Prevalence Of Adverse Drug Reactions Research Articles

Polypharmacy, drug-drug interactions, and adverse drug reactions among systemic sclerosis patients: A cross-sectional risk factor study.

ObjectivesPolypharmacy, drug-drug interactions (DDI) and related adverse drug reaction (ADR) are understudied in SSc. The aim of this work was to determine the prevalence and determinants of DDI and ADR in a real-life prospective cohort of SSc patients. MethodsWe performed a retrospective analysis of the drug prescriptions of SSc patients admitted to the daily scleroderma clinic between January 2020 and April 2022. DDI were identified using 2 prescription analysis applications, and adjudicated related ADRs occurring during a one-year follow-up were reported. Risk factors for DDI and ADR were identified using multivariate analysis. ResultsOne hundred and eight SSc patients were included. The median number of medications per patient was 6 [4–9]. Seventy-one (65.7 %) patients had 5 or more medications, and 23 (21.3 %) had 10 or more. Seventy-two (66.7 %) patients had DDIs on their prescriptions at inclusion. Patients with DDIs had more medications than patients without DDIs (7 [5–10] versus 3 [2–5], p < 0.0001). Six (8.3) patients experienced ADRs during the one-year follow-up. Patients with ADRs had more medications (14 [10–18] versus 7 [5–10] p < 0.001) and more DDIs (12 [7–32] versus 3 [1–6]; p < 0.001) than patients without ADRs. Multivariate analysis confirmed that the number of prescribed medications was independently positively associated with DDIs (OR: 2.25 [1.52–3.32], p < 0.0001) as well as with ADRs (OR: 1.68 [1.17–2.40], p < 0.01). ConclusionsSSc patients are significantly exposed to polypharmacy, DDIs and related ADRs, particularly in cases of severe illness, and especially if 5 or more medications are prescribed.

Phenomic landscape and pharmacogenomic implications for HLA region in a Taiwan Han Chinese population

BackgroundThe human leukocyte antigen (HLA) genes, exhibiting significant genetic diversity, are associated with susceptibility to various clinical diseases and diverse in drug responses. High costs of HLA sequencing and the population-specific architecture of this genetic region necessitate the establishment of a population-specific HLA imputation reference panel. Moreover, there is a lack of understanding about the genetic and phenotypic landscape of HLA variations within the Taiwanese population.MethodsWe created models for a Taiwanese-specific HLA imputation reference panel. These models were trained with the array genotype data and HLA sequencing data from 845 Taiwanese subjects. HLA imputation was applied for 59,448 Taiwanese subjects to characterize the HLA allele and haplotype frequencies. Additionally, a phenome-wide association study (PheWAS) was conducted to identify the phenotypes associated with HLA variations. The association of the biallelic HLA variants with the binary and quantitative traits were evaluated with additive logistic and linear regression models, respectively. Furthermore, an omnibus test with likelihood-ratio test was applied for each HLA amino acid position in the multiallelic HLA amino acid polymorphisms to compare the difference between a fitted model and a null model following a χ2 distribution of n-1 degree of freedom at a position with n residues. Finally, we estimated the prevalence of adverse drug reactions (ADR)-related HLA alleles in the Taiwanese population.ResultsIn this study, the reference panel models displayed remarkable accuracy, with averages of 99.3%, 98.9%, and 99.1% for 2-, 4-, 6-digit alleles of the eight classical HLA genes, respectively. For PheWAS, a total of 18,136 significant associations with HLA variants across 26 phenotypes are identified (p < 5×10-8), highlighting the pleiotropy feature of the HLA region. Among the independent signals, 15 are novel, including the association of HLA-B pos 138 variation with ankylosing spondylitis (AS), and rs9266290 and rs9266292 with allergy. Through an analysis spanning the entire HLA region, we identified clusters of phenotype correlations. Finally, the carriers of pharmacogenomic related HLA alleles, including HLA-C*01:02 (35.86%), HLA-B*58:01 (20.9%), and HLA-B*15:02 (8.38%), were characterized in the Taiwanese general population.ConclusionsWe successfully delivered the HLA imputation for 59,448 Taiwanese subjects and characterized the genetic and phenotypic landscapes of the HLA variations. In addition, we quantified the estimated prevalence of the ADR-related HLA alleles in the Taiwanese population. The developed HLA imputation reference panel could be used for estimation of population HLA allele frequencies, which can facilitate further studies in the role of HLA variants in a wider range of phenotypes in the population.

