Traumatic brain injury (TBI) is a common occurrence that both healthcare professionals and laypeople should be aware of. According to the Centers for Disease Control (CDC), there were 69,000 deaths related to TBI in 2021, which amounts to approximately 190 deaths per day.
Awareness is where it all begins with TBI. This includes but is not limited to the common causes of TBI, what the experience is like for patients and their loved ones, and what nurses need to know to intervene effectively in patients’ often arduous recovery process.
About TBI
Kelly Tuttle, FNP, is a neurology nurse practitioner who suffered a traumatic brain injury after a car accident in 2015. In her book, After the Crash: How to Keep Your Job, Stay in School, and Live Life After a Brain Injury, she chronicles her story and provides firsthand advice on how to recover and thrive after a TBI.
“People usually acquire TBIs from falls, motor vehicle crashes, or assaults,” says Tuttle. “Other causes of TBI are a blow to the head or body, sudden acceleration and deceleration of the head or body, penetration of the skull by an object, and exposure to a blast wave from an explosion.”
When it comes to age and TBI, Tuttle states, “Being older, female, or having had a previous traumatic brain injury can increase your risk of a prolonged recovery.”
TBI can impact employment, relationships, performance of ADLs and IADLs, brain development (in children), and almost every aspect of life. It is an all-pervasive experience that can wreak havoc on the lives of patients and their loved ones, and the road to recovery can be long.
What Nurses Need to Understand
When asked what nurses need to know about working with and supporting TBI patients, Tuttle has a great deal to share.
“TBI affects all aspects of a person’s life by changing their physical, emotional, and cognitive abilities, thereby potentially altering their career, personality, values, and role in the family,” she states.
“TBI survivor’s stories often tell of life before and then after their brain injury. Some will even say that on the day of their TBI, the person they were died.”
“Allowing a brain injury patient to monitor their recovery is a mistake,” Tuttle opines. “After a concussion, patients are not always self-aware of their behavior and limitations. Patients should not leave a clinic until they have scheduled follow-up appointments to monitor their healing.”
Tuttle continues, “If concussion symptoms persist over three weeks, the patient should be referred to a specialist, such as a physical medicine, rehabilitation doctor, and neurotherapist. Delaying care has been shown to prolong recovery.
“Another mistake providers make is diagnosing patients with anxiety or depression, not realizing that the patient is suffering from brain injury symptoms,” warns Tuttle. “Light and sound sensitivity or sensory overload are common symptoms after a concussion, which can cause brain injury patients to feel anxious or overwhelmed.
“Neurofatigue, another brain injury symptom, may lead to an incorrect diagnosis of depression because the patient is too tired to be social or motivated to engage in daily activities.”
Recovery is a process for TBI patients. In this regard, Tuttle shares, “To move forward in recovery, TBI survivors need to grieve what they’ve lost. Some survivors will need talk therapy with a psychologist or counselor. Support groups connect TBI survivors and their caregivers with people who will be understanding and knowledgeable about other community resources and local TBI care providers.”
The resources available for TBI survivors can vary widely. Tuttle states, “There’s support for TBI survivors who are hospitalized and discharged to a rehab facility. However, after being discharged from a rehab facility into outpatient care, the resources become scarce in comparison.
“TBI survivors who see their primary care doctor after their head injuries are often sent home with meager information and left to figure things out on their own, says Tuttle. “I know this from personal experience. Most people recover well from a concussion. However, some people’s symptoms can persist for months to years. Mild TBI survivors usually recover within two years.”
The Road to TBI Recovery
Journaling, mindfulness practices, and spending time outside helped me get out of my head and into the present moment,” says Tuttle when reflecting on her recovery process.
“TBI survivors must get away from negative ruminating thoughts to start their self-discovery. Through journaling and mindfulness, they can identify their brain injury symptoms and what factors in their environment aggravate their symptoms. They can also apply strategies to support their brain performance.”
She adds, “Journaling and mindfulness practices also support grieving and the discovery of a TBI survivor’s core values. Once they have learned to let go of the old and embrace their new brain, they can get to know their new self and move into the next chapter of their life.”
