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FDA approves new extended-release oxycodone with abuse-deterrent properties

July 29, 2014 Comments off

FDA approves new extended-release oxycodone with abuse-deterrent properties
Source: U.S. Food and Drug Administration

Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.

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Promoting Patient Safety Through Effective Health Information Technology Risk Management

July 29, 2014 Comments off

Promoting Patient Safety Through Effective Health Information Technology Risk Management (PDF)
Source: RAND Corporation

The potential for health information technology (IT) to improve health care delivery has been appreciated for decades, but “digitizing” health care can also introduce new risks and even harm. As the use of health IT has grown, these risks have become more apparent. The authors of this report evaluated the efforts of 11 hospitals and ambulatory practices to use an improvement strategy and tools developed to promote safe use of health IT and to diagnose, monitor, and mitigate health IT–related safety risks. Through interviews, the authors discovered that some health care organizations (especially hospitals) with expertise in process improvement were able to identify and begin to mitigate health safety risks, but in most others, awareness of these risks was limited (especially in ambulatory practices). The authors concluded that better tools like the recently released Safety Assurance Factors for EHR Resilience (SAFER) Guides are needed to help organizations optimize the safe use of health IT. However, health care organizations will require a better understanding of the safety risks posed by electronic health record (EHR) use to take full advantage of the SAFER Guides. There may also be a need for additional tools and metrics (and further usability studies of existing tools and metrics) to better support the needs of health care organizations as they increasingly rely on health IT to improve the quality and safety of patient care.

CRS — “Black Boxes” in Passenger Vehicles: Policy Issues

July 25, 2014 Comments off

“Black Boxes” in Passenger Vehicles: Policy Issues (PDF)
Source: Congressional Research Service (via Federation of American Scientists)

An event data recorder (EDR) is an electronic sensor installed in a motor vehicle that records certain technical information about a vehicle’s operational performance for a few seconds immediately prior to and during a crash. Although over 90% of all new cars and light trucks sold in the United States are equipped with them, the National Highway Traffic Safety Administration (NHTSA) is proposing that all new light vehicles have EDRs installed in the future. Under previously adopted NHTSA rules, these devices have to capture at least 15 types of information related to the vehicle’s performance in the few seconds just before and immediately after a crash serious enough to result in deployment of airbags.

EDRs have the potential to make a significant contribution to highway safety. For example, EDR data showed that in several cases a Chevrolet Cobalt’s ignition switch turned the engine off while the car was still moving, causing the car to lose power steering and crash; the data directly contributed to the manufacturer’s decision to recall 2.6 million vehicles. EDR data could also be used, sometimes in conjunction with other vehicle technologies, to record in the few seconds before an accident such data as driver steering input, seat occupant size and position, and sound within a car.

The privacy of information collected by EDRs is a matter of state law, except that federal law bars NHTSA from disclosing personally identifiable information. The privacy aspects of EDRs and the ownership of the data they generate has been the subject of legislation in Congress since at least 2004. The House passed a floor amendment to the transportation appropriations bill in 2012 that would have prohibited use of federal funds to develop an EDR mandate. This provision was not enacted. The Senate passed two EDR-related provisions in its surface transportation reauthorization bill (S. 1813) in 2012, mandating EDRs on new cars sold after 2015 and directing a Department of Transportation study of privacy issues. The provisions were not included in the final bill.

Differences in Time Use and Activity Patterns When Adding a Second Job: Implications for Health and Safety in the United States

July 24, 2014 Comments off

Differences in Time Use and Activity Patterns When Adding a Second Job: Implications for Health and Safety in the United States
Source: American Journal of Public Health

Objectives.
We compared work and lifestyle activities for workers who work in 1 job with those who work in multiple jobs during a 1-week period.

Methods.
We used information from the 2003–2011 American Time Use Survey to classify workers into 6 work groups based on whether they were a single (SJH) or multiple (MJH) job holder and whether they worked their primary, other, multiple, or no job on the diary day.

