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- Druedahl, Louise C., et al.
(författare)
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Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
- 2021
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Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361
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Tidskriftsartikel (refereegranskat)abstract
- Background A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. Objective The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. Methods Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
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- Druedahl, Louise C., et al.
(författare)
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Interchangeability of biosimilars : A study of expert views and visions regarding the science and substitution
- 2022
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 17:1
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Tidskriftsartikel (refereegranskat)abstract
- Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.
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- Druedahl, Louise C, et al.
(författare)
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Managing Complexity : Exploring Decision Making on Medication by Young Adults with ADHD.
- 2018
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Ingår i: Pharmacy. - : MDPI AG. - 2226-4787. ; 6:2
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Tidskriftsartikel (refereegranskat)abstract
- Attention-deficit hyperactivity disorder (ADHD) causes difficulties with hyperactivity, impulsivity and inattention. Treatment of ADHD includes both medication and non-pharmacological options. Knowledge of treatment preferences by young adults with ADHD is sparse. The objective of this study was to explore the beliefs and experiences of young adults with ADHD related to their medication treatment decisions. Data were collected in Denmark in 2016 through a focus group and individual in-depth interviews. Conventional content analysis was used. Ten young adults with ADHD (22-to 29-year-old) participated. Three major themes were identified: (1) the patient’s right to choose concerning ADHD medicine; (2) the patient’s decision of whether or not to treat ADHD with medication; and (3) factors affecting the patient’s decision on whether to take ADHD medication or not. The latter theme contained 15 factors, which were distributed across three levels: individual, between-individuals, and societal. The dominant factors were increasing quality of life and improving oneself e.g., improving social skills. For counselling at the pharmacy and by prescribers, it is important to be aware of the different factors that affect young adult patients’ decisions on whether to take ADHD medication or not. This knowledge will aid to understand reasons for non-adherence and to determine appropriate treatment for the individual patient.
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- Eidhammer Rognan, Stine, et al.
(författare)
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'The way you talk, do I have a choice?' : Patient narratives of medication decision-making during hospitalization
- 2023
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Ingår i: International Journal of Qualitative Studies on Health and Well-being. - : Taylor & Francis. - 1748-2623 .- 1748-2631. ; 18:1
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Tidskriftsartikel (refereegranskat)abstract
- ObjectiveBased on the principle of the autonomy of the patient, shared decision-making (SDM) is the ideal approach in clinical encounters. In SDM, patients and healthcare professionals (HCPs) share knowledge and power when faced with the task of making decisions. However, patients are often not involved in the decision-making process. In this study, we explore medication decision-making during hospitalization and how power in the specific patient—HCP relationship is articulated, as analysed by Foucauldian theory.MethodsA qualitative case study, comprising observations of patient-HCP encounters at an internal medicines ward at a university hospital in Norway, followed by semi-structured interviews. The narratives (n = 4 patients) were selected from a larger study (n = 15 patients). The rationale behind the choice of these patients was to include diverse and rich accounts. The four patients in their 40s–70s were included close to the day of presumed discharge.ResultsThe narratives provide an insight into the patients as persons, their perspectives, including what mattered to them during their hospitalization, especially in relation to medications. Overall, SDM was not observed in this study. Even though all the participants actively tried to keep their autonomous capacity and to resist the HCPs’ use of power, they were not able to change the established dynamics. Moreover, they were not allowed an equal voice to those of HCPs and thus not to escape the system’s objectification and subjectification of them.ConclusionThere is a need for HCPs to get more familiarized with SDM. The healthcare system and the individual HCP need to make more room for dialogue with the patients about their preferences. A part of this is also how health care systems are structured and scheduled, thus, it is important to empower patients and HCPs alike.
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- Kaae, Susanne, et al.
(författare)
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The antibiotic knowledge, attitudes and behaviors of patients, doctors and pharmacists in the WHO Eastern European region - a qualitative, comparative analysis of the culture of antibiotic use in Armenia, Georgia, Kazakhstan, Moldova, Russia and Tajikistan.
- 2020
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Ingår i: Research in Social and Administrative Pharmacy. - : Elsevier BV. - 1551-7411 .- 1934-8150. ; 16:2, s. 238-248
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: To reduce antimicrobial resistance (AMR), initiatives such as surveillance activities and activities to increase knowledge about how and why antibiotics (ABs) are (mis)used are needed. More surveillance systems are in place in the WHO Western European region than in the Eastern region, and only sparse knowledge exists about the current culture of AB use in the Eastern European countries.OBJECTIVE: To investigate AB knowledge, attitudes and behaviors in countries in the WHO Eastern European region in order to identify overall similarities and differences across the region and how AB knowledge, attitudes and behavior patterns may be influenced by the national health care system.METHODS: Semi-structured interviews were conducted in Armenia, Georgia, Kazakhstan, Moldova, Russia and Tajikistan with patients, doctors and pharmacists. In total, 80 interviews were carried out. A directed content analysis was applied, followed by a comparative analysis, identifying the similarities and differences in AB attitudes, knowledge and behaviors between the countries and discussing how the national health care systems might influence these patterns.RESULTS: Cross-national patterns were identified regarding patients seeking ABs over-the-counter (OTC), patient variations in their requests for ABs when consulting doctors, and, finally, doctors and pharmacists appearing knowledgeable about ABs and their uses, with doctors displaying careful attitudes towards AMR. Indications of national differences between the countries included the ability of patients to afford ABs, prescribing practices of doctors and pharmacist attitudes towards selling ABs without prescriptions. Multiple aspects involved in patient and pharmacist AB decision making were detected, such as various rationales involved in buying/selling ABs OTC, implying that these processes are more complex than previously reported in the literature.CONCLUSIONS: Similarities across the Eastern European region could be seen in patient needs and uses of antibiotics obtained OTC at community pharmacies, whereas doctors appeared more influenced by specific structures of the national healthcare system.
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