“We have to make sure we have universal access to diagnosis and treatment for TB patients”

Interview with Mr. Razvan Vulcanescu, Undersecretary of State with the Ministry of Health

The Ministry of Health is the operator of the “Public Health Initiative” programme, under which the Norwegian Grants 2009 – 2014 provide funding for the project “The Improvement of the Health of the Romanian Population through Enhanced Tuberculosis Control.”

The projects’ major activities include the implementation of a nation-wide functional network of TB laboratories and facilities equipped with high-end rapid diagnosis technology, plus training for the specialised staff in operating this equipment, in order to increase the capacity for tuberculosis control in Romania. In order to find out more about the long-term benefits of the creation of this laboratory network  provided with modern equipment and about the training of pulmonology specialists, we talked to Mr. Razvan Vulcanescu, Undersecretary of State with the Ministry of Health.

The project “The Improvement of the Health of the Romanian Population through Enhanced Tuberculosis Control” has provided training for over 500 pulmonology specialists so far. As a result, they have become important resources for the public TB control system. What does the Ministry of Health intend to do in order to further strengthen the TB control network?

I have always been of the opinion that human resources and the correct empowerment and training of the human resources are absolutely vital when embarking on a journey, if you want to reach a certain level of performance, if you want to make a difference compared to what was previously done. Human resources are an asset for this project, but they will continue to bring results after this project is completed as well. The entire pulmonology network needs people who are very well trained with respect to the latest discoveries in the field, in order to be able to ensure the quality of the standard of care. To achieve this, the Ministry of Health and the National TB Control Programme seek to ensure further training for the staff (and here I refer not only to physicians, but to nurses and laboratory staff as well) and to extend the training to the primary healthcare network for TB control (family doctors, their nurses, community nurses, healthcare mediators, etc.). Practitioners who are very well trained can move from knowing and applying the methods, to becoming trainers in their turn. There are countries where tuberculosis has perhaps a lower incidence than in Romania but which, in the context of globalisation, of migration – especially in Europe at present – are now faced with an increased incidence of tuberculosis cases, in particular among certain social categories. They rely on those who have the latest information on how to control TB, and therefore there is a chance for our colleagues trained under this project to become experts at European level and be able to disseminate the information that they learn both during the training, and by treating patients. This is an opportunity, because the World Health Organisations closely monitors the evolution and control of tuberculosis in Romania. The WHO Report for 2015, which has been published recently, makes specific reference to what the development of tuberculosis control has meant for our country lately, and it praises the palpable results generated by he projects run by the “Prof. Dr. Marius Nasta” Institute of Pulmonology, including this one.

A network of very well endowed laboratories with state-of the-art equipment has been put in place. How will the sustainability of the activities performed in these laboratories be ensured once the project is completed? 

The project was developed in line with the National Tuberculosis Control Programme, which, in its turn, is in line with the National Health Strategy 2014-2020. Clear, distinct and targeted stages have been defined, we followed a Gantt chart that set out a number of stages and the financing for each of them. At this moment, with the Norwegian funds, we have managed to put in place a sort of start-up for tuberculosis control. Under this project, the “Marius Nasta” Institute was provided with substantial amounts of money that it has used according to the stage planning. Then, in our opinion, in addition to human resources, there are other important aspects. People must be helped by being provided with this with equipment, with these laboratories. A correct, rapid and high-quality diagnosis is key to ensuing proper treatment and to stopping TB from spreading to the general population. For the following stages, the Ministry of Health is focused on ensuring the continuity of this intervention. This is why, in 2016, we will organise the national centralised procurement procedure for diagnosis consumables, in order to ensure sustainability and the control of tuberculosis in Romania.

This project also comprises activities aimed at increasing treatment adherence by means of social vouchers for patients who comply with the treatment. Do you believe it will be possible for this intervention to be implemented nation-wide?

