WHO Causality Assessment Scale Research Articles

Quality of life and wellbeing among breast cancer patients in Lahore, Pakistan.

Breast cancer has a high incidence rate, emphasizing the necessity of enhanced information on health-related quality of life (HrQOL) in this population of patients. The aim of this study was to identify the factors influencing the QOL experienced by patients in Pakistan. A cross-sectional study was conducted on women with breast cancer, and four instruments were used on a random sample of 130 Pakistani women: FACIT-B Version 4 questionnaire,WHO causality assessment scale, Naranjo's algorithm, and a demographic/clinical characteristics section. Data analysis included descriptive analysis, independent sample t-test, and analysis of variance (ANOVA) test. The patients' mean age was 49.10 (standard deviation (SD) 10.89); 98.5% were married. The mean score was 18.34 for physical wellbeing (SD 5.92; interquartile range (IQR) 11), 16.33 for social/family wellbeing (SD 6.3; IQR 11.25), 13.6 for emotional wellbeing (SD 3.55; IQR 6), 17.13 for functional wellbeing (SD 3.73; IQR 6), and 24.86 for breast cancer subscale (SD 3.64; IQR 4). The study found that the age, entitlement, recurrence, marital status, salary, number of doses, duration of cancer treatment, and chemotherapy sessions were significantly related to QOL terms in the assessment of the FACIT-B scale. The WHO causality evaluation scale determined that 78.1% of the responses were "probable" and 20.1% were "possible". According to Naranjo's algorithm assessment scale, 80% of adverse drug reactions (ADRs) were "probable", whereas 18.4% were declared "possible". Chemotherapy-induced anemia was the most often reported ADR in 64.6% of patients, followed by chemotherapy-induced nausea and vomiting (61.5%). Healthcare practitioners must acknowledge and take into account the significance of QOL in addition to therapy for breast cancer patients in order to enhance their health. The findings of this study will aid in filling gaps in current unknown knowledge and identifying sites where patients require additional assistance. Because cancer and chemotherapy clearly have a negative impact on individuals' QOL, oncologists must concentrate on strategies that help cancer patients during their sickness and treatment while also enhancing self-care and QOL. Those with cancer will benefit from emotional wellbeing and adaptation to their disease.

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.

Pattern of cutaneous adverse drug reactions in an adverse drug monitoring center at a tertiary care hospital in Kerala

Background: Pre-marketing clinical trials can filter only about 50% of the drug reaction. Hence, to prevent the morbidity and mortality due to severe cutaneous reactions early detection, evaluation and monitoring of adverse drug reaction (ADR) especially cutaneous ADR (CADR) are mandatory. Hence, it is imperative that we update our knowledge of the precise nature of ADR which will prevent the reactions as well as to find the offending drug. Aim and Objectives: The aim of the study was to evaluate the pattern of CADR, the suspected drugs and to perform the causality assessment using WHO casualty assessment scale. Materials and Methods: A retrospective descriptive study was done using the data reported to ADR monitoring center in the Department of Pharmacology by the health-care professionals. Suspected CADR was diagnosed by the consultants concerned. The CADRs collected were categorized according to their morphology into maculopapupar rash (MPR), fixed drug eruptions (FDE), urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The causality assessment was done using WHO Causality assessment scale. Results: The mean age was 47.20 + 22.31. The most common CADR reported was Urticaria 65.5% followed MPR 23%, FDE 8.8%, and Steven Johnsons Syndrome 2.2%. Anti-microbial drugs were the most frequent cause of the adverse reactions with Amoxicillin clavulinic acid combination being the most frequent suspected drug producing CADR (13.3%). The WHO causality assessment for majority of CADR was Possible (73.5%). Conclusion: Clinical Patterns of CADRs in this set up have some minor variations when compared to studies done across India. Amoxicillin clavulinic acid is the most common suspected drug in this study which was not frequently reported in other ADR monitoring centers.

