Model for measuring the impact of good pharmacovigilance practices of COVID-19 patients on hcp reactivity: Morocco case study

Oumaima Oullada; Mohamed Ben Ali; Ahmed Adri; Said Rifai

doi:https://doi.org/10.59170/stattrans-2023-064

Model for measuring the impact of good pharmacovigilance practices of COVID-19 patients on hcp reactivity: Morocco case study

Oumaima Oullada National Higher School of Electricity and Mechanics - ENSEM- Hassan II University of Casablanca – B.P: 8118 Oasis – Casablanca – Morocco. Laboratory of Mechanics- Production and Industrial Engineering – LMPGI – Higher School of Technology of Casablanca – EST, Hassan II University of Casablanca – B.P 8112 Oasis – Casablanca, Morocco ORCID:https://orcid.org/0009-0004-6313-5532 , Mohamed Ben Ali Laboratory of Mechanics- Production and Industrial Engineering – LMPGI – Higher School of Technology of Casablanca – ESTC – Hassan II University of Casablanca – B.P 8112 Oasis – Casablanca, Morocco ORCID:https://orcid.org/0000-0002-8615-7935 , Ahmed Adri Laboratory of Mechanics – Production and Industrial Engineering – LMPGI – Higher School of Technology of Casablanca – ESTC – Hassan II University of Casablanca – B.P 8112 Oasis- Casablanca, Mor ORCID:https://orcid.org/0000-0003-1355-5059occo , Said Rifai Laboratory of Mechanics- Production and Industrial Engineering – LMPGI – Higher School of Technology of Casablanca – ESTC – Hassan II University of Casablanca – B.P 8112 Oasis – Casablanca, Morocco ORCID:https://orcid.org/0000-0002-2813-1606 Statistics in Transition new series, vol. 24, 2023, 5, pages: 63-88 Published online: 7 December 2023 https://doi.org/10.59170/stattrans-2023-064 Citation: Oullada, O., Ali, M. B., Adri, A., Rifai, S., 2023. Model for measuring the impact of good pharmacovigilance practices of COVID-19 patients on hcp reactivity: Morocco case study. Statistics in Transition new series, 24(5), pp. 63-88. https://doi.org/10.59170/stattrans-2023-064

675 Views 53 Downloads

ARTICLE

(English) PDF

ABSTRACT

This paper presents a conceptual model used to evaluate how the improvement of good pharmacovigilance practices by patients during COVID-19 period influences the reactivity of the healthcare professionals (HCPs) in the Draa Tafilalet region in Morocco, concerning the reporting of adverse drug reactions (ADRs) through barriers that influence the reporting from both patients and HCPs. The empirical study is based on a survey submitted to a sample of a total of 180 HCP and on the application of latent variable structural modelling through the partial least squares (PLS) method. The 2017 version of the XL-STAT software served to perform the statistical calculations. The study investigates the reliability and validity of the proposed model. Our conclusions show that the improvement of good pharmacovigilance practices impact positively the reactivity of HCP in terms of ADRs reporting. The reliability of the measurement was > 0.7, which allowed us to test the internal and external validity of our conceptual model. 11 hypotheses were validated against two invalid derivative hypotheses. Spontaneous ADRs reporting is the cornerstone of any pharmacovigilance system aiming to maintain patient safety. Our findings indicate the necessity firstly, to initiate a training program on reporting for all HCPs, and secondly, to inform the general public about the national pharmacovigilance center, where ADRs can be reported. Both initiatives aim to keep the culture of ADR reporting perennial.

KEYWORDS

pharmacovigilance, HCP reactivity, structural equations modelling, latent variable, PLS.

REFERENCES

Abubakar, A. R., Simbak, N. Bin, & Haque, M., (2014). A Systematic Review of Knowledge, Attitude and Practice on Adverse Drug Reactions and Pharmacovigilance among Doctors. Journal of Applied Pharmaceutical Science, 4(10), pp. 117–127. https://doi.org/10.7324/japs.2014.401021.

Accueil, (n.d.), Retrieved January 23, (2022). From: https://www.sante.gov.ma/Pages/ Accueil.aspx.

Adisa, R., Omitogun, T. I., (2019). Awareness, knowledge, attitude and practice of adverse drug reaction reporting among health workers and patients in selected primary healthcare centres in Ibadan, southwestern Nigeria. BMC Health Services Research, 19(1), pp. 1–14. https://doi.org/10.1186/s12913-019-4775-9.

