Ask any patient with type 1 diabetes (T1D) about disease management, and you’ll likely hear stories of meticulous monitoring, hardware challenges, and more. So it’s no surprise that enterprising patients and caregivers have begun to hack their insulin pumps and continuous glucose monitors (CGMs) to create hybrid, closed-loop automated insulin delivery (AID) systems using off- the-shelf hardware and do-it-yourself (DIY), open-source smartphone apps to build their own bionic pancreas.

Aaron J. Kowalski, PhD, CEO of the Juvenile Diabetes Research Foundation (JDRF), received a diagnosis of T1D at age 13. When he learned about the DIY closed-loop AID system called Loop,

 he jumped right in. “I was a very early adopter because my first responsibility is to my health and my family. I had worked in the science for many years, and I felt that the risk was worth taking,” Kowalski said.

Kowalski isn’t alone. Many JDRF staffers have T1D, and they often use open-source DIY AID systems. The same is true at Integrated Diabetes Services. Owner and clinical director Gary Scheiner, MS, CDCES, and many of his staff clinicians use open- source AID.

“I wouldn’t consider myself tech savvy; I’m tech comfortable,” Scheiner said. “DIY is not much different conceptually from what’s available commercially today, but DIY systems like Loop are more flexible [and] more customizable. Commercially available systems have serious guardrails [and] very few variables that the user can adjust, which limits functionality. With something like Loop, you can achieve higher time in range, tighter averages, and lower [hemoglobin A levels] than with commercially available systems because you can adjust to your daily needs more easily.”

Insulin pumps and CGMs have been a staple in T1D care since the 1980s and early 2000s, respectively. But for a time, the 2 devices could not communicate, as no feedback loop existed between CGMs and insulin pumps to automatically regulate insulin dosing and blood glucose levels.

In 2014, some insulin pump users realized that a security flaw in the now-discontinued Medtronic pump models let them hack their pumps. Anyone with the right tech savvy could create their own algorithm, load it on a smartphone, and use real-time CGM data to calculate insulin dosing and control their pump. And thus looping—closing the CGM-insulin pump loop using DIY, open-source soft- ware—was born.

Many early adopters were parents of children with T1D who wanted to be able to remotely monitor their child’s serum glucose and adjust insulin dosing as needed, Kowalski explained. Under the banner #WeAreNotWaiting, parents formed an online community, Nightscout,

 an “open-source DIY project that allows real time access to CGM data,” he said. In its first iteration, Nightscout was specifically made to remotely monitor Dexcom G4 CGM data. Eager users shared Open Artificial Pancreas System (OpenAPS)

 documentation, including open-source reference designs, safety information, and step-by-step implementation instructions. Everything was designed touse existing FDA-approved devices, commodity hardware, and open- source software. As the information spread, AndroidAPS (for Android devices) and Loop (for iPhones and later iOS devices) focused on users in device-specific communities.

By 2016, OpenAPS users were presenting data at scientific gatherings sponsored by the American Diabetes Association

 and other medical organizations focused on diabetes research and care. Tidepool added Loop data in 2018

 and began developing a commercial algorithm with financial support from JDRF and other sources. In 2021, Tidepool completed the first open-source AID algorithm 510(k) application to the FDA.

Tidepool forked the original DIY Loop to create a more efficient, easier to use, and better documented app for the FDA submission, said Christopher Snider, Tidepool’s community and clinic success manager. DIY loopers have incorporated some of the updates, but Tidepool remains a dis- tinct algorithm.

“We put a tight code base on the app and used human factors approaches to increase the safety and efficacy of the algorithm and improve the overall user experience,” Snider said. “When Tidepool becomes commercially available, we will have a support team in place to work with [individuals] directly, just as you would expect with any other insulin delivery system. Support is a little more nebulous in the DIY space where you go to Facebook or Twitter with questions.”

In the medical device world, customer support is generally device specific; every pump, CGM, and hybrid closed- loop system has its own support team. Open source, though, lets users mix and match pumps and CGMs from different manufacturers, creating more flexibility and more choices in features.

