Adverse Drug Events
Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population
Maria Bygdell, Gertrud Brunlöf, Susanna M. Wallerstedt and Jenny M. Kindblom*
Clinical Pharmacology, Institute of Medicine, the Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
Purpose Psychiatric Adverse Drug Reactions (ADRs) are frequent in the pediatric population. The aim of the present study was to analyze spontaneously reported psychiatric ADRs in children during a 10-year period.
Methods All spontaneously reported Individual Case Safety Reports (ICSRs) concerning children (<18 years old) and psychiatric adverse reactions assessed as at least possible, registered in the Swedish Drug Information System (SWEDIS) during the period 2001–2010, were extracted and characterized. Age and sex distribution and labeling/registration status were studied.
A total of 600 ICSRs concerning 744 psychiatric adverse reactions were identified and included in the analysis. Boys were overrepresented among included ICSRs (60.3% vs. 39.7%; p < .001). After exclusion of vaccines, the three most frequently suspected drugs were montelukast, centrally working sympathomimetic drugs, and inhaled glucocorticoids. Serious adverse reactions were reported more frequently for drugs used off-label than for drugs used according to the Swedish Physician’s Desk Reference. Aggressiveness was reported more frequently for boys than for girls as were suicidal conditions.
Psychiatric ADRs in the pediatric population have been reported for a wide range of reactions and drugs and display age and sex differences including a higher number of suicidal reactions in boys. An association was seen between serious reactions and off-label drug use. Further studies are needed to elucidate safety aspects of unlicensed drugs and drugs used off-label and whether there are differences in
children’s susceptibility to develop ADRs.
Source : pharmacoepidemiology and drug safety 2012; 21: 79–86
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Prescription Drug Deaths Increase Dramatically
A growing number of overdoses of legal opioids, sedatives and tranquilizers led to a 65 percent increase in hospitalizations over seven years
By Katherine Harmon (Scientific America)
KILLER PAINKILLERS: As the prevalence of prescription painkillers increases, the number of people hospitalized for overdosing on them appears to, too. High-profile celebrity deaths are just a few instances of this growing problem, say authors of a new study. The number of deaths and hospitalizations caused by prescription drugs has risen precipitously in the past decade, with overdoses of pain medications, in particular opioids, sedatives and tranquilizers, more than doubling between 1999 and 2006, according to a new study.
In fact, by 2006, overdoses of opioid analgesics alone (a class of pain relievers that includes morphine and methadone) were already causing more deaths than overdoses of cocaine and heroin combined.
"Teens and others have different attitudes in using these drugs," often presuming the prescription substances are safer and less addictive than illegal drugs such as cocaine or heroin, says Jeffrey Coben, a professor of emergency and community medicine at the West Virginia University School of Medicine in Morgantown and lead author of the new study. "I think that's a false assumption. Aside from the fact they can be taken orally rather than injected…[many prescription drugs] really are every bit as powerful, addictive and dangerous as heroin," he notes, adding that, "when you combine them with other sedatives, that mix can become particularly lethal."
Using data collected by the Nationwide Inpatient Sample, which gathers hospital patient information for about 8 million people every year, Coben and his colleagues were able to assess what drugs were implicated in the majority of poisonings—and in many cases whether the poisonings were intentional or not. The team selected opioids, sedatives and tranquilizers as the focus of the analysis because these substances are "contributing the majority of prescription drug overdose deaths," Coben says. These categories of prescription drugs can kill and injure people by suppressing breathing, depriving the body of oxygen.
For prescription opioids, sedatives and tranquilizers—commonly prescribed for pain management—the number of hospitalizations for poisonings increased 65 percent between 1999 and 2006 (the first and last years, respectively, for which data were comparable and collected). The number of hospitalizations for all poisonings, including illegal drugs, other prescription medications and miscellaneous substances, increased during this time period as well, but that jump (33 percent) was about half the rate of those for the prescription pain drugs.
Unintentional poisonings from these drugs climbed 37 percent during the seven-year period, the researchers found. Intentional overdoses, in which people meant to inflict self-harm or death, jumped 130 percent (a far cry more than the 53 percent increase of intentional poisoning from other substances in the same time period). Intent was not listed in all cases and can be subject to reporting error. The results are detailed online April 6 in the American Journal of Preventive Medicine.
Poisonings, from prescription drugs and other substances, are classified in medical records as injurious or accidental deaths. But regardless of whether the incidents are listed as unintentional or intentional, they are rarely true mistakes, noted Leonard Paulozzi, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention, in congressional testimony in 2007. "Most unintentional drug poisoning deaths are not 'accidents' caused by toddlers or the elderly taking too much medication," he noted. "These deaths are largely due to the misuse and abuse of prescription drugs."
Accidents overall were the fifth most common cause of death in the U.S. as of 2005 (accounting for 117,809 deaths—4.8 percent—that year), according to the National Vital Statistics Report [pdf]. Of injury deaths, poisoning is the second most common cause of death in the U.S., having doubled between 1985 and 2004, according to a 2007 Department of Health and Human Services analysis [pdf]. Among people 35 to 54 years old, poisoning is the most common accidental death—even more so than auto-related deaths.
