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.
A training session dedicated to nurses and community mediators took place in Bucharest on 2 and 3 October. The course was structured in two parts, one for TB experts and the other for community nurses in charge with detecting TB cases, providing directly observed treatment (DOT) and with the proper functioning, at local level, of the TB specialists and nurses team.
The course was addressed to the county teams made of one TB professional (doctor) and a community nurse. 12 people attended the training (6 TB experts and 6 community nurses) in the 6 counties where activities under the Work Package 7 will be implemented: Botosani, Neamt, Gorj, Dolj, Calarasi and Giurgiu.
The participants trained will organize similar training sessions in their counties of origin, where they will teach community nurses and health mediators about Tuberculosis (screening, treatment, DOT, social incentives for DOT patients). The teams will be responsible for organizing information-education-communication (IEC) caravans, with the support of local authorities and the community nurses and mediators they will train.
All 6 training sessions will be organised in the counties, by the end of this year.
Many patients who have been discharged from hospital and continue their treatment for multidrug-resistant tuberculosis in outpatient settings or their caregivers come at the end of each month to the TB dispensaries to receive the social vouchers worth 80 Lei per month. In August, we went to the Outpatient Health Facility on Salcâmilor Street to ask patients how they cope with their disease.
Ionuț Dumitru, 41, retired due to disease.
“Every day I experience the same symptoms, vertigo, nausea. When it’s hot outside, it’s terrible. The only thing that motivates me to keep taking the treatment is the fear of giving the disease to someone else, in particular at home. For me, the effects of the treatment are a nightmare. And there, in the hospital, I saw fellow patients throwing the drugs away. I’m better, because I’m at home I don’t have to put up with the stress in the hospital. My income is 460 Lei, it’s not enough for anything. With the vouchers I can buy about 15 % of all that I need.”
Mihaela Andrei, 47, mother of a 20-year old woman diagnosed with MDR TB in June
“On Easter, in April, she coughed and told me she felt a taste of blood in her mouth. We both thought that it was from a tooth, because otherwise she had no symptoms. Then, a month later, the fever started. We don’t know where she took it from, it’s true that she used the metro and the trolley bus to go to college, but she always hanged around kids from good families. She is in great pain, her whole body hurts, especially the soles of her feet. We use the vouchers for vegetables and fruits. Every day I make her beet, celery or carrot juices. Her emotional state is poor, she is always crying. Now she is in her third college year but she missed the summer exam session and, as a result, she lost her state-subsidised tuition.”
Mirela Stamate, 43, wife of patient diagnosed with MDR for the second time
“He has had this problem for many years, ever since he was in prison, which is where he got sick in the first place. The disease relapsed seven years ago because his immune system is weak. He underwent surgery for stomach cancer and he also has two herniated discs. I was also ill twice, but my system is better and I haven’t had problems that needed medication. We have two pensions that together amount to 600 lei. We work sometimes, I clean people’s houses and he repairs sockets or water taps from time to time. We also have a 15-year old daughter. We keep on giving her immuno-stimulants and medicines so that she doesn’t get sick. For us, the vouchers are really helpful.”
*The names in this issue are fictional; we decided to change them at the patients’ request.
Doctor Emilia Tabacu, member of the Committee for Multidrug-Resistant Tuberculosis in Bucharest, told us about the effects of the complete treatment regimen and the challenges faced by the patients.
What is the standard treatment received by patients with multidrug-resistant tuberculosis?
Multidrug-resistance means that the patient is resistant to two major drugs, Isoniazid and Rifampicin. It is only from this point on that we can call the disease multidrug-resistant; usually, patients are not resistant to just these two drugs, but also to Streptomycin, the injectable drug, and to Ethambutol. This is why all patients must undergo a bacteriological investigation, namely a drug sensitivity test, before the treatment is initiated. Until recently, in Romania, the drug sensitivity test was performed only after testing culture on solid media and the result came very late, at least three months after. Only then the treatment was individualised. There were 3 months when the patients were practically untreated, and the disease would evolve while some of them were hospitalized, at home, or in the care of TB dispensaries. Now that the modern techniques involving liquid media and genotypic methods were introduced in Romania, we are able to know within two hours if a patient is resistant or not.
How could we describe the bacillus that is resistant to two or several medicines? Can this be a bacillus from sensitive tuberculosis that was not treated?
It depends. There are cases of resistant tuberculosis in previously treated patients who either abandoned the treatment or received the treatment a little “by ear”, without a drug sensitivity test being performed. There are the chronic cases which, because of the patient’s negligence may lead to this kind of chemo-resistance, but there are also new cases where the infection was caused directly by this microbe coming from a resistant patient. This happens because the bacillus mutates and the patient can become infected immediately with a resistant microbe, without their fault.
