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Can Your Smartwatch Actually Monitor Vital Health Data—or Just Count Your Steps?

Reference photo: Pexels

In an era where technology is quite literally at our fingertips—or in this case on our wrist—smartwatches have become every day health companions for millions of individuals. By 2026, it is estimated that more than 100 million  Americans will be using a smart watch. Along with there being additional technology we can use, these watches are hugely marketed as fitness trackers and wellness tools. These sleek devices promise to monitor everything from your daily steps to your heart rate, sleep patterns, and even blood oxygen saturation. But as wearable technology becomes more advanced and expensive, a critical question arises: Are these watches truly capable of tracking vital health data, or are they just popular pedometers?


Consumers are increasingly relying on these smartwatches not only to meet fitness goals but also to gain insight into their overall health. Smartwatches are poised to significantly reshape the healthcare landscape, with research predicting that wearable technology could lead to global cost savings of around $200 billion. A key development in this area is the integration of smartwatch data into electronic health records (EHRs), which is increasingly being adopted to improve patient tracking and support more tailored healthcare services. This can allow providers to use the time they would be using to collecting vital signs to instead spend more time completing other important areas during their patient’s appointment. It is to be noted that to retrieve the data one’s watch is collecting, the person much also have a smart phone and connect via Bluetooth.

Let’s dive into some health that can be tracked by the watch, that isn’t your typical 10,000 steps a day.

How Smartwatches Work

Modern smartwatches use photoplethysmography (PPG) to measure pulse and blood oxygen levels. This technique involves a light source and a photodetector that track variations in light absorption on the skin’s surface, reflecting changes in blood volume throughout the cardiac cycle. In practical use, PPG signals consist of two components: a quasi-static direct current (DC) element, which reflects light interactions with static tissues such as skin, venous blood, and non-pulsatile arterial blood; and a pulsatile alternating current (AC) component, which corresponds to dynamic changes in arterial blood volume with each heartbeat. By capturing thousands of readings per second, smartwatches can analyze these fluctuations to estimate heart rate, blood flow, and oxygen saturation levels. This high-frequency sampling allows for ongoing, non-invasive checking of heart activity, helping to spot problems early and improve health monitoring.

Reference photo: Unsplash


Heart Rate

Samsung Galaxy, Fitbit Sense, and Apple Watch are among the few smartwatches that are approved by the US Food and Drug Administration to detect irregular heart rhythms for adults who have never had a history of atrial fibrillation or AF (irregular heart rhythm). This is very significant because over 400,000 hospitalizations in the United States are due to atrial fibrillation. Failure to detect and diagnose AF can lead to more complication or even potential cardiac events.

 A recent study, “Accuracy of a Smartwatch-Derived ECG for Diagnosing Bradyarrhythmias, Tachyarrhythmias, and Cardiac Ischemia,” explored how well the Apple Watch’s one-lead ECG can detect abnormal heart rhythms. The results were promising: the smartwatch was generally accurate in identifying common rhythm disturbances like bradycardia, tachycardia, and atrial fibrillation. However, its accuracy dropped significantly when detecting more complex arrhythmias like atrial flutter and atrial tachycardia—correctly identifying them only about 25% of the time. This highlights both the potential and the current limitations of smartwatch-based ECGs; while they can be helpful tools for basic heart rhythm monitoring, they’re not yet reliable enough for diagnosing more subtle or complex cardiac conditions.

Initially, devices using PPG technology are legally required to include a statement that they are not intended to diagnose medical conditions. In 2022, recent modifications to that statement were made by the FDA enabling the addition of features such as an “atrial fibrillation history,” making it easier for users to track their heart rhythm over time and share that information with their healthcare providers.

If a person with no known history of heart issues receives this type of alert, they should reach out to their primary care physician to discuss what to do next. This may involve undergoing an in-office electrocardiogram (EKG) and potentially using continuous, medical-grade monitoring for further evaluation.

Blood Pressure

Typical blood pressure cuffs have vibration sensors in a pneumatic cuff to obstruct one’s artery before it detects a systolic and diastolic pressure. In cuffless blood pressure monitoring systems, users are initially required to calibrate the device—typically a smartwatch or smartphone—by pairing it with a traditional blood pressure cuff. Multiple blood pressure readings are taken and compared to the PPG-derived blood flow data. This calibration allows the device to estimate future blood pressure readings using only PPG signals, without needing the cuff again.

In one of the first head-to-head comparisons between a wearable watch and a traditional upper-arm ambulatory. researchers evaluated both in-office and out-of-office readings in 50 adults, who both had these devices on the same non-dominant arm.

Researchers found that the wearable devices provided readings that closely matched those of the standard monitor in both environments, suggesting its reliability for continuous blood pressure monitoring. The findings support the clinical potential of wearable technology as a practical and accurate tool for managing hypertension, especially in out-of-office contexts where traditional monitoring can be less convenient.

Oxygen Levels

Next, a recent systematic review assessed how accurately the Apple Watch Series 6 measures blood oxygen levels (SpO2 ) compared to standard medical devices. The findings showed for the most part, the watch provides reasonably reliable readings in healthy adults. However, some discrepancies were noted, especially in cases of low oxygen saturation or among individuals with certain skin tones.

While the Apple Watch isn’t a replacement for clinical pulse oximeters, it can serve as a helpful tool for general wellness monitoring—so long as users recognize its limitations and don’t treat it as a diagnostic device.

Concerns in Regard to Wearable Technology

While wearable technology offers exciting possibilities for health monitoring and early detection of medical issues. It raises several important concerns. There’s a risk of over-reliance on wearables, where users might prioritize device feedback over professional medical advice. Next, accessibility and health equity come into play, as these technologies may be financially out of reach for some populations, potentially widening health disparities. Moreover, many wearables are not FDA-approved medical devices and can produce false positives or miss significant health events, leading to unnecessary anxiety or a false sense of security. Lastly, ensuring that these devices are fully charged and not experiencing any malfunctions, ensure they are computing accurate data.

Conclusion

Smartwatches have evolved far beyond simple step counters like offering users a glimpse into their cardiovascular health, sleep habits, and even blood oxygen levels. With increasing FDA oversight and emerging studies supporting their potential, these devices are starting to find a place in preventive healthcare. However, while the technology is advancing quickly, it still has limitations. Smartwatches can support wellness and early detection, but they are not substitutes for professional medical evaluations. Users must understand that wearable data should not replace clinical advice. As these tools become more integrated into our healthcare systems, staying informed, cautious, and connected to medical professionals will be key to using them safely and effectively. If one starts to feel heart palpitation, chest pain, or other unusual symptoms suddenly, they should contact their physician even if their smart watch says otherwise. Always trust your intuition and seek the appropriate medical attention to prevent further complications.

Grace N., APPE Student

References:

Caillol, T., Strik, M., Ramirez, F. D., Abu-Alrub, S., Marchand, H., Buliard, S., … & Bordachar, P. (2021). Accuracy of a smartwatch-derived ECG for diagnosing bradyarrhythmias, tachyarrhythmias, and cardiac ischemia. Circulation: Arrhythmia and Electrophysiology14(1), e009260. Accessed: June 9th, 2025

Canali, S., Schiaffonati, V., & Aliverti, A. (2022). Challenges and recommendations for wearable devices in digital health: Data quality, interoperability, health equity, fairness. PLOS Digital Health1(10), e0000104. Accessed: June 11th, 2025

Hudock, Nicholas L., et al. “Wearable health monitoring: wave of the future or waste of time?.” Global Cardiology Science & Practice 2024.3 (2024): e202421. Accessed: June 11th, 2025

Kario, K., Shimbo, D., Tomitani, N., Kanegae, H., Schwartz, J. E., & Williams, B. (2020). The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings. The Journal of Clinical Hypertension22(2), 135-141. Accessed: June 9th, 2025

Köhler, Charlotte, et al. “The Value of Smartwatches in the Health Care Sector for Monitoring, Nudging, and Predicting: Viewpoint on 25 Years of Research.” Journal of Medical Internet Research 26 (2024): e58936. Accessed: June 9th, 2025

Should I use a smartwatch to track my health. A doctor explains. https://www.cnn.com/2024/07/26/health/smartwatch-health-tracking-wellness. Accessed June 9, 2025. Accessed: June 9th, 2025

Windisch, Paul, et al. “Accuracy of the apple watch oxygen saturation measurement in adults: a systematic review.” Cureus 15.2 (2023). Accessed: June 11th, 2025.

