Pharmacovigilance Programme Of India Research Articles

EVALUATION OF CUTANEOUS ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL IN SOUTHERN INDIA: A RETROSPECTIVE ANALYSIS

Objective: This study was undertaken to understand the demographic profile, common causative drugs, and the presentations of cutaneous adverse drug reactions (CADR) among the patients of our hospital. Methods: This is a retrospective analytical study. All CADR reported to our adverse drug reaction monitoring center from dermatology outpatient department (OPD), other OPDs, intensive care units, and inpatient wards of our hospital from September 2022 to March 2024 was collected from VIGIFLOW (software used by the pharmacovigilance program of India). The data was then analyzed. Results: A total of 272 CADR were reported over the study period. The median age of presentation was 41 years (Interquartile range=23). Overall 44 (16.18%) serious and 228 (83.82%) non-serious CADR were reported. Erythematous maculopapular rash was the most common clinical presentation (63%). Bullous exfoliative drug eruptions and Stevens Johnson’s syndrome were some of the serious CADR. The most common suspected medications were antibiotics (42.15%) followed by non-steroidal anti-inflammatory drugs (8.92%). In 76% of the cases, the suspected medication was withdrawn. The outcome was reported as “Recovering” in 52% of the cases. On causality assessment, 251 (92%) CADR were classified as “Possible.” Conclusion: A CADR is a common yet preventable health problem. As seen from our study, most of the suspected medications were withdrawn and subsequently the patients were recovering from the CADR. Hence, early diagnosis, identification, and withdrawal of the implicating drugs help in timely recovery and prevention of complications, which in turn help in decreasing the burden on our healthcare system.

A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.

Adverse Drug Reactions (ADR) are one of the essential causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Scale), the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

Safety Profile of Mass Administration of Albendazole Among School Children (6-19 Years): A Prospective Active Surveillance Study.

Infections with Soil-transmitted Helminths (STHs) impact about 24% of the global population. A disproportionate number of individuals, particularly those from low socioeconomic backgrounds, live in emerging nations. In India, between the ages of one and fourteen, almost 220 million children are susceptible to intestinal worm infestations caused by parasites. The National Deworming Day (NDD) initiative was started by the Indian government in February 2015 as a part of the National Health Mission to address this problem. Though the adverse effects of albendazole in routine therapy are known, the mass administration of the medicine in children as part of a public health program has not been adequately studied. This study aimed to determine the occurrence, type, and severity of adverse drug reactions resulting from mass administration of albendazole in school children aged 6-19 years in a district of northern India. Twenty specified clusters were randomly chosen from a total of 94 clusters in the state to participate in this prospective, descriptive, observational study that was carried out in Karnal, Haryana. Both a passive approach and an active adverse drug reaction reporting system were used in the study. The six-step process known as Deb's Active Surveillance & Assisted Reporting System was employed in our study. Adverse drug reactions were recorded using the suspected Adverse Drug Reaction (ADR) reporting form of the Pharmacovigilance Programme of India (PvPI). Twenty clusters with a combined total of 94 schools and 12,751 students were observed during the study. In this study, there were more female participants (N = 8,060; 63.21%) than male participants (N = 4,691; 36.78%). A total of 29 ADRs were reported. All reported ADRs were mild in nature. It was discovered that there were 1.37 incidences for every 1000 individuals. As illustrated in Fig. (1), the most frequently reported Adverse Drug Reactions (ADRs) were vomiting (N = 10), nausea (N = 4), abdominal pain (N = 2), and headache (N = 1). The majority of ADRs were categorized as probable (N=18; 62.06%), followed by possible (N=11; 37.93%). An active surveillance system alongside voluntary passive reporting during the mass administration of medicines can help evaluate the safety profile of the medicinal products. The occurrence of ADRs following mass administration of albendazole in school children was found to be only 1.37 incidences for every 1000 recipients, being mild in nature, with vomiting being the most common.

Sodium Valproate-Induced Hyperammonemia: A Case Series in a Tertiary Care Hospital.

