Publications

2019

Lockhart, Peter B, Malavika P Tampi, Elliot Abt, Anita Aminoshariae, Michael J Durkin, Ashraf F Fouad, Prerna Gopal, et al. (2019) 2019. “Evidence-Based Clinical Practice Guideline on Antibiotic Use for the Urgent Management of Pulpal- and Periapical-Related Dental Pain and Intraoral Swelling: A Report from the American Dental Association.”. Journal of the American Dental Association (1939) 150 (11): 906-921.e12. https://doi.org/10.1016/j.adaj.2019.08.020.

BACKGROUND: An expert panel convened by the American Dental Association Council on Scientific Affairs and the Center for Evidence-Based Dentistry conducted a systematic review and formulated clinical recommendations for the urgent management of symptomatic irreversible pulpitis with or without symptomatic apical periodontitis, pulp necrosis and symptomatic apical periodontitis, or pulp necrosis and localized acute apical abscess using antibiotics, either alone or as adjuncts to definitive, conservative dental treatment (DCDT) in immunocompetent adults.

TYPES OF STUDIES REVIEWED: The authors conducted a search of the literature in MEDLINE, Embase, the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature to retrieve evidence on benefits and harms associated with antibiotic use. The authors used the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty in the evidence and the Evidence-to-Decision framework.

RESULTS: The panel formulated 5 clinical recommendations and 2 good practice statements, each specific to the target conditions, for settings in which DCDT is and is not immediately available. With likely negligible benefits and potentially large harms, the panel recommended against using antibiotics in most clinical scenarios, irrespective of DCDT availability. They recommended antibiotics in patients with systemic involvement (for example, malaise or fever) due to the dental conditions or when the risk of experiencing progression to systemic involvement is high.

CONCLUSION AND PRACTICAL IMPLICATIONS: Evidence suggests that antibiotics for the target conditions may provide negligible benefits and probably contribute to large harms. The expert panel suggests that antibiotics for target conditions be used only when systemic involvement is present and that immediate DCDT should be prioritized in all cases.

Moyo, Patience, Walid F Gellad, Lindsay M Sabik, Gerald T Cochran, Evan S Cole, Adam J Gordon, David K Kelley, and Julie M Donohue. (2019) 2019. “Opioid Prescribing Safety Measures in Medicaid Enrollees With and Without Cancer.”. American Journal of Preventive Medicine 57 (4): 540-44. https://doi.org/10.1016/j.amepre.2019.05.019.

INTRODUCTION: Opioid prescribing safety among individuals with cancer is poorly understood. This study estimates the prevalence of Pharmacy Quality Alliance opioid measures among individuals with cancer undergoing or not undergoing active treatment versus those without cancer.

METHODS: Pennsylvania Medicaid data (2016) were analyzed in 2018 to identify adults aged 18-64 years with and without cancer diagnoses who had 2 or more opioid prescriptions. Active cancer treatment, defined as having chemotherapy, radiotherapy, cancer surgery, or hospitalization with a primary diagnosis of cancer, was evaluated from October 2015 to December 2016 allowing a ≥3-month look-back period for cancer diagnoses observed in the first quarter of 2016. Opioid dosages (>120 morphine milligram equivalents for ≥90 consecutive days), multiple providers (4 or more prescribers and 4 or more pharmacies), and opioid and benzodiazepines overlapping ≥30 days were evaluated.

RESULTS: The sample with opioid prescriptions included 111,491 enrollees without cancer diagnoses and 12,819 with cancer, 58.8% of whom were not in active cancer treatment. Among enrollees undergoing cancer treatment, with cancer but not in active treatment, and without cancer, the prevalence of high morphine milligram equivalents was 7.1%, 6.0%, and 4.7% (p<0.001), respectively. The corresponding prevalence of multiple providers was 6.7%, 4.1%, and 3.4% (p<0.001). Concurrent opioid and benzodiazepine prescriptions occurred in 28.6%, 30.5%, and 26.8% (p<0.001), respectively.

CONCLUSIONS: Individuals with cancer, regardless of treatment status, had higher-risk opioid use based on Pharmacy Quality Alliance measures versus those without cancer. Their systematic exclusion from opioid quality surveillance could create missed opportunities to identify patients at high risk of adverse opioid-related outcomes.

