Stakeholder perspectives on the need for professional education and competence in pharmacovigilance in Zambia: A cross-sectional survey
DOI:
https://doi.org/10.46542/pe.2024.241.364381Keywords:
Cross-sectional survey, educational needs assessment, Pharmacovigilance, Stakeholder, University, ZambiaAbstract
Background: Knowledge and skills in pharmacovigilance (PV) are required to mitigate adverse events associated with medicine use which are among the leading causes of morbidity, mortality, and healthcare costs. This study explored the local perspectives and needs for PV education in Zambia.
Methods: A mixed-methods study utilising a descriptive cross-sectional survey with an embedded desk review was conducted from November 2021 to December 2022 in Zambia. The quantitative survey used a self-administered questionnaire distributed to 150 participants drawn from key stakeholder groups identified. Qualitative information was extracted from the respective university websites for the desk review.
Results: Out of 150 targeted participants, 144 (96%) responded to the survey. The majority (92.4%) affirmed the need for formal PV education programmes locally. Most (95.8%) perceived that training professionals in PV would add value to strengthening the health system. Furthermore, 45.1% preferred a postgraduate diploma and a master’s degree in PV. About half (48.6%) preferred an interprofessional training approach. Only 6/1207 (0.5%) of the universities in Sub-Saharan Africa offered PV education programmes.
Conclusion: This study underscored the pertinent need for formal PV education programmes and identified the type of education, expected competencies, and suggested educational strategies to guide curriculum development. These findings serve as a starting point for developing programmes to consolidate PV practice in Zambia and beyond.
References
Abubakar, A.R., Haque, M. (2016). Pharmacovigilance practice: The current challenges and the gaps in the medical students’ curriculum. Journal of Applied Pharmaceutical Science, 6(05), 210–215. https://doi.org/10.7324/JAPS.2016.60532
Al Meslamani, A. Z. (2023). Underreporting of adverse drug events: A look into the extent, causes, and potential solutions. Expert Opinion on Drug Safety, 22(5), 351–354. https://doi.org/10.1080/14740338.2023.2224558
Altwaijry, N., Ibrahim, A., Binsuwaidan, R., Alnajjar, L. I., Alsfouk, B. A., & Almutairi, R. (2021). Distance education during COVID-19 pandemic: A college of pharmacy experience. Risk Management and Healthcare Policy, 14, 2099–2110. https://doi.org/10.2147/rmhp.S308998
Al-Worafi, Y. M. (2020). Chapter 4—Pharmacovigilance. In Y. Al-Worafi (Ed.), Drug safety in developing countries (pp. 29–38). Academic Press. https://doi.org/10.1016/B978-0-12-819837-7.00004-2
Ampadu, H. H., Hoekman, J., de Bruin, M. L., Pal, S. N., Olsson, S., Sartori, D., Leufkens, H. G., & Dodoo, A. N. (2016). Adverse drug reaction reporting in Africa and a comparison of individual case safety report characteristics between Africa and the rest of the world: Analyses of spontaneous reports in VigiBase®. Drug Safety, 39(4), 335–345. https://doi.org/10.1007/s40264-015-0387-4
Arici, M. A., Gelal, A., Demiral, Y. & Tuncok, Y. (2015). Short and long-term impact of pharmacovigilance training on the pharmacovigilance knowledge of medical students. Indian Journal of Pharmacology, 47(4), 436–439. https://doi.org/10.4103/0253-7613.161272
