National Pharmacovigilance System Research Articles

Exploring Adverse Drug Reactions in Psychotropic Medications: A Retrospective Analysis of Portuguese Pharmacovigilance Data.

Psychotropic drugs (PDs) include anxiolytics, sedatives and hypnotics, antidepressants, and antipsychotics, and they are available as medicines with different safety profiles. Given Portugal's high anxiolytic consumption and the rising prevalence of mental disorders, safety monitoring is crucial. This study aimed to analyze the individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) related to PDs, obtained through spontaneous reporting, and recorded in the Portuguese National Pharmacovigilance System between January 2017 and December 2021. This observational and retrospective study analyzed the ICSRs of suspected ADRs to PDs. Most reports pertained to female individuals (67.78%) between 18 and 64 years of age (63.71%). The pharmaceutical industry was the primary source of these reports (62.16%). Antidepressants were responsible for most ICSRs (61.90%). At least one serious ADR was recorded in 58.44% of the reports, and 43.84% of ADRs evolved into "cure". The most-observed ADRs were nausea (10.92%), dizziness (10.70%), and off-label use (10.30%). In the causality assessment, 45.49% of ADRs were classified as "possible", and only 4.96% were classified as "definitive". The current analysis helps to strengthen the safety evidence for PDs. In the future, some measures could be implemented to improve the use of and/or access to PDs, as well as to reinforce the rate of suspected ADR reports within the community, contributing to the safety data available.

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.

Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems.

Pharmacovigilance (PV) activities aim to identify potential risks of medicines and vaccines after they have been authorised in the market by collecting and analysing information on suspected adverse events from different stakeholders. These can be captured and transmitted electronically in the form of Individual Case Safety Reports (ICSRs). Hence, up-to-date ICSRs management systems, like VigiFlow and signal detection and management systems as VigiLyze, have an important role in the PV system of a country. In 2019, after various attempts to establish a PV database that could fulfil the needs of the country, Mexico's National Regulatory Authority, COFEPRIS (Federal Commission for the Prevention against Sanitary Risks) decided to implement these tools. This has been a successful project that is still ongoing, it has involved national and international organisations, and has required the participation and integration of different components of the national PV system. The implementation of these tools has allowed COFEPRIS to increase its reporting trends and quality of reporting, while contributing to make more efficient interactions and processes with PV stakeholders, even during the COVID-19 pandemic. It has also allowed them to strengthen their commitment to the WHO-Programme for International Drug Monitoring, while highlighting opportunities for improvement in the national PV scenario and in the PV tools themselves. The aim of this article is to describe the implementation process, give an overview of current results regarding ICSR data and processes, and highlight the achievements, challenges, and opportunities for improvement after the three years since the beginning of the project.

Strategies and interventions to strengthen pharmacovigilance systems in low-income and middle-income countries: a scoping review

ObjectivesThe slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far...

Safeguarding human rights to health: a systematic review of supply chain impediments to safe medicines in developing nations

Purpose A key feature of human rights in health is access to safe, effective and affordable medicines. Pharmacovigilance is advocated for monitoring intended/unintended effects of medicines to assure their safety. The purpose of this paper is to synthesize knowledge about supply chain impediments to safe medicines in developing nations and contribute to future development of research in this field. Design/methodology/approach This paper conducts a structured literature review based on Preferred Reporting Items for the Systematic Reviews and Meta-Analyses guidelines. It aims at profiling supply chain impediments to safe medicines in developing nations by reviewing 46 recent pharmacovigilance-specific papers published between 2005 and 2020. Findings Analysis of reviewed articles identified criticality of supply chain impediments that affect constituents across pharmaceutical in developing nations, which still struggle to maintain robust national pharmacovigilance systems due to lack of awareness, policy and practices. Research limitations/implications Research results can be applied by pharmaceutical industry decision-makers and drug safety professionals in developing nations. Because the review is qualitative in nature, its implication ought to be tested after actual implementation. Practical implications This review can help identify underinvestigated impediments and methods to aid in developing new pharmacovigilance knowledge areas in developing nation context. Social implications The review uncovers gaps in global health equity dialogue in developing nations. It also recognizes that macrolevel supply chain impediments exist due to unfair disease burden and health inequities in developing nations. Originality/value The paper examines supply chain impediments to safe medicines in developing nations with insights for future pharmacovigilance research. Identifying and classifying supply chain impediments through this review is the first step toward creating effective interventions for these impediments to safe medicines.