Are the drugs for multidrug-resistant patients available in Romania?
For a patient who is resistant to only one drug, the treatment regimen under the National Tuberculosis Control Programme could have sufficient coverage. However, for multidrug-resistant patients, the drugs are not sufficient and this is where the ones obtained through the programme financed by the Norway Grants intervene.
How long has the complete treatment been available in the other European countries?
It has been available for many years now, maybe even more than ten years. In our country, treatment continuity was also part of the problem. The drugs were available in hospitals but, after the patient was discharged they would refer to the territorial dispensary, only that these facilities would not have the drugs. It was easy for a patient to discontinue their treatment because there was no way of getting the drugs. Thus, patients acquired increased resistance.
Does the individualised treatment scheme under the programme entitled “Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control” cover the treatment needs?
Yes. When we had drugs on various projects, they were always sufficient. Except that not all patients can be included in these programmes. There are patients who are already under treatment, who maybe have one year of treatment or more. We do not include them in the programme we let them continue their treatments with the drugs under the National Programme. There are also patients who refuse the medication.
Do you have cases of patients who tried to procure the drugs from other countries?
Yes, of course, there have been many. However, a complete regimen may amount to more than EUR 10,000, over the two years needed. Most of the patients have low or no income. Although, lately we have found cases in middle class patients. If it used to be said that tuberculosis is a poverty disease, we cannot say this anymore now. We have many students and young employees among our patients. Some of them, unfortunately, get to the hospital too late for fear they would lose their jobs. The disease progresses and they come to us when they have already started eliminating blood through their lungs. Without treatment they are a source of infection for those around them and are contagious for the general population, for all of us.
Why has this myth emerged, of tuberculosis being a poverty disease?
Indeed, patients now come from all types of backgrounds, but nobody can deny that tuberculosis is predominant among the poor. However, it is not only a poverty disease. Here, in our country, people consider it to be shameful. I have seen a teacher recently who said “Doctor, please, don’t write on my medical leave note that I have tuberculosis.” And what should I do, what you have is what I will write. And then she said “I’d rather go on unpaid leave, because I don’t want people at work to know. They would never have me there again.”And there have been cases of people who were isolated at work, and that is a fact. Unfortunately we also have a lack of medical culture in relation to tuberculosis and this is true even amidst the medical staff.
What does this mean?
Let’s say a person with tuberculosis suffers a digestive haemorrhage and that they throw up blood like they would do after an ulcer or something similar. They are sent to another hospital, where they are told it’s tuberculosis but then they are kept at a distance. A brief examination is performed (mostly of the medical chart than of the patient). These things should not exist.
What are the risks that the patients, as well as those in the communities are exposed to if they do not comply with the treatment?
In the patients’ case, the disease progresses, complications develop and the disease becomes chronic. One can no longer hope for a positive outcome, for a cure. The risk for those around, because this disease is practically collective, not only of the patient in question, is to become sick. We do not get those around us sick immediately, we infect them. Once infected, if the body is healthy, it defends itself and the disease does not develop. However, once the body’s immunity is weakened, due to who knows what other cause, the disease develops in one, two or five years.
How long can it take from infection to the disease?
There can be as much as ten years. The risk is huge. This is why even in Europe, when they look for a job, our citizens undertake tests and are monitored because they come from a country that has the highest incidence in the European Union.
What are the chances for a cure if one benefits from a full treatment regimen?
Because of this project, we now have a correct and qualitative treatment, so the chances are very high. The patient’s compliance with the treatment is critical. The drugs are very good, but because the treatment lasts so long, there are various reactions. One has to take a handful of drugs every day. Some of those who are undergoing treatment stay in the hospital for one month, then they run away from the hospital and we cannot expect that they will continue to take that handful of medicines. Through this project, with the help of psychologists and community nurses, we hope that patients will understand that this is their chance, their last train, because they have guaranteed medication throughout the treatment. Any infectious disease that is treatable and curable also requires support from the society, including sympathy from the employers well. These people must no longer be marginalized or cast away.
Interview with dr. Victor Olsavszky, Head of the WHO Country Office in Romania
In August 2015, under the project called Improving the Health Status of the Romanian Population in Romania, by Increasing Tuberculosis Control, a contract was signed whereby the World Health Organisation will ensure the technical assistance for the National Tuberculosis Prevention, Surveillance and Control Programme (NTPSCP). A large part of the assistance actions complete and consolidate the project activities.
In order to find out more about the priorities of the WHO mission and about the concrete working methods, we talked to dr. Victor Olsavszky, the Head of the World Health Organisation Country Office in Romania.
Dr. Olsavszky, what aspects of tuberculosis control in Romania should represent the top priorities of the National Tuberculosis Prevention, Surveillance and Control Programme at the moment?
