A Scoping Review of the Pharmacovigilance Systems in West African region
References
- Uppsala Monitoring Centre. The use of the WHO-UMC system for standardized case causality assessment. Uppsala Monitoring Centre Uppsala. Accessed 15th March 2023. Available from: https://www.who.int/publications/m/item/WHO-causality-assessment
- World Health Organization. World Health Organization [WHO]. The importance of pharmacovigilance. Geneva: World Health Organization. World Health Organization. Accessed 22nd March 2023. Available from: https://www.who.int/publications/i/item/10665-42493
- Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. Journal of Young Pharmacists. 2010;2(3):315-320. https://doi.org/10.4103/0975-1483.66802
- Chen BK, Yang YT. Post-marketing surveillance of prescription drug safety: past, present, and future. Journal of Legal Medicine. 2013;34(2):193-213. https://doi.org/10.1080/01947648.2013.800797
- Burke SP, Stratton K, Baciu A. The future of drug safety: promoting and protecting the health of the public. National Academies Press; 2007.
- Al-Worafi YM. Drug safety in Palestine. In: Drug safety in developing countries. Academic Press, 2020: p. 471-80. https://doi.org/10.1016/B978-0-12-819837-7.00034-0
- Rouveix B. Antibiotic safety assessment. International Journal of Antimicrobial Agents. 2003;21(3):215-221. https://doi.org/10.1016/S0924-8579(02)00354-0
- Woosley RL, Whyte J, Mohamadi A, Romero K. Medical decision support systems and therapeutics: the role of autopilots. Clinical Pharmacology & Therapeutics. 2016;99(2):161-164. https://doi.org/10.1002/cpt.259
- Antropova G, Okonenko T, Fikhtner O, Veber V, Nemyatykh O. Pharmacovigilance as a tool for ensuring economic security in the Russian healthcare system. Atlantis Press; 2021:68-73. https://doi.org/10.2991/aebmr.k.210222.014
- Swathi B, Bhavika D, Begum N. Adverse drug reaction profiles of commonly used platinum compounds in cancer chemotherapy. Int J Basic Clin Pharmacol. 2015;4(2):284-289.
- Pirmohamed M, Atuah KN, Dodoo AN, Winstanley P. Pharmacovigilance in developing countries. British Medical Journal Publishing Group; 2007. p. 462-462. https://doi.org/10.1136/bmj.39323.586123.BE
- Mendoza YG, Jusot V, Adou F, et al. Enhancing Pharmacovigilance in Côte d’Ivoire: Impact of GSK’s Training and Mentoring Pilot Project in the Abidjan Region. Drug Saf. 2024;47(2):147-159. https://doi.org/10.1007/s40264-023-01368-3
- Mgboko CA. Impact of post marketing surveillance on falsified medicine in Nigeria. Innopharma Education. 2021. Available from: https://repository.innoskills.com/items/493459f3-9e29-4017-872c-a12079859ef0
- World Health Organization. Summary of the evidence on patient safety: implications for research. World Health Organization; 22 Sept 2008. Available from: https://www.who.int/publications/i/item/9789241596541
- Opadeyi AO, Fourrier-Réglat A, Isah AO. Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators. BMC Pharmacol Toxicol. 2018;19(1):27. https://doi.org/10.1186/s40360-018-0217-2
- Ejekam C, Fourrier-Réglat A, Isah A. Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators. Sahel Med J. 2020;23(4):226-235. https://doi.org/10.4103/smj.smj_46_19
- Alomar M, Tawfiq AM, Hassan N, Palaian S. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Therapeutic Advances in Drug Safety. 2020;11. https://doi.org/10.1177/2042098620938595
- Chakraborty A, Venkatraman JV. Pharmacovigilance through phased clinical trials, post-marketing surveillance and ongoing life cycle safety. In: The quintessence of basic and clinical research and scientific publishing. Springer; 2023:427-442.
