Promoting Patient Engagement in Adverse Drug Reaction Reporting: A Novel Approach Utilizing Set Induction-Based Skill Questionnaires.

BACKGROUND: All stakeholders must address the global health concern of an increasing frequency of adverse drug reactions (ADRs), regardless of the practice settings. Adverse drug reactions have been found to be a significant cause of morbidity and death across all age groups, hospital admissions, and a significant financial burden on society and healthcare systems. The main objective of this study was to measure patients' awareness and knowledge of reporting adverse drug reactions using a questionnaire and then to help patients become more aware of and sensitive to reporting ADRs. METHODS: The current investigation was carried out in the OPD Block of the All India Institute of Medical Sciences in Deoghar using a pre-experimental study with one group pre-test post-test design. One hundred and ninety-nine patients who were visiting different OPDs and IPDs participated in this study. RESULTS: The average age of the 199 study participants was 34.6 years. The majority of participants were male, illiterate and belonged to rural areas. We found a statistically significant difference [-11.90(0.000*)] in the pre-test and post-test knowledge questionnaire scores of the participants, indicating the efficacy of awareness and sensitization for patients on ADR reporting. CONCLUSIONS: This survey aims to inform patients about the pharmacovigilance Program in India. The questions are structured in a way that allows patients to reflect and become more selfaware while reading them. They also function as a set introduction to ADR (Adverse Drug Reaction) monitoring centers and increase patient awareness of reporting ADRs.

Bisphosphonate- and disumab-related gingival disorders: case analysis from the U.S. Food and Drug Administration Adverse Event Reporting System.

Prior research has indicated that bisphosphonates (BPs) can improve periodontal disease because of their anti-osteoporosis properties. In vitro studies have shown that BPs induce cytotoxicity, inhibit wound healing, and thus affect periodontal disease. Denosumab and BPs have alternative indications. BP and denosumab are not known to correlate with gingival disorders. We assessed such a relationship by applying Bayesian and nonproportional analyses to data in the US FDA Adverse Event Reporting System (FAERS) database. The study analyzed BPs and denosumab-reported incidents with preferred terms found in the narrow Standardized MedDRA Queries for gingival disorders. A total of 5863 reported cases of gingival disorders were associated with five BPs (alendronate, pamidronate, ibandronate, risedronate, and zoledronate) and denosumab. More than 15% of patients with gingival disorders related to BPs and denosumab other than denosumab were hospitalized over short- or long-term periods. Our findings indicated BPs and denosumab had significant reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) with respect to gingival disorders. Pamidronate had the highest association (ROR = 64.58, PRR = 57.99, IC = 5.71), while the weakest association was found with denosumab (ROR = 3.61, PRR = 3.60, IC = 1.77). Significant associations were found between the six drugs and gingival pain, gingival recession, gingivitis, periodontal disease, and periodontitis. In conclusion, our comprehensive overview of the correlations, clinical characteristics, and prognoses of BPs and denosumab-related gingival disorders suggests that these issues deserve continued surveillance and appropriate management.

Adverse events associated with Atogepant: a FAERS-based pharmacovigilance analysis.

BACKGROUND: Migraine, a prevalent neurovascular disorder, can significantly disrupt an individual's daily life. Atogepant (AGN-241689), an orally administered small-molecule drug classified as a calcitonin gene-related peptide receptor antagonist, is utilized for prophylactic migraine treatment. The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety. METHODS: Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023. Disproportionality analysis was employed to quantify relevant AEs associated with atogepant. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA). RESULTS: From the FAERS database, a collection of 7,991,243 reports was obtained. Among these reports, a subset of 3015 was identified as 'primary suspected (PS)' AEs specifically related to atogepant. AEs induced by atogepant were observed across 27 organ systems. A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified. CONCLUSION: Our study has identified adverse events (AEs) associated with atogepant, potentially providing crucial support for the clinical monitoring and risk identification of atogepant.

Patch testing in non-immediate hypersensitivity to cotrimoxazole: Is it useful?