Sodium valproate (VPA) is an extensively used anti-convulsant, which is an effective drug for treatment of epilepsy in adults and children, as well as for conditions like migraine, bipolar disorder, mania, and trigeminal neuralgia. Sedation, vertigo, ataxia, dose-dependent tremors, headaches, and gastrointestinal side effects are the most often reported adverse effects associated with VPA. A potential life-threatening event reported with VPA is hyperammonemia (HA), which is defined as an increase in serum level of ammonia. Only 587 reported cases of HA were found in the VigiAccess database, representing a mere 0.6% of the 95,000 reported adverse events linked to VPA. Hence, this case series was conducted with emphasison monitoring of increased serum ammonia levels with or without hepatic enzymes increase for patients who are on VPA. To assess elevated serum ammonia levels following VPA administration, and to ascertain the percentage of individuals with hepatic enzymes increased who took VPA and subsequently had elevated serum ammonia levels. This study was conducted at the adverse drug reaction (ADR) monitoring centre (AMC) of the Pharmacovigilance Programme of India (PvPI) and Department of Psychiatry, Christian Medical College and Hospital (CMC&H), Ludhiana. The study comprised of 12 patients who were exclusively on VPA and exhibited symptoms related to elevated serum ammonia.An informed consent form (ICF) was provided to the patient prior to taking their personal details. Laboratory investigations were done to establish the diagnosis and liver function tests (LFTs), chiefly ALT (alanine transferase) and AST (aspartate aminotransferase) were also performed.It is a descriptive study which was for a time period of six months. Results: This study includes 12 patients who had HA confirmed by laboratory investigation. Out of these 12 patients, two patients (17%) had a corresponding increase in LFT. The average as of the patients was 53.08 years and average serum ammonia levels were 219.15. None of the patients who presented with HA progressed to hyperammonemic encephalopathy (HAE). This case series on valproate-induced HAshould be of interest to psychiatrists, physicians, internists, family medicine physicians, hospitalists, and surgeons who will have patients on VPA. Delay in recognition of HA can result in the development of potentially life-threatening complications.Rapid diagnosis and management will help in reducing the number of cases which progress to encephalopathy which is highly fatal.

Knowledge, attitude, and practice study of pharmacovigilance in a dental teaching institute in Western India

ABSTRACT Background: India started the National Programme of Pharmacovigilance in 2005, which was renamed as Pharmacovigilance Programme of India in 2010. This is the main portal for detecting and reporting the adverse effects of drugs. Aim: This study aimed to evaluate the knowledge, attitude, and practice (KAP) of pharmacovigilance (Pv) in a dental teaching institute in Western India. Materials and Methods: The KAP questionnaire regarding Pv was distributed among the dental faculties. The knowledge-based questions were corrected and the scoring was given as excellent knowledge, good knowledge, fair knowledge, and poor knowledge for the scores between 0–5, 6–10, 11–15, and 16–20, respectively. Descriptive statistical analysis was performed which is presented as frequencies (n) and percentages (%) in all three sections of the questionnaire. Results and Observations: The knowledge of 24 (44%) participants was found to be fair with scores between 6 and 10. The knowledge of 23 (42%) participants was found to be poor with scores between 0 and 5 and the knowledge of 8 (14%) participants was found to be good with scores between 11 and 15. A positive and promising attitude was exhibited by the dental faculties toward reporting adverse drug reactions (ADRs). Only two study participants had reported an ADR event. Conclusion: The deficiencies in knowledge appear to be the underlying factor for the underreporting of adverse reactions encountered by dental practitioners.

