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Improving the health of the population in Romania by increasing TB control

Project financed by the Norwegian Grants 2009 - 2014, within the RO 19 - Public Health Initiative.

Rapid testing of patients for Multidrug Resistant and Extensive Resistant Tuberculosis

During October, 1368 more patients with tuberculosis from all over the country have been tested in the newly equipped – with modern testing equipment and supplies – laboratories of the NTP network as follows: NRL Bucharest NRL Cluj, laboratories TB in Bacau, Brasov, Constanta, Craiova, Sibiu and Timisoara. Out of the total tested patients, 15 were diagnosed with resistant tuberculosis among which, 5 with multidrug resistance.
The centralized data for the period March-October 2015 show that 6597 patients were screened for free within the project. 514 were detected with resistances, out of which 194 with MDR TB and 4 with XDR TB.

Continue the work for the development of a functional laboratory network for early detection of MDR/XDR TB

In October, the contract was signed with the winner of the procurement procedure for the 8 GeneXpert equipment and the laboratories to be provided with such equipment have been nominated.
Also, the opening of bids for the procurement of 44 laboratory safety cabinets was made. The offers will be assessed and the supplier will be established.
To purchase the 10 LED microscopes for laboratories, the legal process for the selection of the supplier is in the stage of technical evaluation of bids; the winning company will be selected.
The legal procedure for selecting the supplier of vehicles was completed. The purchase contract was signed for 9 cars needed to transport laboratory samples from the country to the laboratories equipped within the project, and in October the vehicles were received. TB laboratories were designated to benefit from the the cars for transport of samples and also bailment contracts were developed in order to be signed with the hospitals in which the laboratories operates. The procedures for vehicles’ registration also started.
It was also concluded the acquisition procedure for 3 Versatrek equipment, and contract will be signed with the successful supplier. For related supplies, the deadline for opening the submitted tenders is November 12.
Regarding the IT equipment, the term for opening the submitted tenders is November 27.
Also in October, the UV lamps procurement procedure was monitored as the procedure undergoing.

Increase the number of patients enrolled in correct, complete and quality treatment and of those who receive incentives for maintaining adherence to treatment

In October there were enrolled 30 more MDR TB patients for correct, complete and quality treatment, and in total, since the beginning of the project, 289 patients with multidrug resistant tuberculosis have been enrolled.
Also in October, out of the total of 1779 patients considered eligible to be enrolled in the project to receive incentives, 584 patients had signed consent forms until 10 September. In addition, during September 11 to October 30, a total of 20 new patients were sent consent forms. Overall 600 patients are enrolled in the project to receive incentives in order to maintain adherence to treatment.
In order to improve the coordination of the work, the project team organized between October 31 – November 1, the second National Meeting of MDR TB coordinators, attended by 34 doctors from Bucharest and the country. The meeting agenda included presentation of project results after 6 months of implementation and participative working sessions focused on the analysis of the project results obtained in different.

Improve the Capacity of the National Programme for Prevention, Surveillance and Control of Tuberculosis to control the TB epidemic

In October, six training courses were organized for medical staff in the PNPSCT as follows: October 9-11 in Alexandria, Brasov and Craiova, 22-24 October in Ramnicu Valcea, 23-25 October in Iasi and 28-30 October in Bucharest. The courses were attended by a total of 134 participants. So far 423 people have been trained.

Also in October:
A technical assistance contract was signed between the World Health Organization and the Pulmonology Institute Marius Nasta and related funds were transferred for the first contractual phase. The discussions started with the WHO for programming the technical assistance missions, which will start next year.
Preparations were made for the next training that will be held in Sinaia, during 18-21 November 2015, the training will target the staff who will be involved in communication activities in order to prevent the spread of TB at community level.

Expenditures for the period 1 to 31 October 2015 are shown in the table below

Training on multiple levels for strengthening the capacity of TB control

During September, trainings for the members of the Technical Assistance and Management Unit of the National Programme for Prevention, Surveillance and Control of Tuberculosis as well as for the pulmonologists, local trainers and other healthcare professionals in the country, have been organized in order to strengthen the capacity of Tuberculosis control.
The training for the Technical Assistance and Management Unit of the PNSPCT included sessions such as: introduction to project management and project planning, financial management principles, principles of financial management and procurement through GDF mechanism, monitoring and evaluation. The training was attended by 10 members of the Technical Assistance Unit and Management of the PNPSCT.