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Can ChatGPT Diagnose You Better Than a Real Provider?

Reference photo: Unsplash

In an age where artificial intelligence can write essays, compose music, and even mimic human conversation, it’s no surprise that many people are turning to tools like ChatGPT for health advice. With just a few keystrokes, you can receive a seemingly intelligent, well-worded explanations for your symptoms, with no waiting room required or appointment needed at that. But as convenient as this sounds, it raises a critical question: Can AI like ChatGPT diagnose you more effectively than a trained healthcare provider? While AI can process vast amounts of medical data in seconds, there’s more to patient care than pattern recognition.


Speed and Accessibility vs. Clinical Judgement

Artificial intelligence has already surpassed humans in various domains like no other, specifically ChatGPT. ChatGPT is available 24/7, doesn’t require insurance, and can provide answers in seconds. This accessibility is a game-changer, especially for people in rural areas, the uninsured, or those facing long wait times to see a provider. AI doesn’t get tired, distracted, or emotionally biased. It processes symptoms and produces a potential diagnosis instantly.

However, speed isn’t everything. Trained providers consider subtle clinical signs, ask tailored follow-up questions, and factor in non-verbal cues. A doctor may hear a patient describe fatigue, weight loss and, based on tone and appearance, explore depression or cancer. These are paths AI might not prioritize without that context. Human judgement remains essential for navigating ambiguous symptoms and considering the full complexity of a patient’s story.


Personalized Care from A.I.

A major 2024 study published in the Journal of Medical Internet Research found that ChatGPT-4 actually outperformed emergency room doctors in diagnostic accuracy in a retrospective analysis. The AI was better at generating the correct diagnosis within its top three suggestions and did so without the common cognitive biases that can cloud human judgment, such as premature closure (settling on a diagnosis too early).

The New York Times followed up on these findings, reporting that AI chatbots like ChatGPT were not only accurate but also often provided more thorough explanations of the reasoning behind a diagnosis. According to the article, researchers were surprised by just how sophisticated the AI’s diagnostic reasoning was, especially for a tool not specifically trained as a physician. This kind of data-driven precision makes AI an invaluable reference—especially when physicians are overworked, rushed, or dealing with diagnostic uncertainty.

Reference photo: Pexels

However, this doesn’t mean AI can replace the personal touch. Doctors don’t just match symptoms to diagnoses. They take into account medical history, mental health, lifestyle, and even socioeconomic factors that influence treatment decisions. AI might be better at identifying textbook presentations, but medicine isn’t always textbook. Real-life clinical care involves subtleties that no AI can fully grasp for example, how a patient’s demeanor changes when asked about stress, how a single comment may reveal hidden trauma, or how knowing a patient’s family situation might influence the type of treatment they’re realistically able to follow. For instance, a doctor might recognize that a patient with frequent migraines is actually suffering from medication overuse headache. A diagnosis like that may be rooted more in familiarity with the patient’s habits than in textbook criteria.

As noted by researchers at the University of Virginia, when AI was used in collaboration with providers, it helped improve diagnostic accuracy but only when guided by human insight. It’s not a matter of one replacing the other, but rather how they can complement each other.

Ethics in Diagnosis

Perhaps the most important distinction is this: if an AI gives you incorrect medical advice, who is responsible? A human provider is bound by legal, ethical, and professional standards. AI is not.A Frontiers article, Human-versus Artificial Intelligence argues that human intelligence is adaptive and intuitive in a way AI simply is not. Humans integrate emotional context, moral reasoning, and situational awareness, making decisions even when data is incomplete or contradictory. AI, by contrast, is only as good as the dataset it was trained on—meaning it can perpetuate biases and overlook rare but critical cases.

So while AI may have raw data accuracy on its side, doctors bring depth, personalization, and an essential understanding of the human condition. The power lies in combining these strengths—AI for its breadth of knowledge and consistency, and physicians for their nuance, empathy, and lived clinical experience.

Reference photo: Pexels

All in All

Think of ChatGPT as a tool, not a replacement. AI like ChatGPT shows immense promise in aiding diagnostics, especially in flagging potential conditions and prompting earlier medical attention. But it lacks the nuance, empathy, and lived experience of a real provider. The smartest approach is not choosing either-or, but rather embracing AI as a supplement, not a substitute.

In short, ChatGPT might help you recognize what’s wrong but it’s your doctor who helps you understand what it means, what to do, and how to heal. Traditional practices will always remain superior when it comes to provide the most exceptional care to patients.

Grace N., APPE Student

References:

A.I. Chatbots Defeated Doctors at Diagnosing Illness. https://www.nytimes.com/2024/11/17/health/chatgpt-ai-doctors-diagnosis.html#. Accessed: June 11th, 2025.

Does Chat GPT Improve Doctors’ Diagnoses? Study Puts It to the Test. https://news.med.virginia.edu/research/does-chat-gpt-improve-doctors-diagnoses-study-puts-it-to-the-test/. Accessed: June 11, 2025.

Hoppe, John Michael, et al. “ChatGPT With GPT-4 outperforms emergency department physicians in diagnostic accuracy: retrospective analysis.” Journal of Medical Internet Research 26 (2024): e56110. Accessed: June 11th, 2025

Korteling, J. H., van de Boer-Visschedijk, G. C., Blankendaal, R. A., Boonekamp, R. C., & Eikelboom, A. R. (2021). Human-versus artificial intelligence. Frontiers in artificial intelligence4, 622364.

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How Pharmacists Can Make a Difference Amid the Rise of Measles  

Reference image: Unsplash

By the beginning of June 2025, the Centers for Disease Control and Prevention (CDC) has reported over 1,000 confirmed cases of measles in the United States. Given that disease control depends on vaccination efforts, pharmacists play a key role in preventing and reducing the spread of measles outbreaks. In many states, pharmacists are authorized to administer the Measles, Mumps, and Rubella (MMR) vaccine to eligible patients without a prescription. Furthermore, an outbreak of measles serves as an indicator for health disparities within a community. Pharmacists following trends in outbreaks can identify these gaps in immunization programs and address these challenges early on. 

What is Measles?  

Measles is one of the most contagious diseases, according to the World Health Organization (WHO). Measles is caused by the measles virus, which spreads by airborne transmission or after contact with contaminated surfaces. Almost everyone without immunity will contract the disease if they have been exposed to the virus. One person infected with measles can infect nine out of 10 of their unvaccinated close contacts. Although the measles virus can infect anyone, children are the most affected.

Reference image: Centers for Disease Control and Prevention 

Common symptoms include fever, cough, runny nose, conjunctivitis (red, watery eyes), and a characteristic maculopapular rash. Symptoms usually begin 10-14 days after exposure. Measles diagnosis is confirmed by using laboratory methods.

