Causality Assessment Scale Research Articles

Improving Medication Adherence in Geriatric T2DM Patients: A Factorial Randomized Controlled Trial

Abstract Background: The complexity of managing type 2 diabetes (T2D) in the elderly is compounded by the need to balance over-prescription, under-prescription, and appropriate prescription. Managing hyperglycemia and its complications, along with geriatric syndromes such as cognitive impairment and falls, often leads to use of an increased number of medications. Quality improvement measures, while aimed at better management, can inadvertently contribute to the burden of polypharmacy. Addressing medication non-adherence is crucial, as it is a significant contributor to poor clinical outcomes, increased hospitalizations, and healthcare costs. Objectives: This study thus aimed to evaluate the effectiveness of interventions to improve medication adherence among elderly patients with T2D. It assessed the impact of a medication adherence device, clinical pharmacological intervention, and their combination compared to standard of care (SOC) alone on adherence rates, adverse drug reactions (ADRs), and glycemic control. Materials and Methods: This pilot study was a factorial randomized controlled trial. A total of 120 elderly T2D patients with a medication adherence rate of less than 80% over the past year were randomized into four groups: (1) medication adherence device + SOC, (2) clinical pharmacological intervention + SOC, (3) combined intervention + SOC, and (4) SOC alone. The primary outcome was medication adherence, assessed through pill counting. ADRs were evaluated using the Naranjo ADR causality assessment scale, and glycemic control was monitored through HbA1c levels. Statistical analyses included chi-square tests and ANOVA, with significance set at P < 0.05. Results: Interim analysis showed the highest adherence rate in the combined intervention group (82.1%), followed by the clinical pharmacological intervention + SOC group (75.3%), the medication adherence device + SOC group (73.1%), and the SOC alone group (70.0%). The combined intervention group also recorded the lowest ADR rate (6.6%). Regarding glycemic control, 81% of the combined intervention group achieved an HbA1c level of less than 7%, compared to 80% in the clinical pharmacological intervention + SOC group, 78% in the medication adherence device + SOC group, and 69% in the SOC alone group. Differences in glycemic control were not statistically significant (P = 0.950). Conclusions: The study indicates that combined interventions including medication adherence devices along with SOC significantly improve medication adherence and reduce ADRs in elderly T2D patients. Future research should focus on diverse populations and long-term sustainability of these interventions.

ACETAMINOPHEN-INDUCED TOXIC EPIDERMAL NECROLYSIS IN PEDIATRIC PATIENTS-A CASE SERIES

Acetaminophen is the most widely used over-the-counter medication for treating fever and pain. While adverse reactions to this drug are infrequent, they can occasionally result in severe and potentially fatal events, such as Toxic Epidermal Necrolysis (TEN). Due to the rarity of such reactions, there is a limited amount of information available about toxic epidermal necrolysis caused by acetaminophen. This case series will contribute to the existing knowledge in this area. In our cases, acetaminophen is the most suspected drug for the development of toxic epidermal necrolysis in patients. Causality assessment in all of these adverse drug reaction in context with World Health Organization (WHO) causality assessment scale suggests “Possible.” This case series concludes that severe hypersensitivity reactions like TEN caused by acetaminophen use and which can be potentially life-threatening which needs additional treatment.

A clinical study to monitor prescription patterns, clinical outcomes, and adverse drug reactions among patients of various interstitial lung diseases attending respiratory medicine outpatient department at tertiary care hospital in Northern India.

The aim of this study was to monitor prescription patterns, clinical outcomes, and adverse drug reactions (ADR) among patients of various interstitial lung diseases (ILDs). This prospective study was conducted in the Department of Pharmacology and Therapeutics in collaboration with the Department of Respiratory Medicine, King George's Medical University, Lucknow, for a period of 12 months (October 2020-September 2021). A total of 77 patients were enrolled after satisfying the inclusion and exclusion criteria. The prescriptions were collected, and necessary details were noted on the case report form. After completion of the study, the data were analyzed for prescription patterns, clinical outcomes, and quality of life with the help of a validated questionnaire-King's Brief ILD (KBILD) questionnaire. At the same time, ADRs, if any, were assessed using Hartwig's Severity Assessment Scale and Naranjo Causality Assessment Scale. The most common ILD was acute/chronic hypersensitivity pneumonitis (HP). Average number of drugs per encounter was 4.45. Crepitations were the most common clinical signs. Clubbing and rhonchi were reported maximum in idiopathic pulmonary fibrosis. It was found that psychological, breathlessness and activities, chest symptoms, and total KBILD reduced significantly after 3 months as compared to baseline with a statistically significant difference as P < 0.01. ADRs were found in 23.38% (18) of the subjects. Maximum ADR reported was gastritis (9.09%), followed by hepatitis (3.90%). The high proportion of patients clinically diagnosed with HP in our study highlights the importance of a detailed environmental exposure history in the diagnostic evaluation of patients with ILD to avoid inaccurate diagnoses. ADR-related hospital admissions are a significant problem in the health-care system.

