Knowledge, Attitude, and Practice of Materiovigilance among Nurses at a Tertiary Care Hospital in South India: A Cross-Sectional Study.

Background and Objective: Inadequate knowledge and underreporting of medical device-associated adverse events (MDAEs) were observed among health-care professionals (HCPs) in studies carried out in other countries. In India, HCP's knowledge, attitude, and practice (KAP) regarding materiovigilance have not been explored extensively. Hence, the present study was carried out to assess KAP of materiovigilance among nurses working in a tertiary care teaching hospital in South India. Materials and Methods: This is a descriptive, cross-sectional study conducted among nurses. A self-administered, validated questionnaire was distributed to 420 nurses. Data were analyzed using the Statistical Package for the Social Sciences software version 21.0. Kruskal-Wallis test was used to compare KAP score of materiovigilance among the study participants. Results: A total of 400 (95.2%) responses were received. About 65.7% (n = 263) of nurses were having adequate knowledge about the various aspects of materiovigilance and 80.5% (n = 322) of nurses had a positive attitude toward MDAE reporting. However, only 18 (4.5%) of nurses have reported about MDAEs. Further, factors such as uncertainty on how to report a MDAE and concerns about their legal issues significantly led to underreporting of MDAEs. Conclusion: The transition of adequate knowledge and positive attitude to good practice of MDAE reporting was lacking among the study participants. Hence, with due consideration of these deficits and the various factors influencing MDAE reporting, it is necessary to conduct periodical workshops and training sessions for HCPs to enhance their spontaneous reporting of MDAEs.

Agreement Among Different Scales for Causality Assessment in Drug-Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

BACKGROUND AND OBJECTIVE: Identification of the offending drug is crucial and challenging in cases of severe cutaneous adverse drug reactions (CADR) like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Poor reproducibility and varying levels of agreement have been observed among different causality assessment tools (CATs) in assessing severe CADRs. This study was conducted to examine the agreement among four different CATs in assessing cases of drug-induced SJS, TEN and SJS/TEN overlap. METHODS: All cases of drug-induced SJS, TEN and SJS/TEN overlap, which were reported between January 2012 and January 2020, were identified from the ADR register at an ADR monitoring centre. Causality assessment was done in these reported cases using the following CATs: The World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo algorithm, Liverpool algorithm and Algorithm of drug causality for epidermal necrolysis (ALDEN). Weighted kappa (κw) test was used to evaluate the agreement among four CATs. RESULTS: A total of 30 cases of drug-induced SJS, TEN and SJS/TEN overlap were included in our analyses. The most common offending groups of drugs were anticonvulsants (46.7%), antimicrobials (40%) and nonsteroidal anti-inflammatory drugs (13.3%). Of the anticonvulsants, phenytoin (13.3%), carbamazepine (10%), and valproate (10%) were the commonly reported offending drugs. Poor agreement was observed among the four different causality assessment scales. CONCLUSION: Discrepancies were observed among four different CATs in assessing drug-induced SJS and TEN. A CAT, which is more specific to drug-induced SJS and TEN, simple, user-friendly with limited subjective interpretation, incorporating new immunological and pharmacogenetic markers, is necessary.

National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials.

The "National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials" prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as a welcome step in the process of regulation of gene therapy research, as there was a lack of Indian guidelines earlier specific to gene therapy. Indian researchers have taken their step in setting the path of gene therapy research, and this guideline serves to provide the standards starting from its development up to translation to new drug including the ethical, scientific, and regulatory requirements to be followed during the conduct of trial. The Indian guidelines were framed with reference to United States-Food and Drug Administration and European Union guidelines on gene therapy. It is the responsibility of all the stakeholders involved in the development of GTP to adhere to the national guidelines. This review provides an outline of the Indian regulatory guidelines on GTP.