NCAA Reaches Preliminary Settlement on Head Injury Case

The NCAA has reached a preliminary settlement in a class action suit with victims of traumatic head injuries during college sports games. The lawsuit was brought against the organization by former college athletes who wanted the NCAA to institute significant reforms on its head-injury policies.

The settlement indicates a big change in the care and safety of both male and female college athletes in all sports and across all divisions. The settlement will not only apply to former athletes, but also current players and those that play in the future. This settlement issued a new national protocol on how to treat head injuries sustained by players during games and practices. Athletes will no longer be allowed to continue playing after a head injury until a full workup has been conducted, and the player has been declared concussion symptom-free.

Concussions will be taken more seriously by coaches and trainers. Medical personnel will be required to attend at all sporting events. Other precautions have been specifically laid out, and all college teams will be required to comply.

According to the lead plaintiffs’ lawyer, Steve Berman, the preliminary offer will be good for the players. “This offers college athletes another level of protection, which is vitally important to their health. Student-athletes – not just football players – have dropped out of school and suffered huge long-term symptoms because of brain injuries. Anything we can do to enhance concussion management is a very important day for student-athletes,” stated Berman.

Financial Compensation for Athletes That Suffer Head Injuries

The preliminary settlement also establishes a $70 million medical monitoring fund to treat injuries that occur during college sports competitions. This fund would give all former college athletes a chance to receive a neurological screening to examine brain function and get diagnostic support for any potential problems. It would also have doctors look for any signs of brain damage.

While this money would be a much-needed step in the right direction, many still say that this does not do enough to compensate athletes who receive brain damage, because the fund is only used for diagnostic purposes. If damage is found, victims will have to pay for treatment on their own.

The settlement does leave open the possibility to sue for damages in individual cases, but some lawyers worry that this will not be a realistic option. “It’s going to be tough to find a lawyer to fight against the NCAA’s machinery when you’re talking about only $20,000 in damages. This is going to snuff out the vast majority of claims,” says Jay Edelson, a lawyer involved in the suit representing one of the plaintiffs.

Still, the majority of people are cautiously optimistic that this settlement will make significant strides towards protecting athletes, as was the original goal of the class action. All that is left now is to wait and see what the final settlement offer will contain.

Source:

http://www.nytimes.com/2014/07/30/sports/ncaa-settlement-overhauls-head-injury-policies.html?ref=health&_r=0

Inconsistency of Prescription Labels Risks Medication Errors

Medication errors cause thousands of deaths in the United States every year. A recent study by the University of Waterloo and the Canadian National Institute for the Blind determined that many of these errors are caused by illegible labeling.

Many factors can affect the legibility of a drug label from a pharmacy. Fonts that are too small, overly crowded instructions, and inconsistencies in the location of information on prescription drug labels can all cause confusion for patients. Elderly adults, who are already susceptible to medication errors, have the most trouble with these details.

According to the study, very few labels actually followed the professionally recommended guidelines for legibility of prescription labels recommended by the following:

  • The US Pharmacopeia
  • The American Society for Consultant Pharmacists
  • The National Patient Safety Agency in the UK
  • The American Foundation for the Blind
  • The Canadian National Institute for the Blind
  • The Royal National Institute of Blind People in the UK
  • The American Council of the Blind

The following discrepancies affected the legibility of the labels in the study:

  • Only 44% of the medication instructions used 12-point font size, the minimum accepted print size for optimal legibility.
  • Not a single drug or patient name on labels in the study met the minimum 12-point font standard.
  • 95% of the labels were judged to have overly crowded information, making it difficult to read important information, especially for those with diminished eyesight.
  • Just 51% of the labels used left alignment, which is recommended for legibility.
  • The instructions were given in complete sentences, making it difficult for patients to interpret.
  • There was a lack of consistency of the location of different types of information.
  • Every label in the study fell short of legibility recommendations in some way.

Improving Prescription Legibility

In order to study the legibility of labels currently used by pharmacies, researchers in the Waterloo study had 45 Canadian pharmacies in Kitchener, Waterloo, and Cambridge print a sample prescription label with the patient’s name, drug name, and instructions. They then compared the labels to each other and to label printing recommendations from pharmaceutical and health organizations and non-governmental organizations for ideal readability.

The researchers determined not only that recommendations were being ignored, but also that there were very few requirements for legibility and readability being handed down to individual pharmacies. In order to rectify this problem, researchers have proposed new guidelines and regulations for label size, font size and color, sentence alignment, and highlighting.

The researchers next plan to create a prototype for a uniform label and test it on both patients and pharmacists to try to improve legibility standards. “We expect that addressing these factors together will improve the accessibility of prescription labels. We need to move from a pharmacy-centered labeling standard, to a patient-centered one,” said Carlos H. Rojas-Fernandez, Professor at Waterloo’s School of Pharmacy and researcher on this study. In the meantime, patients need to be aware of this lack of clarity and make sure to read prescription bottles especially carefully.

 

Source:

http://medicalxpress.com/news/2014-07-prescription-guidelines-dosage-errors.html

FDA to Decide If Testosterone Meds Boost Heart Attack Risks

The Food and Drug Administration (FDA) has decided to hold a special advisory committee meeting to discuss the potential cardiovascular risks posed by testosterone products. This meeting, to be held on September 17, 2014, will be spent examining two recently released trials that indicate that testosterone products may increase the risk of heart attacks in men.

At this advisory meeting, the FDA Bone, Reproductive, and Urologic Drugs panel and the Drug Safety and Risk Management committee will jointly discuss what implications these studies have for consumers and the general safety of testosterone products.

