Medicines Delivery Proximity Programme (PEMProxi) survey results.

OBJECTIVES: To evaluate patients' and community pharmacies' satisfaction towards the Medicines Delivery Proximity Programme (PEMProxi), including patients' level of satisfaction with pharmaceutical services, medication dispensing and delivery, cost, and time saved, community pharmacies' satisfaction with PEMProxi-related information and procedures, contact with the patients, and timings. Additionally, to evaluate patients' and community pharmacies' perception of PEMProxi's advantages and disadvantages. METHODS: Patients and the community pharmacies included in PEMProxi were contacted by telephone to answer a survey. The patient survey included questions regarding their satisfaction level towards PEMProxi, medication dispensing and delivery, and cost and time saved. Patients were also asked to point out the advantages and disadvantages of PEMProxi and give improvement suggestions. The community pharmacy survey included questions regarding satisfaction with entering PEMProxi, related information, procedures, contact with the patients on PEMProxi, and timings. Programme-related advantages, disadvantages and improvement suggestions were also solicited. RESULTS: A total of 101 patients and 49 community pharmacies were included in the analysis. A large majority of patients were very satisfied with PEMProxi (93.1%). The Programme allowed each patient to save on average 30€ and 8 hours per month. More than 95% of the patients reported medication delivery in adequate conditions (n=100), in a timely manner (n=95) and according to the prescription (n=95). Most pharmacies were satisfied or very satisfied with their participation in PEMProxi (63.3%). Nearly half (53.1%) were surprised by its implementation and 98% would be available to participate with more patients if the Programme was extended. CONCLUSIONS: The PEMProxi programme contributed to more convenient and equitable access to medications by chronic patients, thus avoiding unnecessary trips to the hospital, saving them precious time and money.

[Correction to the article "Medication Reconciliation During Admission to an Internal Medicine Department: A Pilot Study", Published as Ahead of Print on Acta Med Port 2022.] / Errata ao artigo "Reconciliação Terapêutica na Admissão de um Serviço de Medicina Interna: Estudo-Piloto", Publicado em Ahead of Print em Acta Med Port 2022.

Na página 9, Figura 2 onde se lê:73,53%Deverá ler-se:76,48%Artigo publicado com erros: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/16892.

[Medication Reconciliation During Admission to an Internal Medicine Department: A Pilot Study]. / Reconciliação Terapêutica na Admissão de um Serviço de Medicina Interna: Estudo-Piloto.

INTRODUCTION: The purpose of medication reconciliation is to promote patient safety by reducing medication errors and adverse events due to medication discrepancies in transition of care. The aim of this pilot study of medication reconciliation at the time of hospital admission was to identify the necessary resources for its implementation in clinical practice. MATERIAL AND METHODS: Pilot study with 100 patients admitted to an Internal Medicine department between October and December 2019, aged 18 and over, and chronically taking at least one medicine. The best possible medication history was obtained systematically, with subsequent identification, classification and resolution of the discrepancies. RESULTS: The study sample, in general characterized by polypharmacy and by having multiple long-term conditions, presented a mean age of 77.04 ± 13.74 years, being 67.0% male. Overall, 791 discrepancies were identified. Intentional discrepancies were 95.7% and 50.9% of them were documented. The difficulties encountered were mainly related with the access and quality of therapeutic information and communication problems between different healthcare professionals. The key priority resources that were identified were related with the process, tools, and personnel categories. CONCLUSION: The data revealed weaknesses in the clinical records available at the primary/hospital care interface. Optimization of data sources, standardization and informatization of the process, multidisciplinary approach and definition of priority groups were identified as opportunities for optimization.

Introdução: A reconciliação terapêutica visa promover a segurança do doente por meio da redução de erros de medicação e eventos adversos decorrentes de discrepâncias de medicação na transição de cuidados. Foi nosso objetivo realizar um estudo-piloto de reconciliação terapêutica no momento da admissão hospitalar para, a partir dele, identificarmos os recursos necessários para a sua implementação na prática clínica.Material e Métodos: Estudo-piloto com 100 doentes admitidos num serviço de Medicina Interna entre outubro e dezembro de 2019, com mais de 18 anos e a tomar cronicamente pelo menos um medicamento. A melhor história farmacoterapêutica possível foi obtida sistematicamente, com posterior identificação, classificação e resolução das discrepâncias.Resultados: A amostra em estudo, em geral polimedicada e com múltiplas morbilidades, apresentou uma média de idades de 77,04 ± 13,74 anos, sendo 67,0% do sexo masculino. Foram identificadas 791 discrepâncias e as intencionais (95,7%) estavam documentadas em 50,9% das situações. As dificuldades encontradas relacionaram-se principalmente com o acesso e a qualidade da informação terapêutica e com a dificuldade de comunicação entre os diversos profissionais de saúde. Os principais recursos prioritários identificados relacionaram-se com as categorias de processo, ferramentas e pessoal.Conclusão: Os dados revelaram fragilidades nos registos clínicos disponíveis na interface dos cuidados primários/hospitalares. A otimização das fontes de dados, normalização e informatização do processo, atuação multidisciplinar e definição de grupos prioritários foram identificadas como oportunidades de otimização.

Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.

Non-Biological Complex Drugs (NBCDs) are complex non-biological drugs comprised of large high molecular weight molecules and, often, nanoparticular structures (including liposomes and block-copolymer micelles). In the case of NBCDs, the entire complex is the active pharmaceutical ingredient and its properties cannot be fully characterized by physicochemical analysis. Moreover, the manufacturing process is fundamental in creating the correct originator product. The same is true for generic versions of the product. A recent appraisal of approval procedures for NBCDs "follow-on products" approved in Europe shows a diversity of regulatory pathways. In fact, three different abridged application procedures, under European legislation, were used: the generic application procedure of Article 10(1), the hybrid application procedure of Article 10(3), and the biosimilar application procedure of Article 10(4). Three informed consent applications via Article 10(c) from innovator companies of glatiramer acetate and sevelamer carbonate were submitted shortly after the approval of the first follow-on products. Furthermore, a number of "well-established use" applications [via Article 10(a)] were approved for iron sucrose and iron dextran complexes. In order to protect patients from the increased risks of NBCD products and NBCD follow-on products, two complementary approaches should be considered: (i) improving the regulatory procedures and their guidance documents within the pre-registration phase, and (ii) not considering interchangeability whenever clinical data is not available. With regards to the latter, the need for adequate safety and efficacy data might also include risk management programmes within post-approval pharmacovigilance actions. This, however, would depend on a risk appraisal that must be considered for individual medicinal products, based on the nature of the submitted relevant set of safety/efficacy data.