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 &gt;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.

Comparison of WHO-UMC and Naranjo Scales for Causality Assessment of Reported Adverse Drug Reactions.

The 2 most commonly used scales worldwide are the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) and the Naranjo scales. The present study was planned to assess the degree of agreement between the 2 scales when the same adverse drug reactions (ADR) were assessed by 5 raters independently. One hundred individual case safety reports were selected randomly from the ADR database of our institute and the details were emailed to 5 different experts (raters), who were DM Clinical Pharmacology residents from different institutes in India. An independent causality assessment of these ADRs was performed independently by these raters using both the WHO-UMC and Naranjo causality assessment scales. The agreement between the 2 scales was assessed for each rater using Cohen κ, and the overall interrater agreement was assessed using Fleiss κ. The Cohen κ level of agreement between the 2 scales for the 5 raters were substantial, fair, substantial, moderate, and substantial, respectively. The most common causality assessment category as per WHO-UMC scale was "possible" but varied among the raters on the Naranjo scale. No ADR was categorized as "certain" by any rater on the Naranjo scale. The Fleiss κ value for agreement among the 5 raters was found to be 0.2 (slight) for the WHO-UMC scale and 0.297 (fair) for the Naranjo scale. A moderate level of agreement was observed in this study between the WHO-UMC and Naranjo scales. The level of agreement among these 5 raters was found to be similar for the WHO-UMC and the Naranjo scales, indicating a similar degree of subjectivity for the 2 scales. Hence, more robust and less subjective scales are required for causality assessment.

Oral Anti-Coagulant (Acitrom) Induced Coagulopathy - A Case Report

The major complication of oral anticoagulants is bleeding. Acitrom Acenocoumarol an oral anticoagulant is similar to Warfarin but has a longer half-life with fewer interactions. To reduce the risk of these complications the Prothrombin time PT ndash usually expressed as the International Normalized Ratio INR is used to monitor the degree of Acenocoumarol or coumarin-associated anticoagulation. In our study a 50 year old male patient presented with a complaint of ecchymosis over abdomen and thigh and hematuria since five days. The patient was on T. Acitrom 4 mg with a history of open-heart surgery 20 years back. On analyzing the subjective and objective evidences the condition was diagnosed as lsquoAcitrom Induced Coagulopathyrsquo which was confirmed using WHO-UMC Uppsala Monitoring Centre Causality Assessment Scale Naranjo Scale Score and Karch and Lasagna scale.

A cross sectional study to analyse the ADR reported in a hospital during the past three years

Introduction: Cross sectional study is a type of observational study that analyzes data from apopulation, or a representative subset, at a specific point in time-that is, cross sectional data. The causality appraisal is assessment of the probability that the detected adverse event is produced by a specific medication. The most commonly used causality assessment scales are Naranjo Probability Scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scales. The study is to analyze the adverse drug reaction reported in a hospital for the past three years. Aim: A cross sectional study to analyze the ADR reported in a hospital during the past three years. Methodology: A cross sectional observational study was conducted at Nirmala medical centre, Muvattupuzha. ADR reported in the past three years in this hospital were analyzed. Drug leading to ADR, department .gender, observed reaction, severity, Naranjo probability scale and WHO UMC causality assessment were done. Classification of drugs according to their drug class, classification of ADR according to the system, based on severity, sex, Naranjo score, WHO UMC criteria were done. The datas were analysed and represented into graphs. Result: A total of 342 ADR reports were analyzed in this study. The key findings of this study include: Skin-related ADRs were the most frequently reported, affecting 27.83% of cases. The majority of reported ADRs were of moderate severity (56.7%).Naranjo probability scale and WHO-UMC causality assessment indicated that most cases were in the probable category, with 63% and 76%, respectively. The general medicine department had the highest number of reported ADRs. Males accounted for the majority of reported ADRs (57.18%).Cardiovascular agents and antibiotics were the drug classes most commonly associated with reported ADRs, at 25.6% and 22.28%, respectively. Among cardiovascular agents, diuretics were found to be the primary culprits, causing 38.66% of reported ADRs. Conclusion: This study highlights the importance of monitoring, assessing, and documenting ADRs in healthcare facilities, as it provides valuable insights into the prevalence, severity, and causality of adverse drug reactions. This information can contribute to improving patient safety and the rational use of medications in clinical practice.

