TY  - THES
AU  - Miljković, Nenad
PY  - 2021
UR  - http://eteze.bg.ac.rs/application/showtheses?thesesId=8411
UR  - https://fedorabg.bg.ac.rs/fedora/get/o:24643/bdef:Content/download
UR  - http://vbs.rs/scripts/cobiss?command=DISPLAY&base=70036&RID=48716809
UR  - https://nardus.mpn.gov.rs/handle/123456789/18774
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4035
AB  - Nestašice lekova narušavaju kontinuitet u primeni terapije pacijentu i uzrokuju brojne zdravstvene rizike tokom propisivanja, izdavanja i primene alternative u okviru terapijske supstitucije uzrokovane nestašicom. Rizici i greške do kojih dovode nisu dovoljno istraženi u okviru procesa upravljanja nestašicama kroz terapijsku supstituciju. Cilj istraživanja bio je procena modaliteta i ograničenja u upravljanju zdravstvenim rizicima, kao i identifikacija, rangiranje i analiza zdravstvenih rizika vezanih za antimikrobnu supstituciju u skladu sa njihovom ozbiljnošću i verovatnoćom. Istraživanje je sprovedeno kroz upitnik i detaljni intervju zdravstvenih radnika, a potom i kroz zdravstvenu analizu vrste i ishoda greške u 6 evropskih univerzitetskih bolnica u Austriji, Belgiji, Grčkoj, Hrvatskoj, Srbiji i Španiji. Više od 60% bolničkih farmaceuta vidi procenu zdravstvenih rizika kao strategiju za upravljanje nestašicama, od kojih je 26,4% upoznato sa analizom vrste ishoda i greške, 23,5% sa analizom ključnih uzroka, a po 14,7% sa zdravstvenom analizom vrste ishoda i greške i analizom opasnosti i kritičnih kontrolnih tačaka. Prema 29,4% bolničkih farmaceuta procena zdravstvenih rizika je deo protokola za upravljanje nestašicama, 14,7% je upoznato sa nacionalnom legislativom koja definiše njenu primenu, dok njih 35,5% sprovodi u okviru multidisciplinarnih timova, a njih 88,2% ne razmenjuje ishode procene sa nacionalnim regulatornim telima. Ključne barijere u primeni procene zdravstvenih rizika su neadekvatno znanje i veštine potrebne za sprovođenje procene, neadekvatna informaciono-tehnološka infrastruktura u bolnicama, neefikasna ekstrakcija i razmena podataka o pacijentu i leku od značaja za procenu. Zdravstvenom analizom vrste i ishoda greške u 6 evropskih bolnica identifikovano je 74 grešaka, od kojih 53 hazard skora iznad 8. Ozbiljnost grešaka se u bolnicama u Hrvatskoj, Grčkoj i Srbiji razlikovala pre i nakon sprovođenja korektivnih mera predloženih od strane istraživačkog tima (p<0,005). Verovatnoća grešaka se razlikovala između svih 6 bolnica pre i nakon primene korektivnih mera (p<0,005). Najveći broj uzroka grešaka je identifikovan u bolnici u Hrvatskoj 46 (28,2%), a najniži u bolnici u Španiji 16 (9,8%). Korektivne mere kojima se smanjuje vrednost hazard skora grešaka i do 83% su strukturirana komunikacija između svih zaintersovanih strana u sprovođenju zdravstvene zaštite tokom nestašica, uvođenje obaveznog elektronskog propisivanja lekova i veće učešće bolničkog farmaceuta u praćenju efikasnosti terapije i zaliha lekova na bolničkom odeljenju.
AB  - Medicine shortages disrupt the continuity of patient treatment and cause numerous clinical risks throughout prescribing, dispensing and administering of alternatives within therapeutic substitution occurring in the course of a shortage. Although clinical risks and associated failures emerging from managing shortages through therapeutic substitution are not thoroughly explored, the aim of this research is to determine current models and limitations in health risks assessments implementation as well as to identify, rank and analyse health risks in antimicrobial substitution according to seriousness and probability. A survey and a detailed interview were conducted among healthcare professionals, followed by healthcare failure mode and effect analysis in six European university hospitals in Austria, Belgium, Croatia, Greece, Serbia and Spain. Hospital pharmacists (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, naming Failure Mode and Effect Analysis (26.4%), Root Cause Analysis (23.5%), and both the Healthcare Failure Mode and Effect Analysis and the Hazard Analysis and Critical Control Point (14.7%). While hospital pharmacists (29.4%) report risk assessment as integrated into mitigation strategy protocols, are aware of legislation stipulating risk assessment implementation in shortages (14.7%) and conduct risk assessment within multidisciplinary teams (35.3%), 88.2% claimed not to have reported risk assessment outputs to their respective authorities. The major obstacles facing health risk assessment are found to be not possessing sufficient knowledge and skills for their application, inadequate hospital information-technology support, as well as both the inefficient data extraction and exchange related to patients and the medicine needed for assessment. Healthcare Failure Mode and Effect Analysis conducted in 6 hospitals revealed 74 failure modes, with 53 of a hazard score higher than 8. The severity of failure modes differed before and after corrective actions in the hospitals in Croatia, Greece, and Serbia (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared prior to and following corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in the hospital in Croatia 46 (28.2%) and the lowest in the hospital in Spain 16 (9.8%). The proposed corrective actions addressing and lowering failure modes hazards scores up to 83% are structured communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement in treatment effectiveness and stock assessment at the wards.
PB  - Универзитет у Београду, Фармацеутски факултет
T2  - Универзитет у Београду
T1  - Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova
UR  - https://hdl.handle.net/21.15107/rcub_nardus_18774
ER  - 