Adverse Drug Reactions in Multimorbid Older People Exposed to Polypharmacy: Epidemiology and Prevention

Adverse drug reactions (ADRs) are frequent and represent a significant healthcare burden. ADRs are a potentially avoidable contributor to excess unscheduled hospital admissions, higher morbidity, mortality, and healthcare costs. The objective of this review is to examine the epidemiology of ADRs in older multimorbid adults and to explore strategies for ADR prevention. ADRs in this population are often linked to commonly prescribed medications, including anticoagulants, antiplatelet agents, insulin, and non-steroidal anti-inflammatory drugs, but ADRs and adverse drug events (ADEs) in fact encompass a much broader range of culprit drugs. Age-related factors such as changes in pharmacokinetics and pharmacodynamics, multimorbidity, polypharmacy, and frailty have been associated with ADR occurrences. Various strategies have been proposed to prevent ADRs in different clinical settings, such as structured routine medication review and the use of bespoke software applications to identify potentially inappropriate prescriptions and drug interactions. Although these approaches have demonstrated some improvement in the quality of prescribing, there is still a lack of consistent evidence regarding their effectiveness in preventing ADRs. The nuanced and often intricate complexities associated with older patients’ pharmacotherapy necessitate a comprehensive approach to attenuate the impact of ADRs within this growing section of most populations globally.

Prevalence of Adverse Drug Reactions in HIV/AIDS Patients on Highly Active Anti-Retroviral Therapy in Bushenyi Medical Centre, Ishaka Adventist Hospital, and Kampala International University Teaching Hospital in Bushenyi District, Western Uganda

The World Health Organization (WHO) delineates an Adverse Drug Reaction (ADR) as an unintended and harmful response to a drug when it is used for disease prevention, diagnosis, treatment, or physiological function modification in humans. This definition specifically excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The objective of this study is to determine the prevalence of ADRs among HIV/AIDS patients undergoing Highly Active Antiretroviral Therapy (HAART) at Bushenyi Medical Centre, Ishaka-Adventist Hospital, and KIU Teaching Hospital in the Bushenyi district, western Uganda. Patient interviews were conducted using structured questionnaires. A cohort of 333 patients participated in the study. The investigation revealed a prevalence of ADRs at 13.5% (95% CI: 10.2-17.6). Among the 333 patients interviewed, 44 reported experiencing ADRs, with a significant 97.8% of these cases occurring in female patients. Importantly, individuals with co-morbidities had a 55.6-fold higher likelihood of developing ADRs compared to those without any co-morbid conditions (95% CI: 2.4-1286.7). Furthermore, the study indicated an increased risk of ADR development among patients starting HAART within the first year of treatment. In summary, our findings highlight the notable prevalence of ADRs among females, emphasizing the need for gender-specific initiatives to raise awareness and prevent ADRs. Regular monitoring is particularly important for patients with co-morbidities due to the established association between co-medication and susceptibility to ADRs. Additionally, adherence to HAART therapy is essential, as the incidence of ADRs tends to decrease over time. Keywords: Adverse drug reaction (ADR), HIV/AIDS, Co-morbidities, Anti-Retroviral Therapy, Uganda

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.