Everything is a priority. Above all, however, we believe that we must place the correct and timely treatment of tuberculosis, particullary of multidrug-and extensively drug-resistant tuberculosis. We say this because it is obvious that, in order to make progress, we have to contain the reservoir. And this reservoir is the infected patient. We know that we have good surveillance, the program in place is very well organised, but the data from the surveillance and from the programme assessment show that there are shortcomings regarding the treatment. This means that the patient is not diagnosed on time. This is what the new project does. It brings the necessary diagnostic instruments, namely those that enable us to make a quick diagnostic instead of waiting for two or three months, as it has been the case so far, before we are able to realise whether the tuberculosis is sensitive or resistant to treatment. Ant then, when this is implemented, one can very quickly shift to a better and more efficient treatment, which means that, at least for the multidrug-resistant tuberculosis cases, the cure percentage can be increased (at this time it is somewhere below 25 %), and this can reduce the flood. It is true that as far as the sensitive tuberculosis is concerned, things are much better. Practically, in this case, the cure rate is already high, but it must nevertheless be increased, because this is where the multidrug-resistant tuberculosis cases originate from (because of treatment interruptions).
So, in short, we could say that the correct, complete and timely treatment is the priority.
What does the WHO assistance to the NTPSCP consist of for the following period?
There are five main lines. Technical assistance has been constant so far as well, even before these projects and financial assistance from donors existed. The most important part goes to the DOT (directly observed treatment). If DOT means that the treatment takes place under the direct supervision of the doctor, of the nurse and so on, we apply the same principle to the Ministry of Health. Meaning that we directly observe what the ministry does in relation to the NTPSCP. In other words, before, we would come every six months and directly observe what was happening. And this will continue.
In particular, under these projects, we will provide assistance for the development of Guidelines for the management of tuberculosis cases in children. In this area, we have already contributed with a donation of paediatric formula drugs, which were not available on the Romanian market. It is natural that they were not available here because, since the market is small, no producer was interested in bringing them. This being the case, we came with this donation, with this support. Then, there will be the Clinical Guidelines for the cases of tuberculosis and HIV – meaning that we will provide technical support for the development of these guidelines. The third important aspect – because we consider that the involvement of the primary care is essential – is that we will conduct an analysis of the financing and compensation of activities at the level of the family doctor. Family doctors should be involved in the project. The fourth important thing is related to the streamlining of the use of resources and is related to the centralised procurement of drugs. Of course, we have centralised procurement now as well, but we consider that this procedure can be improved, and this is related to the fifth important component, what we call governance, or let’s call it the management of the entire programme. Because NTPSCP is based on an entire network that is organised and functions both in hospitals, and in TB dispensaries – sure, the aim is to also involve the family doctor – a series of dysfunctions have been noted with regard to hierarchies and management and, in addition, with regard to the financing mechanisms, at least those from the Ministry of Health budget. This is about not having resources, or that the Ministry of Health does not make these resources available, but in the sense that their use is not optimal, because of bureaucratic procedures which make things move very slowly. This will contribute to all the other aspects that I mentioned above and will solve the number one priority – the rapid and efficient treatment.
How will you actually work, so that the national decision-makers implement the recommendations and information in the reports and guidelines of the technical assistance missions?
First of all, we will do what we have also been doing so far: every six months we come and see what has happened. But most importantly, we will also come with the experience of other countries. Because, sure, Romania is at the top when it comes to cases of multidrug-resistant tuberculosis, but the Baltic Countries come very close to our country. There, MDR-TB is a public health priority and we can show what has been done there in this regard. Secondly, in terms of how the project is conceived with financing from donors, it takes into account what we call direct involvement of the beneficiary, the direct involvement of the decision-maker.
In other words, nothing can be done outside the decision-making chain or outside the system in which the programme must operate.
Interview with Mr. Răzvan Vulcănescu, Undersecretary of State within the Ministry of Health
This year, the Romanian Government passed the National Tuberculosis Control Strategy, a commendable decision that was received with optimism by all stakeholders. The strategy’s objectives, to be reached by 2020, aim mainly to ensure universal access to rapid diagnostic methods, to diagnose at least 85% of all the estimated cases of sensitive and multidrug-resistant tuberculosis (MDR-TB), to successfully treat at least 90% of the new cases and at least 85% of re-treatments, to successfully treat 75% of the multidrug-resistant tuberculosis cases, to decrease the disease incidence and to improve the healthcare system capacity to control tuberculosis.
The Ministry of Health is currently the Operator of the “Public Health Initiatives” programme, through which the Norway Grants 2009 – 2014 finance the project Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control. The project’s major components concern the increase of the rapid diagnostic capacity for multidrug-resistant tuberculosis, the provision of the correct, complete and quality treatment for MDR-TB patients, measures for maintaining treatment compliance and, last but not least, the development of a functional network of TB laboratories and facilities countrywide, with modern equipment and trained staff, in order to enhance the capacity for tuberculosis control.
