Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability.

The complexity and inter-connectedness of operating in a global world for drug product supply has become an undeniable reality, further underscored by the COVID-19 pandemic. For Post-Approval Changes (PACs) that are an inevitable part of a product's commercial life, the impact of the growing global regulatory complexity and related drug shortages has brought the Global PAC Management System to an inflection point in particular for companies that have their products marketed in many countries.This paper illustrates through data analyzed for the first time from 145,000 + PACs for 156 countries, collected by 18 global pharma companies over a 3-year period (2019-2021), how severe the problem of global regulatory complexity is. Only PACs requiring national regulatory agency (NRA) approval prior to implementation were included in the data set. 1 of the 156 country NRAs approved all submitted PACs within a period of 6 months. The 6-month timeline was chosen because it is the recommended review timeline for major changes in the WHO guidance for vaccines and biotherapeutic products. 10 out of the 156 (6%) countries had no more than 10% of the PACs reviewed and approved in > 6 months. In 33 (22%) countries more than half of the PACs took > 6 months for approval. It is rare that the same PAC is approved globally within 6 months as individual NRAs take from a few months to years (in some cases > 5 years) for their review.The global PAC management complexity has steadily grown over the past 20 years. Attempts thus far to solve this problem have not made any meaningful difference. Senior leaders and decision-makers across the interdependent components of the complex Global PAC Management System (industry and regulators) must come together and collaboratively manage the problem holistically with the objective of ensuring global drug product availability instead of continuing with distinct stakeholder or country-focused solutions, which can tend to worsen the problem.In this paper, the Chief Quality Officers (CQOs) from 18 of the largest innovator pharma companies (see Acknowledgements) are speaking with One-Voice-of-Quality for PACs (1VQ for PACs Initiative). They are recommending a set of 8 approaches to activate a holistic transformation of the Global PAC Management System. This article presents their view on the problem of global regulatory complexity for managing PACs, it's impact on continual improvement and the risk to drug product supply, as well as approaches that can help alleviate the problem.

Implementing Systemwide Physician Change Management in an Integrated Health Care Setting: Improving Physician Participation in an Advanced Care at Home Model.

INTRODUCTION: Advanced Care at Home is a clinical model that delivers hospital-level care in a patient's home. This model of care has been studied for decades, but there have been difficulties scaling the model to a higher census because of poor physician participation. Kaiser Permanente at Home, an Advanced Care at Home model created by Kaiser Permanente Northwest, was able to quickly increase its patient census by using several different change management interventions. The aim of this study was to describe the specific physician change management interventions used and to determine their relative impacts on physician participation with Kaiser Permanente at Home. METHODS: This study used a retrospective qualitative approach. Hospitalist and emergency department (ED) physicians completed an online survey in December 2021. This was followed by focused, one-on-one interviews that were held in February 2022. Content analysis was performed using a general inductive approach to identify core themes. RESULTS: Of 78 ED and 79 hospitalist physicians recruited, 35% submitted responses. Of these respondents, 16 (29%) were ED physicians, and 39 (61%) were hospitalist physicians. Of these respondents, 90% rated Kaiser Permanente at Home favorably over the course of a year. More than 90% of respondents rated a combination of multiple approaches as impactful, but respondents overwhelmingly noted that physician-to-physician engagement was the most important (51%). CONCLUSION: In the development of the Kaiser Permanente at Home, physicians highlighted that a multifactorial change management approach centered on peer-to-peer engagement had the most substantial effect on their participation, a process that could extend up to a year.

Leveraging the Five Perspectives of Health Professional Education to Advance Change Management in Virtual Care.

Virtual care (VC) was rapidly introduced into mainstream health service delivery due to COVID-19. To maintain and integrate VC with in-person care, one important change management approach requires a holistic educational strategy for the health professions. Pratt's (1998) "five perspectives of teaching" is an effective framework to guide the development of VC education to holistically increase the knowledge and skills of health professionals and stimulate health system change through the Transmission, Apprenticeship, Developmental, Nurturing and Social Reform perspectives. This article then makes five recommendations to implement this strategy through purposeful involvement and collaborations between stakeholder organizations.

Midwifery leaders' views on the factors considered crucial to implementing evidence-based practice in clinical areas.

