WHO-UMC Scale Research Articles

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome with Multiple Drugs (Leflunomide and Cefuroxime): A Case Report

Background: Adverse Drug Reactions (ADRs) are unexpected reactions to a medicine administered in the correct manner and at the proper dosage. Drug Rash with Eosinophilia and Systemic Symptoms syndrome (DRESS syndrome) is a Severe Cutaneous Adverse Reaction (SCAR) type of ADR with complicated clinical features involving several organ systems of the body; frequently involved organs are the liver, kidney, lungs, and other organs. Prompt recognition and correct diagnosis, followed by withdrawal of the causative agent, can promote appropriate treatment, accelerate recovery, and reduce the related morbidity and mortality. Case presentation: We have, herein, presented a case of a 42-year-old female with a history of leflunomide intake for plantar fasciitis. The patient subsequently developed fever, gastrointestinal tract disturbance, facial edema, liver injury, skin rash, hematologic abnormalities (eosinophilia), hepatosplenomegaly, and lymph node enlargement. The probability of leflunomide-induced DRESS syndrome was rated as “definite”, with seven scores graded by RegiSCAR. The suspected causative agent was withdrawn, and the patient was managed symptomatically. Following her management and discharge, she again encountered similar complaints after administration of the cefuroxime tablet. The causality assessment of the reactions was done using the WHO-UMC scale and Naranjo’s assessment scale, and a “probable” reaction was found for both drugs. Conclusion: The presented case contributes to the existing global literature regarding exceptional clinical presentations. Leflunomide and cefuroxime drugs have the potential to cause DRESS syndrome. Thus, they should be handled cautiously, and if such a reaction occurs, it should be reported to the responsible authorities.

Preventability and manageability of adverse drug reactions in COVID-19 with mucormycosis: An observational study.

In the intricate landscape of healthcare amid the COVID-19 pandemic, the emergence of mucormycosis as a severe complication posed a significant challenge to primary healthcare. This study delved into the complexities of adverse drug reactions (ADRs) in COVID-19 patients with mucormycosis undergoing treatment with conventional amphotericin B. Ethically approved and meticulously conducted, the study scrutinized 154 ADRs in depth, shedding light on their classification, outcomes, and interventions in COVID patients with mucormycosis. A descriptive analysis was carried out to report the findings of this study. The findings revealed that a substantial proportion (85.6%) of these ADRs were manageable, emphasizing the need for vigilant monitoring and timely interventions. Notably, gender disparities surfaced, indicating potential gender-specific responses to amphotericin B. Causality assessments based on the WHO-UMC scale classified the majority of ADRs as certain, providing a robust foundation for understanding the intricate relationships between amphotericin B and the observed adverse events. This research not only categorizes ADRs as preventable and manageable but also offers practical insights into their nature and the diverse strategies employed for their management. The study's outcomes underline the importance of personalized healthcare approaches that can be adopted by primary care physicians for effective patient care.

Toxic Epidermal Necrolysis by Lamotrigine - A Case Report of Fatality

Toxic epidermal necrolysis (TEN) is an immune mediated fatal adverse muco-cutaneous drug reaction characterized by extensive exfoliation of the epidermis and mucous membrane. It may result in sepsis and death. In most cases, TEN is caused by certain drugs & vaccines. TEN involves more than 30% of body surface area. Steven Johnson Syndrome also shows the same disease process and same spectrum of drug-induced epidermolysis. A 37-year-old patient who was on Lamotrigine, Escitalopram & Clonazepam for multiple somatoform disorder developed generalized vesicular rash with fever after 2 weeks of initiation of lamotrigine. The patient was admitted to the hospital and Lamotrigine was taken off. Patient was given conservative management. Adverse drug reaction was reported to Adverse drug reaction monitoring centre (AMC) and severity was assessed by WHO-UMC Scale. Patient died after 5 days of admission. Score of Toxic epidermal necrolysis (SCORTEN Scale) is used to assess severity of the illness and to predict mortality rate. Early Diagnosis, withdrawal of offending agent, timely proper supportive management can help in lowering the mortality. Keywords: Toxic epidermal necrolysis, Lamotrigine, Adverse drug reaction, Multiple somatoform disorder, Steven Johnson Syndrome, Score of Toxic epidermal necrolysis

Safety monitoring of precautionary third dose of COVID-19 vaccines in a district in Northern India.

