Pattern Of Adverse Drug Reactions Research Articles

Detecção de Reações Adversas a Medicamentos em pacientes hospitalizados: uma abordagem de análise em rede

Objective: We aimed to investigate whether network analysis can be used to estimate patterns of Adverse Drug Reactions and drugs involved. Methods: Patients admitted from 18 years of age or older, hospitalized for more than 24 hours, and using at least one drug during hospitalization were included. Results: 8060 patients were observed, and 358 cases of Adverse Drug Reactions were identified (4.43%). The network graph shows that the occurrence of hypotension induced by furosemide, spironolactone and enalapril is related to serum changes in potassium and the occurrence of renal failure. Centered around nausea and vomiting node, there is a great variety of drugs from different classes involved with this Adverse Drug Reaction and without other connections. Conclusion: Network analysis is a promising strategy for identifying patterns that correlate adverse reactions to drugs administered during hospitalization.

Antiseizure adverse drug reaction and associated factors among epileptic patients at Jimma Medical Center: a prospective observational study

A growing body of evidence suggests that adverse drug reactions (ADRs) are a major cause of morbidity and mortality in the healthcare system. Fifteen to twenty-five percent of patients with epilepsy discontinued antiseizure drugs (ASDs) within 6 months of therapy owing to intolerable adverse drug reactions. In Ethiopia, the prevalence of antiseizure adverse drug reactions and associated factors was not extensively conducted in advanced settings like Jimma Medical Centers. Hence, the objective of this study is to assess patterns of adverse drug reactions and associated factors among ambulatory epileptic patients at tertiary hospitals in Ethiopia. A hospital-based prospective observational study was spanned for 1 year. Two hundred ninety patients were consecutively recruited into the study from all epileptic patients attending the ambulatory clinic. Relevant data were collected through patient interviews and medical chart reviews. The causality assessment was done by using the Naranjo Probability Scale. Epi-Data manager version 4.6.0.4 was used for data entry and statistical analysis was performed by Statistical Package for Social Science version 25.0 (SPSS). Stepwise backward logistic regression analysis was done to identify factors that increase the risk of antiseizure adverse drug reactions. The mean (± SD) age of the participants were 29.91(± 11.26) years. The overall prevalence of ADR was 33.8% (95% CI 29.2–39.9%). A total of 110 adverse drug reactions were identified among 98 patients with an average of 1.12 per patient. ADRs were frequently reported with phenobarbital (52.04%) and phenytoin (34.70%). The commonly identified adverse drug reactions were epigastric pain (27.55%) and central nervous system drowsiness (23.46%). Comorbidity (AOR = 5.91, 95% CI (2.14–16.32), seizure-free period of fewer than 2 years (AOR = 1.94, 95% CI (1.18–3.19), and polytherapy (AOR = 1.35, 95% CI (1.80–2.26) were significantly associated with adverse drug reactions. This trial had a comparatively high percentage of adverse medication reactions. Adverse medication reactions were more common in patients with polytherapy, comorbidities, and seizure-free durations less than two years. Therefore, medical practitioners should advise patients who exhibit these traits on how to reduce or avoid bad drug responses or provide comfort in the event of small incidents.

Analysing adverse drug reaction patterns observed during district residency program: a prospective observational study

Background: Adverse drug reactions (ADRs) pose a substantial cost to global healthcare systems. The heterogeneous patient demographics and healthcare environments of district residency programmes (DRPs) provide special possibilities for detecting trends of ADRs. In order recognize recurring trends and related variables, this study will examine ADR incidents that occur during DRPs. Methods: A prospective observational research with forty-three patients was carried out. Standardized reporting forms were used to gather data on ADRs, and descriptive statistical techniques were used to analyse the results. We evaluated medication information, patient demographics, and ADR features to seek for patterns and potential causes. Results: Preliminary analysis revealed a diverse range of ADRs observed during DRPs, spanning various severity levels and therapeutic classes. Common ADRs included gastrointestinal disturbances, allergic reactions, and central nervous system effects. Factors such as patient age, polypharmacy, and comorbidities emerged as potential predictors of ADR occurrence. Conclusions: The panorama of ADRs seen during DRPs is clarified by this study, underscoring the significance of careful monitoring, and reporting mechanisms in these initiatives. Gaining insight into ADR trends and related variables can help in improving patient safety, simplifying drug management plans, and directing future educational initiatives for medical professionals.

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.

