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Drug safety
09, 2017;40 (9): 809-821.

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, Maryse Lapeyre-Mestre, Paul N Newton, Anne Roussin
Author Information
  1. Céline Caillet: Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France. celine.caillet@iddo.org. ORCID
  2. Chanvilay Sichanh: Infectious Diseases Data Observatory-WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Churchill Hospital, CCVTM, University of Oxford, Oxford, UK.
  3. Gaëtan Assemat: Groupe de RMN Biomédicale, Laboratoire SPCMIB, UMR CNRS 5068-Université Toulouse III, Toulouse, France.
  4. Myriam Malet-Martino: Groupe de RMN Biomédicale, Laboratoire SPCMIB, UMR CNRS 5068-Université Toulouse III, Toulouse, France.
  5. Agnès Sommet: Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
  6. Haleh Bagheri: Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
  7. Noudy Sengxeu: Faculty of Pharmacy, University of Health Sciences, Vientiane, Lao People's Democratic Republic.
  8. Niphonh Mongkhonmath: Faculty of Pharmacy, University of Health Sciences, Vientiane, Lao People's Democratic Republic.
  9. Mayfong Mayxay: Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People's Democratic Republic.
  10. Lamphone Syhakhang: Food and Drug Department, Ministry of Health, Vientiane, Lao People's Democratic Republic.
  11. Maryse Lapeyre-Mestre: Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
  12. Paul N Newton: Infectious Diseases Data Observatory-WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Churchill Hospital, CCVTM, University of Oxford, Oxford, UK.
  13. Anne Roussin: Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
PMID: 28528487 DOI: 10.1007/s40264-017-0544-z

Abstract

INTRODUCTION: The 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).
METHODS: All 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.
RESULTS: The 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.
CONCLUSION: According 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.

Keywords

Active Pharmaceutical Ingredient Adverse Drug Reaction Community Pharmacy Solid Oral Dosage Form

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Grants

  1. /Wellcome Trust
  2. AAP-2012-082/French National Agency for the safety of medicines and Health Products

MeSH Term

Cross-Sectional Studies
Developing Countries
Drug Labeling
Drug-Related Side Effects and Adverse Reactions
Female
Hospitalization
Hospitals, Teaching
Humans
Laos
Logistic Models
Male
Mass Spectrometry
Middle Aged
Multivariate Analysis
Prospective Studies
Proton Magnetic Resonance Spectroscopy
Surveys and Questionnaires
Journal Article Research Support, Non-U.S. Gov't

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