Banda, M., Verhamme, K., Mufwambi, W., Mudenda, S., Chabalenge, B., Matafwali, S. K., Mutati, R. K., Hikaambo, C. N., Kampamba, M., & Prashar, L. (2022). Familiarity, knowledge and practices of healthcare professionals regarding the pharmacovigilance of biological medicines in Lusaka, Zambia: A multi-facility cross-sectional study. Pharmacology & Pharmacy, 13(07), 230–251. https://doi.org/10.4236/pp.2022.137019
Beckmann, J., Hagemann, U., Bahri, P., Bate, A., Boyd, I. W., Dal Pan, G. J., Edwards, B. D., Edwards, I. R., Hartigan-Go, K., Lindquist, M., McEwen, J., Moride, Y., Olsson, S., Pal, S. N., Soulaymani-Bencheikh, R., Tuccori, M., Vaca, C. P., & Wong, I. C. (2014). Teaching pharmacovigilance: The WHO-ISoP core elements of a comprehensive modular curriculum. Drug Safety, 37(10), 743–759. https://doi.org/10.1007/s40264-014-0216-1
Belachew, S. A., Hall, L., & Selvey, L. A. (2021). Non-prescription dispensing of antibiotic agents among community drug retail outlets in Sub-Saharan African countries: A systematic review and meta-analysis. Antimicrobial Resistance and Infection Control, 10(1), 13. https://doi.org/10.1186/s13756-020-00880-w
Bell, D., & Schultz Hansen, K. (2021). Relative burdens of the COVID-19, malaria, tuberculosis, and HIV/AIDS epidemics in Sub-Saharan Africa. The American Journal of Tropical Medicine and Hygiene, 105(6), 1510–1515. https://doi.org/10.4269/ajtmh.21-0899
Calac, A. J., Haupt, M. R., Li, Z., & Mackey, T. (2022). Spread of COVID-19 vaccine misinformation in the ninth inning: Retrospective observational infodemic study. JMIR Infodemiology, 2(1), e33587. https://doi.org/10.2196/33587
Chabalenge, B., Jere, E., Nanyangwe, N., Hikaambo, C., Mudenda, S., Banda, M., Kalungia, A., & Matafwali, S. (2022). Substandard and falsified medical product recalls in Zambia from 2018 to 2021 and implications on the quality surveillance systems. The Journal of Medicine Access, 6, 27550834221141767. https://doi.org/10.1177/27550834221141767
Dwyer-Lindgren, L., Cork, M. A., Sligar, A., Steuben, K. M., Wilson, K. F., Provost, N. R., Mayala, B. K., VanderHeide, J. D., Collison, M. L., Hall, J. B., Biehl, M. H., Carter, A., Frank, T., Douwes-Schultz, D., Burstein, R., Casey, D. C., Deshpande, A., Earl, L., El Bcheraoui, C., Farag, T. H., … Hay, S. I. (2019). Mapping HIV prevalence in sub-Saharan Africa between 2000 and 2017. Nature, 570(7760), 189–193. https://doi.org/10.1038/s41586-019-1200-9
Elshafie, S., Zaghloul, I., & Roberti, A. M. (2018). Pharmacovigilance in developing countries (part I): importance and challenges. International Journal of Clinical Pharmacy, 40(4), 758–763. https://doi.org/10.1007/s11096-017-0570-z
Erku, D. A., Belachew, S. A., Abrha, S., Sinnollareddy, M., Thomas, J., Steadman, K. J., & Tesfaye, W. H. (2021). When fear and misinformation go viral: Pharmacists' role in deterring medication misinformation during the 'infodemic' surrounding COVID-19. Research in Social and Administrative Pharmacy, 17(1), 1954–1963. https://doi.org/10.1016/j.sapharm.2020.04.032
Etando, A., Amu, A. A., Haque, M., Schellack, N., Kurdi, A., Alrasheedy, A. A., Timoney, A., Mwita, J. C., Rwegerera, G. M., Patrick, O., Niba, L. L., Boahen-Boaten, B. B., Tabi, F. B., Amu, O. Y., Acolatse, J., Incoom, R., Sefah, I. A., Guantai, A. N., Opanga, S., Chikowe, I., … Godman, B. (2021). Challenges and innovations brought about by the COVID-19 pandemic regarding medical and pharmacy education especially in Africa and implications for the future. Healthcare (Basel), 9(12), 1722. https://doi.org/10.3390/healthcare9121722
Gehlbach, H., Artino, A. R., Jr., & Durning, S. (2010). AM last page: Survey development guidance for medical education researchers. Academic Medicine, 85(5), 925. https://doi.org/10.1097/ACM.0b013e3181dd3e88
