Suchergebnisse

The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries. The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs. The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing regulatory affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company's regulatory affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO. This survey indicated that outsourcing in regulatory affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in regulatory affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present. ; Peer reviewed

Background: The study was carried out as part of the European Network for Patient Safety (EUNetPas) project in 2008-2010. Objective: To investigate facilitators and barriers in implementation process of selected medication safety practices across hospitals within European Union countries. Methods: This was an implementation study of seven selected medication safety practices in 55 volunteering hospitals of 11 European Union (EU) member states. The selected practices were: two different versions of medicine bed dispensation; safety vest; discharge medication list for patients; medication reconciliation at patient discharge; medication reconciliation at patient admission and patient discharge, and sleep card. The participating hospitals submitted an evaluation report describing the implementation process of a chosen practice in their organisation. The reports were analysed with inductive content analysis to identify general and practice-specific facilitators and barriers to the practice implementation. Results: Altogether 75 evaluation reports were submitted from 55 hospitals in 11 EU member states. Implementation of the medication safety practices was challenging and more time consuming than expected. The major reported challenge was to change the work process because of the new practice. General facilitators for successful implementation were: existence of safety culture, national guidelines and projects, expert support, sufficient resources, electronic patient records, interdisciplinary cooperation and clinical pharmacy services supporting the practice implementation. Conclusions: The key for the successful implementation of a medication safety practice is to select the right practice for the right problem, in the right setting and with sufficient resources in an organization with a safety culture. ; Peer reviewed

Background: Multi-dose dispensing (MDD) of medications is a health technology designed to promote medication adherence and patient safety. MDD has been used as an alternative to ordinary prescription dispensing for patients, mostly elderly with high medication use. Objective: To evaluate the initiation phase of the MDD service to older adults >= 65 years and assess wheter the medication use of the new MDD patients is appropriate in terms of drug related problems. Methods: The European Union EU(7)-PIM list and the Inxbase databases were used for identifying potentially inappropriate medications (PIMs) and drug-drug interactions (DDIs). The study sample consisted of a total of 208 patients aged 65-108 years who were involved in the MDD service (PharmaService Ltd.) in Finland in 2015-2016. Clinically significant differences of PIM and DDI occurrences were identified using a Pearson's chi-square test throughout the demographic groups under study. Results: Results demonstrate that for 81% of the study participants, at least one medication from the EU (7)-PIM list was prescribed, and up to 64% of PIMs were clinically significant. According to the Inxbase database, five patients (2.4%) were prescribed category D clinically significant DDIs. Additionally, 61% of the patients saw an increase in the number of medications prescribed within six months after the initial MDD order. Conclusions: The results suggest that the MDD service should be accompanied by a regular medication review tailored to specific patient groups (i.e., older patients) to avoid potential DRPs. ; Peer reviewed

Objective: The Finnish Medicines Agency (Fimea) initiated a programme in 2012 for enhancing interprofessional networking in the medication management of the aged. The goal is to develop national guidelines for interprofessional collaboration with respect to medication management. This study aims to explore the challenges and potential solutions experienced by existing health care teams in managing medication of the aged: (1) at the individual and team level (micro level), (2) organisational level (meso level) and (3) structural level (macro level). Design: Group discussions (n = 10), pair (n = 3) and individual interviews (n = 2). Abductive content analysis combining data and theory was applied. Networking was used as a theoretical framework. Setting: Meetings (n = 15) organised by Fimea in the formation phase of the interprofessional network in 2012. Subjects: Health care professionals (n = 55). Main outcome measures: Challenges and solutions in the medication management of the aged at the micro, meso and macro levels. Results: Challenges in interprofessional collaboration, problems with patient record systems, and the organisation of work and lack of resources were present at all the levels contributing to patients' medication problems. Participants suggested multiple potential solutions to improve interprofessional collaboration, sharing of tasks and responsibilities, better exploitation of pharmaceutical knowledge and developing tools as being the most commonly mentioned. Conclusions: Optimising medication use of the aged requires new systemic solutions within and between different system levels. The main challenges can be solved by clarifying responsibilities, enhancing communication and applying operational models that involve pharmacists and the use of information technology in medication management.KEY POINTSAn interprofessional team approach has been suggested as a solution to promote rational medicine use among the aged.Fragmented health care system and lack of coordinated patient care are reasons for medication related problems of the aged.Challenges in the implementation of interprofessional collaboration in medication management appear in legislation, information systems, operational models and individuals' attitudes.Optimising medications requires better interprofessional networking and new systemic solutions within and between macro, meso and micro levels. ; Peer reviewed

