Ponatinib: a miracle or a disaster in chronic myeloid leukemia

Chronic myeloid leukemia (CML), the most common myeloproliferative disorder, occurring due to balanced reciprocal translocation between chromosome 9 and 22 and resulting in a chimeric oncogene called breakpoint cluster region-abelson (BCR-ABL) whose protein product has tyrosine kinase activity, causes uncontrolled proliferation of the myeloid cells. Although, imatinib, the first-generation tyrosine kinase inhibitor (TKI) achieved an extremely high response rate, some patients developed resistance to it. Thus, second-generation TKIs such as nilotinib, dasatinib, bosutinib were developed which proved very useful, till the emergence of T315I point mutation which occurs in the BCR-ABL gene and renders CML resistant to previous TKIs. Ponatinib, a third generation TKI approved by the United States Food and Drug Administration (FDA), showed great promise as it was effective even against T315I point mutation. However, a recent increase in the incidence of blood clots observed in patients taking ponatinib has resulted in FDA temporarily suspending all trials, marketing and distribution of the drug. Hence, whether ponatinib evolves as a miracle or disaster for the patients of CML is yet to be answered

Functional outcome of arthroscopic Bankart repair in post-traumatic recurrent shoulder dislocation in a private tertiary care teaching hospital in eastern India

Background: Recurrent anterior shoulder dislocations are quite common in young patients with Bankart lesions. The open Bankart repair was the gold standard for years, however arthroscopic Bankart repair has gained popularity. The aim of the study was to evaluate the functional results of arthroscopic Bankart repair in patients with post-traumatic recurrent anterior glenohumeral instability.Methods: Patients who underwent arthroscopic Bankart repair for post-traumatic recurrent anterior shoulder dislocation were included in the study. This was a prospective study conducted at a tertiary care Hospital in Kolkata, India between August 2017 to May 2019. All patients were followed up at an interval of 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months and 1 year. Rowe score was used to assess the functional outcomes of the patients.Results: 34 (91.9%) patients reported good to excellent results, whereas only 2 (5.4%) patients had fair outcome and 1 (2.7%) patient demonstrated poor surgical result. The total rowe score improved from 46.62 pre-operatively to 94.20 post-operatively after 1 year (p<0.01). By the end of 1-year follow-up, 35 (94.6%) patients had full range of motion in all the planes. Majority of (89.2%) patients did not have any complications. Only 1 patient out of 37 had a recurrence (2.7%).Conclusion: Arthroscopic Bankart repair is an effective, cosmetic and safe surgical procedure with good clinical outcomes and excellent post-operative shoulder range of motion. This surgical intervention also has low recurrence rate and minimum surgical complications

Medication errors reported in a tertiary care private hospital in Eastern India: a three years experience

Background: Medication errors (MEs) can cause significant harm to patients. The MEs identified through reporting processes currently report only a fraction of the actual number of MEs. Data about MEs is limited in India, especially from eastern and north-eastern parts of India. The objective of this study was to analyse the various types of Medication errors reported in a tertiary care private hospital in Eastern India. The aim was to determine the various factors associated with these errors and steps to be taken to reduce the MEs in this healthcare setup.Methods: We carried out a prospective passive surveillance study over the course of 3 years (2016-2018) on 50,822 admitted patients after obtaining approval from the Institutional Ethics Committee. A detailed root-cause analysis was performed for every reported error by a team of healthcare quality professionals and clinical pharmacists along with a clinical pharmacologist followed by appropriate preventive and corrective actions.Results: In our study, a total number of 88 medication errors were reported from a sample size of 50,822 (0.0017%). 61 of the reported MEs were administration errors (69.3%). Higher preponderance of medication errors was seen in male patients (53.1%) in comparison to female patients (46.9%).Conclusions: In this study gross under-reporting of MEs were observed which is in line with previously published studies in India. The reasons reported for gross under-reporting can function as an effective tool to ensure improved reporting of MEs and implementation of mitigation strategies

