A multinational Delphi consensus to end the COVID-19 public health threat.

Despite notable scientific and medical advances, broader political, socioeconomic and behavioural factors continue to undercut the response to the COVID-19 pandemic1,2. Here we convened, as part of this Delphi study, a diverse, multidisciplinary panel of 386 academic, health, non-governmental organization, government and other experts in COVID-19 response from 112 countries and territories to recommend specific actions to end this persistent global threat to public health. The panel developed a set of 41 consensus statements and 57 recommendations to governments, health systems, industry and other key stakeholders across six domains: communication; health systems; vaccination; prevention; treatment and care; and inequities. In the wake of nearly three years of fragmented global and national responses, it is instructive to note that three of the highest-ranked recommendations call for the adoption of whole-of-society and whole-of-government approaches1, while maintaining proven prevention measures using a vaccines-plus approach2 that employs a range of public health and financial support measures to complement vaccination. Other recommendations with at least 99% combined agreement advise governments and other stakeholders to improve communication, rebuild public trust and engage communities3 in the management of pandemic responses. The findings of the study, which have been further endorsed by 184 organizations globally, include points of unanimous agreement, as well as six recommendations with >5% disagreement, that provide health and social policy actions to address inadequacies in the pandemic response and help to bring this public health threat to an end.

Securing wider EU commitment to the elimination of hepatitis C virus.

In 2016, the Hepatitis B and C Public Policy Association (HepBCPPA), gathered all the main stakeholders in the field of hepatitis C virus (HCV) to launch the now landmark HCV Elimination Manifesto, calling for the elimination of HCV in the EU by 2030. Since then, many European countries have made progress towards HCV elimination. Multiple programmes-from the municipality level to the EU level-were launched, resulting in an overall decrease in viremic HCV infections and liver-related mortality. However, as of 2021, most countries are not on track to reach the 2030 HCV elimination targets set by the WHO. Moreover, the COVID-19 pandemic has resulted in a decrease in HCV diagnoses and fewer direct-acting antiviral treatment initiations in 2020. Diagnostic and therapeutic tools to easily diagnose and treat chronic HCV infection are now well established. Treating all patients with chronic HCV infection is more cost-saving than treating and caring for patients with liver-related complications, decompensated cirrhosis or hepatocellular carcinoma. It is more important than ever to reinforce and scale-up action towards HCV elimination. Yet, efforts urgently need the dedicated commitment of policymakers at all governmental and policy levels. Therefore, the third EU Policy Summit, held in March 2021, featured EU parliamentarians and other key decision makers to promote dialogue and take strides towards securing wider EU commitment to advance and achieve HCV elimination by 2030. We have summarized the key action points and reported the 'Call-to-Action' statement supported by all the major relevant European associations in the field.

A global investment framework for the elimination of hepatitis B.

BACKGROUND & AIMS: More than 292 million people are living with hepatitis B worldwide and are at risk of death from cirrhosis and liver cancer. The World Health Organization (WHO) has set global targets for the elimination of viral hepatitis as a public health threat by 2030. However, current levels of global investment in viral hepatitis elimination programmes are insufficient to achieve these goals. METHODS: To catalyse political commitment and to encourage domestic and international financing, we used published modelling data and key stakeholder interviews to develop an investment framework to demonstrate the return on investment for viral hepatitis elimination. RESULTS: The framework utilises a public health approach to identify evidence-based national activities that reduce viral hepatitis-related morbidity and mortality, as well as international activities and critical enablers that allow countries to achieve maximum impact on health outcomes from their investments - in the context of the WHO's 2030 viral elimination targets. CONCLUSION: Focusing on hepatitis B, this health policy paper employs the investment framework to estimate the substantial economic benefits of investing in the elimination of hepatitis B and demonstrates how such investments could be cost saving by 2030. LAY SUMMARY: Hepatitis B infection is a major cause of death from liver disease and liver cancer globally. To reduce deaths from hepatitis B infection, we need more people to be tested and treated for hepatitis B. In this paper, we outline a framework of activities to reduce hepatitis B-related deaths and discuss ways in which governments could pay for them.

Securing sustainable funding for viral hepatitis elimination plans.

