A QUESTIONNAIRE-BASED STUDY TO ASSESS THE AWARENESS OF MATERIOVIGILANCE AMONG HEALTH-CARE PROFESSIONALS WORKING IN A TERTIARY CARE TEACHING HOSPITAL IN THE KURNOOL DISTRICT

SANGALA SRIMANTH MANDANNA; SURESHA KR; NARAYANA REDDY S; SAMBA SIVA RAJU

doi:10.22159/ajpcr.2023.v16i11.48777

Authors

SANGALA SRIMANTH MANDANNA Deparment of Pharmacology, Viswabharathi Medical College, Kurnool, Andhra Pradesh, India.
SURESHA KR Deparment of Pharmacology, Viswabharathi Medical College, Kurnool, Andhra Pradesh, India.
NARAYANA REDDY S Deparment of Pharmacology, Viswabharathi Medical College, Kurnool, Andhra Pradesh, India.
SAMBA SIVA RAJU Deparment of Pharmacology, Viswabharathi Medical College, Kurnool, Andhra Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2023.v16i11.48777

Keywords:

Medical devices, Materiovigilance, Health care professionals, Adverse events

Abstract

Objectives: Materiovigilance (MV) is the coordinated system of identification, collection, reporting, and analysis of untoward occurrences associated with the use of medical devices (MD) and enhancing patients safety, also preventing their recurrence by health-care professionals (HCPs). The HCPs have a key role in the identification and reporting of adverse events associated with MD for continued patient safety.

The aim of the study is to assess awareness of the recently launched MV Programme in India among the health-care professionals working in a tertiary care teaching hospital.

Methods: A questionnaire-based study was conducted among health-care professionals of Viswabharathi Medical College and General Hospital, like residents, interns, nurses (OT, emergency, intensive care unit, etc.), and laboratory technicians of various specialties working in a tertiary care teaching hospital in Kurnool. A pre-validated questionnaire consisting of questions pertaining to knowledge, attitude and practice of MV was circulated to HCPs through Google Forms, and data were recorded and analyzed using statistical tests.

Results: One hundred and eighteen doctors responded out of 200 contacted, providing a response rate of 59%. They belonged to medical and allied branches (77), surgical branches (24), and diagnostic branches (17). Sixty-nine (58.5%) doctors strongly agreed that these types of programs are very effective in keeping a check on AE caused by MD. 98 (83%) doctors responded-certainly; we should report all the AEs.

Conclusion: This study creates awareness about MV and imparts a reporting culture among the HCPs.

Downloads

Download data is not yet available.

References

Rani S, Materiovigilance SK. An emerging discipline. Int J Sci Res 2018;7:15-6.

Maisel WH. Medical device regulation: An introduction for the practicing physician. Ann Intern Med 2004;140:296-302. doi: 10.7326/0003-4819-140-4-200402170-00012, PMID 14970153

WHO to Develop Essential Diagnostic List. Available from: http:// www.who.int/medical_devices/en

Jefferys DB. The regulation of medical devices and the role of the medical devices agency. Br J Clin Pharmacol 2001;52:229-35. doi: 10.1046/j.0306-5251.2001.01416.x, PMID 11560554

Balamuralidhara V, Kumar TP, Ravi V, Radhadevi N. Regulatory guidelines for Medical devices in India: An overview. Asian J Pharm 2012;6:10-7. doi: 10.4103/0973-8398.100125

Heneghan C, Thompson M, Billingsley M, Cohen D. Medicaldevice recalls in the UK and the device-regulation process: Retrospective review of safety notices and alerts. BMJ Open 2011;1:e000155. doi: 10.1136/bmjopen-2011-000155, PMID 22021778

Meher BR. Materiovigilance: An Indian perspective. Perspect Clin Res 2018;9:175-8. doi: 10.4103/picr.PICR_26_18, PMID 30319948

Kalaiselvan V, Tripathi SK, Prakash J. Materiovigilance programme of India: A scheme to assure cardiovascular devices safety surveillance. Indian Heart J 2020;72:316-8. doi: 10.1016/j.ihj.2020.06.009, PMID 32861393

Kalaiselvan V, Saxena R. Intraocular devices associated adverse events reporting system in India. Indian J Ophthalmol 2020;68:2343-5. doi: 10.4103/ijo.IJO_298_20, PMID 33120612

Shukla S, Gupta M, Pandit S, Thomson M, Shivhare A, Kalaiselvan V, et al. Implementation of adverse event reporting for medical devices, India. Bull World Health Organ 2020;98:206-11. doi: 10.2471/ BLT.19.232785, PMID 32132755

Chauhan P, Zarreen A, Iqubal MK. Current status of materiovigilance globally an utter overview with clinical case perusal. Int J Pharm Pharm Sci 2019;11:1-8.

Materiovigilance Programme of India-Indian Pharmacopeia. Commission. Available from: http://www.ipc.gov.in/mandates/pvpi/ materiovigilance-programme of India-mvpi.html [Last accessed on 2022 Feb 18].

Kurien S, Satapathy S, Gupta SK, Arya SK, Sharma DK. Study of reporting system for adverse events related to common medical devices at a tertiary care public sector hospital in India. World Acad Sci Eng Technol Int J Health Eng 2014;8:448-53.

Teow N, Siegel SJ. FDA regulation of medical devices and medical device reporting. Pharm Regul Aff 2013;2:110.

Rajesh R, Vidyasagar S, Varma DM. An educational intervention to assess knowledge attitude practice of pharmacovigilance among health care professionals in an Indian tertiary care teaching hospital. Int J Pharm Tech Res 2011;3:678-92.

Fadare JO, Enwere OO, Afolabi AO, Chedi BA, Musa A. Knowledge, attitude and practice of adverse drug reaction reporting among healthcare workers in a tertiary centre in Northern Nigeria. Trop J Pharm Res 2011;10:235-42. doi: 10.4314/tjpr.v10i3.4

Kamtane R, Jayawardhani V. Knowledge, attitude and perception of physicians towards adverse drug reaction reporting: A pharmacoepidemiology study. Asian J Pharm Clin Res 2012;3:210-4.

Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on knowledge, attitude and practice of pharmacovigilance among healthcare professionals in a tertiary care teaching hospital in South India. Perspect Clin Res 2015;6:45-52. doi: 10.4103/2229- 3485.148816, PMID 25657902

Hazari AA, Tadvi NA. A questionnaire-based study to assess knowledge attitude and practice of pharmacovigilance among doctors in a medical college in Telangana, India. Natl J Physiol Pharm Pharmacol 2021;11:519-24. doi: 10.5455/njppp.2021.11.10295202018012021

Rajesh B, Devangi RD, Anjum W. Assessment of knowledge, attitude, and practice of pharmacovigilance among private practitioners in Southern India: A questionnaire-based study. Natl J Physiol Pharm Pharmacol 2017;7:123-6. doi: 10.5455/njppp.2017.7.0824218082016

Mahmoud MA, Alsowaida Y, Alshammari T, Khan TM, Alrasheedy A, Hassali MA, et al. Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia. Saudi Pharm J 2014;22:411-8. doi: 10.1016/j.jsps.2013.07.005, PMID 25473329