Report on the GHPP-BloodTrain online workshop on "Authorisation and Licensing of Blood Establishments - Review of quality documentation of blood and blood components", 5th-8th of July 2021.

The GHPP BloodTrain team developed an e-learning concept in response to the COVID-19 travel restrictions, providing training formats with virtual stages that can be completed during the pandemic (and beyond) and on-site stages, where practical exercises and case reports in smaller groups can lead to a deeper understanding of the content. The virtual training workshop on "Authorisation and Licensing of Blood Establishments", hosted by the PEI GHPP BloodTrain from the 5th to the 8th of July 2021, was the first application of this concept. The number of participants could be substantially increased compared to an on-site event thanks to the virtual setting. Participants came mainly from national regulatory authorities and national blood transfusion services. There were also some Ministry of Health representatives from 19 countries from the WHO regions of AFRO, EMRO, and from Indonesia in attendance. The virtual workshop focused on reviewing and evaluating the quality documentation required for approval of processes used by blood establishments to prepare blood components. Presentations were given by members of the GHPP BloodTrain team as well as by representatives of the German Red Cross. The program was complemented by contributions from the WHO HQ and presentations on country-specific experiences from Ghana and Zimbabwe.

Interstate Licensure: Has The Time Come?

In the midst of the unprecedented public health emergency of COVID-19, many states developed programs to recognize out-of-state practitioners' licenses for in-state practice. This rapid expansion had a profound impact on care during periods of surge and offers lessons for future disasters as well as usual operating periods. As technology improves and care delivery evolves, interstate licensure offers immense opportunities, but there are also risks that must be mitigated.

Expanding Licensure Portability And Access To Care: Lessons Learned During COVID-19.

Regulatory flexibility by US states and territories during the COVID-19 pandemic rapidly facilitated the practice of medicine across state lines by physicians and other health care professionals, both in person and via telehealth, and greatly expanded access to care. Policy makers and health care leaders at the state and federal levels need to better understand which of these efforts (temporary expedited licenses, licensing waivers, interstate licensure compacts, and data credentialing platforms) worked well, under which circumstances, and how they might complement one another to facilitate more rapid and widespread adoption of measures to improve access to care in times of crisis and beyond. Lessons learned during this global public health crisis should better inform the nation's emergency preparedness efforts ahead of the next calamity.

Impact Of The New Jersey COVID-19 Temporary Emergency Reciprocity Licensure Program On Health Care Workforce Supply.

New Jersey's COVID-19 Temporary Emergency Reciprocity Licensure program provided temporary licenses to more than 31,000 out-of-state health care practitioners. As one of the first COVID-19 hot spots in the US, New Jersey is uniquely positioned to provide insights on enabling an out-of-state health care workforce through temporary licensure to address critical, ongoing concerns about health care workforce supply. In January 2021 we surveyed New Jersey temporary licensees. We analyzed more than 10,000 survey responses and found that practitioners who used the temporary license originated from every state in the US, provided both COVID-19- and non-COVID-19-related care, served a combination of new and existing patients, conversed with patients in at least thirty-six languages, and primarily used telehealth. Findings suggest that temporary licensure of out-of-state practitioners, along with telehealth waivers, may be a valuable, short-term solution to mitigating health care workforce shortages during public health emergencies.

Social Work Licensure Portability: A Necessity in a Post-COVID-19 World.

COVID-19 highlights the need for portability of social work licensure to be a priority. The Association of Social Work Boards (ASWB) spearheaded some initiatives, such as the creation and promotion of the Social Work Registry and Model Social Work Practice Act, with the hope that these efforts would enhance the ability of social workers to be licensed in multiple states. Neither has solved the portability problem. Licensure endorsement, an approach historically supported by ASWB, does not have the advantages of mutual recognition that is being supported by other professions to facilitate interstate practice. This article, the first written on licensure portability in the social work scholarly literature, examines existing licensure portability models and supports the establishment of a social work interstate compact to overcome barriers to social work mobility and access to client care.

Commentary: University Technology Transfer Has Made a Significant Contribution to Fighting COVID-19 while Ensuring Global Access.

