National Pharmacovigilance Centre Research Articles

Assessment of knowledge, attitude and practice of pharmacovigilance and adverse drug reactions reporting among the community pharmacies in Dharan

<p class="abstract"><strong>Background:</strong> Community pharmacist’s (CPs) knowledge, attitude and practice (KAP) of pharmacovigilance and adverse drug reactions (ADR) play a vital role in preventing harmful effects of medicine. The objective was to assess the KAP of pharmacovigilance and ADR reporting among CP.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was carried out among 132 CP in Dharan between February-March 2019 by using a self-administered 25-item semi-structured questionnaire. The KAP score was categorized as good (score 13-25) and poor (score 0-12). The descriptive statistics were calculated using Microsoft excel 2010.</p><p class="abstract"><strong>Results:</strong> Out of 132 pharmacies, only 77 responded giving a response rate of 58.3%. There were 45 (58.4%) male. Majority of the participants (45, 58.4%) had completed diploma in pharmacy course. Only 23 (29.9%) respondents gave the correct responses regarding the definition of pharmacovigilance and 23.4% were aware of the national pharmacovigilance centre. 50.9% agreed that reporting of ADRs is a part of pharmacist duty and it was important to report ADRs and was leading cause of hospitalization. Sixty three (81.8%) participants had never ever been trained on how to report ADR. Seventy (90.9%) participants were willing to report ADR, however, 51 (66.2%) had never seen the ADR reporting form. Only 3 (3.9%) participants had good KAP score (23.33±1.54).</p><p class="abstract"><strong>Conclusions:</strong> Despite of relatively better attitude towards pharmacovigilance and ADR reporting, they had a limited knowledge and practice with regard to ADR reporting and pharmacovigilance. The study findings highlights the need to strengthen the community pharmacovigilance program for safer medication use at the community level.</p>

POS0669 HYPOGLYCAEMIA FOLLOWING JAK INHIBITOR TREATMENT IN DIABETES MELLITUS PATIENTS WITH RHEUMATOID ARTHRITIS

Background:Janus kinase (JAK) inhibitors are effective small molecular drugs for rheumatoid arthritis (RA) and other immune mediated inflammatory diseases (IMIDs). JAK inhibitors exert their immunosuppressive effects by suppressing the action of JAK, an intracellular tyrosine. Although infections are the most reported side effects, potential glucose lowering effects in patients with diabetes mellitus (DM) have been described in literature and have also been reported as suspected adverse drug reactions (ADRs) to the National Pharmacovigilance Centre Lareb in the Netherlands (1).Objectives:To assess and describe suspected adverse effects of JAK inhibitors on glucose levels in diabetic patients with rheumatic diseases and other IMIDs, as reported in daily practice.Methods:We describe ADR reports of tofacitinib and baricitinib in the European pharmacovigilance Eudravigiliance (EV) database from initiation to 12 January 2021. All ADRs in EV are coded according to the Medical Dictionary for Regulatory Activities (MedDRA). We included all reports indicating hypoglycaemia in patients with reported DM type 1 and 2 or with antidiabetic drugs as concomitant medication. This could include oral antidiabetics as well as insulins.Results:On 12 January 2021 the EV database included 32 ADR reports, concerning 32 diabetic patients, indicating hypoglycaemia associated with the use of JAK inhibitors (15 tofacitinib, 17 baricitinib), out of 32,484 ADR reports in total concerning tofacitinib or baricitinb (Table 1). Most patients (25 patients, 78%) used the JAK inhibitor for rheumatoid arthritis. The suspected ADR with MedDRA Preferred Term ‘Hypoglycaemia’ was reported for 16 patients and MedDRA Preferred Term ‘Decreased blood glucose’ was reported for 15 patients. In one case, increased insulin sensitivity was described as suspected ADR of baricitinib. In this case, the insulin dose had to be reduced to prevent hypoglycaemia. Of note, the insulin dose had to be increased after temporary discontinuation of baricitinib and was reduced again after baricitinib was restarted. Additionally, in six cases improvements of glycaemic control were described after discontinuation or dose reduction of the JAK inhibitor or antidiabetic drug. Improvements were also described after unknown action or unchanged treatment with JAK inhibitor in eight cases.Conclusion:JAK inhibitors may induce hypoglycaemia by increasing insulin sensitivity, and consequently may reduce the need for antidiabetic medication (2-3). Healthcare professionals should be alert for these potential ADRs when starting a JAK inhibitor in patients with DM as comorbidity. More research is needed to support our findings and elucidate the underlying pharmacological mechanisms of this potentially beneficial effect of JAK inhibitors.Table 1.Suspected adverse drug reaction reports indicating hypoglycaemia in diabetic patients using tofacitinib or baricitinib in the Eudravigilance databaseTofacitinib N (%)Baricitinib N (%)No. of reports15 (100)17 (100)Mean age years (range)65 (56 - 78)62.2 (48 - 78)Female gender13 (87)13 (76)Indication for JAK inhibitor Rheumatoid arthritis11 (73)14 (82) Unknown3 (20)3 (18) Arthritis1 (7)Reported adverse drug reaction Hypoglycaemia6 (40)11 (65)a Decreased blood glucose9 (60)6 (35) aTime to onset after start JAK inhibitorb Within 1 month6 (40)3 (18) 2-6months2 (13)2 (12) More than 6 months1 (7)Improvement after action: Drug withdrawal3 (20)c1 (6)d Dose adjustments1 (6)e Other1 (7)fa.In one case of baricitinib hypoglycaemia as well as decreased blood glucose were reported as adverse drug reactions.b.Time to onset was unknown in 6 reports of tofacitinib and 12 reports of baricitinibc.Tofacitinib withdrawal: 1, sitagliptin withdrawal: 1, tofacitinib and insulin withdrawal: 1d.Baricitinib withdrawal: 1e.Baricitinib: after insulin dose adjustments: 1f.After tofacitinib withdrawal and insulin dose adjustments