Surfactant assisted synthesis of PrM through M site variants (M = Mo, V, and W) for the electrochemical detection of nonsteroidal anti-inflammatory drug – Nimesulide

The putative use of globally prescribed Nimesulide- NSAID drug that spotted its position in WHOs pain ladder comes with a benefit-harm balance that spurs the prevalence of adverse drug reactions. Further, it causes severe setbacks for environmental media by releasing the harmful contaminants into the sphere of living matter. Therefore, the increasing threat to environmental status and human well-being calls for a new design protocol for sensitive and immediate sensing of NS with absolute certainty. For this purpose, electrochemical sensors are recognized as potential tools for detecting the target species benefitting from their quick response time and excellent sensitivity. Herein in this work, the surface of the bare SPCE was modified with cetyltrimethylammonium bromide (CTAB) assisted and hydrothermally synthesized Praseodymium-based metal oxide PrM (M = Mo, V, W) sustainable electrocatalysts. The inclusion of CTAB as a stabilizer in the preparation process enhances the reactivity ofthe as-made PrV, PrMo, and PrW nanoparticles. Moreover, numerous spectroscopic and voltametric techniques were employed to analyse the surface descriptions of the PrV, PrMo, and PrW modified SPCE electrodes. The relative examination of the PrV, PrMo, and PrW modified SPCE validates the varied electrochemical response owing to its discrete M site substitution. It is observed that the as-made PrW/SPCE electrode outcompetes the other two PrMo/SPCE and PrV/SPCE electrodes in electrocatalytic properties. The elevated current signals and lower oxidation overpotential are achieved by PrW/SPCE electrode owing to its enlarged surface area that offers abundant active sites for anchoring the target drug molecule and potential conduits for the fast mobility of ions. The designed electrode exhibited selective sensing of nimesulide with an unprecedented LOD, wide linear working range, enhanced stability, substantiated reproducibility, increased sensibility, and excellent repeatability. The PrW-modified SPCE electrode is utilized for the practical valuation of nimesulide in spiked water samples that establishes its applicability toward the real-time sensing of nimesulide. This prospective electrode material recorded excellent percentage recoveries of ± 96.45–99.12 % that acme the figure of merit and originality of the fabricated PrW/SPCE electrode.

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

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

A RETROSPECTIVE ANALYSIS OF REPORTED CUTANEOUS ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL

Objectives: Analysis of adverse drug reactions (ADR) reports enriches and updates physician’s awareness about the pattern of cutaneous adverse reactions in the population studied and may play an important role to envision the frequency of appearance of reactions to specific drugs and morphological designs. This study intends to portray the clinical profile and causative agents of dermal ADRs in our population. Methods: All the ADR reporting forms received from February 2021 to February 2023 were scrutinized, and forms with cutaneous ADRs (CADRs) were analyzed. The data about the history of drug intake, names of the drug taken, time lag of appearance of reaction, and clinical examination details were collected from the reports. Demography, prevalence, reaction time morphological pattern, and causative agents of CADRs were evaluated. Results: Among the CADRs, acute urticaria 53.4 was the most common followed by acute exanthematous reaction 35.8% and lichenoid drug eruption 3.8%. Among the drugs causing CADRs, antibiotics top the list with 47% followed by ATT at 29.7% and iron sucrose 12.9%. Among the antimicrobials, fluoroquinolones 48% top the list followed by cephalosporins 21.6% and penicillins and vancomycin each 8.3%. Conclusion: Physician’s knowledge about pattern and causative agents of CADR in the specific population can aid in prevention and early management of ADRs and thereby reducing hospitalization.

Spontaneously reported adverse drug reaction pattern in a tertiary care teaching hospital: A cross-sectional study

Background: Adverse drug reactions (ADRs) are unintended and harmful reactions to medications that occur at doses normally used for therapeutic purposes. The reporting of ADRs is essential for the identification and prevention of ADRs. Aims and Objectives: The aim of the study was to estimate the frequency and distribution of spontaneously reported ADRs in the tertiary care teaching hospital. Materials and Methods: A retrospective cross-sectional study was conducted from July 2020 to June 2023, from spontaneously reported ADRs by the ADR Monitoring Centre, MGM Medical College, Kishanganj, Bihar. Distribution of age, gender, department, medication groups, and systems involved were examined. Utilizing certain scales, causality, severity, and preventability were evaluated. Results: Total 47 ADRs were reported during the study period. The most common ADRs were cutaneous ADRs (n = 19,40.43%) followed by the central nervous system (CNS) (n = 12, 25.53%), gastrointestinal system (GI) (n = 9, 19.15%), musculoskeletal (n = 4, 8.51%) and others. The most commonly implicated drugs were Antibiotics (21.28%) followed by analgesics (12.77%), DMARD (12.77%), antihypertensive (12.77%), and others shown in the study. The severity assessment of ADRs was done by Modified Hartwig et al. severity assessment scale and was found mild (87%), followed by moderate (8.5%) and severe (4.3%). Using the modified Schumock and Thronton preventability scale preventability assessment of ADRs was done and was found 51.06% of ADRs were definitely preventable, 38.30% were probably preventable and 12.77% of ADRs were not preventable. Conclusion: The findings of this study emphasize the significance of pharmacovigilance and the requirement that medical personnel be knowledgeable about the indications and symptoms of ADRs.

Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Background: Standard anti-tuberculosis (TB) treatment is highly effective, but managing adverse drug responses is a major challenge that can negatively affect treatment compliance and outcomes of an anti-tubercular treatment (ATT) regimen. Hence, monitoring of these adverse drug reactions (ADRs) is very essential wherein the drug-causing ADR can be detected and an appropriate therapeutic regimen can be given to the patient. Aims and Objectives: To assess the ATT-induced ADRs in Individual Case Safety Reports (ICSRs), to find the incidence and prevalence of ADRs due to ATT, and to analyze the causality assessment of the ADRs due to ATT. Materials and Methods: A retrospective observational study was carried out using spontaneous ICSRs data from the ADR monitoring centre at Madras Medical College, Chennai. A suspected adverse drug reaction reporting form (sADR reporting form) provided by the Pharmacovigilance Programme of India was used to collect the data of an ICSR. Results: A total of 93 ICSRs were assessed during the study period. The majority of the ADRs occurred in males (n = 55), and the maximum number of ADRs were found in the age group of 18–44 years (n = 46). The majority of the ICSRs were categorized as “serious” (n = 60), of which the maximum number of ADRs belonged to the “hospitalization/prolonged hospital stay” category (n = 45). Most of the suspected ATT drugs involved in implicating ADRs were found to be fixed-dose combination pills of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (n = 71). Most of the ADRs were “skin and subcutaneous disorders” (n = 51) of the system organ class. The outcome of the ADRs was assessed and found that the majority of them were in the “recovering” (n = 54) category, and the majority of the ICSRs were found to be “probable” (n = 67). Conclusion: An effective implementation of a Pharmacovigilance system with early detection and management of ADRs is needed to overcome the nonadherence to TB therapy.

Adverse Drug Reactions: Identification, Prevention and Management

This article addresses the critical aspects of adverse drug reactions (ADRs), focusing on their identification, prevention, and management. ADRs, defined as harmful or unintended reactions to drugs, necessitate a nuanced understanding due to their varying severity. Side effects, though not always harmful, can evolve into ADRs, prompting intervention. The decision-making process involves assessing the adverse reaction's severity, potential benefits of the drug, and the overall risk-benefit profile for the patient. Healthcare professionals play a pivotal role in monitoring and reporting ADRs to regulatory authorities for ongoing drug safety assessment. The article further discusses the classification of ADRs and outlines strategies for identification, including clinical manifestations, patient reporting, and pharmacovigilance systems. Management strategies, particularly in the case of anaphylaxis, underscore the importance of early recognition, acute therapy, and drug discontinuation. The prevention of ADRs involves a comprehensive approach, encompassing patient assessment, communication among healthcare providers, education, and the use of electronic health records. The collaborative effort between stakeholders and active participation in pharmacovigilance programs contribute to ongoing drug safety enhancement. The article concludes by emphasizing the collective goal of minimizing ADR occurrence and impact to enhance overall pharmacotherapy safety and effectiveness.

