Cause Of Adverse Drug Reactions Research Articles

Epidemiological investigation of adult emergency infusion adverse drug reactions (EIADR) in Nanjing, China: a prospective cross-sectional study (EIADR II)

ABSTRACT Objective To analyze the clinical characteristics of adverse drug reactions (ADRs) in adults receiving emergency infusions at a tertiary hospital. Methods We conducted a prospective observational cohort study involving 585 adult patients who experienced adverse drug reactions (ADRs) between 20 November 2019, and 20 November 2023, during intravenous infusions in the emergency infusion room of a tertiary hospital. The analysis included patients’ gender, age, type of drugs involved, organ-system involvement, clinical manifestations of ADRs, severity grading of ADRs, and preventability of ADRs. Results The highest percentage of ADRs occurred in the 30–39 age group. Antimicrobials were the most common cause of ADRs, with skin manifestations being the predominant clinical feature. Approximately 23.93% of ADRs were deemed preventable. Conclusion Monitoring ADRs related to antimicrobials is crucial in adult emergency infusions. The 30–39 age group is particularly susceptible to ADRs. Preventive measures and a well-established Electronic Health Record (EHR) system can effectively reduce ADRs incidence.

A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.

Adverse Drug Reactions (ADR) are one of the essential causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Scale), the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

A PROSPECTIVE OBSERVATIONAL STUDY OF MONITORING AND REPORTING OF ANTIMICROBIAL DRUGS ASSOCIATED ADVERSE DRUG REACTIONS AND THEIR SIGNIFICANCE ON PATIENTS SAFETY AND HEALTH-CARE OUTCOMES

Objective: Adverse drug reaction (ADR) surveillance and reporting practices are at an early stage of development within the Indian context. The pharmacovigilance rate in India falls below 1%, which is notably lower compared to the global average of 5%. India holds the position of being the fourth most significant contributor to the pharmaceutical industry worldwide. Therefore, there exists a pressing demand to enhance the pharmacovigilance framework for safeguarding the health of the Indian population. ADR is defined as the unintended, obnoxious, and unwanted reaction due to the use of a drug. The administration of antimicrobial agents causes various ADR that has been analyzed throughout the study. The main objective of the research is to monitor and report the adverse drug reaction caused by antimicrobial drugs Methods: A prospective observational study was carried out in the various departments of the hospital with duration of 3 months including 100 patients using patient profile form and ADR reporting forms and analyzing with the scales for causality, severity, and preventability assessment. Results: During the study, 29 ADRs were found among 100 patients, with an incidence rate of 9.6%, more common in females (52%) than in males (48%). ADRs were most frequently reported in the age group of 35–51 years (34%), then 18–34 years (28%), and 1–17 years (24%). The general medicine department reported the highest number of ADRs (66%), followed by the pediatric department (24%). Cephalosporins caused the most ADRs (35%). Common ADRs included constipation, diarrhea (34%) and rashes, nausea, and vomiting (34%). Naranjo scale indicated that the causality of ADRs was probable (52%). Hartwig severity scale showed 55% ADRS to be mild. Schumock and Thornton method found that 76% of ADRs were preventable.Management of most of ADRs included drug withdrawal (52%). Conclusion: The majority of cephalosporin-related side effects, which included constipation, diarrhoea, and rashes, were observed. Most of the patients got better with the help of ADR monitoring and management. Finding and treating drug-related problems early make patients feel better and keep them safe. This study shows health-care system why it is important to monitor and report ADR caused by drugs.

