TY - JOUR
T1 - Systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages in 28 European and Western Asian countries
AU - Bochenek , Tomasz
AU - Abilova, Vafa
AU - Asanin, Bogdan
AU - Alkan, Ali
AU - de Miguel Beriain, Iñigo
AU - Besovic, Zeljka
AU - Vella Bonanno, Patricia
AU - Bucsics, Anna
AU - Davidescu, Michal
AU - De Weerdt, Elfi
AU - Duborija-Kovacevic, Natasa
AU - Fürst, Jurij
AU - Gaga, Mina
AU - Gailīte, Elma
AU - Gulbinovič , Jolanta
AU - Gürpınar, Emre Umut
AU - Hankó, Balázs
AU - Hargaden, Vincent
AU - Hotvedt, Tor Arne
AU - Hoxha, Iris
AU - Huys, Isabelle
AU - Inotai, Andras
AU - Jakupi, Arianit
AU - Jenzer, Helena
AU - Joppi, Roberta
AU - Laius, Ott
AU - Lenormand, Marie-Camille
AU - Makridaki, Despina
AU - Malaj, Admir
AU - Margus, Kertu
AU - Marković-Peković, Vanda
AU - Miljković, Nina
AU - de Miranda, João Luís
AU - Primožič, Stanislav
AU - Rajinac, Dragana
AU - Schwartz, David
AU - Šebesta, Robin
AU - Simoens, Steven
AU - Slabý, Juraj
AU - Sović Brkičić , Ljiljana
AU - Tesar, Tomas
AU - Tzimis, Leonidas
AU - Warmińska, Ewa
AU - Godman, Brian
PY - 2018/1/18
Y1 - 2018/1/18
N2 - 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.
AB - 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.
KW - drug shortages
KW - pharmaceutical policy
KW - health care systems
KW - legislation
KW - organisational framework
KW - European Union
KW - Western Asia
UR - https://www.frontiersin.org/articles/10.3389/fphar.2017.00942/full
U2 - 10.3389/fphar.2017.00942
DO - 10.3389/fphar.2017.00942
M3 - Article
SN - 1663-9812
VL - 8
JO - Frontiers in Pharmacology
JF - Frontiers in Pharmacology
M1 - 942
ER -