Pharmacovigilance Programme Of India Research Articles

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.

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: 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.

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.

Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience.

Adverse drug reactions (ADRs) are major concerns to the public health. To monitor ADRs and ensure patients' safety, the Pharmacovigilance Programme of India (PvPI) has been established by the Government of India in 2010. The programme is intact with the Public-Private Partnership (3Ps) in pharmacovigilance for quality services, better management of human resources and risk minimization. The present work is aimed at assessing the 3Ps engagement, performance and tangible outcomes in PvPI and also mapping of resources. The study was carried out for the period of 2011 to 2021 by assessing the various benchmarking tools such as 3Ps categorization, utilization of ADRs reporting tools, trainings, and the Individual Case Safety Reports' (ICSRs) quantity, quality and transmission for regulatory intervention (RI). Under PvPI, Central or State Government medical institutions/hospitals and public health programmes constitute public partners while private medical institutions/hospitals, pharmaceutical companies, corporate hospitals and professional bodies account for private partners. We observed that public partners extensively used ADR reporting form and toll-free helpline number while private partners used mobile based app and emails/post as preferred tools for reporting ADRs. Contribution of public sector in training programmes organized, stakeholders trained and sharing of resource materials was way higher than the private sector. The study revealed that 55.1 and 44.9% ICSRs were received from public and private partners, respectively during the study period. The quality completeness of data received from public partners was found to be 0.92/1 as compared to 0.46/1 from the private partners. The ICSRs data transmitted for RI process from the public and private partners (till 2018) was found to be 79 and 21%, respectively. In terms of sharing of resources for training and capacity building, the public sector played a major role. The 3Ps in India are enabled to establish a robust system for medicines' safety surveillance; however a more focused approach is required in mapping the resources.

Pharmacovigilance

The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance Programme of India (PvPI). With advancement in the field of science and technology, India is emerging as a hub for clinical trials and new drug development, which challenges the monitoring of safety concerns in the use of new drugs. It has been difficult to identify or track the adverse drug reactions (ADRs) that occur in the patients due to polypharmacy, use of over the counter (OTC) preparations, change in physician etc. Hence the national programme has gained importance in our country off late. Yet it is observed that the importance of this programme is not realized by all health care professionals. Therefore, to support & strengthen the national programme which aims to identify, report & analyze the identified ADRs, it would be essential to sensitize the health care professionals through various means & faculty development programmes.

Pharmacovigilance: Significance and challenges

The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance Programme of India (PvPI). With advancement in the field of science and technology, India is emerging as a hub for clinical trials and new drug development, which challenges the monitoring of safety concerns in the use of new drugs. It has been difficult to identify or track the adverse drug reactions (ADRs) that occur in the patients due to polypharmacy, use of over the counter (OTC) preparations, change in physician etc. Hence the national programme has gained importance in our country off late. Yet it is observed that the importance of this programme is not realized by all health care professionals. Therefore, to support & strengthen the national programme which aims to identify, report & analyze the identified ADRs, it would be essential to sensitize the health care professionals through various means & faculty development programmes.

A cross-sectional, questionnaire-based study on knowledge, attitude, and practice of pharmacovigilance among post-graduates at a tertiary care teaching hospital, Telangana

Background: Pharmacovigilance is the process of drug safety monitoring that improves patients' quality of life through the collection and analysis of Adverse Drug Reactions (ADRs). In our state, most of the ADRs are reported by a spontaneous reporting system of individual cases from health care professionals to Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). Post-graduates (PGs) play a vital role in reporting ADRs as they are in personal evidence with all events after drug administration. The main objective of our study is to evaluate the Knowledge, Attitude, and Practice of Pharmacovigilance among post-graduates.Methods: The present study was a cross-sectional questionnaire-based study on knowledge, attitude, and practice (KAP) of Pharmacovigilance among 150 post-graduates at a tertiary care teaching hospital, Telangana. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 25 software.Results: The results showed that there is relatively less knowledge among postgraduates. Attitude and practice-based questions evidenced a paradigm shift towards the construction of an organized Pharmacovigilance system. This study also highlights the under-reporting and the interventions needed to improve spontaneous reporting of ADRs.Conclusions: The knowledge of Pharmacovigilance with a positive attitude and practice among post-graduates is essential for reporting ADRs and reducing under-reporting.ng.

