Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals

  • Sony Chandi Shrestha London Metropolitan University, 166-220 Holloway Rd, London N7 8DB
  • Kebreab Ghebremeskel School of Human Sciences London Metropolitan University, 166-220 Holloway Rd, London N7 8DB
  • Kenneth White School of Human Sciences London Metropolitan University, 166-220 Holloway Rd, London N7 8DB
  • Caterina Minelli Surface Technology group National Physical Laboratory, Hampton Rd, Teddington TW11 0LW       
  • Ihab Tewfik University of Westminster, London, UK, 309 Regent St., London W1B 2HW
  • Panna Thapa Kathmandu University, Dhulikhel 45200, Nepal
  • Sundus Tewfik Bloomsnano Limited, 91 Wimpole Street, London, United Kingdom, W1G 0EF
Keywords: Adverse drug reactions, pharmacovigilance, Health professionals, Nepal

Abstract

Introduction: Although Nepal joined the WHO program for International Drug Monitoring in 2006, published data about Nepalese health professionals’ understanding of pharmacovigilance and spontaneous reporting of adverse drug reactions (ADRs) is limited.

Objectives: The purposes of this study were to: (1) investigate awareness, knowledge, attitude, and practice (KAP) of pharmacovigilance among health professionals and (2) gain insight into the ADRs reported for statins in Nepal.

Methods: 125 health professionals (doctors, pharmacists/assistant pharmacists, and nurses) were recruited from health care institutions (hospitals, clinics, pharmacies) in Kathmandu, Nepal. Electronic and paper survey data were collected with the use of a validated questionnaire between April and December 2018. The multiple-choice questionnaire was structured to assess the KAP of pharmacovigilance, and ADRs associated with statins, and consisted of two open-ended questions for health professionals to give suggestions for the improvement of the pharmacovigilance system. Statistical Package for the Social Sciences (SPSS, version 25) was used to analyze the demographic and pharmacovigilance data. The main outcome measures were KAP of pharmacovigilance and ADRs reported for statins.

Results:100 (80%) participants (44 doctors, 32 pharmacists / assistant pharmacists, 24 nurses) completed the self-administered questionnaire. Pharmacovigilance knowledge, attitude, and practice scores were 71%, 81%, and 53%, respectively. There was a significant difference between the number of knowledgeable health professionals (71 vs. 29%, p < 0.05) and had a favorable attitude (81 vs. 19%, p < 0.05) toward pharmacovigilance and ADR reporting compared with those who did not. The number of participants who did not report ADR was higher than those who did (90 vs. 10%, p < 0.05). The adverse reactions associated with statins were muscle symptoms (62%), elevated activity of liver enzymes (24%), and gastrointestinal symptoms (9%).

Conclusion: Despite the knowledge and willingness of health professionals to report ADRs, the practice of pharmacovigilance remains low in Nepal. There is a need for clear and enforceable regulations for monitoring and reporting ADRs, and effective educational interventions to promote pharmacovigilance practices.

Author Biographies

Kebreab Ghebremeskel, School of Human Sciences London Metropolitan University, 166-220 Holloway Rd, London N7 8DB

Professor, Lipidomics and Nutrition Research Centre

Kenneth White, School of Human Sciences London Metropolitan University, 166-220 Holloway Rd, London N7 8DB

Professor of Molecular Biosciences

Caterina Minelli, Surface Technology group National Physical Laboratory, Hampton Rd, Teddington TW11 0LW       

Science Area Leader

Ihab Tewfik, University of Westminster, London, UK, 309 Regent St., London W1B 2HW

Senior Lecturer, Life Sciences

Panna Thapa, Kathmandu University, Dhulikhel 45200, Nepal

Professor of Pharmacy & Controller of Examinations

Sundus Tewfik, Bloomsnano Limited, 91 Wimpole Street, London, United Kingdom, W1G 0EF

Director, Department of Applied Nanomolecules

References

Alam, K., Shah, A. K., Ojha, P., Palaian, S. and Shankar, P. R. (2009). Evaluation of drug promotional materials in a hospital setting in Nepal. Southern Med Review, 2(1), 2–6.

Alhawassi, T. M., Krass, I., Bajorek, B. V and Pont, L. G. (2014). A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clinical interventions in aging, 9, 2079–86.