“Insulin is prescribed as usual and the health care team still needs to figure out how much insulin the patient is using,” said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, endocrine clinical pharmacy specialist and remote monitoring program coordinator at the Cleveland Clinic Endocrinology and Metabolism Institute in Ohio. “With systems like Tidepool and Nightscout, we can view all the user data to figure insulin needs.”

She added, “I can’t configure a DIY system because it’s not FDA approved. But what I can do as a pharmacist is review patients’ data and advise them on ways to remain safe. We have a professional responsibility to support our patients and keep them safe.”

Although Isaacs sees open-source AID due to her location and her high visibility within the diabetes com- munity, data published in a recent international consensus statement in 

 estimated that approximately 10,000 individuals with diabetes are using DIY AID—a miniscule figure considering the 9 million individuals world- wide who have T1D.

John Beckner, RPh, senior director of strategic initiatives at the National Community Pharmacy Association, said that for now DIY is “just not that prevalent. And as technology continues to advance, there isn’t going to be much need to do it.”

The future of DIY will depend largely on industry. Dexcom, Medtronic, Tandem, Insulet, and other manufacturers regularly iterate existing products, bringing new systems online. And for now these products remain a closed ecosystem. “The tendency in industry is to want it all under your own shop,” Kowalski said. “If we fast forward 5 years, it would be shocking to me if we are not plugging and playing most of these com- ponents. We don’t have plug-and-play systems in the United States but we do in Europe.”

European regulators approved CamAPS FX, an Android app created by CamDiab, a JDRF-funded project at Cambridge University, in 2020. The app, which links pumps and CGMs across manufacturers, is approved for systems used by patients 1 year and older.

Kowalski predicted a future with fully interoperable closed-loop systems that combine pump X, sensor Y, and app Z. If industry doesn’t do it, DIYers will do it for them. “I was just talking with some of our team about when the Omnipod system is going to launch,” he said. “They’ve been saying publicly this fall, but in the meantime, there are a lot of [individuals] doing Omnipod DIY. If there is a tool to help diabetes be easier to manage with better numbers, that’s a first consideration.”

Patients with T1D can spend hours managing their condition. This month, 

® sat down with Kate,* a New York City resident who received her T1D diagnosis at age 10, to share her perspective on the current state of diabetes technology.

Q: You’re in the process of making the change to an APS. What do you hope will change?

Kate: I’ve read online that the open-source algorithm designed by Open APS [Artificial Pancreas System] can control blood sugars a lot better than the algorithms currently in use.

I remember reading one testimonial from a teenage boy that the [Open APS] algorithm works so well, [he] doesn’t even tell the pump when he eats, and still keeps his blood sugars in relatively good range.

I’m hoping that once I am able to get all the necessary hardware for Open APS, I’ll have better managed blood sugars, especially after eating meals; that my blood sugars will be better managed when unexpected factors affect my blood sugars (such as stress); and that I will get better sleep.

Q: What do you want your health care providers to know about why you’re making this change?

One of the most frustrating things is knowing how much red tape is out there in terms of insurance coverage and companies being unwilling to work with the Open APS community to create the best product. I’m sure the commercial pump algorithms could work a lot better if they collaborated with the people working on this open- source algorithm.

T1D is a strange condition because it is so finicky and involves so much data management. If I didn’t have educated parents who were knowledgeable about medicine and technology to help me learn how to manage this condition, I would probably be in a much worse state than I am now. The best physicians I have had take the time to educate themselves and keep up to date on pump and sensor technology so they can advise me on what to get. I also think it’s important for diabetics to talk to an experienced diabetes educator regularly for help understanding patterns in their data. I love my endocrinologist, but she just doesn’t have time during appointments to go over that in detail.

