Opioid overdose death following criminal justice involvement: Linking statewide corrections and hospital databases to detect individuals at highest risk.

BACKGROUND: Persons who interact with criminal justice and hospital systems are particularly vulnerable to negative health outcomes, including overdose. However, the relationship between justice involvement, healthcare utilization and overdose risk is not well-understood. This data linkage study seeks to improve our understanding of the link between different types of justice involvement as well as hospital interaction and risk of fatal opioid overdose among persons with incarcerations, arrests and parole/probation records for drug and property crimes in Maryland. METHODS: Maryland statewide criminal justice records were obtained for 2013-2016. Data were linked at the person-level to an all-payer hospitalization database and overdose death records for the same years. Logistic regression was performed to determine which criminal justice and hospital characteristics were associated with greatest risk of overdose death. RESULTS: 89,591 adults had criminal-justice records and were included in the study. During the 2013-2016 study period, 4108 (4.59 %) were hospitalized for a non-fatal opioid overdose, and 519 (0.58 %) died of opioid overdose. Strongest risk factors for death included being older, being white, having had an inpatient or emergency hospitalization, having had more arrests, having been arrested for a drug charge (vs. property charge), having a misdemeanor drug charge (vs. a felony charge), and having been released from incarceration during the study period. CONCLUSION: Linking corrections and healthcare information can help advance understanding of risk and target overdose prevention interventions directed at justice-involved individuals with greatest need.

Predictors of Overdose Death Among High-Risk Emergency Department Patients With Substance-Related Encounters: A Data Linkage Cohort Study.

STUDY OBJECTIVE: Persons with substance use disorders frequently utilize emergency department (ED) services, creating an opportunity for intervention and referral to addiction treatment and harm-reduction services. However, EDs may not have the appropriate tools to distinguish which patients are at greatest risk for negative outcomes. We link hospital ED and medical examiner mortality databases in one state to identify individual-level risk factors associated with overdose death among ED patients with substance-related encounters. METHODS: This retrospective cohort study linked Maryland statewide ED hospital claims records for adults with nonfatal overdose or substance use disorder encounters in 2014 to 2015 with medical examiner mortality records in 2015 to 2016. Logistic regression was used to identify factors in hospital records associated with risk of opioid overdose death. Predicted probabilities for overdose death were calculated for hypothetical patients with different combinations of overdose and substance use diagnostic histories. RESULTS: A total of 139,252 patients had substance-related ED encounters in 2014 to 2015. Of these patients, 963 later experienced an opioid overdose death, indicating a case fatality rate of 69.2 per 10,000 patients, 6 times higher than that of patients who used the ED for any cause. Factors most strongly associated with death included having both an opioid and another substance use disorder (adjusted odds ratio 2.88; 95% confidence interval 2.04 to 4.07), having greater than or equal to 3 previous nonfatal overdoses (adjusted odds ratio 2.89; 95% confidence interval 1.54 to 5.43), and having a previous nonfatal overdose involving heroin (adjusted odds ratio 2.24; 95% confidence interval 1.64 to 3.05). CONCLUSION: These results highlight important differences in overdose risk among patients receiving care in EDs for substance-related conditions. The findings demonstrate the potential utility of incorporating routine data from patient records to assess risk of future negative outcomes and identify primary targets for initiation and linkage to lifesaving care.

Predicting Opioid Overdose Deaths Using Prescription Drug Monitoring Program Data.

