Statistical estimation of deltoid subcutaneous fat pad thickness: implications for needle length for vaccination.

Current US Centers for Disease Control and Prevention intramuscular injection needle length guidelines for injection fo the deltoid muscle are based on weight and gender. The aims of this study are (1) to evaluate whether other biometric data (age, gender, height, weight and body mass index (BMI)) are better predictors of the thickness of the deltoid subcutaneous fat pad (DSFP) than weight and gender and (2) to evaluate the performance of the CDC weight-based needle length guidelines. This was a retrospective single center cohort study of 386 patients who underwent surveillance PET/CT between 01/01/2020 and 04/01/2021. Patient age, gender, height, weight, BMI and CT measurements of the DSFP were evaluated. DSFP was positively correlated with weight and BMI in men (r = 0.67, P < 0.001; r = 0.74, P < 0.001) and women (r = 0.69, P < 0.001; r = 0.75, P < 0.001) respectively. DSFP was negatively correlated with age in women (r = - 0.19, P = 0.013). Age and BMI were better predictors of DSFP than weight. The best model to predict the DSFP is: [Formula: see text] A 1-inch needle is expected to reach the deltoid in 85.3% of women less than 200 pounds, and 98.6% of men less than 260 pounds. This rate differed between genders (P < 0.001, odds ratio (OR) 0.08, 95% CI (0.02, 0.29)). A 1.5-inch needle is expected to reach the deltoid in 76.7% of women greater than 200 pounds, and 75.0% of men greater than 260 pounds. Current CDC deltoid intramuscular injection needle length guidelines result in women and obese individuals being more likely to receive subcutaneous injections. Age and BMI based guidelines for needle length selection are more accurate.

Transition from Intravenous to Subcutaneous Daratumumab Formulation in Clinical Practice.

INTRODUCTION: Daratumumab is an anti-CD38 monoclonal antibody widely used for treating patients with newly diagnosed or relapsed/refractory multiple myeloma. The subcutaneous formulation of daratumumab was developed with the purpose of minimizing the treatment burden (to patients and health care system) associated with intravenous daratumumab. Given its recent approval, there is a knowledge gap regarding the best practices that should be instituted for safe administration of subcutaneous daratumumab. METHODS: A retrospective chart review was performed from August 2020 until November 2020 to identify patients either switched to or treated upfront (daratumumab naive) with any subcutaneous daratumumab-based treatment regimen. All patients received appropriate premedications per institutional standards of care. The study end points were to report real-world data regarding administration-related reaction rates (at or following discharge from infusion center), as well as compare their incidence rates to those noted in the COLUMBA study (historical cohort). RESULTS: The study included 58 patients, of whom 38% (n = 22) were daratumumab naive. The majority (84%, n = 49) received subcutaneous daratumumab in combination with various antimyeloma regimens. There were no cases of administration-related reactions at infusion center or after discharge irrespective of previous exposure to intravenous daratumumab. None of the patients included herein required rescue home medications or visited the emergency department within 24 to 48 hours after subcutaneous daratumumab administration. These translated into a significant difference in incidence of administration-related reactions compared with historical cohort (0% vs. 13%, P = .003). CONCLUSION: Subcutaneous daratumumab was extremely well tolerated and could be safely administered without need for monitoring or rescue home medications.

Alternative Clinical Indications of Botulinum Toxin.

Botulinum toxin type A (BoNTA) is a powerful neurotoxin that inhibits acetylcholine release from presynaptic vesicles. The potency and safety profile of BoNTA grant the toxin vast therapeutic potential. It has been used off-label for a variety of dermatologic conditions. This review aims to analyze published literature regarding the benefits and risks of the off-label use of BoNTA beyond facial lines, including eccrine hidrocystomas, enlarged pores, keloids and hypertrophic scars, hidradenitis suppurativa, hyperhidrosis, masseter muscle hypertrophy, and salivary gland hypertrophy, among others. A MEDLINE search from January 2000 to December 2019 was conducted on the off-label uses of botulinum toxin in dermatology.

Establishing a Standardized Facial Cosmetic Preinjection Safety Tool: The ACIST.