Finland's community pharmacy system provides an example of a privately-owned regulated system being proactively developed by the profession and its stakeholders. Community pharmacists have a legal duty to promote safe and rational medicine use in outpatient care. The development of professionally oriented practice has been nationally coordinated since the 1990s with the support of a national steering group consisting of professional bodies, authorities, pharmacy schools and continuing education centers. The primary focus has been in patient counseling services and public health programs. The services have extended towards prospective medication risk management applying evidence-based tools, databases and digitalization. Research has been essential in informing progress by indicating high-risk patients, medications, practices and processes needing improvement. Despite the commitment of the profession and pharmacy owners, large-scale implementation of services has been challenging because of lack of remuneration, the pharmacy income still consisting primarily of sale of prescription and nonprescription medicines. Policy documents by the Ministry of Social Affairs and Health have supported the extension of the community pharmacists' role beyond traditional dispensing to promote rational pharmacotherapy. The current roadmap by the Ministry of Social Affairs and Health emphasizes ensuring adequate regional availability and accessibility of medicines, regardless of the future pharmacy system. It also emphasizes the importance of strong regulation on pharmacy business operations and sale of medicines to ensure medication safety. At the same time, the roadmap requires that the regulation must enable implementation of new patient-oriented services and procedures, and further promote digitalization in service provision. Competition and balance of funding should be enhanced, e.g., through price competition, but the risk of pharmaceutical market concentration should be managed. The regulation should also consider influence of the new social and health care system on drug delivery. Year 2021 will be crucial for making long-term political decisions on the future direction of tasks and finances of Finnish community pharmacies in this framework. Government-funded studies are underway to guide decision making. Ongoing Covid-19 crisis has demonstrated the readiness of Finnish community pharmacies to adapt fast to meet the changing societal needs. ; publishedVersion ; Peer reviewed

Background Biosimilars are expected to decrease growing health care expenditures. Given that uptake of biosimilars has been modest, automatic substitution has been suggested to increase their use, but the practice is not yet allowed or implemented in many jurisdictions. Methods A systematic review was performed by searching databases Scopus, Medline (Ovid), CINAHL, and Web of Science. Peer-reviewed, original studies written in English and published during the period January 1, 2006 to April 24, 2021 reporting any interventions, pilots or any other studies including experiences or perceptions of any relevant stakeholders on automatic substitution of biologics were included without limitation by setting or geography. The quality of the included studies were evaluated by pre-determined criteria. Results Altogether, 27 studies fulfilled the inclusion criteria, of which 23 were surveys, and four semi-structured interviews reporting mainly stakeholders' perceptions on automatic substitution. Most of the studies (56%, 15/27) were from Europe. Studies were conducted among prescribers (n = 12), pharmacists (n = 5), patients (n = 4), payers (n = 1), and mixed stakeholders (n = 5). The primary objective of the majority (81%, 22/27) of the studies was to investigate some other biosimilar topic than automatic substitution. The reported perceptions of substitution were mainly negative. Studies evaluating risks, safety or effectiveness, or reporting real-life experiences of biologic substitution were lacking except one intervention and two prospective risk management studies. The overall quality of the studies was low to moderate, and the results were not generalizable due to convenience sampling not representing the populations of interest, and low response rates. Conclusions The current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation. ; Peer reviewed