Al Dweik, R., Stacey, D., Kohen, D., & Yaya, S., (2017). Factors affecting patient reporting of adverse drug reactions: a systematic review. British Journal of Clinical Pharmacology, 83(4), pp. 875–883. https://doi.org/10.1111/bcp.13159.

Ali, M. Ben, Rifai, S., Bouksour, O., & Barrijal, S., (2019). Understanding the impact of quality practices on firm performance: insights from a structural equation modeling study of young manufacturing enterprises in Tetouan, Morocco. International Journal of Quality and Innovation, 4(3/4), p. 189. https://doi.org/10.1504/ijqi.2019.105759.

Alsaleh, F. M., Alzaid, S. W., Abahussain, E. A., Bayoud, T., & Lemay, J., (2017). Knowledge, attitude and practices of pharmacovigilance and adverse drug reaction reporting among pharmacists working in secondary and tertiary governmental hospitals in Kuwait. Saudi Pharmaceutical Journal, 25(6), pp. 830–837. https://doi.org/10.1016/j.jsps.2016.12.004.

Amrain, M., Bečić, F., (2014). Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance. Journal of Health Sciences, 4(2), pp. 120–125. https://doi.org/10.17532/jhsci.2014.183.

Assanee, J., Sorofman, B. A., Sirisinsuk, Y., & Kitisopee, T., (2021). Factors influencing patient intention to report adverse drug reaction to community pharmacists: A structural equation modeling approach. Research in Social and Administrative Pharmacy, December 2020. https://doi.org/10.1016/j.sapharm.2021.05.010.

Avery, A. J., Anderson, C., Bond, C. M., Fortnum, H., Gifford, A., Hannaford, P. C., Hazell, L., Krska, J., Lee, A. J., McLernon, D. J., Murphy, E., Shakir, S., & Watson, M. C., (2011). Evaluation of patient reporting of adverse drug reactions to the UK “Yellow card scheme”: Literature review, descriptive and qualitative analyses, and questionnaire surveys. In Health Technology Assessment, Vol. 15, Issue 20, pp. 1– 234. https://doi.org/10.3310/hta15200.

Avkiran, N. K., Ringle, C. M., & Low, R., (2018). Monitoring transmission of systemic risk: Application of partial least squares structural equation modeling in financial stress testing. Journal of Risk, 20(5), 83–115. https://doi.org/10.21314/ JOR.2018.386.

Awodele, O., Akinyede, A., Adeyemi, O. A., & Awodele, D. F., (2011). Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. International Journal of Risk and Safety in Medicine, 23(4), pp. 217–226. https://doi.org/10.3233/JRS-2011-0541.

Bäckström, M., Mjörndal, T., Dahlqvist, R., & Nordkvist-Olsson, T., (2000). Attitudes to reporting adverse drug reactions in northern Sweden. European Journal of Clinical Pharmacology, 56(9–10), pp. 729–732. https://doi.org/10.1007/s002280000202.

Biriell, C., Edwards, I. R., (1997). Reasons for reporting adverse drug reactions - Some thoughts based on an international review. Pharmacoepidemiology and Drug Safety, 6(1), pp. 21–26. https://doi.org/10.1002/(SICI)1099-1557(199701)6:1<21::AIDPDS259> 3.0.CO;2-I.

CAPM Plateforme, (n.d.), Retrieved June 24, (2022). From https://www.capmsante.ma/

Chaouali, W., Souiden, N., & Ringle, C. M., (2021). Elderly customers’ reactions to service failures: the role of future time perspective, wisdom and emotional intelligence. Journal of Services Marketing, 35(1), pp. 65–77. https://doi.org/10.1108/JSM-08-2019-0318.

Cheah, J. H., Sarstedt, M., Ringle, C. M., Ramayah, T., & Ting, H., (2018). Convergent validity assessment of formatively measured constructs in PLS-SEM: On using single-item versus multi-item measures in redundancy analyses. International Journal of Contemporary Hospitality Management, 30(11), pp. 3192–3210. https://doi.org/10.1108/IJCHM-10-2017-0649.

Chin, W. W., (1998). The partial least squares approach for structural equation modeling. Modern Methods for Business Research, April, pp. 295–336.

Chin, W. W., Marcelin, B. L., & Newsted, P. R., (2003). A partial least squares latent variable modeling approach for measuring interaction effects: Results from a Monte Carlo simulation study and an electronic-mail emotion/adoption study. Information Systems Research, 14(2). https://doi.org/10.1287/isre.14.2.189.16018.

Cho, G., Hwang, H., Sarstedt, M., & Ringle, C. M., (2020). Cutoff criteria for overall model fit indexes in generalized structured component analysis. Journal of Marketing Analytics, 8(4), pp. 189–202. https://doi.org/10.1057/s41270-020-00089-1.

