Evidence map›Paper›PMID 36754622›Full record

ArticleEuropean journal of hospital pharmacy : science and practice2024

Public information on shortages in the EU/EEA: improvements made between 2018 and 2020.

Inga Abed, Juan Garcia Burgos, Yngvil Knudsen

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Article in European journal of hospital pharmacy : science and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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2citing papers in PubMed
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3 · Its place in the literature

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2 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Inga AbedPublic and Stakeholders Engagement Department, European Medicines Agency, Amsterdam, The Netherlands Inga.Abed@ema.europa.eu.ORCID http://orcid.org/0000-0003-0520-9076
Juan Garcia BurgosPublic and Stakeholders Engagement Department, European Medicines Agency, Amsterdam, The Netherlands.
Yngvil KnudsenUnit for Communication, Norwegian Medicines Agency, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn July 2019, the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) Task Force on Availability of Authorised Medicines for Human and Veterinary Use (TFAAM) published good practice guidance which provides key principles for European Union (EU) regulatory authorities for communication on shortages and availability issues. The use of a shortage catalogue was a key recommendation.

objectivesTo assess how EU/European Economic Area (EEA) national competent authorities have implemented the recommendations of the good practice guidance.

methodsA survey was run in 2020 among EU/EEA national competent authorities to assess communication practices. The results were compared with those of a similar survey carried out 2 years earlier, before publication of the guidance. The survey covered human medicines only and was sent to 31 authorities: one per EU/EEA member state (and two to Germany's two medicines regulatory authorities).

resultsIn 2020, 81% of authorities (25/31) had a dedicated public shortage catalogue on their website. This was an increase from 74% (23/31) in 2018, when a similar survey was run. In future this is expected to increase to 87% with two more member states making plans to implement catalogues. Although many member states publish information on shortages there is still selection in terms of the details that are being published, and there is further scope to extend the information currently provided.

conclusionSince publication of the EMA/HMA good practice guide in 2019, transparency has increased across the EU/EEA, and public catalogues of shortages are now a routine tool used by many medicines agencies.Further opportunities to improve transparency on supply issues lie ahead with the EMA network strategy to 2025, the revised EU pharmaceutical legislation and the new legal mandate reinforcing the role of the EMA.

Indexed as

European UnionHumansPharmaceutical PreparationsSurveys and QuestionnairesPharmaceutical PreparationsCLINICAL MEDICINEDrug SubstitutionEDUCATION, PHARMACYMedical InformaticsPUBLIC HEALTH

Identifiers

PMID36754622
PMCPMC11228212

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