Monitoring of adverse drug reactions during seasonal malaria chemoprevention campaigns in children aged 3–59 months in Burkina Faso

Seasonal malaria chemoprevention (SMC) by mass administration of sulfadoxine pyrimethamine + amodiaquine (SPAQ) reduces the burden of malaria in children aged 3-59 months. The occurrence of adverse drug reaction (ADR) may affect the success of this intervention. There are few studies of SMC adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso, a highly endemic country. Our main objective was to characterize the ADRs reported during SMC campaigns in Burkina Faso. Secondly, we evaluated the performance of the pharmacovigilance integrated into the SMC program in order to support safe administration of SMC. This was a retrospective descriptive study of SMC individual case safety reports recorded in VigiBase® in Burkina Faso from 2014 to 2021. We used the P-method for the analysis of preventable serious adverse drug reactions and WHO criteria for assessing the performance of pharmacovigilance integrated into the SMC program. A total of 1,105 SMC individual case safety reports were registered in VigiBase® for 23,311,453 doses of SPAQ given between 2014 and 2021. No pharmacovigilance signal was detected. The number of serious cases was 101, of which 23 (22.8%) were preventable. In 38.1% of children, the occurrence of ADRs led to discontinuation of SMC treatment. Vomiting was the most frequently reported adverse drug reaction (48.0%). The proportion of children whose treatment was discontinued due to vomiting was 42.7%, while the proportion of treatment discontinuation for other ADRs was 32.8% (p = 0.01). The SMC program contributed at 46.2% to the national pharmacovigilance database. The reporting rate was 0.03 per 1,000 exposed children in 2021. The median completeness score of the ICSRs was 0.7 (IQR: 0.5-0.7), and the median time to register the ICSRs in VigiBase® was 204 (IQR: 143-333) days. Post-drug administration vomiting may interfere with the purpose of SMC. Measures to manage this adverse drug reaction should be taken to improve the success of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance, including cohort event monitoring, in Burkina Faso.

ADVERSE DRUG REACTIONS AMONG PATIENTS IN DEPARTMENT OF MEDICINE IN A TERTIARY CARE TEACHING HOSPITAL, KOLLAM

Objectives: Pharmacovigilance practices are still in the infancy in India, more so in South India. adverse drug reactions (ADRs) are often underreported and the risks are higher in adults and elderly due to the association of comorbidities, self-medication, combination of indigenous systems of medicines and modern medicine, and so on. The present study was done with the objective to analyze the ADRs among patients in the general medicine department, Government Medical College, Kollam. The primary objective is to determine the prevalence and nature of ADRs and secondary objective to assess the causality, severity, and preventability of the ADRs. Methods: In this cross-sectional study done in the Department of Medicine, Government Medical College, Kollam, 1000 patients of either sex were analyzed using CDSCO ADR reporting forms and the approved scales for causality, severity, and preventability. Results: Among 1000 patients studied, the prevalence of ADRs was 7.6%. The most common system involved were dermatological (41%) followed by cardiovascular (18%) and gastrointestinal and neurology (16% each). Majority of the ADRs came under probable (48.7%) with a Naranjo score of 5 (40.8%), of moderate severity (65.8%) and not preventable (71.1%). Conclusion: ADRs pose a major problem needing hospital stay or prolonging the duration of stay. Developing an ongoing ADR reporting system with continuous motivation and creating awareness among the healthcare professionals for reporting suspected ADRs will help to continue reporting and improving the patient safety. Improved communication of health-care professionals with the pharmacovigilance centers should be promoted for better patient healthcare.

PATTERNS OF ADVERSE DRUG REACTIONS: A STUDY IN A TERTIARY CARE HOSPITAL

Objectives: The purpose of this study was to describe the pattern of adverse drug reactions (ADRs) in a tertiary care hospital, as ADRs are among the most common causes of morbidity and mortality. Methods: This prospective study, which ran from January 2020 to December 2021, observed all patients admitted to the various departments of SKIMS Hospital Srinagar for the development of ADRs. Results: ADRs were found to be slightly more prevalent in female patients (54.82%) and those aged 40–60 years (30.11%). Antibiotics (64.3%), anticancer drugs (9.4%), and gastrointestinal tract (GIT) medications (7.3%) were most commonly associated with ADRs. The commonly involved system organs were the skin (69.9%), the nervous system (24.1%), the GIT (19.5%), and the respiratory system (15.6%). 8.0% of ADRs were serious. Conclusion: The prevalence of ADRs makes them a major concern. To ensure patient safety, active patient surveillance is critical to identifying and controlling ADRs.

