Cause Of Adverse Drug Reactions Research Articles

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.

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.

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.

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.

A cross sectional study to analyse the ADR reported in a hospital during the past three years

Introduction: Cross sectional study is a type of observational study that analyzes data from apopulation, or a representative subset, at a specific point in time-that is, cross sectional data. The causality appraisal is assessment of the probability that the detected adverse event is produced by a specific medication. The most commonly used causality assessment scales are Naranjo Probability Scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scales. The study is to analyze the adverse drug reaction reported in a hospital for the past three years. Aim: A cross sectional study to analyze the ADR reported in a hospital during the past three years. Methodology: A cross sectional observational study was conducted at Nirmala medical centre, Muvattupuzha. ADR reported in the past three years in this hospital were analyzed. Drug leading to ADR, department .gender, observed reaction, severity, Naranjo probability scale and WHO UMC causality assessment were done. Classification of drugs according to their drug class, classification of ADR according to the system, based on severity, sex, Naranjo score, WHO UMC criteria were done. The datas were analysed and represented into graphs. Result: A total of 342 ADR reports were analyzed in this study. The key findings of this study include: Skin-related ADRs were the most frequently reported, affecting 27.83% of cases. The majority of reported ADRs were of moderate severity (56.7%).Naranjo probability scale and WHO-UMC causality assessment indicated that most cases were in the probable category, with 63% and 76%, respectively. The general medicine department had the highest number of reported ADRs. Males accounted for the majority of reported ADRs (57.18%).Cardiovascular agents and antibiotics were the drug classes most commonly associated with reported ADRs, at 25.6% and 22.28%, respectively. Among cardiovascular agents, diuretics were found to be the primary culprits, causing 38.66% of reported ADRs. Conclusion: This study highlights the importance of monitoring, assessing, and documenting ADRs in healthcare facilities, as it provides valuable insights into the prevalence, severity, and causality of adverse drug reactions. This information can contribute to improving patient safety and the rational use of medications in clinical practice.

Evaluating the performance of ChatGPT in clinical pharmacy: A comparative study of ChatGPT and clinical pharmacists.

To evaluate the performance of chat generative pretrained transformer (ChatGPT) in key domains of clinical pharmacy practice, including prescription review, patient medication education, adverse drug reaction (ADR) recognition, ADR causality assessment and drug counselling. Questions and clinical pharmacist's answers were collected from real clinical cases and clinical pharmacist competency assessment. ChatGPT's responses were generated by inputting the same question into the 'New Chat' box of ChatGPT Mar 23 Version. Five licensed clinical pharmacists independently rated these answers on a scale of 0 (Completely incorrect) to 10 (Completely correct). The mean scores of ChatGPT and clinical pharmacists were compared using a paired 2-tailed Student's t-test. The text content of the answers was also descriptively summarized together. The quantitative results indicated that ChatGPT was excellent in drug counselling (ChatGPT: 8.77 vs. clinical pharmacist: 9.50, P = .0791) and weak in prescription review (5.23 vs. 9.90, P = .0089), patient medication education (6.20 vs. 9.07, P = .0032), ADR recognition (5.07 vs. 9.70, P = .0483) and ADR causality assessment (4.03 vs. 9.73, P = .023). The capabilities and limitations of ChatGPT in clinical pharmacy practice were summarized based on the completeness and accuracy of the answers. ChatGPT revealed robust retrieval, information integration and dialogue capabilities. It lacked medicine-specific datasets as well as the ability for handling advanced reasoning and complex instructions. While ChatGPT holds promise in clinical pharmacy practice as a supplementary tool, the ability of ChatGPT to handle complex problems needs further improvement and refinement.

Epidemiological investigation of emergency infusion adverse drug reactions in Nanjing, China: a prospective cross-sectional study

ABSTRACT Objective Little is known about the morbidity and mortality of infusion Adverse drug reactions (ADRs) in the emergency department. We sought to evaluate the epidemiology of emergency infusion ADRs. Materials and Methods This was a prospective study of infusion ADRs in the emergency infusion unit (EIU) of a tertiary hospital from 1 January 20201 January 2020, to 31 December 2021w31 December 2021. Emergency infusion ADRs were identified as intravenous drug-related ADRs that the causality was determined using the Naranjo algorithm. The incidence, severity and preventability of these ADRs were assessed using other standard criteria. Results A total of 327 ADRs were recorded for 320 participants, antibiotics were the class of drugs most commonly involved, and 76.15% of ADRs occurred within the first hour. The most common symptoms observed were skin manifestations, accounting for 46.04% of ADRs. Mild reactions accounted for 85.32% based on the Hartwig and Siegel scale. In 89.30% of the reports, the ADRs were evaluated as not preventable based on the modified Schumock and Thornton scale. The causality and severity of ADRs were related to Charlson Comorbidity Index score and age (P < 0.05). Conclusion This epidemiological study described the pattern of emergency infusion ADRs in East China in detail. These findings may be useful to compare patterns among different centers.