The World Health Organization (WHO) declared Coronavirus disease-19 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) a pandemic on March 11, 2020. On 16th January 2021, India began its vaccination programme using two COVID-19 vaccines (Covishield and Covaxin). Precautionary dose (booster shots) was administered to health and front-line workers in the beginning and then to all eligible populations. This was a descriptive observational study conducted in the COVID-19 vaccination centres of Karnal district and the ADR monitoring centre, KCGMC, Karnal. During the visits to vaccination centres, all beneficiaries of the precautionary third dose of COVID-19 vaccines as well as healthcare workers were sensitized to report in case of any adverse event following vaccination as part of the policy of the vaccination programme run by the government and Pharmacovigilance Programme of India. The data were collected in suspected adverse drug reaction (ADR) reporting form version 1.4, and causality assessment was done as per the WHO-UMC scale. The data were analysed as simple proportions and percentages. The booster dose was administered to 72,853 individuals, while the 1st dose and 2nd dose were given to 13,30,042 and 10,73,050, respectively. Only three ADRs were reported with the booster dose in 34 vaccination centres in the Karnal district. These three ADRs were classified as unlikely on causality assessment and hence not included in the analysis. The booster dose administered for the prevention of COVID-19 has been found to be reasonably safe. The population who received COVID-19 booster doses was significantly less than the populations who received the first and second doses, which suggests a low acceptance rate.

A study to Monitor Adverse drug reactions in a patients of Chronic Obstructive pulmonary Disease

Background: Inappropriate drug usage may preclude ideal benefit due to increased medical cost, adverse effects and mortality. Therefore drug utilization studies have become a plausible means in evaluating the healthcare systems. COPD management usually involves more than one drug which may escalate the risk of ADEs (adverse drug events). The present study aimed at assessing the current drug practice and ADEs in COPD management in ICU. Material and Methods: A prospective, single centered, observational and open labeled study was carried out in Department of Pulmonary Medicine and Pharmacology, Tertiary Care Teaching Hospital. The patient population was broadly divided into four categories based on diagnosis ‑ chronic obstructive pulmonary disease, Infections, Asthma and Others. Suspected ADRs were reported, analyzed, and causality assessment was carried out using Naranjo’s algorithm scal0065. Results: In our study, most important causative drug was Budesonide (11.1%). Causality assessment of ADR by Naranjo’s algorithm showed 11.9% probable and 88.1% possible reactions. According to WHO-UMC scale, 85.9% reactions are possible, 11.1% are probable, and 3% are unlikely. Among the 270 ADR reported, the most common ADR was oral thrush which accounted for 11.1% (n = 30) of the reported cases, followed by palpitation 11.1% (n = 30), sore throat 20 (7.4%), dizziness 17 (6.3%) cases, and headache 20 (7.4%) of reported ADR cases. Conclusion: Many research have been conducted separately on various respiratory diseases such as COPD, tuberculosis, asthma, respiratory tract infections (upper/lower), and so on. However, this study included some of the most common diseases in this field, such as COPD, tuberculosis, and respiratory tract infections. A routine patient follow-up is needed for the early detection and prevention of ADRs in order to improve patient adherence to drug therapy and provide improved drug therapy by avoiding associated morbidity and mortality.

Causality Assessment Between Drugs and Fatal Cerebral Haemorrhage Using Electronic Medical Records: Comparative Evaluation of Disease-Specific and Conventional Methods.