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.

Pantoprazole induced black hairy tongue: a case report

Black hairy tongue (BHT) is characterized by abnormally hypertrophied and elongated filiform papillae, appearing as blackish discoloration on the dorsal surface of the tongue. BHT has been reported as an adverse drug reaction to different categories of drugs. However, pantoprazole induced BHT has been rarely reported. We present the case of a 42-year-old female, admitted in the surgery ward with postoperative wound infection, for which she was prescribed oral clarithromycin and pantoprazole. On the third day of starting medications, she complained of blackish discoloration on the dorsal surface of the tongue with an alteration of taste sensation, which was clinically and microscopically diagnosed as BHT. Suspecting BHT as an adverse drug reaction to pantoprazole, it was stopped, while clarithromycin was continued for the full course. She was also advised to scrape her tongue thrice daily, drink adequate fluids and maintain good oral hygiene. On the third day after stopping pantoprazole, black discoloration and alteration of taste sensation resolved completely. WHO-UMC causality assessment scale showed a ‘probable’ association of the adverse drug reaction with pantoprazole. Physicians should be aware of the possibility of BHT with the use of pantoprazole and that it completely resolves on stoppage of the drug, mechanical debridement and good oral hygiene.

Tachycardia and fever after packed red cell (PRC) infusion: A case report

ABSTRACT A 56-year-old female patient with a body weight of 60 kg was brought to the hospital with hematemesis and received one unit of packed red cells (PRCs) for this condition. After 30 min, the patient experienced tachycardia of 120 beats/min and an increased body temperature of 102°F. The patient had no relevant medical history of allergy or similar episodes in the past. The patient was not suffering from any coagulopathies or sickle cell anaemia, which is a prevalent condition in the region. The patient was receiving the PRC for the first time. After this event, the infusion was stopped and immediately injection meropenem, pantoprazole and ondansetron IV were administered. The patient’s condition normalised after 6 h. No re-challenge was given after the recovery of the patient. Suspected ADR was analysed according to the World Health organization (WHO) causality assessment scale and the causality was “Possible”. Meticulous monitoring and prompt therapy were provided. The patient was discharged after observing for 24 h. The adverse drug reaction was possibly caused due to the PRCs.

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 &amp; 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.

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.

A case report of metronidazole-induced encephalopathy in Bangladesh

Metronidazole-induced encephalopathy (MIE) is a rare disorder that can be reversible but fatal if not recognized early. Here, the author presents a case of encephalopathy in a 36-year-old patient who took 500 mg of metronidazole three times daily for three weeks. The patient was classified as a probable MIE case on the Naranjo causality assessment scale. An interesting neuroimaging finding in this patient was an isolated dentate nucleus signal abnormality. Author aims to report reversible clinical and radiological features of MIE in this patient and compare them with documented cases in recent and old literature. Data from this case report may guide clinicians to make judicious considerations in the early detection of MIE and may influence future researchers to focus on identifying critical mechanisms of devastating adverse effects, predictability of neurotoxicity.

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.

Analysis of Anti-Angiogenesis-Related Adverse Events Associated with Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitors (VEGFR-TKIs) in Patients with Metastatic Renal Cell Carcinoma.