- Zhou S-F, Ming Di Y, Chan E, et al. Clinical pharmacogenetics and potential application in personalized medicine. Current drug metabolism. 2008;9(8):738-784. https://doi.org/10.2174/138920008786049302
- Abiri OT, Johnson WC. Pharmacovigilance systems in resource-limited settings: an evaluative case study of Sierra Leone. Journal of Pharmaceutical Policy and Practice. 2019;12:1-8. https://doi.org/10.1186/s40545-019-0173-2
- Nagumo W-R. Pharmacovigilance and adverse drug reaction reporting practices among Ghanaian healthcare professionals. University of Sheffield; 2020.
- Al-Worafi YM. Patient care related issues in the developing countries: drug related problems (DRPs). In: Handbook of Medical and Health Sciences in Developing Countries: Education, Practice, and Research. Springer; 2023:1-27.
- Shafei L, Mekki L, Maklad E, et al. Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework. International Journal of Clinical Pharmacy. 2023;45(4):801-813. https://doi.org/10.1007/s11096-023-01591-z
- Adenuga BA. Optimising adverse drug reactions reporting and strengthening of pharmacovigilance systems in Namibia. University of Namibia; 2021.
- Cheng W, Du J, Chen C, et al. Exploring the influencing factors of adverse drug reaction reporting among medical personnel: a COM-B model-based study. Journal of Pharmaceutical Policy and Practice. 2024;17(1):
2417410 . https://doi.org/10.1080/20523211.2024.2417410 - Maluleke TL. Development of a direct ADR reporting tool for patients to address under-reporting of ADRs to the National Pharmacovigilance Unit in South Africa. Stellenbosch: Stellenbosch University; 2022.
- Costa C, Abeijon P, Rodrigues DA, Figueiras A, Herdeiro MT, Torre C. Factors associated with underreporting of adverse drug reactions by patients: a systematic review. Int J Clin Pharm. 2023 Dec;45(6):1349-1358. https://doi.org/10.1007/s11096-023-01592-y
- Tricco AC, Lillie E, Zarin W, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Annals of internal medicine. 2018;169(7):467-473. https://doi.org/10.7326/M18-0850
- World Health Organization. WHO Programme for International Drug Monitoring. World Health Organization. Accessed 15th January 2023.
- Onasanya SS, Yamoah P, Oosthuizen F. A Comparative Study of the Pharmacovigilance System in Nigeria and Ghana using WHO-Indicator Based Pharmacovigilance Assessment Tool.(IPAT). 2023. https://doi.org/10.21203/rs.3.rs-2216812/v1
- Aborigo RA, Welaga P, Oduro A, et al. Optimising reporting of adverse events following immunisation by healthcare workers in Ghana: a qualitative study in four regions. PLoS One. 2022;17(12):
e0277197 . https://doi.org/10.1371/journal.pone.0277197 - Acheampong F, Anto BP. Perceived barriers to pharmacist engagement in adverse drug event prevention activities in Ghana using semi-structured interview. BMC Health Serv Res. 2015;15(1):361. https://doi.org/10.1186/s12913-015-1031-9
- Adedeji WA, Adegoke AB, Fehintola FA. Adverse drug reactions reporting practice and associated factors among community health extension workers in public health facilities, Southwest, Nigeria. Pan Afr Med J. 2021;40:165. https://doi.org/10.11604/pamj.2021.40.165.28574
- Adegbuyi TA, Fadare JO, Araromi EJ, et al. Assessment of Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting Among Healthcare Professionals working in Primary, Secondary and Tertiary Healthcare Facilities in Ekiti State, South-West Nigeria. Hospital Pharmacy. Dec 2021;56(6):751-759. https://doi.org/10.1177/0018578720957968
- Adisa R, Adeniyi OR, Fakeye TO. Knowledge, awareness, perception and reporting of experienced adverse drug reactions among outpatients in Nigeria. Int J Clin Pharm. Aug 2019;41(4):1062-1073. https://doi.org/10.1007/s11096-019-00849-9