A new algorithm for causality assessment of drugs and fatal cerebral haemorrhage (ACAD-FCH) was published in 2021. However, its use in clinical practice has not been verified. This study aimed to explore the practical value of the ACAD-FCH when applying information available in clinical practice. The medical records of patients who died at the University of Tokyo Hospital in 2020 were reviewed, and cases with intracranial haemorrhage were selected. Two evaluators independently assessed these cases using three methods (the ACAD-FCH, Naranjo algorithm, and WHO-UMC scale). The number of 'Yes', 'No', and 'No information/Do not know' responses to each question by both evaluators were summed and compared. Inter-rater reliability was evaluated for each method using agreement rates and kappa coefficients with 95% confidence intervals (CI). Among 316 deaths, 24 cases with intracranial haemorrhage were evaluated. The proportion of ‛No information/Do not know' responses for each question was 35.6% (95% CI 31.4-40.6%) for the ACAD-FCH and 66.9% (95% CI 62.5-71.1%) for the Naranjo algorithm. The respective agreement rates and kappa coefficients were 0.917 (0.798-1.00) and 0.867 (0.675-1.00) for the ACAD-FCH, 0.708 (0.512-0.904) and 0.139 (-0.236 to 0.513) for the Naranjo algorithm, and 0.50 (0.284-0.716) and 0.326 (0.110-0.541) for the WHO-UMC scale, respectively. Our findings suggest the utility of the ACAD-FCH when assessing death cases with intracranial haemorrhage. However, larger studies including intra-rater assessments are warranted for further validation of this algorithm.

Assessment of Potential Adverse Drug Reactions Associated with Cardiovascular Medicines

Background: Every drug has the potential to cause ADRs. Cardiovascular medications are a major problem in drug therapy as they can result in several consequences, ranging from allergic reactions to permanent harm. We have undertaken a meta-analytic review of various types of studies performed in different hospital settings to understand the importance of ADRs in CVD patients and how ADRs might be better detected, evaluated, and avoided. Objectives: To study various factors and assess the incidence, causality, severity, and preventability of ADRs associated with cardiovascular drugs. Methods: Meta-analytic study conducted over 6 months by reviewing 24 articles finalized from 58 articles collected from various data sources like Clin Med, Pubmed, and Medline. Information related to ADRs was analyzed by using demographic data through various questionnaires and scales in articles. Results: A total of 4421 ADRs were reported among 9759 patients. 8/24 of the studies performed causality assessment by using the Naranjo scale and 12/24 used the WHO-UMC scale. 9/24 studies assessed severity and 5/24 studies performed preventability assessments. The incidence of ADRs was high in the 40-80 age range (94.69%). Commonly prescribed drugs were calcium-channel blockers and beta-blockers in CVD patients. Organ systems like the cardiovascular, central nervous and respiratory systems were commonly affected. Most ADRs were mild and possible. Females experienced more ADRs compared to males. Conclusion: Although this study provides estimates of the incidence, severity, and preventability of ADRs in different settings, further studies are needed for monitoring ADRs in patients using CVD drugs to address how such ADRs will be prevented.

Incidence of Adverse Drug Reactions (ADRs) and their Determinants among Sputum-Positive Pulmonary TB Patients in A Metropolitan Area, Bengaluru: A Prospective Study

Background: India accounts for 2.42 million new Tuberculosis cases in 2022. Treatment adherence is major challenge, ADRs being one of the main causes of poor adherence. Early identification and addressing of ADRs can improve adherence, reducing associated morbidity and drug resistance. With introduction of daily FDC regimen in India, we intend to study incidence of ADRs and their determinants among Pulmonary TB patients who are on FDC daily regimen. Methodology: Newly diagnosed drug-sensitive PTB patients aged 18 years and above were recruited. A pretested questionnaire was administered and patients were followed up to document ADRs. Causality and severity were assessed using the WHO-UMC scale and Hartwig’s severity assessment scale respectively. Results: Among the study participants’, 95 (78.5%) developed any ADRs. Incidence rate was 13.2 (6.98–19.22) per 100-person month follow-up with GI symptoms being most common. Increasing age [OR=4.7(1.6–14.8)] and weight [OR=5.1(1.3–16.2)] were found to be significantly associated with ADRs. All ADRs were classified as ‘probable’ and ‘mild’ in nature according to WHO scale and Hartwig’s severity assessment scale respectively. Conclusion: Occurrence of ADRs is common, most of them are mild, and occurring in intensive phase. Hence, early identification and appropriate counselling during intensive phase is critical.

