Dr Celine Caillet

Research Area: Global Health
Scientific Themes: Tropical Medicine & Global Health
Keywords: Laos, Medicine quality, Counterfeit, Fake and Substandard
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Dr Céline Caillet has joined the Infectious Diseases Data Observatory as Scientific Coordinator of the Medicine Quality Scientific Group in 2015 to coordinate the scientific activities on medicine quality and was appointed Research Scientist – Medicine Quality in 2016. Céline is a pharmacist and former resident of the Hospital of Toulouse. She has experience in drug safety and has taken part in several research projects at the Center of Pharmacovigilance, Laboratory of Medical and Clinical Pharmacology of Toulouse, France. Following her MSc in Epidemiology and Public Health in Bordeaux, France, Céline completed her PhD in drug safety in Laos. During her PhD, Céline also taught pharmacology in the Department of Pharmacy at the University of Health Sciences, Vientiane.

Medicines are of vital importance in health systems, and access to quality-assured medicines is part of the basic right to health. Nevertheless, poor quality medical products, including medicines, vaccines and diagnostic devices, are widespread due to poor manufacture (substandard medicines) or deliberate falsification. These jeopardise national, regional and global attempts to improve access to effective health care because they lead to avoidable morbidity and mortality, waste financial resources, and contribute to drug resistance.

There is several ways to fight against poor-quality medicines. The medicine quality group of the Infectious Diseases Data Observatory aims at sharing expertise and collating information to increase understanding of the prevalence and distribution of poor quality medicines around the world. The group encourages discussion of poor quality medicine epidemiology, detection and prevention, and aims to facilitate improvement in the quality of medicines that patients actually take. The group also advocates for more investment in the regulation of medicine distribution and treatment adherence and interventions to improve medicine quality.

Name Department Institution Country
Facundo Fernandez Georgia Institute of Technology, Atlanta United States
Mustapha Hajjou United States Pharmaopeia United States
Victor Pribluda United States Pharmaopeia United States
John Brownstein HealthMap United States
Caillet C, Sichanh C, Assemat G, Malet-Martino M, Sommet A, Bagheri H, Sengxeu N, Mongkhonmath N, Mayxay M, Syhakhang L et al. 2017. 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. Drug Saf, 40 (9), pp. 809-821. | Show Abstract | Read more

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.

Newton PN, Caillet C, Guerin PJ. 2016. A link between poor quality antimalarials and malaria drug resistance? Expert Rev Anti Infect Ther, 14 (6), pp. 531-533. | Read more

Caillet C, Sichanh C, Syhakhang L, Delpierre C, Manithip C, Mayxay M, Lapeyre-Mestre M, Newton PN, Roussin A. 2015. Population awareness of risks related to medicinal product use in Vientiane Capital, Lao PDR: A cross-sectional study for public health improvement in low and middle income countries BMC Public Health, 15 (1), | Show Abstract | Read more

© 2015 Caillet et al. Background: While essential medicines have been made more available in all but the most remote areas in low and middle income countries (L/MICs) over the past years, inappropriate and incorrect use of good quality medicines remains a key impediment for public health. In addition, as medicines have a potential to cause harm (medicine risks), adequate awareness by medicine users of the risks of adverse reactions is essential, especially as self-medication is common in L/MICs. This study aimed to investigate the awareness of Lao residents regarding medicine risks in Vientiane Capital, Lao People's Democratic Republic. Methods: Face-to-face interviews using structured questionnaires of 144 residents older than 16 years were carried out in 12 randomly selected villages out of the 146 villages of Vientiane Capital with at least one health facility. Results: The respondents were mainly (85.0 %) the heads of households or their husband/spouse. The majority of the respondents were unaware (61.8 %) of medicine risks. Compared to residents living in the urban district of Xaysetha, living in peri-urban and even more in rural areas were identified as factors associated with being unaware of medicine risks [adjusted odds ratio (aOR) =3.3, 95 % Confidence Interval (CI) = 1.1-9.4]) and aOR =7.5 (95 % CI = 2.3-24.2), respectively] . In addition, more than half of the respondents had never heard of poor quality medicines, with a higher rate in rural/peri-urban compared to urban districts (55.6 % vs 38.9 %, respectively, p = 0.02). Finally, approximately one third of all respondents thought that traditional medicines could not cause harm. Conclusions: Overall, these results suggest a lack of awareness about medicinal product risks. Differences according to the place of residence are apparent and could be partly explained by a lower level of training of healthcare providers in contact with the population in the rural districts in particular. Communication on medicinal product risks to patients through well-trained healthcare providers could probably make a valuable contribution towards the appropriate use of medicines in L/MICs.

Caillet C, Chauvelot-Moachon L, Montastruc J-L, Bagheri H, French Association of Regional Pharmacovigilance Centers. 2012. Safety profile of enantiomers vs. racemic mixtures: it's the same? Br J Clin Pharmacol, 74 (5), pp. 886-889. | Show Abstract | Read more

