94 | Good practices in strengthening health systems for the prevention and care of tuberculosis and drug-resistant tuberculosis
Background
The first steps in establishing an electronic register for TB cases in Belarus were taken in 2006. In 2009, with support from the Global Fund, a Belarussian information technology company developed a module for electronic registration of DS-TB cases and introduced it on the MIS Lekar platform.
It allows data reporting in accordance with WHO reporting requirements. The work was continued, and, in 2012, a mod-ule for MDR-TB was added. In 2013, a laboratory modmod-ule for the electronic TB register was disseminated across the country, and a drug management module has been available since 2014.
Health system challenge
TB surveillance strengthening and operational research were impossible without case-based electronic registration of all TB patients and their drug susceptibility.
Good practice in health system strengthening to improve prevention and care of M/XDR-TB
The electronic register is accessed through a designated server; it has more than 60 secure data access entry points and covers all cases of TB and MDR-TB registered in Belarus.
In 2013, with the support of the Global Fund, a laboratory module was added; since then, all TB laboratories have been connected to the register to enter the results of DSTs into the system.
The data in the register are used to analyse indicators of the TB programme, and laboratory module data are used to inform the consilium on MDR-TB. The register is also used for reporting the number of notified cases and the drug resistance spectrum and for following up patient outcomes and quantifying drug requirements.
Since the start of the register in 2009, 28 000 cases of TB have been registered, including more than 10 000 cases of MDR-TB. Since 2013, the laboratory module has held diag-nostic and treatment monitoring results for each registered TB patients. The database is used for operational research, analysis of key socio-demographic and clinical
characteris-tics of patients, surveillance of drug resistance and assess-ment of treatassess-ment outcomes at all levels. These functions lead to improved TB control interventions in targeted groups. At present, the register holds about 80 variables on each registered case. It has a patient search function at national level, and any file can be downloaded for further analyses with application programs.
The data in the register are used to analyse the key indica-tors of the TB programme, and DST results are verified dur-ing consilium meetdur-ings on MDR-TB cases. The number of registered TB patients and the spectrum of drug resistance are reported, TB treatment outcomes are followed up, and drug requirements are quantified from register data.
Outcomes
The electronic register allows in-depth analysis of pro-gramme performance at district, regional and country lev-els. The results of the analyses allow goal-oriented planning of activities to improve the quality of health services. The TB programme can be analysed in depth, in accordance with WHO requirements. The data are used to assess the perfor-mance of TB services and are incorporated into the State sta-tistical reporting system.
Since 2014, it has been possible to identify the use of rapid TB diagnostic methods and to analyse the time required to diagnose TB and MDR-TB. In the past, use of paper forms delayed DST results by up to 2 weeks. At present, as soon as a test is performed, the results are immediately available to the attending physician. Thus, the time between a patient’s attendance for medical help and diagnosis has been reduced by 7–8 days. All consilia also have access to the electronic register, which not only provides statistical information but also holds medical records and data on social determinants that could affect the course of treatment and patient adher-ence.
Case-based recording has improved quantification of TB drug requirements and stock management in the region.
Introduction of the laboratory component of the register
Belarus
Introduction of a public electronic register for TB
G .L ..Hurevich,1.E .M ..Skrahina,1.L .A ..Zhilevich,2.A .P ..Astrovko,1.D ..Klimuk,1.I ..Nekrasova,3.V .Z ..Rusovich4
1.Republican.Research.and.Practical.Centre.for.Pulmonology.and.TB;.2.Ministry.of.Health.of.Belarus;.3.Grant.Portfolio.Management,.Global.Fund,.
Belarus;.4.WHO.Country.Office.in.Belarus
Consolidated Action Plan, area of intervention 5
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and the possibility of verifying all laboratory diagnostic tests results has increased the use of register data by TB physicians.
Important factors for success
An important factor in the success of the register is that it allows automated generation of reports on indicators to be submitted to State bodies and international organizations.
Ensuring sustainability
Since 2012, State statistical reports have been based on data from the electronic TB register. In 2016, with financial sup-port from the Global Fund, a pharmacovigilance component will be introduced. Since 2014, the maintenance of the regis-ter has been paid from local budgets.
96 | Good practices in strengthening health systems for the prevention and care of tuberculosis and drug-resistant tuberculosis
Background
In 2010–2011, Belarus had one of the highest burdens of MDR-TB in the world, comprising 32.3% of newly diagnosed cases of TB and 75.6% of previously treated patients. New drugs and technologies are urgently needed to stop the spread of M/XDR-TB. Despite the benefits of complex TB regimens, they are accompanied by attributable risks such as drug-in-duced adverse reactions, which make a significant contribu-tion to avoidable morbidity, treatment failure, reduced quality of life and death. The administration of new TB regimen com-ponents should be closely monitored to ensure optimal drug effectiveness and safety and to obtain new, relevant data.
The national TB treatment policy in Belarus is based on WHO recommendations, and the national treatment guidelines have been standardized since 2005. The National Pharmacov-igilance Centre operates under a regulatory body, the Centre of Examinations and Tests in Health Service of the Minis-try of Health. Legislation on pharmacovigilance has been in place since 2006 and is continuously updated. The National Pharmacovigilance Centre has designated staff, technical and material resources and standard operating procedures for pharmacovigilance, including safety data management, signal detection, evaluation, risk minimization measures and communication. Active pharmacovigilance has been used with the support of WHO in the HIV programme since 2012, and currently 620 patients with HIV infection are monitored.
Every year, more than 30 drug profiles are re-evaluated for safety and effectiveness by local and foreign safety moni-toring. The results are used to modify recommendations, impose various types of restriction, withdraw drugs from the market and conduct quality control and technological and biopharmaceutical investigations and changes. Starting in 2015, Good Pharmacovigilance Practice will be instituted in national legislation, and the national pharmacovigilance system and those of all manufacturers operating in the mar-ket in Belarus will be required to adhere to it.
Health system challenge
The introduction of repurposed and new TB drugs for which there are limited data about safety and effectiveness into
intensive DR-TB therapy requires additional pharmacovigi-lance by the NTP in order to ensure that patients have opti-mal care and proper risk management.
Good practice in health system strengthening to improve prevention and care of M/XDR-TB
“Cohort event monitoring” is used for monitoring adverse drug reactions. In Belarus, this procedure provides new data on safety and a mechanism for drug administration under close monitoring. It allows the detection, evaluation, pre-vention or minimization of risk and safe, rational, effective use of medicines, which are important for both patients and public health and safety.
The goals of the pharmacovigilance plan for TB drugs are:
» to introduce an effective pharmacovigilance system into the TB programme, with continuous monitoring of the safety and efficacy of TB treatment to ensure the safety of TB patients; and
» to improve the effectiveness and safety of pharmaco-therapy for TB and M/XDR-TB patients.
The specific objectives of the plan include:
» increasing reporting and professional skills among TB health care professionals;
» introducing effective early warning of problems related to the use of TB drugs and concomitant medicines;
» finding approaches for further optimizing TB patient management and monitoring and minimizing unfa-vourable consequences of pharmacotherapy of patients with M/XDR-TB;
» encouraging safe, rational, more effective use of TB drugs;
» contributing to the assessment of benefits, harm, effec-tiveness and risks associated with the medicines used in M/XDR-TB patients, leading to maximization of bene-fits; and
» promoting understanding, education and training in pharmacovigilance and its effective communication to the public.