Adverse drug reactions in the ambulatory internal patients at the emergency department: Focus on causality assessment and drug-drug interactions.

A non-interventional retrospective study in ambulatory patients was conducted at the emergency department of the Division of internal medicine. In 2 months, 266 suspected adverse drug reactions (ADRs) were identified in 224/3453 patients (6.5 %). In 158/3453 patients (4.6 %), an ADR was the reason for emergency department visit and in 49 patients (1.4 %), ADRs led to hospitalisation. A causality assessment algorithm was developed, which included Naranjo algorithm and levels of ADR recognition by the treating physician and the investigators. Using this algorithm, 63/266 ADRs (23.7 %) were classified as "certain", whereas using solely the Naranjo score calculation, only 19/266 ADRs (7.1 %) were assessed as "probable" or "certain", and the rest of ADRs (namely, 247/266 = 92.9 %) were assessed as "possible". There were 116/266 (43.6 %) ADRs related to potential drug-drug interactions (DDIs), stated in at least one of the literature sources used. Based on the causality relationship, the rate of the clinically expressed DDIs was 19.0 %, or 12/63 "certain" ADR cases. Of these, 10 cases presented serious DDI-related ADRs. In summary, ADR causality assessment based exclusively on Naranjo algorithm demonstrated low sensitivity at an ambulatory emergency setting. Additional clinical judgment, including the opinion of the treating physician, proved necessary to avoid under-rating of the causality relationship, and enabled the determination of clinically expressed DDIs.

A Case of Oral-Vancomycin-Induced Rash in a Patient with Acute Kidney Injury

Clostridioides difficile infection (CDI) is one of the most common hospital-acquired infections. Its incidence has increased during the last decade in the community among individuals with no previous risk factors; however, morbidity and mortality are still considered high in elderly patients. Oral Vancomycin and Fidaxomicin are the first lines of treatment for CDI. The systemic bioavailability of oral Vancomycin is thought to be undetectable due to its poor absorption in the gastrointestinal tract; therefore, routine monitoring is not warranted. Only 12 case reports were found in the literature that described adverse reactions associated with oral Vancomycin and its related risk factors. We present a case of a 66-year-old gentleman with severe CDI and acute renal failure who was started on oral Vancomycin upon admission. On day five of treatment, he developed leukocytosis associated with neutrophilia, eosinophilia, and atypical lymphocytes, with no evidence of active infection. Three days later, he developed a pruritic maculopapular rash in more than 50% of his body surface area. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) was ruled out since the patient only had three inclusion criteria for this diagnosis. No clear inciting agent was found. Oral Vancomycin was stopped and supportive treatment was supplied for a presumed Vancomycin-induced allergic reaction. The patient had an excellent response, with complete resolution of the rash and leukocytosis in less than 48 h. By reporting this case, we want to raise awareness among clinicians to remember that, albeit rare, oral Vancomycin can be the cause of adverse drug reactions in patients with severe illnesses.

Adverse drug reactions in an ageing PopulaTion (ADAPT) study: Prevalence and risk factors associated with adverse drug reaction-related hospital admissions in older patients.

Background: Older people experience greater morbidity with a corresponding increase in medication use resulting in a potentially higher risk of adverse drug reactions (ADRs). Objectives: The aim of this study was to; 1) determine the prevalence and characteristics of ADR-related hospital admissions among older patients (≥65years) in Ireland; and 2) identify the risk factors associated with ADR-related hospital admissions. Methods: A cross-sectional study of ADR prevalence in patients aged ≥65years admitted acutely to hospital in Ireland over a 8 month period (November 2016- June 2017). A multifaceted review of each hospital admission was undertaken to assess the likelihood of an ADR being a reason for admission (cause of admission or contributing to admission) in the context of the patient's medication, clinical conditions, comorbidities and investigations. A number of decision aids were applied by two independent reviewers to assess ADR causality, avoidability and severity. A random sample of patients, determined not to have a suspected ADR on screening, were assigned to a non-ADR control group. Multivariable logistic regression was used to assess the association between potential risk factors for ADR-related admissions compared with non-ADR-related admissions. Results: In total, 3,760 hospital admission episodes (in 3,091 patients) were screened and 377 admissions were considered ADR-related (10.0%, 95% CI 9.1%, 11.0%). 219 (58.1%) ADR-related admissions were caused by an ADR, while ADRs contributed to 158 (41.9%) admissions. 268 (71.1%) of all ADR-related admissions were deemed definitely or possibly preventable/avoidable. 350 (92.8%) ADRs were classified as being of moderate severity, with 27 (7.2%) classified as severe. Antithrombotic agents, mainly aspirin and warfarin, were the drugs most frequently associated with ADR-related admissions (gastrointestinal and vascular haemorrhagic disorders). In multivariable analysis, immobility, frailty, having delirium or ulcer disease and taking anticoagulant and antiplatelet medication on admission were significantly associated with an ADR-related hospital admission. Conclusion: One in ten hospital admissions, among those aged 65 + years, were considered ADR-related, with approximately 70% potentially avoidable. Reliable and validated ADR detection and prediction tools are needed to develop prevention strategies.