Mr. Răzvan Vulcănescu, Undersecretary of State within the Ministry of Health, has given us an interview in which he spoke about the role of this project in the context of the National Tuberculosis Control Strategy and the way in which the institution he represents will ensure the sustainability of the implemented interventions.
So, mister Undersecretary, what is the role of the project Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control in the implementation of the National TB Control Strategy 2015-2020?
Thank you for addressing this subject in this interview, one that we also consider very actual and very important, and we appreciate the collaboration we have with the Marius Nasta Institute and its partners in this project. Before I answer your question, I would like to make a little introduction, because just like this project comes to support the National Tuberculosis Control Strategy, the National Tuberculosis Control Strategy is part of our Health Strategy called Health for Prosperity, which we passed last year, by Government Decision, an initiative that has been built over the course of several years. I started this initiative, as coordinator of the working group at that time (2012), which aimed at bringing together the entire medical community responsible in Romania in order to build this health strategy to which we could all contribute and make sure it would help us solve the major health problems we are facing. I was very glad that the final outcome was this strategy, which was passed at the end of 2014 by the Government of Romania. It is very important to remember that it is part of the Partnership Agreement with the European Union for the programme period 2014 – 2020 and that it seeks to ensure the necessary funding for a complementary financing to what is provided by the Government, and the funding necessary for us to be able to control the major public health problems that we are facing. Obviously, after the National Health Strategy was passed, the National Tuberculosis Control Strategy followed and it was precisely in order to support this strategy that we were very happy with the existence of the Norway Grants that we tried to use in order to cover those very gaps that were not covered by our Government funds, or as a supplement to the allocated money. So, there are elements of complementarity, elements of similarity, but, of course, our main purpose is to seek and support, in all our initiatives, the control of tuberculosis in Romania.
What are the plans of the Ministry of Health in order to ensure the sustainability of the interventions implemented in Romania through the two projects which, at this moment, come to support the Strategy? (I’m talking about the two major national projects: Project RO 19.01, financed by the Norway Grants, and ROM-T-RAA, financed by the Global Fund to Fight AIDS, Tuberculosis and Malaria. Under these two projects, Romania receives support for ensuring the rapid and qualitative diagnostic, the correct, continuous and complete treatment for the patients with MDR/XDRTB, the start of the reform in relation to the outpatient care of TB patients through social support services, in order to maintain compliance, the early detection of TB cases among vulnerable populations – the homeless and the injecting drugs users.
What you have mentioned are in fact the objectives that we would like to reach by implementing these projects. In fact through the two projects, Romania receives support for ensuring rapid and qualitative diagnostic and continuous and complete treatment for TB and MDR-TB cases, practically the beginning of the reform of outpatient care for TB patients, through social support services, in order to maintain compliance and actively detect TB cases among those vulnerable populations (here we can think of the homeless or people of a certain ethnic origin, or users of injecting drugs). The interventions financed from the Norway Grants and from other international funds as well, will be taken over and will be ensured the amounts and financing resources in accordance with the National Tuberculosis Control Strategy.
I would also like to present a part of the concrete results that we have already obtained through the implementation of the two projects. Specifically, speaking about the activities set out in each project, we can say that, halfway through, we already have palpable results that motivate us to take these projects further as they have been carried out so far. First of all, with regards to the strengthening of the capacity to control the TB epidemics, I can tell you that more than one third of the pulmonology medical staff has been trained on TB control since the beginning of the project. The total number is 600 professionals. Furthermore, if we consider the activity related to the strengthening of the rapid diagnostic capacity for TB and MDR TB cases and the increase of the detection rate when using rapid diagnostic method that are standardised in terms of quality, the methods that we used until now will be doubled by much more efficient methods and, in the following two months, at most, along with the existent tests, we will also have available the GeneXpert tests that can give the diagnostic for TB and for Rifampicin resistance. This test can give a result in two hours. Also, since April 2015, over 6600 persons have been tested, of which 1643 were detected with tuberculosis and 171 with multidrug-resistant tuberculosis. So, we already see real results and we begin to identify and treat patients from the risk categories that we have on record. Also, starting this month –September 2015 – we will also have available under the project the vehicles that will carry the samples from the peripheral laboratories to the regional and national reference laboratories, in order to ensure a correct and rapid diagnostic.
