This research paper revolves around the process of the quantification of bupivacaine in human plasma through the selection of a sensitive high performance liquid chromatography method. The extraction of bupivacaine and ropivacaïne as an internal standard from plasma was performed through the use of hexane along with iso-propylalcohol. After liquid-liquid extraction we moved straightforward to the process of the mobile phase in which we had a combination of acetonitrile and potassium dihydrogen phosphate (65:35, v/v). The separation was carried out on a reversed phase C18 column with UV-detector at 210 nm for bupivacaine and 230nm for the internal standard. This particular examination exhibited excellent linearity (r2=0.999) in peak response over the concentration range of 0.1–1.5µg/mL bupivacaine in human plasma. The mean absolute recoveries for 0.5 and 1.5µg/mL of bupivacaine in plasma using the present extraction procedure were 97.43% and 95.03%, respectively. The intra- and inter-day coefficients of variation in the plasma were less than 12% at the lowest, and less than 10% at other concentrations, and the percent error values were less than 6%. The method displayed a high caliber of sensitivity and selectivity for therapeutic monitoring concentrations of bupivacaine in human plasma.
Nalbuphine (Nubain) is a unique opioid analgesic that was first manufactured in the 1970s. It is not a controlled substance in the United States as it was removed from the shedule II drug list in 1976 in response to assuring safety data. Considering ongooing opioid shortages in the acute settings, it is prudent to re-examine malbuphine as an analgesic for serious ill patients.
Evidence to support the use of antipsychotic medications for the management of delirium symptoms remains limited. The primary objective of this study was to compare the effect of antipsychotic and non-antipsychotic treatments for delirium symptoms among palliative care inpatients. Secondary outcomes were use of midazolam and overall survival. This involved retrospective analysis of medical records (November 2018 to April 2019) for adult palliative care patients diagnosed with delirium at an Australian tertiary hospital. NuDESC was used to assess symptoms daily from baseline to Day 3. All 65 patients (mean age 73.5 ± 13.7 years, 48% female, 59% with cancer) included received standard care which included management of underlying causes of delirium symptoms, of which 17 received additional treatment using antipsychotic medications. Forty-eight did not receive any antipsychotic medication. An absolute reduction in NuDESC score was observed in the group that did not receive additional treatment using antipsychotics (by 1.37 units, 95% CI 0.79–1.95, p < 0.0001). A significantly higher proportion of midazolam use (n = 9, 53% versus n = 2, 4%, p < 0.001) and shorter median survival (13 days versus 26 days, p = 0.03) was observed in the group of patients that received antipsychotics. The use of antipsychotic medications in addition to standard treatments targeting underlying precipitants did not lead to a significant improvement in delirium symptoms and was associated with a greater midazolam use and lower median duration of survival. Individualized treatment of underlying causes still appears to be essential in the management of delirium in patients receiving palliative care.
Objectives: The objectives of this study are to investigate how many advanced cancer patients became unconscious or non-communicative after pharmacological treatment for delirium, and to explore whether existing delirium assessment tools can successfully evaluate its severity at the end of life.
Methods: This was a secondary analysis of a registry study that examined the efficacy and safety of antipsychotics for advanced cancer patients with delirium. A total of 818 patients were recruited from 39 specialized palliative care services in Japan. The severity of delirium was measured using the Richmond Agitation-Sedation Scale-Palliative care version, the Delirium Rating Scale-Revised-98 (DRS-R-98), and the Nursing Delirium Screening Scale (Nu-DESC) on Day 3. Data from 302 patients with motor anxiety with an Agitation Distress Scale score =2 on Day 0 were analyzed for this study. The patients were categorized into four treatment response groups: complete response (CR: no agitation and fully communicative), partial response (PR: no/mild agitation and partially communicative), unconscious/non-communicative (UC), and no change (NC).
Results: On Day 3, 29 (10%; 95% confidence intervals (CI), 7-13) and 2 (1%; 95% CI, 0-2) patients became unconscious and non-communicative, respectively. Forty-four patients were categorized as CR, 97 as PR, 31 as UC, and 96 as NC. The scores of the DRS-R-98 and Nu-DESC in the UC group were rated higher than patients in the NC group were.
Conclusions: A considerable number of cancer patients with delirium became unconscious or non-communicative. Existing delirium assessment tools may be inappropriate for measuring the severity of delirium in end-of-life.
