National Pharmacovigilance Centre Research Articles

Pharmacovigilance and Its Importance for Primary Health Care Professionals.

Pharmacovigilance is used to detect, assess, understand, and prevent the adverse effects of medications. The need for safety monitoring has evolved around unfortunate incidents in history, with deaths caused by anesthesia and congenital malformations from thalidomide use. Reports from adverse drug reactions (ADRs) are stored in a global database and can be used to evaluate the associations between various medications and associated ADRs. Clinicians play an important role in the recognition and reporting of ADRs to national pharmacovigilance centers (NPCs). The purpose of NPCs is to make the clinicians understand their functions, including the monitoring, investigation, and assessment of ADR reports, along with periodical benefit-risk assessments of medications via multiple sources. A case study on NPCs and the types of safety issues evaluated by them are provided to illustrate their role in medicine safety surveillance. ADR monitoring was also combined with vaccine safety surveillance approaches. Overall, this study will provide insights to clinicians on the importance of pharmacovigilance in maintaining patient safety with the proper use of medications.

Pharmacovigilance regulatory actions by national pharmacovigilance centers in Arab countries following COVID-19 pandemic

ABSTRACT Background Pharmacovigilance (PV) activities were affected by COVID-19. Therefore, several health authorities around the world have issued guidelines and practices to ensure that PV activities are maintained and continued during the pandemic. This study aimed to assess the impact of COVID-19 on the preparedness and performance of national PV systems in 14 Arab countries. Research design and methods This was a cross-sectional study that was conducted between July and October 2020. National PV centers in 18 Arab countries were invited to participate in this study. Descriptive analysis was used to summarize and present the results of this study. Results Responses were obtained from 14 (77.8%) countries. Adverse events reporting was the main PV activity that was covered by PV guidelines and practices. National guidelines and practices covered other PV activities in 8 (57.14%) of the participating countries. Performance and practices of national PV centers vary considerably among participating countries during the pandemic. Conclusion The findings highlight the differences in preparedness and performance of different national PV centers in participating Arab countries. Improving digital infrastructure among participating countries could serve as a useful tool to minimize the impact of the pandemic on PV activities.

Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d’Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country’s needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000–2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d’Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1–2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture.

Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey.

The timely reporting of adverse drug reactions (ADRs) could improve pharmacovigilance (PV) in a healthcare system. However, in almost all healthcare systems barriers exist that lead to the underreporting of ADRs. The objective of this study was to identify the barriers and facilitators regarding PV activities from the point of view of healthcare professionals (HCPs) in Lahore, Pakistan. A cross-sectional questionnaire-based survey was conducted between September 2018 to January 2019. The data was collected through convenience sampling of physicians, pharmacists, and nurses at tertiary care public hospitals in Lahore. A total of 384 questionnaires were distributed, and 346 HCPs responded to the survey. Over 62% percent of physicians and 54.8% of nurses agreed that they did not know how to report an ADR in their workplace. About 43.2% of pharmacists and 40.1% of nurses disagreed that they were not aware of the need for ADR reporting. Furthermore, 41.6% of nurses identified a lack of financial reimbursement and 51.8% highlighted a lack of support from a colleague as a reason that could lead to the underreporting of ADR. The majority of participants, including 69.6% physicians, 48.6% pharmacists, and 55.3% nurses identified the lack of knowledge about the existence of a national PV centre. Extra time for ADR reporting, incentives, continuous medical education, reminders, and availability of an online ADR reporting system was classed as the facilitators and were agreed upon by the majority of HCPs.

A National Survey of Community Pharmacists' Viewpoints About Pharmacovigilance and Adverse Drug Reaction Reporting in Saudi Arabia.

