Pharmacovigilance Program Research Articles

Knowledge, attitude and practice towards pharmacovigilance among ayurveda physicians and teachers of Gujarat State: A cross sectional study.

Aim:The aim of this study was to assess the knowledge, attitude, and practice towards pharmacovigilance for Ayurveda among the teachers and practitioners working in Ayurveda colleges of Gujarat State.Materials and Methods:A survey questionnaire with 29 questions covering points like participants’ knowledge, attitude and practice towards pharmacovigilance, adverse drug reaction reporting, and misleading advertisements related Ayurveda drugs was developed in Google form format. The study was carried out during December 2020 and January 2021. Question-wise analysis was made and their percentage value was calculated with the help of a Microsoft Excel spreadsheet in MS Office 2010. The result was presented using simple frequencies with percentages in appropriate tables.Results:Results from this study show that majority of the respondents were having a good knowledge regarding the concept of pharmacovigilance and ADRs in terms of their definitions and purposes. But, a complete knowledge regarding the structure of present national and international pharmacovigilance programme, reporting the ADR and its format were still lacking among majority of the participants. An encouraging attitude towards reporting of adverse drug reaction of ASU&H drugs and teaching of Pharmacovigilance for all the healthcare professionals by majority of the participants was observed. Further maximum participants opine a mandatory rule for reporting of ADR by Physicians, Pharmacist and Nursing staff. A major part of respondents (78.03%) opine that poor quality of drug, medication errors, prescription errors, dispensing errors are part of Pharmacovigilance under drug-related problems. The observed positive attitude is not being reflected in term of practice i.e., reporting of ADR related to Ayurveda drugs. One-third of the participants reported their experience about adverse drug reactions during their professional practice, out of which very few have reported ADRs. Difficulty in deciding or identifying the ADR and lack of time to report ADR is one of the major factor discouraging the participants from reporting ADRs. A large number of respondents were also not familiar with reporting misleading advertisements.Conclusion:Findings of this study reflects a good knowledge of the participants about the concept of Pharmacovigilance but unfamiliarity about the programme. The positive attitude towards practice of Pharmacovigilance and ADR reporting can be converted to foster pharmacovigilance practice through series of awareness programmes.

Intensive Safety Monitoring of Rituximab (Biosimilar Novex® and the Innovator) in Pediatric Patients With Complex Diseases.

Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex® and innovator, and to identify risk factors for the development of ADR in a real-life follow-up cohort of pediatric patients with complex diseases. We conducted a prospective, longitudinal, observational, single-centre study in patients that received rituximab for any complex disease, and as part of an intensive pharmacovigilance program. Demographic, pharmacological, clinical, and drug-related data were collected for all patients. ADR-free survival, including infusion-related reactions (IRR) and delayed ADR (dADR), was estimated using Kaplan-Meier curves. Risk factors were evaluated by multivariable Cox regression models. In total, 77 patients (<19 y.o.) received 187 infusions of rituximab Novex® (n = 155) or innovator rituximab (n = 32) for neurologic (Neu), immune-hematologic-rheumatic (IHR), oncologic (O) diseases, and hematopoietic stem-cell transplantation (HSCT) or solid-organ transplantation (SOT). We recorded 29 IRR and 58 dADR that occurred in 27 (35.1%) and 29 (37.7%) patients, respectively. The respiratory tract was the most affected during IRR (29.6%) and hypogammaglobulinemia (37.9 %) was the most frequent dADR. First versus subsequent infusions (HR 5.4, CI95% 2.4–12.1, p<0.05), sex (boys vs. girls, HR 0.3, CI95% 0.1–0.8, and p<0.05), and diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 2.3, CI95% 1.02–5.4, and p < 0.05) were significantly associated with the development of IRR. For dADR, risk factors were diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 0.4, CI95% 0.2–0.9, and p < 0.05) and cumulative body surface area-normalized dosage (HR 1.0003, CI95% 1.0001–1.0006, and p < 0.05). The present is the largest real-world safety assessment of rituximab in Latin-American children with complex diseases supporting its use based on the overall acceptable safety. Identification of risk factors may contribute to optimization of off-label rituximab treatment in pediatrics.