In terms of science, Tuttle states, “The discovery of neuroplasticity provides hope that healing can occur even after several years after a brain injury. Neuroscientists have learned that when an area of the brain is damaged, the brain can make new connections to replace lost connections.”
In addition to her book, Tuttle also recommends Norman Doidge’s The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science.
There are many resources for TBI survivors, and science and medicine will continue to improve the potential for recovery in the future.
Nursing is highly relational, and the nurse-patient relationship is central to creating an optimal collaborative environment and the best possible patient outcomes. For nurses seeking to maximize their connection with patients, we must recognize how to work around obstacles in our way. This is where the relational rubber hits the road.
The Critical Importance of the Nurse-Patient Relationship
In his work helping healthcare providers improve communication with patients and enhance care delivery, Goldman has discovered that positive change comes from many sources, including patient-centered care plans, improved communication, and patient satisfaction improvement strategies.
When asked how he would define the importance of the patient experience, Goldman states, “This is bothcritical and potentially life-changing. Patients and their families come to us for clinical advice. The interaction we have determines whether they will understand and trust us enough to follow that advice. Once they have the right support, the likelihood of a bad outcome drops precipitously.”
Dr. Goldman has specific observations regarding how we fall short. “We have shortcomings when it comes to effectively communicating with patients and their families. Here are some examples: we fail to realize that our tone of voice, facial expression, and body language matter; we fail to listen; and we fail to be very specific in the purpose, results, and capabilities of our tests.”
But this isn’t all. Goldman adds, “We also forget that patients don’t speak our technical language, and we forget that patient care doesn’t stop when patients leave our facility.”
Where Did We Go Wrong?
We can’t avoid the fact that healthcare is transactional; patients and insurers pay facilities to address injuries and illnesses. Healthcare is a business — at least here in the U.S. — and it’s largely profit-driven. Since that can’t be easily changed, other things must change, like how we approach relationships with patients and their families.
Goldman has a clear opinion on whether these skills are taught in nursing or medical school.
“Historically, medical programs have seen themselves as responsible for imparting clinical knowledge, often at the expense of how to deliver that care,” Goldman reflects. “The patient and family experience during clinical training is often dictated by preceptors’ beliefs and training. At the end of medical education, you’re left with a hodgepodge of providers who are asked to figure out how to effectively engage patients, their families, and other team members.”
Most nurses can relate, but some may have been lucky enough to attend a program that discussed communication, empathy, emotional and relational intelligence, and nurse-patient relationships. We may also have sadly witnessed our preceptors talking negatively about patients, treating them as burdens rather than moral and ethical responsibilities.
Solutions to Maximizing the Nurse-Patient Relationship
According to Goldman, we have work to do to make these relationships more meaningful and impactful, and providers and facilities do just that every day.
In terms of improving things, Dr. Goldman feels that even the now-common 15-minute visit can still be a positive experience.
“Is it possible to connect authentically in 15 minutes?” Goldman asks. “Often, the quality of a physician-patient interaction is more important than the duration of the visit. Even brief visits can lead to a meaningful connection if they are empathetic, respectful, and focused on patients’ concerns.”
Goldman recommends the post-visit process to improve outcomes. “To further extend its impact, the initial interaction should be supplemented by the provider understanding how the patient experience continues after the patient leaves, so making use of tools like email and phone calls can facilitate that post-discharge conversation.”
If our goal is to engage patients in their care and achieve optimal outcomes, we need to have a sense of purpose. Goldman shares three points:
“The first determinant of effective patient engagement is our disposition and attitude before we enter the patient’s room. That attitude is born out of ensuring we have a clear sense of purpose as providers. Satisfaction from our personal and professional lives also contribute to that disposition.”
He continues, “My second would be to see the patient and their family as partners who will collaborate about the patient’s care in our absence. Third: we must touch the patient by examining them in a friendly manner. Touch is an integral part of caring and building trust. The fourth is to use language that everyone can understand.”
We’re All in it Together
As healthcare providers, we can individually contribute to patient engagement by creating excellent collaborative relationships. Nurses’ skills in relationship-building, motivational interviewing, communication, and emotional and relational intelligence can contribute to this goal.
