Early factors for predicting discontinuation to subcutaneous Apomorphine infusion in Parkinson's disease: A prospective analysis of the Thai Apomorphine Registry.

INTRODUCTION: Although continuous subcutaneous apomorphine infusion (CSAI) is an effective therapy for Parkinson's disease (PD) with motor fluctuations, data from Asian cohorts is limited. The therapy is often discontinued due to the complexity of its delivery. METHODS: Fifty-one PD patients undergoing CSAI as an add-on therapy were enrolled in the Thai Apomorphine Registry, an electronic database that recorded clinical characteristics and parameters during the 14-consecutive-day titration and long-term follow-up. Factors at the time of titration were documented in order to identify predictors of long-term discontinuation. RESULTS: Following initiation, PD patients were administered a mean CSAI dose of 5.89 mg/h (SD 1.36) over a mean time of 12.28 h (SD 1.90) each day. The mean follow-up period was 626.2 days (SD 619.17). Significant reductions in UPDRS-I, II, III, and IV scores, total NMSQ score, PDQ-8 score, daily off and dyskinesia hours, Timed Up and Go test, walking step test, levodopa-equivalent daily dose, number of times a day the levodopa was taken versus pre-CSAI values were observed (p < 0.05, each). Thirty-five (68.6%) patients discontinued during the follow-up period. Relative risks of variables recorded at the time of titration that determined discontinuation of CSAI therapy were an absence of full-time caregivers, achieving a daily off hours reduction <3.5 h, and NMSQ scores at the time of CSAI titration ≥9.5 points. CONCLUSION: Identifying factors that predict discontinuation of CSAI at the time of its initiation may help physicians to better understand the patient's drug response and how to manage them long-term.

An evaluation of continuous subcutaneous infusions across seven NHS acute hospitals: is there potential for 48-hour infusions?

BACKGROUND: Continuous subcutaneous infusions (CSCIs) are commonly used in the United Kingdom as a way of administering medication to patients requiring symptom control when the oral route is compromised. These infusions are typically administered over 24 h due to currently available safety data. The ability to deliver prescribed medication by CSCI over 48 h may have numerous benefits in both patient care and health service resource utilisation. This service evaluation aims to identify the frequency at which CSCI prescriptions are altered at NHS Acute Hospitals. METHODS: Pharmacists or members of palliative care teams at seven acute NHS hospitals recorded anonymised prescription data relating to the drug combination(s), doses, diluent and compatibility of CSCIs containing two or more drugs on a daily basis for a minimum of 2 days, to a maximum of 7 days. RESULTS: A total of 1301 prescriptions from 288 patients were recorded across the seven sites, yielding 584 discrete drug combinations. Of the 584 combinations, 91% (n = 533) included an opioid. The 10 most-common CSCI drug combinations represented 37% of the combinations recorded. Median duration of an unchanged CSCI prescription across all sites was 2 days. CONCLUSION: Data suggests medication delivered by CSCI over 48 h may be a viable option. Before a clinical feasibility study can be undertaken, a pharmacoeconomic assessment and robust chemical and microbiological stability data will be required, as will the assessment of the perceptions from clinical staff, patients and their families on the acceptability of such a change in practice.

Quality of Life Differences for Primary Immunodeficiency Patients on Home SCIG versus IVIG.

BACKGROUND: Patients with primary immunodeficiency disease (PIDD) and antibody deficiency require lifelong immunoglobulin replacement therapy. While both subcutaneous immunoglobulin (SCIG) and intravenous immunoglobulin (IVIG) replacement therapy are effective in preventing infection, patients with PIDD still experience worse health-related quality of life (hrQOL) outcomes. OBJECTIVE: Assess differences in hrQOL for PIDD patients receiving home SCIG versus IVIG. METHODS: SF-36 surveys were administered by a specialty pharmacy to 630 PIDD patients receiving home SCIG and IVIG at baseline and then every 3 months between 2014 and 2016. Results were analyzed using two-sample t tests and linear mixed effects model. Analysis was repeated for different age categories and trended over time. RESULTS: Patients receiving SCIG reported statistically significant higher energy fatigue scores (+ 9 points, p < 0.001) but lower perceived role limitations due to physical health scores (- 14 points, p < 0.001). These differences were only observed in patients > 36 years of age. There were no differences in the composite SF-36 score for patients receiving SCIG versus IVIG (+ 1, p = 0.66). Immunoglobulin-naïve patients all improved their hrQOL, but a larger improvement was seen in those initiating SCIG versus IVIG. CONCLUSION: Patients with PIDD on home IVIG versus SCIG have similar composite hrQOL scores as measured by the SF-36. In the adult population, initiating immunoglobulin replacement with SCIG may result in more hrQOL improvement compared with IVIG, although personal preferences should also be considered. CLINICAL IMPLICATIONS: Patients with PIDD on home IVIG versus SCIG have similar composite health-related quality of life scores as measured by the SF-36. Patients with primary immune-deficiency on home IVIG versus SCIG have similar composite health-related quality of life scores as measured by the SF-36. Personal preferences are important in deciding whether to treat with IVIG or SCIG.

