Vigilance Program Research Articles

Ensuring Safe Transfusion Practices through Haemovigilance: India vis-a-vis Global Scenario.

Haemovigilance is the monitoring of the essential components of blood transfusion from its initial stages to the final outcome considering all the safety parameters and hazards that co-exist with it. It primarily aims to ensure the quality as well as safety related to the use of blood and blood products utilizing the standard healthcare framework and a tailored vigilance program for efficient outcomes. Initially, the art of vigilance was started with the therapeutic products available in the market giving some groundbreaking data on their safety which later led to the implementation of timely measures to control adverse events significantly. Several incidents have occurred during the collection, transport, storage, and transfusion of blood and to stop these incidences of hazard, haemovigilance came into existence with France becoming the first country to step in followed by several nations across the world with customized guidelines directing it to the best. The majorly reported problems include bacterial infections, hemolytic and immune reactions. The present writeup reviews the inception and development of haemovigilance programs with a global scenario, a detailed study of the haemovigilance program adopted in India, and the updated status of these programs in various countries across the globe.

Knowledge assessment of a donor adverse reaction severity grading tool by the National Blood Donor Vigilance Programme of India.

The severity grading tool (SGT) was recently designed by the Association for Advancement of Blood and Biotherapies (AABB) to have more objectivity in severity assignment for an adverse donor reaction after blood donation. A study was performed in India to assess the knowledge (post-training) and determine the degree of agreement of the SGT between participating centres and the subject expert group. This prospective cross-sectional survey-based study was conducted by the National Coordinating Centre (NCC) of the National Blood Donor Vigilance Programme (NBDVP) of India. Thirty-five real-world case scenarios, validated by seven national and two international experts, were sent to the participating centres, and their responses received (diagnosis and severity grade) were compared and analysed. A total of 50 blood centres participated in the study. The overall agreement between the participating centres and the expert group was 66.4%, with a fair Kendall's coefficient of concordance (W) of 0.271 (p-value < 0.05). The degree of agreement was observed to be more than 80% for 12 centres, 60%-80% for 27 centres and <60% for 11 centres. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. The SGT will be an efficient mode to have uniform objective reporting of the adverse donor reactions and may be implemented in the NBDVP of India. This study also highlights the need for training of the blood centres on the basic definitions and categorization of the donor's adverse reaction.

Environmental Variables Related to Aedes aegypti Breeding Spots and the Occurrence of Arbovirus Diseases

Outbreaks of dengue fever, Zika and chikungunya are realities that manifest themselves in almost the entire world. These are diseases whose main vector is Aedes aegypti. This is a synanthropic that needs three factors in order to survive: water, food, and shelter, which are available under favorable socio-environmental conditions. The goal of this work was to identify and evaluate the pertinence of environmental variables that can allow the growth of Aedes aegypti breeding spots and the eventual increase of dengue fever, Zika and chikungunya in rural areas. A systematic literature review was conducted by searching for works published in bibliometric databases, and the results were analyzed in qualitative and quantitative forms (statistical analysis). This search found 1007 works, of which 50 were considered pertinent to the subject. Each work was analyzed individually, and 16 distinct variables were found to be relevant and were afterward grouped into three categories: sanitation (SAN), climatology (CLIM) and socio-environmental factors, which are named “integrative” (INT) variables. The use of two or more categories was present in 52% of the works, highlighting the SAN + INT combination. Around 16% of the works have included rural areas, relating the arbovirus diseases in these regions to socio-economic and sanitation conditions. The paper analyses the impact of water characteristics on the growth of the mosquito, as well as on the increase of the three diseases. The monitoring of these 16 variables may allow for better arbovirus disease control and could be integrated into entomological vigilance programs for helping make decision processes concerning the prevention of diseases associated with water.