BACKGROUND: Existing literature has questioned the sensitivity of patch testing (PT) with cotrimoxazole (CTX) in the study of drug hypersensitivity. OBJECTIVES: Assess the sensitivity of PT with CTX in non-immediate cutaneous adverse drug reactions (CADR). PATIENTS/MATERIALS/METHODS: Retrospective analysis (2000-2022) of PT with an antibiotic series including CTX 10% pet (Chemotechnique Diagnostics©) performed according to ESCD guidelines in patients with suspected non-immediate CADR reactions to CTX. Some patients were additionally tested with in-house preparations of CTX from Bactrim DS® tablets at 10% in pet or water and trimethoprim 10% pet (Laboratórios Edol©). RESULTS: Sixty-four patients (48F/16M; mean age 47 ± 18) were included, mostly with maculopapular exanthema (51, 80%). Notably, CTX was sole suspect in 24 patients. There was no positive reaction to CTX at 10% from Chemotechnique or Bactrim DS® tablets prepared at 10% pet for patch testing. One patient reacted exclusively to trimethoprim with 1+ reaction. Two patients had a faint reaction (1+) only with the powder of Bactrim DS® tablets in water at D2, but as the reactions faded completely in 24 or 48 h, they were interpreted as irritant non-specific reactions. CONCLUSION: These findings suggest that patch testing may lack sufficient sensitivity to diagnose CTX-induced non-immediate CADR. Therefore, clinicians should be cautious interpreting CTX patch test results.

Assessment of chemotherapy-related adverse drug reactions among multiple myeloma patients at Kenyatta national hospital.

BACKGROUND: Despite treatment modalities for multiple myeloma can cause adverse drug reactions (ADRs), data are scarce about the types, severity and preventability of chemotherapy-related ADRs in Kenya. This study aimed to assess the chemotherapy-related ADRs among multiple myeloma patients at Kenyatta National Hospital (KNH). METHODS: A one-arm retrospective cohort study was carried out among all eligible adult patients with a documented diagnosis of multiple myeloma between 1st January 2017 to 31st December 2023. A data abstraction tool was used to assess sociodemographics, clinical characteristics and chemotherapy-related ADRs. The Schumock and Thornton scale and the modified Hartwig and Siegel severity scale were employed to evaluate the preventability and severity of ADRs, respectively. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 29.0 software. The results were presented using mean, frequency and percentage. Binary logistic regression was employed to assess factors influencing ADRs. A p-value of less than 0.05 was considered statistically significant. RESULTS: The prevalence of ADRs in this study was 81.5% with a total of 230 ADRs identified. The primary ADRs identified were peripheral neuropathy (21.7%), nausea and vomiting (14.8%), neutropenia (12.2%) and anemia (11.3%). The majority of the ADRs (51.7%) were moderate in severity, and 29.8% were of mild severity. Preventability assessments of the ADRs showed that most of them (68.2%) were definitely preventable and 13.2% were probably preventable. VRD (Bortezomib/Lenalidomide/Dexamethasone) and VCD (Bortezomib/Cyclophosphamide/Dexamethasone) treatment regimens were responsible for most of the ADRs. VRD (AOR = 11.1, 95% CI = 3.7-32.8, p < 0.001) and VCD treatment regimens (AOR = 4.8, 95% CI = 1.1-20.0, p = 0.033) were the significant factors affecting the occurrence of ADRs. CONCLUSION: Overall, the incidence of chemotherapy-related ADRs in multiple myeloma patients at KNH was notably high (81.5%). Despite the moderate severity of the ADRs, their preventable nature highlights the potential for improved patient outcomes through careful regimen selection and monitoring.

Pharmacovigilance and outcomes: experience from Saudi Arabia narrative review.

INTRODUCTION: Pharmacovigilance (PV) plays a central role as a quality benchmark for healthcare systems in any country. Adverse drug reactions (ADRs) contribute significantly to patient hospitalization and are major contributors to morbidity and mortality worldwide. Achieving improvements in health infrastructure and employing precise monitoring tools are essential components of drug safety. As reliance on drug therapy increases, patient exposure to potential risks rises, emphasizing the importance of minimizing ADRs. AREA COVERED: A search for studies published from January 2010 to November 2023 was retrieved from PubMed, Medline, and Google Scholar databases. We developed the search strategies using the Mesh terms and keywords. Only English-language literature was included. EXPERT OPINION: Twenty-nine studies met the inclusion criteria and utilized to evaluate the pharmacovigilance and its outcomes. The Saudi 2030 vision outlines an initiative to enhance patient care through a robust, safety- and quality-centered culture, fostering collaboration between drug manufacturers and regulatory authorities. This collaborative approach is expected to result in higher-quality care for the public. Moreover, a unified, simple, and advanced ADR reporting portal, in collaboration with stakeholders, is recommended to enhance the quality of ADR reporting. Also, commitment to training, updating courses, and incorporating PV practices into curricula demonstrates progress in Saudi PV System.