Alomar, M. J. (2014). Factors affecting the development of adverse drug reactions. Saudi Pharmaceutical Journal, 22(2), 83–94.

Alsaleh, F. M., Alzaid, S. W., Abahussain, E. A., Bayoud, T. and Lemay, J. (2017). Knowledge, attitude and practices of pharmacovigilance and adverse drug reaction reporting among pharmacists working in secondary and tertiary governmental hospitals in Kuwait. Saudi Pharmaceutical Journal, 25(6), 830–837.

Alshakka, M., Bassalim, H., Alsakkaf, K., Mokhtar, M., Alshagga, M., Al-Dubai, S., Jha, N., Abdoraboo, A. and Shanker, P. (2016). Knowledge and Perception towards Pharmacovigilance among Healthcare Professionals in Tertiary Care Teaching Hospital in Aden, Yemen. Journal of Pharmacy Practice and Community Medicine, 2(1), 21–28.

Alshakka, M. (2017). Effect of an educational intervention on knowledge and attitude regarding pharmacovigilance and consumer pharmacovigilance among community pharmacists in Lalitpur district, Nepal. BMC Research Notes, 10(1), 1–8.

Alshammari, T. M. and Alshakka, M. A. (2014) Unhelpful information about adverse drug reactions. British Medical Journal, 349, g5019.

Amedome, S. N. and and Dadson, B. A. (2017).Pharmacovigilance Practices: Knowledge and Attitudes among the Healthcare Professionals at the Volta Regional Hospital of Ghana. Journal of Pharmacovigilance, 05(03), 1–9.

Angamo, M. T., Chalmers, L., Curtain, C. M. and Bereznicki, L. R. E. (2016). Adverse-Drug-Reaction-Related Hospitalisations in Developed and Developing Countries: A Review of Prevalence and Contributing Factors. Drug Safety, 39(9), 847–857.

Ansari, M., Humagain, B. and Hassali, M. A. (2017). Generic medicines utilizations and generic prescribing in Nepal: A reflection of current scenario and possible solutions. Research in Social and Administrative Pharmacy, 13(3), 658–659.

Aronson, J, K. (2007) Adverse drug reactions – no farewell to harms. British Journal of Clinical Pharmacology, 63 (2), 131-135.

Bamji, A. N. (2014) Adverse effects of statins. British Medical Journal, 348, g3306.

Baniasadi, S., Fahimi, F. and Shalviri, G. (2008). Developing an Adverse Drug Reaction Reporting System at a Teaching Hospital. Basic & Clinical Pharmacology & Toxicology, 102(4), 408–411.

Beijer, H. J. M. and De Blaey, C. J. (2002). Hospitalisations caused by adverse drug reactions (ADR): A meta-analysis of observational studies. Pharmacy World and Science, 24(2), 46–54.

Bhagavathula, A. S. K., Elnour, A. A., Jamshed, S. Q. and Shehab, A. (2016). Health professionals’ knowledge, attitudes and practices about Pharmacovigilance in India: A systematic review and meta-analysis. PLoS ONE, 11(3), 1–15.

Bouvy, J. C., De Bruin, M. L. and Koopmanschap, M. A. (2015). Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies. Drug Safety, 38(5), 437–453.

Davies, E. A., and O' Mahony, M. S. (2015). Adverse drug reactions in special populations - the elderly. British Journal of Clinical Pharmacology, 80(4), 796–807.

Department of Drug Administration. 2021. Pharmacovigilance. http://www.dda.gov.np/content/pharmacovigilance

Department of Drug Administration. Pharmacovigilance, Drug Bulletin of Nepal. 2021; 32(2): 28-29.

Eekeren, R. van, Rolfes, L., Koster, A. S., Magro, L., Parthasarathi, G., Al Ramimmy, H., Schutte, T., Tanaka, D., van Puijenbroek, E. and 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.

Ekman, E. and Bäckström, M. (2009). Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden. European Journal of Clinical Pharmacology, 65(1), 43–46.

Gavaza, P., Brown, C. M., Lawson, K. A., Rascati, K. L., Wilson, J. P. and Steinhardt, M. (2011). Influence of attitudes on pharmacists ’ intention to report serious adverse drug events to the Food and Drug Administration. British Journal of Clinical Pharmacology, 72(1), 143–152.

