| 1. |
- Beer, Netta, et al.
(författare)
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Magistral Compounding with 3D Printing : A Promising Way to Achieve Personalized Medicine
- 2023
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Ingår i: Therapeutic Innovation and Regulatory Science. - : Springer Nature. - 2168-4790 .- 2168-4804. ; 57:1, s. 26-36
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Tidskriftsartikel (refereegranskat)abstract
- Background Magistral compounding has always been an integral part of pharmacy practice. The increasing demand worldwide for personalized drug treatments might be accommodated by an increase in magistral compounding. The new, flexible technology of 3D medicine printing could advance this process even further. However, the issue of how 3D medicine printing can be implemented within the existing magistral compounding infrastructure has not been explored. Aims To investigate how 3D printing can be integrated into the existing compounding system by taking regulatory, economic, and profession-oriented aspects into account. Methods Semi-structured interviews were conducted with relevant Dutch stakeholders representing various health institutions, such as health ministries and boards, professional bodies, and different types of pharmacies. Participants were identified through purposeful sampling. Content analysis was applied to identify the main themes. Results A total of 15 Dutch stakeholders were interviewed. It was found that the prevalence of compounding in community pharmacies in the Netherlands has decreased as a result of the practice shifting to specialized compounding pharmacies due to higher costs, lack of space, and the need to fulfill quality requirements. All interviewees considered 3D printing to be a promising compounding technique for community pharmacies, as it offers an automated approach with high digital flexibility and enables adapted formulations, including 'polypills.' Regulatory and quality assurance challenges were considered comparable to those of normal magistral products; however, there remain pending regulatory issues regarding quality control, particularly for Active Pharmaceutical Ingredients containing intermediate feedstock materials (e.g., prefilled cartridges) in 3D printing. 3D printing was believed to become cost effective over time. Conclusion In the Netherlands, specialized compounding pharmacies have largely taken over compounding activities. 3D printing could be introduced within this system; however, challenges regarding how to regulate prefilled cartridges have yet to be addressed. Compounding using 3D printing in regular community pharmacies could enhance patients' individualized treatment; however, this activity would require incentives to stimulate the return of compounding to normal pharmacy practice.
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| 2. |
- Beer, Netta, et al.
(författare)
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Scenarios for 3D printing of personalized medicines : A case study
- 2021
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Ingår i: Exploratory Research in Clinical and Social Pharmacy. - : Elsevier. - 2667-2766. ; 4
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Tidskriftsartikel (refereegranskat)abstract
- Background3D printing is a promising new technology for medicines' production. It employs additive manufacturing techniques, and is ideal for producing personalized medicines (e.g., patient-tailored dose, dosage form, drug release kinetics).ObjectiveTo investigate how 3D printing technologies can be implemented in a European pharmaceutical system, by suggesting different scenarios and assessing aspects that could affect its implementation.MethodQualitative, semi-structured interviews were conducted with key stakeholders (e.g., from ministry, authorities, research organizations, pharmacies) in the Netherlands to elicit perspectives on 3D printing of personalized medicines. The Netherlands were chosen since it has a strong tradition in compounding. Five general scenarios were investigated: placing the 3D printers in industry, community pharmacies, hospital pharmacies, compounding facilities, and in patients' homes. Content analysis was used, building on verbatim transcripts.ResultsFifteen stakeholders were interviewed. Regulatory, economic, ethical and organizational challenges were identified to varying degrees in the different scenarios. The industry and home scenarios were associated with the most challenges, hospital pharmacies and compounding facilities with the least. Other important aspects identified were the role of community pharmacies, and who should design the tablets to be printed.ConclusionAll potential scenarios for 3D printing of personalized medicines include challenges. These should be taken into account when pursuing the use of 3D printing of medicine.
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| 3. |
- Bengtsson, Kajsa Rebecka, et al.
(författare)
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Health literacy in medication communication during hospital discharge : a qualitative study at an internal medicines ward in Norway
- 2022
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 12:6
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Tidskriftsartikel (refereegranskat)abstract
- Objective When discharged from hospital patients are often assumed to have sufficient health literacy (HL) to participate in their medical treatment and manage medical self-care after discharge. However, limited HL is a widespread concern and patient participation during discharge is lacking. In this study, we explore how HL influences medication communication during hospital discharge.Design A qualitative case study, comprising unstructured observations of patient–healthcare personnel (HCP) encounters followed by semistructured interviews. Data were analysed using content analysis.Setting An internal medicines ward at a university hospital in Norway.Participant Fifteen patients aged 40–89 years were included close to the day of discharge.Results The following themes describing dimensions of HL emerged: (1) access, (2) understand, (3) appraise and (4) apply. Most patients sought access to medication information from HCP, while some felt dependent on HCP to provide it. However, their abilities to understand, evaluate and make informed decisions were challenged, partly because HCPs’ ability to adapt their communication to the patient’s knowledgebase varied.Conclusion The results give a broader understanding of how HL influences medication communication during hospital discharge. To consider central dimensions of HL is important to achieve optimal medication communication, as the communication only can be exercised within the frames of the patient’s HL. The findings in this study support that HL should be described as a shared responsibility between the patients and HCP. Attention should be focused to the HCP’s responsibility to adapt the communication to the patient’s knowledgebase.
