence settings (such as in Ukraine) make it imperative to prioritize the introduction of administrative, environmental and individual control measures based on risk assessments of the facilities. |
Not implemented
|
The Order of the Ministry of Health of Ukraine No. 684 dated 18.08.2010 approved “Standard for TB infection control at health care centres, places of long stay of people and residence of TB patients”, which sets forth the conditions for implementation of infection control measures at tuberculosis facilities. However, in practice, infection control measures are being taken partially; not only insufficient financing is observed but incompliance with the relevant regulations as well. In 2012, monitoring groups on the national and regional levels were expanded and now include an infection control specialist who inspects during his/her visits all components of the infection control and provides respective recommendations as for their improvement. |
UCDC
The State Penitentiary Service of Ukraine
|
31.12.14
|
| Management of medicines and other commodities | ||||
Специальные рекомендации
|
||||
|
11. Legal, regulatory, policy or other barriers to effective management of first- and second-line TB medicines and other commodities should be identified and addressed. An intersectoral approach should be used to address those areas governed by laws and regulations outside the Ministry of Health. |
Not implemented
|
Considering that procurement of anti-TB drugs on the state level is realized under incomplete schemes, and that supply agreements do not envisage any penalties for a failure to comply with delivery terms, anti-TB drugs are not available at the national and regional warehouses from time to time. |
MOH
|
|
|
10. The prescribing and dispensing of first- and second-line medicines should be evaluated to identify patterns of inappropriate drug use and develop interventions to address them. |
Implemented
|
Prescribed therapy compliance is estimated during monitoring visits by the treatment specialists of the national and regional levels. Moreover, electronic register of TB-patients (e-TB Manager) allows for control over prescription of treatment regimens on the national and regional levels. |
UCDC
|
On an ongoing basis |
|
9. Efforts to strengthen pharmaceutical management should be coordinated between programmes, donors and partners across the civil, penal and other sectors. |
Implemented
|
On the national level (state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”), management over medicinal products and consumables for laboratory diagnosis is coordinated by specialists of procurement and supply department. Functional responsibilities of employees in this department include, in particular, coordination of order placement, distribution and re-distribution of anti-TB drugs procured for the money from the state budget, Global Fund and Global Medical Fund. |
UCDC
|
On an ongoing basis |
|
8. Manual and electronic reporting and recording systems for TB should be strengthened to facilitate the appropriate diagnosis and management of TB cases, evaluate treatment outcomes and improve the management and use of TB medicines. |
Not implemented
|
In 2014 it is planned to revise existing manual and electronic system of TB reporting in accordance with WHO recommendations. Moreover, respective amendments will be made to “Drug” modules in the electronic register of TB patients (e-TB manager), which would make it possible to calculate need for anti-TB drugs of the first and second line and to control their use. |
UCDC
|
31.01.15
|
|
7. The efficiency of pharmaceutical management should be strengthened and improved to ensure consistent access to TB first- and second-line medicines of assured quality. This should be done through: |
Partially
|
a) “Method for Calculation of Need for Anti-TB Drugs”, which was updated in 2013), requires improvement with the consideration of the WHO recommendations to the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” (drawn up in 2012). |
UCDC
Regional healthcare departments
|
On an ongoing basis |
|
6. The necessary human resources and public funds should be made available to support the regulatory activities that protect public health and ensure drug safety. |
Partially
|
The function of drug safety control is performed by the state institution “State Expert Centre of the Ministry of Health of Ukraine” having its structural divisions in all regions of Ukraine. However, pursuant to the Order of the Ministry of Health of Ukraine “On Staff Standards and Typical Staff for Healthcare Facilities” dated 23. 02. 2000, No.33, TB facilities do not have a position of a pharmacist and a pharmacist-in-charge, who would be responsible for drug quality control. |
