A conceptual framework on health professionals' engagement towards pharmacovigilance: a qualitative exploration

Authors

  • Swagatika Priyadarsini Swain ICMR-RMRC, Bhubaneswar, Odisha, India
  • Kripalini Patel ICMR-RMRC, Bhubaneswar, Odisha, India
  • Subrata Kumar Palo ICMR-RMRC, Bhubaneswar, Odisha, India
  • Bijaya Mishra ICMR-RMRC, Bhubaneswar, Odisha, India
  • Sanghamitra Pati ICMR-RMRC, Bhubaneswar, Odisha, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20213361

Keywords:

Pharmacovigilance, Adverse drug reaction, Drug safety, Pharmacovigilance programme of India

Abstract

Background: With the growing reliance on drug therapy in the recent era, the safety of medications is one of the vital parameters for the success of any medicine. Considering this, pharmacovigilance (PV) was developed to provide adequate identification, reporting, evaluation, and understanding of adverse drug reactions (ADR). The objective of this study was to understand the opinion of health care providers on PV, the current reporting mechanisms, identifying the causes for underreporting, and the existing process in clinical practice.

Methods: A qualitative study using pretested interview guide was conducted among 20 different cadres of healthcare personnel (doctors, pharmacists, and staff nurses) from various hospitals such as government, private, corporate, and medical college of Odisha state. The data were analysed using a thematic analysis. The meaning units have been identified from the transcript and coded with MAXQDA software (MAXQDA Analytics Pro 2020, VERBI GmbH Berlin).

Results: Participants showed a lack of awareness regarding the concept of PV. A cluster of challenges such as lack of ADR monitoring, non-conducive work atmosphere and lack of cooperation between staff, lack of knowledge among the health professionals, and fear of legal liability as major pitfalls causing poor ADR reporting. To enhance the pharmacovigilance practice, participants suggested context-specific strategies such as IEC activities, innovative ideas to improve ADR monitoring, regular monitoring.

Conclusions: Capacity building through training, regular monitoring and supervision to strengthen the pharmacovigilance practices is the current need in India.

References

Giardina C, Cutroneo PM, Mocciaro E, Russo GT, Mandraffino G, Basile G, et al. Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study. Front Pharmacol. 2018;9:350.

Aljadhey H, Mahmoud MA, Alshammari TM, Dhaeefi M, Louet H, Gutthann S, et al. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia. Saudi Med J. 2015;36(9):1097-102.

Opadeyi AO, Reglat 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.

Singh A, Bhatt P. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form. J Pharmacol Pharmacother. 2012;3(3):228-32.

Singh J, Singh H, Rohilla R, Kumar R, Gautam CS. Lack of Awareness of Pharmacovigilance among Young Health-care Professionals in India: An Issue Requiring Urgent Intervention. Int J Appl Basic Med Res. 2018;8(3):158-63.

Abubakar AR, Simbak NB, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharm Sci. 2014;4(11):117-27.

Ganesan S, Sandhiya S, Subrahmanyam D. Frequency of ADRs and their Economic Impact in a Tertiary Care Public Sector Hospital in South India. SBV J Basic Clin Appl Health Sci. 2020;3(1):23-31.

Alshammari TM, Devadasu VR, Rathnam RP. Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada. Saudi Pharm J. 2017;25(8):1103-7.

Inacio P, Cavaco A, Airaksinen M. Current trends in pharmacovigilance: value and gaps of patient reporting. Int J Clin Pharm. 2018;40(4):754-7.

Davazdahemami B, Delen D. A chronological pharmacovigilance network analytics approach for predicting adverse drug events. J Am Med Inform Assoc. 2018;25(10):1311-21.

Hartmann K, Pagliusi S, Precioso A. Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries. Vaccine. 2020;38(34):5490-7.

Farha R, Abu HK, Rizik M, Aljanabi R, Alsakran L. Effect of educational intervention on healthcare providers knowledge and perception towards pharmacovigilance: A tertiary teaching hospital experience. Saudi Pharm J. 2018;26(5):611-6.

Nasir M, Zahan T, Farha N, Chowdhury AS. Acquaintance, approach and application of pharmacovigilance: questionnaire-based study at a tertiary care teaching hospital in Dhaka. Int J Basic Clinic Pharmacol. 2020;9(10):1497.

Adenuga BA, Kibuule D, Bamitale KDS, Rennie TW. Effective integration of pharmacovigilance systems at public health facilities in resource-limited settings: A qualitative study. Res Social Adm Pharm. 2020;16(8):1111-6.

Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. Indian J Med Res. 2014;140(4):563-4.

Callaghan J, Griffin BT, Morris JM, Bermingham M. Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland. Bio Drugs. 2018;32(3):267-80.

Mota DM, Vigo Á, Kuchenbecker RS. Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency. Cad Saude Publica. 2018;34(10):18.

Hadi MA, Neoh CF, Zin RM, Elrggal ME, Cheema E. Pharmacovigilance: pharmacists' perspective on spontaneous adverse drug reaction reporting. Integr Pharm Res Pract. 2017;6:91-98.

Sales I, Aljadhey H, Albogami Y, Mahmoud MA. Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia. Saudi Pharm J. 2017;25(6):868-72.

Khan LM, Harthi SE, Saadah OI. Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR. Saudi Pharm J. 2013;21(3):261-6.

Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. European J Clin Pharmacol. 1997;52(6):423-7.

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Published

2021-08-24

How to Cite

Swain, S. P., Patel, K., Palo, S. K., Mishra, B., & Pati, S. (2021). A conceptual framework on health professionals’ engagement towards pharmacovigilance: a qualitative exploration. International Journal of Basic & Clinical Pharmacology, 10(9), 1087–1094. https://doi.org/10.18203/2319-2003.ijbcp20213361

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Section

Original Research Articles