However, Dr. Goldman feels that healthcare organizations must do more to engage their employees and treat them like the human beings they are. After all, it’s not robots caring for patients — nurses and their colleagues are flesh-and-blood and have their own needs.
He advises, “First, focus on the employee/provider, ensuring that they’re fully engaged. Ensure that organizational leaders have clearly demonstrated through actions (not just providing pizza) that they care about the intricate human beings caring for their patients.”
Goldman is referring to the fact that many organizations feel they care about employees by serving pizza on special occasions. Nurses often complain that Nurses Week appreciation usually defaults to pizza, tote bags, or travel mugs, all of which can feel demeaning and insignificant in the face of their challenging life-saving work.
“Second, an organization must have complete buy-in from the entire leadership team, starting with the C-suite,” Goldman continues. “They will not only have to talk the talk but lead by example.
“Third, only then can an organization operationalize a patient experience program, and that must start early by including a valuation of the patient and family experience in the new employee interview. For long-term effectiveness, the patient experience program must include: a mandatory onboarding patient experience training program, a patient experience monitoring component, a coaching/reinoculation (as needed) component, and a celebratory component.”
Fourth, Goldman recommends having “a practicing clinician at the organization’s helm.”
A multifaceted approach is essential to maximizing nurse-patient relationships. Every clinician has a role, but leadership must also be involved at the institutional level.
Patients are our reason for being the central characters of the plot. If we remain focused on the quality of that relationship, we can improve outcomes and the ultimate satisfaction of patients, their families, and the nurses and other staff who serve them with dedication, professionalism, and kindness.
Dr. Lokelani Ahyo, a dedicated nurse educator from Yuma, Arizona, has committed to lifelong learning by recently attaining her sixth degree – a Bachelor’s in Psychology. At 52 years old, Dr. Ahyo, a mother of seven, is a nursing professor at Southern New Hampshire University and has accumulated an impressive academic background with two associate’s degrees, a bachelor’s, a master’s, and a doctorate.
In a recent interview, Dr. Ahyo expressed her excitement about achieving this milestone and described it as a stepping stone in her educational journey. Her family jokingly anticipates her next academic pursuit as she prioritizes personal and professional growth.
Daily Nurse is honored to recognize Dr. Lokelani Ahyo as Nurse of the Week for her dedication to patient well-being and lifelong learning.
Dr. Ahyo’s career in nursing began after the birth of her third son, inspired by a midwife who left a lasting impression. Despite the challenges of raising four young children, working full-time, and attending school full-time, she persevered and found a second passion in nursing education while working as an RN at Yuma Regional Medical Center.
As a nurse educator at Southern New Hampshire University, Dr. Ahyo has found a deep connection with her students and a profound sense of fulfillment in shaping them into skilled nurses. Her leadership as the chapter president of the Arizona Nurses Association further demonstrates her dedication to the profession and her commitment to its growth and development.
Driven by personal experiences, such as her son’s diagnosis of Schizoaffective Disorder, Dr. Ahyo has set her sights on a new frontier in nursing. Her pursuit of a degree in psychology is not just for personal growth but to better support young adults with mental health challenges. Her aspiration to contribute to a mental health practitioner program and address the national nursing shortage through her teaching is a testament to her forward-thinking and innovative approach.
Dr. Ahyo’s story is a testament to the multifaceted opportunities within the nursing profession and the importance of continuous learning and growth in providing quality patient care.
Nominate a Nurse of the Week! Every Wednesday, DailyNurse.com features a nurse making a difference in the lives of their patients, students, and colleagues. We encourage you to nominate a nurse who has impacted your life as the next Nurse of the Week, and we’ll feature them online and in our weekly newsletter.
Michael Charlton was recently named CEO of AtlantiCare, a healthcare organization operating across five counties in southern New Jersey and serving a region of 1 million residents. In conversation with Mr. Charlton, we learned more about AtlantiCare’s mission and his philosophy for being a transformational leader in the 21st-century healthcare space.