Regional healthcare departments
|
|
|
5. A risk−benefit analysis approach should be used to the quality, safety and efficacy of medicinal products at all stages of the regulation of medicines, including post-marketing quality control, and unnecessary duplication of regulatory activities avoided. |
Partially
|
In 2014, state institution ”Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine” started to cooperate with the state institution “State Expert Centre of the Ministry of Health of Ukraine” with regard to analysis of side effects of anti-TB drugs. Currently, spontaneous reporting on side effects (regulated with the Order of the Ministry of Health of Ukraine “On Approval of the Procedure for Supervision of Side Effects Made by Medicinal Products Allowed for Medical Use” dated 27.12.2006, No. 898 (last revised on 29.12.2011) is on a very low level at TB service. Reported data are not exhaustive and may not be used as a source for making managerial decisions concerning quality and replacement of drugs procured. Active pharmacological surveillance as a component of pharmacological surveillance is not applied in Ukraine at all. |
State Expert Center
|
|
|
4. The registration of first- and second-line TB medicines according to current national standards should be facilitated, to enable their procurement and distribution through the Green Light Committee, national budget or other sources. |
Not implemented
|
Anti-TB drugs of the first and the second line that are procured for the money from the state budget are registered, but not all of them have the WHO prequalification. All anti-TB drugs of the second line that are procured for the Global Fund grant have WHO prequalification, however the majority of them are still not registered in Ukraine (Levofloxacin, Ethionamide, Moxifloxacin, Capreomycin and Kanamycin). For supply of these drugs to Ukraine, a permit for single import to Ukraine should be obtained for each delivery. Meanwhile, the procedure for registration of drugs which have the WHO prequalification is simplified in Ukraine. Moreover, the International Charitable Foundation “International Alliance of Ukraine” together with the state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine” holds active negotiation with the manufacturers concerning registration of additional forms of anti-TB drugs which comply with the requirements of quality control set by the Global Fund. According to the preliminary data, all drugs except for Kanamycin and Capreomycin will have been registered until the end September 2014. |
International HIV/AIDS Alliance in Ukraine
|
30.09.14
|
|
3. Major funding gaps in drug procurement should be overcome by giving preference to solid forms of anti-TB medicines over expensive and often unnecessary injectable products (isoniazid, fluoroquinolones). |
Implemented
|
Anti-TB drugs are procured based on calculations provided in the “Method for Calculation of Need for Anti-TB Drugs” approved with the Order of the Ministry of Health of Ukraine dated 25.03.2011 No. 163 (as revised by the Order the Ministry of Health of Ukraine dated 22.02.2013 No. 156, registered with the Ministry of Justice of Ukraine on June 22, 2011 under No. 742/19480). This method gives preference to application of solid dosage forms of anti-TB drugs rather than prescription of more expensive injectable preparations. |
||
Общие рекомендации
|
||||
|
2. Pharmaceutical management should be strengthened at all levels to ensure consistent access to TB first- and second-line medicines of assured quality and their appropriate use. |
Partially
|
On the national level (state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”), management over medicinal products and consumables for laboratory diagnosis is coordinated by specialists of procurement and supply department. Functional responsibilities of employees in this department include, in particular, coordination of order placement, distribution and re-distribution of anti-TB drugs procured for the money from the state budget, Global Fund and Global Medical Fund. Compliance of drug and consumables use is inspected by specialists of treatment and laboratory diagnosis during monitoring visits and through analysis of data entered to the electronic register of TB patients. On the regional level, currently there is no separate FTE responsible for pharmacological management and pharmacological surveillance. These functions are imposed to deputy chief doctors for treatment and to non-tenured regional phthisiatricians. Control over pharmacological management and pharmacological surveillance on the regional level is exercised in the course of monitoring visits which have been financed since 2012 with Global Fund and USAID grants. |