DRUGS UTILIZATION STUDY IN NEONATAL SEPSIS IN TERTIARY CARE HOSPITAL

Objectives: The present study was taken up to evaluate the drug utilization pattern and adverse drug reactions (ADRs) seen in patients of neonatal sepsis admitted to sick newborn care unit of a tertiary care hospital in Uttarakhand. Methods: This was a prospective observational study. A suitable case record form was designed to collect all the necessary and relevant information. Data of 175 neonatal sepsis matching inclusion criteria were recorded. Pattern of prescription of drug for various diseases in sick newborns was analyzed. Information on ADR were analyzed. ADR was analyzed using Naranjo scale and the WHO causality assessment scale. Results: Blood culture was positive in 137 (78.29%) neonates. Staphylococcus aureus (45.26%) was the most common microorganism followed by Klebsiella pneumoniae (26.28%) and Escherichia coli (14.60%). Out of 137 blood culture-positive neonates, 30.66% were suffering from meningitis. Out of 38 blood culture-negative neonates, 63.16% were suffering from meningitis. Average number of drugs per encounter was 1.71. Percentage of drugs prescribed by generic name was 91%. Parenteral route was the most common route of drug administration. Ampicillin was the most common antimicrobial prescribed. Next common classes of drug used were vasopressor. Out of 10 (5.71%) ADRs identified, 70% were possible and 30% were doubtful as per Naranjo’s causality assessment scale. Case fatality rate was 27.42% during the course of study. Conclusion: Parenteral antibiotics (ampicillin plus gentamycin) and vasopressors remain the most commonly prescribed drugs in neonatal sepsis in sick newborn unit. The study concluded that doses and duration, for which drugs were used, were in accordance to AIIMS protocol for neonatal sepsis.

CURRENT TRENDS IN PHARMACOLOGICAL TREATMENT OF TYPE 2 DIABETES MELLITUS IN TERTIARY CARE CENTRE IN BUNDELKHAND REGION

Introduction: Type 2 diabetes mellitus (DM) is a chronic metabolic condition with an increasing global prevalence. Because of this tendency, it is rapidly becoming an epidemic in some nations, with the number of affected anticipated to quadruple in the next decade as the population ages. The present study aimed to determine the prescribing pattern and adverse drug reaction of different groups of antidiabetic drug in type 2 Diabetes mellitus. Methodology: The present study was an analytical cross-sectional study conducted on total 430 type II diabetes mellitus patients attending OPD in diabetes clinic at M.L.B Medical College, Jhansi during the study period. Various scoring system including WHO causality assessment scale, CDSCO ADR, WHO-UMC Scale, Naranjo algorithm scale were used for assessment. Results: Majority of patients were male [n=248(57.67%) followed by female [n=182(42.33%], respectively. Signicant patients were of middle class [n=201(46.74%) followed by low class [n=139(32.32%] and High class [n=90(20.93%) (P<0.0001*). ADRs reported hypoglycemia was the commonest followed by dyspepsia and epigastric pain and heart burn common. Majority of patients had HbA1c between 7.0-8.0 which is in fair control 37.67% followed by 8.0-10.0 which is unsatisfactory 35.81% and above 10 which is in poor control 18.14% respectively. Signicant Correlation between Medicine with ADR (p=0.0429), Total Cholesterol (p=0.0396*) and Triglycerides (p= 0.0167*). Conclusion: According to causality assessments, majority of patients had possible causalities. Therefore, we may say that present study results provide insight to the healthcare providers on the importance of monitoring and reporting ADR associated with the drugs.

Analysis of Adverse Drug Reactions associated with Anti-tubercular drugs – A Retrospective Study

Background: Adverse Drug Reactions (ADR’s) to anti-TB drugs might contribute to the extension of treatment period, final termination, drug resistance and treatment failure as Anti-TB medications are the main stay treatment in Tuberculosis. These ADR’s may cause unintended interruption of treatment which may pose a challenge in TB management. Aim: This study aims to explore and observe adverse reactions of 1st line antitubercular drugs in DOTS treatment. Methodology: This is a analysis of ADRs of antitubercular drugs that were reported to ADR monitoring centre (AMC), SDSTRC and RGICD ,Bangalore either by spontaneous reporting or found by active surveillance methods. This study was for about 32 months. During this period all the ADRs caused by antitubercular drugs reported to the AMC were collected and classified based on WHO causality assessment. Later all those data were analyzed and results were generated Results: A total of 507 ADR’s were reported and out of which the majority of ADR’s were reported in adult population (45%). Based on gender, Male had a higher incidence of ADR (324, 63.9%). Based on WHO causality assessment scale, 69.4% of ADRs were ‘possible’ followed by 25.2% being ‘probable’ and 4.1% being ‘certain’. Conclusion: Monitoring of patients on Anti tubercular treatment with early identification and appropriate management of ADR becomes very essential. The timely and aggressive management of adverse effects of anti-tubercular drugs greatly facilitates patient adherence.