HbA1c values and hospital admissions in children and adolescents receiving continuous subcutaneous insulin infusion therapy.

AIMS: To assess HbA1c values and hospitalization rates before, during and after continuous subcutaneous insulin infusion (CSII) therapy. METHODS: Demographic and hospitalization data were extracted from 161 individuals with Type 1 diabetes who received continuous subcutaneous insulin infusion (CSII) therapy between 2002 and 2013 at the Leeds Children and Young People's Diabetes Service for those aged < 20 years. The median (range) age at CSII start was 11.9 (1.1-17.6) years. The median (range) follow-up time was 2.3 (0-8.1) years. Random intercept models were used to compare HbA1c values before and during CSII initiation (and after CSII for those who discontinued it). Hospitalization rates were calculated for diabetic ketoacidosis and severe hypoglycaemia. RESULTS: The mean HbA1c concentration decreased by 7 mmol/mol [95% CI 6-8; 0.6% (95% CI 0.5-0.7%)]. For the discontinued group (n=30), mean HbA1c decreased by 5 mmol/mol [95% CI 2-8; 0.4% (95% CI 0.2-0.7%)]. HbA1c returned to pre-CSII start levels at the end of this therapy. Diabetic ketoacidosis admissions increased threefold during CSII compared with before CSII start [2.2 per 100 person-years (95% CI 1.3 to 3.6) vs 7.4 per 100 person-years (95% CI 5.1 to 10.8)] and was highest during the first year of CSII. No difference in severe hypoglycaemia incidence rate was found during CSII compared with the pre-CSII period. CONCLUSIONS: Despite significant reductions in HbA1c levels for individuals treated with CSII, improvements are needed to reduce diabetic ketoacidosis hospitalizations for those new to the therapy.

Identification of drug combinations administered by continuous subcutaneous infusion that require analysis for compatibility and stability.

BACKGROUND: A continuous subcutaneous infusion (CSCI) delivered via syringe pump is a method of drug administration used to maintain symptom control when a patient is no longer able to tolerate oral medication. Several classes of drugs, such as opioids, antiemetics, anticholinergics, antipsychotics and benzodiazepines are routinely administered by CSCI alone or in combinations. Previous studies attempting to identify the most-common CSCI combinations are now several years old and no longer reflect current clinical practice. The aim of this work was to review current clinical practice and identify CSCI drug combinations requiring analysis for chemical compatibility and stability. METHODS: UK pharmacy professionals involved in the delivery of care to palliative patients in hospitals and hospices were invited to enter CSCI combinations comprised of two or more drugs onto an electronic database over a 12-month period. In addition, a separate Delphi study with a panel of 15 expert healthcare professionals was completed to identify a maximum of five combinations of drugs used to treat more complex, but less commonly encountered symptoms unlikely to be identified by the national survey. RESULTS: A total of 57 individuals representing 33 separate palliative care services entered 1,945 drug combinations suitable for analysis, with 278 discrete combinations identified. The top 40 drug combinations represented nearly two-thirds of combinations recorded. A total of 23 different drugs were administered in combination and the median number of drugs in a combination was three. The Delphi study identified five combinations for the relief of complex or refractory symptoms. CONCLUSION: This study represents the first step towards developing authoritative national guidance on the administration of drugs by CSCI. Further work will ensure healthcare practitioners have the knowledge and confidence that a prescribed combination will be both safe and efficacious.

