New pricing models for generic medicines to ensure long-term sustainable competition in Europe.

Background: Price erosion of generic medicines over time as a result of existing pricing policies in combination with increasing operational costs of these products due to high inflation, undermine long-term sustainable competition in European off-patent medicines markets. Therefore, the aim of this study is to identify new potential pricing models for retail generic medicines in Europe, examine their pros and cons, and illustrate them with examples inside or outside the pharmaceutical sector. Methods: A targeted literature review, one-to-one interviews and a joint advisory board meeting with experts from five European countries were carried out to assess potential pricing models for generic medicines. Results: We identified ten pricing models that can be applied to generic medicines. The tiered pricing model is viewed as a sustainable solution ensuring competitiveness, but requires market monitoring using a supportive IT infrastructure. De-linking the price of generic medicines from that of the off-patent originator medicine prevents the originator from forcing generic medicines' prices to unsustainable levels. Higher costs due to inflation can be compensated in the automatic indexation model. Other pricing models that have less implementation potential include the one-in-one/multiple-out model, tax credits, value-based pricing, volume for savings and guaranteed margin/fee models. The hypothecated tax and cost allocation models, which add a patient fee to generic medicines prices, are not likely to be socially acceptable. Conclusion: When considering a new pricing model for generic medicines, the impact on innovative medicines and the characteristics of the healthcare system in a given country need to be taken into account. Also, there is a need to continuously follow up the level of competition in off-patent medicines markets and to identify sustainability risks.

Exploring barriers and facilitators to pharmacist-provided diabetes self-management education and support.

BACKGROUND: Pharmacists have the necessary clinical experience and medication knowledge to effectively provide diabetes self-management education and support (DSMES); however, barriers exist to DSMES implementation by community pharmacists. OBJECTIVE: The aim of this study is to explore DSMES from the community pharmacists' perspectives, identify barriers and facilitators to pharmacist DSMES implementation, and guide development of pharmacist-provided DSMES programs in Idaho. METHODS: Implementation climate, the theoretical framework for this project, is focused on how community pharmacists in Idaho perceive they will be supported by patients, health care providers, and insurers in DSMES implementation. Pharmacist investigators with qualitative research experience conducted semistructured interviews with 6 licensed community pharmacists from Idaho via Zoom between March and June 2020. Recordings were transcribed verbatim and analyzed using HyperRESEARCH 4.5.1. Themes, patterns, and dominant concepts that emerged from respondents' about DSMES were explored, labeled, and categorized into modifiable and nonmodifiable barriers and facilitators. This study was granted expedited approval by the Idaho State University Investigational Review Board. RESULTS: Relevant themes included current scope of practice, barriers, and facilitators. Subthemes related to the current scope of pharmacy practice included unclear roles and responsibilities and legislative constraints to practice. For barriers, subthemes included cost of set-up, billing and coding education, and the sustainability of services based on current reimbursement models. For facilitators, subthemes included the need for additional collaborations (external and internal), technology access, and trained pharmacy staff. CONCLUSION: Pharmacists are underutilized health care providers, capable of providing DSMES services if provided the necessary resources. This work identifies barriers and facilitators to pharmacist-led DSMES that can be considered by others when implementing DSMES or other disease management services.

Interactions of Antiretroviral Drugs with Food, Beverages, Dietary Supplements, and Alcohol: A Systematic Review and Meta-analyses.

Multiple factors may affect combined antiretroviral therapy (cART). We investigated the impact of food, beverages, dietary supplements, and alcohol on the pharmacokinetic and pharmacodynamic parameters of 33 antiretroviral drugs. Systematic review in adherence to PRISMA guidelines was performed, with 109 reports of 120 studies included. For each drug, meta-analyses or qualitative analyses were conducted. We have found clinically significant interactions with food for more than half of antiretroviral agents. The following drugs should be taken with or immediately after the meal: tenofovir disoproxil, etravirine, rilpivirine, dolutegravir, elvitegravir, atazanavir, darunavir, lopinavir, nelfinavir, ritonavir, saquinavir. Didanosine, zalcitabine, zidovudine, efavirenz, amprenavir, fosamprenavir, and indinavir should be taken on an empty stomach for maximum patient benefit. Antiretroviral agents not mentioned above can be administered regardless of food. There is insufficient evidence available to make recommendations about consuming juice or alcohol with antiretroviral drugs. Resolving drug-food interactions may contribute to maximized cART effectiveness and safety.

RESUMEN: Múltiples factores pueden afectar la terapia antirretroviral combinada (cART). Investigamos el impacto de los alimentos, las bebidas, los suplementos dietéticos y el alcohol en los parámetros farmacocinéticos y farmacodinámicos de 33 medicamentos antirretrovirales. Se realizó la revisión sistemática en apego a las guías PRISMA, con 109 reportes de 120 estudios incluidos. Para cada fármaco se realizaron metanálisis o análisis cualitativos. Hemos encontrado interacciones clínicamente significativas con alimentos para más de la mitad de los fármacos antirretrovirales. Los siguientes medicamentos deben tomarse durante o inmediatamente después de comer: tenofovir, disoproxil, etravirina, rilpivirine, dolutegravir, elvitegravir, atazanavir, darunavir, lopinavir, nelfinavir, ritonavir, saquinavir. Didanosina, zalcitabina, zidovudina, efavirenz, amprenavir, fosamprenavir e indinavir deben tomarse con el estómago vacío para obtener el máximo beneficio para el paciente. Los fármacos antirretrovirales no mencionados anteriormente se pueden administrar independientemente de los alimentos. No hay suficiente evidencia disponible para hacer recomendaciones sobre el consumo de jugo o alcohol con medicamentos antirretrovirales. Resolver las interacciones entre medicamentos y alimentos puede contribuir a maximizar la eficacia y la seguridad de cART.