Evidence map›Paper›PMID 32139487›Full record

Observational studyBMJ open2020

The French reporting system for drug shortages: description and trends from 2012 to 2018: an observational retrospective study.

Amine Benhabib, Saïd Ioughlissen, Christelle Ratignier-Carbonneil, Patrick Maison

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
7.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 43 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Medicine shortages in France: a 6-year retrospective study in a university medical centre.European journal of hospital pharmacy : science and practice · 2023
    Article
  9. Drug shortages in China: a cross-sectional study.BMC health services research · 2023
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Amine BenhabibFrench Health Products Safety Agency, Saint-Denis, Île-de-France, France.ORCID 0000-0003-1109-3102
Saïd IoughlissenFrench Health Products Safety Agency, Saint-Denis, Île-de-France, France.
Christelle Ratignier-CarbonneilFrench Health Products Safety Agency, Saint-Denis, Île-de-France, France.
Patrick MaisonFrench Health Products Safety Agency, Saint-Denis, Île-de-France, France patrick.maison@ansm.sante.fr.
Agence Nationale de Sécurité Sanitaire de l’Alimentation, de l’Environnement et du Travail · FRUniversité Paris-Est Créteil · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim was to provide figures for drug shortages in France and describe their characteristics, causes and trends between 2012 and 2018.

methodsData from the national reporting system from the Agency of Medicine and Health Product Safety (ANSM) was analysed. This database contains information regarding effective and predicted shortages of major therapeutic of interest drugs (ie, drugs whose shortage would be life-threatening or representing a loss of treatment opportunity for patients with a severe disease) which are mandatory reported by marketing authorisation holders to the ANSM. Data are presented as numbers or percentages of pharmaceutical products (ie, the product name and its formulation) reported on shortage between 2012 and 2018.

resultsThere were 3530 pharmaceutical products reported on shortage during the period, including 1833 different active substances. Drugs on shortage were mostly old products (63.4%) with national marketing authorisation procedures (62.8%), as well as injectable and oral forms (47.5% and 43.3%, respectively). Anti-infectives for systemic use ranked first (18%), followed by nervous and cardiovascular system drugs and by antineoplastic and immunomodulating agents (17.4%, 12.5% and 10.4%, respectively). The number of reported shortages presented a fourfold increase between 2012 and 2018 and a sharp rise in 2017 and 2018, along with a rise in the number of active substances on shortage. The therapeutic classes concerned remained similar over time. Manufacturing and material supply issues were the main reported reasons for the shortage each year (30%) and there was an overall rise of pharmaceutical market reasons.

conclusionDrug shortages were increasingly reported in France. Preventive measures should specifically target the products most on shortage, in particular old drugs, injectable, anti-infective, nervous system and cardiovascular system drugs as well as antineoplastic and immunomodulating agents.

Indexed as

Databases, FactualDrugs, GenericFranceHumansPrescription DrugsRetrospective StudiesDrugs, GenericPrescription Drugsdrug shortagesFrancemajor therapeutic interestnational reporting systempharmacosurveillanceshort supplysupply of medicines

Identifiers

PMID32139487
PMCPMC7059530
OpenAlexW3010153665

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.