Meet AtlantiCare
With over 100 locations, AtlantiCare has over 100 locations, including two hospitals, 11 urgent care centers, and six federally qualified health centers (FQHCs). AtlantiCare also boasts four health parks, healthcare facility campuses, and amenities grouped in one location. These consist of multi-specialty and mixed-use spaces. For example, the Egg Harbor Township health park has multiple buildings housing its Cancer Care Institute, surgical center, urgent care, medical and corporate offices, and other services.
“We have over 6,500 team members,” Charlton shares, “and nursing makes up over 2,000 of those team members (including LPNs, RNs, and APRNs). We have 600 nurses working in ambulatory, 220 APRNs, 1000+ nurses within the hospital setting, and 150+ working in leadership or other corporate support positions. There are an additional 800+ team members working in nursing support.”
When asked about AtlantiCare’s mission, Charlton states, “Our mission is simple: we always care for our patients with kindness and excellence. Our #1 goal is to make a difference in health and healing, one person at a time.”
A CEO’s Story
Mr. Charlton’s CEO journey is an interesting one. He states, “I assumed the CEO role in June of 2023, with my appointment becoming official a few months later in October. Before my tenure as President & CEO of AtlantiCare, I was a member of the Board of Trustees for 15 years, with 7 of those years serving as Chair.””
Charlton continues, “While healthcare has long been a passion, my career started in the hospitality industry. I founded Icon Hospitality, a successful family of businesses dedicated to superior quality and service.”
When Charlton wanted to understand the intricacies and nuances of the night shift, he embarked on a learning process to truly grasp the challenges faced by employees who work those late nights.
“The night shift is a lifestyle for many team members, so it was important to me to experience it in a meaningful way,” Charlton opines. “Night shift comes with a unique set of challenges that are difficult to understand until you see them happening in real-time. It’s critical that these teams achieve the same level of excellence as other shifts, but they don’t always have the same set of resources. I wanted to see how decisions are made in that environment.”
To accomplish his goals, Charlton was on-site for many night shifts with the intent to be present, visible, and supportive. He brought food to the team and observed their workflow, needs, and interactions. Most importantly, Charlton experienced their challenges and obstacles firsthand and in real-time and was thus able to address them in meaningful ways. He still regularly stays connected to the nursing team in this manner, focusing on spending time on hospital units on nights and weekends.
Charlton reflected on the experience by saying, “It was truly an eye-opening experience that is helping to shape the design of our nursing organization.”
Lessons Learned
Charlton left with strong impressions of what happens during the night in AtlantiCare facilities.
“The lessons I learned are universal. Our hospitals run 24/7, and the care patients receive at 1 pm must be the same as the care they receive at 1 am.”
“The night shift should not be any different than any other shift, “Charlton observes. “Appropriate staffing is critical at all times, every day. That means providing the right assets to our nurses, such as housekeeping staff, security, and access to leadership. Resources must be the same regardless of shift. That is best for our team members and our patients.
“I found that the administrative ways in which we ran the night shift were an outdated model. It is distressing that weekends are staffed differently when care is required around the clock. Nursing leadership was being asked to pick up the administrative burden when others went home for the night. We need hospital administration in the building at night to provide support and direction because care doesn’t stop at 5 pm. However, like many hospitals, most of our team was not working nights.”
“We need to ensure we have the right number of team members to care for our patients. I believe that when we take good care of our team members, they can provide their patients the highest level of care.”
Charlton has a clear vision regarding the administrative burden of ensuring that AtlantiCare facilities run well at all hours of the day and night. He shared, “We must focus on reducing non-productive administrative work placed upon our nursing team. Less time at the computer and more time at the bedside providing the personalized care that called so many to this field.”
As CEO, Charlton drafted plans for solutions.
“I immediately started working on a new model of what our hospital schedule should look like. At the time of this writing, we are now 90 days away from implementation. The initial stages will be administrators placed in the hospitals on nights and weekends to support the nursing team. We will be appropriately staffed across all services needed to operate effectively and efficiently.”
Charlton adds, “Clinical quality and care are always our priority. We serve a large population, many of whom are the most vulnerable in the community. Because of this, we must put our mission ahead of anything else. We have finite resources, so we make sure the allocation of resources is a collaborative effort to meet all needs. When fiscal responsibility is framed within the context of mission and something to take on as a team, you set yourself up for success.”
