BACKGROUND:Veterans enrolled in both Veterans Affairs (VA) health care and Medicare Part D can choose to obtain medications through the VA, Medicare Part D, or both, with each option differing in cost, coverage, and coordination of care. Poorly informed choices can lead to veteran frustration when their expectations are not met, delays in medication access, and increased risks. This study aimed to develop a decision aid (DA) to help veterans with diabetes make informed choices about medication sourcing (ie, whether to fill medications through VA health care only, Part D only, or both). METHODS:DA development was guided by the International Patient DA Standards and the Ottawa Decision Support Framework. Interviews with veterans and care partners informed the prototype design. Alpha testing with 18 end users (mostly veterans) and 12 stakeholders (pharmacists, doctors, payers, Medicare counselors, and others) assessed comprehensibility, usability, and acceptability. During beta testing, the feasibility of the revised DA was assessed during interviews with 20 end users and 8 stakeholders. For end-user interviews, a survey assessing decisional conflict, satisfaction, and knowledge was provided before and after respondents filled out the DA. RESULTS:Alpha testing feedback led to simplifying the cost and formulary comparison chart and expanding the medication list template to include more medications, fill location, and prescriber contact information. Based on beta testing responses (n = 16), the mean system usability scale score for the DA was 77.5 (SD = 14.4), suggesting usability. Beta testers also reported the DA to be acceptable in length (94%), balance (88%), and amount of information (81%). Based on pre- vs post-DA survey responses, decisional conflict was reduced, as indicated by an increase in the mean Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) score (pre-DA: 3.1, SD = 1.4 to all 16 respondents reporting a maximum SURE score of 4.0). Knowledge about VA and Medicare coverage of diabetes medications also improved: the proportion who answered all 5 comprehension questions correctly increased from 57% to 81%. Last, the proportion of respondents who reported being "very satisfied" with how they were currently filling their diabetes medicines (VA only, Part D only, or both) improved from 64% pre-DA to 81% post-DA. CONCLUSIONS:The DA developed iteratively was usable and acceptable and showed potential in reducing decisional conflict, increasing knowledge, and increasing satisfaction, so it may help Part D-enrolled veterans with decisions about medication sourcing.
BACKGROUND:Falls are the most common medication-related safety event in older adults. Deprescribing fall risk-increasing drugs (FRIDs) may mitigate fall risk. This study assesses the effects of an innovative deprescribing program in reducing FRID burden and falls-related acute visits over 1 year. METHODS:The Falls Assessment of Medications in the Elderly (FAME) Program is a pilot deprescribing program designed to improve medication safety in Veterans aged ≥65, screening positive for high fall risk at the Durham Veterans Affairs Health Care System. Central case finding and electronic case reviews with deprescribing recommendations were completed by an interdisciplinary team, forwarded to prescribers for approval, then implemented during follow-up telephone visits by FAME team. Primary outcome was change in FRID burden calculated by modified Drug Burden Index (DBI) at 1 year and an exploratory outcome was 1-year fall-related acute visits. RESULTS:Overall, 472 patients (236 intervention cases, 236 matched controls) were included in the study. Of the 236 patients receiving a FAME deprescribing plan, 147 had recommendations approved by prescriber and patient. In the intention-to-treat analysis, the 1-year change in modified DBI was -0.15 (95% CI -0.23, -0.08) in the intervention cohort and -0.11 (-0.21, -0.00) in the matched control cohort (p = 0.47). The odds of increasing DBI by a clinically important threshold of 0.5 was significantly lower in the FAME cohort (OR 0.37, 0.21, 0.66). Fall-related acute events occurred in 6.3% of patients in the intervention group versus 11.0% in control patients over a one-year period (p = 0.10). CONCLUSIONS:The program was associated with a significantly lower odds of further increasing FRID burden at 1 year compared to matched controls. An electronic case review and telephone counseling program has the potential to reduce drug-related falls in high-risk older adults.