Behavioral And Psychiatric Adverse Events Induced By Brivaracetam: A Case Report

Background: Brivaracetam (BRV) is an anti-convulsant belonging to third-generation antiepileptic and approved by FDA as an add-on therapy as well as monotherapy for management of partial onset seizures in both adults and pediatrics as young as 1 month of age. Brivaracetam induces psychiatric adverse reactions, including non-psychotic and psychotic symptoms. Case Report: A 26-year-old male patient having a past medical history of dyslexia was diagnosed with Seizure disorder during February 2021. Initially, the patient was prescribed Levetiracetam 500 mg BD to control his seizure. The drug was well tolerated and there were no episodes of seizure for a period of 6 months. In August 2021, the patient had a recurrence of convulsions. As a consequence, Brivaracetam 50mg BD and Sodium Valproate 500mg BD were prescribed. The patient gradually started exhibiting unusual behavioral and psychiatric adverse events. The reaction was primarily ascribable to brivaracetam based on the temporal association between non-contributable disease and co-medication. The WHO causality assessment scale graded the ADR to be ‘probable’ and Naranjo’s algorithm with a score of 6. The physician recommended discontinuation of Brivaracetam and advised to continue Sodium Valproate 500mg BD, while Clobazam 5mg BD was added to patient treatment regimen. The patient’s symptoms progressively alleviated, and his behavior returned to normal within one week of discontinuing the Brivaracetam. Conclusion: When initiating treatment with Brivaracetam, close clinical assessment and monitoring is required and recommended to identify any behavioral and psychiatric adverse effects to achieve optimum treatment outcome.

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.

Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was...

Glucocorticoids: Boon or Bane-An assessment of safety proϐiling of steroids in a tertiary care hospital

Glucocorticoids are used in therapy empirically, but undesirable effects occur with large doses or prolonged administration. The aim of the study is to assess the pattern of adverse drug reactions of glucocorticoids in a tertiary care hospital. A retrospective analysis of adverse drug reactions (ADRs) following administration of glucocorticoids was conducted in the ADR monitoring center, Department of Pharmacology, Kasturba Medical College, Manipal. Clinical and treatment data were collected from the patient case records in the suspected adverse drug reaction reporting form as per the World Health Organization guidelines. ADRs were assessed for Causality, Preventability and Severity using WHO causality assessment scale, Modified Schumock and Thornton’s scale and Hartwig’s severity scale, respectively. 100 ADRs were observed in 85 patients, with 51% males and 49% females. Prednisolone (53%) was the most common drug responsible for ADRs, followed by betamethasone (9%) and dexamethasone (8%). Hyperglycemia (34%) was the most common ADR, followed by cutaneous adverse reactions (32%). Acne (20%) was common among them. Over 86% reactions were categorized "possible". Among ADRs (91%) treated, only 16 % recovered. About 39% of cases were "probably preventable". The majority of ADRs (72%) were moderate in “severity”. Given the number and severity of side effects, the institution of glucocorticoids requires careful consideration of the relative risks and benefits in each patient.

PDG30 A Study on Adverse Drug Reaction Related Hospital Admissions of a Tertiary Care Hospital in South India