Limits on insurance coverage are also problematic; some patents are restricted in terms of what’s covered and what’s compatible with Open APS. I’ve waited years for my insurance to approve an insulin pump from a different company that I think will likely work much better for me. But without insurance, insulin and supplies would be outrageously expensive. I have been scared to leave jobs, or even take a leap to start my own business, because I worry about insurance coverage for T1D. Health care providers are likely just as frustrated by these things as I am; it’s one of the most challenging aspects of managing diabetes in this country.

2. The Nightscout Foundation. Accessed May 20, 2022. https://www.nightscoutfoundation.org/

4. Lewis D. Real-world use of Open Source Artificial Pancreas Systems—poster presented at American Diabetes Association Scientific Sessions. OpenAPS.org. Published June 11, 2016. Accessed May 20, 2022.

6. Tidepool completes FDA 510(k) submission of Tidepool Loop. News release. Tidepool. January 7, 2021. Accessed May 20, 2022. 

https://www.businesswire.com/news/home/20210107005324/en/Tidepool-Completes-FDA-510-k-Submission-of-Tidepool-Loop

7. Look H. 99 years closer: About our FDA submission of Tidepool Loop. Tidepool. Published January 11, 2021. Accessed May 20, 2022. 

https://www.tidepool.org/blog/99-years-closer-about-our-fda-submission-of-tidepool-loop

8. Braune K, Lal RA, Petruzelkova L, et al; for the OPEN International Healthcare Professional Network and OPEN Legal Advisory Group. Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

. 2022;10(1):58-74. doi:10.1016/S2213-8587(21)00267-9

9. Jeyaventhan R, Gallen G, Choudhary P, Hussain S. A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G. 

. 2021;23(8):1989-1994. doi:10.1111/dom.14439

10. CamAPS® FX. CamDiab. Accessed May 20, 2022. 

Articles

A do-it-yourself option to replace traditional diabetes management technology is growing in popularity. 

Hacking Diabetes: The DIY Bionic Pancreas Is Here to Stay

Cigarette smoking claims more than 480,000 American lives—approximately 1 in 5 of total US deaths—each year, according to the CDC. This makes smoking the leading cause of preventable disease, disability, and death in the United States.

Although the number of smokers continues to fall, about 13 of every 100 US adults were smoking cigarettes in 2020 (12.5% vs 20.9% in 2005). This means that approximately 30.8 million American adults smoke cigarettes,

 and more than 16 million are living with smoking- related conditions.

According to Joe Moose, PharmD, a clinical pharmacist, co-owner of Mount Pleasant, North Carolina-based Moose Pharmacy, and director of strategy and luminary development with CPESN USA, smoking-cessation programs are an ideal way for independent pharmacists to collaborate with physician practices.

“What we don’t have in health care are good signals of failure,” said Moose. A primary care physician (PCP) can tell their patient to quit smoking, write prescriptions for nicotine patches and amlodipine to control their blood pressure, and ask the patient to buy a blood pressure cuff for monitoring purposes. But too often, the patient doesn’t act on their physician’s recommendations.

The PCP’s goals include controlling their patient’s blood pressure and starting them on a smoking-cessation program. But without access to the patient’s care plan, the pharmacist doesn’t know that the PCP wants their patient to start the program and monitor their blood pressure in the first place.

At Moose Pharmacy, prescriptions will pop up for smoking-cessation patches and amlodipine, but the patient may tell Moose they are not ready to quit smoking. The conversation could end right there, the patient becoming a statistic who joins the more than 16 million Americans living with smoking-related conditions. Or the pharmacist can seize the opportunity to partner with the PCP and ensure they have access to the patient’s care plan, said Moose. The challenge is getting paid for this work. The solution, according to Moose, is what he calls a neighborhood accountable care organization (ACO).

Embed Pharmacists in the Physician’s Practice

The immediate impact of the pharmacist’s lack of awareness of the patient’s care plan is that the patient may pick up their amlodipine but not start the smoking-cessation program or use the cuff to monitor their blood pressure at home, said Moose.

