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 PP  Vol.13 No.7 , July 2022
Familiarity, Knowledge and Practices of Healthcare Professionals Regarding the Pharmacovigilance of Biological Medicines in Lusaka, Zambia: A Multi-Facility Cross-Sectional Study
Abstract: Background: Pharmacovigilance of biological medicines is crucial because it ensures that medicines meet the World Health Organization (WHO) standards. In Zambia, there is little information on healthcare professionals’ familiarity, knowledge and practices on the pharmacovigilance of biological and biosimilar medicines. Therefore, this study investigated the familiarity, knowledge, and practices related to the pharmacovigilance (PV) of biological and biosimilar medicines at selected hospitals in Lusaka, Zambia. Methods: The study was an analytical questionnaire-based cross-sectional study conducted among healthcare professionals (HCPs) at the Adult hospital, Cancer Diseases hospital, Paediatrics hospital and Women and New Born Hospital in Lusaka. Data were collected over four weeks in May and June 2021 and subsequently analysed using IBM SPSS version 21. The statistical significance was set at a 95% confidence interval. Results: Of 245 participants, only 115 (48.9%) of the HCPs were familiar with biological medicines to a basic understanding. Regarding the term biosimilars, most of the HCPs (40.9%) never heard of this word. The mean score for knowledge regarding the PV considerations of biological medicines was 4.1 out of 8 questions. Most HCPs used non-proprietary names (44.2%) when prescribing, dispensing, or administering biological medicines. Additionally, more than half (57.3%) of HCPs did not record batch numbers when dispensing or administering biological medicines. Conclusion: Healthcare professionals were more familiar with the term biological medicines than biosimilars. Healthcare professionals generally scored poorly when their knowledge regarding the PV considerations of biological medicines was assessed. Thus, there is a need to provide adequate training and continuous professional development among healthcare professionals on the pharmacovigilance of biological and biosimilar medicines.
Cite this paper: Banda, M. , Verhamme, K. , Mufwambi, W. , Mudenda, S. , Chabalenge, B. , Matafwali, S. , Mutati, R. , Hikaambo, C. , 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, 230-251. doi: 10.4236/pp.2022.137019.
References

[1]   Stricker, B.H. and Psaty, B.M. (2004) Detection, Verification, and Quantification of Adverse Drug Reactions. BMJ, 329, 44-47. https://doi.org/10.1136/bmj.329.7456.44

[2]   Giezen, T.J., Mantel-Teeuwisse, A.K. and Leufkens, H.G. (2009) Pharmacovigilance of Biopharmaceuticals: Challenges Remain. Drug Safety, 32, 811-817.
https://doi.org/10.2165/11316550-000000000-00000

[3]   Giezen, T.J., Mantel-Teeuwisse, A.K., Straus, S.M.J.M., Schellekens, H., Leufkens, H.G.M. and Egberts, A.C.G. (2008) Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union. JAMA, 300, 1887- 1896. https://doi.org/10.1001/jama.300.16.1887

[4]   International Federation of Pharmaceutical Manufacturers & Associations (2016) Pharmacovigilance of Biotherapeutic Medicines: Identifying Global Case Studies Illustrating Successes and Challenges.

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

[6]   Sagi, S., Cohen, H.P. and Woollett, G.R. (2017) Pharmacovigilance of Biologics in a Multisource Environment. Journal of Managed Care & Specialty Pharmacy, 23, 1249- 1254. https://doi.org/10.18553/jmcp.2017.23.12.1249

[7]   Food and Drugs Administration (2017) Nonproprietary Naming of Biological Products: Guidance for Industry. U.S. Department of Health and Human Services, Washington DC.

[8]   Vanderlaan, M., Maniatis, A., Olney, R., Rahmaoui, A., Yau, L., Quarmby, V., Azzolino, C., Woods, C. and Moawad, D. (2020) Changes in Manufacturing Processes of Biologic Therapies Can Alter the Immunogenicity Profile of the Product. Clinical Pharmacology & Therapeutics, 107, 988-993. https://doi.org/10.1002/cpt.1694

[9]   Calvo, B. and Zuñiga, L. (2014) EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars. Drug Safety, 37, 9-18.
https://doi.org/10.1007/s40264-013-0121-z

[10]   Zambia Medicines Regulatory Authority (2019) Medicines for Human Use 2019 Register.

[11]   WHO Expert Committee on Biological Standardization (2013) Annexe 2. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Technical Report Series No. 977. World Health Organisation, Geneva.

