Adverse Drug Reactions Monitoring Centre Research Articles

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

ABSTRACT Background: 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. Material and Methods: 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. Results: 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. Conclusion: The booster dose administered for the prevention of COVID-19 has been found to be reasonably safe. The population who received COVID-19 booster doses was significantly less than the populations who received the first and second doses, which suggests a low acceptance rate.

A retrospective and observational study of the adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

COVID-19 pandemic period - adverse drug reactions reporting, observing, assessing and analysis at tertiary care teaching hospital, IMS-BHU Varanasi – 3-years observational study

Background: Effects of drugs that are undesirable and beyond their therapeutic effect are labeled as adverse drug reactions (ADRs). These often lead to increase hospital stay, repeated hospitalization, adversely affecting the quality of life, and perhaps, one of the causes of mortality making it a chief challenge in modern health-care system. This observational study analyzed and summarized details linked to ADRs identification, reporting, severity, treatment, and preventive measures for health professionals. Aims and Objectives: The objectives of the study are to assess and evaluate demographic profile, drug prescribed with its dosage, clinical findings, seriousness, outcome, causality, and organ system affected by concerned ADRs. Materials and Methods: An observational prospective study analyzing submitted ADRs mentioned in individual case safety reports (ICSR), mentioning demographics profile, suspected drug, involved bodily organ system, causality and reaction severity in different age groups of indoor and outdoor patients reported from 2020 January to 2022 December at ADR monitoring center, Department of Pharmacology, IMS-BHU. Performa used for ADRs reporting is ICSR, which later on transferred to the Indian database (VigiFlow) for data collection and analysis. Results: Total 1096 ADRs were identified and reported in 36-month duration, with male (629/1096) to female (466/1096) ratio of 1.35:1. On age group analysis, 74.8% (820/1096) adults (18–59 years) followed by 23.4% (256/1096) elderly (>59 years) and only 1.8% (20/1096) children and adolescents (<17 years) cases were found. Endocrine system was the most common organ system affected with 27.9% case (306/1096), succeeded by 25.4% (278/1096). ADRs were linked to the gastrointestinal system and 15.69% (172/1096) cases were related to dermatological problems. Antimicrobial drugs were most involved group, which on further analyzing and classifying revealed majority of ADRs were related to antiviral drugs, followed by antibiotics with 27.2% (298/1096) and 23.4% (257/1096) cases, respectively. Antiallergic and antifungal drug groups were found be least involved with only 1.6% (17/1096) cases each. On assessment of causality, majority of ADRs were possible in 60.40% (662/1096) cases and probable in 39.14% (429/1096) cases. Conclusion: Occurrence of ADRs is very common and perhaps a serious concern regarding well-being and safety of public as may lead to non-serious to serious health problems. This observational study identified the need of increased awareness of ADR monitoring, reporting and benefits, to fulfill the space created by under-reporting, especially in geriatrics and pediatric age group patients. A detail evaluation and removal of the barriers so that all the patients may easily approach for spontaneous reporting of side effects after start usage of any medicinal product, if any. In addition, surveillance studies emphasizing on reporting are essential for early recognition, detection, and avoidance of ADRs leading to appropriate with safe usage of drugs.

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.

A RETROSPECTIVE ANALYSIS OF SPONTANEOUSLY REPORTED ADVERSE DRUG REACTIONS TO ANTIRETROVIRAL THERAPY DURING AND POST-TRANSITIONAL PHASE OF DOLUTEGRAVIR

Objectives: The main objective of this study was to analyze the pattern of reported adverse drug reaction (ADRs) in people receiving antiretroviral therapy (ART) mainly during and post-transitional phase of dolutegravir-based regimens. Methods: This is a retrospective observational study initiated after the approval of the Institutional Ethics Committee and from the ART Center. Sources of data are spontaneously reported ADR data of human immunodeficiency virus (HIV) persons to the ADR monitoring center (AMC). Results: A total of 190 patients who are on ART reported at AMC from April 2020 to June 2022 had a total of 204 ADRs. Among them, 108 (57%) were females and had a higher prevalence than 82 (43%) males. ADRs were higher among the age group of 41–50 years (33.68%) followed by 31–40 years (32.10%). Among dolutegravir-based regimens, tenofovir, lamivudine, and dolutegravir were given to more patients (118). The most common ADRs encountered were peripheral neuropathy 16.66%, followed by hyperglycemia (14.21%), renal toxicity (10.29%), hyperbilirubinemia (9.31%), and anemia (7.84%) of all ADRs. Conclusion: In this study, it has been observed that HIV patients on dolutegravir-based regimens are associated with more ADRs. Nervous system disorders were the most commonly observed group of ADRs, followed by metabolism and nutritional disorders, the others being skin diseases and renal toxicity. This incidence of ADRs to ART calls for efficient pharmacovigilance surveillance to improve patient care 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.