To study and assess the Adverse drug reaction (ADR) related hospital admissions in a tertiary care hospital. This prospective observational study was conducted over six months in a tertiary care hospital. Patients of any age and gender who were admitted to General Medicine, Emergency, Nephrology, Psychiatry, Pulmonology wards due to ADR were enrolled in the study. All the necessary data pertaining to ADRs were collected for assessing causality, severity, preventability and predictability and predisposing factors for ADR related hospital admissions. Out of 14395 admissions to the hospital during this period, 85 admissions were identified to be caused by ADRs. Among ADR related hospital admissions, maximum admissions were seen in medicine department (50 cases). 37 males (43.52%) and 48 females (56.47%) were admitted due to ADRs. The age >61 was a risk factor for ADR related hospital admissions. As per WHO causality assessment scale and Naranjo scale, majority of the ADRs that resulted in hospital admission were deemed probable (81.17%) and 18.82% admissions possible. 72% of ADR related hospital admissions were moderate and 28% were severe.55.29% of ADR related hospital admissions were found to be predictable and 44.7% were not predictable. Among the 85 ADR related hospital admissions,9.47% were definitely preventable ,35.29% were probably preventable and 55.29% were not preventable. Long term use of the drug (16.47%) was the most common predisposing factor for developing ADR which resulted in hospital admission. Other predisposing factors identified were multiple drug therapy (12.99%). The prevalence of ADR related hospital admissions was found to be 0.6%.

A STUDY ON CLINICAL PATTERN OF ADVERSE DRUG REACTIONS TO THE DRUGS USED FOR HYPERTENSION AND ASSESMENT OF MEDICATION KNOWLEDGE IN SUCH PATIENTS.

The aim of the present study was to monitor adverse drug reactions associated with antihypertensive drugs. due to its high prevalence, Hypertension is a major health problem throughout the world and very less studies has been aimed at assessing the patient’s knowledge and awareness about hypertension and adherence to antihypertensive medication among hypertensive patients .Hypertension is a major health problem and risk factor for stroke, coronary heart diseases and antihypertensive treatment is used to reduce renal and cardiovascular diseases by lowering blood pressure. Occurrence of adverse reactions among hypertensive patients could prevent or delay patients from achieving desired therapeutic goals. The study was conducted by one to one patient interview using a questionnaire-based medication knowledge form, Adverse Drug Reaction Monitoring Form drafted according to the World Health Organisation Monitoring Guidelines. A total of 86 adverse drug reactions were observed in 127 hypertensive patients during the 6 month study. In this study the ADRs were found probable (51.16%), possible (32.56%), unclassifiable (11.63%) and unlikely (4.65%) by using WHO causality assessment scale. By using Naranjo algorithm scale it was found that ADRs were possible in 77.91% and probable in 22.09% of cases. This study also found that amlodipine was responsible for most of the ADRs and among the entire ADRs reported headache was the commonest followed by dizziness, pedal oedema, fatigue, abdominal pain, dry cough, breathlessness, bradycardia, muscle cramps, sedation, diarrhoea and irritation all over thebody. After counseling by clinical pharmacist medication knowledge was found to be increased.
 Keywords: Adverse drug reaction, medication knowledge, hypertension

Pattern of adverse drug reactions of antitubercular drugs in tuberculosis patients with comorbidities and risk factors in South Indian government health-care facilities

Background: Tuberculosis (TB) is one of the common infectious diseases in India with a high socioeconomic impact. It is estimated that more than 5% of the patients on antitubercular drugs develop adverse drug reactions (ADRs) and subsequently this proportion is expected to increase with comorbidities due to drug-disease interactions and also drug-drug interactions used to treat the comorbidities. Aims and Objectives: This study aims to assess the prevalence and pattern of ADRs due to antitubercular therapy in TB patients with comorbidities and risk factors. Materials and Methods: Fifty TB patients were enrolled, their sociodemographic data, concurrent diseases, and medications other than antitubercular agents that the patients might be taking were investigated. Any adverse reaction and the steps taken toward the management of adverse reaction were immediately noted on the Suspected ADR Reporting Form. The severity of ADRs was assessed using the Naranjo scale and WHO causality assessment scale. Results: Out of 50 patients, 10 ADRs were reported, out of which seven ADRs were reported by males and two were reported by females (P > 0.05). All ADRs were from patients with pulmonary TB. The most common ADRs were gastrointestinal problems such as loss of appetite, symptoms suggestive of gastritis such as heart burns and abdominal pain. About 50% of the patients who developed ADR had diabetes as comorbidity (χ2 = 0.5208, P > 0.05) and all were having diabetes for more than 5 years duration. Conclusion: Most common comorbid condition with TB was found to be combined diabetes and hypertension.

