Patient-reported Adverse Effects Research Articles

Evaluating the Impact of a Clinical Pharmacist in Patients Receiving New Chemotherapy for Breast Cancer: Analysis of a Pilot Study

Purpose: Breast cancer treatment may include chemotherapy, which is associated with significant toxicities. At the Sidney Kimmel Cancer Center at Jefferson Health, a pilot program was developed to add an oncology clinical pharmacist to the breast cancer clinic. The purpose of this study is to identify the impact of the clinical pharmacist in supportive care management, add to existing literature discussing the impact of the clinical pharmacist in ambulatory oncology settings, and justify future, permanent ambulatory oncology pharmacist positions within the institution. Methods: This single-center retrospective chart review assesses interventions made by the clinical pharmacist in patients with any stage of breast cancer who presented to the breast clinic for new chemotherapy treatment between September 1, 2020, and February 28, 2021. The primary outcome was to describe clinical pharmacist interventions at the first follow-up encounter after chemotherapy initiation. Secondary outcomes included classifying and quantifying total interventions and comparing intervention details between total and included patients within the 6-month timeframe. Results: Of 44 included patients, 29 had a follow-up encounter. The clinical pharmacist directly managed 33% of the 58 patient-reported adverse drug effects. In 6 months, the clinical pharmacist made 1,068 interventions spanning 189.6 documented hours. The most common interventions were coordination of care, education, and supportive care pharmacotherapy interventions. Conclusion: This study identified the pharmacist’s role in supportive care management and reports the successful integration of a clinical pharmacist into a breast cancer clinic. Future directions include conducting prospective studies to further explore the impact of the clinical pharmacist on treatment outcomes.

The health effects of non-prescribed anabolic-androgenic steroid use: Findings from The Performance and image-enhancing drugs UseRS' Health (PUSH) audit.

To ascertain the adverse health outcomes experienced by those using prescribed testosterone and non-prescribed anabolic-androgenic steroids presenting to general practitioner (GP) clinics. Retrospective clinical audit from nine GP clinics in major metropolitan areas across three Australian states. Data included demographic and individual characteristics (age, sexuality, body mass index, smoking status and HIV status); performance and image-enhancing drug use (type, reasons for use, patient-reported adverse effects); and blood biochemistry measurements (lipid profiles, liver function tests and red blood cell tests). Adverse health outcomes included evidence of polycythaemia, hypertension, liver abnormalities and hypercholesterolemia. Three hundred men were identified as either using prescribed testosterone (66%; n = 197) or non-prescribed anabolic-androgenic steroids (AAS) (34%; n = 103). Individuals in the prescribed group were more likely to be older (p < 0.001), gay or bisexual (p < 0.001) and living with diagnosed HIV (p < 0.001) compared to individuals in the non-prescribed group. Abnormal liver function, polycythemia and gynecomastia were the top three adverse events experienced. When adjusting for age, sexuality, HIV status and smoking status, those who used non-prescribed AAS were more likely to experience any adverse event (aPR = 1.28; 95% CI 1.01-1.60; p = 0.038), hypertension (aPR = 1.86; 95% CI 1.19-2.91; p = 0.006) and liver abnormalities (aPR = 1.51; 95% CI 1.04-2.20; p = 0.030) compared to those using prescribed testosterone. For GPs who have clients who may be using, or who they suspect of using, AAS, these findings highlight the importance of not only exploring a patient's history of the adverse effects they have experienced, but that measuring for these other conditions may provide a more accurate clinical picture.

Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication

Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication

Patient-Reported Adverse Effects in 15-Fraction Pancreatic Cancer Radiation Therapy

Fifteen-fraction radiotherapy (RT) regimens have emerged as a standard option in the treatment of patients with pancreas cancer. Patient-reported outcomes (PROs) during and after pancreas cancer RT have not been well characterized. There is an even greater paucity of data among patients treated with 15-fraction regimens. We aimed to characterize gastrointestinal (GI) PROs in a cohort of patients treated with 15-fraction pancreas RT. This was an IRB-approved retrospective cohort study including patients with primary pancreas tumors treated with pre-operative or definitive 15-fraction RT from 2013 to 2022. PROs, including anorexia, nausea, diarrhea, stool incontinence, and abdominal pain, were prospectively collected and characterized per PRO-common terminology criteria for adverse events (PRO-CTCAE). Acute PROs were defined as occurring during RT through 110 days post-RT but prior to oncological surgery. Grade 3 or 4 PROs were respectively scored as "quite a bit" or "very much" in symptom interference questions, "frequently" or "almost constantly" in symptom frequency questions, and "severe" or "very severe" in symptom severity questions. A total of 330 patients were analyzed. Patient characteristics included a median age of 67 years (IQR: 60 - 72), ECOG 0-1 (96%), and male sex (56%). Most patients had pancreatic ductal adenocarcinoma (96%). Resectability status included resectable (12%), borderline resectable (46%), and locally advanced (42%). 37% had lymph node involvement. 97% of patients received neoadjuvant chemotherapy and 98% received concurrent chemotherapy, most commonly with 5-fluorouracil or capecitabine (88%) or gemcitabine (11%). 99% were treated with intensity modulated RT. Median RT dose was 4500 cGy (IQR 4500 - 4500) to gross disease with margin and 3750 cGy (IQR 3750 - 3750) to elective nodal regions. 59% proceeded with oncologic resection. Grade 3 or higher acute PROs are demonstrated in the table. Often considered more sensitive than physician assessments, PROs provide vital metrics that allow for a better understanding of the patient experience during cancer treatment. We report a comprehensive assessment of prospectively collected PROs per standardized PRO-CTCAE with the goals of raising awareness of the patient experience during 15-fraction pancreas cancer RT and helping guide future clinical trial designs focused on patient quality of life endpoints.

An in vivo analysis of implanted programmable device interference during magnetically controlled growing rod lengthenings: a story of 129 lengthenings.

Early-onset scoliosis (EOS) is often treated with magnetically controlled growing rods (MCGR) which can be lengthened with a magnetic external remote control (ERC). Many individuals with EOS have concomitant medical conditions which are managed with other implanted programmable devices (IPD). Some providers are concerned that the magnetic field generated during MCGR lengthening may interfere with other IPD, such as ventriculoperitoneal shunts (VPS), intrathecal baclofen pumps (ITBP), vagal nerve stimulators (VNS), and cochlear implants (CI). The aim of this study was to evaluate the safety of MCGR lengthenings in patients with EOS and other IPD. This single-center, single-surgeon case series followed 12 patients with 13 IPD as they underwent treatment with MCGR. Post MCGR lengthening, monitoring of patient symptoms, and interrogation of IPD were conducted to evaluate for magnetic interference. After 129 MCGR lengthenings, post-lengthening VPS interrogation found 2 instances of potential interference in settings (both in Medtronic Strata shunts); however, no pre-lengthening interrogation was completed to confirm if these changes occurred prior to or during the lengthening procedure. ITBP interrogation found no changes, and there were no patient-reported adverse effects related to VNS or CI function. It is safe and effective to utilize MCGR in patients with IPD. However, the possibility of magnetic interference must be considered, particularly in individuals with VPS. We recommend approaching with the ERC from a caudal direction to minimize potential interference and all patients be monitored during treatment. If possible, IPD settings should be assessed pre-lengthening, confirmed afterwards and readjusted if necessary. Level IV.