We can go further and look at the activity related to the provision of continuous, complete and quality treatment for 1000 patients with TB and MDR TB, and I can confirm to you that so far, over 200 patients have been enrolled in the treatment cohort. These patients receive complete, continuous and quality treatment, in accordance with the identified resistances and, moreover, starting this month, the patients enrolled in this project will also receive a drug that has been approved by the World Health Organisation (editor’s note WHO) for the treatment of MDR TB. As for the provision of directly observed treatment and incentives for TB patients treated in outpatient care facilities, in order to increase treatment compliance, so far, around 440 TB patients with increased default risk treated in these facilities have received support in order to maintain treatment compliance. This means that over 80 % of them have continued to be compliant for a period of 4 months. This initiative is very important for us, because before we had to monitor them and each time we would lose track of them they would return in a more complicate stage of their condition, which also implied higher costs. So, it is very important that once the procedure is initiated for each identified patient, the procedure is continuous and focused in terms of the efforts that we all make in order to motivate them to stay with the treatment until there is a medical confirmation that the risk period has been surpassed entirely or even that the patient is completely cured.
Basically, all the activities are implemented according to the schedule and, at this point, approximately 45 % of the results initially planned for this time interval have already been achieved. This is an effort that has been assumed by both the Ministry of Health and the project management team within the ministry, which coordinates and monitors the entire activity of our partners in the system. It is an effort that we have assumed precisely in order to properly carry out the projects.
You talked earlier about the provision of funds for the sustainability of the activities. Have the sources of these funds been identified so far?
Yes, there are multiple sources and, of course, as we are nearing the end of the year, we must consider about the budget planning for next year, for 2016. Soon, all the aspects related to the budget law for the following period will begin to be discussed, and we will have much to say about how things stand at this point, given the experience we have gained with the implementation of these projects. The main idea and the idea that we are trying to focus on is, as I was telling you earlier, related to funding complementarity, so that we can have continuity in the provision of the funds. Also, for what the Government is unable to provide during a certain period of time, we have to make sure that there are other financing sources available that we can use for that period. However, there is support and openness from the Ministry of Finance as well, and it is very important for us that we are now able to show clear results. Because the Ministry of Finance is interested as well to see that these measures that we have undertaken lead to concrete results that justify the need to continue to fund these activities from the national budget.
In order to ensure the sustainability of the interventions financed from international funds, how will the Ministry of Health deal with the current constraints of the National Tuberculosis Control Programme, which are shown in the latest WHO / ECDC (European Centre for Disease Prevention and Control) assessment report? Among these, we mention only a few:
a.The updating of the C2 list of drugs with all the tuberculosis drugs necessary for the complete and correct treatment of MDR and XDR TB patients, in accordance with the WHO recommendation
b.The reorganisation of the laboratories in the NTPSCP network
c.The review of the financial payment mechanism for the NTPSCP programme (e.g. the payment per services instead of per invoices issued)
d.The review of the procurement procedure for drugs for TB patients
I appreciate your question in the context of the meeting that will take place next week, in Vilnius. It is the Annual WHO Congress, where I will represent Romania (I have also represented Romania on previous occasions). The World Health Organisation is very preoccupied with the eradication of tuberculosis worldwide, and is in particular concerned about Romania, but not only. Because there are states right know where we can speak of a relapse. And this happens precisely in the current context of the migration. Probably this will be a topic on the agenda of the talks next week – what happens in the context of the migration and in the context of the allocation of these categories of population to the European states, with all the implications that their health might have on the health of the population where they are to be relocated. So, tuberculosis is not only a health problem, it also has socioeconomic implications. As such, in order to improve and control tuberculosis in Romania, we need the involvement of each and every institution and organisation, as well as of the partners who have a say in what tuberculosis represents in Romania. I would like to say that, in accordance with the National Tuberculosis Control Strategy, the Ministry of Health and the National Tuberculosis Prevention, Surveillance and Control Programme will also benefit, under internationally funded projects, from technical assistance from the WHO, in addition to the European Financial Mechanism, the Norway Grants and the Global Fund. I will personally discuss these key aspects during the meetings next week, and they could become the topic of further talks with you, where I could present the latest elements resulted from the meeting that I will attend.
Thank you for giving us this interview.
Thank you for our collaboration in working to keep under control a disease that is challenging for us and that we are trying to eradicate.
At the end of March, 18 specialists from the national tuberculosis laboratories in Bucharest and Cluj and from bacteriology laboratories in Bacău, Constanța, Craiova, Timișoara and Sibiu were trained in using the MGIT960 rapid testing equipment. Within the project “Improving the Health Status of the Romanian Population through the Increase of the TB Control Capacity”, in Bucharest and Bisericani arrived two pieces of equipment which help the doctors find out in a few weeks if the tuberculosis is drug-resistant or not. Within the project, rapid diagnostic tests for testing 10,000 people will also be procured.