Measles can be fatal due to complications from the disease. On average, 3 out of every 1,000 cases will end in death from complications. Complications from the disease include ear infections, severe diarrhea, pneumonia, or permanent neurological damage from encephalitis (swelling in the brain). Individuals most at risk for complications are unvaccinated young children (<5 years old) and those who are pregnant.  There is no antiviral therapy or other FDA-approved agent indicated for the treatment of measles, and treatment largely consists of supportive care. 

Vaccine Overview 

The Measles, Mumps, and Rubella (MMR) vaccine is indicated for the routine immunization of children and adolescents by the Food and Drug Administration (FDA). Disruptions to routine vaccination activities during the COVID-19 pandemic have left millions of children vulnerable to measles. This is believed to be a major contributor to the current resurgence of the disease. 

The MMR vaccine is formulated with live attenuated viruses. This means that although the virus is alive, it is a weakened or modified version. Because it is attenuated, the vaccine is harmless and less virulent but remains highly effective. The vaccine works by stimulating the immune system to protect against measles, in addition to mumps and rubella.  

The vaccine requires a two-dose series, which is typical for attenuated vaccines in order to achieve lifetime immunity. Regarding measles specifically, there is 95% effectiveness after the first dose, and 99% after the second dose. The first dose is typically administered to individuals aged 12-15 months, followed by the second dose given between the ages of 4-6 years. 

Although it is preferred to have the 2-dose series completed prior to school entry, the vaccine can be administered in 2 doses in individuals aged 12 months to 12 years old. Booster doses after appropriate vaccination are not necessary. Adults should also be up to date on MMR vaccinations, unless they have presumptive evidence of immunity. This is often the case for individuals born before 1957. 

The Measles, Mumps, Rubella, and Varicella (MMRV) vaccine is not recommended for children aged 12-47 months, per the CDC. The MMRV is typically given as a preference to parents or caregivers. Ten percent of vaccine recipients experience adverse effects to the MMR vaccine. The most common side effects being fever are redness and pain at the injection site. Less than 10% experience a rash and/or severe fever. 

The vaccine is not indicated for everyone. The MMR vaccine should not be administered to the following populations: 

  • Pregnant individuals  
  • Patients on long-term immunosuppressive treatment with high doses of steroids 
  • Patients with Human Immunodeficiency Virus (HIV) and patients with severe immunocompromised conditions
  • Individuals with a family history or confirmed immunodeficiency  
  • Patients on chemotherapy or who have solid tumors  

Prevention 

The WHO reports that maintaining high population immunity is required in order to prevent outbreaks. Those who are eligible for the vaccine should receive it to protect themselves as well as the individuals who are not able to be vaccinated (see above in MMR vaccine overview). This contributes to herd immunity, indirectly protecting those who are not immune.  Post-exposure prophylaxis with the MMR vaccine or immunoglobulin may be indicated for individuals exposed to the virus who do not have immunity. The MMR vaccine should be given within 72 hours after exposure. Immunoglobulin should be given within 6 days after exposure. 

Measles can be transmitted from an infected person up to 4 days prior to the onset of their rash, and up to four days after the rash erupts. To prevent spreading the virus, it is crucial for someone with measles to isolate themselves, especially from high-risk individuals. 

How Pharmacist Can Make a Difference 

To prevent outbreaks, vaccination efforts must be made. As highlighted from the COVID-19 pandemic, pharmacists provide an invaluable contribution to vaccination activities. In the case of parents or patients who are hesitant to vaccinate, pharmacists can address individualized concerns. Their clinical expertise can provide accurate information and dismiss misinformation. Furthermore, pharmacists have access to pertinent information that can be used to identify patients who are eligible for the MMR or MMRV vaccine. This allows pharmacists to streamline the vaccination process and opens an opportunity to answer questions and provide education.  

Pharmacists also play a key role in monitoring outbreak trends to help protect their communities. If confirmed measles cases are reported near their area, pharmacists can provide timely public health interventions. As members of interdisciplinary healthcare teams, they bring strong collaborative skills, enabling them to effectively partner with local health systems to strengthen vaccine programs. 

Timely vaccination is needed to prevent measles and reduce the risk of severe complications associated with the disease. The role of the pharmacist supports outbreak prevention by encouraging widespread immunization and educating patients about the disease. 

Cierra L., APPE student

References:  

  1. Hübschen JM, Gouandjika-Vasilache I, Dina J. Measles. Lancet. 2022;399(10325):678-690. doi:10.1016/S0140-6736(21)02004-3  
  1. Centers for Disease Control and Prevention. Measles (Rubeola): Data and Statistics. Updated June 6, 2025. Accessed June 9, 2025. 
  1. Texas Department of State Health Services. Measles: Frequently Asked Questions. Updated March 18, 2024. Accessed June 11, 2025. https://www.dshs.texas.gov/measles/measles-frequently-asked-questions#:~:text=Call%20your%20doctor%20before%20going,readily%20kill%20the%20measles%20virus 
  1. World Health Organization. Measles and Rubella Strategic Framework 2021–2030. World Health Organization; 2021. Accessed June 11, 2025. https://www.who.int/publications/i/item/measles-and-rubella-strategic-framework-2021-2030 
  1. Johns Hopkins Medicine. Measles: What You Should Know. Johns Hopkins Medicine website. Accessed June 11, 2025. https://www.hopkinsmedicine.org/health/conditions-and-diseases/measles-what-you-should-know 
  1. Patel P, Tobin EH. MMR Vaccine. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; January 2025–. Updated May 5, 2025. Accessed June 11, 2025. https://www.ncbi.nlm.nih.gov/books/NBK554450/ 
  1. Centers for Disease Control and Prevention. Measles, Mumps, and Rubella (MMR) Vaccination: Recommendations for Healthcare Professionals. Updated February 5, 2018. Accessed June 11, 2025. https://www.cdc.gov/vaccines/vpd/mmr/hcp/recommendations.html#:~:text=Post%2Dexposure%20prophylaxis-,Measles,dose%20of%20MMR%20or%20MMRV
  1. PowerPak CE. Managing measles resurgence and stemming the tide. Accessed June 11, 2025. https://journalce.powerpak.com/ce/managing-measles-resurgence-and-stemming 

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Long-acting Injectables in Schizophrenia: A Considerable Alternative to Oral Therapy 

Reference image: Unsplash 

Antipsychotic agents are a key approach in the treatment and management of schizophrenia. Despite their crucial role, medication non-adherence remains a significant concern. Long-acting injectable (LAI) antipsychotics are specifically designed formulations of antipsychotics that release medication consistently over a period of days to weeks, ensuring patients receive stable therapeutic concentrations. LAI’s offer more stable drug levels that minimize peak-related side effects, reduction in the risk of relapse, and improved adherence due to less dosing frequency than oral antipsychotics.  

Who Should Receive an LAI?  

Patients with recent-onset schizophrenia or those who are expected to need long-term antipsychotic therapy may benefit from incorporating LAI into their treatment. In cases where there are concerns about adherence to oral medications, LAIs should be highly considered. LAIs can support autonomy in treatment decisions, which may empower vulnerable populations such as individuals living with schizophrenia. However, the decision to use an LAI should be guided by a patient-centered approach. 

How Do LAI Antipsychotics Treat Schizophrenia?  

The Dopamine Hypothesis of schizophrenia proposes that dysregulation of activity in dopamine receptors located in distinct brain pathways contributes to symptoms. Specifically, excess dopamine in the mesolimbic pathway contributes to positive symptoms such as hallucinations and delusions. On the other hand, decreased dopamine in the mesocortical pathway is associated with negative (flat affect) and cognitive symptoms. The primary therapeutic goal in managing schizophrenia is to restore the balance of dopamine across these pathways.  