What we want to raise awareness about is what the WHO itself wants to raise awareness about in each and every country. It is what is called health in all policies, and it is a centralised and cross-institutional approach to health problems that may have socioeconomic implications. This is why we need the involvement of all institutions, organisations and partners who can play a part in the control of tuberculosis in Romania. Results have already begun to show due to these projects financed by the Norwegian funds. We can see that the treatment success rate for sensitive TB is of over 85%, but the same rate for multidrug-resistant tuberculosis unfortunately continues to remain at approximately 32%, according to our latest data, which means that these interventions that I was referring to before should directly target the categories that are most vulnerable and most exposed to the risk of treatment default. It is important, before ensuring treatment adherence, to make sure that we have universal access to diagnosis and treatment for the patients. Of course, we will take all necessary steps in order to be able to reduce the number of TB cases in Romania and to increase patient adherence to the treatment. We can definitely say that the partnership* for this project between the authorities, patient care institutions and NGOs with a vast experience in the field has functioned very well and is an example to be followed: when everybody sits at the table and knows what it is that must be done, it can lead to the achievement of common goals. When the project is completed, we will be able to effectively assess where we have started from and where we are.

* The project is implemented by the “Prof. Dr. Marius Nasta” Institute of Pulmonology, the Romanian Angel Appeal Foundation, the Centre for Healthcare Policies and Services and LHL’s International Tuberculosis Foundation (Norway)

Tuberculosis control in hospitals

A training session for supervising physicians was organised at the end of November.

25 supervising physicians, who work under the National Tuberculosis Prevention, Supervision and Control Programme (PNPSCT), in Bucharest, attended the training session “Control of TB transmission in healthcare facilities” organised in November by the “Marius Nasta” Institute of Pulmonology. This training is part of the project “The Improvement of the Health of the Romanian Population through Enhanced Tuberculosis Control,” under the “Public Health Initiatives” programme, financed by the Norway Grants 2009-2014.

The training of supervising physicians is an important stage of a process that seeks to strengthen the capacity of the PNPSCT to prevent and control tuberculosis in Romania, as they are those who monitor the tuberculosis control activities in healthcare facilities and who train the medical staff of pulmonology hospitals around the country so that the disease may not be transmitted from the patients to the medical and auxiliary staff, to patient carers or other persons who come to the hospital. The aim of these staff training sessions is, among others, to create a common understanding of tuberculosis control activities among physicians and nurses, as well as to ensure their appropriate knowledge of the steps that have to be taken in order to prevent people from becoming ill with tuberculosis in hospitals, given that the risk the medical staff is exposed to is, according to estimates, three or four times higher than in the case of the general population.

During the training, the participants discussed the classification of tuberculosis among hospital-acquired diseases, the assessment of the risk of tuberculosis transmission in laboratories and during the specialised investigations (bronchoscopy, radioscopy, radiology), and about the respiratory protection measures for patients and the medical staff. The conclusion drawn at the end was that supervisor visits must not be seen an instrument for the control of healthcare facilities, but as exchanges of experiences between physicians, as pointed out by dr. Cristian Popa, from the “Marius Nasta” Institute of Pulmonology, one of the trainers.

“I believe mental balance can do wonders for the cure”

Pulmonologist Cristina Popa, from the “Marius Nasta” Institute of Pulmonology, on the challenges faced by patients with multidrug-resistant tuberculosis.

Cristina Popa has been working as a physician in the multidrug-resistant and extensively drug-resistant tuberculosis patient ward of the “Marius Nasta” Institute of Pulmonology in Bucharest for over 11 years. She has seen, examined and spoken to thousands of patients and the couch in her office is not where she invites her colleagues to sit during coffee breaks, but where she has piled up files of patients hospitalised in this ward, separated by green notes labelled “A,” “B”…, “S,” “T,” “V”.

– I am aware of my human limits and, to be honest, for me it would be very hard to take this kind of treatment… No matter how careful I may be, I would certainly skip doses now and then.

She voices her thoughts out loud. She understands very well how hard it is for her patients to take between 12 and 30 pills every day, with side effects that are difficult to bear.

 – We try to help the patients to go through with the treatment until it is completed. Ignorance is the most important factor that makes you stop the treatment, because if you don’t know what tuberculosis is, you most certainly will not give very much importance to the drug dose that you have to take that day. They tell themselves: It’s fine, now I feel better anyway, what’s the point in taking any more pills today?

