The FDA has concluded their investigation into testosterone replacement therapy (TRT) and based on the evidence, there is an increased risk for cardiovascular side effects associated with these products. This week, they announced an update with official recommendations for use and distribution of TRT.

The FDA only approves the use of TRT in men who suffer from low testosterone levels in conjunction with an associated medical condition confirmed by laboratory tests. It is NOT an approved treatment for men with low testosterone due to aging stating, “the benefits and safety of this use have not been established.”

In the Safety Announcement released on March 3, the FDA is now requiring manufacturers to make specific changes for labeling testosterone products:

1. There must be clarification of FDA-approved uses for TRT.
   
2. There must be a warning for possible increased risk of heart attacks and stroke associated with testosterone use.

The FDA is also requiring manufactures to conduct more research examining further the correlation between testosterone and cardiovascular side effects among users.

In April 2013, a Sentinel Event Alert provided by The Joint Commission cited 98 alarm-related events over a 3 ½ year time frame. It reported 80 of those events actually resulted in death and 13 caused permanent loss of function. This was a result of  “alarm fatigue;” a new phenomenon characterized by caregivers becoming overwhelmed, distracted or desensitized by the large number of physiological alarms generated by modern monitoring systems. In fact, a recent study reported by the American Nurses Association shows that, in a single month, there are more than 2.5 million alarms triggered on bedside monitors!

Medical device alarms aid in timely, life-saving interventions that have been instrumental in improving patient outcomes. However, as discussed in my last blog, technology is not foolproof. In nursing school, we teach, “treat the patient, not the machine.” Current monitoring systems do not take into account differences between patients. There is not a “one size fits all” setting and this can lead to many clinically insignificant alarms. As a result, alarms are sometimes disabled, silenced or the volume is turned down to an inaudible level. Obviously, this increases the risk for missing an important alarm that could potentially make a difference between life and death.

There are a variety of medical device alarms in a hospital to inform about changes in a patient’s status or circumstance that could adversely affect the patient’s care. For example, physiological monitors will alarm when a patient’s heart rate, blood pressure or oxygenation falls outside of specified parameters. Ventilators will alarm when breathing circuits become disconnected. Infusion pumps will also alarm when an IV solution runs out or when there is air in the IV line. These examples all necessitate an action by a healthcare worker in a timely manner. 

Nevertheless, there are also many alarms for conditions that may not be as clinically significant. For example, an alarm warning when an EKG electrode has poor contact with the patient’s skin or an alarm warning when a patient bends his arm to eat something because it momentarily occludes the IV line. Minimizing the number of clinically insignificant alarms can facilitate better recognition of conditions that truly require attention. 

Any failure for staff to be informed of a valid condition in a timely manner or failure to take necessary action to an alarm can be considered an alarm hazard. As a result, The Joint Commission announced a new National Patient Safety Goal (NPSG.06.01.01) on clinical alarm safety. Hospitals will be expected to develop and implement policies and procedures for alarm system management as well as provide staff education no later than January 1, 2016. 

1. Alarm Hazards: Inadequate Alarm Configuration Policies and Practices. Concern for “alarm fatigue," a situation in which clinicians become overwhelmed by alarm signals, came about after a number of reported deaths were attributed to hospital alarms being turned down, turned off or being manually programmed outside of safe limits. As a result, this became a new National Patient Safety Goal by Joint Commission in 2014 requiring healthcare facilities to make improvements in the management of clinical alarm systems before January 1, 2016. 

2. Data Integrity: Incorrect or Missing Data in Electronic Health Records and Other Health IT Systems. Whether it’s the wrong patient's information in another patient’s record or outdated data being copied and pasted into a new report, any type of incomplete, inaccurate or out of date information can potentially lead to incorrect treatment decisions and thus, lead to a harmful outcome for a patient.

3.  Mix-Up of IV Lines Leading to Misadmin-istration of Drugs and Solutions. When a patient has more than one infusion line, for medication administration, it can be easy for lines to get tangled and create confusion leading to a potential medication error where the wrong medication, or IV solution, is delivered to the wrong site or at the wrong rate. 

6. Patient-Handling Device Use Errors and Device Failures. 
The single greatest risk factor for overexertion injuries in healthcare workers is the manual lifting, moving and repositioning of patients. “Safe Patient Handling and Mobility” is a national safety standard that was initiated almost 10 years ago to prevent injury of healthcare workers as well as patients during these activities. However, musculoskeletal injuries in healthcare occupations is still among the highest of all U.S. industries.