The primary mechanism of action for antipsychotic medications is dopamine antagonism, specifically at D2 receptors. Although D2 receptors are inhibitory, blocking them reduces overstimulation and restores normal activity of dopamine.  

Reference image: Unsplash 

Reformulating traditional dopamine antagonists in a way that allows them to be deposited under the skin or in muscle is what causes the sustained release of the medication. This medication depot allows for an extended dosing interval. Depending on the formulation, the site of injection varies from subcutaneous, deltoid, or gluteal.  

The following antipsychotic medications are available in LAI formulations: 

Please note that not all LAI formulations are FDA approved for the treatment of schizophrenia. 

How do I Know Which LAI is Right for My Patient?  

LAIs offer differing pharmacokinetic properties from each other. Pharmacists play an important role in assessing and selecting the most appropriate LAI for individual patients.  

First generation antipsychotics (FGAs) also known as typical antipsychotics, carry a high binding affinity for D2 receptors. The high binding affinity keeps them bound for longer. This extended period of activity on the receptor is associated with a higher risk of extrapyramidal symptoms (EPS). In contrast, second generation antipsychotics, or atypical antipsychotics, tend to not bind as tightly. As a result, they tend to dissociate more rapidly, making them less likely to cause EPS. However, second generation antipsychotics are associated with a risk of metabolic disturbances (e.g., weight gain, diabetes, high cholesterol). 

Establishing prior tolerance to an oral antipsychotic is a first step in determining what LAI is the most appropriate for your patient. While some LAIs require a period of oral overlap, others do not. Collecting a thorough patient history can offer valuable insight into past medication tolerability, which can guide your selection. For example, you will want to steer away from choosing an FGA LAI if the patient has a history of EPS from prior oral medication. However, if a patient has had a good response with prior oral antipsychotic treatment, it should be used as their LAI. 

Insurance coverage is another key consideration. All LAI formulations of aripiprazole, risperidone, and paliperidone are FDA approved for the treatment of schizophrenia, in addition to fluphenazine and haloperidol. Insurance plans may restrict coverage to FDA approved treatments; FDA-approved options should be prioritized to avoid the prior authorization process or denial. If a patient does not have current prescription coverage, it is vital to discuss out of pocket expenses prior to initiating LAI therapy. Certain LAIs, such as aripiprazole and paliperidone have patient assistance programs.  

Other considerations include post-injection monitoring requirements. For example, patients are at a very high risk for developing Post-Injection Delirium/Sedation Syndrome (PDSS) after each injection of olanzapine pamoate. Because of this, patients are required to be observed at a registered facility for at least 3 hours post injection. 

Reference image: Unsplash

How Do I Start an LAI? 

Certain LAIs require oral overlap before injection. To determine if the LAI you have selected requires an oral bridge, or other important prescribing information, refer to the package insert or the manufacturer’s website.  

Reasons for LAI Underutilization and Addressing These Challenges 

Psychiatric practitioners may carry the false assumption that their patients will reject LAI as a treatment option. Negative attitudes and perceptions are a common barrier to LAIs, with one study identifying perceived negative patient attitudes as the most reported barrier among practitioners. However, the same study found that the presence of a psychiatric pharmacist helped to reduce barriers. This highlights the valuable role of pharmacists in psychiatric care. Pharmacists can provide education about LAIs to help dismiss misconceptions and guide more informed treatment decisions. 

Another barrier is the complex dosing schedules for formulations that require oral overlap. The skills pharmacists carry allow them to be well-equipped in navigating these challenges, including an assessment of the patient’s history. They can help to determine if past treatment failures were caused by medication intolerance or non-adherence. In cases where a patient is hesitant to start or restart oral medications, the pharmacist can guide appropriate LAI selection based on the patient’s side effect profile and treatment history. Additionally, pharmacists can use their clinical expertise to ensure oral overlap requirements have been met.

There is a unique opportunity for hospital pharmacists to evaluate and initiate appropriate long-term treatment plans. Pharmacists can collaborate with the patient’s healthcare team to select a LAI regimen and coordinate the necessary overlap as needed. Because the patient is being monitored and their medications are provided, the concern for adherence is greatly reduced. This strategy can expedite the LAI initiation process, allowing patients to receive their first dose before or shortly after discharge.  

Reference image: Unsplash

The Final Say in the Role of LAIs in Schizophrenia 

LAIs offer a unique alternative to oral antipsychotics. Given the challenges of nonadherence to antipsychotics, LAIs provide an advantage for patients to receive a sustained release of medication without the need for daily dosing. The decision to initiate LAI therapy should be patient-centered, with the selection of a specific agent tailored to the patient’s individualized needs and history. 

Cierra L., APPE student

References:  

  1. Schwartz S, Carilli C, Mian T, Ruekert L, Kumar A. Attitudes and perceptions about the use of long-acting injectable antipsychotics among behavioral health practitioners. Ment Health Clin. 2022;12(4):232-240. Published 2022 Aug 23. doi:10.9740/mhc.2022.08.232  
  1. Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia: overview and treatment options. P & T: a peer-reviewed journal for formulary management, 39(9), 638–645. 
  1. Krishna A, Goicochea S, Shah R, Stamper B, Harrell G, Turner A. Long-acting injectable antipsychotics in primary care: A review. J Am Board Fam Med. 2024;37(4):773–784. https://www.jabfm.org/content/37/4/773. Accessed June 5, 2025.  
  1. PsychDB. Long-Acting Injectable (LAI) Antipsychotics. PsychDB. https://www.psychdb.com/meds/antipsychotics/0-long-acting-injectables. Accessed June 9, 2025.  
  1. Acosta, F. J., Hernández, J. L., Pereira, J., Herrera, J., & Rodríguez, C. J. (2012). Medication adherence in schizophrenia. World journal of psychiatry, 2(5), 74–82. https://doi.org/10.5498/wjp.v2.i5.74 
  1. Texas Health and Human Services. Long-Acting Injectable Antipsychotics: Quick Reference Guide. Published February 2022. Accessed June 10, 2025. https://www.hhs.texas.gov/sites/default/files/documents/lai-antipsychotic-quick-reference.pdf 

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GLP-1s newest indication – Obstructive Sleep Apnea (OSA)

Reference photo: Unsplash

GLP-1 Indications

Glucagon-like peptide (GLP-1) medications were first approved by FDA in 2005 for type 2 diabetes. In the treatment of type 2 diabetes, GLP-1s work by stimulating insulin secretion from the pancreas to lower glucose levels. Since then, these medications have had many additional indications. Some of those indications include cardiovascular, weight management, and chronic kidney disease (CKD).  

On December 20, 2024, the U.S. Food and Drug Administration added another indication to that list. Zepbound (tirzepatide) was initially FDA approved in 2023 to treat adults with obesity or those who are overweight who have weight-related medical issues. Later, tirzepatide was approved for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Tirzepatide (Zepbound) works on agonism of GLP-1 receptors and glucose dependent insulinotropic polypeptide (GIP) receptors. The duality of this medication is multi-faceted and is making great strides for patients with OSA.

Obstructive Sleep Apnea and Zepbound’s Role

So, what is obstructive sleep apnea (OSA)? Obstructive sleep apnea is a very serious sleep disorder that involves one’s airway to become repeatedly blocked during sleep, causing the person to stop breathing briefly and oxygen deprivation. This is typically caused by the closing of the throat tissue, leading to choking noises, loud snoring, gasping for air during sleep, and frequent awakening. Now, OSA can affect anyone, but is it more likely to affect those who are overweight or obese.

