After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently.

Objective To compare adherence to opioid prescribing guidelines and potential opioid misuse in patients of resident versus attending physicians. Design Retrospective cross-sectional study. Setting Large primary care practice at a safety-net hospital in New England. Subjects Patients 18–89 years old, with at least one visit to the primary care clinic within the past year and were prescribed long-term opioid treatment for chronic non-cancer pain. Methods Data were abstracted from the EMR by a trained data analyst through a clinical data warehouse. The primary outcomes were adherence to any one of two American Pain Society Guidelines; 1) documentation of at least one opioid agreement (contract) ever, and 2) any urine drug testing in the past year; and 3) evidence of potential prescription misuse defined as ≥2 early refills. We employed logistic regression analysis to assess whether patients’ physician status predicts guideline adherence and/or potential opioid misuse. Results Similar proportions of resident and attending patients had a controlled substance agreement (45.1% of resident patients vs. 42.4% of attending patient, p=0.47) or urine drug testing (58.6% of resident patients vs. 63.6% of attending patients, p=0.16). Resident patients were more likely to have two or more early refills in the past year relative to attending patients (42.8% vs. 32.5%; p=0.004). In the adjusted regression analysis, resident patients were more likely to receive early refills (OR 1.82, 95% CI 1.26–2.62) than attending patients. Conclusions With some variability, residents and attending physicians were only partly compliant with national guidelines. Residents were more likely to manage patients with a higher likelihood of opioid misuse.

Background Prescription opioid misuse is a significant public health problem as well as a patient safety concern. Primary care providers (PCPs) are the leading prescribers of opioids for chronic pain, yet few PCPs follow standard practice guidelines regarding assessment and monitoring. This cluster randomized controlled trial will determine whether four implementation strategies; nurse care management, use of a patient registry, academic detailing, and electronic tools, will increase PCP adherence to chronic opioid therapy guidelines and reduce opioid misuse among patients, relative to electronic tools alone. The implementation strategies and intervention content are based on the Chronic Care Model. Methods We include 53 PCPs from three Boston-area community health centers and one urban safety-net hospital-based primary care practice who have at least four patients meeting the following inclusion criteria: 1) age ≥ 18; 2) one or more completed visits to the primary care practice in the past year; 3) long-term opioid treatment defined as three or more opioid prescriptions written at least 21 days apart within six months and 4) an inpatient or outpatient ICD-9-CM diagnosis for musculoskeletal or neuropathic pain. We consider PCPs to be study subjects, and obtained a waiver of informed consent for patients because the study is promoting an established standard of care. We enrolled participants (PCPs) from December 2012 through March 2015. PCPs were randomized to receive the intervention, which includes four components: 1) nurse care management, 2) use of a patient registry, 3) academic detailing, and 4) electronic tools, or a control condition, which includes only the use of the electronic tools. The intervention PCPs receive the services of a nurse-managed registry for planning individual patient care and conducting population-based care for patients receiving opioids for chronic pain. In academic detailing visits, trained co-investigators provide intervention PCPs with individualized education to change prescribing practice. Electronic tools, located on a website external to the EMR, www.mytopcare.org, include validated instruments to assess patient status, and management resources to facilitate PCP adherence to suggested monitoring. Electronic tools are available to PCPs in both study arms. The primary outcomes are PCP adherence to chronic opioid therapy guidelines and patient opioid misuse. Secondary outcomes include measures of substance abuse, possible opioid diversion, and level of opioid risk among patients. We will follow PCPs and their estimated 1200 chronic pain patients for one year after study enrollment. To determine whether the intervention condition achieves greater adherence to guidelines and reduced opioid misuse after one year compared to the control condition, we will compare the baseline and follow-up measures of the individual patients, stratifying by intervention status and noting differences that are statistically significant at the p=0.05 level. Analyses will be based on intent-to-treat....