San-Juan-Rodriguez, Alvaro, Walid F Gellad, Chester B Good, and Inmaculada Hernandez. (2019) 2019. “Trends in List Prices, Net Prices, and Discounts for Originator Biologics Facing Biosimilar Competition.”. JAMA Network Open 2 (12): e1917379. https://doi.org/10.1001/jamanetworkopen.2019.17379.

In this cohort study, pricing data from January 2007 to June 2018 from SSR Health were used to determine how list prices, net prices, and discounts for the originator biologics changed with biosimilar competition.

Linsky, Amy, Walid F Gellad, Jeffrey A Linder, and Mark W Friedberg. (2019) 2019. “Advancing the Science of Deprescribing: A Novel Comprehensive Conceptual Framework.”. Journal of the American Geriatrics Society 67 (10): 2018-22. https://doi.org/10.1111/jgs.16136.

Polypharmacy is common in older adults and associated with inappropriate medication use, adverse drug events, medication nonadherence, higher costs, and increased mortality compared with those without polypharmacy. Deprescribing, the clinically supervised process of stopping or reducing the dose of medications when they cause harm or no longer provide benefit, may improve outcomes. Although potentially beneficial, clinicians struggle to overcome structural, organizational, technological, and cognitive barriers to deprescribing, limiting its use in clinical practice. Deprescribing science would benefit from a unifying conceptual framework to prioritize research. Current deprescribing conceptual frameworks have made important contributions to the field but often with a focus on specific medication classes or aspects of deprescribing. To further this relatively nascent field, we developed a broader deprescribing conceptual framework that builds on prior frameworks and includes patient, prescriber, and system influences; the process of deprescribing; outcomes; and dissemination. Patient factors include patients' biology, experience, values, and preferences. Prescriber factors include rational (eg, based on explicit knowledge) and nonrational (eg, behavioral tendencies, biases, and heuristics) decision making. System factors include resources, incentives, goals, and culture that contribute to deprescribing. The framework separates the deprescribing decision from the deprescribing process. The framework captures the results of deprescribing by examining changes in clinical structures, performance processes, patient experience, health outcomes, and cost. Through testing and refinement, this novel, more comprehensive conceptual framework has the potential to advance deprescribing research by organizing the existing evidence, identifying evidence gaps, and categorizing deprescribing interventions and the settings in which they are applied. J Am Geriatr Soc 67:2018-2022, 2019.

Hernandez, Inmaculada, Chester B Good, William H Shrank, and Walid F Gellad. (2019) 2019. “Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018.”. JAMA 321 (16): 1627-29. https://doi.org/10.1001/jama.2019.2990.

This study uses Medicaid drug utilization data to describe reimbursement and market share of long-acting insulins before and after approval of new insulin products and to estimate savings associated with a “biosimilar” for insulin glargine approved in 2015.

Rogal, Shari S, Lauren A Beste, Ada Youk, Michael J Fine, Bryan Ketterer, Hongwei Zhang, Steven Leipertz, et al. (2019) 2019. “Characteristics of Opioid Prescriptions to Veterans With Cirrhosis.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 17 (6): 1165-1174.e3. https://doi.org/10.1016/j.cgh.2018.10.021.

BACKGROUND & AIMS: Despite increased risks for adverse effects in patients with cirrhosis, little is known about opioid prescriptions for this population. We aimed to assess time trends in opioid prescribing and factors associated with receiving opioids among patients with cirrhosis.

METHODS: Among Veterans with cirrhosis, identified using national Veterans Health Administration data (2005-2014), we assessed characteristics of patients and their prescriptions for opioids. We calculated the annual proportion of patients receiving any opioid prescription. Among opioid recipients, we assessed prescriptions that were long-term (>90 days' supply), for high doses (>100 MME/day), or involved combinations of opioids and acetaminophen or benzodiazepine. We evaluated patient characteristics independently associated with long-term and any opioid prescriptions using mixed-effects regression models.

RESULTS: Among 127,239 Veterans with cirrhosis, 97,974 (77.0%) received a prescription for an opioid. Annual opioid prescriptions increased from 36% in 2005 to 47% in 2014 (P < .01). Among recipients of opioids, the proportions of those receiving long-term prescriptions increased from 47% in 2005 to 54% in 2014 (P < .01), and19%-21% received prescriptions for high-dose opioids. Prescriptions for combinations of opioids and acetaminophen decreased from 68% in 2005 to 50% in 2014 (P < .01) and for combinations of opioids and benzodiazepines decreased from 24% to 19% over this time (P < .01). Greater probability of long-term opioid prescriptions was independently associated with younger age, female sex, white race, hepatitis C, prior hepatic decompensation, hepatocellular carcinoma, mental health disorders, nicotine use disorders, medical comorbidities, surgery, and pain-related conditions.