Influence of Educational Intervention on Awareness and Attitude of Nursing Students Towards Adverse Drug Reaction Reporting During Coronavirus Disease 2019 (COVID-19) Pandemic: A Quasi-Experimental Study.

Under-reporting of adverse drug reactions (ADRs) is a major concern of the pharmacovigilance program of India and has deteriorated further with the Coronavirus Disease 2019 (COVID-19) pandemic. Imparting the knowledge of pharmacovigilance among nursing students would significantly enhance patient care. Hence, this study was framed to evaluate the effect of an educational intervention on awareness and attitude of ADR reporting among nursing students during the COVID-19 pandemic. A quasi-experimental pretest-post-test study was conducted among nursing students of a tertiary care hospital in South India. The students were asked to fill out a validated questionnaire to assess Knowledge, Attitude, and Practice on ADR reporting, before and after the educational intervention. Knowledge and attitude results were analysed using Mc Nemar's test. A total of 135 nursing students attended the educational intervention and completed pretest and post-test questionnaires. Around 130 (96.3%) and 107 (79.3%) students were aware of pharmacovigilance and ADR monitoring center following the intervention. Median (interquartile range) of knowledge scores before and after the intervention were 3 (2-3) and 5 (3-7), respectively. Overall knowledge score of ADR reporting significantly improved after the intervention. Sixty two (45.9%) students agreed that ADR reporting would enhance patient safety. ADR reporting was practised by 52 (38.5%) participants. Nearly, 107 (79.3%) students were interested to participate in similar pharmacovigilance training programs. Educational intervention in pharmacovigilance improved the cognitive and affective domains of pharmacovigilance in nursing students. Periodic training programs are essential for sustained behavioural change in students.

Metronidazole induced neurotoxicity: a case report

Metronidazole is a well-known antimicrobial agent, used for the treatment of anaerobic bacterial and protozoal infections. It is generally well tolerated with common side effects like nausea, dizziness, headache and metallic taste in the mouth. But prolonged use of metronidazole can cause neurotoxicity like ataxic gait, dysarthria, seizures and encephalopathy. Here, we are reporting a case of a 60 years old male patient who was a chronic alcoholic with liver abscess and he developed acute ataxia and dysarthria after four weeks use of metronidazole. The causality of metronidazole in this case was “probable” with score 7 as per Naranjo scale. The patient was managed by discontinuing the metronidazole and there was considerable improvement in his gait and speech after that. The case was recorded properly in adverse drug reaction reporting form and was sent to nearby adverse drug reaction (ADR) monitoring centre.

Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India

Background: The aim of the present study was to determine the pattern of adverse drug reactions (ADRs) reported at ADR monitoring centre (AMC) in Punjab. Methods: This observational retrospective study was done in department of Pharmacology, GGS Medical College and Hospital, Faridkot from September 2020 to August 2021. A total of 148 ADRs were reported during the study period. Each ADR was analyzed for demographic data and characteristics of ADR. Assessment of causality, severity and preventability was done according to WHO UMC scale, modified Hartwig and Siegel scale and Modified Schumock and Thornton Preventability Scale respectively. Results: A total of 148 ADRs were reported from both outpatients and in patients of various departments. Most of the ADRs were found in males (55%) and patients of age group 31-45 years (33%). Majority of ADRs were reported from dermatology department (40%). Overall, 38% of ADRs were due to antimicrobial drugs. Most of the ADRs were reported as possible (57%), followed by probable (41%) as per WHO causality assessment. Most of the ADRs were moderate severity (83%). 97% of the ADRs were found to be definitely preventable type. Conclusions: We concluded that most of the ADRs were reported from antimicrobial drugs, so it is advisable to have close monitoring of the antimicrobial drug therapy to prevent ADRs in the patients. Although the majority of ADRs were moderate in nature but mostly were recovered. The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