Multicentric Post-Marketing Surveillance (PMS) Observational Study of Ascorbic Acid and Zinc Effervescent Tablets in Indian Patients with Vitamin C and Zinc Deficiency.

AIM: The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication. METHODS: This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population. RESULTS: Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The P-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions). CONCLUSION: The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.

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Efficacy and safety of combinations of H1 antihistamines in the treatment of urticaria: A scoping review.

The efficacy and safety of combining H1 antihistamines (AHs) for treating urticaria are currently unclear. This scoping review aims to provide a comprehensive overview of the evidence regarding the efficacy and safety of H1 AH combinations in the management of urticaria up to May 2023. The search encompassed databases such as PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, and the China Biological Medicine Database. The inclusion criteria comprised randomised controlled trials (RCTs), non-randomised trials (NRTs), case reports, and case series focusing on urticaria treatment. Initially screening 12,887 studies, this review ultimately selected 109 studies involving 11,435 patients. These studies documented 43 different combination treatments across 11 types of urticaria. In comparison to monotherapy, combination therapy exhibited superior efficacy in 94 studies that reported treatment efficacy. Regarding adverse drug reactions (ADRs), 67 studies disclosed ADR incidences, with combination therapy showing lower ADR rates in 32 studies. Additionally, 7 studies reported similar ADR rates between combination therapy and monotherapy with AHs. Common ADRs included symptoms such as drowsiness, nausea, fatigue, dry mouth, dizziness, and headache, while less frequent side effects encompassed hypotension, otitis media, polyuria, rhinorrhoea, abnormal liver function, and rash. ADR rates ranged from 0% to 21% in the treatment group, and from 0.5% to 75% in the control group. Importantly, patients generally tolerated these ADRs well, with symptoms resolving upon discontinuation of treatment. The study's findings suggest that combining AHs leads to enhanced efficacy and reduced safety risks compared to monotherapy in the context of urticaria treatment. These results advocate for considering combination therapy as a viable option in clinical practice, especially for chronic urticaria cases. Nonetheless, caution is advised, and close monitoring for potential ADRs is crucial during treatment.

Role of age and sex in the incidence of adverse effects among diabetic patients treated with glipizide.

Glipizide is an antidiabetic drug that belongs to a class of medication known as sulfonylureas. It is considered one of the highly prescribed antidiabetic drugs for the treatment of type II diabetes in patients following a kidney transplant. It lowers blood glucose levels by causing the release of insulin from ß-cells in the pancreas. Its main metabolizing pathway is through the liver. It has several adverse effects, which range from an upset stomach to glipizide-induced haemolytic anaemia and hypoglycaemia. These adverse effects may be spontaneous, or they could have a genetic cause. The present study aimed to assess and document the incidence of glipizide-induced adverse reactions among patients prescribed the drug. The present retrospective case-control study used the electronic medical records of patients prescribed glipizide for the past 3 years. These records were reviewed to extract and document cases and/or signs of glipizide-induced adverse reactions. The results revealed that the incidence of adverse effects was higher among female patients (odds ratio, 2.40, P<0.001). Moreover, the results revealed that the likelihood of developing adverse drug reactions among patients <40 years of age was higher than in older patients (P>0.05). The outcomes of the present study are expected to prompt future studies to take sex and age into consideration, in an aim to improve treatment outcomes, reduce adverse events and decrease the burden of unnecessary costs for healthcare systems. Recommendations also include genetic screening prior to administering the medication, educating the patients and caregivers on the possibility of adverse drug reactions, and routine follow-up. This issue is of utmost importance to achieve the optimal outcomes with the minimal detrimental effects.

Serious gaming as potential training tool for recognition of adverse drug reactions: side-effect exposure-medical education (SeeMe).