P684 Extra intravenous reinduction of ustekinumab on an already shortening interval is an effective optimisation strategy for patients with refractory Crohn’s disease

Abstract Background Designing treatment optimisation strategy for ustekinumab (UST) is challenging. We aimed to evaluate the efficacy and safety of extra weight-based intravenous reinduction of UST on an already shortening interval in patients with refractory Crohn’s disease (CD). To the best of our knowledge, this is the first study to report optimised UST treatment in a Chinese population. Methods This was a single-center retrospective observational study. Dosing optimisation strategies were designed for CD patients showing partial or loss of response to standardised UST with a shortened interval of every-8-week (q8w) dosing, or an extra weight-based intravenous reinduction followed by q8w subcutaneous administration. Clinical, biochemical, and endoscopic findings and trough concentrations of UST were analyzed. Results Dose optimisation strategies were developed for 27 out of 64 patients; 13 patients required a shortened q8w interval and 14 patients required intravenous reinduction. Crohn’s disease activity index [96.5 (39.8,156.3) vs. 158.0 (101.5,175.3), P=0.009] and C-reactive protein [3.3 (1.1,7.0) vs. 4.8 (0.5,15.1), P=0.023] levels decreased significantly after intravenous reinduction, while the trough concentration of UST increased [1.8 (1.2,8.6) vs. 1.1 (0.2, 6.4), P=0.009]. Clinical and endoscopic remission was achieved in 57.1% (8/14) and 33.3% (2/3) of patients, respectively, while 53.8% (7/13) and 25.0% (2/8) of patients achieved clinical and endoscopic remission at around week 8 in the q8w cohort, respectively. The incidence of patient-reported adverse effects was 3.7%. (Figure 1) Conclusion Intravenous reinduction improved clinical and endoscopic remission safely and effectively in patients showing poor response to standardised UST treatment, which should be an optimal rescue optimisation strategy before switching to biologics targeting other pathways.

Patient Insight With Collagenase Treatment for Dupuytren: A Prospective Study

There appears to be controversy regarding differing patient and physician perceptions of adverse effects (AEs) in the treatment of Dupuytren disease with collagenase clostridium histolyticum (CCH). The aim of this study was to compare the number, type, and severity of AEs perceived and reported by patients and by their physician METHODS: To assess AEs following CCH injection in a standardized way, patients were given a list of predefined complications and asked to rate their severity on a 4-point Likert scale ranging from 1 (serious) to 4 (insignificant). Eighty-five patients were included. Patients reported fewer AEs than their physician (mean, 1.48 vs 2.18). There was no agreement between physician- and patient-reported AEs except for skin lacerations, which showed fair agreement (κ= 0.257). Patients and physicians differ in their evaluation of AEs due to CCH treatment in Dupuytren disease. A fair level of agreement was observed for skin lacerations. Greater consensus is needed when defining AEs associated with CCH in the treatment of Dupuytren disease.

Compression stockings for treating vasovagal syncope (COMFORTS-II) trial: Rationale and design of a triple-blind, multi-center, randomized controlled trial

Reduced venous return is an important trigger of vasovagal syncope (VVS). Elastic compression stockings (ECS) can modify venous return and be of therapeutic interest; however, evidence for ECS efficacy in VVS is scarce. This randomized controlled trial was designed to address the issue. COMFORTS-II is a multicenter, triple-blind, parallel design, randomized controlled trial aimed to assess the efficacy of ECS in preventing VVS recurrences. Using central online randomization, 268 participants will be allocated to 2 arms (1:1 ratio), wearing intervention ECS (25-30 mm Hg pressure) or sham ECS (≤10 mm Hg pressure). All participants will receive standard VVS treatment in the form of education, and lifestyle modification recommendations (drinking 2-3 l/d of fluids and consuming 10 g/d-roughly half a tablespoon-of table salt). Adherence to ECS treatment will be evaluated through diary sheets, and compared between study arms. Follow-up continues for 1 year, and is conducted via a 24/7 phone line available to patients and trimonthly visits. The co-primary outcomes are proportion of participants with any syncopal recurrence and time to first syncopal episode. Secondary outcomes include frequency of VVS spells, time intervals between recurrences, and incidence of any patient-reported adverse effects. To the best of our knowledge, COMFORTS-II is the first clinical trial to assess ECS efficacy among patients with VVS, addressing an important gap in evidence for VVS treatments.

