Administration of label and off-label drugs by the subcutaneous route in palliative care: an observational cohort study

2020 ◽  
pp. bmjspcare-2020-002185
Author(s):  
Jesper Jørgen Jensen ◽  
Per Sjøgren
Keyword(s):  
Palliative Care ◽  
Drug Administration ◽  
Subcutaneous Administration ◽  
Drug Discontinuation ◽  
Subcutaneous Route ◽  
Scientific Publications ◽  
Prospective Data ◽  
Off Label ◽  
Injectable Drugs ◽  
Observational Cohort

BackgroundThe marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.AimTo assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.Material and methodsRetrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.ResultsDrugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.ConclusionSubcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

2017 ◽  
Vol 1 (3) ◽  
pp. 117-127
Author(s):  
Yasaman Mansouri ◽  
Yasmin Amir ◽  
Michelle Min ◽  
Raveena Khanna ◽  
Ruiqi Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Open Label ◽  
Post Dose ◽  
Subcutaneous Injections ◽  
Pain Scores ◽  
Observational Cohort ◽  
Vas Scores ◽  
Pre Treatment ◽  
To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

Subcutaneous administration of paracetamol—Good local tolerability in palliative care patients: An observational study

2018 ◽  
Vol 32 (7) ◽  
pp. 1216-1221 ◽  
Author(s):  
Benoît F Leheup ◽  
Stéphanie Ducousso ◽  
Stéphane Picard ◽  
Raphaël Alluin ◽  
Christophe Goetz
Keyword(s):  
Palliative Care ◽  
Observational Study ◽  
Subcutaneous Administration ◽  
Local Tolerability

PALLIATIVE CARE FOR CHILDREN WITH SEVERE, REFRACTORY DISEASES. ANALYTICAL REVIEW

2020 ◽  
Vol 66 (6) ◽  
pp. 11-11
Author(s):  
A.A. Ishutin ◽  
◽  
V.S. Stupak ◽  
T.A. Sokolovskaya ◽  
◽  
...  
Keyword(s):  
Palliative Care ◽  
Care Delivery ◽  
Well Being ◽  
Scientific Publications ◽  
Symptoms Of Depression ◽  
Balanced Assessment ◽  
Russian Scientific ◽  
Analytical Review ◽  
Refractory Diseases

Significance. Improving quality and availability of palliative care for children with severe refractory diseases is one of the main objectives of the federal and reginal authorities. The efforts are focused on improving quality of patients’ life, increasing satisfaction of patients (their legal representatives) and families with availability of palliative care, that relieves suffering of patients and reduces symptoms of depression. Purpose of the study. To analyze modern forms and methods of palliative care delivery to children with severe refractory diseases. Material and methods. The authors have conducted a content analysis of scientific publications on organization of palliative care delivery to children with severe refractory diseases. A total of 153 publications were analyzed, including 141 foreign publications for the period from 1998 to the second quarter of 2020. A total of 44 publications have been selected for the analytical review including 28 publications from the international Scopus database, 12 – from the Russian scientific citation index database, including 7 publications from the list of VAK journals (Higher Attestation Commission Journals), and 4 - materials of international medical organizations (WHO, WHA, AHA, European Council). Results. Children with severe refractory diseases need specialized medical, psychological and social assistance. Palliative care includes active and comprehensive support for physical, psychological, social and spiritual well-being of these children, relieving their suffering, from diagnosis to outcome, reducing symptoms of depression in their families, ensuring the best quality of life. More than 21 million children worldwide require palliative care every year, ranging from 20 to 120 per 10,000 children around the world. However, palliative care is often discussed in the late stages of the disease, not always resulting in its early initiation, only little more than half the patients in need receive palliative care, there are differences in tools for assessing care results. It is necessary to early initiate palliative care, increase volumes of its provision, increase the number of specialists and institutions involved in palliative care delivery, as well as implement a comprehensive balanced assessment of care results.

scholarly journals Morphine for Postoperative Analgesia. A Comparison of Intramuscular and Subcutaneous Routes of Administration

1996 ◽  
Vol 24 (5) ◽  
pp. 574-578 ◽  
Author(s):  
I. M. Cooper
Keyword(s):  
Postoperative Analgesia ◽  
Intramuscular Injection ◽  
Arterial Oxygen Saturation ◽  
Subcutaneous Administration ◽  
Arterial Oxygen ◽  
Patient Acceptance ◽  
Subcutaneous Route ◽  
Double Blind ◽  
Routes Of Administration ◽  
Pain Scores

Intermittent parenteral bolus doses of morphine are commonly used for postoperative analgesia. Morphine is typically given by intramuscular or intravenous injection but there are theoretical advantages for the subcutaneous route of administration. Fifty-nine patients entered a prospective randomized double-blind cross-over study comparing intermittent intramuscular and subcutaneous morphine boluses. Patients received 0.15 mg/kg of morphine by subcutaneous or intramuscular injection. They were reviewed at the time of injection, after 15 minutes and each hour for four hours. The majority of patients indicated a strong preference for the subcutaneous route. There were no significant differences in pain scores, respiratory rate, arterial oxygen saturation, heart rate, mean arterial pressure, sedation or nausea scores between intramuscular and subcutaneous administration of morphine. Postoperative analgesia by subcutaneous morphine bolus injection is as effective as intramuscular injection with a similar side-effect profile but with greater patient acceptance and less risk.

