Publications

2018

Cochran, Gerald, Wei-Hsuan Lo-Ciganic, Walid F Gellad, Adam J Gordon, Evan Cole, Carroline Lobo, Winfred Frazier, et al. (2018) 2018. “Prescription Opioid Quality Measures Applied Among Pennsylvania Medicaid Enrollees.”. Journal of Managed Care & Specialty Pharmacy 24 (9): 875-85. https://doi.org/10.18553/jmcp.2018.24.9.875.

BACKGROUND: The Pharmacy Quality Alliance (PQA) recently developed 3 quality measures for prescribing opioids: high dosages, multiple providers and pharmacies, and concurrent use of opioids and benzodiazepines.

OBJECTIVE: To examine the prevalence of the PQA measures and identify the patient demographic and health characteristics associated with the measures.

METHODS: We conducted a cross-sectional analysis using Pennsylvania Medicaid data (2013-2015). We limited our analyses to noncancer patients who were aged 18-64 years and not dual-eligible for Medicare/Medicaid. Per PQA specifications, patients were required to possess ≥ 2 opioid prescriptions for ≥ 15 days annual supply each year. Outcome measures included (a) high dosages, defined as > 120 morphine milligram equivalents for ≥ 90 consecutive days; (b) multiple providers/pharmacies, defined as receiving opioid prescriptions from ≥ 4 providers and ≥ 4 pharmacies; and (c) concurrent use of opioids and benzodiazepines, defined as ≥ 30 cumulative days of overlapping opioids and benzodiazepines among individuals having ≥ 2 opioid and ≥ 2 benzodiazepine fills. Patient characteristics assessed included demographics; other medication use; and physical, mental, and behavioral health comorbidities. We present descriptive and multivariable statistical analyses of the data to describe trends in quality measure prevalence and associations with enrollee health characteristics.

RESULTS: Numbers of enrollees meeting inclusion criteria ranged from 73,082 in 2013 to 85,710 in 2015. From 2013 to 2015, high dosage prevalence increased from 5.1% to 5.5%; the use of multiple providers/pharmacies decreased from 7.1% to 5.0%; and concurrent use of opioids and benzodiazepines decreased from 29.1% to 28.4% (all P < 0.05). A substantial portion of patients with > 1 PQA measure from 2013 to 2015 was eligible for Medicaid because of disability (41.8%-81.9%). Enrollees with opioid use disorder were more likely to have high dosages (adjusted odds ratio [AOR] = 2.01, 95% CI = 1.83-2.21). Enrollees with anxiety and mood disorders were more likely to have multiple providers/pharmacies (anxiety: AOR = 1.54, 95% CI = 1.43-1.65; mood: AOR = 1.15, 95% CI = 1.06-1.25) and concurrent use of opioids and benzodiazepines (anxiety: AOR = 3.50, 95% CI = 3.38-3.63; mood: AOR = 1.42, 95% CI = 1.36-1.48).

CONCLUSIONS: Given high levels of eligibility based on disability and the prevalence of mood, anxiety, and opioid use disorders among those identified by the quality measures, providers may require additional support to care for this patient population.

DISCLOSURES: This project was supported by a grant from the Centers for Disease Control and Prevention and was also supported by an intergovernmental agreement between the Pennsylvania Department of Human Services and the University of Pittsburgh. Lo-Ciganic was supported by the University of Arizona Health Sciences Career Development Award. The other authors have nothing to disclose. The conclusions, findings, and opinions expressed by authors contributing to this article do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the Commonwealth of Pennsylvania. A portion of these results was presented at the Association for Medical Education and Research in Substance Abuse 41st National Conference; November 2-4, 2017; Washington, DC.

2017

Vajravelu, Ravy K, Mark T Osterman, Faten N Aberra, Jason A Roy, Gary R Lichtenstein, Ronac Mamtani, David S Goldberg, James D Lewis, and Frank I Scott. (2017) 2017. “Indeterminate QuantiFERON-TB Gold Increases Likelihood of Inflammatory Bowel Disease Treatment Delay and Hospitalization.”. Inflammatory Bowel Diseases 24 (1): 217-26. https://doi.org/10.1093/ibd/izx019.