Results.
The MJHs often worked 2 part-time jobs (20%), long weekly hours (27% worked 60+ hours), and on weekends. The MJHs working multiple jobs on the diary day averaged more than 2 additional work hours (2.25 weekday, 2.75 weekend day; P < .05), odd hours (more often between 5 pm and 7 am), with more work travel time (10 minutes weekday, 9 minutes weekend day; P < .05) and less sleep (–45 minutes weekday, −62 minutes weekend day; P < .05) and time for other household (P < .05) and leisure (P < .05) activities than SJHs.

Conclusions.
Because of long work hours, long daily commutes, multiple shifts, and less sleep and leisure time, MJHs may be at heightened risk of fatigue and injury.

Fire/EMS Department Operational Considerations and Guide for Active Shooter and Mass Casualty Incidents

July 23, 2014 Comments off

Fire/EMS Department Operational Considerations and Guide for Active Shooter and Mass Casualty Incidents (PDF)
Source: U.S. Fire Administration

This guide is a fire and emergency medical services (EMS) resource that can be used to support planning and preparation for active shooter and mass casualty incidents. These complex and demanding incidents may be well beyond the traditional training and experience of the majority of firefighters and emergency medical technicians. The U.S. Fire Administration offers this guide as one source of many available for the public safety community, but it takes into consideration the diverse local service levels available across America. In developing the guide, we consulted with individuals and groups engaged in fire and pre-hospital emergency medical services, law enforcement, and hospital medical and trauma care. We also consulted with public safety organizations and numerous federal agencies.

Use of St. John’s Wort in Potentially Dangerous Combinations

July 22, 2014 Comments off

Use of St. John’s Wort in Potentially Dangerous Combinations
Source: Journal of Alternative and Complementary Medicine

Objectives:
The objective of this study was to assess how often St. John’s wort (SJW) is prescribed with medications that may interact dangerously with it.

Design:
The study design was a retrospective analysis of nationally representative data from the National Ambulatory Medical Care Survey.

Settings:
The study setting was U.S. nonfederal outpatient physician offices.

Subjects:
Those prescribed SJW between 1993 and 2010 were the subjects.

Outcome Measures:
The outcome measures were medications co-prescribed with SJW.

Results: Twenty-eight percent (28%) of SJW visits involved a drug that has potentially dangerous interaction with SJW. These included selective serotonin reuptake inhibitors, benzodiazepines, warfarin, statins, verapamil, digoxin, and oral contraceptives.

Conclusions:
SJW is frequently used in potentially dangerous combinations. Physicians should be aware of these common interactions and warn patients appropriately.

CRS — Unaccompanied Alien Children: Potential Factors Contributing to Recent Immigration

July 21, 2014 Comments off

Unaccompanied Alien Children: Potential Factors Contributing to Recent Immigration (PDF)
Source: Congressional Research Service (via U.S. State Department Foreign Press Center)

Since FY2008, the growth in the number of unaccompanied alien children (UAC) from Mexico, El Salvador, Guatemala, and Honduras seeking to enter the United States has increased substantially. Total unaccompanied child apprehensions increased from about 8,000 in FY2008 to 52,000 in the first 8 ½ months of FY2014. Since 2012, children from El Salvador, Guatemala, and Honduras (Central America’s “northern triangle”) account for almost all of this increase. Apprehension trends for these three countries are similar and diverge sharply from those for Mexican children. Unaccompanied child migrants’ motives for migrating to the United States are often multifaceted and difficult to measure analytically.

Four recent out-migration-related factors distinguishing northern triangle Central American countries are high violent crime rates, poor economic conditions fueled by relatively low economic growth rates, high rates of poverty, and the presence of transnational gangs.