BACKGROUND: Refractory status epilepticus (RSE) represents a serious medical condition requiring early and targeted therapy. Given the increasing number of elderly or multimorbid patients with a limitation of life-sustaining therapy (LOT) or within a palliative care setting (PCS), guidelines-oriented therapy escalation options for RSE have to be omitted frequently.
OBJECTIVES: This systematic review sought to summarize the evidence for fourth-line antiseizure drugs (ASDs) and other minimally or non-invasive therapeutic options beyond guideline recommendations in patients with RSE to elaborate on possible treatment options for patients undergoing LOT or in a PCS.
METHODS: A systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, focusing on fourth-line ASDs or other minimally or non-invasive therapeutic options was performed in February and June 2020 using the MEDLINE, EMBASE and Cochrane databases. The search terminology was constructed using the name of the specific ASD or therapy option and the term 'status epilepticus' with the use of Boolean operators, e.g. "(brivaracetam) AND (status epilepticus)". The respective Medical Subject Headings (MeSH) and Emtree terms were used, if available.
RESULTS: There is currently no level 1, grade A evidence for the use of ASDs in RSE. The best evidence was found for the use of lacosamide and topiramate (level 3, grade C), followed by brivaracetam, perampanel (each level 4, grade D) and stiripentol, oxcarbazepine and zonisamide (each level 5, grade D). Regarding non-medicinal options, there is little evidence for the use of the ketogenic diet (level 4, grade D) and magnesium sulfate (level 5, grade D) in RSE. The broad use of immunomodulatory or immunosuppressive treatment options in the absence of a presumed autoimmune etiology cannot be recommended; however, if an autoimmune etiology is assumed, steroid pulse, intravenous immunoglobulins and plasma exchange/plasmapheresis should be considered (level 4, grade D). Even if several studies suggested that the use of neurosteroids (level 5, grade D) is beneficial in RSE, the current data situation indicates that there is formal evidence against it.
CONCLUSIONS: RSE in patients undergoing LOT or in a PCS represents a challenge for modern clinicians and epileptologists. The evidence for the use of ASDs in RSE beyond that in current guidelines is low, but several effective and well-tolerated options are available that should be considered in this patient population. More so than in any other population, advance care planning, advance directives, and medical ethical aspects have to be considered carefully before and during therapy.
OBJECTIVES: The issue of polypharmacy and medication use in people with life limiting illness raises important questions from a clinical and ethical viewpoint. The objectives of our study were to (1) explore medication use among people with life limiting illness receiving hospice care; (2) apply consensus criteria to assess medication appropriateness; and (3) determine the overall pill burden in this patient population.
METHODS: Six hospices in the North East of England were included. All deceased adult patients who received hospice care in 2018 were eligible for study inclusion. Descriptive statistics were used to report medication details; while medication appropriateness was assessed according to consensus criteria developed by Morin and colleagues.
RESULTS: Six hundred and ninety patients were included in the study. Patients were using a mean number of 8.8 medications per day, while polypharmacy was evident in 80% of patients. In terms of potentially questionable medication, patients were prescribed a mean number of 1.3 per day. Common potentially questionable medications included vitamin and mineral supplements, antihypertensives, antiplatelets, lipid regulating agents and anticoagulants. The pill burden in this population was also high with, on average, people using 13.7 oral doses per day.
CONCLUSIONS: Polypharmacy is common in patients accessing hospice care, as is the use of potentially questionable medication. The pill burden in this patient population is also high, which may be an additional treatment burden to patients. Holistic deprescribing approaches for this population should be developed and implemented.
BACKGROUND: Infections are common in terminally ill patients (pts), and although antibiotics are frequently prescribed, their benefit for symptom relief is not clear. Antimicrobials at the end of life (EOL) may increase the risk of antimicrobial resistance and Clostrioides difficile infection. Our aim was to determine the frequency of symptom occurrence at the EOL when comparing pts who did or did not receive antibiotics (AB+ or AB-).
METHODS: We reviewed electronic medical records of pts admitted to a palliative care unit of a quarternary care hospital between 01/09/2017 and 07/16/2017 and assessed antimicrobial use in the last 14 days of life. Differences in demographics and symptom control between AB+ and AB- pts were analyzed using chi-square analyses; p-values were computed using Mann-Whitney tests.
