Pharmacovigilance Program Research Articles

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.

Utility of Lymphocyte Transformation Test for Assisting Updated Roussel Uclaf Causality Assessment Method in Drug-Induced Liver Injury: A Case-Control Study.

Background: The Roussel Uclaf Causality Assessment Method (RUCAM) is a validated tool for assessing causality in cases of suspected drug-induced liver injury (DILI). However, RUCAM cannot discriminate between concomitant hepatotoxic drugs with the same temporal sequence. Objective: To analyse the utility of the lymphocyte transformation test (LTT) for assisting updated RUCAM in 45 patients and 40 controls with a clinical diagnosis of DILI. Methods: Suspected DILI cases were detected through the Prospective Pharmacovigilance Program from Laboratory Signals in Hospital (PPLSH) or by consultations. The controls completed the drug therapy with no adverse reactions during the study period. A receiver operating characteristics (ROC) curve analysis was performed to calculate the optimal cut-off value for the stimulation index (SI), corresponding to the largest sum for the specificity and sensitivity values of LTT for true DILI cases. Results: Out of 45 patients diagnosed with DILI, 42 cases were detected by the PPLSH, two cases by consultation and one case by both methods. Most DILI cases (64.4%) arose during hospitalization. According to the biochemical parameters, 24 cases (53.3%) had the hepatocellular phenotype, 14 (31.1%) had the cholestatic phenotype, and 7 cases (15.6%) had the mixed phenotype. Considering the severity criteria, 7 (15.5%) cases were classified as moderate DILI, and 4 (8.9%) were severe DILI; there were no fatal cases. A total of 149 drugs (median/case, 3; IQR, 2–5) were suspected to be involved in the DILI cases (RUCAM score ≥3). In 8 cases, only one drug was suspected, and polypharmacy (≥5 drugs) was identified in 29% of the cases. Of all DILI cases, 46 (30.9%) of the 149 suspected drugs produced positive LTT results, and the LTT was positive in 34 (75.5%) of the 45 patients. No exposed controls produced positive LTT results. The optimal cut-off of 1.95 for the SI was obtained with a sensitivity of 77% and specificity of 100% (area under the curve, 0.91; 95% asymptotic confidence interval 0.84–0.97; p < 0.001). The sensitivity of the hepatocellular phenotype was 92%. Conclusion: Our results demonstrate that LTT is an add on strengthening causality in cases of suspected idiosyncratic DILI, especially for patients with several suspected drugs and a hepatocellular phenotype.

Exploring the factors and barriers of healthcare professionals in tertiary care hospitals toward pharmacovigilance: a multicenter study from Khyber Pakhtunkhwa, Pakistan

Background Spontaneous Adverse drug reactions (ADRs) reporting is a cornerstone for a successful pharmacovigilance program as under-reporting of ADRs remains a major issue around the globe. The current study aimed to assess the knowledge attitude and practices of health care professionals regarding pharmacovigilance along with barriers and factors to encourage ADR reporting at tertiary care hospitals of Khyber-Pakhtunkhwa, Pakistan. Methods A questionnaire-based cross-sectional survey was conducted, using the convenience sampling method to collect the data from doctors, nurses, and pharmacists working in seven tertiary care hospitals from seven districts of Khyber-Pakhtunkhwa province, Pakistan, between July 2019 and March 2020. Results During the study, a total of 830 questionnaires were distributed, out of which 669 were returned (response rate 80.6%). Overall, Healthcare professionals exhibited poor knowledge (79.5%) about ADR reporting and pharmacovigilance however, 73.5% of pharmacists were more knowledgeable as compared to 18.7% doctors and 13.8% nurses (p < .001). Moreover, poor reporting practices were displayed by 95.6% doctors, 94.4% nurses, 94.4 and 75.5% pharmacists (p < .001). However, the majority of healthcare professionals showed an overall positive attitude (94%) toward ADR reporting. The most frequently cited barriers were unavailability of reporting forms (92.5%), absence of a professional environment to discuss ADRs (82.5%), and lack of training (81.8%) whereas, most common factors to encourage ADR reporting were obligatory reporting (85.9%) and provision of ADR management guidelines and training (84.3%). A significant relation was found between the healthcare professionals and their professional status with the overall knowledge, attitude, and practice (KAP) scores (p < .001) whereas a medium, positive correlation was found between the knowledge and practice of pharmacovigilance and ADR reporting by the healthcare professionals (r = 0.321, n = 669, p < .001). Conclusion There is an overall lack of knowledge and poor reporting practices among health care professionals on ADR reporting and pharmacovigilance. Hence the study suggests that strategies should be devised by all the stakeholders to properly educate and train the healthcare professionals in this area to enhance overall patient safety and safe use of medicines.

The Safety of Anti-SARS-CoV-2 Vaccines: Vigilance Is Still Required.

The opinion I put forward in this paper is that attention must continue to be paid to clinical observations compatible with a detrimental effect of anti-SARS-CoV-2 in certain diseases of immunological nature. Using the example of the atypical thrombocytopenic thromboses caused by adenoviral-vector-based vaccines, I argue that usual post-marketing pharmacovigilance programs may fail in identifying very rare vaccine-related disorders. Since the robust protective immunity induced by mRNA vaccines is related to their distinct capacity to induce strong stimulation of T follicular helper cells, I suggest that the safety of mRNA vaccines should be further assessed by appropriately designed epidemiological and mechanistic studies focusing on lymphoproliferative and autoimmune diseases in which T follicular helper cells were found to play a key role.

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.