BACKGROUND: QuantiFERON-TB Gold (QFTG) is a blood test used to diagnose latent tuberculosis infection (LTBI) prior to TNF-α inhibitor (anti-TNF) initiation. We sought to determine factors associated with indeterminate QFTG results in inflammatory bowel disease (IBD) patients and whether indeterminate results are associated with IBD-related morbidity.

METHODS: This nested case-control study included IBD patients who underwent QFTG testing. Cases were patients with indeterminate QFTG and controls were those with negative QFTG. The association of demographic and clinical data with indeterminate QFTG result was assessed using logistic regression. We examined the clinical impact of indeterminate QFTG results on risk of hospitalization and delay in anti-TNF initiation using inverse probability-of-treatment weighting (IPTW) regression.

RESULTS: We identified 411 patients with QFTG testing (320 negative, 80 indeterminate, and 11 positive results). No patient with an indeterminate result subsequently had LTBI. Systemic corticosteroid use (OR, 4.4; 95% CI, 2.0-9.6) and hospitalization at the time of QFTG (OR, 3.8; 95% CI, 1.9-7.7) were associated with indeterminate QFTG, while immunomodulator use was nearly statistically significant (OR, 3.1; 95% CI, 0.9-9.8) and anti-TNF use was not (OR, 0.9; 95% CI, 0.2-4.6). After IPTW adjustment, indeterminate QFTG was associated with a 23.1% (95% CI, 8.2%-37.9%) greater probability of delay in anti-TNF initiation beyond 30 days and an 11.9% (95% CI, 0.6%-23.1%) greater probability of hospitalization within 60 days.

CONCLUSIONS: Systemic corticosteroid use and hospitalization were associated with an indeterminate QFTG result. Indeterminate QFTG results were associated with delayed anti-TNF initiation and subsequent hospitalization.

Papamichael, Konstantinos, Karen A Chachu, Ravy K Vajravelu, Byron P Vaughn, Josephine Ni, Mark T Osterman, and Adam S Cheifetz. (2017) 2017. “Improved Long-Term Outcomes of Patients With Inflammatory Bowel Disease Receiving Proactive Compared With Reactive Monitoring of Serum Concentrations of Infliximab.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 15 (10): 1580-1588.e3. https://doi.org/10.1016/j.cgh.2017.03.031.

BACKGROUND & AIMS: Monitoring serum concentrations of tumor necrosis factor antagonists in patients receiving these drugs as treatment for inflammatory bowel disease (IBD), also called therapeutic drug monitoring, is performed either after patient loss of response (reactive drug monitoring) or in patients in clinical remission in which the drug is titrated to a target concentration (proactive drug monitoring). We compared long-term outcomes of patients with IBD undergoing proactive vs reactive monitoring of serum concentrations of infliximab.

METHODS: We performed a multicenter, retrospective study of 264 consecutive patients with IBD (167 with Crohn's disease) receiving infliximab maintenance therapy. The subjects received proactive (n = 130) or reactive (n = 134) drug monitoring, based on measurements of first infliximab concentration and antibodies to infliximab, from September 2006 to January 2015; they were followed through December 2015 (median time of 2.4 years). We analyzed time to treatment failure, first IBD-related surgery or hospitalization, serious infusion reaction, and detection of antibodies to infliximab. Treatment failure was defined as drug discontinuation for loss of response or serious adverse event, or need for surgery.

RESULTS: Multiple Cox regression analysis independently associated proactive drug monitoring, compared with reactive monitoring, with reduced risk for treatment failure (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.09-0.27; P < .001), IBD-related surgery (HR, 0.30; 95% CI, 0.11-0.80; P = .017), IBD-related hospitalization (HR, 0.16; 95% CI, 0.07-0.33; P < .001), antibodies to infliximab (HR, 0.25; 95% CI, 0.07-0.84; P = .025), and serious infusion reaction (HR, 0.17; 95% CI, 0.04-0.78; P = .023).