The remedy is to embed a pharmacist in the PCP’s office for 40 hours a week to learn about patients’ care plans and reinforce and support their efforts to quit smoking, manage their diabetes, or control their blood pressure, he added. This enables the pharmacist to meet with patients directly following their visits to the practice. Immediate benefits include the opportunity for the pharmacist to earn in real time about patients’ care plans, access the practice’s electronic health record, and receive a “warm hand-off” from the clinicians at the practice as an integrated part of the patient experience, Moose explained. These connections are initially made in person at the practice between the embedded pharmacist and the clinical team. And when patients receive a follow-up call from a pharmacy technician at Moose Pharmacy, the whole process feels seamless.

This same collaborative model can be applied in the treatment of other chronic conditions, such as diabetes and hypertension. It can also help the practice successfully achieve quality measures to ensure the practice gets its full value-based care payments, Moose added.

That’s where the neighborhood ACO model comes in, explained Moose. Creating a neighborhood ACO means that accountability for patients doesn’t just rest with the PCP while the pharmacist focuses only on dispensing medications and working with the pharmacy benefit manager. Instead, both physician and pharmacist are accountable for the same measures, which can include reducing blood pressure or getting patients to stop smoking, 2 goals of the value-based model, according to Moose.

What’s missing, though, is assurances that the pharmacist is paid in addition to the PCP’s practice. Moose kickstarts compensation conversations with the practice leader after collaborating on data mining to determine missed annual wellness visits for adult patients, chronic care management opportunities, remote patient monitoring opportunities, and the number of patients with diabetes whose glycated hemoglobin A1C levels are above 9, an indication their condition is being poorly treated.

The simple question Moose poses to practice leaders is this: “If [our pharmacists] complete these things and bring in half a million dollars in payments to the practice, is that worth making a $100,000 payment to Moose Pharmacy?”

But even if Moose is successful with this pitch and delivers on the value promised to the practice, he knows his pharmacists must continue to deliver value or he risks the practice choosing to hire a nurse to take on the same work at 70% of the cost.

Moose’s advice? “You have to be valuable...and help generate income.”

Jessica Gustin, PharmD, pharmacy manager at Gwinnett Drugs in Lawrenceville, Georgia, agreed it’s important for pharmacists to show their worth to physicians. Consultations with patients experiencing chronic pain is one area in which she has achieved success. Providing this service is important because many people pass judgment on individuals taking opioids for pain management when they may actually need them, said Gustin. She is also cofounder and chief operating officer of SynerGrx, based in Chamblee, Georgia, which facilitates collaboration between pharmacists and physicians.

After asking patients about their pain management challenges, Gustin can discuss the adverse effects of opioids, provide access to naloxone HCl (Narcan), and suggest patients participate in physical therapy.

Collaborate With Physicians on Diabetes Management

Eklavya Lalwani, PharmD, pharmacist-in-charge at Olden Pharmacy in Hamilton, New Jersey, said that pharmacists—with their 6 to 8 years of education in a pharmacy school program in addition to clinical knowledge and skills—are uniquely prepared to provide clinical services. Despite this education and experience, though, pharmacists are “extremely underutilized,” he said.

Lalwani, who is also a preceptor for Fairleigh Dickinson University School of Pharmacy and Health Sciences, said a good way to start collaborating with physician practices is to focus more closely on patients with diabetes. For example, when a patient says their insulin is too expensive, the pharmacist can call the physician and suggest the patient switch to a less expensive biosimilar with a lower co-pay. Most of the time, the pharmacist is talking to the receptionist, a medical assistant, or a nurse in these conversations. Over time, these team members start to remember the pharmacist and look to them as an expert. Lalwani also steals a page from the pharmaceutical sales rep’s book by occasionally showing up for quick in-person meetings at practices.

The ever-present challenge, though, is getting paid for chronic condition management, Lalwani noted. The American Society of Health-System Pharmacists (ASHP) provides guidance to pharmacies on billing Medicare for diabetes self-management. First, the pharmacy needs to set up a diabetes self-management training/education program that has been accredited or recognized by the American Diabetes Association or Association of Diabetes Care & Education Specialists. The program can be run and managed by a registered dietician, nurse, or pharmacist.

