Pattern Of Adverse Drug Reactions Research Articles

Pattern of Adverse Drug Reactions and Performed Monitoring Laboratory-Tests in Patients Receiving Anti Tuberculosis Treatment in an Endemic Region, Zabol

Background: Efficient anti TB treatment considered crucial globally. Anti TB drugs can cause various adverse drug reactions (ADRs). Clinical and laboratory monitoring will decrease rate of these ADRs, improve patient safety as well as drug adherence and treatment outcome. Methods: In this cross-sectional study total of 136 newly diagnosed TB patients were included. All patients received standard anti-TB 4 drug regimen. Predesigned data collection forms were used to gather patient’s lab data as well as clinical symptoms they experienced during treatment course. Monthly follow up visits or phone calls were also performed by investigators and all health issues were recorded. Results: The majority of our patients aged over 70-year-old. About 54% of them were female. We recorded at least one ADR in 80.8% of patients, and hepatic-gastrointestinal (GI) ADRs ranked first (64.7%). Although ADRs were more common in women and patients over 70-year-old, but there was no statistically significant relationship between sex or age and rate of ADRs (P> 0.05). We also observed that recommended baseline laboratory tests for monitoring anti TB treatment was not performed in any of our patients, except complete blood count (CBC) that was performed in 11 cases. This led to diagnoses of anemia and thrombocytopenia in one case. Conclusion: The majority of our patients experienced ADR. Recommended drug monitoring tests that could guarantee safe and effective treatment were not performed routinely in our TB management centres. These facts highlighted the importance of improving surveillance system for TB management based on national standards.

Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital

Background: Incidences of adverse drug reactions were reported through spontane-ous reporting at an ADR monitoring unit in a tertiary care hospital. Aims: This study was conducted to describe the distribution pattern of adverse drug reaction (ADR). Objective: The objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causality, severity, and preventability of adverse drug reactions. Methods: A prospective, observational study was conducted at a tertiary care hospital in Punjab for 6 months. All patients admitted to the hospital above 18 years of age were included in the study. Results: A total of 103 ADRs were observed over the study period of 6 months. The majority of them were females (60), comprising of 58.25%. The therapeutic class of drug associated with most of the ADRs was antibiotics 18 (17.5%). Maximum number of ADRs occurred in the gen-eral medicine ward with frequency of 27 (26.2%) and were of type b 58 (56.3%). Causality was assessed using the Naranjo scale, and most of the ADRs came out to be probable 64 (62.1%) in nature. Severity was assessed using Hartwig’s severity assessment scale, and most of the cases, 66 (64.1%), were moderate in intensity. ADR preventability was assessed using the Schumock and Thornton preventability scale, and it was observed that most of the cases, 82 (79.6%), were not preventable. Conclusion: This study seeks to strengthen the ADR database through analysis of spontaneous reporting patterns of ADRs from various clinical departments of a tertiary care teaching hospital, thereby increasing awareness and improving the reporting culture among health care practition-ers. It can be concluded that continuous medication monitoring and a well-organized and com-mitted pharmacovigilance system led by a clinical pharmacist in a hospital setting would un-doubtedly lower the incidence of adverse drug reactions.

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

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

Adverse Medication Response Recorded in a Referral Health Facility: An Observational Study

Introduction: The incidence of adverse drug reactions (ADRs) has significant implications for patient safety and public health. In 1937, the introduction of sulphanilamide for streptococcal infections marked a pivotal moment in drug safety. Present study assessed the pattern, causality and severity of the ADRs reported from a tertiary referral centre.  Materials and Methods: Study conducted at the Mahatma Gandhi Mission Medical College and Hospital Kamothe Navi Mumbai recorded the pattern of ADRs between January 2021 and December 2022. The data was collected from the ADR Monitoring Center using the suspected ADR reporting form, version 1.4 of IPC, Ghaziabad, India. The suspected ADR forms were assessed to understand the pattern of ADRs regarding the completeness score of the ADR form.  Findings and Discussion: A total of 111 ADRs were recorded, with 43.24% of cases falling within the age range of 21 to 40. Antimicrobial medications were the main culprits behind the majority of ADRs reported by the departments of dermatology and general medicine. Rashes, edema, and urticaria are among the skin-related symptoms among the most frequently reported adverse drug reactions (ADRs). 72.9% of instances were classified as mild, according to severity assessment, whereas 57.65% of ADRs were found to be likely.  Conclusions: Because ADRs represent a serious threat to public health, our study highlights the significance of pharmacovigilance in tracking and preventing them. Databases on a national and international level are enhanced by systematic, regular reporting and monitoring of ADRs. In order to raise awareness of ADRs among patients and healthcare professionals, spontaneous reporting is still essential.

Assessment of pattern of adverse drug reactions with chemo-therapeutic drugs in a tertiary care hospital of Government Medical College Anantnag: a prospective observational study

Assessment of pattern of adverse drug reactions with chemo-therapeutic drugs in a tertiary care hospital of Government Medical College Anantnag: a prospective observational study

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.

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

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

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.

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

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

Incidence of side effects of antituberculosis drugs and their related factors in northern Iran: a retrospective cohort study.

Antituberculosis drugs may cause mild, moderate or severe adverse drug reactions (ADR) leading to poor compliance. Description of the pattern of ADR and their related factors can help tuberculosis (TB) control program as part of the WHO programs. This study aims to investigate the incidence of ADR and associated factors among TB patients in northern Iran. This is a retrospective cohort study. The required information, including year of diagnosis, age, gender, residence area, nationality, HIV co-morbidity, history of anti TB treatment and ADR, was obtained from the Deputy of Health, Mazandaran University of Medical Sciences, Iran. All data were analyzed using SPSS version 21 software. Out of 3903 TB patients, 136 (3.5%) experienced major ADR. The incidence of ADR for men and women as well as for those with and without previous treatment history were 3.9% vs. 3.3% and 5.3% vs. 3.4%, respectively (p>0.05). Multiple logistic regression models showed a higher chance of ADR among those aged over 59 compared with those aged under 29 (OR=2.63, 95% confidence interval: 1.54-4.49). Age over 59 can be considered a risk factor for ADR with anti-TB drug administration.

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.

Adverse Drug Reaction Patterns of First-line Anti-tubercular Drugs among Saharia Tuberculosis Patients: An Observational Study in Particularly Vulnerable Tribal Group of Madhya Pradesh, India.

The Saharia tribe of Madhya Pradesh has a very high tuberculosis (TB) burden. However, there is no report of adverse drug reaction (ADR) available in patients receiving anti-TB chemotherapy in the community. Reporting and monitoring of ADRs among TB patients is still rare in marginalized communities. An observational prospective study was performed from November 2019 to June 2020 to assess the patterns of ADRs in 250 Saharia TB patients, who were prescribed Category-I daily DOTS (HRZE) by the physician. Both male and female participants equally experienced ADR during the treatment, but relatively more females (92.6%) than males (88.6%) reported ADR during Phase I. Out of 250 patients, 224 patients (89.6%) experienced one or more ADRs in Phase I. The central nervous system-related (75.6%) ADR was mostly reported followed by any gastrointestinal (74.4%), cardiovascular (49.2%) and any dermatological related (44.4%) ADRs. It is paramount to timely monitor and proactively manages ADRs pertaining to anti-TB drug treatment with minimal alteration in the treatment course.