A review of pharmacovigilance

  • Garima Dhingra Jaipur National University, Jaipur-302017, India
  • Sonia Tanwar Jaipur National University, Jaipur-302017, India
  • Devender Sharma Lovely Professional University, Phagwara, Punjab, India
  • Shweta Parihar Maharishi Dayanand University, Rohtak
Keywords: adverse event case management, risk management, aggregate reporting, ethical approach, case causality assessment

Abstract

Introduction: Pharmacovigilance involves more than spontaneous reporting, and is more than just evaluating marketed medications. It has grown from a minor component of drug control to a major activity and expanded its scope to encompass the assistance for patient safety during clinical trials by ensuring adequate informed consent and institutional review boards (ethical committees); development of a safety profile for proper use of a new molecular entity and appropriate communication of that information to a range of relevant stakeholders; selection of the first safe dose for use in humans based on pharmacologic data obtained in animal studies; development of a safety profile. This study implicates the growth of pharmacovigilance in assessing the safety of drugs.

Methods: The subsequent information was obtained by reviewing the data from earlier published material. The obtained information was evaluated, compiled, deconstructed, reassembled, interpreted, and conclusions were reached.

Results: The supply of data necessary for assessing the advantages and dangers of medicines is, first and foremost, a scientific task. Good pharmacovigilance practice must be created to guarantee that data is gathered and used correctly for the intended purpose.

Conclusion: Pharmacovigilance has grown into an essential part of drug control. Signal management protocols ensure that surveillance operations monitor the produced product through collaborative actions with manufacturing specialists, analyze benefit-risk management and inspection readiness maintenance as a corporate culture process.

Author Biographies

Garima Dhingra, Jaipur National University, Jaipur-302017, India

Research Scholar, Department of Pharmacology

Sonia Tanwar, Jaipur National University, Jaipur-302017, India

Research Scholar, Department of Pharmacology

Devender Sharma, Lovely Professional University, Phagwara, Punjab, India

Research Scholar

Shweta Parihar, Maharishi Dayanand University, Rohtak

Research scholar, Department of pharmaceutical science

References

Almandil N. B. (2016). Healthcare professionals' awareness and knowledge of adverse drug reactions and pharmacovigilance. Saudi medical journal, 37(12), 1359–1364.

Alwhaibi, M., & Al Aloola, N. A. (2020). Healthcare students' knowledge, attitude and perception of pharmacovigilance: A systematic review. PloS one, 15(5), e0233393.

Bagheri, H., Laroche, M. L., & Montastruc, J. L. (2016). Pharmacovigilance: The new challenges. Therapie, 71(2), 121–122.

Beninger P. (2018). Pharmacovigilance: An Overview. Clinical therapeutics, 40(12), 1991–2004.

Beninger P. (2020). Signal Management in Pharmacovigilance: A Review of Activities and Case Studies. Clinical therapeutics, 42(6), 1110–1129.

Diesel, G., & Cooles, S. (2018). Annual review of pharmacovigilance. The Veterinary record, 183(2), 72.

Donzanti B. A. (2018). Pharmacovigilance is Everyone's Concern: Let's Work It Out Together. Clinical therapeutics, 40(12), 1967–1972.

Dylan Fernandes, S., Anoop, N. V., Castelino, L. J., & Narayana Charyulu, R. (2019). A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. Research in social & administrative pharmacy: RSAP, 15(1), 109–113.

Garcia-Doval, I., Segovia, E., Hunter, H., Frew, J., & Naldi, L. (2020). The value of case reports in pharmacovigilance. The British journal of dermatology, 183(5), 795–796.

Hartman, J., Härmark, L., & van Puijenbroek, E. (2017). A global view of undergraduate education in pharmacovigilance. European journal of clinical pharmacology, 73(7), 891–899.

Hegerius, A., Caduff-Janosa, P., Savage, R., & Ellenius, J. (2020). E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre. Drug safety, 43(11), 1171–1180.

Inacio, P., Cavaco, A., & Airaksinen, M. (2017). The value of patient reporting to the pharmacovigilance system: a systematic review. British journal of clinical pharmacology, 83(2), 227–246.

Jose, J., & Rafeek, N. R. (2019). Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives. Therapeutic innovation & regulatory science, 53(6), 781–786.

Kalaiselvan, V., Srivastava, S., Singh, A., & Gupta, S. K. (2019). Pharmacovigilance in India: Present Scenario and Future Challenges. Drug safety, 42(3), 339–346.

Kalaiselvan, V., Thota, P., & Singh, G. N. (2016). Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian journal of pharmacology, 48(6), 624–628.

Lihite, R. J., & Lahkar, M. (2015). An update on the Pharmacovigilance Programme of India. Frontiers in pharmacology, 6, 194.

Martin, L. G., Hanssens, Y., & Paudyal, V. (2018). Overview of this issue: pharmacovigilance, what is new? International journal of clinical pharmacy, 40(4), 737–739.

Montané, E., & Santesmases, J. (2020). Adverse drug reactions. Reacciones adversas a medicamentos. Medicina clinica, 154(5), 178–184.

Manzanera, R., Moya, D., Guilabert, M., Plana, M., Gálvez, G., Ortner, J., & Mira, J. J. (2018). Quality Assurance and Patient Safety Measures: A Comparative Longitudinal Analysis. International journal of environmental research and public health, 15(8), 1568.

Olsson, S., & Harrison-Woolrych, M. (2018). The role and strategy of ISoP in global pharmacovigilance. International journal of clinical pharmacy, 40(4), 740–743.

van Leeuwen, B., & Edwards, B. (2021). The Road to Pharmacovigilance Outsourcing Guidance. Therapeutic innovation & regulatory science, 55(2), 408–414.

Published
2022-03-01
How to Cite
1.
Dhingra G, Tanwar S, Sharma D, Parihar S. A review of pharmacovigilance. jpadr [Internet]. 2022Mar.1 [cited 2022May25];3(1):7-11. Available from: https://jpadr.com/index.php/jpadr/article/view/54