Current Status and Challenges of Pharmacovigilance of Traditional Medicines in French-Speaking West African (UEMOA) Countries.

West African Economic and Monetary Union (UEMOA) countries are characterised by a high prevalence of informal use of medicinal plants and traditional medicines by their population for health care, requiring the establishment of pharmacovigilance, in order to monitor the associated health risks. However, the state of implementation of pharmacovigilance for traditional medicines in UEMOA countries is not known. This study aimed to assess the state of implementation of pharmacovigilance for traditional medicines in the eight UEMOA countries, describing the relevant community provisions, assessing the integration of traditional medicines monitoring into national pharmacovigilance systems and identifying related national challenges. This was a cross-sectional study using questionnaires, conducted between 1 May and 31 August 2022. A face-to-face questionnaire was administered to officials responsible for the issue within UEMOA and the West African Health Organisation (WAHO). A second online questionnaire was specifically sent to the pharmacovigilance focal points of the eight UEMOA countries. Questionnaires were designed using the WHO indicators for pharmacovigilance. The face-to-face questionnaire collected two types of data, namely community policies and regulations on pharmacovigilance and technical and financial support from sub-regional organisations to countries. The online questionnaire sent to countries collected four categories of data on the study issue: structural data, process data, impact data and data on national challenges. As a community provision, WAHO has a harmonised regulatory framework for phytovigilance. The monitoring of traditional medicines is not effectively implemented in the pharmacovigilance systems of UEMOA countries. Only two reports of adverse events due to traditional medicines have so far been recorded in the Union. The countries have neither funding nor sufficient human resources for pharmacovigilance in general. Monitoring of traditional medicines in the unregulated market, training of stakeholders, risk communication, and integration of traditional health practitioners in reporting systems are the main challenges of countries for the development of pharmacovigilance for traditional medicines. The effective compliance of WAHO's harmonised phytovigilance regulatory framework by UEMOA countries and addressing the challenges identified by the countries constitute the basis for the development of pharmacovigilance for traditional medicines within UEMOA.

Pharmacovigilance in the Caribbean Countries: an Overview.

The constant surge in accessing essential medicines creates a greater need for continuous monitoring of usage. The inability to source active pharmaceutical ingredients during the COVID-19 pandemic resulted in drug shortages that increased online requests for medications. E-commerce and social sites have opened the floodgate for the marketing of falsified, substandard, and unregistered pharmaceuticals, making them easily accessible to consumers with the click of a button. A high prevalence of such products with compromised quality highlights further the need for enhanced post-marketing vigilance of safety and quality within the pharmaceutical industry. This review aims to assess the extent to which pharmacovigilance (PV) systems in selected Caribbean countries conform to the minimum World Health Organization (WHO) requirements, highlight the importance of PV in ensuring the safer use of medicines across the Caribbean region, and identify opportunities and challenges in building comprehensive PV systems. The review finds that while major advancements in PV and adverse drug reaction (ADR) monitoring have occurred in Europe and other parts of the Americas, little has been done in the Caribbean region. Only a few countries in the region are active members of the WHO's global PV network, and ADR reporting is minimal. The reason for low reporting includes a lack of awareness, commitment, and participation of healthcare professionals, manufacturers, authorized distributors, and the general consumers. Nearly all established national PV systems do not fully conform to the minimum PV requirements by the WHO. Legislation, regulatory framework, political commitment, adequate funding, strategies, and incentives to encourage reporting of ADRs are needed to build sustainable PV systems in the Caribbean.