Annual report of all ARs reported to Canada Vigilance Program in 2021

Annual report of all ARs reported to Canada Vigilance Program in 2021

Nithya Kalyana Special Program in Month of Shravana of Murughamath of Chitrhradurga under the Blessings of Dr. Sri. Shivamurthy Murugha Sharanaru- A Study

Abstract: Nithya Kalyana-Which means there are two terms Nithya and Kalyana, Nithya which means Daily, Kalyana means Welfare. So totally the meaning of Nithya Kalyana, Daily welfare of Society, especially poor, needy, physically disabled person. Welfare is the good fortune, health, happiness, prosperity, etc., of a person, group, or organization; well-being:Welfare is the state of good health, happiness and comfort or financial assistance from the government.The month of Shravana is coming in August and September, The Indian Society especially in Karnataka traditional citizens worshiping the Cobra or Snake, Cobra is a representative of god that is believe of traditional citizens. And they practiced the Milk infusion. But scientifically the Cobra can’t drink liquid food. Especially the traditional citizens Milk infusion on Stone Cobra, and Worshipping the Stone Cobra. That is meaningless practice, no use to anybody, So many peoples, children, dying daily without food in country. In this situation, we are citizen of India we must create the general awareness among the traditional citizens about meaningless practices. But they can’t listen of our suggestions. The vigilance programme conducted by Three Vidha Dasohigalu, [Education, Food, Occupation] [THREE TYPES DONER] Dr.Shivamurthy Murugha Sharanaru of Murugha math. Keywords: DR.SHARANARU, MURUGHAMATH, DASOHA, EDUCATION, WORK, NITHYA KALYANA, WELFARE, CHILDEREN.

Climatic Change and Population Control

Climatic Change and Population Control

National blood donor vigilance programme of India: Analysis of donor adverse reactions reported during initial 2 years of implementation (2016 and 2017).

INTRODUCTION:The donor vigilance program is intended to collect and assess information on unexpected or undesirable effects or reactions resulting from blood donation. In this report, we discuss the analysis of the blood donor adverse reactions (DARs) reported in the National Blood Donor Vigilance Programme of India during the first 2 years of implementation.MATERIALS AND METHODS:DAR reporting form prepared and approved by the National Executive Committee of the Haemovigilance Programme of India was used to capture the data by the blood centers and submitted to Donor-Vigil software prepared and hosted by the official website of the National Institute of Biologicals. Data reported for the years 2016 and 2017 were reviewed, analyzed, and validated by independent transfusion medicine experts.RESULTS:During this period, a total of 19,98,101 donations denominator data were reported, in which 1,622,600 (80.9%) were valid. A total of 6091 DARs were reported, out of which 3980 (65.35%) were found valid. Only validated numerator and denominator data were included in the analysis. Generalized DARs were the most common type of DARs reported (83.7%), followed by “others” type (7.7%), localized (7.6%), allergic (0.4%), and complications related to apheresis (0.4%). The overall DAR rate was 2.45/1000 blood donations, which was higher in apheresis donations (3.07/1000) as compared to whole blood donations (2.39/1000). The DARs rates were higher in females (3.5/1000) compared to male donors (2.3/1000) and in the first time (2.5/1000) compared to repeat donors (2.15/1000).CONCLUSION:In this report, we concluded that younger age, first time, and female donors are more prone to DARs as compared to older age, repeat, and male donors. During the analysis of the data, we found some limitations, which can be improved by upgrading the reporting form and conducting regular continuing medical education (CMEs) of participant blood centers.

An updated review on Materiovigilance for safe use of medical devices

In the last two decades, there has been an upsurge in the volume of medical devices and thereby increasing medical device-related adverse events. So, materiovigilance is an essential system for identifying, collecting, reporting and analysing adverse events related to medical devices. The Vigilance programme for the medical device was initiated in many countries many years ago but, is a quite new concept for India. The Materiovigilance programme in India was launched on July 6 2015, at the Indian Pharmacopoeial Commission (IPC) with the objective of monitoring adverse events, thereby reducing risks related to use of medical devices and also creating awareness among different stakeholders for improving patients’ safety. The intent of this review article is to provide holistic understanding of medical device related adverse events; classification, reporting criteria, what, where, how, who and why, timeframe and tools used for reporting. Data collected using various search engines and compiled to give complete information regarding the subject matter. The thorough understanding of current status of materiovigilance programme in India including challenges involved in the programme and future directions for improving has been stated. Case studies have been reviewed for Johnson &amp; Johnson’s faulty hip implant and Medtronic premature battery depletion. Implementation of Materiovigilance programme of India (MvPI) version 1.1 lead to safeguard the health of device user by preventing recurrence and risk associated with medical device.

