Adverse Drug Reactions In Patients Research Articles

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

A study to monitor adverse drug reactions in patients of chronic obstructive pulmonary disease, asthma and bronchiectasis

A study to monitor adverse drug reactions in patients of chronic obstructive pulmonary disease, asthma and bronchiectasis

Analysis and Management of Adverse Drug Reactions after Injection of Amphotericin B in AIDS Patients with Fungal Infection

Objective: To understand the condition of adverse drug reactions and the treatment procedures of amphotericin B for injection in patients with AIDS complicated with fungal infection. Methods: For the research object, a retrospective analysis of adverse reactions of amphotericin B injection in 121 patients of AIDS complicated with fungal infection was reported in our hospital from October 2017 to June 2021 to observe the adverse drug reactions of patients after treatment with amphotericin B for injection, 87 cases with general degree (regarded as the general group) and 34 cases with serious degree (regarded as the serious group), and analyze the general data, medication and course of disease of the two groups for symptomatic treatment. Results: Adverse reactions such as hypokalemia, abnormal liver function, renal impairment, leucopenia and drug fever were more common in the two groups, and there were also many adverse reactions such as bone marrow suppression, rash, anemia, thrombocytopenia, nausea, vomiting, fatigue, dizziness, pruritus, angina pectoris, vertigo, abdominal pain and diarrhea. The rates of leukopenia and drug fever in general group were significantly lower than those in severe group (P < 0.05); in the dose of amphotericin B used, the rate of using 25 mg and more than 25 mg in the general group was significantly lower than that in the severe group (P < 0.05). After symptomatic treat-ment, most patients have improved, and a few are unknown or have not improved. Con-clusion: Amphotericin B for injection has great side effects and will cause different degrees of adverse drug reactions. The dose of amphotericin B for clinical treatment should be ad-justed and disposed according to the adverse reactions to avoid serious consequences.

Ontogeny of Pediatric Pharmacogenetics: Celebrating the Past and Vision for the Future.

Ontogeny of Pediatric Pharmacogenetics: Celebrating the Past and Vision for the Future.

Abstract 10547: Communication of Potential Adverse Drug Reactions in Patients Undergoing Percutaneous Coronary Intervention

Background: Patients need information on all aspects of prescribed drug therapy to make informed decisions about their treatment for autonomy. Purpose: This study assessed whether patients received information about potential adverse drug reactions (ADRs) from prescribed drug therapy before or after discharge following percutaneous coronary intervention (PCI). Furthermore, we sought to estimate associations with socio-demographics and concerns related to prescribed drug therapy. Methods: CONCARD PCI is a prospective multicentre cohort study including 3424 patients undergoing PCI. The study was conducted between June 2017 and May 2020 at seven large referral PCI centres in two Scandinavian countries. Clinical data were collected from patients’ medical records. Socio-demographic characteristics were obtained by self-report during index hospitalization. Four questions from the Heart Continuity of Care Questionnaire were used to determine if information about potential ADRs was provided before or after discharge. The Specific-Concerns Scale of the Beliefs about Medicines Questionnaire was used to assess concerns related to prescribed drug therapy. Logistic regression estimated whether lack of information was associated with sociodemographic characteristics. Results: Most patients were men (78%), with a mean age of 66 years (SD11, range 20-96 years) and married or living with a partner (75%). Before discharge from hospital, 59% reported being informed of potential ADRs and 50% were informed what to do if ADRs occurred. After hospital discharge, 26% reported having reviewed potential ADRs with healthcare providers, and 24% had reviewed what to do if ADRs occurred. Those who were not informed had increased concerns about their prescribed drug therapy compared to those who were informed at both time points (p&lt;0.001). Women (51%) were less likely to receive information about potential ADRs than men (63%) (p&lt;0.001). However, there were no substantial associations with age, education, income, or marital status. Conclusion: Four in ten patients reported not receiving information on potential ADRs from prescribed drug therapy, and this applied especially for women. Efforts to improve communication on ADRs and gender equity should be a priority.