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| 4. |
- Cam, Henrik, et al.
(författare)
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Failure to Involve Older Hospitalised Patients in Medication Decisions : A Change of Approach is Called For
- 2024
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Ingår i: Research in Social and Administrative Pharmacy. - : Elsevier. - 1551-7411 .- 1934-8150. ; 20:2, s. 216-217
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Tidskriftsartikel (refereegranskat)abstract
- Background: Patient involvement in medical-decision making is linked to improved patient outcomes and increased patient satisfaction.Objectives: The aim was to explore how hospitalised older patients are and wish to be involved in medication decisions affecting their medication therapy after hospital discharge.Methods: Naturalistic observations of consultations between healthcare professionals and hospitalised older patients who were about to be discharged were performed at in total three medical wards at two hospitals in Sweden. Subsequent semi-structured interviews with the patients were conducted within one week after discharge. The data were thematically analysed, guided by systematic text condensation.Results: Twenty patients were included (mean age: 81 (SD 8) years, 45 % female). Three themes were identified: 1) Predetermined authoritarian structures; describes that neither patients nor healthcare professionals expected patients to be involved in medication decisions. The medication decisions were frequently already taken by the healthcare professionals prior to the consultations, 2) Difficulties in finding the right time and setting; displays inhibitory factors in patient involvement in medication decisions when the consultations occur in hospital, and 3) Communication focusing on benefits over side-effects; demonstrates that newly prescribed medications were rarely accompanied with information about side-effects. Patients felt they lacked sufficient knowledge to take informed decisions about medications.Conclusions: There are structures limiting involvement of older patients in medication decisions prior to hospital discharge. A change in approach to consultations from both the patients and healthcare professionals is needed to provide patients with the knowledge they feel is needed to be sufficiently involved.
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| 5. |
- Cam, Henrik, et al.
(författare)
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The complexities of communication at hospital discharge of older patients : a qualitative study of healthcare professionals' views
- 2023
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Ingår i: BMC Health Services Research. - : BioMed Central (BMC). - 1472-6963. ; 23
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Tidskriftsartikel (refereegranskat)abstract
- Background: Hospital discharge of older patients is a high-risk situation in terms of patient safety. Due to the fragmentation of the healthcare system, communication and coordination between stakeholders are required at discharge. The aim of this study was to explore communication in general and medication information transfer in particular at hospital discharge of older patients from the perspective of healthcare professionals (HCPs) across different organisations within the healthcare system.Methods: We conducted a qualitative study using focus group and individual or group interviews with HCPs (physicians, nurses and pharmacists) across different healthcare organisations in Sweden. Data were collected from September to October 2021. A semi-structured interview guide including questions on current medication communication practices, possible improvements and feedback on suggestions for alternative processes was used. The data were analysed thematically, guided by the systematic text condensation method.Results: In total, four focus group and three semi-structured interviews were conducted with 23 HCPs. Three main themes were identified: 1) Support systems that help and hinder describes the use of support systems in the discharge process to compensate for the fragmentation of the healthcare system and the impact of these systems on HCPs' communication; 2) Communication between two separate worlds depicts the difficulties in communication experienced by HCPs in different healthcare organisations and how they cope with them; and 3) The large number of medically complex patients disrupts the communication reveals how the highly pressurised healthcare system impacts on HCPs' communication at hospital discharge.Conclusions: Communication at hospital discharge is hindered by the fragmented, highly pressurised healthcare system. HCPs are at risk of moral distress when coping with communication difficulties. Improved communication methods at hospital discharge are needed for the benefit of both patients and HCPs.
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| 6. |
- Cantarero-Arevalo, Lourdes, et al.