Improving Medication Adherence in Geriatric T2DM Patients: A Factorial Randomized Controlled Trial

Abstract Background: The complexity of managing type 2 diabetes (T2D) in the elderly is compounded by the need to balance over-prescription, under-prescription, and appropriate prescription. Managing hyperglycemia and its complications, along with geriatric syndromes such as cognitive impairment and falls, often leads to use of an increased number of medications. Quality improvement measures, while aimed at better management, can inadvertently contribute to the burden of polypharmacy. Addressing medication non-adherence is crucial, as it is a significant contributor to poor clinical outcomes, increased hospitalizations, and healthcare costs. Objectives: This study thus aimed to evaluate the effectiveness of interventions to improve medication adherence among elderly patients with T2D. It assessed the impact of a medication adherence device, clinical pharmacological intervention, and their combination compared to standard of care (SOC) alone on adherence rates, adverse drug reactions (ADRs), and glycemic control. Materials and Methods: This pilot study was a factorial randomized controlled trial. A total of 120 elderly T2D patients with a medication adherence rate of less than 80% over the past year were randomized into four groups: (1) medication adherence device + SOC, (2) clinical pharmacological intervention + SOC, (3) combined intervention + SOC, and (4) SOC alone. The primary outcome was medication adherence, assessed through pill counting. ADRs were evaluated using the Naranjo ADR causality assessment scale, and glycemic control was monitored through HbA1c levels. Statistical analyses included chi-square tests and ANOVA, with significance set at P < 0.05. Results: Interim analysis showed the highest adherence rate in the combined intervention group (82.1%), followed by the clinical pharmacological intervention + SOC group (75.3%), the medication adherence device + SOC group (73.1%), and the SOC alone group (70.0%). The combined intervention group also recorded the lowest ADR rate (6.6%). Regarding glycemic control, 81% of the combined intervention group achieved an HbA1c level of less than 7%, compared to 80% in the clinical pharmacological intervention + SOC group, 78% in the medication adherence device + SOC group, and 69% in the SOC alone group. Differences in glycemic control were not statistically significant (P = 0.950). Conclusions: The study indicates that combined interventions including medication adherence devices along with SOC significantly improve medication adherence and reduce ADRs in elderly T2D patients. Future research should focus on diverse populations and long-term sustainability of these interventions.

Medication prescribing trends and its associated adverse drug reactions among hospitalized stroke patients from a main stroke center in Penang, Malaysia: A retrospective 5-year study

Adverse drug reactions (ADRs) are one of the major threats in our healthcare system, which profusely affects health, transience, and quality of life, especially among hospitalized patients. This 5-year study was conducted to determine the incidence and analyze the pattern of ADRs among stroke patients at Hospital Seberang Jaya (HSJ), Malaysia which is the main stroke center for all tertiary healthcare institutions in Penang, Malaysia. A total of 1,993 patients were hospitalized for stroke during the study period of 5 years out of which only 30 of them were reported to experience ADRs during hospitalization. The study patients had a mean (SD) of 61 (±11.8) years, Modified Rankin Score (mRS) score of 1.8 (±1.6), NIH Stroke Scale (NIHSS) score of 3.0 (4.0) with median (IQR) duration of adverse drug reaction of 3.0 (7.0) days. The majority of the patients were Malay (66.7%); female (50.0%); experienced ischemic stroke (90.0%); with first episode of stroke (93.3%); with comorbidity dyslipidemia (60.0%); and mostly recovered post ADRs (80.0%). The major drug classes that contributed to ADRs were vaccines, anti-infective, anti-epileptic, anti-platelets, and others. Evaluation of the causality of ADRs indicated majority were possible (50.0%) ADRs based on the Naranjo scale. The evaluated incidence of ADRs among stroke patients is low in this study. This low incidence rate could be possibly due to active clinical interventions by healthcare professionals during hospitalization. ADR monitoring is highly warranted among the sub-population of stroke patients due to the existence of multiple risk factors and their state of vulnerability.

Enhancing Healthcare Through Early drug allergy Detection: A Systematic Review

Drug allergies are a significant cause of adverse drug reactions (ADRs), affecting patient safety and healthcare outcomes. Early detection of drug allergies is crucial for preventing these reactions and improving clinical care. This systematic review explores the current methods of early drug allergy detection, including patient history, skin testing, in vitro tests, and emerging genomic approaches. Findings indicate that accurate early identification of drug allergies, particularly with the use of skin testing and electronic health records (EHR)-based alerts, reduces the likelihood of adverse reactions and unnecessary drug avoidance. In vitro testing, including drug-specific IgE and basophil activation tests, provides non-invasive alternatives, while pharmacogenomic data show promise for predicting hypersensitivity in the future. The review emphasizes the importance of integrating detection methods into healthcare systems to enhance medication safety, lower healthcare costs, and improve patient outcomes. However, challenges remain, such as mislabeling allergies, limited access to testing in some settings, and the need for standardized protocols. Further research is recommended to develop more accessible testing methods and explore the long-term impact of early drug allergy detection on healthcare systems.

