Patient Voices in Pharmacovigilance: Understanding Adverse Drug Reactions Through Consumer Narratives Shatavisa Mukherjee, Siddhartha Roy, Nikhil Era Journal of Evaluation in Clinical Practice, 2025 BackgroundAdverse drug reactions (ADRs) are unintended and harmful responses to medications. Although clinicians and researchers often focus on the clinical aspects and prevention of ADRs, consumers—the patients themselves—experience and interpret these events in personal, social, and cultural contexts. Understanding consumers' perspectives on ADRs is essential to improving communication, therapeutic decision‐making, and patient safety strategies.ObjectiveThis study aimed to explore consumers' views and experiences of ADRs, including their perceptions of risk, attribution of causes, and the impact on medication adherence and trust in healthcare providers.MethodsA qualitative research design was employed. Purposive sampling was used to recruit adult participants who had experienced at least one ADR or were caregivers of someone with an ADR experience. Four focus group discussions (FGDs) were conducted (n = 28). A semi‐structured discussion guide elicited participants' personal accounts and interpretations of ADRs. Data were transcribed verbatim and analyzed using thematic analysis.ResultsSix major themes emerged: (1) Understanding and Knowledge of ADRs, (2) Severity and Impact on Daily Life, (3) Trust and Communication with Healthcare Providers, (4) Self‐Medication Practices and ADR Risk, (5) Emotional and Psychological Responses, and (6) Recommendations for Improved ADR Awareness and Reporting. Participants expressed anxiety about the unpredictability of ADRs, citing both mild and severe reactions. Many shared difficulties with navigating information sources, feeling that healthcare professionals sometimes minimized or overlooked their concerns. The emotional toll of ADRs ranged from worry and frustration to lowered trust in medical recommendations.ConclusionConsumers' experiences of ADRs are deeply personal, often influenced by prior knowledge, trust in healthcare providers, and the perceived severity of reactions. Patient‐centered communication strategies, clearer information on risks and benefits, and robust ADR reporting mechanisms are recommended to empower consumers and enhance medication safety. Understanding the consumer perspective is pivotal for healthcare policy and practice to reduce the burden of preventable ADRs and to improve patient‐centered care.
Medication Adherence and Quality of Life Among Type 2 Diabetes Patients: A Cross-Sectional, Observational Study in an Eastern India Set Up Samsuj Joha, Amar Kumar Gupta, Shatavisa Mukherjee, Nikhil Era Clinical Diabetology, 2025 Objective: This study aimed to assess medication adherence and its association with quality of life (QoL) in type 2 diabetes (T2D) patients. Materials and methods: This cross-sectional study included 374 T2D patients aged 18–75 years, receiving treatment for at least six months. Medication adherence was evaluated using the Medication Adherence Rating Scale (MARS), and QoL was assessed using the WHO-QoL-BREF instrument. Data were analyzed using descriptive statistics and multiple regression to identify predictors of adherence and QoL. Results: The study reports a mean age of 55.69 years, with a male preponderance (59.89%). Sixty-one per cent exhibited low adherence scores (MARS 0–5), with a mean adherence score of 6.98. Higher adherence was significantly associated with improved fasting plasma glucose and postprandial glucose levels, although HbA1c levels were similar across adherence groups. QoL scores were highest in the physical, psychological, and social domains for patients with better adherence. Multiple regression analysis identified adherence as an independent predictor of QoL (p < 0.05) after adjusting for sociodemographic and clinical variables. Conclusions: This study highlights the critical link between medication adherence and improved QoL in T2D patients. Interventions targeting adherence barriers, particularly in rural populations, can enhance glycemic outcomes and QoL, underscoring the importance of patient-centered strategies in diabetes care.
Safety incident reporting and barriers (SIRaB) study: Strategies and approaches for investigating patient safety events in a hospital set-up Shatavisa Mukherjee, Siddhartha Roy, Nikhil Era Journal of Evaluation in Clinical Practice, 2024 BackgroundUnsafe patient events not only entail a clinical impact but also lead to economic burden in terms of prolonged hospitalization or unintended harm and delay in care delivery. Monitoring and time‐bound investigation of patient safety events (PSEs) is of paramount importance in a healthcare set‐up.ObjectivesTo explore the safety incident reporting behaviour and the barriers in a hospital set‐up.MethodsThe study had two sections: (a) Retrospective assessment of all safety incidents in the past 1 year, and (b) Understanding the barriers of safety reporting by interviewing the major stakeholders in patient safety reporting framework. Further root cause analysis and failure mode effect analysis were performed for the situation observed. Results were statistically analyzed.ResultsOf the total of 106 PSEs reported voluntarily to the system, the highest reporting functional group was that of nurses (40.57%), followed by physicians (18.87%) and pharmacists (17.92%). Among the various factors identified as barriers in safety incident reporting, fear of litigation was the most observed component. The most commonly observed event was those pertaining to medication management, followed by diagnostic delay. Glitches in healthcare delivery accounted for 8.73% of the total reported PSEs, followed by 5.72% of events occurring due to inter‐stakeholder communication errors. 4.22% of the PSEs were attributed to organizational managerial dysfunctionalities. Majority of medication‐related PSE has moderate risk prioritization gradation.ConclusionEffective training and sensitization regarding the need to report the patient unsafe incidents or near misses to the healthcare system can help avert many untoward experiences. The notion of ‘No Blame No Shame’ should be well inculcated within the minds of each hospital unit such that even if an error occurs, its prompt reporting does not get harmed.