Continuous subcutaneous insulin infusion in Italy: third national survey.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. MATERIALS AND METHODS: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. RESULTS: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+nurse+dietician+psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units. CONCLUSIONS: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.

Subcutaneous administration of drugs in palliative care: results of a systematic observational study.

CONTEXT: Especially in palliative care, safe and manageable administration of medication is essential. Subcutaneous drug administration is a possible alternative, when oral intake is hampered. However, evidence for this method is rare. OBJECTIVES: This observational study assessed the clinical practice of subcutaneous drug administration, focusing on the evaluation of local reactions or complications to further develop recommendations. METHODS: Over 14 months, patients in a specialized inpatient palliative care unit treated by the subcutaneous route were invited to participate in this clinical study. All subcutaneous medications including dosage and volume of injection, type of needles, and injection site were documented. The injection sites were systematically assessed including the subjective perceptions of patients for analysis of patient tolerability and acceptability. T-tests and Chi-squared tests of these variables were performed to calculate group differences between needles with vs. without complications (P < 0.05). RESULTS: In 120 patients, 3957 applications were administered via 243 needles. The needles were placed in thighs (38.7%) and upper arms (28.8%). Most frequently used medications were hydromorphone (59.0%), haloperidol (12.3%), and midazolam (8.3%). Complications were diagnosed most often on the third or fourth day of the needle in situ and occurred significantly more often in (fully) active patients and patients transferred or discharged at the end of treatment. The mean time of needle in situ was significantly lower (4.1 vs. 5.0 days) in complication cases than in noncomplication cases (t-test: P = 0.027). CONCLUSION: The results of this study acknowledge the clinical practice of subcutaneous administration of medication as a very flexible, broadly feasible, rather safe, and nonburdensome method. Nevertheless, this practice is not free from complications, needs appropriate nursing care, and requires standardized policies and procedures.

Psychopathology and continuous subcutaneous insulin infusion in type 1 diabetes.

AIM: Continuous subcutaneous insulin infusion (CSII) is used as an option in patients with diabetes failing to multiple daily injections (MDI). Psychological factors may play a relevant role in the failure to attain therapeutic goals in patients on MDI. This could lead to an overrepresentation of psychopathology in patients treated with CSII. METHODS: A consecutive series of 100 patients with type 1 diabetes was studied, collecting main clinical parameters and assessing psychopathology with the self-reported questionnaire Symptom Checklist 90-revised. Patients on CSII were then compared with those on MDI. RESULTS: Of the 100 enrolled patients, 44 and 56 were on CSII and MDI, respectively. Among men, those on CSII were younger than those on MDI; conversely, no difference in age was observed in women. Women on CSII showed higher scores on most Symptom Checklist 90 subscales than those on MDI, whereas no differences were observed in men. CONCLUSION: Women with type 1 diabetes treated with CSII display higher levels of psychopathology than those on MDI. This is probably the consequence of the fact that patients selected for CSII are those failing to MDI. Higher levels of psychopathology could represent a limit for the attainment and maintenance of therapeutic goals with CSII.

Use of continuous insulin infusion pumps in young children with type 1 diabetes: a systematic review.

INTRODUCTION: Although insulin pump therapy has been successful in adults and adolescents, its use has been limited in young children because of perceived risk of severe or frequent hypoglycemia. The purpose of this review is to evaluate the safety and efficacy of continuous subcutaneous insulin infusion (CSII) in young children with type 1 diabetes. METHODS: We searched Medline, PubMed, and CINAHL for clinical trials comparing multiple-dose injection therapy to CSII therapy in children 6 years of age or younger who were diagnosed with type 1 diabetes at least 6 months prior to study. Primary outcome measures were glycosylated hemoglobin (HbA1c) and hypoglycemic episodes. Other outcomes of interest were quality of life and parental satisfaction. RESULTS: Most studies showed significant improvements in HbA1c and trends of decreased hypoglycemia. Quality of life improved in most CSII groups. Parental satisfaction with therapy was evidenced by continuation of CSII after study completion. DISCUSSION: Current evidence indicates CSII is a safe and effective method of insulin delivery in young children. When parents are highly motivated, CSII should be offered as a mode of insulin delivery for this age group.