NCPDP Recommendations and Guidance for Standardizing the Dosing Designations on Prescription Container Labels of Oral Liquid Medications

July 18, 2014 Comments off

NCPDP Recommendations and Guidance for Standardizing the Dosing Designations on Prescription Container Labels of Oral Liquid Medications (PDF)
Source: National Council for Prescription Drug Programs

This paper provides the healthcare industry, in particular the pharmacy sector, with historical and background information on the patient risks associated with the dosing of liquid medications and recommendations to mitigate those risks through best practices in prescription orders, prescription labeling and the provision of dosing devices.

Using Dietary Supplements Wisely

July 18, 2014 Comments off

Using Dietary Supplements Wisely
Source: National Center for Complementary and Alternative Medicine

Like many Americans, you may take dietary supplements in an effort to stay healthy. With so many dietary supplements available and so many claims made about their health benefits, how can you decide whether a supplement is safe or useful? This fact sheet provides a general overview of dietary supplements, discusses safety considerations, and suggests sources for additional information.

Unsafe and Harassed in Public Spaces: A National Street Harassment Report

July 17, 2014 Comments off

Unsafe and Harassed in Public Spaces: A National Street Harassment Report
Source: Stop Street Harassment

In 2014, SSH commissioned a 2,000-person nationally representative survey in the USA with firm GfK. The survey found that 65% of all women had experienced street harassment. Among all women, 23% had been sexually touched, 20% had been followed, and 9% had been forced to do something sexual.

Among men, 25% had been street harassed (a higher percentage of LGBT-identified men than heterosexual men reported this) and their most common form of harassment was homophobic or transphobic slurs (9%).

Update on findings in the FDA cold storage area on the NIH campus

July 17, 2014 Comments off

Update on findings in the FDA cold storage area on the NIH campus
Source: U.S. Food and Drug Administration

As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.

The investigation found 12 boxes containing a total of 327 carefully packaged vials labeled with names of various biological agents such as dengue, influenza, Q fever, and rickettsia. Upon the discovery of these vials on July 1, 2014, FDA employees followed standard protocol and turned them all over to the appropriate NIH safety program officials, who in turn transferred them to the appropriate investigative agencies, as per standard protocols.

IIHS issues recommendations on used vehicles for teens after research finds many aren’t driving the safest ones

July 17, 2014 Comments off

IIHS issues recommendations on used vehicles for teens after research finds many aren’t driving the safest ones
Source: Insurance Institute for Highway Safety

Many teenagers are driving vehicles that don’t offer good crash protection and lack important safety technology, new research by the Insurance Institute for Highway Safety shows. To help guide parents toward safer choices, IIHS has compiled its first-ever list of recommended used vehicles for teens.

IIHS is known for its ratings of new vehicles, but for many families, a 2014 TOP SAFETY PICK or TOP SAFETY PICK+ isn’t in the budget. In a national phone survey conducted for IIHS of parents of teen drivers, 83 percent of those who bought a vehicle for their teenagers said they bought it used.

With that reality in mind, the Institute has compiled a list of affordable used vehicles that meet important safety criteria for teen drivers (see below). There are two tiers of recommended vehicles with options at various price points, ranging from less than $5,000 to nearly $20,000, so parents can buy the most safety for their money, whatever their budget.

New From the GAO

July 16, 2014 Comments off

New GAO Reports and Testimonies
Source: Government Accountability Office

Reports

1. Medicaid: Assessment of Variation among States in Per-Enrollee Spending. GAO-14-456, June 16.
http://www.gao.gov/products/GAO-14-456
Highlights – http://www.gao.gov/assets/670/664114.pdf

2. Special Education: Additional Federal Actions Could Help Address Unique Challenges of Educating Children in Nursing Homes. GAO-14-585, July 16.
http://www.gao.gov/products/GAO-14-585
Highlights – http://www.gao.gov/assets/670/664821.pdf

3. Coastal Zone Management: Opportunities Exist for NOAA to Enhance Its Use of Performance Information. GAO-14-592, July 16.
http://www.gao.gov/products/GAO-14-592
Highlights – http://www.gao.gov/assets/670/664805.pdf

