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. 2019 Dec 2;14(12):e0225429.
doi: 10.1371/journal.pone.0225429. eCollection 2019.

Withdrawn medicines included in the essential medicines lists of 136 countries

Onella Charles  1 , Igho Onakpoya  2 , Simran Benipal  1 , Hannah Woods  1 , Anjli Bali  1 , Jeffrey K Aronson  2 , Carl Heneghan  2 , Nav Persaud  1   3
Affiliations

Withdrawn medicines included in the essential medicines lists of 136 countries

Onella Charles et al. PLoS One. .

Abstract

Background: Essential medicines lists and related policies are intended to meet the priority health needs of populations and their implementation is associated with more appropriate use of medicines. The World Health Organization (WHO) recommends that countries carefully select the medicines to be included in their national essential medicines lists. Lists that are used to prioritize access to important treatments should not include medicines that have been withdrawn elsewhere because of an unfavourable benefit-to-harm balance; however, countries still list and use medicines that have been withdrawn worldwide. The objective of this study was to determine whether the national essential medicines lists of 137 countries include medicines that have been withdrawn in other countries.

Methods and findings: We performed an audit of national essential medicines lists for medicines that had been withdrawn. Medicines withdrawn from worldwide markets between 1953 and 2014 were identified using a systematic review of published literature and regulatory documents. The reviewers used sources including the WHO's database of drugs, PubMed, and the websites of regulatory agencies to obtain information regarding adverse effects associated with the medicines, the year of first withdrawal, markets of withdrawal, and the level of evidence supporting each withdrawal. We recorded the number of countries with a withdrawn medicine included in their national medicines list, the number of withdrawn medicines included in each nation's list, and the number of national essential medicines including each withdrawn medicine. 97 medicines were withdrawn in at least one country but still included in one more national essential medicines list. Of 137 countries with a national essential medicines list, 136 lists included at least one withdrawn medicine, with 54% of the lists containing 5 or fewer withdrawn medicines, and 27% including 10 or more withdrawn medicines. 11 medicines were withdrawn worldwide but still included on at least one national essential medicines list. Countries with longer essential medicines lists had more withdrawn medicines included in their lists.

Conclusions: This study found that withdrawn medicines are included in all but one national essential medicines list, representing a need for more stringent processes for selecting and removing medicines on these lists. Countries may wish to apply special scrutiny to medicines withdrawn in other nations when selecting medicines to include on their lists.

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Conflict of interest statement

NP reports grants from Canadian Institutes for Health Research, the Ontario SPOR Support Unit, and Physicians Services Incorporated during the conduct of the study. IO is a part of the Evidence Synthesis Working Group which is funded by the National Institute of Health Research School for Primary Care Research (NIHR SPCR) [Project Number 390]. JKA has written reviews, commentaries, and medicolegal reports on various aspects of prescribing, and has sometimes received remuneration. CH has received expenses and fees for his media work. CH has received expenses from the WHO and holds grant funding from the NIHR, the NIHR School of Primary Care Research, The Wellcome Trust and is a NIHR Senior Investigator. CH has received financial remuneration from an asbestos case. CH has also received income from the publication of a series of toolkit books published by Blackwell’s. On occasion, CH receives expenses for teaching EBM and is also paid for his GP work in NHS out of hours. This does not alter our adherence to PLOS ONE policies on sharing data and materials. All other authors declare no competing interests.

Figures

Fig 1
Fig 1. Diagram illustrating inclusion of withdrawn medicines identified on an essential medicines list.
The figure shows the process of determining the total number of withdrawn medicines included in this study.
Fig 2
Fig 2. Number of withdrawn medicines included in the national essential medicines lists of 137 countries.
The countries that are shaded grey do not have a publically available essential medicines list. Countries are shaded on a color scale where lighter list fewer withdrawn medicines on their essential medicines lists and darker list more.
Fig 3
Fig 3. Number of essential medicines lists including withdrawn medicines.
The left side of the Figure shows the number of withdrawn medicines included in a small number of national essential medicines lists (e.g. 22 withdrawn medicines are listed by only one national essential medicines list). The right side of the Figure shows withdrawn medicines listed by many countries (e.g. 1 withdrawn medicine is listed by 121 countries).
Fig 4
Fig 4. Number of withdrawn medicines included on national essential medicines lists according to the number of medicines on each essential medicines lists, country sub-region, and national GDP.
The area of the circle represents national GDP (larger circle, larger national GDP), and the color of the circle represents sub-region.
See this image and copyright information in PMC

References

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