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.

Teaching Pharmacovigilance to Undergraduate Students: Our Experience in Poor-Resource Setting.

Using medicines associated with adverse drug reactions (ADRs) might cause serious health complications. The pharmacist plays a unique role in monitoring ADRs, either by themselves or with the assistance of other health-care professionals, to diminish the hazards of ADRs by distinguishing, reporting, and evaluating any proposed ADRs. To train future pharmacists who have adequate knowledge of ADRs and related aspects, it is highly recommended to introduce the WHO-ISoP pharmacovigilance (PV) in the core curriculum. In this article, we shared the suggested curriculum in Aden University. It is based on comprehensive outlines and reference books that offer a broad view of all aspects related to PV. A brief student course evaluation was carried out. Fifty students participated in the survey. Students expressed the importance of the course and indicated that they wanted to know more about the types of ADRs and common medication errors. Some of them lacked an understanding of the causal relationship between ADRs and risk assessment and not familiar with the reporting forms. They suggested for PV awareness programs for health-care staff and public. The curriculum should be tailored according to the country's needs because each country has its own medication safety issues and PV program. To reach the ultimate objective, this article reports the initiative to develop PV proficiencies in a university setting.

An evaluation of knowledge, attitude, and perception about adverse drug reactions and pharmacovigilance among postgraduate students in a Medical College Teaching Hospital of Sangli

Background: National Pharmacovigilance (PV) program is an ongoing program to monitor the adverse drug reactions (ADRs) and reporting at the earliest. ADRs reporting by physicians, consultants are very less leading to various problems. As postgraduate students are future physicians and consultants, this study was undertaken with following objectives. Aim and Objectives: The aim of the study was to study the knowledge about ADRs, PV, and to know the attitude about ADR reporting-in postgraduate students. Materials and Methods: A cross-sectional questionnaire-based study was conducted after approval by our institutional ethics committee pretested and validated questions consisting of 20 questions (knowledge, attitude, and perception) were administrated to postgraduate students. The filled questionnaires were collected and analyzed. Results: In our study, postgraduates from all branches had fair enough idea about ADR and PV. In knowledge domain, postgraduate students were aware of term ADRs (100%), PV (89.6%). In attitude domain majority of students (87.9%) know the availability of ADR forms, compulsory of PV unit (96.5%). In perception domain very poor response (23.3%) had reported ADR filled form till duration of study. About 89.7% of them knew the meaning of re-challenge and de-challenge, and majority of students (98.3%) also know how to manage the ADRs in emergency conditions. Conclusions: Under reporting problem can be improved by doing more sensitizing activities at UG and PG level including various workshops, CMEs, and problem based teaching. These exercises will improve their reporting frequency and sensitize them from the postgraduate days itself in their upcoming clinical practice in community to avoid drug related complications.

Scope of Pharmacovigilance for Ayurvedic Drugs in Nepal: A Review

Ayurveda along with complementary and alternative medicine (CAM) systems have their own principles, have their own pharmacopeia, but are practiced as over the counter drugs without an authentic prescription. Government of Nepal nominated Department of Drug Administration (DDA) in October 2004 as the focal point (National Pharmacovigilance Centre) to liaison with WHO collaborating centre for International Drug Monitoring (IDM), Sweden and started collecting adverse drug reactions (Nepal became a WHO program member in July 2006). Nepal joined the international pharmacovigilance program as a full member in 2007. This study is to reflect the present status of pharmacovigilance in Nepal and put light on scope of pharmacovigilance on drugs of Ayurveda and other complementary alternative systems in Nepal. For which review and analysis of concerned published literatures in print form and in online database. At present; 12 regional pharmacovigilance centers are there in Nepal. Currently, the clear pattern and scope of adverse drug reactions (ADRs) in Nepal remains unexplored. For Ayurveda drugs the concept of pharmacovigilance is not yet formally introduced in Nepal. No policy has been formulated for the same. The conventional belief that Ayurveda drugs have no ADRs should be transformed.

Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic.

Pharmacovigilance plays a lifesaving role in the practice of medicine. In 2021, during the Coronavirus Infectious Disease 2019 (COVID-19) pandemic, Loyola University Chicago launched a graduate-level Pharmacovigilance Certificate Program (PV-CERT) and a pre-professional non-graduate Pharmacovigilance Certificate Course (EPEC-PV), to provide students a comprehensive and contemporary understanding of the principles and practices of pharmacovigilance. Formal training in pharmacovigilance through this course provided a structured understanding of how safety data are generated through clinical trials and from real-world evidence as well as the regulatory environment in which data are monitored and interpreted. Pharmacovigilance training is of critical importance, especially during the COVID-19 pandemic, during which several drugs were re-purposed for the management of various stages of COVID-19 without conventional safety data. Moreover, the safety of currently-used vaccines is of concern in some populations. Although anticoagulants and antithrombotic medications are crucial in the management of COVID-19, a clear pharmacovigilance program on their use in this indication is not established. As the century progresses, new diseases and infectious agents will require novel therapies for which the evaluation of benefits versus risks will be as essential as it has been for the current COVID-19 pandemic. As such, the Loyola course and accompanying programs on pharmacovigilance will play a key role in educating the next generation of professionals in pursuing careers in the development of therapies that ultimately improve patient outcomes while maintaining rigorous safety standards.

A study on the knowledge, attitude, and practice on adverse drug reactions and pharmacovigilance among nursing staff

Background: Lack of knowledge of pharmacovigilance and underreporting of adverse drug reaction (ADR) are worldwide problems of big concern. Gross underreporting of ADR in India led to increased hospital admissions, increase in length of hospital stay, and increase in healthcare cost burden. Aims and Objectives: This study was planned to assess knowledge, attitude, and practice on ADR and pharmacovigilance among nursing staff in Gandhi Medical College and Associated Hospitals, Bhopal Madhya Pradesh. Materials and Methods: A questionnaire-based, cross-sectional, and observational study was conducted among nursing staff in a tertiary care Centre. Data were collected in the form of a validated questionnaire comprised of 17 questions regarding knowledge, attitude, and practice of nursing staff toward ADR and Pharmacovigilance. Data were analysis by descriptive statistics and result was computed. Results: Around 33% of respondents were aware of Pharmacovigilance program of India and 99% of them had knowledge about main objective of pharmacovigilance. Out of total filled questionnaire received, only 12% nurses practiced reporting ADR. The major factor discouraging participants from reporting ADR was lack of time to report. The majority of nursing staff had a positive attitude toward awareness of pharmacovigilance and ADR reporting. Conclusion: Our study has shown that there is lack of correct knowledge regarding ADR reporting and pharmacovigilance among staff nurses. Although, the attitude toward ADR reporting was adequate, the actual practice of ADR reporting is unsatisfactory. Hence, it is essential to train staff nurses regarding pharmacovigilance and ADR reporting.

Knowledge, attitude and practice (KAP) of pharmacovigilance among paediatricians of Odisha and factors related to poor reporting of adverse drug reactions

Children are very much vulnerable to adverse drug reactions (ADRs) and also tend to have more severe form of adverse effects compared to adults. Though ADR is a significant problem in children, paediatricians seem to neglect this aspect. Knowledge, attitude and practice (KAP) studies related to pharmacovigilance among paediatricians are lacking in literature. Hence, this study was planned to know the gaps in KAP among paediatricians of Odisha and factors related to underreporting of ADR. Google Form containing the questions was shared to paediatricians of Odisha state working in both private and government organisations. The questionnaire was prepared based on previous studies and some new questions relevant to our scenario were added. The questionnaire contained six questions based on knowledge, four on attitude and three on practice of ADR. Apart from that, it contained questions to know their response regarding the factors that discourage paediatricians to report ADRs. There were 60 responses. Among the paediatricians, 70%-80% were aware of the pharmacovigilance programme running in India. Also, 80%-90% agreed that ADR reporting is crucial in paediatric health care, while most of them were trained regarding ADR reporting. But only 50% of them had reported an ADR in their clinical practice, which clearly indicates towards underreporting. The motivation for voluntary reporting of ADRs among paediatricians for preventing the morbidity and mortality in this vulnerable population could be of immense importance, and hence, various workshops and CMEs should be conducted to improve the KAP of these doctors, so that the problem of underreporting could be minimised.