Many experts think that the sheer prevalence of many of these drugs recently has contributed to the drastic increase in poisonings. Although growing illegal markets and distribution of these drugs might be a driving factor in their increasingly large role in poisonings and deaths, perfectly legal prescriptions are probably playing a role as well, Coben says.
"I think the whole issue of the availability of these drugs and whether they're being over-prescribed" should be investigated, says Susan Baker, a professor at Johns Hopkins Center for Injury Research and Policy, who was not involved in the new study but coauthored a 2009 report in the same journal about recent trends in injury mortality.
SOURCE: SCIENTIFIC AMERICA
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National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events
Daniel S. Budnitz, MD, MPH, Daniel A. Pollock, MD, Kelly N. Weidenbach, MPH, Aaron B. Mendelsohn, PhD, MPH
Thomas J. Schroeder, MS, Joseph L. Annest, PhD
OUTPATIENT USE OF DRUG therapies in the United States is common and may confer serious risks along
with substantial therapeutic benefits. Historically, the public health burden of adverse events from therapeutic
drug use among communitydwelling, nonhospitalized patients has been difficult to estimate, but the problem
is large and can be expected to increase. In 2004, 82% of the US population reported using at least 1
prescription medication, over-the counter medication, or dietary supplement in the previous week and 30% reported using 5 or more of these drugs. Outpatient drug use will likely increase due to an aging population, the
trend toward outpatient service delivery, the development of new prescription medications, the transition of
prescription medications to over-the counter availability, and the increasing use of drugs for chemoprevention.
The recent implementation of the new Medicare prescription drug coverage benefit is designed to provide beneficiaries with additional financial support to help ensure their continued access to drug treatments,6 which may further increase outpatient drug use. These trends underscore the need for ongoing surveillance of outpatient drug safety. Although much attention and effort have been directed to measuring,
understanding, and preventing adverse drug events (ADEs) in hospitalized patients, less attention has been
focused on ADEs occurring outside of health care facilities. This is due in part to the difficulty of obtaining timely, nationally representative surveillance data on outpatient ADEs. To enhance surveillance of outpatient
drug safety, the Centers for Disease Control and Prevention (CDC), the US Consumer Product Safety Commission
(CPSC), and the US Food and Drug Author Affiliations: Division of Healthcare Quality Promotion,
National Center for Infectious Diseases, Coordinating Center for Infectious Diseases (Drs Budnitz
and Pollock and Ms Weidenbach), Office of Statistics and Programming, National Center for Injury Prevention
and Control (Dr Annest), Centers for Disease Control and Prevention, Atlanta, Ga; Office of Drug Safety,
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Md, and Epidemic Intelligence Service, Office of Workforce and Career Development, Centers for Disease Control and Prevention
(Dr Mendelsohn); and US Consumer Product Safety Commission, Bethesda, Md (Mr Schroeder). Dr Mendelsohn is now director of epidemiology, Product Safety, MedImmune, Gaithersburg, Md.Corresponding Author: Daniel S. Budnitz, MD, MPH, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, Mailstop A-24, Atlanta,GA30333 (firstname.lastname@example.org).
Context Adverse drug events are common and often preventable causes of medical
injuries. However, timely, nationally representative information on outpatient adverse
drug events is limited.
Objective To describe the frequency and characteristics of adverse drug events that
lead to emergency department visits in the United States.
Design, Setting, and Participants Active surveillance from January 1, 2004, through
December 31, 2005, through the National Electronic Injury Surveillance System–
Cooperative Adverse Drug Event Surveillance project.
Main Outcome Measures National estimates of the numbers, population rates,
and severity (measured by hospitalization) of individuals with adverse drug events treated
in emergency departments.
Results Over the 2-year study period, 21 298 adverse drug event cases were reported,
producing weighted annual estimates of 701 547 individuals (95% confidence interval
[CI], 509 642-893 452) or 2.4 individuals per 1000 population (95% CI, 1.7-3.0) treated
in emergency departments. Of these cases, 3487 individuals required hospitalization
(annual estimate, 117 318 [16.7%];95%CI, 13.1%-20.3%). Adverse drug events accounted
for 2.5% (95% CI, 2.0%-3.1%) of estimated emergency department visits for
all unintentional injuries and 6.7% (95% CI, 4.7%-8.7%) of those leading to hospitalization
and accounted for0.6%of estimated emergency department visits for all causes.
Individuals aged 65 years or older were more likely than younger individuals to sustain
adverse drug events (annual estimate, 4.9 vs 2.0 per 1000; rate ratio [RR], 2.4;95%CI,
1.8-3.0) and more likely to require hospitalization (annual estimate, 1.6 vs 0.23 per 1000;
RR, 6.8;95%CI, 4.3-9.2). Drugs for which regular outpatient monitoring is used to prevent
acute toxicity accounted for41.5%of estimated hospitalizations overall (1381 cases;
95% CI, 30.9%-52.1%) and 54.4% of estimated hospitalizations among individuals
aged 65 years or older (829 cases; 95% CI, 45.0%-63.7%).
Conclusions Adverse drug events among outpatients that lead to emergency department
visits are an important cause of morbidity in the United States, particularly
among individuals aged 65 years or older. Ongoing, population-based surveillance can
help monitor these events and target prevention strategies.
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