7.“Dose Creep”: Unnoticed Variations in Diagnostic Radiation Exposures. In healthcare, radiation is used for imaging studies as well as to treat certain forms of cancer. Two concepts necessary in radiation safety is “timing” and “spacing,” which refers to the length of time a person is exposed to radiation and how close in proximity a person is to the radiation source. ALARA is a safety standard that refers to using radiation “as low as reasonably achievable” to provide the necessary treatment or imaging.

In healthcare, the process of informed consent requires disclosure of pertinent information regarding procedures performed, risks, benefits, etc, in a manner that the patient understands. To reinforce that the consent form has been read and understood, a signature is also obtained. However, excessively long consent forms containing complex information can be intimidating, particularly for those patients with low education or poor literacy abilities. Likewise, studies show that individuals do not read consent documents carefully. So, is it safe to assume that the patient is truly informed despite obtaining a signature? With concerns surrounding the inability of many to comprehend information for informed consent,  it makes sense to consider other modes of information delivery.

Consider an esophagogastroduodenoscopy. This is the formal medical term required to be used on a consent form when an individual undergoes a diagnostic procedure where a scope is placed in the mouth, to visualize the tissue lining in the esophagus, all the way into the stomach and ending in the the duodenum. This is an easy concept, right? Now, think about the visual salience provided by the pictorial superiority effect when using graphical media to present risks and benefits for individuals with poor literacy. After all, a picture is worth a thousand words.

Computer based multimedia can promote active participation in learning through interaction, whereas information acquisition using paper consent forms is mostly passive. Studies have found that individuals remember approximately 10% of what they read, 20% of what they hear, 30% of what they visualize and hear, 50% if they observe someone doing something along with an explanation, and 90% if they perform the task themselves. Since paper consent forms can only be read, digital multimedia has the potential to enhance understanding by utilizing all of these approaches (i.e. reading, hearing, watching and doing). Essentially, digital media has the potential to “tailor” information to the individual’s learning style and information preferences thereby helping individuals understand the material being presented.

Evidence supporting the effectiveness and acceptance of digital media for research and health care consent is increasing. Video informed consent has been shown to improve patient comprehension of various surgical procedures. Studies also show that computer-based educational interventions for chronic conditions such as asthma, diabetes and arthritis elicit a better understanding of the condition and provides a greater sense of control and empowerment.

With the expanding societal use of computers and the universal trend toward medical informatics and electronic medical records, it’s not a surprise that digital multimedia could offer unique opportunities for improving the approach to the informed consent process. 

Stay tuned for my next post discussing healthcare's top technology hazards for 2015!

Testosterone replacement therapy (TRT) is used by millions of men to treat low testosterone, otherwise known as “Low T.” In fact,  sales in 2012 were reportedly as high as $2 billion and this is projected to more than double before 2017. However, since 2010, information has disseminated suggesting the increase of serious side effects such as heart attacks, strokes and thrombolytic events among groups of men prescribed TRT products. These products include AndroGel, Testopel, Androderm, Striant, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta and many more.

"GO RED FOR WOMEN!"  is a national campaign to bring awareness of heart disease and stroke in women as well as advocate for more research. Additionally, in support of this campaign, February 6th, 2015 has been designated "National Wear RED Day!" 

Heart disease is the No. 1 killer of women, causing 1 in 3 deaths each year. The challenges is that it does not affect all women alike, and the warning signs for women are not the same in men which can lead to misunderstanding. 

Know the signs and symptoms of heart disease!
Most believe that the cardinal sign of a heart attack is extreme chest pain. However, 64% of women who die suddenly of heart disease had no previous symptoms. Women are more likely to experience shortness 
of breath, nausea/vomiting and back or jaw pain. Other symptoms women should look out for are dizziness, lightheadedness or fainting, pain in  
the lower chest or upper abdomen and extreme fatigue. 

Know what your risk factors are! 
Risk factors for heart disease that an individual has no control over include age 
and family history. However, there are many risk factors that an individual 
can adapt and change:

• Blood pressure (BP) - For women over 20 years, BP should be no higher than 120/80. High BP makes the heart work harder and causes atherosclerosis (this causes a narrowing of the arteries) which in turn creates more resistance for the heart to pump blood throughout the body.
  
• High cholesterol - There are different types of cholesterol. Some are good for our body and some are not. Know what your levels are and try to keep them in normal range. A total cholesterol level should be less than 200, but when it goes above 240 it will double an individuals's risk for heart disease.
  
