Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

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

T. Bochenek, V. Abilova, A. Alkan, B. Asanin, I. de Miguel Beriain, Z. Besovic, P. Vella Bonanno, A. Bucsics, M. Davidescu, E. De Weerdt, N. Duborija-Kovacevic, J. Fürst, M. Gaga, E. Gailīte, J. Gulbinovič, EU. Gürpınar, B. Hankó, V. Hargaden,...

. 2018 ; 8 (-) : 942. [pub] 2017

Jazyk angličtina Země Švýcarsko

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc18010028

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.

7th Respiratory Medicine Department Athens Chest Hospital Sotiria Athens Greece

Agency for Medicinal Products and Medicinal Devices Ljubljana Slovenia

Analytical Expertise Centre Ministry of Health Baku Azerbaijan

Chania General Hospital Crete Greece

Clalit Health Services Headquarters Tel Aviv Israel

Clinical Centre of Serbia Belgrade Serbia

CNAMTS Statutory Health Insurance for Salaried Workers Paris France

Croatian Health Insurance Fund Zagreb Croatia

Dentons Europe Dąbrowski i Wspólnicy sp k Warszawa Poland

Department of Drug Management Faculty of Health Sciences Jagiellonian University Medical College Krakow Poland

Department of Drug Management Faculty of Pharmacy UBT Prishtina Albania

Department of Medicines Health Insurance Institute Ljubljana Slovenia

Department of Organisation and Management in Pharmacy Pharmaceutical Faculty Comenius University Bratislava Slovakia

Department of Pathology Forensic Medicine and Pharmacology Vilnius University Vilnius Lithuania State Medicine Control Agency Vilnius Lithuania

Department of Pharmaceutical and Pharmacological Sciences KU Leuven Leuven Belgium

Department of Pharmacoepidemiology Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow United Kingdom

Department of Pharmacoepidemiology Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow United Kingdom Division of Clinical Pharmacology Karolinska University Hospital Karolinska Institutet Stockholm Sweden Health Economics Centre Liverpool University Management School Liverpool United Kingdom

Department of Pharmacology and Clinical Pharmacology Medical Faculty of the University of Montenegro Podgorica Montenegro

Department of Pharmacy University of Medicine Tirana Albania

Department of Surgery Department of Medical Ethics Medical Faculty of the University of Montenegro Podgorica Montenegro

Escola Superior de Tecnologia e Gestão Instituto Politécnico de Portalegre Portalegre Portugal Centro de Recursos Naturais e Ambiente Instituto Superior Técnico Universidade de Lisboa Lisboa Portugal

Estonian State Agency of Medicines Tartu Estonia

Graduate School of Business Administration Bar Ilan University Ramat Gan Israel

Health Department Bern University of Applied Sciences Bern Switzerland University Hospital of Psychiatry Zurich Zurich Switzerland

Institute of Orthopaedic Surgery Banjica Belgrade Serbia

Local Health Unit of Verona Veneto Region Verona Italy

Mechanism of Coordinated Access to Orphan Medicinal Products Brussels Belgium

Ministry of Health and Social Welfare Banja Luka Republic of Srpska Bosnia and Herzegovina Faculty of Medicine Department of Social Pharmacy University of Banja Luka Banja Luka Bosnia and Herzegovina

Montenegrin Agency for Drugs and Medical Devices Sector for Drugs and Medical Devices Podgorica Montenegro

Norwegian Medicines Agency Oslo Norway

Panhellenic Association of Hospital Pharmacists Athens Greece National Organization for Medicines Athens Greece

RG Chair in Law and the Human Genome University of the Basque Country Leioa Spain

School of Mechanical and Materials Engineering University College Dublin Dublin Ireland

State Agency of Medicines Riga Latvia

State Agency of Medicines Tartu Estonia

State Institute for Drug Control Prague Czechia

Syreon Research Institute Budapest Hungary Department of Health Policy and Health Economics Institute of Economics Eötvös Loránd University Budapest Hungary