Regional healthcare departments
|
|
|
1. The harmonization of drug regulatory procedures should be continued, including drug quality control, with European Union standards. Transparency and accountability in the regulation of medicines should be enhanced. |
Partially
|
On May 28, 2013 the Guidelines “Medicinal Products. Good Regulatory Practice” No. 247 took effect, which was developed by the Ministry of Health of Ukraine and state institution “State Expert Centre of the Ministry of Health of Ukraine”. This document complies with WHO recommendations specified in the guidelines for the National Medicines Regulatory Authorities (NMRAs): “Marketing authorization of pharmaceutical products with special reference to multisource (generic) products – 2nd ed”. |
MOH
|
|
| Monitoring and evaluation | ||||
Специальные рекомендации
|
||||
|
6. A system of field supervision should be created at all administrative levels. |
Partially
|
The system of field supervision on the national and regional levels is not currently approved with any regulations. In fact, monitoring visits from the national level to the regional one have been financed since 2012 under the Global Fund grant. Until 2016, monitoring visits from the regional level to the district one will be partially financed by the Global Fund grant (17 regions) and partially by USAID project (10 regions). Furthermore, the applicable Order of the Ministry of Health of Ukraine dated February 23, 2000 No. 33 “On Staff Standards and Typical Staff for Healthcare Facilities” does not provide for establishment of a competent M&E department at regional TB dispensaries. Respective amendments should be made while revising this Order, which would provide for separate FTEs whose functional responsibilities would comply with the international approaches to M&E system arrangement. |
UCDC
|
15.08.14
|
|
5. Extensive training should be conducted at oblast and rayon levels for recording and reporting TB, with priority given to those oblasts without previous international support. |
Implemented
|
During the phase 1 of the round 9 grant of the Global Fund, 386 healthcare professionals were trained in M&E (systems of reporting and accounting and/or data and strategic information management), with specialists of district and regional level from various regions of Ukraine among them. |
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4. The e-TB Manager program should be introduced countrywide by the end of the first phase of implementation of the Global Fund Round 9 grant, but only after the development of automatic outputs for case detection and treatment outcome and the importation of existing databases from the pilot oblasts. |
Not implemented
|
At the end of Phase 1 of the Global Fund grant (2012), the system of electronic register of TB-patients (e-TB Manager) was not introduced all over Ukraine. Only at the end of 2013, data from manual and electronic reports of TB 07 form were united in one pilot region, i.e. Odesa region. Until the end of 2014, it is planned to achieve accordance in data of manual and electronic reports, pursuant to the implementation plan for electronic register of TB-patients (e-TB Manager). |
UCDC
|
31.12.14
|
|
3. The development of recording and reporting of MDR-TB should be completed, endorsed by the Ministry of Health and adopted by all other ministries and departments. National guidelines should be updated accordingly. |
Not implemented
|
MDR-TB accounting and reporting system which was approved in accordance with the Order of the Ministry of Health of Ukraine dated 07.03.2013; No. 188 “On Approval of Primary Reporting and Accounting Forms for Chemoresistant Tuberculosis and Guidelines on Their Completion” does not comply with WHO recommendations. In 2014 it is planned to revise current manual and electronic system of TB and MDR-TB reporting to bring them in line with WHO recommendations. Moreover, respective amendments will be made to the electronic register of TB patients (e-TB Manager). Applicable guidelines on completion of TB/RR-TB/XDR-TB, cohort analysis and indicator analysis must be revised and improved by the end 2014 as recommended by WHO after updating reporting and accounting forms. |
UCDC
State Service
|
01.09.14
|
Общие рекомендации
|
||||
|
2. The former TB recording and reporting system should be discontinued, and the two systems compliant with WHO recommendations and in use by the anitary–epidemiological services should be maintained. |
Not implemented
|