CAN WE USE THE CANADIAN POSTMARKETING SPONTANEOUS PHARMACOVIGILANCE SYSTEM FOR CARDIOVASCULAR DRUG SAFETY RESEARCH?

Postmarketing studies involve the detection and interpretation of potential problems associated with the use of a given drug. Postmarketing Spontaneous Pharmacovigilance Systems, such as the Canada Vigilance program, may constitute a gold mine of free data for drug safety research. However, the quantity and the quality of data remains to be demonstrated. The objective is to assess the feasibility to use the Canada Vigilance database for academic drug safety research, and to document the characteristics of the data that are extractable.

Using Data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for Drug Safety Research: A Feasibility Study.

Post-marketing studies involve the detection and interpretation of potential problems associated with the use of a given drug. Post-marketing spontaneous pharmacovigilance systems, such as the Canada Vigilance program, may constitute a gold mine of free data for drug safety research. However, the quantity and the quality of data remain to be demonstrated. To assess the feasibility to use the Canada Vigilance database for academic drug safety research, and to document the characteristics of data that are extractable. This is a descriptive retrospective analysis study design. The beta-blocker and anticoagulant adverse reactions (AR) in Canada were analyzed. Tests for data extraction from the Canada Vigilance database were performed in October 2019; data were then available from January 1, 1966 to June 30, 2019. There were 41 variables with extractable data. For anticoagulants, data were extracted in Excel and.pdf file format, while it was only plain text.pdf files for beta-blockers. Overall, there were 4707 reported ARs with the use of anticoagulants and 6332 cases reported for beta-blockers. The trend of ARs related to anticoagulants steadily increased in the study period, with a notable increase in 2009 while direct oral anticoagulants were marketed. The proportion of missing data varied from 0 to 98%, but most important variables were all available. It was not possible to distinguish brand names and generic drugs in the database. It seems feasible to use data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for academic drug safety research. Upcoming studies should validate the quality of reports compared to actual medical charts.

Vigilance System Requirements Across US and EU for Medical Device

Medical device vigilance is concerned about device problems (incidents) their analysis and mitigation to ensure that device performance is good and that patient safety are maintained. The main aim of this is to outline the criteria of the medical device vigilance program and to highlight the requirements that still remain in the state laws of regulated markets (US and EU) and to increase access to safe, reliable and therapeutic benefits. The severity of the Subject, risk assessment should carried out by the manufacturer prior to marketing. In US, Medical Device surveillance deals with post-marketing monitoring where the manufacturer or importer is required submit reports to regulatory authorities; same as in the EU. US medical device tracking system involved with different sections to update adverse event. The user or manufacturer has to report incidents to member states where necessary actions are to be taken as early as possible to protect or reduce hazard of casualty or severe decline in terms of safety and quality by implementing the CAPA for risk analysis.

Incidence and analysis of blood donor adverse reactions – an opportunity to establish a donor vigilance programme at an institution in Eastern India

Background and objectivesBlood donors are the essential pillars for safe blood transfusion service. This study aimed to analyse the spectrum of blood donor adverse events (AE) and design strategies for their prevention; to improve donor safety and increase donation frequency; and to encourage the establishment of a donor vigilance across different blood centres.Material and methodsA prospective study was conducted within the Department IHBT over eighteen months on whole blood (voluntary/replacement) and aphaeresis donors who were selected as per the national guidelines. Statistical analysis was done using Spss software.ResultsAltogether, 576 AE were observed in 11 371 donors, with significantly higher rate in plateletpheresis [61 in 314 donors] than WB donation. First time (451/4551), replacement (172/2894), female (158/1535) and young donors (18–40 years) (485/7969) were significantly prone to AE. Generalized vasovagal reactions (n = 349) were the commonest AE followed by haematoma. The onset of AE was mainly during postdonation period. Vasovagal reactions were significantly high in first time (P = 0·0001), replacement (P = 0·0001), female (P = 0·0001), young (18–40 years) (P = 0·0001) and low body weight donors (45–54 kg) (P = 0·0001) when compared to repeat, voluntary, male, older and heavier donors. Haematoma was found significantly higher in aphaeresis [P = 0·0001], first time [P = 0·0001] and heavier donors [P = 0·0001] as compared to WB, repeat and low body weight donors.ConclusionWe attempted to identify the spectrum of donor AE at our institution and also propose certain preventive measures, which would help in reducing the frequency of these AE. It is an evidence‐based approach to guide other blood centres and motivate them to establish their own donor vigilance.

