Impact of newer direct-acting antiviral drugs based on quality-adjusted life years: A prospective pharmacoeconomic study in hepatitis C patients.

CONTEXT: The Indian government is dispensing newer direct-acting antiviral (DAA) drugs, which may have impact on hepatitis C virus (HCV) patients' quality of life (QoL). AIMS: To evaluate different DAA regimens and impact on QoL in terms of quality-adjusted life year (QALY) in HCV patients and to measure cost-effectiveness. METHODS: This prospective, observational study was carried out on patients who were diagnosed with HCV. Recruited patients were followed up until 12-24 weeks. Patients were recruited following the selection criteria. Along with demographic and drug details, the regimens used were analyzed and evaluated for cost minimization, cost-effectiveness, and cost-utility analysis. For health quality check, the Chronic Liver Disease questionnaire (CLDQ) was used which was also used for QALY assessment. Data were entered into MS Excel 2016. Difference in between the regimens for total cost was done using unpaired t-test and ANOVA test using SPSS 25.0. Overall cost-effectiveness, cost minimization, cost utility and cost of illness analysis was also calculated. P < 0.05 was considered statistically significant. RESULTS: A total of 31 patients were enrolled. A total of five drugs, namely, sofosbuvir, daclatasvir, ribavirin, velpatasvir, and ledipasvir were widely used. Sofosbuvir was most common (46.25%)component of drug combination in our study. A total of five types of regimen were used according to the genotype of patients. With 44,260.13 ± 15,884.92 INR of the total drug cost, 70.97% of patients spent around 30,000-40,000 INR for the whole pharmacotherapy. The total indirect cost was 2768.39 ± 3916.13 INR with the total direct cost of 48,660.90 ± 15,356.39 INR. The total cost including direct as well as indirect cost spent during 6-month therapy by 61.29% of patients was 40,000-50,000 INR. Based on the CLDQ score, QoL was 64.1 ± 25. Regimen 2 (sofosbuvir + velpatasavir) stood out with the lowest cost. Regimen 5 (ribavirin [200 mg] + sofosbuvir [400 mg] + velpatasvir [100 mg]) was found to be the most cost-effective. Considering 1 life year with good health after treatment, QALY was 0.31. CONCLUSIONS: Ribavirin (200 mg) + sofosbuvir (400 mg) + velpatasvir (100 mg) was found to be the cost-effective and cost-saving regimen among DAAs.

Global Trigger Tool: Proficient Adverse Drug Reaction Autodetection Method in Critical Care Patient Units.

BACKGROUND: Emergency department (ED) being the most crucial part of hospital, where adverse drug reactions (ADRs) often go undetected. Trigger tools are proficient ADR detection methods, which have only been applied for retrospective surveillance. We did a prospective analysis to further refine the trigger tool application in healthcare settings. OBJECTIVE: To estimate the prevalence of ADRs and prospectively evaluate the importance of using trigger tools for their detection. MATERIALS AND METHODS: A prospective study was conducted in the ED for the presence of triggers in patient records to monitor and report ADRs by applying the Institute for Healthcare Improvement (IHI) trigger tool methodology. RESULTS: Four hundred sixty-three medical records were analyzed randomly using 51 trigger tools, where triggers were found in 181 (39.09%) and ADRs in 62 (13.39%) patients. The prevalence of ADR was 13.39%. According to the World Health Organization (WHO)-Uppsala Monitoring Centre (UMC) causality scale, 47 (75.8%) were classified as probable and 15 (24.2%) as possible, wherein 39 (62.9%) were predictable and 8 (12.9%) were definitely preventable. Most common triggers were abrupt medication stoppage (34.98%), antiemetic use (25.91%), and time in ED >6 hours (17.49%). The positive predictive values (PPVs) of triggers such as international normalized ratio (INR) > 4 (p = 0.0384), vitamin K administration (p = 0.002), steroid use (p = 0.0001), abrupt medication stoppage (p = 0.0077), transfusion of blood or blood products (p = 0.004), and rash (p = 0.0042) showed statistically significant results, which make the event detection process more structured when these triggers are positive. Presence of five or more triggers has statistically significant chances of developing an ADR (p < 0.05). CONCLUSION: Trigger tool could be a viable method to identify ADRs when compared to the traditional ADR identification methods, but there is insufficient data on IHI tool and its use to identify ADRs in the general outpatient setting. Healthcare providers may benefit from better trigger tools to help them detect ADRs. HOW TO CITE THIS ARTICLE: Pandya AD, Patel K, Rana D, Gupta SD, Malhotra SD, Patel P. Global Trigger Tool: Proficient Adverse Drug Reaction Autodetection Method in Critical Care Patient Units. Indian J Crit Care Med 2020;24(3):172-178.

