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 . .

TY  - JOUR
AU  - Tubić, Biljana
AU  - Dobričić, Vladimir
AU  - Poljarević, Jelena
AU  - Savić, Aleksandar
AU  - Sabo, Tibor
AU  - Marković, Bojan
PY  - 2020
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3553
AB  - Passive gastrointestinal absorption and membrane retention of twelve esters of (S,S)-ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid (EDCP) and (S,S)-1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid (PDCP), as well as of these two non-esterified acids were estimated using PAMPA test. Artificial PAMPA membrane used in this study for the simulation of gastrointestinal barrier was solution of egg lecithin in dodecane (1 % w/v). All tested compounds belong to class III (high membrane retention and low permeation), whereas EDCP, dipentyl ester of PDCP (DPE-PDCP) and diisopentyl ester of PDCP (DIPE-PDCP) belong to class I (negligible membrane retention and low permeation). Finally, quantitative structure – permeability and structure – retention relationships models were created in order to find quantitative relationships between physico-chemical properties of tested compounds and PAMPA membrane permeability/membrane retention parameters. Statistically the most reliable models were analysed and used for the design of new compounds for which favourable membrane permeability and retention can be expected.
PB  - Elsevier B.V.
T2  - Journal of Pharmaceutical and Biomedical Analysis
T1  - Estimation of passive gastrointestinal absorption and membrane retention using PAMPA test, quantitative structure-permeability and quantitative structure-retention relationship analyses of ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid and 1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid derivatives
VL  - 184
DO  - 10.1016/j.jpba.2020.113213
ER  - 

@article{
author = "Tubić, Biljana and Dobričić, Vladimir and Poljarević, Jelena and Savić, Aleksandar and Sabo, Tibor and Marković, Bojan",
year = "2020",
abstract = "Passive gastrointestinal absorption and membrane retention of twelve esters of (S,S)-ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid (EDCP) and (S,S)-1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid (PDCP), as well as of these two non-esterified acids were estimated using PAMPA test. Artificial PAMPA membrane used in this study for the simulation of gastrointestinal barrier was solution of egg lecithin in dodecane (1 % w/v). All tested compounds belong to class III (high membrane retention and low permeation), whereas EDCP, dipentyl ester of PDCP (DPE-PDCP) and diisopentyl ester of PDCP (DIPE-PDCP) belong to class I (negligible membrane retention and low permeation). Finally, quantitative structure – permeability and structure – retention relationships models were created in order to find quantitative relationships between physico-chemical properties of tested compounds and PAMPA membrane permeability/membrane retention parameters. Statistically the most reliable models were analysed and used for the design of new compounds for which favourable membrane permeability and retention can be expected.",
publisher = "Elsevier B.V.",
journal = "Journal of Pharmaceutical and Biomedical Analysis",
title = "Estimation of passive gastrointestinal absorption and membrane retention using PAMPA test, quantitative structure-permeability and quantitative structure-retention relationship analyses of ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid and 1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid derivatives",
volume = "184",
doi = "10.1016/j.jpba.2020.113213"
}

Tubić, B., Dobričić, V., Poljarević, J., Savić, A., Sabo, T.,& Marković, B.. (2020). Estimation of passive gastrointestinal absorption and membrane retention using PAMPA test, quantitative structure-permeability and quantitative structure-retention relationship analyses of ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid and 1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid derivatives. in Journal of Pharmaceutical and Biomedical Analysis
Elsevier B.V.., 184.
https://doi.org/10.1016/j.jpba.2020.113213

Tubić B, Dobričić V, Poljarević J, Savić A, Sabo T, Marković B. Estimation of passive gastrointestinal absorption and membrane retention using PAMPA test, quantitative structure-permeability and quantitative structure-retention relationship analyses of ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid and 1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid derivatives. in Journal of Pharmaceutical and Biomedical Analysis. 2020;184.
doi:10.1016/j.jpba.2020.113213 .

Tubić, Biljana, Dobričić, Vladimir, Poljarević, Jelena, Savić, Aleksandar, Sabo, Tibor, Marković, Bojan, "Estimation of passive gastrointestinal absorption and membrane retention using PAMPA test, quantitative structure-permeability and quantitative structure-retention relationship analyses of ethylenediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid and 1,3-propanediamine-N,N'-di-2-(3-cyclohexyl)propanoic acid derivatives" in Journal of Pharmaceutical and Biomedical Analysis, 184 (2020),
https://doi.org/10.1016/j.jpba.2020.113213 . .