A Nonprofit Drug Development Model Is Part of the Antimicrobial Resistance (AMR) Solution.

Antibiotics underpin modern medicine and are critical for pandemic preparedness. Push funding has revitalized the preclinical antimicrobial resistance (AMR) pipeline and government funding via CARB-X and BARDA, as well as private sector-led investment via the AMR Action Fund, will help several new antibiotics obtain regulatory approval. Nevertheless, revenues generated by new antibiotics are not considered sufficiently profitable by commercial developers to address unmet need. The question remains: Who could viably fund development and secure global equitable access for new antibiotics? Public health need should be the primary driver for antibiotic development. Improved prioritization and government oversight by funders who allocate public resources are a needed first step. In this framework, nonprofit research and development organizations, with support from public funders, and unconstrained by commercial profitability requirements are well positioned to work with public and private actors to viably provide new antibiotics to all in need.

Recommendations from parents, administrative staff and clinicians to improve paediatric ambulatory appointment scheduling.

BACKGROUND: Stakeholders can provide valuable input to improve scheduling paediatric ambulatory clinic appointments, a complex process that requires effective planning and communication between parents, administrative staff and clinicians. The purpose of our study was to characterize recommendations from parents, administrative staff and clinicians to improve paediatric ambulatory appointment scheduling. METHODS: Conducted between February 2018 and January 2019, this qualitative study was guided by qualitative description. Data collection was completed using focus groups with three stakeholder groups: parents, administrative staff and clinicians. Participants provided recommendations to optimize paediatric ambulatory appointment scheduling at the Stollery Children's Hospital in Edmonton, Alberta, Canada. Focus group data were transcribed verbatim and analysed using manifest inductive content analysis. RESULTS: Forty-six participants (mean age: 42.7; 87% female) participated in 12 focus groups. Parents (n = 11), administrative staff (n = 22) and clinicians (n = 13) made recommendations that were organized into two categories: appointment triaging and arranging. Triaging recommendations were related to appointment availability (e.g. providing alternatives to cancelling clinics with short notice) and waitlist management (e.g. developing clear and consistent policies regarding information flow and communication between clinics and administrative staff). Appointment arranging recommendations referred to booking (e.g. directly involving parents in the booking process), reminders (e.g. using text message reminders) and attendance (e.g. providing parents with a single point of contact who can provide the correct information about late and cancellation policies). Recommendations were similar across stakeholder groups. CONCLUSION: Our findings showed congruent recommendations across stakeholder groups to address challenges with scheduling ambulatory appointments, many of which have the potential to be modified. Experimental research and quality improvement initiatives are needed to determine the feasibility, acceptability and effectiveness of stakeholder recommendations to improve triaging and scheduling paediatric ambulatory appointments.

Pediatric ambulatory appointment scheduling: a qualitative study of stakeholders' perceptions and experiences.

OBJECTIVE: Scheduling ambulatory clinic appointments includes a complex set of factors and diverse stakeholders. Families, administrative staff and clinicians may have varied experiences with scheduling clinic appointments. The objective of our study was to understand stakeholders' perceptions and experiences with scheduling pediatric ambulatory clinic appointments. DESIGN: Guided methodologically by qualitative description, focus groups were conducted separately with three stakeholder groups and analyzed using qualitative content analysis. SETTING: This qualitative study was completed at a children's hospital in Alberta, Canada. PARTICIPANTS: Parents, administrative professionals and clinicians who used the pediatric ambulatory scheduling system regularly to elicit perceptions and experiences about issues and areas where improvements could be made. RESULTS: Across 12 focus groups, parents (n = 11), administrative professionals (n = 23) and clinicians (n = 13) discussed areas for improvement related to the pediatric ambulatory scheduling system. The perceived areas for improvement were grouped into three categories regarding levels of influence: (i) 'intrapersonal': knowledge, skills and behaviors (e.g. insufficient training of administrative professionals); (ii) 'interpersonal': communication processes (e.g. parents not receiving confirmation letters); and (iii) 'institutional': structures and processes (e.g. varying practices and processes across clinics). CONCLUSIONS: Stakeholders provided a rich description of the interrelated factors and processes that influenced the scheduling of pediatric ambulatory clinic appointments. Multilevel, experimental interventions are needed to test whether the findings described herein can enhance the structure and function of pediatric ambulatory appointment scheduling.