For billing, the pharmacy must use the practice’s or pharmacy’s National Provider Identifier (NPI) rather than the pharmacist’s NPI. Payment can range from $15 per patient for a group-based diabetes self-management training education session to $51 for a 30-minute session for an individual patient, according to ASHP.

“Ultimately...the primary role of the pharmacist is ensuring that medications are utilized in the safest, most effective, most efficient manner,” said Tom Kalista, PharmD, a lecturer at the University of Rhode Island College of Pharmacy. “Facilitating communication is only going to enhance that.”

Frequently, the biggest pitfalls are difficulties that occur between prescribing and dispensing, he said. Reviewing drug use and insurance coverage and addressing questions about cost and dosing concerns can take weeks, which introduces delays in patients’ receiving therapy, Kalista explained. “Any delays have an impact in terms of long-term outcomes.”

Kalista recalled a time over the Christmas holidays when a family of 5 came to the pharmacy unsure if they all had COVID-19 or strep throat. As a result of the pharmacy’s collaboration with a local physician, the family was able to access a diagnosis and treatment within 25 minutes. In addition, they were advised against going to a New Year’s Eve party to avoid spreading the strep infection.

“Picking up the phone or walking into the physician’s office is probably the biggest hurdle to [collaboration] because all the parties have the same intention, [which is caring for patients],” Kalista said.

1. Current cigarette smoking among adults in the United States. CDC. Updated March 17, 2022. Accessed May 16, 2022. 

https://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm

2. Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco product use among adults – United States, 2020. 

. 2022;71(11):397-405. doi:10.15585/mmwr. mm7111a1

3. National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking—50 Years of Progress. CDC; 2014. Accessed May 16, 2022. 

https://www.ncbi.nlm.nih.gov/books/NBK179276/

4. FAQ: alternatives to “incident-to” billing for revenue generation in non-facility (physician-based) ambulatory clinics for pharmacists. American Society of Health-System Pharmacists. March 2019. Accessed May 16, 2022. 

https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/ambulatory-care/alternatives-to-incident-to-billing-2019.pdf

As a pharmacist, embedding yourself in a primary care practice can have positive outcomes for both patients and your business.

Empowering Pharmacist-Physician Collaboration

Long COVID goes by several names: post-COVID conditions, postacute sequelae of SARS-COV-2 infection (PASC), long-haul COVID, post-acute COVID syndrome (PACS), and chronic COVID.

 But regardless of the term used, the exact definition and symptomology of the condition are still developing as the science unfolds.

Long COVID involves a constellation of mild to severe symptoms across body systems.

 According to the CDC, it consists of “new, recurring, or ongoing symptoms and clinical findings 4 or more weeks after infection, sometimes after initial symptom recovery.”

 Even those who have never tested positive—due to inadequate or inaccurate testing, false-negative antibody tests, or waning antibody levels—can develop long COVID, noted the agency. At present, no avail- able laboratory tests exist to confirm the condition.

Patients of any age can develop long COVID, but it is more common in adults.

 A recent meta-analysis of 41 studies published online in the 

 found the global prevalence of the condition to be 43%, which is higher than that of previously published findings.

 The authors estimated that approximately 200 million people have experienced or are experiencing long COVID worldwide.

Long COVID has documented, multiorgan system effects.

 According to Yale Medicine, the CDC, and Britain’s National Institute for Health and Care Excellence,

 these symptoms include, but are not limited to, the following:

 Rapid or irregular heartbeat (palpitations), autonomic dysfunction such as postural orthostatic tachycardia syndrome (POTS)

 Shortness of breath, chest pain or discomfort, cough

 Diarrhea, nausea and/ or abdominal pain, reduced appetite

Memory loss, brain fog, loss of smell and/or taste, headache, insomnia, numbness, delirium, visual impairment, and mobility problems

 Anxiety, depression, posttraumatic stress disorder

 Sore throat, earache, tinnitus, hearing loss

 Fatigue, dizziness, intermittent low-grade fever, postexertional malaise

Mary Ann Kliethermes, PharmD, director of medication safety and quality at the American Society of Health-System Pharmacists, shared some ways in which pharmacists can recognize long COVID in patients and assist them with managing their symptoms.

