@article {77, title = {An Overview of Spontaneous Reporting, Targeted Spontaneous Reporting and Cohort Event Monitoring-Pharmacovigilance Methods: Myths and Facts}, journal = {Journal of Pharmacy Practice and Community Medicine}, volume = {8}, year = {2022}, month = {May 2022}, pages = {8-13}, type = {Review Article}, chapter = {8}, abstract = {

Adverse drug reaction (ADR) reporting is an important safety concern to monitor safety among the patient. Pharmacovigilance (PV) is usually involves in detection of spontaneous adverse reaction, therefore these shall be submitted to the National Coordination Centre Pharmacovigilance programme of India (NCC-PVPI) which is located at Ghaziabad functioning under ministry of health and family welfare, Government of India. ADR is a global concern that causes serious impact on consumers both in terms of health and financial aspects. Hence monitoring of these adverse reactions is utmost important attribute to enhance patient safety. Perhaps, India is adopting spontaneous reporting (SR) system since 1998, henceforth targeted spontaneous reporting (TSR) system came into consideration in 2010, and that is a complimentary method to spontaneous reporting. This system is useful to establish evidence-based reports generation of specific drug and ADR combination, increase alertness and also helpful in recognizing harmful risks The main aim of this article is to encourage evidence-based decision making to enhance patient safety. In addition to this, establish a functional reporting system i.e. targeted spontaneous reporting system to monitor the safety of targeted medicines and to learn more about the safety profile of new medicines in the early post marketing phase in our population.

}, keywords = {Adverse drug reaction, Pharmacovigilance, Spontaneous reporting system, Targeted spontaneous reporting and cohort event monitoring.}, doi = {10.5530/jppcm.2022.1.3}, author = {Prasad Thota and Anusha Thota and Phulen Sarma and Bikash Medhi} } @article {23, title = {Incidence and Assessment of Adverse Drug Reactions at a Tertiary Care Hospital}, journal = {Journal of Pharmacy Practice and Community Medicine}, volume = {6}, year = {2020}, month = {April 2020}, pages = {15-17}, type = {Short Communication}, chapter = {15}, abstract = {

Background: Adverse drug reactions have proved a significant problem in healthcare for decade. Healthcare professionals have a responsibility in use of rational drugs for their patients. Objectives: The aim of the study was to determine the prevalence of ADRs in a tertiary care hospital to determine the most common Therapeutic Class of Drugs causing ADR and to determine the most common Organ system affected by ADR. Methods: The Prospective, observational study was conducted in the wards of St. Philomena{\textquoteright}s Hospital, Bangalore between January 2016 and August 2016. All In-patients were monitored for ADRs during their admission period. Results: Over the study period of 12 months, a total of 374 ADRs were reported in 600 patients. The ADRs observed were higher in female patients [196 (52.4\%)]. A predominance of gastro- intestinal reactions [70 (18.71\%)] was observed. Therapeutic classes of drugs frequently associated with ADRs were antibiotics [84(22.4\%)] followed by antihypertensive agents [63 (16.84\%)] and antidiabetic [37 (9.89\%)]. The most common drugs involved in causing ADRs were Furosemide and Cefoperazone and the most commonly reported ADR was Diarrhoea [28 (7.4.8\%)] followed by Itching 2[9 (7.75\%)]. Majority of the ADRs [95 (74.80\%)] were managed by withdrawing the suspected drug. The causality assessment of the ADRs were carried out using the Naranjo{\textquoteright}s Scale algorithm and the majority of the ADRs were found to be definite [41 (32\%)]. Conclusion: Continuous monitoring by a clinical pharmacist in hospital setup will reduce the occurrence of ADR and improve the patient safety.

}, keywords = {Adverse drug reaction, Causality assessment, Naranjo scale, Patient safety, Pharmacovigilance}, doi = {10.5530/jppcm.2020.1.5}, author = {Pulimi Divya Priyanka and T. Vithya and Shobha Rani Rajeev Hiremath and Shankar Prasad} }