In the past 20 years, the American population has seen an increased demand for nonsurgical minimally invasive facial rejuvenation solutions for the aging process. This widespread and increased demand for cosmetic injections brings a greater propensity for complications and adverse events. Choosing suitable patients for dermal filler is essential, as is concrete knowledge of the factors related to adverse events; however, there was no standardized tool to facilitate this process. The Joint Commission's Universal Safety checklist tools have been integrated into hospital surgical operating rooms and ambulatory outpatient settings across America and internationally and have successfully reduced errors in patient safety and outcomes. This article establishes the importance of integrating the Assessment Cosmetic Injection Safety Tool (ACIST), a standardized preinjection safety tool, into the cosmetic practice to decrease the incidence of adverse events associated with dermal filler and to achieve optimal patient satisfaction and outcomes. The ACIST was designed from the scientific literature, piloted at an urban cosmetic practice in the southern United States, finalized on the basis of feedback from participating staff members at the pilot study center, and disseminated to cosmetic nurse injectors.

Differentiating Nonpermanent Injectable Fillers: Prevention and Treatment of Filler Complications.

Though the incidence of complications and adverse events with dermatological fillers is inherently low, practitioners should be well versed in both prevention of filler complications and the treatment algorithms for addressing "granulomas," nodules, infection, and vascular compromise. Appropriate preventative measures, coupled with timely and effective treatment, are critically important for patient safety and satisfaction. In addition to the preventive measures and treatment algorithms outlined here, the authors emphasize that the broad classification and treatment of nodules as "granulomas" is likely to lead to ineffective treatment, or worse, unnecessary exposure to incorrect treatment. In practice, nodules are classified and treated based on clinical manifestation (eg, late vs early or noninflammatory vs inflammatory) rather than on histology. Indeed, classification of a nodule as a granuloma requires a histological examination, rarely available (or necessary) in clinical practice to guide treatment. Thus, the apparent inflammatory nature of the nodule and the time of onset should drive treatment approach. The treatment algorithms presented here are based on these clinically meaningful parameters.

Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development.

Rituximab (MabThera®/Rituxan®), a chimeric murine/human monoclonal antibody that binds specifically to the transmembrane antigen CD20, was the first therapeutic antibody to enter clinical practice for the treatment of cancer. As monotherapy and in combination with chemotherapy, rituximab has been shown to prolong progression-free survival and, in some indications overall survival, in patients with various B-cell malignancies, while having a well-established and manageable safety profile and a wide therapeutic window. As a result, rituximab is considered to have revolutionized treatment practices for patients with B-cell malignancies. A subcutaneous (SC) formulation of rituximab has been developed, comprising the same monoclonal antibody as the originally marketed formulation [rituximab concentrate for solution for intravenous (IV) infusion], and has undergone a detailed, sequential clinical development program. This program demonstrated that, at fixed doses, rituximab SC achieves non-inferior serum trough concentrations in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia, with comparable efficacy and safety relative to the IV formulation. The added benefit of rituximab SC was demonstrated in dedicated studies showing that rituximab SC allows for simplified and shortened drug preparation and administration times resulting in a reduced treatment burden for patients as well as improved resource utilization (efficiency) at the treatment facility. The improved efficiency of delivering rituximab's benefit to patients may broaden patient access to rituximab therapy in areas with low levels of healthcare resources, including IV-chair capacity constraints. This article is a companion paper to G. Salles, et al., which is also published in this issue. FUNDING: F. Hoffmann-La Roche Ltd.

Taking the alternative route: Women's experience of intranasal fentanyl, subcutaneous fentanyl or intramuscular pethidine for labour analgesia.

OBJECTIVE: To compare women's experience of receiving either intranasal fentanyl, subcutaneous fentanyl or intramuscular pethidine for labour analgesia. DESIGN: A content analysis was undertaken as part of the third phase of a larger randomised controlled trial, using the per-protocol dataset to examine women's experiences of treatment received. Healthy women birthing at term, who received intranasal fentanyl (n=41), subcutaneous fentanyl (n=37) and/or intramuscular pethidine (n=38) for labour analgesia, were contacted at 6 weeks postpartum to complete a phone questionnaire. SETTING: A tertiary and regional maternity unit in South Australia. FINDINGS: Over 80% of women who received intranasal or subcutaneous fentanyl reported that they would use the treatment again compared to 44.8% of women who had received pethidine (self-administered intranasal fentanyl provided more expressive responses emphasising the route provided a strong sense of control and enablement. KEY CONCLUSIONS: Route of administration influenced the women's experience, more women who self-administered intranasal fentanyl reported positive emotional responses, with women reporting increased autonomy and satisfaction. Whereas, women who relied on the midwife to administer subcutaneous fentanyl or intramuscular pethidine, were more often focused on the physical effect of the drug. Pethidine was the least preferred option due to adverse effects. IMPLICATIONS FOR PRACTICE: For women requesting parenteral analgesia, fentanyl administered by less invasive routes offers women additional options that may better meet their emotional, cognitive and physical needs than the current practice of administering intramuscular pethidine.