Clinical profile of adverse drug reactions in patients admitted to internal medicine wards of a tertiary care hospital

Introduction: Adverse drug reactions (ADRs) are unwanted, often harmful reaction resulting from a pharmacological intervention that warrants treatment, prevention, and future precautions. ADRs are highly prevalent with 10%–20% of patients suffering from one when admitted. The aim of this study was to identify cases and provide data on the incidence, severity, causality, and preventability of ADRs in a clinical setting in various age groups. The study also aimed to identify ADR risk factors which can be used to create ADR risk prediction models for application in everyday clinical practice to proactively detect patients at risk of developing these reactions. Materials and Methods: This was an inpatient, prospective, observational cohort study in the internal medicine ward of a major tertiary care hospital. Once the institutional ethics approval was obtained, patients fulfilling the inclusion criteria were enrolled with informed consent. Their data were recorded in an ADR data form. These data were then analyzed using standardized scales to identify causality, severity, preventability, and avoidability along with specific risk factors and comparing them across age groups and drug classes. Results: One hundred and sixty-four patients were eligible and enrolled. Seventy percent of those suffering from ADRs were in the 30–60 years age group. Oral hypoglycemics and antituberculosis drugs were most commonly implicated, whereas metabolic and hepatic systems were the most frequent organ systems involved. Polypharmacy and hypertension were the most common risk factors identified. The cause of 96.3% of ADRs was probable, and 51.2% of the ADRs were categorized as severe. Nearly a fourth of the severe ADRs were categorized as life-threatening. A majority of the ADRs were treated by terminating the suspected drug, and 54% of patients recovered completely. 6.1% of the ADRs were definitely avoidable while 42.1% were unavoidable. Conclusion: This study clearly demonstrates the massive burden of ADRs, both on the patients and the hospitals. There is a dire need for a standardized, easily accessible means of mandatory reporting of ADRs, and that data need to be utilized to treat, decrease morbidity, and prevent ADRs by proactively anticipating them to ultimately improve patient care. The following core competencies are addressed in this article: Patient care, Medical knowledge, Interpersonal and communication skills, Practice-based learning and improvement, and Systems-based practice

A retrospective study of adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reactions (ADRs) are defined as noxious changes due to a drug, which can occur at doses normally used in humans that require treatment or dose reduction, and also indicate that caution should be exercised with future use of the same drug. Periodic monitoring of ADRs in hospitals can motivate health-care professionals to realize their role and responsibility in the detection, management, and reporting of suspected ADRs and also make them learn how to make sure patients stay safe and healthy. The current study is expected to raise awareness among health-care professionals on the importance of ADR reporting. Aims and Objectives: The objective of the study was to analyze the incidence and pattern of ADRs with assessing the severity and causality of ADRs reported in the hospital. Materials and Methods: All ADR cases which were reported to the pharmacovigilance unit between January 2022 and December 2022 have been evaluated. A total of 220 ADR cases were reported during the study. The demography of patients, causative drugs, reactions, causality assessment, and severity have been analyzed. Causality assessment using the WHO-Uppsala Monitoring Center Scale and severity analysis using the modified Hartwig and Siegel Scale have been done. Results: A total of 220 ADR cases have been evaluated. The main age group affected in our study was 31–45 years with male preponderance. Maximum cases were reported from the dermatology department. The most commonly affected organ was the skin. Antibiotics like cephalosporins caused most of the ADRs. After causality assessment, the maximum cases were probable type (60%), and severity assessment revealed that most of the cases were moderate in severity (64%). Conclusion: ADRs are one of the growing causes of morbidity and mortality worldwide. Underreporting of ADRs may result in a loss of clinical information that could prevent significant harm to patients. The need of the hour is to encourage health-care professionals to report any suspected ADR and also keep accurate records to analyze, process, and draw conclusions from data to ensure patient safety.