Godman, B., Haque, M., Leong, T., Allocati, E., Kumar, S., Islam, S., Charan, J., Akter, F., Kurdi, A., Vassalo, C., Bakar, M. A., Rahim, S. A., Sultana, N., Deeba, F., Khan, M. A. H., Alam, A. B. M. M., Jahan, I., Kamal, Z. M., Hasin, H., Munzur-E-Murshid, … Jakovljevic, M. (2021). The current situation regarding long-acting insulin analogues including biosimilars among African, Asian, European, and South American countries: Findings and implications for the future. Frontiers in Public Health, 9, 671961. https://doi.org/10.3389/fpubh.2021.671961
Guma, S. P., Godman, B., Campbell, S. M., & Mahomed, O. (2022). Determinants of the empiric use of antibiotics by general practitioners in South Africa: Observational, analytic, cross-sectional study. Antibiotics (Basel, Switzerland), 11(10), 1423. https://doi.org/10.3390/antibiotics11101423
Haines, H. M., Meyer, J. C., Summers, R. S., & Godman, B. B. (2020). Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district. European Journal of Clinical Pharmacology, 76(7), 991–1001. https://doi.org/10.1007/s00228-020-02862-8
Hofer U. (2019). The cost of antimicrobial resistance. Nature reviews. Microbiology, 17(1), 3. https://doi.org/10.1038/s41579-018-0125-x
Hohwü, L., Lyshol, H., Gissler, M., Jonsson, S. H., Petzold, M., & Obel, C. (2013). Web-based versus traditional paper questionnaires: A mixed-mode survey with a Nordic perspective. Journal of Medical Internet Research, 15(8), e173. https://doi.org/10.2196/jmir.2595
Isah, A. O., Pal, S. N., Olsson, S., Dodoo, A., & Bencheikh, R. S. (2012). Specific features of medicines safety and pharmacovigilance in Africa. Therapeutic Advances in Drug Safety, 3(1), 25–34. https://doi.org/10.1177/2042098611425695
Kandasamy, G., Sivanandy, P., Almaghaslah, D., Khobrani, M., Chinnadhurai, M., Vasudevan, R., & Almeleebia, T. (2020). Knowledge, attitude, perception and practice of antibiotics usage among the pharmacy students. International Journal of Clinical Practice, 74(11), e13599. https://doi.org/10.1111/ijcp.13599
Khanna, K., Kohli, S. K., Kaur, R., Bhardwaj, A., Bhardwaj, V., Ohri, P., Sharma, A., Ahmad, A., Bhardwaj, R., & Ahmad, P. (2021). Herbal immune-boosters: Substantial warriors of pandemic Covid-19 battle. Phytomedicine, 85, 153361. https://doi.org/10.1016/j.phymed.2020.153361
Kiguba, R., Olsson, S. & Waitt, C. (2023). Pharmacovigilance in low- and middle-income countries: A review with particular focus on Africa. British Journal of Clinical Pharmacology, 89, 491–509. https://doi.org/10.1111/bcp.15193
Li, C., He, J., Yuan, C., Chen, B., & Sun, Z. (2019). The effects of blended learning on knowledge, skills, and satisfaction in nursing students: A meta-analysis. Nurse Education Today, 82, 51–57. https://doi.org/10.1016/j.nedt.2019.08.004
Mahmoud, M. A., Meyer, J. C., Awaisu, A., Fadare, J., Fathelrahman, A. I., Saleem, F., Aljadhey, H., & Godman, B. (2023). Editorial: Medication safety and interventions to reduce patient harm in low- and middle-income countries. Frontiers in Pharmacology, 13, 1124371. https://doi.org/10.3389/fphar.2022.1124371
Masuka, J. T., & Khoza, S. (2020). An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme. Pharmacology Research & Perspectives, 8(5), e00657. https://doi.org/10.1002/prp2.657
Mbonane, H., Sibanda, M., Godman, B., Meyer, J. C., & Matlala, M. (2023). Knowledge, attitudes and practices of healthcare professionals on the use of an electronic stock visibility and management tool in a middle-income country: Implications for access to medicines. Exploratory Research in Clinical and Social Pharmacy, 100233. https://doi.org/10.1016/j.rcsop.2023.100233