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

Overview on Pharmacovigilance: Ensuring Medication Safety

Pharmacovigilance plays a pivotal role in ensuring drug safety by monitoring and evaluating the effects of medications before and after their market launch. In India, a rapidly expanding pharmaceutical industry coupled with a diverse patient population and growing drug consumption necessitates robust pharmacovigilance measures. This abstract highlights the need for pharmacovigilance in India, emphasizing factors such as the expansion of the pharmaceutical sector, diverse patient demographics, increased drug consumption, limited awareness and reporting, regulatory compliance, globalization of clinical trials, and emerging safety concerns. The Pharmacovigilance Programme of India (PvPI) serves as a cornerstone for patient safety, focusing on data collection, signal detection, capacity building, and regulatory collaboration. Reporting adverse drug reactions (ADRs) to PvPI is crucial, and various reporting methods, including online reporting, Vigiflow software, ADR reporting forms, direct communication, telephone reporting, and email, are discussed. Additionally, advice on what to report, who can report, where to report, and the handling of submitted information is provided to encourage effective ADR reporting. Overall, pharmacovigilance in India is essential for ensuring the safe and effective use of pharmaceutical products, protecting public health, and minimizing risks associated with medications.

Inter-rater agreement between WHO- Uppsala Monitoring Centre system and Naranjo algorithm for causality assessment of adverse drug reactions

Determining the causality of Adverse Drug Reactions (ADRs) is essential for management and prevention of future occurrences. The WHO-Uppsala Monitoring Centre (UMC) system is recommended under the Pharmacovigilance Program of India whereas Naranjo's algorithm is commonly utilized by clinicians, but their agreement remains a subject of investigation. This study aims to compare the inter-rater agreement between these two scales for causality assessment of ADRs. In this cross-sectional study, two groups of pharmacovigilance experts were given a set of total 399 anonymized individual case safety reports, collected over six months. The raters were blinded to each other's assessments and applied the WHO-UMC system and Naranjo algorithm to each case independently. Inter-rater agreement was then evaluated utilizing Cohen's kappa. The suspected ADRs were also comprehensively analysed on parameters like age, sex, route of administration, speciality, organ system affected, most common drug categories and individual drugs, outcome of ADRs. Analysis of 399 suspected ADRs revealed that mean age of patients was 36.8 ± 18.0 years, females were more frequently affected, highest proportion of reports were from psychiatry inpatients, seen with antipsychotic drugs, involved the central nervous system, with oral administration, and 91% resolved. On causality assessment by the WHO-UMC system, 53.3% were “Certain” whereas Naranjo's algorithm categorized 96.74% of ADRs as “Probable”. Cohen's kappa showed a “Minimal” agreement (0.22) between WHO-UMC and Naranjo system of causality assessment. The considerable lack of agreement between the two commonly employed systems of causality assessment of ADRs warrants further investigation into specific factors influencing the disagreement to improve the accuracy of causality assessments.

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.

Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Background: Standard anti-tuberculosis (TB) treatment is highly effective, but managing adverse drug responses is a major challenge that can negatively affect treatment compliance and outcomes of an anti-tubercular treatment (ATT) regimen. Hence, monitoring of these adverse drug reactions (ADRs) is very essential wherein the drug-causing ADR can be detected and an appropriate therapeutic regimen can be given to the patient. Aims and Objectives: To assess the ATT-induced ADRs in Individual Case Safety Reports (ICSRs), to find the incidence and prevalence of ADRs due to ATT, and to analyze the causality assessment of the ADRs due to ATT. Materials and Methods: A retrospective observational study was carried out using spontaneous ICSRs data from the ADR monitoring centre at Madras Medical College, Chennai. A suspected adverse drug reaction reporting form (sADR reporting form) provided by the Pharmacovigilance Programme of India was used to collect the data of an ICSR. Results: A total of 93 ICSRs were assessed during the study period. The majority of the ADRs occurred in males (n = 55), and the maximum number of ADRs were found in the age group of 18–44 years (n = 46). The majority of the ICSRs were categorized as “serious” (n = 60), of which the maximum number of ADRs belonged to the “hospitalization/prolonged hospital stay” category (n = 45). Most of the suspected ATT drugs involved in implicating ADRs were found to be fixed-dose combination pills of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (n = 71). Most of the ADRs were “skin and subcutaneous disorders” (n = 51) of the system organ class. The outcome of the ADRs was assessed and found that the majority of them were in the “recovering” (n = 54) category, and the majority of the ICSRs were found to be “probable” (n = 67). Conclusion: An effective implementation of a Pharmacovigilance system with early detection and management of ADRs is needed to overcome the nonadherence to TB therapy.