Continuous airway positive pressure (CPAP) is considered to be the gold standard of therapy for the treatment of OSA. A CPAP machine uses a hose connected to a mask or nose piece that delivers constant air while one sleeps. A comprehensive systematic literature review was conducted in 2016 using reliable databases searching for data regarding CPAP adherence. The research revealed that over a 20-year period, 1994-2015, a CPAP non-adherence rate of 34.1% occured when assuming a sleep duration of 7 hours per night. This rate showed no significant improvement throughout the studied timeframe. Even after behavioral intervention, adherence only improved by about 1 hour per night on average.


 Reference photo: Unsplash

So where does Zepbound come to aid in the treatment of OSA? Zepbound functions by suppressing appetite and decreasing food consumption. Research indicates that by promoting weight loss, Zepbound can also lead to improvements in obstructive sleep apnea. Zepbound is also approved for use alongside a reduced-calorie diet and increased physical activity to help adults with obesity. Zepbound is also indicated for those who are overweight with at least one weight-related health condition and this can help patients lose excess weight and maintain long-term weight reduction.

FDA Approval

The FDA approval for using Zepbound came from the SURMOUNT-OSA Phase 3 clinical trials. This study randomized 469 participants, where two Phase 3, double-blind controlled trials were conducted in adults with moderate-to-severe obstructive sleep apnea and obesity. Trial 1 included participants who were not on positive airway pressure (PAP) therapy at the start, while Trial 2 included those already using PAP therapy. Participants were randomly assigned in a 1:1 ratio to receive either a placebo or their maximum tolerated dose of tirzepatide (10 mg or 15 mg) for a duration of 52 weeks.

Reference photo: Unsplash

After one year of treatment, Zepbound led to a reduction in breathing interruptions by 25 to 29 events per hour, compared to a 5 to 6 event reduction with placebo. Remission or transition to mild sleep apnea was observed in 42% of participants not using PAP therapy and 50% of those using PAP (versus 16% and 14%) respectively, in the placebo groups.

Participants treated with Zepbound also experienced substantial weight loss, averaging 18–20% of their body weight (approximately 45–50 pounds), while those receiving placebo lost only about 2% (roughly 4–6 pounds). The weight reduction was more pronounced in individuals using PAP therapy. The improvement in the Apnea- Hypopnea Index (AHI), a key measure used to diagnose and assess the severity of OSA, in participants with OSA is more than likely related to body weight reduction with Zepbound.


The Bottom Line

Like any other GLP-1 medication, the side effects remain the same with the most reported being nausea, vomiting, and diarrhea. Other side effects include constipation, abdominal (stomach) discomfort and pain, injection site reaction, fatigue, and more. Additionally, if Zepbound is taken alongside insulin or medications that increase insulin production, it’s important to discuss with a healthcare provider whether adjustments to those medications are needed to help lower the risk of hypoglycemia (low blood sugar). Health care providers should routinely monitor weight, kidney function, complete blood count, and blood glucose levels. Dieticians also need to make recommendation for patients to consume smaller meals, eating slowly, and avoiding fatty foods while taking these medications so the patient can continue to achieve maximum treatment benefit.  

Zepbound (tirzepatide) represents a significant advancement in the management of obstructive sleep apnea (OSA), particularly for individuals with obesity. With longstanding challenges in CPAP adherence and the strong link between excess weight and OSA severity, the introduction of a medication that addresses both issues offers a promising new approach. The SURMOUNT-OSA Phase 3 trials demonstrated meaningful reductions in apnea events and body weight, highlighting Zepbound’s dual benefit in both sleep and metabolic health. While side effects are consistent with those seen in other GLP-1 therapies, the potential improvements in quality of life and disease burden make this an important new option for appropriate patients. As with any treatment, shared decision-making between patients and healthcare providers will be essential in weighing risks, benefits, and individual goals.

Grace N., APPE Student

References:

CPAP machines: Tips for avoiding 10 common problems. https://www.mayoclinic.org/diseases-conditions/sleep-apnea/in-depth/cpap/art-20044164#:~:text=Continuous%20positive%20airway%20pressure%20(CPAP,you%20breathe%20while%20you%20sleep. Accessed: June 5, 2025.

FDA Approves First Medication for Obstructive Sleep Apnea. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea. Accessed: June 4, 2025.

Latif, W., Lambrinos, K. J., & Rodriguez, R. (2021). Compare and contrast the glucagon-like peptide-1 receptor agonists (GLP1RAs).

Malhotra, Atul, et al. “Tirzepatide for the treatment of obstructive sleep apnea and obesity.” New England Journal of Medicine 391.13 (2024): 1193-1205.

Romariz, Livia, et al. “GLP-1 receptor agonists for the treatment of obstructive sleep apnea and obesity.” European Journal of Internal Medicine 132 (2025): 153-155. Accessed June 4, 2025.

Rotenberg, B. W., Murariu, D., & Pang, K. P. (2016). Trends in CPAP adherence over twenty years of data collection: a flattened curve. Journal of Otolaryngology-Head & Neck Surgery45(1), 43. Accessed: June 5, 2025

Zepbound approved by FDA as first sleep apnea medication. https://aasm.org/zepbound-approved-fda-first-sleep-apnea-medication/. Accessed June 4, 2025.

Zepbound Approved for Obstructive Sleep Apnea in Patients With Obesity. https://www.pulmonologyadvisor.com/news/zepbound-approved-for-obstructive-sleep-apnea-in-patients-with-obesity/#:~:text=%E2%80%9CNearly%20half%20of%20clinical%20trial,1%20weight%2Drelated%20comorbid%20condition.&text=References:,us/zepbound%2Duspi.pdf. Accessed: June 5, 2025.

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Getting SMART With Asthma Management

Reference image: Unsplash

Why SMART Should be Adopted in Asthma Management

Single Maintenance and Reliever Therapy (SMART) is a technique where a single inhaler is used for daily asthma control and used for as- needed symptom relief. This strategy combines prescription inhalers containing an inhaled corticosteroid (budesonide or mometasone) and a long-acting beta2-agonist (formoterol), which are indicated for indicated for SMART. Given its dual-purpose approach, adopting SMART in asthma management improves disease control and enhances the quality of life for patients.

Components of SMART Therapy

Inhaled corticosteroids (ICS) function to reduce and control inflammation within the lungs through its potent glucocorticoid activity, which helps prevent the occurrence of asthma attacks. Below are examples of ICS medications:

Inhaled corticosteroids  (ICS

  • Fluticasone
  • Budesonide 
  • Mometasone
  • Beclomethasone
  • Flunisolide 

The intended use for ICS in asthma is for controller therapy. During episodes of inflammation, capillaries in the lung become more permeable or “leaky.” This contributes to immune cells and fluid accumulating in the surrounding tissues, and ultimately it leads to swelling and airway narrowing. Budesonide and mometasone, two ICSs typically used in SMART, work to reverse the permeability of capillaries, leading to the reduction of airway obstruction caused by swelling. In addition, budesonide and mometasone also work to prevent tissue damage. They contribute to the lysosome stabilization, which reduces the quantity of degrading enzymes released. This limits the extent of injury to tissues in the airway.  Previously, ICS treatment was only used in patients who experienced persistent symptoms. However, large clinical studies have demonstrated that regularly using ICS reduces the risk of severe asthma exacerbation. This reduction decreases the number of asthma-related hospitalizations and death.