Although pharmacists do not diagnose long COVID in patients, they can help identify the condition, Kliethermes said. Pharmacists are increasingly likely to have contact with patients affected by long COVID and can use current data to identify those who may be at risk.

“Patients come to the pharmacy for help and may discuss their symptoms, seeking OTC relief for long COVID,” Kliethermes noted. She added that this is a good opportunity for pharmacists to provide counsel and recommend to patients that they visit a physician rather than attempt to treat themselves.

For long COVID management, currently, “there is no standard treatment protocol other than pulmonary and cardiac rehabilitation and the administration of supplemental oxygen,” Kliethermes told 

®. Patients may be treated for specific symptoms by a primary care physician or a specialist of the affected body system.

Pharmacists should help patients coordinate their prescriptions across specialties to prevent drug interactions, Kliethermes added. They can also coordinate with patients to evaluate what OTC drugs they are taking along with prescribed medicines, to prevent additional interactions and maximize effectiveness. Pharmacists can also advise patients which OTC products can help alleviate symptoms.

Kliethermes emphasized that there are no proven alternative medicine treatments for long COVID, so pharmacists should ensure these substances do not interact with medically approved treatments. Finally, she advised pharmacists to keep up with developments in the literature as the science evolves by monitoring clinical trials and using research databases such as PubMed.

Other medications are being examined for their potential global effectiveness, rather than just the ability to target individual symptoms. One theory is that long COVID symptoms are caused by microclotting. One study, whose findings were recently published in 

, explored the therapeutic implications of anticoagulant use: “Consistent with this [study’s data], in a preliminary report, it has been shown that suitable and closely monitored ‘triple’ anticoagulant therapy that leads to the removal of the micro clots also removes the other [long COVID] symptoms,” the study authors wrote.

Another possible avenue of treatment is antihistamines, with data from 2 case studies published in the 

 showing positive results for long COVID symptoms.

 The study authors noted that these data add to those of “previous studies, [whose authors] have reported that patients hospitalized with COVID-19 demonstrated symptom improvement after administration of a histamine antagonist.”

 Research in these areas is still nascent, and not yet clinically approved.

The biological mechanism of long COVID remains unclear. Recent studies findings published in 

 examined the potential causes, including injury to 1 or more organs due to acute SARS-CoV-2 infection, the virus persistently infecting specific tissues, or the reactivation of neurotrophic pathogens (such as herpesviruses), as COVID-19 dysregulates the immune system. Those investigators also noted that long COVID may be caused by SARS-CoV-2 interacting with the patient’s virome or microbiome communities or by coagulation or clotting issues, or result from dysfunctional vagus nerve or brainstem signals. Other possibilities include primed immune cell ongoing activity, and autoimmunity caused by “molecular mimicry between pathogen and host proteins.”

 Because of the wide range of potential causes, the authors emphasized that the individualized array of symptoms in each patient will require different approaches to offer the best care.

While the science develops, pharmacists can help patients manage this mysterious and often debilitating condition. Pharmacists and providers can follow the CDC’s interim guidance

 on evaluating and caring for patients with long COVID.

“Understanding of post-COVID conditions remains incomplete and guidance for healthcare professionals will likely change over time as the evidence evolves,” the CDC wrote.

It is essential to afford practicing pharmacists the time and access to resources and professional development to keep up with emerging research, so they are prepared to identify patients with long COVID and assist them with symptom management and recovery.