- Kukula VA, Dodoo AAN, Akpakli J, et al. Feasibility and cost of using mobile phones for capturing drug safety information in peri-urban settlement in Ghana: a prospective cohort study of patients with uncomplicated malaria. Article. Malaria Journal. 2015;14(1)411. https://doi.org/10.1186/s12936-015-0932-8
- Adisa R, Omitogun TI. 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 Serv Res. Dec 3, 2019;19(1):926. https://doi.org/10.1186/s12913-019-4775-9
- Adu-Gyamfi PKT, Mensah KB, Ocansey J, et al. Assessment of knowledge, practices, and barriers to pharmacovigilance among nurses at a teaching hospital, Ghana: a cross-sectional study. Article. BMC Nursing. 2022;21(1)242. https://doi.org/10.1186/s12912-022-00965-4
- Agu KA, Oparah AC, Ochei UM. Knowledge and attitudes of HIV-infected patients on antiretroviral therapy regarding adverse drug reactions (ADRs) in selected hospitals in Nigeria. Perspectives in clinical research. 2012;3(3):95-101. https://doi.org/10.4103/2229-3485.100657
- Anyachebelu O, Aluh D. Pharmacists compliance to practice regulations and good professional practice: a case study of Nigerian community pharmacists. Int J Pharm Pharm Sci. 2018;10:98-104. https://doi.org/10.22159/ijpps.2018v10i7.25858
- Appiah B, Poudyal A, Burdine JN, et al. Factors that influence the intention to use mobile phone caller tunes for patients reporting of adverse drug reactions: a qualitative study. THERAPEUTIC ADVANCES IN DRUG SAFETY. SEP 2019;
102042098619871190 . https://doi.org/10.1177/2042098619871190 - Asiamah M, Akuffo KO, Nortey P, Donkor N, Danso-Appiah A. Spontaneous reporting of adverse drug reaction among health professionals in Ghana. Archives of Public Health. 20 Jan 2022;80(1)33. https://doi.org/10.1186/s13690-021-00783-1
- Avong YK, Jatau B, Gurumnaan R, et al. Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study. Article. PLoS ONE. 2018;13(8)
e0200810 . https://doi.org/10.1371/journal.pone.0200810 - Awodele O, Adeniran A, Awodele DF. Pharmacovigilance amongst patent medicine vendors (PMVs) in Ekiti state, Nigeria. The International Journal of Risk & Safety in Medicine. 2012;24(2):65-72. https://doi.org/10.3233/JRS-2012-0562
- Awodele O, Akinyede A, Adeyemi OA, Awodele DF. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria. International Journal of Risk and Safety in Medicine. 2011;23(4):217-226. https://doi.org/10.3233/JRS-2011-0541
- Awodele O, Daniel A, Popoola TD, Salami EF. A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria. The International journal of risk & safety in medicine. 2013;25(4):205-217. https://doi.org/10.3233/JRS-130604
- Balogun SH, Adeleye OA. Patient reporting practices of suspected adverse drug reactions to antiretroviral drugs in a tertiary health facility in Nigeria. The Nigerian postgraduate medical journal. 2014;21(4):331-337. https://doi.org/10.4103/1117-1936.163489
- Balogun ST, Okon KO, Akanmu AO, Paul LM, Sodipo OA. Safety monitoring of herbal medicines in Nigeria: worrying state of pharmacovigilance system based on WHO core pharmacovigilance indicators. Journal of Herbmed Pharmacology. 2021;10(2):202-208. https://doi.org/10.34172/jhp.2021.22
- Bello SO, Umar MT. Knowledge and attitudes of physicians relating to reporting of adverse drug reactions in Sokoto, north-western Nigeria. Ann Afr Med. Jan-Mar 2011;10(1):13-8. https://doi.org/10.4103/1596-3519.76563
- Chatio S, Aborigo R, Adongo PB, et al. Factors influencing adverse events reporting within the health care system: the case of artemisinin-based combination treatments in northern Ghana. Malaria Journal. 27 Feb 2016;15125. https://doi.org/10.1186/s12936-016-1172-2