At the Veterans Health Administration, cataract surgeries involving residents had higher intraoperative complication rates than attending-only cases, but these complications were significantly reduced with increasing case volumes. Purpose: To characterize intraoperative complications, case complexity, and changes in complication rates with surgical experience for cataract surgeries involving residents at the Veterans Health Administration (VHA). Setting: All VHA facilities where cataract surgery was performed. Design: Multicenter, retrospective cohort study. Methods: A retrospective review of all cataract surgeries within the VHA between July 2010 and June 2021 was conducted. Several parameters, including resident involvement, intraoperative complications, and case complexity as determined by Current Procedural Terminology codes, and use of pupil expansion or capsular support devices, were collected. Complication rates were compared between residents and attendings. Results: Of 392 428 cataract surgeries completed across 108 VHA facilities, 90 504 were performed by attendings alone, while 301 924 involved a resident. Of these, 10 244 (11.3%) of attending cases were complex compared with 32 446 (10.7%) of resident cases. Pupil expansion devices were required in 8191 of attending cases (9.05%) and 31 659 (10.5%) of cases involving residents (P < .001). Similarly, cases involving residents were more likely than attending-only cases to require a capsular support device (0.835% vs 0.586%, P < .001). Cases involving residents were more likely to have posterior capsular rupture (4.75% vs 2.58%, P < .001) and dropped nucleus (0.338% vs 0.198%, P < .001). Higher resident case volumes were associated with significantly lower complication rates for posterior capsular rupture, dropped nucleus, zonular loss, and suprachoroidal hemorrhage. Conclusions: Although residents had higher intraoperative complication rates than attendings, these rates were reduced with surgical experience. Residents were involved in a similar number of complex surgical cases as attendings.
Introduction: Black patients continue to have disproportionately higher rates of death after Coronary Artery Bypass Graft (CABG) procedures. Data are needed to guide interventions to eliminate inequity. We examine race-related differences in when death occurred after CABG by comparing the proportions of 1-yr mortality occurring within versus after the first 30-days. Hypothesis: When compared with White patients, 1-yr mortality after isolated CABG among Black patients is significantly more likely to occur within the first 30-days postoperatively. Methods: Using comprehensive death ascertainment files in the most extensive integrated health system in the US, the Veterans Health Administration (VHA), we extracted 30-day and 1-year mortality data after isolated CABG (defined using procedural codes) between January 2006 and December 2015 (follow-up through to December 2016). We classified patients as non-Hispanic Black versus White. We compare 1-yr mortality and the proportions of 1-yr mortality occurring within the first 30-days. We examine trends over the 10-year period. Results: Among 14743 White versus 1545 Black veterans who underwent isolated CABG over the 10-year period, 589 versus 85 had died within 1-yr (4% versus 5.5% respectively, p<0.05). The proportions who died within the first 30-days was significantly lower among White when compared with Black veterans, 31.7% versus 36.5%, p<0.05. Over the 10-year period, the difference between races in when patients died grew substantially (Figure) whereas race-related differences in 1-yr mortality decreased (Figure). Conclusions: While racial disparities in death after CABG are well known, we present the first study showing differences in when death occurs within 1-yr. Using accurate nationwide data, we found that Black patients who died within 1-yr after isolated CABG increasingly died within the first 30-days.
Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California, USA Stanford Institute for Economic Policy Research, Stanford University, Stanford, California, USA Anesthesiology and Perioperative Care Service, VA Palo Alto Health Care System, Palo Alto, California, USA CAPER Unit, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA Research Affiliate Department of Anesthesiology, Durham VA Health Care System, Durham, North Carolina, USA Department of Anesthesiology, University of Nebraska Medical Center, Omaha, Nebraska, USA Department of Health Policy, Stanford University School of Medicine, Stanford, California, USA
PURPOSE:To describe the development of a pilot specialty medication clinical dashboard targeting tumor necrosis factor (TNF)-α inhibitor therapy. SUMMARY:This was a quality improvement project conducted between August 2019 and April 2020. The dashboard was designed with collaboration between clinical pharmacists and specialty providers in rheumatology, gastroenterology, and dermatology. Data was queried from the Veterans Affairs Corporate Data Warehouse. Patients with an active prescription or intravenous order for a TNF-α inhibitor were included. Dashboard flag criteria focused on TNF-α inhibitor safety and adherence monitoring. Flag results from the dashboard were characterized from data captured at a single time point. For 431 patients on TNF-α inhibitor treatment at the institution, 304 flags corresponding to 223 unique patients (51.7%) were identified on the dashboard: 3% of patients had a new infection, 9% had overdue monitoring laboratory tests, 5% had a critical laboratory result, 2% were on 2 biologic agents, 27% were overdue for a refill, 6% had an emergency department visit, and 2% had an inpatient admission. No patients were flagged for heart failure exacerbation or new malignancy. Seventeen percent of patients were prescribed high-dose etanercept or adalimumab, representing a potential annual cost savings of $302,497 if 50% of these patients had their dose successfully reduced to labeled dosing. Opportunities for pharmacist intervention utilizing the dashboard were identified and characterized through chart review of flagged patients. CONCLUSION:Pharmacists have the opportunity to improve safety and adherence for TNF-α inhibitor therapy through use of a specialty medication clinical dashboard. The dashboard should be used in conjunction with collaborative practice protocols.
Acute pain after total knee arthroplasty (TKA) may be moderate to severe for over a week and may lead to chronic pain.[1][1] Continuous peripheral nerve block (CPNB) techniques have been recommended by guidelines as a non-opioid modality to provide titratable pain relief of extended duration.[2][2]
Objective The purpose of this systematic review is to assess the efficacy and safety of memantine for the prophylactic treatment of episodic migraine. Background Migraine is a prevalent chronic disease with significant costs to the health care system. Although various prophylactic treatment options are available, these medications have limitations based on efficacy, potential side effects, and patient preference. Memantine is an N-methyl-d-aspartate receptor antagonist used in dementia treatment that may have potential benefit for migraine prophylaxis. Methods A systematic search of PubMed, Embase, and CENTRAL databases was conducted to identify relevant published studies through December 2020 using the search terms: migraine disorders, migraine, headache disorders, or headache and memantine. Studies selected for the systematic review included prospective, interventional designs and evaluated memantine for prophylaxis of migraine. Animal studies, case reports, abstracts, review articles, protocols without results, and studies not written in English were excluded. Data were extracted using a standardized systematic process and included author, publication date, study design, sample size, patient characteristics, treatment regimen, clinical efficacy outcomes, and adverse drug effects. Results Four articles were identified for inclusion representing two prospective open-label studies and two randomized, double-blind trials, evaluating 183 patients on memantine overall. A reduction in number of migraine days and headache severity were shown in all four studies in the participants treated with memantine. The most common adverse effects included somnolence, sedation, and nausea, none of which were severe. Conclusion The studies in this review establish that memantine has the potential for use as a treatment option for episodic migraine. Additional long-term studies using an active comparator would be useful to further elucidate its role.