• Smoking - Nicotine elevates heart rate and BP. Women who smoke have a 25% higher rate of developing heart disease than men and it causes pre-mature death by more than 10 years. Overall, smoking increases the risk of heart disease by 2 - 4 times. 
• Diabetes - The incidence of heart disease is also 2 - 4 times greater among persons who have diabetes, even those with well-controlled blood glucose levels, than the general population. 
• Weight - The increased risk of heart disease is proportional to the degree of obesity. Obesity is also often associated with high cholesterol and high BP. A body mass index (BMI) greater than 30 is considered obese. (To calculate BMI, multiply your weight in pounds by 703, divide by your height in inches, then divide again by that same number of height in inches).
• Activity level - Individuals who are inactive also tend to have higher cholesterol and higher BP. By participating in regular moderate to vigorous activity, women can reduce their risk of heart disease by 30-40% and stroke by 25%. 

Know how to prevent heart disease!
Prevention is key to heart health. It has been proven to significantly lower the risk for heart disease when health promotion is achieved. This includes making healthy diet choices, getting appropriate exercise and sleep, as well as stress reduction. For example, choose a diet that is low in dietary cholesterol and total and saturated fat, that is also high in fruits and vegetables. Reduce caloric intake to achieve a BMI between 18.5 and 25. Reduce sodium intake. Develop and maintain at least 30 minutes of moderate physical activity on most days of the week. Enroll in a smoking cessation program and limit daily alcohol intake to small to moderate amounts. Lastly, have regular check-ups with your healthcare provider to help monitor your health preventatively and/or to manage the risk factors already identified.

Join me this Friday, February 6th, and "GO RED FOR WOMEN!"  Increase your awareness of behaviors that are detrimental to your health.  NOW is the time to be motivated and encourage lifestyle changes for health promotion to reduce the risk of heart disease! 

In the latest Texas Nursing Voice (a quarterly publication by the Texas Nurse Association), there is an article about reporting elder abuse and neglect with a summary of the actual reporting requirements based on the Nursing Practice Act. According to the 2014 Gallup-Poll, 80% of Americans said nurses have "very high" or "high" standards of honesty and ethics, which makes the nursing profession the most trustworthy since 1999 (with the exception of 2001 when firefighters were listed after the 9/11 attacks). 

This places nurses and other healthcare providers in a very important position to intervene and report signs of elder mistreatment (abuse or neglect). Findings of elder abuse may be subtle and often are not physical injuries. In fact, the National Center of Elder Abuse (NCEA) actually defines seven different types of elder abuse:

1. Physical abuse: Use of physical force that my result in bodily injury, physical pain, or impairment.
   
2. Sexual abuse: Nonconsensual sexual contact of any kind with an elderly person.
   
3. Emotional abuse: Infliction of anguish, pain or distress through verbal or nonverbal acts. This may also include failure to provide social stimulation, as illustrated in the above photo.
   
4. Financial/material exploitation: Illegal or improper use of an elder’s funds, property or assets.
   
5. Neglect: The refusal or failure to fulfill any part of a person’s obligations or duties to an elderly person.
   
6. Abandonment: The desertion of an elderly person by an individual who has physical custody of the elder or by a person who has assumed responsibility for providing care to the elder.
   
7. Self-neglect: Behaviors of an elderly person that threaten the elder’s health or safety.
   

Alarmingly, in a 2010 study, over 50% of nursing home staff admitted to mistreating older patients within the prior year, noting that two thirds of those incidents involved neglect. Unfortunately, victims of elder mistreatment rarely self-report due to fear of retaliation, lack of ability to report or because they don’t want the abuser to get in trouble. Studies also show as high as 90% of elder abusers are family members. 

Whether or not the act of abuse is observed or if there is a suspicion of elder mistreatment, healthcare providers must take appropriate steps to ensure the patient’s safety.  Professionally, reporting is the standard of care for nurses, but personally it is simply a moral and ethical obligation. 

Reporting requirements may vary slightly among jurisdictions, however in most states, Adult Protective Services is the first to respond to any report of abuse, neglect or exploitation of a vulnerable adult. Early in my nursing career, I had the experience of reporting to Adult Protective Services and Child Protective Services. If it were my  loved one, I would hope and expect that a fellow nurse or other healthcare provider intervene and take appropriate action by reporting.

To read the article go to http://c.ymcdn.com/sites/www.texasnurses.org/resource/resmgr/TNV/TX1_15.pdf
or to learn more about elder abuse visit the NCEA website at http://www.ncea.aoa.gov

Nobody wants to see a loved one put in restraints under any circumstances. Not only is it difficult for the individual and their family, but also for the healthcare providers involved. In healthcare facilities, the use of restraints is never a first line remedy and is only implemented to maintain patient safety when a patient is violent, has self-destructive behavior or other behavior that interferes with medical treatment. For example, confusion, agitation or delirium in hospitalized patients may cause an individual to pull out IV lines, take off telemetry leads, remove oxygen-delivering equipment or even dislodge urinary catheters. This is counterproductive to recovery.