Patient-reported adverse effects when switching from oral to subcutaneous administration of methotrexate: A prospective, multicenter, paired cohort study

To the Editor: Many inflammatory skin disorders can be treated with weekly low-dose oral methotrexate (oMTX). However, nausea (25%) and asthenia (15%) are common adverse effects (AEs) that reduce drug survival. Changing from oral to subcutaneous methotrexate (scMTX) may reduce the AEs, but the results of a few prior studies are inconsistent.1,2

Safety and Efficacy of 2 Intracavernous Injections of Allogeneic Wharton’s Jelly-Derived Mesenchymal Stem Cells in Diabetic Patients with Erectile Dysfunction: Phase 1/2 Clinical Trial

Background and Objectives: Stem cell therapy is a novel treatment with regenerative ability that can treat erectile dysfunction (ED). This phase 1/2 clinical trial (NCT02945449) using 2 consecutive intracavernous (IC) injections of allogeneic Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) was studied for the first time in the treatment of diabetic patients with ED. The primary outcome was to assess the safety and tolerability, and the secondary outcome was to assess the efficacy of 2 consecutive IC injections of allogeneic WJ-MSCs in diabetic ED. Patients and Methods: Twenty-two diabetic patients with refractory ED were included. Two consecutive IC injections of allogeneic WJ-MSCs were performed. Tolerability was assessed immediately, and at 24 h, safety was evaluated for 12 months. Efficacy was assessed using International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS), and Color Duplex Doppler Ultrasound for 12 months. Results: The procedure was well-tolerated. Minimal and transient adverse events were redness and bruising at the site of injections. There were no patient-reported serious adverse effects. There were significant improvements in IIEF-5, EHS, peak systolic velocity (PSV) basal, and 20-min PSV, all over the follow-up time points in comparison to the baseline. Conclusion: This is the first human study with proven tolerability, safety, and efficacy of IC injections of allogeneic WJ-MSCs for the treatment of diabetic patients with ED.

Managing postoperative pain in adult outpatients: a systematic review and meta-analysis comparing codeine with NSAIDs.

BACKGROUND:Analgesics that contain codeine are commonly prescribed for postoperative pain, but it is unclear how they compare with nonopioid alternatives. We sought to compare the effectiveness of codeine and nonsteroidal anti-inflammatory drugs (NSAIDs) for adults who underwent outpatient surgery.METHODS:We conducted a systematic review and meta-analysis of randomized controlled trials comparing codeine and NSAIDs for postoperative pain in outpatient surgery. We searched MEDLINE and Embase from inception to October 2019 for eligible studies. Our primary outcome was the patient pain score, converted to a standard 10-point intensity scale. Our secondary outcomes were patient-reported global assessments and adverse effects. We used random-effects models and grading of recommendations assessment, development and evaluation (GRADE) to assess the quality of evidence.RESULTS:Forty studies, including 102 trial arms and 5116 patients, met inclusion criteria. The studies had low risk of bias and low-to-moderate heterogeneity. Compared with codeine, NSAIDs were associated with better pain scores at 6 hours (weighted mean difference [WMD] 0.93 points, 95% confidence interval [CI] 0.71 to 1.15) and at 12 hours (WMD 0.79, 95% CI 0.38 to 1.19). Stronger NSAID superiority at 6 hours was observed among trials where acetaminophen was coadministered at equivalent doses between groups (WMD 1.18, 95% CI 0.87 to 1.48). NSAIDs were associated with better global assessments at 6 hours (WMD −0.88, 95% CI −1.04 to −0.72) and at 24 hours (WMD −0.67, 95% CI −0.95 to −0.40), and were associated with fewer adverse effects, including bleeding events.INTERPRETATION:We found that adult outpatients report better pain scores, better global assessments and fewer adverse effects when their postoperative pain is treated with NSAIDs than with codeine. Clinicians across all specialties can use this information to improve both pain management and opioid stewardship.