New High Dose Pulsed Hyaluronidase Protocol for Hyaluronic Acid Filler Vascular Adverse Events.

The purpose of this article is to update the changes to the author's protocols used to manage acute filler related vascular events from those previously published in this journal. For lack of a better term, this new protocol has been called the High Dose Pulsed Hyaluronidase (HDPH) protocol for vascular embolic events with hyaluronic acid (HA) fillers. The initial protocol used involved many different modalities of treatment. The current protocol is exceedingly simple and involves solely the use of hyaluronidase in repeated high doses. Despite the simplicity of the treatment, it has proven itself to be very successful over the past two years of clinical use. There has been no partial or complete skin loss associated with this protocol since its implementation if the protocol was implemented within 2 days of the ischemic event onset. The protocol involves diagnosis and repeated administration of relatively high doses hyaluronidase (HYAL) into the ischemic tissue repeated hourly until resolution (as detected clinically through capillary refill, skin color, and absence of pain). The dosage of HYAL varies as the amount of ischemic tissue, consistent with the new underlying hypothesis that we must flood the occluded vessels with a sufficient concentration of HYAL for a sufficient period of time in order to dissolve the HA obstruction to the point where the products of hydrolysis can pass through the capillary beds. Although vascular embolic events are rare, it is important to note that the face has higher risk and lower risk areas for filler treatment, but there are no "zero risk" areas with respect to filler treatments. Even with good anatomic knowledge and correct technique, there is still some nonzero risk of vascular embolic events (including highly skilled, experienced injectors). However, with careful low pressure, low volume injection technique, and adequate preparation for treatment of acute vascular events, the risk is quite manageable and the vast majority of adverse events are very treatable with an excellent prognosis, with a few exceptions. This new protocol offers excellent results, but requires further research to determine optimal parameters for various HA fillers.

Math-free guides for glycerin and allergens at variable subcutaneous injection volumes: How's my dosing? Update.

BACKGROUND: Current summaries of effective maintenance dose ranges for subcutaneous immunotherapy (SCIT) are based on administration of 0.5-mL volumes. Extract formulations delivering equivalent dose ranges for practices using different injection volumes have not been reported, and calculation of the final glycerin concentrations in these solutions remains an inconvenient and repetitive process. OBJECTIVE: To create math-free guides for allergen doses and glycerin concentrations that identify the extract concentrate volumes required to deliver doses within the ranges cited in the 2011 immunotherapy practice parameters for clinicians using 5.0-mL maintenance vials and injection volumes ranging from 0.2 to 1.0 mL. METHODS: Algebraic calculations were performed to determine the specific combinations of extract concentrate strengths, volumes of these products in patient vaccines, and injection volumes needed for administration of target allergen doses spanning the current SCIT practice parameter recommendations. RESULTS: For each product or group (nonstandardized extracts), tables were constructed to define the allergen doses provided by various combinations of extract concentrate volumes and injection volumes. The values within the effective dose ranges for each product were highlighted to facilitate comparisons of specific conditions relevant to allergy specialists. Glycerin tables were also created to permit convenient assessments of the final concentrations of this stabilizer in patient prescriptions. CONCLUSION: SCIT dosing and glycerin tables are useful tools to assist allergists with practice decisions that involve variable patient formulas and injection volumes and can help identify suitable conditions for treatment of patients presenting with diverse allergen sensitivities and specificity profiles.

WHO guideline on the use of safety-engineered syringes for intramuscular, intradermal and subcutaneous injections in health care settings / Lignes directrices de l'OMS sur l'utilisation de seringues sécurisées pour les injections intramusculaires, intradermiques et sous-cutanées dans les structures de soins

Injections are one of the most common health care procedures. Every year at least 16 billion injections are administered worldwide. The vast majority around 90% are given in curative care. Immunization injections account for around 5% of all injections, with the remaining covering other indications, including transfusion of blood and blood products, intravenous administration of drugs and fluids and the administration of injectable contraceptives. This guideline provides global, evidence-based recommendations on the use of safety-engineered injection devices to prevent the re-use of syringes and/or prevent needle-stick injuries in health care workers (HCWs). The ultimate aim is to make injection practices safer for patients and HCWs, and to prevent the injection-related transmission of deadly viruses, particularly HIV, hepatitis C and hepatitis B. The procedures covered are intramuscular (IM), intradermal (ID) and subcutaneous (SC) injections, including the syringes needed for the reconstitution of medication or vaccines when required.