Classification and clinical features of adverse drug reactions in patients with ulcerative colitis treated with 5‐aminosalicylate acid: a single-center, observational study

Background 5-Aminosalicylate acid (5-ASA) is a crucial drug for ulcerative colitis (UC) patients. 5-ASA has several side effects. However, the types of side effects vary and are sometimes severe. Methods A single-center, retrospective cohort study was conducted from September 2001 to June 2020. We surveyed consecutive UC patients who visited our hospital and investigated adverse drug reactions (ADRs) related to 5-ASA formulations. We grouped patients into four subgroups: (1) lupus-like symptoms, (2) blood test abnormalities, (3) mimicking IBD exacerbation and (4) others. Their clinical courses were evaluated. Results We surveyed 288 consecutive UC patients, 35 of whom developed ADRs of any grade (12.9%), and analyzed 27 patients. The median age and 5-ASA doses were 43 years and 4000 mg, respectively, and 48% were male. The ADR triggers were the first use of 5-ASA (n = 17, 63%), 5-ASA switch (n = 9, 33%) and 5-ASA dose escalation (n = 1, 3.7%). The median time to ADR was 15 days (IQR: 7, 63). Ten patients (37%) had grade 3/4 ADRs. Fever was the most common ADR (n = 6, 23%), followed by hyperamylasemia and headache (n = 4, 15%). Lupus-like symptoms accounted for 56% (n = 15), blood test abnormalities for 26% (n = 7), mimicking IBD exacerbation for 15% (n = 4) and others for 3.7% (n = 1). The time to ADR was shorter in the mimicking IBD exacerbation group (median 11 days) than in the lupus-like symptoms (22 days) and blood test abnormalities (55 days) groups. Conclusion Classification of ADRs related to 5-ASA into four groups might lead to early recognition of ADRs.

Antibiotic-Related Adverse Drug Reactions in Patients Treated on the Dermatology Ward of Medical University of Gdańsk.

Adverse drug reactions (ADRs) are unexpected reactions to a medication administered in a correct way at a standard dose. Drug-induced skin reactions account for 60–70% of all ADRs. The aim of the study is to determine the prevalence of antibiotic-related dermatological ADR in patients treated in the department of Dermatology, Venerology and Allergology of the University Clinical Center in Gdańsk, Poland, in the years 2004–2021. A retrospective analysis of patients’ medical files was conducted in order to identify cases of ADR connected with the use of antibiotics, yielding 84 cases. The most common group of antibiotics were β-lactam, causing ADR in 47 patients. β-lactam antibiotics in our study included amoxicillin, alone and combined with clavulanic acid, and cephalosporins, affecting 22, 18 and 7 patients, respectively. In conclusion, β-lactam antibiotics showed the highest prevalence among antibiotic-induced skin reactions. They accounted for 15% of cases of all dermatological drug reactions and 55% of those caused by antibiotics. Especially amoxicillin, prescribed as a single drug or in combination with clavulanic acid, was commonly the culprit. Due to its wide use in the hospital and outpatient clinic, these adverse reactions have to be kept in mind by both hospital staff and general practitioners.

Risk factors for adverse drug reactions in patients admitted to intensive care units

Patients hospitalized in intensive care units (ICU) are at higher risk of having adverse drug reactions (ADR). To determine risk factors for ADR, through intensive pharmacological surveillance at the ICU. An observational, descriptive and prospective study was made, determining risk parameters in patients who experienced ADR. Eighty-five patients were surveilled and 24 (28%) had an ADR. A total of 48 drugs responsible for at least one ADR were identified. Seventy-three percent ADR were moderate and 27% were severe. The clinical variables significantly associated with ADR were a history of allergies, a high body mass index, the reason for admission, an APACHE II score ≥ 14 points, the use of invasive mechanical ventilation and more than seven days of hospitalization. The pharmacological variables associated with ADR were polypharmacy and medication associations and combinations. The identified risk factors have a great impact on pharmacokinetic and pharmacodynamic parameters, and should be considered to avoid the appearance of ADR.

Detection of unknown ototoxic adverse drug reactions: an electronic healthcare record-based longitudinal nationwide cohort analysis

Ototoxic medications can lead to significant morbidity. Thus, pre-marketing clinical trials have assessed new drugs that have ototoxic potential. Nevertheless, several ototoxic side effects of drugs may remain undetected. Hence, we sought to retrospectively investigate the potential risk of ototoxic adverse drug reactions among commonly used drugs via a longitudinal cohort study. An electronic health records-based data analysis with a propensity-matched comparator group was carried out. This study was conducted using the MetaNurse algorithm for standard nursing statements on electronic healthcare records and the National Sample Cohort obtained from the South Korea National Health Insurance Service. Five target drugs capable of causing ototoxic adverse drug reactions were identified using MetaNurse; two drugs were excluded after database-based analysis because of the absence of bilateral hearing loss events in patients. Survival analysis, log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio of bilateral hearing loss among patients who were prescribed candidate ototoxic drugs. The adjusted hazard ratio of bilateral hearing loss was 1.31 (1.03–1.68), 2.20 (1.05–4.60), and 2.26 (1.18–4.33) in cimetidine, hydroxyzine, and sucralfate users, respectively. Our results indicated that hydroxyzine and sucralfate may cause ototoxic adverse drug reactions in patients. Thus, clinicians should consider avoiding co-administration of these drugs with other well-confirmed ototoxic drugs should be emphasized.