4. Supplemental Security Income: Wages Reported for Recipients Show Indications of Possible SSN Misuse. GAO-14-597, July 16.
http://www.gao.gov/products/GAO-14-597
Highlights – http://www.gao.gov/assets/670/664795.pdf

Testimonies

1. U.S. Launch Enterprise: Acquisition Best Practices Can Benefit Future Efforts, by Cristina Chaplain, director, acquisition and sourcing management, before the Senate Committee on Commerce, Science, and Transportation and the Subcommittee on Strategic Forces, Senate Committee on Armed Services. GAO-14-776T, July 16.
http://www.gao.gov/products/GAO-14-776T

2. High-Containment Laboratories: Recent Incidents of Biosafety Lapses, by Nancy Kingsbury, Ph.D., managing director, applied research and methods, before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce. GAO-14-785T, July 16.
http://www.gao.gov/products/GAO-14-785T
Highlights – http://www.gao.gov/assets/670/664800.pdf

New From the GAO

July 14, 2014 Comments off

New GAO Report
Source: Government Accountability Office

Military Training: Observations on Efforts to Prepare Personnel to Survive Helicopter Crashes into Water. GAO-14-615R, July 14.
http://www.gao.gov/products/GAO-14-615R

The Cruise Passenger’s Rights and Remedies 2014: The COSTA CONCORDIA Disaster: One Year Later, Many More Incidents Both on Board Megaships and During Risky Shore Excursions

July 11, 2014 Comments off

The Cruise Passenger’s Rights and Remedies 2014: The COSTA CONCORDIA Disaster: One Year Later, Many More Incidents Both on Board Megaships and During Risky Shore Excursions (PDF)
Source: Tulane Maritime Law Journal

Between January 2012 and May 2013, there were a series of disasters involving, inter alia, a megaship thought to be unsinkable that sank faster than the TITANIC, megaships thought to be fireproof that were not, and megaships thought to be secured by appropriate backup systems, both mechanical and electrical, that did not exist.

Modern cruise ships are best view ed as floating deluxe hotels that transport their guests from exotic port to exotic port where they stay a few hours for shopping, snorkeling, scuba diving, jet skiing, parasailing, and touring. Although there are problems on board cruise ships, generally it is safer to be on board than on a shore excursion. However, shore excursions are highly promoted 11 by the cruise lines, generate substantial revenues, and cause an increasing number of reported deaths and serious injuries to cruise passengers. Examples of such injuries include quadriplegia after an unforgettable swim at Lover’s Beach in Cabo San Lucas, Mexico; 13 quadriplegia after ta king a dive at Señor Frog’s Restaurant in Cozumel, Mexico; 14 being shot to death near Coki Beach in St. Thomas; 15 injury while riding an ATV in Acapulco, Mexico; 16 being struck by lightning during a catamaran ride in Montego Bay, Jamaica; 17 injury during a zip-line excursion in Jamaica; 18 assault and robbery during an excursion to Earth Village in Nassau; 19 slip and fall during a Laughton Glacier Hike Tour; 20 asphyxiation in a diving bell in Bermuda; 21 death while parasailing in Cozumel, Mexico; 22 death after being run over by a tour bus after re turning from the Ra in Forest Aerial Tram in Dominica; 23 and death after a tour bus ran off a mountain road in Chile.

III — Sports Injuries

July 9, 2014 Comments off

Sports Injuries
Source: Insurance Information Institute
Includes statistics/charts for injuries related to school sports, winter sports, bicycle and motorcycle crashes, recreational boating, ATVs, sports injuries by age/sport.