Acneiform eruptions associated with nintedanib – A case report

Interstitial lung diseases (ILDs) these are a group of diffuse parenchymal lung disorders present with increased risk of morbidity and mortality. The patient presents with symptoms of gradual onset of dyspnea, dry cough, chest discomfort, and extreme tiredness, which causes decreased quality of life. Treatment of ILD includes the use of immunomodulatory therapies such as corticosteroids, azathioprine, cyclophosphamide, and monoclonal antibodies. Antifibrotic therapies include the use of pirfenidone and nintedanib. The most common adverse effects associated with tyrosine kinase inhibitors include hepatotoxicity, hypertension, Steven–Johnson syndrome, acne-like skin rash, and pruritus. The patient presented to the dermatology outpatient department with complaints of acneiform eruptions over the forehead and cheeks. Lesions started within 7–15 days of starting nintedanib for ILD. Post-dermatology consultation and local examination, acneiform eruptions due to the drug are the probable diagnosis made, and therefore, capsule nintedanib was withheld and prescribed Vitamin C tablets, tretinoin 0.05% with azelaic acid 10% and sunscreen. At the time of discharge tapering doses of prednisolone, tablet deriphylline 150 mg BD and tablet n-acetyl-cysteine 600 mg BD for 14 days were prescribed. Detailed history of the patient was taken and the relevant medical documents were scrutinized. This case was assessed as per the pharmacovigilance program of India. A very rare adverse reaction was seen with the use of nintedanib. After discontinuation of capsule nintedanib and acne management, patient experienced an improvement in the acne lesions. The case reported is a very rare adverse reaction seen with the use of nintedanib for the management of ILD. Our study is supported by temporal association, biological plausibility, and successful de-challenge.

Unveiling vaccine safety: a narrative review of pharmacovigilance in India's COVID-19 vaccination.

In India, a robust vaccine pharmacovigilance system is essential to the effective implementation of COVID-19 immunization programs, ensuring the safety and efficacy of the administered vaccines. The National Expert Group on Vaccine Administration for COVID-19 and the Pharmacovigilance Programme of India have played vital roles in monitoring and analyzing adverse events following immunization (AEFI). These tools have made it easier to gather, assess, and report information about different adverse drug reactions connected to COVID-19 vaccines. However, there are several issues with India's vaccination pharmacovigilance, including underreporting and sluggish data gathering. To improve the efficiency of the pharmacovigilance system, it is crucial to address these issues and encourage active reporting by healthcare professionals and the general public. This insightful review article serves as a critical resource for shedding light on India's vaccine pharmacovigilance efforts throughout the COVID-19 vaccination drive. It also elucidates how these efforts are pivotal in bolstering public confidence in vaccines. The comprehensive coverage of reported AEFI not only showcases the commitment to vaccine safety but also helps healthcare professionals and policymakers make informed decisions to enhance the overall vaccination program.

Development of Pharmacovigilance System in India and Paradigm of Pharmacovigilance Research: An Overview.

The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.

Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Teaching Hospital in North India: A Retrospective Study.

Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. This is an observational, retrospectiveand non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

Knowledge of pharmacovigilance among healthcare professionals and the impact of an educational intervention

Aim. To determine the knowledge regarding various aspects of pharmacovigilance among doctors and nurses of a tertiary care teaching hospital and to evaluate the effect of an educational intervention. 
 Methods. A cross-sectional study was conducted among doctors and nurses of a tertiary care teaching hospital. The participants attended a one-hour educational session during which the concept of pharmacovigilance, the Pharmacovigilance Program of India, the need for reporting ADRs, and the method of reporting were explained by a subject expert. A 20-item questionnaire was used to assess their knowledge regarding pharmacovigilance before and after an educational session. The pre-post comparisons were done using Wilcoxon’s signed-rank test. A p-value less than 0.05 was considered statistically significant. 
 Results. Forty-two doctors and 115 nurses participated in the study. A significant improvement in the participant scores was seen following the educational intervention in both doctors (Z = −5.344, p < 0.001) and nurses (Z = −8.808, p < 0.001). Lack of knowledge/awareness was perceived as the major barrier for ADR reporting among nurses as well as doctors. 
 Conclusion. There is need for education and training among doctors and nurses to enhance their knowledge about drug safety and reporting practices. Educational intervention is likely to improve the knowledge regarding pharmacovigilance, and thereby enhance reporting by healthcare professionals.