PROBLEM: The evidence-to-practice gap continues to persist in healthcare and midwives report limited knowledge and use of effective intervention strategies to support the implementation of new evidence-based practices in clinical settings. BACKGROUND: Despite ongoing development and dissemination of high quality research findings, the translation of latest research evidence by midwives into new evidence-based practices remains sub-optimal. This inefficiency places consumers at risk of obsolete or potentially dangerous healthcare interventions. AIM: To explore midwifery leaders' views on what information and support midwives require to lead practice change initiatives in clinical areas. METHODS: The study formed part of a broader Participatory Action Research (PAR) project designed to improve the processes by which midwives implement evidence-based practice change in clinical settings. The study employed a qualitative design and was guided by the methodological underpinnings of Action Research (AR). FINDINGS: One core finding emerged to fulfil the aim and objectives of the study. To lead implementation of evidence-based practices, midwives need practical solutions and a map of the process, packaged into a centralised web-based resource. DISCUSSION: The findings reported in this study provide valuable insight into the specific needs of midwives wanting to improve the uptake and longevity of new evidence based practices in clinical areas. This includes information specific to evidence implementation, support networks and knowledge of Implementation Science. CONCLUSION: To lead practice change initiatives, midwives require a web-based resource that standardises the process of evidence implementation, while providing midwives with clear direction and the support needed to confidently champion for evidence base change in clinical areas.

Hungarian adaptation and launch of the 2019 ARIA care pathways of allergic rhinitis in Hungary / A 2019. évi ARIA kezelési irányelvek magyar adaptációja és a hazai alkalmazás lehetoségei allergiás rhinitisben.

Összefoglaló. Az allergiás betegségekben szenvedo emberek száma világszerte, köztük Magyarországon is növekszik. Az egészségügyi ellátórendszerek azon dolgoznak, hogy minél hatékonyabban tudják felhasználni a rendelkezésre álló forrásokat. Az Allergic Rhinitis and its Impact on Asthma (ARIA) szervezet célja az allergiás náthában szenvedo betegek ellátásának javítása, szakmai ajánlások készítése, aktualizálása. Ennek egyik módja integrált betegellátási utak kidolgozása. Célunk ezek hazai elérhetové tétele, az ajánlások széles köru elterjesztése az Európai Unió (EU) többi tagállamához hasonlóan Magyarországon is. Az ARIA más nemzetközi innovatív szervezetek bevonásával olyan integrált betegellátási utakat fejlesztett ki, amelyek allergiás nátha, esetleg társbetegsége, az asztma esetén támogatják a kezelést. Ezeket újgenerációs irányelvek kidolgozása útján alkották, amelyekhez felhasználták a mobiltechnológiából és pollenkamra-vizsgálatokból származó valós evidenciákat is. A gyógyszeres terápia optimalizálásához a vizuális analóg skálán alapuló, úgynevezett Mobil Légúti Figyelo Hálózat algoritmusát digitalizálták, és valós evidenciák felhasználásával tovább finomították. Allergén immunterápiára az ARIA a világon elsoként dolgozott ki integrált betegellátási utakat 2019-ben. A kezelési irányelvekhez való adherenciaszint alacsony, a betegek a tüneteik erossége alapján módosítják a kezelést. A flutikazon-propionát-azelasztin kombináció hatása erosebb az intranasalis kortikoszteroidokénál, míg az utóbbi hatásosabb az oralis H1-antihisztaminoknál. A mobiltelefonokban tárolt elektronikus napló vagy más 'mobile health' (mHealth) eszközök használata segíti a betegek kiválasztását allergén immunterápiára. Az ARIA által javasolt algoritmus megfelelonek mutatkozott az allergiás rhinitis kezelésére, ezért ezek az irányelvek bekerülnek integrált betegellátási utakba, és részét fogják képezni az EU Egészségügyi és Élelmiszer-biztonsági Foigazgatósága digitalizált, személyközpontú gondozási anyagainak. Az allergén immunterápia hatékony az inhalatív allergének által okozott allergiás betegségekben, alkalmazását azonban korlátozni kell gondosan válogatott betegekre. Orv Hetil. 2020; 161(49): 2059-2071. Summary. The number of allergic patients is increasing all over the world, also in Hungary. Delivering effective and cost-effective health care is essential for all health care systems. ARIA (Allergic Rhinitis and its Impact on Asthma) aims to improve the care of patients who suffer from allergic rhinitis by setting up guidelines and updating them. Development of ICPs (integrated care pathways) can play an essential role in attaining this goal. Our aim is to make ICP-s developed by ARIA available also in Hungary, as is already the case in other countries of the European Union (EU). Together with other international initiatives, ARIA has worked out digitally-enabled ICPs to support care in allergic rhinitis and comorbid asthma. ICPs are based on new-generation guidelines using RWE (real-world evidence) from chamber studies and mobile technology. The MASK (Mobile Airways Sentinel NetworK) algorithm - based on visual analogue scale - was digitalized to support pharmacotherapy, and was refined by using RWE. ARIA was the first to develop ICPs for allergen immunotherapy (AIT) in 2019. Based on MASK data, patients did not follow guidelines and their adherence to treatment was poor. Patients would modify their treatments, depending on the disease control. The effect of fluticasone propionate-azelastine combination is superior to intranasal corticosteroids which are superior to oral H1-antihistamines. Electronic diaries obtained from cell phones and other 'mobile health' (mHealth) devices help select patients for AIT. The ARIA algorithm for AR was found appropriate and no change is necessary. These guidelines will inform ICPs and will be included in the DG Santé digitally-enabled, person-centred care system. AIT is an effective treatment for allergic diseases caused by inhaled allergens. Its use should, however, be restricted to carefully selected patients. Orv Hetil. 2020; 161(49): 2059-2071.