An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center, Nalgonda

Background: Adverse drug reaction (ADR) monitoring is important for risk benefit analysis and for patient’s safety. ADR monitoring helps in maintaining the database which is specific to Indian population. Aims and Objectives: This study aims to analyze the pattern of ADRs, drug implicated, organ system affected, severity of ADRs, and their causality assessment. Materials and Methods: It was a retrospective analysis of all the ADRs reported to ADR monitoring center, Nalgonda, from January 2019 to December 2019. Prior ethics committee approval was obtained. ADRs were collected using suspected ADR forms provided by National Coordination Center-Pharmacovigilance Programme of India (NCC PVPI). All the ADRs were reported to NCC PVPI through VigiFlow software. Results: A total of 273 ADRs were reported of which 59% were female and 41% were male. According to the age group, 30–39 years were the most common age group affected about 26%. The most common drug class implicated for ADRs was antimicrobials. Skin was the most common system affected. Most of the ADRs belonged to probable category according to the WHO causality assessment scale. Only 9 (3%) ADRs were of serious nature. Conclusion: Pharmacovigilance is important for identification of ADRs due to drugs. Still, lot of awareness about pharmacovigilance needs to be created among health-care professionals to improve the reporting of ADRs. This, in turn, will improve the drug safety among patients.

ANALYSIS OF ADVERSE DRUG EVENTS REPORTED AT PERIPHERAL ADR MONITORING CENTRE IN GUJARAT

Objective: Hospital-based ADR (Adverse drug reaction) monitoring and reporting programmes are useful for identifying and minimizing preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The objective of this study was to evaluate and analyze the spontaneously reported adverse drug events from various departments of Shree Krishna Hospital, Karamsad.
 Methods: This was a retrospective study and data was analyzed for adverse drug events reported during the period of April 2018 to March 2019 from various departments of Shree Krishna Hospital, Karamsad. Analysis was done on the basis of the demographic profile of patients, health care professionals who have reported and drugs causing ADRs, with their causality assessment using WHO probability scale.
 Results: Out of 36 patients, 20 (55.55%) were males and 16 (44.44%) were females. Antibiotics were the most common culprit group of drugs for reported ADRs in 21 patients. The number of ADRS related to the skin was 21 (58.33%) followed by GIT 11 (30.55%), cardiovascular 2(5.55%) and neuronal 2(5.55%). According to WHO causality assessment scale 01 (2.77%) of the suspected ADR was certain, 27(75%) were probable and 8 (22.22%) were possible.
 Conclusion: Our study concluded that the most commonly reported ADRs were dermatological reactions like itching and rashes. Antimicrobials were the most common drug group involved in causing ADRs. Even though there were continuous efforts for adverse drug event reporting awareness, still there is need to sensitize health care professionals to improve reporting.

A pattern of serious adverse drug reactions reported in a tertiary care hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh

Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.

A study of adverse drug reactions to iodinated contrast agents in tertiary care teaching hospital

Background: Contrast agents have long been used for the imaging of anatomic boundaries and to explore normal and abnormal findings in X-ray based imaging technique. These agents are not completely devoid of risk. Adverse effects from administration of contrast media vary from minor physiological disturbance to rare life threatening situation.Methods: A cross-sectional retrospective observational study over one-year duration from 1st August 2015 to 31st July 2016 was conducted at radiology department of a Pandit Deendayal Upadhyay Government Medical College and Teaching hospital, Rajkot, Gujarat. Adverse drug reactions were analyzed to study the nature of reactions caused by iodinated contrast agents. The temporal relationship of time of administration of contrast agents to the occurrence of adverse reaction was analyzed and classified as immediate or delayed type of reaction.Results: Out of 868 patients that were analysed 15 out of 497 male patients and 11 out of 371 female patients developed adverse reaction. Age range of patients that developed reactions was 20-55 years. Most common adverse drug reaction occurred in our study was nausea and vomiting which was treated by parenteral Ondansetron. All the reactions were found to be ‘probable’ in causality as per WHO causality assessment scale and Naranjo’s algorithm.Conclusions: Physicians performing diagnostic or therapeutic procedures with contrast agents must be aware of the risk, preventability & treatment so that reactions can be prevented. Sensitization of physicians is required to increase reporting of adverse drug reactions occurred due to radiocontrast agents.

