Siegel Scale Research Articles

Prevalence of Adverse Drug Reactions in Diabetic patients receiving Antidiabetic Medications at Tertiary Care Hospital

Background: Diabetes mellitus is a chronic metabolic condition defined by elevated blood glucose levels caused by abnormalities in insulin secretion, insulin action, or both. Anti-diabetic drug pharmacovigilance can be extremely useful in identifying and resolving the adverse drug reactions (ADRs) and safeguarding patients from needless injury. Objective: The objective of the study was to determine the prevalence of various adverse events caused by the use of anti-diabetic medications in patients treated at tertiary care hospital. Method: It was a randomized controlled study where the participants were randomized into two groups i.e., interventional or study group and control group. All suspected ADRs were collected, analysed and confirmed by the physician-in-charge and were assessed for causality using WHO-UMC Causality Categories, Naranjo’s causality assessment scale, preventability using Modified-Schumock and Thornton scale, severity using Modified Hartwig and Siegel scale by the Causality Assessment Committee (CAC). Results: The study included a total of 300 subjects among which 218 were male (72.67%) and 82 were female (27.33%). A total of 300 patients, 104 ADRs were identified, in which 46.15% were observed in the control group and 53.85% in the interventional group. Females were more prevalent to the ADRs. The majority of ADRs were seen in age group of >70 in which 15.38% were observed in the control group and 18.27% in the interventional group. The Highest observed ADR of 20 (19.23%) was Hypoglycemia in which 9(8.65) were observed in the control group and 11(10.57) in the interventional group followed by weight gain i.e, 10 (9.61%) in which 5(4.80%) were observed in the control group and 5(4.80%) in the interventional group. Conclusion: ADR relating to antidiabetic therapy utilizing oral antidiabetics and insulin was found to be prevalent. The doctors and clinical pharmacists are therefore needed to identify and report the appropriate signals generated to the nearest ADR monitoring centre or Pharmacovigilance Programme of India for the benefit of the patients.

MONITORING OF CONTRAST AGENT-INDUCED TOXICITY IN A TERTIARY HEALTH-CARE CENTER

Objective: The objective of the study is to monitor radiological contrast agent-induced toxicity in patients and compare the toxicity and safety profiles of different radiological contrast agents. Methods: This is an open-label, prospective, observational study conducted in a tertiary care hospital in April 2021 and September 2021. The study assessed the incidence of contrast-induced adverse events in different radiological procedures, i.e., contrast-enhanced computerized tomography (CECT) scans and contrast-enhanced magnetic resonance imaging (CEMRI). Adverse drug reactions (ADRs) were recorded using the standard central drug standard control organization ADR reporting form. Causality assessment of the ADRs was done using Naranjo’s scale while severity assessment was measured using the Modified Hartwig and Siegel scale. Results: The baseline characteristics of patients were almost similar in both groups. The mean age and gender distribution of the patients were not significantly different among both groups. For the adverse reaction in CECT, the male-to-female ratio was 1.88, and for CEMRI, it was 1.61. The ADRs due to CEMRI and CECT were mild in severity. The results showed that ADRs between contrast-enhanced MRI and contrast-enhanced CT were not significantly different. Conclusion: Based on the results obtained, we concluded that the contrast agents used in the radio-diagnostic procedures are safe, and further research in this field is of fundamental importance.

THE ADVERSE DRUG REACTIONS OF INTERMITTENT AND DAILY REGIMENS IN THE TREATMENT OF THE INTENSIVE PHASE OF TUBERCULOSIS

Objective: To study the adverse drug reactions (ADRs) of intermittent and daily anti-tubercular therapy in intensive phase (IP), in patients attending the RNTCP unit, Government Medical College (GMC), Thrissur. Methods: A prospective observational study was done at the RNTCP unit, GMC, Thrissur, during October 2016-2017. Two hundred and thirty-five patients satisfying inclusion criteria, receiving anti-tubercular therapy as intermittent and daily regimens were selected. Demographic data, risk factors, comorbidities, and investigations were recorded and patients were followed up for IP. Results of investigations, treatment outcome, and ADRs recorded after IP. ADRs were monitored and its causality and severity were assessed. Data were entered in MS Excel and analyzed using SPSS. Qualitative variables are represented as proportions and quantitative as mean and standard deviation. Associations were analyzed using appropriate statistical tests. Analysis was performed using paired t-test p<0.05 taken as significant. Results: Orange-red urine and secretions were the most common ADR, followed by nausea, fatigue, heartburn, etc. Significant increase in random blood sugar, renal function tests (RFTs), and liver function tests (LFT) after treatment, then before noticed. 84.4% of patients from the daily group and 78% of patients from the intermittent group experienced ADRs. Causality was assessed using Naranjo’s algorithm and severity using a modified Hartwig and Siegel scale. Conclusion: The majority of patients developed ADRs, which were mild and managed symptomatically. Some reactions required alteration of therapy, reduction of drug dose, or change of suspected drug. To conclude, meticulous monitoring of ADRs in patients on anti-tubercular drugs is mandatory.

