Trends in rates of acetaminophen-related adverse events in the United States.

Purpose: The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality.

Methods: A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings, including calls to poison centers (2008-2012), emergency department visits (2004-2012), and inpatient hospitalizations (1998-2011). Rates of acetaminophen-related events were calculated per setting, census population, and distributed drug units.

Patient understanding of drug risks: an evaluation of medication guide assessments.

Purpose: When a Medication Guide (MG) is part of Risk Evaluation and Mitigation Strategy (REMS), manufacturers assess the effectiveness of MGs through patient surveys, which have not undergone systematic evaluation. We aimed to characterize knowledge rates from these patient surveys, describe their design and respondent characteristics, and explore predictors of acceptable knowledge rates.

Methods: We analyzed MG assessments submitted to the Food and Drug Administration from September 2008 through June 2012.

Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics.

Objective: The objective of this study was to develop metrics to assess opioid prescribing behavior as part of the evaluation of the Extended-Release/Long-Acting (ER/LA) Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS).

Design: Candidate metrics were selected using published guidelines, examined using sensitivity analyses, and applied to cross-sectional rolling cohorts of Medicare patients prescribed with extended-release oxycodone (ERO) between July 2, 2006 and July 1, 2011. Potential metrics included prescribing opioid-tolerant-only ER/LA opioid analgesics to non-opioid-tolerant patients, prescribing early fills to patients, and ordering drug screens.

Characterization of acetaminophen overdose-related emergency department visits and hospitalizations in the United States.

Purpose: To estimate the number of acetaminophen overdose-related emergency department (ED) visits and hospitalizations in the United States, characterize these by intentionality, age, and gender, and compare the strengths and limitations of the utilized databases.

Methods: We used data from the National Hospital Ambulatory Medical Care Survey (NHAMCS) and the National Electronic Injury Surveillance System (NEISS) to estimate the number of relevant ED visits in the United States between 2000 and 2007, and the National Hospital Discharge Survey (NHDS) to estimate the number of relevant hospitalizations in the United States between 1991 and 2006. National estimates and their standard errors were calculated using information provided in each database.

Prevalence of osteonecrosis of the jaw in patients with oral bisphosphonate exposure.

Purpose: Osteonecrosis of the jaw (ONJ) is a serious complication associated with bisphosphonate therapy, but its epidemiology in the setting of oral bisphosphonate therapy is poorly understood. The present study examined the prevalence of ONJ in patients receiving chronic oral bisphosphonate therapy.

Materials And Methods: We mailed a survey to 13,946 members who had received chronic oral bisphosphonate therapy as of 2006 within a large integrated health care delivery system in Northern California.

Antidepressant medication use and risk of persistent pulmonary hypertension of the newborn.

Purpose: To determine the prevalence of persistent pulmonary hypertension of the newborn (PPHN) among infants whose mothers were exposed to antidepressants in the third trimester of pregnancy compared to the prevalence among infants whose mothers were not exposed to antidepressants in the third trimester.

Methods: A retrospective study was conducted using the automated databases of four health plans participating in the HMO Research Network Center for Education and Research on Therapeutics. Women who delivered an infant in a hospital from 1 January 1996 through 31 December 2000 were identified.

Emergency department visits attributed to selected analgesics, United States, 2004-2005.

Purpose: To estimate the rate of emergency department (ED) visits attributed to selected analgesic-containing medications.

Methods: We used a nationally representative public health surveillance system to provide estimates of adverse events identified in EDs, and a national telephone survey to provide estimates of selected analgesic-containing medication usage in the US population, 2004-2005. Analysis was restricted to products containing acetaminophen, aspirin, ibuprofen, or naproxen.

Drug-risk communication to pharmacists: assessing the impact of risk-minimization strategies on the practice of pharmacy.

Objectives: To gain insight on the knowledge, opinions, barriers, and practices of pharmacists regarding drug risk-minimization tools.

Design: Descriptive, nonexperimental, cross-sectional survey.

Setting: 20 states in the United States, fall 2004.

Informatic tools and approaches in postmarketing pharmacovigilance used by FDA.

The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products.

Use of antidepressant medications during pregnancy: a multisite study.

Objective: This study was undertaken to provide information on the prevalence of use of antidepressant drugs among pregnant women in the United States.

Study Design: A retrospective study was conducted using the automated databases of 7 health plans. Women who delivered an infant in a hospital were identified.

Increasing use of antidepressants in pregnancy.

Objective: The purpose of this study was to quantify the rate of exposures to antidepressants during pregnancy in a large cohort of women.

Study Design: This was a retrospective cohort study of 105,335 pregnancies among women enrolled in Tennessee Medicaid from 1999-2003. Pregnancies were classified according to antidepressant exposures during pregnancy using previously validated computerized pharmacy records linked with birth certificates.

Estimates of acetaminophen (Paracetomal)-associated overdoses in the United States.

Objective: To estimate the number of acetaminophen-associated overdoses in the United States and identify possible risk factors for intervention.

Methods: The investigators obtained estimates of acetaminophen-associated overdoses using different national databases. Two emergency room databases, a hospital discharge database, a national mortality file, and a poison surveillance database were used to identify cases.

What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling.

Purpose: The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States.

Methods: We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content.

Surveillance of medical device-related hazards and adverse events in hospitalized patients.

Context: Although adverse drug events have been extensively evaluated by computer-based surveillance, medical device errors have no comparable surveillance techniques.

Objectives: To determine whether computer-based surveillance can reliably identify medical device-related hazards (no known harm to patient) and adverse medical device events (AMDEs; patient experienced harm) and to compare alternative methods of detection of device-related problems.

Design, Setting, And Participants: This descriptive study was conducted from January through September 2000 at a 520-bed tertiary teaching institution in the United States with experience in using computer tools to detect and prevent adverse drug events.

A study of compliance with FDA recommendations for pemoline (Cylert).

Objective: To assess compliance with product labeling recommendations to use pemoline as second-line therapy for attention-deficit/hyperactivity disorder (ADHD) and to obtain baseline and biweekly liver enzyme tests.

Method: Retrospective cohort study using administrative claims data to identify first-line therapies and liver enzyme tests among pemoline users between January 1, 1998, and March 31, 2000. Prescriptions for first-line therapy were searched for 90 days prior to the first pemoline claim.