In Romania, the global TB incidence is the highest the European Union and one of the highest in the World Health Organization European Region. The good news is that incidence decreased, in the last 12 years, by almost 50%. In the present context of the illness spreading in our country, the coordinator of the TB Laboratory Working Group in Romania, Mrs. Daniela Homorodean, MD, chief of the laboratory within the „Leon Daniello” Clinical Pulmonology Hospital in Cluj-Napoca, says that several diagnostic methods are necessary, and the new equipment shall make the difference.
We asked Dr. Daniela Homorodean how the national laboratory network looks now, what are the challenges of the specialists’ activity and what will the new equipment bring. This is what she said for us:
“For the current situation in Romania, doing a microscopic exam for tuberculosis control is not enough. For a better surveillance of the endemic we need, for each patient, microscopic exam, as well as culture and drug sensitivity test. In the sputum we examine routinely for the pulmonary tuberculosis there must be 10,000 bacilli per millilitre of product, for us to be able to see one bacillus at the microscopic exam.
When bacilli appear, which we see coloured through special colorations at the microscopic exam, the lesions of the lung are quite advanced. Then, using other methods, we increase the chances to highlight the bacilli in early stages of the diseases, when the lesions are not so advanced. Thus, the chances of curing with less scars and lesions on the lung increase, because tuberculosis is a treatable infectious disease which can be cured. But, if the lesions are too extended, then it is cured through fibrosation, a scar-like tissue is formed. It is a fibrous tissue which doesn’t allow the lung to normally expand and relax. The bigger the lesions, the more extended is the fibrosis.
There are about 100 laboratories that diagnose and have as scope of work the bacteriologic diagnosis of tuberculosis, spread in all the counties. In each county there is a lab doing tuberculosis diagnosis. Starting with 2003, we began to run visits in the laboratory network and we selected some enthusiasts among the colleagues working in TB labs, good professionals, willing to participate in the control and guidance visits in the laboratories in the country. Immediately after we had the opportunity to accredit the laboratories according to the EU quality standards. Initially, 38 laboratories out of 50 proposed got accreditation, because only those met the criteria. Through the methods we’ve had so far, we got results after two or two and a half months, when we found out whether the germs eliminated by the patients were sensitive to the antimicrobials or resistant.
In eight regional laboratories and two national ones – Bucharest and Cluj – we have now the possibility to run genetic testing, in 24 or 48 ours, for the presence of the microbe in the sputum and the resistance of that microbe to the most powerful drugs – Isoniazid and Rifampicine. The resistance to these two drugs defines the multidrug-resistant TB. If the microbe is resistant to these two drugs, other substances, more powerful and more expensive, some of them with toxic effects, should be added to the treatment. It is best if, from the beginning, the patients accept the treatment so that the microbes not gain resistance, follow exactly the treatment without missing one single doze and not give up some of the drugs, because they think that three or four are too many. It is a big mistake, because from a treatable and curable disease, the person can develop a form difficult to treat and maybe impossible to cure. Then, such a non-compliant patient could make other people ill, and they will have since the beginning drug resistant tuberculosis. To find out about these cases as soon as possible, the genetic tests received through the Norwegian funds are essential. These are equipments which function with specific reagents and need special fit-up design. The reagents are procured also from Norwegian funds.
Through these projects, 9 cars shall be procured for the transport of products from the periphery to the diagnostic centres, so that by collecting the products we shall have rapid and quality diagnosis. It is not at all cost-efficient to keep a laboratory that only tests 3 sputa per day.
In 1999 we had other funding from the World Bank and five laboratories received the same equipment for doing culture on liquid media. Through that project, the laboratories had reagents for one year. Then, due to lack of funding, some of the laboratories stopped their activity, some others continued, but at a very low level, for serious forms.
We have to make sure that all the laboratories provide comparable diagnosis. The patients are quite mobile during the months or years of illness and go from one hospital to another. Or maybe they travel, get sick and get another set of tests. The results are compared with the previous bacteriological tests and they should be comparable, so that the monitoring can be correct and real and we can use the same scale and system of expressing results. I really like to believe that we had good results in the laboratories. It’s not a pleasure to work daily with sputum – not the best sight – but if you can deal with it and consider it a necessity, then you understand the relief of establishing a positive diagnosis and telling the patient that they have tuberculosis, not cancer. It is indeed, a relief.”
The non-reimbursable grants from public funds represent a real opportunity for the beneficiary countries, to address specific problems of the vulnerable communities, for which the country policies haven’t yet succeed, in some situations, to establish concrete measures. Furthermore, the development of several projects in public-private partnerships allows, through the non-reimbursable grants for the support and improvement of the measures included in the national strategies for the control or eradication of some diseases or for the improvement of the life quality of some groups at risk of social exclusion.
