National Pharmacovigilance Centre Research Articles

Monitoring of adverse effects of antituberculosis drugs: case study of hepatic cytolysis and skin reactions

Introduction. Tuberculosis remains a major public health issue worldwide. Progress in treatment, particularly with the emergence of anti-tuberculosis drugs, has been significant. However, identifying the drugs responsible for adverse effects is crucial to establish a practical approach in clinical situations, including the assessment and monitoring of these effects. Methods. This case study describes the monitoring and management of adverse effects of anti-tuberculosis drugs in patients at the Tuberculosis and Respiratory Diseases Control Department (SCTMR) in Sidi Bel Abbes (Algeria). Results. The observed effects include nine cases of hepatic cytolysis and two cases of skin reactions. This work revealed a predominantly high intrinsic imputability of anti-tuberculosis drugs, with a rating of I3 (C2S2) for six cases and I5 (C2S3) for five cases. The therapeutic interventions implemented and their compliance with international recommendations are discussed. Discussion. SCTMR specialists generally follow international recommendations to manage adverse effects of antituberculosis drugs. However, the high imputability of anti-tuberculosis drugs indicates that they are strongly incriminated in the occurrence of these adverse effects. Conclusion. Adverse effects of anti-tuberculosis treatment are not rare, requiring rigorous clinical, biological and pharmacovigilance monitoring. These surveillances can reduce mortality and morbidity associated with tuberculosis treatment. A government commitment is essential to revitalize the national pharmacovigilance center and improve the detection of serious adverse effects.

Characteristics and trends in adverse drug reactions in Ghana-evidence of spontaneous reports, 2005-2021.

Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety. However, there is a lack of evidence regarding ADR reporting trend pattern in Ghana. This study, therefore, aimed to analyse and characterise trends in ADRs reported in Ghana over 16years. We retrospectively analysed individual case safety retorts (ICSRs) received by the Ghana National Pharmacovigilance Centre from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications, and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used. We identified a total of 6853 ICSRs from 2005 to 2021. The age-adjusted ICSR rates increased significantly from 2005 to 2019, with an annual increase of 18.6%; however, there was a downward trend from 2019 to 2021, although not statistically significant. Males accounted for the majority (64.3%) of ICSRs compared to females (35.7%). The suspected medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ICSRs, while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ICSR rates was noted for gastrointestinal disorders with an annual increase of 32.5% (95% CI, 20.6-45.6%; p < 0.001). Amodiaquine was the most commonly suspected medication (8.9%) associated with ADRs, while pruritus (7.2%) was the most frequently reported preferred term. The study provides a detailed overview of ICSRs received by the Ghana National Pharmacovigilance Centre over the past 16years and demonstrates an increasing trend of ADR-related medication use as well as clinical indications over time. The findings of this study call for multifaceted strategies aimed at reducing the risks associated with inappropriate drug use, and enhancing knowledge of medication safety, thus improving healthcare service delivery and patient safety.

A Review of COVID-19 Vaccine Adverse Event Following Immunization Case Reports by four CARICOM Countries to VigiBase

The World Health Organization declared COVID-19 a pandemic on 12 March 2020. One of the strategies to combat the pandemic was the development of novel COVID-19 vaccines. Once these vaccines were deployed, immunizations followed. The objective of this study was to identify the characteristics of case reports of adverse events following immunization (AEFIs) with COVID-19 vaccines based on Individual Case Safety Reports (ICSRs) in VigiBase, submitted by four CARICOM countries: Barbados, Haiti, Jamaica and St. Vincent and the Grenadines. A review of the publicly available data on AEFIs with COVID-19 vaccines based on ICSRs in VigiBase was conducted from March 1, 2021 to December 14, 2022. A total of 1,582 AEFI case reports were identified for this period. Most of these were non-serious events, involving persons under 65 years (84.9%), and females (74.1%); 19% were classified as serious events. The top age group reported for AEFIs in VigiBase were 18-44 years (46.6%). The most frequently reported reactions were headache (29.3%), pyrexia (19.3%), dizziness (19.3%). Altogether for the four countries, the AEFIs per 100,000 doses was 64.1 and 12.2 serious AEFIs per 100,000 doses. Recommended actions identified were strengthening national pharmacovigilance regulatory frameworks, establishing robust national pharmacovigilance centres, capacity building of professionals, enhancing communication with key stakeholders and consider relying in a regional pharmacovigilance system.

Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.

Spontaneous reporting of adverse events (AEs) is a mainstay of pharmacovigilance, and an ongoing challenge is how to ensure that more high-quality reports are collected for comprehensive information provision. The Med Safety App, a smartphone-based application, was launched in Nigeria in November 2020 to provide an electronic platform for users to seamlessly report AEs. There has been a paucity of evidence on the use of this application or other mobile applications for reporting adverse drug reactions/AEs following immunization in the Nigerian environment. The aim of this study was to evaluate the trends in adverse event reporting before and after the introduction of the Med Safety App in Nigeria. This was a retrospective, observational study using data from the VigiFlow database to compare adverse event reporting in Nigeria before and after the deployment of the Med Safety App. The baseline period was 1st April 2019to 30th October 2020 and the comparison period was 1st November 2020to 31st May 2022. We used Vigilance Hub, the back-end system for the Med Safety App, to extract data on App downloads and de-identified user statistics. Data were summarized using descriptive statistics, frequencies and proportions. Quality was assessed by assigning a completeness score to each individual case safety report. The Kruskal-Wallis test was used to test for differences in medians between groups. Following deployment of the App, the Nigerian National Pharmacovigilance Centre recorded an increase in the total number of adverse event reports received in VigiFlow, from 2051 in the baseline period to 18,995 following deployment of the App, with 81.7% of those reported via the Med Safety App. There was a reduction in the proportion of paper-based reporting from 98.4 to 15.7% post-deployment, and direct reporting by consumers increased from 2.7 to 17.6%. Of the 15,526 reports submitted via the App, 15,111 (97.3%) had a completeness score above 70% and 6993 (45%) had a completeness score of 100%. The median completeness score of adverse event reports on the Med Safety App was 6 out of 7. On bivariate analysis using the Kruskal-Wallis test, there was an association between means of reporting and completeness score, and this association was significant, with a p value of 0.0001, which may reflect the validation rules that are applied within the App. Deployment of the Med Safety App increased both the number and quality of adverse event reports; however, more awareness and capacity building are needed to strengthen and sustain reporting on the tool by all categories of healthcare professionals and consumers/patients.

Pharmacovigilance: Safeguarding Vision

Pharmacovigilance defined by the World Health Organization as 'the science and activities relating todetection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge of drug's adverse reactions can be increased by various means, including spontaneous reporting; intensive 1monitoring and database studies.Thalidomide was marketed in 1957 and was considered harmless for use in pregnancy by the 1manufacturer. However, its use during pregnancy led to development of abnormal fetal and limb 2 deformities in 46 countries world wide. The thalidomide tragedy served as a catalyst for the formation of Uppsala Monitoring Centre (UMC) as the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. UMC operates the technical and scientific aspects of the WHO' sworld wide 3 pharma covigilance network. Reports from adverse drug reactions (ADRs) are stored in a global database (VigiBase) and can be used by health professionals to evaluate the associations between various medications and associated ADRs. Drug Regulatory Authority of Pakistan (DRAP), established Pakistan National Pharmacovigilance Centre (PNPC) in 2015, under the division of Pharmacy Services to provide a basic framework for the implementation of pharmacovigilance programme of Pakistan at provincial and national 4 level. National data (VigiFlow) is directly connected to WHO Global Database (VigiBase).

Implementation Status and Challenges of Pharmacovigilance Program in Ethiopia: A Mixed-Methods Study