Adverse Drug Reactions Of Cardiovascular Drugs In Intensive Cardiac Care Unit In A Tertiary Care Hospital: A Prospective Study

Cardiovascular diseases are prevalent in developing countries like India. Patients with cardiovascular diseases are prescribed multiple drugs, hence polypharmacy may attribute to higher incidence of adverse drug reactions in these patients. To monitor and to analyze the pattern of occurrence of adverse drug reactions reported with cardiovascular drugs in intensive cardiac care unit of a tertiary care hospital, Chennai. This was a prospective surveillance study carried out for a period of 6 months. Analysis of various adverse drug reactions reported were done using various assessment scales. Descriptive statistics was used and values were expressed in numbers and percentage. During the study period, 282 adverse reactions were reported from 389 patientsat includes 232 males and 157 females. The average age of the patients included in this study was 58.1± 16.8 years . The most common ADRs observed were electrolyte imbalance (14.89%), headache (13.12%) and gastritis (12.41%). Assessment using WHO Causality assessment scale revealed 60.28% were possible, 18.43% probable, 12.76% certain and 8.51% unlikely. According to Schumock and Thornton scale 65.9% of ADRs were preventable and 34% non preventable. Analysis with Hartwig and Seigel’s scale 62.05% of ADRs were moderate in severity, 27.95% mild and 10.99% severe. Drugs attributing to highest ADRs were Digoxin and Furosemide. The common ADRs due to cardiovascular drugs can be reduced by improving the prescription pattern. Intense monitoring and reporting of ADRs could help in minimizing the preventable ADRs, among the health care professionals.

Adverse Drug Reactions Affiliated with Atypical Antipsychotics in Patients with Schizophrenia

: An Adverse drug reaction cannot be avoided especially with drugs like antipsychotics which are the mainstay for the treatment of schizophrenia, a chronic disease, as well for the treatment of psychosis. Hence monitoring of adverse drug reactions is the key factor in ensuring patient compliance and safety. This study was a prospective, descriptive, follow up study. The reported ADRs were assessed for causality using both WHO causality assessment scale and Naranjo’s algorithm. The severity of the reported reactions was assessed using Modified Hartwig and Siegel scale. The predictability and preventability of the reported ADRs was assessed using developed criteria for determining predictability of an ADR and Modified Schumock and Thornton scale respectively. A total of one hundred and forty three adverse drug reactions were observed from One hundred and two patients that were recruited. ADR’s were noted and the majority of these adverse reactions was seen with Olanzapine and Risperidone. These include weight gain, sedation, tremors, drug induced parkinsonism and disturbances in menstrual cycle. Mild ADR’s using Hartwig scale were fatigue, dry mouth, insomnia, weight gain and GI disturbances. Moderate ADR’s were tardive dyskinesia, pill rolling movements, drug induced parkinsonism and hyper salivation. Severe reactions included disturbances in lipid profile, delirium, menstrual disturbances and hypertension Of the ADR’s, 92% were predictable and 7.4% unpredictable. 67.8% ADR’s were not preventable, 29.6% ADR’s were definitely preventable and 3.70% probably preventable. WHO causality assessment revealed 55.5% ADR’s to be certain, 29.6% to be probable and 14.8% to be possible. Need of the hour is active surveillance of adverse drug reaction with an efficient pharmacovigilance centre in every established hospital.Key words: Adverse drug reaction, World Health Organization, Pharmacovigillance, Atypical antipsychotics, Schizophrenia.

The study of adverse drug reactions of antihypertensive medicines in essential hypertension patients in Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha, India

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 of ADRs to antihypertensive agents used for the essential hypertensive patients attending at the general medicine out patients departments of Hi-Tech Medical College and Hospital, Bhubaneswar Odisha, during the time period of November 2016 to October 2018.Methods: This prospective-observational study was carried out in general medicine outpatient department of Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha.Results: Out of 254 patients, 78 (30.71%) patients were developed ADRs to antihypertensive drugs. 51 (65.38%) were female and 27 (34.62%) were male. 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 were “probable” 41 (52.56%), followed by “possible” 21 (26.92%), unclassifiable 13 (16.67%) and unlikely 3 (3.85%).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.