INTRODUCTION: Rethinking Pharmaceutical Policies in Latin America and the Caribbean: An Overview.

The demographic and epidemiological transitions are driving pharmaceutical expenditures up in Latin American and the Caribbean, with much of the cost falling on households. The domestic development and manufacturing of bio-similars could make medicines more affordable.

Emerging trends: the involvement of community pharmacists in the planning and execution of pharmaceutical policies and economics.

INTRODUCTION: The aim of this study was to analyze existing research on the involvement of community pharmacists in the planning and execution of pharmaceutical policies and economic strategies. METHODS: The researcher searched five scholarly databases: Medline, BioMed Central (BMC), Excerpta Medica Database (EMBASE), ProQuest, and PubMed for the reviewed articles. The search and selection of the articles involved searching each of the databases using specific keywords and a combination of them to form phrases and the Boolean search string. The researcher adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in developing this study. RESULTS: From the original search, a total of 537 articles emerged from which 17 articles remained upon screening. Findings show that the community pharmacy role has expanded over the past years to enable pharmacists serve diverse roles, but there is a high lack of involvement of these stakeholders in the planning and execution of policies. The pharmaceutical and health-care sectors operate in a way that does not recognize nor engage community pharmacists sufficiently in the policy planning and execution. CONCLUSIONS: Relevant stakeholders need to create an enabling and supportive environment for utilizing the abilities, knowledge, and skills of community pharmacists in policy planning and execution.

Pharmacovigilance in the Caribbean Countries: an Overview.

Purpose of 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. Recent Findings: 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. Summary: 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.

A Hypothesis-Free Bridging of Disease Dynamics and Non-pharmaceutical Policies.

Accurate prediction of the number of daily or weekly confirmed cases of COVID-19 is critical to the control of the pandemic. Existing mechanistic models nicely capture the disease dynamics. However, to forecast the future, they require the transmission rate to be known, limiting their prediction power. Typically, a hypothesis is made on the form of the transmission rate with respect to time. Yet the real form is too complex to be mechanistically modeled due to the unknown dynamics of many influential factors. We tackle this problem by using a hypothesis-free machine-learning algorithm to estimate the transmission rate from data on non-pharmaceutical policies, and in turn forecast the confirmed cases using a mechanistic disease model. More specifically, we build a hybrid model consisting of a mechanistic ordinary differential equation (ODE) model and a gradient boosting model (GBM). To calibrate the parameters, we develop an "inverse method" that obtains the transmission rate inversely from the other variables in the ODE model and then feed it into the GBM to connect with the policy data. The resulting model forecasted the number of daily confirmed cases up to 35 days in the future in the USA with an averaged mean absolute percentage error of 27%. It can identify the most informative predictive variables, which can be helpful in designing improved forecasters as well as informing policymakers.

How value-based policy interventions influence price negotiations for new medicines: An experimental approach and initial evidence.

BACKGROUND: Various forms of value-based pricing policies for new medicines have recently been introduced in OECD countries. While these initiatives are expected to have a positive impact on societal outcomes such as availability, affordability and value for money, scientific evidence on this impact is scarce due to confidential agreements. OBJECTIVE: We aimed to assess the impact of value-based policy interventions in price negotiations on patient benefit in an experimental setting. METHODS: An online experiment was conducted (n = 269). Participants were randomly assigned into the active role of either a buyer or seller in two intervention groups (cost-benefit, risk-sharing) and one control group. Decisions had real monetary consequences on other participants and through donations to a patient association. RESULTS: Patient access, benefit and value for money were higher in the cost-benefit group than in the risk-sharing group. An available alternative to the agreement led to higher price offers. This effect was weaker in the cost-benefit group. CONCLUSIONS: Outcomes of price negotiations on patient benefit depend on the alternatives available for failed or delayed negotiations. A shared but voluntary valuation framework might increase patient access, benefit, and value for money. The cost containment effect of risk-sharing agreements may be offset by the negative impact on overall patient benefit. Further development of the approach could provide support for policy design of pharmaceutical pricing regulations.