Soviet system of TB accounting and reporting is still applicable. Thus, TB reporting in Ukraine is currently performed under two systems – Soviet system and the one recommended by WHO. This leads to ineffective doubling and accumulation of useless data. |
UCDC
State Service
|
01.09.14
|
|
1. The capacity of the Monitoring and Evaluation Unit of the Centre for TB Control should be expanded by increasing the number of technical staff and funding for field supervision. |
Implemented
|
In 2012, a new structure was established – state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine" – which was made responsible for M&E in the sphere of TB and HIV. This authority has expanded possibilities for monitoring and evaluation of all directions of TB program, at the expense of funds allotted for monitoring visits to the regions from the Global Fund grant. It is planned to make two visits to each region of Ukraine throughout the phase II of the round 9 grant of the Global Fund. |
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| Human resources development | ||||
Специальные рекомендации
|
||||
|
4. The capacity for human resources development under the NTP should be enhanced by: |
Implemented
|
a) TB training of specialists is coordinated at the national level by the training department of the state institution “Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine”. Moreover, under the project launched by the Charity Foundation for Development of Ukraine, a training centre for fighting TB epidemics was established in Donetsk in 2010. b) Training curricula are revised on an annual basis with a possibility of amendments to the information (15% per year) in accordance with the amendments to the regulations. Revised and updated modules are taught within the framework of advanced courses for phthisiatricians. c) Specialists of the national and regional levels carry out on-the-job training during their respective monitoring visits. |
||
|
3. Pre- and postgraduate curricula should be reviewed and modernized by moving from knowledge- to competence-oriented training and including teaching on the Stop TB Strategy and the Practical Approach to Lung Health. |
Partially
|
Within the framework of the Phase 1 of the Global Fund grant, training modules for TB and MDR-TB diagnosis, treatment, monitoring and evaluation were developed. From 2011 to 2013, trainings were held in the following directions:
In 2012-2013, under the USAID project “Enhanced TB Control in Ukraine”, the following trainings were held:
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), as well as HIV/TB trainings (Institute of Epidemiology and Infectious Diseases named after L.V. Hromashevskyi of the Academy of Medical Sciences of Ukraine). 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. |
MOH
|
31.01.15
|
|
2. A strategic plan for the development of human resources should be drawn up, based on an assessment by the TB Human Resource Working Group and including a task analysis, the consequent development of job descriptions, changes in the legal and normative bases and the development of an annual implementation plan. |
Not implemented
|
HR operational research planned within the framework of the phase I of the Global Fund grant was rescheduled for the phase II (2014, responsible – WHO). |
UCDC
|
31.01.15
|
Общие рекомендации
|
||||
|
1. Understanding of and compliance with the Stop TB Strategy should be improved. Despite official adoption of the Strategy, there is widespread scepticism about its appropriateness and potential for successful implementation. Most doctors have their own personal approaches, resulting in a mixture of old and new interventions which may harm the clinical management of the individual patient and the overall public health impact of the NTP. The Ministry of Health should provide ample information on the do’s and don’ts in TB control – more than can be contained in a letter or a ministerial order. Doctors need an explanation of why the Ministry of Health is promoting a certain approach. A manual with guidelines and training are also necessary. |
Not implemented
|
The unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis” was revised, which was approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091, does not conform to all components of “Stop TB” strategy. In particular, it provides for a 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). This 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) available at WHO web-site. |
MOH
UCDC
State Service
|
On an ongoing basis |
| Operational research | ||||
Специальные рекомендации
|
||||
|
3. A process should be developed to facilitate and encourage operational research in the NTP. |
Not implemented