Adverse Drug Reactions Monitoring in New Patients Admitted to the Cardiac Care Unit in a Tertiary Care Hospital

Background: Adverse Drug Reactions (ADRs) are amongst the commonly occurring event in the intensive care unit where patients are mostly on the polypharmacy. They affect the quality of life of patients and increase the burden on the health care system. Aim and Objectives: The study aimed to estimate the incidence of ADRs and to assess the causality and seriousness of such ADRs by using the Naranjo probability scale. A prospective, observational, longitudinal study was conducted on patients admitted to the cardiac care unit over a period of 10 months. ADRs profile was noted by spontaneous and intensive monitoring. For analysis, descriptive statistics with 95% CI were used. Results: A total of 77 ADRs were reported from the 173 patients, out of which 31 patients suffered from ADRs, with an incidence of 17.9%. The gastrointestinal system was the most common affected system followed by the cardiovascular and respiratory systems. When analyzed on the Naranjo ADR probability scale, the majority of the ADRs (67.5%) were rated as probable followed by possible (32.4%). It was observed that the number of drugs used as well as the duration of stay in the hospital, in patients with ADRs, was significantly higher than those who did not have any adverse effect. The pattern and spectrum of ADRs need to be studied further so that their occurrence can be prevented. Conclusion: The study can be useful in identifying and minimizing preventable ADRs and can be an effort to make the use of drugs more rational and safe

Bridging the gap between bench and clinic: the importance of understanding the mechanism of iodinated contrast media hypersensitivity.

Since the advent of CT, iodinated contract media (ICM) has become one of the most regularly administered intravenous medications in clinical settings. Although considered generally safe, ICM is one of the most common causes of adverse drug reactions in clinical practice, accounting for more than 2 million adverse reactions worldwide. Currently, there are few useful tools to diagnose patient hypersensitivity, with the major limitation being the lack of consensus regarding the mechanisms of hypersensitivity to ICM. While there is an overwhelming abundance of literature pertaining to clinical features including incidence, symptomatology, and risk, few studies have further investigated the underlying mechanisms behind their clinical observations. Of the available literature discussing pathophysiology, most primary studies were completed over 20 years ago, since which the molecular characteristics of ICM have changed. Furthermore, many reviews mentioning pathophysiology fail to adequately emphasize the clinical importance of understanding the molecular pathways involved in hypersensitivity. In this review, we aim to emphasize the clinical relevance of pathophysiology as it relates to the prediction and diagnosis of hypersensitivity reactions to ICM. To this end, we will first briefly characterize hypersensitivity reactions to ICM with respect to epidemiology and clinical presentation. We will then present the existing evidence supporting various proposed mechanisms of hypersensitivity, highlighting the gaps that remain in the mechanistic delineation of both immediate and delayed reactions. Finally, we discuss the possibility of in vitro testing as a way to predict and diagnose hypersensitivity reactions, pending a more complete elucidation of mechanisms.

Predicting drug-drug and drug-gene interactions in a community pharmacy population.

Drug-drug interactions (DDIs) are among the most common causes of adverse drug reactions and are further complicated by genetic variants of drug-metabolizing enzymes. The aim of this study is to quantify and describe potential DDIs, drug-gene interactions (DGIs), and drug-drug-gene interactions (DDGIs) in a community-basedpopulation. This was an analysis of deidentified retail pharmacy prescription data for 4761 individuals. Data were first assessed for DDIs, and individuals were stratified to a risk category using the logic of a commercially available digital DDGI tool. To calculate the frequency of potential DGIs and DDGIs, genotypes were imputed and randomly allocated to the cohort 100 times via Monte Carlo simulation according to each variant's frequency in the general population. The probability of a DDI of any impact was 26.0% and increased to 49.6% (95% CI, 48.4%-50.7%) when drug-metabolizing phenotypes were ascribed according to the distribution of variants of 11 genes as found in a Caucasian population. There was a 7.8% probability of major DDIs, which increased to a 10.1% (95% CI, 9.5%-10.8%) probability with the addition of genetic contributions. The probability of DDGIs of any impact was correlated with the number of medications. Antidepressants, antiemetics, blood products and modifiers, analgesics, and antipsychotics had the highest probability of DDGIs. The probability of drug interaction risk increased when phenotypes associated with genetic polymorphisms were attributed to the population. These data suggest that pharmacogenomic assessment may be useful in predicting drug interactions and severity when evaluating patient medication profiles.