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3. Corrigendum to “Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications”

Author

Godman, Brian, primary, Wladysiuk, Magdalene, additional, McTaggart, Stuart, additional, Kurdi, Amanj, additional, Allocati, Eleonora, additional, Jakovljevic, Mihajlo, additional, Kalemeera, Francis, additional, Hoxha, Iris, additional, Nachtnebel, Anna, additional, Sauermann, Robert, additional, Hinteregger, Manfred, additional, Marković-Peković, Vanda, additional, Tubic, Biljana, additional, Petrova, Guenka, additional, Tachkov, Konstantin, additional, Slabý, Juraj, additional, Nejezchlebova, Radka, additional, Krulichová, Iva Selke, additional, Laius, Ott, additional, Selke, Gisbert, additional, Langner, Irene, additional, Harsanyi, András, additional, Inotai, András, additional, Jakupi, Arianit, additional, Henkuzens, Svens, additional, Garuolienė, Kristina, additional, Gulbinovič, Jolanta, additional, Bonanno, Patricia Vella, additional, Rutkowski, Jakub, additional, Ingeberg, Skule, additional, Melien, Øyvind, additional, Mardare, Ileana, additional, Fürst, Jurij, additional, MacBride-Stewart, Sean, additional, Holmes, Carol, additional, Pontes, Caridad, additional, Zara, Corinne, additional, Pedrola, Marta Turu, additional, Hoffmann, Mikael, additional, Kourafalos, Vasileios, additional, Pisana, Alice, additional, Banzi, Rita, additional, Campbell, Stephen, additional, and Wettermark, Bjorn, additional

Published
2023
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4. The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications

Author

Ferrario, Alessandra, Arāja, Diāna, Bochenek, Tomasz, Čatić, Tarik, Dankó, Dávid, Dimitrova, Maria, Fürst, Jurij, Greičiūtė-Kuprijanov, Ieva, Hoxha, Iris, Jakupi, Arianit, Laidmäe, Erki, Löblová, Olga, Mardare, Ileana, Markovic-Pekovic, Vanda, Meshkov, Dmitry, Novakovic, Tanja, Petrova, Guenka, Pomorski, Maciej, Tomek, Dominik, Voncina, Luka, Haycox, Alan, Kanavos, Panos, Vella Bonanno, Patricia, and Godman, Brian

Published
2017
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8. Biosimilars are essential for sustainable healthcare systems across Europe; however, key challenges remain as seen with biosimilars for long-acting insulin analogues

Author

Godman, Brian, Tubić, Biljana, Allocati, Eleonora, Wladysiuk, Magdalene, McTaggart, Stuart, Kurdi, Amanj, Haque, Mainul, MacBride-Stewart, Sean, Kalemeera, Francis, Massele, Amos, Hoxha, Iris, Marković-Peković, Vanda, Petrova, Guenka, Tachkov, Konstantin, Laius, Ott, Harsanyi, András, Inotai, Andras, Jakupi, Arianit, Henkuzens, Svens, Garuolienė, Kristina, Vella Bonanno, Patricia, Rutkowski, Jakub, Mardare, Ileana, Fürst, Jurij, Pontes, Caridad, Zara, Corinne, Turu Pedrola, Marta, Akter, Farhana, Kwon, Hye-Young, Martin, Antony P, Banzi, Rita, Wale, Janney, and Gulbinovic, Jolanta

Subjects
RS
Abstract

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of long-acting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100IU/ml driven by increasing use of patented 300IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues.

Published
2022

10. Biosimilars are essential for sustainable healthcare systems; however, key challenges remain as seen with long-acting insulin analogues

Author

Godman Brian, Tubic Biljana, Allocati Eleonora, Wladysiuk Magdalene, McTaggart Stuart, Kurdi Amanj, Haque Mainul, MacBride-Stewart Sean, Kalemeera Francis, Massele Amos, Hoxha Iris, Pekovic Vanda Markovic, Petrova Guenka, Tachkov Konstantin, Laius Ott, Harsanyi András, Inotai András, Jakupi Arianit, Henkuzens Svens, Garuoliené Kristina, Bonanno Patricia Vella, Rutkowski Jakub, Mardare Ileana, Fürst Jurij, Pontes Caridad, Zara Corinne, Pedrola Marta Turu, Akter Farhana, Kwon Hye-Young, Martin Antony P., Banzi Rita, Wale Janney, and Gulbinovic Jolanta

Subjects
Drug monitoring -- Europe, Biosimilar pharmaceuticals -- Europe, Drugs -- Prescribing -- Economic aspects, Insulin -- Costs, Drug accessibility -- Law and legislation -- Europe, Biosimilars, Demand-side measures, Europe, Health policies, Insulin glargine, Prices, Medicine (miscellaneous), Pharmacology (medical), General Pharmacology, Toxicology and Pharmaceutics
Abstract

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of longacting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including researching measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across the countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100 IU/ml driven by increasing use of patented 300 IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues., peer-reviewed

Published
2022

11. Systemic antimycotic and antifungal use in eastern Europe: a cross-national database study in coordination with the WHO Regional Office for Europe

Author

Adriaenssens, Niels, Uka, Valdet, Versporten, Ann, Bolokhovets, Ganna, Ghazaryan, Lilit, Abilova, Vafa, Pyshnik, Galina, Spasojevic, Tijana, Korinteli, Irma, Kambaralieva, Baktygul, Cizmovic, Lidija, Carp, Angela, Radonjic, Vesela, Maqsudova, Nargis, Alkan, Ali, Coenen, Samuel, Pedersen, Hanne Bak, Sautenkova, Nina, Goossens, Herman, Pipero, Pellumb, Ghazaryan, Lilit, Martirosyan, Hasmik, Abilova, Vafa, Aliyev, Farid, Pyshnik, Galina, Spasojevic, Tijana, Korinteli, Irma, Pagava, Karaman, Kambaralieva, Baktygul, Mamasheva, Ainura, Bosevska, Gobulinska, Cizmovic, Lidija, Carp, Angela, Chitan, Elena, Raka, Lul, Jakupi, Arianit, Uka, Valdet, Radonjic, Vesela, Plüss-Suard, Catherine, Maqsudova, Nargis, Isupov, Salomudin, Iyakovleva, Larisa, Posokhova, Kateryna, Matvieva, Elena, Melik, Bahar, Aksoy, Mesil, Celik, Hatice Demet, Seckin, Cem, Gursoz, Hakki, Savur, Fatma, Payerl-Pal, Marina, and Andrasevic, Arjana Tambic

Published
2015
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12. Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications

Author

Godman, Brian, primary, Wladysiuk, Magdalene, additional, McTaggart, Stuart, additional, Kurdi, Amanj, additional, Allocati, Eleonora, additional, Jakovljevic, Mihajlo, additional, Kalemeera, Francis, additional, Hoxha, Iris, additional, Nachtnebel, Anna, additional, Sauermann, Robert, additional, Hinteregger, Manfred, additional, Marković-Peković, Vanda, additional, Tubic, Biljana, additional, Petrova, Guenka, additional, Tachkov, Konstantin, additional, Slabý, Juraj, additional, Nejezchlebova, Radka, additional, Krulichová, Iva Selke, additional, Laius, Ott, additional, Selke, Gisbert, additional, Langner, Irene, additional, Harsanyi, András, additional, Inotai, András, additional, Jakupi, Arianit, additional, Henkuzens, Svens, additional, Garuolienė, Kristina, additional, Gulbinovič, Jolanta, additional, Bonanno, Patricia Vella, additional, Rutkowski, Jakub, additional, Ingeberg, Skule, additional, Melien, Øyvind, additional, Mardare, Ileana, additional, Fürst, Jurij, additional, MacBride-Stewart, Sean, additional, Holmes, Carol, additional, Pontes, Caridad, additional, Zara, Corinne, additional, Pedrola, Marta Turu, additional, Hoffmann, Mikael, additional, Kourafalos, Vasileios, additional, Pisana, Alice, additional, Banzi, Rita, additional, Campbell, Stephen, additional, and Wettermark, Bjorn, additional

Published
2021
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13. Market exclusivity and the entry of adalimumab biosimilars in Europe : an overview of pricing and national policy measures

Author

Moorkens, Evelien, Godman, Brian, Huys, Isabelle, Hoxha, Iris, Malaj, Admir, Keuerleber, Simon, Stockinger, Silvia, Mörtenhuber, Sarah, Dimitrova, Maria, Tachkov, Konstantin, Vončina, Luka, Palčevski, Vera Vlahović, Achniotou, Gnosia, Slabý, Juraj, Popelková, Leona, Kohoutová, Kateřina, Bartels, Dorthe, Laius, Ott, Martikainen, Jaana E., Selke, Gisbert W., Kourafalos, Vasileios, Magnússon, Einar, Einarsdóttir, Rannveig, Adams, Roisín, Joppi, Roberta, Allocati, Eleonora, Jakupi, Arianit, Viksna, Anita, Greičiūtė-Kuprijanov, Ieva, Vella Bonanno, Patricia, Suttorp, Vincent, Melien, Øyvind, Plisko, Robert, Mardare, Ileana, Meshkov, Dmitry, Novakovic, Tanja, Fürst, Jurij, Zara, Corinne, Marković-Peković, Vanda, Grubiša, Nataša, Befrits, Gustaf, Puckett, Robert, and Vulto, Arnold G.

Subjects
Drugs -- Pricing -- Europe, Drug accessibility -- Europe, Medical care surveys -- Europe, Biological agents -- Pharmacology, Drugs -- Law and legislation -- Europe
Abstract

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries., peer-reviewed

Published
2021

14. Variation in the prices of oncology medicines across Europe and the implications for the future

Author

Godman, Brian, primary, Simoens, Steven, additional, Kurdi, Amanj, additional, Selke, Gisbert, additional, Yfantopoulos, John, additional, Hill, Andrew, additional, Gulbinovic, Jolanta, additional, Martin, Antony P, additional, Timoney, Angela, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Bochenek, Tomasz, additional, Selke Krulichova, Iva, additional, Allocati, Eleonora, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Nachtnebel, Anna, additional, Hamelinck, Wouter, additional, Mitkova, Zornitza, additional, Petrova, Guenka, additional, Laius, Ott, additional, Sermet, Catherine, additional, Langner, Irene, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Poplavska, Elita, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, JF Hans, additional, de Valk, Vincent, additional, Plisko, Robert, additional, Wladysiuk, Magdalene, additional, Markovic-Pekovic, Vanda, additional, Mardare, Ileana, additional, Novakovic, Tanja, additional, Parker, Mark, additional, Furst, Jurij, additional, Tomek, Dominik, additional, Banasova, Katarina, additional, Obach Cortadellas, Merce, additional, Zara, Corrine, additional, Pontes, Caridad, additional, Juhasz-Haverinen, Maria, additional, Skiold, Peter, additional, McTaggart, Stuart, additional, Wong-Rieger, Durhane, additional, Campbell, Stephen, additional, and Hill, Ruaraidh, additional

Published
2021
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15. Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe : Findings and Implications

Author

Godman, Brian, Wladysiuk, Magdalene, McTaggart, Stuart, Kurdi, Amanj, Allocati, Eleonora, Jakovljevic, Mihajlo, Kalemeera, Francis, Hoxha, Iris, Nachtnebel, Anna, Sauermann, Robert, Hinteregger, Manfred, Marković-Peković, Vanda, Tubic, Biljana, Petrova, Guenka, Tachkov, Konstantin, Slabý, Juraj, Nejezchlebova, Radka, Krulichová, Iva Selke, Laius, Ott, Selke, Gisbert, Langner, Irene, Harsanyi, András, Inotai, András, Jakupi, Arianit, Henkuzens, Svens, Garuolienė, Kristina, Gulbinovič, Jolanta, Bonanno, Patricia Vella, Rutkowski, Jakub, Ingeberg, Skule, Melien, Øyvind, Mardare, Ileana, Fürst, Jurij, MacBride-Stewart, Sean, Holmes, Carol, Pontes, Caridad, Zara, Corinne, Pedrola, Marta Turu, Hoffmann, Mikael, Kourafalos, Vasileios, Pisana, Alice, Banzi, Rita, Campbell, Stephen, Wettermark, Björn, Godman, Brian, Wladysiuk, Magdalene, McTaggart, Stuart, Kurdi, Amanj, Allocati, Eleonora, Jakovljevic, Mihajlo, Kalemeera, Francis, Hoxha, Iris, Nachtnebel, Anna, Sauermann, Robert, Hinteregger, Manfred, Marković-Peković, Vanda, Tubic, Biljana, Petrova, Guenka, Tachkov, Konstantin, Slabý, Juraj, Nejezchlebova, Radka, Krulichová, Iva Selke, Laius, Ott, Selke, Gisbert, Langner, Irene, Harsanyi, András, Inotai, András, Jakupi, Arianit, Henkuzens, Svens, Garuolienė, Kristina, Gulbinovič, Jolanta, Bonanno, Patricia Vella, Rutkowski, Jakub, Ingeberg, Skule, Melien, Øyvind, Mardare, Ileana, Fürst, Jurij, MacBride-Stewart, Sean, Holmes, Carol, Pontes, Caridad, Zara, Corinne, Pedrola, Marta Turu, Hoffmann, Mikael, Kourafalos, Vasileios, Pisana, Alice, Banzi, Rita, Campbell, Stephen, and Wettermark, Björn

Abstract

Background. Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. Results. Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder g, Correction in: Biomed Research International, Volume 2023 | Article ID 9757348DOI: 10.1155/2023/9757348

Published
2021
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16. Pharmacy practice architecture challenges in handling COVID-19 pandemic - sharing experience from a Kosovo pharmacy practice