|
Under the National TB Program, no procedures for facilitation and encouragement of operational studies have been developed, planning and implementation of which is assigned to the state institution “Yanovsky National Institute of Tuberculosis and Pulmonology, for the funds from the state budget. Plans of studies intended to be carried out under the Global Fund grant are approved with the National TB and HIV/AIDS Council. Studies under other international projects are approved with the state institution “Ukrainian Centre for Socially Dangerous Diseases Control”. |
MOH
UCDC
State Service
FG Yanovsky National Institute of tuberculosis and pulmonology
|
On an ongoing basis |
|
2. Operational research should be conducted on: |
Partially
|
Under the Program “Stop TB in Ukraine”, the following researches are planned for 2011-2013 with the financial support of the Global Fund:
Organizer – International Charitable Foundation “International HIV/AIDS Alliance in Ukraine”:
The performed studies did not cover all the directions which should have been studied in accordance with the recommendations. |
MOH
UCDC
State Service
FG Yanovsky National Institute of tuberculosis and pulmonology
|
On an ongoing basis |
Общие рекомендации
|
||||
|
1. An operational research agenda should be developed, outlining the priority topics to be studied, identifying key investigators and providing an adequate study budget. |
Partially
|
Under the program “Stop TB in Ukraine”, the following researches are planned for 2011-2015 with the financial support of the Global Fund:
Organizer – Representative Office of the PATH International Organization in Ukraine:
Organizer – International Charitable Foundation “International HIV/AIDS Alliance in Ukraine”:
However, not all of these studies planned could be carried out. |
MOH
FG Yanovsky National Institute of tuberculosis and pulmonology
|
On an ongoing basis |
| Ethics and human rights | ||||
Специальные рекомендации
|
||||
|
3. The public health dimension of TB interventions should be strengthened by involving civil society more actively and effectively in redesigning TB services. |
Not implemented
|
No work related to strengthening the issue of public health in TB measures is being now carried out in Ukraine. |
MOH
UCDC
State Service
|
On an ongoing basis |
|
2. Ethical and human rights values should be carefully evaluated and reflected in the new national law on TB. |
Partially
|
The applicable Law of Ukraine “On Fighting Tuberculosis” specifies that medical aid must be provided to all patients with TB without any exception, in particular to incarcerated, convicted for restraint or imprisonment, foreigners and stateless persons (articles 18-19). Moreover, it stipulates that the patients have a right for free medical care, information from a healthcare professional, free treatment at a health resort, psychological help, for communication with the family and other persons, for religious ceremonies (article 20). |
MOH
|
|
Общие рекомендации
|
||||
|
1. Internationally recognized ethical principles should be adopted and promoted actively to ensure universal access to TB prevention, treatment and care. |
Partially
|
Applicable regulations regulating ethic principles of a patient and medical staff rights now do not fully comply with the international recommendations. |
MOH
Regional healthcare departments
|
On an ongoing basis |
| Advocacy, communication, social mobilization | ||||
Специальные рекомендации
|
||||
|
8. The International Standards for Tuberculosis Care (31) and the Patients’ Charter for Tuberculosis Care (30) should be promoted. The Patients’ Charter should be used to increase the involvement of people affected by TB. |
Not implemented
|
Applicable regulations related to fight against tuberculosis do not fully comply with the Standards for Tuberculosis Care and Patients’ Charter, these documents are not promoted. |
UCDC
|
On an ongoing basis |
|
7. Work with the mass and print media, including the training of journalists, should be properly planned and overseen. |
Partially
|
Within the framework of Global Fund grant, a sub-recipient in communication sphere – International Non-Governmental Organization “labour and Health Social Initiatives (LHSI)” – within 2011-2012 held TB trainings for mass media. In general, 50 persons took part in trainings. |
||
|
6. Training for health care and social service providers (including for staff in nongovernmental organizations) should be supported, built on successful advocacy, communication and social mobilization pilot projects, in the following specific areas: |
Implemented
|
Within the framework of Global Fund grant, a range of trainings was held.