Mengesha, A., Bastiaens, H., Ravinetto, R., Gibson, L. & Dingwall, R. (2024). Substandard and falsified medicines in African pharmaceutical markets: A case study from Ethiopia. Social Science & Medicine, 349, 116882. https://doi.org/10.1016/j.socscimed.2024.116882
Murray, C. J. L., Ikuta, K. S., Sharara, F., Swetschinski, L., Aguilar, G. R., Gray, A., Han, C., Bisignano, C., Rao, P., Wool, E., Johnson, S. C., Browne, A. J., Chipeta, M. G., Fell, F., Hackett, S., Haines-Woodhouse, G., Hamadani, B. H. K., Kumaran, E. A. P., McManigal, B., … Naghavi, M. (2022). Global burden of bacterial antimicrobial resistance in 2019: A systematic analysis. The Lancet, 399(10325), 629–655. https://doi.org/10.1016/S0140-6736(21)02724-0
Musenge, E. M., Nzala, S. H., Kabinga-Makukula, M., Wahila, R., Machona, P., Kalungia, A. C., Daka, H., Simpamba, M., Imakando, M. M., Kayamba, V., Mwiinga-Kalusopa, V., Soko, G., Simuyemba, M. C., Kampata-Olowski, L., Zyambo, C., Katowa-Mukwato, P., Chigunta, M., Phiri, M. M., Mwiinga, C., Kwaleyela, C., … Goma, F. M. (2022). Application of interprofessional education model to university pre-licensure health students in the management of chronic care conditions in Zambia. Medical Journal of Zambia, 49(2), 185–197. https://doi.org/10.55320/mjz.49.2.1118
Nkengasong, J. N., & Tessema, S. K. (2020). Africa needs a new public health order to tackle infectious disease threats. Cell, 183(2), 296–300. https://doi.org/10.1016/j.cell.2020.09.041
Ogunleye, O. O., Basu, D., Mueller, D., Sneddon, J., Seaton, R. A., Yinka-Ogunleye, A. F., Wamboga, J., Miljković, N., Mwita, J. C., Rwegerera, G. M., Massele, A., Patrick, O., Niba, L. L., Nsaikila, M., Rashed, W. M., Hussein, M. A., Hegazy, R., Amu, A. A., Boahen-Boaten, B. B., Matsebula, Z., … Godman, B. (2020). Response to the novel Corona Virus (COVID-19) pandemic across Africa: Successes, challenges, and implications for the future. Frontiers in Pharmacology, 11, 1205. https://doi.org/10.3389/fphar.2020.01205
Ogunleye, O. O., Godman, B., Fadare, J. O., Mudenda, S., Adeoti, A. O., Yinka-Ogunleye, A. F., Ogundele, S. O., Oyawole, M. R., Schönfeldt, M., Rashed, W. M., Galal, A. M., Masuka, N., Zaranyika, T., Kalungia, A. C., Malande, O. O., Kibuule, D., Massele, A., Chikowe, I., Khuluza, F., Taruvinga, T., … Meyer, J. C. (2022). Coronavirus Disease 2019 (COVID-19) pandemic across Africa: Current status of vaccinations and implications for the future. Vaccines, 10(9), 1553. https://doi.org/10.3390/vaccines10091553
Olsson, S., Pal, S. N., & Dodoo, A. (2015). Pharmacovigilance in resource-limited countries. Expert Review of Clinical Pharmacology, 8(4), 449–460. https://doi.org/10.1586/17512433.2015.1053391
Pires, C. (2021). A systematic review on learning outcomes of pharmacovigilance issues: Undergraduates of pharmacy. International Journal of Educational Research, 109, 101845. https://doi.org/10.1016/j.ijer.2021.101845
Prashar, L. & Musoke, P. (2014). A preliminary study of knowledge, attitude and practice of adverse drug reaction reporting in a teaching hospital in Lusaka, Zambia. Medical Journal of Zambia, 41(4), 155–161. https://dspace.unza.zm/items/89a52d6b-835c-4d2c-8cfe-8df99f4279f7
Prashar, L., Jere, E., & Kalungia, C. A. (2019). Inadequate knowledge and practice of pharmacovigilance affecting adverse drug reaction reporting by health professionals in private healthcare facilities in Lusaka, Zambia. Medical Journal of Zambia, 46(4), 314–320. https://www.ajol.info/index.php/mjz/article/view/193885/183152
Rasheed, R. A., Kamsin, A., & Abdullah, N. A. (2020). Challenges in the online component of blended learning: A systematic review. Computers & Education, 144, 103701. https://doi.org/10.1016/j.compedu.2019.103701