Author

Jakupi, Arianit, Basha Jakupi, Arta, Jakupi, Arianit, and Basha Jakupi, Arta

Abstract

Background: Community pharmacies deliver an essential healthcare service, which is broadly established, encompassing the favored and primary contact for community members. The COVID-19 pandemic is continuing to shift the pharmacy roles and services in order to meet the needs of customers. The important value of community pharmacies was more underlined during the pandemic crisis when they were supposed to undertake abundant precautions to avoid cross-infection among users of the space. Their responsibility is also to create a compatible, efficient, and safe environment inside their premises during this outbreak. The built environment is an important share of pandemic solutions and emergency planning preparations. Objectives: The aim of this paper was to explore the preparedness of community pharmacies in Kosovo for the COVID-19 outbreak in regards to pharmacy design modifications while ensuring adequate medicine management, information, and public health. Consequently, at what stage can the pandemic affect the physical and built environment of pharmacies. Methods: The methods for this study include a cross‐sectional survey of 104 community pharmacies operating in seven municipalities in Kosovo during the pandemic. Data collection was conducted from October 1 to October 14, 2021, using self-administered online questionnaires. The questionnaire consisted of a combination of closed and open-ended questions, optional statements, and multiple answers. Data were analyzed in SPSS for Windows version 20 using descriptive statistics. Results: The results show that communities should be prepared ahead in regard to the emergency situations and some of these preparations might be also part of the legislation requirements. Although the pandemic exposed many errors in the Kosovo community pharmacy system, it has also discovered a unique possibility for collaboration and novelty. Conclusions: The study concludes with the recommendation for the architectural design of pharmacies to

Published
2021

17. The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe:An Overview of Pricing and National Policy Measures

Author

Moorkens, Evelien, Godman, Brian, Huys, Isabelle, Hoxha, Iris, Malaj, Admir, Keuerleber, Simon, Stockinger, Silvia, Mörtenhuber, Sarah, Dimitrova, Maria, Tachkov, Konstantin, Vončina, Luka, Palčevski, Vera Vlahović, Achniotou, Gnosia, Slabý, Juraj, Popelková, Leona, Kohoutová, Kateřina, Bartels, Dorthe, Laius, Ott, Martikainen, Jaana E., Selke, Gisbert W., Kourafalos, Vasileios, Magnússon, Einar, Einarsdóttir, Rannveig, Adams, Roisín, Joppi, Roberta, Allocati, Eleonora, Jakupi, Arianit, Viksna, Anita, Greičiūtė-Kuprijanov, Ieva, Vella Bonanno, Patricia, Suttorp, Vincent, Melien, Øyvind, Plisko, Robert, Mardare, Ileana, Meshkov, Dmitry, Novakovic, Tanja, Fürst, Jurij, Zara, Corinne, Marković-Peković, Vanda, Grubiša, Nataša, Befrits, Gustaf, Puckett, Robert, Vulto, Arnold G., Moorkens, Evelien, Godman, Brian, Huys, Isabelle, Hoxha, Iris, Malaj, Admir, Keuerleber, Simon, Stockinger, Silvia, Mörtenhuber, Sarah, Dimitrova, Maria, Tachkov, Konstantin, Vončina, Luka, Palčevski, Vera Vlahović, Achniotou, Gnosia, Slabý, Juraj, Popelková, Leona, Kohoutová, Kateřina, Bartels, Dorthe, Laius, Ott, Martikainen, Jaana E., Selke, Gisbert W., Kourafalos, Vasileios, Magnússon, Einar, Einarsdóttir, Rannveig, Adams, Roisín, Joppi, Roberta, Allocati, Eleonora, Jakupi, Arianit, Viksna, Anita, Greičiūtė-Kuprijanov, Ieva, Vella Bonanno, Patricia, Suttorp, Vincent, Melien, Øyvind, Plisko, Robert, Mardare, Ileana, Meshkov, Dmitry, Novakovic, Tanja, Fürst, Jurij, Zara, Corinne, Marković-Peković, Vanda, Grubiša, Nataša, Befrits, Gustaf, Puckett, Robert, and Vulto, Arnold G.

Abstract

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few co

Published
2021

18. Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Author

Godman, Brian, primary, Hill, Andrew, additional, Simoens, Steven, additional, Selke, Gisbert, additional, Selke Krulichová, Iva, additional, Zampirolli Dias, Carolina, additional, Martin, Antony P, additional, Oortwijn, Wija, additional, Timoney, Angela, additional, Gustafsson, Lars L, additional, Voncina, Luka, additional, Kwon, Hye-Young, additional, Gulbinovic, Jolanta, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Cristina Da Silva, Wânia, additional, Bochenek, Tomasz, additional, Allocati, Eleonora, additional, Kurdi, Amanj, additional, Ogunleye, Olayinka O., additional, Meyer, Johanna C, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Hierländer, Christian, additional, Sauermann, Robert, additional, Hamelinck, Wouter, additional, Petrova, Guenka, additional, Laius, Ott, additional, Langner, Irene, additional, Yfantopoulos, John, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, Jf (Hans), additional, de Valk, Vincent, additional, Wladysiuk, Magdalene, additional, Marković-Peković, Vanda, additional, Mardare, Ileana, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Obach Cortadellas, Mercè, additional, Zara, Corinne, additional, Pontes, Caridad, additional, McTaggart, Stuart, additional, Laba, Tracey-Lea, additional, Melien, Øyvind, additional, Wong-Rieger, Durhane, additional, Bae, SeungJin, additional, and Hill, Ruaraidh, additional

Published
2021
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19. The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures

Author

Moorkens, Evelien, primary, Godman, Brian, additional, Huys, Isabelle, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Keuerleber, Simon, additional, Stockinger, Silvia, additional, Mörtenhuber, Sarah, additional, Dimitrova, Maria, additional, Tachkov, Konstantin, additional, Vončina, Luka, additional, Palčevski, Vera Vlahović, additional, Achniotou, Gnosia, additional, Slabý, Juraj, additional, Popelková, Leona, additional, Kohoutová, Kateřina, additional, Bartels, Dorthe, additional, Laius, Ott, additional, Martikainen, Jaana E., additional, Selke, Gisbert W., additional, Kourafalos, Vasileios, additional, Magnússon, Einar, additional, Einarsdóttir, Rannveig, additional, Adams, Roisín, additional, Joppi, Roberta, additional, Allocati, Eleonora, additional, Jakupi, Arianit, additional, Viksna, Anita, additional, Greičiūtė-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Suttorp, Vincent, additional, Melien, Øyvind, additional, Plisko, Robert, additional, Mardare, Ileana, additional, Meshkov, Dmitry, additional, Novakovic, Tanja, additional, Fürst, Jurij, additional, Zara, Corinne, additional, Marković-Peković, Vanda, additional, Grubiša, Nataša, additional, Befrits, Gustaf, additional, Puckett, Robert, additional, and Vulto, Arnold G., additional

Published
2021
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21. Culture of antibiotic use in Kosovo - an interview study with patients and health professionals

Author

Jakupi, Arianit, Raka, Denis, Kaae, Susanne, and Sporrong., Sofia K.