In 2012, Charity Foundation “Intelligence Prospect” held trainings for doctors, nurses, representatives of clergy, penitentiary workers, psychologists, community workers and other non-medical staff of non-governmental organizations, with the following topics:
In 2011-2012, International Non-Governmental Organization “labour and Health Social Initiatives” (LHSI) held TB trainings for mass media. In general, 50 persons took part in trainings. |
||
|
5. There should be a significant increase in the involvement and number of civil society organizations and affected communities in TB care and support, building from the experience of the HIV organizations. These should include such organizations as those working with prisoners and former prisoners and social groups that support homeless people. |
Implemented
|
The National Targeted Social Program on Combating Tuberculosis for 2012-2016 provides for complying with an indicator “Number of regions where non-governmental organizations cooperate with TB facilities”, which aims to improve access to hard-to-contact or vulnerable population groups with the participation of non-governmental organizations. |
||
|
4. Advocacy, communication and social mobilization interventions should be incorporated into wider strategies to control TB, MDR-TB and TB/HIV, ensuring a community-based, clientcentred outpatient approach which also reaches the most vulnerable population groups. |
Partially
|
Elements of ACSM strategy (advocacy of regulations adoption, arrangement of a system for social and psychological aid to vulnerable population groups, involvement of non-governmental organizations into cooperation with TB institutions, carrying out social surveys, development and implementation of the National Strategy for the Tuberculosis Awareness Campaign, regional ACSM plans) were included to the National Targeted Social Program on Combating Tuberculosis for 2012-2016 approved with the Law of Ukraine on October 16, 2012 No. 5451-VI. |
UCDC
|
31.12.14
|
|
3. Coordination councils should be designated at all levels to coordinate the implementation of the advocacy, communication and social mobilization strategy and a dedicated focal person and unit appointed within the NTP to oversee its implementation. |
Implemented
|
In each region of Ukraine, there are Tuberculosis and HIV/AIDS Coordination Councils operating in regional governors’ offices. The commission includes a person responsible for implementation of this component – ACSM coordinator. Since March 2012 to April 2014, the Charity Foundation “Development of Ukraine” was financing their operation in all regions of Ukraine (from 2012 to October 2013 – from the budget of Global Fund grant, from October 2013 to April 2014 – from the budget of “Awareness Campaign” project launched by the Charity Foundation “Development of Ukraine”). |
||
Общие рекомендации
|
||||
|
2. Financial and human resources should be allocated to implement country and oblast-specific advocacy, communication and social mobilization activities and support the efforts of local organizations to reach out to marginalized populations for TB-intensive case-finding and management in order to prevent defaulting on treatment. |
Partially
|
Within the framework of implementation of the Global Fund grant in the sphere of social mobilization, since 2011 All-Ukrainian Charity Foundation “Coalition of HIV-Service NGOs” has been implementing the following projects together with local non-governmental organizations:
|
UCDC
|
On an ongoing basis |
|
1. A comprehensive written national strategy and implementation plan for advocacy, communication and social mobilization should be developed and approved. Based on this, consistent oblast/rayon strategies and implementation plans should be developed and linked to the goals and objectives of the NTP. |
Partially
|
National ACSM strategy to support the National Tuberculosis Program in Ukraine for 2012-2016 was developed and coordinated with the key stakeholders as early as 2012; however, it has not been adopted on the national level yet. Elements of ACSM strategy (advocacy of regulations adoption, arrangement of a system for social and psychological aid to vulnerable population groups, involvement of non-governmental organizations into cooperation with TB institutions, carrying out social surveys, development and implementation of the National Strategy for the Tuberculosis Awareness Campaign, regional ACSM plans) were included to the National Targeted Social Program on Combating Tuberculosis for 2012-2016 approved with the Law of Ukraine on October 16, 2012 No. 5451-VI. |
UCDC
|
31.12.14
|
| Health system and TB control | ||||
Общие рекомендации
|
||||
|
4. To improve the technical and allocative efficiency of the NTP, health interventions should be assessed for their cost–effectiveness before being translated into orders. Cost–effectiveness analysis is a sub-set of health technology assessments. To support and monitor the wider health system reform programmes, consideration should be given to setting up a semiindependent health technology analysis unit or a health policy analysis centre with the cost–effectiveness analysis of TB interventions and a master plan for TB facilities (as part of the re-profiling exercise) included in its terms of reference. |