Ekman, E., Bäckström, M., (2009). Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. European Journal of Clinical Pharmacology, 65(1), pp. 43–46. https://doi.org/10.1007/s00228-008-0564-9.

El Hamdouni, M., Ahid, S., Bourkadi, J. E., Benamor, J., Hassar, M., & Cherrah, Y., (2020). Incidence of adverse reactions caused by first-line anti-tuberculosis drugs and treatment outcome of pulmonary tuberculosis patients in Morocco. Infection, 48(1), pp. 43–50. https://doi.org/10.1007/s15010-019-01324-3.

Engla, N. E. W., Journal, N. D., (2010). New engla nd journal, pp. 865–869.

Faizan, A., Rasoolimanesh, M., Sarstedt, M., Ringle, C., & Ryu, K., (2018). An Assessment of The Use of Partial Least Squares Structural Equation Modeling. International Journal of Contemporary Hospitality Management, 34(1), pp. 1–5. https://doi.org/10.1108/IJCHM-10-2016.

Fornell, C., Bookstein, F. L., (1982). Structural to Consumer. Journal of Marketin Research, 19(4), pp. 440–452.

Guenther, P., Guenther, M., Ringle, C. M., Zaefarian, G., & Cartwright, S., (2023). Improving PLS-SEM use for business marketing research. Industrial Marketing Management, 111(October 2020), pp. 127–142. https://doi.org/10.1016/j.indmarman.2023.03.010.

Hadi, M. A., Neoh, C. F., Zin, R. M., Elrggal, M., & Cheema, E., (2017). Pharmacovigilance: pharmacists’ perspective on spontaneous adverse drug reaction reporting. Integrated Pharmacy Research and Practice, Vol. 6, pp. 91–98. https://doi.org/10.2147/iprp.s105881.

Hagedoorn, J., Schakenraad, J. O. S., (1994). The Effect of Strategic Technology Alliances on Company Performance Author ( s ): John Hagedoorn and Jos Schakenraad Published by : Wiley Stable URL : http://www.jstor.org/stable/ 2486887 REFERENCES Linked references are available on JSTOR for this article. Strategic Management Journal, 15(4), pp. 291–309.

Hair carole l. Hollingswoth, Chong, Jeo, A. B. R. A., (2017). Industrial Management & Data Systems. Industrial Management & Data Systems Business Process Management Journal Iss Management Decision, 110(5), pp. 111–133. http://dx.doi.org/10.1108/02635571011008434%5Cnhttp://%5Cnhttp://dx.doi.org/10. 1108/00251741211194903%5Cnhttp://dx.doi.org/10.1108/10878571111161507.

Hair, Joe F., Ringle, C. M., & Sarstedt, M., (2011). PLS-SEM: Indeed a silver bullet. Journal of Marketing Theory and Practice, 19(2), pp. 139–152. https://doi.org/ 10.2753/MTP1069-6679190202.

Hair, Joseph F., Risher, J. J., Sarstedt, M., & Ringle, C. M., (2019). When to use and how to report the results of PLS-SEM. European Business Review, 31(1), pp. 2–24. https://doi.org/10.1108/EBR-11-2018-0203.

Härmark, L., Raine, J., Leufkens, H., Edwards, I. R., Moretti, U., Sarinic, V. M., & Kant, A., (2016). Patient-Reported Safety Information: A Renaissance of Pharmacovigilance? Drug Safety, 39(10), pp. 883–890. https://doi.org/10.1007/ s40264-016-0441-x.

Hazell, L., Cornelius, V., Hannaford, P., Shakir, S., & Avery, A. J., (2013). How do patients contribute to signal detection?: A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s yellow card scheme. Drug Safety, 36(3), pp. 199–206. https://doi.org/10.1007/s40264-013-0021-2.

Hazell, L., Shakir, S. A. W. (2006). Under-reporting of adverse drug reactions: A systematic review. Drug Safety, 29(5), pp. 385–396. https://doi.org/10.2165/00002018-200629050-00003.

Hulland, J., (1999). of Four Recent Studies. Strategic Management Journal, 20(2), pp. 195–204.

Inácio, P., Cavaco, A., & Airaksinen, M., (2017). The value of patient reporting to the pharmacovigilance system: a systematic review. British Journal of Clinical Pharmacology, 83(2), pp. 227–246. https://doi.org/10.1111/bcp.13098.

Jöreskog, (1978). Structural Analysis of Covariance and Correlation Matrices Karl. NEC Technical Journal, 3(2), pp. 27–32.