CONCLUSIONS: In a retrospective analysis of patients with IBD receiving proactive vs reactive monitoring of serum concentration of infliximab, proactive monitoring was associated with better clinical outcomes, including greater drug durability, less need for IBD-related surgery or hospitalization, and lower risk of antibodies to infliximab or serious infusion reactions.

Thorpe, Joshua M, Carolyn T Thorpe, Walid F Gellad, Chester B Good, Joseph T Hanlon, Maria K Mor, John R Pleis, Loren J Schleiden, and Courtney Harold Van Houtven. (2017) 2017. “Dual Health Care System Use and High-Risk Prescribing in Patients With Dementia: A National Cohort Study.”. Annals of Internal Medicine 166 (3): 157-63. https://doi.org/10.7326/M16-0551.

BACKGROUND: Recent federal policy changes attempt to expand veterans' access to providers outside the Department of Veterans Affairs (VA). Receipt of prescription medications across unconnected systems of care may increase the risk for unsafe prescribing, particularly in persons with dementia.

OBJECTIVE: To investigate the association between dual health care system use and potentially unsafe medication (PUM) prescribing.

DESIGN: Retrospective cohort study.

SETTING: National VA outpatient care facilities in 2010.

PARTICIPANTS: 75 829 veterans with dementia who were continuously enrolled in Medicare from 2007 to 2010; 80% were VA-only users, and 20% were VA-Medicare Part D (dual) users.

MEASUREMENTS: Augmented inverse propensity weighting was used to estimate the effect of dual-system versus VA-only prescribing on 4 indicators of PUM prescribing in 2010: any exposure to Healthcare Effectiveness Data and Information Set (HEDIS) high-risk medication in older adults (PUM-HEDIS), any daily exposure to prescriptions with a cumulative Anticholinergic Cognitive Burden (ACB) score of 3 or higher (PUM-ACB), any antipsychotic prescription (PUM-antipsychotic), and any PUM exposure (any-PUM). The annual number of days of each PUM exposure was also examined.

RESULTS: Compared with VA-only users, dual users had more than double the odds of exposure to any-PUM (odds ratio [OR], 2.2 [95% CI, 2.2 to 2.3]), PUM-HEDIS (OR, 2.4 [CI, 2.2 to 2.8]), and PUM-ACB (OR, 2.1 [CI, 2.0 to 2.2]). The odds of PUM-antipsychotic exposure were also greater in dual users (OR, 1.5 [CI, 1.4 to 1.6]). Dual users had an adjusted average of 44.1 additional days of any-PUM exposure (CI, 37.2 to 45.0 days).

LIMITATION: Observational study design of veteran outpatients only.

CONCLUSION: Among veterans with dementia, rates of PUM prescribing are significantly higher among dual-system users than with VA-only users.

PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.

Gellad, Walid F, Xinhua Zhao, Carolyn T Thorpe, Joshua M Thorpe, Florentina E Sileanu, John P Cashy, Maria Mor, et al. (2017) 2017. “Overlapping Buprenorphine, Opioid, and Benzodiazepine Prescriptions Among Veterans Dually Enrolled in Department of Veterans Affairs and Medicare Part D.”. Substance Abuse 38 (1): 22-25. https://doi.org/10.1080/08897077.2016.1267071.

BACKGROUND: Buprenorphine is a key tool in the management of opioid use disorder, but there are growing concerns about abuse, diversion, and safety. These concerns are amplified for the Department of Veterans Affairs (VA), whose patients may receive care concurrently from multiple prescribers within and outside VA. To illustrate the extent of this challenge, we examined overlapping prescriptions for buprenorphine, opioids, and benzodiazepines among veterans dually enrolled in VA and Medicare Part D.

METHODS: We constructed a cohort of all veterans dually enrolled in VA and Part D who filled an opioid prescription in 2012. We identified patients who received tablet or film buprenorphine products from either source. We calculated the proportion of buprenorphine recipients with any overlapping prescription (based on days supply) for a nonbuprenorphine opioid or benzodiazepine, focusing on veterans who received overlapping prescriptions from a different system than their buprenorphine prescription (Part D buprenorphine recipients receiving overlapping opioids or benzodiazepines from VA and vice versa).

