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

      research-article
      1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 3 , 17 , 18 , 19 , 20 , 10 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 20 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 10 , 40 , 41 , 42 , 43 , 44 , 7 , 45 , 46
      Frontiers in Pharmacology
      Frontiers Media S.A.
      drug shortage, pharmaceutical policy, health care system, legislation, organizational framework, Europe, European Union, Western Asia

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          Abstract

          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.

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          Most cited references35

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          Insights into European Drug Shortages: A Survey of Hospital Pharmacists

          Drug shortages are a complex and global phenomenon. When a drug cannot be delivered at the moment of patient demand, every stakeholder in the health care system is affected. The aim of this study was to investigate the characteristics, clinical impact, financial impact and management of drug shortages in European hospital pharmacies and identify opportunities for prevention and mitigation of drug shortages in Europe. An online survey was designed based on a review of the literature and interviews and was sent to subscribers of Hospital Pharmacy Europe between June and September 2013. Forty-five percent of respondents (n = 161) indicated that life sustaining or life preserving drugs such as oncology drugs were affected by drug shortages. More than 30% of respondents indicated that drug shortages in Europe were always or often associated with increased costs for hospitals, increased personnel costs and more expensive alternative drugs (n = 161). On the question when information about a drug shortage was obtained, 42% of respondents answered that information from the pharmaceutical company was obtained at the time of no delivery, 50% indicated that information from the wholesaler was obtained at the time of no delivery, while 40% of respondents indicated that information was never or rarely received from the government (n = 161). Fifty seven percent of respondents strongly agreed that an obligation to the producer to notify further shortages could help to solve the problem (n = 161). These results showed that pharmaceutical companies and wholesalers are already involved in the management of drug shortages, while a role is still reserved for the government. Mandatory notification in advance and centralized information can help to reduce workload for hospital pharmacists, will allow early anticipation of drug shortages and will facilitate mitigation of the clinical impact on patients.
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            Effects on Patient Care Caused by Drug Shortages: A Survey

            BACKGROUND: Drug shortages pose a serious challenge for health care institutions, often interfering with patient care. A common practice during a drug shortage is to select an alternate therapeutic; however, these agents often present challenges and may create safety concerns. Patient harms including adverse events and medication errors may occur. Patients may also file complaints because of drug shortages. OBJECTIVES: To measure the effect of drug shortages on patient outcomes, clinical pharmacy operations, patient complaints, and institutional cost. METHODS: An e-mail link to an online survey was sent to pharmacy director members in the MedAssets Pharmacy Group Purchasing Organization. Data were collected within a 3-week period from October 2-23, 2012. The survey focused on 6 different domains: demographics, adverse events, medication errors, patient outcomes, patient complaints, and institutional cost. RESULTS: The survey was sent to 1,516 directors of pharmacy. There were 193 respondents (response rate 13%) who participated in the survey. Approximately 40% of respondents reported between 1 and 5 adverse events probably or possibly associated with drug shortages at their institution. The majority of respondents reported between 1 and 10 medication errors. The most common types of medication errors reported were omission (n = 86, 55.5%), wrong dose dispensed/administered (n=85, 54.8%), and wrong drug dispensed/administered (n=54, 34.8%). The most common outcomes reported by respondents were alternative medication used (n=146, 85.3%), delay of therapy (n=121, 70.8%), and increased patient monitoring necessary (n=84, 49.1%). Patient complaints were reported by 38% of respondents. The majority of respondents reported an estimated quarterly institutional cost from shortages of less than $100,000, and approximately one quarter of respondents reported adding at least 1 full-time equivalent to manage drug shortages. The majority of participant comments mentioned the increasing institutional costs attributed to drug shortages. CONCLUSIONS: Medication errors and adverse events continue to occur from drug shortages, often resulting in inadequate patient care, high institutional costs, and patient complaints. Delayed care and cancelled care have been reported from shortages. Further research is necessary to better classify medication errors and adverse events during a drug shortage.
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              Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs

              Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. Objective: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. Methodology: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. Results: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
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                Author and article information