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: The physicochemical properties of racemates and stereoisomers of medicines can differ significantly, and this may affect the side-effect profile in addition to the pharmacokinetics and intended pharmacology. WHAT THIS STUDY ADDS: This is a study to investigate the profile of adverse drug reactions of racemic and enantiomeric forms of drugs. Our data suggest differences in the safety profile for ofloxacin and omeprazole. This area requires more work to investigate this for other compounds. AIMS: The objective was to investigate the safety profile of four drugs marketed as racemic and enantiomeric forms in France. METHODS: Data from the French PharmacoVigilance Data Base (January 2005 to June 2010) were analysed for four pairs of racemic/isomeric drugs. A case-noncase approach was used to measure the disproportionality of combination between adverse drug reaction (ADR) and exposure to drug. RESULTS: No significant difference in the number of ADRs was observed between Rac-cetirizine/(R)-cetirizine or Rac-citalopram/(S)-citalopram pairs. (S)-Omeprazole induced more haematological effects than Rac-omeprazole. Rac-Ofloxacin induced more haematological, renal and neuropsychiatric ADRs than (S)-ofloxacin, whereas levofloxacin was associated with more reports of musculoskeletal ADRs. CONCLUSIONS: The profile of ADRs could differ for some drugs marketed as racemic and enantiomeric forms. Further studies would be necessary to confirm these data.

Durrieu G, Palmaro A, Pourcel L, Caillet C, Faucher A, Jacquet A, Ouaret S, Perault-Pochat MC, Kreft-Jais C, Castot A et al. 2012. First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals. Drug Saf, 35 (10), pp. 845-854. | Show Abstract | Read more

BACKGROUND: Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients' reports with reports from healthcare professionals (HCPs). During the 2009-10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations. For the first time, patients were offered the opportunity to report suspected ADRs to pandemic vaccines directly to regional pharmacovigilance centres. OBJECTIVE: The aim of the study was to compare the characteristics of patient and HCP ADR reports in order to assess the qualitative and quantitative contribution of patient reporting to the French Pharmacovigilance System. METHODS: All spontaneous ADRs registered into the French Pharmacovigilance Database from 21 October 2009 to 15 June 2010, in which either one of the most frequently administered pandemic vaccines (i.e. Panenza® or Pandemrix®) was involved, were analysed. ADRs were classified as 'serious', 'medically serious' and 'non-serious'. This study focused on 'serious' and 'medically serious' ADRs. An ADR was ranked as 'medically serious' when it required medical intervention or hospitalization within less than 24 hours. In each level of seriousness, frequency of 'unlabelled' ADRs, ADRs of 'special interest', imputability scores and category of ADRs according to Medical Dictionary for Regulatory Activitives (MedDRA®) primary System Organ Class were compared between patient and professional reports. RESULTS: Among the 4746 reports received during the study period, 1006 (21.2%) originated from patients. HCPs reported significantly more 'medically serious' or 'serious' ADRs than patients (15.1% [565/3740] vs 8.4% [85/1006], respectively; p < 0.001). No difference was found in 'unlabelled, serious' ADRs between patients and HCPs (56.5% [n = 13] vs 56.7% [n = 136], respectively). CONCLUSIONS: In this first French experience of formal patient participation to ADR reporting, patient contribution to the total number of ADRs reached 21.2%. This study revealed no major qualitative difference between patient and HCP reports. ADR profiles reported by patients appeared to be consistent with those from professionals. Further investigations are necessary to assess the intrinsic quality of notification forms coming from non-professional reporters. However, this study is of particular interest in the context of publication of the first governmental decree that will formally integrate patient participation to the current French ADR reporting scheme.

Durrieu G, Caillet C, Lacroix I, Jacquet A, Faucher A, Ouaret S, Sommet A, Perault-Pochat M-C, Kreft-Jaïs C, Castot A et al. 2011. [National Campaign of Vaccination against the flu A (H1N1)v: National Follow-up of Pharmacovigilance]. Therapie, 66 (6), pp. 527-540. | Show Abstract | Read more

OBJECTIVES: The present study was performed to evaluate safety data collected by the French Network of Pharmacovigilance centres network, from October 21, 2009 to June 15, 2010. METHODS: French Health Authorities (Afssaps [Agence française de sécurité sanitaire des produits de santé]) heightened awareness to extensive notifications with online health practitioners' reports and patients' reports via the Regional Centre concerned. RESULTS: During the campaign, 4.1 millions doses of Pandemrix(®) and 1.6 million doses of Panenza(®) were administered. Following Pandemrix(®), 4 183 adverse effects (AEs) were reported including 193 "serious" AEs. Concerning Panenza(®), 591 AEs were reported including 70 "serious" AE. The most frequently reported "serious" AEs were neurological for both Pandemrix(®) (38.9%, mainly isolated ascending paresthesia without any other neurological symptom and complication) and Panenza(®) (28.9%). Febrile convulsions were the most common neurological AEs with Panenza(®) in children. All reported deaths (n = 22) described causes other than recent A(H1N1)v vaccination. No causal relationship was established between these AEs and vaccination. Among AEs of "special" interest, 13 reports of confirmed GBS and 15 reports of demyelinating disorders were notified. No report of narcolepsy was made during the study period. CONCLUSION: For both vaccines, neurological AEs (isolated ascending paresthesia with Pandemrix(®) and febrile convulsions with Panenza(®)) were among the most frequently reported "serious" AEs. Despite limits of this survey based on spontaneous reporting, the study did not detect any safety signals, at least with an 8-month follow-up.

Caillet C, Durrieu G, Jacquet A, Faucher A, Ouaret S, Perrault-Pochat M-C, Kreft-Jaïs C, Castot A, Montastruc J-L, French Network of Pharmacovigilance Centres. 2011. Safety surveillance of influenza A(H1N1)v monovalent vaccines during the 2009-2010 mass vaccination campaign in France. Eur J Clin Pharmacol, 67 (6), pp. 649-651. | Read more