To Observe the patterns of Cutaneous Adverse Drug Reactions in a Tertiary health care teaching hospital in Hyderabad

Cutaneous adverse drug reactions are very common and seen quite often during clinical practice. It is difficult to get a comprehensive list of the various types of drug reactions and their corresponding drug due to many cases going unreported. There is a possibility of a cutaneous drug reaction every time a new drug is introduced into the market. While most types of drug reactions are trivial and benign, there is always a possibility of the reaction attaining a more malignant nature. The diagnosis of a CADR is more often based on a clinical examination. However, in order to understand the full scope of the reaction it must be reported and studied. The pharmacovigilance programme takes into account the spontaneous nature of the cases and employs alogical approach based on clinical characteristics, chronologic factors, and generation of a focused differential diagnosis. Using study tools like Naranjo scale and Modified Hartwig and Siegel scale, a physician can easily determine the severity and causality of the drug reaction. After compiling the data, one can determine the trend of the morphology of these CADRs, and determine the most likely drug responsible for the reaction. The data obtained in this study is useful for helping the clinician in the proper identification, approach and treatment of a patient suffering from a cutaneous adverse rug reaction.

Adverse Drug Reactions in the Bipolar Disorder Patients Treated With Mood Stabilizers

Abstract Background: Bipolar disorder is a chronic illness requiring long-term use of mood stabilizers such as lithium and sodium valproate. The adverse drug reactions (ADRs) of these medicines can severely affect the quality of life of the patients. A comparative study of ADR profile of lithium and valproate in terms of prevalence, severity, and causality has not been done in the rural population of India. Methodology: A cross-sectional, observational study was done in the psychiatry outpatient department of a tertiary health care center. The bipolar disorder patients on lithium carbonate or divalproate monotherapy were chosen for documentation of ADRs after informed consent. The Naranjo causality algorithm and Modified Hartwig and Siegel scale for severity assessment were applied to all participants. The data obtained were statistically analyzed using Epi Info open-source software. Results: The study participants having mean age of 33.83 ± 12.02 years comprised nearly equal number of males and females. Tremors (19.4%), polyuria (11.5%), and polydipsia (11.2%) were the most common ADRs due to lithium, whereas nausea (12.6%), anorexia (10.6%), and sedation (9.1%) were more commonly seen in patients on valproate. Most of the ADRs had a mild severity and were categorized as possible in the Naranjo causality algorithm. Conclusion: Although ADRs are common in bipolar disorder patients treated with lithium or valproate, they are often mild and well tolerated by the patients.

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.

Terbinafine-induced Myositis: A Case Report

We report a case of terbinafine-induced myositis in a 37-year-old Asian male patient treated for Tinea cruris. The patient complained of severe generalized body aches, weakness, fever, fatigue, and passing of concentrated urine after consuming one dose of terbinafine 250 mg tablet, which worsened after the second dose. At the presentation, the patient was afebrile, fatigued, and had difficulty moving. All the laboratory parameters were normal, except N-acetyl-cysteine-(NAC)-activated creatine kinase, which was elevated to 276 U/L. There was a slight elevation in alanine transaminase (ALT) levels (44 U/L) and albumin-to-globulin ratio (1.8). The oral terbinafine was stopped. Patient was prescribed with tablet acetaminophen 650 mg thrice daily for two days and as needed thereafter, to manage myalgia. The patient reported being symptomatically better after six days of terbinafine withdrawal. The Naranjo’s causality assessment scale score was eight, indicating a probable relation between drug exposure (terbinafine use) and adverse drug reaction (myositis). The severity of terbinafine-induced myositis in this patient was moderate (level 3) as categorized by the Modified Hartwig and Siegel scale.