Off-label drugs use in neurology outpatient department: A prospective study at a tertiary care teaching hospital.

BACKGROUND: Off-label drug use refers to any use of an approved or cleared drug that is not included in that product's approved labeling or cleared indications for use. It may be in terms of indication, age group, dosage, or route of administration. Off-label drug prescriptions are common neurology practice. AIM: The aim of the study is to evaluate the prevalence pattern of off-label drug use in neurology. SUBJECTS AND METHODS: A prospective, observational, cross-sectional study was carried out in the neurology outpatient department of tertiary care teaching hospital. Data of patients above 18 years were recorded after obtaining their informed consent. The National Formulary of India (NFI) and British National Formulary (BNF) guidelines were used as tools for evaluation of the prevalence of off-label drug use. RESULTS: A total of 709 drugs were recorded from the prescription data of 205 patients collected in the duration of 2 months. The results reported 145 (20.45%) and 317 (44.71%) drugs as off-label as per the NFI and BNF, respectively. Prescriptions with minimum 1 off-label drug use were 78.05% - BNF and 46.83% - NFI. The indication was one of the most common causes of drugs being off-label. Out of the total 317 off-label drug uses reported, 84 were unlicensed drug use as per the BNF. There is strong and positive correlation established between the age of the patients, number of drugs prescribed, and total off-label drugs prescribed per patient in the given study. The most common off-label drug use noted was with clonazepam and amitriptyline. CONCLUSION: Off-label prescriptions practice is common in the field of neurology.

Students' perceptions on feedback module in pharmacology.

CONTEXT: Feedback is an integral part of formative assessment though underutilized in medical education. The objective of this study was to review our feedback module through students' perceptions. METHODOLOGY: We have developed a feedback module which is practiced by us for last 10 years for term ending examination that gives collective feedback to the whole class, followed by individual student-teacher interactions. Students were also exposed to 6-7 multiple choice questions (MCQs) based assessment during the course of pharmacology. Immediately after each MCQ test the answer keys is displayed along with an explanation. Two classes of students were requested to give their perceptions about the feedback by responding on Likert scale for the statements in the questionnaire. All the 206 students who volunteered for the study were enrolled in the study. Mann-Whitney test was used to calculate the difference in perceptions. RESULTS: Of 278 students of two classes, 206 responded (74%). Students' agreement varied from 93% to 98% for 5 items in the questionnaire for the feedback after term ending examinations. Perception of students attending one or more than one feedback session did not differ significantly. For MCQs, tests agreement was 91% to 98% for the 4 items. There was no significant difference between two classes in their perceptions regarding feedback practices (P < 0.05). CONCLUSION: Students gave a favorable opinion for our feedback module. In the medical colleges with a large number of students, this module is feasible for feedback in formative assessment in the form of written tests.

Antiepileptic Drugs-induced Stevens-Johnson syndrome: A case Series.

Stevens-Johnson syndrome (SJS) is an acute life-threatening mucocutaneous reaction, characterized by extensive necrosis and detachment of the epidermis from the skin. The overall incidence of SJS is seen in five cases per million people per year. SJS is typically caused by drugs and is a kind of idiosyncratic reaction. Adverse drug reactions such an SJS have a remarkable effect on patient's safety issues. We encountered nine cases of antiepileptic drug (AED)-induced SJS, specifically with carbamazepine, oxcarbazepine, and phenytoin. To manage the reaction, the clinician withdrew the drug in all 8 cases, and in 1 case, the patient was shifted to valproate and symptomatic treatment was provided. There is still a controversy whether or not all AEDs can cause SJS. Recent studies have investigated the role of genetic factors - HLAB*502 allele in the development of AED-induced SJS in patients of Asian ancestry.

Drug utilization in pediatric neurology outpatient department: A prospective study at a tertiary care teaching hospital.