Pattern of Adverse Drug Reactions in Extremes of Age Group Reported to a Tertiary Care Hospital

ABSTRACT Background: The World Health Organization (WHO), defined adverse drug reactions (ADRs) as “any noxious and unintended response to a drug, which occurs at doses normally used in humans for prophylaxis, diagnosis and treatment of the disease or for the modification of physiological functions.” Pediatrics (≤12 years) and geriatrics (≥65 years) are the extreme age groups that are more vulnerable for ADRs. Aim and Objectives: To determine ADRs time-plausible relationship, clinical spectrum, causality, and severity in extreme age group patients. Materials and Methods: All the ADRs reported to ADR monitoring center among geriatrics and pediatrics patients after Institutional Ethics Committee approval were collected from January 2015 to July 2022. The collected reports were analyzed for ADR pattern, drug groups, Causality (as per WHO-Uppsala Monitoring Centre scale) and severity (Modified Hartwig scale). Results: Out of 4705 ADRs, 176 (3.74%) were reported in geriatric and 181 (3.84%) in pediatric patients. In geriatric patients, anti-neoplastic drugs followed by cardiovascular drugs were the most commonly implicated drugs, erythematous rash and dyspnea were the most common ADRs. Erythematous rash and diarrhea were the most commonly ADRs and immunological agents followed by antimicrobials were implicated drugs in pediatric patients. In geriatric patients 84.1% were mild, 14.8% moderate, and 1.1% severe reactions whereas in pediatric group 91.2% were mild, 8.3% moderate, and 0.5% severe ADRs. Two cases of toxic epidermal necrolysis and one case of Steven–Johnson syndrome were reported in geriatric and pediatric patients respectively. Causality assessment of the majority of ADRs in geriatric age group was possible (79.5%) and in pediatric age group it was probable (61.3%). Conclusion: Extreme age group populations are more vulnerable to ADRs due to comorbidities, polypharmacy and drug interactions in elderly people and immature hepatobiliary and renal systems in pediatric age. Hence, active surveillance of drugs and education of prescribers will help to minimize the risk of ADRs in this susceptible population.

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.

Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were “Certain” whereas Naranjo's algorithm categorized 96.74% of ADRs as “Probable”. Cohen's kappa showed a “Minimal” agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments.

ADVERSE DRUG REACTIONS OF BACLOFEN, NALTREXONE, AND ACAMPROSATE IN PATIENTS HAVING ALCOHOL DEPENDENCE: A CROSS-SECTIONAL PHARMACOVIGILANCE STUDY

Objectives: The research aims to investigate the prevalence and patterns of adverse drug reactions (ADRs), gauge the severity of these reactions, establish causality in ADR cases, and assess the preventability of such adverse reactions. Methods: ADR information was gathered through personal interviews with patients or their relatives. Causality was assessed using the Naranjo algorithm, and a modified Hartwig and Siegel Severity Assessment Scale was used for estimating the severity of ADR. ADRs were grouped into various preventability categories based on the modified Schumock and Thornton criteria. Results: The total number of patients evaluated in the baclofen, naltrexone, and acamprosate groups was 65, 28, and 42, respectively. The most commonly reported adverse events with baclofen were nausea (31.25%), followed by fatigue (18.75%) and headache (12.50%). The majority of patients receiving acamprosate reported nausea (57.14%), followed by diarrhea (28.57%). Patients receiving naltrexone most commonly reported nausea (35.71%), followed by abdominal pain (21.43%) and headache (14.28%). Conclusion: This study shed light on the prevalence, severity, causality, and preventability of ADRs associated with anti-craving agents used to treat patients with alcohol withdrawal syndrome, providing valuable insights into the safety profiles of these medications.