Prostatectomy with or without post-operative radiotherapy: long-term adverse effects and quality of life

Background Few longitudinal studies have compared patient-reported long-term adverse effects after radical prostatectomy (RP) alone and RP followed by radiotherapy (RAD), also analyzing the effect of the development of post-treatment dysfunctions/problems (Symptom Burden) on Health-Related Quality of Life (HRQoL). Material and methods After median seven years since RP and six years since post-RP RAD, development of EPIC-26 Domain Summary Scores (DSS Changes) and HRQoL scores (SF-12) since the pre-RP situation were evaluated in respectively 317 prostatectomized men without and in 63 patients with additional post-RP RAD. Post-treatment inter-group differences of the prevalent Symptom Burden and of the DSS Changes were calculated. Multivariable logistic regressions evaluated the associations between DSS Changes and post-treatment impaired HRQoL. Results Compared to RP alone, post-RP RAD increased the post-treatment Symptom Burden, with least inter-group differences within the urinary irritative/obstructive and bowel domain. No significant inter-group difference emerged for the proportions of men with impaired HRQoL. The odds of impaired HRQoL increased significantly with rising DSS Changes (worsening) within the vitality/hormonal domain. Worsening within urinary incontinence and bowel domains significantly increased the odds of impaired physical QoL. High HRQoL scores before RP reduced the odds of post-treatment impaired HRQoL. Living without a partner and use of androgen deprivation therapy increased this odds. Conslusions Post-RP radiotherapy increases post-treatment Symptom Burden with negative, though limited impact on the patient’s HRQoL. Counceling before post-RP radiotherapy should cover this possible development, taking into account the patient’s social situation.

Cochrane in CORR®: Shoulder Replacement Surgery For Osteoarthritis And Rotator Cuff Tear Arthropathy.

Cochrane in CORR®: Shoulder Replacement Surgery For Osteoarthritis And Rotator Cuff Tear Arthropathy.

Exploring the Feasibility and Effects of a Ketogenic Diet in Patients With CNS Malignancies: A Retrospective Case Series.

Background: Recently, the ketogenic diet has been proposed as an adjunct treatment for a range of medical conditions including weight loss, diabetes, cancer, and neurodegenerative diseases. Because malignant CNS tumors are highly dependent on glucose, the use of a ketogenic diet as an adjunct therapy is currently being explored. This case series summarizes our experience implementing a ketogenic diet for patients with CNS malignancies.Methods: Patients diagnosed with CNS malignancies following a ketogenic diet were identified between 2015 and 2017. Malignancies included confirmed diagnoses of glioblastoma (GBM), astrocytoma, or oligodendroglioma. With guidance from a registered dietitian, ketone levels, glucose levels, and weight were regularly collected for several patients along with patient-reported symptoms and adverse effects. Interested patients were asked to follow a 3:1 ketogenic diet for 120 days. The ketogenic diet is a high-fat, moderate protein, and very low carbohydrate diet, where patients limited carbohydrate intake to ≤20 g per day. Brain imaging was reviewed. A series of descriptive analyses were conducted.Results: The ketogenic diet was initiated in 12 patients of which 8 patients contributed data on their blood glucose and ketone levels. The majority of patients were male (n = 10) with a median age of 45 (range 32–62). Diagnoses included GBM (n = 6), grade 2/3 astrocytomas (n = 5) and one patient with a grade 2 spinal cord astrocytoma. Ten of the 12 patients were receiving concurrent treatment; two received supportive care only. The majority of patients with evaluable data (n = 8) maintained ketone levels above 0.5 mM for the duration of 120-day period. Ketone levels generally increased from baseline while glucose levels and BMI decreased. Overall, patients reported improved symptoms over the course of the diet. Imaging also suggested improved disease control and reduction in vasogenic edema.Conclusion: Taking advantage of a tumor’s metabolic inflexibility can have a positive impact on patients, particularly those with CNS malignancies. More structured and statistically planned clinical trials are needed to determine the margin of impact of a ketogenic diet.

