Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative.

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

Ethical and Legal Considerations in End-of-Life Care.

In caring for dying patients, family medicine practitioners intentionally adopt care plans that affect the manner and timing of death. These decisions are morally weighty. This article provides guidance regarding the ethical and legal appropriateness of practitioner decisions near the end of life. Topics include surrogate decision making, advance care planning, medical nutrition and hydration, double effect, futile care, physician-assisted death, voluntarily stopping eating and drinking, palliative sedation to unconsciousness, and cultural humility.

Achieving the Goals of Dementia Plans: A Review of Evidence-Informed Implementation Strategies.

A 2019 report by the Canadian Academy of Health Sciences identified the importance of evidence-informed implementation strategies in reforming dementia care. Such implementation strategies may be relevant to changing clinical practice in the wake of Canada's impending federal dementia plan (initiated by Bill C-233). As this federal dementia plan is elaborated, there may be value in looking ahead to some of the implementation challenges likely to be faced "on the ground" in healthcare settings. We thus conducted a rapid review of provincial and national dementia plans from high-income countries and reviewed studies on implementation strategies to dementia care. We advance seven key implementation strategies that may be useful for future dementia care reform.

The Impact of the Psychiatrist on the Life Care Plan.

A life care plan is a tool that is used for medical treatment planning and management purposes in many settings, including legal and forensic applications. This article summarizes the life care planning process and emphasizes the role of the psychiatrist in establishing a strong medical foundation for the plan. The psychiatrist's expertise in determining the nature and extent of the evaluee's psychiatric illness, prognosis, need for and likely benefit from treatment, and costs of care inform the life care planning process. Advising life care planners on these matters is a natural extension of the work of psychiatrists and forensic psychiatrists, who are accustomed to providing medical opinions to the courts. There are specific challenges when the psychiatrist creates recommendations for the life care plan; they include determining long-term prognosis, devising treatment plans, and identifying malingering. These questions are explored to assist the psychiatrist in providing the foundation for a life care plan.

Documento sobre la situación del modelo español de Medicina Intensiva. Plan estratégico SEMICYUC 2018-2022 / Document on the state of affairs of the Spanish model of Intensive Care Medicine. SEMICYUC Strategic Plan 2018-2022

El modelo español de Medicina Intensiva requiere una revisión y reflexión continuas. Tenemos valores y fortalezas que se concretan en nuestra actividad y en el importante papel que realizamos a diario a nivel hospitalario. Otras especialidades pugnan por compartir actividades de cuidados del paciente crítico y otras circunstancias pueden hacer mermar esa actividad. Este artículo es el reflejo de la reflexión de un importante número de miembros del Grupo de Trabajo de Planificación, Organización y Gestión de nuestra Sociedad (GTPOG-SEMICYUC). Se afrontan las acciones que se deben llevar a cabo para la actualización del modelo de Medicina Intensiva, hacia un modelo más abierto de UCI sin paredes o UCI extendida. Se aborda desde tres puntos de vista que deben ser complementarios: las acciones a nivel de la Administración, las acciones a nivel de nuestra Sociedad Científica y las llevadas a cabo por cada uno de los Servicios (liderados por sus representantes), tanto a nivel hospitalario como a nivel de las autoridades sanitarias en cada comunidad autónoma

The role of Critical Care Medicine in Spain requires continuous revision and reflection. We have values and strengths that are evidenced in our daily work and by their important effects in routine hospital activity. Other medical specialties seeking to assume activities referred to critical patient care, as well as a number of other circumstances, may have a negative impact upon our routine duties. This article reflects the impressions of an important number of members of the Planning, Organization and Management Task Force of the Spanish Society of Critical Medicine Society (Grupo de Trabajo de Planificación, Organización y Gestión; GTPOG-SEMICYUC). The actions required to upgrade our Critical Care Medicine model are presented, evolving towards a broader view such as the 'ICU without walls' or 'Expanded ICU'. The subject is addressed from three complementary standpoints: actions involving the administrative authorities; actions required on the part of our scientific Society; and initiatives to be implemented locally in each Intensive Care Unit (led by the corresponding Unit representatives) at both hospital level and involving the regional authorities

Informed, advance refusals of treatment by people with severe mental illness in a randomised controlled trial of joint crisis plans: demand, content and correlates.

