An overview of the feasibility of pharmacoepidemiological studies based on clinical and medico-administrative data in Mali.
DOI:
https://doi.org/10.4314/rasp.v6i2.11Keywords:
Pharmacoépidémiologie, Données Cliniques, Données médico-administratives, MaliAbstract
Our study aimed to assess the feasibility of population-based use studies of health products based on clinical data from the Mother Hospital Center "Le Luxembourg" and medico-administrative data from the National Health Insurance Fund of Mali (CANAM). This was a descriptive cross-sectional study with prospective data collection from May 1 to July 30, 2023. One hundred records were randomly drawn from each database to assess parameters such as content, reference systems used, and frequency of missing data. The international reference recommendations were those issued by pharmaceutical regulatory bodies and learned societies such as the Food and Drug Administration (FDA) and the International Society of Pharmacoepidemiology (ISPE). The databases of both structures contain general patient information and clinical information for the CHME clinical database. The two databases studied are not available in Open Access on the Internet. They are not anonymised or de-identified in advance without the motivated request of a third party. The primary use of the data remains financial in the context of the management of the said structures. Data collection is instantaneous for the CHME but deferred for the CANAM. The rate of missing data was 48% for the CHME and 0% for the CANAM. Efforts still need to be made regarding the completeness of clinical data through the appropriation of the CINZ@N Hospital Information System (HIS) by CHME practitioners "Le Luxembourg. The urgent adoption of a unique health identifier will facilitate the chaining between these data sources.
References
Agence Technique de l’Information sur l’Hospitalisation (ATIH). (s. d.). Formats PMSI 2023 | Publication ATIH. Consulté 30 juillet 2023, à l’adresse https://www.atih.sante.fr/formats-pmsi-2023
Ajami, S., & Bagheri-Tadi, T. (2013). Barriers for Adopting Electronic Health Records (EHRs) by Physicians. Acta Informatica Medica, 21(2), 129‑134. https://doi.org/10.5455/aim.2013.21.129-134
Bamberger, M., Moore, N., Lechat, P., Azizi, M., Blin, P., Bouhassira, M., Cellier, D., Demarez, J.-P., Duval, X., Gueyffier, F., Le Jeunne, C., Libersa, C., Mahlberg-Gaudin, F., Maison, P., Marquet, P., Molimard, M., Moser, A., Pavlovic, M., Piedbois, P., … Vignal, F. (2011). How to Improve the Clinical Development Paradigm and its Division into Phases I, II and III. Therapies, 66(4), 331‑334. https://doi.org/10.2515/therapie/2011046
Bayo, S., Parkin, D. M., Koumaré, A. K., Diallo, A. N., Ba, T., Soumaré, S., & Sangaré, S. (1990). Cancer in Mali, 1987-1988. International Journal of Cancer, 45(4), 679‑684. https://doi.org/10.1002/ijc.2910450418
Begaud B. (1998). Dictionnaire de Pharmacoépidémiologie ? (3e éd.). https://www.yumpu.com/fr/document/read/16572483/bernard-begaud-arme-pharmacovigilance
Bégaud, B., & Dangoumau, J. (2000). [Pharmacoepidemiology : Definitions, problems, methodology]. Therapie, 55(1), 113‑117.
Bérard, A. (2021). Pharmacoepidemiology Research-Real-World Evidence for Decision Making. Frontiers in Pharmacology, 12. https://www.frontiersin.org/articles/10.3389/fphar.2021.723427
Bert, J. M., Beach, W. R., McIntyre, L. F., & Sachdev, R. (2016). Getting Ready for ICD-10 and Meaningful Use Stage 2. Instructional Course Lectures, 65, 609‑622.