Three specialized courses for pulmonologists were organized, as follows: from 18 to 20 September, in Arad and Deva, and from 22 to 27 September, in Oradea. The course organized in Deva was performed including a monitoring visit.
The courses were attended by 75 doctors, so that total number of trained physicians trained so far in the project is 289.

Also during September, Training of Trainers (TOT) for local trainers and workshops for health communication for healthcare professionals in 4 counties (Neamt, Iasi and Botosani Braila) were organized. The training was attended by 23 people.

The work for the organization of the second National Meeting of the MDR Coordinators also started in September.

Preparation of poor communities to prevent TB transmission and to increase adherence to treatment of patients with tuberculosis

In September, the training courses for the trainers who will deliver training on education and prevention in poor communities in Romania have been prepared.
Two experts were employed to provide Training of Trainers (TOT) sessions; documents where collected for 12 local officers (six community nurses and six TB experts) of 6 counties (Botosani, Neamt, Gorj, Dolj, Calarasi and Giurgiu) who will attend the course.
The TOT course will take place on 2 and 3 October in Bucharest.

Testing of TB patients in order to detect MDR TB rapid, continued in September

1430 new patients across the country were screened for resistant TB during September, in the following laboratories of PNPSCT network equipped with appropriate equipment and supplies: NRL Bucharest, NRL Cluj, TB laboratories from Bacau, Brasov, Constanta, Craiova, Sibiu and Timisoara. Out of the tested patients, 60 were found TB resistant, while 21 of them were diagnosed with MDR TB.

From March to September, since the rapid testing activity actually started, 8093 patients across the country were screened free of charge. 504 patients were detected with resistance to TB drugs, of which 192 with MDR TB and 4 with XDR TB.

New MDR TB patients enrolled for correct, complete and quality treatment

In September, 50 more patients with MDR TB were enrolled in treatment, and in total, since the beginning of the project, 259 patients with MDR TB have been enrolled.
During September, 7 of MDR coordinators who have responsibility to identify new patients, sent to the project team updated databases of patients diagnosed with MDR-TB / XDR, registered in the period May to September 2015.
In parallel, the project team continued to follow-up correspondence with GDF and IDA in order to fill the information dossier submitted by UNIFARM to NMA, for issuing the authorization of special needs for the next batches of drugs. Also the samples for testing the quality of medicines (received in July) have been finalized by the National Institute of Pharmaceutical Chemistry Research and Development.
At the end of the month, the Bedaquilin (one of the anti-tuberculosis drugs necessary for treating patients with XDR TB) was delivered to UNIFARM.

Incentives for maintaining treatment adherence of patients treated in ambulatory

In September, out of the total of 1761 patients considered eligible to be enrolled in the project, 558 signed consent forms until 10th of August, and between August 11 to September 30, 15 new patients sumitted the consent sheets. Currently, 572 patients are enrolled in the project in order to receive incentives, meaning 38% of the 1500 planned.

Regarding the patients eligible to receive social support for anti-TB treatment adherence throughout the month of August, the following information has been centralized: 514 patients received so far social support in order to maintain adherence to treatment; cumulatively, from May to September, social vouchers were distributed to a total of 1678 patients (172 in April, 250 in May, 362 in June, 426 in July and 468 in August). Out of the 172 patients who received support for April, 80% (138 patients) received social vouchers for maintaining adherence during all five mentioned months.

Developing a functional network of laboratories in the country, for better TB control – in progress

In September, the acquisition contract was signed with the company declared the winner of the selection procedure for the procurement of 8 GeneXpert equipment. The procedure regarding the procurement of laboratory testing kits, is in progress through the GDF mechanism.
In order to purchase the 44 safety cabinets for laboratories, in September the legal procedure for centralized procurement has been launched; the date for opening of tenders is 16 October 2015.
Regarding the procurement of 10 LED laboratory microscopes, the supplier selection procedure is in the phase of evaluation of tenders; the winning company will be named in the near future.
The legal procedure for selecting the supplier of vehicles was completed. The vehicles will be delivered by 20th of October.