Epidemiology of adverse drug reactions to antihypertensive, antithrombotic and antidiabetic medications among adult inpatients at a National Referral Hospital, Uganda

ABSTRACT Introduction Treatment for hypertension, thrombosis and type 2 diabetes mellitus is long term and usually requires a combination of drugs which increases the risk of adverse drug reactions (ADRs). This study aimed to establish the prevalence at admission, incidence during hospitalization and characteristics of ADRs linked to antihypertensive, antithrombotic and antidiabetic drugs among adult inpatients in Uganda. Methods We conducted a secondary analysis of data from a previously assembled prospective cohort study in Uganda’s Mulago National Referral Hospital. We reviewed the files of inpatients who received antihypertensive, antithrombotic and/or antidiabetic medications prior to and/or during hospitalization. The modified Schumock and Thornton Preventability Scale, the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events and the World Health Organization – Uppsala Monitoring Centre seriousness criteria were used to characterize the ADRs. Results More than a quarter (27%, 42/155) of the inpatients experienced an ADR at admission or during hospitalization. The point prevalence of ADRs at admission was 8% (13/155) and the incidence of ADRs during hospitalization was 23% (36/155). Forty-one percent (35/86) of the ADRs were serious and the majority (59%, 51/86) were preventable. Conclusion One in 13 inpatients experienced an ADR on admission and one in four experienced an ADR that developed during hospitalization. Clinicians ought to prescribe medicines with lower ADR risk profile for cardiovascular and/or diabetic patients whenever possible.

Pharmacogenetics-Informed Pharmacometabolomics as an Innovative Approach to Assessing the Safety and Risk of Pharmacotherapy with Valproic Acid

Scientific relevance. Valproic acid (VPA) is a psychotropic medicinal product, which may be associated with serious adverse drug reactions (ADRs). While pharmacogenetics and pharmacometabolomics can significantly affect the safety of valproates, there are no unified approaches to predicting, preventing, and correcting VPA-induced ADRs.Aim. This study aimed to collate the results of national and international studies on toxic VPA metabolites and to develop a novel personalised approach to assessing the safety and risks of valproate therapy in real-world clinical practice.Discussion. This study analysed national and international publications reflecting the results of preclinical and clinical studies on toxic VPA metabolites submitted to e-Library, PubMed, Scopus, and Google Scholar in 2012–2022. The inclusion criteria were full-text original articles, systematic reviews, meta-analyses, Cochrane reviews, and clinical cases in Russian or English. According to the analysis results, VPA has 20 studied toxic metabolites, which result from hepatic VPA metabolism involving P-oxidation, acetylation (β-oxidation), and glucuronidation enzymes. The functional activity of these enzymes is genetically determined and associated with heterozygous or homozygous carriage of non-functional/low-function single-nucleotide variant alleles in genes encoding these enzymes. The safety of VPA and its compounds can be improved by transferring the results of preclinical and clinical studies into real-world clinical practice using pharmacogenetics-informed pharmacometabolomics. Pharmacogenetics-informed pharmacometabolomics is a novel and personalised approach that helps, based on pharmacogenetic profiling, identify patients at high risk of VPA-induced ADRs, individually select starting and target doses of VPA and its compounds, determine the timing and frequency for therapeutic drug monitoring and monitoring toxic VPA metabolites in biological fluids (blood, saliva, and urine), and select a strategy for the prevention and correction of VPA-induced ADRs, taking into account patients’ individual pharmacometabolic profiles.Conclusions. The quality of medical care for patients with neurological diseases and mental disorders will improve with proper monitoring of VPA-induced ADRs by all entities involved in the medicinal product life cycle; active involvement of neurologists and psychiatrists in the prediction, prevention, and monitoring of the safety of valproate treatment; and inclusion of specific sections on practical pharmacogenetics-informed pharmacometabolomics and pharmacovigilance in the professional training curricula for neurologists and psychiatrists.

