Cited by 112Pharmaceutical Economics and PolicyPharmaceutical Quality and CounterfeitingHealthcare Regulation

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

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Bochenek, Tomasz, Abilova, Vafa, Alkan, Ali, Asanin, Bogdan, de Miguel Beriain, Iñigo, Besovic, Zeljka, Vella Bonanno, Patricia, Bucsics, Anna +36 more·2018·Frontiers in Pharmacology

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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Crossref · 10.3389/fphar.2017.00942

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  • Medicine shortages are a complex global challenge affecting all countries, including South Africa, with shortages of even essential medicines becoming a global problem irrespective of the economic status of countries.

    “Over the years, the shortage of medicines has been a challenge to the effective delivery of quality healthcare services worldwide including South Africa [1–10], with shortages of even essential medicines becoming a global problem irrespective of the economic status of countries [11–13].”

    From Medicine shortages and challenges with the procurement process among public sector hospitals in South Africa; findings and implications (2020) · cites this paper as [6]

    The Introduction reports shortages of WHO-defined essential medicines in several European countries, and the Discussion says shortages occurred in all 28 countries studied regardless of economic development. These passages support the broad concern, but they do not establish shortages in every country or specifically in South Africa. The South Africa wording belongs to a separately cited clause in the printed sentence. (LLM, conf=0.84)

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  • Multiple factors contribute to medicine shortages, including manufacturing and quality problems, production delays, lack of manufacturing capacity, shortage of raw materials, political instability, profitability issues, long lead times, delays in awarding tenders, absence of national contracts on regional code lists, failure of suppliers to meet demand, and failure to pay suppliers.

    “Some of the contributing factors to the shortage of medicines include manufacturing and quality problems, production delays, lack of manufacturing capacity, shortage of raw materials, political instability, and profitability issues [5, 6, 8, 9, 18].”

    From Medicine shortages and challenges with the procurement process among public sector hospitals in South Africa; findings and implications (2020) · cites this paper as [6]

    The Introduction lists manufacturing problems, raw-material shortages, regulatory non-compliance, and limited manufacturing capacity as reasons for shortages; it also identifies economic problems as a group of determinants. It does not specifically identify production delays or political instability as causes, and its discussion of economic problems does not establish profitability issues specifically. The additional factors in the supplied claim are not in the printed citing sentence. (LLM, conf=0.86)

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  • The origins of medicine shortages are complicated, can differ among regions and countries, and consequently potentially require different strategies to address them.

    “The origins of medicine shortages are complicated, can differ among regions and countries, and consequently potentially require different strategies to address them [5, 6, 15].”

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21 of the 56 references couldn’t be matched to a known paper.

Research works printed but not linked: 4

  1. Desabastecimientos de Medicamentos: Un Problema Sin Resolver (2015). INFAC, Inf Farmacoter la Comarc, Vol. 23. Available online at: https://www.osakidetza.euskadi.eus/contenidos/informacion/cevime_infac/es_cevime/adjuntos/INFAC_Vol_23_N_7_Desabastecimientos.pdf
  2. Kavanagh J. (2017). How Pharmaceutical Supply Chains Can Be Managed to Minimise the Number of Medicines Shortages, Unpublished Master's thesis, University College Dublin, Ireland.
  3. Pfeffer K. Mozolová B. (2018). Re-export of drugs in the Slovak Republic vol. 2 – the Act [Internet]. Available: https://www.twobirds.com/en/news/articles/2017/uk/ils/re-export-of-drugs-in-the-slovak-republic-vol-2-the-act
  4. Ventola C. L. (2011). The drug shortage crisis in the United States: causes, impact, and management strategies. P T. 36, 740– 757. 22346307 PMC3278171

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Authors
Bochenek, T., Abilova, V., Alkan, A., Asanin, B., de Miguel Beriain, I., Besovic, Z., Vella Bonanno, P., Bucsics, A., Davidescu, M., De Weerdt, E., Duborija-Kovacevic, N., Fürst, J., Gaga, M., Gailīte, E., Gulbinovič, J., Gürpınar, E. U., Hankó, B., Hargaden, V., Hotvedt, T. A., Hoxha, I., Huys, I., Inotai, A., Jakupi, A., Jenzer, H., Joppi, R., Laius, O., Lenormand, M.-C., Makridaki, D., Malaj, A., Margus, K., Marković-Peković, V., Miljković, N., de Miranda, J. L., Primožič, S., Rajinac, D., Schwartz, D. G., Šebesta, R., Simoens, S., Slaby, J., Sović-Brkičić, L., Tesar, T., Tzimis, L., Warmińska, E., & Godman, B.
Affiliations
  • Jagiellonian University (PL)
  • Ministry of Healthcare (AZ)
  • Clalit Health Services (IL)
  • Health Insurance Institute of Slovenia (SI)
  • Vilnius University (LT)
  • Semmelweis University (HU)
  • University College Dublin (IE)
  • University of Medicine Tirana (AL)
  • KU Leuven (BE)
  • University for Business and Technology (XK)
  • Bern University of Applied Sciences (CH)
  • l'Assurance Maladie (FR)
  • Institute of Orthopedics Banjica (RS)
  • Univerzitetski Klinički Centar Srbije (RS)
  • Bar-Ilan University (IL)
  • State Institute for Drug Control (CZ)
  • Chania General Hospital ”St. George” (GR)
  • University of Warsaw (PL)
  • Karolinska University Hospital (SE)
Corresponding author
Bochenek, Tomasz
Venue
Frontiers in Pharmacology
Published
2018-01-18
Volume
8
Pages
942-942
ISSN
1663-9812 (ISSN-L)
OpenAlex
W2788385076
Cited by
112
References
56
Citations by year
2026: 7 · 2025: 8 · 2024: 12 · 2023: 10 · 2022: 16 · 2021: 16 · 2020: 26 · 2019: 14 · 2018: 3
FWCI
22.42
Type
journal article
Language
en
Open access
Locations
  • Frontiers in Pharmacology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Strathprints: The University of Strathclyde institutional repository (University of Strathclyde) (acceptedVersion, cc-by)
  • Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
  • Lirias (KU Leuven) (submittedVersion, cc-by)
  • Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion)
  • Jagiellonian University Repository (Jagiellonian University) (submittedVersion, cc-by-nc-nd)
  • OAR@UM (University of Malta) (submittedVersion, other-oa)
  • ARBOR - Bern University of Applied Sciences Repository (submittedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • ELTE Digital Institutional Repository (EDIT) (Eötvös Loránd University) (submittedVersion, other-oa)
  • Semmelweis University Repository (Semmelweis University) (submittedVersion)
  • BFH: ARBOR
Funders
Uniwersytet Jagielloński Collegium Medicum (K/ZDS/006990)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
  • Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
Keywords
drug shortages, pharmaceutical policy, health care legislation, drug regulation, unlicensed medicines, public service obligations, health care system

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