RESULTS: Of a total of 133 pts included, 90 (68%) received antimicrobials (AB+). The indication for antibiotics was documented in only 12% of pts. The AB+ and AB- groups were similar with respect to demographics, including sex, and Charleston Comorbidity Index except for age (p = 0.01) and race (p = 0.03). Documented infections were similar between AB+ and AB- groups, except urinary tract infections. No statistically significant differences were noted in documented symptoms including pain, dyspnea, fever, lethargy, and alteration of mental state or length of stay.
CONCLUSION: Our study did not show differences in frequencies of documented symptoms with use of antimicrobials at EOL. Antimicrobial stewardship programs and further research can help with developing EOL care antimicrobial guidelines supporting patients and providers through shared decision-making.
PURPOSE: To review and summarize the most frequent medications and dosages used during withholding and withdrawal of life-prolonging measures in critically ill patients in the intensive care unit.
METHODS: We searched PubMed, EMBASE, the Cochrane Database of Systematic Reviews, and the Virtual Health Library from inception through March 2019. We considered any study evaluating pharmaceutical interventions for pain management during the withholding or withdrawing of life support in adult critically ill patients at the end-of-life. Two independent investigators performed the screening and data extraction. We pooled data on utilization rate of analgesic and sedative drugs and summarized the dosing between the moment prior to withholding or withdrawal of life support and the moment before death.
RESULTS: Thirteen studies met inclusion criteria. Studies were conducted in the United States (38%), Canada (31%), and the Netherlands (31%). Eleven studies were single-cohort and twelve had a Newcastle-Ottawa Scale score of less than 7. The mean age of the patients ranged from 59 to 71 years, 59-100% were mechanically ventilated, and 47-100% of the patients underwent life support withdrawal. The most commonly used opioid and sedative were morphine [utilization rate 60% (95% CI 48-71%)] and midazolam [utilization rate 28% (95% CI 23-32%)], respectively. Doses increased during the end-of-life process (pooled mean increase in the dose of morphine: 2.6 mg/h, 95% CI 1.2-4).
CONCLUSIONS: Pain control is centered on opioids and adjunctive benzodiazepines, with dosages exceeding those recommended by guidelines. Despite consistency among guidelines, there is significant heterogeneity among practices in end-of-life care.
OBJECTIVES: A vital component of the coronavirus response is care of the dying COVID-19 patient. We document the demographics, symptoms experienced, medications required, effectiveness observed, and challenges to high-quality holistic palliative care in 31 patients. This will aid colleagues in primary and secondary care settings anticipate common symptoms and formulate management plans.
METHODS: A retrospective survey was conducted of patients referred to the hospital palliative care service in a tertiary hospital, south east of England between March 21 and April 26, 2020. Patients included had a confirmed laboratory diagnosis of COVID-19 via reverse transcription polymerase chain reaction nasopharyngeal swab for SARS-Cov-2 or radiological evidence of COVID-19.
RESULTS: The thirty-one patients included were predominantly male (77%), elderly (median [interquartile range]: 84 [76-89]), and had multiple (4 [3-5]) comorbidities. Referral was made in the last 2 [1-3] days of life. Common symptoms were breathlessness (84%) and delirium (77%). Fifty-eight percent of patients received at least 1 "as required" dose of an opioid or midazolam in the 24 hours before death. Sixty percent of patients needed a continuous subcutaneous infusion and the median morphine dose was 10 mg S/C per 24 hours and midazolam 10 mg S/C per 24 hours. Nineteen percent of our cohort had a loved one or relative present when dying.
CONCLUSION: We provide additional data to the internationally reported pool examining death arising from infection with SARS-CoV-19. The majority of patients had symptoms controlled with low doses of morphine and midazolam, and death was rapid. The impact of low visitation during dying needs exploring.
Patients frequently have comorbidities that when combined with their primary diagnosis qualifies the patient for hospice. Consequently, patients are at risk for polypharmacy due to the number of medications prescribed to treat both the underlying conditions and the related symptoms. Polypharmacy is associated with negative consequences, including increased risk for adverse drug events, drug-drug and drug-disease interactions, reduced functional status and falls, multiple geriatric syndromes, medication nonadherence, and increased mortality. Polypharmacy also increases the complexity of medication management for caregivers and contributes to the cost of prescription drugs for hospices and patients. Deprescribing or removing nonbeneficial or ineffective medications can reduce polypharmacy in hospice. We study medication possession ratios and rates of deprescribing of commonly prescribed but potentially nonbeneficial classes of medication using a large hospice pharmacy database. Prevalence of some classes of potentially inappropriate medications is high. We report possession ratios for 10 frequently prescribed classes, and, because death and prescription termination are competing events, we calculate prescription termination rates using Cumulative Incidence Functions. Median duration of antifungal and antiviral medications is brief (5 and 7 days, respectively), while statins and diabetes medications have slow discontinuance rates (median termination durations of 93 and 197 days). Almost all patients with a proton pump inhibitor prescription have the drug for their entire hospice stay. Data from this study identify those drug classes that are commonly deprescribed slowly, suggesting drug classes and diagnoses that hospices may wish to focus on more closely, as they act to limit polypharmacy and reduce prescription costs.