Drowsy Driving and Risk Behaviors — 10 States and Puerto Rico, 2011–2012

July 8, 2014 Comments off

Drowsy Driving and Risk Behaviors — 10 States and Puerto Rico, 2011–2012
Source: Morbidity and Mortality Weekly Report (CDC)

Findings in published reports have suggested that drowsy driving is a factor each year in as many as 7,500 fatal motor vehicle crashes (approximately 25%) in the United States (1,2). CDC previously reported that, in 2009–2010, 4.2% of adult respondents in 19 states and the District of Columbia reported having fallen asleep while driving at least once during the previous 30 days (3). Adults who reported usually sleeping ≤6 hours per day, snoring, or unintentionally falling asleep during the day were more likely to report falling asleep while driving compared with adults who did not report these sleep patterns (3). However, limited information has been published on the association between drowsy driving and other risk behaviors that might contribute to crash injuries or fatalities. Therefore, CDC analyzed responses to survey questions regarding drowsy driving among 92,102 respondents in 10 states and Puerto Rico to the 2011–2012 Behavioral Risk Factor Surveillance System (BRFSS) surveys. The results showed that 4.0% reported falling asleep while driving during the previous 30 days. In addition to known risk factors, drowsy driving was more prevalent among binge drinkers than non-binge drinkers or abstainers and also more prevalent among drivers who sometimes, seldom, or never wear seatbelts while driving or riding in a car, compared with those who always or almost always wear seatbelts. Drowsy driving did not vary significantly by self-reported smoking status. Interventions designed to reduce binge drinking and alcohol-impaired driving, to increase enforcement of seatbelt use, and to encourage adequate sleep and seeking treatment for sleep disorders might contribute to reductions in drowsy driving crashes and related injuries.

CPSC Reports Increase in Fireworks-Related Deaths and Injuries in 2013

July 3, 2014 Comments off

CPSC Reports Increase in Fireworks-Related Deaths and Injuries in 2013
Source: Consumer Product Safety Commission

As the nation prepares to celebrate Independence Day, the U.S. Consumer Product Safety Commission (CPSC) urges consumers to celebrate safely. A new CPSC study issued today highlights an increase in the number of fireworks-related deaths and injuries. Device malfunction and improper use are associated with the most injuries.

In 2013, there were eight deaths and an estimated 11,400 consumers who sustained injuries related to fireworks. This is an increase from 8,700 injuries in 2012. Sixty-five percent, or 7,400, of the injuries in 2013 occurred in the 30 days surrounding July 4, 2013. CPSC staff reviewed fireworks incident reports from hospital emergency rooms, death certificate files, news clippings and other sources to estimate deaths, injuries and incident scenarios. Injuries were frequently the result of the user playing with lit fireworks or igniting fireworks while holding the device. Consumers also reported injuries related to devices that malfunctioned or devices that did not work as expected, including injuries due to errant flight paths, devices that tipped over and blowouts.

Dating Violence Among Male and Female Youth Seeking Emergency Department Care

July 3, 2014 Comments off

Dating Violence Among Male and Female Youth Seeking Emergency Department Care
Source: Annals of Emergency Medicine

Study objective
We determine prevalence and correlates of dating violence, dating victimization, and dating aggression among male and female patients aged 14 to 20 years seeking emergency department (ED) care.

Methods
This was a systematic sampling of subjects aged 14 to 20 years seeking care at a single large academic ED between September 2010 and March 2013. Participants completed a computerized, self-administered, cross-sectional survey of demographics, dating violence from physical abuse measures of the Conflict in Adolescent Dating Relationships Inventory, associated behaviors, and ED health service use. Separate analyses were conducted for male and female patients.

Results
Four thousand three hundred eighty-nine youths (86.1% participation rate) were screened, and 4,089 (mean age 17.5 years; 58% female patients) were eligible for analysis. Almost 1 in 5 female patients (n=215; 18.4%) and 1 in 8 male patients (n=212; 12.5%) reported past-year dating violence. Of female patients, 10.6% reported dating victimization and 14.6% dating aggression, whereas of male patients, 11.7% reported dating victimization and 4.9% reported dating aggression. Multivariate analyses showed that variables associated with any male dating violence were black race (adjusted odds ratio [AOR] 2.26; 95% CI 1.54 to 3.32), alcohol misuse (AOR 1.03; 95% CI 1.00 to 1.06), illicit drug use (AOR 2.38; 95% CI 1.68 to 3.38), and depression (AOR 2.13; 95% CI 1.46 to 3.10); any female dating violence was associated with black race (AOR 1.68; 95% CI 1.25 to 2.25), public assistance (AOR 1.64; 95% CI 1.28 to 2.09), grades D and below (AOR 1.62; 95% CI 1.07 to 2.43), alcohol misuse (AOR 1.04; 95% CI 1.02 to 1.07), illicit drug use (AOR 2.85; 95% CI 2.22 to 3.66), depression (AOR 1.86; 95% CI 1.42 to 2.44), and any past year ED visit for intentional injury (AOR 2.64; 95% CI 1.30 to 5.40).