- Daniel A, Muhammad AS. Adverse drug reactions reporting among health professionals in government hospitals in Katsina State, Nigeria. Texila International Journal of Public Health. 2021;9(3) https://doi.org/10.21522/TIJPH.2013.09.03.Art002
- Eze SC, Odoh EC, Eze KC, et al. Assessment of pharmacovigilance activities among pharmacist interns in Nigeria: a cross-sectional study. Future Journal of Pharmaceutical Sciences. 8 Feb 2023;9(1)11. https://doi.org/10.1186/s43094-023-00463-7
- Fadare JO, Enwere OO, Afolabi A, Chedi B, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Tropical Journal of Pharmaceutical Research. 2011;10(3) https://doi.org/10.4314/tjpr.v10i3.4
- Gidudu JF, Shaum A, Dodoo A, et al. Barriers to healthcare workers reporting adverse events following immunization in four regions of Ghana. Article. Vaccine. 2020;38(5):1009-1014. https://doi.org/10.1016/j.vaccine.2019.11.050
- Gulma KA. An exploratory study of seasonal malaria chemoprevention and pharmacovigilance for under-five children in Kebbi State, Nigeria. Indian J Public Health. Jul-Sep 2023;67(3):352-356. https://doi.org/10.4103/ijph.ijph_577_23
- Jaquet A, Djima MM, Coffie P, et al. Pharmacovigilance for antiretroviral drugs in Africa: lessons from a study in Abidjan, Cote d’Ivoire. Pharmacoepidemiol Drug Saf. Dec 2011;20(12):1303-10. https://doi.org/10.1002/pds.2182
- Kabore L, Millet P, Fofana S, Berdai D, Adam C, Haramburu F. Pharmacovigilance systems in developing countries: an evaluative case study in Burkina Faso. Drug Safety. May 2013;36(5):349-58. https://doi.org/10.1007/s40264-013-0043-9
- Mohammed LA, Aliyu AA, Maiha BB, Isa A. Knowledge, perception and reporting attitude of adverse effects following immunization among primary healthcare workers in sabon gari local government area Zaria, Kaduna State, Nigeria. Article. Nigerian Journal of Basic and Clinical Sciences. 2018;15(1):81-86. https://doi.org/10.4103/njbcs.njbcs_18_17
- Mohammed M, Umar FI, Labaran KS, et al. Evaluation of adverse drug reaction reporting among traditional medicine practitioners in zaria kaduna state nigeria. Article. Tropical Journal of Natural Product Research. 2019;3(3):85-90. https://doi.org/10.26538/tjnpr/v3i3.4
- Ndiaye JLA, Diallo I, Ndiaye Y, et al. Evaluation of two strategies for communitybased safety monitoring during seasonal malaria chemoprevention campaigns in Senegal, compared with the National Spontaneous Reporting System. Pharmaceutical Medicine. 2018;32(3):189-200. https://doi.org/10.1007/s40290-018-0232-z
- Obieze A, Adigwe OP, Ibegbunam I, et al. Assessment of knowledge attitude and practice of pharmacovigilance by leaders in public health pharmaceutical supply chain in Nigeria. Journal of Phytomedicine and Therapeutics. 2022;21(2):910-921. https://doi.org/10.4314/jopat.v21i2.13
- Ohaju-Obodo JO, Iribhogbe OI. Extent of pharmacovigilance among resident doctors in Edo and Lagos states of Nigeria. Pharmacoepidemiol Drug Saf. Feb 2010;19(2):191-5. https://doi.org/10.1002/pds.1724
- Okezie EO, Fawole OI. Adverse drug reactions reporting by physicians in Ibadan, Nigeria. Pharmacoepidemiology and Drug Safety. May 2008;17(5):517-522. https://doi.org/10.1002/pds.1597
- Omoleke SA, Getachew B, Isyaku A, et al. Understanding and experience of adverse event following immunization (AEFI) and its consequences among healthcare providers in Kebbi State, Nigeria: a qualitative study. BMC Health Serv Res. Jun 3, 2022;22(1):741. https://doi.org/10.1186/s12913-022-08133-9
- Opadeyi AO, Fourrier-Réglat A, Isah AO. Educational intervention to improve the knowledge, attitude and practice of healthcare professionals regarding pharmacovigilance in South-South Nigeria. Therapeutic Advances in Drug Safety. 25 Jan 2019;10. https://doi.org/10.1177/2042098618816279