Functional pharmacovigilance systems are vital to ensure patient safety. There is a paucity of information on the organizational functionality of pharmacovigilance program in Ethiopia. This study assessed the pharmacovigilance programs and its implementation status in Ethiopia. A mixed study design was employed to assess pharmacovigilance functionality in hospitals, pharmaceutical companies, and the National Regulatory Authority. World Health Organization’s Pharmacovigilance Indicators and Key Informant Interview Guide were used for data collection. Quantitative data were analyzed using Microsoft Excel (2013), while thematic analysis was used for qualitative study. Of the 30 hospitals covered, only one had a Pharmacovigilance Unit with a dedicated budget, three (10%) had assigned staff, and seven (23.3%) had implemented Standard Operating Procedures. Similarly, 4 (12.5%) of the 32 pharmaceutical companies had separate pharmacovigilance divisions, 12 (37.5%) had a regulatory affairs unit, and 5 (15.6%) had a pharmacovigilance budget. The National Pharmacovigilance Center has the most structure, process, and pharmacovigilance practices. Resource constraints and a weak reporting system were identified as major challenges, while patient harm, loss of confidence, increased circulation of unsafe products, and economic costs were reported as consequences. Increasing training, engaging stakeholders, and improving the regulatory system were recommended as key interventional strategies. Most hospitals and pharmaceutical companies lack most of pharmacovigilance system indicators. However, the national regulatory authority fulfilled most of the elements of Pharmacovigilance systems.

Diverse pharmacovigilance jurisdiction-The right way for global drug safety?

The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.

Model for measuring the impact of good pharmacovigilance practices of COVID-19 patients on hcp reactivity: Morocco case study

This paper presents a conceptual model used to evaluate how the improvement of good pharmacovigilance practices by patients during COVID-19 period influences the reactivity of the healthcare professionals (HCPs) in the Draa Tafilalet region in Morocco, concerning the reporting of adverse drug reactions (ADRs) through barriers that influence the reporting from both patients and HCPs. The empirical study is based on a survey submitted to a sample of a total of 180 HCP and on the application of latent variable structural modelling through the partial least squares (PLS) method. The 2017 version of the XL-STAT software served to perform the statistical calculations. The study investigates the reliability and validity of the proposed model. Our conclusions show that the improvement of good pharmacovigilance practices impact positively the reactivity of HCP in terms of ADRs reporting. The reliability of the measurement was &gt; 0.7, which allowed us to test the internal and external validity of our conceptual model. 11 hypotheses were validated against two invalid derivative hypotheses. Spontaneous ADRs reporting is the cornerstone of any pharmacovigilance system aiming to maintain patient safety. Our findings indicate the necessity firstly, to initiate a training program on reporting for all HCPs, and secondly, to inform the general public about the national pharmacovigilance center, where ADRs can be reported. Both initiatives aim to keep the culture of ADR reporting perennial.

Documenting capacity and existing gaps in reporting adverse events following immunisation in Northern Ghana: a quantitative cross-sectional survey of healthcare workers

BackgroundImmunisation remains an indispensable tool in preventing infectious diseases. A robust pharmacovigilance system assures the public of vaccine safety, particularly in countries like Ghana where there is relatively low reporting...

Exfoliative dermatitis; new safety signal detection regarding Meropenem in VigiBase™: A study based on WHO database

Background Cutaneous adverse drug reactions (CADRs) account for nearly one-third of all adverse drug reactions (ADRs), and severe reactions while they are rare, can dramatically affect patients’ quality of life or even cost them their lives. While clinical trials may prove medicine’s effectiveness, they cannot give a thorough picture of the drug’s safety profile. Spontaneous surveillance and data mining techniques provide a promising complementary technique for post-marketing monitoring to detect safety signals. Objective The objective of this research was to assess the data obtained and uploaded to VigiBase about adverse medication responses affecting the skin and surrounding structures, with a specific focus on identifying any possible signals linked with Meropenem that are not currently indicated on the medicine label. Methods A retrospective study involved clinical review and data mining of patients who suffered cutaneous reactions reported to national Pharmacovigilance centers in Iraq and other countries from January 2010 to December 2021; a total of 4,510 reports were found in Iraq and filtered according to several criteria to obtain a safety signal with the most significant impact on public health. To improve the signal quality, all global cases were included in evaluating the detected signal, excluding duplicate and incomplete reports. Results In a total of 65 cases that contained Meropenem as the suspected cause of exfoliative dermatitis (ED), only 53 cases met the inclusion criteria. Assessment of the included cases proved the detection of a new unlabeled signal that links Meropenem to ED. The mean affected age was 59 years, and males outnumbered females (30:23). The combination showed to be statistically significant (IC025, 2.961; PRR025, 8.227; ROR025, 8.244), and causality assessment showed a possible relation in more than 70% of the cases. Conclusion Spontaneous reporting systems, despite their limitations, are vital to pharmacovigilance systems and the identified signal needs further research.