@phdthesis{
author = "Miljković, Nenad",
year = "2021",
abstract = "Nestašice lekova narušavaju kontinuitet u primeni terapije pacijentu i uzrokuju brojne zdravstvene rizike tokom propisivanja, izdavanja i primene alternative u okviru terapijske supstitucije uzrokovane nestašicom. Rizici i greške do kojih dovode nisu dovoljno istraženi u okviru procesa upravljanja nestašicama kroz terapijsku supstituciju. Cilj istraživanja bio je procena modaliteta i ograničenja u upravljanju zdravstvenim rizicima, kao i identifikacija, rangiranje i analiza zdravstvenih rizika vezanih za antimikrobnu supstituciju u skladu sa njihovom ozbiljnošću i verovatnoćom. Istraživanje je sprovedeno kroz upitnik i detaljni intervju zdravstvenih radnika, a potom i kroz zdravstvenu analizu vrste i ishoda greške u 6 evropskih univerzitetskih bolnica u Austriji, Belgiji, Grčkoj, Hrvatskoj, Srbiji i Španiji. Više od 60% bolničkih farmaceuta vidi procenu zdravstvenih rizika kao strategiju za upravljanje nestašicama, od kojih je 26,4% upoznato sa analizom vrste ishoda i greške, 23,5% sa analizom ključnih uzroka, a po 14,7% sa zdravstvenom analizom vrste ishoda i greške i analizom opasnosti i kritičnih kontrolnih tačaka. Prema 29,4% bolničkih farmaceuta procena zdravstvenih rizika je deo protokola za upravljanje nestašicama, 14,7% je upoznato sa nacionalnom legislativom koja definiše njenu primenu, dok njih 35,5% sprovodi u okviru multidisciplinarnih timova, a njih 88,2% ne razmenjuje ishode procene sa nacionalnim regulatornim telima. Ključne barijere u primeni procene zdravstvenih rizika su neadekvatno znanje i veštine potrebne za sprovođenje procene, neadekvatna informaciono-tehnološka infrastruktura u bolnicama, neefikasna ekstrakcija i razmena podataka o pacijentu i leku od značaja za procenu. Zdravstvenom analizom vrste i ishoda greške u 6 evropskih bolnica identifikovano je 74 grešaka, od kojih 53 hazard skora iznad 8. Ozbiljnost grešaka se u bolnicama u Hrvatskoj, Grčkoj i Srbiji razlikovala pre i nakon sprovođenja korektivnih mera predloženih od strane istraživačkog tima (p<0,005). Verovatnoća grešaka se razlikovala između svih 6 bolnica pre i nakon primene korektivnih mera (p<0,005). Najveći broj uzroka grešaka je identifikovan u bolnici u Hrvatskoj 46 (28,2%), a najniži u bolnici u Španiji 16 (9,8%). Korektivne mere kojima se smanjuje vrednost hazard skora grešaka i do 83% su strukturirana komunikacija između svih zaintersovanih strana u sprovođenju zdravstvene zaštite tokom nestašica, uvođenje obaveznog elektronskog propisivanja lekova i veće učešće bolničkog farmaceuta u praćenju efikasnosti terapije i zaliha lekova na bolničkom odeljenju., Medicine shortages disrupt the continuity of patient treatment and cause numerous clinical risks throughout prescribing, dispensing and administering of alternatives within therapeutic substitution occurring in the course of a shortage. Although clinical risks and associated failures emerging from managing shortages through therapeutic substitution are not thoroughly explored, the aim of this research is to determine current models and limitations in health risks assessments implementation as well as to identify, rank and analyse health risks in antimicrobial substitution according to seriousness and probability. A survey and a detailed interview were conducted among healthcare professionals, followed by healthcare failure mode and effect analysis in six European university hospitals in Austria, Belgium, Croatia, Greece, Serbia and Spain. Hospital pharmacists (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, naming Failure Mode and Effect Analysis (26.4%), Root Cause Analysis (23.5%), and both the Healthcare Failure Mode and Effect Analysis and the Hazard Analysis and Critical Control Point (14.7%). While hospital pharmacists (29.4%) report risk assessment as integrated into mitigation strategy protocols, are aware of legislation stipulating risk assessment implementation in shortages (14.7%) and conduct risk assessment within multidisciplinary teams (35.3%), 88.2% claimed not to have reported risk assessment outputs to their respective authorities. The major obstacles facing health risk assessment are found to be not possessing sufficient knowledge and skills for their application, inadequate hospital information-technology support, as well as both the inefficient data extraction and exchange related to patients and the medicine needed for assessment. Healthcare Failure Mode and Effect Analysis conducted in 6 hospitals revealed 74 failure modes, with 53 of a hazard score higher than 8. The severity of failure modes differed before and after corrective actions in the hospitals in Croatia, Greece, and Serbia (p<0.005). Their probability differed in all study hospitals (p<0.005) when compared prior to and following corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in the hospital in Croatia 46 (28.2%) and the lowest in the hospital in Spain 16 (9.8%). The proposed corrective actions addressing and lowering failure modes hazards scores up to 83% are structured communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement in treatment effectiveness and stock assessment at the wards.",
publisher = "Универзитет у Београду, Фармацеутски факултет",
journal = "Универзитет у Београду",
title = "Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova",
url = "https://hdl.handle.net/21.15107/rcub_nardus_18774"
}