The majority of people infected with chronic hepatitis C virus (HCV) in the European Union (EU) remain undiagnosed and untreated. During recent years, immigration to EU has further increased HCV prevalence. It has been estimated that, out of the 4.2 million adults affected by HCV infection in the 31 EU/ European Economic Area (EEA) countries, as many as 580 000 are migrants. Additionally, HCV is highly prevalent and under addressed in Eastern Europe. In 2013, the introduction of highly effective treatments for HCV with direct-acting antivirals created an unprecedented opportunity to cure almost all patients, reduce HCV transmission and eliminate the disease. However, in many settings, HCV elimination poses a serious challenge for countries' health spending. On 6 June 2018, the Hepatitis B and C Public Policy Association held the 2nd EU HCV Policy summit. It was emphasized that key stakeholders should work collaboratively since only a few countries in the EU are on track to achieve HCV elimination by 2030. In particular, more effort is needed for universal screening. The micro-elimination approach in specific populations is less complex and less costly than country-wide elimination programmes and is an important first step in many settings. Preliminary data suggest that implementation of the World Health Organization (WHO) Global Health Sector Strategy on Viral Hepatitis can be cost saving. However, innovative financing mechanisms are needed to raise funds upfront for scaling up screening, treatment and harm reduction interventions that can lead to HCV elimination by 2030, the stated goal of the WHO.

Innovative strategies for the elimination of viral hepatitis at a national level: A country case series.

Viral hepatitis is a leading cause of morbidity and mortality worldwide, but has long been neglected by national and international policymakers. Recent modelling studies suggest that investing in the global elimination of viral hepatitis is feasible and cost-effective. In 2016, all 194 member states of the World Health Organization endorsed the goal to eliminate viral hepatitis as a public health threat by 2030, but complex systemic and social realities hamper implementation efforts. This paper presents eight case studies from a diverse range of countries that have invested in responses to viral hepatitis and adopted innovative approaches to tackle their respective epidemics. Based on an investment framework developed to build a global investment case for the elimination of viral hepatitis by 2030, national activities and key enablers are highlighted that showcase the feasibility and impact of concerted hepatitis responses across a range of settings, with different levels of available resources and infrastructural development. These case studies demonstrate the utility of taking a multipronged, public health approach to: (a) evidence-gathering and planning; (b) implementation; and (c) integration of viral hepatitis services into the Agenda for Sustainable Development. They provide models for planning, investment and implementation strategies for other countries facing similar challenges and resource constraints.

Beyond viral suppression of HIV - the new quality of life frontier.

BACKGROUND: In 2016, the World Health Organization (WHO) adopted a new Global Health Sector Strategy on HIV for 2016-2021. It establishes 15 ambitious targets, including the '90-90-90' target calling on health systems to reduce under-diagnosis of HIV, treat a greater number of those diagnosed, and ensure that those being treated achieve viral suppression. DISCUSSION: The WHO strategy calls for person-centered chronic care for people living with HIV (PLHIV), implicitly acknowledging that viral suppression is not the ultimate goal of treatment. However, it stops short of providing an explicit target for health-related quality of life. It thus fails to take into account the needs of PLHIV who have achieved viral suppression but still must contend with other intense challenges such as serious non-communicable diseases, depression, anxiety, financial stress, and experiences of or apprehension about HIV-related discrimination. We propose adding a 'fourth 90' to the testing and treatment target: ensure that 90 % of people with viral load suppression have good health-related quality of life. The new target would expand the continuum-of-services paradigm beyond the existing endpoint of viral suppression. Good health-related quality of life for PLHIV entails attention to two domains: comorbidities and self-perceived quality of life. CONCLUSIONS: Health systems everywhere need to become more integrated and more people-centered to successfully meet the needs of virally suppressed PLHIV. By doing so, these systems can better meet the needs of all of their constituents - regardless of HIV status - in an era when many populations worldwide are living much longer with multiple comorbidities.

Digital Gamification Tool (Let's Control Flu) to Increase Vaccination Coverage Rates: Proposal for Algorithm Development.