Rasmussen, P. (2022). Pharmacovigilance for herbal medicines: A perspective from the herbal medicines industry. In J. Barnes (Ed.), Pharmacovigilance for herbal and traditional medicines: Advances, challenges and international perspectives (pp. 249–259). Springer International Publishing. https://doi.org/10.1007/978-3-031-07275-8_14
Reumerman, M., Tichelaar, J., Piersma, B., Richir, M. C. & Van Agtmael, M. A. (2018). Urgent need to modernize pharmacovigilance education in healthcare curricula: Review of the literature. European Journal of Clinical Pharmacology, 74, 1235–1248. https://doi.org/10.1007/s00228-018-2500-y
Sabaté, M., & Montané, E. (2023). Pharmacoepidemiology: An overview. Journal of Clinical Medicine, 12(22), 7033. https://doi.org/10.3390/jcm12227033
Saint-Raymond, A., Valentin, M., Nakashima, N., Orphanos, N., Santos, G., Balkamos, G., & Azatyan, S. (2022). Reliance is key to effective access and oversight of medical products in case of public health emergencies. Expert Review Of Clinical Pharmacology, 15(7), 805–810. https://doi.org/10.1080/17512433.2022.2088503
Saleem, Z., Godman, B., Cook, A., Khan, M. A., Campbell, S. M., Seaton, R. A., Siachalinga, L., Haseeb, A., Amir, A., Kurdi, A., Mwita, J. C., Sefah, I. A., Opanga, S. A., Fadare, J. O., Ogunleye, O. O., Meyer, J. C., Massele, A., Kibuule, D., Kalungia, A. C., Shahwan, M., … Moore, C. E. (2022). Ongoing efforts to improve antimicrobial utilization in hospitals among African countries and implications for the future. Antibiotics (Basel, Switzerland), 11(12), 1824. https://doi.org/10.3390/antibiotics11121824
SAQA. (2017). National qualifications framework ABET levels and the national senior certificate. Department of Higher Education & Training, Republic of South Africa. South Africa Qualifications Authority. https://www.saqa.org.za/wp-content/uploads/2023/02/National-Qualifications-Framework.pdf [Accessed: May 2024]
Schellack, N., Strydom, M., Pepper, M. S., Herd, C. L., Hendricks, C. L., Bronkhorst, E., Meyer, J. C., Padayachee, N., Bangalee, V., Truter, I., Ellero, A. A., Myaka, T., Naidoo, E., & Godman, B. (2022). Social media and COVID-19; Perceptions and public deceptions of ivermectin, colchicine and hydroxychloroquine: Lessons for future pandemics. Antibiotics, 11(4), 445. https://doi.org/10.3390/antibiotics11040445
Sefah, I., Kordorwu, H., Essah, D., Kurdi, A., & Godman, B. (2021). Prevalence rate of spontaneously reported adverse events and determinants of serious adverse events amongst three outpatient care settings in ghana: Findings and implications. Advances in Human Biology, 11(1), 97–105. https://doi.org/10.4103/aihb.aihb_148_20
Shrestha, S., Sharma, S., Bhasima, R., Kunwor, P., Adhikari, B., & Sapkota, B. (2020). Impact of an educational intervention on pharmacovigilance knowledge and attitudes among health professionals in a Nepal cancer hospital. BMC Medical Education, 20(1), 179. https://doi.org/10.1186/s12909-020-02084-7
Silveira, D., Prieto-Garcia, J. M., Boylan, F., Estrada, O., Fonseca-Bazzo, Y. M., Jamal, C. M., Magalhães, P. O., Pereira, E. O., Tomczyk, M., & Heinrich, M. (2020). COVID-19: Is there evidence for the use of herbal medicines as adjuvant symptomatic therapy? Frontiers in Pharmacology, 11, 581840. https://doi.org/10.3389/fphar.2020.581840
Smith, M. P. & Webley, S. D. (2013). Pharmacovigilance teaching in UK undergraduate pharmacy programmes. Pharmacoepidemiology and Drug Safety, 22(3), 223–228. https://doi.org/10.1002/pds.3311