Miljković, N.. (2021). Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova. in Универзитет у Београду
Универзитет у Београду, Фармацеутски факултет..
https://hdl.handle.net/21.15107/rcub_nardus_18774

Miljković N. Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova. in Универзитет у Београду. 2021;.
https://hdl.handle.net/21.15107/rcub_nardus_18774 .

Miljković, Nenad, "Procena zdravstvenih rizika u primeni supstitucione terapije tokom nestašice lekova" in Универзитет у Београду (2021),
https://hdl.handle.net/21.15107/rcub_nardus_18774 .

TY  - JOUR
AU  - Miljković, Nenad
AU  - van Overbeeke, Eline
AU  - Godman, Brian
AU  - Kovačević, Milena
AU  - Anastasi, Alison
AU  - Bochenek, Tomasz
AU  - Huys, Isabelle
AU  - Miljković, Branislava
PY  - 2020
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3732
AB  - Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe.

Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code.

Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment.

Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.
PB  - Frontiers Media S.A.
T2  - Frontiers in Medicine
T1  - Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages
VL  - 7
EP  - 1-12
DO  - 10.3389/fmed.2020.00407
ER  - 

@article{
author = "Miljković, Nenad and van Overbeeke, Eline and Godman, Brian and Kovačević, Milena and Anastasi, Alison and Bochenek, Tomasz and Huys, Isabelle and Miljković, Branislava",
year = "2020",
abstract = "Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe.

Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code.

Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment.

Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.",
publisher = "Frontiers Media S.A.",
journal = "Frontiers in Medicine",
title = "Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages",
volume = "7",
pages = "1-12",
doi = "10.3389/fmed.2020.00407"
}

Miljković, N., van Overbeeke, E., Godman, B., Kovačević, M., Anastasi, A., Bochenek, T., Huys, I.,& Miljković, B.. (2020). Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages. in Frontiers in Medicine
Frontiers Media S.A.., 7.
https://doi.org/10.3389/fmed.2020.00407

Miljković N, van Overbeeke E, Godman B, Kovačević M, Anastasi A, Bochenek T, Huys I, Miljković B. Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages. in Frontiers in Medicine. 2020;7:null-1-12.
doi:10.3389/fmed.2020.00407 .

Miljković, Nenad, van Overbeeke, Eline, Godman, Brian, Kovačević, Milena, Anastasi, Alison, Bochenek, Tomasz, Huys, Isabelle, Miljković, Branislava, "Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages" in Frontiers in Medicine, 7 (2020),
https://doi.org/10.3389/fmed.2020.00407 . .

TY  - JOUR
AU  - Miljković, Nenad
AU  - Godman, Brian
AU  - van Overbeeke, Eline
AU  - Kovačević, Milena
AU  - Tsiakitzis, Karyofyllis
AU  - Apatsidou, Athina
AU  - Nikopoulou, Anna
AU  - Garcia Yubero, Cristina
AU  - Portillo Horcajada, Laura
AU  - Stemer, Gunar
AU  - Kuruc-Poje, Darija
AU  - De Rijdt, Thomas
AU  - Bochenek, Tomasz
AU  - Huys, Isabelle
AU  - Miljković, Branislava
PY  - 2020
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3731
AB  - Introduction: Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care.

Methods: Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics.

Results: Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR (p < 0.005). Their probability differed in all study hospitals (p < 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%.

Conclusion: There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.
PB  - Frontiers Media S.A.
T2  - Frontiers in Medicine
T1  - Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals
VL  - 7
DO  - 10.3389/fmed.2020.00157
ER  - 

@article{
author = "Miljković, Nenad and Godman, Brian and van Overbeeke, Eline and Kovačević, Milena and Tsiakitzis, Karyofyllis and Apatsidou, Athina and Nikopoulou, Anna and Garcia Yubero, Cristina and Portillo Horcajada, Laura and Stemer, Gunar and Kuruc-Poje, Darija and De Rijdt, Thomas and Bochenek, Tomasz and Huys, Isabelle and Miljković, Branislava",
year = "2020",
abstract = "Introduction: Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care.

Methods: Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics.

Results: Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR (p < 0.005). Their probability differed in all study hospitals (p < 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%.

Conclusion: There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources.",
publisher = "Frontiers Media S.A.",
journal = "Frontiers in Medicine",
title = "Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals",
volume = "7",
doi = "10.3389/fmed.2020.00157"
}

Miljković, N., Godman, B., van Overbeeke, E., Kovačević, M., Tsiakitzis, K., Apatsidou, A., Nikopoulou, A., Garcia Yubero, C., Portillo Horcajada, L., Stemer, G., Kuruc-Poje, D., De Rijdt, T., Bochenek, T., Huys, I.,& Miljković, B.. (2020). Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals. in Frontiers in Medicine
Frontiers Media S.A.., 7.
https://doi.org/10.3389/fmed.2020.00157

Miljković N, Godman B, van Overbeeke E, Kovačević M, Tsiakitzis K, Apatsidou A, Nikopoulou A, Garcia Yubero C, Portillo Horcajada L, Stemer G, Kuruc-Poje D, De Rijdt T, Bochenek T, Huys I, Miljković B. Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals. in Frontiers in Medicine. 2020;7.
doi:10.3389/fmed.2020.00157 .

Miljković, Nenad, Godman, Brian, van Overbeeke, Eline, Kovačević, Milena, Tsiakitzis, Karyofyllis, Apatsidou, Athina, Nikopoulou, Anna, Garcia Yubero, Cristina, Portillo Horcajada, Laura, Stemer, Gunar, Kuruc-Poje, Darija, De Rijdt, Thomas, Bochenek, Tomasz, Huys, Isabelle, Miljković, Branislava, "Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals" in Frontiers in Medicine, 7 (2020),
https://doi.org/10.3389/fmed.2020.00157 . .

TY  - 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 . .