BACKGROUND: Neurological disorders are a significant cause of morbidity, mortality and adversely affect quality of life among pediatric patients. In India, more than 30% population is under 20 years of age, many of whom present late during the course of illness. Several drugs prescribed to pediatric population suffering from neurological disorders may be off label or unlicensed. AIMS AND OBJECTIVES: To study drug use pattern, identify off-label/unlicensed drug use and to check potential for drug-drug interactions in patients attending outpatient department of pediatric neurology at a tertiary care teaching hospital. METHODOLOGY: Prescriptions of patients attending pediatric neurology outpatient department were collected prospectively for 8 weeks. They were analyzed for prescribing pattern, WHO core prescribing indicators, off-label/unlicensed drug use and potential for drug-drug interactions. RESULT: A total of 140 prescriptions were collected, male female ratio being 2:1. Epilepsy was the most common diagnosis (73.57%) followed by breath holding spells, migraine and developmental disorders. Partial seizure was the most common type of epilepsy (52.42%). Average number of drugs prescribed per patient was 1.56. Most commonly prescribed drug was sodium valproate (25.11%) followed by phenytoin (11.41%). About 16% of the prescriptions contained newer antiepileptic drugs. More than 60% of the drugs were prescribed from WHO essential drug list. In 8.57% of cases drugs were prescribed in off-label/unlicensed manner. Twenty-six percent prescriptions showed potential for drug interactions. CONCLUSION: Epilepsy is the most common neurological disease among children and adolescents. Sodium valproate is the most commonly prescribed drug. A few prescriptions contained off-label/unlicensed drugs.

A study of potential adverse drug-drug interactions among prescribed drugs in medicine outpatient department of a tertiary care teaching hospital.

OBJECTIVE: To evaluate prevalence, types, and severity of potential adverse drug-drug interaction in medicine out-patient department. MATERIALS AND METHODS: A single-point, prospective, and observational study was carried out in medicine OPD. Study began after obtaining approval Institutional Ethics Committee. Data were collected and potential drug-drug interactions (pDDIs) were identified using medscape drug interaction checker and were analyzed. RESULT: A total of 350 prescriptions with mean age 52.45 ± 14.49 years were collected over a period of 5 months. A total of 2066 pDDIs were recorded with mean of 5.90 ± 6.0. The prevalence of pDDI was 83.42%. Aspirin was most frequently prescribed drug in 185 (10.15%) out of total of 1821 drugs It was also the most frequent drug implicated in pDDI i.e. in 48.16%. The most common pDDI identified was metoprolol with aspirin in 126 (6.09%). Mechanism of interactions was pharmacokinetic in 553 (26.76%), pharmacodynamic in 1424 (68.92%) and 89 (4.30%) having an unknown mechanism. Out of all interactions, 76 (3.67%) were serious, 1516 (73.37%) significant, and 474 (22.94%) were minor interaction. Age of the patients (r = 0.327, P = 0.0001) and number of drugs prescribed (r = 0.714, P = 0.0001) are significantly correlated with drug interactions. CONCLUSION: Aspirin being the most common drug interacting. The use of electronic decision support tools, continuing education and vigilance on the part of prescribers toward drug selection may decrease the problem of pDDIs.

Evaluation of rationality in prescribing, adherence to treatment guidelines, and direct cost of treatment in intensive cardiac care unit: A prospective observational study.

BACKGROUND: Cardiovascular diseases (CVDs) remain the most common cause of sudden death. Hence, appropriate drug therapy in intensive cardiac care unit (ICCU) is crucial in managing cardiovascular emergencies and to decrease morbidity and mortality. OBJECTIVE: To evaluate prescribing pattern of drugs and direct cost of therapy in patients admitted in ICCU. MATERIALS AND METHODS: Patients admitted in ICCU of a tertiary care teaching hospital were enrolled. Demographic data, clinical history, and complete drug therapy received during their stay in ICCU were noted. Data were analyzed for drug utilization pattern and direct cost of treatment calculated using patient's hospital and pharmacy bills. Rationality of therapy was evaluated based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines. RESULT: Data of 170 patients were collected over 2 months. Mean age of patients was 54.67 ± 13.42 years. Male to female ratio was 2.33:1. Most common comorbid condition was hypertension 76 (44.7%). Most common diagnosis was acute coronary syndrome (ACS) 49.4%. Mean stay in ICCU was 4.42 ± 1.9 days. Mean number of drugs prescribed per patient was 11.43 ± 2.85. Antiplatelet drugs were the most frequently prescribed drug group (86.5%). Mean cost of pharmacotherapy per patient was '2701.24 ± 3111.94. Mean direct cost of treatment per patient was '10564.74 ± 14968.70. Parenteral drugs constituted 42% of total drugs and 90% of total cost of pharmacotherapy. Cost of pharmacotherapy was positively correlated with number of drugs (P = 0.000) and duration of stay (P = 0.027). CONCLUSION: Antiplatelet drugs were the most frequently prescribed drug group. Mean number of drugs per encounter were high, which contributed to the higher cost of pharmacotherapy. ACC/AHA guidelines were followed in majority of the cases.