Background Naloxone prescribing among patients undergoing surgery is not well described. This cohort study was designed to examine patients' risk factors for opioid overdose and their association with naloxone prescribing among veterans undergoing total knee arthroplasty (TKA) after a systemwide Overdose Education and Naloxone Distribution (OEND) initiative. Methods A retrospective analysis of Veterans Health Administration (VHA) records was performed and consisted of 38,011 veterans undergoing primary TKA from 2013 to 2016. Patient overdose risk was determined using a validated risk index for overdose or serious opioid-induced respiratory depression (RIOSORD) based on patient diagnoses, health care utilization, and prescription drug use. Naloxone dispensing was examined from the year before surgery until 7 days after discharge. These rates were examined the year prior to implementation of a national OEND initiative (2013), the year of implementation (2014), and 2 years following implementation (2015-2016). Results In 2013, 3.3% of patients presenting for TKA had moderate or high risk for overdose and none were prescribed naloxone. By 2016, after OEND implementation, 2.2% of patients presenting for TKA had moderate or high risk for overdose, but only 10.9% of the moderate-risk and 12.7% of the high-risk patients were prescribed naloxone. Conclusions Patients presenting for TKA routinely have risk factors for opioid overdose and significant proportions are at moderate or high risk for overdose. Despite this, most patients at moderate and high risk do not receive perioperative naloxone. Risk mitigation strategies using validated tools such as RIOSORD may help identify surgical patients at greatest risk for opioid overdose who could benefit from OEND.
Background: Guidelines suggest screening for polypharmacy and documentation of high-risk medications in the geriatric Emergency Department (ED) setting. The purpose of this quality improvement initiative was to describe high-risk medications and polypharmacy in older Veterans presenting to the ED in order to inform the workflow of a Geriatric ED pharmacist.
BACKGROUND:New immunotherapy agents have provided additional options for the treatment of a variety of malignancies, including the programmed death 1 (PD-1) protein inhibitors nivolumab and pembrolizumab. Initial dosing was based on patient weight, but subsequent studies supported fixed dosing, thereby prompting a change in US Food and Drug Administration-approved dosing. Depending on patient weight, one dosing strategy may be more cost-effective than another; thereby, a combination of dosing strategies may be beneficial for institutions. While these agents have been shown to be efficacious, they have been associated with immune-related adverse events (IrAEs). The purpose of this study was to determine the dosing strategy used and identify actual and potential cost savings, as well as to determine the incidence of hypothyroidism with PD-1 inhibitors in patients of the US Department of Veterans Affairs (VA).METHODS:This was a retrospective chart review of VA patients who received a PD-1 inhibitor for the treatment of a solid tumor between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for a PD-1 inhibitor was categorized into weight-based vs fixed-dosing where possible and used to identify actual and potential cost-savings opportunities. Thyroid laboratory values and levothyroxine prescriptions were evaluated to determine the overall incidence of the prespecified IrAEs. Descriptive statistics were used for primary and secondary outcomes.RESULTS:Nivolumab was the primary PD-1 inhibitor used for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. Nivolumab orders resulted in $8,514,300 estimated actual cost savings with $5,591,250 estimated missed cost savings identified. Of the patients who received nivolumab, 3249 patients were evaluated for thyroid dysfunction; 514 (15.8%) developed primary hypothyroidism based on laboratory values and levothyroxine prescription data.CONCLUSIONS:Utilization of a combination of both weight-based and fixed-dosing strategies for nivolumab has the potential for cost savings, thereby benefiting the health care institution. The incidence of IrAEs identified among patients who received PD-1 inhibitor within the VA health care system was similar to the incidences reported in published literature. This further supports recommendations for close IrAE monitoring and treatment.