An approach toward cutaneous granulomatous lesion: A retrospective analysis in a tertiary care setup Mala Mukherjee, Deblina Bhunia, Nikhil Era, Shatavisa Mukherjee Medical Journal of Dr D Y Patil Vidyapeeth, 2022 Background: Granulomatous disorders of the skin are commonly encountered and pose a diagnostic challenge due to its diverse etiology with several histological patterns. Granulomatous diseases of skin comprise a large family sharing the common histological finding as of granuloma formation. The various histological types of granulomas can be identified on the basis of the constituent cells and other changes within the granulomas. However, significant overlap exists in histopathological findings of different granulomatous reactions. Thus, morphology alone is seldom specific and cannot be used as a diagnostic tool for the identification of specific diseases. A keen understanding of the manifestations, workup, and subsequent treatment of both infectious and noninfectious cutaneous granulomatous lesion is essential for every practicing clinician and dermatopathologist. Materials and Methods: A 2-year retrospective study involved all the skin biopsies. Detailed clinical and histopathological features were analyzed and were categorized according to the type of granuloma. Special stains were used in few cases for diagnostic purposes. Cases were reviewed and analyzed. Results: In histopathological subtyping, tuberculoid granuloma was the most common type and the most common etiology was leprosy. Others were cutaneous tuberculosis, foreign body granulomas, fungal lesions, cutaneous leishmaniasis, and granuloma annulare. Conclusion: Histopathology when combined with special stain can serve as a gold standard investigation for diagnosis, categorization, and clinicopathological correlation in such cases.
Leukocytoclastic vasculitis secondary to clozapine Shatavisa Mukherjee, Nikhil Era, M. Mukherjee, S. Tripathi Indian Journal of Psychiatry, 2019 Leukocytoclastic vasculitis (LCV) may be secondary to drugs, underlying infection, collagen vascular disorders, or malignancy. Drug-induced vasculitis contributes to 10% of vasculitic skin lesions cases usually developing within 7–21 days of treatment initiation. The present case highlights a report of LCV in a 59-year-old male with a history of paranoid schizophrenia on clozapine therapy. The report upsurges the need to promote awareness and expedite diagnosis and treatment of drug-induced LCVs.
Etoricoxib-induced toxic epidermal necrolysis: A fatal case report Shatavisa Mukherjee, SukalyanSaha Roy, Nikhil Era, Mala Mukherjee Indian Journal of Pharmacology, 2018 Cyclooxygenase inhibitors were developed in the quest of enhanced analgesic efficacy devoid of gastric side effects. High usage of etoricoxib by prescription as well as self-administered routes has led to increasing reports of side effects and adverse reactions including dermatologic reactions in 0.1%–0.3% of cases. The present report enumerates a case of toxic epidermal necrolysis induced by etoricoxib.
Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India Shatavisa Mukherjee, Nikhil Era, Bibhuti Saha, SantanuKumar Tripathi Indian Journal of Pharmacology, 2017 BACKGROUND: Besides unparalleled benefits, highly active antiretroviral therapy is also associated with wide range of potential adverse drug reactions (ADRs), which hinders treatment adherence. The present study was thus designed to monitor and explore the pattern of occurrence of ADRs to various antiretroviral therapy (ART) regimens in a tertiary care ART setup. MATERIALS AND METHODS: A prospective, observational clinical study was carried out in the outpatient setting of nodal ART center of Eastern India. A total of 610 patients on various ART regimens were studied for suspected ADRs over 12 months. Adverse event history, medication history, and other relevant details were captured. Causality and severity of each reported ADR were duly assessed. RESULTS: 32.45% patients of total study participants presented with a total of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia (up to 36%), central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, however, found to be mildly safer. The combination with Efavirenz was associated with majorly CNS side effects while that of nevirapine was associated with rash and pigmentation of nails. Atazanavir boosted second-line regimens were notably associated with increased serum lipid levels followed by other GI and CNS adverse effects. Increased liver enzymes were found in atazanavir-based second-line ART. CONCLUSION: The study enables to obtain information on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs thus seems to be a mandate.
Assessment of corticosteroid utilization pattern among dermatology outpatients in a tertiary care teaching hospital in Eastern India International Journal of Green Pharmacy, 2016
Fatal nevirapine-induced toxic epidermal necrolysis in a HIV infected patient Sabyasachi Paik Journal of Clinical and Diagnostic Research, 2016 Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are the most Severe Cutaneous Adverse Reactions (SCARs) which mainly caused by exposure to drugs and having significant morbidity and mortality. TEN represents an immunologic reaction to a foreign antigen and is most often caused by drugs. Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is an important component of Highly Active Antiretroviral Therapy (HAART). It is sometimes associated with life-threatening adverse reactions. Here, we report the fatal case of 72-year-old male who developed TEN secondary to intake of nevirapine. This fatal case report will increase awareness among treating physicians for careful monitoring of patients on NNRTI-based antiretroviral therapy and better counseling of the patient on NVP regimen for early identification and reporting of SCARs so that fatalities due to adverse drug reactions can be prevented with timely intervention.