Knowledge and attitude towards pharmacovigilance among healthcare students at a medical college in Nepal

Background: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and any other possible drug-related problems. Under reporting of adverse drugs reactions are the global health problem. The adequate knowledge and skills towards pharmacovigilance and adverse drugs reactions reporting are crucial for the health care students to ensure patients’ medication safety. This study aims to assess the knowledge and attitude of the health care students towards pharmacovigilance and ADRs. Methods: A closed ended, structured, self-administered questionnaire was administered to 204 undergraduate health care students to collect the data. Data were analyzed using SPSS version 21. Non-parametric tests (Mann Whitney U test and Kruskal Wallis test) were used for analysis. Results: Among 204 respondents, the majority of them had a poor knowledge (91.18%) and positive attitude (87.25%) towards Pharmacovigilance. The inter quartile range (median) score of the respondents’ knowledge was 5.0±2.211 and attitude was 27.0±2.88 towards Pharmacovigilance and ADRs reporting. The main reason for under reporting of ADRs was difficulty to decide whether ADR has occurred or not (32.4%) due to the lack of appropriate knowledge and training. There is a poor knowledge and positive attitude towards Pharmacovigilance. Conclusions: Adequate coverage of Pharmacovigilance and ADRs reporting issues should be covered in the curriculum as well as hand on training and workshop should be conducted to increase the knowledge and confidence in detecting, monitoring and reporting ADR in their clinical posting.

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

The Implementation and Evaluation of Pharmaceutical Care Plan in Stroke Patients at Tertiary Care Hospital

Objective: To assess the pattern and prevalence of adverse drug reactions (ADRs) reported by the neurology department and review the benefits of the pharmaceutical care plan. Materials and Methods: A total of 148 stroke cases with previous medication history correlated with current complaints leading to hospitalization were included in the prospective study for one year in the neurology department. Results: This study identified non-adherence (50%) and ADRs (38%). Ignorance of the disease, its complications, and the possible adverse effects of self-medication have been identified as risk factors. The medication-related problems were mainly observed with antimicrobials, central nervous system (CNS), central venous system (CVS), and inflammatory and immune modulators. Conclusion: The risk factors involved are illiteracy regarding prescribed therapy benefits. In the patient’s medication therapy, warfarin has more adverse events, and an observation of the patient’s plasma concentration levels increased.

Costs associated with adverse drug reactions in an older population admitted to hospital: a prospective cohort study

PurposeThis study examines healthcare costs associated with adverse drug reactions (ADR) in an older population admitted acutely to an Irish tertiary hospital. MethodsProspective cohort study involving older persons admitted to hospital with and without an ADR. Data was collected at baseline, during hospitalisation and post-discharge. Participants provided information on healthcare resource use three months before admission (baseline) and three months after discharge (follow-up). For each healthcare resource, unit costs were derived and applied. The average cost (standard deviation (SD)) associated with the hospital admission for the ADR and non-ADR are presented. In addition, baseline and follow-up care costs were compared using difference-in-difference analysis and presented with 95% confidence intervals (CI). Costs by preventability and severity of ADR are also presented.ResultsA total of n = 230 participants were included (n = 93 ADR and n = 137 without ADR). The average cost associated with hospital admission for an ADR was €9538 (SD €10442) and €9828 (SD €11770) for non-ADR. The additional follow-up costs (difference-in-difference) associated with the ADR was estimated at €2047 (95% CI: -€889 to €4983). The mean incremental follow-up cost of definite preventable ADRs was estimated at €1648 (95% CI: -€4310 to €7605), possible preventable ADRs €2259 (95 CI: -€1194 to €5712) and unavoidable ADRs €1757 (95% CI: -€3377 to €6890). The mean incremental follow-up cost associated with moderate severe ADRs was estimated at €1922 (95% CI: -€1088 to €4932) and €3580 (95% CI: -€4898 to €12,058) for severe ADRs. ConclusionADRs leading to hospital admission are associated with modest incremental healthcare costs during and three months after admission. Severe and possibly preventable ADRs were associated with higher costs.