Background: An adverse drug reaction (ADR) is defined by World Health Organization (WHO) as 'Any response to a drug which is noxious, unintended and occurs at doses used in man for prophylaxis, diagnosis or therapy'. ADRs associated with cancer chemotherapy warrant analysis on their severity and preventability. The outcome would create awareness among health care providers and prevent their recurrence. We have performed a hospital-based prospective observational study designed to analyze the pattern of ADRs to chemotherapeutic agents in cancer patients of a tertiary care hospital. Methods: A total of 119 cancer patients were monitored for suspected ADRs during the course of chemotherapy from November 2014 to December 2015. Clinical events were recorded and analyzed with regard to the demographics and drug details of the patients. Results: A total of 106 ADRs were recorded from 119 cases. The ADRs commonly encountered included constipation, nausea, vomiting, alopecia and hematological changes. Cisplatin, cyclophosphamide, paclitaxel and 5-FU were used for the treatment of commonly found cancers in this region affecting the lungs, esophagus and lymphomas. Naranjo's causality assessment showed 86.7% possible (score 4) and 13.2% probable (score 5-6). Severity of adverse reactions showed 77.4% mild, 18.9% moderate and 3.8% severe. A total of 45.3% of ADRs were preventable reactions such as nausea, vomiting and constipation. Conclusions: This study highlights the role of active monitoring as an important tool for early detection, assessment and timely management of ADRs in patients undergoing cancer chemotherapy. The observed ADRs were preventable although ADRs such as hiccough, anemia, neutropenia and alopecia were not preventable.

Background: Dexmedetomidine has been approved as a sedative agent in critical patients. It is also frequently used as an adjuvant with local anesthetic in spinal anesthesia. However, its use as an adjuvant has not been approved due to the paucity of data. The present systematic review and meta-analysis were undertaken to synthesize evidence for efficacy and safety when dexmedetomidine is combined with bupivacaine in spinal anesthesia.Methods: A literature search was done using PubMed, Google Scholar, Embase, and Cochrane Library. Search results were screened and eligible studies were included to perform a systematic review and meta-analysis using the software 'Review Manager (RevMan) version 5.4.1' using a random effect model. Cochrane's' Risk of Bias tool (RoB2)' was used for quality assessment. Mean and standard deviation was used to calculate the standardized mean difference and its forest plot for efficacy measures. For the adverse event, a number of events were used to determine the risk ratio and its forest plot using RevMan software. Publication bias is visualized using a funnel plot.Results: A total of 21 randomized control trials evaluating the efficacy and safety of intrathecal dexmedetomidine were included in the meta-analysis. A total of 1382 participants was included in this meta-analysis. The effect estimates for efficacy parameters, i.e. duration of the sensory block having SMD 2.33; CI, 1.83-2.83, motor block with SMD 1.83, CI 1.21, 2.46, and analgesia SMD 2.81; CI, 2.11-3.51. The risk ratio for adverse effects, i.e. nausea/vomiting, bradycardia, hypotension was not significant whereas it was significant for the incidence of shivering with RR 0.38; CI 0.23-0.97. The overall risk of bias among included studies was either of 'some concern' or 'high risk.' Conclusions: Intrathecal dexmedetomidine when combined with bupivacaine was found to significantly increase the three efficacy parameters, i.e. duration of sensory block, motor block, and analgesia. It also appears to be safe with no increased risk of bradycardia or hypotension. It is also associated with decreased postoperative shivering.

Background: Adverse drug reactions (ADRs) are among the leading cause of morbidity and mortality in hospital setup. This study was conducted with the aim of understanding the pattern and occurrence of ADRs to minimize their risk and safeguard public health.Methods: This study is a retrospective analysis of pattern of ADRs reported at ADR monitoring centre (AMC) in a tertiary care hospital. A total of 207 spontaneous ADR reports collected over a period of 18 months were analysed for pattern and type of reactions, demographic profile of patients, organ system affected by ADRs, causative drugs, route of drug administration, severity of reaction, their outcome, management and causality assessment.Results: Most common age group affected by ADRs was 41-50 years with almost equal involvement of male and female gender. Cutaneous reactions involving skin like rashes and itching were most common ADRs. The most common causative drug for ADRs were antimicrobials agents like Penicillin and Cephalosporin group of antibiotics. Orally administered drugs were most commonly involved in causing ADRs. Most of the ADRs belonged to Type A category, were non-serious and moderate in severity. Most of the patients recovered from the ADRs on stopping the suspected drug. On assessing the causality, most of the ADRs were probable with the suspected drugs.Conclusions: Most of the patients recover from ADRs with appropriate and timely intervention, but it is important to understand the pattern and occurrence of ADRs for patient safety and this is possible only with an effective and robust pharmacovigilance system.

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Objective: Knowledge of doctors and their understanding of generic drugs could facilitate in recognizing potential barriers to larger generic medicine prescriptions. Hence, the primary objective of this study was focused to explore knowledge, attitude, and practice (KAP) of doctors toward generic medicines. Methods: It is a cross-sectional questionnaire-based study. The study participants are the doctors working in the hospital during the study period (2016–2017). The questionnaire designed for this study comprised of thirty-five questions related to the knowledge, attitude, and practice (KAP) of generic medicine and about demographic details of the participants. Results: A total of 86 questionnaires were distributed among the health care professionals and the response rate is 37%. The majority of doctors who participated in this survey perceived that generic medicine is effective, safe and need to have the same active component, dose and bioequivalent as the brand name medicines. Most of the doctors (72%) were of the view that generic drugs were manufactured in poor quality than branded medicines. More than three-quarters of doctors (78%) prescribed generic drugs. Conclusion: Majority of the participants had an honest angle about the efficaciousness and safety of generic and though they sometimes prescribe generic medicine, however a high range of doctors (72%) were of the opinion that generic was of poorer quality than brand medicine. To have a better understanding of the generic drug, the doctor must be well informed about the generics during their academic career resulting in savings to healthcare budgets.