(författare)
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A Qualitative Analysis of the Culture of Antibiotic Use for Upper Respiratory Tract Infections Among Patients in Northwest Russia
- 2022
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Ingår i: Frontiers in Pharmacology. - : Frontiers Media S.A.. - 1663-9812. ; 13
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Due to the globally persistent threat of Antimicrobial Resistance (AMR), the purpose of this study was to gain an in-depth understanding of the antibiotic (AB) practices, knowledge and attitudes among patients residing in five regions in the northwest part of Russia. Given the high prevalence, this study focused on ABs for Upper Respiratory Tract Infections (URTI).Methods: The qualitative, semi-structured interviews followed a guide organized by major themes such as common symptoms, consultations with doctors and external influences in decision-making. Patient participants were recruited via convenience sampling. Fifty-five interviews were conducted among patients using ABs for URTIs purchased with or without prescription. Data was analyzed using a direct content analysis and validation rounds were conducted between interviewers and data analyzers.Results: Self-medication with ABs seemed a common practice across all five Russian regions; in some cases, patients tried to persuade pharmacists into selling them ABs without prescription. Factors, such as time spent going to the doctor, need of a sick leave or self-persuasion, influenced the decisions of whether or not to seek the doctor for symptoms of URTIs. Knowledge of ABs and AMR was generally low; however, some patients with seemingly good knowledge practiced self-medication from time to time. Family members and friends were often involved in decisions about how to handle symptoms of URTIs, especially among those patients using ABs without prescription. Few patients had noticed ABs awareness campaigns, and very few reported having learned something important from them.Conclusion: Despite enforced regulation of AB use in Russia, self-medication still exists. Knowledge is not always linked to appropriate use of AB, and the few campaigns conducted were not always noticed.
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| 7. |
- Chao, Meie, et al.
(författare)
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Data-Enriched Edible Pharmaceuticals (DEEP) with Bespoke Design, Dose and Drug Release
- 2021
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Ingår i: Pharmaceutics. - : MDPI. - 1999-4923. ; 13:11
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Tidskriftsartikel (refereegranskat)abstract
- Data-enriched edible pharmaceuticals (DEEP) is an approach to obtain personalized medicine, in terms of flexible and precise drug doses, while at the same time containing data, embedded in quick response (QR) codes at a single dosage unit level. The aim of this study was to fabricate DEEP with a patient-tailored dose, modify drug release and design to meet patients' preferences. It also aimed to investigate physical stability in terms of the readability of QR code patterns of DEEP during storage. Cannabinoids, namely, cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), were used as the model active pharmaceutical ingredients (APIs). Three different substrates and two colorants for the ink were tested for their suitability to fabricate DEEP by desktop inkjet printing. Flexible doses and customizable designs of DEEP were obtained by manipulating the digital design of the QR code, particularly, by exploring different pattern types, embedded images and the physical size of the QR code pattern. Modification of the release of both APIs from DEEP was achieved by applying a hydroxypropyl cellulose (HPC) polymer coating. The appearance and readability of uncoated and polymer-coated DEEP did not change on storage in cold and dry conditions; however, the HPC polymer layer was insufficient in preserving the readability of the QR code pattern in the extreme storage condition (40 °C and 75% relative humidity). To sum up, the DEEP concept provides opportunities for the personalization of medicines, considering also patients’ preferences.
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| 8. |
- Chao, Meie, et al.
(författare)
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Data-enriched edible pharmaceuticals (DEEPs) : Patients' preferences, perceptions, and acceptability of new dosage forms and their digital aspects – An interview study
- 2022
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Ingår i: Exploratory Research in Clinical and Social Pharmacy. - : Elsevier. - 2667-2766. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundIn the field of pharmaceuticals, there is a shift away from the traditional “one-size-fits-all” concept to a more patient-centered one. A potential approach to obtain personalized medicine is with printed Data-Enriched Edible Pharmaceuticals (DEEPs). DEEPs that are printed in the pattern of QR codes contain both the patient-tailored dose and data that can be used to give patients personalized drug information and combat counterfeit medicines.ObjectivesThe study aims to explore patients' preferences, perceptions, and acceptability of DEEPs, and the digital aspects of them.MethodsThirteen participants, living in Denmark, were interviewed twice using a semi-structured approach. Interviews were conducted face-to-face or via video calls. The interviews were transcribed, translated, and analyzed using thematic coding analysis.ResultsThe participants found it useful to participate in the design of their own medicine. The orodispersible nature of DEEPs and the possibility to select color, embedded images, flavors, and physical dimensions of DEEPs were considered beneficial for patients' adherence. Patients' personal preferences, convenience, and aesthetics were the main drivers for their favored design of DEEPs. The acceptability of digital healthcare in connection to DEEPs was found to be related to the participants' level of digital literacy.ConclusionsThe participants generally had a positive attitude towards DEEPs and the digital aspects of them. However, to accept digital healthcare in connection to DEEPs, it should be adaptable and easy to use for everyone. The combination of digital healthcare and on-demand fabricated DEEPs could potentially contribute to higher patient adherence and safety in the future.
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| 9. |
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| 10. |
- 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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