A Contingency Theory Approach to Understanding Small Retail Business Continuity During COVID-19.

Small retail businesses are particularly vulnerable to turbulence caused from the COVID-19 pandemic. To consider what actions retailer owners/managers can take to maneuver during such trying times, this study investigated leadership qualities associated with managing during times of crisis. Through in-depth interviews with 12 small retail leaders, thematic data analysis revealed an emergence of contingent leadership, including an internal focus on cash flow and employees and an external focus on preserving key stakeholder relationships. Retail leaders displayed a resilient mindset, showing passion, agility, innovation, and relationship development. A conceptual model is proposed to further illustrate findings from the study.

A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries.

BACKGROUND: Tiered pricing - the concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries - has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to medicines for the poor. We carried out case studies based on a review of international drug price developments for antiretrovirals, artemisinin combination therapies, drug-resistant tuberculosis medicines, liposomal amphotericin B (for visceral leishmaniasis), and pneumococcal vaccines. DISCUSSION: We found several critical shortcomings to tiered pricing: it is inferior to competition for achieving the lowest sustainable prices; it often involves arbitrary divisions between markets and/or countries, which can lead to very high prices for middle-income markets; and it leaves a disproportionate amount of decision-making power in the hands of sellers vis-à-vis consumers. In many developing countries, resources are often stretched so tight that affordability can only be approached by selling medicines at or near the cost of production. Policies that "de-link" the financing of R&D from the price of medicines merit further attention, since they can reward innovation while exploiting robust competition in production to generate the lowest sustainable prices. However, in special cases - such as when market volumes are very small or multi-source production capacity is lacking - tiered pricing may offer the only practical option to meet short-term needs for access to a product. In such cases, steps should be taken to ensure affordability and availability in the longer-term. SUMMARY: To ensure access to medicines for populations in need, alternate strategies should be explored that harness the power of competition, avoid arbitrary market segmentation, and/or recognize government responsibilities. Competition should generally be the default option for achieving affordability, as it has proven superior to tiered pricing for reliably achieving the lowest sustainable prices.

When falsified medicines enter the supply chain: description of an incident in Kenya and lessons learned for rapid response.

Falsified and substandard medicines present serious concerns for public health. We describe an event that occurred in late 2011 involving falsified antiretroviral medicines found in the supplies of Médecins Sans Frontières (MSF) projects in Kenya. We discuss factors contributing to these falsified medicines entering the supply chain as well as the response by MSF and others. We make recommendations to help defend against future episodes of entry of falsified medicines into the supply chain as well as comments on appropriate responses in cases of falsified medicines.

Towards a Patent Pool for HIV Medicines: The Background.

Recent WHO guidelines for antiretroviral therapy recommend switching to less toxic, but more expensive medicines for first-line and second-line ART, raising questions about the financial sustainability of many AIDS treatment programmes. At the same time, many key generic producing countries such as India now grant pharmaceutical product patents so competition between multiple manufacturers will not be able to play the role it has in bringing down the price of newer drugs.Overcoming these patent barriers will require a range of solutions, such as restricting patentability criteria, or compulsory licensing. One additional systematic solution is provided by the patent pool, a collective solution to the management of patent rights, initially presented by Médecins Sans Frontières to the French Foreign Ministry and subsequently the UNITAID Executive Board in 2006.A patent pool must not be implemented at any costs, but answer medical needs, be based on economic realities and meet the access needs of the developing world, including middle-income countries.