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  1. Article: Is telerehabilitation a top priority for the Bulgarian healthcare system in the post COVID-19 era?

    Papathanasiou, Jannis / Petrov, Ivo / Kashilska, Yana / Kostov, Kosta / Dzhafer, Nigyar

    Health policy and technology

    2022  Volume 11, Issue 4, Page(s) 100664

    Language English
    Publishing date 2022-08-24
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-8837
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2022.100664
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Compassionate drug use: an imperative challenge for Bulgarian health system during COVID-19.

    Dzhafer, Nigyar / Papathanasiou, Jannis

    Health policy and technology

    2020  Volume 9, Issue 3, Page(s) 274–275

    Abstract: The health care system in Bulgaria faces unprecedented challenges trying to take control over the pandemic of COVID-19.•The existing national regulation in Bulgaria leads to delayed and difficult access to investigational drugs via compassionate use ... ...

    Abstract •The health care system in Bulgaria faces unprecedented challenges trying to take control over the pandemic of COVID-19.•The existing national regulation in Bulgaria leads to delayed and difficult access to investigational drugs via compassionate use programs.•The COVID-19 pandemic will initiate a dialogue among health policy makers and BDA for the establishment of new health policy and clear national regulation due to higher demand for investigational drugs.
    Keywords covid19
    Language English
    Publishing date 2020-05-21
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2211-8837
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2020.05.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19.

    Dzhafer, Nigyar / Papathanasiou, Jannis V

    Folia medica

    2020  Volume 62, Issue 3, Page(s) 592–596

    Abstract: Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding ... ...

    Abstract Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond.
    Aim: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19.
    Materials and methods: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme.
    Results: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died.
    Conclusion: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.
    MeSH term(s) Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/therapeutic use ; Betacoronavirus ; Bulgaria ; Compassionate Use Trials/legislation & jurisprudence ; Coronavirus Infections/drug therapy ; Drugs, Investigational ; Health Policy/legislation & jurisprudence ; Humans ; Pandemics ; Pneumonia, Viral/drug therapy
    Chemical Substances Antiviral Agents ; Drugs, Investigational ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
    Keywords covid19
    Language English
    Publishing date 2020-10-02
    Publishing country Bulgaria
    Document type Journal Article
    ZDB-ID 300275-5
    ISSN 1314-2143 ; 0430-8638 ; 0204-8043
    ISSN (online) 1314-2143
    ISSN 0430-8638 ; 0204-8043
    DOI 10.3897/folmed.62.e53742
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 972: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  4. Book ; Online: Compassionate Drug Use – Time Arising for a New Law in Bulgaria in the Era of COVID-19

    Dzhafer, Nigyar / Jannis, Papathanasiou

    Folia Medica 62(3): 592-596

    2020  

    Abstract: Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding ... ...

    Abstract Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond.Aim: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19.Materials and Methods: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme.Results: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died.Conclusion: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.
    Keywords COVID-19 ; compassionate use ; off-label ; regulation ; remdesivir ; covid19
    Subject code 340
    Language English
    Publisher Plovdiv Medical University
    Publishing country bg
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Compassionate Drug Use – Time Arising for a New Law in Bulgaria in the Era of COVID-19

    Nigyar Dzhafer / Jannis V. Papathanasiou

    Folia Medica, Vol 62, Iss 3, Pp 592-

    2020  Volume 596

    Abstract: Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding ... ...

    Abstract Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond.Aim: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19.Materials and Methods: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme.Results: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died.Conclusion: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.
    Keywords COVID-19 ; compassionate use ; off-label ; regulation ; Medicine ; R ; covid19
    Subject code 340
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher Pensoft Publishers
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  6. Article ; Online: Compassionate drug use

    Dzhafer, Nigyar / Papathanasiou, Jannis

    Health Policy and Technology

    an imperative challenge for Bulgarian health system during COVID-19

    2020  Volume 9, Issue 3, Page(s) 274–275

    Keywords Health Policy ; Biomedical Engineering ; covid19
    Language English
    Publisher Elsevier BV
    Publishing country us
    Document type Article ; Online
    ISSN 2211-8837
    DOI 10.1016/j.hlpt.2020.05.001
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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    Order via subito

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  7. Article: Frailty: future prospectives in rehabilitation medicine.

    Dionyssiotis, Yannis / Masiero, Stefano / Maccarone, Maria Chiara / Prokopidis, Konstantinos / Dzhafer, Nigyar / Matzaroglou, Charalampos / Tsekoura, Maria / Panayotov, Kiril / Papathanasiou, Jannis

    European journal of translational myology

    2023  Volume 33, Issue 2

    Abstract: Modern rehabilitation is based on the International Classification of Functioning, Disability and Health (ICF). We will discuss this Classification process in frailty. Frailty is defined as a condition of reduced functional reserve, a state of ... ...

    Abstract Modern rehabilitation is based on the International Classification of Functioning, Disability and Health (ICF). We will discuss this Classification process in frailty. Frailty is defined as a condition of reduced functional reserve, a state of vulnerability that involves poor recovery of homeostasis and increased susceptibility to stressor mechanisms, with consequent difficulty in returning to the previous condition of balance. Rehabilitation of frailty is reported in the ICF, although, its consensus is not sufficiently addressed due to its recent identification and the limited available information regarding how it should be formulated. Thus, the aim of the present article is to present the current evidence-based rehabilitation strategies applied in management of frailty.
    Language English
    Publishing date 2023-06-23
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 2545577-1
    ISSN 2037-7460 ; 2037-7452
    ISSN (online) 2037-7460
    ISSN 2037-7452
    DOI 10.4081/ejtm.2023.11347
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Compassionate drug use: an imperative challenge for Bulgarian health system during COVID-19

    Dzhafer, Nigyar / Papathanasiou, Jannis

    Abstract: •The health care system in Bulgaria faces unprecedented challenges trying to take control over the pandemic of COVID-19.•The existing national regulation in Bulgaria leads to delayed and difficult access to investigational drugs via compassionate use ...