BACKGROUND: Influenza represents a critical public health challenge, disproportionately affecting at-risk populations, including older adults and those with chronic conditions, often compounded by socioeconomic factors. Innovative strategies, such as gamification, are essential for augmenting risk communication and community engagement efforts to address this threat. OBJECTIVE: This study aims to introduce the "Let's Control Flu" (LCF) tool, a gamified, interactive platform aimed at simulating the impact of various public health policies (PHPs) on influenza vaccination coverage rates and health outcomes. The tool aligns with the World Health Organization's goal of achieving a 75% influenza vaccination rate by 2030, facilitating strategic decision-making to enhance vaccination uptake. METHODS: The LCF tool integrates a selection of 13 PHPs from an initial set proposed in another study, targeting specific population groups to evaluate 7 key health outcomes. A prioritization mechanism accounts for societal resistance and the synergistic effects of PHPs, projecting the potential policy impacts from 2022 to 2031. This methodology enables users to assess how PHPs could influence public health strategies within distinct target groups. RESULTS: The LCF project began in February 2021 and is scheduled to end in December 2024. The model creation phase and its application to the pilot country, Sweden, took place between May 2021 and May 2023, with subsequent application to other European countries. The pilot phase demonstrated the tool's potential, indicating a promising increase in the national influenza vaccination coverage rate, with uniform improvements across all targeted demographic groups. These initial findings highlight the tool's capacity to model the effects of PHPs on improving vaccination rates and mitigating the health impact of influenza. CONCLUSIONS: By incorporating gamification into the analysis of PHPs, the LCF tool offers an innovative and accessible approach to supporting health decision makers and patient advocacy groups. It enhances the comprehension of policy impacts, promoting more effective influenza prevention and control strategies. This paper underscores the critical need for adaptable and engaging tools in PHP planning and implementation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/55613.

Epidemiological Modeling of the Impact of Public Health Policies on Hepatitis C: Protocol for a Gamification Tool Targeting Microelimination.

BACKGROUND: Hepatitis C is a disease with a strong social component, as its main transmission route is via blood, making it associated with lifestyle. Therefore, it is suitable to be worked on from the perspective of public health policy, which still has a lot of room to explore and improve, contrary to diagnoses and treatments, which are already very refined and effective. OBJECTIVE: An interactive gamified policy tool, designated as Let's End HepC (LEHC), was created to understand the impact of policies related to hepatitis C on the disease's epidemiology on a yearly basis until 2030. METHODS: To this end, an innovative epidemiological model was developed, integrating Markov chains to model the natural history of the disease and adaptive conjoint analysis to reflect the degree of application of each of the 24 public health policies included in the model. This double imputation model makes it possible to assess a set of indicators such as liver transplant, incidence, and deaths year by year until 2030 in different risk groups. Populations at a higher risk were integrated into the model to understand the specific epidemiological dynamics within the total population of each country and within segments that comprise people who have received blood products, prisoners, people who inject drugs, people infected through vertical transmission, and the remaining population. RESULTS: The model has already been applied to a group of countries, and studies in 5 of these countries have already been concluded, showing results very close to those obtained through other forms of evaluation. CONCLUSIONS: The LEHC model allows the simulation of different degrees of implementation of each policy and thus the verification of its epidemiological impact on each studied population. The gamification feature allows assessing the adequate fulfillment of the World Health Organization goals for the elimination of hepatitis C by 2030. LEHC supports health decision makers and people who practice patient advocacy in making decisions based on science, and because LEHC is democratically shared, it ends up contributing to the increase of citizenship in health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/38521.

360 Health Analysis (H360)-A Comparison of Key Performance Indicators in Breast Cancer Management across Health Institution Settings in Portugal.

BACKGROUND: The increased focus on quality indicators (QIs) and the use of clinical registries in real-world cancer studies have increased compliance with therapeutic standards and patient survival. The European Society of Breast Cancer Specialists (EUSOMA) established QIs to assess compliance with current standards in breast cancer care. METHODS: This retrospective study is part of H360 Health Analysis and aims to describe compliance with EUSOMA QIs in breast cancer management in different hospital settings (public vs. private; general hospitals vs. oncology centers). A set of key performance indicators (KPIs) was selected based on EUSOMA and previously identified QIs. Secondary data were retrieved from patients' clinical records. Compliance with target KPIs in different disease stages was compared with minimum and target EUSOMA standards. RESULTS: A total of 259 patient records were assessed. In stages I, II, and III, 18 KPIs met target EUSOMA standards, 5 met minimum standards, and 8 failed to meet minimum standards. Compliance with KPIs varied according to the type of hospital (particularly regarding diagnosis) and disease stage. Although small differences were found in KPI compliance among institutions, several statistical differences were found among treatment KPIs according to disease stage, particularly in stage III. CONCLUSIONS: This study represents the first assessment of the quality of breast cancer care in different hospital settings in Portugal and shows that, although most QIs meet EUSOMA standards, there is room for improvement. Differences have been found across institutions, particularly between oncology centers and general hospitals, in diagnosis and compliance with KPIs among disease stages. Stage III showed the greatest variability in compliance with treatment KPIs, probably related to the lower specificity of the guidelines in this disease stage.