- Oppong KG, Attakorah J, Enimil A, Ansah C, Buabeng KO. Antibiotic stewardship and its impact on antibiotic use at the child health directorate of a teaching hospital in Ghana. African Journal of Applied Research. 2022;8(2):322-331. https://doi.org/10.26437/ajar.31.10.2022.22
- Oreagba IA, Ogunleye OJ, Olayemi SO. The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, southwest Nigeria. Pharmacoepidemiology and Drug Safety. 2011;20(1):30-35. https://doi.org/10.1002/pds.2021
- Osakwe A, Oreagba I, Adewunmi AJ, Adekoya A, Fajolu I. Impact of training on Nigerian healthcare professionals’ knowledge and practice of pharmacovigilance. The International journal of risk & safety in medicine. 2013;25(4):219-227. https://doi.org/10.3233/JRS-130605
- Osei JY, Nortey PA, Bandoh DA, Kenu E, Addo-Lartey AA. Adverse drug reaction reporting by community pharmacists in the Greater Accra Region of Ghana, 2016. Ghana Med J. Mar 2021;55(1):9-17. https://doi.org/10.4314/gmj.v55i1.3
- Osemene KP, Afolabi MO. An evaluation of the knowledge and perceptions of pharmacy students on pharmacovigilance activities in Nigeria. Article. BMC Research Notes. 2017;10(1)273. https://doi.org/10.1186/s13104-017-2586-9
- Osemene KP, Ayeni MI, Afolabi MO. The role of community pharmacists in monitoring adverse drug reactions in Nigeria. Article. Journal of Pharmaceutical Health Services Research. 2012;3(4):197-204. https://doi.org/10.1111/j.1759-8893.2012.00100.x
- Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. Article. BMC Clinical Pharmacology. 2009;914. https://doi.org/10.1186/1472-6904-9-14
- Oshikoya KA, Senbanjo IO, Amole OO. Interns’ knowledge of clinical pharmacology and therapeutics after undergraduate and on-going internship training in Nigeria: a pilot study. BMC medical education. 2009;9:50. https://doi.org/10.1186/1472-6920-9-50
- Oshikoya KA, Senbanjo IO, Njokanma OF. Parental reporting of suspected adverse drug reactions in children in Lagos, Nigeria. Arch Dis Child. Jun 2009;94(6):469-73. https://doi.org/10.1136/adc.2008.152629
- Powell JF, Henneh IT, Ekor M. Knowledge, attitude and practice of physicians and nurses at the cape coast teaching hospital in the Central Region of Ghana on spontaneous adverse drug reaction reporting. PLOS ONE. JUL 7, 2023;18(7)
e0288100 . https://doi.org/10.1371/journal.pone.0288100 - Rouamba T, Sondo P, Derra K, et al. Optimal approach and strategies to strengthen pharmacovigilance in Sub-Saharan Africa: a cohort study of patients treated with first-line artemisinin-based combination therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso. Drug Des Devel Ther. 2020;14:1507-1521. https://doi.org/10.2147/dddt.S224857
- Sabblah GT, Akweongo P, Darko D, Dodoo AN, Sulley AM. Adverse drug reaction reporting by doctors in a developing country: a case study from Ghana. Ghana medical journal. 2014;48(4):189-193. https://doi.org/10.4314/gmj.v48i4.4
- Sabblah GT, Darko D, Härmark L, Van Puijenbroek E. Patient preferences and expectation for feedback on adverse drug reaction reports submitted in Ghana. Article. Ghana Medical Journal. 2019;53(2):150-155. https://doi.org/10.4314/gmj.v53i2.10
- Sabblah GT, Darko DM, Mogtari H, Härmark L, van Puijenbroek E. Patients’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana. Drug Saf. Oct 2017;40(10):911-921. https://doi.org/10.1007/s40264-017-0563-9
- Seaneke SK, Darko DM, Nkansah E, et al. First results from the lessons learnt from the deployment of the Med Safety App for reporting adverse drug reactions in Ghana. Digital Health. 2023. https://doi.org/10.1177/20552076231211276
- Showande JS, Oyelola FT. The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university. Internet Journal of Medical Update. 2013;8(1):24-30.
