“The multidrug resistance patients are the real public health problem”

A functional network of laboratories has been put in place under the project “The Improvement of the Health of the Romanian Population through Enhanced Tuberculosis Control,” financed by the Norway Grants 2009-2014. As a result, multidrug-resistant tuberculosis is more rapidly diagnosed. Dr. Gilda Popescu, manager of the “Marius Nasta” Institute of Pulmonology, gave us an insight into these improvements.

What did this project mean for the national tuberculosis control programme?

For us, the project run with the Norwegian funds is vital for ensuring TB control in Romania, because it meant the establishment of the national network of bacteriological laboratories that will ensure a more rapid diagnosis of tuberculosis and, more importantly, of chemo-resistances. With this project we now have 18 laboratories equipped with everything that means modern technology, from liquid phenotypic methods that facilitate cultures and DSTs, to genetic methods that identify bacterial DNA and rifampicin resistance, and to complex methods that we use to detect drug resistance to antibiotics and second-line anti-TB drugs.

In addition to the technical equipment provided for these laboratories, we also benefitted from staff training. Practical training sessions were organised on how to use the new equipment and how to obtain the results in order to identify the bacteria and drug resistances.

Also, one of the most important activities is ensuring the correct and complete treatment regimens for patients with multidrug resistance. Approximately 300 patients with complete anti-TB regimens have already been enrolled for treatment under this project. In addition to the drugs, we also ensure treatment adherence with the help of our MDR coordinators, who observe the treatment of multidrug-resistant patients.

As far as tuberculosis is concerned, the multidrug resistant patients are the real public health issue. Drug-sensitive tuberculosis is a controlled phenomenon, although the number of cases in Romania is very high – Romania is the country with the highest incidence in the European Union. We have a very good detection rate, one of the highest in the European Union, and a treatment success rate of 86% for drug sensitive cases treated. Multidrug resistance cases continue to be the real problem, as the detection rate is 52% and, in addition, the treatment success rate is very low, 32% – the lowest in the WHO Europe region.

It’s here that we have to act in order to reduce the increased incidence and deal with this public health issue. This is why we need rapid diagnosis and we perform it in the TB microbiology laboratories; we need efficient medication and we are providing it under this project whereby 1,000 patients should receive complete treatment regimens.

Will the laboratory network be sustainable after the project is completed?

The promise made by the Ministry and by the Government, who approved the Tuberculosis Control Strategy 2016 – 2020 by Government Decision, includes assurances that the budget will be available. In fact, what the support from the Ministry will effectively have to cover starting from 2016 are the rapid diagnosis methods and the correct treatment, because the other activities that we perform – monitoring, assessment, epidemiological surveillance investigations – do not entail very high costs. These rapid diagnosis methods and the correct treatment are the very expensive part. In autumn last year, we talked to representatives of the European Pulmonology Society about the rapid diagnosis and they were particularly pleased to hear that Romania now has all this equipment that enables us to perform rapid diagnosis. We would have liked for each county laboratory plus the six in the sectors of Bucharest, meaning 47 laboratories, to be equipped with everything that means rapid technology – both liquid phenotypic methods and genetic TB diagnosis methods. In addition to these, the laboratories of penitentiary hospitals should have been provided with equipment as well, in particular since the incidence of tuberculosis in penitentiaries remains at least six times higher than in the general population, which would call for special rapid diagnosis and correct treatment measures.

What does rapid diagnosis mean and what is the difference from the methods used before?

Until a little over a year, we were only able to use the conventional method – microscopy, culture and drug sensitivity tests. According to the WHO definition, the confirmation of a TB case is a confirmation obtained after a culture test, or if we refer to the ECDC (e.n. – European Centre for Disease Control), the confirmation is given by a rapid genetic method and the positive microscopy. In order to be able to do this, we need rapid technology. The conventional method means a complete diagnostic that is obtained as follows: culture in 60 days, then another 30 days for obtaining the DST. Practically we were waiting for around 100 days until the results were communicated. At present, the GeneXpert method solves this problem in two hours and the liquid phenotypic methods take another 21 days. In the diagnosis of a disease like tuberculosis, there is a considerable difference between 100 days and 21 days. For example, in the past, we would have a patient with tuberculosis but we would realise 100 days later that the drugs initially administered were not all of them effective because the bacillus had already become resistant to at least 1 or 2 drugs, and therefore we needed to rethink the therapeutic formula. For the patient, this means isolation, removal from the family environment, absence from work, financial burden, and these aspects can be significantly reduced and improved with the application of these rapid diagnosis methods.

Did the new laboratory network also require new jobs?

No, on the contrary, what did increase was the workload because before we would only use the conventional method and now we are also using the rapid methods, which means extra work. The workload increased approximately three times for the 18 functional laboratories. We proposed the Ministry to consider additional workforce and we showed that the previously established work norms, set according to the number of beds, had to be reassessed. The analysis concerning the staff required should be based on workload, not on the number of beds.