Fragmentation and low density as major conservation challenges for the southernmost populations of the European wildcat.

Knowledge of population dynamics of threatened species in the wild is key to effective conservation actions. However, at present, there are many examples of endangered animals for which their current situation is unknown, and not just in remote areas and less developed countries. We have explored this topic by studying the paradigmatic case of the European wildcat (Felis silvestris silvestris), an endangered small carnivore whose status has been subjectively established on the basis of non-systematic approaches and opportunistic records. Little is known about its demographic situation, prompting the need for information to improve conservation measures. However, the secretive behaviour of felines along with its low density in natural conditions have prevented the gathering of sufficient data. We developed a field sampling strategy for one of the largest populations (Andalusia, South Spain, 87,268 km2), based on a logistically viable systematic non-intrusive survey by camera-trapping. This study offers the first large-scale estimation for any European wildcat population, based on analytical approaches applied on Species Distribution Models. A hierarchical approach based on a Maxent model for distribution estimation was used, along with Generalised Linear Models for density estimation from explicit spatial capture-recapture data. Our results show that the distribution range is smaller and more highly fragmented than previously assumed. The overall estimated density was very low (0.069 ±0.0019 wildcats/km2) and the protected areas network seems to be insufficient to cover a significant part of the population or a viable nucleus in demographic terms. Indeed, the most important areas remain unprotected. Our main recommendations are to improve the protected area network and/or vigilance programs in hunting estates, in addition to studying and improving connectivity between the main population patches.

SAT-052 VIGILANCE, SURVEILLANCE AND EDUCATION REDUCES RATES OF TUNNELLED HAEMODIALYSIS CATHETER-RELATED BLOODSTREAM INFECTIONS

Tunnelled haemodialysis catheter-related bloodstream infections (CRBSI) are associated with significantly increased patient morbidity, mortality and health care costs. A policy-driven systematic approach to haemodialysis catheter care, vigilance and surveillance, and focussed education of staff, is a mandatory part of implementing best practice, optimising patient outcomes and minimising the health care burden. Infection rates of < 1 infection per 1000 catheter-days is considered an excellent benchmark to target (REF - Semin Dial. 2008; 21(6):528-38). International guidelines and studies address infection prevention procedures but day-to-day practices and procedures vary, and account for a range of infection rates between clinical centres. Our vigilance and surveillance program for infection rates noted an increase in CRBSI at our clinical centre. An evaluation and assessment of our catheter care techniques and a mandatory education program to standardise practices and procedures was implemented. Following implementation of an infection surveillance program, an increase in infection rates was noted (graph 1). A policy to implement in-centre standardised catheter care and staff education was introduced. Analysis of CRBSI was performed before and after the policy change. Senior haemodialysis nursing staff evaluated tunnelled haemodialysis catheter care techniques by piloting a competency assessment program. Standard practice included (a) the use of personal protective equipment and aseptic technique with connection and disconnection of tunnelled haemodialysis catheters (b) the application of dressings with topical antimicrobial preparations (chlorhexidine solution) applied to the insertion sites. The trial of a competency assessment ensured systematic and stringent practices that were standardised across our clinical centre. The mandatory use of an insertion site observation chart was also instituted. This chart acted as “trigger” for closer follow up, medical review, and microbiological cultures of the insertion site or blood cultures from the catheter lumen if infection was clinically suspected. The competency pilot was introduced through formal education sessions, mandated reminders at every nursing handover and regular electronic-mail reminders to all haemodialysis nurses. Rates of CRBSI decreased with the introduction of standardised tunnelled haemodialysis catheter care practices and procedures from 2.1 CRBSI episodes per 1000 catheter-days to 1.3 per 1000 catheter-days in the first six months of implementation. This demonstrates a fall in infection rates trending towards a desirable target of excellence (<1 infection per 1000 catheter-days). Our Quality Assurance program will maintain continued monitoring, evaluation and improved practice changes. Centre-wide systematic evaluation and education of haemodialysis tunnelled catheter-care techniques dramatically reduced the incidence rates of CRBSI. The implementation of a formalised policy and annual competency assessment of catheter care, vigilance and surveillance and education is an effective method of improving the rates of CRBSI, patient care and outcomes.

