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Background Cutaneous adverse drug reactions (ADRs) are among the most frequent ADRs. Knowledge of the pattern of cutaneous ADRs (CADRs) and causal drugs helps prevent and reduce the incidence of CADR, which in turn reduces the incidence of hospitalization and expenses for the patient. Objectives To analyze CADR according to demographic profile, morphological pattern, causative drugs, severity, and outcome in patients suffering from CADRs. Materials and methods Retrospective data analysis was conducted in the Adverse Drug Reaction Monitoring Centre (AMC) of the tertiary care teaching institute between February 2020 and September 2023 under the Pharmacovigilance Program of India (PvPI). All ADRs reported were analyzed based on the following parameters: total number of ADRs reported, number of CADRs, information related to demographic parameters, the clinical presentation of CADRs, and suspected medication. Causality assessment was done using the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) scale. Severity was assessed using a modified Hartwig and Seigel scale. Results A total of 125 CADRs were analyzed. Considering the gender-wise distribution, 65 females and 60 males suffered from CADR. The most common drug category responsible for CADRs was antimicrobials (63.2%), followed by topical agents (12.8%). Maculopapular rash (33.6%) was the most common presenting symptom, followed by itching (27.2%). Few patients suffered from serious CADRs such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Conclusion A wide clinical spectrum of CADRs ranging from maculopapular rash to fixed-drug eruption to serious SJS was observed in our study. The most common causative agents for CADRs were antimicrobials, followed by topical agents and NSAIDs. For early diagnosis and management of CADRs, it is critical to have data on the potential cutaneous adverse effects of commonly used drugs, to educate the patients regarding common early symptoms of drug reactions (e.g., erythematous rash, edema, urticaria, mucosal erosions, itching, burning of skin, etc.), and to monitor the patient, especially during the start of therapy. To ease the burden of CADRs, a therapeutic plan of anticipating, avoiding, recognizing, and responding to ADRs should be implemented.
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OBJECTIVE: To compare efficacy, safety, and cost-effectiveness of sertaconazole (2%) and luliconazole (1%) cream in patients with dermatophytoses. MATERIALS AND METHODS: Sixty-four patients with tinea corporis and tinea cruris infections were enrolled in this single-center, randomized, open-label, parallel study. Following inclusion and exclusion criteria, patients were randomly divided into two treatment groups and received either sertaconazole 2% cream applied topically twice daily for 4 weeks and luliconazole 1% cream once daily for 2 weeks. At follow-up, efficacy was assessed clinically using 4-point physician global assessment (PGA) scale, composite score, and mycologically by KOH mount. Safety was assessed by monitoring adverse drug events at each visit. RESULTS: The primary efficacy variables including changes in pruritus, erythema, vesicle, and desquamation (4-point PGA) were significantly (P < 0.0001) improved in both the groups, at the end of treatment. There was a significant reduction in mean total composite score (pruritus, erythema, vesicle, and desquamation) after the end of treatment in the sertaconazole group (P = 0.0002) compared to the luliconazole group. Both the groups showed equal negative mycological assessment. Both the study drugs were well tolerated. Only one patient in the sertaconazole group showed allergic contact dermatitis. CONCLUSION: Sertaconazole was better than luliconazole in relieving signs and symptoms during the study and follow-up period, but cost-effectiveness wise, luliconazole was better than sertaconazole.
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CONTEXT: Chronic obstructive pulmonary disease (COPD) is the second leading contributor to the disease burden of India. The current COPD burden cannot be managed effectively just through a physician-based approach. In a primary care setting, community health workers (CHWs) can play an effective role in making COPD care accessible and effective. AIM: Findings of an assessment of a training program for CHWs on COPD have been reported here. Methods: 90 CHWs working as a part of a noncommunicable disease prevention and care program in a rural primary care setting were exposed to a series of five training sessions. The sessions were designed and administered jointly by a team of public health experts and physiotherapists in the year 2017-18. Topics covered were basic clinical aspects of COPD, monitoring a patient with COPD, and basic aspects of pulmonary rehabilitation. The assessment comprised 12 MCQs and short questions, 7 video exercises, 2 case vignettes, and 5 skill assessments through objectively structured clinical examination (OSCE). STATISTICAL ANALYSIS: Mean percentage scores were calculated for each domain of assessment to make it comparable. RESULTS: 70 CHWs with a mean age of 42.2 years completed all the training and underwent the assessment. Mean percentage score (SD) for knowledge was 62% (16.3). In OSCE assessment, scores were best in sputum clearance technique demonstration (92.1%) and the least in dyspnea relieving positions (59.2%). The CHWs had difficulties in identifying signs of respiratory distress (score - 55.1%). No statistically significant association was observed between performance scores and their sociodemographic profile. CONCLUSION: The results were encouraging and the program may be pilot tested in a government setting particularly using the health and wellness centers (HWC) platform.