Embracing Appropriate Technology
“The administrative burden placed on the healthcare industry is especially felt by nursing, and the right technology can help,” says Mr. Charlton. “At AtlantiCare, we are exploring solutions like virtual nursing, which helps balance workload by streamlining tasks such as admissions, patient education, observation, and discharge.” “We are also building our Command Center to up-end the model of care and allow us to reach out to our patients when we know they need care – even if they don’t know it yet. This is the gold standard for personalized, proactive, preventative medicine that builds long-term, trusting relationships, which our patients and our team want.”
But is technology always the right fix?
“Not all problems are solved through technology,” Charlton observes. “We have also taken a hard look at the span of control for our nurse managers to give them more administration and clinical support so they can be present with their teams.”
Finding Balance
Charlton clearly views how AtlantiCare approaches this crucial issue regarding staff work-life balance.
“I prefer to talk about work-life harmony, not just work-life balance. We have five generations working right now, and they each have different wants, needs, and desires. It’s important to understand our team as individuals whose work at AtlantiCare lends itself to the richness of their lives. Different individuals have different needs and priorities. We want to provide each team member with the tools they need to create the best balance or harmony for them.”
How can healthcare organizations and facilities recognize events like Nurses Week in a manner that goes beyond the usual tropes of tote bags, water bottles, pizza parties, and “heroes work here” banners?
Beyond Nurses Week
When asked about how healthcare organizations can move beyond the superficialities of Nurses Week, which is usually celebrated with pizza parties and free travel mugs, Charlton is clear in his response.
“My leadership philosophy is “Be visible. Be kind.” A week of recognition is great, but our leaders must be consistently present, supportive, and working with our nursing staff 52 weeks a year. True recognition, in my view, comes from meaningful interactions and acknowledgment of the hard work our nurses put in day in and day out.”
“We also make it a point to provide personalized recognition throughout the year,” he adds. “Our participation in the DAISY Awards is an excellent example of how we celebrate individual contributions. As a team, we all take pride in our national recognition as 5x Magnet, a distinction only achieved by 1% of US hospitals. This achievement speaks volumes about our nursing team and their focus on excellence.
“Nurses Week is certainly important, but to me, it’s more important to focus on creating a culture where our nursing team feels appreciated and recognized for their hard work and dedication all year long.”
Lauren Rizzo and Maggie Hopkins, two compassionate nurses at the renowned John Theurer Cancer Center in Hackensack, New Jersey, under Hackensack Meridian Health (HMH), view their role as more than just a job. To them, nursing is a calling, a profound opportunity to positively impact the lives of their most vulnerable patients who are courageously battling against illness.
Recognizing their unwavering commitment to their patients at the John Theurer Cancer Center, Daily Nurse is honored to name Lauren Rizzo and Maggie Hopkins as the Nurses of the Week. Their selflessness and passion for the nursing profession shine brightly in their daily interactions with those in need.
Lauren Rizzo, a registered nurse in the infusion center at JTCC, once found herself on the other side of the hospital bed as a patient diagnosed with non-Hodgkin’s lymphoma at the tender age of 10. Having undergone two years of treatment, she vividly recalls the impact her nurses had on her recovery journey. Inspired by their care and dedication, Rizzo pursued a career in nursing, driven by her desire to give back and support others during their most challenging times.
“I always joked I was on the nurses’ schedule because I would be at the hospital three days a week, 12 hours at a time. I had written papers in middle and high school about my heroes – and it was always the nurses who took care of me. My mom says, wouldn’t nursing be great to pursue? So, I went to nursing school, and I couldn’t imagine doing anything else,” Rizzo says.
A registered nurse for eight years, Rizzo also volunteers at a camp she once attended for children going through chemotherapy. She says her calling to care for others is her full circle moment.
“I really feel like I can empathize with our patients during the toughest times. I lost my hair, I gained weight, I was throwing up, I understand what they’re going through. I can give back in ways I didn’t know I could,” Rizzo says.