Assessing social preferences in reimbursement negotiations for new Pharmaceuticals in Oncology: an experimental design to analyse willingness to pay and willingness to accept.

BACKGROUND: Price negotiations for specialty pharmaceuticals take place in a complex market setting. The determination of the added value of new treatments and the related societal willingness to pay are of increasing importance in policy reform debates. From a behavioural economics perspective, potential cognitive biases and other-regarding concerns affecting outcomes of reimbursement negotiations are of interest. An experimental setting to investigate social preferences in reimbursement negotiations for novel, oncology pharmaceuticals was used. Of interest were differences in social preferences caused by incremental changes of the patient outcome. METHODS: An online experiment was conducted in two separate runs (n = 202, n = 404) on the Amazon Mechanical Turk (MTurk) platform. Populations were split into two (run one) and four (run two) equally sized treatment groups for hypothetical reimbursement decisions. Participants were randomly assigned to the role of a public price regulator for pharmaceuticals (buyer) or a representative of a pharmaceutical company (seller). In run two, role groups were further split into two different price magnitude framings ("real world" vs unconverted "real payoff" prices). Decisions had real monetary effects on other participants (in the role of premium payers or investors) and via charitable donations to a patient organisation (patient benefit). RESULTS: 56 (run one) and 59 (run two) percent of participants stated strictly monotone preferences for incremental patient benefit. The mean incremental cost-effectiveness ratio (ICER) against standard of care (SoC) was higher than the initial ICER of the SoC against no care. Regulators stated lower reservation prices in the "real world" prices group compared to their colleagues in the unconverted payoff group. No price group showed any reluctance to trade. Overall, regulators rated the relevance of the patient for their decision higher and the relevance of their own role lower compared to sellers. CONCLUSIONS: The price magnitude of current oncology treatments affects stated preferences for incremental survival, and assigned responsibilities lead to different opinions on the relevance of affected stakeholders. The design is useful to further assess effects of reimbursement negotiations on societal outcomes like affordability (cost) or availability (access) of new pharmaceuticals and test behavioural policy interventions.

Use of medicines in São Paulo, Brazil, and State Health Care Coverage, 2003 and 2015

OBJECTIVES: To analyze the use and acquisition of medicines in São Paulo, Brazil, in 2003 and 2015, according to sociodemographic factors, socioeconomic status, and health conditions of the population. METHODS: Data were obtained from population health surveys "ISA-Capital". Descriptive analysis, bivariate analysis, and logistic regression models were used to evaluate the use of medicines and coverage by the Brazilian Unified Health System (SUS) according to socioeconomic status and health conditions in two periods: 2003 and 2015. RESULTS: From 2003 to 2015, the surveys showed an increase in the income and education level of the study population. There was no increase in the prevalence of chronic diseases and use of medicines from 2003 to 2015. The provision of medicines by SUS was higher in 2015 than in 2003, and the coverage by SUS was higher in the population with lower education level and income in both 2003 and 2015. CONCLUSIONS: The use of medicines, mainly for chronic disease control, did not change over the years, and there was an increase in SUS coverage for medicines during 2003-2015 in all population groups, with a greater impact on the lower socioeconomic status population. The programs of the provision of medicines implanted since 2003 had influenced the greater SUS coverage for medicines and in the reduction of inequalities in access to medicines.

Avaliação dos usuários sobre as farmácias públicas no Brasil / User evaluation of public pharmacy services in Brazil

Resumo O objetivo deste artigo é avaliar aspectos relacionados aos serviços prestados nas farmácias do SUS do Brasil, segundo a percepção dos usuários. Utilizou-se dados da Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos, realizada entre 2013 e 2014. Analisou-se indivíduos que obtiveram algum medicamento nas farmácias públicas. Para o cálculo das estimativas de prevalências, foi usado como denominador o total de usuários de medicamentos com IC95%. A partir da faixa etária de 20 a 24 anos até 60 a 64 anos observa-se diferenças significativas entre homens e mulheres, em relação ao uso de farmácias públicas. Mais de 30% das pessoas de todas as classes socioeconômica que não obtiveram medicamentos nas farmácias do SUS, nunca pensaram nessa possibilidade. Não costumam esperar para obtenção dos medicamentos e avaliação positiva do horário de funcionamento tiveram uma associação mais forte em relação a avaliação positiva dos usuários das farmácias do SUS. O horário de funcionamento e o tempo de espera são potenciais barreiras nas farmácias do SUS. A avaliação dos usuários que utilizam o SUS é positiva, mas aponta diferenças regionais e a identificação da magnitude dessas pode contribuir na formulação de políticas mais eficazes e equânimes.

