Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications
Аутори
Miljković, NenadGodman, Brian
Kovačević, Milena
Polidori, Piera
Tzimis, Leonidas
Hoppe-Tichy, Torsten
Saar, Marika
Antofie, Ioan
Horvath, Laszlo
De Rijdt, Thomas
Vida, Róbert György
Kkolou, Elena
Preece, David
Tubić, Biljana
Peppard, Joan
Martinez, Alicia
Yubero, Cristina Garcia
Haddad, Ratiba
Rajinac, Dragana
Zelić, Pavle
Jenzer, Helena
Tartar, Franci
Gitler, Gunda
Jeske, Martina
Davidescu, Michal
Beraud, Michal
Kuruc-Poje, Darija
Haag, Sakstrup Haag
Fischer, Hanne
Sviestina, Inese
Ljubojević, Gordana
Markestad, Anne
Vujić-Aleksić, Vesna
Nežić, Lana
Crkvenčić, Anica
Linnolahti, Johanna
Ašanin, Bogdan
Duborija-Kovačević, Nataša
Bochenek, Tomasz
Huys, Isabelle
Miljković, Branislava
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Introduction: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics...®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe. © Copyright © 2020 Miljković, Godman, Kovačević, Polidori, Tzimis, Hoppe-Tichy, Saar, Antofie, Horvath, De Rijdt, Vida, Kkolou, Preece, Tubić, Peppard, Martinez, Yubero, Haddad, Rajinac, Zelić, Jenzer, Tartar, Gitler, Jeske, Davidescu, Beraud, Kuruc-Poje, Haag, Fischer, Sviestina, Ljubojević, Markestad, Vujić-Aleksić, Nežić, Crkvenčić, Linnolahti, Ašanin, Duborija-Kovačević, Bochenek, Huys and Miljković.
Кључне речи:
Europe / medicine shortage / mitigation strategy / risk assessment / substitution / Medicine: Pharmacology (medical) / Pharmacology, Toxicology and Pharmaceutics: PharmacologyИзвор:
Frontiers in Pharmacology, 2020, 11Издавач:
- Frontiers Media S.A.
Финансирање / пројекти:
- COST Action CA 15105 [European Medicines Shortages Research Network
- COST (European Cooperation in Science and Technology)
DOI: 10.3389/fphar.2020.00357
ISSN: 1663-9812
WoS: 000526919700001
Scopus: 2-s2.0-85083242118
Институција/група
PharmacyTY - JOUR AU - Miljković, Nenad AU - Godman, Brian AU - Kovačević, Milena AU - Polidori, Piera AU - Tzimis, Leonidas AU - Hoppe-Tichy, Torsten AU - Saar, Marika AU - Antofie, Ioan AU - Horvath, Laszlo AU - De Rijdt, Thomas AU - Vida, Róbert György AU - Kkolou, Elena AU - Preece, David AU - Tubić, Biljana AU - Peppard, Joan AU - Martinez, Alicia AU - Yubero, Cristina Garcia AU - Haddad, Ratiba AU - Rajinac, Dragana AU - Zelić, Pavle AU - Jenzer, Helena AU - Tartar, Franci AU - Gitler, Gunda AU - Jeske, Martina AU - Davidescu, Michal AU - Beraud, Michal AU - Kuruc-Poje, Darija AU - Haag, Sakstrup Haag AU - Fischer, Hanne AU - Sviestina, Inese AU - Ljubojević, Gordana AU - Markestad, Anne AU - Vujić-Aleksić, Vesna AU - Nežić, Lana AU - Crkvenčić, Anica AU - Linnolahti, Johanna AU - Ašanin, Bogdan AU - Duborija-Kovačević, Nataša AU - Bochenek, Tomasz AU - Huys, Isabelle AU - Miljković, Branislava PY - 2020 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3586 AB - Introduction: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe. © Copyright © 2020 Miljković, Godman, Kovačević, Polidori, Tzimis, Hoppe-Tichy, Saar, Antofie, Horvath, De Rijdt, Vida, Kkolou, Preece, Tubić, Peppard, Martinez, Yubero, Haddad, Rajinac, Zelić, Jenzer, Tartar, Gitler, Jeske, Davidescu, Beraud, Kuruc-Poje, Haag, Fischer, Sviestina, Ljubojević, Markestad, Vujić-Aleksić, Nežić, Crkvenčić, Linnolahti, Ašanin, Duborija-Kovačević, Bochenek, Huys and Miljković. PB - Frontiers Media S.A. T2 - Frontiers in Pharmacology T1 - Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications VL - 11 DO - 10.3389/fphar.2020.00357 ER -
