TY - JOUR T1 - Case Report on Amlodipine Induced Pitting Type Pedal Edema JF - Journal of Pharmacy Practice and Community Medicine Y1 - 2022 A1 - Sahithya Sunil KW - Adverse drug reaction KW - Amlodipine KW - Calcium channel blocker KW - Pedal edema AB -

Amlodipine is 1,4 dihydropyridine class of third generation calcium channel blocker which is indicated for the management of hypertension, coronary atherosclerosis, stable angina and it is also an alternative used for the nifedipine induced pedal edema. This case study aims to make report of the common adverse reaction pitting type pedal edema is occurring during the treatment with the same. Amlodipine has increased incidence rate of pedal edema compared to other calcium channel blockers. Here present 67 years old male patient who gradually develops pitting type pedal edema after the initiation of oral amlodipine for hypertension. The symptoms have been relieved after the cessation of drug and patient has been managed with alternative antihypertensive agent. This study helps to consider more regarding amlodipine therapy and aids to earlier prevention of serious adverse drug reactions occurring in patients.

VL - 8 IS - 3 ER - TY - JOUR T1 - An Overview of Spontaneous Reporting, Targeted Spontaneous Reporting and Cohort Event Monitoring-Pharmacovigilance Methods: Myths and Facts JF - Journal of Pharmacy Practice and Community Medicine Y1 - 2022 A1 - Prasad Thota A1 - Anusha Thota A1 - Phulen Sarma A1 - Bikash Medhi KW - Adverse drug reaction KW - Pharmacovigilance KW - Spontaneous reporting system KW - Targeted spontaneous reporting and cohort event monitoring. AB -

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.

VL - 8 IS - 1 ER - TY - JOUR T1 - Incidence and Assessment of Adverse Drug Reactions at a Tertiary Care Hospital JF - Journal of Pharmacy Practice and Community Medicine Y1 - 2020 A1 - Pulimi Divya Priyanka A1 - T. Vithya A1 - Shobha Rani Rajeev Hiremath A1 - Shankar Prasad KW - Adverse drug reaction KW - Causality assessment KW - Naranjo scale KW - Patient safety KW - Pharmacovigilance AB -

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’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’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.

VL - 6 IS - 1 ER -