BACKGROUND:Gabapentinoids are commonly prescribed in perioperative multimodal analgesia protocols. Despite widespread use, the optimal dose to reduce opioid consumption while minimizing risks is unknown. We assessed dose-dependent effects of gabapentinoids on opioid consumption and postoperative pulmonary complications following total hip or knee arthroplasty (THA or TKA). We hypothesized that use of a gabapentinoid on the day of THA or TKA is associated with an increased risk of postoperative pulmonary complications in a dose-response fashion compared with the risk for patients who did not receive the drug. METHODS:Using the Premier Database, we identified adults who underwent elective primary THA or TKA from 2009 to 2014. The exposure was receipt of a gabapentinoid (gabapentin or pregabalin) on the day of surgery. Gabapentin dose was categorized into 5 groups: none, 1 to 350, 351 to 700, 701 to 1,050, and >1,050 mg per day. Pregabalin dose was categorized into 4 groups: none, 1 to 110, 111 to 250, and >250 mg per day. The primary outcome was a composite of postoperative pulmonary complications, defined as respiratory failure, pneumonia, reintubation, pulmonary edema, noninvasive ventilation, or invasive mechanical ventilation. RESULTS:Of 858,306 patients who underwent THA or TKA, 11.0% received gabapentin and 10.2% received pregabalin. The mean age (and standard deviation) of the patients was 65.6 ± 10.7 years, 39.6% were male, 78.2% were Caucasian, and 55.2% were covered by Medicare. In multilevel regression analysis, receipt of gabapentinoid at any dose on the day of surgery was associated with increased odds of postoperative pulmonary complications. Compared with no exposure to the drug being used by the particular group, all dose ranges of gabapentin and pregabalin were associated with greater odds of postoperative pulmonary complications (odds ratio, 95% confidence interval = 1.51, 1.40 to 1.63, for >1,050 mg of gabapentin and 1.81, 1.57 to 2.09, for >250 mg of pregabalin). We found no clinically meaningful associations between exposure to either gabapentin or pregabalin and perioperative opioid consumption or the length of the hospital stay. CONCLUSIONS:Exposure to gabapentinoids at any dose on the day of THA or TKA was associated with increased odds of postoperative pulmonary complications in a dose-response fashion, with minimal effects on perioperative opioid consumption. LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
OBJECTIVE: To describe recommendations made by geriatric clinical pharmacists within an innovative care model focusing on patients with dementia living at home. DESIGN: Retrospective chart review. SETTING: Outpatients in a tertiary care Veterans Affairs health care system. PARTICIPANTS: Veterans who underwent a Caring for Older Adults and Caregivers at Home (COACH) Program assessment and had at least one medicationrelated recommendation made by a geriatric clinical pharmacist. MAIN OUTCOME MEASURES: The primary endpoint was the number and category of medication-related recommendations made by a geriatric clinical pharmacist at the initial COACH program assessment. Secondary endpoints were recommendation acceptance rates and change in potentially inappropriate medications (PIMs) at six months. RESULTS: There were 104 patients included. The mean age was 81 years and the majority of patients were male and Caucasian. At baseline, patients were receiving a mean of 12 medications/person, and 59% of patients were receiving at least one PIM. There were 248 total medication recommendations made, with a mean of 2.4 recommendations/person (range 1-5). The three most common recommendation categories were to discontinue a drug, decrease the dose, and switch to a potentially safer alternative. Providers accepted 110 (44%) recommendations within six months. Patients were receiving a mean of one PIM/person at baseline, and no change was observed at six months.CONCLUSION: This study describes recommendations made through medication reviews by geriatric clinical pharmacists within an innovative care model for patients with dementia living at home. These data may provide information to other clinical pharmacists implementing consult services in similar settings.
Previous studies have reported an association of proton pump inhibitor (PPI) use and decreased sustained viral response rate (SVR) in patients taking ledipasvir/sofosbuvir (LDV/SOF). The relationship between PPI usage and SVR is less clear in patients with HIV/HCV coinfection, where concomitant antiretrovirals may result in more complex drug interactions. This retrospective study evaluates the effects of acid suppression medications (PPI or H2‐receptor antagonist [H2B]) use and SVR rates in patients with HIV/HCV or HCV and taking LDV/SOF in a large multicentre veteran cohort. Patients in the Veterans Affairs Health Care System who received LDV/SOF ± ribavirin from 10/10/2014 to 12/31/2015 were included. The odds ratios (OR) of PPI or H2B use for SVR were adjusted for clinical factors and with inverse probability of treatment weighting for non‐random treatment selection for acid suppression medication use. There were 9703 veterans included in our final analysis. After adjustment of other clinical factors, PPI use is associated with a lower SVR in the overall cohort (95.0% vs. 96.1%, OR: 0.86, 95% CI: 0.74–0.99, p = .03, number needed to harm 90.9) and HIV/HCV coinfection subgroup (93.4% vs. 96.9%, OR: 0.47, 95% CI: 0.26–0.85, p = .01, number needed to harm 28.6). This present study reveals PPI use is associated with reduced SVR after LDV/SOF treatment, with a more significant impact in the subgroup of patients with HIV/HCV coinfection. Precautions need to be taken when using PPI and LDV/SOF in this group of patients.