Until now, in Romania, only in the fields of human resources, health, and human rights, the non-reimbursable public funds supported the development and piloting, at national level, of some infrastructure of services specific for the people affected by diseases difficult to cure or chronic (diagnosis, specialized interventions etc.), gave way to the implementation of some training programs for different professional categories, were the basis of several research programs and the development of studies in fields uncovered in Romania (such as autism) or allowed the development of some information campaigns addressed to the general population on different diseases, non-discrimination campaigns or advocacy campaigns to improve the existing legislation regarding the rights of the people with disabilities and those affected by TB, HIV/AIDS, etc.
The benefits of the European funding or those granted by the government of some European countries are priceless.
Maybe that is exactly why their management at national level and the reporting systems for the reimbursement of the expenditure might try to complete this balance that the external funding re-establishes in countries like Romania. The modern technology and the electronic systems of data storage allow today to replace the paper support with electronic support which is without any doubt equally ecologic and durable. More and more campaigns try nowadays to educate the population in the spirit of a proper use of electronic devices, avoiding hard storage of the information.
The current systems of reporting to the national management authorities for the international funding, related to expenditure reimbursement, is based largely on data presentation and storage on paper, leading to impressive quantities of files, ring-binders and paper sheets for each monthly report, for each project, everything in up to 3 copies for each document. Only for the project “Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control”for the January – April 2015 reporting, the data storage needed 70 ring-binders, each having an average 400 A4 sheets of paper. Considering that each A4 sheet of paper weighs 5 grams (80 gr/sqm), after doing the math we conclude that only the content of 70 ring-binders, for one periodical reporting, weighs 140 kg of paper (without adding the weight of the ring-binders).
Of course, at a first glance the situation might create opportunities to access new financing lines for solutions to protect the forests and local ecosystem.
Nonetheless, at a more realistic assessment of the situation, there is a need to reconsider and change the reporting system (regarding data storage), with higher focus on using modern filing technology and information storage. No doubt, it’s a win-win situation, for the national management authorities, project implementers and general population who, although far away from these details, breathe the air which Romanian forests help to breath.
The change can come from the first decision maker who understands its benefits.
Marian Istrate is 41 years old, lives in Bucharest and in April 2015 was hospitalized at the “Marius Nasta” Pulmonology Institute in Bucharest, with the diagnostic of multidrug resistant tuberculosis. He left at home his wife and their 19 years old daughter who just had the bachelor degree exam, worried that there are chances he would have given them the Koch bacillus. In an interview conducted in his room from “Marius Nasta” Institute, Istrate told us how he ended up being diagnosed with tuberculosis and what his hopes for the future are.
“I don’t know, I have several problems, and the most important is Crohn’s disease, which I have been fighting for 10 years now. (ed.: Chron’s is a chronic inflammatory disease, localized in the digestive tract wall). Because of this disease I had a stroke, trombophlebitis, there were several things linked to each other. Then some biologic treatments for the Chron’s disease appeared and the doctors proposed to follow them.
Thus, as I ended up doing all sorts of investigations in hospitals, in 2007 they discovered I had pleurisy. Then, in 2013, they noticed a spot on the right superior lobe of the lungs and the doctors told me I had TB. I followed 1st line treatment, except that the spot didn’t become larger, but it didn’t shrink also. And I thought to myself: if I cut my finger, then it swallows, it gets infected or it heals. But in my case the spot remained there, even after the treatment.
I took the TB treatment for 6 months, plus the biologic treatment for my disease and it went ok. I used to go to Fundeni, but I wasn’t hospitalized, I was going twice a month and get a dose every two weeks. And at the end of last year they changed my treatment with an intravenous one. I had only two doses and during New Years Eve, in December 2014, I had fever, chills. It passed after 2-3 days or so and, after about half a month, I thought I should go to the hospital to see what’s going on.
I had an X-ray and they told me I had a tumour. And I had to have a bronchoscopy done afterwards and it didn’t turn out to be TB, cancer, or any tumour, but some sort of pneumonia. I was put for 20 days on Cefort iv treatment, and in the sputum sample didn’t appear anything. In March, they put me on 1st line treatment, but the spot remained. By end of April, a lady doctor calls me, telling they did the drug sensitivity test and that it turned out multidrug resistant tuberculosis. “Wouldn’t I better go and buy a coffin?” I said to myself.
On 29 April I was hospitalized. It is suspected that I took it (ed. the bacillus) from somewhere in a hospital. At least 2 month I’ll stay here at “Nasta”. To my surprise, I coped with the treatment, although I was afraid I couldn’t do it. As a patient here, one begins to get used with the idea of the disease, of tuberculosis, of severe diagnostic. I still have bad nausea, sometimes I even feel sick to drink water. It has to pass, you end up saying to yourself.”