Analysis of drug-drug interactions in spontaneous adverse drug reaction reports from EudraVigilance focusing on psychiatric drugs and somatic medication

IntroductionPatients with severe mental illnesses (SMI) are often exposed to polymedication. Additionally, the risk of somatic diseases is twice as high in patients with SMI as in individuals without a psychiatric disorder. Furthermore, drug–drug interactions (DDI) between psychiatric drugs and somatic medications are a well-known cause of adverse drug reactions (ADR).ObjectivesThe aim of this study was to analyse whether already known DDI related to psychiatric drugs and somatic medication still occur in everyday clinical practice.MethodsTherefore we identified all spontaneous ADR reports contained in the European ADR database EudraVigilance from Germany received between 01/2017 and 12/2021 reported for patients older than 17 years in which antidepressants, antipsychotics and mood stabilizers were reported as suspected/interacting (n= 9,665). ADR reports referring to intentional overdoses and suicide attempts were excluded (n= 9,276 left). We used the ABDATA drug information system in order to identify all potential DDI (pDDI). The identified reports with pDDI were then assessed individually to determine whether the respective DDI occurred.Results 1,271 reports with 728 potentially interacting drugs pairs related to psychiatric drugs and somatic medications with 2,655 pDDI were found. Restricted to potentially interacting drug pairs with more than 10 reports, (i) hyponatremias related to antidepressants and diuretics (n= 362, 32.6%), (ii) bleeding events related to selective serotonin reuptake inhibitors (SSRI) and platelet aggregation inhibitors, anticoagulants or non-steroidal antiinflammatory drugs (NSAID) (n= 295, 17.5%), and (iii) increased beta-blocker effects related to SSRIs and beta-blockers (n= 126, 11.3%) were the most frequently identified pDDI. After individual case assessment, in 33.3% (14/42), 23.7% (45/190) and 17.4% (8/46) of the reports bleeding events related to SSRIs and anticoagulants, SSRIs and platelet aggregation inhibitors and SSRIs and NSAIDs were reported. Hyponatremia was reported in 7.6% (22/289) of the reports related to antidepressants and diuretics and increased beta-blocker effects in 6.9% (8/116) of the reports related to SSRIs and beta-blockers.ConclusionsAccording to our analysis, well-known DDI still occur in the treatment of psychiatric patients with psychiatric drugs and somatic medication. Whenever possible, alternative drug combinations with a lower potential of DDIs may be considered or appropriate monitoring measures should be conducted.Disclosure of InterestNone Declared

반려동물의 장내 마이크로바이옴과 약물의 상호 작용; 중개연구 관점

Drug responses are showed in individual variability. It can be main causes of adverse drug reactions or extended therapies, which result in burden of substantial health. Despite of extensive investigation in pharmacogenomics in terms of the impact of individual genetics on drug-metabolism, a limited proportion of drug-individual variability explains genetic diversity. The gut microbiota and its metabolites have been proven a role to modulate therapeutic outcomes in diseases. Therefore, in this article, we present the interaction between microbiota and drug responses in companion animal diseases, including cancer, endocrine diseases, and others. Also, we summarize how microbiota modify metabolism and distribution of drugs. The practical challenges and opportunities are also discussed in this new field, emphasizing the needs to translate human data into clinical veterinary practice. In summary pharmacomicrobiomics, the interaction between gut microbiota and drug response, may be a promising research field to improve the outcomes of drug effects in patients.

Ptosis Following the use of Dexamethasone-Based Eye Drops

Ptosis is a known adverse reaction of local ocular corticosteroids, mainly due to those administered by local injections. Topical corticosteroid eye drop-induced ptosis is becoming increasingly observed in ophthalmology practice. We report the case of a 6-year-old child hospitalized in the Hematology Department for first consolidation chemotherapy for acute myeloblastic leukemia, who received local corticosteroids via dexamethasone eye drops for ocular prevention and who presented five days later with bilateral ptosis of abrupt onset. Given the normality of ophthalmological examination and cerebral CT scan, and following an adverse drug reaction causality assessment, incrimination of Dexamethasone was suspected and thus it was stopped. The ptosis improved rapidly and disappeared after one week. Ptosis is a little-known adverse effect of corticosteroid eye drops in our context; therefore, more vigilance is required to better understand and manage it.