Magnitude and Impacts of Adverse Events of Injectable Containing Shorter Regimen in Programmatic Management of Multi-Drug Resistant Tuberculosis in Ethiopia: A Retrospective Cohort Study.

Since its launch as a standardized treatment for multidrug-resistant tuberculosis (MDR-TB) in Ethiopia in April 2018, the safety profile of the shorter injectable regimen under a programmatic setting has not been well studied. Thus, this study aimed to assess the status of adverse events in patients treated with a shorter injectable regimen in Ethiopia. This is a retrospective cohort study. Data were collected using a structured data abstraction form and analyzed using SPSS, version 25, both descriptively and analytically. Logistic regression was conducted to assess predictors, and Kaplan-Meier analysis was used to examine the time to AEs and survival experiences. Of 256 patients, 245 (95.7%) were eligible for the study. Of 245, 107 (43.7%) patients experienced at least one AE. In total, 276 AE cases were observed out of which the most common were nausea/vomiting (20.3%), dyspepsia (18.1%), and ototoxicity (11.6%). Of 276 AEs, approximately 49 (17.8%) were serious. AEs led to drug discontinuation, dose modification, and regimen change in 29 (27%), 15 (14%) and 10 (9.3%) patients, respectively. Only 19.2% of 276 the overall AEs and 22.6% of 62 AE of special interest (AESI) were reported to the National Pharmacovigilance Center. Although the observed extent of AEs associated with the shorter regimen (SR) seemed to be moderate, it significantly influenced the treatment schemes and patient conditions. Reporting of AEs was low, irrespective of their severity and AESI. Therefore, strengthening the implementation of active drug safety monitoring and management is required.

Pharmacovigilance in Saudi Arabia: A Narrative Review on Adverse Drug Reaction Reporting

Adverse drug reaction (ADR) reporting is an important aspect of pharmacovigilance (PV) in ensuring drug safety during the post-marketing surveillance phase. Currently, the National Pharmacovigilance Center (NPC) established by the Saudi Food and Drug Authority (SFDA) is the regulatory authority receiving ADR reports in Saudi Arabia. Spontaneous ADR reports from healthcare professionals and the public are received by the NPC through an electronic platform known as the Saudi Vigilance System. Signal analysis of the received ADR reports aids the decision-making initiatives related to the reported drugs. Stakeholders’ contribution to ADR reporting, and implementation of effective electronic platforms are important factors affecting the national PV performance. The concept of stakeholders reporting on ADR is relatively new in Saudi Arabia, especially to the public. In this narrative review the national studies describing the stakeholders’ knowledge, perception and barriers toward ADR reporting, and the incidence of ADR reporting by healthcare institutions in Saudi Arabia were evaluated. The findings indicate that more efforts are needed by the SFDA to educate stakeholders about the importance of ADR reporting. The study recommends ADR electronic systems integration between the SFDA and healthcare institutions to improve the frequency and quality of ADR reports, and regular feedback on decisions made about ADR reports should be provided by the SFDA to stakeholders to improve their awareness of the importance of ADR reporting and enhance their contribution to PV and ADR reporting process.

Under-reporting of adverse drug reactions: Surveillance system evaluation in Ho Municipality of the Volta Region, Ghana.