Evaluation of Cutaneous Adverse Drug Reactions Reported in a Teaching Hospital of Coastal Andhra

Adverse drug reactions (ADR) can be manifested in different forms, among these cutaneous adverse drug reactions (CADRs) are the commonest. They have been steadily gaining importance and constitute a major proportion of all ADRs. As available data on CADRs is very less, more research is required to have reliable data, hence the current study was undertaken. This prospective study was carried out to evaluate the age and gender distribution, presenting complaints, spectrum of CADRs, causative drugs, causality, severity, and outcomes in patients with or suspected CADRs attending the department of Dermatology of Konaseema Institute of Medical Sciences & Research Foundation Hospital between January 2014 and June 2015. In cooperation with the Dermatologist, patients’ reactions were analyzed based on morphology, and laboratory investigations. Causality was assessed as per the World Health Organization- Uppsala Monitoring Centre (WHO-UMC)causality assessment scale. Modified Hartwig and Siegel Scale was used for the severity assessment of reactions. CADRs occurred most commonly in the 31-40 years age group (32%) with no sign of the difference in both sexes. The most common complaint of CADRs by the patients was skin rash (42%) anddiagnoses were Erythematous drug eruption (ERDE) and Fixed drug eruption (FDE) (28%). The commonest causative drug categories were antimicrobials (52%) and Non-Steroidal Anti-inflammatory Drugs (NSAIDs) (24%).Among antimicrobials, ciprofloxacin, and in NSAIDs, diclofenac were the commonest causative drugs. In causality, majority of the cases were under possible category(42%). Most of the reactions were mild (46%), and moderate (46%) in severity. The majority of the cases showed good recovery without any mortality or disability. The limitations of this study were the relatively small sample size, inability to confirm the particular causative drug in majority of the patients. Future research should focus on the genetic factors concerning to CADRs and molecular-level evaluation should be done for a better understanding of the pathophysiology of various ADRs.

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

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

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.

EVALUATION OF DERMATOLOGICAL ADVERSE DRUG REACTIONS IN THE OUTPATIENT DEPARTMENT OF DERMATOLOGY AT A TERTIARY CARE HOSPITAL – AN OBSERVATIONAL STUDY

Background: Drugs, no matter how safe and efcacious, come together with the risk of adverse reactions. Of all organs affected by drug reactions, the skin is most frequently involved. To evaluate the dermatological adverse drug Aim and Objectives: reactions in patients attending the Dermatology outpatient department of a tertiary care hospital. An observational, Materials and Methods: cross-sectional study was conducted to evaluate the adverse drug reactions in the Outpatient Department of Dermatology in an Tertiary Care Hospital for a period of 1.5 years. The causality of ADRs was evaluated using WHO-UMC Scale, Naranjo's scale, severity was assessed using Modied Hartwig and Siegel's scale, Preventability was assessed using Schumock and Thorton's criteria. Total 78 Result: drugs were suspected of 67 ADRs. Most common ADR encountered was Maculopapular rash and most common drug causing ADR was found to be antimicrobials. Causality assessment using Naranjo's scale revealed that 59.70% cases were probable, 34.33% cases were possible, 5.97% cases were denite. Causality assessment using WHO-UMC scale revealed that out of total 67 ADR, majority of cases 40 (59.70%) were probable. 19 (28.36%) cases were possible. 8 (11.94%) cases were certain. On preventability assessment 79.1% ADRs were denitely preventable, 20.9 ADRs were probably preventable. Severity assessment concluded that 67.16% were mild, 29.85% moderate, 2.99 % were severe. Proper implementation Conclusion: of ADR monitoring will help to reduce the harmful effects resulting from the use of medicinal products by early detection of drug safety problems in patients.

Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India

Background: The aim of the present study was to determine the pattern of adverse drug reactions (ADRs) reported at ADR monitoring centre (AMC) in Punjab. Methods: This observational retrospective study was done in department of Pharmacology, GGS Medical College and Hospital, Faridkot from September 2020 to August 2021. A total of 148 ADRs were reported during the study period. Each ADR was analyzed for demographic data and characteristics of ADR. Assessment of causality, severity and preventability was done according to WHO UMC scale, modified Hartwig and Siegel scale and Modified Schumock and Thornton Preventability Scale respectively. Results: A total of 148 ADRs were reported from both outpatients and in patients of various departments. Most of the ADRs were found in males (55%) and patients of age group 31-45 years (33%). Majority of ADRs were reported from dermatology department (40%). Overall, 38% of ADRs were due to antimicrobial drugs. Most of the ADRs were reported as possible (57%), followed by probable (41%) as per WHO causality assessment. Most of the ADRs were moderate severity (83%). 97% of the ADRs were found to be definitely preventable type. Conclusions: We concluded that most of the ADRs were reported from antimicrobial drugs, so it is advisable to have close monitoring of the antimicrobial drug therapy to prevent ADRs in the patients. Although the majority of ADRs were moderate in nature but mostly were recovered. The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