@article{ author = "Miljković, Nenad and Godman, Brian and Kovačević, Milena and Polidori, Piera and Tzimis, Leonidas and Hoppe-Tichy, Torsten and Saar, Marika and Antofie, Ioan and Horvath, Laszlo and De Rijdt, Thomas and Vida, Róbert György and Kkolou, Elena and Preece, David and Tubić, Biljana and Peppard, Joan and Martinez, Alicia and Yubero, Cristina Garcia and Haddad, Ratiba and Rajinac, Dragana and Zelić, Pavle and Jenzer, Helena and Tartar, Franci and Gitler, Gunda and Jeske, Martina and Davidescu, Michal and Beraud, Michal and Kuruc-Poje, Darija and Haag, Sakstrup Haag and Fischer, Hanne and Sviestina, Inese and Ljubojević, Gordana and Markestad, Anne and Vujić-Aleksić, Vesna and Nežić, Lana and Crkvenčić, Anica and Linnolahti, Johanna and Ašanin, Bogdan and Duborija-Kovačević, Nataša and Bochenek, Tomasz and Huys, Isabelle and Miljković, Branislava", year = "2020", abstract = "Introduction: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe. © Copyright © 2020 Miljković, Godman, Kovačević, Polidori, Tzimis, Hoppe-Tichy, Saar, Antofie, Horvath, De Rijdt, Vida, Kkolou, Preece, Tubić, Peppard, Martinez, Yubero, Haddad, Rajinac, Zelić, Jenzer, Tartar, Gitler, Jeske, Davidescu, Beraud, Kuruc-Poje, Haag, Fischer, Sviestina, Ljubojević, Markestad, Vujić-Aleksić, Nežić, Crkvenčić, Linnolahti, Ašanin, Duborija-Kovačević, Bochenek, Huys and Miljković.", publisher = "Frontiers Media S.A.", journal = "Frontiers in Pharmacology", title = "Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications", volume = "11", doi = "10.3389/fphar.2020.00357" }
Miljković, N., Godman, B., Kovačević, M., Polidori, P., Tzimis, L., Hoppe-Tichy, T., Saar, M., Antofie, I., Horvath, L., De Rijdt, T., Vida, R. G., Kkolou, E., Preece, D., Tubić, B., Peppard, J., Martinez, A., Yubero, C. G., Haddad, R., Rajinac, D., Zelić, P., Jenzer, H., Tartar, F., Gitler, G., Jeske, M., Davidescu, M., Beraud, M., Kuruc-Poje, D., Haag, S. H., Fischer, H., Sviestina, I., Ljubojević, G., Markestad, A., Vujić-Aleksić, V., Nežić, L., Crkvenčić, A., Linnolahti, J., Ašanin, B., Duborija-Kovačević, N., Bochenek, T., Huys, I.,& Miljković, B.. (2020). Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications. in Frontiers in Pharmacology Frontiers Media S.A.., 11. https://doi.org/10.3389/fphar.2020.00357
Miljković N, Godman B, Kovačević M, Polidori P, Tzimis L, Hoppe-Tichy T, Saar M, Antofie I, Horvath L, De Rijdt T, Vida RG, Kkolou E, Preece D, Tubić B, Peppard J, Martinez A, Yubero CG, Haddad R, Rajinac D, Zelić P, Jenzer H, Tartar F, Gitler G, Jeske M, Davidescu M, Beraud M, Kuruc-Poje D, Haag SH, Fischer H, Sviestina I, Ljubojević G, Markestad A, Vujić-Aleksić V, Nežić L, Crkvenčić A, Linnolahti J, Ašanin B, Duborija-Kovačević N, Bochenek T, Huys I, Miljković B. Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications. in Frontiers in Pharmacology. 2020;11. doi:10.3389/fphar.2020.00357 .
Miljković, Nenad, Godman, Brian, Kovačević, Milena, Polidori, Piera, Tzimis, Leonidas, Hoppe-Tichy, Torsten, Saar, Marika, Antofie, Ioan, Horvath, Laszlo, De Rijdt, Thomas, Vida, Róbert György, Kkolou, Elena, Preece, David, Tubić, Biljana, Peppard, Joan, Martinez, Alicia, Yubero, Cristina Garcia, Haddad, Ratiba, Rajinac, Dragana, Zelić, Pavle, Jenzer, Helena, Tartar, Franci, Gitler, Gunda, Jeske, Martina, Davidescu, Michal, Beraud, Michal, Kuruc-Poje, Darija, Haag, Sakstrup Haag, Fischer, Hanne, Sviestina, Inese, Ljubojević, Gordana, Markestad, Anne, Vujić-Aleksić, Vesna, Nežić, Lana, Crkvenčić, Anica, Linnolahti, Johanna, Ašanin, Bogdan, Duborija-Kovačević, Nataša, Bochenek, Tomasz, Huys, Isabelle, Miljković, Branislava, "Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications" in Frontiers in Pharmacology, 11 (2020), https://doi.org/10.3389/fphar.2020.00357 . .