BACKGROUND: In the UK, crisis planning for mental health care should acknowledge the right to make an informed advance treatment refusal under the Mental Capacity Act 2005. Our aims were to estimate the demand for such treatment refusals within a sample of service users who had had a recent hospital admission for psychosis or bipolar disorder, and to examine the relationship between refusals, and service user characteristics. METHODS: To identify refusals we conducted content analysis of Joint Crisis Plans, which are plans formulated by service users and their clinical team with involvement from an external facilitator, and routine care plans in sub-samples from a multi-centre randomised controlled trial of Joint Crisis Plans (plus routine mental health care) versus routine care alone (CRIMSON) in England. Factors hypothesised to be associated with refusals were identified using the trial data collected through baseline interviews of service users and clinicians and collection of routine clinical data. RESULTS: Ninety-nine of 221 (45%) of the Joint Crisis Plans contained a treatment refusal compared to 10 of 424 (2.4%) baseline routine care plans. No Joint Crisis Plans recorded disagreement with refusals on the part of clinicians. Among those with completed Joint Crisis Plans, adjusted analyses indicated a significant association between treatment refusals and perceived coercion at baseline (odds ratio = 1.21, 95% CI 1.02-1.43), but not with baseline working alliance or a past history of involuntary admission. CONCLUSIONS: We demonstrated significant demand for written treatment refusals in line with the Mental Capacity Act 2005, which had not previously been elicited by the process of treatment planning. Future treatment/crisis plans should incorporate the opportunity for service users to record a treatment refusal during the drafting of such plans. TRIAL REGISTRATION: ISRCTN11501328 Registered 13th March 2008.

Use of fused deposit modeling for additive manufacturing in hospital facilities: European certification directives.

PURPOSE: The goal of this study was to identify current European Union regulations governing hospital-based use of fused deposit modeling (FDM), as implemented via desktop three-dimensional (3D) printers. MATERIALS AND METHODS: Literature and Internet sources were screened, searching for official documents, regulations/legislation, and views of specialized attorneys or consultants regarding European regulations for 3D printing or additive manufacturing (AM) in a healthcare facility. A detailed review of the latest amendment (2016) of the European Parliament and Council legislation for medical devices and its classification was performed, which has regularly updated published guidelines for medical devices, that are classified by type and duration of patient contact. As expected, regulations increase in accordance with the level (I-III) of classification. RESULTS: Custom-made medical devices are subject to different regulations than those controlling serially mass-produced items, as originally specified in 98/79/EC European Parliament and Council legislation (1993) and again recently amended (2016). Healthcare facilities undertaking in-house custom production are not obliged to fully follow the directives as stipulated, given an exception for this scenario (Article 4.4a, 98/79/EC). CONCLUSION: Patient treatment and diagnosis with the aid of customized 3D printing in a healthcare facility can be performed without fully meeting the European Parliament and Council legislation if the materials used are ISO 10993 certified and article 4.4a applies.

Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies. Final rule.

This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

[Decision Support for the Therapy Planning for Young Refugees and Asylum-Seekers with Posttraumatic Disorders]. / Entscheidungshilfe zur Therapieplanung bei jugendlichen Flüchtlingen und Asylbewerbern mit Traumafolgestörungen in der ambulanten Praxis.

Decision Support for the Therapy Planning for Young Refugees and Asylum-Seekers with Posttraumatic Disorders Due to the Convention on the Rights of the Child and § 6 of the Asylum Seekers' Benefit Act, there are legal and ethical obligations for the care of minor refugees suffering from trauma-related disorders. In Germany, psychotherapeutic care of adolescent refugees is provided by specialized treatment centers and Child and Adolescent psychiatries with specialized consultation-hours for refugees. Treatment of minor refugees is impeded by various legal and organizational barriers. Many therapists have reservations and uncertainties regarding an appropriate therapy for refugees due to a lack of experience. This means that only a fraction of the young refugees with trauma-related disorders find an ambulatory therapist. In a review of international literature, empirical findings on (interpreter-aided) diagnostics and therapy of young refugees were presented. Practical experiences on therapeutic work with traumatized young refugees were summarized in a decision tree for therapy planning in the ambulatory setting. The decision tree was developed to support therapists in private practices by structuring the therapy process.

A framework of pediatric hospital discharge care informed by legislation, research, and practice.

To our knowledge, no widely used pediatric standards for hospital discharge care exist, despite nearly 10 000 pediatric discharges per day in the United States. This lack of standards undermines the quality of pediatric hospital discharge, hinders quality-improvement efforts, and adversely affects the health and well-being of children and their families after they leave the hospital. In this article, we first review guidance regarding the discharge process for adult patients, including federal law within the Social Security Act that outlines standards for hospital discharge; a variety of toolkits that aim to improve discharge care; and the research evidence that supports the discharge process. We then outline a framework within which to organize the diverse activities that constitute discharge care to be executed throughout the hospitalization of a child from admission to the actual discharge. In the framework, we describe processes to (1) initiate pediatric discharge care, (2) develop discharge care plans, (3) monitor discharge progress, and (4) finalize discharge. We contextualize these processes with a clinical case of a child undergoing hospital discharge. Use of this narrative review will help pediatric health care professionals (eg, nurses, social workers, and physicians) move forward to better understand what works and what does not during hospital discharge for children, while steadily improving their quality of care and health outcomes.