Pharmacovigilance network as an additional tool for the surveillance of antimicrobial resistance.

The WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports. Pharmacovigilance Experts have suggested that antimicrobial resistance (AMR) is an overlooked adverse event. We undertook this study to investigate the potential role of Pharmacovigilance databases in the surveillance of AMR. Using the AWaRe (Access, Watch and Reserve) list and the WHO Priority Pathogens List, we established a list of antimicrobials and carried out a VigiBase search via VigiAccess, looking for ADR reports with Preferred Terms (PTs) that contained AMR-relevant information. Identified Terms were matched with codes from the Medical Dictionary for Regulatory Activities (MedDRA Version 21.1). Records on 86 drugs were retrieved with a total of 1 170 751 ADR reports submitted between 1968 and 2018. Seventeen PTs suggesting suspected resistance, ineffectiveness, inappropriate use, or medication error were used to code 15 250 reports. The most frequently used PTs were "Drug Ineffective" (45.6%), "Off label use" (9.5%) and "Pathogen Resistance" (8.9%). A group of six agents (Amoxicillin, Cefalotin, Ciprofloxacin, Clarithromycin, Levofloxacin and Daptomycin) accounted for 38% (n=5806) of all 15 250 AMR-relevant ADR reports. The PTs most frequently used in 5806 reports were grouped in 4 categories: drug ineffectiveness (62.5%), resistance (19.2%), off-label use (12.1%) and prescription errors (6.2%). Our findings suggest that Pharmacovigilance databases could serve as a tool in tracking antimicrobial use and resistance especially in settings where laboratory capacity is still in its development stages. National Pharmacovigilance centers could play a proactive role in stimulating the reporting of AMR-relevant ADRs which can serve as a basis for resistance suspicion alerts. Further studies focusing on the narrative and other clinical pharmacology details in ADR reports are required.

Perspectives of Pharmacovigilance of AYUSH Drugs among Teaching faculty, Post graduate students and Interns of three different Ayurvedic Teaching Institute in Amravati District of Maharashtra state – A cross sectional survey.