Integrating public health policies in the epidemiological modeling of hepatitis C with LEHC tool: application in Austria.

BACKGROUND: Eliminating hepatitis C requires addressing issues other than medicines or therapies. Public health policies focused on the hepatitis C virus (HCV) must be emphasized and worked to know the impacts on its epidemiologic dynamics. This research aims to provide a tool to evaluate and simulate alternatives by redefining policies meeting specific needs in each country towards the HCV elimination target by 2030. METHODS: The development of a gamified model with 24 public health policies focused on HCV was conducted to evaluate the impact of measures in the disease epidemiologic dynamics. The Let's End HepC (LEHC) project encompassed key populations (people who inject drugs [PWID], prisoners, blood products and remnant population) in Austria and other countries, presenting prospects for every year from 2019 to 2030. The LEHC epidemiological model comprised an integrated solution for HCV, with adaptive conjoint analysis (ACA) and Markov chains constituting its main processes. RESULTS: Despite Austria's efforts towards achieving the HCV elimination goal by 2030, the LEHC model forecast quantitative analysis predicts that it is still not enough to meet the target; however, prospects are very optimistic if public health policies are adapted to the country's needs, being possible to achieve the goal as early as 2026. CONCLUSION: In Austria, the LEHC tool allowed to forecast the HCV elimination year anticipation to 2026, instead of being achieved after 2030. This target will only be valid if adequate management of the 24 public health policies focused on this pathology is further implemented.

Let's End HepC: Modelling Public Health Epidemiological Policies Applied to Hepatitis C in Spain.

Background: The WHO has defined international targets toward the elimination of hepatitis C by 2030. Most countries cannot be on track to achieve this goal unless many challenges are surpassed. The Let's End HepC (LEHC) tool aims to contribute to the control of hepatitis C. The innovation of this tool combines the modelling of public health policies (PHP) focused on hepatitis C with epidemiological modelling of the disease, obtaining a unique result that allows to forecast the impact of policy outcomes. The model was applied to several countries, including Spain. Methods: To address the stated objective, we applied the "Adaptive Conjoint Analysis" for PHP decision-making and Markov Chains in the LEHC modelling tool. The tool also aims to be used as an element of health literacy for patient advocacy through gamification mechanisms and country comparability. The LEHC project has been conducted in several countries, including Spain. The population segments comprised in the project are: People Who Inject Drugs (PWID), prisoners, blood products, remnant population. Results: A total of 24 PHP related to hepatitis C were included in the LEHC project. It was identified that Spain had fully implemented 14 of those policies to control hepatitis C. According to LEHC's model forecast, the WHO's Hepatitis C elimination goal on reducing the number of patients living with Hepatitis C to 10% can be achieved in Spain by 2026 if current policies are maintained. The model estimates that the total population in Spain, by 2026, is expected to comprise 26,367 individuals living with hepatitis C. Moreover, if the 24 PHP considered for this study are fully implemented in Spain, the elimination goal may be achieved in 2024, with 29,615 individuals living with hepatitis C by that year. Conclusion: The findings corroborate the view that Spain has set great efforts in directing PHP toward Hepatitis C Virus (HCV) elimination by 2030. However, there is still room for improvement, namely in further implementing 10 of the 24 PHP considered for the LEHC project. By maintaining the 14 PHP in force, the LEHC model estimates the HCV elimination in the country by 2026, and by 2024 if further measures are employed to control the disease.

Modeling the Puzzle of Hepatitis C Epidemiology in Romania: A Pathway to Control.

BACKGROUND AND AIMS: To combat hepatitis C virus (HCV) and achieve its elimination by 2030, the emphasis should be on public health policies. In this study, we investigated the dynamics of epidemiology of HCV in Romanian risk groups that are characterized by higher occurrence densities with the aid of The Let's End HepC (LEHC) project. METHODS: The LEHC project addressed the modelling of HCV epidemiology, being applied in several countries, one of which is Romania. The model comprised an integrated solution of public health policies focused on the disease, using Adaptive Conjoint Analysis and Markov chains systems. This tool allowed the quantitative evaluation of public health policies' impact, for every year until 2030, in five population groups: people who inject drugs (PWID), prisoners, individuals who have received blood products, children at risk for vertical transmission, and the remnant population. RESULTS: It appears that Romania was already making great efforts in the context of public policies, allowing the achievement of HCV elimination by 2028 if current policies were maintained. Through additional work and greater efforts in further implementing public policies, the LEHC model estimated the possibility of anticipating this outcome to 2026. CONCLUSION: The LEHC model estimated an anticipation of the HCV elimination year in Romania to be 2026 if the twenty-four health policies in the study are fully implemented and consistently maintained over the years.