RESULTS: There were 1790 dually enrolled veterans with buprenorphine prescriptions, including 760 (43%) from VA and 1091 (61%) from Part D (61 veterans with buprenorphine from both systems were included in each group). Among VA buprenorphine recipients, 199 (26%) received an overlapping opioid prescription and 11 (1%) received an overlapping benzodiazepine prescription from Part D. Among Part D buprenorphine recipients, 208 (19%) received an overlapping opioid prescription and 178 (16%) received an overlapping benzodiazepine prescription from VA. Among VA and Part D buprenorphine recipients with cross-system opioid overlap, 25% (49/199) and 35% (72/208), respectively, had >90 days of overlap.

CONCLUSIONS: Many buprenorphine recipients receive overlapping prescriptions for opioids and benzodiazepines from a different health care system than the one in which their buprenorphine was filled. These findings highlight a previously undocumented safety risk for veterans dually enrolled in VA and Medicare.

Radomski, Thomas R, Xinhua Zhao, Carolyn T Thorpe, Joshua M Thorpe, Jennifer G Naples, Maria K Mor, Chester B Good, Michael J Fine, and Walid F Gellad. (2017) 2017. “The Impact of Medication-Based Risk Adjustment on the Association Between Veteran Health Outcomes and Dual Health System Use.”. Journal of General Internal Medicine 32 (9): 967-73. https://doi.org/10.1007/s11606-017-4064-4.

BACKGROUND: Veterans commonly receive care from both Veterans Health Administration (VA) and non-VA sources (i.e., dual use). A major challenge in comparing health outcomes between dual users and VA-predominant users is applying an accurate method of risk adjustment.

OBJECTIVE: To determine how different comorbidity indices affect the association between patterns of dual use and health outcomes.

DESIGN: Retrospective cohort.

PARTICIPANTS: A total of 316,775 community-dwelling Veterans (≥65 years) with type 2 diabetes who were enrolled in VA and fee-for-service Medicare from 2008 to 2010.

METHODS: We determined the associations between dual use and death or diabetes-related hospitalization in FY 2010 using multivariable models incorporating claims-based (Elixhauser) or medication-based (RxRisk-V) risk adjustment. Dual use was classified using four previously identified groups of health services users: 1) VA-predominant, 2) VA + Medicare visits and labs, 3) VA + Medicare test strips, and 4) VA + Medicare medications.

KEY RESULTS: Controlling for Elixhauser comorbidities, dual-use groups 2-4 had significantly decreased odds of death or hospitalization compared to VA-predominant users. Controlling for RxRisk-V comorbidities, groups 2-4 had increased odds of death compared to VA-predominant users, but variable odds of hospitalization, with group 2 having increased odds (OR 1.06, CI 1.04-1.09), while groups 3 (OR 0.96, CI 0.94-0.99) and 4 (OR 0.93, CI 0.89-0.97) had decreased odds.

CONCLUSIONS: The method of risk adjustment drastically influences the direction of effect in health outcomes among dual users of VA and Medicare. These findings underscore the need for standardized and reliable risk adjustment methods that are not susceptible to measurement differences across different health systems.

Gellad, Walid F, Francesca E Cunningham, Chester B Good, Joshua M Thorpe, Carolyn T Thorpe, Brandi Bair, KatieLynn Roman, and Susan L Zickmund. (2017) 2017. “Pharmacy Use in the First Year of the Veterans Choice Program: A Mixed-Methods Evaluation.”. Medical Care 55 Suppl 7 Suppl 1: S26-S32. https://doi.org/10.1097/MLR.0000000000000661.

BACKGROUND: The Veterans Choice Program (VCP) was created to ensure timely access to health care in the Department of Veterans Affairs (VA). Under this program, medications may be ordered by select non-VA clinicians to be dispensed by VA pharmacies, creating new challenges in ensuring medication safety.

OBJECTIVES: To examine pharmaceutical use during the first year of the VCP and to understand barriers and facilitators for VA pharmacists to dispensing medications under the VCP.

STUDY DESIGN: Mixed-methods evaluation.