Pharmacovigilance helps to prove the system safe, more scientific in the terms of modern terminology. It is an absolute requirement to ensure public safety and to promote the AYUSH systems of medicine. Pharmacovigilance program launched in the India by Department of AYUSH, Ministry of health and family welfare, on 29/09/2008. Though it is helpful for development of system and government emphasized for implementation of it in root level, till date there is lack of awareness about this program among teaching faculties of AYUSH system. So to find out level of perspective of Pharmacovigilance in Teaching faculty, Post graduate students and Interns of Three different Ayurvedic Institutes in Amravati districts present study was carried out in November 2020. Method:A structured and validated questionnaire with some miner modification used3 and distributed in the form of Hard copy among Teaching faculty, Residential medical officer and Interns of Three Ayurvedic colleges in Amravati District of Maharashtra state. Total of 50 teaching faculties with 62% of Lecturer cadre, 32% are of Reader and 2.50% of Professor Cadre responded to the questionnaires, with this one medical officer also responded to the questionnaire. Total 12 PG (Post graduate students) of different department take participation in the study while 88 Interns recorded their response in this study, so total participants in this study are 150 (n=150).Result:52% (78) of participants aware of Pharmacovigilance program for Ayurvedic drugs in India and44% (66) of participants actually know exactly where the National Pharmacovigilance center for AYUSH Drugs is situated. Only 11.33% (17) of participants responded correct answer to question where the International Pharmacovigilance center for AYUSH drug is situated. In this study 58.66% (88) of participants accept that Ayurvedic drugs have adverse effect. Only 32.66% (49) participants responded that they are encountered with adverse event due to Ayurvedic drug in there clinical practice and out of which only 12% (18) of participants reported the adverse event. 18% of participant’s familiar with standardized format for reporting ADR.Only 3.33% of participants give the example of Ayurvedic drugs banned due to ADR. Only 5.33% of participants attended the CME or training program about Pharmacovigilance of Ayurvedic drugs.Conclusion: Over all result shows the lack of awareness towards Pharmacovigilance program of AYUSH drugs in faculty and students of all Ayurvedic colleges in Amravati. Also Bletonism to point out adverse drug reaction (ADR) caused due to Ayurvedic drug and report it to the authorized center in standardized format. So to increase awareness about PV it should be include in Syllabus and more CME, Seminar and workshop should organized for students, teaching faculty and private practioner.

Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa-Ethiopia, Kenya, Rwanda, and Tanzania.

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

Minireview of drug safety and pharmacovigilance

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. ADR causing intrinsic factors include the active ingredients in the drug itself. In Saudi Arabia, the National Pharmacovigilance Center (NPC) was established in March, 2009 as a semi-autonomous department of Saudi Food and Drug Authority (SFDA). The purpose of NPC was to perform early detection of ADR and safe use of drugs. We need pharmacovigilance because animal experiments and clinical trials performed before marketing are insufficient evidence of drug safety.

Risk management of adverse effects of antimalarial drugs: Knowledge of Physicians and Pharmacists in KAYES, MALI

In order to improve therapeutic compliance and prevent antimalarial drug resistance, we conducted this study to evaluate the knowledge of physicians and pharmacists in Kayes on the management of adverse effects of antimalarial drugs. Methods: A cross-sectional study was conducted from July to November 2017 among physicians and pharmacists selected by simple random sampling and practicing in the Kayes region for more than one year. The survey was based on a questionnaire proposed by the national pharmacovigilance center. In addition to a descriptive analysis of the results, a logistic regression analysis was performed to assess potential factors that could be associated with knowledge. Results: Among 151 physicians and pharmacists participated in the study, less than 40% had better knowledge about the management of antimalarial drug adverse events. Physicians and pharmacists working in government facilities were more likely to have better knowledge compared with those working in other facilities (OR=8.38; 95% CI: 2.48-28.30). In addition, pharmacists were more likely to have better knowledge than physicians (OR=3.48; 95% CI: 1.21-12.19). Conclusions: The frequency of good knowledge of the management of adverse drug reactions to antimalarials is insufficient, although membership in government structures and profession seem likely to improve it.

Knowledge and Perception Assessment of Pharmacy Technicians on Biosimilars at the University Hospital Center -Tlemcen

Biosimilars are similar products, but not identical, to a reference biological drug already approved by the authorities, whose protection certificate has expired. Biosimilars have recently been introduced at Tlemcen University Hospital Center (TUHC). Pharmacy technicians are essential health actors for good distribution and use of biodrugs in particular biosimilars within the TUHC. For this, we have done a study to assess the knowledge of pharmacy technicians on biosimilars as well as their opinion on their efficacy-safety profiles. The data collection was carried out by the distribution of a questionnaire with 12 questions (Figure 1). We have analyzed the questionnaires of the 10 pharmacy technicians who agreed to join our study. More than half of pharmacy technicians could not correctly define a biosimilar. In addition, according to the answers provided, the stages of development and approval of biosimilars are not well known. Continuous training on the topic of biosimilars is necessary in order to raise awareness in this category of the importance of rigorous monitoring of these treatments within the TUHC. Regarding the accessory goal of the questionnaire attributed to pharmacy technicians, to provide their opinions on the efficacy and safety of biosimilars according to their daily professional experience, a large part of pharmacy technicians has expressed a satisfaction with the efficiency and safety of these drugs. However, since a certain category of pharmacy technicians affirms to witness suspicion of side effects of biosimilar treatment without informing the Central Pharmacy, it is imperative to raise awareness of the need to declare them to regional and national pharmacovigilance centers.