1. Post-Covid Conditions: Information for Healthcare Providers. Centers for Disease Control and Prevention. Updated July 9, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fclinical-care%2Flate-sequelae.html

2. Chen C, Haupert SR, Zimmermann L, Shi X, Fritsche LG, Mukherjee B. Global Prevalence of Post COVID-19 Condition or Long COVID: A Meta-Analysis and Systematic Review [published online ahead of print, 2022 Apr 16]. 

. 2022;jiac136. doi:10.1093/infdis/jiac136

3. Long COVID (Post-Acute Sequelae of SARS CoV-2 infection, PASC). Yale Medicine. 2022. Accessed April 20, 2022. 

https://www.yalemedicine.org/conditions/long-covid-post-acute-sequelae-of-sars-cov-2-infection-pasc#:~:text=Lon20COVID%2C%20or%20what,)%20COVID%2D19

4. COVID-19 rapid guideline: managing the long-term effects of COVID-19. National Institute for Health and Care Excellence. Published December 18, 2020. Updated November 21, 2021. Accessed April 20, 2022. 

https://www.nice.org.uk/guidance/ng188/chapter/Recommendations

5. Kell DB, Laubscher GJ, Pretorius E. A central role for amyloid fibrin microclots in long COVID/PASC: origins and therapeutic implications. 

. 2022;479(4):537-559. doi:10.1042/BCJ20220016

6. Pinto MD, Lambert N, Downs CA, Abrahim H, Hughes TD, Rahmani AM, Burton CW, Chakraborty R. Antihistamines for Postacute Sequelae of SARS-CoV-2 Infection. 

. 2022 Mar;18(3):335-338. doi: 10.1016/j.nurpra.2021.12.016. Epub 2022 Feb 7. PMID: 35153633; PMCID: PMC8820139.

7. Malone RW, Tisdall P, Fremont-Smith P, et al. COVID-19: Famotidine, Histamine, Mast Cells, and Mechanisms. 

. 2021;12:633680. Published 2021 Mar 23. doi:10.3389/fphar.2021.633680

8. Hogan Ii RB, Hogan Iii RB, Cannon T, et al. Dual-histamine receptor blockade with cetirizine - famotidine reduces pulmonary symptoms in COVID-19 patients. 

. 2020;63:101942. doi:10.1016/j.pupt.2020.101942

9. Ennis M, Tiligada K. Histamine receptors and COVID-19. 

. 2021;70(1):67-75. doi:10.1007/s00011-020-01422-1

10. Proal AD, VanElzakker MB. Long COVID or Post-acute Sequelae of COVID-19 (PASC): An Overview of Biological Factors That May Contribute to Persistent Symptoms. 

. 2021;12:698169. Published 2021 Jun 23. doi:10.3389/fmicb.2021.698169

11. Evaluating and Caring for Patients with Post-COVID Conditions: Interim Guidance. Centers for Disease Control and Prevention. Updated June 14, 2021. Accessed April 20, 2002. 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-index.html

Staying abreast of current data on the condition is vital. 

How Pharmacists Can Help with Long COVID Symptom Management

Individuals who identify as a member of the LGBTQ+ community—lesbian, gay, bisexual, trans- gender, and questioning/queer— face significant health care disparities and have higher risks for depression and suicide compared with other individuals.

 Pharmacists and health care providers across the spectrum must be aware of the needs of this patient population, from which terminology to use to the health care inequalities patients face.

Pharmacy owners looking to create a comfortable environment for LGBTQ+ individuals to pick up prescriptions or obtain counseling, begin by assessing pharmacists and their staff, said Alex R. Mills, PharmD, BCACP, an assistant professor of pharmacy practice (HIV, LGBTQ+ Health) at the University of Mississippi School of Pharmacy in Jackson.

"There are opportunities for cultural humility. Assess pharmacists and their staff on their understanding of the LGBTQ+ community. Are they even aware of the challenges that are happening?” Mills told 

®. "That’s the first place to start. Then identify the resources or training they need.”