Spontaneous adverse drug reaction reporting during the seasonal malaria chemoprevention campaign in 2022

BackgroundSeasonal administration of antimalaria drug, sulphadoxine/pyrimethamine plus amodiaquine to children 3–59 months is a malaria preventive intervention used for the reduction of childhood malaria morbidity and mortality in area with highly seasonal malaria transmission like sub-Saharan Africa. This intervention has been deployed in Nigeria and other sub-Saharan African countries for years and may continue for more years to come either alone or combination with other novel interventions. Despite the importance of pharmacovigilance, there is currently a dearth of pharmacovigilance data in most African countries, especially in public health interventions like seasonal malaria chemoprevention campaigns. The availability of quality safety data is likely to improve the acceptability of this preventive intervention.ResultsThe study identified vomiting as the most reported adverse drug reaction. Other reported reactions include weakness, fever, abdominal pain, convulsion, redness of the eyes, swollen hand/face, rash, itching, cough, headache, and excessive salivation. Using Naranjo scale, 69.2% of the reported reactions can be classified as possible; while 29.5% can be classified as probable, only 1.3% is classified as definite. 92.3% of reported adverse drug reactions were from children 12–59 months and 7.7% were from those 3–11 months. The proportion of ADRs classified according to the affected organ/system is as follows: central nervous system (10.26%), gastrointestinal (60.26%), ocular (10.26%), musculoskeletal (7.69%), and dermatological (11.53%). The study also suggests better tolerability to the seasonal malaria chemoprevention medicines with more implementation experience, as states with more implementation experiences reported fewer suspected adverse drug reactions.ConclusionsThe findings from this study provide additional information on possible adverse drug reactions during seasonal malaria chemoprevention campaigns. This additional information should be communicated to caregivers during the seasonal malaria chemoprevention campaigns as a way of building trust and improving acceptability of the intervention. Also, strengthening of the national pharmacovigilance system is vital to ensure improved timeliness, quality, and quantity of pharmacovigilance reporting on SMC intervention in Africa, as results from the study show low levels of pharmacovigilance reporting across the states.

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.

COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal.

Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty®, Spikevax®, Vaxzevria® and Jcovden®. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.

Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon's Success Story.

Implementation of Pharmacovigilance (PV) systems in resource-limited countries is a real challenge. The objective of this paper is to describe the implementation of an effective national PV system in Lebanon in the context of COVID-19, within a limited resources setting and with the absence of a guaranteed funding. In 2018, the PV center hosted at the Lebanese University, Faculty of Pharmacy under the supervision of the Quality Assurance of Pharmaceutical Products Program within the Lebanese Ministry of Public Health became an associate member of the World Health Organization (WHO) Program of International Drug Monitoring and recognized as Full member in 2021.This analysis highlights the requirements of the WHO that were met in Lebanon to create an effective PV system. The Lebanese experience shows that it is not only possible, but also crucial to implement a PV system in low to middle-income countries with limited resources and with the absence of a guaranteed funding in order to be able to promote patients’ safety. Support from organizations like WHO and World Bank, skilled leadership, hard work and dedicated staff with efficient training, and finally mass awareness initiatives were all considered as key elements to implement a successful PV System. In the midst of a turbulent political, economic and health context, Lebanon has been able to develop one of the most active and rapidly evolving PV systems in the Middle East.

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.

Pharmacovigilance reporting during seasonal malaria chemoprevention campaign: Findings from northern Nigeria

BackgroundSeasonal malaria chemoprevention (SMC) campaign is known to reduce malaria-related morbidity and mortality among children aged 3 -59 months in the Sahel regions of Africa. However, the success of the intervention may be adversely affected by the absence of a robust pharmacovigilance system to monitor safety. This paper aims to describe our pharmacovigilance reporting experience during the campaigns conducted across seven states in Nigeria in 2020. MethodsThe SMC campaigns were held over four cycles from July to November 2020, with nearly 12 million eligible children reached by trained community drug distributors. Suspected adverse drug reactions were reported routinely through the national pharmacovigilance (PV) system. Completed PV forms submitted to the National Agency for Food, Drugs Administration and Control were retrieved and analyzed. ResultsThe adverse drug reaction (ADR) reporting across the seven states was low, with no ADR reports from five states. The ADRs reported included abdominal pain, weakness, diarrhea, fever, rash, and vomiting. Vomiting was the most reported ADR, accounting for almost half (28/57) of all reported cases. Children aged 12–59 months accounted for most (∼86%, 49/57) of the ADR reports, with over 70% (40/57) of these reports completed by community health extension workers. The system organ classification of ADRs showed that the gastrointestinal system was mainly affected (65%, 37/57). ConclusionOur experience suggests gaps with the pharmacovigilance surveillance system, highlighting the need to consider an active surveillance system, address behavioural factors, and explore the use of a digital reporting system.