This paper reviews the response by public sector research organizations and their technology transfer offices to the COVID-19 pandemic. It shows that leading universities and technology transfer associations quickly enacted licensing principles for the duration of the pandemic to maximize availability and minimize delays in translating public sector research institutes' (PSRIs') COVID-19 inventions to the public - in both the developed and the developing world - while waiving payment of royalties. It discusses examples of vaccines, drugs, diagnostics and personal protective equipment that were developed in PSRIs and swiftly deployed throughout the world on socially responsible terms. It reviews the case cited by Herder et al. (2022) and concludes that their proposed mandates are unnecessary and may inhibit the free flow of healthcare innovation from bench to bedside.

Commentary: Fulfilling the Promise of Global Access Licensing Principles to Enable Equitable Access.

In their piece, Herder and colleagues (2022) reveal the university origins of a key technology used in COVID-19 mRNA vaccines. They note that despite federal funding support and the university adopting "Global Access Principles," equitable, global access remains a challenge - in part due to the university's technology transfer practices. While for the past two decades university students have been successful in engaging institutional technology transfer offices in adopting similar access principles, implementation of these principles has been limited. This rejoinder points to the need for greater federal oversight and regulation to incentivize university action that enables equitable, global access.

Factors influencing changes in medication-taking and driving behavior after warnings about prescription medications that prohibit driving: an online survey.

BACKGROUND: This study examined warning messages as a strategy for preventing automobile crashes by drivers on medications. We investigated the degree of awareness regarding the effects of medication on automobile driving and changes in medication-taking and driving behavior. We also assessed associations between socio-environmental factors and the driving and medication-taking behavior adopted by individuals after being warned about driving-related risks. METHODS: Responses to an online questionnaire from 1200 people with a driving license who were taking prescription medications at the time of inquiry (March 2019) were collected and analyzed. The items surveyed were sex, age, educational history, health literacy, current medications, and medication-taking and driving behavior after being warned. RESULTS: Of the total respondents, 30% were taking medicine that prohibited driving. Of those taking prohibited medications, 25.7% did not receive a warning about driving from healthcare professionals. Most respondents taking prohibited medications received euphemistic warnings, such as "practice caution" (30%), "refrain from calling attention" (29.4%), and "avoid driving" (19.8%); 16% of the direct warnings were about not driving. Medication's effects on driving were recognized by 80% of the total respondents. The degree of awareness was significantly higher among respondents taking medications that prohibit driving than among those taking medications that did not prohibit driving or those taking unknown medications. Awareness of medicine's influence on driving was associated with health literacy. No association was found between age, gender, health literacy, history of side effects, and driving and medication-taking behavior. Approximately 22% of respondents adjusted their medication use at their discretion and 39% maintained treatment compliance but continued driving. Among respondents taking medications that prohibit driving, whether driving was required for work was a significant factor in their driving and medication-taking behavior after being warned. CONCLUSIONS: Healthcare professionals do not always fully inform patients about the driving-related risks of medications. To encourage patients who are taking medications that have a significant impact on their driving to either stop driving or consult a healthcare professional, healthcare professionals must first understand the patient's social environment, such as whether driving is required for work, and then create an environment conducive to advice-seeking.

Identifying research priorities for road safety in Nepal: a Delphi study.

OBJECTIVE: To identify and prioritise the research needed to help Nepali agencies develop an improved road safety system. DESIGN: Delphi study. SETTING: Nepal. PARTICIPANTS: Stakeholders from government institutions, academia, engineering, healthcare and civil society were interviewed to identify knowledge gaps and research questions. Participants then completed two rounds of ranking and a workshop. RESULTS: A total of 93 participants took part in interviews and two rounds of ranking. Participants were grouped with others sharing expertise relating to each of the five WHO 'pillars' of road safety: (1) road safety management; (2) safer roads; (3) safer vehicles; (4) safer road users and (5) effective postcrash response. Interviews yielded 1019 research suggestions across the five pillars. Two rounds of ranking within expert groups yielded consensus on the important questions for each pillar. A workshop involving all participants then led to the selection of 6 questions considered the most urgent: (1) How can implementing agencies be made more accountable? (2) How should different types of roads, and roads in different geographical locations, be designed to make them safer for all road users? (3) What vehicle fitness factors lead to road traffic crashes? (4) How can the driver licensing system be improved to ensure safer drivers? (5) What factors lead to public vehicle crashes and how can they be addressed? and (6) What factors affect emergency response services getting to the patient and then getting them to the right hospital in the best possible time? CONCLUSIONS: The application of the Delphi approach is useful to enable participants representing a range of institutions and expertise to contribute to the identification of road safety research priorities. Outcomes from this study provide Nepali researchers with a greater understanding of the necessary focus for future road safety research.