Interventions for the management of malignant pleural effusions: a network meta-analysis.

Interventions for the management of malignant pleural effusions: a network meta-analysis.

Patient Experience of Chimeric Antigen Receptor (CAR)-T Cell Therapy Vs. Stem Cell Transplant: Longitudinal Patient Reported Adverse Events, Cognition and Quality of Life

Patient Experience of Chimeric Antigen Receptor (CAR)-T Cell Therapy Vs. Stem Cell Transplant: Longitudinal Patient Reported Adverse Events, Cognition and Quality of Life

256 Intravenous Sub-Dissociative Dose Ketamine for Analgesia in the Emergency Department: A Dosing Comparison

Sub-dissociative ketamine (SDK) is a safe and efficacious alternative and adjunctive agent to opioids in the treatment of acute pain in the emergency department (ED). While SDK via short intravenous (IV) infusion has shown decreased side effects compared to IV push, there is a wide range of acceptable analgesic dose. The purpose of this study is to compare the analgesic efficacy and safety of IV SDK at 0.15 mg/kg versus 0.3 mg/kg in ED patients with acute pain. This was a randomized, prospective, double-blinded, non-inferiority trial. A convenience sample of patients age 18-59 years with acute abdominal, flank, back, musculoskeletal pain, or headache with visual analog scale (VAS) pain score of ≥5 were included. Subjects were randomized to either IV SDK 0.15mg/kg (“low” dose) or 0.3 mg/kg (“high” dose) over 15 minutes. The primary endpoint was change in 11-point VAS pain score from baseline to 30 minutes after administration. Secondary endpoints included change in VAS at 15 and 60 minutes, and rescue analgesia. Safety endpoints included patient-reported adverse effects according to the Side Effects Rating Scale of Dissociative Anesthetics (SERSDA), and Richmond Agitation Sedation Scale (RASS) at 15, 30 and 60 minutes post-administration. Of the 93 patients screened, 65 (70%) were included (low dose group: n=33; high dose group: n=32). Most exclusions were due to patient refusal (n= 25; 68%). The most common type of pain was abdominal (45%) or musculoskeletal (32%) pain. Pain onset was <24 hours of presentation for most (53%) patients. Baseline comorbidities were similar between groups, with the exception of diabetes (27% low dose group vs. 5.7% high dose group, p=0.03), depression (2.7% low dose group vs. 20% high dose group, p=0.03) and anxiety (0% low dose group vs. 11.4% high dose group, p=0.03) (Table 1). Median ketamine dose was 13.6 mg and 25.3 mg, respectively. Median baseline pain scores were similar between groups (10 [IQR 8-10] vs. 9 [IQR 7 -10] , p =0.07). There was no difference in the primary endpoint of median change in VAS score from baseline to 30 minutes (- 4 [IQR [-2 to -6] low dose group vs. -3.5 high dose group [IQR -1 to -5], p=.43). Additionally, there were no differences in median pain scores or adverse effects at any time point (Table 1). IV SDK 0.15 mg/kg was non-inferior to SDK 0.3 mg/kg for treatment of acute pain in the ED with similar adverse effects between groups. Clinicians should consider using 0.15 mg/kg for treatment of acute pain as it is efficacious, and there is no apparent benefit to higher doses.

Real-world evaluation of the safety and tolerability of abacavir/dolutegravir/lamivudine in an incarcerated population.