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

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

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.

PSORIASIFORM DRUG ERUPTION INDUCED BY ANTI-TUBERCULOSIS MEDICATION: A CASE REPORT

Objective: Psoriasiform drug eruptions can be induced by several drugs. Psoriasis is a chronic inflammatory disease characterized by T-cell-mediated cytokine production that drives the hyperproliferation and abnormal differentiation of keratinocytes. Drugs can cause new lesions when there is no prior history or family history of psoriasis. Based on the psoriatic drug eruption probability score, β‐blockers, synthetic anti‐malarial drugs, non‐steroidal anti‐inflammatory drugs (NSAIDs), lithium, digoxin and tetracycline antibiotics are relevant in psoriasis.
 Methods: A 58-year-old male was admitted to the Department of Respiratory Medicine at B. P. S G. M. C, Khanpur Kalan, Sonepat as a case of pulmonary tuberculosis and was put on anti-tubercular drugs CAT-I (according to RNTCP guidelines). The patient had a history of diabetes mellitus and hypertension for the past six years. On the third day of initiation of ATT, the patient started developing a psoriasiform rash. The psoriasiform rash began to improve within a few days after discontinuing the ATT. A causality assessment was done as per the WHO-UMC scale, which showed that the adverse events were likely caused due to the ATT.
 Results: Psoriasiform rash is a severe adverse drug reaction characterized by widespread lesions. Among all the various adverse drug reactions, lichenoid drug eruption is commonly associated with anti-tuberculosis medication and needs to be differentiated from psoriasiform eruption. The underlying pathomechanism of drug-induced psoriasiform eruptions remains uncertain, although several immunological interactions have been hypothesized.
 Conclusion: ATT has been reported to cause psoriasiform rash, and its drug component needs to be reconsidered in view of safer alternatives available.

Taxanes induced hypersensitivity reactions in cancer chemotherapy patients reported at adverse drug reaction monitoring centre at a tertiary care hospital

Background: Cancer chemotherapy involves highly complex regimens using antineoplastic agents like taxanes (paclitaxel, docetaxel) etc. Taxanes cause hypersensitivity reactions (HSRs) like redness, rashes, dyspnoea, severe anaphylaxis and death. In this study, adverse drug reactions (ADRs) associated with taxanes are described & analysed on their severity and preventability. The present study aims to analyse and determine the prevalence of ADRs, especially HSRs in patients treated with taxanes.Methods: After getting IEC approval, the present study is done retrospectively by assessing the HSRs in suspected ADR reporting forms from December 2019 to February 2022 in ADR monitoring centre (AMC) in the Department of Pharmacology at Kurnool Medical College, Kurnool. Descriptive statistics used to analyse patient demography, frequency, various carcinomas under treatment & organ involved, causality assessment using WHO-UMC Scale and Naranjo's Algorithm, severity assessment using modified Hartwig & Siegel’s scale and preventability by modified Schumock & Thornton scale.Results: A total of 258 ADRs were recorded, of which 30 cases reported HSRs with taxanes-paclitaxel (22) and docetaxel (8). The most commonly occurred HSR is shortness of breath. Naranjo’s algorithm showed 52.5% possible (score 1-4) HSRs. WHO-UMC causality assessment scale showed 56.4% as probable HSRs. Modified Hartwig & Siegel severity scale showed 46.6% moderate (level 3). Modified Schumock and Thornton scale showed 76.9% as not preventable.Conclusions: Chemotherapy-related ADRs among cancer patients urges the oncologists to be actively involved in ADR reporting, in the need of the hour in order to mitigate, avoid their occurrence and reducing morbidity and mortality, when practiced with diligence.

ADR Profile of the Covishield Vaccine Among Healthcare Workers in a Tertiary Care Teaching Hospital in India.