                Contributors
                Journal
                Front Pharmacol
                Front Pharmacol
                Front. Pharmacol.
                Frontiers in Pharmacology
                Frontiers Media S.A.
                1663-9812
                18 January 2018
                2017
                : 8
                : 942
                Affiliations
                [1] 1Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College , Krakow, Poland
                [2] 2Analytical Expertise Centre, Ministry of Health , Baku, Azerbaijan
                [3] 3Turkish Medicines and Medical Devices Agency , Ankara, Turkey
                [4] 4Department of Surgery, Department of Medical Ethics, Medical Faculty of the University of Montenegro , Podgorica, Montenegro
                [5] 5RG Chair in Law and the Human Genome, University of the Basque Country , Leioa, Spain
                [6] 6Montenegrin Agency for Drugs and Medical Devices, Sector for Drugs and Medical Devices , Podgorica, Montenegro
                [7] 7Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde , Glasgow, United Kingdom
                [8] 8Mechanism of Coordinated Access to Orphan Medicinal Products , Brussels, Belgium
                [9] 9Clalit Health Services Headquarters , Tel-Aviv, Israel
                [10] 10Department of Pharmaceutical and Pharmacological Sciences, KU Leuven , Leuven, Belgium
                [11] 11Department of Pharmacology and Clinical Pharmacology, Medical Faculty of the University of Montenegro , Podgorica, Montenegro
                [12] 12Department of Medicines, Health Insurance Institute , Ljubljana, Slovenia
                [13] 137th Respiratory Medicine Department, Athens Chest Hospital Sotiria , Athens, Greece
                [14] 14State Agency of Medicines , Riga, Latvia
                [15] 15Department of Pathology, Forensic Medicine and Pharmacology, Vilnius University , Vilnius, Lithuania
                [16] 16State Medicine Control Agency , Vilnius, Lithuania
                [17] 17University Pharmacy Department of Pharmacy Administration, Semmelweis University , Budapest, Hungary
                [18] 18School of Mechanical and Materials Engineering, University College Dublin , Dublin, Ireland
                [19] 19Norwegian Medicines Agency , Oslo, Norway
                [20] 20Department of Pharmacy, University of Medicine , Tirana, Albania
                [21] 21Syreon Research Institute , Budapest, Hungary
                [22] 22Department of Health Policy and Health Economics, Institute of Economics, Eötvös Loránd University , Budapest, Hungary
                [23] 23Department of Drug Management, Faculty of Pharmacy, UBT (Kosovo) , Prishtina, Albania
                [24] 24Health Department, Bern University of Applied Sciences , Bern, Switzerland
                [25] 25University Hospital of Psychiatry Zurich (PUK) , Zurich, Switzerland
                [26] 26Local Health Unit of Verona—Veneto Region , Verona, Italy
                [27] 27State Agency of Medicines , Tartu, Estonia
                [28] 28CNAMTS, Statutory Health Insurance for Salaried Workers , Paris, France
                [29] 29Panhellenic Association of Hospital Pharmacists , Athens, Greece
                [30] 30National Organization for Medicines , Athens, Greece
                [31] 31Estonian State Agency of Medicines , Tartu, Estonia
                [32] 32Ministry of Health and Social Welfare , Banja Luka, Republic of Srpska, Bosnia and Herzegovina
                [33] 33Faculty of Medicine, Department of Social Pharmacy, University of Banja Luka (Republic of Srpska) , Banja Luka, Bosnia and Herzegovina
                [34] 34Institute of Orthopaedic Surgery Banjica , Belgrade, Serbia
                [35] 35Escola Superior de Tecnologia e Gestão, Instituto Politécnico de Portalegre , Portalegre, Portugal
                [36] 36Centro de Recursos Naturais e Ambiente, Instituto Superior Técnico, Universidade de Lisboa , Lisboa, Portugal
                [37] 37Agency for Medicinal Products and Medicinal Devices , Ljubljana, Slovenia
                [38] 38Clinical Centre of Serbia , Belgrade, Serbia
                [39] 39Graduate School of Business Administration, Bar-Ilan University , Ramat-Gan, Israel
                [40] 40State Institute for Drug Control , Prague, Czechia
                [41] 41Croatian Health Insurance Fund , Zagreb, Croatia
                [42] 42Department of Organisation and Management in Pharmacy, Pharmaceutical Faculty, Comenius University , Bratislava, Slovakia
                [43] 43Chania General Hospital , Crete, Greece
                [44] 44Dentons Europe Dąbrowski i Wspólnicy sp. k. , Warszawa, Poland
                [45] 45Division of Clinical Pharmacology, Karolinska University Hospital, Karolinska Institutet , Stockholm, Sweden
                [46] 46Health Economics Centre, Liverpool University Management School , Liverpool, United Kingdom
                Author notes

                Edited by: Dominique J. Dubois, Université libre de Bruxelles, Belgium

                Reviewed by: David Pruce, ICON, United Kingdom; Domenico Criscuolo, Genovax S.r.l., Italy

                *Correspondence: Tomasz Bochenek mxbochen@ 123456cyf-kr.edu.pl

                This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology

                Article
                10.3389/fphar.2017.00942
                5779072
                29403372
                bf57c067-4528-4795-8913-07e72388de30
                Copyright © 2018 Bochenek, Abilova, Alkan, Asanin, de Miguel Beriain, Besovic, Vella Bonanno, Bucsics, Davidescu, De Weerdt, Duborija-Kovacevic, Fürst, Gaga, Gailīte, Gulbinovič, Gürpınar, Hankó, Hargaden, Hotvedt, Hoxha, Huys, Inotai, Jakupi, Jenzer, Joppi, Laius, Lenormand, Makridaki, Malaj, Margus, Marković-Peković, Miljković, de Miranda, Primožič, Rajinac, Schwartz, Šebesta, Simoens, Slaby, Sović-Brkičić, Tesar, Tzimis, Warmińska and Godman.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 23 October 2017
                : 11 December 2017
                Page count
                Figures: 0, Tables: 6, Equations: 0, References: 60, Pages: 24, Words: 18637
                Funding
                Funded by: Uniwersytet Jagielloński Collegium Medicum 10.13039/100009045
                Award ID: K/ZDS/006990
                Funded by: COST Action is the name
                Award ID: CA 15105
                Categories
                Pharmacology
                Original Research

                Pharmacology & Pharmaceutical medicine
                drug shortage,pharmaceutical policy,health care system,legislation,organizational framework,europe,european union,western asia

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