To Assess Causality, Severity and Preventability of Adverse drug reactions of Amlodipine in the treatment of hypertension

Background: Every drug has the potentiality to cause an adverse drug reaction (ADR). ADRs are a major problem in drug therapy. The aim of this study was to assess the incidence and causality, severity and Preventability of ADRs Amlodipine (antihypertensive agents) used for the essential hypertensive patients during the time period of April 2022 to Jun 2022. Methods: This prospective-observational study was carried out in general medicine outpatient department in 15 Patients. Results: Out of 15 patients, 10 (66.66%) patients were developed ADRs to antihypertensive drugs. 8 (85.72%) were male and 2 (14.28%) were female. Calcium channel blockers were the commonest therapeutic class of antihypertensive drugs associated with ADRS (n = 50, 64.10%). According to WHO causality assessment scale most of the ADRs of Amlodipine were "probable" 8(57.14%) followed by "possible" 2 (14.28%), certain 4 (28.57%)). According to Hartwig and Siegel scale of severity assessment, the most of the adrs were mild 10(71.42%) and moderate 4 (28.57%). According to Schumock and Thornton scale of preventability assessment all ADR are definitely preventable. Conclusions: The results of this study concluded that antihypertensive drugs able to induce the development of adverse drug reactions, which were significant cause of increase burden on health care system and decrease the quality of life, the health care professionals should take care about the rational use of antihypertensive agents. Thus, to minimize the incidence of adverse drug reaction and to increase the quality of life.

Adverse drug reactions to first-line antituberculosis drugs at four DOTS centers in Goa, India

BACKGROUND: Major adverse drug reactions (ADRs) can cause significant morbidity and can compromise the treatment regimen. This can result in substantial additional cost due to added outpatient visits to the health facility or laboratory investigations or hospitalization in serious instances. Treatment is often prolonged with additional challenge of compliance. Hence, there is a need to monitor and manage these ADRs timely for better patient care and outcome. This study was carried out with the objective of studying the pattern of ADRs due to first-line antitubercular drugs and to carry out the causality and severity assessment of the reported ADRs.METHODOLOGY: A prospective observational study was conducted at four DOTS centers. All tuberculosis (TB) patients registered and receiving treatment under DOTS were enrolled for the study and were followed up at regular intervals till the end of their treatment. Patients' demographic, personal, disease, investigation, and ADRs details were entered in a predesigned patient recording form. Causality assessment of all ADRs were done using Naranjo algorithm. Severity assessment was done using modified Hartwig and Siegel scale. The study was approved by the institutional ethics committee of the institute. Statistical analysis was conducted using IBM SPSS Statistics for Windows.RESULTS: Of 186 patients, 23 patients (12.26%) developed one or more ADRs. The average number of ADRs per person was 1.43. Majority of the ADRs were reported in the 20–40 years of age group and ADRs were more likely to be among females compared to males. There was no association between type of TB, site of TB, regimen of anti-TB drugs, treatment outcomes, and ADRs. Around 84.85% and 15.15% of ADRs were classified as of mild and moderate severity, respectively, as per modified Hartwig and Siegel scale, while, as per Naranjo algorithm, 72.73% of the ADRs were classified as probable and 27.27% of ADRs as possible. No ADRs were classified as definite.CONCLUSION: Thorough understanding of the various ADRs and their management will help in the effective treatment of TB as well as designing effective counseling methods, which will help in adherence to treatment and also to have better compliance.