Marian Istrate is only one of the thousands of patients with multidrug-resistant tuberculosis in Romania, to whom the lack of high performance methods of rapid and correct diagnosis of the disease made loose precious time. Two years – the time when Marian was incorrectly treated for sensitive tuberculosis – represent a period when multidrug resistant tuberculosis would have been cured, with the proper and timely initiated medication.
Access to rapid diagnostic, thanks to the high-end equipment procured through the project “Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control” allows receiving the diagnostic in very short time (from few hours up to few days) and beginning the correct treatment, offering the patients like Marian Istrate the chance to be cured and have a normal life.
*Marian Istrate is a fictional name; we decided to change it at the patient’s request.
Starting with March 2015, 1,000 people with multidrug resistant tuberculosis shall receive complete, continuous and quality treatment. By the end of June, 139 MDR TB patients were enrolled countrywide and receive treatment within the project “Improving the Health Status of the Romanian Population in Romania by Increasing Tuberculosis Control”.
The doctors in the local tuberculosis dispensaries monitor the health status of the patients enrolled in the program, thus helping them not to give up the treatment. We asked Dr Ariadna Petronela Fildan, MDR coordinator in Constanţa county, which are the advantages of this integrated system of patients treatment. Medical sciences PhD and associated professor at the Faculty of Medicine of the Ovidius Univerity, Dr. Fildan has been a pulmonology doctor at the Constanţa Pulmonology Clinical Hospital starting with 2008.
In this project, what does patient-centred approach mean?
The core of the project is the patient, everything – from human to material resources –gravitating around him, aiming to heal the patient and contain the spread of the disease. Once the multidrug-resistant tuberculosis diagnostic confirmed, the fight with the disease begins, fight which is based on well established rules. First of all, the patient is informed by the attending doctor about the new diagnostic methods, the therapeutic options, the duration, advantages and possible complications of the therapy, concurrently underlying the fact that the disease can be defeated if the treatment if followed on a continuous basis, without interruption for the entire duration indicated by the doctor. One shall try to motivate the patient in order to enter the program, bringing as supreme argument the cure and the chance to a normal life. Each patient represents a specific case; they don’t come only with a diagnostic and a disease we must treat, but with an emotional, cultural and social background which we must consider when trying to motivate the patient. We try to answer to all the questions related to the disease and treatment, to provide them as much information as possible, in a clear way, tailored to the personal level of understating.
How important is the medical care accompanied by psychological care, how does this actually take place in hospitals? Which are the advantages and what is the difference between the new possibilities and what was done before?
Evidently, the psychological support is very important; a trained person can find the methods adequate to each patient to motivate them not to give up the treatment. In fact, the most important aspects in the success of a treatment are, first and foremost, the compliance and ensuring continuity. Psychological counselling at the initiation of the treatment but also during the entire course, when complications – some quite difficult to deal with and to control – might appear, is a major contributor to the therapeutic success. Unfortunately, not all the hospitals have trained staff and in this situation is our hospital in Constanţa as well. To bridge the gap, the discussions with the patient take place with the participation of the attending doctor, the chief of department or the chief of dispensary (according to the case, if the patient is hospitalized or in ambulatory), the medical director and the program coordinator. The advantages we have at this moment are considerable, starting with the fact that we can have an MDR TB diagnostic in a few hours, compared to a few months, through access to the newest molecular diagnostic methods, continuing with access to modern therapy, ensuring continuity, the treatment regimens being those established by the MDR commission, according to the international guidelines.
Social support: what is the role of the social vouchers?
The role of these vouchers is a motivational one. It has been observed that providing monthly “bonuses” – if the patient came to the doctor and was given the treatment in the presence of the doctor or nurse – increases the treatment compliance rate. As it is very well known, many of the patients face serious material difficulties and thus any help is welcome.
What feedback do you have from your patients, regarding this approach?
The patients are satisfied because they have the continuous treatment ensured, have an additional chance, by being included in this program, and understand the importance of the correct administration, without interruption, of the medication, because this is the only way they can be cured.
How many patients are enrolled in this program in Constanța?
Currently there are five patients enrolled for complete regimens and eleven patients enrolled for social support in order to increase their compliance to treatment. We hope as many as possible will be accepted.
What is the situation in the county regarding tuberculosis?
In Constanţa County, the tuberculosis incidence decreased constantly in the past 10 years, from the 3rd place at national level to the 12th place. Last year 634 cases of tuberculosis, new cases and relapses were notified, representing an incidence of 87.6 versus 89.9 per 100,000 inhabitants, in 2013. 38 cases were notified in children. What we noticed for the first half of this year is the high number of severe cases registered in our hospital, extended, milliary forms, meningo-encephalitis. Until now we had 13 deaths due to tuberculosis, which probably can be explained by the long latent period between the occurrence of the symptoms and the visit to the doctor.
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