This study assessed the knowledge, attitudes, and practices of community pharmacists regarding pharmacovigilance and adverse drug reaction (ADR) reporting system in Saudi Arabia. A cross-sectional survey of community pharmacists from different regions in Saudi Arabia was performed through convenience sampling between November 2020 and January 2021. The responses were received from 1,172 community pharmacists. Most respondents (86.7%) were familiar with the National Pharmacovigilance and Drug Safety Center, and 830 (70.8%) knew about the ADR reporting form. The majority (94%) of the respondents agreed with the importance of reporting ADRs for patient care and national health. Although 92.2% of the participants asked their patients about ADRs, 90.2% agreed that more training programs are required to be organized by the Saudi Food and Drug Authority for healthcare professionals on the ADR detection and reporting system. Analgesic agents were the most common drug category for which ADRs were reported (67.4%). The majority (92.1%) of ADRs reportedly occurred in patients with chronic diseases. The study concluded that most community pharmacists in Saudi Arabia are knowledgeable and have good attitudes and practices regarding pharmacovigilance and ADR reporting.

Analysis of Reports on Adverse Drug Reactions Related to Herbal Medicinal Products and Herbal Supplements in the Netherlands Received by the National Pharmacovigilance Centre Lareb.

The inclusion of herbal medicinal products and herbal supplements in pharmacovigilance systems is important because a systematic approach of collecting and analyzing adverse drug reactions related to these products will help practitioners, patients, and regulators to gain more knowledge and prevent harm. We aimed to categorize the adverse drug reaction reports on herbal medicinal products and herbal supplements submitted to the Pharmacovigilance Centre Lareb between 1991 and February 2021 on the basis oftheir regulatory status, herbsincluded, and adverse drug reactions involved. We categorized products on the basis of their registration status and herbal ingredients. The products were then categorized according to the Herbal Anatomical Therapeutic Chemical Classification System. We used descriptive statistics in Microsoft Excel 2019. Pivot tables were used for the analysis and presentation of the data. Until February 2021, a total of 789 reports of herbal medicinal products and herbal supplements were received by Lareb. In these reports, a total of 823 herbal products were labeled as suspect. These products caused a total of 1727 adverse drug reactions. Of the 823 products, 229 were registered as a medicine, and 594 were on the market as a herbal supplement. Of the 823 herbal products, 522 reports concerned single-herb products, 256 reports concerned combination products, 27 reports concerned vitamin products containing herbal ingredients, and 18 reports concerned product issues. Approximately 15% of reports concerned serious adverse drug reactions, and adulterated products harbored a high risk of causing serious adverse drug reactions. Analysis of the herbal medicinal products and herbal supplements in the Dutch pharmacovigilance database revealed a variety of suspected herbal ingredients. The reports provide insight into the variety of herbal products used in the Netherlands and the adverse reactions associated with their use. Pharmacovigilance of herbal products is essential to ensure their safe use.

Covid-19 Vaccine safety and adverse event analysis from Pakistan.

Covid immunization commenced on 2nd Feb 2021 in Pakistan and as of 7th Sep 2021, over 84 million vaccine doses were administered in Pakistan, of which 72% procured by the government, 22% received through Covax and 6% were donated. The vaccines rolled out nationally included: Sinopharm, Sinovac and CanSinoBIO (China), AstraZeneca (UK), Moderna and Pfizer (USA), Sputnik (Russia), and PakVac (China/Pakistan). About half of the eligible population in Pakistan (63 m) had received at least one dose of Covid vaccine as of Sep 2021. Pakistan National Pharmacovigilance Centre (PNPC) in coordination with WHO, MHRA and Uppsala Monitoring Centre (UMC) established pharmacovigilance centers across Pakistan. The Covid vaccine AEFIs in Pakistan were mainly reported via NIMS (National Immunization Management System), COVIM (Covid-19 Vaccine Inventory Management System), 1166 freephone helpline and MedSafety. There have been 39,291 ADRs reported as of 30th Sept 2021, where most reported after the first dose (n = 27,108) and within 24–72 h of immunization (n = 27,591). Fever or shivering accounted for most AEFI (35%) followed by injection-site pain or redness (28%), headache (26%), nausea/vomiting (4%), and diarrhoea (3%). 24 serious AEFIs were also reported and investigated in detail by the National AEFI review committee. The rate of AEFIs reports ranged from 0.27 to 0.79 per 1000 for various Covid vaccines in Pakistan that was significantly lower than the rates in UK (∼4 per 1000), primarily atrributed to underreporting of cases in Pakistan. Finally, Covid vaccines were well tolerated and no significant cause for concern was flagged up in Pakistan's Covid vaccine surveillance system concluding overall benefits outweighed risks.

Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries.

Patients are recognized as important players in the pharmacovigilance system. This study aims to describe and compare the characteristics of patient reporting systems, reporting forms, awareness raising-activities, and the statistics related to patient reporting in the selected countries. Fifteen countries (eight Western countries and seven Asian countries) were purposively selected. A questionnaire survey was distributed to national pharmacovigilance authorities in those countries. Nine countries (five Western countries and four Asian countries) returned the questionnaire. A review of the websites of national pharmacovigilance centres was conducted. The proportion of patient reports in the selected Western countries ranged from 57.83% to 14.37%, while it was accounted for less than 1% in the selected Asian countries. Currently, patients in all nine countries can report adverse drug reactions online via a website. The number of clicks from the national pharmacovigilance website to reach the online reporting form range from one to five clicks. Countries with higher patient reporting rates seemed to share the following characteristics; provision of feedback, engagement with patient organizations, and implementation of several activities to raise the awareness of the general public on the importance of pharmacovigilance. To increase the number of patient reports, the strengths of each country’s system should be adopted.

Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries’ (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries’ national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait’s NPVCs. Using the framework, system strengths were attributed to the presence of “core” structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as “complementary” structural indicators, e.g., a computerised case-report management system. Contrastingly, weaknesses were attributed to the absence of these indicators plus other “core” structural indicators, namely, regular financial provision and adequate staff. Other weaknesses were attributed to low performance in “core” process and outcome indicators including reporting rates, reporter awareness, and signal detection. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool.

Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan. Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations. Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps. Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

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.

Adverse drug reaction profile of patients taking amantadine for traumatic brain injury in a tertiary care hospital

Background: Amantadine is found to be effective for the treatment of complications associated with traumatic brain injury. Drug-related side effects are common with Amantadine especially when combined with other drugs. Comprehensive information about the incidence and severity of these adverse effects is not available. Aim and Objectives: The aim of the study was to analyze the pattern of occurrence of adverse drug reactions (ADRs) in patients receiving Amantadine for traumatic brain injury in a tertiary care hospital. We also assessed the causality, severity, and preventability of ADRs. Materials and Methods: This prospective and cohort study was conducted among patients taking Amantadine for a continuous period of 1 month for traumatic brain injury in neurosurgery department between June 2020 and December 2020. Tools used were ADR Reporting form of National Pharmacovigilance Centre, WHO causality scale, Hartwig and Siegel scale, and Schumock and Thornton scale. Descriptive statistics were used and the values were expressed in numbers and percentages. Results: ADRs were experienced in 55 patients (36.7%) out of 150 patients and all the patients were on combination therapy. ADR was present more in male patients (63.6%) compared to females (36.4%). The most common ADRs were headache, ankle edema, and dry mouth. Majority of ADRs belonged to the possible category according to the WHO causality assessment scale. Majority of the ADRs (61.9%) were mild level 1 according to severity scale. All the ADRs came under the definitely or probably preventable category. Conclusion: ADRs with Amantadine are common but mild and preventable.