Commentary: Blockchain technology and its current importance in toxic anterior segment syndrome outbreak in India.

Commentary: Blockchain technology and its current importance in toxic anterior segment syndrome outbreak in India.

Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.

Pharmacovigilance: Study of pattern of adverse drug reactions at a tertiary care teaching hospital, Aurangabad, and Maharashtra, India: A prospective study and forthcoming challenge for the future

Background: Reporting adverse drug reaction (ADRs) through Pharmacovigilance program of India is very important for effectiveness of drug treatment. It allows professionals to detect, assess, monitor and derive ways to reduce the incidence of ADRs. Aims and Objectives: The aim of the study was to study the patterns of ADRs reported in a tertiary care teaching hospital. Material and Methods: This study was conducted for a period of 10 months. We included all the forms of ADRs caused by drugs which were sent to the Pharmacovigilance cell, Department of Pharmacology. The reports were analyzed for age group, anatomical therapeutic classification, organ system involvement, type, severity, and the causality assessment. Results: A total of 104 ADRs form were analyzed. The highest percentage 59.6% of ADRs was seen in 19–59 years of age group. Females were reported more reactions. The most common class of drugs involved was antimicrobial agents (51.9%). Major organ system affected was skin constituted a major component (73.0%). Our study showed that 75% reactions were predictable while 13.4% were unpredictable reactions. About 51.9% of reactions were moderate according to severity grading. The WHO causality assessment showed that 37.5% reactions were probable/likely and 32.6% were possible. About 75.9% of patients suffered from temporary harm and require intervention while 17.3% requires hospitalization. About 53.8% of reactions were from definitely preventable category and 43.2% were probably preventable. Conclusion: The results suggest that staff of our hospital is reporting ADR according to the guidelines. There will be increase in spontaneous reporting and decrease in number of ADRs with further reinforcement. The data generated from Pharmacovigilance department will also help in finding ways for safer use of drugs in our hospital.

Pharmacovigilance of cutaneous adverse drug reactions-a focused research in times of COVID pandemic

Severe cutaneous adverse drug reactions are limiting, ranging from 5 cases per million including acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia systemic symptoms (DRESS) to 1 case per million of toxic epidermal necrolysis. Cutaneous adverse drug reactions following drug therapy of COVID-19 are not uncommon. Viral infection and drug interactions predisposes to the development of cutaneous adverse drug reactions, as already documented with Epstein-Barr virus, cytomegalovirus, human herpesvirus 6, and HIV. The Adverse drug reaction monitoring center of CNMCH has actively participated in pharmacovigilance programme of India by reporting few adverse drug reactions including the following cases. It is iterated that pharmacovigilance programme extends beyond just mere detection and reporting of adverse drug reactions and also should involve in assessment and understanding the cases, thus facilitating control and prevention of these cases. Particularly in times of COVID pandemic there has been continuous amendment in the treatment guidelines both at the central and state level. Incorporation of various antibiotics, antiparasites and antiviral drugs for the treatment of COVID, has potentiated the risk of development of drug allergies. Admittedly, the detailed understanding of drug allergy cases has been in general constrained with a relative lack of access to standardized laboratory diagnostic tests. Focused research is the need of the hour in order to understand the drug allergies better. In this study we have included those cases reported by department of medicine and dermatology of Calcutta national medical college and hospital in the past six months. All the cases were COVID positive and were treated conservatively by de-challenging the culprit drug and administration of antihistamines, topical steroids, while a few was put on systemic steroid therapy. There were six such reported cases of cutaneous adverse drug reaction following COVID treatment. There were four cases of maculopapular drug eruptions, while the other cases were diagnosed with fixed drug eruptions and acute generalized exanthematous pustulosis respectively. All the cases were reported under pharmacovigilance programme of India.

Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines.

In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.