Análisis de Reacciones Adversas a Medicamentos por fármacos antipsicóticos en un instituto de salud mexicano

Introduction: Adverse Drug Reactions (ADR) are unwanted clinical or laboratory manifestations that are related to drug use. ADR are common and are associated with significant risk of morbidity, mortality and hospital admissions. Antipsychotics have a reduced therapeutic window, and have been related to the manifestation of a variety of ADR. Objective: To evaluate the pattern of ADRs due to antipsychotic drugs detected in patients treated at the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz between December 2021 and May 2022. Methods: Observational, descriptive, prospective and cross-sectional study of a series of cases. The seriousness, severity, and quality of the information in the notification of the ADR were defined in accordance with NOM-220-SSA1-2016, Installation and Operation of Pharmacovigilance, while causality was determined using the Naranjo algorithm. Results: The incidence of ADRs was 59%, with one or more ADR detected in 52 of the 88 patients who were receiving antipsychotic treatment during the study period. Forty-five percent of the ADR had probable causality and 55% possible; only three ADR were classified as serious as they prolonged the hospital stay and endangered the patient's life. Conclusions: The ADR of the gastrointestinal and endocrine systems were the most incidental, with hyperprolactinemia being the most frequent. Olanzapine and clozapine were the medications that caused the most ADR. It is recommended to promote the culture of notification and follow-up of ADR caused by antipsychotic drugs.

Adverse Drug Reactions at Primary Health Centres in Malaysia

Background: Adverse drug reactions can lead to a substantial economic burden on patients and the country. This study aims to analyze the pattern of adverse drug reactions and assess the causality of the adverse events and severity of adverse drug reactions in primary health centers in Malaysia. Methodology: This retrospective study used case series analysis and data from six Malaysian primary health centers. The patients were analyzed for gender, age, class of drugs involved, organ system involved in the adverse reaction, severity using Hartwig’s severity assessment scale and causality using the Naranjo ADR probability scale. Data were analyzed using descriptive statistics. Results: In 113 adverse drug reactions were reported. Cardiovascular drugs commonly caused adverse drug reaction (38%), followed by anti-infective agents (20%), skin and subcutaneous disorders were the common adverse drug reactions encountered (23%). The severity of the adverse reaction was level 2 in most patients (69. 9%). Adverse drug reaction was mostly found to be probable (48.7%), and 64% of the patients recovered from the adverse drug reaction. Conclusion: Cardiovascular drugs commonly cause adverse drug reactions. Level 2 and mild reactions were widely observed. The causality assessment was probable in most of the patients.

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.

Evaluation of adverse drug reactions to off-label use of drugs in children from spontaneously reported cases at a tertiary care hospital

Background: Off-label use of drugs (OLUDs) is relatively common in pediatric and this may be associated with adverse drug reactions (ADRs). The studies about the safety of drugs used in children cannot be applied to safety of drugs during OLUDs as drug is used in way that is different from that described in regulatory body. Hence, it is worthwhile to evaluate the off-label status of the suspected drugs causing ADRs. Aims and Objectives: The aim of the study was to analyze the pattern of ADRs occurring during OLUDs in pediatric patients from the spontaneously reported ADRs cases at the pharmacovigilance unit of a tertiary care hospital. Materials and Methods: Single center, retrospective, observational study was conducted in the department of pharmacology. ADRs spontaneously reported from January 2016 to December 2017, which occurred during OLUDs in children, where causality is certain, probable and possible. Results: A total of 46 ADRs occurred during OLUDs in 44 patients, these patients received 174 medicines among which 66 were off-labeled drugs. Off-label drugs mainly belonged to anti-infectives for systemic use (70.31%) and it is associated with 30 ADRs (68.18%). The most commonly affected organ system is skin and subcutaneous tissue (43.18%). Conclusion: OLUDs is associated with ADR, so caution should be taken while prescribing a drug in off-label manner in children.

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.

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.

An observational study to evaluate the awareness of drug treatment, prescription pattern, adverse drug reactions, and adherence in patients of major depressive disorder.