Stegmann, J. U., Jusot, V., Menang, O., Gardiner, G., Vesce, S., Volpe, S., Ndalama, A., Adou, F., Ofori-Anyinam, O., Oladehin, O., & Mendoza, Y. G. (2022). Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa. BMC Public Health, 22(1), 1568. https://doi.org/10.1186/s12889-022-13867-6
Sulis, G., Sayood, S., Katukoori, S., Bollam, N., George, I., Yaeger, L. H., Chavez, M. A., Tetteh, E., Yarrabelli, S., Pulcini, C., Harbarth, S., Mertz, D., Sharland, M., Moja, L., Huttner, B., & Gandra, S. (2022). Exposure to World Health Organization's AWaRe antibiotics and isolation of multidrug resistant bacteria: A systematic review and meta-analysis. Clinical Microbiology and Infection, 28(9), 1193–1202. https://doi.org/10.1016/j.cmi.2022.03.014
Terblanche, A., Meyer, J. C., Godman, B., & Summers, R. S. (2017). Knowledge, attitudes and perspective on adverse drug reaction reporting in a public sector hospital in South Africa: Baseline analysis. Hospital Practice (1995), 45(5), 238–245. https://doi.org/10.1080/21548331.2017.1381013
Terblanche, A., Meyer, J. C., Godman, B., & Summers, R. S. (2018). Impact of a pharmacist-driven pharmacovigilance system in a secondary hospital in the Gauteng Province of South Africa. Hospital Practice (1995), 46(4), 221–228. https://doi.org/10.1080/21548331.2018.1510708
Vallée, A., Blacher, J., Cariou, A., & Sorbets, E. (2020). Blended learning compared to traditional learning in medical education: Systematic review and meta-analysis. Journal of Medical Internet Research, 22(8), e16504. https://doi.org/10.2196/16504
van Eekeren, R., Rolfes, L., Koster, A. S., Magro, L., Parthasarathi, G., Al Ramimmy, H., Schutte, T., Tanaka, D., van Puijenbroek, E., & Härmark, L. (2018). What future healthcare professionals need to know about pharmacovigilance: Introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug Safety, 41(11), 1003–1011. https://doi.org/10.1007/s40264-018-0681-z
Walker, R., Lang, T., & Allen, E. (2019). Can building a community of practice improve pharmacovigilance in Africa? Transactions of the Royal Society of Tropical Medicine and Hygiene, 113(S1), S72–S72. https://www.tropicalmedicine.ox.ac.uk/publications/1070759
WHO. (2002). The importance of pharmacovigilance - Safety monitoring of medicinal products, Geneva, Switzerland. World Health Organization. https://iris.who.int/bitstream/handle/10665/42493/a75646.pdf [Accessed May 2024]
WHO. (2021). What is pharmacovigilance? World Health Organisation. https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance [Accessed: Feb 2022]
Wildbret, S., Stuck, L., Luchen, C. C., Simuyandi, M., Chisenga, C., Schultsz, C., & Harris, V. C. (2023). Drivers of informal sector and non-prescription medication use in pediatric populations in a low-and middle-income setting: A prospective cohort study in Zambia. PLOS Global Public Health, 3(7), e0002072. https://doi.org/10.1371/journal.pgph.0002072
Yeika, E. V., Ingelbeen, B., Kemah, B. L., Wirsiy, F. S., Fomengia, J. N., & van der Sande, M. A. B. (2021). Comparative assessment of the prevalence, practices and factors associated with self-medication with antibiotics in Africa. Tropical Medicine and International Health, 26(8), 862–881. https://doi.org/10.1111/tmi.13600
ZAMRA. (2023). Zambia Pharmacovigilance Handbook. Zambia Medicines Regulatory Authority. https://www.zamra.co.zm/wp-content/uploads/2023/06/ZAMBIA-PHARMACOVIGILANCE-Handbook-March-2020-Edited-June-23.pdf [Accessed: May 2024]
ZAQA. (2016). Zambia Qualifications Framework Level Descriptors. Zambia Qualifications Authority. https://www.zaqa.gov.zm/wp-content/uploads/2020/07/ZAMBIA-QUALIFICATIONS-FRAMEWORK-LEVEL-DESCRIPTORS-June-2016-v02.pdf
