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Interpretation and integration of the federal substance use privacy protection rule in integrated health systems: A qualitative analysis

Campbell, Aimee N C; McCarty, Dennis; Rieckmann, Traci; McNeely, Jennifer; Rotrosen, John; Wu, Li-Tzy; Bart, Gavin
BACKGROUND:Federal regulations (42 CFR Part 2) provide special privacy protections for persons seeking treatment for substance use disorders. Primary care providers, hospitals, and health care organizations have struggled to balance best practices for medical care with adherence to 42 CFR Part 2, but little formal research has examined this issue. The aim of this study was to explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies, and information technology architecture. METHODS:This was a cross-sectional qualitative study using purposive sampling to conduct interviews with privacy/legal officers (n = 17) and information technology specialists (n = 10) from 15 integrated healthcare organizations affiliated with three research nodes of the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN). Trained staff completed a short survey and digitally recorded semi-structured qualitative interview with each participant. Interviews were transcribed and coded within Atlas.ti. Framework analysis was used to identify and organize key themes across selected codes. RESULTS:Participants voiced concern over balancing patient safety with 42 CFR Part 2 privacy protections. Although similar standards of protection regarding release of information outside of the health system was described, numerous workarounds were used to manage intra-institutional communication and care coordination. To align 42 CFR Part 2 restrictions with electronic health records, health systems used sensitive note designation, "break the glass" technology, limited role-based access for providers, and ad hoc solutions (e.g., provider messaging). CONCLUSIONS:In contemporary integrated care systems, substance-related EHR records (e.g., patient visit history, medication logs) are often accessible internally without specific consent for sharing despite the intent of 42 CFR Part 2. Recent amendments to 42 CFR Part 2 have not addressed information sharing needs within integrated care settings.
PMID: 30577898
ISSN: 1873-6483
CID: 3550272

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse

Murphy, Sean M; McCollister, Kathryn E; Leff, Jared A; Yang, Xuan; Jeng, Philip J; Lee, Joshua D; Nunes, Edward V; Novo, Patricia; Rotrosen, John; Schackman, Bruce R
Background/UNASSIGNED:Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective/UNASSIGNED:To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design/UNASSIGNED:Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources/UNASSIGNED:Study instruments. Target Population/UNASSIGNED:Adults with opioid use disorder. Time Horizon/UNASSIGNED:24-week intervention with an additional 12 weeks of observation. Perspective/UNASSIGNED:Health care sector and societal. Interventions/UNASSIGNED:Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures/UNASSIGNED:Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis/UNASSIGNED:Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective. Results of Sensitivity Analysis/UNASSIGNED:The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation/UNASSIGNED:Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion/UNASSIGNED:Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone. Primary Funding Source/UNASSIGNED:National Institute on Drug Abuse, National Institutes of Health.
PMID: 30557443
ISSN: 1539-3704
CID: 3556922

Facing Opioids in the Shadow of the HIV Epidemic

Parker, Caroline M; Hirsch, Jennifer S; Hansen, Helena B; Branas, Charles; Martins, Sylvia
PMID: 30601748
ISSN: 1533-4406
CID: 4181952

Perceptions and Experiences of Emergency Department Patients With Opioid Use Disorder [Meeting Abstract]

Hawk, K.; McCormack, R.; Edelman, E. J.; Coupet, E.; Toledo, N.; Gauiter, P.; Rotrosen, J.; Chawarski, M.; Fiellin, D.; D\Onofrio, G.
ISI:000489265600254
ISSN: 0196-0644
CID: 4155962

A Polydrug and Psychosocial Profile of Synthetic Cannabinoid Use in a New York City Community Sample, 2016-2017

Joseph, Adriana; Lekas, Helen-Maria; Manseau, Marc; Lewis, Crystal
BACKGROUND:Epidemiologic reports available on synthetic cannabinoids (SCs) have focused on sociodemographics, indicating high prevalence of SC use predominantly among white, relatively affluent, males. However, there is emerging evidence suggesting high SC prevalence among socioeconomically disadvantaged, racial/ethnic minority males. OBJECTIVES/OBJECTIVE:The purpose of this study is to investigate the risk correlates of SC use among psychosocial vulnerable communities. METHOD/METHODS:The sample of 100 participants was recruited from two harm reduction-focused, community-based organizations in the South Bronx and East Harlem neighborhoods in New York City. Consented individuals 18 years and older underwent a 30- minute survey ascertaining sociodemographics, psychosocial characteristics, SC and polydrug use characteristics, and mental health history. RESULTS:The study population was majority male (61%), Latino (56%), commonly diagnosed with psychiatric illness (67%), and with a mean age of 45.4. Those reporting SC use (74%) were more likely to be male, homeless, and report polydrug use. After adjustment, being male (AOR = 5.64), homelessness (AOR = 4.88) along with cocaine (AOR = 5.63) and opiate use (AOR = 31.1) were independently associated with SC use. The most common reasons for using SC were affordability, inability to detect SC in drug tests, and perceived physical and emotional benefits. Conclusion/importance: This work is significant in expanding the populations thought to be impacted by and understanding social disparities related to SC use. Further investigation is needed to assess the relationship between concomitant use of SC and other drug, particularly opiates. This may suggest that the sequelae of one drug may enhance or alleviate the effects of the other.
PMID: 30526203
ISSN: 1532-2491
CID: 3678692