BACKGROUND: Fibrotic interstitial lung diseases (f-ILDs) are often progressive and incurable. As patients experience significant symptoms and have a poor prognosis, early palliative care referral is recommended.
OBJECTIVE: To examine the care delivered to patients with f-ILD during the terminal hospital admission and the past 2 years of life.
METHODS: A retrospective audit was performed for consecutive patients who died from f-ILD at 2 Australian teaching hospitals between January 1, 2012, and December 31, 2016.
RESULTS: Of 67 patients, 44 (66%) had idiopathic pulmonary fibrosis. Median age was 78 years. Median respiratory function: forced expiratory volume in 1 second 69.0% predicted (interquartile range [IQR]: 58.0%-77.0%), forced vital capacity 64.0% predicted (IQR = 46.8%-74.3%), and diffusing capacity of carbon monoxide 36.0% predicted (IQR = 31.0%-44.0%). In the 2 years prior to the terminal admission, 38 (57%) patients reported severe breathlessness and 17 (25%) used opioids for symptom relief. Twenty-four (36%) patients received specialist palliative care (SPC) and 11 (16%) completed advance care planning. During the terminal admission, 10 (15%) patients were admitted directly under SPC. A further 33 (49%) patients were referred to SPC, on average 1 day prior to death. Sixty-three (94%) patients received opioids and 49 (73%) received benzodiazepines for symptom management. Median starting and final opioid doses were 10 and 23 mg oral morphine equivalent/24 hours, respectively. Opioids were commenced on average 2 (IQR 1-3) days prior to death.
CONCLUSIONS: Although most patients were identified as actively dying in the final admission, referral to SPC and use of palliative medications occurred late. Additionally, few patients accessed symptom palliation earlier in their illness.
OBJECTIVES: to describe the experience of conducting workshops for teaching the subcutaneous fluid infusion therapy in palliative care patients.
METHODS: experience report based on four workshops with a workload of nine hours each, addressing the teaching, implementation of the technique, and management in the use of subcutaneous fluid infusion therapy in patients in palliative care. The host institution was a private hospital, which had two care units in the state of Rio de Janeiro.
RESULTS: we identified little knowledge about the theme. Due to the dynamics used, the workshops made it possible to qualify the participants to perform and manage the subcutaneous route in palliative care environments.
CONCLUSIONS: the workshops were an important means of training, qualification, and dissemination of nursing care in a palliative care environment. The resources used to enable the qualification in the execution and management of the presented technique.
Background: Palliative care has been widely implemented in clinical practice for patients with cancer but is not routinely provided to people with chronic obstructive pulmonary disease.
Aim: The study aims were to compare palliative care services, medications, life-sustaining interventions, place of death, symptom burden and health-related quality of life among chronic obstructive pulmonary disease and lung cancer populations.
Design: Systematic review with meta-analysis (PROSPERO: CRD42019139425).
Data sources: MEDLINE, EMBASE, PubMed, CINAHL and PsycINFO were searched for studies comparing palliative care, symptom burden or health-related quality of life among chronic obstructive pulmonary disease, lung cancer or populations with both conditions. Quality scores were assigned using the QualSyst tool.
Results: Nineteen studies were included. There was significant heterogeneity in study design and sample size. A random effects meta-analysis ( n = 3–7) determined that people with lung cancer had higher odds of receiving hospital (odds ratio: 9.95, 95% confidence interval: 6.37–15.55, p < 0.001) or home-based palliative care (8.79, 6.76–11.43, p < 0.001), opioids (4.76, 1.87–12.11, p = 0.001), sedatives (2.03, 1.78–2.32, p < 0.001) and dying at home (1.47, 1.14–1.89, p = 0.003) compared to people with chronic obstructive pulmonary disease. People with lung cancer had lower odds of receiving invasive ventilation (0.26, 0.22–0.32, p < 0.001), non-invasive ventilation (0.63, 0.44–0.89, p = 0.009), cardiopulmonary resuscitation (0.29, 0.18–0.47, p < 0.001) or dying at a nursing home/long-term care facility (0.32, 0.16–0.64, p < 0.001) than people with chronic obstructive pulmonary disease. Symptom burden and health-related quality of life were relatively similar between the two populations.