Not implemented
|
Assessment of economic effectiveness and efficient allocation of finance for measures envisaged by the National TB Program was not carried out on the national level. Under the Global Fund grant, medical and economic reasoning of structural changes within the TB facilities network in the city of Kyiv was carried out in 2012. Research findings were represented at the meeting of Kyiv Healthcare Authority and submitted to members of the city council. Based on recommendations relying on the data obtained, Kyiv facilities were re-arranged, in particular, a unified territorial medical unit in Kyiv was established and a further optimization plan was outlined. |
MOH
State Service
Regional healthcare departments
|
|
|
3. Current TB legislation should be revised. Several laws and regulations have had an impact on the organization and delivery of TB services. New laws and regulations, with high relevance for TB control, are coming within the framework of the health sector reform. An overarching TB law should be developed, that can be further detailed through updated issues of a national main reference TB manual for all providers. |
Implemented
|
The Law of Ukraine on fighting tuberculosis is now effective in Ukraine after being enacted in 2001 (last amendments were made in accordance with the Law No. 5460-VI dated 16.10.2012, ВВР, 2014, No. 2-3, article 41). No new laws which would regulate all TB measures have been adopted. |
||
|
2. TB indicators (output, outcome, impact) should be included in monitoring the implementation of the health care reform (see Annex 4). TB is a condition which encompasses several areas as it is often the result of socioeconomic determinants and poor access to health care. For this reason, it can be used as a proxy for monitoring the overall development and performance of the health sector. |
Not implemented
|
In 2012, under the Global Fund grant, a Draft National Plan for TB/HIV Co-infection Monitoring and Assessment was developed in Ukraine for 2013-2016, which complies with WHO recommendations. This plan includes indicators of output, outcome and impact which fully reflect actual state of epidemics and efficiency of measures envisaged by the National TB Plan. However, the applicable regulations have only two indicators for “Tuberculosis” component which estimate the effectiveness of TB measures taken within general treatment network. They are represented in the Procedure on Extra Fees for Volume and Quality of Work Done Payable to Healthcare Professionals that provide primary medical assistance approved with the Decree of the Cabinet of Ministers of Ukraine dated December 30, 2013 No. 977: - performance indicator for a plan of X-ray examination within a medical risk group (90 percent and over); - indicator of specific weight of patients with acid-resistant bacteria (+) in sputum among all patients suspicious of TB or its relapse who underwent bacteriologically tested at TB laboratories of level I after seeking for medical care at primary health care facilities (from 5 to 10 percent inclusive). |
MOH
UCDC
|
01.08.14
|
|
1. TB control should be included in the initial design and pilot implementation of the health care reform. This is an opportunity for the NTP to test new methods of financing and service delivery which can increase the quality of inpatient and outpatient care while readjusting gaps in TB human resources. It also offers an opportunity for re-profiling TB facilities (converting beds without closing facilities). In particular, the role of TB hospitals to offer “roof and food” to patients calls for a wider discussion of this role – especially in TB hospitals − in the social support system. |
Not implemented
|
Management of the health reform project immediately targeted at removing major reasons of the entire system inefficiency, revision of financing principles, as well as implementation of new models of assistance within the basic health care system was started in 2011 in three regions (Dnipropetrovsk, Vinnytsia and Donetsk regions). However, this reform did not cover the entire territory of Ukraine, and no new ways of financing and service provision were introduced. No TB hospitals were re-profiled or closed. |
MOH
|
31.12.14
|
The agreement on cooperation between the Ministry of Health of Ukraine (state-owned institution Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine) and the State Penitentiary Department was concluded in December 2013 within the framework of the grant of The Global Fund. Starting 2013, supervision over the laboratories of level ІІІ which join the penitentiary system has been realized by the National Reference Laboratory with the financial support of The Charity Foundation “Development of Ukraine” under the project ”Support to the National Reference Laboratory”.