Coronavirus disease 2019 (COVID-19) is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/2019-nCoV). Though many classes of drugs have been advocated/used for the treatment of this disease, vaccines are being targeted for its ultimate prevention. Indian Government has approved Covishield (ChAdOx1 nCoV19 Corona Virus Vaccine-Recombinant) for restricted use in emergency circumstances. This study is aimed at evaluating the safety profile of the Covishield vaccine among healthcare workers in a tertiary care hospital. All Adverse Drug Reactions (ADRs) reported to the ADR monitoring centre by healthcare workers who received the Covishield vaccine during the study period of 3 months were analysed on various parameters, and the assessment was done using the WHO-UMC scale. During the study period, a total of 1216 beneficiaries were vaccinated with 1st dose of Covishield, and out of these, 727 beneficiaries also received 2nd dose of the vaccine. Out of the 1216 beneficiaries vaccinated, 69 ADRs were reported in 24 healthcare workers. The most common ADR reported was fever (24.64%), followed by myalgia (18.84%). No death or any serious anaphylactic reaction was observed. None of the healthcare workers experienced any adverse event during the observation period of 30 minutes. Serious reactions were reported in 4 healthcare workers as per the Pharmacovigilance Programme of India (PvPI) criteria of serious AEFI. 92% of healthcare workers recovered from ADRs during the study period. 84% of ADRs were classified as probable as per the WHO-UMC scale. As per the Government of India directives, all the healthcare workers in the institute were encouraged to take both doses of the Covishield vaccine. The beneficiaries were kept under observation for 30 minutes and monitored for any adverse drug reaction following vaccination. The vaccine was found to be safe with a very low incidence of ADRs.

Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment

The combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortriptyline (100 mg/10 mg) orally for the neuropathic pain. After 3 days she developed erythematous maculopapular rash on face, upper limbs and back. Following this the drug was then discontinued and pheniramine, hydrocortisone and combination tablet of levocetirizine and montelukast was administered to treat the rashes. Causality assessment was done using the Naranjo scale and WHO UMC assessment scale. The ADRs was reported by VigiFlow in the pharmacovigilance centre. Causality assessment using Naranjo scale (Score 6) and WHO UMC scale indicates probable relationship. Hence, monitoring is essential for any ADRs while using combination of gabapentin and nortriptyline therapy. In case of ADRs, discontinue the therapy and report the adverse drug reactions to pharmacovigilance centre.

AN EVALUATION OF ADVERSE DRUG REACTIONS WITH REMDESIVIR IN PATIENTS OF COVID-19

Objectives: The aim of the study was to evaluate the adverse drug reactions (ADR) following Remdesivir therapy in patients of COVID-19. Methods: All patients more than 18 years of age of any gender, diagnosed with COVID-19 infection receiving remdesivir therapy and fulfilling the selection criteria were included in the study after informed consent. They were monitored for ADRs till end of treatment and analyzed for characteristics of the ADRs: Causality, severity, and preventability. Results: Out of 80 patients (mean age of 49.27±16.22 years) enrolled, 51 (63.75%) developed 84 ADRs. Most common ADRs included increased aspartate transaminases, (20.23%), increased bilirubin (19.04%), increased alanine transaminases (13.09%), increased creatinine (11.90%), and increased blood urea (9.52%). Causality assessment using WHO-UMC scale showed, 85.71% possible, 13.09% probable, and 1% certain causal association of the ADRs with remdesivir. A total 75% ADRs were mild in severity and 45% patients recovered from the event at the end of treatment. Conclusion: Hepatic and Renal dysfunctions are observed with remdesivir in COVID-19 patients. Intensive monitoring of ADRs with newer drugs with EUA such as remdesivir is warranted to ensure safer use in patients.

Clinical Pattern and Causality Assessment of Drug-induced Cutaneous Reactions in a Tertiary Care Hospital in India: A Prospective Study.

Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy, or self-administers over-the-counter medications. The objective of this study is to analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo's scale. The severity of the reactions was determined by the Hartwig scale. This was conducted as a prospective observational study in patients admitted to SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the hospital. Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate. It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve the outcome of the treatment.