- Showande SJ, Ikuomola IF. Pharmacists’ involvement with and pharmacy clients’ awareness of adverse drug reaction reporting in Nigeria: a mixed-methods approach. Journal of Pharmaceutical Health Services Research. 30 Dec 2022;13(4):276-288. https://doi.org/10.1093/jphsr/rmac032
- Udoye JA, Ozolua RI, Nwokike J. Assessment of the knowledge, attitude and practice of pharmacovigilance by pharmacists in two states in south-eastern Nigeria. Tropical Journal of Pharmaceutical Research. May 2018;17(5):937-945. https://doi.org/10.4314/tjpr.v17i5.25
- Yamoah P, Bangalee V, Oosthuizen F. Knowledge and perceptions of adverse events following immunization among healthcare professionals in Africa: a case study from Ghana. Vaccines. 2019;7(1):28. https://doi.org/10.3390/vaccines7010028
- Yawson AA, Abekah-Nkrumah G, Okai GA, Ofori CG. Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana. Therapeutic Advances in Drug Safety. 2022;13. https://doi.org/10.1177/20420986221116468
- van Puijenbroek E, Barry A, Khaemba C, et al. Short-term training: a useful approach for sustainable pharmacovigilance knowledge development in Tanzania, Kenya, Ethiopia and Rwanda. Drug Safety. 2024;47(12):1193-1202. https://doi.org/10.1007/s40264-024-01469-7
- World Health Organization. Western Pacific regional action agenda on regulatory strengthening, convergence and cooperation for medicines and the health workforce. World Health Organization. 30 April 2020. Accessed 20 February 2023. Available from: https://www.who.int/publications/i/item/9789290618942
- Al-Worafi YM, Ming LC. Healthcare systems in developing countries. In: Handbook of medical and health sciences in developing countries: education, practice, and research. Springer; 2024:1-22. https://doi.org/10.1007/978-3-030-74786-2_207-1
- Amanatullah ET, Morris MW. Negotiating gender roles: Gender differences in assertive negotiating are mediated by women’s fear of backlash and attenuated when negotiating on behalf of others. Journal of Personality and Social Psychology. 2010;98(2):256. https://doi.org/10.1037/a0017094
DOI: https://doi.org/10.15566/cjgh.v12i2.419 | Journal eISSN: 2167-2415
Language: English
Page range: 33 - 59
Submitted on: Jan 23, 2025
Accepted on: Apr 25, 2025
Published on: Aug 29, 2025
Published by: Global Health Institute at William Carey International University
In partnership with: Paradigm Publishing Services
Keywords:
© 2025 Isatu Jalloh, Peter Bai James, Onome Thomas Abiri, Ebenezer Wiafe, Kofi Mensah, Neelaveni Padayachee, published by Global Health Institute at William Carey International University
This work is licensed under the Creative Commons Attribution 4.0 License.