Subcutaneous pantoprazole in an elderly, palliative care patient

2019 ◽  
pp. bmjspcare-2019-001916
Author(s):  
Hugues Michelon ◽  
Hélène Souchu ◽  
Bénédicte Chauvron-Defilippi ◽  
Anne Lecoeur ◽  
Maryvonne Villart ◽  
...  
Keyword(s):  
Palliative Care ◽  
Linitis Plastica ◽  
Care Patient ◽  
Intravenous Route ◽  
Published Data ◽  
Clinical Safety ◽  
Off Label ◽  
Improve Patient ◽  
Efficiency Data ◽  
Interesting Alternative

Proton pump inhibitors (PPIs) have become the agents of choice for acid-related diseases. In some clinical situations, PPI therapy by oral or intravenous route may be difficult especially among elderly and patients in palliative care. Off-label PPI subcutaneous injection could be the last alternative to improve patient relief, despite limited published data. We report a case of linitis plastica, peritoneal carcinomatosis and occlusive syndrome who suffered from painful regurgitations which rapidly improved after subcutaneous pantoprazole. No related adverse effects were observed during PPI therapy. Despite some limitations, this report suggests that off-label subcutaneous pantoprazole could be an interesting alternative route when intravenous infusion may be difficult or harmful for elderly and patients in palliative care. Nevertheless, clinical safety and efficiency data on larger populations are needed to validate this use in such population.

Death in delirious palliative-care patients occurs irrespective of age: A prospective, observational cohort study of 229 delirious palliative-care patients

2020 ◽  
pp. 1-9
Author(s):  
Annina Seiler ◽  
David Blum ◽  
Caroline Hertler ◽  
Markus Schettle ◽  
Carl Moritz Zipser ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cohort Study ◽  
Care Center ◽  
Tertiary Care ◽  
Age Groups ◽  
Observational Cohort Study ◽  
Adverse Outcomes ◽  
Prospective Observational Cohort Study ◽  
Precipitating Factors ◽  
Observational Cohort

Abstract Objectives Patients with terminal illness are at high risk of developing delirium, in particular, those with multiple predisposing and precipitating risk factors. Delirium in palliative care is largely under-researched, and few studies have systematically assessed key aspects of delirium in elderly, palliative-care patients. Methods In this prospective, observational cohort study at a tertiary care center, 229 delirious palliative-care patients stratified by age: <65 (N = 105) and ≥65 years (N = 124), were analyzed with logistic regression models to identify associations with respect to predisposing and precipitating factors. Results In 88% of the patients, the underlying diagnosis was cancer. Mortality rate and median time to death did not differ significantly between the two age groups. No inter-group differences were detected with respect to gender, care requirements, length of hospital stay, or medical costs. In patients ≥65 years, exclusively predisposing factors were relevant for delirium, including hearing impairment [odds ratio (OR) 3.64; confidence interval (CI) 1.90–6.99; P < 0.001], hypertonia (OR 3.57; CI 1.84–6.92; P < 0.001), and chronic kidney disease (OR 4.84; CI 1.19–19.72; P = 0.028). In contrast, in patients <65 years, only precipitating factors were relevant for delirium, including cerebral edema (OR 0.02; CI 0.01–0.43; P = 0.012). Significance of results The results of this study demonstrate that death in delirious palliative-care patients occurs irrespective of age. The multifactorial nature and adverse outcomes of delirium across all age in these patients require clinical recognition. Potentially reversible factors should be detected early to prevent or mitigate delirium and its poor survival outcomes.

scholarly journals Tale of Two Erythropoiesis-Stimulating Agents: Utilization, Dosing, Litigation, and Costs of Darbepoetin and Epoetin Among South Carolina Medicaid-Covered Patients With Cancer and Chemotherapy-Induced Anemia

2017 ◽  
Vol 13 (6) ◽  
pp. e562-e573 ◽  
Author(s):  
Virginia Noxon ◽  
Kevin B. Knopf ◽  
LeAnn B. Norris ◽  
Brian Chen ◽  
Y. Tony Yang ◽  
...  
Keyword(s):  
South Carolina ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Advisory Committees ◽  
Criminal Conviction ◽  
Erythropoiesis Stimulating Agents ◽  
Off Label ◽  
Patient Costs ◽  
Patients With Cancer ◽  
The Us

Purpose: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA. Methods: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA. Results: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010. Conclusion: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.

Drugs to Be Used With a Filter for Preparation and/or Administration—2019

2019 ◽  
pp. 001857871986766
Author(s):  
Heather J. Ipema ◽  
Jessica M. Zacher ◽  
Eva Galka ◽  
Jonathan Nazari ◽  
Alina Varabyeva ◽  
...  
Keyword(s):  
Drug Administration ◽  
Hospital Pharmacy ◽  
Food And Drug Administration ◽  
National Standards ◽  
Injectable Drugs ◽  
Standards Of Practice ◽  
Prescribing Information

This chart is an update to the 2012 article published in Hospital Pharmacy on injectable drugs to be used with a filter. To update the chart, drugs approved from December 2011 to April 2019 were reviewed to determine if they require filtration and drugs included in the 2012 table were reviewed for accuracy. Readers are urged to review national standards of practice for information about clinical situations that warrant the use of a filter for medication preparation or administration, independent of the drug being given, and the reader should consult the Food and Drug Administration (FDA)-approved prescribing information for the most up-to-date information.

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