If alternatives have been attempted and a restraint is necessary, there are 3 different categories of restraints: physical, chemical and seclusion. A physical restraint is a device or intervention that prevents a patient from moving freely. It is the most common form of restraint and includes applying hand mitts and wrist, ankle, chest or lap restraints. It also includes keeping all side rails up to prevent a patient from getting out of bed, tucking in linens tightly to restrict movement and even use of an enclosure bed. 

Regardless of the type of restraint being utilized, it is considered a high-risk intervention by the Centers for Medicare and Medicaid Services and The Joint Commission. Restraints should never to be used for coercion, punishment, discipline or convenience. Restraints can cause serious injury and The Joint Commission as a result considers any death that may occur a sentinel event. 

Regulation requires proper assessment, intervention and documentation. For example, ongoing nursing assessment of patient status, including frequent vital signs and skin assessment, along with reevaluation of need for restraint, is required while any restraint is in place. Additionally, a physician assessment and written order is also required for application of a restraint and must be renewed every 24 hours. Any healthcare facility will have specific policies outlining safe practices for restraint utilization.  

Before the holidays, I posted an article discussing how past health conditions and medication histories of a defendant driver may impact an auto collision case. Now, let me share how investigating the medical records of an injured plaintiff can also impact your case. Again, I'm not talking about the obvious injuries identified after an accident like whiplash or other back problems. Of course, the current medical records are crucial in assessing damages. However, the past medical history is equally important.

I’m sure you’ve all been confronted with the issue of "pre-existing conditions." In traditional context, when the injury reported from the accident is being disputed as “pre-existing,” sometimes it can be beneficial to do more investigation. Often times, it warrants looking further back, even more than a year or two before the auto accident, into the plaintiff's medical history to identify a true pattern.

Did you know a person on long-term steroid therapy is also at risk for fractures? This is a side effect of steroid use over time. Long-term steroid therapy is common for individuals with autoimmune disorders such as lupus or rheumatoid arthritis. A person with a history of any type of organ transplant is also likely to be on steroid therapy. 

Another significant pre-existing condition impacting recovery is diabetes. A person with diabetes, over time, will develop vascular insufficiency or poor circulation. If they are injured and develop a significant wound, they are at risk for poor wound healing as a result of the decrease in blood supply to oxygenate and ultimately heal the injured tissue. Again, it may require more time and treatment (supplies, medicine, office appointments, etc.), not to mention the added pain and suffering involved with wound care treatments, to recover and thus, increasing the settlement value. 

HAPPY NEW YEAR!!! We are in the middle of flu season and a not so happy fact is that every year hundreds of people die from complications as a result of the influenza virus. This season, the virus has already taken the lives of 15 children, 3 in which have been reported from Texas. Everyone is at risk. In the United States, most colds, flu cases, and other respiratory infections occur during the fall and winter. This may be due to the school year resuming and/or to cold weather, which prompt people to spend more time indoors and increase the chances that germs will spread from person to person. Those most susceptible to these infections are the very young, the very old, those with long-term (chronic) diseases, or with weak immune systems.

According to the latest reports, U.S. flu activity has continued to increase in intensity and expand geographically in many areas of the country. Flu season typically peaks between December and February and lasts until May. 
Surveillance information indicates that influenza A (H3N2) is the strain of flu virus circulating most widely. The severity of flu disease this season also appears to be similar to previous seasons in which influenza A (H3N2) viruses have circulated predominantly. 

Question arose last month regarding the effectiveness of the this year’s flu vaccine. Traditional flu vaccines are made to protect against three different flu viruses (called “trivalent” vaccines). This year’s trivalent flu vaccine protects against two influenza A viruses (H1N1 and H3N2) and an influenza B virus. 

Influenza viruses are constantly changing so it’s common for new strains of influenza viruses to appear each year. The effectiveness of the vaccine depends in part on the match between the viruses in the vaccine and influenza viruses that are circulating in the community. If these are closely matched, vaccine effectiveness is higher. If they are not closely matched, vaccine effectiveness can be reduced. However, even when the viruses are not closely matched, the vaccine can still protect many people and prevent flu-related complications. Such protection is possible because antibodies made in response to the vaccine can provide some protection (called cross-protection) against different, but related strains of influenza viruses. 

Vaccination remains the best method for preventing influenza and its potentially severe complications in children and adults even in years where there is a suboptimal match between vaccine and circulating strains of influenza viruses. The CDC continues to recommend vaccination as long as flu viruses are circulating and encourages prompt treatment with flu antiviral drugs for people at high risk of serious flu complications.