Blotière, P.-O., Miranda, S., Weill, A., Mikaeloff, Y., Peyre, H., Ramus, F., Mahmoud, Z., Coste, J., & Dray-Spira, R. (2020). Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy : A French nationwide population-based cohort study. BMJ Open, 10(6), e034829. https://doi.org/10.1136/bmjopen-2019-034829
CANAM. (s. d.). Canam Mali—Caisse Nationale d’Assurance Maladie. Canam Mali. Consulté 3 octobre 2022, à l’adresse http://canammali.ml/
Chikowe, I., Mwakilama, E. P., Chikowe, I., & Mwakilama, E. P. (2021). Computer-Aided Pharmacoepidemiology in Drug Use and Safety : Examining the Intersection between Data Science and Medicines Research. In New Insights into the Future of Pharmacoepidemiology and Drug Safety. IntechOpen. https://doi.org/10.5772/intechopen.98730
Cohen, G. R., Friedman, C. P., Ryan, A. M., Richardson, C. R., & Adler-Milstein, J. (2019). Variation in Physicians’ Electronic Health Record Documentation and Potential Patient Harm from That Variation. Journal of General Internal Medicine, 34(11), 2355‑2367. https://doi.org/10.1007/s11606-019-05025-3
Dong, Y., & Peng, C.-Y. J. (2013). Principled missing data methods for researchers. SpringerPlus, 2(1), 222. https://doi.org/10.1186/2193-1801-2-222
García Rodríguez, L. A., & Pérez Gutthann, S. (1998). Use of the UK General Practice Research Database for pharmacoepidemiology. British Journal of Clinical Pharmacology, 45(5), 419‑425. https://doi.org/10.1046/j.1365-2125.1998.00701.x
Hartzema, A. G., Racoosin, J. A., MaCurdy, T. E., Gibbs, J. M., & Kelman, J. A. (2011). Utilizing Medicare claims data for real‐time drug safety evaluations:is it feasible? Pharmacoepidemiology and Drug Safety, 20(7), 684‑688. https://doi.org/10.1002/pds.2143
International Society of Pharmacoepidemiology (ISPE). (s. d.). Guidelines for Good Pharmacoepidemiology Practices (GPP)—International Society for Pharmacoepidemiology. Consulté 30 juillet 2023, à l’adresse https://www.pharmacoepi.org/resources/policies/guidelines-08027/
Joubert, J., Rao, C., Bradshaw, D., Dorrington, R. E., Vos, T., & Lopez, A. D. (2012). Characteristics, availability and uses of vital registration and other mortality data sources in post-democracy South Africa. Global Health Action, 5, 1‑19. https://doi.org/10.3402/gha.v5i0.19263
Kimura, S., Sato, T., Ikeda, S., Noda, M., & Nakayama, T. (2010). Development of a Database of Health Insurance Claims : Standardization of Disease Classifications and Anonymous Record Linkage. Journal of Epidemiology, 20(5), 413‑419. https://doi.org/10.2188/jea.JE20090066
L’Assurance Maladie. (s. d.). Etudes et données. Consulté 30 juillet 2023, à l’adresse https://assurance-maladie.ameli.fr/etudes-et-donnees/par-theme/pathologies
l’assurance maladie. (s. d.). Études pharmaco-épidémiologiques. Consulté 2 octobre 2022, à l’adresse https://assurance-maladie.ameli.fr/etudes-et-donnees/etudes-publications/assurance-maladie/etudes-pharmaco-epidemiologiques
M. Obeng-Kusi. (2019). Research methods for conducting pharmacoepidemiological studies using medicines claims data [Thèse Pharm, North West University]. https://repository.nwu.ac.za/bitstream/handle/10394/32816/Obeng-Kusi_M_27959716.pdf?sequence=1
Martin, K., Bégaud, B., Latry, P., Miremont-Salamé, G., Fourrier, A., & Moore, N. (2004). Differences between clinical trials and postmarketing use. British Journal of Clinical Pharmacology, 57(1), 86‑92. https://doi.org/10.1046/j.1365-2125.2003.01953.x