Global hepatitis C elimination: an investment framework.

WHO has set global targets for the elimination of hepatitis B and hepatitis C as a public health threat by 2030. However, investment in elimination programmes remains low. To help drive political commitment and catalyse domestic and international financing, we have developed a global investment framework for the elimination of hepatitis B and hepatitis C. The global investment framework presented in this Health Policy paper outlines national and international activities that will enable reductions in hepatitis C incidence and mortality, and identifies potential sources of funding and tools to help countries build the economic case for investing in national elimination activities. The goal of this framework is to provide a way for countries, particularly those with minimal resources, to gain the substantial economic benefit and cost savings that come from investing in hepatitis C elimination.

[The Road towards the Responsible and Safe Legalization of Cannabis Use in Portugal]. / O Caminho para a Legalização Responsável e Segura do Uso de Cannabis em Portugal.

INTRODUCTION: Recently, the world has seen examples of the legalization of cannabis for recreational purposes. Due to the diversity of experiences in progress, it is urgent to analyze the impacts of this legalization, from a public health perspective. Therefore, this article aims to review the accumulated knowledge in the states and countries where the use of cannabis is legal and to ponder over the relevance of starting a similar path towards legalization in Portugal, thus supporting political decisions to be properly informed and evidence-based. MATERIAL AND METHODS: An extensive literature review was performed using databases and scientific journals, such as PubMed, as well as the search of institutional documentation, including the EMCDDA and SICAD. RESULTS: The gathered information provided insights and enabled assessment of (1) the acute and chronic effects of cannabis use on health, (2) the Portuguese situation related to cannabis and (3) the processes and lessons learned after the legalization of cannabis in other countries or states. Given the above, and according to the data presented, the authors argue for a safe and responsible strategy towards the legalization of cannabis use in Portugal. In accordance, a set of concrete proposals are presented. DISCUSSION: From a public health perspective, it is assumed that the interest of this proposal is to reduce the problematic use of cannabis, to effectively fight against illicit drug trafficking and drug-related crime, as well as health promotion and prevention of addictions and other adverse health impacts. This article reveals that the effects of legalization might, contrary to general beliefs, generate positive results with respect to these aims, given that there will be greater control on the market, price, quality, and information - to name a few - if implementation occurs with proper consideration and definition. CONCLUSION: The debate on the responsible and safe legalization of cannabis use in Portugal should be open and promoted, based on a public health perspective.

Introdução: Recentemente, o mundo assistiu a múltiplos exemplos de legalização do uso de cannabis para fins recreativos. Numa perspetiva de saúde pública, pela diversidade das experiências em curso, torna-se premente analisar os impactos desta legalização. Por conseguinte, este artigo tem por objetivo rever os conhecimentos acumulados nos estados e países onde o uso de cannabis é legal e ponderar sobre a pertinência de iniciar semelhante caminho para a legalização em Portugal. O objetivo é, não apenas promover a reflexão, mas também apoiar uma eventual tomada de decisão política para que possa ser devidamente informada e assente no mais avançado conhecimento científico, económico e jurídico. Material e Métodos: Foi realizada uma revisão extensa da literatura, tendo-se recorrido a bases de dados e revistas científicas, tais como PubMed, bem como pesquisas de documentação institucionais, nomeadamente do OEDT e SICAD. Resultados: A revisão da literatura permitiu sistematizar informação sobre o estado da arte sobre (1) os efeitos agudos e crónicos do consumo de cannabis na saúde, (2) a situação portuguesa relacionada com o uso de cannabis e, (3) os processos e lições aprendidas após a legalização de cannabis em outros países ou estados. Face ao exposto, e de acordo com os dados apresentados, os autores argumentam favoravelmente por uma estratégia de legalização responsável do uso de cannabis em Portugal e encadeiam um conjunto de propostas concretas nesse sentido. Discussão: Partindo de uma perspetiva de saúde pública, assume-se que o interesse da presente proposta reside na redução do consumo problemático de cannabis, no combate eficaz contra o tráfico de drogas ilícitas e crime relacionado, assim como a promoção da saúde, e a prevenção de dependências e outras consequências nefastas para a saúde. Este artigo revela que os efeitos de uma estratégia de legalização responsável podem, em contraste com as crenças comuns, gerar resultados positivos em relação a estes objetivos uma vez que passará a haver um maior controle sobre o mercado, preço, qualidade e informação - para citar alguns exemplos - se a implementação ocorrer de acordo com um programa devidamente desenhado e implementado com esses fins. Conclusão: Tendo por base uma perspetiva de saúde pública, o debate sobre a legalização responsável e segura do uso de cannabis em Portugal deve ser aberto e promovido.

[Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal]. / Medicamentos Biológicos e Biossimilares: Descontinuidades no Sistema de Farmacovigilância em Portugal.

INTRODUCTION: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations. MATERIAL AND METHODS: A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted. RESULTS: Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals. DISCUSSION: Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile. CONCLUSION: The existing pharmacovigilance's regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.

Introdução: A monitorização da segurança associada aos medicamentos biológicos e biossimilares exige um sistema de informação alinhado com o enquadramento regulamentar. Tendo em conta que podem ocorrer descontinuidades entre a regulamentação europeia, nacional e a respetiva tradução operacional, importa pesquisar e identificar essas lacunas. Material e Métodos: Foi desenvolvida uma análise qualitativa dos suportes legais vigentes em julho de 2016 ao nível europeu e nacional, com foco na farmacovigilância. Desta análise decorreu a caracterização operacional do sistema em Portugal. Resultados: Foram identificadas zonas de descontinuidade no âmbito do sistema de farmacovigilância em Portugal, pela ausência de especificidade para os medicamentos biológicos e biossimilares. Discussão: A segurança associada à terapêutica biológica apresenta determinantes específicos relacionados com os medicamentos, prescrição e traçabilidade, que não encontram replicação nos outros segmentos do mercado farmacêutico. Conclusão: Com base nas lacunas identificadas, são apresentadas propostas de intervenção com o objetivo de incrementar a segurança associada à utilização clínica de medicamentos biológicos e biossimilares.

Biologicals and biosimilars: safety issues in Europe.

INTRODUCTION: Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution. The terminology, information systems and traceability systems aren't entirely appropriate to ensure the safety requirements for therapy with medicinal products of a biological origin. Areas covered: This article aims to identify the prescription and dispensing profiles of reference biological medicines and biosimilars in the EU, and the determinants that support their safe use. Expert opinion: The European pharmacovigilance system must evolve to ensure the safety along all of the biologicals' therapeutic cycle. It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure.

Tuberculosis, injecting drug use and integrated HIV-TB care: a review of the literature.

BACKGROUND: People who inject drugs (PWID) are at increased risk of tuberculosis (TB) and reduced retention in treatment. There is a need to document strategies for integrated delivery of HIV, TB and drug dependency care. METHODS: This article reviews the literature on rates of TB mono- and co-infection, and published and grey literature descriptions of TB and HIV-TB care, among PWID. RESULTS: Latent TB infection prevalence was high and active disease more common among HIV-positive PWID. Data on multidrug-resistant TB and co-infections among PWID were scarce. Models of TB care fell into six categories: screening and prevention within HIV-risk studies; prevention at TB clinics; screening and prevention within needle-and-syringe-exchange (NSP) and drug treatment programmes; pharmacy-based TB treatment; TB service-led care with harm reduction/drug treatment programmes; and TB treatment within drug treatment programmes. Co-location with NSP and opioid substitution therapy (OST), combined with incentives, consistently improved screening and prevention uptake. Small-scale combined TB treatment and OST achieved good adherence in diverse settings. Successful interventions involved collaboration across services; a client-centred approach; and provision of social care. No peer-reviewed studies described models of integrated HIV-TB care for PWID but grey literature highlighted key components: co-located services, provision of drug treatment, multidisciplinary staff training; and remaining barriers: staffing inefficiencies, inadequate funding, police interference, and limited OST availability. CONCLUSIONS: Integration with drug treatment improves PWID engagement in TB services but there is a need to document approaches to HIV-TB care, improve surveillance of TB and co-infections among PWID, and advocate for improved OST availability.