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Background Injurious falls among older adults are both common and costly. The prevalence of falls is known to increase with age and with use of fall-risk drugs/potentially inappropriate medications (FRD/PIM). Little is known about the joint effects of these two risk factors. Methods Data for 2013–2015 were obtained from the Truven Health MarketScan® Medicare database comprising utilization and eligibility (enrollment) data for approximately 4 million enrollees annually. A case-control design was used to compare enrollees aged 65–99 years diagnosed with >  1 fall event ( n  = 110,625) with enrollees without falls (n = 1,567,412). An exploratory analysis of joint age-FRD/PIM effects on fall risks was based on number needed to harm (NNH) calculations for each FRD/PIM therapy class count (compared with 0 FRD/PIMs), stratified by age group. Logistic regression analyses adjusted for demographics, comorbidities, and fracture history, measured in the 1 year prior to the fall date (cases) or a randomly assigned date (controls). Results For each FRD/PIM class count, NNH values decreased with older age (e.g., for 1 FRD/PIM class: from NNH = 333 for ages 65–74 years to NNH = 83 for ages 90–99 years; for 2 FRD/PIM classes: from NNH = 91 for ages 65–74 years to NNH = 38 for ages 90–99 years). NNH decreased to < 15 patients at >  6 classes for age 65–74 years, >  5 classes for age 75–84 years, and  >  4 classes for age 85–99 years. Adjusted odds of falling were increased for age-FRD/PIM combinations with smaller NNH values: adjusted odds ratio (AOR) = 1.127 (95% confidence interval [CI] = 1.098–1.156) for NNH = 83–91; AOR = 1.427 (95% CI = 1.398–1.456) for NNH = 17–48; AOR = 1.983 (1.9034–2.032) for NNH < 15. Conclusion FRD/PIM use and age appear to have joint effects on fall risk. Older adults at high risk, indicated by small NNH, may be appropriate for fall prevention initiatives, and clinicians may wish to consider decreasing the number of FRD/PIMs utilized by these patients.

Introduction Overuse of gabapentin and/or opioids occurs in a small percentage of patients at > 3-fold labeled dosages. Gabapentin may potentiate opioid effects. Objective The aim was to assess patient harm, defined as use of inpatient hospital (IPH) or emergency department (ED) services, associated with overuse of gabapentin with or without concomitant overuse of opioids. Data source Data were sourced from the Truven Health MarketScan ® Commercial Claims and Encounters database, for the years 2013–2015. Eligibility criteria The eligibility criteria were two or more claims (billed encounters) and ≥120 days of treatment with gabapentin and/or opioids. Methods Cohort identification was based on daily-dosage thresholds of 50 morphine-milligram equivalents and 3600 mg of gabapentin in a 12-month follow-up: (1) no overuse; (2) mild overuse (two or more claims or two or fewer calendar quarters over threshold); and (3) sustained overuse (three or more over-threshold calendar quarters). IPH and ED use were measured for 6 months after the first overuse date (cohorts 2 and 3) or a randomly assigned date (cohort 1). Logistic regression analyses controlled for pre-treatment IPH/ED utilization, indication, addiction diagnosis, concomitant sedative/hypnotic use, and demographics. Results All-cause and drug-related IPH/ED utilization increased monotonically with degree of overuse, particularly of more than one medication. Sustained overuse of gabapentin multiplied odds of all-cause IPH by 1.366 [95% confidence interval (CI) 1.055–1.769], drug-related IPH by 1.440 (95% CI 1.010–2.053), and IPH/ED for altered mental status (e.g., euphoria, anxiety) by 1.864 (95% CI 1.324–2.624). Sustained overuse of both medications quadrupled odds of all-cause IPH, drug-related IPH, and IPH/ED for altered mental status or respiratory depression. Conclusion Despite modest effects of gabapentin overuse alone, overuse of gabapentin with opioids may increase risk of harm and health-service utilization, supporting calls to make gabapentin a controlled substance in the USA.