A 3' UTR SNP rs885863, a cis-eQTL for the circadian gene VIPR2 and lincRNA 689, is associated with opioid addiction

Levran, Orna; Randesi, Matthew; Rotrosen, John; Ott, Jurg; Adelson, Miriam; Kreek, Mary Jeanne
There is a reciprocal relationship between the circadian and the reward systems. Polymorphisms in several circadian rhythm-related (clock) genes were associated with drug addiction. This study aims to search for associations between 895 variants in 39 circadian rhythm-related genes and opioid addiction (OUD). Genotyping was performed with the Smokescreen® array. Ancestry was verified by principal/MDS component analysis and the sample was limited to European Americans (EA) (OUD; n = 435, controls; n = 138). Nominally significant associations (p < 0.01) were detected for several variants in genes encoding vasoactive intestinal peptide receptor 2 (VIPR2), period circadian regulator 2 (PER2), casein kinase 1 epsilon (CSNK1E), and activator of transcription and developmental regulator (AUTS2), but no signal survived correction for multiple testing. There was intriguing association signal for the untranslated region (3' UTR) variant rs885863 in VIPR2, (p = .0065; OR = 0.51; 95% CI 0.31-0.51). The result was corroborated in an independent EA OUD sample (n = 398, p = 0.0036; for the combined samples). Notably, this SNP is an expression quantitative trait locus (cis-eQTL) for VIPR2 and a long intergenic non-coding RNA, lincRNA 689, in a tissue-specific manner, based on the Genotype-Tissue Expression (GTEx) project. Vasoactive intestinal peptide (VIP) is an important peptide of light-activated suprachiasmatic nucleus cells. It regulates diverse physiological processes including circadian rhythms, learning and memory, and stress response. This is the first report of an association of a VIPR2 variant and OUD. Additionally, analysis of combinations of single nucleotide polymorphisms (SNPs) genotypes revealed an association of PER2 SNP rs80136044, and SNP rs4128839, located 41.6 kb downstream of neuropeptide Y receptor type 1 gene, NPY1R (p = 3.4 × 10-6, OR = 11.4, 95% CI 2.7-48.2). The study provides preliminary insight into the relationship between genetic variants in circadian rhythm genes and long non-coding RNA (lncRNAs) in their vicinity, and opioid addiction.
PMID: 31689297
ISSN: 1932-6203
CID: 4179382

Implementing Emergency Department-Initiated Buprenorphine in Low-Resource, High-Need Settings [Meeting Abstract]

McCormack, R. P.; Hawk, K.; D\Onofrio, G.; Rotrosen, J.; Gauthier, P.; Edelman, E. E. J.; Fiellin, D.; Novo, P.; Marsch, L.; Knight, R.; Goodman, W.
ISI:000489265600156
ISSN: 0196-0644
CID: 4155952

DETERMINANTS OF AN EFFICIENT MODEL OF EXTENDED-RELEASE NALTREXONE INITIATION FOR THE TREATMENT OF OPIOID USE DISORDER [Meeting Abstract]

Murphy, S.; McCollister, K. E.; Jeng, P.; Leff, J.; Lee, J. D.; Nunes, E., V; Novo, P.; Rotrosen, J.; Schackman, B. R.
ISI:000472670101292
ISSN: 1098-3015
CID: 4026052

How Massachusetts, Vermont, and New York Are Taking Action to Address the Opioid Epidemic

Hernandez, Yamilette; Meyers-Ohki, Sarah; Farkas, Sarah; Ball, Samuel; Leonard, Kenneth; Rotrosen, John; Saitz, Richard
PMID: 30403507
ISSN: 1541-0048
CID: 3490062

Case Studies in Social Medicine - Attending to Structural Forces in Clinical Practice

Stonington, Scott D; Holmes, Seth M; Hansen, Helena; Greene, Jeremy A; Wailoo, Keith A; Malina, Debra; Morrissey, Stephen; Farmer, Paul E; Marmot, Michael G
PMID: 30428284
ISSN: 1533-4406
CID: 4269732