Joubert, M. C., Naidoo, P., (2016). Knowledge, perceptions and practices of pharmacovigilance amongst community and hospital pharmacists in a selected district of North West Province, South Africa. In Health SA Gesondheid, Vol. 21, pp. 238–244. https://doi.org/10.1016/j.hsag.2016.04.005.

Kaufmann, L., Gaeckler, J., (2015). A structured review of partial least squares in supply chain management research. Journal of Purchasing and Supply Management, 21(4), pp. 259–272. https://doi.org/10.1016/j.pursup.2015.04.005.

Kitabayashi, A., Inoue, Y., (2022). Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan. Therapeutic Innovation and Regulatory Science, 56(4), pp. 616–624. https://doi.org/10.1007/s43441-022-00397-x.

Kline, R. B., (1999). Book Review: Psychometric theory (3rd ed.). Journal of Psychoeducational Assessment, 17(3), pp. 275–280. https://doi.org/10.1177/073428299901700307.

Kroonenberg, P. M., Lohmoller, J.-B., (1990). Latent Variable Path Modeling with Partial Least Squares. In Journal of the American Statistical Association, Vol. 85, Issue 411. https://doi.org/10.2307/2290049.

Law, L., Fong, N., (2020). Applying partial least squares structural equation modeling (PLS-SEM) in an investigation of undergraduate students’ learning transfer of academic English. Journal of English for Academic Purposes, 46, 100884. https://doi.org/10.1016/j.jeap.2020.100884.

Liu, Y. X., (2012). A new antihypertensive drug ameliorate insulin resistance. Acta Pharmacologica Sinica, 33(4), pp. 429–430. https://doi.org/10.1038/aps.2012.31.

Magno, F., Cassia, F., & Ringle, C. M. M., (2022). A brief review of partial least squares structural equation modeling (PLS-SEM) use in quality management studies. TQM Journal. https://doi.org/10.1108/TQM-06-2022-0197.

Maguire, A., Douglas, I., Smeeth, L., & Thompson, M., (2007). Determinants of cholesterol and triglycerides recording in patients treated with lipid lowering therapy in UK primary care. Pharmacoepidemiology and Drug Safety, 16(January), pp. 228–228. https://doi.org/10.1002/pds.

Margraff, F., Bertram, D., (2014). Adverse drug reaction reporting by patients: An overview of fifty countries. Drug Safety, 37(6), pp. 409–419. https://doi.org/10.1007/s40264-014-0162-y.

MERLEN, C., (2017). Gestion et maîtrise des risques des procédés de fabrication : le cas de l’industriepharmaceutiqueSous. https://pepite-depot.univlille2.fr/nuxeo/site/esupversions/5443012c-4c8e-4c4d-bd12-1832dc0ff279.

Mirosevic Skvrce, N., Galic, I., Pacadi, C., Kandzija, N., & Mucalo, I., (2020). Adverse drug reactions that arise from the use of medicinal products outside the terms of the marketing authorisation. Research in Social and Administrative Pharmacy, 16(7), pp. 928–934. https://doi.org/10.1016/j.sapharm.2019.10.003.

Montané, E., Arellano, A. L., Sanz, Y., Roca, J., & Farré, M., (2018). Drug-related deaths in hospital inpatients: A retrospective cohort study. British Journal of Clinical Pharmacology, 84(3), pp. 542–552. https://doi.org/10.1111/bcp.13471.

Nchinech, N., Lachhab, Z., Obtel, M., Cherrah, Y., & Serragui, S., (2020). Moroccan pharmacy students’ knowledge and perceptions about pharmacovigilance. Annales Pharmaceutiques Francaises. https://doi.org/10.1016/j.pharma.2020.10.005.

Nchinech, N, Lachhab, Z., Cherrah, Y., & Serragui, S., (2019). 6ER-023 Establishment of group work: what is the effect on the state of knowledge and perception of pharmacovigilance among our future moroccan pharmacists? March 2019, A287.2- A288. https://doi.org/10.1136/ejhpharm-2019-eahpconf.620.

Nchinech, Naoual, Lachhab, Z., Obtel, M., Cherrah, Y., & Serragui, S., (2020). Connaissances et perception de la pharmacovigilance par les futurs pharmaciens marocains. Annales Pharmaceutiques Françaises. https://doi.org/10.1016/j.pharma.2020.10.005.

O’Callaghan, J., Griffin, B. T., Morris, J. M., & Bermingham, M., (2018). Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland. BioDrugs, 32(3), pp. 267–280. https://doi.org/10.1007/s40259-018-0281-6.