Adverse drug events in AYUSH interventions for cervical and lumbar spondylosis

Abstract Introduction: The prevalence of musculoskeletal disorders ranges between 20%–33% and also varies by age and diagnosis. In India, low back and neck pain are important leading contributors to the disability burden irrespective of gender. Many Ayurveda, Yoga and naturopathy, Unani, Siddha and Sowa-rigpa and Homeopathy (AYUSH) interventions used for the treatment of cervical and lumbar spondylosis conditions due to its availability and accessibility. Even though it's widely practiced, there is no documentation of adverse events of AYUSH interventions for cervical and lumbar spondylosis. The primary objective of this systematic review is to synthesize evidence of adverse events attributable to pharmacological and non-pharmacological AYUSH interventions for cervical and lumbar spondylosis. Methods: We will conduct a systematic search in all standard biomedical databases and AYUSH system portals to identify and retrieve both the published and unpublished research articles. We will include all study designs such as the randomized and non-randomized controlled trials (RCTs), cross-sectional studies, prospective and retrospective cohort studies, case-control studies, case series, and case studies. They should have reported the Adverse events of AYUSH systems of interventions for cervical and lumbar spondylosis. Using predefined search strategy with suitable medical subject headings terms and field terms, we will retrieve all the relevant articles from PubMed, Embase, Scopus, Google Scholar, ProQuest, AYUSH research portal, Digital Helpline for Ayurveda Research Articles, Shodhganga and reports of National Pharmacovigilance Centres. We will include the articles that are in English language. Data synthesis will be conducted using meta-analysis. Results: The systematic review will provide adverse events information attributable to pharmacological and non-pharmacological AYUSH interventions for cervical and lumbar spondylosis. Discussion: We will generate a report on the frequency and types of adverse drug events among patients with lumbar and cervical spondylosis treated with AYUSH system and characteristics of adverse event such as type and nature of medications. This study may help Indian AYUSH pharmacovigilance centres to develop methods to improve quality of data on adverse events. Systematic review registration number: PROSPERO CRD42020167433 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020167433)

Pharmacovigilance in Pakistan: A Peek into the Future Prospects

Pharmacovigilance in Pakistan: A Peek into the Future Prospects

Situation analysis of the pharmacovigilance system in Nepal using the indicator-based pharmacovigilance assessment tool (IPAT)

Abstract Objectives The aim of this study was to assess the national and regional pharmacovigilance centres in Nepal in terms of their policy frameworks, structure and functioning. Methods A descriptive cross-sectional study was conducted during January 2021 among regional pharmacovigilance centres, and the national pharmacovigilance centre and the Ministry of Health and Population. The indicator-based pharmacovigilance assessment tool (IPAT) consisting of 43 indicators (26 core and 17 supplementary) assessing different aspects of pharmacovigilance was used. Key findings Of a total of 14 candidates representing regional pharmacovigilance centres, 12 agreed to participate. The national pharmacovigilance centre located at the Department of Drug Administration had an acceptable level of infrastructure and manpower but poor functioning and weak collaboration with regional centres. There are no policies and procedures specifically related to pharmacovigilance and no requirement for pharmaceutical companies to report adverse drug reactions (ADRs). The national centre received only 42 ADR reports during the evaluation period. The regional centres are mostly located (10 out of 14) in the Kathmandu Valley and had qualified manpower and basic resources. There were poor process indicators suggesting problems with functioning in terms of ADR reporting, signal generation and drug safety communication. Conclusions Underreporting of ADRs, weak processes and poor coordination among centres limit functioning of the system. Creating more awareness, involving consumers and pharmaceutical companies in the reporting process, and conducting more training programmes are needed for the proper functioning of pharmacovigilance services in Nepal.

Patterns of adverse drug reactions (ADRs) in Saudi Arabia

BackgroundPharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded. ObjectiveTo describe patterns of ADRs submitted to the Saudi Central National Pharmacovigilance and Drug Safety Center (NPC), Saudi Food and Drug Administration (SFDA), from its inception in 2015 until the end of 2017 to understand the pattern of ADR reporting in Saudi Arabia. MethodsIn this retrospective study, data from cases reported to the NPC were used to determine ADRs and identify the most common associated drug classes based on anatomical therapeutic chemical (ATC) classification system. ResultA total of 17,730 ADR cases were reported during study period. An annual increase in ADRs was clearly evident. Approximately 54% of the total ADRs reported were serious. Most commonly reported ATC drug classes were anti-infective agents for systemic use (22.27%), antineoplastic and immunomodulating agents (21.49%), alimentary tract and metabolism (15.48 %), cardiovascular system (11.11%) and nervous system (10.23%). Vancomycin (2.7%), ceftiraxone (1.8%), fingolimod (1.4%) and paracetamol (1.4%) were the most common drugs associated with serious ADRs. ConclusionThis study provide valuable insights in hypothesis generation for future studies on drug-event interactions and amplification studies. The NPC educational programs and awareness campaigns to promote systematic reporting of ADRs among healthcare professionals and general public should be continued.

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.