Conclusion: People with chronic obstructive pulmonary disease receive less palliative measures at the end of life compared to people with lung cancer, despite a relatively similar symptom profile.
Objectives: This study aimed to identify gaps in palliative care (PC) provision across the National Cancer Grid (NCG) centres in India.
Methods: We performed a cross-sectional validated web-based survey on 102 NCG cancer centres (Nov ’17 to April ’18). The survey questionnaire had seven sections collecting data relating to the capacity to provide cancer care and PC, drug availability for pain and symptom control, education, advocacy, and quality assurance activities for PC.
Results: Eighty-nine NCG centres responded for this study—72.5% of centres had doctors with generalist PC training, whereas 34.1% of centres had full-time PC physicians; 53.8% had nurses with 6 weeks of PC training; 68.1% of the centres have an outpatient PC and 66.3% have the facility to provide inpatient PC; 38.5% of centres offer home-based PC services; 44% of the centres make a hospice referral and 68.1% of the centres offer concurrent cancer therapy alongside PC. Among the centres, 84.3% have a licence to procure, store and dispense opioids, but only 77.5% have an uninterrupted supply of oral morphine for patients; 61.5% centres have no dedicated funds for PC, 23.1% centres have no support from hospital administration, staff shortage—69.2% have no social workers, 60.4% have no counsellors and 76.9% have no volunteers. Although end-of-life care is recognised, there is a lack of institutional policy. Very few centres take part in quality control measures.
Conclusions: The majority of the NCG centres have the facilities to provide PC but suffer from poor implementation of existing policies, funding and human resources.
Dexmedetomidine is a selective a2-adrenoreceptor agonist with a broad range of effects, including easily controllable sedation, analgesia and anxiolysis. Because of these favorable features, it has replaced traditional sedatives, such as benzodiazepines, and is becoming the first-line sedative for the patients in intensive care units. Terminally ill patients often need sedatives for symptom management, especially for dyspnoea. However, the use of dexmedetomidine in a palliative care setting has rarely been recognised to date. We experienced a patient nearing the end of life due to uncontrollable pulmonary haemorrhage on ventilator, whose dyspnoea was successfully managed by dexmedetomidine in addition to continuous intravenous infusion of oxycodone.
Context: Off-label and unlicensed use of drugs is a widespread practice in pediatric care due to the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, though no studies have established the prevalence of this practice.
Aim: to describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit.
Methods: A prospective, cross-sectional observational study carried out between January and October 2019.
Setting/participants: The study included all patients admitted to the pediatric palliative care unit for home hospitalization and with at least one prescribed drug treatment.
Results: eighty-five patients involving 1198 prescriptions were analyzed. A total of 39.6% were off-label and 12.9% were unlicensed. All received at least one off-label drug, with a median of 5 per patient (IQR = 3–7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off-label due to indication, 33.8% due to dosage, and 26.6% due to age. The main drugs used off-label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting.
Conclusions: Over half of the prescriptions in this PPCU were off-label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.
Context: Uremic pruritus (UP) affects up to half of all patients with kidney disease and has been independently associated with poor patient outcomes. UP is a challenging symptom for clinicians to manage as there are no validated guidelines for its treatment.
Objectives: The study aimed to develop and validate an algorithm and patient information toolkit for the treatment of UP in patients with kidney disease.
Methods: The study involved a literature search and development of an initial draft algorithm, followed by content and face validation of this algorithm. Validation entailed three rounds of interviews with six nephrology clinicians per round. Participants assessed the relevance of each component of the algorithm and then rated a series of statements on a scale of 1-5 to assess face validity of the algorithm. After each round, the content validity index (CVI) of each algorithm component was calculated, and the algorithm was revised by the study team in response to findings. This process was followed by a second study that developed and validated a patient information pamphlet and video.
Results: Algorithm validation participants were affiliated with three institutions and included seven physicians, four registered nurses, three nurse practitioners, three pharmacists, and a dietician. The average CVI of the algorithm components across all three rounds was 0.89, with 0.80 commonly cited as the lower acceptable limit for content validation. More than 78% of participants rated each face validity statement as “Agree” or “Strongly Agree”. For the patient information tools, five clinicians and 15 patients were included in validation. The average CVI was 1.00 for both tools, and the average face validity was 92%.
