Evidence map›Paper›PMID 28528487›Full record

ArticleDrug safety2017

Role of Medicines of Unknown Identity in Adverse Drug Reaction-Related Hospitalizations in Developing Countries: Evidence from a Cross-Sectional Study in a Teaching Hospital in the Lao People's Democratic Republic.

Céline Caillet, Chanvilay Sichanh, Gaëtan Assemat, Myriam Malet-Martino, Agnès Sommet, Haleh Bagheri, Noudy Sengxeu, Niphonh Mongkhonmath, Mayfong Mayxay, Lamphone Syhakhang and 3 more

Abstract read
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

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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

13 authors.

Céline CailletPharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France. celine.caillet@iddo.org.ORCID 0000-0002-5554-2603
Chanvilay SichanhInfectious Diseases Data Observatory-WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Churchill Hospital, CCVTM, University of Oxford, Oxford, UK.
Gaëtan AssematGroupe de RMN Biomédicale, Laboratoire SPCMIB, UMR CNRS 5068-Université Toulouse III, Toulouse, France.
Myriam Malet-MartinoGroupe de RMN Biomédicale, Laboratoire SPCMIB, UMR CNRS 5068-Université Toulouse III, Toulouse, France.
Agnès SommetPharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
Haleh BagheriPharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
Noudy SengxeuFaculty of Pharmacy, University of Health Sciences, Vientiane, Lao People's Democratic Republic.
Niphonh MongkhonmathFaculty of Pharmacy, University of Health Sciences, Vientiane, Lao People's Democratic Republic.
Mayfong MayxayLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
Lamphone SyhakhangFood and Drug Department, Ministry of Health, Vientiane, Lao People's Democratic Republic.
Maryse Lapeyre-MestrePharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
Paul N NewtonInfectious Diseases Data Observatory-WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Churchill Hospital, CCVTM, University of Oxford, Oxford, UK.
Anne RoussinPharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.

Funding

French National Agency for the safety of medicines and Health Products AAP-2012-082Wellcome Trust
6 · The paper itself

Abstract

introductionThe health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR).

methodsAll unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h. The patients or their relatives were interviewed to complete the study questionnaire. MUIs suspected of being involved in ADR(s) were identified through comparison of visual characteristics of tablets/capsules with that of reference medicines (photograph tool), and by proton nuclear magnetic resonance and mass spectrometry analyses. Factors associated with ADRs were identified by multivariate logistic regression.

resultsThe frequency of hospitalizations related to an ADR was 5.1% (23/453, 95% confidence interval [CI] 3.1-7.1). Forty-eight (12.8%) patients used MUI(s) in the last 2 weeks preceding hospitalization. They were more likely to be hospitalized because of an ADR (adjusted odds ratio 4.5, 95% CI 1.7-11.5) than patients using medicines of known identity. MUIs were mainly involved in bleeding gastroduodenal ulcers. The photograph tool led to the misidentifications because of look-alike pharmaceutical units in the medicines photograph collection.

conclusionAccording to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients' care in developing countries with limited capacities for drug analysis.

Indexed as

Cross-Sectional StudiesDeveloping CountriesDrug LabelingDrug-Related Side Effects and Adverse ReactionsFemaleHospitalizationHospitals, TeachingHumansLaosLogistic ModelsMaleMass SpectrometryMiddle AgedMultivariate AnalysisProspective StudiesProton Magnetic Resonance SpectroscopyActive Pharmaceutical IngredientAdverse Drug ReactionCommunity PharmacySolid Oral Dosage Form

Identifiers

PMID28528487
PMCPMC5569138

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Registered trials

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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.