PURPOSE: The recognition of adverse drug reactions (ADRs) is an important part of daily clinical work. However, medical education in this field is mostly drug-based and does not address adequately the complexity of this field regarding individual risk factors and polypharmacy. This study investigates the potential of the web-based serious game SeeMe (side-effect exposure-medical education) in pharmacological education of medical students to improve the recognition of relevant ADRs. METHODS: One hundred fifty-seven medical students were recruited to evaluate the serious game SeeMe. SeeMe was developed to improve knowledge and recognition of ADRs in clinical practice. Players take on the role of a physician trying to understand fictional patients with ADRs. Before and after an 8-week playing period, an evaluation was carried out through a pre- and post-questionnaire and a pre- and post- knowledge test. RESULTS: The students achieved significantly better results in the knowledge test, as almost twice as many exam-relevant questions were answered correctly (p < 0.001). The serious game had a positive effect on the students' perception of the importance of ADRs. CONCLUSION: This study demonstrates the potential of web- and case-based fictional serious games in medical education. The improved recognition of side effects represents a crucial step for education and training in clinical pharmacology. Future versions of the serious game may take this further and focus on training in the treatment of ADRs and their relevance in various healthcare professions.

Drugs with a negative impact on cognitive functions (part 3): antibacterial agents in patients with chronic kidney disease.

The relationship between chronic kidney disease (CKD) and cognitive function has received increased attention in recent years. Antibacterial agents (ABs) represent a critical component of therapy regimens in patients with CKD due to increased susceptibility to infections. Following our reviewing work on the neurocognitive impact of long-term medications in patients with CKD, we propose to focus on AB-induced direct and indirect consequences on cognitive function. Patients with CKD are predisposed to adverse drug reactions (ADRs) due to altered drug pharmacokinetics, glomerular filtration decline, and the potential disruption of the blood-brain barrier. ABs have been identified as a major cause of ADRs in vulnerable patient populations. This review examines the direct neurotoxic effects of AB classes (e.g. beta-lactams, fluoroquinolones, aminoglycosides, and metronidazole) on the central nervous system (CNS) in patients with CKD. We will mainly focus on the acute effects on the CNS associated with AB since they are the most extensively studied effects in CKD patients. Moreover, the review describes the modulation of the gut microbiota by ABs, potentially influencing CNS symptoms. The intricate brain-gut-kidney axis emerges as a pivotal focus, revealing the interplay between microbiota alterations induced by ABs and CNS manifestations in patients with CKD. The prevalence of antibiotic-associated encephalopathy in patients with CKD undergoing intravenous AB therapy supports the use of therapeutic drug monitoring for ABs to reduce the number and seriousness of ADRs in this patient population. In conclusion, elucidating AB-induced cognitive effects in patients with CKD demands a comprehensive understanding and tailored therapeutic strategies that account for altered pharmacokinetics and the brain-gut-kidney axis.

Adverse drug reactions of intravesical instillation therapy for bladder cancer: based on FDA adverse event reporting system.

BACKGROUND: Intravesical chemotherapy and immunotherapy are common adjuvant treatments for non-muscle invasive bladder cancer post-surgery. Analyzing adverse events linked to these therapies, can assist in clinical decision-making and risk assessment. STUDY DESIGN AND METHODS: Disproportionality analysis was conducted to analyze data from the Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the first quarter of 2024, exploring potential positive signals between Bacillus Calmette-Guérin, mitomycin-C, epirubicin, gemcitabine, and adverse events. RESULTS: The database retrieved 2018, 140, 31, and 85 adverse event reports associated with Bacillus Calmette-Guérin, mitomycin-C, epirubicin, and gemcitabine, respectively. Adverse reactions not mentioned in the label, such as aortic aneurysm and ocular congestion, were observed in preferred term level related to Bacillus Calmette-Guérin. Mitomycin-C exhibited specificity in skin and subcutaneous tissue diseases not reflected in the package insert. Gemcitabine-induced adverse drug reactions showed signals in vascular and lymphatic diseases meeting the screening criteria of all 4 indicators, with capillary leakage syndrome being the preferred term with the highest signal intensity. CONCLUSION: This study observed new adverse event signals, providing important assistance for drug selection in adjuvant therapy for non-muscle invasive bladder cancer postoperatively.

Women have a higher risk of hospital admission associated with hyponatremia than men while using diuretics.