Observations from a nationwide vigilance program in medical care for spinal muscular atrophy patients in Chile.

Spinal muscular atrophy (SMA) has gained much attention in the last few years because of the approval of the first intrathecal treatment for this neurodegenerative disease. Latin America needs to develop the demographics of SMA, timely access to diagnosis, and appropriate following of the standards of care recommendations for patients. These are essential steps to guide health policies. This was a descriptive study of a cohort of SMA patients from all over Chile. We analyzed the clinical, motor functional, and social data, as well as the care status of nutritional, respiratory and skeletal conditions. We also measured the SMN2 copy number in this population. We recruited 92 patients: 50 male; 23 SMA type-1, 36 SMA type-2 and 33 SMA type-3. The median age at genetic diagnosis was 5, 24 and 132 months. We evaluated the SMN2 copy number in 57 patients. The SMA type-1 patients were tracheostomized and fed by gastrostomy in a 69.6 % of cases, 65% of SMA type-2 patients received nocturnal noninvasive ventilation, and 37% of the whole cohort underwent scoliosis surgery. Ventilatory care for SMA type-1 is still based mainly on tracheostomy. This Chilean cohort of SMA patients had timely access to genetic diagnosis, ventilatory assistance, nutritional support, and scoliosis surgery. In this series, SMA type-1 is underrepresented, probably due to restrictions in access to early diagnosis and the high and early mortality rate.

A donor hemovigilance study: evaluation of adverse reactions to blood donors at tertiary care teaching hospital

Background: Donor hemovigilance is an important aspect of the hemovigilance system and contributes to decrease the blood donor’s complications and improving blood donor safety and functioning of blood bank. Reporting of adverse reactions associated with blood donations has been covered under National blood donor vigilance programme. This study was carried out to estimate the adverse events in blood donors and to promote their safety.Methods: The study was conducted over a period of 6 months, from 1st January 2017 to 30th June 2017 after getting approval from institutional ethics committee at tertiary care teaching hospital. Prior informed consent was obtained and donor confidentiality was ensured. The donors were observed for adverse event during or after donation. For delayed reactions, donors were requested to contact the researcher or designated departmental staff. Data was collected in case record form. Data entry was done in excel 2013 and appropriate Statistical test (chi square) was applied.Results: During study period total 7970 donors were registered, out of which 53.27% donors have donated their blood in blood camps and 46.72% have in blood bank. Incidence of donor reactions was 1.54%. Incidence of adverse reaction was higher at blood camps (58.53%). Authors found highest number of cases of mild vaso vagal type reactions (53%). Other types of reactions observed were painful arm, hematoma, delayed bleeding, tingling and moderate type of vaso vagal reaction.Conclusions: Authors did not find any major serious events like convulsion, thrombophlebitis or arterial puncture during study period. It considers that safety of donors was maintained.

Alteraciones neuropsicológicas tempranas por exposición a solventes en pintores de una compañía automotriz