Opioids are not recommended for routine treatment of migraine because their benefits are outweighed by risks of medication overuse headache and abuse/dependence. A March 2016 US Food and Drug Administration (FDA) safety communication warned of the risk of serotonin syndrome from using opioids concomitantly with 5-hydroxytryptamine receptor agonists (triptans) or serotonergic antidepressants: selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). Epidemiological information about co-prescribing of these medications is limited. The objective of this study was to estimate the nationwide prevalence of co-prescribing of an opioid with a serotonergic antidepressant and/or triptan in US office-based physician visits made by 1) all patients and 2) patients diagnosed with migraine. National Ambulatory Medical Care Survey (NAMCS) data were obtained for 2013 and 2014. Physician office visits that included the new or continued prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI were identified. Co-prescribed opioids were stratified by agent to determine the proportion of co-prescriptions with opioids posing a higher risk of serotonergic agonism (meperidine, tapentadol, and tramadol). Of an annualized mean 903.6 million office-based physician visits in 2013-2014, 17.7 million (2.0% of all US visits) resulted in the prescribing of ≥1 opioid medication with a triptan or an SSRI/SNRI. Opioid-SSRI/SNRI was co-prescribed in 16,044,721 visits, while opioid-triptan was co-prescribed in 1,622,827 visits. One-fifth of opioid co-prescribing was attributable to higher-risk opioids, predominantly tramadol (18.6% of opioid-SSRI/SNRI, 21.8% of opioid-triptan). Of 7,672,193 visits for patients diagnosed with migraine, 16.3% included opioid prescribing and 2.0% included co-prescribed opioid-triptan. During a period approximately 2 years prior to an FDA warning about the risk of serotonin syndrome from opioid-SSRI/SNRI or opioid-triptan co-prescribing, use of these combinations was common in the USA. Studies on prescribing patterns following the March 2016 warning, and on the risk of serotonin syndrome associated with these co-prescriptions, are needed.

Objective To conduct a proof-of-concept study comparing Lorenz-curve analysis (LCA) with power-law (exponential function) analysis (PLA), by applying segmented regression modeling to 1-year prescription claims data for three medications—alprazolam, opioids, and gabapentin—to predict abuse and/or diversion using power-law zone (PLZ) classification. Results In 1-year baseline observation, patients classified into the top PLZ groups (PLGs) were demographically and diagnostically similar to those in Lorenz-1 (top 1% of utilizers) and Lorenz-25 (top 25%). For prediction of follow-up (6-month post-baseline) Lorenz-1 use of alprazolam and opioids (i.e., potential abuse/diversion), PLA had somewhat lower sensitivity compared with LCA (83.5–95.4% vs. 99.5–99.9%, respectively) but better specificity (98.2–98.8% vs. 75.5%) and much better positive predictive value (PPV; 34.5–45.3% vs. 4.0–4.6%). Of top-PLG alprazolam- and opioid-treated patients, respectively, 20.7 and 9.9% developed incident (new) Lorenz-1 in followup, compared with < 3% of Lorenz-25 patients. For gabapentin, neither PLA nor LCA predicted incident Lorenz-1 (PPV = 0.0–1.4%). For all three medications, PLA sensitivity for follow-up hospitalization was < 5%, but specificity was better for PLA (97.3–99.2%) than for LCA (74.3–75.4%). PLA better identified patients at risk of future controlled substance abuse/diversion than did LCA, but the technique needs refinement before widespread use.

The abuse potential of gabapentin is well documented; with gabapentin having been noted as an agent highly sought after for use in potentiating opioids. When combined with opioids, the risk of respiratory depression and opioid-related mortality increases significantly. In the US, gabapentin was approved by the Food and Drug Administration as a non-controlled substance. To date, and in spite of empirical evidence suggestive of diversion and abuse with opioids, gabapentin remains a non-controlled substance at the federal level. This has forced individual US states and jurisdictions - often significantly impacted by the opioid epidemic - to forge ahead with legislative initiatives designed to reclassify and/or monitor the use of gabapentin. Since August 1, 2016, 14 of 51 US states and jurisdictions have either implemented legislative mandates requiring pharmacovigilance programs, amended rules and regulations, are in the throes of crafting policy, or are in the midst of gathering additional data for decision making. This fragmented geographic approach yields only a modest benefit in combating the abuse of gabapentin and/or the national opioid epidemic. Herein, we report state-by-state efforts to enhance pharmacovigilance and call for a re-evaluation of the schedule status of gabapentin at the federal level, and design and implementation of a national pharmacovigilance program.

All-cause and drug-related medical events associated with overuse of gabapentin and/or opioid medications: a retrospective cohort analysis of a commercially insured US population. Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: an analysis of the Food and Drug Administration Adverse Events Reporting System (FAERS). 12 Gomes T Juurlink DN Antoniou T Mamdani MM Paterson JM van den Brink W. Gabapentin, opioids, and the risk of opioid-related death: a population-based nested case-control study.

Sleep disorders such as insomnia, obstructive sleep apnoea (OSA), excessive daytime sleepiness (EDS) and fatigue, sleep deprivation and restless legs syndrome (RLS) are increasingly seen in clinical practice. Sleep is considered vital for preserving daytime cognitive function and physiological well-being. Sleep insufficiency may have deleterious effects on work-life balance, overall health and safety. The consequential economic burden at both the individual and societal levels is significant. Moreover, sleep disorders are commonly associated with other major medical problems such as chronic pain, cardiovascular disease, mental illness, dementias, gastrointestinal disorders and diabetes mellitus. Thus, in order to properly care for patients presenting with sleep-related morbidity, and to reduce the consequential economic burden, accurate screening efforts and efficacious/cost-effective treatments need to be developed and employed.