INTRODUCTION: Prescription Drug Monitoring Program data can provide insights into a patient's likelihood of an opioid overdose, yet clinicians and public health officials lack indicators to identify individuals at highest risk accurately. A predictive model was developed and validated using Prescription Drug Monitoring Program prescription histories to identify those at risk for fatal overdose because of any opioid or illicit opioids. METHODS: From December 2018 to July 2019, a retrospective cohort analysis was performed on Maryland residents aged 18-80 years with a filled opioid prescription (n=565,175) from January to June 2016. Fatal opioid overdoses were identified from the Office of the Chief Medical Examiner and were linked at the person-level with Prescription Drug Monitoring Program data. Split-half technique was used to develop and validate a multivariate logistic regression with a 6-month lookback period and assessed model calibration and discrimination. RESULTS: Predictors of any opioid-related fatal overdose included male sex, age 65-80 years, Medicaid, Medicare, 1 or more long-acting opioid fills, 1 or more buprenorphine fills, 2 to 3 and 4 or more short-acting schedule II opioid fills, opioid days' supply ≥91 days, average morphine milligram equivalent daily dose, 2 or more benzodiazepine fills, and 1 or more muscle relaxant fills. Model discrimination for the validation cohort was good (area under the curve: any, 0.81; illicit, 0.77). CONCLUSIONS: A model for predicting fatal opioid overdoses was developed using Prescription Drug Monitoring Program data. Given the recent national epidemic of deaths involving heroin and fentanyl, it is noteworthy that the model performed equally well in identifying those at risk for overdose deaths from both illicit and prescription opioids.

A predictive risk model for nonfatal opioid overdose in a statewide population of buprenorphine patients.

BACKGROUND: Predicting which individuals who are prescribed buprenorphine for opioid use disorder are most likely to experience an overdose can help target interventions to prevent relapse and subsequent consequences. METHODS: We used Maryland prescription drug monitoring data from 2015 to identify risk factors for nonfatal opioid overdoses that were identified in hospital discharge records in 2016. We developed a predictive risk model for prospective nonfatal opioid overdoses among buprenorphine patients (N = 25,487). We estimated a series of models that included demographics plus opioid, buprenorphine and benzodiazepine prescription variables. We applied logistic regression to generate performance measures. RESULTS: About 3.24% of the study cohort had ≥1 nonfatal opioid overdoses. In the model with all predictors, odds of nonfatal overdoses among buprenorphine patients were higher among males (OR = 1.39, 95% CI:1.21-1.62) and those with more buprenorphine pharmacies (OR = 1.19, 95% CI:1.11-1.28), 1+ buprenorphine prescription paid by Medicaid (OR = 1.21, 95% CI:1.02-1.48), Medicare (OR = 1.93, 95% CI:1.63-2.43), or a commercial plan (OR = 1.98, 95% CI:1.30-2.89), 1+ opioid prescription paid by Medicare (OR = 1.30, 95% CI:1.03-1.68), and more benzodiazepine prescriptions (OR = 1.04, 95% CI:1.02-1.05). The odds were lower among those with longer days of buprenorphine (OR = 0.64, 95% CI:0.60-0.69) or opioid (OR = 0.79, 95% CI:0.65-0.95) supply. The model had moderate predictive ability (c-statistic = 0.69). CONCLUSIONS: Several modifiable risk factors, such as length of buprenorphine treatment, may be targets for interventions to improve clinical care and reduce harms. This model could be practically implemented with common prescription-related information and allow payers and clinical systems to better target overdose risk reduction interventions, such as naloxone distribution.

Zalutumumab in head and neck cancer.

INTRODUCTION: Over 90% of head and neck cancers overexpress EGFR. This correlates with advanced disease stage and worse prognosis. Strategies to inhibit the EGFR pathway have been developed over the last decade. Zalutumumab is a recent high-affinity completely human IgG1k antibody targeting EGFR. AREAS COVERED: The mechanism of action and data on efficacy and safety of zalutumumab in head and neck cancer. EXPERT OPINION: Zalutumumab has demonstrated acceptable toxicity in head and neck cancer patients, with rash being the most common adverse event. The toxicity profile makes zalutumumab an attractive option for patients who are heavily pretreated and/or have poor performance status due to concurrent co-morbidities. As the molecule is fully human, the likelihood of hypersensitivity to the drug is low. Zalutumumab may be effective at low concentrations through antibody-dependent cellular cytotoxicity. Current data from Phase I and II trials identify zalutumumab as a promising drug for the treatment of locally advanced head and neck cancer and recent data from a Phase III randomized trial showed encouraging survival results compared with best supportive care. Results from other ongoing Phase III trials will provide clarification on zalutumumab as a treatment option. The clinical development of this compound has been suspended from June 2011 until a development and commercialization partner is found.