Out of the energy given by the passion for her profession, dr. Cristina Popa finds resources to convince the patients to complete the treatment, for their own good, and she does this day after day. She explains to them, for their understanding, everything about tuberculosis, about the effects that skipping the doses has, not only on them, as persons who have the illness, but on their families as well. And when a patient observes his or her treatment thoroughly, she is even happier than the patient, because she knows, better than anyone, that this is the key for the cure.

– We are a team here, and we try to explain things to the patients. Besides me, there is the nurse on duty on the day in question, and the psychologist. The nurses’ role is very important, because, in the end, a repetitive message is better understood. The psychologist is also very important, because of the meetings she organises with the patients. The message is conveyed differently by a psychologist and the fact that we give the same information in several ways is the most important of all. We give the patients a clear idea about the disease, and this idea sticks with them.

With all the joint efforts of the team of specialists, from time to time there are cases of patients who do not really pay heed to what they say. These are the patients who, several months or years later, return to the hospital beds of the pulmonology wards and restart the treatment, but this time it is a much tougher treatment, with even more drugs, for a form of tuberculosis that in the meantime has become much more resistant to the treatment than in the initial phase.

– Some do not take their treatment constantly and, after they are discharged from the hospital, they continue not taking it. Two months later they are assessed as “treatment discontinuation” but I would assess them as “treatment default.” When the treatment is provided for free and you do not care about it, I think that you, the patient, are most to blame.

Each death caused by the discontinuation or default of the treatment convinces her once again that she must do everything possible to help the patients take their medication as recommended by their attending physician. To some of the them, she talks about cases of patients who, sometime after beginning the medication, are already fit to return to work and still do not abandon their treatment.

– In my opinion, there are cases when you can take the treatment and go to work. There are patients who can do that, and I encourage it. They feel better when they feel useful and get back to their previous active life. I believe that mental balance can do wonders for the cure. They tell themselves: “I take the treatment and feel able to live as I did before the disease.”

Tuberculosis, as all specialists keep repeating, and as dr. Cristina Popa keeps repeating as well, is not a poverty disease, it does not pick and choose. Hospitalised patients include booth poor and wealthy people, blue-collars and engineers, homeless and managers or businessmen.

– It’s hard to sketch a profile of the multidrug-resistant patient now. I could not say that they are necessarily people living on outskirts of the society, that they do not have a home or are deprived of food… Generally, around 50% of the patients are persons who know and have lived with someone who had this disease and they took the tuberculosis bacillus from that person. Later on, unfortunately, due to a personal trauma or because they went through an extraordinarily stressful event or they lost someone in their family, the bacillus was activated and they developed this disease.

In case of suspected tuberculosis, the first hospital stay is, according to the classical approach, of around three months, during which the patient undergoes medical investigations. Only at the end of those three months and based on the laboratory test results we can know for certain whether the patient is contagious or not, whether he or she has sensitive tuberculosis, multidrug-resistant tuberculosis (MDR TB) or extensive multidrug-resistant tuberculosis (XDR TB).

– The major shock is when they find out that they must complete two years of treatment, in the case of MDR tuberculosis. Two years is a lot. Most patients are men and, in the majority of cases their knowledge is limited and their level of education is low, which often leads to carelessness in complying with the treatment. Most of them have graduated only middle or vocational school. There is a relatively limited number of patients with university degrees, who give importance to the detailed information about the disease and to the correct attitude towards a treatment that is by no means easy, but which may cure them.

Staying in hospital for three months, far from home, from family and from friends is another difficult challenge for the patients. Moreover, if the patient does not become negative, meaning that he or she continues to be contagious, hospital stay may be extended, sometimes even up to six months.

– Many patients at “Marius Nasta” are people who come to Bucharest because they are strongly motivated to go through with this treatment and therefore are capable to deal with this long stay away from their families. They are patients who either had a previous tuberculosis episode or received other treatments.

And, dr. Cristina Popa adds, there is yet another obstacle for the early detection of tuberculosis.

– Most patients who come to the emergency ward do so because they experienced abundant sweating, not because they have been coughing for two weeks, they have lost weight and feel more tired in the afternoon. They attribute these symptoms to smoking, stress or working too hard, and this delays the diagnosis.

“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.