[12]   Claus, B.O., Lunddahl, B. and van Gelder, T. (2017) Pharmacovigilance, Traceability and Building Trust in Biosimilar Medicines. GaBI Journal, 6, 135-140.
https://doi.org/10.5639/gabij.2017.0603.026

[13]   Annese, V., Solá, C., Breedveld, F., Ekman, N., Giezen, T., Gomollón, F., et al. (2016) Roundtable on Biosimilars with European Regulators and Medical Societies, Brussels, Belgium, 12 January 2016. Generics and Biosimilars Initiative Journal, 5, 74-83.
https://doi.org/10.5639/gabij.2016.0502.019

[14]   Cassar, K., Zammit Dimech, D., Grech, L., Balzan, D., Cutajar, A. and Cassar, P.J. (2016) SAT0637-HPR Biosimilars: The Perception amongst Maltese Clinicians. Annals of the Rheumatic Diseases, 75, 1294.
https://doi.org/10.1136/annrheumdis-2016-eular.1061

[15]   Reilly, M.S. and Gewanter, H.L. (2015) Prescribing Practices for Biosimilars: Questionnaire Survey Findings from Physicians in Argentina, Brazil, Colombia and Mexico. Generics and Biosimilars Initiative Journal, 4, 161-167.
https://doi.org/10.5639/gabij.2015.0404.036

[16]   Karateev, D. and Belokoneva, N. (2019) Evaluation of Physicians’ Knowledge and Attitudes towards Biosimilars in Russia and Issues Associated with Their Prescribing. Biomolecules, 9, Article No. 57. https://doi.org/10.3390/biom9020057

[17]   Klein, K., Hazell, L., Stolk, P. and Shakir, S. (2020) The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK. Drug Safety, 43, 255-263. https://doi.org/10.1007/s40264-019-00891-6

[18]   Cochran, W. (1963) Sampling Techniques. 2nd Edition, John Wiley and Sons Inc., New York.

[19]   Israel, G.D. (1992) Sampling the Evidence of Extension Program Impact.

[20]   Prashar, L. and 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, 155-161.

[21]   GaBI Online—Generics and Biosimilars Initiative. Biosimilars in EU to Be Identified by Brand Names.
https://www.gabionline.net/Policies-Legislation/Biologicals-in-EU-to-be-identified-by-brandnames

[22]   Dolinar, R.O. and Reilly, M.S. (2014) Biosimilars Naming, Label Transparency and Authority of Choice-Survey Findings among European Physicians. Generics and Biosimilars Initiative Journal, 3, 58-62. https://doi.org/10.5639/gabij.2014.0302.018

[23]   Murby, S.P. and Reilly, M.S. (2017) A Survey of Australian Prescribers’ Views on the Naming and Substitution of Biologicals. Generics and Biosimilars Initiative Journal, 6, 107-114. https://doi.org/10.5639/gabij.2017.0603.022

[24]   Klein, K., Scholl, J.H., Vermeer, N.S., Broekmans, A.W., Van Puijenbroek, E.P., De Bruin, M.L., et al. (2016) Traceability of Biologics in the Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Safety, 39, 185-192. https://doi.org/10.1007/s40264-015-0383-8

[25]   Saavedra, M.A., Aimo, C. andrade, J.A., Alvarez, D., Sequeira, G. and Kerzberg, E. (2019) Survey on Transportation and Storage of Biological Therapies by Patients. European Journal of Rheumatology, 6, 94-97.
https://doi.org/10.5152/eurjrheum.2019.18182

[26]   Prashar, L., Jere, E. and 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, 314-320.

[27]   Lopez-Gonzalez, E., Herdeiro, M.T. and Figueiras, A. (2009) Determinants of Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Safety, 32, 19-31. https://doi.org/10.2165/00002018-200932010-00002

[28]   Elnour, A.A., Ahmed, A.D., Yousif, M.A. and Shehab, A. (2009) Awareness and Reporting of Adverse Drug Reactions among Health Care Professionals in Sudan. Joint Commission Journal on Quality and Patient Safety, 35, 324-329.
https://doi.org/10.1016/S1553-7250(09)35046-1

[29]   Terblanche, A., Meyer, J.C., Godman, B. and 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, 238-245.
https://doi.org/10.1080/21548331.2017.1381013

[30]   Bogolubova, S., Padayachee, N. and Schellack, N. (2018) Knowledge, Attitudes and Practices of Nurses and Pharmacists towards Adverse Drug Reaction Reporting in the South African Private Hospital Sector. Health SA, 23, 1064.
https://doi.org/10.4102/hsag.v23i0.1064

 
 
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