Maggie Hopkins, on the other hand, transitioned into nursing as a second career after spending years as a veterinary technician. With 16 years of nursing experience at HMH, Hopkins emphasizes that it’s never too late to follow your passion. Drawn to JTCC due to her own experience as a cancer survivor, Hopkins finds solace in connecting with and bringing joy to her patients during their toughest moments.
“I spent the first 15 years working in NICU as a staff nurse, and then just one day, I realized I wanted a change. One of the great things about nursing is that there are so many departments you can go to. The thing that drew me to JTCC is I’m a survivor myself – I am coming up on five years of remission! So, these are my people,” Hopkins says.
“The best part of my day is when I can connect with someone. If I can make them laugh or give them some joy during a tough time, I’ve really accomplished something,” she adds.
Rizzo and Hopkins highlight the importance of supporting and uplifting the next generation of nurses amidst the ongoing challenges in the healthcare industry. They find solace in the heartfelt “thank you’s” from their loved ones, colleagues, and patients, recognizing the value of their work and dedication.
For Rizzo, the camaraderie and support from fellow nurses who share her unwavering dedication to the profession are invaluable. The bond they share in serving their patients with compassion and excellence is truly special and drives them to continue making a difference every day.
In the eyes of Lauren Rizzo and Maggie Hopkins, nursing is not just a profession—it’s a profound calling to care, support, and uplift those in need, embodying the true essence of compassion and selflessness in the healthcare field.
Nominate a Nurse of the Week! Every Wednesday, DailyNurse.com features a nurse making a difference in the lives of their patients, students, and colleagues. We encourage you to nominate a nurse who has impacted your life as the next Nurse of the Week, and we’ll feature them online and in our weekly newsletter.
As a nurse practitioner, I work with patients living with a variety of mental health conditions. Given our role in supporting patient care, healthcare professionals have an opportunity to help patients by carefully listening to their experiences and goals, correctly diagnosing patients as early as possible, and bringing our training to bear in helping them navigate their treatment journey to find the right therapy for them.
One challenge I see in my practice is patients who come to me after being prescribed multiple medications over the course of their illness to treat their mental health condition, but are still experiencing symptoms or having adverse effects from their treatment. In cases like these, we often need to dig deeper to ensure that the patient has a correct diagnosis, so we can offer treatment options that might help them.
DIAGNOSIS CHALLENGES
One mental health condition I treat is bipolar disorder. Bipolar disorder is a brain disorder that causes changes in a person’s mood, energy, and ability to function. People with bipolar disorder may experience intense emotional states, called mood episodes, that typically occur during distinct periods of days to weeks. These mood episodes are characterized as manic/hypomanic (abnormally happy or irritable mood) or depressive (sad mood). Bipolar disorder is a category that includes three different diagnoses: bipolar I, bipolar II and cyclothymic disorder.1
In this article, we focus on bipolar I disorder, which affects about 1% of the U.S. population.The symptoms of bipolar I disorder can often lead to it being initially misdiagnosed. It is estimated that a third of misdiagnosed patients can wait 10 years or longer to receive a correct bipolar disorder diagnosis, which can delay finding treatment that works for them.2,3,4
Given the complexity of bipolar I disorder and its many possible presentations, I believe it is important to ask a lot of questions during new patient intake appointments and throughout the course of their treatment. This active listening approach helps me gain a comprehensive understanding of the patient’s experience and can be helpful in identifying symptoms of bipolar 1 disorder, such as a manic episode. The ability to recognize different presentations of the disease helps us arrive at an accurate diagnosis to guide their treatment journey. In my own practice, I take a personal, holistic approach that considers a patient’s lifestyle, family environment, family history, stressors, and more.
HELPING PATIENTS FIND MEDICATION THAT WORKS FOR THEM
My first step when working with a new patient is to take a comprehensive medication history to identify any potential drug interactions and/or side effects they may be experiencing and to assess efficacy. Then we discuss their short- and long-term treatment goals. This helps build trust with the patient, which can help when partnering with them on treatment decisions. I also like to stay abreast of current available treatment options and consider what may work for each patient.