Health related quality of life in hypertensive patients in a tertiary care teaching hospital.

BACKGROUND: Quality of life (QOL) evaluation has emerged as an important outcome measure for chronic diseases like hypertension. AIMS: To determine QOL in patients suffering from hypertension using MINICHAL and WHOQOL-BREF tools. METHODS AND MATERIAL: The study was carried out for eight weeks in medicine outpatient department of a tertiary care hospital. All patients diagnosed with essential hypertension and on drug therapy for at least one month were included. Their socio-demographic and clinical data were noted. Patients were interviewed for QOL using two questionnaires - WHOQOL-BREF and MINICHAL scale. RESULTS: Total 269 patients had mean age and duration of hypertension 58.25 ± 10.35 and 7.65 ± 8.00 years respectively. Age, duration of illness, number of symptoms, systolic blood pressure and number of drugs prescribed showed statistically significant (P < 0.05) negative correlation with WHOQOL-BREF score while number of symptoms, systolic blood pressure and duration of illness showed statistically significant positive correlation with MINICHAL scale (P < 0.05). MINICHAL scale and WHOQOL-BREF were significantly correlated with each other (P < 0.01). Women had significantly poorer QOL compared to men. CONCLUSIONS: Age, female gender, duration, number of symptoms, systolic blood pressure and number of medications may be important predictors of QOL in hypertensive patients.

Objective structured practical examination as a tool for the formative assessment of practical skills of undergraduate students in pharmacology.

INTRODUCTION: Assessment for practical skills in medical education needs improvement from subjective methods to objective ones. An Objective Structured Practical Examination (OSPE) has been considered as one such method. This study is an attempt to evaluate the feasibility of using OSPE as a tool for the formative assessment of undergraduate medical education in pharmacology. MATERIALS AND METHODS: Students of second year MBBS, at the end of the first term, were assessed by both the conventional practical examination and the Objective Structured Practical Examination (OSPE). A five-station OSPE was conducted one week after the conventional examination. The scores obtained in both were compared and a Bland Altman plot was also used for comparison of the two methods. Perceptions of students regarding the new method were obtained using a questionnaire. RESULTS: There was no significant difference in the mean scores between the two methods (P = 0.44) using the unpaired t test. The Bland Altman plot comparing the CPE (conventional practical examination) with the OSPE showed that 96% of the differences in the scores between OSPE and CPE were within the acceptable limit of 1.96 SD. Regarding the students' perceptions of OSPE compared to CPE, 73% responded that OSPE could partially or completely replace CPE. OSPE was judged as an objective and unbiased test as compared to CPE, by 66.4% of the students. CONCLUSION: Use of OSPE is feasible for formative assessment in the undergraduate pharmacology curriculum.

Drug utilization in emergency medicine department at a tertiary care teaching hospital: A prospective study.

BACKGROUND AND OBJECTIVES: The practice of emergency medicine has the primary mission of evaluating, managing and providing treatment to those patients with unexpected injury or illness. Instituting appropriate therapy is necessary for safety of the patients and to decrease mortality and morbidity. The objectives were to study the drug utilization pattern and direct cost of therapy in emergency medicine department of a tertiary care teaching hospital. MATERIALS AND METHODS: Data of the patients admitted to emergency medicine department was collected prospectively for 48 h from the time of admission over 2 months. The prescriptions were analyzed for drug use pattern and direct cost of therapy was calculated. RESULTS: A total of 156 patients received 1635 drugs with the mean of 9.99 ± 2.55 drugs/patient. Most common diagnosis was acute coronary syndrome 35 (21.79%). Ondansetron 135 (86.53%) was most frequently prescribed drug followed by pantoprazole 133 (85.25%) and furosemide 68 (43.58%). Amongst antimicrobials ceftriaxone 51 (32.69%) was the most commonly prescribed drug. Direct cost of treatment per patient for the first 48 h was र 4051 ± 1641. CONCLUSION: Ondansetron and pantoprazole were the most commonly prescribed drugs in the emergency department. However, their use in all patients was not justified. Polypharmacy was prevalent. A closer look at the rationality of therapy would help in highlighting issues involved and would be helpful to authorities in deciding prescribing policies.