Conclusion: A treatment algorithm and patient information toolkit for managing UP in patients with kidney disease were developed and validated through expert review. Further research will be conducted on implementation of the treatment algorithm and evaluating patient-reported outcomes.
Context: Older adults with advanced lung cancer experience high symptom burden at end of life (EOL), yet hospice enrollment often happens late or not at all. Receipt of medications to manage symptoms in the outpatient setting, outside the Medicare hospice benefit, has not been described.
Objectives: We examined patterns of symptom management medication receipt at EOL for older adults who died of lung cancer.
Methods: This retrospective cohort used the Surveillance, Epidemiology, and End Results—Medicare database to identify decedents diagnosed with lung cancer at age 67 years and older between January 2008 and December 2013 who survived six months and greater after diagnosis. Using Medicare Part B and D claims, we identified monthly receipt of outpatient medications for symptomatic management of pain, emotional distress, fatigue, dyspnea, anorexia, and nausea/vomiting. Multivariable logistic regression estimated associations between medication receipt and patient demographic characteristics, comorbidity, and concurrent therapy.
Results: Of the 16,246 included patients, large proportions received medications for dyspnea (70.7%), pain (62.5%), and emotional distress (49.4%), with lower prevalence for other symptoms. Medication receipt increased from six months to one month before death. Women and dual Medicaid enrolled were more likely to receive medications for pain, emotional distress, dyspnea, and nausea/vomiting. Receipt of symptom management medications decreased with increasing age and racial/ethnical minorities.
Conclusion: Symptom management medication receipt was common and increasing toward EOL. Lower use by males, older adults, and nonwhites may reflect poor access or poor patient-provider communication. Further research is needed to understand these patterns and assess adequacy of symptom management in the outpatient setting.
Objectives: Common terminal phase symptoms include pain, dyspnoea, anxiety, terminal restlessness, nausea and noisy breathing. This study identified the proportion of community pharmacies across two Australian states stocking medicines useful in managing terminal phase symptoms, while exploring factors considered predictive of pharmacies carrying these medicines.
Methods: Community pharmacies from across the states of New South Wales (NSW) and South Australia (SA) were concurrently mailed a survey. Respondents were asked questions relating to medicines stocked, expiry date of stock, awareness of people with palliative care needs and demographic characteristics of the pharmacy. A ‘prepared pharmacy’ was defined as a pharmacy that held medicines useful in the management of terminal phase symptoms.
Results: The proportion of prepared pharmacies across NSW and SA was 21.9%. Multiple logistic regression demonstrated eight predictors of prepared pharmacies, of which awareness of people with palliative needs using their service was the strongest.
Conclusions: One-fifth of community pharmacies carry formulations useful in managing terminal phase symptoms. The main factor associated with this was awareness of people with palliative needs using the pharmacy. Strategies that engage with pharmacists in anticipation of the terminal phase are critical, supporting people with palliative needs to remain at home to die, if desired.
OBJECTIVES: The use of drugs beyond their marketing authorisation, that is, off-label use, is common practice in palliative care with over 70% of off-label use having little or no scientific support. The lack of evidence makes recommendations for off-label use essential, in order to increase the safety of drug therapy and thus patient safety. The aim of this study was to develop a guide for preparing and consenting drug-specific recommendations for off-label use in palliative care.
METHODS: Group Delphi Study with three rounds and a prior online survey to identify topics of dissent. Participants represented professional groups working in palliative care involved in direct patient care and/or drug management and various care settings. Furthermore, representatives of relevant professional associations, experts with academic, non-clinical background and experts with international expertise were invited.
RESULTS: 18/20 invited professionals participated in the prior online-survey. 15 experts participated in the Group Delphi process. Six domains, including identification of drugs, drug uses, assessment of evidence, formulation, consensus and updating of recommendations were generated and respective statements were included in the Group Delphi process. The consensus process resulted in 28 statements forming the guide for recommendations.
CONCLUSIONS: The resultant systematic approach for preparing and consenting drug-specific recommendations for off-label use will allow the development of recommendations with transparent and reproducible monographs. This will help to increase treatment quality and patient safety as well as security of decision-making in palliative care. The developed guide is part of a larger project aiming to provide therapy recommendations for areas that have little or no scientific evidence.