Need for involving the pharmaceutical industry in the national pharmacovigilance program of Nepal
Abstract
Introduction: Adverse drug reactions (ADRs) have high morbidity and mortality and can cause a significant burden on patients. Most of the data on ADRs are generated from the developed world, and these data cannot be generalized to developing nations due to the variation in prescribing patterns, regulatory policies, and varied effects of drugs. Implementing a successful pharmacovigilance program in many developing countries faces several challenges including under-reporting, human resource shortage, financial challenges as well as poor policy and legal framework.
Method: In this commentary, we aim to explore the situation of Pharmacovigilance in Nepal through a close comparison with India and suggest ways to strengthen the same.
Results: Nepal is still in the beginning stage of Pharmacovigilance and ADR reporting is quite low. The Pharmacovigilance System in Nepal is limited to regional centers which report ADRs to the national center. There is no involvement of pharmaceutical industries in the system which may be a major reason for underreporting and suboptimal functioning of the pharmacovigilance system.
Discussion: Nepal must mandatorily involve pharmaceutical industries in pharmacovigilance. The new drug policy is under revision and addresses aspects of pharmacovigilance in terms of patient safety and the role of pharmaceutical companies.
Downloads
References
Alam, K., Shakya, R., Ojha, P. (2014). Reporting Adverse Drug Reactions Among Hospitalized Medical Patients: A Prospective Study From Tertiary Care Hospital in Western Nepal. Nepal J Epidemiology, 4(1), 330-336.
Bates, D. W., Spell, N., Cullen, D. J., Burdick, E., Laird, N., Petersen, L. A., Small, S. D., Sweitzer, B. J., & Leape, L. L. (1997). The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA, 277(4), 307–311.
Davies, E. C., Green, C. F., Taylor, S., Williamson, P. R., Mottram, D. R., & Pirmohamed, M. (2009). Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PloS one, 4(2), e4439.
DDA, (2022). Department of Drug Administration. Pharmacovigilance, Retrieved on 20 April 2022.
Dhakal, N. (2021). National Joint Annual Review 2020/21. Department of Drug Administration, Kathmandu, Nepal, December 23, 2021.
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.
European, C. (2014). The EU Pharmacovigilance System. Retrieved from European Commission: http://ec.europa.eu/health/human-use/pharmacovigilance_en
GAO, (2006). Improvement Needed in FDA's Postmarket DecisionMaking and Oversight Process, General Accounting Office,GAO-06-402.
Griffin J. P. (1998). The evolution of human medicines control from a national to an international perspective. Adverse drug reactions and toxicological reviews, 17(1), 19–50.
Hamilton, H. J., Gallagher, P. F., & O'Mahony, D. (2009). Inappropriate prescribing and adverse drug events in older people. BMC geriatrics, 9, 5.
Mammì, M., Citraro, R., Torcasio, G., Cusato, G., Palleria, C., & di Paola, E. D. (2013). Pharmacovigilance in pharmaceutical companies: An overview. Journal of pharmacology & pharmacotherapeutics, 4(Suppl 1), S33–S37.
Matrix services, (2005). Promoting the quality of medicines plus. Reforming Nepal’s Pharmaceutical Sector. Presentation slide NHRC Conference.
Mehta, U., Dheda, M., Steel, G., Blockman, M., Ntilivamunda, A., Maartens, G., Pillay, Y., & Cohen, K. (2014). Strengthening pharmacovigilance in South Africa. South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 104(2), 104–106.
Moore, N., Lecointre, D., Noblet, C., & Mabille, M. (1998). Frequency and cost of serious adverse drug reactions in a department of general medicine. British journal of clinical pharmacology, 45(3), 301–308.
Nepal Economic Forum. (2020). Expert Speak: Pharmaceutical Industry. Nepal Economic Forum, May 20, 2020
Pirmohamed, M., James, S., Meakin, S., Green, C., Scott, A. K., Walley, T. J., Farrar, K., Park, B. K., & Breckenridge, A. M. (2004). Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ (Clinical research ed.), 329(7456), 15–19.
Schedule Y. 2005 Jan; CDSCO, Ministry of Health and Family Welfare, Government of India.
Shani, S., & Yahalom, Z. (2008). The role of the pharmaceutical industry in disseminating pharmacovigilance practice in developing countries. Food and drug law journal, 63(3), 701–711.
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.
WHO. (2006). The safety of medicines in public health programmes: pharmacovigilance, an essential tool. Geneva: World Health Organization.

Copyright (c) 2022 Nisha Jha, Yunima Sapkota, Pathiyil Ravi Shankar

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.