Background: Hyponatremia is a common electrolyte disturbance and known adverse drug reaction of diuretics. Women tend to be more susceptible for diuretic associated hyponatremia. The aim of this study was to find more evidence whether women have a higher risk of diuretic associated hyponatremia than men measured at hospital admission for specific diuretic groups and whether there is a sex difference in risk of severity of hyponatremia. Methods: All patients using a diuretic and admitted for any reason to Tergooi MC and Haga Teaching hospital in the Netherlands between the 1st of January 2017 and the 31st of December 2021, with recorded sodium levels at admission were included in this study. Cases were defined as patients with a sodium level <135 mmol/L, while control patients had a sodium level ≥135 mmol/L at admission. Logistic regression analysis was used to calculate odds ratios (OR) with 95% CIs for women versus men and adjusted for potential confounding covariables (age, body mass index, potassium serum level, systolic and diastolic blood pressure, estimated glomerular filtration rate, number of diuretics, comedications and comorbidities). Stratified analyses were conducted for specific diuretic groups (thiazides, loop diuretics and aldosterone antagonists), and adjusted for dose. Furthermore, stratified analyses were performed by severity of hyponatremia (severe: <125 mmol/L), mild: 125-134 mmol/L). Results: A total of 2,506 patients (50.0% women) were included, of which 516 had hyponatremia at admission (20.6%, 56.2% women). Women had a statistically significantly higher risk for hyponatremia at admission than men (OR 1.37; 95% CI 1.12-1.66) and after adjustment for potential risk factors (ORadj 1.55; 95% CI 1.22-1.98). Stratified analyses showed increased odds ratios for thiazides (ORadj 1.35; 95% CI 1.00-1.83) and loop diuretics (ORadj 1.62; 95% CI 1.19-2.19) among women. Use of aldosterone antagonists was also increased but not statistically significant (ORadj 1.15; 95% CI 0.73-1.81). Women had a statistically higher risk to develop mild and severe hyponatremia than men (ORadj 1.36; 95% CI 1.10-1.68 and ORadj 1.96; 95%CI 1.04-3.68, respectively). Conclusion: Women have a higher risk of a hospital admission associated with hyponatremia while using diuretics than men. Further research is necessary to provide sex-specific recommendations.

Drug fever-an immune-mediated delayed type hypersensitivity reaction to Vinca alkaloids in pediatric oncology patients, possibly mediated by cysteinyl leukotrienes.

Background: Drug hypersensitivity reactions are common in pediatric hemato-oncology patients due to multiple factors including immune compromise and pharmacological complexities. Fever can signify severe delayed-type hypersensitivity reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS). The etiology of fever as an isolated hypersensitivity reaction to chemotherapeutic agents not fully understood. Here, we report three children with intracranial neoplasms experiencing recurrent febrile reactions following Vinca alkaloid-based chemotherapy, mitigated by cysteinyl leukotriene receptor antagonist therapy. Methods: We present a series of pediatric patients with diverse intracranial neoplasms who developed recurrent fever episodes after multiple courses of Vinca alkaloid-based chemotherapy. Treatment involved prophylactic and post-chemotherapy administration of a cysteinyl leukotriene receptor antagonist to prevent fever episodes and enable completion of chemotherapy regimens without protocol modifications or desensitization. Results: All three patients experienced fever consistent with delayed-type hypersensitivity reactions to Vinca alkaloids. Prophylactic use of the leukotriene antagonist Montelukast successfully prevented fever recurrence, allowing uninterrupted completion of chemotherapy courses. Conclusion: Our findings suggest that Montelukast, a leukotriene antagonist, may be beneficial in managing fever as a delayed-type hypersensitivity reaction to Vinca alkaloids in pediatric patients. Further research is warranted to elucidate the underlying mechanisms and leukotriene pathways involved in drug-induced fever reactions.

Cardiac adverse drug reactions to COVID-19 vaccines. A cross-sectional study based on the Europe-wide data.