A case of drug induced dizziness in a patient on anti-Parkinson drugs

Parkinson’s disease (PD) is the second most common age-related neurodegenerative disease, exceeded only by Alzheimer’s disease. Clinically, PD is characterized by resting tremor, rigidity (stiffness), bradykinesia (slowing), and gait dysfunction with postural instability. These are known as the classical or “cardinal” features of the disease. Levodopa remains the most effective symptomatic treatment for PD and the gold standard against which new therapies are compared. Levodopa is routinely administered in combination with a peripheral decarboxylase inhibitor to prevent its peripheral metabolism to dopamine and the development of nausea, vomiting, and orthostatic hypotension. The major concern with levodopa is that chronic levodopa treatment is associated with the development of motor complications, nausea and dizziness in the large majority of patients. We are here reporting a case of Syndopa plus (Levodopa+Carbidopa) induced dizziness in a 76 years old male patient on anti- parkinsonism treatment. The causality assessment was done by Naranjo scale. The causality of Syndopa plus in the case was “probable” as per Naranjo scale. The patient was managed by reducing the dose of Syndopa plus to the half of it’s initial dose. The case was recorded properly in adverse drug reaction reporting form and was sent to nearby ADR (adverse drug reaction) monitoring centre.

Pattern of adverse drug reactions with chemotherapeutic drugs in a tertiary care hospital of North India: a retrospective study

Background: Adverse drug reactions are important causes of mortality and morbidity in the patients. Early detection, evaluation and monitoring of ADRs is essential to improve public health. Methods: This was an observational, non-interventional and retrospective study conducted at the ADR monitoring centre of a tertiary care hospital of North India. Suspected ADR forms reported over a period of 4 years involving at least one chemotherapeutic drug with at least one dose were analyzed. Results: A total of 261 chemotherapeutic drugs associated ADRs were analyzed. Out of these, maximum numbers of ADRs were reported by males (54%). Maximum reporting was done by Skin and VD department (37.93%). Causality assessment was probable in maximum number of cases (54%). Most common ADRs were skin rashes (21.46%), followed by jaundice, urticaria and fixed drug eruptions. Maximum ADRs were suspected to be caused by Anti tubercular drugs (31.42%) followed by anticancer drugs (14.56%). Conclusions: ADRs due to antibiotics and anticancer drugs is a significant health problem.

Safety profile of CoviShield (ChAdOx1nCoV-19) vaccine among healthcare workers in a tertiary care hospital

Background: Coronavirus 2019 was declared as a pandemic by the World Health Organization in March 2020. Bereft of specific treatment for the disease, vaccinations and COVID appropriate behavior have come to be the main approaches to combat the pandemic. A number of vaccines have been approved after clearing clinical trials. Hence, it is essential to evaluate the safety profile of each vaccine for ensuring optimum health of the general population. This study was conducted to evaluate the adverse events following CoviShield vaccination in a tertiary care center. Aims and Objectives: The aim of the study was to describe the pattern of adverse effects, treatment given, and comorbidities seen in healthcare workers (HCW) who reported to the adverse drug reaction (ADR) monitoring center in the department of pharmacology Government T.D. Medical College, Alappuzha, following CoviShield vaccination from January 2021 to October 2021. Materials and Methods: A retrospective and descriptive study was carried out at Department of Pharmacology, GTDMCA involving all HCW who reported side effects following CoviShield vaccination in the ADR monitoring centre (AMC) in the Department of Pharmacology, GTDMCA from January 2021 to Oct 2021. Results: Out of 620 HCWs who reported adverse event following vaccination, majority (45%) were from the age group 21–30 years. About 83% of HCWs who reported adverse effect were women. Majority of the respondents (96%) experienced the adverse effects within 24 h. About 88% of respondents experienced these adverse effects after the initial dose alone. Commonly encountered adverse effects were fever (57%), headache (43%), myalgia (38%) etc. Hypertension (7%) was the most common comorbidity seen. Majority of the beneficiaries (70%) took paracetamol for the treatment of the adverse effect. Conclusion: Majority of the vaccinated HCWs experienced minor and self-limiting adverse event following immunization (AEFI) with Chimpanzee Adenovirus Oxford novel CoronaVirus-19. No serious AEFI were reported to the AMC. Despite the record speed at which the vaccine has been developed, it has shown to have a good safety profile considering the millions of doses that have been administered.

Pattern of cutaneous adverse drug reactions in an adverse drug monitoring center at a tertiary care hospital in Kerala

Background: Pre-marketing clinical trials can filter only about 50% of the drug reaction. Hence, to prevent the morbidity and mortality due to severe cutaneous reactions early detection, evaluation and monitoring of adverse drug reaction (ADR) especially cutaneous ADR (CADR) are mandatory. Hence, it is imperative that we update our knowledge of the precise nature of ADR which will prevent the reactions as well as to find the offending drug. Aim and Objectives: The aim of the study was to evaluate the pattern of CADR, the suspected drugs and to perform the causality assessment using WHO casualty assessment scale. Materials and Methods: A retrospective descriptive study was done using the data reported to ADR monitoring center in the Department of Pharmacology by the health-care professionals. Suspected CADR was diagnosed by the consultants concerned. The CADRs collected were categorized according to their morphology into maculopapupar rash (MPR), fixed drug eruptions (FDE), urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The causality assessment was done using WHO Causality assessment scale. Results: The mean age was 47.20 + 22.31. The most common CADR reported was Urticaria 65.5% followed MPR 23%, FDE 8.8%, and Steven Johnsons Syndrome 2.2%. Anti-microbial drugs were the most frequent cause of the adverse reactions with Amoxicillin clavulinic acid combination being the most frequent suspected drug producing CADR (13.3%). The WHO causality assessment for majority of CADR was Possible (73.5%). Conclusion: Clinical Patterns of CADRs in this set up have some minor variations when compared to studies done across India. Amoxicillin clavulinic acid is the most common suspected drug in this study which was not frequently reported in other ADR monitoring centers.

Knowledge, attitude, and practice of pharmacovigilance among health-care professionals in an Indian tertiary care hospital

Background: Adverse drug reaction (ADR) is any undesirable or unintended consequence of drug administration. Pharmacovigilance is the science and activities concerned with the monitoring of the safety of drugs. Underreporting of ADRs is a major challenge for pharmacovigilance programs. Aims and Objectives: (1) To assess knowledge, attitude, and practice of pharmacovigilance among health-care professionals working in tertiary care hospital. (2) To create awareness and strengthen the ongoing pharmacovigilance activities among health-care professionals. Materials and Methods: This is a questionnaire-based cross-sectional study conducted at BIMS Hospital Belagavi, Karnataka, India; A pre-designed and structured multiple choice questionnaire containing 23 questions was used to assess knowledge of pharmacovigilance, attitude toward ADR reporting, the practice of pharmacovigilance and their suggestions to improve ADR reporting (Q no.23). Questionnaire was distributed among 150 doctors working in the hospital. Results: 133 doctors responded to the questionnaire. 124 (93.23%) were aware of the purpose of reporting ADR. 55 (41.35%) had an opinion that ADR reporting should be voluntary. 46.62% of subjects believed that the identity of the reporter can be revealed. 86.47% of doctors had seen patients experiencing ADR, and 27.07% maintained a record of it and reported it to the ADR monitoring center. To improve the knowledge, attitude, and practice, the majority of participants suggested conducting training and continuing medical education for all health professionals. Conclusion: Doctors have good knowledge and attitude towards pharmacovigilance program, but there is underreporting of ADRs. Creating awareness among all health-care professionals, motivating them to report ADRs through training, and providing ADR reporting forms to hospital wards may improve the outcome.

ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICES OF PHARMA-COVIGILANCE PRESCRIBERS AT LIAQUAT UNIVERSITY HOSPITAL HYDERABAD, PAKISTAN