Regarding the procurement of 3 Versatrek equipment and necessary laboratory supplies, the legal procedures for the selection of suppliers are underway, the time for opening bids is October 3 (for Versatrek equipment) and November 12 (for testing kits).
Regarding the procurement of IT equipment, the documents relating to the selection procedure of suppliers is in the evaluation phase at ANRMAP.

Also during September:
It was signed by the World Health Organization, the contract concerning the provision of technical assistance from WHO to the National Programme for Tuberculosis Prevention, Surveillance and Control. The contract was sent for review and signing to Marius Nasta Pulmonology Institute.

Expenditures for the period 1 to 30 September 2015 are shown in the table below:

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.

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.
Foro curs 2 Foto curs 1 Foto curs 3

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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.

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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.

Foto V.Olsavszky_OMS Romania

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.

6628 patients were screened from March until the end of August through modern methods of detecting TB bacillus drug resistance

Testing TB patients for detecting TB bacillus drug resistance continued during August. The laboratories in the PNPSCT network provided with modern equipment and appropriate supplies (NRL Bucharest NRL Cluj, TB laboratories from Bacau, Brasov, Constanta, Craiova, Sibiu and Timisoara) receive evidence from TB units across the country, in order to ensure patients access to rapid diagnosis techniques.
1103 new patients were tested only in August 2015. 39 of them were found with resistant TB, and 15 of whom were diagnosed with Multidrug resistant TB.
The project pooled data show that in March (when they started testing) by the end of August, 6628 patients across the country were tested with modern equipment. 434 patients were found with resistances and 171 of whom were diagnosed with MDR TB.

Medicines for correct, complete and quality treatment for all patients with MDR TB

In August, another 26 patients with MDR TB were enrolled to receive correct, complete and quality drug treatment, and in total, from the beginning of the project, 208 MDR TB patients were enrolled. Also in August, the project team has centralized state enrollment in treatment of patients in Bucharest and in each county. After this update, the Marius Nasta Institute, as promoter of the project, sent a letter to inform the MDR coordinators, announce the first monitoring visits to be carried out by MDR experts focused on case management of TB MDR / XDR and accelerate the enrollment of eligible patients to receive treatment for tuberculosis.
By the end of August, the MDR coordinators continued to send, to the project team, databases updated with patients diagnosed with resistant and extremely resistant to treatment tuberculosis and recorded in the period May to July 2015.

Incentives for outpatients treated TB patients in order to increase adherence to treatment

In August, form the total of 1740 patients considered eligible to be enrolled in the project, 487 patients sent (by the 10’th of July) signed consent records. In addition, during July 11 – August 31, 1 of 62 new patients were sent sheets consent. Overall, 549 patients were enrolled by the end of August 2015 (36.6% of the 1,500 planned for the entire implementation period). For patients eligible to receive social support for treatment adherence as medically administered throughout July, the project team has centralized the following information:
– 441 patients received single social support so far in the project to maintain adherence to treatment,
– Cumulatively in the period May to August, vouchers were distributed to a total of 1,193 patients (172 in May, 249 in June, 359 in July and 413 in August). Of the 172 patients who received support in May, more than 87% and 151 patients received vouchers for maintaining adherence in the 4 months mentioned.

Equipment for TB laboratories and TB units in the country

A contract was signed for the acquisition of 8 GeneXpert equipment and the procurement procedures for work kits were initiated with GDF mechanism.
For the acquisition of 3 Versatrek equipment and necessary supplies documents required have been completed the process for selecting the supplier, and the acquisition will be officially launched on specialized sites.
Legal procurement procedures were launched for the purchase of 44 protective hoods for laboratories (date set for the opening of tenders is 16 October 2015) and 10 LED microscopes for laboratories.
It was completed the legal procedure and signed the purchase contract for nine vehicles who will ensure the transport of samples from TB units in the country to laboratories with modern equipment diagnostics.
And last but not least, for the purchase of IT equipment provided there were completed: the technical specifications, the requirement reports and the lists of the TB units to be equipped (the criteria for selecting the units PNF, the lists of units to be first appointed, the PNPSCT management decision).