Long-acting Beta2-agonist (LABA) drugs functions as a potent bronchodilator through stimulating beta2 receptors located on bronchial smooth muscle, increasing cyclic adenosine monophosphate (cAMP). The downstream effects of cAMP lead to muscle relaxation and bronchodilation. Below are examples of LABA medications:

Long-acting Beta2-agonist (LABA)

  • Salmeterol
  • Formoterol
  • Vilanterol

Compared to short-acting Beta2-agonists (SABAs), LABAs have a higher degree of selectivity for bronchial smooth muscle beta2 receptors. This increased receptor selectivity contributes to a more favorable adverse effect profile, offering a therapeutic advantage over SABAs. However, the greatest difference between LABAs and SABAs is their onset of action and duration of therapeutic effects. SABAs act quickly, but wear off quickly, making them ideal for the use of rescue/reliever therapy. In contrast, LABAs have a slower onset of action and a longer duration of action. Because of this, we have typically have only seen LABAs used as controller therapy. However, unlike other LABAs, formoterol offers a rapid onset of action, typically seen within 1-2 minutes. This unique pharmacokinetic profile gives formoterol the advantage over other LABAs because it may be of being used as a rescue/reliever in addition to controller therapy. There is an FDA black box warning for LABA monotherapy in asthma treatment. It is important to note that LABA without ICS is contraindicated in asthma due to the increase in severe exacerbations and asthma-related death. 

Where do SABAs Fit in SMART?

Previously, SABA monotherapy was a cornerstone approach to patients with mild asthma. However, the use of SABA monotherapy in asthma treatment has been found to have severe clinical consequences, largely due to their unfavorable dose-response relationship. One of the key concerns is the development of tolerance, which can occur within a week of regular use. Tolerance is driven by the downregulation of bronchial smooth muscle beta2-receptors and a decrease in drug-receptor binding affinity. As a result, the bronchodilator response to SABAs becomes less effective over time, which results in reduced symptom control. In addition to reduced efficacy, there is evidence to support that the frequent use of SABA alone, even over short durations, is associated with an increased risk for asthma-related death. This prompted The Global Initiative for Asthma (GINA) to reassess the role of SABAs, and search for a new approach in the treatment and management of asthma. Formoterol has been found to be effective as a controller and as a rescue/reliever, causing a shift in what the guidelines previously recommended in 2019.

Reference image: Unsplash

Why use SMART?

GINA and the National Asthma Education and Prevention Program (NAEPP) recommend SMART in patients with mild asthma who are 12 years of age or older. ICS-formoterol combination is the preferred approach to SMART because it is widely available as either Symbicort or Dulera. In addition, since SMART uses a single inhaler to provide maintenance and symptom control, patients no longer will need two inhalers for asthma management. Simplifying the treatment regimen to one inhaler leads to reduced confusion, increased adherence, and potentially cost savings.

The FDA has not approved the use of ICS-formoterol inhalers as part of SMART in the United States. This can affect prescription drug coverage as insurance may not cover a treatment that has not formally been approved. Despite this, GINA and the NAEPP endorse SMART for asthma. Although there is no FDA approval for SMART, ICS-formoterol can still be prescribed “off-label” as a rescue/reliever and controller.

Reference image: Wikimedia

Where do Pharmacists Fit in with SMART?

There is an overwhelming  overwhelming number of medications available on the market for management and treatment of asthma. Pharmacists specialize in product selection and therapeutic substitution to ensure that patients receive the most appropriate medication regimen. For patients who are currently using separate inhalers for controller and rescue/reliever therapy, or those relying solely on SABA monotherapy due to adherence challenges or other barriers, pharmacists can recommend SMART. Pharmacists can help identify formulary-preferred options that are covered by the patient’s insurance plan, leading to cost savings. Additionally, pharmacists can advocate for this therapeutic switch in practices that operate under a Collaborative Practice Agreement (CPA), and pharmacists are also authorized to initiate this change directly. Another impactful way pharmacists can support the implementation of SMART is through comprehensive patient education, particularly in teaching proper inhaler techniques and reinforcing adherence. Ensuring that patients understand the dual purpose of the inhaler and clarifying when and how to use it is important to optimize treatment. Lastly, pharmacists can monitor for potential drug-drug interactions that may interfere with treatment or exacerbate asthma symptoms.

SMART Takeaway

SMART represents a significant advancement in the treatment and management of asthma by combining an ICS with formoterol in a single inhaler for both control and symptom relief. This approach simplifies therapy and reduces costs. Clinical trials have demonstrated effectiveness in reducing exacerbations and improving overall asthma control. Supported by current guideline recommendations, including those from GINA, SMART is now the preferred treatment strategy for patients 12 years of age or older. Adopting SMART into clinical practice provides the opportunity to significantly enhance patient outcomes and quality of life.

Cierra L., APPE Student

References: 

  1. Reddel HK, FitzGerald JM, Bateman ED, et al. GINA 2019: a fundamental change in asthma management: Treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. Eur Respir J. 2019;53(6):1901046. Published 2019 Jun 27. doi:10.1183/13993003.01046-2019
  2. Liang TZ, Chao JH. Inhaled Corticosteroids. Updated May 8, 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; January 2025–. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470556/
  3. Hsu E, Bajaj T. Beta2-Agonists. Updated June 20, 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; January 2025–. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542249/
  4. Suissa S, Ernst P, Benayoun S, Baltzan M, Cai B. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Engl J Med. 2000;343(5):332-336. doi:10.1056/NEJM200008033430504
  5. Sharma S, Hashmi MF, Chakraborty RK. Asthma Medications. [Updated 2023 Jun 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531455/
  6. American Academy of Allergy, Asthma & Immunology. SMART Therapy for Asthma. Published 2024. Accessed June 5, 2025. https://www.aaaai.org/tools-for-the-public/conditions-library/asthma/smart

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Intern Testimonial: Invested in your future with hands-on real world experience

During my final year of pharmacy school, I had the unique opportunity to join the RxPharmacist team as a medical writing intern. I was particularly drawn to this role because it aligned well with my passion for education and my interest in the test prep industry. First, my experiences in various tutoring and mentoring roles taught me how impactful it can be to equip patients and students with the knowledge they need to achieve their individual goals. Second, I believe that accessible, digestible education is key, and that medical writing is an effective medium to provide it. As such, the internship program offered by RxPharmacist stood out to me because it provided an opportunity to improve my medical writing skills, which are important for both pharmacists and educators, while giving back to the pharmacy community.

RxPharmacist is a company that is deeply invested in the academic and professional success of students. They offer a multitude of up-to-date, high-quality test prep guides and resources that equip students to excel in diverse environments beyond the classroom. Driving this company is a team that works harmoniously together and continuously innovates to improve the quality of their services. I had the privilege of working with this dedicated team when creating a test prep guide for the Pharmacy Technician Certification Exam (PTCE), where I received expert guidance and encouragement that helped me grow both personally and professionally.

During my internship, I gained valuable hands-on experience developing a book, designing an online course, and writing mock exam questions. Balancing the creation of the test prep guide with my APPE rotations was undoubtedly challenging, but it significantly improved my time management, communication, and organizational skills. Moreover, I have become more confident in my medical writing abilities, as I am able to present complex concepts clearly and concisely. The skills I refined, including researching and extracting pertinent information from reliable resources, tailoring my writing to specific audiences, and presenting details with clarity, position me for success as I continue to develop as an effective clinician and educator.

As an intern, I also participated in the “How to Get a Job” training series, which allowed me to gain insight into the importance of networking, managing finances, negotiation, and other critical skills needed to navigate the job market and attain professional success. This series provided practical modules packed with high-yield strategies to help users maximize the potential of their degrees. Thanks to this series, I emerged feeling more confident about crafting a strong CV and interviewing. I would highly recommend this resource to any pharmacy student interested in pursuing a fellowship, residency, or other career path.