Spontaneous reporting is an important tool in pharmacovigilance. Underreporting of adverse drug reactions (ADRs) is a common problem. In order to improve the ADR reporting, it is essential to improve the knowledge, attitude and practice (KAP) of the healthcare professionals. Various factors are related with the KAP of under reporting of ADR. Objectives: The present study was undertaken to evaluate the KAP regarding ADR reporting of among the prescribers of a tertiary care teaching hospital with ADR monitoring Liaquat University hospital, Hyderabad to get insight into the causes of underreporting of ADR. It was questionnaire based cross sectional study. A questionnaire (knowledge -1-10, attitude -11-23 and practice -24-28) was administered to 200 prescribers. The questionnaire was assessed regarding the ADR reporting. Microsoft excels worksheet and chi-square test was used for statistical analysis. A total 170(85%) prescribers completed and returned the questionnaire. Regarding definition of pharmacovigilance, specific aim of pharma covigiilance, functions of ADR monitoring center (AMC), 93%, 79% and 51.8% participants respectively could answer correctly. Only 54% respondents opined correctly that reporting of ADR is voluntary. 76.5% participants know the existence of AMC in the institution. 27.6% participants expressed that ADR reporting will generate extra work. 22.4% of participants reported ADR. Regarding reasons of under reporting many factors has been pointed out namely “do not know how to report”, “lack of knowledge about reporting procedure”, “not knowing where to report”, lack of time to report and lack of access to ADR form. The medical professionals are aware and have partial knowledge about ADRs. However, under reporting and lack of knowledge about reporting system are clearly evident. There is great need of creating awareness about ADR reporting system. Regular sensitization program to motivate the medical professionals may improve the ADR reporting. Keywords: Adverse drug reactions (ADR), Knowledge, Attitude and practice, Pharmacovigilance, Spontaneous reporting

Assessment of knowledge and attitude on pharmacovigilance among the healthcare professional and pharmacy student at Dharan

Introduction: Pharmacovigilance is the process of identifying, assigning, and reporting the adverse drug reaction (ADR) to prevent its possible effect of it. There are increasing cases of ADR in Nepal which is affecting the treatment protocol. This is due to the lack of knowledge and practice of pharmacovigilance-related activities. Methods: It is a cross-sectional questionnaire-based study conducted among 105 healthcare professionals and pharmacy students at Dharan. Total 17 open and closed ended structured questions were provided to the participant. Out of 17 questions, 11 were ‘knowledge’ related and 6 were ‘attituded’ related. All the doctors, nurses, and pharmacists working in hospital and pharmacy premises during the data collection period were included. The response of the participant is analyzed by plotting the data on an excel sheet and the result is interpreted. Result: Almost 93.33% of participants gave a response and more than half of them (n=48; 54.54%) were female. Almost all the healthcare professionals 86.20% (n=50) were positive about establishing an ADR monitoring center in every hospital. Though the majority of respondent defined the term “pharmacovigilance”, less than half were aware the activities of national pharmacovigilance center. This shows that there is a need to address on the important of pharmacovigilance course at college level. The knowledge and attitude of respondents have shown difference with education qualification, age category, and profession category. Conclusion: Respondents had moderate to good knowledge about pharmacovigilance and had a positive attitude towards it. Most of them believe that the establishment of a pharmacovigilance center in each hospital is necessary.

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

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

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

Adverse drug reactions due to gabapentin-nortriptyline in patients with neuropathic pain in a tertiary care teaching hospital

Gabapentin and Nortriptyline are used to treat neuropathic pain. Gabapentin belongs to a group of drugs called anti-convulsant and Nortriptyline belongs to tricyclic antidepressant. Gabapentin acts by binding to the specific site on voltage- gated calcium channels. This helps in relieving nerve pain and lowers the risk of seizure. Nortriptyline works by preventing the released chemical messengers in brain (serotonin and norepinephrine) from being reabsorbed back into the nerve cells. As a result, it prolongs the effect of serotonin and norepinephrine in the brain and over time, this helps to relieve depression and lighten the mood. We are reporting a case series including 3 patients having neuropathic pain and taking tablet gabapentin-nortriptyline in department of neurology, Patna medical college and hospital, Patna developed some adverse drug reactions. Causality assessment was done in each case by Naranjo scale. Each case was filled properly in ADR (adverse drug reaction) reporting form and was sent to nearby adverse drug reaction monitoring centre (AMC). During the posting for pharmacovigilance in neurology department of Patna medical college and hospital, Patna from 01/07/2022 to 30/09/2022 we got three adverse drug reactions due to gabapentin-nortriptyline. Two of them were due to Gabapentin and one was due to nortriptyline. Gabapentin-nortriptyline is one of the most commonly used drugs in neurology department. It causes some frequent as well as some rare adverse drug reactions which are required to be assessed and finally reported to the nearby AMC.

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.