Mills, S., Lee, J. K., & Rassekh, B. M. (2019). Benefits of linking civil registration and vital statistics with identity management systems for measuring and achieving Sustainable Development Goal 3 indicators. Journal of Health, Population, and Nutrition, 38(Suppl 1), 18. https://doi.org/10.1186/s41043-019-0178-0
Montastruc, J.-L., Sommet, A., Montastruc, F., Moulis, G., Bagheri, H., Damasemichel, C., & Lapeyre-Mestre, et M. (2015). Qu’est-ce que la pharmacoépidémiologie? Bulletin de l’Académie Nationale de Médecine, 199(2), 263‑273. https://doi.org/10.1016/S0001-4079(19)30970-7
Pierre-Olivier Blotière. (2019). Utilisation des bases de données de l’Assurance Maladie pour l’étude de l’utilisation des antiépileptiques pendant la grossesse et des risques associés à l’exposition in utero chez l’enfant [Thèse de doctorat, Université de LORRAINE]. https://hal.univ-lorraine.fr/tel-02348024/document
Rogers, A. S. (1987). Adverse drug events : Identification and attribution. Drug Intelligence & Clinical Pharmacy, 21(11), 915‑920. https://doi.org/10.1177/106002808702101114
Sarri, G., Bennett, D., Debray, T., Deruaz‐Luyet, A., Soriano Gabarró, M., Largent, J. A., Li, X., Liu, W., Lund, J. L., Moga, D. C., Gokhale, M., Rentsch, C. T., Wen, X., Yanover, C., Ye, Y., Yun, H., Zullo, A. R., & Lin, K. J. (2022). ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19 : Opportunities and Trade‐Offs. Clinical Pharmacology and Therapeutics, 10.1002/cpt.2560. https://doi.org/10.1002/cpt.2560
Schlegel, D. R., & Ficheur, G. (2017). Secondary Use of Patient Data : Review of the Literature Published in 2016. Yearbook of Medical Informatics, 26(1), 68‑71. https://doi.org/10.15265/IY-2017-032
Sørensen, H. T., Johnsen, S. P., & Nørgård, B. (2001). Methodological issues in using prescription and other databases in pharmacoepidemiology. Norsk Epidemiologi, 11(1), Article 1. https://doi.org/10.5324/nje.v11i1.528
Strom, B. L. (2019). What Is Pharmacoepidemiology? In Pharmacoepidemiology (p. 1‑26). John Wiley & Sons, Ltd. https://doi.org/10.1002/9781119413431.ch1
Trifirò, G., Gini, R., Barone-Adesi, F., Beghi, E., Cantarutti, A., Capuano, A., Carnovale, C., Clavenna, A., Dellagiovanna, M., Ferrajolo, C., Franchi, M., Ingrasciotta, Y., Kirchmayer, U., Lapi, F., Leone, R., Leoni, O., Lucenteforte, E., Moretti, U., Mugelli, A., … Corrao, G. (2019). The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation : Where Does Italy Stand? Drug Safety, 42(3), 347‑363. https://doi.org/10.1007/s40264-018-0732-5
US Food and Drug Administration. (2018). FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM. https://www.fda.gov/media/120060/download
U.S. Food and Drug Administration. (2020, août 5). Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry
West, S. L., Johnson, W., Visscher, W., Kluckman, M., Qin, Y., & Larsen, A. (2014). The challenges of linking health insurer claims with electronic medical records. Health Informatics Journal, 20(1), 22‑34. https://doi.org/10.1177/1460458213476506
Williams, H. C., Burden-Teh, E., & Nunn, A. J. (2015). What is a pragmatic clinical trial? The Journal of Investigative Dermatology, 135(6), 1‑3. https://doi.org/10.1038/jid.2015.134
Downloads
Published
Issue
Section
License
Copyright (c) 2024 Zoumana cheick BERETE
This work is licensed under a Creative Commons Attribution 4.0 International License.
https://creativecommons.org/licenses/by/4.0/
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms