Adverse Drug Reactions in Corona Virus Disease Patients Admitted to Intensive Care Unit: An Observational Study.

BACKGROUND: Occurrence of adverse drug reactions (ADRs) in COVID-19 patients has not been extensively studied. AIM: The present study was conducted to analyze the pattern of suspected ADRs in the COVID-19 Intensive Care Unit (ICU). METHODS: In this cross-sectional study, all the individual case study reports of patients admitted to the COVID ICU (August-October 2020) were analyzed for type of ADRs, system involved, suspected drug, onset time, time to revert and management. RESULTS: Thirty six patients (out of 395 patients admitted) experienced 44 ADRs. Dermatological manifestations were the most frequent ADRs. Remdesivir was the most common drug associated with ADRs. The female gender, polypharmacy (>5 drugs) and presence of comorbidities were the independent risk factors for the occurrence of ADRs. CONCLUSION: Use of many of these drugs in COVID-19 is experimental and the literature does not guarantee their safety and efficacy. During these times of uncertainty, the results from the present study reinforce the importance of monitoring patients.

Head-to-Head Comparison of Tazarotene and Calcitriol with or without Sequential Therapy in Mild-to-Moderate Psoriasis: A Randomized Open-label Study.

Objective: Psoriasis is an autoimmune disease that causes rapid turnover of skin cells. It is a chronic disease that affects a patient's quality of life significantly and frequently requires long-term treatment. The study on sequential therapy with tazarotene 0.1% and calcitriol 0.0003% has not been tried so far; hence, we designed this study to compare the safety and efficacy of sequential therapy with tazarotene 0.1% cream and calcitriol 0.0003% ointment versus monotherapy in mild-to-moderate stable plaque psoriasis (SPP). The objective of this study was to compare the safety and efficacy of topical sequential treatment with tazarotene followed by calcitriol, topical calcitriol followed by tazarotene, tazarotene monotherapy, calcitriol monotherapy, and compare the safety and efficacy of the sequential therapies with monotherapies. Methods: The study was a single center, prospective parallel-group, active control, randomized study of 16 weeks duration (treatment for 8 weeks and follow-up for 16 weeks), randomized to either of the four groups, i.e., tazarotene 0.1% for 4 weeks followed by calcitriol 0.0003% for 4 weeks or calcitriol 0.0003% for 4 weeks followed by tazarotene 0.1% for 4 weeks or tazarotene 0.1% for 8 weeks or calcitriol 0.0003% for 8 weeks. Both tazarotene and calcitriol were applied once daily in all the groups. Findings: There was no significant difference with regard to age and duration of illness among the four treatment groups. Statistically significant improvement was observed in erythema, scaling, and induration scores, and Physician`s global assessment scale at 8 weeks and 16 weeks as compared to baseline in tazarotene - calcitriol, calcitriol - tazarotene, and calcitriol versus tazarotene groups. Conclusion: This study concluded that topical treatment with tazarotene 0.1% and calcitriol 0.003% was efficacious in treating mild-to-moderate SPP as both sequential and monotherapy. However, topical treatment with tazarotene as monotherapy was the least efficacious.

Chimeric antigen receptor T cell: A cancer immunotherapy.

During present decade, targeted drug therapy has been the epitome for treatment of cancer. Drugs like Imatinib, a tyrosine kinase receptor inhibitor and Trastuzumab, an human epidermal growth factor receptor-2/neu inhibitor, has been developed and accepted widely for management of chronic myeloid leukaemia and breast cancer respectively. Recent development among the various immunotherapies is adoptive cell transfer (ACT). Research on development of various types of ACT immunotherapy is going on, but so far, Chimeric antigen receptors T cell therapy (CAR-T) has achieved the maximum advancement in terms of clinical development. CARs are the modified receptors that integrates specificity and responsiveness onto immune cells to enhance the recognition of cancer cells. For the CAR-T, the T cells are sequestered from a blood of a participant via apheresis. DNA of particular antigen is injected into harvested T cells to generate CARs on cell surface. Following surface manifestation of receptors, multiplication is carried out in enriched media followed by infusion into patient. After infusion, CAR-T cells targeted and exterminate the cancer cells. Initially, only two drugs targeting CD19 as genetically modified autologous immunotherapy has been approved in CAR-T therapy i.e., Tisagenlecleucel and Axicabtagene Ciloleucel, which are discussed in detail in current review. Recently two more drugs got approval i.e., brexucabtagene ciloleucel and lisocabtagene maraleucel, both are directed against CD19, similar to tisagenlecleucel. CAR-T cell therapy is approved for management of Acute Lymphoblastic Leukaemia, Chronic Lymphocytic Leukaemia and lymphoma. CAR-T cell persistence responsible for effectiveness and safety concerns are barriers for their wide application among patients. Growth factor receptors and cluster of differentiation are new drugs targets that are being explored as effective immunotherapy against cancers.

Hydroxychloroquine: Adverse Drug Reaction Profile of an Old Drug in a New Situation.

BACKGROUND: Hydroxychloroquine (HCQ) has been extensively used during the COVID-19 pandemic both as a therapeutic and prophylactic drug. HCQ is generally well tolerated; however, adverse drug reactions (ADRs) in COVID-19 need further exploration. In this study, we have determined the type and pattern of ADRs of HCQ as a prophylactic and therapeutic drug in COVID-19. METHODS: All spontaneous suspected ADR reports due to HCQ in COVID-19 patients submitted to the ADR monitoring of a tertiary care hospital were included. Additionally, a survey was designed for active surveillance of ADRs among healthcare professionals (HCPs) who were on prophylaxis with HCQ. The ADRs were analyzed to determine severity, causality, and preventability using the Hartwig Scale, World Health Organisation-Uppasala Monitoring Centre (WHO-UMC) scale, and modified Schumock and Thornton criterion respectively. RESULTS: Sixty-four ADR reports were received from COVID-19 patients. A total of 78 ADRs were reported by 49 HCPs who were on HCQ prophylaxis. The majority of the patients had ADRs related to skin and soft tissues (37.5%), whereas the HCPs on prophylaxis mostly had gastrointestinal complaints (42.3%). ADRs observed in HCPs on prophylaxis were mild, not requiring any intervention. However, 50% of ADRs in patients were of "moderate" category. CONCLUSION: Undiscerning and unsupervised use of HCQ can expose the general population as well as patients to serious adverse drug effects. Utmost care is necessary before using HCQ prophylactically or for treatment in COVID-19.

Adverse Drug Reactions in Psychiatry Outpatient Department of a Tertiary Care Hospital in Western Uttar Pradesh: An Observational Study.

Objective: Psychiatric disorders are chronic in nature which require medications for a long duration. These medications have been associated with many adverse events. Failure to recognize an adverse drug reaction (ADR) exposes the patient to continuing risk of ADR, leading to a significant impact on patient's quality of life. Thus, the present study carried out to identify the pattern of ADRs reported due to psychotropic medication. Methods: This was a cross-sectional study conducted to analyze ADRs reported from the psychiatry department of a tertiary care teaching hospital from October 2021 to March 2022. Findings: A total of 137 ADRs were identified from 102 patients. Majority of the ADRs were reported from antidepressants, with paroxetine being the leading offending drug. The central nervous system was most commonly affected, and dizziness (13.13%) was the most common ADR noted. On causality assessment, 97 ADRs (70.8%) were of "possible" type. Almost half of the patients with ADRs (47.5%) recovered spontaneously. No ADR encountered turned out to be fatal. Conclusion: The present study revealed that the majority of ADRs reported from psychiatry OPD were mild in nature. We reinforce the identification of ADR is crucial in the hospital setting process as it gives an insight into the risk-benefit ratio for rational use of the drug.

Prevalence of self-reported anxiety and self-medication among upper and middle socioeconomic strata amidst COVID-19 pandemic.

BACKGROUND: Amidst corona virus disease-2019 (COVID-19) pandemic, disruption to the usual ways of life can lead to anxiety and feeling of being unsafe, which may be associated with self-medication. The study was planned to investigate the prevalence of anxiety and self-medication during COVID-19 pandemic. MATERIALS AND METHODS: In this cross-sectional study, data were collected through an anonymous online survey with questionnaire consisting of four sections: demographic data of the participants, validated COVID-19 Anxiety Inventory Items, Self-rating Anxiety Scale, and self-medication practices during COVID-19 pandemic. The data were organized and analyzed using Windows Microsoft excel and SPSS software (Version 21). Descriptive statistics were calculated for all patient characteristics and survey responses. Analytical analysis included relationship between various parameters using Chi-square test. RESULTS: A total of 1100 responses were received. Approximately half of the participants were worried about getting severely ill. Majority reported reduced social contact (71.3%, n = 784) and also communicated that the pandemic has influenced their use of safety measures (86.5%, n = 951). The prevalence of mild-to-moderate, moderate-to severe, and extremely severe anxiety cases were 23.1%, 4.7%, and 0.54%, respectively. One-fourth of the responders reported self-medication, out of which 60% were found to be anxious. Nonsteroidal anti-inflammatory drugs were most commonly used. CONCLUSIONS: Rising to the present challenge will require integration across different sectors with the immediate aim of getting people safely through the pandemic. As the world focuses on containing and delaying the spread of the COVID-19, with burdened health-care systems, we should not miss out on people with anxiety disorders and self-medication problem, which may worsen with the pandemic.