Abstract Objective of this article is to evaluate aspects related to the services provided in SUS pharmacies in Brazil, according to users' perception. Data from the National Survey of Access, Use and Promotion of Rational Use of Medicines carried out between 2013 and 2014 were used. Individuals who obtained drugs from public pharmacies were analyzed. To calculate prevalence estimates, the total number of users of drugs with 95%CI was used as denominator. From the age group of 20 to 24 years up to 60 to 64 years, there were significant differences between men and women in terms of use of public pharmacies. More than 30% of people from all socioeconomic classes who did not obtain drugs from SUS pharmacies never thought about this possibility. Not having to wait much time to obtain the medication and a positive evaluation of the opening hours had a strong association with the positive evaluation of users of SUS pharmacies. Opening hours and waiting time are potential barriers in SUS pharmacies. The evaluation of users of SUS was positive, but it pointed to regional differences, and the identification of the magnitude of such differences can contribute to the planning of more effective and equitable policies.

Community pharmacists’ perceptions, awareness and practices regarding counterfeit medicines: a cross-sectional survey in Alexandria, Egypt

Background: Counterfeit medicines are a threat to public health and the national economy in Egypt. The many communi-ty pharmacists in the country could help prevent counterfeit medicines reaching the patient. Information on community pharmacists’ perceptions of counterfeit medicines is lacking.Aims: This study assessed the awareness, practices and perceptions of community pharmacists in Alexandria, Egypt with regard to counterfeit medicines. The aim was to identify gaps and inadequacies in pharmacy practice that might allow infiltration of counterfeit medicines in the legitimate medicine supply chain.Methods: A cross-sectional study was conducted of 175 community pharmacists in Alexandria in 2014–2015. A semi-struc-tured interview questionnaire was used to assess their perceptions, awareness and practices. The chi-squared test was used to assess the relationships between selected pharmacists’ characteristics and their awareness, purchasing practice and training related to counterfeit medicines.Results: Most pharmacists thought medicine counterfeiting was widespread in Egypt and that they could contribute to combatting the problem. However, most also lacked a clear perception of counterfeit medicines, an awareness of their danger to patients or the legislation to reduce them. Their procurement practices and detection of counterfeit medicines and handling of incidents of counterfeit medicines were inadequate. Pharmacists who thought counterfeit medicines were widespread or a health threat were significantly more likely to purchase medicines from certified sources (P < 0.05).Conclusion: Pharmacists should be developed as a frontline resource to combat counterfeit medicines. To enhance their role, the pharmacy curriculum needs to be updated and continuing professional development activities mandated.