Knowledge and Perception Assessment of Pharmacy Technicians on Biosimilars at the University Hospital Center-Tlemcen

Biosimilars are similar products, but not identical, to a reference biological drug already approved by the authorities, whose protection certificate has expired. Biosimilars have recently been introduced at Tlemcen University Hospital Center (TUHC). Pharmacy technicians are essential health actors for good distribution and use of bio-drugs in particular biosimilars within the TUHC. For this, we have done a study to assess the knowledge of pharmacy technicians on biosimilars as well as their opinion on their efficacy-safety profiles. The data collection was carried out by the distribution of a questionnaire with 12 questions. We have analyzed the questionnaires of the 10 pharmacy technicians who agreed to join our study. More than half of pharmacy technicians could not correctly define a biosimilar. In addition, according to the answers provided, the stages of develo in order to raise aw pment and approval of biosimilars are not well known. Continuous training on the topic of biosimilars is necessary areness in this category of the importance of rigorous monitoring of these treatments within the TUHC. Regarding the accessory goal of the questionnaire attributed to pharmacy technicians, to provide their opinions on the efficacy and safety of biosimilars according to their daily professional experience, a large part of pharmacy technicians has expressed a satisfaction with the efficiency and safety of these drugs. However, since a certain category of pharmacy technicians affirms to witness suspicion of side effects of biosimilar treatment without informing the Central Pharmacy, it is imperative to raise awareness of the need to declare them to regional and national pharmacovigilance centers.

Pharmacovigilance in Covid-19 vaccines

The ongoing pandemic coronavirus disease of 2019 (COVID-19), originated from Wuhan, China, has caused universal challenging and threatening with considerable health impact and economic losses. Therefore, vaccination, as preventive and protective medical countermeasure, remains an excellent issue for reducing morbidity and mortality of this emerging infectious disease. As of April 2021 and by Emergency Use Authorization (EUA) process, 16 vaccines were authorized by at least one national regulatory authority for public use: two Ribonucleic Acid (RNA) vaccines (Pfizer–BioNTech and Moderna), seven conventional inactivated vaccines (BBIBP-CorV manufactured by Siinopharm, CoronaVac, Covaxin, WIBP-CorV, CoviVac, Minhai-Kangtai and QazVac), five viral vector vaccines (Sputnik Light, Sputnik V, Oxford–AstraZeneca, Convidecia, and Johnson & Johnson) and two protein subunit vaccines (EpiVacCorona and RBD-Dimer). As other countries, Morocco has established an anti-COVID-19 vaccine strategy in order to effectively contribute to the monitoring of vaccine safety supported by the national platform health vigilance and regulated by the National Anti-Poison and Pharmacovigilance Center (CAPM). In this review, we recorded the main current developed COVID-19 vaccines and discussed pharmacovigilance strategies and tools related safety and tolerability of those therapies. In parallel, a review of the Moroccan experience in this field is also conducted.

Prevalence Rate of Spontaneously Reported Adverse Events and Determinants of Serious Adverse Events Amongst Three Outpatient Care Settings in Ghana

Introduction: Most evidence of adverse drug events (ADEs) comes from hospitals as the risks associated with hospital care are higher. However, underreporting of ADEs is a critical problem in all healthcare settings. This is important in sub-Saharan African countries including Ghana with limited resources and a high prevalence of both infectious and non-infectious diseases. Consequently, this study sought to determine the annual prevalence of spontaneously reported ADEs using 6-year reports and factors associated with the occurrence of serious ADEs amongst outpatient care settings in hospitals in Ghana to provide future guidance. Methodology: This is a cross-sectional study using duplicates of the Ghana Food and Drugs Authority adverse event forms retrieved from three outpatient care settings submitting their reports to the National Pharmacovigilance Centre in Ghana between 2013 and 2018. Descriptive and bivariate analyses were performed. Results: Overall, 93 spontaneously reported cases of ADEs were identified during the study period. The annual prevalence rate was 192 reports/1000,000 population amongst our study population, and the rate of serious ADE was 35.48% (95% confidence interval: 25.83%–46.09%). Serious ADEs were associated with the type of indication for which the drug was prescribed (P = 0.048), the duration of the ADE (P = 0.047) and the need to administer treatment for the ADE at the reporting facility (P = 0.017). Conclusion: Early spontaneous reporting of ADEs at outpatient settings is essential. Patient and provider education and awareness of potential ADEs must be intensified for early identification and reporting.