Pharmacovigilance in emerging economies: modeling interaction among barriers

PurposeThe main purpose of this paper is to identify and rank various barriers to pharmacovigilance (PV) in context of emerging economies and examine their interrelationships using the interpretive structural modeling (ISM) approach. The result is a model that offers insights about how to achieve rational and safe use of medicines and ensure patient safety as realized through robust national PV systems.Design/methodology/approachThe paper develops a model to analyze the interactions among PV barriers using the ISM approach. Based on input from clinical and medical product development experts, PV barriers in emerging economies were identified and reviewed. The hierarchical interrelationships among these PV barriers were analyzed in context of their driving/dependence powers.FindingsFindings of the study identify key PV barriers—lack of resources/infrastructure, weak legislation, unfair burden of disease, lack of PV capacity, training, and enforcement authority—that drive, or strongly influence, other barriers and thwart implementation of robust national PV systems in emerging economies. Pharmaceutical industry factors were PV barriers that were identified as autonomous, implying their relative disconnection from other barriers, and patient PV practices barrier was strongly dependent on other barriers.Research limitations/implicationsThe paper offers policy- and decision-makers alike with a framework to support further research into interdependencies among key PV barriers in emerging economies. It can serve as an impetus for further research with potential to broadening the understanding of how and why PV systems may be rendered ineffective. Future studies can be planned to apply the ISM approach to study PV barriers in the context of developed economies and draw lessons and implications for policy- and decision-makers by contrasting results from these studies.Practical implicationsThis paper contributes to the understanding of the multifaceted nature of PV and its barriers. The proposed approach gives public health decision-makers a better comprehension of driver PV barriers that have most influence on others versus dependent PV barriers, which are most influenced by others. Also, knowledge, attitude and practices of patients and caregivers can also be critical PV barriers in emerging economies. This information can be instrumental for public health policymakers, government entities, and health/PV practitioners to identify the PV barriers that they should prioritize for improvement and how to manage trade-offs between these barriers.Social implicationsPV barriers in emerging economies, as compared to developed economies, are inherently different and need to be examined in their specific context. The hierarchical ISM model suggests that resources and regulation initiatives by governments in emerging economies lead to through informed/enabled pharmaceutical supply chain players and eventually drive PV-specific knowledge, attitude, and practice outcomes improvements across their populace.Originality/valueThis paper highlights the deployment of ISM approach as a health policy decision support tool in the identifying and ranking barriers to effective PV systems in emerging economies, in terms of their contextual relationships, to achieve a better understanding as to how these interrelationships can affect national PV system outcomes.

Under-reporting of Adverse Drug Reactions among Healthcare Professionals in Brazil: An Estimate Based on National Pharmacovigilance Survey

Background: Adverse Drug Reaction (ADR) is a public health problem with an impact on health care costs. Spontaneous reporting comprises the primary method for detection ADR’s. However, high levels under-reporting represents a barrier in pharmacovigilance. Objectives: The present study aims to estimate the prevalence of under-reporting ADR professionals in Brazil and to analyze the factors associated with under-reporting. Methods: Used a cross-sectional study based on an online survey for healthcare professionals conducted by the Brazilian Health Regulatory Agency (Anvisa). Unconditional logistic regression was performed and adjusted odd ratios (OR) were estimated. Results: In total 789 questionnaires were analyzed and based on the criteria, 67.5% of professionals were considered under-reporters. The main reason for under-reporting was the lack of access to vital data for notification (33.8%). 52.7% of the participants stated that the existence of a simpler system to notify motivated its use. It was found that residents in the Southern region of Brazil have 2.3 times the chance of under-reporting an ADR than those in the Southeast region (OR = 2.3; IC 95%:1.3-4.2). Having advanced knowledge in pharmacovigilance (OR=0.5; IC 95%: 0.4-0.7) and performing notification even without the causal certainty of the event (OR = 0.5; IC 95%:0.3-0.7) were protective factors for under-reporting, while not applicating knowledge routinely was considered a risk factor for under-reporting (OR = 4.4; IC 95%:2.1-9.2). Conclusion: A high rate of professionals considered as under-reporters of ADRs in Brazil has been detected. This study will make an important contribution to health managers and drug regulators for strengthen the national pharmacovigilance system.