Subjects
medicine.medical_specialty, medicine.drug_class, Antibiotics, Kosovo, Pharmacist, Drug Resistance, Pharmaceutical Science, lcsh:RS1-441, Pharmacy, mesh:Qualitative Research, Drug resistance, Pharmacists, 030226 pharmacology & pharmacy, mesh:Drug Resistance, mesh:Respiratory Tract Infections, mesh:Drug Misuse, lcsh:Pharmacy and materia medica, 03 medical and health sciences, 0302 clinical medicine, Antibiotic resistance, Drug Misuse, medicine, Drug Resistance Bacterial, mesh:Pharmacists, Medical prescription, Respiratory Tract Infections, Qualitative Research, Original Research, Pharmacies, mesh:Kosovo, business.industry, mesh:Pharmacies, lcsh:RM1-950, Bacterial, medicine.disease, mesh:Anti-Bacterial Agents, mesh:Attitude, Anti-Bacterial Agents, mesh:Bacterial, Upper respiratory tract infection, lcsh:Therapeutics. Pharmacology, Attitude, Family medicine, business, Qualitative research
Abstract

Background: Kosovo is a new state and has a high consumption of antibiotics in relation to other European countries. Existing quantitative studies have shown that practices exist that is not optimal when it comes to antibiotic use in Kosovo, this includes citizens’ use of antibiotics, pharmacy practices of selling antibiotics without prescriptions and physicians’ prescribing behaviours. To address these problems, there is a need for a deeper understanding of why antibiotics are handled in a suboptimal way. Objective: The objective was to explore antibiotic users’, community pharmacists’ and prescribers’ attitudes towards, experiences of, and knowledge about antibiotics in Kosovo. Methods: Semi-structured interviews were conducted with patients who recently received an antibiotic prescription for an upper respiratory tract infection (URTI), patients who recently received antibiotics for a URTI without a prescription, community pharmacists, and physicians. Interviews were recorded, translated into English, and analysed using deductive content analysis. Results: In total, 16 interviews were conducted in the period from 2015-2016. Five themes were identified: Obtaining antibiotics, Choice of antibiotics, Patient information, Patients’ knowledge and views on when to use antibiotics, and Professionals’ knowledge and attitudes towards antimicrobial resistance. Antibiotics were sometimes obtained without a prescription, also by patients who currently had received one. The specific antibiotic could be chosen by a physician, a pharmacist or the patient him/herself. Former experience was one reason given by patients for their choice. Patients’ knowledge on antibiotics was mixed, however health professionals were knowledgeable about e.g. antimicrobial resistance. Conclusions: There is currently a culture of antibiotic use in Kosovo, including attitudes and behaviours, and hence also experiences, which is possibly underlying the high consumption of antibiotics in the country. The culture is reproduced by patients, pharmacists and physicians. There is, however, an awareness of the current problematic situation among practitioners and policy makers; and as Kosovo is a new country, opportunities to effectively tackle antimicrobial resistance exist.

Published
2019
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22. Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author

Godman, Brian Hill, Andrew Simoens, Professor Steven Kurdi, Amanj Gulbinovic, Jolanta Martin, Antony P. Timoney, Angela and Gotham, Dzintars Wale, Janet Bochenek, Tomasz Rothe, Celia C. Hoxha, Iris Malaj, Admir Hierlaender, Christian and Sauermann, Robert Hamelinck, Wouter Mitkova, Zornitsa and Petrova, Guenka Laius, Ott Sermet, Catherine Langer, Irene and Selke, Gisbert W. Yfantopoulos, John Joppi, Roberta and Jakupi, Arianit Poplavska, Elita Greiciute-Kuprijanov, Ieva and Bonanno, Patricia Vella Piepenbrink, J. F. (Hans) de Valk, Vincent Hagen, Carolin Ringerud, Anne Marthe Plisko, Robert and Wladysiuk, Magdalene Markovic-Pekovic, Vanda Grubisa, Natasa and Ponorac, Tatjana Mardare, Ileana Novakovic, Tanja and Parker, Mark Furst, Jurij Tomek, Dominik Cortadellas, Merce Obach Zara, Corinne Juhasz-Haverinen, Maria Skiold, Peter and McTaggart, Stuart Haycox, Alan

Subjects
health care economics and organizations
Abstract

Introduction: There are appreciable concerns among European health authorities with growing expenditure on cancer medicines and issues of sustainability. The enhanced use of low-cost generics could help. Aims: Consequently, there is a need to comprehensively document current and future arrangements regarding the pricing of generic cancer medicines across Europe, and whether these are indication specific, as well as how this translates into actual prices to provide future direction. Methodology: Mixed-method approach with qualitative research among senior health authority personnel and their advisers. Quantitative research via health authority databases to ascertain current prices for oral cancer medicines that had lost their patent and the influence of population size and economics on prices. Results: Twenty-five European countries participated. The research found the following issues: (a) variable approaches to the pricing of generic cancer medicines, which will continue; (b) no concerns with substitution for oral generic cancer medicines; (c) substantial price reductions versus originators for generic capecitabine (up to -93.1%), generic imatinib (up to -97.8%) and generic temozolomide (up to -80.7%). Prices for oncology medicines are not generally indication specific, and are not affected by population size although influenced by pricing approaches. There have also been price increases for some non-patented cancer medicines following manufacturer changes although now stabilizing. Conclusion: The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines. Countries are also starting to address price increases for generics following changes in the manufacturer.

Published
2019

23. Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

Author

Godman, Brian, primary, McCabe, Holly, additional, D Leong, Trudy, additional, Mueller, Debjani, additional, Martin, Antony P., additional, Hoxha, Iris, additional, Mwita, Julius C., additional, Rwegerera, Godfrey Mutashambara, additional, Massele, Amos, additional, Costa, Juliana de Oliveira, additional, do Nascimento, Renata Cristina Rezende Macedo, additional, Lemos, Livia Lovato Pires de, additional, Tachkov, Konstantin, additional, Milushewa, Petya, additional, Patrick, Okwen, additional, Niba, Loveline Lum, additional, Laius, Ott, additional, Sefah, Israel, additional, Abdulsalim, Suhaj, additional, Soleymani, Fatemeh, additional, Guantai, Anastasia N, additional, Achieng, Loice, additional, Oluka, Margaret, additional, Jakupi, Arianit, additional, Logviss, Konstantīns, additional, Hassali, Mohamed Azmi, additional, Kibuule, Dan, additional, Kalemeera, Francis, additional, Mubita, Mwangana, additional, Fadare, Joseph, additional, Ogunleye, Olayinka O., additional, Saleem, Zikria, additional, Hussain, Shazhad, additional, Bochenek, Tomasz, additional, Mardare, Ileana, additional, Alrasheedy, Alian A., additional, Furst, Jurij, additional, Tomek, Dominik, additional, Markovic-Pekovic, Vanda, additional, Rampamba, Enos M., additional, Alfadl, Abubakr, additional, Amu, Adefolarin A, additional, Matsebula, Zinhle, additional, Phuong, Thuy Nguyen Thi, additional, Thanh, Binh Nguyen, additional, Chichonyi Kalungia, Aubrey, additional, Zaranyika, Trust, additional, Masuka, Nyasha, additional, Olaru, Ioana D., additional, Wale, Janney, additional, Hill, Ruaraidh, additional, Kurdi, Amanj, additional, Timoney, Angela, additional, Campbell, Stephen, additional, and Meyer, Johanna C., additional