Little is known about variability in primary care providers’ (PCPs) adherence to opioid-monitoring guidelines for patients. We examined variability of adherence to monitoring guidelines among PCPs and ascertained the relationship between PCP adherence and opioid misuse by their patients. We included primary care patients receiving long-term opioids (≥3 prescriptions within 6 months) for chronic noncancer pain and PCPs with ≥4 eligible patients. We examined guideline adherence using: (1) electronic health record documentation of opioid treatment agreement, (2) past-year urine drug screen (UDS), and (3) evidence of misuse through early refills (≥2 opioid prescriptions written 7–25 days after the previous prescription). Covariates included morphine equivalent daily opioid medication dose (MED, >50 mg/d vs ≤50mg/d). Multilevel regression models assessed variability among PCPs, and odds ratios examined associations among patient-level binary outcomes. Sixty-seven PCPs prescribed opioids to 1546 patients. Significant variability was found between PCPs in use of agreement (variance = 1.27, P<0.001), UDS (variance = 1.75, P <0.001), and early refills (variance = 0.29, P = 0.002). Primary care providers had a mean of 48% of patients with agreement (range, 9%–84%), 56% with ≥1 UDS (range, 7%–91%) and 36% with early refills (range, 19%–60%). High MED among patients was associated with increased odds of agreement (1.93, confidence interval [CI], 1.53–2.44), UDS (2.65, CI: 2.06–3.41), and early refill (2.92, CI: 2.30–3.70). Primary care providers varied significantly in adherence to opioid prescription guidelines. Increased patient risk was associated with increased monitoring and with greater misuse. Future work should study system-level interventions to enable clinical monitoring and support opioid guideline adherence.

As European countries have mandated quotas for women’s representation on boards, and as women have increasingly entered the ranks of management, a persistent gender gap in managerial pay remains. Drawing a sample of managers in the 2010 European Social Survey, the gender gap in pay was decomposed, finding that employer devaluation of women accounted for the majority of the gender gap in pay. This was especially true in countries without mandated quotas, but in countries that had adopted quotas for female representation on boards, results were consistent with the proposition that quotas moderated the labour market for managers (i.e. the gender gap in managerial pay was smaller as was the portion of the gap attributable to discrimination). As board quotas have increasingly been adopted across Europe, more research is needed on their ameliorative effects on gender inequality in the wider labour market.

Recent shifts in the abortion provision landscape have generated increased concern about how people find abortion care as regulations make abortion less accessible and clinics close. Few studies examine the reasons that people select particular facilities in such constrained contexts. Drawing from interviews with 41 Ohio residents, we find that people’s clinic selections are influenced by the risks they associate with abortion care. Participants’ strategies for selecting an abortion clinic included: drawing on previous experience with clinics, consulting others online, discerning reputation through name recognition and clinic type, and considering location, especially perceptions about place (privacy, legality, safety). We argue that social myths inform the risks people anticipate when seeking health care facilities, shaping care seeking in ways that are both abortion-specific and more general. These findings can also inform research in other health care contexts where patients increasingly find their options constrained by rising costs, consolidation, and facility closure.

Understanding behavioral resilience among at-risk adolescents may guide public policy decisions and future programs. We examined factors predicting behavioral resilience following intrauterine substance exposure (IUSE) in a prospective longitudinal birth-cohort study of 136 early adolescents (age 12.4–15.9) at-risk for poor behavioral outcomes. We defined behavioral resilience as a composite measure of lack of early substance use initiation (before age 14), lack of risky sexual behavior, or lack of delinquency. IUSEs included in this analysis were cocaine (IUCE), tobacco (IUTE), alcohol (IUAE), and marijuana (IUME). We recruited participants from Boston Medical Center as mother-infant dyads between 1990 and 1993. The majority of the sample was African-American/Caribbean (88%) and 49% female. In bivariate analyses, none and lower IUCE level predicted resilience compared to higher IUCE, but this effect was not found in an adjusted model. Instead, strict caregiver supervision (adjusted odds ratio (AOR)=6.02, 95% confidence interval (CI)=1.90–19.00, p=0.002), lower violence exposure (AOR=4.07, 95% CI=1.77–9.38, p<0.001), and absence of intrauterine tobacco exposure (AOR=3.71, 95% CI= 1.28–10.74, p=0.02) predicted behavioral resilience. In conclusion, caregiver supervision in early adolescence, lower violence exposure in childhood, and lack of intrauterine tobacco exposure predict behavioral resilience among a cohort of early adolescents with significant social and environmental risk. Future interventions should work to enhance parental supervision as a way to mitigate the effects of adversity on high-risk groups of adolescents.

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