Adverse Events Following Immunization to CovId-19 vaccines in A Tertiary Care Hospital – A descriptive Study

Introduction: The pandemic due to Coronavirus disease 2019 (COVID-19) is a major health issue resulting in mortality across the globe. Multiple newer medications are being tried in treatment but with minimal success. The development of vaccines is occurring with unprecedented speed using different platforms with collaborations of academia and the pharmaceutical industries globally. These vaccines are approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there is a need for active surveillance of vaccine recipients to monitor for safety. Methods: Adverse drug reaction monitoring centre (AMC) of our institute is actively involved in surveillance of recipients for adverse events following immunization (AEFI) who received vaccines for COVID-19 from the vaccination centre of the institute. As per the guidelines of National Coordinating Centre (NCC), Pharmacovigilance Programme of India (PvPI), designated staff of AMC follows up vaccine recipients over their registered mobile number post-vaccination for AEFI if any. This is a descriptive study of all the AEFI reported to NCC, PvPI between 16th January 2021 and 31st March 2021. Results: Of the 5793 doses of vaccination administered during the study period, 59.4% (3443) responded to follow up and 8.6% (299 of 3443) recipients reported 509 AEFI. The most common reported AEFI include fever, generalized body pains, and headache constituting 36.1%, 30.5%, and 18.5% respectively. 64.2% (327 of 509) of AEFI were reported from people younger than 45 years of age. Though females constituted 53.8% (161 of 299) of people who reported AEFI, total number of events reported from this group was 58% (295 of 509). More number of AEFI were observed after first dose of COVISHIELD compared to second dose. Conclusion: COVID-19 vaccination drive is rolled out in multiple phases for different age groups across the country. Many vaccinations are being approved for use in general public with limited data from clinical trials. Active surveillance of COVID-19 vaccines for AEFI helps us in further understanding safety issues beyond the clinical trial environment.

Identifying barriers to report adverse drug reactions using the Delphi method: Experience from an institute of national importance of India.

Background: Spontaneous reporting of suspected adverse drug reaction (ADR) is an essential component of pharmacovigilance program, however, under reporting is a major drawback of it. Medical professionals cite many reasons for their inability to report suspected ADRs. Objective: This study aimed to seek consensus among resident doctors regarding barriers to report ADRs. Method: A two-round Delphi consensus study was conducted among resident doctors of a tertiary care institute of India. The participants used a five-point Likert scale to indicate each question of an initial questionnaire whether it should be considered a barrier for reporting ADR. The items for which ≥80% of all respondents agreed or strongly agreed were accepted as barrier for reporting ADR. Results: Forty-five participants completed the Delphi survey. Out of 25 questions participants unanimously selected 9 items such as unavailability of reporting form, complexity in filling reporting form and lack of motivation as barriers for reporting ADR. Conclusion: Using a Delphi method, this study identified a set of statements perceived as barriers by participants for reporting ADR

Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital.

The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day–17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs.

ASSESSMENT OF COMMUNITY PHARMACIST AWARENESS ON ADVERSE DRUG REACTION (ADR) AND PHARMACOVIGILANCE REPORTING SYSTEM IN KHARTOUM LOCALITY, SUDAN