Adverse Drug Reactions (ADRs) can occur with all medicines even after successful extensive clinical trials. ADRs result in more than 10% of hospital admissions worldwide. In Ghana, there has been an increase of 13 to 126 ADR reports per million population from 2012 to 2018. ADR Surveillance System (ADRSS) also known as pharmacovigilance has been put in place by the Ghana Food and Drugs Authority (FDA) to collect and manage suspected ADR reports and communicate safety issues to healthcare professionals and the general public. The ADRSS in Ho Municipality was evaluated to assess the extent of reporting of ADRs and the system's attributes; determine its usefulness, and assess if the ADRSS is achieving its objectives. We evaluated the ADRSS of the Ho Municipality from January 2015 to December 2019. Quantitative data were collected through interviews and review of records. We adapted the updated CDC guidelines to develop interview guides and a checklist for data collection. Attributes reviewed included simplicity, data quality, acceptability, representativeness, timeliness, sensitivity, predictive value positive and stability. We found a total of 1,237 suspected ADR during the period, of which only 36 (3%) were reported by healthcare professionals in the Ho Municipality to the National Pharmacovigilance Centre (NPC). Only 43.9% of health staff interviewed were familiar with the ADRSS and its reporting channel. Staff who could mention at least one objective of the ADRSS were 34.2%, and 12.2% knew the timelines for reporting ADR. Reports took a median time of 41 (IQR = 25, 81) days from reporter to NPC. Reports sent on time constituted 37.5%. Fully completed case forms constituted 77.1% and the predictive value positive (PVP) was 20%. About 53% of ADRs were reported for female patients. Up to 88.9% of ADRs were classified as drug related. Anti-tuberculosis agents and other antibiotics constituted (40.6%) and (18.8%) of all reports. The ADRSS was not integrated into the disease surveillance and response system of Ghana's Health Service and so was not flexible to changes. A dedicated ADR surveillance officer in regions helped with the system's stability. Data from Ghana feeds into a WHO database for global decision making. There was under-reporting of ADRs in the Ho Municipality from January 2015 to December 2019. The ADR surveillance system was simple, stable, acceptable, representative, had a strong PVP but was not flexible or timely. The ADRSS was found useful and partially met its objectives.

EPH93 Traceability of Infliximab Reference Medicinal Product and Its Biosimilar Products Adverse Drug Events Reports in Saudi Arabia

Infliximab reference product and two biosimilar products were approved by the Saudi Food & Drug Authority (SFDA) for the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis. Recording both the product trade name and the batch number are essential in the spontaneous reporting of adverse drug events (ADEs) of biological medicines due to the variability of the bio-manufacturing process that may cause safety risks such as immunogenicity. This study aims to assess the availability of batch number and trade name in the ADE reports of Infliximab (reference product) and biosimilar products in the National Pharmacovigilance Center (NPC) database at SFDA.

Spontaneously reported adverse events following COVID-19 basic and booster immunizations in the Netherlands

IntroductionThe rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown. MethodsThe primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences. ResultsLareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed. ConclusionSpontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.

Jordanians' knowledge, attitude and practice regarding adverse drug reactions reporting

ObjectivesThe purpose of the current study was to evaluate the general public knowledge, attitudes, and practice regarding Adverse Drug Reactions (ADRs) reporting and pharmacovigilance in Jordan. MethodsA cross‐sectional study was conducted between July 16, 2022, and July 30, 2022, in Jordan. During the study period, an electronic survey consisting of 4 sections was administered to a convenience sample of Jordanians (aged 18 or above) using 2 social media platforms (Facebook and WhatsApp). Logistic regression analysis was used to screen the predictors of ADRs reporting by the participants. ResultsA total of 441 participants completed the survey. The majority of the participants (67.6%) were females, 53.1% between 26 and 45 years old. Almost all participants (96.3%) were always aware of the indication of the medications they take, the time and frequency (87.8%), and the duration of medications (84.4%). Nearly one-third of the participants (37.4%) asked about their medications' ADRs. However, the drug information leaflet was the most frequently used source of ADR information (33.3%). The majority of responders believed that both healthcare providers and consumers should report ADRs (93.4% and 80.3%, respectively). Only one-quarter of respondents (27.2%) believed that consumers could directly report ADRs through the Jordan pharmacovigilance program. The majority of patients who had experienced ADRs (70.3%) were aware that ADRs should be reported, and among them, 91.9% had reported the ADRs to healthcare providers. Furthermore, few participants (8.1%) reported it to the Jordan National Pharmacovigilance Centre (JNCP). Linear regression revealed that none of the demographic characteristics (age, gender, education, job, and social status) were affecting public reporting practice of the ADRs (P > 0.05 for all). ConclusionRespondents showed fair knowledge about adverse drug reactions and their reporting. However, there is a need to initiate educational activities and intervention programs to raise awareness about the JNPC, which will have a positive impact on public health and ensure safe medication use in Jordan.

Observed-over-Expected analysis as additional method for pharmacovigilance signal detection in large-scaled spontaneous adverse event reporting.