Assessment of Knowledge, Attitude, and Practice of Pharmacovigilance among Healthcare Professionals in Brazil

Background: Adverse Drug Events represent a public health problem with high morbidity and mortality rates around the world. Knowledge, attitudes and practices of health professionals toward pharmacovigilance and reporting these events are important factors to promote safe drug therapy use. Objectives: The aim of this study was to evaluate Knowledge, attitudes and practices of health professionals and reporting of Adverse Drug Events by health professionals in Brazil. Methods: across-sectional study with a pretested questionnaire available online on the website of the Brazilian drug regulatory agency. Pharmacovigilance related Knowledge, attitudes and practices and Adverse Drug Events reporting were evaluated and correlations were estimated. Results: In total, 761health professionals responded to the survey. The overall knowledge, attitudes and practices was of 57.7% for pharmacists, 56.9% for nurses and 40% for physicians 40% (considered to be a poor level). When evaluating performance by region, one physician (100%) from the South region and one nurse from the Central-West (83.3%) performed well on this indicator. Professionals in the age group older than 45 years and those with postgraduate degrees had the best performance in knowledge, attitudes and practices. The statistical analysis was performed with the software State version 15. Conclusion: The study identified knowledge, attitudes and practices deficiencies in pharmacovigilance and mapped its main weaknesses, which makes it possible to better delineate measures to address these challenges and improve the Brazilian national pharmacovigilance system. Key words: Adverse Drug Reaction Reporting Systems, Health Knowledge, Attitudes, Practice, Patient Safety, Pharmaco epidemiology, Product Surveillance, Post marketing.

An analysis of the trends, characteristics, scope, and performance of the Zimbabwean pharmacovigilance reporting scheme.

We aimed to determine the reporting trends and characteristics of Individual Case Safety Reports (ICSRs) from the Zimbabwean national pharmacovigilance system. ICSRs submitted to VigiBaseTM, the World Health Organisation's ICSR database between January 1993 and December 2017 were retrospectively reviewed with respect to the suspected medicine, System Organ Class (SOC), adverse drug reaction (ADR) type and seriousness, Anatomic Therapeutic Chemical (ATC) group, age, and gender. In total, 4071 ICSRs were submitted to VigiBaseTM from targeted spontaneous reporting (n = 2909; 71.5%), vaccine surveillance (n = 679; 16.7%), and passive spontaneous reporting (n = 483; 11.9%), respectively. The median age, ICSR completeness score and timeliness of reporting were 34.0 years (IQR: 14.0; 43.0), 0.90 (IQR: 0.70; 1.00), and 548.0 days (IQR: 266:1131), respectively. More than half of the ICRS were from female patients (n = 2233; 54.9%). Antiretrovirals, antibiotics, vaccines, and anti‐tubercular medicines were reported in 62.9%, 27.9%, 16.7%, and 13.3% of submitted ICSRs, respectively. The most frequent ADRs involved the skin and subcutaneous systems (n = 1111; 20.5%), nervous system (n = 733; 13.5%), and gastrointestinal disorders system (n = 654; 12.1%). The number of ADRs reported for each patient was significantly related to the reported medicine's ATC category (P = .001. The number of ADRs was significantly related to the use of antiretroviral agents. In conclusion, Zimbabwe has made significant progress in establishing a functional pharmacovigilance system. However, the present system reports on a limited therapeutic spectrum of medicines and potentially underestimates the national ADR burden. Further work is required to strengthen the more sustainable spontaneous reporting system which potentially captures a variety of therapeutic classes.

Using real-world evidence for pharmacovigilance and drug safety-related decision making by a resource-limited health authority: 10 years of experience in Taiwan.