Les injections font partie des procédures de soins les plus courantes. Chaque année, au moins 16 milliards d'injections sont administrées dans le monde, dont la grande majorité (environ 90 %) à des fins thérapeutiques. La vaccination représente environ 5 % des injections et les 5 % restants concernent la transfusion de sang et de produits sanguins, l'administration de médicaments et de liquides par voie intraveineuse et l'administration de contraceptifs injectables. Ces lignes directrices présentent des recommandations générales s'appuyant sur des preuves relatives à l'utilisation de matériel d'injection sécurisé afin d'empêcher la réutilisation des seringues et/ou de prévenir les accidents dus à des piqûres d'aiguille chez les agents de santé. L'objectif ultime est de réduire le plus possible les risques associés aux pratiques d'injection, tant pour les patients que pour les agents de santé, et d'éviter la transmission de virus mortels, en particulier le VIH, l'hépatite C et l'hépatite B. Ces lignes directrices couvrent les procédures suivantes : injections intramusculaires (IM), intradermiques (ID) et sous-cutanées (SC), y compris les seringues utilisées pour la reconstitution de médicaments ou de vaccins.

Accuracy and Injection Force of the Gla-300 Injection Device Compared With Other Commercialized Disposable Insulin Pens.

BACKGROUND: To deliver insulin glargine 300 U/mL (Gla-300), the widely used SoloSTAR(®) pen has been modified to allow for accurate and precise delivery of required insulin units in one-third of the volume compared with insulin glargine 100 U/mL, while improving usability. Here we compare the accuracy and injection force of 3 disposable insulin pens: Gla-300 SoloSTAR(®), FlexPen(®), and KwikPen™. METHODS: For the accuracy assessment, 60 of each of the 3 tested devices were used for the delivery of 3 different doses (1 U, half-maximal dose, and maximal dose), which were measured gravimetrically. For the injection force assessment, 20 pens of each of the 3 types were tested twice at half-maximal and once at maximal dose, at an injection speed of 6 U/s. RESULTS: All tested pens met the International Organization for Standardization (ISO) requirements for dosing accuracy, with Gla-300 SoloSTAR showing the lowest between-dose variation (greatest reproducibility) at all dose levels. Mean injection force was significantly lower for Gla-300 SoloSTAR than for the other 2 pens at both half maximal and maximal doses (P < .0271). CONCLUSION: All tested pens were accurate according to ISO criteria, and the Gla-300 SoloSTAR pen displayed the greatest reproducibility and lowest injection force of any of the 3 tested devices.

Dosing Accuracy of Two Disposable Insulin Pens According to New ISO 11608-1: 2012 Requirements.

OBJECTIVE: The aim was to compare 2 disposable insulin pens, FlexTouch® (Novo Nordisk, insulin aspart) and SoloSTAR® (Sanofi, insulin glulisine), according to new ISO 11608-1:2012 requirements for dosing accuracy. METHODS: Sixty pens of each type were tested at 1, 40, and 80 U doses. Following the new ISO requirements, each dose was delivered from the front, middle, and rear one-third of the pen. Statistical analysis was performed using Student's t test. RESULTS: Both pens delivered all doses within ISO limits. The difference between the average measured dose and the target dose was significantly smaller for SoloSTAR than FlexTouch at 40 U (P = .009) and 80 U (P = .008), but not at 1 U (P = .417). CONCLUSION: Both insulin pens fulfilled the dosing accuracy requirements defined by ISO 11608-1:2012 at all 3 dosage levels.

Improved insulin absorption by means of standardized injection site modulation results in a safer and more efficient prandial insulin treatment. A review of the existing clinical data.

Temperature changes on the surface of the skin lead to modifications of subcutaneous microcirculation. This phenomenon is employed in a standardized way by the InsuPad device to stabilize skin conditions before injections, which is associated with enhanced prandial insulin absorption. Three programmed warming cycles to 40°C within 50 minutes are resulting in faster insulin appearance in the plasma. Early standardized meal tolerance studies indicated a substantial improvement in postprandial glucose control when the same short-acting insulin analog dose was applied using InsuPad, and a dose reduction by 20% resulted in comparable glucose excursions. Similar results were obtained when patients applied the device under real-world conditions for 1 month. The InsuPad device was also tested in a prospective, controlled, parallel 3-month real-world study with 145 well-controlled but insulin-resistant patients with type 1 or type 2 diabetes. Patients were treated to target in both treatment arms (6.2 ± 0.5% in each group), with or without the device. However, patients with InsuPad needed 28% less prandial insulin, needed 12.5% less total insulin, and had 46% less confirmed hypoglycemic events (blood glucose < 63 mg/dL) as compared to the control group. Except for very few inflammatory or allergic skin reactions, there were no device-specific adverse events reported from these studies. In conclusion, use of InsuPad when applying prandial insulin doses may result in a safer and more efficient treatment of type 1 or type 2 diabetes.