Contexte : La contrefaçon de médicament constitue une menace pour la santé publique et l’économie nationale en Égypte. Les nombreux pharmaciens d’officine du pays pourraient contribuer à empêcher les médicaments contrefaits de parvenir jusqu’aux patients. Les informations relatives aux perceptions des pharmaciens d’officine quant à la contrefaçon de médicament font défaut. Objectifs : La présente étude visait à évaluer les perceptions, les connaissances et les pratiques des pharmaciens d’officine d’Alexandrie (Égypte) à l’égard des médicaments contrefaits. L’objectif était d’identifier les lacunes et les insuffisances dans la pratique pharmaceutique susceptibles de permettre l’infiltration de médicaments contrefaits dans la chaîne d’approvisionnement des médicaments licites. Méthodes : Une étude transversale a été menée auprès de 175 pharmaciens d’officine à Alexandrie durant la période comprise entre 2014 et 2015. Un questionnaire d’entretien semi-structuré a été utilisé pour évaluer leurs perceptions, connaissances et pratiques. Le test khi carré a été utilisé pour évaluer les liens entre les caractéristiques de certains pharmaciens et leurs connaissances, leurs pratiques d’achat et leur formation en association avec les médicaments contrefaits. Résultats : La plupart des pharmaciens pensaient que la contrefaçon de médicament était répandue en Égypte et qu’ils pouvaient contribuer à lutter contre ce problème. Cependant, ils n’avaient pas non plus pour la plupart de perception claire de la contrefaçon de médicament, de connaissance du danger qu’elle représente pour les patients, ni de la législation en vigueur pour la limiter. Par ailleurs, leurs pratiques d’approvisionnement en médicaments, leur détection des médicaments contrefaits et leur gestion des incidents relatifs à la contrefaçon de médicament étaient inadaptées. Les pharmaciens qui pensaient que les médicaments contrefaits étaient répandus ou représentaient une menace pour la santé étaient beaucoup plus susceptibles d’acheter les médicaments auprès de sources certifiées (p < 0,05). Conclusion : Les pharmaciens devaient être placés en première ligne de lutte contre la contrefaçon de médicament. Pour renforcer leur rôle, le programme d’études de pharmacie doit être mis à jour, et des activités de formation professionnelle continue doivent être rendues obligatoires.

Variations in non-prescription drug consumption and expenditure: Determinants and policy implications.

This paper analyses the determinants of cross-regional variations in expenditure and consumption for non-prescription drugs using the Italian Health Care Service as a case study. This research question has never been posed in other literature contributions. Per capita income, the incidence of elderly people, the presence of distribution points alternative to community pharmacies (para-pharmacies and drug corners in supermarkets), and the disease prevalence were included as possible explanatory variables. A trade-off between consumption of non-prescription and prescription-only drugs was also investigated. Correlation was tested through linear regression models with regional fixed-effects. Demand-driven variables, including the prevalence of the target diseases and income, were found to be more influential than supply-side variables, such as the presence of alternative distribution points. Hence, the consumption of non-prescription drugs appears to respond to needs and is not induced by the supply. The expected trade-off between consumption for prescription-only and non-prescription drugs was not empirically found: increasing the use of non-prescription drugs did not automatically imply savings on prescription-only drugs covered by third payers. Despite some caveats (the short period of time covered by the longitudinal data and some missing monthly data), the regression model revealed a high explanatory power of the variability and a strong predictive ability of future values.

Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. CONTEXT: Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. METHODS: We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. FINDINGS: The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. CONCLUSIONS: Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States.

Coordinación entre servicios farmacéuticos para una farmacoterapia integrada: el caso de Cataluña / Coordination between pharmaceutical services for integrated pharmacotherapy: the case of Catalonia

Resumen Las políticas farmacéuticas han sido consideradas como estratégicas para contribuir con la garantía de la coordinación asistencial y la integración clínica. El presente estudio tiene como objetivo describir los servicios farmacéuticos desarrollados en diferentes niveles asistenciales en la red de salud de Cataluña, así como identificar y analizar los mecanismos e instrumentos que actúan como facilitadores y/o barreras para la coordinación de la farmacoterapia. Se trata de un estudio descriptivo de 12 casos de los servicios farmacéuticos hospitalarios, atención primaria y oficinas de farmacia comunitarias. Se identifica avances que relacionan la percepción, formalización y la coordinación asistencial y clínica de los servicios farmacéuticos. Sin embargo, se identifican también fragilidades y situaciones mejorables en cuanto a la coordinación. Se concluyó que las diferentes herramientas e instrumentos implantados, parece facilitar una mayor posibilidad de integración entre servicios farmacéuticos y de éstos con la red de salud para contribuir con una farmacoterapia integrada.

Abstract Pharmaceutical policies have been considered strategies to contribute to the guarantee of care coordination and clinical integration. This study sought to describe the pharmaceutical services developed at different levels of care in the health network in Catalonia, as well as to identify and analyze the mechanisms and instruments that act as facilitators and/or barriers to the coordination of pharmacotherapy. This is a descriptive study of 12 cases of hospital pharmacy services, primary care and community pharmacies. Advances related to the perception, formalization and clinical and assistance coordination of the pharmaceutical services were identified. However, weaknesses and potential improvements in coordination were observed. The conclusion drawn was that the different tools and instruments implemented appear to facilitate a greater possibility of integration between pharmaceutical services and the latter with the health services network to contribute to integrated pharmacotherapy.