&#x0D; &#x0D; &#x0D; Con el propósito de identi car alteraciones en el área neuropsicológica, se realizó un estudio cuantitativo, epidemiológico, descriptivo de corte transversal, a 50 pintores de cabina que aplican primer color y barniz. La edad promedio fue de 33.6 años, 80% (n= 40) bachilleres, con 10 años en promedio de antigüedad en el puesto. Se aplicó el mini test del estado mental, la prueba del reloj, el inventario de depresión de Beck, se tomaron datos de la historia laboral, se formularon 30 preguntas en la anamnesis y se practicó un examen neurológico de nervios periféricos y pares craneales. &#x0D; El 26% (n=13) presentó un posible deterioro y el 16% (n=8) deterioro leve a la aplicación del mini test del estado mental. De los 8 casos con deterioro leve, dos deben realizarse pruebas complementarias. El 8% (n=4) presentó deterioro cognitivo en la prueba del dibujo del reloj. El test depresión de Beck demostró un 12% (n=6) con depresión leve y un solo caso depresión grave. El factor de riesgo exposición por más de 10 años se asoció con mayor frecuencia de parosmia, hipoacusia, disminución de re ejos, deterioro cognitivo y depresión. El factor de riesgo exposición más de 4 horas se asoció con mayor frecuencia de parestesia y di cultad para dormir. Se planteó la necesidad de incluir pruebas de valoración neuropsicológica en el programa de vigilancia al personal expuesto a solventes. &#x0D; &#x0D; &#x0D;

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets.

Did the New Italian Law on Mandatory Vaccines Affect Adverse Event Following Immunization's Reporting? A Pharmacovigilance Study in Southern Italy.

Despite the well-recognized role of vaccines, coverage is far from optimal especially in children, representing a growing concern also in Italy. In order to reverse this emergency, the Italian Ministry approved in July 2017 the Law 119/2017, which renders mandatory and free of charge 10 vaccinations for patients aged 0–16. We aim to investigate the effects of the new Law 119/2017 on the reporting of adverse events following immunization related to mandatory vaccines into the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza – RNF). Therefore, we analyzed the spontaneous reports of suspected adverse events following immunization recorded in Campania Region (South of Italy) from December 1, 2016, to March 31, 2018. During the study period, 69 reports, covering 179 AEFIs, related to mandatory vaccines were sent to Campania Pharmacovigilance Regional Center. A substantial increase in AEFIs reporting was observed after the adoption of Law 119/2017. Out of 69 reports, 62% reported AEFIs that were considered as not serious and 78% had a favorable outcome. Out of 179 AEFIs, more than half referred to the following SOC: “general disorders and administration site conditions,” “nervous system disorders,” and “psychiatric disorders.” The highest number of reports came from patient/citizen. After the adoption of the Law 119/2017, there was an increase in the number of reports (18 before the adoption of the Law vs. 51 after). According to reported AEFIs during the entire period, no worrying safety data have emerged. In our opinion, the increase in the number of AEFIs’ reports should be related to the increase in vaccination coverage as well as to the intense debate that has followed the new Law. In this context, the continuous monitoring of vaccine safety and the fully implementation of vaccine–vigilance programs play a key role in achieving higher confidence in immunization programs and optimal vaccination coverage rate.

Profile of cutaneous adverse drug reactions of carbamazepine

Background: Carbamazepine, a commonly used antiepileptic drug is known to produce adverse effects including dangerous reactions like cutaneous hypersensitivity reactions such as drug induced hypersensitivity syndrome (DHS), Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The FDA released a warning that serious and potentially fatal skin reactions may occur after carbamazepine in patients positive for the HLA-B*1502 allele which occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. This study profiles the cutaneous adverse drug reactions reported in this institute over a period of 3 years.Methods: This retrospective study was conducted at Tirunelveli Medical College Hospital by analysing patient case records based on adverse drug reactions reported between August 2014 and July 2017 in the adverse drug reaction monitoring centre. The age, gender, diagnosis, type of cutaneous ADR, duration of treatment, seriousness of reaction and outcome were recorded and analysed.Results: Among the total 25 reactions 36% were benign and 64% were severe reactions. According to Pharmaco vigilance Program of India 80% of the reactions were serious and 20% non serious. The commonest benign skin reaction was maculopapular eruption. SJS and TEN were the two very serious reactions which affected 8 patients totally. Exfoliative dermatitis was reported in 7 patients and Drug Hypersensitivity Syndrome (DHS) in one patient.Conclusions: Severe cutaneous reactions occur after carbamazepine and prevention of ADR requires prediction of predisposition which requires special studies of HLA or genomic assessment. These are the issues of interest for future research.