Retrospective Analysis of Adverse Drug Reactions at South Indian Tertiary Care Teaching Hospital

Background: Adverse drug reaction (ADR) is an appreciably harmful reaction from an intervention related to the use of the medicinal product, which predicts hazard from future administration and specific treatment, or alteration of the dosage regimen, or withdrawal of the product. This study aimed to analyze ADRs retrospectively to understand their nature at the study site.
 Methods: Retrospective analysis of the ADRs reported over 6 months was conducted at a South Indian Tertiary Care Teaching Hospital.We analyzed Patient characteristics, Causality, Severity,Dechallenge, Rechallenge, Management, Outcomes, Department, Drug Class, and Organ system involved related adverse events.
 Results: Out of 116 ADRs females developed 51.72 % of reactions, and ADRs are more common in the adult population (73.2 %), followed by geriatrics (11.2 %). Antibiotics were the most frequently used medication class and also lead to the majority of reactions (16.3%). A total of 55 ADRs were assessed for causality, and 31 (57.4%) reactions were possibly linked to the implicated medications. At the time of reporting, 41 (35.6 %) patients had recovered from the reaction, 37 % of ADRs were non-serious, and no deaths had been reported.
 Conclusions: The majority of ADRs were minor, and patients were able to recover from them after discontinuing the implicated medicine. We were unable to estimate the severity of the ADRs using this reporting form, and the majority of ADRs lacked a causation assessment, which is not a mandatory condition for reporting any suspected ADR.
 Keywords: ADRs, Retrospective study, Causality assessment, HCPs, Pharmacovigilance program of India.

EXPLORATORY STUDY ABOUT KNOWLEDGE, ATTITUDE AND PRACTICE ABOUT PHARMACOVIGILANCE AND ADR REPORTING AMONG RESIDENTS OF A TERTIARY CARE TEACHING HOSPITAL

Objective: This study, aimed at investigating the knowledge and attitude of resident doctors about ADR reporting in a tertiary care teaching hospital. Methods: This was a cross-sectional, observational, questionnaire-based study conducted in Shri Krishna Hospital and Medical Research Centre, 550 bed tertiary care teaching rural hospital attached to Pramukhswami medical college, Karamsad, Gujarat. Results: 50 questionnaire forms were analysed, giving a response rate 86.20%. Of the respondents 56% were men, remaining were women. Mean age of the respondents was 25+1.05 y. All but one resident have heard the term ‘pharmacovigilance,’ but 34 out of 50 were able to define it accurately. Twenty participants preferred email for ADR reporting while 14 preferred direct contacts for ADR reporting. Telephone is liked by 9 participants. All residents admitted the importance of pharmacovigilance in unison. Majority of the residents (96%) were in view to teach pharmacovigilance actively to students. Seventeen out of 50 residents were aware about Pharmacovigilance Program of India, a program by Government of India for pharmacovigilance and ADR reporting. 28 residents did not know about any such program. Three residents opined that no specific national program is running and India is following a program undertaken by WHO. The most preferred method of ADR reporting by residents is email/website followed by direct contact. Twenty were in favour of the first method, while 14 preferred the later method. Nine residents selected the telephone method as method of ADR reporting. Conclusion: Today’s residents are future’s consultants. So it is the need of the hour to stimulate residents to report ADRs.

Pharmacovigilance: The extent of knowledge, attitude, and practice in MBBS interns of rural tertiary health center of Maharashtra

Background: Adverse drug reactions (ADRs) are one of the leading causes of death and are responsible of 5–10% of the hospital costs. Every drug having more or less adverse effects which may leads to medical and economic burdens on patients. Some ADRs are severe enough to increase the risk of death. Pharmacovigilance aims to detect and monitor the ADR, to identify the risk factors responsible of it, and to disseminate the knowledge required for the improvement of prescription of drugs. Aim and Objective: This study aims to assess the knowledge, attitude, and practice (KAP) of pharmacovigilance in MBBS interns of rural tertiary health center of Maharashtra. Materials and Methods: This was a cross-sectional study to evaluate the KAP regarding pharmacovigilance among MBBS interns. KAP questionnaire contained 20 questions along with options and correct answer. For pre-test, 20 min were given to them for answering all questions then a seminar (an educational intervention) was taken on pharmacovigilance and its importance and last, post-test was conducted in 20 min. Results: A total of 75 MBBS interns attended the CME on pharmacovigilance and filled the pre- and post-test questionnaire. Fifty-three (70.66%) participants were not known when the Pharmacovigilance Program of India (PvPI) started and 57 (76%) participants were unaware of regulatory body which is responsible for monitoring ADR in PvPI. Forty-seven (62.66%) participants had no clue that a serious adverse event should be reported within a stipulated time period to the regulatory body. Conclusion: Interns are new budding health care workers and they do not have sufficient knowledge of pharmacovigilance. Inclusion of pharmacovigilance in undergraduate curriculum, conducting CME for doctors, nurses, and pharmacist and motivation of doctors for reporting ADRs are some measures which can improve the spontaneous reporting system, patient safety, and Indian pharmacovigilance program.