Rapidly scaling video visits during COVID-19: The ethos of virtual care at Yale Medicine.

Lesson 1: The loosening of federal government regulations enabled the rapid scaling of telehealth, as it enabled providers to be reimbursed for video visits at the same rate as in-person services. Lesson 2: While resistance to change was the norm, the COVID-19 crisis motivated improvements to four major internal operational workflows (scheduling, appointment conversions, patient support and Virtual Rooming Assistants) for video visits, which were met with acceptance by both clinical and non-clinical staff. Lesson 3: Leveraging prior intraorganizational relationships and active collaboration between different stakeholders, helped drive rapid operational change. An ongoing centralized communication and support strategy, ensured all stakeholders were informed and engaged during these uncertain times. Lesson 4: Regular electronic health record (EHR) training and educational material increased end-user knowledge of video visits and helped ensure the visit was safe, medically effective and maintained patient-provider relationships. Lesson 5: A clearly defined intake and evaluation process to filter out technologies that do not integrate with the patient portal or the EHR, ensures operational consistency and long-term sustainability. Lesson 6: Personalized support to patients of different levels of technical literacy with using the preferred patient portal and application, was vital to its use, adoption and overall patient experience.

Who is driving change, and where is it taking us? Interview with an expert.

In addition to providing critical behavioral health services for those with mental health issues and substance use disorders, some Community Mental Health Centers (CMHCs) in the United States have begun integrating primary care services, referred to as "reverse integration". Representing the interests of CMHCs across the United States, the National Council for Behavioral Health (NCBH) represents over 3,000 member organizations delivering mental health and/or addictions treatment and services to roughly 10 million patients and families. This article reflects a recent wide-ranging conversation with Linda Rosenberg, the president and CEO of NCBH. Trained as a social worker, Rosenberg was senior deputy commissioner of the New York State Office of Mental Health prior to joining the NCBH and is a dynamic and high-energy strategist and thought leader in the field of community mental health and integrated care. We discussed issues impacting payment for integrated care, including private equity investment, capitated payment, and the role of risk, and how these market dynamics impact vulnerable populations. For the sake of brevity, we summarize our conversation with Ms. Rosenberg and offer her perspective to integrated care practitioners and researchers who largely operate outside of this world of business built on calculated risks and rewards. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Practice Facilitators' and Leaders' Perspectives on a Facilitated Quality Improvement Program.