OMS, (2004). Pharmacovigilance : assurer la sécurité d’emploi des médicaments, pp. 1–6.

Rabba, A. K., Ain, M. R. (2015). Pharmacovigilance study: Exploring the role of community pharmacists in adverse drug reactions reporting in Alkharj city, Saudi Arabia. Latin American Journal of Pharmacy, 34(5), 901–906.

Regulation and Prequalification, (n.d.), Retrieved January 22, (2022). From https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance.

Richter, N. F., Sinkovics, R. R., Ringle, C. M., & Schlägel, C., (2016). A critical look at the use of SEM in international business research. International Marketing Review, 33(3), 376–404. https://doi.org/10.1108/IMR-04-2014-0148.

Robert, B., Brown, E. B., (2004). A study of willigness to use chines hospital pharmacovigilance system based on structural equation modeling, 1, pp. 1–14.

Ronald E. Walpole, Raymond H. Myers, S. L. M. Y. K. Y., (2012). Title. BMC Public Health, 5(1), pp. 1–8.

Routledge, P., (1998). 150 Years of Pharmacovigilance. Lancet, 351(9110), pp. 1200– 1201. https://doi.org/10.1016/S0140-6736(98)03148-1.

Sahaf, K., Ali, M. Ben, Rifai, S., Bouksour, O., & Adri, A., (2018). Improvement of the hospital supply chain and its impact on reduction of patient waiting times. Case of the Oncology department of University Hospital IBN ROCHD. 2018 5th International Conference on Control, Decision and Information Technologies, CoDIT 2018, pp. 222–227. https://doi.org/10.1109/CoDIT.2018.8394876.

Sales, I., Aljadhey, H., Albogami, Y., & Mahmoud, M. A., (2017). Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia. Saudi Pharmaceutical Journal, 25(6), pp. 868–872. https://doi.org/10.1016/j.jsps.2017.01.004.

Sandberg, A., Salminen, V., Heinonen, S., & Sivén, M., (2022). Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals’ Perspectives on How to Improve Reporting. Healthcare (Switzerland), 10(6). https://doi.org/10.3390/healthcare10061015.

Sebtaoui, F. E., Adri, A., Rifai, S., & Sahaf, K., (2020). How will the risk management impact the success of just-in-time implementation? Journal of Industrial and Production Engineering, 37(7), pp. 333–344. https://doi.org/10.1080/21681015.2020.1806121.

Sosik, J. J., Kahai, S. S., & Piovoso, M. J., (2009). Silver bullet or voodoo statistics?: A primer for using the partial least squares data analytic technique in group and organization research. Group and Organization Management, 34(1), pp. 5–36. https://doi.org/10.1177/1059601108329198.

Starfield, B., (2000). Is US Health Really the Best. Jama, 284(4), 483. http://jama.amaassn.org/cgi/content/abstract/284/4/483.

Stergiopoulos, S., Brown, C. A., Felix, T., Grampp, G., & Getz, K. A., (2016). A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals. Drug Safety, 39(11), 1117–1127. https://doi.org/10.1007/s40264-016-0455-4.

Thomas, D., Zachariah, S., (2018). Knowledge, Attitude, and Practice of Pharmacovigilance in Developing Countries. In Social and Administrative Aspects of Pharmacy in Low-and Middle-Income Countries: Present Challenges and Future Solutions. Elsevier Inc. https://doi.org/10.1016/B978-0-12-811228-1.00011-X.

Toklu, H. Z., Uysal, M. K., (2008). The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharmacy World and Science, 30(5), pp. 556–562. https://doi.org/10.1007/s11096-008-9209-4.

Vaismoradi, Logan, Jordan, & Sletvold, (2019). Adverse Drug Reactions in Norway: A Systematic Review. Pharmacy, 7(3), 102. https://doi.org/10.3390/pharmacy7030102.

Weigmann, K., (2016). Consumer reporting of adverse drug reactions. EMBO Reports, 17(7), 949–952. https://doi.org/10.15252/embr.201642616.

Wetzels, M., Odekerken-Schröder, G., & Oppen, C. Van, (2009). Assessing Using PLS Path Modeling Hierarchical and Empirical Construct Models : Guidelines. MIS Quarterly, 33(1).

Wold, H., (1985). Systems Analysis by Partial Least Squares. Measuring the Unmeasurable, September, pp. 221–251. https://doi.org/10.1007/978-94-009-5079-5_11.

Yarrow, A., (1961). Smoking By Schoolchildren. The Lancet, 278(7216), p. 1358. https://doi.org/10.1016/S0140-6736(61)90926-6.