Introduction: Adverse drug reactions resulting from the use of a medicinal product and were harmful or unpleasant reaction. Pharmacovigilance is related pharmaceuticals product after marketing and associated with collection, detection, assessment, monitoring and prevention of adverse effects. The aim of study is to recognize the awareness of pharmacists regarding pharmacovigilance and adverse drug reactions reporting. Methodology: Descriptive cross-sectional study conducted to 237 pharmacists working in Khartoum’s locality pharmacies from August 2019 to March 2020 selected by simple randomization. The data were collected by face to face interview using self-administrated Questionnaire and analyzed by SPSS version 23. Results: 57.4% from the total sample size never seen adverse drug reactions reporting form, 76.4% never receive training on how to report it and only 10.5% from the pharmacists in the study report it to pharmacovigilance center. 79% from pharmacists in the study were not aware about existence of pharmacovigilance program in Sudan. 51.5 % from pharmacists have good attitude about adverse drug reactions and pharmacovigilance in Sudan while 48.5% had poor attitude. Difficulty in communicating with pharmacovigilance centre in Sudan and how to write the report were the factors discourage pharmacists from reporting of adverse drug reactions. Conclusion: Community pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting while they had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting, this can be strengthened by educational trainings and workshops. Peer Review History: Received: 4 September 2021; Revised: 9 October; Accepted: 29 October, Available online: 15 November 2021 Academic Editor: Dr. Jennifer Audu-Peter, University of Jos, Nigeria, drambia44@gmail.com UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file: Reviewer's Comments: Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Neelam H. Zaidi, Fiji National University, Fiji, drneelamzaidi@gmail.com Dr. U. S. Mahadeva Rao, Universiti Sultan Zainal Abidin, Terengganu Malaysia, raousm@gmail.com Dr. Hayriye Eda Şatana Kara, Gazi University, Turkey, eda@gazi.edu.tr Dr. Andrzej Szymański, Poznan University of Technology, Poland, andrzej.szymanski@put.poznan.pl Similar Articles: AWARENESS OF PHARMACISTS TOWARDS ASPARTAME SIDE EFFECTS IN KHARTOUM CITY, SUDAN ASSESSMENT OF THE ROLE OF COMMUNITY PHARMACISTS IN MANAGEMENT OF HIV-POSITIVE INDIVIDUALS IN THE SOUTHERN REGION OF NIGERIA

Importance of Pharmacovigilance in Ayurveda

Introduction: Ayurveda has been introduced in India around 1500 BC. Ayurvedic medicines are more accepted these days as people are looking out for the natural medications. The major function of this system is to preserve the normal wellness of people and to cure the patient. These medicines, which are generally considered as safer, are now in the aura of doubt, due to some of the recent incidences of Adverse Drug Reaction (ADR), during their usage. Objective: Pharmacovigilance is an important step in Ayurveda to overcome and continuously monitor the ADR. Pharmacovigilance is the law and regulations for pharma industries, which deal with the detection, assessment, monitoring, understanding, prevention and reporting of adverse effects of medicines. Thus, this is the recurrent theme of ayurvedic pharmacology (dravyagunavigyan) and healing (chikitsa). The most important aim of pharmacovigilance, that is to enhance patient care and safety of the drug use, and as a result elevate rational drug use are recurring premise of ayurvedic pharmacology cology (dravyagunavigyan) and therapeutics (chikitsa). Methods: The data was collected from different websites and databases such as PubMed, Biomedical Sciences, Science Direct, Wiley Online Library, Google Scholar, WHO, Bentham science etc. A total of 80 articles were downloaded, studied, categorized and 52 were selected to write the manuscript. Results and Conclusion: There is requirement of an appropriate post-clinical surveillance program for ayurvedic drugs based on its quality, safety, and efficacy, for public health and disease management, which is now accessible in National Pharmacovigilance Programme for ASU (Ayurveda, Siddha, Unani) drugs, Ayurveda has explained a broad hypothesis on homeopathy medicines, in relation with its usage, causal ADR, treatment and its prevention. Spontaneous reporting of ADR related to Ayurveda plays an essential role in the identification and detection of new signals and communicating novel research questions.

