Authors :
Shamisale Keegan; Harriet. C. Kwenda; Kasonde Bowa; Chisotwa Muyembe
Volume/Issue :
Volume 11 - 2026, Issue 3 - March
Google Scholar :
https://tinyurl.com/57erd3b4
Scribd :
https://tinyurl.com/y6fpccyr
DOI :
https://doi.org/10.38124/ijisrt/26mar297
Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.
Abstract :
Pharmacovigilance has grown significantly in recent years and its importance in the healthcare system has been
recognized worldwide. However, there are considerable issues which need to be addressed to ensure the safety of medicines.
WHO pharmacovigilance indicators have been endorsed as a suitable tool regarding refining pharmacovigilance activities.
Zambia with numerous challenges of medicines related issues is supporting the growth of pharmacovigilance in the public
health facilities. The study assessed the status of pharmacovigilance in the public health facilities (health Centres) of Kafue
District with a vision of improving the pharmacovigilance system in the district.
The researcher was guided by the objectives of the study which included: To identify the existence of pharmacovigilance
committees in the public health facilities of Kafue district; to assess the status of pharmacovigilance reports in the public
health facilities of Kafue district and to determine the impact of poor pharmacovigilance in the public health facilities of
Kafue district. The significance of adverse drug reaction reporting was noted as it had a critical role in pharmacovigilance.
The study adopted a cross-sectional descriptive study design in the Six (6) selected health centres in Kafue District. The
data was collected using prescribed pharmacovigilance indicators. Data was displayed qualitatively and quantitatively. A
statistical Software (SPSS version 21.0 used to analyze quantitative data and the results were presented using graphs and
frequency tables. Out of a total of six (6) health facilities sampled in Kafue district, Five (5) had showed availability of a
pharmacovigilance focal point person.
Standardized functional accommodation was a challenged in all the six facilities. Additionally, only one (1) facility (The
District Hospital) had shown availability a financial provision for pharmacovigilance activities in the district. Another
common parameter noted was the absence of the adverse drug reaction reports in the four (4) facilities. The number of
adverse drug reaction reports found in the system ranged from 0 to 7 and only 2 health facilities had fully submitted their
reports to the National Pharmacovigilance Centre.
Limited documented medicines related admissions were noted, ranging from 0.0874/1000 to 0.0532/1000. Additionally,
poor documentation of pharmacovigilance services was a common variable observed in all the six (6) selected facilities in the
district. The study findings call for an urgent need to develop and improve pharmacovigilance in health facilities of Kafue
District.
References :
- Almandil (2016). Healthcare professionals’ awareness and knowledge of adverse drug reactions and pharmacovigilance.
- Bouvy and Koopmanschap (2015). Epidemiology of adverse drug reactions in Europe. A review of recent observational studies. Drug Safety.
- Benkirane et al (2009). Prevalence and preventability of adverse drug events in a teaching hospital. A cross-sectional study. Eastern Mediterranean Health Journal.
- Clarke and Shakir (2006). An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets. Drug Safety.
- Duijnhoven et al (2013). Number of patients studied prior to approval of new medicines: A database analysis.
- Elzagallaai, Greff and Rieder (2017). Adverse Drug Reactions in Children: The Double-Edged Sword of Therapeutics, Clinical Pharmacology.
- European Commission (2008). Strengthening pharmacovigilance to reduce adverse effects of medicine. MEMO/08/782, Brussels. Accessed 30 July, 2019.
- Isah and Olowofela (2014). Clinical pharmacology in Nigeria. The Benin City experience, pharmacology matters.
- Kim and Scialli (2011). Thalidomide. The tragedy of birth defects and the effective treatment of disease. Toxicology Science.
- Lalvani and Milstein (2013). Access to New Health Products in Low Income Countries and the Challenge of Pharmacovigilance. [Accessed 29 July, 2019]. Available from: http://pdpaccess.org/ downloads/projects/full-papers/Pharmacovigilance%20 Discussion%20Paper.pdf
- Matthews and McCoy (2003). Thalidomide. A review of approved and investigational uses.
- Olowofela and Isah (2016). Pharmacovigilance in Nigeria: an overview. Pharmaceutics Med.
- Olsson and Couper (2010). Pharmacovigilance activities in 55 low- and middle- income countries. A questionnaire-based analysis.
- Olowofela and Isah (2017). A profile of adverse effects of antihypertensive medicines in a tertiary care clinic in Nigeria. Ann Afr Med.
- Thiesen et al (2013). Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children. A prospective observational cohort study of 6,601 admissions. BMCMed.
- The Ellen MacArthur foundation (2017). Home page. 1–5https://www. ellenmacarthurfoundation.org/.
- Strengthening Pharmaceutical Systems (2011). Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance. Arlington, VA: US Agency for international development by the strengthening pharmaceutical Systems (SPS) program.
- World Health Organization (2015). Fast facts on Pharmacovigilance.
- World Health Organisation (WHO). The importance of pharmacovigilance. Geneva: World Health Organisation; 2002
- World Health Organization (2002). The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products. 2002; 2002:1–52. http://dx.doi.org/10.1002/04708
- World Health Organization (2008). WHO Programme for International Drug Monitoring.
Pharmacovigilance has grown significantly in recent years and its importance in the healthcare system has been
recognized worldwide. However, there are considerable issues which need to be addressed to ensure the safety of medicines.
WHO pharmacovigilance indicators have been endorsed as a suitable tool regarding refining pharmacovigilance activities.
Zambia with numerous challenges of medicines related issues is supporting the growth of pharmacovigilance in the public
health facilities. The study assessed the status of pharmacovigilance in the public health facilities (health Centres) of Kafue
District with a vision of improving the pharmacovigilance system in the district.
The researcher was guided by the objectives of the study which included: To identify the existence of pharmacovigilance
committees in the public health facilities of Kafue district; to assess the status of pharmacovigilance reports in the public
health facilities of Kafue district and to determine the impact of poor pharmacovigilance in the public health facilities of
Kafue district. The significance of adverse drug reaction reporting was noted as it had a critical role in pharmacovigilance.
The study adopted a cross-sectional descriptive study design in the Six (6) selected health centres in Kafue District. The
data was collected using prescribed pharmacovigilance indicators. Data was displayed qualitatively and quantitatively. A
statistical Software (SPSS version 21.0 used to analyze quantitative data and the results were presented using graphs and
frequency tables. Out of a total of six (6) health facilities sampled in Kafue district, Five (5) had showed availability of a
pharmacovigilance focal point person.
Standardized functional accommodation was a challenged in all the six facilities. Additionally, only one (1) facility (The
District Hospital) had shown availability a financial provision for pharmacovigilance activities in the district. Another
common parameter noted was the absence of the adverse drug reaction reports in the four (4) facilities. The number of
adverse drug reaction reports found in the system ranged from 0 to 7 and only 2 health facilities had fully submitted their
reports to the National Pharmacovigilance Centre.
Limited documented medicines related admissions were noted, ranging from 0.0874/1000 to 0.0532/1000. Additionally,
poor documentation of pharmacovigilance services was a common variable observed in all the six (6) selected facilities in the
district. The study findings call for an urgent need to develop and improve pharmacovigilance in health facilities of Kafue
District.