Limited studies have evaluated anti-angiogenesis-related adverse events involving oral vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) in metastatic renal cell carcinoma using real-world data. This study aimed to investigate the incidence, patterns, and impact on the dose intensity of anti-angiogenesis-related adverse events associated with the use of VEGFR-TKIs in patients with metastatic renal cell carcinoma using real-world data. This cross-sectional study included patients with a diagnosis of metastatic renal cell carcinoma who received axitinib, cabozantinib, pazopanib, sorafenib, and sunitinib at a tertiary hospital in South Korea. We categorized the patients into those who had not previously received a VEGFR-TKI (VEGFR-TKI-naive) and those who had previously received a VEGFR-TKI (VEGFR-TKI-experienced). Anti-angiogenesis-related adverse events were defined as hypertension, proteinuria, bleeding, thrombosis, hypothyroidism, and left ventricular dysfunction, which were rated "possible" or higher based on a causality assessment scale. Among a total of 988 patients, 674 patients were VEGFR-TKI-naïve and 314 patients were VEGFR-TKI-experienced. Anti-angiogenesis-related adverse events of any grade and severe adverse events occurred in 65.1 and 34.6% of VEGFR-TKI-naïve patients and 54.8 and 36.0% of VEGFR-TKI-experienced patients, respectively. Regardless of treatment history, the most common adverse event was hypertension, with 48.6% in VEGFR-TKI-naïve patients and 35.0% in VEGFR-TKI-experienced patients. For VEGFR-TKI-experienced patients, the overall rate of anti-angiogenesis-related adverse events for sorafenib (24.3%) was lower than that for other VEGFR-TKIs (p < 0.05). Patients experiencing anti-angiogenesis-related adverse events were 1.6 times more likely to receive a low relative dose intensity. More than half and more than one-third of patients with renal cell carcinoma receiving VEGFR-TKIs experienced any and severe anti-angiogenesis-related adverse events, respectively. The relative dose intensity of VEGFR-TKI treatment was associated with anti-angiogenesis-related adverse events.

Evaluation of Metabolic Parameters on Use of Newer Antiepileptics Versus Conventional Antiepileptics in Patients of Generalised Tonic-Clonic Seizure: An Observational Study.

Background and objective Epilepsy is the commonest serious neurological condition and around 50 million people live with epilepsy (PWE). Primary and secondary generalised tonic-clonic seizures (GTCS) together constitute up to 50% of adult and adolescent epilepsy. GTCS respond well to broad-spectrum AEDs like valproate, phenytoin, levetiracetam, lamotrigine, and topiramate. Carbamazepine and oxcarbazepine are considered alternatives. Metabolic derangements with the conventional AEDs (phenytoin causes loss of bone mass in women, phenytoin and carbamazepine produce increases in serum lipid and C-reactive protein, weight gain with valproate) are well documented. But, there is limited data regarding the effect of the newer AEDs on metabolic parameters. Thus, this study was undertaken to assess the effects of the newer AEDs on the metabolic profile of patients with epilepsy. Material and methods A prospective observational study was conducted in the Department of Pharmacology, in collaboration with the Department of Neurology at S.C.B. Medical College and Hospital, Cuttack. 100 diagnosed patients with GTCS receiving monotherapy of either conventional or newer anti-epileptics were included in the study. Their metabolic parameters like total cholesterol, serum sodium, serum TSH and fasting blood glucose were collected at baseline, three months, and six months. ADRs were collected during the entire study period and causality assessment was done using WHO-UMC Causality Assessment Scale. All the data were analysed using SPSS 20.0 after applying appropriate statistical tests. Results There was a significant increase in total cholesterol in all four groups (p=0.002) but a pathological increasein the phenytoin and oxcarbazepine groups. There was a significant rise in the serum TSH levels in all groups except levetiracetam, but a pathological increase was seen with phenytoin and valproate, i.e., the conventional ones. Statistically significant hyponatremia was seen with valproate and oxcarbazepine. A rise in the FBS was seen with both phenytoin and valproate (p=0.002) but a pathological rise was seen with phenytoin. Out of the total reported ADRs, 53.5% were seen with conventional AEDs, and the rest 46.5% were seen with newer ones. Conclusion The advent of newer anti-epileptic drugs has unfolded wider horizons to the treatment of epilepsy. Each of these drugs has a unique mechanism of action, making it less prone to resistance. Metabolic derangements are a key determinant in the compliance of these drugs as they can predispose to other co-morbidities. Periodic monitoring of the various metabolic parameters is useful and together with patient counselling can improve the effectiveness of the anti-epileptic drugs.

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.

Adverse drug reactions of oral non-steroidal anti-inflammatory drugs and its fixed drug combinations: A 5-year retrospective observational study

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are very commonly prescribed worldwide. Due to this, the incidence of adverse drug reactions (ADRs) to NSAIDs is increased. Aims and Objectives: This study aims to analyze the ADRs reported to NSAIDs. Patient demographics, organ system affected severity of ADRs, and their causal association with the drug will be studied. Materials and Methods: It was a retrospective analysis of ADRs reported to oral NSAIDs and its combinations over a period of 5 years from January 2015 to December 2020. Prior ethics committee approval was obtained. These ADRs were collected as part of pharmacovigilance activities. Results: A total of 100 ADRs were reported due to NSAIDs. Most ADRs due to NSAIDs were reported in 30–39 years age group. Female gender was most affected by ADRs. Diclofenac was the most common NSAID causing ADRs. Skin and subcutaneous organ system was most affected. Six ADRs were reported as serious. Sixty-seven ADRs were categorized as probable using the World Health Organization causality assessment scale. Conclusion: NSAIDs are commonly prescribed drugs. Analyzing the ADRs reported to NSAIDs will help in finding the risk factors. Based on this knowledge, rational prescription of NSAIDs can be done which will improve the patient safety.