    Abstract •The health care system in Bulgaria faces unprecedented challenges trying to take control over the pandemic of COVID-19.•The existing national regulation in Bulgaria leads to delayed and difficult access to investigational drugs via compassionate use programs.•The COVID-19 pandemic will initiate a dialogue among health policy makers and BDA for the establishment of new health policy and clear national regulation due to higher demand for investigational drugs.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #438046
    Database COVID19

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  9. Article ; Online: Does the Bulgarian Health Care System Need a Health Ombudsman?

    Dzhafer, Nigyar / Vodenicharov, Tzekomir / Papathanasiou, Janis

    Folia medica

    2020  Volume 62, Issue 2, Page(s) 391–397

    Abstract: Background: The Office of the Ombudsman of the Republic of Bulgaria (ORB) is an independent constitutional body elected by Bul-garian Parliament in 2005. It serves to protect the rights of all citizens, including the rights of patients, children, people ...

    Abstract Background: The Office of the Ombudsman of the Republic of Bulgaria (ORB) is an independent constitutional body elected by Bul-garian Parliament in 2005. It serves to protect the rights of all citizens, including the rights of patients, children, people with disabilities, minorities, foreigners, etc. Bulgarian healthcare users complain when they feel that the healthcare system (HCS) has failed their needs or they have been recipients of an inappropriate treatment.
    Aim: The aim of the present study was to analyze the structure and dynamics of all complaints from Bulgarian healthcare users referred to the ORB over a 13-year period (2005 - 2018).
    Materials and methods: Retrospective documental research was used in the present study. The data included the complaints ob-tained from the official annual reports of the ORB that are available online. Bibliographic and documental searches were also used as sources. The complaints were analyzed by their annual distribution and classified by problem areas in the HCS.
    Results: Between 2005 and 2018, there were a total of 3288 complaints filed to ORB against HCS. In 2015, 368 complaints were re-ceived by ORB from Bulgarian healthcare users and from various patient organizations concerning problems in the HCS. The filed complaints to ORB increased by 82% in 2016 (n=421). In 2017, the overall number of ORB-referred complaints amounted to 494, and in 2018 their number was as high as 607, which represents an increase by 23% compared to the number of complaints in 2017.
    Conclusion: The great number of complaints referred to ORB about the HCS over the last four years strongly suggests that the institu-tion of the Ombudsman in Bulgaria enjoys high confidence among Bulgarian healthcare users.
    MeSH term(s) Bulgaria ; Delivery of Health Care ; Health Services/legislation & jurisprudence ; Health Services Accessibility ; Humans ; Medical Errors ; Patient Advocacy ; Patient Rights ; Practice Guidelines as Topic ; Quality of Health Care ; Retrospective Studies
    Language English
    Publishing date 2020-08-04
    Publishing country Bulgaria
    Document type Journal Article
    ZDB-ID 300275-5
    ISSN 1314-2143 ; 0430-8638 ; 0204-8043
    ISSN (online) 1314-2143
    ISSN 0430-8638 ; 0204-8043
    DOI 10.3897/folmed.62.e47655
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 972: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

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  10. Article ; Online: Does the Bulgarian Health Care System Need a Health Ombudsman?

    Nigyar Dzhafer / Tzekomir Vodenicharov / Janis Papathanasiou

    Folia Medica, Vol 62, Iss 2, Pp 391-

    2020  Volume 397

    Abstract: Background: The Office of the Ombudsman of the Republic of Bulgaria (ORB) is an independent constitutional body elected by Bul­garian Parliament in 2005. It serves to protect the rights of all citizens, including the rights of patients, children, people ... ...

    Abstract Background: The Office of the Ombudsman of the Republic of Bulgaria (ORB) is an independent constitutional body elected by Bul­garian Parliament in 2005. It serves to protect the rights of all citizens, including the rights of patients, children, people with disabilities, minorities, foreigners, etc. Bulgarian healthcare users complain when they feel that the healthcare system (HCS) has failed their needs or they have been recipients of an inappropriate treatment.Aim: The aim of the present study was to analyze the structure and dynamics of all complaints from Bulgarian healthcare users referred to the ORB over a 13-year period (2005 – 2018).Materials and methods: Retrospective documental research was used in the present study. The data included the complaints ob­tained from the official annual reports of the ORB that are available online. Bibliographic and documental searches were also used as sources. The complaints were analyzed by their annual distribution and classified by problem areas in the HCS.Results: Between 2005 and 2018, there were a total of 3288 complaints filed to ORB against HCS. In 2015, 368 complaints were re­ceived by ORB from Bulgarian healthcare users and from various patient organizations concerning problems in the HCS. The filed complaints to ORB increased by 82% in 2016 (n=421). In 2017, the overall number of ORB-referred complaints amounted to 494, and in 2018 their number was as high as 607, which represents an increase by 23% compared to the number of complaints in 2017.Conclusion: The great number of complaints referred to ORB about the HCS over the last four years strongly suggests that the institu­tion of the Ombudsman in Bulgaria enjoys high confidence among Bulgarian healthcare users.
    Keywords Ombudsman ; Bulgarian health users ; complaints ; lim ; Medicine ; R
    Subject code 360
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher Pensoft Publishers
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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