Published
2020
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24. Ongoing strategies to improve the management of upper respiratory tract infections and reduce inappropriate antibiotic use particularly among lower and middle-income countries: findings and implications for the future

Author

Godman, Brian, primary, Haque, Mainul, additional, McKimm, Judy, additional, Abu Bakar, Muhamad, additional, Sneddon, Jacqueline, additional, Wale, Janney, additional, Campbell, Stephen, additional, Martin, Antony P., additional, Hoxha, Iris, additional, Abilova, Vafa, additional, Anand Paramadhas, Bene D., additional, Mpinda-Joseph, Pinkie, additional, Matome, Matshediso, additional, de Lemos, Livia Lovato Pires, additional, Sefah, Israel, additional, Kurdi, Amanj, additional, Opanga, Sylvia, additional, Jakupi, Arianit, additional, Saleem, Zikria, additional, Hassali, Mohamed Azmi, additional, Kibuule, Dan, additional, Fadare, Joseph, additional, Bochenek, Tomasz, additional, Rothe, Celia, additional, Furst, Jurij, additional, Markovic-Pekovic, Vanda, additional, Bojanić, Ljubica, additional, Schellack, Natalie, additional, Meyer, Johanna C., additional, Matsebula, Zinhle, additional, Phuong, Thuy Nguyen Thi, additional, Thanh, Binh Nguyen, additional, Jan, Saira, additional, Kalungia, Aubrey, additional, Mtapuri-Zinyowera, Sekesai, additional, Sartelli, Massimo, additional, and Hill, Ruaraidh, additional

Published
2019
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26. Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author

Godman, Brian, primary, Hill, Andrew, additional, Simoens, Steven, additional, Kurdi, Amanj, additional, Gulbinovič, Jolanta, additional, Martin, Antony P, additional, Timoney, Angela, additional, Gotham, Dzintars, additional, Wale, Janet, additional, Bochenek, Tomasz, additional, Rothe, Celia C, additional, Hoxha, Iris, additional, Malaj, Admir, additional, Hierländer, Christian, additional, Sauermann, Robert, additional, Hamelinck, Wouter, additional, Mitkova, Zornitza, additional, Petrova, Guenka, additional, Laius, Ott, additional, Sermet, Catherine, additional, Langer, Irene, additional, Selke, Gisbert, additional, Yfantopoulos, John, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Poplavska, Elita, additional, Greiciute-Kuprijanov, Ieva, additional, Vella Bonanno, Patricia, additional, Piepenbrink, JF (Hans), additional, de Valk, Vincent, additional, Hagen, Carolin, additional, Ringerud, Anne Marthe, additional, Plisko, Robert, additional, Wladysiuk, Magdalene, additional, Marković-Peković, Vanda, additional, Grubiša, Nataša, additional, Ponorac, Tatjana, additional, Mardare, Ileana, additional, Novakovic, Tanja, additional, Parker, Mark, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Cortadellas, Mercè Obach, additional, Zara, Corinne, additional, Juhasz-Haverinen, Maria, additional, Skiold, Peter, additional, McTaggart, Stuart, additional, and Haycox, Alan, additional

Published
2019
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27. Antimicrobial Medicines Consumption in Eastern Europeand Central Asia – An Updated Cross-National Study and Assessment of QuantitativeMetrics for Policy Action

Author

Robertson, Jane, primary, Iwamoto, Kotoji, additional, Hoxha, Iris, additional, Ghazaryan, Lilit, additional, Abilova, Vafa, additional, Cvijanovic, Ana, additional, Pyshnik, Halina, additional, Darakhvelidze, Marina, additional, Makalkina, Larissa, additional, Jakupi, Arianit, additional, Dzhakubekova, Aigul, additional, Carp, Angela, additional, Cizmovic, Lidija, additional, Rachina, Svetlana, additional, Radonjic, Vesela, additional, Yusufi, Salomudin, additional, Aksoy, Mesil, additional, Ibragimova, Muhabbat, additional, Godman, Brian, additional, Kluge, Hans, additional, and Pedersen, Hanne Bak, additional

Published
2019
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29. Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA

Author

Vella Bonanno, Patricia, primary, Bucsics, Anna, additional, Simoens, Steven, additional, Martin, Antony P, additional, Oortwijn, Wija, additional, Gulbinovič, Jolanta, additional, Rothe, Celia, additional, Timoney, Angela, additional, Ferrario, Alessandra, additional, Gad, Mohamed, additional, Salem, Ahmed, additional, Hoxha, Iris, additional, Sauermann, Robert, additional, Kamusheva, Maria, additional, Dimitrova, Maria, additional, Petrova, Guenka, additional, Laius, Ott, additional, Selke, Gisbert, additional, Kourafalos, Vasilios, additional, Yfantopoulos, John, additional, Magnusson, Einar, additional, Joppi, Roberta, additional, Jakupi, Arianit, additional, Bochenek, Tomasz, additional, Wladysiuk, Magdalene, additional, Furtado, Claudia, additional, Marković-Peković, Vanda, additional, Mardare, Ileana, additional, Meshkov, Dmitry, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Cortadellas, Merce Obach, additional, Zara, Corrine, additional, Haycox, Alan, additional, Campbell, Stephen, additional, and Godman, Brian, additional

Published
2019
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30. Systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages in 28 European and Western Asian countries

Author

Bochenek, Tomasz, Abilova, Vafa, Alkan, Ali, Asanin, Bogdan, Iñigo de Migue, Beriain, Besovic, Zeljka, Vella Bonanno, Patricia, Bucsics, Anna, Davidescu, Michal, De Weerd, Elfi, Duborija-Kovacevic, Natasa, Fürst, Jurij, Gaga, Mina, Gailīte, Elma, Gulbinovič, Jolanta, Gürpınar, Emre U., Hankó, Balázs, Hargaden, Vincent, Hotvedt, Tor A., Hoxha, Iris, Huys, Isabelle, Inotai, Andras, Jakupi, Arianit, Jenzer, Helena, Joppi, Roberta, Laius, Ott, Lenormand, Marie-Camilleri, Makridaki, Despina, Malaj, Admir, Margus, Kertu, Marković-Peković, Vanda, Miljković, Nenad, de Miranda, João L., Primožič, Stanislav, Rajinac, Dragana, Schwartz, David G., Šebesta, Robin, Simoens, Steven, Slaby, Juraj, Sović-Brkičić, Ljiljana, Tesar, Tomas, Tzimis, Leonidas, Ewa, Warmińska, and Godman, Brian

Subjects
Pharmacology, Western Asia, RM, Health services administration, health care system, drug shortage, pharmaceutical policy, organizational framework, legislation, Europe, European Union, Drug accessibility -- Law and legislation, Pharmacy -- Law and legislation -- Europe, Pharmacy -- Law and legislation -- Middle East, Original Research
Abstract

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed., peer-reviewed

Published
2018

31. Ongoing strategies to improve the management of upper respiratory tract infections and reduce inappropriate antibiotic use particularly among lower and middle-income countries: findings and implications for the future.