Can acupuncture enhance the therapeutic effectiveness of an-tidepressants and reduce adverse drug reactions in patients with depression? A systematic review and meta-analysis

Can acupuncture enhance the therapeutic effectiveness of an-tidepressants and reduce adverse drug reactions in patients with depression? A systematic review and meta-analysis

Pharmacogenetics of chlorpromazine and its role in the development of antipsychotic-induced parkinsonism

Antipsychotics (AP) is a group of psychotropic drugs for the treatment of mental disorders, in particular schizophrenia. In the mid-1950s, the first AP was synthesized (known as chlorpromazine (CPZ)). This drug has revolutionized the treatment of psychotic disorders. This drug, in addition to the antipsychotic effect, caused severe adverse drug reactions in patients, in particular from the neurological system, such as AP-induced extrapyramidal syndrome (EPS) — chlorpromazine-in-duced parkinsonism (CPZ-IP). CPZ-IP characterized by the occurrence of motor disorders. CPZ-IP is as a result of damage to the basal ganglia and subcortical-thalamic connections. Drug-induced EPS is subdivided into primary and secondary. Among the primary EPS, drug-IP is the most common (the leading form of secondary parkinsonism). Pharmacogenetic markers of CPZ safety are being actively studied. Some pharmacogenetic markers of therapy safety have been established: single nucleotide variants/polymorphisms of candidate genes for dopaminergic receptors D2 and D3 (DRD2 (rs1799732 (-141C Ins/Del)), DRD3 (rs6280 (Ser9Gly)), laforine phosphatase (EPM2A (rs1415744 (C/T)).

A Comparative Study to Evaluate Safety of Antidiabetic Drugs and Its Complications; Emphasis on the Adverse Drug Reaction in Patients Visiting Tertiary Center and Private Clinic

A Comparative Study to Evaluate Safety of Antidiabetic Drugs and Its Complications; Emphasis on the Adverse Drug Reaction in Patients Visiting Tertiary Center and Private Clinic

Study of the Effect of Polymorphic Markers of the NAT2 Gene on the Risk of Adverse Drug Reactions in Patients with Pulmonary Tuberculosis Who Received Isoniazid and Rifampicin

Tuberculosis remains one of the most dangerous and widespread infectious diseases. More than 20 medicinal products are currently available for the treatment of tuberculosis. One of the most serious adverse drug reactions (ADRs) associated with anti-tuberculosis medicines is hepatotoxicity.The aim of the study was to assess the effect of polymorphic markers of the NAT2 gene on the ADR risk in patients with pulmonary tuberculosis who received isoniazid and rifampicin.Materials and methods. The study included 67 patients with different forms of pulmonary tuberculosis who received combination therapy with isoniazid and rifampicin. Single nucleotide polymorphisms (SNPs) of the NAT2 gene were determined by real-time PCR. Statistical processing was performed using SPSS Statistics 20.0.Results: Six SNPs were identified in the NAT2 gene. Based on these SNPs the following phenotypes were determined by the rate of NAT2 acetylation: fast acetylators—6 subjects, intermediate acetylators—24 subjects, and slow acetylators—37 subjects. The study assessed the relationship between the acetylator phenotype and the development of ADRs during combination therapy with isoniazid and rifampicin. Slow acetylators had a significantly greater increase in total bilirubin level (p=0.011) compared to intermediate acetylators. Loss of appetite was more often observed in fast acetylators than in intermediate acetylators (p=0.021).Conclusions. The obtained data suggest interrelation between the slow type of NAT2 acetylation and the risk of ADRs in patients undergoing pulmonary tuberculosis chemotherapy with isoniazid and rifampicin. Out of all the ADRs registered in the study, the fast acetylators were more likely to have loss of appetite, however, the expansion of the study population is needed to verify this observation. The studied polymorphisms have an impact on the development of ADRs in patients undergoing pulmonary tuberculosis chemotherapy with isoniazid and rifampicin and may be used to predict the safety profile of pharmacotherapy in this group of patients.