Applying a health system perspective to the evolving Farmácia Popular medicines access programme in Brazil.

The Farmácia Popular Program (FPP) launched a subsidy system in Brazil, but in coexistence with the ongoing regular governmental access to medicines (Unified Health System (SUS) dispensings) mechanisms, causing overlaps in terms of financing and target population. This characteristic is quite different from most countries with medicines cost-sharing schemes. This paper aims to analyse the FPP under a health systems perspective considering the different health system levels. We analysed the findings from the study 'Impact of consecutive subsidies policies on access to and use of medicines in Brazil - ISAUM-Br', designed with the objective of describing and evaluating the impact of the government medicines subsidy policies implemented between 2004 and 2011. Patient share of copayment increased with the implementation of the intervention, which decreased the reference price and decreased with SNP (Saúde Não Tem Preço; zero copayment for patients). There was an increased number of FPP dispensations over time, but SUS dispensings remained the most important source for medicines, especially for hypertension and diabetes. FPP allowed the establishment of a well-designed pharmaceutical information system in the country. Despite the improvement on control mechanism, fraud remained a problem. There were important effects on the pharmaceutical market and sales of generic medicines. FPP has proven to be a very important policy for promoting access to medicines for hypertension and diabetes in Brazil. Examining this policy with a health system perspective has allowed us to highlight many of its important consequences, including for the first time a broad and consistent information system on access to medicines in the country.

The simultaneous effects of pharmaceutical policies from payers' and patients' perspectives: Italy as a case study.

OBJECTIVES: This paper aims at covering a literature gap on the effects of copayments, prescription quotas and therapeutic reference pricing on public and private expenditures and volumes (1) When these policies are implemented in different areas at different times, (2) estimating their impact in the short and long run, (3) assessing the extent to which these impacts are interdependent, (4) scrutinising the extent to which the effects are mediated by prescribers' and patients' behaviours. METHODS: Monthly regional data on pharmaceutical expenditures, volumes and policies in Italy from 2000 to 2014 are analysed using a difference-in-differences model enriched to capture short- versus long-term effects and simultaneous and interactive effects. Sobel-Goodman test and bootstrap analyses were used to test for mediation. RESULTS: The three policies have different short- and long-run effects. Interactions support the hypothesis of reinforcing effects. Behavioural reactions to policies such as reducing the demand or total per capita expenditures mediate the impact of policies, thus explaining the different effects between the short and long term. CONCLUSIONS: Evidence on the impact over time of regional policies diversely introduced in different times have important policy implications. First, pharmaceutical policies interact with each other, and the combined effect may be different from what we would expect from the sum of each single policy. Hence, policymakers should be very careful in designing mixed policies for their unexpected combined effects. Second, the impact of policies tends to reduce over time. If longer-term impact is desired, it would be appropriate to introduce some adjustments over time. Third, policies have multiple effects, and this should be considered when they are designed. Finally, pharmaceutical policies may have an unintended impact on health and health care.

The relevance of systematic reviews on pharmaceutical policy to low- and middle-income countries.