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

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

COVID-19 impact on the prevalence of PIMS in elderly patients according to STOPP/ START criteria: a record base study

Background: Polypharmacy, contribute to an increased risk of adverse drug reaction morbidity, and mortality, and increases the length of hospital stay, hospital revisits and readmissions. We aimed to evaluate the prevalence and trends of polypharmacy and potentially inappropriate medications in elderly patients with version 2. STOPP/START criteria, and assess the severity of adverse drug events in patients with PIMs.Methods: This is a retrospective, record-based study of over-the-counter, and potentially inappropriate medications in the prescriptions of patients (&gt;60 years). PIMs have been identified and further investigated to determine any adverse effects. If harm occurred, the severity of an adverse effect was rated using a modified Hartwig and Siegel scale. The causality of the events was assessed by using Naranjo's scale.Results: Out of 583 patients polypharmacy and excessive polypharmacy were found in 36.0%, and 42.8% of pre-admission medications. The most common over-the-counter (OTC) drugs were hydrocortisone (39.86%), ranitidine (21.62%), bisacodyl (14.86%), and diphenhydramine (12.84%). A statistically significant positive correlation was seen between age and the number of drugs prescribed (r2=0.16), while a non-significant positive correlation was found between sex, length of stay (LOS), and the number of drugs prescribed (r2 =0.0002, r2 =0.001). Common PIMs related incidence reported include Insulin (regular) 31.25% (N=20), Trihexyphenidyl (THP) 18.75%, zolpidem 12.5%, acetylsalicylic acid 9.3%, pantoprazole 52 7.81%, furosemide 7.8%, hydrocortisone 6.25%, and glimepiride 6.25%. Total of 130 ADRs 50% were mild, 28.4% were moderate, and 21.5% were severe. Out of 130 incidents, 64.6% were preventable, 22.3% were probably preventable, and 13.0% were not preventable. A total of 50.0% recovered completely from the ADRs, 33.0% had been recovering, 12.3% recovered with a squeal, 2.3% could not recover and 2.3% had been fatal.Conclusions: The study shows high uses of OTC and PIMs and PGx in elderly patients; which encourage intent need to develop awareness and action plans.

Pattern of adverse drug reactions to anticancer drugs at an apex hospital in south India: A retrospective study

Cancer chemotherapy is rampant as cancer is the 2nd most common cause of global mortality. It is challenged by a horde of adverse drug reactions (ADRs) and adverse events. A proper study of these ADRs is very crucial to limit their occurrences and thereby ameliorate the sufferings of the patients. Our study was to assess the frequency, nature and profile of the ADRs with anticancer drugs. A retrospective analysis of the ADR data collected over a period of 5 years was considered. Demography, drug related changes and clinical details of the patients were recorded and analysed. A total of 1145 ADR events were reported during the study period of January 01, 2017 to December 31st 2021 of which 232 cases (20.26 %) were due to anticancer drugs. The majority of the ADRs were accounted in females and in the elderly age group (&amp;#62;60 years). The commonly reported ADRs included breathing difficulty, chest discomfort, itching all over the body, numbness, neuropathy, mucositis and hand foot syndrome. The most common drugs that caused ADRs were Platinum coordination complex drugs, Taxanes, Rituximab and pyrimidine antagonists like Capecitabine and Gemcitabine. Causality assessment done using WHO-Uppsala Monitoring Centre causality assessment scale which showed 69.4% cases as “probable”, 29.3% cases as “possible” and 1.3% as “certain”. Severity assessed using the modified Hartwig and Siegel scale showed most of the cases as of moderate severity. Most of the ADR events in our study was manageable although a few required the withdrawal of the causative drug. Rigorous monitoring and adequate reporting are very crucial for the prompt identification, assessment and timely management of ADRs in the patients receiving chemotherapy so as to improve the quality of life in these patients.

ADVERSE DRUG REACTIONS: AN ACTIVE MONITORING STUDY IN A TERTIARY CARE HOSPITAL

Identication of Adverse drug reactions is a key factor to improve the overall health outcome. The study aimed to assess the adverse drug reactions reported in hospitalized patients. The study was conducted for 6 months to assess the incidence of adverse drug reactions where the assessment of various parameters was done using Naranjo, modied Schumock and Thornton, and modied Hartwig and Siegel scale. A total of 500 cases were analyzed, out of which 38 adverse drug reactions were reported. The demographic details showed that geriatric male patients have a greater number of adverse drug reactions than females. It was found that rashes were the most commonly seen adverse drug reaction and most of occurred adverse drug reactions were found to be probable. Drugs acting on the central nervous system showed a greater number of adverse drug reactions and the most affected system was found to be the skin. Occurrence of adverse drug reaction was also found and the causality, preventability, severity, seriousness, and outcome were found using various scales. A prospective study was conducted to assess the knowledge among the healthcare providers by circulating questionnaire survey forms to 200 healthcare providers. The practice of adverse drug reaction reporting is poor among healthcare providers due to various reasons like lack of knowledge, unavailability of reporting form, not knowing where and how to report, and lack of time. However, this study reveals that there is a greater need to create awareness and promote reporting of adverse drug reactions for better health outcomes.

