Comparing the experiences of community and hospital pharmacy learners completing a pre-registrant research training program.

BACKGROUND AND PURPOSE: Research training programs in the community pharmacy sector have not been well established. This study showcases a year-long guided research training program undertaken in hospital and community workplaces by pre-registrant pharmacists, and compares the perceived impact on learners in both sectors. EDUCATIONAL ACTIVITY AND SETTING: A two-year cohort study (2021-2022) of pre-registrant pharmacists enrolled in a research training program requiring them to undertake an individual project at their workplace over one year at either a community or hospital workplace. Outcome measures were pre-registrant perceptions of training impact and type of projects completed. FINDINGS: The results of this study demonstrate that the year-long guided research training program delivered to 403 pre-registrant pharmacists was perceived to be impactful to both community and hospital pre-registrant pharmacists and gave them the confidence to pursue further research and see research skills as an important attribute for the profession. Barriers to research included lack of time for both sectors but workplace support and lack of project ideas were especially noted in the community sector. Research project designs were mainly cross-sectional surveys or retrospective audits. SUMMARY: Programs seeking to adopt a similar model may wish to pay particular attention to supporting community pharmacy learners in providing a pre-selection of project ideas, offering training to workplace supervisors, ensuring enough academic support is given and having more check-in points/deliverables to ensure more feedback opportunities.

[Reflections on Research and Development Institutions Becoming Medical Device Registrants].

As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.

Reflections on Research and Development Institutions Becoming Medical Device Registrants / 中国医疗器械杂志

As the special subject of the applicant for registration of medical device, the research and development institutions have insufficient conditions and abilities to become medical device registrants, and there are certain difficulties in the actual registration application process, such as not clearing the certification path for the research and development institutions to hold the certificate. In view of the existing problems, by comparing the path of medicine research and development institutions to become medical device registrants and combining with the actual medical device industry to give relevant suggestions, including improving quality management over the whole life cycle of medical devices, quality and safety responsibility ability of research and development institutions, establishing the registration and certification path of research and development institutions, supporting laws and regulations, etc., so as to ensure that the research and development institutions become medical device registrants successfully.

Demonstrating institutional trustworthiness: A framework for pharmacy regulatory authorities.

BACKGROUND: Self-regulation is well suited for health care providers as the distinctive knowledge requirements can be effectively managed by those with the specific knowledge base compared to national or provincial/state governments. Despite their prevalence and long history in health care, self-regulating professions have become a topic of increasing debate as a result of evidence of declines in trust in a number of institutional contexts. OBJECTIVE: It is important that Pharmacy Regulatory Authorities (PRAs), as the regulating body for a critical health profession, can demonstrate and proactively respond to issues related to public trust. Such capabilities are needed to address an overall decline in trust in self-regulated professions and allow PRAs to quickly address issues that may impact public trust within their own jurisdiction. However, a process and best practices that allow PRAs to demonstrate institutional trustworthiness to the public is lacking. Given the need from both a research and practice perspective, this research develops a conceptual framework of how PRAs can demonstrate institutional trustworthiness to the public. METHODS: The literature was reviewed to identify dominant themes associated with regulatory practice that would serve to demonstrate institutional trustworthiness of PRAs to the public. Eight best practice themes emerged: public interest objective, transparency, engagement, accountability, independence, collaboration, adaptability, and awareness. RESULTS: The conceptual framework is comprised of six key steps, related to defining public interest orientation, implementing trust-related best practices, developing a communication strategy to increase public awareness of PRA activities, monitoring symbolic capital, assessing public trust in registrants (interpersonal trust), and assessing public and registrant trust in the regulator (institutional trust). CONCLUSION: Future research should develop pharmacy-focused instruments related to trust, establish baseline measures of registrant and public trust in pharmacy regulatory authorities, and explore issues of public trust in PRAs between different cultures and developed and developing countries.

[Risk Management to Shanghai Medical Device Registrants].

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.

Risk Management to Shanghai Medical Device Registrants / 中国医疗器械杂志

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.

A scoping review of how new midwifery practitioners transition to practice in Australia, New Zealand, Canada, United Kingdom and The Netherlands.

BACKGROUND: contemporary knowledge related to the experiences of new midwifery practitioners is limited to countries that run hospital-based transition to practice programmes within an employment contract arrangement, such as the United Kingdom, and Australia. Less is known of the experiences of New Midwifery Practitioners (NMPs) who transition into autonomous private practice in New Zealand, Canada and the Netherlands. PURPOSE: the purpose of this paper is to report on a scoping review of the way NMPs are transitioned to practice in the first year of registered practice across the selected countries. METHODS: this review accessed literature and government and professional sites to make comparisons between the transition to practice processes within five countries, and discusses the benefits and issues, associated with public hospital employment programs versus community based government funded midwifery group practices. FINDINGS: comparison of the way in which NMPs are transitioned to practice in the first year of registered practice between the selected countries shows important differences based on occupational organisation. Funding of maternity services influences how NMPs in each country are orientated and supported in their transition to registered practice. Direct comparisons between countries were difficult. More research is recommended to investigate NMPs' experiences of transition to practice in private practice.

Mentors in waiting.

A four stage framework, developed by the Nursing and Midwifery Council for the preparation of nurses and midwives who support learners within practice and educational settings was implemented in the United Kingdom in September 2007. Since then the focus of debate and discussion within the literature has centred on stage 2 of the developmental framework i.e. the mentor role. The three other stages of registrant, practice teacher and teacher have received little attention. This paper argues that currently, the provisions made within the developmental framework in relation to the stage 1 registrant's role in supporting students within practice settings, has yet to be realised. The paper begins by contemplating both the pros and cons of the 'should all nurses be mentors' debate. The argument for embracing and utilising the stage 1 role more fully in practice is then presented. The paper concludes by underlining the need to recognise the stage 1 registrants as 'mentors in waiting' and the need to support the full potential of their contribution to students' learning and assessment in practice.