A trend of increased adverse effects and laboratory abnormalities was observed in patients treated at the University of Illinois Hospital and Health Sciences System (UIH) HIV Telemedicine Clinic after switching to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). Therefore, we sought to investigate if major clinical trials overestimated the safety and tolerability of DTG-based antiretroviral therapy (ART). This study was a single-center, retrospective, pre- and post-analysis of incarcerated patients receiving care at the UIH HIV Telemedicine Clinic, USA. Patients included were adults with HIV switched from previous ART to ABC/DTG/3TC. Primary endpoints included patient-reported adverse effects and changes in renal and hepatic function from baseline. A total of 95 patients were included in the study. After switching from previous ART to ABC/DTG/3TC, 20% of patients reported incidence of adverse effects. Most common were headache (7.4%), nausea (6.3%) rash (3.2%), fatigue (3.2%), and insomnia (2.1%). There were statistically significant increases in serum creatinine (SCr), in 20% of the patients (P &lt; 0.0001), with a median increase of 0.38 mg/dl. ABC/DTG/3TC appears to have similar or fewer adverse effects in the real-world incarcerated population compared to clinical trials. DTG-based ART can cause statistically significant increases in SCr in some patients.

Estimated Cost and Savings in a Patient Management Program for Oral Oncology Medications: Impact of a Split-Fill Component.

PURPOSE:A national specialty pharmacy implemented a split-fill option within an oral oncology patient management program to reduce pharmacy costs and medication wastage resulting from early discontinuations. Payers covered dispensed medications at half-quantity intervals for each dispense up to 3 months. Proactive outreach to patients before they had used up the initial dispensed medication quantity helped assess the patient’s tolerance to the new medication and adverse effects. This study compared costs for patients with a split-fill option to similar costs for patients without this option taking into account patient discontinuation rates, patient-reported adverse effects rates, estimated pharmacy costs, and potential wastage.METHODS:This retrospective cohort study included patients who were new to therapy on a split-fill medication between September 2015 and August 2017. A 1:1 greedy match algorithm was conducted using propensity variables to match patients from each cohort. Per-month discontinuation rates were determined for both split-fill and non–split-fill groups. The non–split-fill potential wastage was calculated as monthly costs for discontinuations in the following month and weighted by split-fill discontinuation rates.RESULTS:Of the 2,363 program patients who met selection criteria for the 11 medications, 671 patients from each group were matched. Payers with a split-fill program had significant medication savings per covered month ($2,147.60 at 1 month) and at a cumulative 6 months. Modeled wastage indicated that payers without a split-fill program could expect to save $2,646.74 monthly by using this option. Both cohorts had similar rates of adverse effects and time until first reported adverse effect.CONCLUSION:In the first 6 months, the split-fill patient managed program had lower discontinuation rates, significantly reduced pharmacy costs, and reduced potential wastage.

Revisiting the physiology of nausea and vomiting-challenging the paradigm.

The predominant neurotransmitters and receptors for acute and delayed chemotherapy-induced nausea and vomiting (CINV) are represented in the current paradigm, which reflects successful control of emesis. However, control of nausea (N) lags behind management of vomiting (V). This review aims to re-examine and incorporate new information about the mechanisms of V and N. The initial literature search focused on CINV. Keywords in articles led to subsequent discovery of publications focused on N&V in other medical and scientific fields (e.g., gastroenterology, neurology, cannabinoid science, neuropharmacology, and motion sickness). Using keywords to identify other sources continued until no further recent, meaningful publications were found. More than 86% of references were from recent non-oncology journals and books, suggesting there are many areas for cross-fertilization research into mechanisms and management of N&V-particularly of N, which involves overlapping and dissimilar CNS areas from V. Information from cited articles was incorporated into visual representation of N&V, which is certainly not exhaustive but supports highly complex processes in the stomach and gut, the vagus nerve and spinal cord neurons, the nucleus tractus solitarii, and the anterior insular cortex and anterior cingulate cortex with input from the amygdala. These data support the idea that mechanisms for N, whatever the cause, must be highly similar. Continued research into nausea, including patient-reported evaluation and outcomes, is important; interventions for nausea could be considered adjuvants to current standard of care antiemetics and be individualized, depending on patient-reported efficacy and adverse effects and preferences.