Rapid multichannel fluorescent probe assay for CYP450 inhibition screening and drug interaction monitoring

Cytochrome P450 (CYP450) inhibition induced drug interactions (DDIs) are a primary cause of adverse drug reactions (ADRs). The rapid identification of CYP450 inhibitors is an important method for reducing potential ADRs. However, the existing methods are often intricate and time consuming, making them difficult to use for high-throughput rapid monitoring. Based on the specificity of CYP450 to the catalysis of different fluorescent substrate probes, an assay was developed to monitor the activity of six CYP450 isoforms simultaneously. The production rate of fluorescent metabolites characterized CYP450 activity. Method specificity was evaluated using inhibitors recommended by the FDA Guidelines for Drug Interaction Studies. We screened 28 clinically utilized medications for inhibition of CYP450 and evaluated the potential interaction by comparing inhibition constants (Ki) and maximum plasma concentration (Cmax). The analysis of the positive inhibitors using this method suggests that it allows for quick screening and identification of CYP450 inhibitors. Six drugs, including latoxefin, diclofenac, erythromycin lactate, labetalol, cimetidine, and droperidol, showed an interaction risk. The three isoforms of the CYP1A2, CYP3A4 and CYP3A5 metabolizing enzyme mediate a greater number of interactions, which should be specifically monitored in clinical applications. The established method permits rapid screening for inhibiting CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP3A4 and CYP3A5 with simple, stable, inexpensive, and high-throughput. This method will provide technical support for rapid discovery of clinical CYP450 inhibitors and risk avoidance of drug combination.

Prevalence and clinical significance of potential drug-drug interactions among lung transplant patients.

Background: Drug-drug interactions (DDIs) are a major but preventable cause of adverse drug reactions. There is insufficient information regarding DDIs in lung transplant recipients. Objective: This study aimed to determine the prevalence of potential DDIs (pDDIs) in intensive care unit (ICU) lung transplant recipients, identify the real DDIs and the most frequently implicated medications in this vulnerable population, and determine the risk factors associated with pDDIs. Methods: This retrospective cross-sectional study included lung transplant recipients from January 2018 to December 2021. Pertinent information was retrieved from medical records. All prescribed medications were screened for pDDIs using the Lexicomp® drug interaction software. According to this interaction software, pDDIs were classified as C, D, or X (C = monitor therapy, D = consider therapy modification, X = avoid combination). The Drug Interaction Probability Scale was used to determine the causation of DDIs. All statistical analysis was performed in SPSS version 26.0. Results: 114 patients were qualified for pDDI analysis, and total pDDIs were 4051. The most common type of pDDIs was category C (3323; 82.0%), followed by D (653; 16.1%) and X (75; 1.9%). Voriconazole and posaconazole were the antifungal medicine with the most genuine DDIs. Mean tacrolimus concentration/dose (Tac C/D) before or after co-therapy was considerably lower than the Tac C/D during voriconazole or posaconazole co-therapy (p < 0.001, p = 0.027). Real DDIs caused adverse drug events (ADEs) in 20 patients. Multivariable logistic regression analyses found the number of drugs per patient (OR, 1.095; 95% CI, 1.048-1.145; p < 0.001) and the Acute Physiology and Chronic Health Evaluation II (APACHE Ⅱ) score (OR, 1.097; 95% CI, 1.021-1.179; p = 0.012) as independent risk factors predicting category X pDDIs. Conclusion: This study revealed a high incidence of both potential and real DDIs in ICU lung transplant recipients. Immunosuppressive drugs administered with azole had a high risk of causing clinically significant interactions. The number of co-administered drugs and APACHE Ⅱ score were associated with an increased risk of category × drug interactions. Close monitoring of clinical and laboratory parameters is essential for ensuring successful lung transplantation and preventing adverse drug events associated with DDIs.