I am incredibly grateful for the opportunity to hone my skills as a medical writer under the guidance of the talented and passionate team at RxPharmacist. Serving as an intern was a transformative journey that has prepared me to make meaningful contributions to the pharmacy profession and beyond. I would wholeheartedly recommend this internship to students interested in professional development and gaining hands-on experience in medical writing while working with a supportive team.

  • M.K., Rutgers University

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Intern Testimonial: Unique perspectives, hands on experience and a great supportive team!

As an intern at RxPharmacist, I have experienced significant personal and professional growth. This internship has provided me with the opportunity to dive deep into areas of pharmacy that I may not have been exposed to during my academic coursework. I gained a better understanding of the behind-the-scenes work that contributes to the development of medical resources and educational tools that benefit not only pharmacy professionals but also the broader healthcare community. The major focus of my internship was strengthening my understanding of the core principles behind medical writing, which is an essential skill for anyone looking to pursue a career in the pharmaceutical industry. Throughout my internship, I had the opportunity to work on several projects that involved creating educational materials, writing study guides, and simplifying complex pharmacy law concepts.

One of the most valuable lessons I learned was the importance of clarity and precision when writing about medical and legal topics. Medical writing requires a delicate balance between accuracy and readability, as these concepts must be easily understood by both professionals and students alike. The ability to communicate complicated ideas in a straightforward manner is crucial in ensuring that the information reaches its intended audience effectively. Simplifying complicated pharmacy law concepts, in particular, was a challenge that pushed me to refine my communication skills. Pharmacy law, with its detailed regulations and legal jargon, can often seem overwhelming. However, by breaking down these intricate regulations into digestible pieces, I was able to better appreciate the technicalities of pharmacy law while also contributing to the development of resources that would be valuable to others. This experience allowed me to further develop skills that will be indispensable throughout my career.

Another important aspect of my internship at RxPharmacist was the mentorship I received from my preceptor and the executive team at RxPharmacist. My preceptor’s guidance and constructive feedback were instrumental in helping me refine my writing and improve my overall approach to medical writing. Their mentorship was invaluable, providing me with the tools and confidence needed to succeed. Similarly, the leadership team exemplified their dedication to the company’s mission created an environment where us interns could thrive. The information shared in the “How to Get a Job Series” was very insightful and will be beneficial in many years to come. The RxPharmacist team was always willing to provide advice, answer questions, and share their wealth of knowledge, which greatly enhanced my learning experience.

Overall, my time at RxPharmacist has been incredibly rewarding, and I am deeply grateful for the opportunity. One of the most rewarding aspects of my internship was the chance to collaborate with a diverse group of individuals, each bringing unique perspectives and expertise to the table. This allowed me to gain new insights, learn from others’ experiences, and broaden my professional network. Working alongside experienced professionals has not only helped me apply the skills I have learned in pharmacy school but also provided me with hands-on experience that will benefit me in the future. This internship taught me how to approach problems from different angles, prioritize tasks effectively, and communicate with a variety of audiences.

I am confident that the skills and insights I gained during this internship will continue to shape my professional journey as I move forward in my career. I now feel better prepared to tackle future challenges in the pharmacy field and contribute meaningfully to the healthcare community. My time at RxPharmacist has helped me develop critical thinking skills, enhanced my writing abilities, and provided me with a deeper understanding of pharmacy law and medical writing.

I would like to extend my heartfelt thanks to everyone at RxPharmacist for providing me with this memorable and enriching opportunity. I would highly recommend this program to any pharmacy student who is looking to challenge themselves beyond the typical curriculum. The experience at RxPharmacist offers hands-on learning, mentorship, and the chance to contribute meaningfully to real-world projects. It is a great way to enhance your knowledge and skills, while also gaining a deeper understanding of the many facets of the pharmacy profession. The lessons learned and experiences gained will undoubtedly have a lasting impact on my career, and I am grateful for the opportunity to be part of such a dynamic and supportive team.

-Chloe G., Wilkes University PharmD Candidate 2025

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Testimonial from one of our first rotation students at RxPharmacist!

“I also had the chance to work with members of the RxPharmacist team to clarify my personal brand and improve my networking, interviewing, and job offer negotiation skills.”

I recently completed an APPE rotation with RxPharmacist. As someone with no experience in medical writing and a limited understanding of what medical writers do, I am not sure what motivated me to choose this APPE rotation. However, after spending 5 weeks learning from the RxPharmacist team I can say I am very happy with my choice.

 For the first part of this rotation, I updated the Minnesota MPJE study guide. This was the perfect start to my medical writing journey as I was able to use the previous edition of the study guide to direct my writing. My preceptor guided me through state and federal law updates as well as how to write the best MPJE practice questions! I received thoughtful feedback throughout the process that helped me develop a product that I am proud of.

The second half of my rotation focused on creating blog posts about a variety of pharmacy topics. This challenged me to expand my writing knowledge and to practice condensing complex pharmacy topics into short, understandable posts. I had the freedom to choose topics that interested me which made the whole process very enjoyable. It was a great way to review core pharmacy information from my pharmacotherapy courses while practicing medical writing. My preceptor provided helpful feedback that improved the clarity of each of the blog posts I wrote. She also gave me an overview of the different types of medical writing and shared many of the places medical writing and pharmacy overlap.

As a bonus, I also had the chance to work with members of the RxPharmacist team to clarify my personal brand and improve my networking, interviewing, and job offer negotiation skills. While this was not directly related to medical writing, it was yet another valuable piece of this rotation.

Here are my top 3 takeaways:

  1. There is something for everyone, whether you want to work on creative writing or dig into state laws.
  2. Everyone can benefit from learning more about medical writing, regardless of past writing experience.
  3. It is fun to take a break from direct patient care while still focusing on pharmacy topics!

Completing an APPE with RxPharmacist taught me skills that I would not have learned through other APPE rotations. I would recommend this rotation to all pharmacy students regardless of the pharmacy career they are aiming for. I believe that the experience I gained will help me with upcoming job applications and interviews as well as in my day-to-day work as a pharmacist.

Maggie M.

University of Minnesota 2024 APPE Student

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Cabenuva: A New Treatment Option for Patients Living with HIV

Reference image: Freepik

Human immunodeficiency virus (HIV) is a retrovirus that can lead to acquired immunodeficiency syndrome (AIDs) if left untreated. Almost 40 million people worldwide have HIV and 630,000 people died from HIV in 2023. HIV attacks the immune system by targeting white blood cells. Patients infected with HIV are more likely to contract diseases such as tuberculosis and cancer due to their decreased immune function. Currently, there is no cure for HIV, but many medications exist to treat HIV and prevent its spread. The long-term effectiveness of these medications is directly related to patient adherence and treatment resistance. Long-acting injectable medications may be a good option for patients who struggle with adherence to daily oral treatments.

What was the FLAIR trial?

The FLAIR trial was a randomized, open-label, noninferiority trial taking place in multiple treatment centers. It aimed to prove noninferiority of an injectable two-drug antiviral regimen versus an established oral three-drug antiviral regimen in patients who had never received treatment for HIV.

The experimental medication, now known as Cabenuva, is a long-acting treatment containing two medications, both of which were individually FDA-approved for the treatment of HIV prior to this trial. The first is cabotegravir, an integrase strand-transfer inhibitor (INSTI). INSTIs work by blocking the integration of viral DNA, stopping the replication of HIV. The second medication is rilpivirine, which is a nonnucleoside reverse-transcriptase inhibitor (NNRTI). NNRTIs work by inhibiting HIV-1 transcriptase which prevents HIV replication. In this trial, Cabenuva was given as an intramuscular injection once monthly.