Author

Godman, Brian, Haque, Mainul, McKimm, Judy, Abu Bakar, Muhamad, Sneddon, Jacqueline, Wale, Janney, Campbell, Stephen, Martin, Antony P., Hoxha, Iris, Abilova, Vafa, Anand Paramadhas, Bene D., Mpinda-Joseph, Pinkie, Matome, Matshediso, de Lemos, Livia Lovato Pires, Sefah, Israel, Kurdi, Amanj, Opanga, Sylvia, Jakupi, Arianit, Saleem, Zikria, and Hassali, Mohamed Azmi

Subjects
MIDDLE-income countries, EXECUTIVES, RESPIRATORY infections, MEDICAL personnel, DRUG resistance in microorganisms, HEALTH education
Abstract

Introduction: Antibiotics are indispensable to maintaining human health; however, their overuse has resulted in resistant organisms, increasing morbidity, mortality and costs. Increasing antimicrobial resistance (AMR) is a major public health threat, resulting in multiple campaigns across countries to improve appropriate antimicrobial use. This includes addressing the overuse of antimicrobials for self-limiting infections, such as upper respiratory tract infections (URTIs), particularly in lower- and middle-income countries (LMICs) where there is the greatest inappropriate use and where antibiotic utilization has increased the most in recent years. Consequently, there is a need to document current practices and successful initiatives in LMICs to improve future antimicrobial use.Methodology: Documentation of current epidemiology and management of URTIs, particularly in LMICs, as well as campaigns to improve future antimicrobial use and their influence where known.Results: Much concern remains regarding the prescribing and dispensing of antibiotics for URTIs among LMICs. This includes considerable self-purchasing, up to 100% of pharmacies in some LMICs. However, multiple activities are now ongoing to improve future use. These incorporate educational initiatives among all key stakeholder groups, as well as legislation and other activities to reduce self-purchasing as part of National Action Plans (NAPs). Further activities are still needed however. These include increased physician and pharmacist education, starting in medical and pharmacy schools; greater monitoring of prescribing and dispensing practices, including the development of pertinent quality indicators; and targeted patient information and health education campaigns. It is recognized that such activities are more challenging in LMICs given more limited resources and a lack of healthcare professionals.Conclusion: Initiatives will grow across LMICs to reduce inappropriate prescribing and dispensing of antimicrobials for URTIs as part of NAPs and other activities, and these will be monitored. [ABSTRACT FROM AUTHOR]

Published
2020
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32. Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets

Author

Godman, Brian, primary, Bucsics, Anna, additional, Vella Bonanno, Patricia, additional, Oortwijn, Wija, additional, Rothe, Celia C., additional, Ferrario, Alessandra, additional, Bosselli, Simone, additional, Hill, Andrew, additional, Martin, Antony P., additional, Simoens, Steven, additional, Kurdi, Amanj, additional, Gad, Mohamed, additional, Gulbinovič, Jolanta, additional, Timoney, Angela, additional, Bochenek, Tomasz, additional, Salem, Ahmed, additional, Hoxha, Iris, additional, Sauermann, Robert, additional, Massele, Amos, additional, Guerra, Augusto Alfonso, additional, Petrova, Guenka, additional, Mitkova, Zornitsa, additional, Achniotou, Gnosia, additional, Laius, Ott, additional, Sermet, Catherine, additional, Selke, Gisbert, additional, Kourafalos, Vasileios, additional, Yfantopoulos, John, additional, Magnusson, Einar, additional, Joppi, Roberta, additional, Oluka, Margaret, additional, Kwon, Hye-Young, additional, Jakupi, Arianit, additional, Kalemeera, Francis, additional, Fadare, Joseph O., additional, Melien, Oyvind, additional, Pomorski, Maciej, additional, Wladysiuk, Magdalene, additional, Marković-Peković, Vanda, additional, Mardare, Ileana, additional, Meshkov, Dmitry, additional, Novakovic, Tanja, additional, Fürst, Jurij, additional, Tomek, Dominik, additional, Zara, Corrine, additional, Diogene, Eduardo, additional, Meyer, Johanna C., additional, Malmström, Rickard, additional, Wettermark, Björn, additional, Matsebula, Zinhle, additional, Campbell, Stephen, additional, and Haycox, Alan, additional

Published
2018
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35. Antibiotic utilisation in adult and children patients in Kosovo hospitals

Author

Krasniqi, Shaip, primary, Versporten, Ann, additional, Jakupi, Arianit, additional, Raka, Denis, additional, Daci, Armond, additional, Krasniqi, Valon, additional, Deva, Zana, additional, Rashiti, Albiona, additional, Brajshori, Naime, additional, Hajdari, Shefqet, additional, Bytyqi, Jetëmira, additional, Neziri, Burim, additional, Goossens, Herman, additional, and Raka, Lul, additional

Published
2017
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38. Experiences from a pilot study on how to conduct a qualitative multi-country research project regarding use of antibiotics in Southeast Europe.

Author

Kaae, Susanne, Sporrong, Sofia Kälvemark, Traulsen, Janine Morgall, Wallach Kildemoes, Helle, Nørgaard, Lotte Stig, Jakupi, Arianit, Raka, Denis, Gürpinar, Emre Umut, Alkan, Ali, Hoxha, Iris, Malaj, Admir, Cantarero, Lourdes Arevalo, Kaae, Susanne, Sporrong, Sofia Kälvemark, Traulsen, Janine Morgall, Wallach Kildemoes, Helle, Nørgaard, Lotte Stig, Jakupi, Arianit, Raka, Denis, Gürpinar, Emre Umut, Alkan, Ali, Hoxha, Iris, Malaj, Admir, and Cantarero, Lourdes Arevalo

Abstract

BACKGROUND: In 2014, a qualitative multi-country research project was launched to study the reasons behind the high use of antibiotics in regions of Southeast Europe by using previously untrained national interviewers (who were engaged in other antibiotic microbial resistance-related investigations) to conduct qualitative interviews with local patients, physicians and pharmacists. Little knowledge exists about how to implement qualitative multi-country research collaborations involving previously untrained local data collectors. The aim of this paper was therefore to contribute to the knowledge regarding how to conduct these types of research projects by evaluating a pilot study of the project. METHODS: Local data collectors conducted the study according to a developed protocol and evaluated the study with the responsible researcher-team from University of Copenhagen. The pilot study focused on 'local ownership', 'research quality' and 'feasibility' with regard to successful implementation and evaluation. The evaluation was achieved by interpreting 'Skype' and 'face to face' meetings and email correspondence by applying 'critical common sense'. RESULTS: Local data collectors achieved a sense of joint ownership. Overall, the protocol worked well. Several minor challenges pertaining to research quality and feasibility were identified, in particular obtaining narratives when conducting interviews and recruiting patients for the study. Furthermore, local data collectors found it difficult to allocate sufficient time to the project. Solutions were discussed and added to the protocol. CONCLUSIONS: Despite the challenges, it was possible to achieve an acceptable scientific level of research when conducting qualitative multi-country research collaboration under the given circumstances. Specific recommendations to achieve this are provided by the authors.