Guner, M. D. and Ekmekci, P. E.(2019) Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. Journal of Drug Assessment, 8(1), 13–20.

Hans, M. and Gupta, S. K. (2018). Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices. Perspectives in Clinical Research, 9(4), 170–174.

Hartwig, S. C., Siegel, J. and Schneider, P. J. (1992). Preventability and severity assessment in reporting adverse drug reactions. American Journal of Health-System Pharmacy, 49(9), 2229–2232.

Hasford, J., Goettler, M., Munter, K. H. and Müller-Oerlinghausen, B. (2002). Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. Journal of Clinical Epidemiology, 55(9), 945–950.

Hayes, B. W. and Shakya, R. (2013). Career choices and what influences Nepali medical students and young doctors: A cross-sectional study. Human Resources for Health, 11(1), 1.

Hazell, L. and Shakir, S. A. W. (2006). Under-Reporting of Adverse Drug Reactions. Drug Safety, 29(5), 385–396.

Hovingh, G. K., Gandra, S. R., McKendrick, J., Dent, R., Wieffer, H., Catapano, A. L., Oh, P., Rosenson, R. S. and Stroes, E. S. (2016) Identification and management of patients with statin-associated symptoms in clinical practice: A clinician survey. Atherosclerosis, 245, 111-117.

Inácio, P., Cavaco, A., Allan, E. and Airaksinen, M. (2018). Key pharmacovigilance stakeholders’ experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union. Public Health, 155, 119–128.

Jha, N., Bajracharya, O. and Namgyal, T. (2007). Prevalence of adverse drug reactions with commonly prescribed drugs in different hospitals of Kathmandu valley. Kathmandu University Medical Journal, 5(4), 504–10.

Jha, N., Rathore, D. S., Shankar, P. R., Bhandary, S., Pandit, R. B., Gyawali, S. (2017) Knowledge, Attitude and Practice Regarding Pharmacovigilance and Consumer Pharmacovigilance among Consumers at Lalitpur District, Nepal. Journal of Nepal Health Research Council, 15 (35), 31-37.

Johnston, L. (2015) EXCLUSIVE: Statins linked to 20,000 side effects and 227 deaths. Sunday Express, July 05.

Junge T. (2016). Practical Pharmacology for the Surgical Technologist. Boston: Cengage Learning.

KC, S., Tragulpiankit, P., Edwards, I. R. and Gorsanan, S. (2013). Knowledge about adverse drug reactions reporting among healthcare professionals in Nepal. International Journal of Risk and Safety in Medicine, 25(1), 1–16.

KC, S., Tragulpiankit, P., Gorsanan, S. and Edwards, I. R. (2013). Attitudes among healthcare professionals to the reporting of adverse drug reactions in Nepal. BMC Pharmacology and Toxicology, 14(16), 1–7.

Khanal, D. P. (2017). History of Pharmaceutical Development in Nepal. Journal of Manmohan Memorial Institute of Health Sciences, 3(1), 86–93.

Li, Q., Zhang, S., Chen, H., Fang, S., Yu, X., Liu, D., Shi, L. and Zeng, F. (2004). Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chinese Medical Journal, 117(6), 856–61.

Li, R., Curtain, C., Bereznicki, L. and Zaidi, S. T. R. (2018). Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey. International Journal of Clinical Pharmacy, 40(4), 878–889.

Margraff, F. and Bertram, D. (2014). Adverse drug reaction reporting by patients: An overview of fifty countries. Drug Safety, 37(6), 409–19.

Martin, R.M., Biswas, P. N., Freemantle, S. N., Pearce, G. L., and Mann, R. D. (1998). Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: analysis of 48 cohort studies. British Journal of Clinical Pharmacology, 46(5), 505–511.

Mouton, J. P., Njuguna, C., Kramer, N., Stewart, A., Mehta, U., Blockman, M., Fortuin-De Smidt, M., De Waal, R., Parrish, A. G., Wilson, D. P. K., Igumbor, E. U., Aynalem, G., Dheda, M., Maartens, G. and Cohen, K. (2016). Adverse Drug Reactions Causing Admission to Medical Wards. Medicine, 95(19), e3437.

Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janacek, E., Domecq, C. and Greenblatt, D. J. (1981). A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics, 30(2), 239–245

Nisa, Z. U., Zafar, A. and Sher, F. (2018). Assessment of knowledge, attitude and practice of adverse drug reaction reporting among healthcare professionals in secondary and tertiary hospitals in the capital of Pakistan. Saudi Pharmaceutical Journal, 26(4), 453–461.

Nwokike, J. and Ludeman, E, and Thumm, M. (2013) Comparative Analysis of Pharmacovigilance Systems in Five Asian Countries. Submitted to the US Agency for International Development. Arlington, VA: Management Sciences for Health.

Opadeyi, A. O., Fourrier-Réglat, A. and Isah, A. O. (2019). Educational intervention to improve the knowledge, attitude and practice of healthcare professionals regarding pharmacovigilance in South-South Nigeria. Therapeutic Advances in Drug Safety, 10, 1–12.

Oshikoya, K. A. and Awobusuyi, J. O. (2009). Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos , Nigeria. BMC Clinical Pharmacology, 9(14), 1–8.

Palaian, S., Khanal, S., Alam, K. and Paudel, A. (2009). Introducing pharmacovigilance to postgraduate pharmacy students in Nepal. American Journal of Pharmaceutical Education, 73(6), 114.

Palaian, S., Ibrahim, M. I. and Mishra, P. (2011). Health professionals’ knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharmacy Practice, 9(4), 228–235

Pambos, M., NG J., Loukes. J,, Matheson. J., Aryal, B., Adhikari, Kerry, S., Reid, F. and Oakeshott, P. (2012). Demographics and diagnoses at rural health camps in Nepal: cross-sectional study. Family Practice, 29(5), 528-33.

Panthee, B., Panthee, S., Gyawali, S. and Kawakami, N. (2017). Prevalence and correlates of substance use among health care students in Nepal: A cross sectional study. BMC Public Health, 17(1), 1–10.

Pirmohamed, M., James, S., Meakin, S., Green, C., Scott, A. K., Walley, T. J., Farrar, K., Park, B. K. and Breckenridge, A. M. (2004). Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. British Medical Journal, 329, 15–19.

Pourhoseingholi, M. A., Vahedi, M. and Rahimzadeh, M. (2013). Sample size calculation in medical studies. Gastroenterology and Hepatology From Bed to Bench, 6(1), 14–17.

Prakash, S., Yadav, P. and Yadav, K. (2018). Perspectives of developing nursing education in Nepal. Nursing & Care Open Access Journal, 5(4), 214–220.

Poudel, B. K. and Ishii, I. (2017). Regulation of the price of medicines in developing countries: The case in Nepal. Journal of Pharmacy Practice and Research, 47(4), 319–323.

Rai, D. (2004). Which is real, and which is fake? Nepali Times, 188.

Regmi, N. and Chautari, M. (2017). Expectations versus reality: A case of internet in Nepal. The Electronic Journal of Information System in Developing Countries, 82(7), 1–20.

Rehan, H. S., Chopra, D., Sah, R. K. and Mishra, R. (2012). Adverse drug reactions: trends in a tertiary care hospital. Current drug safety, 7(5), 384–8.

Ribeiro-Vaz, I., Silva, A. M., Costa Santos, C. and Cruz-Correia, R. (2016). How to promote adverse drug reaction reports using information systems - A systematic review and meta-analysis. BMC Medical Informatics and Decision Making, 16(1), 1–10.

Rimal T. (2019). Govt policy hinders growth of pharmaceutical industry. The Himalayan Times, April 08.

Rosenson, R. S., Gandra, S. R., McKendrick, J., Dent, R., Wieffer, H., Cheng, L. I., Catapano, A. L., Oh, P., Kees Hovingh, G. and Stroes, E. S. (2017). Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries. Cardiovascular Drugs and Therapy, 31(2), 187–195.

Saleh, H. A., Figueras, A. and Fourrier-Réglat, A. (2016). Knowledge, attitude and practice of health professionals towards adverse drug reactions reporting. European Journal of Pharmaceutical and Medical Research, 3(8), 12–21.

