White Paper for Global Palliative Care Advocacy: Recommendations from a PAL-LIFE Expert Advisory Group of the Pontifical Academy for Life, Vatican City.

BACKGROUND: The Pontifical Academy for Life (PAV) is an academic institution of the Holy See (Vatican), which aims to develop and promote Catholic teachings on questions of biomedical ethics. Palliative care (PC) experts from around the world professing different faiths were invited by the PAV to develop strategic recommendations for the global development of PC ("PAL-LIFE group"). DESIGN: Thirteen experts in PC advocacy participated in an online Delphi process. In four iterative rounds, participants were asked to identify the most significant stakeholder groups and then propose for each, strategic recommendations to advance PC. Each round incorporated the feedback from previous rounds until consensus was achieved on the most important recommendations. In a last step, the ad hoc group was asked to rank the stakeholders' groups by order of importance on a 13-point scale and to propose suggestions for implementation. A cluster analysis provided a classification of the stakeholders in different levels of importance for PC development. RESULTS: Thirteen stakeholder groups and 43 recommendations resulted from the first round, and, of those, 13 recommendations were chosen as the most important (1 for each stakeholder group). Five groups had higher scores. The recommendation chosen for these top 5 groups were as follows: (1) Policy makers: Ensure universal access to PC; (2) Academia: Offer mandatory PC courses to undergraduates; (3) Healthcare workers: PC professionals should receive adequate certification; (4) Hospitals and healthcare centers: Every healthcare center should ensure access to PC medicines; and (5) PC associations: National Associations should be effective advocates and work with their governments in the process of implementing international policy framework. A recommendation for each of the remaining eight groups is also presented. DISCUSSION: This white paper represents a position statement of the PAV developed through a consensus process in regard to advocacy strategies for the advancement of PC in the world.

Documento de Posición Oficial sobre la Promoción Global de Cuidados Paliativos: Recomendaciones del Grupo Internacional Asesor PAL-LIFE de la Academia Pontificia de la Vida, Ciudad del Vaticano.

Resumen Contexto: La Academia Pontificia de la Vida (PAV) es una institución académica de la Santa Sede (Vaticano) cuyo objetivo es promover una visión católica de la ética biomédica. La PAV invitó a una serie de expertos en Cuidados Paliativos (CP) de todo el mundo, de todas las creencias, a desarrollar recomendaciones estratégicas para el desarrollo global de CP ("Grupo PAL-LIFE"). Diseño: Trece expertos internacionales reconocidos por su actividad promotora global de CP participaron en un estudio Delphi on-line. En un proceso de cuatro rondas, se pidió a los participantes que identificasen los grupos de interés o instituciones claves para la promoción de CP y que propusieran, para cada uno de ellos, recomendaciones estratégicas para el desarrollo de CP. Cada ronda incorporaba los comentarios de las rondas previas hasta lograr el consenso en las recomendaciones más importantes. En una última fase, al grupo de expertos se le solicitó la jerarquización por importancia de los grupos clave en una escala de 1 a 13. También se solicitaron sugerencias concretas para la implementación de las recomendaciones. Mediante análisis clúster se ordenaron los grupos de interés en dos niveles de importancia para el desarrollo de CP. Resultados: Trece recomendaciones fueron seleccionadas como las más importantes (una por cada grupo clave). Las recomendaciones para los grupos mejor puntuados fueron: (1) Responsables Políticos: garantizar el acceso universal a los CP; (2) Academia: ofrecer cursos obligatorios de CP en el pregrado; (3) Profesionales sanitarios: promover una certificación adecuada; (4) Hospitales e Instituciones sanitarias: asegurar el acceso a medicamentos de CP; y (5) Asociaciones de CP: ser promotoras eficaces y trabajar con los gobiernos en la implementación de las recomendaciones internacionales sobre CP. También se presentan recomendaciones para los ocho grupos clave restantes. Discusión: Este documento representa la posición oficial de la PAV en lo que respecta a estrategias de promoción para el desarrollo de los CP en el mundo.

Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain.

CONTEXT: We recently reported that fentanyl pectin nasal spray (FPNS) provides superior pain relief from breakthrough cancer pain (BTCP) compared with immediate-release morphine sulfate (IRMS), with significant effects by five minutes and clinically meaningful pain relief from 10 minutes postdose. OBJECTIVES: To report the consistency of efficacy, tolerability, and patient acceptability of FPNS vs. IRMS. METHODS: Patients (n=110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Those who completed an open-label titration phase (n=84) continued to a DB/DD phase; 10 episodes were randomly treated with FPNS and overencapsulated placebo or IRMS and nasal spray placebo (five episodes each). Pain intensity (PI) and pain relief scores were assessed. Patient acceptability scores were assessed at 30 and 60 minutes. Safety and tolerability were assessed by adverse events (AEs) and nasal assessments. RESULTS: Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than IRMS; by 10 minutes, there were significant differences in PI difference scores and in the percentages of episodes showing clinically meaningful pain relief (P<0.05). Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 (P<0.01) and 60 (P<0.05) minutes. Patients were "satisfied/very satisfied" with the convenience (79.8%) and ease of use (77.2%) of FPNS. Only 4.7% of patients withdrew from titration because of AEs; no significant nasal effects were reported. CONCLUSION: This study demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with BTCP.

Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients.

OBJECTIVE: to assess the long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer pain (BTCP). DESIGN: a multicenter, open-label study. PATIENTS: patients with chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent experiencing 1-4 episodes per day of BTCP. INTERVENTION: all patients entered into a 16-week treatment phase after undergoing a dose-titration phase with FPNS. MAIN OUTCOME MEASURES: safety and tolerability were assessed by adverse events (AEs) and by nasal tolerability assessments. Consistency of effect was monitored through additional rescue medication use and FPNS dose change. RESULTS: four hundred three patients were included in the safety analyses. Of these, 356 patients entered the treatment phase and 110 patients completed the study. FPNS was self-administered for 42,227 episodes. During the treatment phase, 99 patients (24.6 percent) reported treatment-related AEs; most were mild or moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 percent), but only five were considered related to study drug. Of the 80 deaths that occurred during this study, one was assessed as possibly related to study drug. Nasal assessments revealed no significant local effects. No additional rescue medication was required after 94 percent of FPNS-treated episodes. More than 90 percent of patients required no increase in their initial dose of FPNS. CONCLUSIONS: FPNS use for BTCP was associated with AEs, typical of opioids, with no evidence of nasal toxicity. A large proportion of BTCP episodes were treated with a single dose, and doses remained stable over the 4-month period.

[Nasal application of fentanyl citrate as symptom control against breathlessness in palliative care--overview and case report]. / Nasale Anwendung von Fentanylzitrat zur Kupierung von Atemnot in der Palliativversorgung - Uberblick und Fallbeispiel.

Severe dyspnoea is the most threatening symptom of the dying and one of the main reasons for undesirable hospitalisation in end of life. Especially in home care there is a need for a noninvasive, safe and highly effective method for symptom control. Fentanyl is an appropriate drug because of its fast onset and short duration of action. Since 2003 medicated the Palliative Net Easthessia (PNO) more than 600 home care patients with nasal Fentanyl (naF). The method is simple and the user should bear in mind that the substance is highly effective. Both physician and pharmacist should inform themselves adequately before the first use about the basics of the manufacturing and use. Two typical case reports will be shown. Clinical experience let us assume that intranasal administration against dyspnoea is not inferior to the intravenous symptom control. In ambulant care caused by the use of the caring relatives or the patients themselves non-invasivity is a great advantage. Prospective studies are in need to prove the method.