After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns.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 We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).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....