Also during August activities were conducted to organize the second training of trainers in health communication (participant’s identification, location identification).

Expenditures for the period 1 to 31 August 2015 are shown in the table below:

More and more patients with tuberculosis across the country are being screened for tuberculosis multidrug resistance, in the labs provided with modern equipment for rapid diagnosis of MDR-TB / XDR.

During July, it continued the rapid testing of TB patients in the laboratories of the PNPSCT network, equipped with modern diagnostic (national reference laboratories in Bucharest and Cluj and TB laboratories in Bacau, Brasov, Constanta, Craiova, Sibiu and Timisoara).
In total, in July, 1,327 people were tested within MGIT and LPA techniques; of these, 42 patients were found with resistant TB, including 15 patients with MDR TB.

The centralized data during March-July 2015 show that in 5 months only since eight laboratories in the country are carried out rapid testing for MDR TB using modern equipment procured under the project, 5428 people were tested. Of these, 333 patients were detected with resistant TB, including 122 patients with MDR TB.

Medicines for correct, complete and quality treatment of MDR TB, available for 200 patients

44 new patients with MDR TB were enrolled in the project in July, to receive correct, complete and quality treatment, adding to those already enrolled 138 patients by the end of June 2015. Currently, there are drugs available for the treatment of 200 patients. Medicines for the remaining 550 patients to be treated in the project will be available in approximately two months, after completion of quality controls and labeling exemption from approval by ANMDM.

Also in July, 27 of MDR project coordinators sent to the central team the databases updated with patients diagnosed with TB MDR / XDR and recorded during May – July 2015.

DOT and incentives for TB outpatients

In July, from 1723 patients considered eligible to be enrolled in the project, 409 patients were submitted signed consent forms, by 10th of June, and between June 11 to July 31, other 56 new patients were sent signed consent forms completed. Overall, the project enrolled 465 patients for receiving incentives (ie 31% of the 1,500 planned).
For patients eligible to receive social support adherence to anti-TB treatment administered according to the doctor’s recommendations throughout June, the project team has centralized the following information:
– 373 unique patients received social support so far in the project,
– cumulatively in July, June and May, vouchers were distributed to a number of 778 patients (172 in May, 249 in June, 357 in July). Of the 172 patients who received support in May, more than 91% (ie 158 patients) received vouchers for maintaining adherence in all three months.

By the end of July, 42 of MDR TB coordinators in Bucharest and the country received incentives for activities carried out in order to increase patient adherence to treatment, during April-June 2015.

Continue the training for the health professionals that are part of PNPSCT, in order to increase capacity to control the epidemic tubeculoza

Between 2nd – 4th of July, 2015 it was held a course for 25 health professionals in the field of respiratory medicine at Buzau. Lecturers were Dr. Luminita Palaghianu and dr. Emilia Tabacu. The course was attended by health professionals from Buzau and Vrancea counties.
In total, to date, 214 have been trained in the field of respiratory medicine by health professionals (109 nurses and 105 doctors), representing 36% of the proposed target of 600.
Also, on 2nd and 3rd of July was made a monitoring visit to Buzau, for the course held here.

Working on updating the national electronic database of PNPSCT

In July 2015, several working meetings were held with company representatives selected to provide services for updating and maintaining the national database of PNPSCT and were discussed the modules that require changes in line with the international recommendations in the field.

Steps to strengthen the capacity of preventing TB transmission in poor communities

On the 6th and 7th of July, the project team representatives attended the international seminar entitled „Services health for vulnerable communities”, along with representatives of Ministry of Health and five County Departments of Public Health of six Departments included in the project RO19.01.
The communication with experts appointed on completion of the course curriculum for community workers continued.
Also in July there were identified the two experts who will provide TOT course and the 12 representatives who will monitor the work of local officers and will prepare all community nurses in their communities.

The World Health Organization (WHO) will provide technical assistance to the PNPSCT

During July, the contract was drafted, for the World Health Organisation to provide technical assistance to the National Programme for Prevention, Surveillance and Control of Tuberculosis. The contract was sent to the office of the World Health Organizationin Copenhagen.

Expenditure for the period 1 to 31 July 2015 are shown in the table below:

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