AIMS: We aimed to analyse serious cardiac adverse drug reactions to COVID-19 vaccines from the Europe-wide EudraVigilance database. METHODS AND RESULTS: In this retrospective, cross-sectional study, the EudraVigilance database was searched to identify suspected serious cardiac postvaccination adverse drug reactions to COVID-19 vaccines. This data was coupled with the number of total vaccine doses administered in the European Economic Area for Comirnaty (Pfizer BioNTech), Spikevax (Moderna), Vaxzevria (AstraZeneca), Jcovden (Janssen), Nuvaxovid (Novavax), products, available from the European Centre for Disease Prevention and Control "Vaccine Tracker" database. The analysis included 772,228,309 administered doses of eligible vaccines from the "Vaccine Tracker" database and 86,051 eligible records of cardiac adverse drug reactions from the EudraVigilance database.The frequency of most of the investigated adverse drug reactions was very rare (<1/10,000 i.e. <100/1,000,000 doses). The lowest risk of any serious cardiac adverse drug reactions was noticed for vaccination with Comirnaty (135.5 per million doses), while Spikevax, Jcovden, Vaxzevria and Nuvaxovid were characterised by higher risk (respectively, 140.9, 194.8, 313.6 and 1065.2 per million doses). The most common complications of vaccinations included syncope, arrhythmia, tachycardia, palpitations, angina pectoris, hypertension, myocarditis, thrombosis and pulmonary embolism. CONCLUSIONS: The risk of serious cardiac adverse drug reactions to COVID-19 vaccines is low and the benefit of active immunisation against that disease seems to outweigh the potential risk of serious postvaccination cardiac adverse drug reactions.

Evaluation of the Effectiveness of the Adverse Drug Reaction Alert Card System in Preventing the Recurrence of Adverse Drug Reactions.

Introduction Adverse drug reactions (ADRs) are among the leading causes of morbidity and mortality. It causes a significant prolongation of hospital stays, leading to an increased economic and infrastructural burden on the healthcare system. Thus, primary prevention will help in preventing recurrent ADRs. People are often unable to state whether they have suffered an ADR from a medicine or not. The patients also find it difficult to recall the offending drug. They seldom seem to carry any information that would warn others of their reactions. Thus, there was a need to introduce the ADR Alert Card. A pilot study was first conducted in 2018 to assess the feasibility of this card. All patients suffering from an ADR were thus provided an alert card. Following its implementation, there was a general acceptability regarding the potential of this card in ADR recurrence prevention among healthcare professionals (HCPs). Therefore, there is a need to assess the effectiveness of this card for ADR recurrence prevention. Objective This study aims to estimate the percentage of people who have shown the ADR Alert Card to their HCPs and benefited from it. Methods This was a prospective observational study, which was conducted at Dr. D. Y. Patil Medical College, Pune, from November 2022 to May 2024 and received approval from the Institutional Ethics Committee (IEC) before its initiation. All the patients who faced an ADR were given an ADR Alert Card by their HCP. All the patients to whom their HCP had given the card were part of this study. Any patient who suffered an ADR due to overdosage of medication was excluded from the study. After screening for inclusion and exclusion criteria, the data were analyzed using MS Excel (Microsoft Corporation, Redmond, Washington). A questionnaire was validated by professors in pharmacology, medicine, and community medicine. The patients were contacted through telephone conversations and provided with this questionnaire. They were asked questions regarding the ease of carrying the card, the benefit it provided them, whether they had shown it to their HCP, whether it helped them in an emergency, and their willingness to link it digitally. Their responses were recorded in Google Forms, and pie charts were generated. Results All 110 patients (100%) agreed that the ADR Alert Card was beneficial. Most (99, 90%) patients had shown the card to their HCP at their subsequent visit. The card helped 107 (97%) patients to describe their medical history easily. All the patients (110, 100%) agreed that carrying the card was easy, and most patients (95, 86%) agreed to recommend using the card to others. Additionally, most patients (79, 72%) were willing to link their card to their National Health ID. However, a small proportion of patients (28, ~25%) were skeptical whether they would link the card to the National Health ID or not. The card had helped 28 (25%) patients in an emergency. Approximately 11 (10%) patients had reported an ADR to the regulatory authority. Conclusion The patients welcomed this new concept to be inculcated in their daily lives as an effective means to enhance their healthcare. This study evaluates the number of patients who actually benefitted from using this card. It encourages patients to participate actively in their own healthcare. In an emergency situation, it proves to be a source of important health information. This study could lay the foundation for further research to prevent recurrent ADRs.

Prospective Analysis of Cutaneous Adverse Drug Reactions Encountered in a Tertiary Care Hospital.