Shakya-Gurung, M., Shrestha, D., Thapa, R. (2019). Assessment on Knowledge, Attitude and Practice of Pharmacovigilance among the Healthcare Professionals in a Tertiary Hospital of Kathmandu. Nepal Medical College Journal, 21(1), 53-59.

Seiter, A. (2009). Health and Economic Consequences of Counterfeit Drugs. Clinical Pharmacology & Therapeutics, 85(6), 576–578.

Singh, S., Sarraf, D. P., Singh, P. and Poudyel, P. (2021) Knowledge, Attitude and Practices of Pharmacovigilance among doctors at a tertiary care teaching hospital in Birgunj, Nepal. Journal of National Medical College, 6 (1), 14 -18.

Shrestha, R., Shakya, S., Bista, D., Shreshtha, R. K., Khan, G. M., Joshi, S. and Rao, B. S. (2006). Case Studies of Hospitalized Patients due to Drug Related Complications. Kathmandu University Journal of Science, Engineering and Technology, 2(1), 1–9.

Shrestha, C. and Bhandari, R. (2013). Insight into Human Resources for Health Status in Nepal. Health Prospect, 11, 40–41.

Shrestha, M., Moles, R., Ranjit, E. and Chaar, B. (2018). Medicine procurement in hospital pharmacies of Nepal: A qualitative study based on the basel statements. PLoS ONE, 13(2), 1–21.

Shrestha, S., Sharma, S., Bhasima, R., Kunwor, P., Adhikari, B. and Saptoka, B. (2020) Impact of an educational intervention on pharmacovigilance knowledge and attitudies among health professionals in a Nepal cancer hospital. BMC Medical Education, 20 (179), 1 – 10.

Smyth, R. M. D., Gargon, E., Kirkham, J., Cresswell, L., Golder, S., Smyth, R. and Williamson, P. (2012). Adverse drug reactions in children-A systematic review. PLoS ONE, 7(3), 1–24.

Star, K., Norén, G. N., Nordin, K. and Edwards, I. R. (2011). Suspected Adverse Drug Reactions Reported For Children Worldwide. Drug Safety, 34(5),415 –428.

Stausberg, J. (2014). International prevalence of adverse drug events in hospitals: An analysis of routine data from England, Germany, and the USA. BMC Health Services Research, 14(125), 1–9.

Thapa, S., Palaian, S., Ibrahim, M. and Izham, M. (2017). Establishing a Hospital Pharmacy in Nepal: Experiences and Challenges. Journal of Pharmacy Practice and Community Medicine, 3(1), 31–33.

Ting, K. N., Stratton-Powell, D. M. and Anderson, C. (2010). Community pharmacists’ views on adverse drug reactions reporting in Malaysia: A pilot study. Pharmacy World and Science, 32(3), 339–342.

Uppsala Monitoring Centre (2019). Vigibase. https://www.who-umc.org/vigibase/vigibase/

Wertheimer, A. I. and Santella, T. M. (2005). Counterfeit drugs: defining the problem and finding solutions. Expert Opinion on Drug Safety, 4(4), 619–622.

Wester, K., Jönsson, A. K., Spigset, O., Druid, H. and Hägg, S. (2007). Incidence of fatal adverse drug reactions: A population based study. British Journal of Clinical Pharmacology, 65(4), 573–579.

World Health Organization (2018). Safety of Medicines - A Guide to Detecting and Reporting Adverse Drug Reactions. http://apps.who.int/medicinedocs/en/d/Jh2992e/4.html#Jh2992e.4

World Health Organization. Nepal (2019). https://www.who.int/workforcealliance/countries/npl/en/

World Health Organization. Pharmacovigilance (2019.). https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/

World Medical Association (2013). World Medical Association Declaration of Helsinki. Journal of the American Medical Association, 310(20), 2191–2194.

Published
2022-09-01
How to Cite
1.
Shrestha SC, Ghebremeskel K, White K, Minelli C, Tewfik I, Thapa P, Tewfik S. Knowledge, attitude and practice of pharmacovigilance among Nepalese health professionals. jpadr [Internet]. 2022Sep.1 [cited 2022Nov.26];3(3):40-. Available from: https://jpadr.com/index.php/jpadr/article/view/99