Turkish Medicines and Medical Devices Agency Ankara Turkey

University Pharmacy Department of Pharmacy Administration Semmelweis University Budapest Hungary

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc18010028
003      
CZ-PrNML
005      
20210316130604.0
007      
ta
008      
180404s2018 sz f 000 0|eng||
009      
AR
024    7_
$a 10.3389/fphar.2017.00942 $2 doi
035    __
$a (PubMed)29403372
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a sz
100    1_
$a Bochenek, Tomasz $u Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland.
245    10
$a Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries / $c T. Bochenek, V. Abilova, A. Alkan, B. Asanin, I. de Miguel Beriain, Z. Besovic, P. Vella Bonanno, A. Bucsics, M. Davidescu, E. De Weerdt, N. Duborija-Kovacevic, J. Fürst, M. Gaga, E. Gailīte, J. Gulbinovič, EU. Gürpınar, B. Hankó, V. Hargaden, TA. Hotvedt, I. Hoxha, I. Huys, A. Inotai, A. Jakupi, H. Jenzer, R. Joppi, O. Laius, MC. Lenormand, D. Makridaki, A. Malaj, K. Margus, V. Marković-Peković, N. Miljković, JL. de Miranda, S. Primožič, D. Rajinac, DG. Schwartz, R. Šebesta, S. Simoens, J. Slaby, L. Sović-Brkičić, T. Tesar, L. Tzimis, E. Warmińska, B. Godman,
520    9_
$a 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.
655    _2
$a časopisecké články $7 D016428
700    1_
$a Abilova, Vafa $u Analytical Expertise Centre, Ministry of Health, Baku, Azerbaijan.
700    1_
$a Alkan, Ali $u Turkish Medicines and Medical Devices Agency, Ankara, Turkey.
700    1_
$a Asanin, Bogdan $u Department of Surgery, Department of Medical Ethics, Medical Faculty of the University of Montenegro, Podgorica, Montenegro.
700    1_
$a de Miguel Beriain, Iñigo $u RG Chair in Law and the Human Genome, University of the Basque Country, Leioa, Spain.
700    1_
$a Besovic, Zeljka $u Montenegrin Agency for Drugs and Medical Devices, Sector for Drugs and Medical Devices, Podgorica, Montenegro.
700    1_
$a Vella Bonanno, Patricia $u Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
700    1_
$a Bucsics, Anna $u Mechanism of Coordinated Access to Orphan Medicinal Products, Brussels, Belgium.
700    1_
$a Davidescu, Michal $u Clalit Health Services Headquarters, Tel-Aviv, Israel.
700    1_
$a De Weerdt, Elfi $u Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
700    1_
$a Duborija-Kovacevic, Natasa $u Department of Pharmacology and Clinical Pharmacology, Medical Faculty of the University of Montenegro, Podgorica, Montenegro.
700    1_
$a Fürst, Jurij $u Department of Medicines, Health Insurance Institute, Ljubljana, Slovenia.
700    1_
$a Gaga, Mina $u 7th Respiratory Medicine Department, Athens Chest Hospital Sotiria, Athens, Greece.
700    1_
$a Gailīte, Elma $u State Agency of Medicines, Riga, Latvia.
700    1_
$a Gulbinovič, Jolanta $u Department of Pathology, Forensic Medicine and Pharmacology, Vilnius University, Vilnius, Lithuania. State Medicine Control Agency, Vilnius, Lithuania.
700    1_
$a Gürpınar, Emre U $u Turkish Medicines and Medical Devices Agency, Ankara, Turkey.
700    1_
$a Hankó, Balázs $u University Pharmacy Department of Pharmacy Administration, Semmelweis University, Budapest, Hungary.
700    1_
$a Hargaden, Vincent $u School of Mechanical and Materials Engineering, University College Dublin, Dublin, Ireland.
700    1_
$a Hotvedt, Tor A $u Norwegian Medicines Agency, Oslo, Norway.
700    1_
$a Hoxha, Iris $u Department of Pharmacy, University of Medicine, Tirana, Albania.
700    1_
$a Huys, Isabelle $u Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