Background: In 1998, the American Academy of Child and Adolescent Psychiatry (AACAP) published a position paper supporting the use of selective serotonin reuptake inhibitors (SSRIs) as first-line pharma-cotherapy for the treatment of depression among children and adolescents. Tricyclic antidepressants (TCAs) were not recommended because of insufficient efficacy evidence, as well as adverse events. Objective: The present study was designed to discern the prescribing patterns for antidepressants among US children and adolescents aged 5 to 18 years diagnosed with depression between 1990 and 2001 (ie, before and after the publication of the AACAP paper). Methods: Data derived from the US National Ambulatory Medical Care Survey for the years 1990 through 2001 were used for this retrospective, cross-sectional analysis examining children and adolescents aged 5 to 18 years. Information from physician-patient encounters (office-based visits), documenting a diagnosis of depression ( International Classification of Diseases, Ninth Revision, Clinical Modification [ ICD-9-CM] codes 296.2–296.36, 300.4, or 311) were extracted. Data were categorized into three 4-year time intervals: 1990 through 1993; 1994 through 1997; and 1998 through 2001. Results: Overall, the rate of antidepressant prescriptions for US patients who received a diagnosis of depression increased from 44.4% (1,138,689/2,561,890) in the period from 1990 through 1993 to 59.3% (4,103,683/6,923,040) in the period from 1998 through 2001. SSRI prescriptions increased from 20.7% (530,642/2,561,890) in the period from 1990 through 1993 to 39.7% (2,745,293/6,923,040) in the period from 1998 through 2001; TCA prescriptions decreased from 21.0% (537,906/2,561,890) in the period from 1990 through 1993 to 2.7% (188,823/6,923,040) in the period from 1998 through 2001. The US population-adjusted rate of a diagnosis of depression with or without comorbid mental illness ( ICD-9-CM codes 290–296.19, 296.4–300.39, 300.5–310.99, or 312.0–319) increased 2.4-fold from 12.9 per 1000 in the period from 1990 through 1993 to 31.1 in the period from 1998 through 2001. Among these patients, the prescribing of an antidepressant increased 3.2-fold (5.7 per 1000 in the period from 1990 through 1993 to 18.4 in the period from 1998 through 2001). The population-adjusted rate of SSRI prescribing increased 4.6-fold from 2.7 per 1000 children and adolescents in the period from 1990 through 1993 to 12.3 in the period from 1998 through 2001. Conclusions: From 1990 through 2001, prescription patterns for antidepressant pharmacotherapy among children and adolescents aged 5 to 18 years changed. In accordance with the recommendation made by the AACAP in 1998, prescriptions for SSRIs increased, whereas prescriptions for TCAs all but disappeared.

Background Despite international calls to make gabapentin a controlled substance, studies of gabapentin use/abuse patterns are limited to small/high-risk samples and adverse event reports. Objective The aim of this study was to conduct a systematic assessment of the abuse potential/prevalence of gabapentin in a large sample. Data Source Truven Health MarketScan ® Commercial Claims and Encounters database, years 2013–2015. Eligibility Criteria Patients with two or more claims for one or more abusable drugs and ≥12 months’ continuous enrollment were sampled for Lorenz curve analysis. Prevalence analysis was limited to those with ≥120 days of therapy. Methods Abuse potential was measured as Lorenz-1 (consumption of drug supply by top 1% of users) of ≥15%. Dose thresholds were morphine milligram equivalent (MME) standards for opioids, and maximum labeled doses in milligrams (mg) for other drugs. Results Lorenz-1 values were 37% opioids, 19% gabapentin, 15% pregabalin, 14% alprazolam, and 13% zolpidem. The top 1% gabapentin users filled prescriptions for a mean (median) 11,274 (9534) mg/day, more than three times the recommended maximum (3600 mg). Of these, one-quarter used or diverted ≥12,822 mg/day. The top 1% opioid and pregabalin users filled prescriptions for a mean (median) 180 (127) MMEs and 2474 (2219) mg/day, respectively. Of patients using opioids + gabapentin simultaneously, 24% had three or more claims exceeding the dose threshold within 12 months. Limitations Established threshold criteria for gabapentinoid abuse are uncertain. Indications for gabapentinoid use (e.g. hot flashes, restless legs syndrome) were not measured. Conclusion Gabapentin use patterns are similar to those of other abusable medications. High daily doses pose safety and/or diversion concerns, and investigation of the medical consequences of gabapentin abuse is needed.