The Burden Of Self-Reported Adverse Drug Reactions in Patients Referred To An Outpatient Allergy Practice At A Tertiary Referral Center

Adverse drug reactions (ADRs) play a significant role in patient care. With the use of electronic health records (EHR) patients self-report ADRs, but these are not always confirmed/validated by healthcare providers. Studies have described the prevalence in outpatient (11.4%)/inpatient (15.9%) settings, but to our knowledge, no data is available to describe self-reported ADRs in patients referred to an allergy practice. We aimed to describe such patients referred to our tertiary referral center.

A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report

ObjectivesSince the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy...

Predicting Opioid Therapy Safety In Pancreatic Cancer Patients

Background — Obligatory use of strong opioids for treating chronic pain syndrome in patients with pancreatic cancer provides the implementation of opioid-associated adverse reactions. Genetic and non-genetic risk factors are predictive of the opioid therapy safety. Contemporary methods of information analysis allow using prognostic risk models for practical application. Objective — Identification of significant risk factors for the development of opioid-associated adverse drug reactions in patients with chronic pain syndrome against the background of pancreatic cancer. Material and Methods — The study included 90 patients with chronic pain against the background of pancreatic cancer, randomized at a ratio of 1: 1. Group 1 received morphine sulfate (MS), group 2 received fentanyl transdermal therapeutic system (FTTS) with standard adjuvant therapy (ketoprofen, diazepam, amitriptyline). To assess pain level, the 10-point Digital Rating Scale, the Visual Analogue Scale and the pain questionnaires were used. The assessment of the treatment safety was conducted by the Naranjo Scale. Assessment of prognostic genetic and non-genetic factors was carried out using ROC analysis with calculation of AUC (the area under the ROC-curve). Results — Prognostic models of good quality were determined with the optimal ratio of sensitivity and specificity for the influence of genetic and non-genetic risk factors on the development of opioid-associated adverse drug reactions (OA-ADRs) in comparison groups. Various prognostic factors, complementing each other, were identified in the comparison groups. Conclusion — The following OA-ADRs predicting factors were identified: for FTTS-associated nausea and vomiting – age and carriage of rs7438135 AG genotype of UGT2B7 gene; for local reactions – the sum of points on the ESAS scale and carriage of rs7438135 AA genotype of UGT2B7 gene; for difficulty urinating – the level of glomerular filtration rate; for neurotoxicity – the level of AST and bilirubin, and the carriage of rs1128503 GG genotype of ABCB1 gene; for pruritus – carriage of rs1045642642 AA genotype of ABCB1 gene. The prognostic factors for the implementation of MS-associated neurotoxicity were age and comorbidity; for dry mouth was predicted best from the sum of points on the MMCE scale; weakness was predicted by the carriage of rs7668258 TT genotype of UGT2B7 gene.

Adverse drug reactions in patients on aspirin therapy with concomitant antihypertensive medication in a tertiary care hospital of deccan plateau

Introduction: To know adverse drug reactions when Aspirin is prescribed with Antihypertensive medications. Materials and Methods:Prospective observational study conducted in a tertiary care hospital, total 60 patients of age Casuality assessment of all ADRs was done by Naranjo ADR scalegroup 18 to 65 years were included in the study, It is a 12 week study, clinical examination done at enrollment and with subsequent follow up at 4,8 and 12 weeks,Base line investigations done at enrollment and at 12 weeks ,ADR monitoring done at each follow up Results:Out of 45 patients who experienced adverse effects, causality assessment shows that Aspirin is responsible for producing ADRs in 15 patients and in Betablocker therapy and 26% in Aspirin with thiazide diuretics and 16% in aspirin with ACE inhibitors or Calcium channel blockersremaining 30 patients, Aspirin interaction is likely cause for ADRs, Incidence of adverse effects is 40% in Aspirin with concomitant Conclusion: This study shows Betablockers and Thiazide diuretics in treatment of hypertension,Incidence of ADRs is high in elderly patients,increased incidence of Adverse drug reactions (though these are mild ADRs) when Aspirin is added to Betablockers and Thiazide diuretics in treatment of hypertension,Incidence of ADRs is high in elderly patients. Keywords:Aspirin, Betablockers, Calcium channel blockers, ACE inhibitors, Thiazide diuretics, Naranjo scale

Impact of Adverse Drug Reactions in Patients with End Stage Renal Disease in Greece