A study on adverse drug reactions to non-ionic contrast medium in an Indian population: a 1-year experience

Background: To the best of our understanding, very few studies focusing on the adverse drug reaction (ADR) profile of non-ionic contrast medium (NICM) has been carried out until date among the Indian population. Hence, this study was planned. We sincerely believe that the knowledge gathered from this study can improve safer usage of these agents among the patients of Indian origin. The objective was to evaluate the incidence and severity of ADRs of non-ionic radio contrast media (CM) used in tertiary care hospital in Eastern India.Methods: For the duration of 1-year from July 2011 to July 2012, we prospectively recorded all the ADRs associated with the administration of NICM (iohexol and ioversol) in 3708 patients of Indian origin undergoing computed tomography scan at the hospital. The average median age, weight, dose used; types of ADRs, concomitant medication, final diagnosis, reasons for use were recorded and analyzed with appropriate statistical tools. Causality assessment was performed using Naranjo scale.Results: Eleven of 3708 patients who received either ioversol or iohexol developed ADRs (i.e. 0.3% of patients). The most common ADR was rigor. The incidences of mild, moderate and severe reactions were 55%, 36% and 9%, respectively. Average median age, weight, and dose used were 35 years, 66 kg and 70 ml, respectively. All the ADRs were early (occurred within 1 hr of CM administration). Due to logical constraints, the follow-up of these patients was not possible and hence late ADRs were not captured. The common concomitant medication used was pantoprazole (63.63% of patients). The difference in the incidence of ADRs by age distribution (Group 1 - Iohexol, Group 2 - Ioversol) and weight distribution was not statistically significant (p=0.75 and p=0.18, respectively). Causality analysis revealed that all the ADRs were possible (Score of 4). Interestingly, the incidence of reactions was noted to be higher in patients with a history of gastro intestinal disorders (45.45%).Conclusions: This pilot study reveals that adverse reactions to NICM are rare and severe reactions are less common among the patients of Indian origin. However, a larger multicentric study across the country should be carried out to understand the safety profile of these CM better among the Indian population

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial s ubject safe t y in the long run

Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital

Objectives : Adverse drug reactions (ADRs) to psychotropic agents are common and can lead to noncompliance or even discontinuation of therapy. There is paucity of such data in the Indian context. We deemed it worthwhile to assess the suspected ADR profile of psychotropic drugs in an ambulatory setting in a public teaching hospital in Kolkata. Materials and Methods : A longitudinal observational study was conducted in the outpatient department (OPD) of the concerned psychiatry unit. Twenty consecutive patients per day, irrespective of their psychiatric diagnosis, were screened for suspected ADRs, 2 days in a week, over 15 months. Adverse event history, medication history and other relevant details were captured in a format as adopted in the Indian National Pharmacovigilance Programme. Causality was assessed by criteria of World Health Organization-Uppsala Monitoring Center (WHO-UPC). Results : We screened 2000 patients (68.69% males, median age 34.4 years), of whom 429 were suspected of having at least one ADR; 84 cases had insufficient evidence about causality (WHO-UMC causality status "unlikely") and were excluded from further analysis. Thus, 17.25% (95% confidence interval: 15.59-18.91%) of our study population reported ADRs with at least "possible" causality. Of 352 events recorded, 327 (92.90%) were "probable" and the rest "possible". None was labeled "certain" as rechallenge was not performed. Patients received a median of 3.2 psychotropic drugs each. Thirty-three different kinds of ADRs were noted, including tremor (19.60%), weight gain (15.34%) and constipation (14.49%). Among the incriminated drugs, antipsychotics represented the majority (57.10%), with olanzapine topping the list. Conclusions : This study offers a representative profile of ADRs to be expected in psychiatry out-patients in an Indian public hospital. Establishment of a psychotropic drug ADR database can be a worthy long-term goal in the Indian context