Urological adverse drug reactions of psychotropic medication in psychiatric inpatients – A drug surveillance report from German-speaking countries

Urological adverse drug reactions (UADR) are common during treatment with psychotropic medication. The aim of this study was to provide a systematic description of the differential profile of UADR of psychotropic drugs in a large naturalistic population. Data stems from psychiatric hospitals collected by AMSP (Arzneimittelsicherheit in der Psychiatrie), a continuous multi-center pharmacovigilance program in Austria, Germany, and Switzerland. 171 cases of severe UADR (0.037%) among a total population of 462 661 inpatients treated with psychotropic drugs in 99 psychiatric hospitals between 1993 and 2016 were examined. Urinary retention (129 cases, 0.028%) was the most common UADR followed by incontinence (23 cases, 0.005%) and nocturnal enuresis (16 cases, 0.003%). Risk of UADR was higher in patients with mania than in other diagnostic groups. Promethazine and haloperidol were the antipsychotics with the highest rate of UADR. Tricyclic antidepressants had a higher and selective serotonin reuptake inhibitors a lower risk for UADR than the respective other antidepressants. Amitriptyline and clomipramine were the most common causes of urinary retention and clozapine of urinary incontinence. This research improves our knowledge of the urological risk profiles of psychotropic drugs in inpatients and highlights compounds associated with higher or lower risk.

A questionnaire-based knowledge, attitude and practice study to determine the awareness of pharmacovigilance among the health care professionals in a tertiary care hospital of West Bengal

Background: Pharmacovigilance programs have been introduced to keep an eye on adverse drug reactions and safe use of drugs. All Healthcare professionals (HCPs) should report each and every adverse events which they come across. Pharmacovigilance programme of India is running actively since 2010 but India contributes only 2% of Adverse drug reactions (ADR’s) reported worldwide. There is need to monitor awareness of HCP’s about pharmacovigilance to achieve the goals. Such studies from peripheries of Eastern India are lacking. The aim of the study was to assess the knowledge, attitude and practice and overall awareness among HCP’s about pharmacovigilance and to understand actual barriers of ADR reporting.Methods: A cross-sectional questionnaire-based study was done in Burdwan Medical College and Hospital. Ninety-nine HCP’s completed the pre-designed questionnaire. There were 15 questions to assess the awareness and cause(s) of underreporting. Data were analysed using appropriate statistical software.Results: We analysed data of 67 doctors and 32 nurses. We found, 67.2% doctors and 59.4% nurses knew definition of pharmacovigilance. About half HCP’s had knowledge about existing pharmacovigilance committee in our hospital. Almost all HCP’s felt ADR reporting is necessary. Surprisingly 88.1% doctors and 46.9% nurses experienced ADR at least once but 25.4% and 3.1% reported them respectively. For knowledge and practice related questions, correct responses were significantly higher for doctors. Most common discouraging factors regarding ADR reporting were, didn’t know how to report (52.5%) where to report (41.4%).Conclusions: Attitude of HCP’s towards pharmacovigilance activities was appreciable and combining it with periodic sensitizing programs, and training sessions will increase the knowledge, clear doubts about ADR reporting and improve the awareness about pharmacovigilance.

A Review on Adverse Drug Reactions

Adverse Drug Reactions (ADRs) became as one of the global problems that affect both children and adults with varying intensities. A significant number of ADRs may occur in elderly due to the contribution of drug-drug interactions, who are under polypharmacy. Various definitions are available all over the world in case of ADRs. But the definition by the World health organization was well adopted and widely accepted by many countries across the world. To promote the identification and reporting of ADRs and also to ensure and enhance the patient safety certain measures has to be taken by all health care professionals. The contribution of health care professionals, in regard to ADRs database is very much important and has encouraged the ongoing certainty of benefit risk ratio of drugs and also contributed to detect the unusual ADRs which are undetected during the basic evaluation of the drug. Pharmacists have a vital role in the maintenance of drug safety by contributing towards the prevention, detection, documentation and reporting of ADRs. The hospital or clinical pharmacist should actively participate in the area of pharmacovigilence in order to strengthen the National pharmacovigilance program.

Characterisation of Drug-Induced Liver Injury in Patients with COVID-19 Detected by a Proactive Pharmacovigilance Program from Laboratory Signals.

Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical manifestations. An elevation of liver damage markers has been observed in numerous cases, which could be related to the empirical use of potentially hepatotoxic drugs. The aim of this study was to describe the clinical and analytical characteristics and perform a causality analysis from laboratory signals available of drug-induced liver injury (DILI) detected by a proactive pharmacovigilance program in patients hospitalised for COVID-19 at La Paz University Hospital in Madrid (Spain) from 1 March 2020 to 31 December 2020. The updated Roussel Uclaf Causality Assessment Method (RUCAM) was employed to assess DILI causality. A lymphocyte transformation test (LTT) was performed on 10 patients. Ultimately, 160 patients were included. The incidence of DILI (alanine aminotransferase >5, upper limit of normal) was 4.9%; of these, 60% had previous COVID-19 hepatitis, the stay was 8.1 days longer and 98.1% were being treated with more than 5 drugs. The most frequent mechanism was hepatocellular (57.5%), with mild severity (87.5%) and subsequent recovery (88.1%). The most commonly associated drugs were hydroxychloroquine, azithromycin, tocilizumab and ceftriaxone. The highest incidence rate of DILI per 10,000 defined daily doses (DDD) was with remdesivir (992.7/10,000 DDD). Some 80% of the LTTs performed were positive, with a RUCAM score of ≥4. The presence of DILI after COVID-19 was associated with longer hospital stays. An immune mechanism has been demonstrated in a small subset of DILI cases.

Drug-Related Deaths in a Tertiary Hospital: Characteristics of Spontaneously Reported Cases and Comparison to Cases Detected from a Retrospective Study.

Drug-related deaths (DRDs) are a common cause of hospital death. Pharmacovigilance, either as spontaneous reporting or active surveillance, plays a key role in the detection and reporting of suspected adverse drug reactions (ADRs). We conducted a retrospective analysis of all DRDs spontaneously reported to a pharmacovigilance program of a tertiary hospital, by health care professionals. We compared these results to those of a previous retrospective study conducted in the same hospital from the hospital’s mortality registry. From 1460 spontaneous reported ADRs in a 10-year period, 73 (5%) were DRDs. The median age of DRD was 75 years (range 1 month–94) and 60.3% were men. The most frequent DRDs were hemorrhages (41.1%), followed by infections (17.8%). The most frequently involved drugs were anticoagulants and/or antithrombotic (30%), and antineoplastics (26.3%). When comparing both studies, spontaneous reporting detected more type B reactions (p < 0.001) and hospital-acquired DRD (p < 0.001); the number of concomitant drugs was higher (p = 0.0035); and the kind of ADR were different. The combination of several methods is mandatory to detect, assess, understand, and design strategies to prevent ADRs in a hospital setting, to ensure patient safety.

An Overview about Safety Surveillance of Adverse Drug Reactions and Pharmacovigilance in India

One pathway for more actively monitoring Adverse Drug Reactions (ADRs) and, as a result, improving patient care safety is a structured Adverse Drug Reaction Surveillance network. Multiple methods for testing and recording the efficacy of drugs in clinical use are important for avoiding or reducing patient injury and strengthening public health. This entails establishing a well-structured Pharmacovigilance programme in clinical practise. Once a prescription has been published into the "true world," pharmacovigilance is an important method of monitoring medication-related issues. Pharmacovigilance and other drug-related problems should be familiar to those whose life is impacted by prescription procedures in some way. In modern times, pharmacovigilance has gained prominence as a technology critical to sound clinical practise and public health science. Since ADRs have such a detrimental influence on patients' wellbeing and inflict too much financial strain, it's critical to carefully monitor each medication for any potential adverse effects in animal models (preclinical studies) and clinical trials until releasing it. Pharmacovigilance aims to serve a significant part in combating the dangers faced by an ever-growing number of drugs, each of which is vulnerable to unpredictably negative side effects. When adverse effects and toxicity occur, they must be recorded, analysed and the importance of the results correctly communicated to those who may understand the evidence. By ensuring that prescription drugs of high consistency, purity and effectiveness are used rationally, the risk of injury will be minimised. In this study it will briefly explore adverse drug reaction safety control and pharmacovigilance in India.