CONCLUSION: Among Veterans with cirrhosis, 36%-47% were prescribed opioids in each year. Mental health disorders and hepatic decompensation were independently associated with long-term opioid prescriptions.

Barnett, Michael L, Xinhua Zhao, Michael J Fine, Carolyn T Thorpe, Florentina E Sileanu, John P Cashy, Maria K Mor, et al. (2019) 2019. “Emergency Physician Opioid Prescribing and Risk of Long-Term Use in the Veterans Health Administration: An Observational Analysis.”. Journal of General Internal Medicine 34 (8): 1522-29. https://doi.org/10.1007/s11606-019-05023-5.

BACKGROUND: Treatment by high-opioid prescribing physicians in the emergency department (ED) is associated with higher rates of long-term opioid use among Medicare beneficiaries. However, it is unclear if this result is true in other high-risk populations such as Veterans.

OBJECTIVE: To estimate the effect of exposure to high-opioid prescribing physicians on long-term opioid use for opioid-naïve Veterans.

DESIGN: Observational study using Veterans Health Administration (VA) encounter and prescription data.

SETTING AND PARTICIPANTS: Veterans with an index ED visit at any VA facility in 2012 and without opioid prescriptions in the prior 6 months in the VA system ("opioid naïve").

MEASUREMENTS: We assigned patients to emergency physicians and categorized physicians into within-hospital quartiles based on their opioid prescribing rates. Our primary outcome was long-term opioid use, defined as 6 months of days supplied in the 12 months subsequent to the ED visit. We compared rates of long-term opioid use among patients treated by high versus low quartile prescribers, adjusting for patient demographic, clinical characteristics, and ED diagnoses.

RESULTS: We identified 57,738 and 86,393 opioid-naïve Veterans managed by 362 and 440 low and high quartile prescribers, respectively. Patient characteristics were similar across groups. ED opioid prescribing rates varied more than threefold between the low and high quartile prescribers within hospitals (6.4% vs. 20.8%, p < 0.001). The frequency of long-term opioid use was higher among Veterans treated by high versus low quartile prescribers, though above the threshold for statistical significance (1.39% vs. 1.26%; adjusted OR 1.11, 95% CI 0.997-1.24, p = 0.056). In subgroup analyses, there were significant associations for patients with back pain (adjusted OR 1.25, 95% CI 1.01-1.55, p = 0.04) and for those with a history of depression (adjusted OR 1.28, 95% CI 1.08-1.51, p = 0.004).

CONCLUSIONS: ED physician opioid prescribing varied by over 300% within facility, with a statistically non-significant increased rate of long-term use among opioid-naïve Veterans exposed to the highest intensity prescribers.

Hernandez, Inmaculada, Chester B Good, David M Cutler, Walid F Gellad, Natasha Parekh, and William H Shrank. (2019) 2019. “The Contribution Of New Product Entry Versus Existing Product Inflation In The Rising Costs Of Drugs.”. Health Affairs (Project Hope) 38 (1): 76-83. https://doi.org/10.1377/hlthaff.2018.05147.

It is unknown to what extent rising drug costs are due to inflation in the prices of existing drugs versus the entry of new products. We used pricing data from First Databank and pharmacy claims from UPMC Health Plan to quantify the contribution of new versus existing drugs to the changes in costs of oral and injectable drugs used in the outpatient setting in 2008-16. The costs of oral and injectable brand-name drugs increased annually by 9.2 percent and 15.1 percent, respectively, largely driven by existing drugs. For oral and injectable specialty drugs, costs increased 20.6 percent and 12.5 percent, respectively, with 71.1 percent and 52.4 percent of these increases attributable to new drugs. Costs of oral and injectable generics increased by 4.4 percent and 7.3 percent, respectively, driven by new drug entry. The rising costs of generic and specialty drugs were mostly driven by new product entry, whereas the rising costs of brand-name drugs were due to existing drug price inflation.