Study of pattern &amp; distribution of adverse drug reactions in acute coronary syndrome patients in a tertiary care hospital

With the availability of a wide range of drugs to treat patients with acute coronary syndrome (ACS), adverse drug reactions (ADRs) have become inevitable in clinical practice. Thorough knowledge of such reactions is essential for the treating physician for optimal treatment and better outcomes. There are many scales to define, measure and assess the ADRs, but there is a dearth of data available on such drug reactions among ACS patients. Hence, this study attempted to analyze the pattern, causality, severity, predictability and preventability of ADRs in ACS patients. All the ADRs reported during the study period were analyzed for causality by the World Health Organization-Uppsala Monitoring Centre (WHO-UMC), Naranjo's and Karch and Lasagna scales; severity by modified Hartwig and Siegel scale; predictability by Rawlins and Thompson criterion and preventability by Schumock and Thornton scale. A single-centre, record-based analysis for the occurrence of ADRs was done among ACS patients admitted to the department of Cardiology between January and October 2017. Demographic data, comorbid conditions, reported ADRs and ADR assessment details were noted from the hospital case records and ADR monitoring centre (AMC) records. The data were analyzed and presented in a descriptive manner using percentages, mean and standard deviation. The Pearson's chi-squared test was used to ascertain the significance of the association between different groups. Out of 324 patients under evaluation, 67 had developed one or more ADRs. There were 30 different types of ADRs reported, headache being the most common. Among the drugs, heparin was the most common factor, causing 27 per cent of ADRs. Definite causality of a suspected drug causing ADRs was seen in 11.9 (n=8), nine (n=6) and 7.5 (n=5) per cent cases as per WHO-UMC, Naranjo (Naranjo algorithm) and Karch and Lasagna scales, respectively. In the severity of ADRs, the most severe reactions according to the modified Hartwig-Siegel scale (level 4a in our study) were seen in 17.5 (n=12) per cent of patients, and the rest were either level 2 or 3 reactions. Nearly 92.5 (n=62) per cent of reactions were predictable according to the Rawlins and Thompson criterion. Application of the modified Schumock-Thornton scale showed that 22.4 per cent of ACS patients had preventable reactions, and the rest were not preventable. The study results suggest that ADRs are relatively common among ACS patients. Most of these can be identified and assessed for causality, severity, predictability and preventability using various available scales. Diligent pharmacovigilance for identifying and assessing ADRs may help manage and mitigate morbidity associated with these in high-risk ACS patients.

Adverse drug reaction profile of patients taking amantadine for traumatic brain injury in a tertiary care hospital

Background: Amantadine is found to be effective for the treatment of complications associated with traumatic brain injury. Drug-related side effects are common with Amantadine especially when combined with other drugs. Comprehensive information about the incidence and severity of these adverse effects is not available. Aim and Objectives: The aim of the study was to analyze the pattern of occurrence of adverse drug reactions (ADRs) in patients receiving Amantadine for traumatic brain injury in a tertiary care hospital. We also assessed the causality, severity, and preventability of ADRs. Materials and Methods: This prospective and cohort study was conducted among patients taking Amantadine for a continuous period of 1 month for traumatic brain injury in neurosurgery department between June 2020 and December 2020. Tools used were ADR Reporting form of National Pharmacovigilance Centre, WHO causality scale, Hartwig and Siegel scale, and Schumock and Thornton scale. Descriptive statistics were used and the values were expressed in numbers and percentages. Results: ADRs were experienced in 55 patients (36.7%) out of 150 patients and all the patients were on combination therapy. ADR was present more in male patients (63.6%) compared to females (36.4%). The most common ADRs were headache, ankle edema, and dry mouth. Majority of ADRs belonged to the possible category according to the WHO causality assessment scale. Majority of the ADRs (61.9%) were mild level 1 according to severity scale. All the ADRs came under the definitely or probably preventable category. Conclusion: ADRs with Amantadine are common but mild and preventable.