Study of Clinicodemographic Profile of Adverse Cutaneous Drug Reactions in Indian Perspective

Background: Cutaneous adverse drug reactions are an important group of disorders which pose considerable amount of diagnostic and therapeutic challenges. The incidence of CADRs is estimated to be 1–2% in the general population. Newer insights have been developing in the field of factors affecting CADRs and the need for studies in the Indian population regarding the newer trends in cutaneous adverse effects. Materials and Methods: A prospective and observational study was conducted in the Department of Pharmacology and Collaboration with Department of Dermatology in MGM Medical College and LSK Hospital. All cases of suspected CADRs in patients with systemically administered drugs were actively screen by a senior dermatologist. Causality assessment was done by a Pharmacologist using WHO UMC scale. Only those cases where the causality was certain probable/likely were recorded. Results: This sampling comprised of 77 CADRs over a period of 1 year from June 2012 to May 2013. The clinical pattern and spectrum of CADRs were studied in 77 subjects. A wide clinical spectrum of CADRs ranging fixed drug eruptions to serious Stevens Johnson syndrome (SJS) was observed. The predominant pattern of reactions observed was fixed drug eruptions FDE (35.1%) followed by acneiform eruptions (23.4%), erythema multiforme (9.1%), and phototoxic drug reactions (7.8%). The antimicrobials causing FDE were macrolides, cephalosporins, and fluoroquinolones. Among the NSAIDs causing FDE, most were due to diclofenac (70%). CADRs were seen most commonly in the 31–40 (26%) years age group followed by 11–20 (24.7%) years and 41–50 (19.5%) years with mean age 32.09 years. Only 5.2% patients were more than 60 years, oldest being 67 years. Antimicrobials were the most common drug group incriminated in 34% patients followed by NSAIDs in 29% cases and steroids in 25% cases. Among NSAIDs, maximum number of CADRs were caused by ibuprofen (40.9%) followed by diclofenac (36.4%), paracetamol (9%), aceclofenac (9%), and nimesulide (4.5%). Serious reactions were infrequent. Conclusion: Most of the reactions were mild (53%) to moderate (42%) requiring no major medical intervention. However, a larger and multi-centric study needs to be conducted across the state to obtain more information about CADRs among the state population.

A A Rare Case Report of Toxic Epidermal Necrolysis with Iron Sucrose/first line Anti-tuberculosis Treatment Drugs

Toxic Epidermal Necrolysis [TEN] is life-threatening condition with mortality rate of 30-60%. Most common etiology of TEN is drug induced. Though Anaphylactic [Type I Hypersensitivity] reactions have been reported with Iron Sucrose, we present first case of TEN [Type IV Hypersensitivity], associated with Iron Sucrose along with Anti-tuberculosis treatment [ATT], to our knowledge. Iron Sucrose is considered relatively safer than other iron formulations. After 48 hours of administering Intravenous Iron Sucrose [20 mg in 200 ml N.S] infusion [first day], patient developed TEN symptoms [third day]. He was taking first line ATT drugs since past one month for Pulmonary Tuberculosis. On basis of history, 80-90% Body Surface area involvement, positive Nikolsky sign and laboratory findings, patient was diagnosed with drug induced TEN [fifth day]. For TEN management, ATT was withdrawn and patient was treated with intravenous Dexamethasone, Piperacillin/Tazobactam, Metronidazole, Pantoprazole, Intravenous fluids with dermatologically supportive local applications and patient was monitored. Patient died due to septic shock despite all resuscitative measures [seventh day]. Causality assessment (WHO UMC scale and Naranjo scale) was ‘Possible’ for both Iron Sucrose and ATT drugs. No improvement in patient’s condition after withholding ATT and short duration between Iron sucrose and symptoms of TEN onset suggests an increased likelihood of TEN induction by Iron sucrose. However, either ATT or Iron Sucrose could trigger TEN in presence of other drug. Improved understanding by physicians of these relatively unknown life-threatening ADR’s and interactions can aid in early identification and enhanced vigilance in future scenarios.
 Keywords: WHO UMC Scale, SCORTEN score, Naranjo scale, Anaphylactic reactions

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.