Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.
- Miljković N Institute of Orthopaedic Surgery "Banjica", University of Belgrade, Belgrade, Serbia.
- Godman B Division of Clinical Pharmacology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
- Kovačević M Department of Pharmacokinetics and Clinical Pharmacy, University of Belgrade, Belgrade, Serbia.
- Polidori P Department of Clinical Pharmacy, IRCCS, ISMETT, Palermo, Italy.
- Tzimis L Hospital Pharmacy Department, Chania General Hospital, Crete, Greece.
- Hoppe-Tichy T Pharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.
- Saar M Pharmacy Department, Tartu University Hospital, Tartu, Estonia.
- Antofie I Hospital Pharmacy Department, Spitalul Clinic C. F. Cluj-Napoca, Cluj-Napoca, Romania.
- Horvath L Department of Pharmaceutical Surveillance and Economics, University of Debrecen, Debrecen, Hungary.
- De Rijdt T Pharmacy Department, University Hospitals Leuven, UZ Herestraat, Leuven, Belgium.
- Vida RG Department of Pharmaceutics and Central Clinical Pharmacy, Faculty of Pharmacy, University of Pécs, Pécs, Hungary.
- Kkolou E Hospital Pharmacy Department, The Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus.
- Preece D Leeds Medicines Advisory Service, The Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, United Kingdom.
- Tubić B Sector for Medicinal Products, Agency for Medicines and Medical Devices of Bosnia and Herzegovina, Banja Luka, Bosnia and Herzegovina.
- Peppard J Hospital Pharmacy Department, Midland Regional Hospital, Tullamore, Ireland.
- Martinez A Servicio de Farmacia, Hospital Universitario Infanta Sofía, Madrid, Spain.
- Yubero CG Servicio de Farmacia, Hospital Universitario Infanta Sofía, Madrid, Spain.
- Haddad R Hospital Pharmacy Department, Hôpital Antoine Béclère, Clamart, France.
- Rajinac D Hospital Pharmacy Department, Clinical Centre of Serbia, Belgrade, Serbia.
- Zelić P International Cooperation and Public Relation Department, Medicines and Medical Device Agency of Serbia, Belgrade, Serbia.
- Jenzer H Health Division, Berner Fachhochschule Health Professions Ernährung und Diätetik, Bern, Switzerland.
- Tartar F Department of Hospital Pharmacy, General Hospital Celje, Celje, Slovenia.
- Gitler G Hospital Pharmacy Department, Apotheke der Barmherzigen Brüdere. U., Linz, Austria.
- Jeske M Pharmacy Department, University Clinic-State Hospital of Innsbruck, Innsbruck, Austria.
- Davidescu M Faculty of Social Sciences, The Graduate School of Business Administration, Tel Aviv, Israel.
- Beraud G Médecine Interne et Maladies Infectieuses, CHU de Poitiers, Poitiers, France.
- Kuruc-Poje D Hospital Pharmacy Department, General hospital "dr. Tomislav Bardek", Koprivnica, Croatia.
- Haag KS Nomeco-Hospital&Customer Service, Nomeco Commercial Affairs, Copenhagen, Denmark.
- Fischer H Strategic Procurement and Supply of Pharmaceuticals, Amgros I/S, Copenhagen, Denmark.
- Sviestina I Hospital Pharmacy Department, Children's Clinical University Hospital, Riga, Latvia.
- Ljubojević G Department of Physical Medicine and Rehabilitation "Dr Miroslav Zotović", Banja Luka, Bosnia and Herzegovina.
- Markestad A National Center for Medicine Shortages in Hospitals, Oslo universitetssykehus HF, Nydalen, Norway.
- Vujić-Aleksić V Certification Department, The Republic of Srpska Agency for Certification, Accreditation and Quality Improvement in Health Care, Banja Luka, Bosnia and Herzegovina.
- Nežić L Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
- Crkvenčić A Community Pharmacy Department, Pharmacy "Biljana", Banja Luka, Bosnia and Herzegovina.
- Linnolahti J Division DEFO, Finnish Medicines Agency, Helsinki, Finland.
- Ašanin B Department of Surgery, Department of Medical Ethics, Medical Faculty of the University of Montenegro, Podgorica, Montenegro.
- Duborija-Kovačević N Department of Pharmacology and Clinical Pharmacology, Medical Faculty of the University of Montenegro, Podgorica, Montenegro.
- Bochenek T Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
- Huys I Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
- Miljković B Department of Pharmacokinetics and Clinical Pharmacy, University of Belgrade, Belgrade, Serbia.
- 2020-04-11
Published in:
- Frontiers in pharmacology. - 2020
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.3389/fphar.2020.00357
- PMID 32273845
- Persistent URL
- https://sonar.ch/global/documents/13525
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