Due to the paucity of studies in and out of India that dealt with treatment awareness of major depressive disorder (MDD), we decided to assess the awareness of MDD patients, and since adherence and awareness are linked to each other, we assessed adherence too. Prescription pattern studies identify changes in prescriptions due to poor initial response or adverse drug reactions (ADRs), which may result in dose reduction or switching medications and delay remission. Therefore, the study assessed the ADR pattern. A cross-sectional questionnaire-based study was carried out on 200 MDD patients with treatment records for at least 3 months after getting approval from the Institutional Ethics Committee and consent from the patients. The data obtained were entered in Microsoft Excel and analyzed using descriptive statistics. The mean age was 44.65 ± 12.02 years, and females were 70%. Maximum patients (98%) were aware of the consequence of stopping the drugs suddenly, and only 12.5% were aware of the onset of response to treatment. Escitalopram was the most common antidepressant prescribed (43.77%), and 67 ADRs out of 136 were attributable to it. Weakness and fatigue were the most common ADRs. The majority (97) of the ADRs were possibly related to antidepressants, and 65% of patients showed optimal adherence to medications. This study sheds light on the treatment awareness and adherence of MDD patients in India and highlights the need for educating patients about treatment response. It also emphasizes the importance of monitoring ADRs and adjusting prescription patterns accordingly to improve treatment outcomes.

Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Teaching Hospital in North India: A Retrospective Study.

Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. This is an observational, retrospectiveand non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

ADVERSE DRUG REACTIONS (ADRS) OF CISPLATIN IN PULMONARY CANCER PATIENTS- ONE YEAR PROSPECTIVE STUDY

Background: A cross sectional prospective observational study evaluated the trends and patterns of Adverse drug reactions of cisplatin in pulmonary cancer patients . Methods:Pulmonary cancer patients, who received cisplatin as chemotherapy regimen, were monitored for adverse reactions. New and old diagnosed cases of pulmonary cancer patients belonging to either gender and of all ages, who were receiving cisplatin under any standard regimen, were included for the study. Any ADR due to poisoning, over dosage were excluded from the study. The ADRs were recorded in Central Drugs Standard Control Organization forms. Casuality was assessed by the WHO Casuality Assessment Scale and Naranjos Alograthim. Results:A total number of 98 patients were reported during the study period, wherein a total number of 114 ADR cases were observed.The majority of patients were in the age group of 61-80 (n=45), followed by 41 -60 years (n=41, 41.83%) .Out of the total ADRs, most frequently reported one was vomiting 18 (15.78%) followed by anemia 16 (14.03%), nausea 13(11.40%) and hair loss 12 (10.52 %) which together constituted 51.73 % of the total ADRs. The other commonly encountered ADRs were diarrhea 8 (7.01%), thrombocytopenia 6 (5.26%), constipation 6 (5.26%) neutropenia 5(4.38) and neuropathy 5(4.38%).According to WHO-UMC scale, 37(37.75%) of reports to be certain,33(33.67%) of reports to be possible and 28(28.57%) of reports to be probable where there was no case recorded as unclassified or inaccessible.Naranjos scale which classified 65 (66.32%) to be probable and remaining 33 (33.67%) to be possible. Conclusion:Cisplatin has high potential for adverse effects. There is a need to improve the management of adverse effects. This study also emphasizes the need to improve pharmacovigilance awareness among physicians in order to improve the pharmacovigilance in India.

A STUDY TO ASSESS, MONITOR, AND REPORTING OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: HIMS, HASSAN

Objective: An adverse drug reaction (ADR) is an unwanted, undesirable effect of a medication that occurs during usual clinical use. ADR should be quickly identified and managed to limit their detrimental effects on the patient. This study was undertaken to characterize the pattern of ADRs reported through spontaneous reporting system at ADR reporting unit in a tertiary care teaching hospital. Methods: A prospective, observational study was conducted over 3 years between September, 2017 and August, 2019. The ADRs reported were from patients admitted inpatient department of hospital. Evaluation of patient demographics, drug and ADR characteristics, and outcome of the ADRs. Causality and severity assessment was done by the World Health Organization system and Naranjos scale. Results: 82 cases of ADRs were reported during the study period. More number of ADRs was from General Medicine and Pediatric departments, in which the most affected organ systems were the skin and the gastrointestinal tract. The antibiotic classes mostly accounted were cephalosporins. None of the ADR was fatal. Conclusion: ADRs to antibiotics are common and will be resulted in increased health-care cost due to the need of some interventions and increased length of hospital stay. The health-care system should promote proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

Trends in adverse drug reactions related to oral weak opioid analgesics in therapeutic use in adults: A 10-year French vigilances retrospective study.