The Regulatory Evaluation of Vaccines for Human Use.

A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to prevent, ameliorate, or treat a disease or infection. A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), mRNA, living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive testing and characterization. Special expertise and procedures are required for the manufacture, control, and regulation of vaccines. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and national regulatory authorities. In this chapter, an overview of the regulatory evaluation and testing requirements for vaccines is presented.

Creating a National Standard for Prelicensure Clinical Evaluation in Nursing.

BACKGROUND: Measuring clinical outcomes in prelicensure students is desired by key stakeholders but is fraught with challenges. There are currently no standardized, psychometrically validated clinical-outcome measures available for prelicensure nursing programs, requiring each program to design its own measures. METHOD: We conducted a review of the potential antecedents of this gap, as well as models for standardized clinical outcome measures and recommendations from within health-professions education. RESULTS: There are benefits to pursuing a standardized clinical outcome tool, including an improved student learning experience and unifying our communication regarding graduate nurse preparation to valued stakeholders. CONCLUSION: Nursing education has a unique opportunity to emulate our colleagues in medicine and pharmacy by working at the national level to create a standardized tool using current psychometric methods for development and validation. [J Nurs Educ. 2021;60(12):686-689.].

The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study.

BACKGROUND: Non-exclusive voluntary licensing that is access-oriented has been suggested as an option to increase access to medicines to address the COVID-19 pandemic. To date, there has been little research on the effect of licensing, mainly focused on economic and supply chain considerations, and not on the benefits in terms of health outcomes. We aimed to study the economic and health effect of voluntary licensing for medicines for HIV and hepatitis C virus (HCV) in low-income and middle-income countries (LMICs). METHODS: A robust modelling framework was created to examine the difference between scenarios, with (factual) and without (counterfactual) a Medicines Patent Pool (MPP) licence for two medicines, dolutegravir and daclatasvir. Data were obtained from MPP licensees, as well as a large number of external sources. The primary outcomes were the cost savings and health impact between scenarios with and without MPP licences across all LMICs. Through its licences, MPP had access to the volumes and prices of licensed generic products sold in all covered countries on a quarterly basis. These data informed the volumes, prices, and uptake for the past factual scenarios and were the basis for modelling the future factual scenarios. These scenarios were then compared with a set of counterfactual scenarios in the absence of the studied licences. FINDINGS: Cumulatively, between 2017 and 2032, the model's central assumptions predicted an additional uptake of 15·494 (range 14·406-15·494) million patient-years of dolutegravir-based HIV treatments, 151 839 (34 575-312 973) deaths averted, and US$3·074 (1·837-5·617) billion saved through the MPP licence compared with the counterfactual scenario. For daclatasvir-based HCV treatments, the cumulative effect from 2015 to 2026 was predicted to be an additional uptake of 428 244 (127 584-636 270) patients treated with daclatasvir, 4070 (225-6323) deaths averted, and $107·593 (30·377-121·284) million saved with the licence compared with the counterfactual scenario. INTERPRETATION: The chain of effects linking upstream licensing to downstream outcomes can be modelled. Accordingly, credible quantitative estimates of economic and health effects arising from access-oriented voluntary licensing were obtained based on assumptions that early generic competition leads to price reductions that influence procurement decisions and enable the faster and broader uptake of recommended medicines, with beneficial economic and health effects. FUNDING: Unitaid.

[The institution of licensing and application of procedures of medical care support during COVID-19 pandemic].

The article presents the analysis of procedures of medical care support as implemented in case of patients with new coronavirus infection in Russia ("infectious diseases" profile), including their requirements as the main licensing requirement. The analysis of the results of public control of compliance with the requirements.