The comparator treatment was a standard HIV treatment regimen, containing three oral antivirals: dolutegravir, abacavir, and lamivudine. This combination is taken once daily and represents a guideline-recommended treatment option for HIV.

The goal of HIV treatment is to reduce morbidity and mortality as well as decrease the spread of HIV. Antiviral medications are used to reduce a patient’s viral load to an undetectable level, which prevents HIV transmission. As defined by the CDC, antiviral treatment that results in a viral load of < 200 copies per mL is considered to be successful.

How was the study conducted?

The FLAIR trial contained two main phases, the induction phase and the maintenance phase. In the induction phase, all enrolled patients were given the three-drug oral regimen daily for 20 weeks. After 16 weeks, patients underwent additional testing to ensure that their viral load was less than 50 copies per mL. Patients who met the criteria continued to the maintenance phase where they were randomized into either the experimental or comparator treatment group. Members in the experimental group were given an oral lead-in of daily cabotegravir and rilpivirine, followed by a loading dose injection, and then continued with the monthly injectable maintenance dose thereafter. Members in the comparator group continued on the daily three-drug oral regimen. The intention-to-treat population was analyzed with a total of 566 patients split evenly between the two treatment groups.

Image created with Canva

Patients included in the FLAIR trial had to have active HIV, as determined by a plasma screening, that had never been treated with antiviral medications. This is because resistance is common in patients who have previously been treated with antiviral medications. To avoid complicating the results, the trial only included patients who had no history of antiviral use and therefore had the lowest likelihood of treatment resistance. Patients were excluded from this trial if they could not take antiviral medications due to their comorbid health conditions.

Notable inclusion criteria:

  • HIV infection that has never been treated with antiviral medications
  • HIV RNA level ³ 1000 copies per mL
  • 18 years old or older

Notable* exclusion criteria:

  • Anyone who was pregnant or breastfeeding
  • Patients with active Stage 3 disease as defined by the CDC
  • Hepatic impairment
  • Current or previous hepatitis B infection

*This list includes highlights from the patient enrollment parameters. It does not include all exclusion criteria.

The primary endpoint measured during this trial reflects the ability of the long-acting treatment and comparator medications to provide viral suppression, which is the main goal of HIV treatment. This was defined as the percentage of participants with a plasma HIV RNA level of ³ 50 copies/mL at week 48.

The secondary endpoints provide additional data regarding treatment effectiveness, adverse events, and pharmacokinetics. The key secondary endpoint measured was the percentage of patients with a plasma HIV RNA level of < 50 copies/mL at week 48.

Some additional secondary endpoints included:

  • Virologic failure
  • Adverse events
  • Plasma pharmacokinetics
  • Adherence

The intention-to-treat population was statistically analyzed. The adjusted difference between the treatment and comparator groups was determined for the primary and secondary endpoints using a stratified Cochran-Mantel-Haenszel analysis. Based on the power of the study and the size of each study group, noninferiority for the primary outcome was proven if the difference between the two groups was less than 6 percentage points.

Outcomes of the trial

The primary endpoint occurred for 6 patients in the Cabenuva group and 7 patients in the comparator group. This was a difference of -0.4 percentage points, demonstrating noninferiority of the study drug.

The key secondary endpoint occurred in 93.6% of patients in the Cabenuva group and 93.3% of patients in the comparator group, also demonstrating noninferiority of the treatment group with an adjusted difference of 0.4 percentage points (95% CI: -3.7 to 4.5).

Adverse events were more common in the Cabenuva group (94%) versus the comparator group (80%). The most common side effect of Cabenuva was injection site reaction, occurring in 86% of patients. Injection site pain accounted for most of these and was most commonly characterized as mild in severity. After the initial injection, 71% of patients reported injection-site reactions, and at week 48, the prevalence dropped to 20% of patients who received the trial medication. Additional common adverse effects included headache, diarrhea, and upper respiratory tract infection.

The FLAIR trial showed noninferiority of Cabenuva, a long-acting injectable medication when compared to a three-drug oral regimen to treat HIV. Cabenuva achieved similar rates of viral suppression for patients who had not previously been treated with antivirals for HIV. However, it also had higher rates of adverse effects. These were most commonly injection site reactions, which can be accounted for by the difference in the route of administration.

Another clinical trial, the ATLAS trial, studied the efficacy of Cabenuva in patients who had been successfully treated for HIV with antivirals in the past. Similar outcomes were reported for both the FLAIR and ATLAS trials. These two trials provided data supporting the efficacy of Cabenuva in viral suppression for patients with HIV regardless of their previous antiviral use.

Barriers to successful HIV treatment

HIV is an extremely complex disease state to treat. Many medications can be used in a variety of combinations to treat patients. The table below outlines a few common first-line treatment recommendations.

Regimens that contain bictegravir or dolutegravir are highly effective and tolerable. They also have a lower pill burden and high barrier to resistance compared to other medications, making them good options for initial HIV treatment. Treatment is extremely patient-specific and should take into consideration a variety of factors, including viral load, previous antiviral use, resistance, concurrent infections, and patient intolerance.

Cabenuva is now part of the HIV treatment guidelines. However, Cabenuva is not currently a first-line treatment option. It should not be used if the patient has any history of treatment failure or resistance to either cabotegravir or rilpivirine. Additionally, Cabenuva is not recommended for initial viral suppression. Patients should undergo successful viral suppression with an alternative treatment regimen before switching to a long-acting injectable medication.

Adherence to antiviral medications is key to HIV treatment. These medications reduce morbidity and mortality for patients as well as prevent the spread of HIV. However, their effectiveness is directly related to patient adherence. Poor adherence increases the risk of resistance to HIV medications, limiting treatment options. Barriers to patient adherence include pill burden, complex dosing, side effects, limited access to care, stigma, poor health literacy, and more. Long-acting injectable medications could improve adherence by eliminating pill burden and reducing complex dosing schedules. However, they come with unique side effects and require monthly appointments for administration.

Treatment resistance is a major problem that occurs with HIV medications. Patients should undergo genotype testing for antiviral resistance before starting treatment. This step is of greater importance for patients who acquire HIV while using pre-exposure prophylaxis (PrEP), because some of the medications for PrEP and HIV treatment overlap. Poor adherence is a common cause of treatment resistance. However, resistance can develop even with perfect adherence. Virologic failure (HIV RNA plasma level > 200 copies/mL) due to treatment resistance often requires patients to switch treatment regimens. As patients acquire resistance to first-line treatments, they may have to switch to more complex regimens.

Pharmacists play an important role in HIV care by educating patients on treatment options and encouraging adherence.

Margaret M., APPE Student

References

  1. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. The New England Journal of Medicine vol. 382,12 (2020): 1124-1135. doi:10.1056/NEJMoa1909512. Available at: https://pubmed.ncbi.nlm.nih.gov/32130806/. Accessed August 29, 2024.
  2. About HIV. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/hiv/about/index.html. Accessed August 29, 2024.
  3. HIV and AIDS. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hiv-aids#:~:text=Human%20immunodeficiency%20virus%20(HIV)%20is,cells%2C%20weakening%20the%20immune%20system. Accessed August 29, 2024.
  4. The Importance of Treatment Adherence in HIV. AJMC. Available at: https://www.ajmc.com/view/a472_sep13_schaecher_s231. Accessed August 29, 2024.
  5. Antiretroviral Drugs for Treatment and Prevention of HIV Infections in Adults: 2022 Recommendations of the International Antiviral Society – USA Panel. International Antiviral Society. Available at: https://pubmed.ncbi.nlm.nih.gov/36454551/. Accessed August 30, 2024.

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