Treatment Reconciliation in Parkinson’s Disease Patients with Particular Reference to Wearing-off and Motor fluctuations: A Registry-based, Prospective, Observational Study

Introduction: Parkinson’s Disease (PD) is the second most frequent neurodegenerative disease and dopaminergic agents are frequently used as a treatment while ‘end of dose deterioration’ or ‘Wearing-Off (WO)’ phenomenon is common with these agents. Treatment reconciliation may be helpful in this situation and there is dearth of studies especially in India. Aim: To study the WO effects in patients of PD, their pharmacotherapy and outcome. Materials and Methods: This registry-based, prospective, observational, outcomes-based study was conducted in the Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, India, in collaboration with Department of Neuromedicine of Kolkata Medical College and private clinics of a Neurologist from January 2020 to December 2021. An attempt was also undertaken to make a registry of Idiopathic Parkinson’s Disease (IPD) patients. WO Questionnaire 19-items (WOQ19), Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS Scale), The 39-items Parkinson’s Disease Questionnaire (PDQ-39 questionnaire), The 8-items Morisky Medication Adherence Scale (MMAS scale), suspected Adverse Drug Reaction (ADR) Reporting Form of Indian Pharmacoepia commission (version 1.3), World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) Scale, Naranjo causality assessment scale, Hartwig and Seigel’s Severity Assessment Scale were used in the present study. The study was commenced after obtaining approval from institutional ethics committee. The data was then analysed with parametric or non parametric tests using (mean±Standard Deviation (SD), median, Fisher’s-exact test, Friedman’s Analysis of Variance (ANOVA) test, Wilcoxon matched pair signedrank test). Data collected and then statistically analysed by using WPS Excel version 2021 and GraphPad Prism version 9 software. Results: Total IPD patients were found to be 111 in the present study with a mean age of IPD patients as 61.85±7.20 years. Incidence of WO in the present study was found to be 40.5% among IPD patients. Most common characteristic of WO was found to be tremor in 104 (28.8%) patients followed by slowness of movement in 63 (17.5%) patients. WHO-UMC scale and Naranjo causality assesment scale both revealed 36.4% ADRs were probable category and 63.6% were possible category. MDS-UPDRS Score, PDQ-39 Score, MMAS-8 score significantly (p-value&lt;0.05) improved during the course of treatment. Conclusion: Dose adjustment of syndopa was mostly used in the management of WO phenomenon and significant improvement in the quality of life of the patients was seen.

Severity in schizophrenia patients receiving atypical antipsychotic medications.

Atypical antipsychotic drugs are nowadays the mainstay of treatment of schizophrenia due to their lesser extrapyramidal symptoms (EPS) as adverse effects. However, these drugs have different profiles of adverse drug reactions (ADRs). Here, the objective of this study was to analyze the probability, occurrences, and more significant involvement of various risk factors. A prospective observational study was carried out on a patient with schizophrenia who has prescribed atypical antipsychotic drugs for their treatment. The probability of the ADR was analyzed by using the Naranjo causality assessment scale. While Glasgow antipsychotic Side effect Scale (GASS) was used to estimate the severity of side effects. Statistical software for social science (SPSS) ver 25; was used for different descriptive statistics and chi-square analysis. A total of 140 patients were included in the study of which the majority (58.57 %) was male. However, atypical antipsychotic drugs were primarily prescribed to the patient as mono therapy (81.43 %). Interestingly, COVID-19 infections were reported as positive in 39.29 % of total patients. Probability assessment of ADRs revealed that most (55 %) were "Probable". Subsequently, the GASS score was evaluated for severity, the majority (55.71 %) were reported as "Mild". The statistically significant association between gender and severity of side effects & duration of illness and severity of side effects were found (P>0.5).The Present study aids in knowing the risk factors and improving the management practices of ADR, thereby improving the guidelines in terms of safe clinical approaches for psychiatric patients.