A case report on ofloxacin-induced Stevens–Johnson syndrome: Scorten-based approach

Stevens–Johnson syndrome (SJS) is a rare immune-mediated severe cutaneous adverse reaction with an incidence rate of 0.05–2 persons/ million population/month. Drugs are the most commonly implicated in 95% of cases. In our report, a 52-year-old male patient presented with chief complaints of skin rashes over the body and was having a history of using a tab. ofloxacin for gastroenteritis. The severity of SJS was assessed using SCORTEN (=1). The drug can be considered as a probable/likely cause of adverse drug reaction as per causality assessment of the suspected adverse drug reactions. Early diagnosis helps the clinician to elude secondary infection and subsequent complications. It highlights the mandatory reporting of the offending drug and the necessity of pharmacovigilance in different countries.

Levofloxacin-Induced Oromandibular Dystonia in a 9-Year-Old Patient.

Extrapyramidal symptoms (EPS) that include akathisia, dystonia, pseudoparkinsonism, and dyskinesia are abnormal movements commonly induced by antipsychotic medications. These symptoms are also associated with specific non-antipsychotic agents. This case report describes a case of a 9-year-old boy on antibiotics treatment that developed EPS. A 9-year-old boy presented to the emergency department of Imam Hossein Children›s Hospital with chief complaints of trismus, difficulty speaking, and tongue protrusion. One week before these presentations, he had been prescribed Tavanex® (levofloxacin) and clindamycin. His symptoms improved after the withdrawal of antibiotics and administering Biperiden, and he was discharged in good condition. On a follow-up visit one week after discharge, no remaining symptoms were present, and he was in good condition. Based on the questions in the Naranjo criteria, levofloxacin receives a score of 7 and is a probable cause of adverse drug reaction (ADR). Clindamycin, with a score of 6, is also a probable cause for this adverse drug reaction, but clinical judgment was in favor of levofloxacin as the culprit. Clinicians should be aware of the potential EPS of levofloxacin at standard doses. Effective management of adverse events is necessary to ensure patient safety and optimal outcomes.

Pattern of adverse drug reactions to commonly prescribed antibiotics in a tertiary care hospital

Background: Antibiotics have been one of the most significant discoveries in the history of medicine, as they saved countless lives and prevented many serious complications from bacterial infections. Antibiotics are usually safe and effective in treating bacterial infections but can result in adverse drug reactions (ADRs) in some patients. Antibiotics are the most common class of drugs which implicate a greater number of ADRs, because of overuse and misuse of antibiotics, antibiotic resistance, and decreased efficacy. Aims and Objectives: The aims and objectives of the study are to determine clinical symptoms, causality, and severity of antibiotic-associated ADRs. Materials and Methods: A retrospective study was carried out from January 2021 to June 2022; data were collected from Adverse Drug Monitoring Center, GMC/Government General Hospital, Guntur. Prior Institutional Ethics Committee Approval and Permission from Indian Pharmacopoeia Commission, Ghaziabad, were taken. The collected reports were analyzed for ADR pattern, drug groups, causality, and severity. Descriptive statistics were used. Results: Out of 847 ADRs reported, 119 (14%) ADRs were related to antibiotics. The majority of ADRs (65%) were reported in males. A greater number of ADRs were reported in mean age group 31–40 years. Anti-tubercular drugs (27%) were the most commonly implicated antibiotics followed by cephalosporins (22%). Most commonly affected system was cutaneous system (45%) followed by gastrointestinal system (21%). Most common ADRs reported were pruritus (20%), followed by rash (14%). 93% of ADRs were possible and 7% were probable. 87% of ADRs were mild, 12% were moderate, and 2% were severe ADRs. Conclusion: ADRs can be prevented by taking proper action at an early stage. Implementation of antibiotic guideline policy for the hospital and strict adherence to it should be ensured to promote their rational and safe use.