This safety reassessment is the culmination of a months-long investigation by the FDA. The agency has been researching claims made in the testosterone market and the safety of such products. The FDA has already put a warning on all testosterone drugs about blood-clot risks posed by these products. Depending on the outcome of these hearings, the market may be more tightly regulated or some products could even be banned.

Concerns about Testosterone Medications

In recent years, men have been buying testosterone medications in increasing amounts. The drugs for low testosterone count, or hypogonadism, are intended to increase sex drive, improve mood, and strengthen muscle tone. While testosterone medications have been advertised as a panacea for any male problem, the medications for “Low T” may pose serious risks. As the testosterone market is currently valued at $1.6 billion and is expected to grow to $5 billion by 2017, it is important for the FDA to take an active role in determining the health impact of these drugs.

A study of 55,000 men taking prescribed testosterone medications in the United States found that in the first 90 days using testosterone drugs, 1 in 167 men aged 65 or older could suffer a heart attack. These risks increased to 1 in 100 men under 65 for those with pre-existing heart conditions. These risks are more than double the normal risk for men in this age bracket. There were nearly doubled risks for younger men with previous risk factors for cardiovascular problems.

Many doctors have expressed concerns about these medications, and the FDA is taking these concerns seriously. However, the risk may be mitigated by other factors. The solution to make these drugs safer may be in requiring more stringent patient testing before starting the medication.
Source:

http://www.fiercepharma.com/story/do-testosterone-meds-boost-heart-attack-risks-fda-asks-advisory-panels-weig/2014-07-22?utm_medium=nl&utm_source=internal

2014 Breaks Auto Recall Records Halfway through the Year

By the beginning of July of 2014, the country has already broken records to have more automobile recalls than any other year in history. The National Highway Traffic Safety Administration (NHTSA) lists 37.5 million cars recalled so far this year in the most recent preliminary data available on the agency’s website. This tops the previous 30.8 million car recall record set in 2004.

While the number of cars recalled so far this year is already staggering, it is likely to grow over the course of the rest of the year. Faulty airbags made by the Takata Corporation have already sparked several recalls this year. As soon as Japan’s three largest carmakers finish an evaluation of their models, more recalls are likely.

The official recall numbers for 2014 from the NHTSA will not be available until 2015, but it is clear that the total number of recalled vehicles is going to far exceed traditional averages. According to the NHTSA database, recalls historically range from 10 to 20 million cars in the United States each year. In 2013, just fewer than 22 million vehicles were recalled and in 2012, 16.4 million vehicles were recalled. Besides the previous record-setting year in 2004, the total number of recalls passed 30 million only in one other year, which was 1981.

The Biggest Auto Recalls in 2014

General Motors vehicles account for about two-thirds of the total number of vehicles recalled so far in 2014. This year’s record-breaking auto recall started when GM recalled 2.59 million cars in February to fix a faulty ignition switch. This design problem has already been linked to at least 13 deaths in car crashes.

As it was revealed that the company had known about problems with the ignition switch for over ten years, congressional investigations into GM’s actions began. The company has since been issued a $35 million civil fine, and the Department of Justice has even begun a criminal investigation into the actions of executives.

This controversy and the fallout that followed led GM to investigate the safety of all of its models. GM ended up recalling 25.7 million vehicles for issues ranging from faulty ignition switches to ineffective door wiring to dangerous seatbelt retractors. This massive number of recalls constitutes 40% of the company’s models currently on the roads in the United States.

The other issue that has led to recalls is related to Takata airbags. While this is not nearly on the same scale as the GM recalls, it will continue to add numbers to this year’s total. What is clear, however, is that after all of the recalls this year, people will be actively looking out for any car defects in the future.

Source:
http://www.chicagotribune.com/classified/automotive/sns-wp-blm-news-bc-autos-recall08-20140708,0,4002137.story

Olympic Swimmer in Spinal Accident

Six-time Olympic gold medalist and swimmer, Amy Van Dyken-Rouen, suffered a spinal cord injury in an ATV accident on June 6, 2014 near Show Low, Arizona. The 41-year-old swimming champion had been riding an ATV on the way home from dinner in front of her husband who was on a motorcycle. While driving the ATV, Van Dyken-Rouen hit the curb for unknown reasons according to the report. The ATV then went over an embankment, seriously injuring her in the process.

According to reports after the crash, Van Dyken-Rouen’s spine was severed and her husband found her unconscious and not breathing after the impact. She reportedly told emergency responders that she was unable to feel her legs when they arrived after the accident, but it is unclear whether she was paralyzed. She was taken by helicopter to the Scottsdale Osborn Medical Center where she underwent surgery.

A letter released by the family said that the swimming champion’s spinal cord was completely severed at the T11 vertebrae in the accident and was pushed into her body, but miraculously stopped just short of hitting her aorta. It was later revealed that had the aorta been nicked, she most likely would have bled to death very quickly. The letter also praised Van Dyken-Rouen for her “strength and determination,” but said that she had a “long, trying road” of recovery ahead of her. They seem hopeful of her full recovery and Van Dyken-Rouen vows to walk again. She is currently starting her rehabilitation at Craig Hospital in Englewood, Colorado. Reports indicate that Van Dyken-Rouen will continue to recover at Craig Hospital over the next few months.

Dyken-Rouen Faces an Uphill Battle during Rehabilitation

It will be an uphill battle for Van Dyken-Rouen in the months to come, as she works on rehabilitating herself. Spinal cord injuries are one of the most devastating types of injuries to experience, especially in cases where the spine is totally severed. Often these injuries can require multiple surgeries, months of rehabilitative therapy, and even potentially lifelong complications.

Source:
http://www.foxsports.com/olympics/story/olympic-swimming-champion-amy-van-dyken-rouen-injured-in-arizona-atv-accident-060914