Antitubercular therapy causing drug reaction with eosinophilia and systemic symptoms manifesting multi-organ dysfunction syndrome and death in an elderly patient: A case report with review of literature.

We present the case of a drug reaction with eosinophilia and systemic symptoms (DRESS) manifesting multi-organ dysfunction syndrome (MODS) that led to death in an elderly patient during the intensive phase of antitubercular therapy (ATT). A 74-year-old male developed skin rash (morbilliform), patchy erythematous macules, pustular-purpuric nonblanching spots, fever, lymphadenopathy, liver dysfunction, leukocytosis, and eosinophilia during intensive phase of ATT (ATT: day 45). Laboratory tests revealed hypereosinophilia (eosinophils; 10500/µL), hyperacute fulminant hepatic failure (aspartate transaminase/alanine transaminase; 1444/1375 IU/L, total bilirubin; 11.3 mg/dL), hepatic encephalopathy (Child-Pugh score: 15), coagulopathy (international normalized ratio; 3.0 and activated partial thromboplastin time; 52 s), and acute renal failure (serum creatinine; 2.6 mg/dL). The patient was diagnosed with DRESS with a RegiSCAR score of 7 (definite). ATT was discontinued. Despite immediate treatment with pulse methylprednisolone, N-acetylcysteine and sustained low-efficiency dialysis, the patient's clinical condition evolved to shock due to MODS (sequential organ failure Assessment: 15 points), and on day 51, he succumbed. Concluding, an elderly patient with high-dose antitubercular drugs needs a clinical management review. Clinical symptoms pertaining to DRESS may paradoxically worsen after 3-4 days of discontinuation of the offending drug.

Incidence and Severity of Adverse Drug Reactions in Medical Intensive Care Unit.

BACKGROUND: Adverse drug reactions (ADRs) curtail patients' quality of life by virtue of increasing therapeutic complexity and rising multimorbidity. In India, the frequency of ADRs for individual drugs and their economic burdens are rarely evaluated. This study aimed at identifying the incidence and severity of ADRs leading to hospitalization (ADRA) and occurring during a hospital stay (ADRH). OBJECTIVE: The objective of this study is to study the incidence and severity of ADRs in the ICU and their impact on the duration of hospitalization, along with the cost incurred to treat ADRs in the ICU. METHOD: Demographic, clinical, and pharmacological data on patients admitted to the ICU were collected, analyzed and evaluated for ADRs. According to the setting analyzed, a descriptive analysis of the reactions, suspected medicines, and associated factors was undertaken. RESULT: A total of 208 patients were admitted to the ICU during the study period, of which ADRA contributed 9.1% of the incidence rate and 8.1% of ADRH in 36 patients. Males had a higher incidence of ADRs than females. Patients who had ADRs had a substantially longer length of stay than those who did not. Electrolyte disturbance was the most commonly found ADR. According to the Hartwig scale and WHO-causality scale, 88.9% were moderate, and 97.2% were possible ADRs, respectively. CONCLUSION: In this study, a similar incidence rate of ADRA and ADRH was observed. The average cost for treating ADRA was higher than that for treating ADRH. As a result, identifying and preventing these reactions is critical, as they cause the patient greater suffering.

Anxiety and depression among patients with axial spondyloarthritis.

OBJECTIVE: The axial spondyloarthritis (axSpA) mainly affects young population and often leads to reduced mobility, but less is known about the impact it has on mental health. The objective of this study was to determine the prevalence of symptoms of anxiety and depression among axSpA patients and explore the underlying associated factors. METHODS: A cross sectional survey-based study was conducted from a single center. A convenient sampling was done to include 100 patients. We included questions about disease activity, sleep, fatigue, quality of life (QoL), and work productivity. All patients were asked to fill the patient health questionnaire-9 (PHQ) for depression and general anxiety disorder-7 (GAD) for anxiety. A multivariate binomial logistic regression analysis was performed to determine associations between PHQ-9 and GAD-7 scores with various socio-demographic factors, disease activity scores, and other variables. RESULTS: Clinically significant symptoms of anxiety and depression were present in 38% and 36% patients, respectively. Both were significantly associated with younger age at disease onset (P < .05), high disease activity, sleep disturbances, fatigue, poor QoL, and high impact on work productivity. Misbeliefs that "doctors hide side-effects of medicines" and "all modern medicine used in treatment of axSpA causes side-effects" were also related to higher anxiety and depression scores. Depression was also found to be associated with female patients. CONCLUSION: Anxiety and depression are common in axSpA. They are associated with high disease activity and reduced work productivity. Patients should be regularly screened for these symptoms.