Changing practice for safe insulin administration.

Insulin is a life-saving medication but, if wrongly administered, it can cause death or severe harm. Errors in insulin administration are common, including the inappropriate use of intravenous syringes. We surveyed all clinical areas in our trust to identify types of syringes and needles available and how these were stored and distinguished from IV syringes. Based on these results, we developed recommendations to promote safety and good practice and are standardising insulin syringes throughout the trust.

Injection-site reactions upon Kineret (anakinra) administration: experiences and explanations.

Anakinra (Kineret), a recombinant form of human interleukin-1 (IL-1) receptor antagonist, is approved for the treatment of rheumatoid arthritis (RA) in combination with methotrexate. Kineret is self-administered by daily subcutaneous injections in patients with active RA. The mechanism of action of anakinra is to competitively inhibit the local inflammatory effects of IL-1. Kineret is generally safe and well tolerated and the only major treatment-related side effects that appear are skin reactions at the injection site. Due to the relatively short half-life of anakinra, daily injection of the drug is required. This, in combination with the comparably high rates of injection-site reactions (ISRs) associated with the drug, can become a problem for the patient. The present review summarises published data concerning ISRs associated with Kineret and provides some explanations as to their cause. The objective is also to present some clinical experiences of how the ISRs can be managed.

Position paper on mesotherapy.

Mesotherapy is a controversial cosmetic procedure which has received publicity among the lay people, in the internet and in the media. It refers to minimally invasive techniques which consist of the use of intra- or subcutaneous injections containing liquid mixture of compounds (pharmaceutical and homeopathic medications, plant extracts, vitamins and other ingredients) to treat local medical and cosmetic conditions. This position paper has examined the available evidence and finds that acceptable scientific evidence for its effectiveness and safety is lacking. IADVL taskforce, therefore would like to state that the use of this technique remains controversial at present. Further research and well-designed controlled scientific studies are required to substantiate the claims of benefit of this mode of therapy.

Dosing accuracy of commonly used disposable insulin pens.

OBJECTIVE: The present study aimed to assess the dosing accuracy of commonly used disposable insulin pens including SoloStar (SR)*, FlexPen (FP) dagger, Next Generation FlexPen (NGFP) dagger, and KwikPen (KP) double dagger. It is the first comparative study covering the whole dosing range from 1 U to 60 U. It also covers the accuracy of SR at 80 U. RESEARCH DESIGN AND METHOD: A total of sixty insulin pens from two lots of each pen type were used. From each pen 1 U, 10 U, 30 U, 40 U, 60 U and 80 U were dispensed in random order. The 80 U dose was only evaluated for the SR as the other insulin pens do not deliver this dose in one injection. The actual doses were determined gravimetrically taking density of the different insulin preparations into account. The evaluation of dose accuracy was based on the regulations of the International Organization for Standardization (DIN EN ISO 11608-1:2000). RESULTS: All tested insulin pens met the requirements for accuracy with none of the single values at all dose levels being outside the defined range of the ISO recommendations (1 +/- 1 U, 10 +/- 1 U, 30 +/- 1.5 U, 40 +/- 2 U, 60 +/- 3 U and 80 +/- 4 U). For the investigated dosage levels the absolute average deviation of all insulin pens ranged between 0.09 and 0.81 U. CONCLUSION: The present study demonstrates an excellent dosing accuracy for all tested insulin pens, with no clinically relevant differences between the products.

Early responses in randomized clinical trials of triptans in acute migraine treatment. Are they clinically relevant? A comment.

One can question the clinical relevance of early headache responses after oral and intranasal triptans. Thus, for pain-free the early responses were significant but in absolute values they were only a few percentages: the therapeutic gains (TGs) were 1.8% (95% CI = 0.3-3%) for oral almotriptan 12.5 after 30 minutes and 1.0% (95% CI = 0-2%) after intranasal zolmitriptan 5 mg after 15 minutes. These results are compared with subcutaneous sumatriptan 6 mg which has TGs of 11% (95% CI = 7-15%) to 14% (95% CI = 11-17%) for pain-free after 30 minutes. Subcutaneous sumatriptan has a 2 times higher response rate than intranasal zolmitriptan and is 5 times more effective than oral almotriptan at these early time points. It is concluded that if a very early and clinically relevant effect is desired then the migraine patient should use the subcutaneous administration form of sumatriptan.