Evaluation of Pharmacovigilance System in Iran.

Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement. This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran. Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed. A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators' status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.

Analysis of adverse drug reactions reported to national pharmacovigilance center of Bhutan

Introduction: Medicines prescribed for diseases often causes adverse drug reactions in patients ranging from mere inconvenience to permanent disability and death. This is because, most of the adverse drug reactions especially the serious and latent ones may not have occurred during the clinical trials and vulnerable populations like children, pregnant women and the elderly are not all included in clinical trial studies considering the ethical and safety issues. Objectives: To study the demographic characteristics, types of adverse drug reactions and common drugs causing these reactions from the adverse drug reaction reports received by the national pharmacovigilance of Bhutan. Methods: A total of 222 adverse drug reactions were received at the national pharmacovigilance center from January 2016 to May 2018 were analyzed retrospectively. The Drug Regulatory Authority is the national pharmacovigilance center of Bhutan and is a member to the International Drug Monitoring Program since 2014. Results: 73% of adverse drug reactions occurred in adults while 13.5% occurred each in children and elderly. 48.7% of the total adverse drug reactions reports were caused by antibiotics out of which penicillin was the most common causal drug (32.4%). The most commonly reported adverse drug reactions was rashes (36.5%) followed by gastro-intestinal system disorder (14.9%). Conclusions: Antibiotics are common causal drugs for adverse drug reactions. All categories of health professional must be encouraged to report adverse drug reactions. Active surveillance for drug safety monitoring especially for those of patients who are on antibiotics is recommended.

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting

BackgroundTherapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.MethodsSurvey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness.ResultsOne in five (20%, 137/685; 95% CI 17–23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI 1.41–4.21), HCPs aged under 25 years (OR = 2.2, 95% CI 1.29–3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI 1.29–3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI 1.62–5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI 0.28–0.93) and western (vs central; OR = 0.4, 95% CI 0.17–0.77) parts of Uganda.ConclusionOne in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.

Comparative Analysis of International Databases of Adverse Drug Reactions

In 1968 the World Health Organisation initiated the development of an international programme for collection of data from the maximum number of sources about potential adverse effects of medicines. In order to implement this programme, a number of databases were created, such as the global database VigiBase, the European database EudraVigilance, and the database of the Eurasian Economic Union (EAEU). The aim of the present study was to compare approaches of the international spontaneous reports databases to collection, processing, and analysis of information on adverse drug reactions. It was demonstrated that the international databases VigiBase, EudraVigilance, and the EAEU database of adverse drug reactions contain different numbers of spontaneous reports, but serve the same objectives, namely to collect, process, and analyse information submitted as spontaneous reports. Unlike VigiBase that contains reports on authorised medicines coming from the national pharmacovigilance centres only, EudraVigilance also receives data from marketing authorisation holders and has reports on adverse drug reactions observed during clinical trials. The exchange of information between countries ensures rapid identification of safety signals concerning potential risks of medicines, and increases the likelihood of detecting rare and late-onset adverse reactions that may go unnoticed when analysing national data in a particular country. Spontaneous reports databases are an essential tool of the international drug safety monitoring community. Effective measures in this area will ultimately help to improve patients’ health and quality of life.

The Beginning of Pharmacovigilance in Bosnia and Herzegovina

Aims: The aims of this article are to present the impact of the pharmacovigilance performance improvement in Bosnia and Herzegovina on the reporting results gathered at the national pharmacovigilance database. Subjects and methods: Bosnia and Herzegovina is a country in Europe with a complicated political structure, the highest rate of unemployment and a low Gross Domestic Product. Although the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina was established in 2009, with the Main Office for Pharmacovigilance as the national pharmacovigilance center, there were no activities and work in the field of pharmacovigilance. In 2017 several changes were made in the work of the Main Office such as: employment of an external expert for the work of pharmacovigilance, holding lectures and workshops, collecting and analyzing adverse drug reactions, signing various co-operations with professional chambers and health institutions forwarding reports to the World Health Organization and writing annual reports. Results: These changes showed an increase in the collected adverse drug reactions by 130% and 28% on an annual level for 2017 and 2018, respectively. Bosnia and Herzegovina became a full member of the Uppsala Monitoring Center, a global office for drug monitoring by the World Health Organization. Conclusion: Bosnia and Herzegovina can be used as an example for developing a sustainable pharmacovigilance system in countries with low economical standards.

