ABSTRACT
Background: Chemotherapy induced Nausea and Vomiting (CINV) is one the most common adverse effects associated with chemotherapeutic management of carcinoma breast. Preventing CINV becomes a vital part in treatment of these cancer patients for better compliance. The conventional regimen of newer 5-HT3 receptor antagonist and dexamethasone along with newer agents - Aprepitant, a NK-1 receptor antagonist and a recently approved atypical antipsychotic, Olanzapine have shown better control of CINV. These newer agents are effective but also very expensive.Methods: The study included carcinoma breast patients scheduled for chemotherapy (n = 55 in each group) who either received aprepitant or olanzapine or a combination of both as the anti-emetic regimen. Considering Cost-Effectiveness Analysis (CEA), the cost included was the cost of anti-emetic agents (sponsor’s perspective) and outcome measured as control of nausea and vomiting - as Complete Protection (CP), Complete Response to Best (CRB) and Incomplete Response (IR) for acute (0-24 hours) and delayed (24-120 hours) phases. The cost effectiveness(CE) ratio for emesis and CINV free days were calculated.Results: CP was seen better during the acute period than the delayed period. With Aprepitant, delayed CRB and IR was seen with 13 (23.6%) and 10 (18.2%) subjects. 16 (29.1%) showed IR with Olanzapine during the delayed period.The average number of Emesis and CINV free days were 4.65, 4.51, 4.89 and 3.38, 3.96, 4.15 for the three groups respectively. The cost required to achieve 1 emesis and 1 CINV free day per subject in the 3 groups was INR 351.19, INR 27.20, INR 339.54 and INR 483.36, INR 30.94, INR 400.60 respectively.Conclusions: The newer anti-emetic even though being expensive at cost, pharmacoeconomically provide better outcomes and seem to have better control rates than the conventional regimen.
ABSTRACT
Background: Pharmacovigilance and adverse drug reactions monitoring has become an integral part to ensure patient safety. Targeting the younger doctors for sensitization towards pharmacovigilance is the key to ensure practice of ADR reporting in clinical practice. The objective of the study is to understand and assess the knowledge and perception of students towards pharmacovigilance and adverse drug reactions reporting.Methods: The study included undergraduate medical students of second, pre-final and final years of Mysore Medical College. A validated and standardized KAP based questionnaire was distributed to all students. Willingness to answer and complete the questionnaire was considered as consent.Results: The questions were statistically analysed individually and compared. Q1-Q10 compared knowledge towards pharmacovigilance, Q11-Q20 on the attitude and Q21-Q23 on the practice of ADR reporting. 325 questionnaires were distributed of which only 280 consented (second year - 114, pre-final - 98, final - 68). 112(49.1%), 137(69.9%) and 79(58.1%) of the three groups respectively knew what pharmacovigilance and ADR is. 79.8%, 76.5% and 75% knew who can report ADRs while 18.4%, 32.7% and 33.8% did not know what ADRs to report. 73(64.1%); 93(81.6%), 18(18.4%); 69(70.4%), 13(19.1%); 37(54.4%) knew the existence of AMC in the institute and the PvPI respectively. More than 92% agreed that ADR reporting is necessary. Majority (>90%) agreed that PV and ADR reporting should be taught to all health care students while 28%, 30% and 54% said that it was not well covered in their curriculum.73(64%), 51(52%) and 63(93%) were not familiar with the ADR reporting form.Conclusions: Pharmacovigilance and ADR reporting needs to be made compulsory, have better, interesting ways to learn and understand it, so that the students can practice it with confidence in their clinical practice.