700    1_
$a Inotai, Andras $u Syreon Research Institute, Budapest, Hungary. Department of Health Policy and Health Economics, Institute of Economics, Eötvös Loránd University, Budapest, Hungary.
700    1_
$a Jakupi, Arianit $u Department of Drug Management, Faculty of Pharmacy, UBT (Kosovo), Prishtina, Albania.
700    1_
$a Jenzer, Helena $u Health Department, Bern University of Applied Sciences, Bern, Switzerland. University Hospital of Psychiatry Zurich (PUK), Zurich, Switzerland.
700    1_
$a Joppi, Roberta $u Local Health Unit of Verona-Veneto Region, Verona, Italy.
700    1_
$a Laius, Ott $u State Agency of Medicines, Tartu, Estonia.
700    1_
$a Lenormand, Marie-Camille $u CNAMTS, Statutory Health Insurance for Salaried Workers, Paris, France.
700    1_
$a Makridaki, Despina $u Panhellenic Association of Hospital Pharmacists, Athens, Greece. National Organization for Medicines, Athens, Greece.
700    1_
$a Malaj, Admir $u Department of Pharmacy, University of Medicine, Tirana, Albania.
700    1_
$a Margus, Kertu $u Estonian State Agency of Medicines, Tartu, Estonia.
700    1_
$a Marković-Peković, Vanda $u Ministry of Health and Social Welfare, Banja Luka, Republic of Srpska, Bosnia and Herzegovina. Faculty of Medicine, Department of Social Pharmacy, University of Banja Luka (Republic of Srpska), Banja Luka, Bosnia and Herzegovina.
700    1_
$a Miljković, Nenad $u Institute of Orthopaedic Surgery Banjica, Belgrade, Serbia.
700    1_
$a de Miranda, João L $u Escola Superior de Tecnologia e Gestão, Instituto Politécnico de Portalegre, Portalegre, Portugal. Centro de Recursos Naturais e Ambiente, Instituto Superior Técnico, Universidade de Lisboa, Lisboa, Portugal.
700    1_
$a Primožič, Stanislav $u Agency for Medicinal Products and Medicinal Devices, Ljubljana, Slovenia.
700    1_
$a Rajinac, Dragana $u Clinical Centre of Serbia, Belgrade, Serbia.
700    1_
$a Schwartz, David G $u Graduate School of Business Administration, Bar-Ilan University, Ramat-Gan, Israel.
700    1_
$a Šebesta, Robin $u State Institute for Drug Control, Prague, Czechia.
700    1_
$a Simoens, Steven $u Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
700    1_
$a Slaby, Juraj $u State Institute for Drug Control, Prague, Czechia.
700    1_
$a Sović-Brkičić, Ljiljana $u Croatian Health Insurance Fund, Zagreb, Croatia.
700    1_
$a Tesar, Tomas $u Department of Organisation and Management in Pharmacy, Pharmaceutical Faculty, Comenius University, Bratislava, Slovakia.
700    1_
$a Tzimis, Leonidas $u Chania General Hospital, Crete, Greece.
700    1_
$a Warmińska, Ewa $u Dentons Europe Dąbrowski i Wspólnicy sp. k., Warszawa, Poland.
700    1_
$a Godman, Brian $u Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom. Division of Clinical Pharmacology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden. Health Economics Centre, Liverpool University Management School, Liverpool, United Kingdom.
773    0_
$w MED00174597 $t Frontiers in pharmacology $x 1663-9812 $g Roč. 8, č. - (2018), s. 942
856    41
$u https://pubmed.ncbi.nlm.nih.gov/29403372 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20180404 $b ABA008
991    __
$a 20210316130600 $b ABA008
999    __
$a ind $b bmc $g 1287513 $s 1006840
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2018 $b 8 $c - $d 942 $e 2017 $i 1663-9812 $m Frontiers in pharmacology $n Front Pharmacol $x MED00174597
LZP    __
$a Pubmed-20180404

Najít záznam

Citační ukazatele

Pouze přihlášení uživatelé

Možnosti archivace

Nahrávání dat ...