Background: Patients with end-stage renal disease (ESRD) require specialized therapeutic interventions. The decreased renal function that modulates the physiology and presence of comorbidities is often associated with variations in the pharmacological response, thus increasing the risk of adverse drug events or reactions (ADE/ADRs) from co-administered drugs. Methods: A cross-sectional study to record comorbidities, drug–drug interactions (DDIs), ADE/ADRs in patients with chronic kidney disease of stage five in Greece. The study enrolled 60 patients of mean age 64.8 ± 12.9 years, undergoing hemodialysis three times a week. Demographic and social factors, comorbidities, laboratory test data, medication regimens, DDIs and the reporting of ADE/ADRs were analyzed. Results: Cardiovascular diseases and diabetes were the main comorbidities. In total, 50 different DDIs of various clinical significance were identified. CNS, GI-track, and musculoskeletal-system-related ADE/ADRs were most often reported by patients. ADE/ADRs as clinical outcome from DDIs were associated in 64% of the total identified DDIs. There was a positive trend between number of medications, ADE/ADRs report and DDIs. Conclusions: The impact of ADE/ADRs in ESRD patients should be always considered. Guidelines as well as continuous training in the context of evidence-based clinical practice by healthcare personnel on therapy administration and prevention of adverse events are important.

Analysis of adverse drug reactions reported to national pharmacovigilance center of Bhutan

Introduction: Medicines prescribed for diseases often causes adverse drug reactions in patients ranging from mere inconvenience to permanent disability and death. This is because, most of the adverse drug reactions especially the serious and latent ones may not have occurred during the clinical trials and vulnerable populations like children, pregnant women and the elderly are not all included in clinical trial studies considering the ethical and safety issues. Objectives: To study the demographic characteristics, types of adverse drug reactions and common drugs causing these reactions from the adverse drug reaction reports received by the national pharmacovigilance of Bhutan. Methods: A total of 222 adverse drug reactions were received at the national pharmacovigilance center from January 2016 to May 2018 were analyzed retrospectively. The Drug Regulatory Authority is the national pharmacovigilance center of Bhutan and is a member to the International Drug Monitoring Program since 2014. Results: 73% of adverse drug reactions occurred in adults while 13.5% occurred each in children and elderly. 48.7% of the total adverse drug reactions reports were caused by antibiotics out of which penicillin was the most common causal drug (32.4%). The most commonly reported adverse drug reactions was rashes (36.5%) followed by gastro-intestinal system disorder (14.9%). Conclusions: Antibiotics are common causal drugs for adverse drug reactions. All categories of health professional must be encouraged to report adverse drug reactions. Active surveillance for drug safety monitoring especially for those of patients who are on antibiotics is recommended.

Incident adverse drug reactions and their effect on the length of hospital stay in older inpatients.

Background Acutely ill older persons are more likely to suffer adverse drug reactions, increasing morbidity, and mortality. The incident adverse drug reactions and their consequences on the length of hospital stay (LOS) in older persons have been little explored. Objective To determine the incident adverse drug reactions in acutely ill older inpatients and their effect on the LOS. Setting Internal medicine service in a Chilean teaching hospital. Method A prospective cohort study was conducted in patients aged ≥ 60years admitted into the internal medicine service of the Hospital from University of Chile. Characteristics, severity, and causality of adverse drug reactions were assessed. Effect of incident adverse drug reactions on the LOS was determined using multiple Cox regression. A secondary analysis was conducted in patients aged ≥ 65years. Main outcome measure Incident adverse drug reactions (new events occurring in hospital) and their effect on the LOS in older inpatients. Results A total of 229 acutely ill older persons ≥ 60years were followed-up. Fifty-six of them suffered 77 adverse drug reactions (incident rate 24.5%; 95% CI: 19.0, 30.5), 70.1% type A. Adverse drug reactions were severe in 5.4% of cases. Causality assessment indicated the majority were probable (57.1%) and 3.9% certain. Cardiovascular agents were the therapeutic class more frequently involved. The most frequent adverse drug reaction was hypotension (19.5%). Patients with adverse drug reactions had a significantly prolonged LOS than those without adverse drug reactions (12.4 ± 11.0 versus 7.3 ± 6.4days; p < 0.0001) (adjusted Hazard Ratio 0.63; 95% CI: 0.46, 0.87; p < 0.01), respectively. The incidence rate of adverse drug reactions in patients ≥ 65years was 25.1% (95% CI: 19.0; 32.1), and their occurrence was significantly associated with a prolonged LOS (p < 0.05). Conclusion One in four acutely ill older persons hospitalized in the internal medicine service suffered at least one incident adverse drug reaction, which prolonged the LOS by 5days. There is a potential to optimize the use of hospital beds and medication safety by preventing adverse drug reactions in geriatric patients.