The large-scale COVID-19 vaccination campaigns in 2021 and 2022 led to a rapid increase in numbers of received adverse event reports in spontaneous reporting systems. As background incidences of naturally occurring medical events became increasingly relevant for causality assessment of potential associations with the vaccines, a novel approach for signal detection was warranted. This article illustrates the Observed-over-Expected (O/E) analysis as an additional method for signal detection and risk assessment in large-scaled spontaneous reporting systems. All individual case safety reports (ICSRs) concerning idiopathic peripheral facial paralysis or Bell's palsy following administration of the COVID-19 vaccines (n= 291) manufactured by Pfizer/BioNTech (Comirnaty), Moderna (Spikevax), AstraZeneca (Vaxzevria) and Janssen (JCOVDEN) received by the National Pharmacovigilance Centre Lareb until 24th March 2022 were included in the O/E analysis, within a risk window of 7 and 14 days following immunisation. Dutch background incidence rates from 2019 and exposure of the Dutch population to the vaccines were obtained from the PHARMO institute and RIVM. The data was stratified in age groups, gender and administered dose in order to differentiate between population subgroups. Bell's palsy was reported more frequently than expected in several population subgroups following administration of all four COVID-19 vaccines, including children and adolescents. Among children, a high O/E ratio was found for boys aged 5-14 years after receiving the Pfizer/BioNTech vaccine. Regarding adolescents and young adults, women aged 15-24 years receiving Pfizer/BioNTech and Moderna, and men aged 15-24 years receiving Janssen developed Bell's palsy more often than expected. Furthermore, O/E ratios were high for individuals aged 25-64, regarding females receiving Pfizer, Moderna and AstraZeneca and males receiving Janssen. As facial paralysis was not labelled as an adverse event for the Janssen vaccine, this analysis contributed to signalling the association and warranting further regulatory action. The O/E method is a useful approach for signal detection of potential adverse reactions when handling large numbers of ICSRs. Further research is needed to attest to the causality on a clinical basis.

Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries.

An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used. The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa. The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out. The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions. In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa.

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

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

Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.

To assess the prevalence and factors associated with substandard and falsified (SF) medicines among antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. We conducted a cross-sectional study in 23 public, faith-based and private health facilities in Zomba, Machinga and Nsanje districts. We analyzed oral medicine samples of commonly used medicines among antibiotics, antimalarial, antihypertensive and antidiabetics in accordance with Malawi Essential Medicines List and local treatment guidelines. These medicines were subjected to visual inspection for any defects and screening for the content of active pharmaceutical ingredient and disintegration of dosage units. Samples that failed during screening and at least 10% of those that passed were subjected to pharmacopeia assay and dissolution test for confirmation. We used thin layer chromatography and disintegration test methods provided in the Global Pharma Health Fund minilab® for the screening purposes. We conducted confirmatory test using High-Performance Liquid Chromatography (HPLC) or ultra-violet/visible spectrophotometer and dissolution. Of the 293 medicine samples collected, 14.3% were SF medicines. Among the SF medicines were 12.5% of Amlodipine (1/8), 19.2% of Amoxicillin (5/26), 72.2% of Atenolol (8/11), 21.2% of Ciprofloxacin (7/33), 14.3% of Enalapril (1/7), 44.4% of Flucloxacillin (4/9), and 35.7% of sulfadoxine/ pyrimethamine (10/28). Medicine quality was associated with therapeutic medicine class, stated origin of manufacturer, primary packaging material and geographical location. Antimalarial and antidiabetic medicines were of better quality as compared to antibiotics, odds ratio OR 4.2 (95% CI 1.7-9.49), p < 0.002 and OR 5.6 (95% CI 1.21-26.09), p < 0.028 respectively. In terms of stated country of origin, the prevalence of SF medicines was 30% (15/50), 33% (9/27), 26.7% (4/15) and 6.6% (8/122) for medicines stated to be manufactured in Malawi, China, Kenya and India respectively. This study presents the first findings on the assessment of quality of medicines since the establishment of the national pharmacovigilance center in 2019 in Malawi. It is revealed that the problem of SF medicines is not improving and hence the need for further strengthening of quality assurance systems in Malawi.