One medication I may consider for appropriate patients with bipolar I is LYBALVI® (olanzapine and samidorphan), which was approved in 2021. LYBALVI is indicated for the treatment of adults with schizophrenia; or bipolar I disorder for acute treatment of manic or mixed episodes as monotherapy, and as an adjunct to lithium or valproate or as a maintenance monotherapy treatment. It’s important to note that LYBALVI has a boxed warning for increased mortality in elderly patients with dementia-related psychosis and is not approved for the treatment of patients with dementia-related psychosis.Please see additional Important Safety Information below and full Prescribing Information, including Boxed Warning, for LYBALVI.5
There are still patients struggling to find the right diagnosis – and the right treatment regimen for them – to help their mental health conditions. Every patient and treatment journey is unique, but by asking the right questions and working together with patients, I believe nurse practitioners are in a position to help find the treatment approach that works for each patient. And I’m honored to have that privilege and that responsibility.
This is Ms. Holliday’s perspective and does not represent the opinion of all clinicians. The information included is not a substitute for professional medical advice. This article is sponsored by Alkermes, Inc.
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis.
Contraindications: LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products.
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke, transient ischemia attack, and fatalities. See Boxed Warning.
Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids: LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7‑day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers.
Vulnerability to Life-Threatening Opioid Overdose: Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued, subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage.
Neuroleptic Malignant Syndrome, a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and close monitoring.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically.
Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered.
Orthostatic Hypotension and Syncope: Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease.
Falls: LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases): Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors.
Dysphagia: Use LYBALVI with caution in patients at risk for aspiration.
Seizures: Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: Because LYBALVI may cause somnolence, and may impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely.
Body Temperature Dysregulation: Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).
Anticholinergic (Antimuscarinic) Effects: Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.
Hyperprolactinemia: LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.
Risks Associated with Combination Treatment with Lithium or Valproate: If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products.
Interference with Laboratory Tests for Opioid Detection: LYBALVI may cause false positive results with urinary immunoassay methods for detecting opioids. Use an alternative analytical technique (e.g., chromatographic methods) to confirm positive opioid urine drug screen results.
Most Common Adverse Reactions observed in clinical trials were:
Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache
Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): somnolence, dry mouth, dizziness, asthenia, constipation, dyspepsia, increased appetite, and tremor
Bipolar I Disorder, Manic or Mixed Episodes, adjunct to lithium or valproate (olanzapine): dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia
Concomitant Medication: LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.
Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy.
Renal Impairment: LYBALVI is not recommended for patients with end-stage renal disease (eGFR of <15 mL/minute/1.73 m2).
To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-235-8008 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
LYBALVI is indicated for the treatment of:
Schizophrenia in adults
Bipolar I disorder in adults
Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate
LYBALVI is available as 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg tablet.
Tarrah Holliday Bio:
Tarrah Holliday, based in Atlantic, IA, is a Masters-prepared ANCC board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP-BC), with experience in inpatient and outpatient settings, providing services to approximately 2,400 patients. She works with two crisis stabilization centers, four residential substance abuse treatment centers and 17 mental health care facilities. Primary diagnoses she treats are schizophrenia and bipolar disorder, and she has vast experience in treating patients. Her professional goal is to reframe the conversation from mental illness to brain health to help patients increase acceptance in seeking treatment.
References: 1.American Psychiatric Association. What are bipolar disorders? Accessed March 15, 2024. https://www.psychiatry.org/patients-families/bipolar-disorders/what-are-bipolar-disorders 2. Merikangas KR, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007 May; 64(5): 543–552. 3. McIntyre RS, Laliberté F, Germain G, et al. The real-world health resource use and costs of misdiagnosing bipolar I disorder. J Affect Disord. 2022;316:26-33. 4. Hirschfeld RMA, et al. Perceptions and impact of bipolar disorder: How far have we really come? Results of the National Depressive and Manic-Depressive Association 2000 Survey of individuals with bipolar disorder.J Clin Psychiatry. 2003 February; 64:(2):161-174 5. LYBALVI [prescribing information]. Waltham, MA: Alkermes, Inc.
ALKERMES® is a registered trademark of Alkermes, Inc. LYBALVI® is a registered trademark of Alkermes Pharma Ireland Limited, used by Alkermes, Inc., under license.