Real-world evidence has become increasingly relevant in regulatory decision making. Compared to large regulatory bodies, the national pharmacovigilance system in Taiwan is still under development, and the aim of this study is to demonstrate how a resource-limited health authority utilizes real-world evidence in decision making. We described different sources of real-world data available in Taiwan and illustrated the structural framework that integrates real-world evidence into Taiwan's national pharmacovigilance system. Additionally, we reviewed real-world studies conducted in the past 10 years and provided examples to show how these studies influenced drug safety-related decision making in Taiwan. During the past 10 years, real-world evidence used when making drug safety-related regulatory decisions in Taiwan was mainly generated from nationwide claims databases, but other sources of real-world data, such as national registries and large electronic hospital databases, also became available recently. Different types of real-world evidence, including drug utilization studies, risk evaluation studies, and risk minimization measure evaluation studies, have been used to support regulatory decisions in Taiwan. Through collaborations between the government and academics, Taiwan has started to integrate real-world evidence into the national pharmacovigilance system. However, future efforts, including linkages between different sources of real-world data and improvements in procedural and methodological practices, are needed to generate more regulatory-quality real-world evidence.

Adverse drug reactions in adolescents: a review of reporting to a national pharmacovigilance system

ABSTRACT Objective Adverse drug reactions (ADR) cause significant morbidity, mortality and health costs and have an important prevalence in all ages. Few studies focus on ADR in adolescents. The goal of this study was to characterize a case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) of the National Authority of Medicines and Health Products (INFARMED, I.P.) during an eleven-year period (from 2006 to 2016) concerning this specific population. Methods Retrospective analysis of reports concerning patients from 10 to 18 years received by the PPS between 2006 and 2016. The authors evaluated patients’ demographics (age and sex). The characteristics and seriousness of the reactions, the type of reaction reported, and the drugs involved were assessed. Results The authors found 782 reports (59% females). Most reports came from physicians (61%). Overall 80% of the reports described serious ADR. A greater proportion of serious events was found among males. Most reactions referred to general disorders and administration site conditions (38%), followed by skin and subcutaneous tissue reactions (33%). In 3rd and 4th were gastrointestinal disorders (24%) and the nervous system disorders (23%), the former more frequent among females. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (19%). Conclusion Major findings considering drugs involved and the reported reactions varied according to age and sex.

Analysis of Reporting Adverse Drug Reactions in Paediatric Patients in a University Hospital in the Netherlands.

AimsThe risk to develop adverse drug reactions (ADRs) is high for paediatric patients. This is, amongst other reasons, due to the inevitable use of off-label and unlicensed medicines. Moreover, there is limited knowledge on ADRs in children. Thus, adequate recognition may be challenging. The lack of dedicated studies and the voluntary nature of pharmacovigilance systems used to gain insight into the characteristics of ADRs contribute to this problem. The goal of this study is to identify whether ADRs in paediatric patients are adequately documented by the medical team and whether they are subsequently reported to the national pharmacovigilance system.MethodsAll patients admitted to the paediatric medium care of the Radboudumc Amalia Children’s hospital during 1 month, and using one or more drugs, were included. Two researchers analysed retrospectively and independently the number of possible ADRs in the medical records. The ADRs were listed per paediatric subspecialty, to evaluate any differences in documentation and reporting of the ADRs. Subsequently, the causality, severity, and seriousness of the ADRs were assessed. The ADRs were categorised by system organ class and drug class. The national pharmacovigilance centre was consulted to check if there were any reports coming from our hospital and to collect the total number of reports.ResultsThe medical records of 301 patients were analysed, 81 patients were suffering from one or more ADRs. In total 132 suspected ADRs were found, divided among 19 different paediatric subspecialties. Numbers were too small to investigate the differences in ADR documentation. Of these found ADRs, 55% were not explicitly noted as such in the medical records by the treating physician. None of the ADRs were reported to the national pharmacovigilance centre. Most ADRs scored ‘possible’ in the causality assessment, were mild or moderate, and a small number were serious. The ADRs occurred in 25 different organ systems. In total 25 different drug classes were involved.ConclusionsThe results of the present study show that a large number of ADRs are not registered in the medical records and are not reported to the national pharmacovigilance system. Furthermore, it is shown that the number of ADRs occurring at our centre is much higher than the number reported to the national pharmacovigilance centre. Only an average of 513 ADRs in paediatric patients are reported per year nationwide, suggesting that there is extensive underreporting.