Published
2016
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39. Experiences from a pilot study on how to conduct a qualitative multi-country research project regarding use of antibiotics in Southeast Europe

Author

Kaae, Susanne, primary, Sporrong, Sofia Kälvemark, additional, Traulsen, Janine Morgall, additional, Wallach Kildemoes, Helle, additional, Nørgaard, Lotte Stig, additional, Jakupi, Arianit, additional, Raka, Denis, additional, Gürpinar, Emre Umut, additional, Alkan, Ali, additional, Hoxha, Iris, additional, Malaj, Admir, additional, and Cantarero, Lourdes Arevalo, additional

Published
2016
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40. ANTIBIOTIC PRESCRIBING IN THE CLINIC OF ORAL SURGERY OF THE UNIVERSITY CLINICAL DENTISTRY CENTRE OF KOSOVA IN THE PERIOD 2019-2021.

Author

Hoti, Agon, Šutej, Ivana, and Jakupi, Arianit

Subjects
DRUG prescribing, ORAL surgery, SURGICAL clinics, HEALTH facilities, MEDICAL care
Abstract

Aim: The Ministry of Health in Kosovo, by national decision (2020), has suspended dental services from March 20, 2020, to June 18, 2020. The suspension has complicated the situation of patients due to the lack of provision of these health services. Based on this, the aim of this research was to analyze the results of the administration of different classes of antibiotics to patients at the University Dental Clinical Center of Kosovo for the treatment of dental patients, compared to the time before the imposition of suspension measures. Materials and Methods: Antibiotic prescribing was monitored for three years (2019-2021) in the clinic of oral surgery of the University Clinical Dentistry Centre of Kosova. The analysis included the number of prescriptions and the type of antibiotic prescribed. The World Health Organization's INN and ATC codes are used for the classification of antibiotics. Data were processed using MS Office Excel. Results: During the time studied, there were 552 patients who received antibiotic therapy, 44% were males and 56% were females. In addition, to these, 552 patients, a total of 662 different antibiotics have been prescribed. The most prescribed antibiotic was Amoxicillin with enzyme inhibitor (J01CR01), with 408 prescriptions or 62% of all prescriptions. However, this study noted a decrease during the observed period in Amoxicillin and enzyme inhibitors (J01CR01) from 65% to 60% of all prescribing. In comparison, there is an increase in Clindamycin (J01FF01) from 1-5%, Metronidazole (J01XD01) and Azithromycin (J01FA10) 19-23% respectively 0-2% of all prescribing. Conclusion: The results of the study provide a clear situation on antibiotic prescribing during health emergencies such as epidemics/pandemics and provide an opportunity to establish clear models of approach to epidemic/pandemic problems for patients and dental practitioners, especially in the design and approval of therapeutic protocols for specific indications in dentistry. [ABSTRACT FROM AUTHOR]

Published
2023

43. Strategies to improve the management of upper respiratory tract infections and reduce inappropriate antibiotic use particularly among lower and middle-income countries; findings and implications

Author

Godman, Brian, Haque, Mainul, McKimm, Judy, Bakar, Muhamad Abu, Sneddon, Jacqueline, Wale, Janney, Campbell, Stephen, Martin, Antony, Hoxha, Iris, Abilova, Vafa, Paramadhas, Bene D Anand, Mpinda-Joseph, Pinkie, Matome, Matshediso, Pires de Lemos, Livia Lovato, Sefah, Israel, Kurdi, Amanj, Opanga, Sylvia, Jakupi, Arianit, Saleem, Zikria, Azmi Hassali, Mohamed, Kibuule, Dan, Fadare, Joseph, Bochenek, Tomasz, Rothe, Celia, Furst, Jurij, Markovic-Pekovic, Vanda, Bojanić, Ljubica, Schellack, Natalie, Meyer, Johanna C, Matsebula, Zinhle, Phuong, Thuy Nguyen Thi, Thanh, Binh Nguyen, Jan, Saira, Kalungia, Aubrey, Mtapuri-Zinyowera, Sekesai, Sartelli, Massimo, and Hill, Ruaraidh

44. The implementation of managed entry agreements in Central and Eastern Europe: findings and implications

Author

Ferrario, Alessandra, Arāja, Diāna, Bochenek, Tomasz, Čatić, Tarik, Dankó, Dávid, Dimitrova, Maria, Fürst, Jurij, Greičiūtė-Kuprijanov, Ieva, Hoxha, Iris, Jakupi, Arianit, Laidmäe, Erki, Löblová, Olga, Mardare, Ileana, Markovic-Pekovic, Vanda, Meshkov, Dmitry, Novakovic, Tanja, Petrova, Guenka, Pomorski, Maciej, Tomek, Dominik, Voncina, Luka, Haycox, Alan, Kanavos, Panos, Vella Bonanno, Patricia, Godman, Brian, Ferrario, Alessandra, Arāja, Diāna, Bochenek, Tomasz, Čatić, Tarik, Dankó, Dávid, Dimitrova, Maria, Fürst, Jurij, Greičiūtė-Kuprijanov, Ieva, Hoxha, Iris, Jakupi, Arianit, Laidmäe, Erki, Löblová, Olga, Mardare, Ileana, Markovic-Pekovic, Vanda, Meshkov, Dmitry, Novakovic, Tanja, Petrova, Guenka, Pomorski, Maciej, Tomek, Dominik, Voncina, Luka, Haycox, Alan, Kanavos, Panos, Vella Bonanno, Patricia, and Godman, Brian

Abstract

Background Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. Method We conducted a survey on the implementation of MEAs in CEE between January and March 2017. Results Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). Conclusions Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation. Alessandra Ferrario was a Research Officer at the LSE Health at the time this research was conducted. She is now a postdoctoral Research Fellow at the

45. Pharmacy practice architecture challenges in handling COVID-19 pandemic - sharing experience from a Kosovo pharmacy practice.