Conclusion
Nearly 1 of 6 male and female patients aged 14 to 20 years and seeking ED care report recent dating violence, and health disparities remain among this population. Dating violence was strongly associated with alcohol, illicit drug use, and depression and correlated with previous ED service use among female youths. ED interventions should consider addressing these associated health conditions, as well as improving screening protocols to address dating violence among male and female youths.

Drug Safety in the Digital Age

July 2, 2014 Comments off

Drug Safety in the Digital Age
Source: New England Journal of Medicine

In this digital age, engaging with new media offers an unparalleled opportunity for medical and public health professionals to find information they need and to interactively reach out to patients and their support networks. One domain where these capabilities may have far-reaching effects that are currently undefined is drug safety. As the volume of health-related information on the Internet has grown, important questions have emerged. How are messages from regulators — for example, warnings against using a drug in a specific patient population — diffused digitally? And are the messages still accurate when they reach the general population?

Despite debates over its credibility, Wikipedia is reportedly the most frequently consulted online health care resource globally: Wikipedia pages typically appear among the top few Google search results and are among the references most likely to be checked by Internet users. We therefore evaluated Google searches and Wikipedia page views for each drug in our sample. We also examined the content of Wikipedia pages, looking specifically for references to safety warnings. To control for secular trends, we examined results from a 120-day window around the date of the announcement (from 60 days before the announcement to 60 days after it) and constructed a baseline period for comparison that ran from 60 days to 10 days before the period of interest began.

We identified safety warnings for 22 prescription drugs that are indicated for a range of clinical conditions, including primary hypertension, chronic myelogenous leukemia, and hepatitis C. Collectively, these drugs triggered 13 million searches on Google and 5 million Wikipedia page views annually during the study period. FDA safety warnings were associated with an 82% increase, on average, in Google searches for the drugs during the week after the announcement and a 175% increase in views of Wikipedia pages for the drugs on the day of the announcement, as compared with baseline trends.

Did users find accurate information on the drugs’ safety? We found that 41% of Wikipedia pages pertaining to the drugs with new safety warnings were updated within 2 weeks after the warning was issued with information provided in the FDA announcements. The Wikipedia pages for drugs that were intended for treatment of highly prevalent diseases (affecting more than 1 million people in the United States) were more likely to be updated quickly (58% were updated within 2 weeks) than were those for drugs designed to treat less-prevalent conditions (20% were updated within 2 weeks, P=0.03; see Fig. S2 in the Supplementary Appendix).

Overall, 23% of Wikipedia pages were updated more than 2 weeks after the FDA warning was issued (average, 42 days), and 36% of pages remained unchanged more than 1 year later (as of January 2014). For example, the FDA issued a safety communication on January 13, 2012, that brentuximab vedotin (Adcetris), used to treat Hodgkin’s lymphoma and systemic anaplastic large-cell lymphoma, had been linked to two cases of progressive multifocal leukoencephalopathy. As a result, the FDA placed a new black-box warning about this risk on the drug label, a move that was followed by a 50% increase in Google searches for the drug during the ensuing week and a 141% increase in views of the drug’s Wikipedia page. However, there was still no mention of the new black-box warning on Wikipedia 2 years later, a discrepancy that substantiates concerns raised by previous studies over the reliability of online drug information.

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