To describe the symptoms, patient demographics, and trends over time of adverse drug reactions (ADRs) related to weak opioid analgesics reported to the French vigilance networks. Retrospective study of data from French Poison Control Centers and Pharmacovigilance Centers databases of weak opioid analgesics-related ADRs cases, with high causality score, in adults, in therapeutic analgesic use, without co-exposure, between 2011 and 2020. The number of cases was 388 in the Poisonings database and 155 in the Pharmacovigilance database; ratio of the number of these cases to all reported cases during the study period was 0.02% and 0.03%, respectively. Tramadol was most often involved (74% and 56.1%, respectively), followed by codeine (26% and 38.7%, respectively). There was no significant variation in the number of cases reported. Cases most often involved young adults (median age: 40 years) and mostly women (76%). Gastrointestinal symptoms were mostly reported (80% and 65%, respectively) as described in the Summary of Products Characteristics. Patterns of ADRs were comparable in both databases, except for codeine-associated acute pancreatitis and anaphylaxis that were reported in the Pharmacovigilance database. No fatality was observed. Severity was more often observed in the Pharmacovigilance database (30%) than in the Poisonings database (moderate toxicity: 7%). ADRs mostly occurred among young women using tramadol, without significant variation in the number of reported cases over time. Serious ADRs were more frequently reported to the Pharmacovigilance database, particularly for codeine. Women seemed to be at greater risk of ADRs.

Patterns of adverse drug reactions in Jordan: a retrospective analysis of the National Pharmacovigilance Data Registry (2015–2021)

ABSTRACT Background Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of adverse drug reactions (ADRs) reported in Jordan. Research design and methods ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015–2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs, and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs. Results A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infectives for systemic use (14.2%), and alimentary tract and metabolism (12.1%). Covid−19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%), and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient’s age and intravenous medication use largely predicted reporting serious ADRs. Conclusions This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.

A Prospective Observational Study to Evaluate the Prevalence of Adverse Drug Reactions and its Impact on Quality of life in Psychiatric Patients at a Tertiary Care Teaching Hospital

Background: In recent times, emphasis on pharmacovigilance (PV) is elevated due to increased cases of adverse drug reactions (ADRs) coming into notice. Psychotropic medications that are the mainstay of treating psychiatric patients are linked to various adverse drug reactions. The given study lays accentuation on determining the pattern of ADRs due to the use of antipsychotics and antidepressants. Objectives: In this study, we aim to determine the incidence of ADRs and their effect on the quality of life (QOL) of the patients after the ADR (s). Methodology: This is a prospective observational study of a total of 300 subjects receiving antipsychotics and/or antidepressants. They were screened for possible ADRs. Possible risk factors for the development of ADRs were also assessed. The difference in the pattern of ADRs in patients prescribed with Antidepressants (ADs) and/or Antipsychotics (APs) was observed. The average number of APs and/or ADs per prescription was calculated. The causality and severity assessment of the observed ADRs was done by the World Health Organization-Uppsala Monitoring Center (WHO-UMC) scale, Naranjo’s algorithm, and Hartwig–Siegel scale, respectively. Lastly, the impact of ADRs on the QOL of the patients receiving APs and/or ADs was evaluated. Results: The prevalence of ADRs in patients receiving APs and/or ADs is 24.33%. Olanzapine is the most commonly prescribed AP while sertraline is the most commonly prescribed AD. Olanzapine and sertraline are responsible for the highest number of ADRs as AP and AD, respectively. Females are found to be at higher risk for developing ADRs. Multiple comorbidities and polypharmacy are also considered to be possible risk factors. The average number of APs and/or antidepressants per prescription is 1.94 drugs. APs are found to be responsible for a higher number of ADRs in comparison with ADs. The maximum number of ADRs falls into the possible criteria of causality assessment by the WHO-UMC scale and Naranjo’s algorithm. All the observed ADRs fall into the mild and moderate category of severity by the Hartwig–Siegel scale. The ADRs have a significant impact on the physical health and psychological domain of QOL assessment. Conclusion: The need for PV is highlighted by the results obtained in this study. Intense monitoring and increased awareness can help improve the rate of ADR (s) occurrence in patients receiving psychotropic medications. As a result, the impact of ADRs on the QOL of the patients can also be reduced.