Author

Jakupi A and Jakupi AB

Abstract

Background: Community pharmacies deliver an essential healthcare service, which is broadly established, encompassing the favored and primary contact for community members. The COVID-19 pandemic is continuing to shift the pharmacy roles and services in order to meet the needs of customers. The important value of community pharmacies was more underlined during the pandemic crisis when they were supposed to undertake abundant precautions to avoid cross-infection among users of the space. Their responsibility is also to create a compatible, efficient, and safe environment inside their premises during this outbreak. The built environment is an important share of pandemic solutions and emergency planning preparations., Objectives: The aim of this paper was to explore the preparedness of community pharmacies in Kosovo for the COVID-19 outbreak in regards to pharmacy design modifications while ensuring adequate medicine management, information, and public health. Consequently, at what stage can the pandemic affect the physical and built environment of pharmacies., Methods: The methods for this study include a cross-sectional survey of 104 community pharmacies operating in seven municipalities in Kosovo during the pandemic. Data collection was conducted from October 1 to October 14, 2021, using self-administered online questionnaires. The questionnaire consisted of a combination of closed and open-ended questions, optional statements, and multiple answers. Data were analyzed in SPSS for Windows version 20 using descriptive statistics., Results: The results show that communities should be prepared ahead in regard to the emergency situations and some of these preparations might be also part of the legislation requirements. Although the pandemic exposed many errors in the Kosovo community pharmacy system, it has also discovered a unique possibility for collaboration and novelty., Conclusions: The study concludes with the recommendation for the architectural design of pharmacies to be positioned as an active mediator in the fight against the COVID 19, with a critical lesson aimed at the flexibility of the space to accommodate emergent situations and create alternative areas for use., (Copyright: © Pharmacy Practice.)

Published
2021
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46. The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future.

Author

Godman B, Haque M, Leong T, Allocati E, Kumar S, Islam S, Charan J, Akter F, Kurdi A, Vassalo C, Bakar MA, Rahim SA, Sultana N, Deeba F, Khan MAH, Alam ABMM, Jahan I, Kamal ZM, Hasin H, Munzur-E-Murshid, Nahar S, Haque M, Dutta S, Abhayanand JP, Kaur RJ, Rwegerera GM, do Nascimento RCRM, Dias Godói IP, Irfan M, Amu AA, Matowa P, Acolatse J, Incoom R, Sefah IA, Acharya J, Opanga S, Njeri LW, Kimonge D, Kwon HY, Bae S, Khuan KKP, Abubakar AR, Sani IH, Khan TA, Hussain S, Saleem Z, Malande OO, Piloya-Were T, Gambogi R, Hernandez Ortiz C, Alutuli L, Kalungia AC, Hoxha I, Marković-Peković V, Tubic B, Petrova G, Tachkov K, Laius O, Harsanyi A, Inotai A, Jakupi A, Henkuzens S, Garuoliene K, Gulbinovič J, Wladysiuk M, Rutkowski J, Mardare I, Fürst J, McTaggart S, MacBride-Stewart S, Pontes C, Zara C, Tagoe ET, Banzi R, Wale J, and Jakovljevic M

Subjects
Africa, Bangladesh, Brazil, Europe, Hypoglycemic Agents therapeutic use, India, Pakistan, Republic of Korea, Biosimilar Pharmaceuticals therapeutic use, Insulin, Long-Acting therapeutic use
Abstract

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities., Competing Interests: MW and JR work for HTA Consulting and MH works for Square Toiletries Limited. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Godman, Haque, Leong, Allocati, Kumar, Islam, Charan, Akter, Kurdi, Vassalo, Bakar, Rahim, Sultana, Deeba, Khan, Alam, Jahan, Kamal, Hasin, Munzur-E-Murshid, Nahar, Haque, Dutta, Abhayanand, Kaur, Rwegerera, Nascimento, Dias Godói, Irfan, Amu, Matowa, Acolatse, Incoom, Sefah, Acharya, Opanga, Njeri, Kimonge, Kwon, Bae, Khuan, Abubakar, Sani, Khan, Hussain, Saleem, Malande, Piloya-Were, Gambogi, Hernandez Ortiz, Alutuli, Kalungia, Hoxha, Marković-Peković, Tubic, Petrova, Tachkov, Laius, Harsanyi, Inotai, Jakupi, Henkuzens, Garuoliene, Gulbinovič, Wladysiuk, Rutkowski, Mardare, Fürst, McTaggart, MacBride-Stewart, Pontes, Zara, Tagoe, Banzi, Wale and Jakovljevic.)

Published
2021
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47. The Expiry of Humira ® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Author

Moorkens E, Godman B, Huys I, Hoxha I, Malaj A, Keuerleber S, Stockinger S, Mörtenhuber S, Dimitrova M, Tachkov K, Vončina L, Palčevski VV, Achniotou G, Slabý J, Popelková L, Kohoutová K, Bartels D, Laius O, Martikainen JE, Selke GW, Kourafalos V, Magnússon E, Einarsdóttir R, Adams R, Joppi R, Allocati E, Jakupi A, Viksna A, Greičiūtė-Kuprijanov I, Vella Bonanno P, Suttorp V, Melien Ø, Plisko R, Mardare I, Meshkov D, Novakovic T, Fürst J, Zara C, Marković-Peković V, Grubiša N, Befrits G, Puckett R, and Vulto AG

Abstract

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries., Competing Interests: AGV is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. AbbVie, Accord, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. RP runs a consulting company and previously worked with, a.o., Abbvie, Biogen, Sandoz, Pfizer, MSD, Roche, GSK, Sanofi. IM is involved in consulting and advisory work and recently worked with I&S Hungary, Ewopharma, Genesis Pharma, GSK. RP was employed by HTA Consulting at the time of the study. TN was employed by ZEM Solutions at the time of the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Moorkens, Godman, Huys, Hoxha, Malaj, Keuerleber, Stockinger, Mörtenhuber, Dimitrova, Tachkov, Vončina, Palčevski, Achniotou, Slabý, Popelková, Kohoutová, Bartels, Laius, Martikainen, Selke, Kourafalos, Magnússon, Einarsdóttir, Adams, Joppi, Allocati, Jakupi, Viksna, Greičiūtė-Kuprijanov, Vella Bonanno, Suttorp, Melien, Plisko, Mardare, Meshkov, Novakovuc, Fürst, Zara, Marković-Peković, Grubiša, Befrits, Puckett and Vulto.)

Published
2021
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48. Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries.

Author

Bochenek T, Abilova V, Alkan A, Asanin B, de Miguel Beriain I, Besovic Z, Vella Bonanno P, Bucsics A, Davidescu M, De Weerdt E, Duborija-Kovacevic N, Fürst J, Gaga M, Gailīte E, Gulbinovič J, Gürpınar EU, Hankó B, Hargaden V, Hotvedt TA, Hoxha I, Huys I, Inotai A, Jakupi A, Jenzer H, Joppi R, Laius O, Lenormand MC, Makridaki D, Malaj A, Margus K, Marković-Peković V, Miljković N, de Miranda JL, Primožič S, Rajinac D, Schwartz DG, Šebesta R, Simoens S, Slaby J, Sović-Brkičić L, Tesar T, Tzimis L, Warmińska E, and Godman B

Abstract

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.

Published
2018
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