OBJECTIVE:Multimodal analgesia has gained popularity in total hip arthroplasty (THA) and total knee arthroplasty (TKA), but large multicenter studies evaluating specific analgesic combinations are lacking.DESIGN:A retrospective study using the Premier Healthcare Database (2009-2014).SUBJECTS:Adults who underwent elective primary THA or TKA.METHODS:We categorized day-of-surgery analgesic exposure using eight mutually exclusive categories: acetaminophen (Ac), nonsteroidal anti-inflammatory drugs (Ns), gabapentinoids (Ga; gabapentin or pregabalin), Ac+Ns, Ac+Ga, Ns+Ga, Ac+Ns+Ga, and none of the three drugs. Multilevel models measured associations of the analgesic categories with a composite of postoperative pulmonary complications (PPCs).RESULTS:Among 863,139 patients, 75.2% received at least one of the three drugs. In multilevel models, compared with none of the three drugs, Ga use was associated with increased odds of PPCs when used alone (adjusted odds ratio [aOR] = 1.35, 95% confidence interval [CI] = 1.27 to 1.44), combined with Ac (aOR = 1.16, 95% CI = 1.08 to 1.26), or combined with Ns (aOR = 1.28, 95% CI = 1.21 to 1.34). In contrast, the Ac+Ns pair was associated with decreased odds of PPCs (OR = 0.86, 95% CI = 0.83 to 0.90) and lower opioid consumption. Ac+Ns+Ga was not associated with PPCs, whereas it was associated with the lowest opioid consumption on the day of surgery.CONCLUSIONS:Gabapentinoids, alone and in single combination with either acetaminophen or nonsteroidal anti-inflammatory drugs, were associated with higher PPCs, whereas the Ac+Ns pair was associated with fewer PPCs and an opioid-sparing effect. Ac+Ns+Ga was not associated with PPCs, whereas it was associated with the lowest opioid consumption on the day of surgery.
Influenza prophylaxis with oseltamivir is recommended for exposed high-risk patients. Patients with many comorbidities have an increased likelihood of co-administration of oseltamivir and warfarin. Evidence of a drug interaction is conflicting in the literature and is limited to a 5-day treatment course. This study evaluates the impact of prophylactic oseltamivir on international normalized ratio (INR) in patients taking warfarin. This retrospective cohort study conducted within the Veterans Health Administration included patients on warfarin who received oseltamivir for influenza prophylaxis. The primary endpoint was change in INR from baseline to day 10 of oseltamivir treatment. Secondary endpoints included change in INR based on renal function and duration of oseltamivir prophylaxis, trend in INR, and frequency of bleeding and thrombosis events. A total of 1041 patients were included and received oseltamivir for a mean of 12.9 days. The mean post-oseltamivir INR was significantly increased compared to the pre-oseltamivir INR (2.39 to 2.52; p < 0.001). Patients with a creatinine clearance of 31–60 mL/min had a significant increase in INR (2.40 to 2.59; p < 0.01). There was an increase in INR when oseltamivir was used for 7 or 8–10 days. Of included patients, 5.1% and 1.8% had a recorded thrombosis or bleeding event, respectively. There was a significant increase in INR in patients on chronic warfarin therapy and concomitant prophylactic oseltamivir, but this change may only be clinically significant for certain patient populations. The most impact on INR was within 7–10 days of oseltamivir initiation and in patients with impaired renal function.