Pattern of Adverse Drug Reactions at a Tertiary Care Hospital, Kerala, India: A Cross-sectional Study

Introduction: With the rising use of medications, Adverse Drug Reactions (ADRs) have emerged as a significant public health issue. Therefore, establishing a robust pharmacovigilance system across the nation has become imperative. The present study focussed to analyse the trends and frequency of ADRs to enhance the safety of drug prescriptions and ensure public health protection. Aim: To assess the pattern of adverse effects, drugs implicated, causality, severity, and outcomes of ADRs reported to the ADR monitoring centre in the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India. Materials and Methods: This was a cross-sectional study in which 262 ADRs reported to the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India from May 2022 to April 2023 were analysed for patient demographics, drug and ADR characteristics, and the outcomes of the ADR. Causality and severity assessments of these ADRs were performed using the World Health Organisation (WHO)-Uppsala Monitoring Centre (UMC) scale and the modified Hartwig and Siegel’s scale, respectively. Data were tabulated using Microsoft Excel and expressed as mean, standard deviation, frequency, and percentage as appropriate, with the help of descriptive statistics using Epi Info 7 software. Results: A total of 262 ADRs were analysed. The mean age of the patients was 47.4±20.1 years. The majority were females 160 (61.1%). The intravenous route was the most common route involved in ADRs 158 (59.8%), followed by the oral route 91 (34.5%). Skin reactions accounted for more than half of the ADRs 151 (53.2%), followed by blood dyscrasias 48 (16.9%). Antibiotics were the most common group of implicated drugs 124 (44.9%), followed by anticancer drugs 43 (15.6%) and antitubercular drugs 34 (12.3%). Among antibiotics, cephalosporins (36.3%) were the most frequently encountered, followed by penicillins (30.6%). A total of 148 patients (56.5%) had recovered by the day of reporting, 146 (55.7%) ADRs were found to be ‘possible’ using the WHO-UMC causality scale, and 144 (54.9%) ADRs were classified as moderate severity. Conclusion: The study identified a widespread occurrence of ADRs, some of which increased healthcare costs due to prolonged hospital stays. The high incidence of ADRs from antimicrobials is concerning, as it contributes to antimicrobial resistance. This underscores the urgent need for prudent antimicrobial usage. The present study emphasises the importance of ADR reporting among healthcare workers and the necessity for hospitals to establish ADR reporting strategies for optimal patient care.

How potentially inapropriate are psychotropic drugs prescribing in acute psychiatric unit for the elderly? Results from a large multicentric audit in France

Adverse drug reactions (ADRs) are a major public health issue, especially when it comes to the elderly. Potentially inappropriate prescribing (PIP) are one of the causes of ADRs in older people. A PIP can be defined as a prescription for which the benefit/risk ratio is unfavourable compared to other therapeutic alternatives. Psychotropic drugs are the second highest risk class for ADRs in the elderly. In order to reduce the prevalence of PIP, prescription assistance tools have been created. An inventory of PIP of psychotropic drugs in older patients hospitalized in psychiatry units was carried out in a French regional setting in 2019. A criteria grid was established based on 2 tools: STOPP/START criteria and Laroche's list adapted to French practice. This grid targeted each class of psychotropic drugs, drugs with a high anticholinergic burden and non-recommended combinations of psychotropic drugs. Three hundred forty-seven patients were included. A high prevalence of PPI was found for each class of psychotropic drugs. The highest prevalence of PPI was found among benzodiazepines (90.3%): long-term prescription, long half-life drugs, respiratory insufficiency or cognitive impairment condition. 56.5% of the subjects had a not-recommended combination of psychotropic drugs (prescription of drugs of the same pharmacotherapeutic class), 26% had a PIP of antipsychotics: prescription for insomnia, use of phenothiazine, 11.8% of drugs with anticholinergic properties and 7.4% of antidepressants: especially prescription of tricyclic drugs. These results obtained on a large population underline the interest of considering the specificities of prescriptions in the elderly. It shows both the interest and the limits of the current criteria defining the PIP in the context of a hospitalization in psychiatry for an acute disorder in elderly subjects.