Impact of Adherence, Patient Perception, and Knowledge to Statin Therapy - A Cross-Sectional Study.

BACKGROUND AND OBJECTIVE: Cardiovascular diseases and its risk factors, such as diabetes and hyperlipidemia, are common in Indian population. Statin utilization is high across the country and it is important to assess the adherence because it plays an important role in treatment outcome. Statin adherence is not studied well in India. This study aims at measuring the adherence, perception, and knowledge of individuals on statin therapy. STUDY DESIGN: Cross-sectional observational study on 130 consented individuals visiting a tertiary care teaching hospital. Study was conducted for a duration of 9 months. METHODS AND MATERIALS: After obtaining approval from the institutional ethics committee the study subjects were assessed for knowledge, perception, and adherence to statin therapy using a systematically developed interview questionnaire. RESULTS: Good adherence was seen in 42.30% patients. Higher proportions of females were reported to have good adherence. Good adherence was observed in patients with a history of coronary heart disease and atorvastatin as monotherapy (P = 0.0029) and fixed dose combination (P = 0.0012), whereas lipid reduction was found directly related to type of adherence. Lack of knowledge, cost, re-fill issues, and adverse effects were some of the barriers identified. INTERPRETATION AND CONCLUSION: Knowledge and patient perception plays a very important role in determining the adherence to statin therapy. A history of coronary heart disease, choice of statin, and cost of therapy are the contributing factors to adherence. Patient counselling and improving the cost-effectiveness of statin therapy can be considered as interventional strategies to overcome adherence issues.

Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit.

Introduction: The utilization of prescription drugs as off-label is common. While this practice can be beneficial to some patients, it can raise a safety concern when scientific evidence is lacking; hence, this study was conducted to evaluate the off-label drug consumption and its adverse drug reactions (ADRs) in the medical intensive care unit (ICU). Materials and methods: In the prospective cohort study conducted for a duration of 6 months, data pertaining to ICU patients' (age ≥18 years) demography, diagnosis, treatment, and laboratory investigation were collected to assess for off-label use as well as the strength of evidence and the occurrence of ADRs by using MICROMEDEX 2017 version (Healthcare Series Thomson Reuter, Greenwood, CO). Results: Of total 3574 drugs prescribed, 1453 (41%) were off-label indications and 65 (1.81%) were off-label dose. On the evaluation of off-label indication use, 1279 (88%) were evidence-based and 174 (12%) were low/no evidence-based medications (EBMs); 59 (91%) were evidence-based and 6 (9%) were low/no EBMs for off-label dose. Most commonly prescribed evidence-based off-label drug belonged to the gastrointestinal class while low/no evidence drugs were mostly of anti-infective class. A total of 383 ADRs were identified and 139 (36.2%) were implicated due to off-label medications, of which ADRs with evidence off-label medications (87.8%) were higher than low/no evidence off-label medication (12.2%) (P < 0.001). Conclusion: Widespread presence of off-label use was observed in medical ICU. Although incidence of ADRs was similar to the FDA-approved use, ongoing monitoring of such practice is needed. How to cite this article: Raut A, Krishna K, Adake U, Sharma AA, Thomas A, Shah J. Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit. Indian J Crit Care Med 2021;25(8):872-877.

Levetiracetam.

Levetiracetam (LEV) is a novel antiepileptic drug (AED) which was discovered in early 1980s and soon, in 1999 FDA approved LEV for the management of partial onset seizure. In India, LEV tablet was approved in April 2005. It acts by binding to the synaptic vesicle protein SV2A, which is present on synaptic vesicles and some neuroendocrine cells. Pharmacokinetics of LEV such as, less protein binding and lack of hepatic metabolism makes LEV less susceptible to drug interactions with other anticonvulsants. Evidence also suggests that LEV is much better than other AEDs in the way of broad therapeutic window, convenient dosing and less adverse effect. Besides the pharmacological effects, pharmacoeconomically also, LEV is a beneficial drug. All these valuable pharmacological and pharmacoeconomic aspect makes LEV an important option in management of various types of epilepsy.