BACKGROUND: Low- and middle-income countries (LMICs) rely on available evidence when devising and implementing pharmaceutical policies. Aim of the review To provide a critical overview of systematic reviews of pharmaceutical policies, with particular focus on the relevance of such reviews in low- and middle-income countries. METHODS: A search for systematic reviews (SRs) of studies of the interventions of interest was conducted until May 2009 in MEDLINE, EconLit, CINAHL, the Cochrane site, ProQuest, EMBASE, JOLIS, ISI Web of Science, International Pharmaceutical Abstracts, International Network for Rational Use of Drugs, National Technical Information Service, Public Affairs Information Service, SourceOECD, the System for Information on Grey Literature in Europe, and the WHO library database. The search was updated to July 2013, based on the yields of the initial search strategy. RESULTS: 20 SRs that met all inclusion criteria were retrieved in full text. Four SRs were subsequently rejected on the basis of quality considerations and the findings of 16 SRs were extracted and their applicability in LMICs considered. Of these, 5 were Cochrane Reviews. All included SRs were published in English. SRs related to registration and classification policies, marketing policies, prescribing policies, reimbursement policies, policies on price and payments, co-payments and caps and multi-component policies were retrieved. No SRs related to patent and profit policies, sales and dispensing policies, policies that regulate the provision of health insurance, or policies on patient information were retrieved. CONCLUSION: Only one of the systematic reviews retrieved utilised a study conducted in a developing country. The direct applicability of the evidence from these SRs in LMICs is limited. However, as middle-income countries move towards universal health coverage, the multi-component policies that govern reimbursement for medicines, and which impose caps on payments and co-payments by patients, may become more applicable. As such they will have direct implications for the practice of clinical pharmacy in such settings. Considerable effort will be needed to systemically review the available primary evidence from studies conducted in developing country settings, where such data exist.

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives.

Paediatric psychopharmacology holds great promise in two equally important areas of enormous biomedical and social impact, namely the treatment of behavioural abnormalities in children and adolescents, and the prevention of psychiatric disorders with adolescent- or adult-onset. Yet, in striking contrast, pharmacological treatment options presently available in child and adolescent psychiatry are dramatically limited. The most important currently unmet needs in paediatric psychopharmacology are: the frequent off-label prescription of medications to children and adolescents based exclusively on data from randomized controlled studies involving adult patients; the frequent lack of age-specific dose, long-term efficacy and tolerability/safety data; the lack of effective medications for many paediatric psychiatric disorders, most critically autism spectrum disorder; the scarcity and limitations of randomized placebo-controlled trials in paediatric psychopharmacology; the unexplored potential for the prevention of psychiatric disorders with adolescent- and adult-onset; the current lack of biomarkers to predict treatment response and severe adverse effects; the need for better preclinical data to foster the successful development of novel drug therapies; and the effective dissemination of evidence-based treatments to the general public, to better inform patients and families of the benefits and risks of pharmacological interventions during development. Priorities and strategies are proposed to overcome some of these limitations, including the European Child and Adolescent Clinical Psychopharmacology Network, as an overarching Pan-European infrastructure aimed at reliably carrying out much needed psychopharmacological trials in children and adolescents, in order to fill the identified gaps and improve overall outcomes.

Investigating the Economic Impacts of New Public Pharmaceutical Policies in Greece: Focusing on Price Reductions and Cost-Sharing Rates.

OBJECTIVE: Since 2010, cost-containment efforts in Greece focused on the reduction of public pharmaceutical expenditure. Changes in cost-sharing levels, reductions in prices, and generic substitution are some of the measures implemented after the second quarter of 2012. The objective of this study was to investigate the economic impact of the measures on public funds and households. METHODS: Data on volume and value for prescribed drugs for each therapeutic category and cost-sharing levels were obtained from the National Organization for Health Care Services Provision (EOPYY), the main reimbursement agency covering 95% of the population. Four different periods were compared, taking into consideration the implementation of different regulation, data availability, and disease seasonality. The periods compared were January-March 2012 versus January-March 2013 and April-August 2012 versus April-August 2013. RESULTS: In 2013, only 8% of prescribed drug boxes were provided with 0% cosharing arrangement versus 13% in 2012. Α 25% cost-sharing level was imposed on 77% of the prescribed medicines in 2013 compared with 53% in 2012. Consequently, the mean cost-sharing burden for pharmaceuticals in 2013 was estimated at 18% versus 13.3% in 2012. The average price per package declined in 2013 by 28%, from €17.8 in 2012 to €12.8 in 2013. Major (>50%) savings were achieved in cardiovascular and nervous system drugs, accounting in volume for almost 60% of total pharmaceutical consumption. CONCLUSIONS: The economic results of the measures for third-party payers were positive. The measures, however, should be reconsidered and examined more closely considering social effects, such as accessibility, especially for vulnerable groups in need of essential pharmaceutical care.