Adverse Drug Reactions of Antiepileptic Drugs in Neurology Department of M.Y.H Indore, India: An Observational, Prospective Study

Background: Epilepsy is the second most common neurological disorder that affects 1 percent of global population. Since antiepileptics have narrow therapeutic index having multiple adverse drug reactions (ADRs) thus have significant safety concerns. The aim of this study was to observe adverse drug reactions due to antiepileptics in neurology department M.Y.H. Indore, India.
 Methods: An observational prospective study was done from November 2021 to January 2022. Patients having history of seizures attending neurology outpatient department at MYH Hospital, who were on antiepileptic drugs were recruited. Suspected adverse drug reaction forms were recorded and their causality assessment was done by Naranjo’s scale.
 Results: Data of total 70 patients were recorded. Males reporting ADRs due to antiepileptics were 67.1% and females 32.8%. Using Naranjo’s scale, we noted 93.3% ADRs as “probable” and 6.7% as “possible”. Common causes of prescribing antiepileptic drugs were known case of epilepsy (78.5%),old case of neurocysticercosis (11.4%),post traumatic(4.3%),gliosis (2.8%) and tuberculoma (2.8%) .Most ADRs were dermatological 76% (rashes),central nervous system (16%) (nocturnal enuresis, poor school performance, dizziness, headache, sleep disturbances, personality changes) ,Gastrointestinal (8%) (gastric irritation, nausea, vomiting and hepatotoxicity) .Most common drug for causing ADRs were sodium valproate(58.5%),carbamazepine(17.14%),phenytoin(14.2%),leviteracetam(7.1%),and lamotrigine(2.8%).
 Conclusion: Our study aimed us to know the incidence and patterns of adverse drug reactions due to antiepileptics in a tertiary care institute of central India. Despite of recent advances and novel therapies used for the treatment of epilepsy, conventional drugs like sodium valproate, phenytoin and carbamazepine still are the first choice for the management and treatment of seizures and their ADRs are very common.

Antibiotics-Related Adverse Drug Reaction in a Tertiary Hospital in Saudi Arabia: A Cohort, Retrospective Study.

Adverse drug reactions (ADR) are caused by a wide range of drugs including antibiotics. Currently, the prevalence and pattern of antibiotic-related ADR in Saudi Arabia are not well reported. The present study aimed to evaluate the ADR pattern caused by antibiotics in a tertiary healthcare center. This was a retrospective study conducted on 85 patients admitted to tertiary care hospitalmedical wards during the period from 2015 to 2019.The following data such as patient demographics (age, gender, weight, height), reason for admission, number of antibiotics use, comorbid condition, antibiotic(s) involved in ADR, classification of ADR, and type of ADR were recorded. Naranjo's scale was used to measure the probability of ADR. Among the 85 patients, the most frequent type of antibiotic was cephalosporins in 36.47%, followed by penicillins in 31.76% of the patients. The major type of ADR was rash (52.95%), followed by anaphylaxis reactions (10.59%) of the patients. Based on the Naranjo scale, the ADR was possible in 80% and probable in 18.82% of the cases. The presence of medical conditions displayed a significant association with the development of rashes (p=0.03). In addition, the female gender (p=0.009) and the presence of medical conditions (p=0.03) showed significant association with the development of anaphylaxis. Cephalosporin and penicillins were the most common antibiotics responsible for ADR, and the rash was the most common ADR.

Pattern of Adverse Drug Reactions among Pregnant Women and Pediatric Patients in a Tertiary Care Hospital.

Adverse drug reactions (ADRs) among pregnant women and pediatric patients are a significant public health concern. ADRs monitoring and documentation are considered essential practices to decrease the chances of ADRs and ensure the safe use of drugs. Therefore, the study was designed to evaluate the pattern of adverse drug reactions among pregnant women and pediatric patients in a tertiary care hospital. The study was conducted at Kalpana Chawla Government Medical College and Hospital, Karnal, Haryana, for a period of 2 years. During this period, ADRs reported by the healthcare professionals of gynecology and pediatric department to the ADRs monitoring centre of our institute were included in the study. Out of 54 total ADRs, 40 ADRs occurred among pregnant women, and 14 ADRs were reported in pediatric patients. The majority of the ADRs were observed in the age group of 21-30 years (pregnant women) and 3-5 years (pediatric patients). Antibiotics were most commonly implicated in ADRs among pregnant women (60%) and pediatric patients (79%). In our study, the dermatological system was mostly affected among pregnant women and pediatric patients. Urticaria, contact dermatitis, and erythematous rash were the most commonly reported ADRs among pregnant women and pediatric patients. Over-prescribing and irrational use of antibiotics make these vulnerable populations more susceptible to ADRs and antibiotic resistance. Therefore, there is a need to create awareness among health care professionals regarding the spontaneous reporting of ADRs for ensuring drug safety and reducing morbidity and mortality among pregnant women and pediatric patients.