A Case Study of Pharmacovigilance in Nigeria: Challenges and Solutions

Pharmacovigilance is concern with the monitoring and examining of drugs to prevent its adverse effect on patients in a given nation. In spite, of the intensive efforts made by the Nigeria government to improve pharmacovigilance little seems to be achieved. This may be due to the challenges faced by the national pharmacovigilance centre (NPC) which range from lack of skilled manpower, lack of sufficient funding among others. Due to these underlining facts, Nigeria government, citizens and health stakeholders often map-out modalities for ensuring effective and efficient pharmacovigilance, but much result have not been achieved as anticipated. It is a consonance with the forgoing that the researcher carried out an investigative approach into the challenges facing pharmacovigilance in Nigeria with solution insight for the challenges. It was recommended among others that, the Nigeria Government should ensure that only qualified persons especially pharmacologist are employed in National Pharmacovigilance Centre (NPC).

E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre.

IntroductionAn increasing global need for pharmacovigilance training cannot be met with classroom courses alone. Several e-learning modules have been developed by Uppsala Monitoring Centre (UMC). With distance learners and technological challenges such as poor internet bandwidth to be considered, UMC opted for the microlearning approach based on small learning units connected to specific learning objectives. The aim of this study was to evaluate how this e-learning course was received.MethodsThe course was evaluated through usage data and the results of two user surveys, one for modules 1–4, signal detection and causality assessment, and the other for module 5, statistical reasoning and algorithms in pharmacovigilance. The evaluation model used was based on the Unified Theory of Acceptance and Use of Technology (UTAUT). A questionnaire was developed, divided into demographic profile, performance expectancy, effort expectancy, educational compatibility and behavioural intention. The two surveys were disseminated to 2067 learners for modules 1–4 and 1685 learners for module 5.ResultsLearners from 137 countries participated, predominantly from industry (36.6%), national pharmacovigilance centres (22.6%) and academia (16.3%). The overall satisfaction level was very high for all modules, with over 90% of the learners rating it as either ‘excellent’ or ‘good’. The majority were satisfied with the learning platform, the course content and the lesson duration. Most learners thought they would be able to apply the knowledge in practice. Almost 100% of the learners would recommend the modules to others and would also study future modules. Suggested improvements were an interactive forum, more practical examples in the lessons and practical exercises.ConclusionThis e-learning course in pharmacovigilance based on microlearning was well received with a global coverage among relevant professional disciplines.Electronic supplementary materialThe online version of this article (10.1007/s40264-020-00981-w) contains supplementary material, which is available to authorized users.

Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019

Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection.1,2 In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19.3 In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported.4,5 In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n= 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0).6 Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.

Adverse Drug Reactions Reporting: Knowledge and Perception among General Public in Eastern Province, Saudi Arabia

<!DOCTYPE html> <html> <head> </head> <body> <p style="text-align: justify;"><strong>Objectives:</strong> The current study aims to assess general public knowledge and perception toward Adverse Drug Reaction (ADR) reporting systems in Eastern province, Saudi Arabia. <strong>Methods: </strong>A cross-sectional survey based study was conducted from 1st September 2019 to 31st October 2019 among the community in Eastern province, Saudi Arabia. A validated self-administered questionnaire were distributed among easily approachable 1500 participants through social media in which 1038 respondents were completely filled the survey form. Chi square test were used for the calculation of variance among the group. <em>P</em>-value less than and equal to 0.05 is considered statistically significant. <strong>Results:</strong> The response rate of survey was 69.20%. The mean age of the survey respondents were 30.5&plusmn; 8.37years. Among all the respondents 335(32.27%) respondents were male and 703(67.72%) respondents were female from community of Eastern province, Saudi Arabia. Only, 7.61% of the respondents were familiar with the Saudi National Pharmacovigilance Centre (NPC) (<em>p</em>&lt;0.05). 87.57% general public of Eastern province, Saudi Arabia were aware about electronic Adverse drug reaction (ADR) reporting procedure (<em>p</em>&lt;0.05). While 89.88% population think that all marketed drugs are safe (<em>p</em>&lt;0.05). <strong>Conclusion: </strong>General public of Eastern province, Saudi Arabia are not aware about ADRs reporting procedure and the currently implemented reporting system. Awareness about ADR reporting must be foster by healthcare workers and the other relevant stakeholder&rsquo;s bodies on issues related to ADRs detection. <p style="text-align: justify;"><strong>Key words: </strong>ADR (Adverse Drug Reaction), Saudi National Pharmacovigilance Centre (Saudi NPC), Eastern province, Knowledge, Perception, Saudi Arabia. </body> </html>