INTRODUCTION: Adverse drug reactions (ADRs), including cutaneous adverse drug reactions (CADRs), are significant global health concerns with India among the top affected countries. CADRs represent a significant concern in healthcare, impacting the skin, its appendages and mucous membranes ranging from mild rashes to severe, life-threatening conditions like Stevens-Johnson syndrome and toxic epidermal necrolysis. Self-medication with over-the-counter drugs is a notable public health issue linked to CADRs. Clinical trials often miss long-term and rare CADRs making early detection and monitoring crucial. This study aims to evaluate CADRs by assessing their causality, severity and preventability; determining onset lag time; identifying morphological patterns; and investigating associations with different drug classes. It also explores the links between self-medication and CADRs and analyses related outcomes. This research addresses gaps in understanding CADRs' epidemiology, impact and management providing valuable insights for healthcare practitioners. MATERIAL AND METHODS: A 12-month prospective observational study conducted at a tertiary care hospital involved dermatology patients from both outpatient and inpatient units. Inclusion criteria comprised patients diagnosed with CADRs by physicians in the outpatient department (OPD) (active surveillance) and reported cases to pharmacovigilance unit (passive surveillance) while those unwilling to provide written consent were excluded. RESULT: The majority (44.25%) of the patients were aged 18-39 years. Maculopapular rash (53.98%) and urticarial rash (9.73%) were the most common CADR types. Anti-bacterials (42.63%) were the primary suspected drug class. Serious CADRs were predominant (74.34%) with 1.77% resulting in fatalities. Severity was moderate in 79.65% and mild in 17.7% of the cases. Preventability was low (5.31%) with three CADRs attributed to self-medication. Recovery was seen in 46.9% of the patients with 42.48% still in recovery at discharge and a mortality rate of 1.77% due to Stevens-Johnson syndrome. CONCLUSION: A comprehensive pharmacovigilance system for continuous monitoring of patients' health status can lead to opportunities to reduce the CADRs, lower drug-related morbidity and rationalize drug therapy.

Over the Counter: Self-Care or Self-Harm? A Mixed Method Study Protocol on Prevalence and Determinants of Self-Medication Practices in Wardha.

Background Self-medication (SM), a common practice globally, possesses a dual challenge of being a self-care strategy and a potential source of harm observed across all age groups. The study is being conducted to gauge the prevalence of SM of prescription drugs with their over-the-counter access, thus addressing the delicate balance between self-care and self-harm related to SM. Material and methods This ongoing convergent parallel mixed method study with quantitative and qualitative components will be conducted on a sample size of 180 subjects aged more than 18 years from an urban community. For the quantitative component, a semi-structured questionnaire will assess the prevalence of SM, types of medications used, reasons for self-medicating, and socio-demographic factors influencing these practices. Concurrently, qualitative interviews delve deeper into the beliefs shaping SM practices. Sampling will be purposive to capture diverse perspectives, with data analyzed using statistical tools. Results This study protocol will offer a comprehensive understanding of the prevalence and determinants of SM practices. The quantitative data provide numerical insights into SM trends, while the qualitative findings elucidate the nuanced factors driving individuals' SM choices. Conclusions A multifaceted view of SM practices will be provided, aiding in developing interventions to promote safe and effective self-care while mitigating the risks of self-harm through SM. Anticipated findings can include a widespread prevalence of SM amongst the general urban populace. Significant associations can also be expected to be found with various independent variables. The results will be instrumental in informing public health policies and healthcare practices toward enhancing patient safety and well-being.

Adverse events associated with benznidazole treatment for Chagas disease in children and adults.

AIMS: Chagas disease (ChD) affects approximately 7 million people in Latin America, with benznidazole being the most commonly used treatment. METHODS: Data from a retrospective cohort study in Argentina, covering January 1980 to July 2019, was reanalysed to identify and characterize benznidazole-related adverse drug reactions (ADRs). RESULTS: The study included 518 patients: 449 children and 69 adults (median age in children: 4 years; adults: 25 years; age ranges: 1 month-17.75 years and 18-59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days in adults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs, with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults (odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19-0.54, P < .001). The incidence rate was 177 cases per 1000 person-years (95% CI = 145-214) in children and 537 per 1000 person-years (95% CI = 360-771) in adults. There were 240 ADRs identified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) of children and 1.45% (1/69) of adults. The skin was the most affected system. A total of 10.23% (53/518) of patients discontinued treatment. More adults than children discontinued treatment (OR = 3.36, 95% CI = 1.7-6.4, P < .001). CONCLUSIONS: Although 29.34% of patients experienced ADRs, most were mild to moderate, indicating a manageable safety profile for benznidazole. While optimized dosing schedules and new drugs are needed, avoiding benznidazole solely due to safety concerns is not justified.