PURPOSE: Practice facilitation is a promising approach to helping practices implement quality improvements. Our purpose was to describe practice facilitators' and practice leaders' perspectives on implementation of a practice facilitator-supported quality improvement program and describe where their perspectives aligned and diverged. METHODS: We conducted interviews with practice leaders and practice facilitators who participated in a program that included 35 improvement strategies aimed at the ABCS of heart health (aspirin use in high-risk individuals, blood pressure control, cholesterol management, and smoking cessation). Rapid qualitative analysis was used to collect, organize, and analyze the data. RESULTS: We interviewed 17 of the 33 eligible practice leaders, and the 10 practice facilitators assigned to those practices. Practice leaders and practice facilitators both reported value in the program's ability to bring needed, high-quality resources to practices. Practice leaders appreciated being able to set the schedule for facilitation and select among the 35 interventions. According to practice facilitators, however, relying on practice leaders to set the pace of the intervention resulted in a lower level of program intensity than intended. Practice leaders preferred targeted assistance, particularly electronic health record documentation guidance and linkages to state smoking cessation programs. Practice facilitators reported that the easiest interventions were those that did not alter care practices. CONCLUSIONS: The dual perspectives of practice leaders and practice facilitators provide a more holistic picture of enablers and barriers to program implementation. There may be greater opportunities to assist small practices through simple, targeted practice facilitator-supported efforts rather than larger, comprehensive quality improvement projects.

Comparing Hospital Staff Nutrition Knowledge, Attitudes, and Practices Before and 1 Year After Improving Nutrition Care: Results From the More-2-Eat Implementation Project.

BACKGROUND: Staff play key roles in the prevention, detection, and treatment of hospital malnutrition. Understanding staff knowledge, attitudes, and practices (KAP) is important for developing and evaluating change management strategies. METHODS: The More-2-Eat project improved nutrition care in 5 Canadian hospitals by implementing the Integrated Nutrition Pathway for Acute Care (INPAC). To understand staff views before (T1) and after 1 year of implementation (T2), a reliable KAP questionnaire, based on INPAC, was administered. T2 included questions about involvement in implementation. The mean difference between T2 and T1 responses was calculated, and t tests were used for comparisons. RESULTS: The questionnaire was completed at T1 (n = 189) and T2 (n = 147) (unpaired); 57 staff completed both questionnaires (paired). A significant increase in total score was seen in unpaired results at T2 (from 93.6/128 [range, 51-124] to 99.5/128 [range, 54-119]; t = 5.97, P < .0001), with an increase in knowledge/attitudes (KA) (t = 2.4, P = .016) and practice (t = 3.57, P < .0001) components. There were no statistically significant changes in paired responses. Seventy percent (n = 102/147) noticed positive changes in practices, 12% (n = 18) noticed positive/negative changes, 1% (n = 1) noticed negative change, and 17% (n = 25) noticed no change. Fifty-nine percent (n = 86) felt involved in the change, and these staff had higher KA and KAP scores than those who did not feel involved. CONCLUSION: Staff involvement is important in the implementation process for improving nutrition care.

Integration of nurse practitioners using a change management framework: the way forward.

Objective The aim of the present study was to investigate and describe the application of a change management theoretical framework in relation to nurse practitioner (NP) role integration. Methods A survey formed Phase 1 of a broader mixed-methods study to explore perceptions of the change process involved with integrating NPs into Australian health care settings. The stakeholder participants were NPs, nurse managers and nurse policy advisers. Results Key themes were identified adding information about how NPs, nurse managers and nurse policy advisers perceive the integration of NPs into Australian healthcare. The themes correlate to the components of organisational change management necessary to embed NPs into the healthcare workforce. Conclusions Healthcare reform is a complex organisational change. Alignment of several key elements is required for the process to be successful. A change management proposal for reframing organisations provides an apt framework for use in the Australian context of reforming workforce to integrate NPs into healthcare teams. The theoretical framework proposes that multiple lenses be applied to change processes, to integrate NPs into the workforce and highlights the need for exceptional leadership throughout such endeavours. What is known about the topic? NPs provide safe and efficient care to patients, often in settings where access to health care is limited. NPs have been identified as a key strategic workforce reform initiative to address some of the known healthcare gaps. What does this paper add? This paper adds information about how NPs, nurse managers and nurse policy advisers perceive progress of the integration of NPs into healthcare settings. The findings are contextualised within an organisational change framework and highlight the complexity of healthcare reform. What are the implications for practitioners? The findings provide a novel approach for managing workforce reform and identify the components of change management necessary to embed NPs into the healthcare workforce.