METHODS: We captured all prescriptions dispensed through the VCP and described the demographics of VCP users and their medications. We also conducted semistructured interviews of VA pharmacists, focusing on VA formulary management and experiences dispensing opioid and hepatitis C (HCV) medications. Codebook development and coding followed iterative qualitative methods.

RESULTS: Overall, 17,346 Veterans received 56,426 VCP prescriptions from November 7, 2014 through November 7, 2015. The total medication cost was $27 million, 90% of which was for only 2772 HCV prescriptions. Topical eye drops and opioids represented the most commonly dispensed prescriptions (15.6% and 9.2% of all prescriptions, respectively). Pharmacists reported numerous challenges to dispensing VCP medications, including time required to contact non-VA clinicians about formulary issues, requiring controlled substance prescriptions to be hand delivered to VA pharmacies, and lack of access to laboratory data required to safely dispense medications.

CONCLUSIONS: HCV-related medication costs predominated the first year of VCP, but this is likely to change going forward. The safe use of opioids, efficient management of nonformulary medications, and unintended new barriers to access created by the VCP must be addressed.

Semla, Todd P, Chris Ruser, Chester B Good, Susan Z Yanovski, Donna Ames, Laurel A Copeland, Charles Billington, et al. (2017) 2017. “Pharmacotherapy for Weight Management in the VHA.”. Journal of General Internal Medicine 32 (Suppl 1): 70-73. https://doi.org/10.1007/s11606-016-3949-y.

Weight management medications (WMM) are underutilized as an adjunct to behavioral and lifestyle interventions. In fiscal years 2014-2015, a total of approximately 2500 veterans-a mere 2% of veterans receiving care from the Veterans Health Administration (VHA)-eligible for a WMM received a prescription for one. A State of the Art Conference on Weight Management workgroup, focused on pharmacotherapy, developed evidence-based recommendations and strategies to foster the appropriate use of WMM in the VHA. The workgroup identified patient, prescriber, and health system barriers to and facilitators for prescribing WMM. Barriers included patient and provider concerns about medication safety and efficacy, limited involvement of primary care, restrictive medication criteria for use (CFU), and skepticism among providers regarding the safety and efficacy of WMM and the perception of obesity as a disease. Potential facilitators for removing barriers included patient and provider education about WMM and the health benefits of weight loss, increased engagement of primary care providers in weight management, relaxation of the CFU, and creation of a system to help patients navigate through weight management treatment options. Several research questions were framed with regard to WMM in general, and specifically to the care of obese veterans. While some of the workgroup's conclusions reflect issues specific to the VHA, many are likely to be applicable to other health organizations.

Gazda, Nicholas P, Lucas A Berenbrok, and Stefanie P Ferreri. (2017) 2017. “Comparison of Two Medication Therapy Management Practice Models on Return on Investment.”. Journal of Pharmacy Practice 30 (3): 282-85. https://doi.org/10.1177/0897190016628962.

OBJECTIVE: To compare the return on investment (ROI) of an integrated practice model versus a "hub and spoke" practice model of pharmacist provided medication therapy management (MTM).

METHODS: A cohort retrospective analysis of MTM claims billed in 76 pharmacies in North Carolina in the 2010 hub and spoke practice model and the 2012 "integrated" practice model were analyzed to calculate the ROI.

RESULTS: In 2010, 4089 patients received an MTM resulting in 8757 claims in the hub and spoke model. In 2012, 4896 patients received an MTM resulting in 13 730 claims in the integrated model. In 2010, US$165 897.26 was invested in pharmacist salary and $173 498.00 was received in reimbursement, resulting in an ROI of +US$7600.74 (+4.6%). In 2012, US$280 890.09 was invested in pharmacist salary and US$302 963 was received in reimbursement, resulting in an ROI of +US$22 072.91 or (+7.9%).

CONCLUSION: The integrated model of MTM showed an increase in number of claims submitted and in number of patients receiving MTM services, ultimately resulting in a higher ROI. While a higher ROI was evident in the integrated model, both models resulted in positive ROI (1:12-1:21), highlighting that MTM programs can be cost effective with different strategies of execution.