Next, evaluate the physical environment. "Can you provide an affirming environment? Is there an opportunity for your [electronic medical records] system to include pronouns?” One big challenge Mills has seen at community pharmacies is the difficulties LGBTQ+ patients face in getting their prescription if their legal name is different from their affirmed name. Take, for example, a transgender patient whose legal name was John but is now Jennifer. Their insurance may still list their legal name as John, Mills explained. “Running the prescription through insurance, that name [John] will print on their prescription packaging. Is there a way to develop systems to capture the name needed to run through insurance but the end product prints the person’s name they are using now?” he asked.

The LGBTQ+ community already faces health care disparities related to insurance and health care visits. According to the 2015 US Transgender Survey,

 25% of respondents had experienced a problem with their insurance in the past year related to being transgender, such as being denied coverage for care related to gender transition or being denied coverage for routine care. Additionally, 33% of respondents who saw a health care provider in the past year reported having at least 1 negative experience related to being transgender, including being refused treatment, verbally harassed, or physically or sexually assaulted, or having to teach the provider about transgender people to obtain appropriate care, said Mills and Kyle Melin, PharmD, MSc, BCPS, during an American Society of Health-Systems Pharmacists webinar.

 Melin is an associate professor at the University of Puerto Rico School of Pharmacy in San Juan.

Sexual and gender minorities are disproportionately affected by poverty, housing instability, and discrimination within the health care system, as well as by stigma, Mills and Melin noted. "These differences in social determinants of health can lead to health disparities and poorer health outcomes,” they added.

"Embracing the diversity of all patients and understanding where patients come from is going to affect the ability to provide good care,” Mills said. Not every patient who comes into the pharmacy to pick up their medications has had a good experience with the health care system. "That is what is preventing them from being engaged in their care. It’s recognizing that we need to paint that patient in a different picture and appreciate how the intersectionality between sexual orientation and/or gender identity affects one’s health care experience, so we can provide a holistic, person-centered approach to their health.”

Being comfortable with basic terminology used by sexual and gender minorities goes a long way toward creating a welcoming and affirming environment for LGBTQ+ patients. Some of the most important terms to know are transgender woman, someone assigned male at birth who identifies as a woman, and transgender man, someone assigned female at birth who identifies as a man.

It’s also important to understand that 

can be used by someone who doesn’t identify under just one aspect of the LGBTQ+ umbrella, and to be mindful that some individuals find this term offensive, according to Mills. Instead, allow individuals to self-disclose the term, rather than assigning it to them.

Pharmacists should also be wary of deadnaming—identifying a patient by the wrong name—or misgendering someone by using the wrong pronoun, Mills advised. Patients may even see the error themselves when they log into patient portals. "Those who are charting should know that it is very dysphoric for patients who may be using a different name, and be mindful of this during the documentation process” Mills noted.

"Stop making assumptions about people,” Mills advised. "If you make assumptions that they identify as a transgender male, for example, and assume they are romantically attracted to females, you may miss an opportunity to discuss with a high-risk patient the benefits of taking HIV pre-exposure prophylaxis [PrEP]. Essentially, sexual orientation and gender identity can be independent of each other.”

1. Suicide risk and prevention for LGBTQ people. National LGBT Health Education Center. September 2018. Accessed May 16,2022. 

https://www.lgbtqiahealtheducation.org/wp-content/uploads/2018/10/Suicide-Risk-and-Prevention-for-LGBTQ-Patients-Brief.pdf

2. James SE, Herman JL, Rankin S, Keisling M, Mottet L, Anafi M. The Report of the U.S. 2015 Transgender Survey. National Center for Transgender Equality. December 2016. Accessed May 16, 2022. 

https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf

3. Melin K, Mills AR. Affirming pharmacist care: understanding disparities and creating an inclusive environment for sexual and gender minorities. American Society of Health-Systems Pharmacists webinar. March 22, 2022. Accessed May 16, 2022. 

https://elearning.ashp.org/products/9728/affirming-pharmacist-care-understanding-disparities-and-creating-an-inclusive-environment-for-sexual-and-gender-minorities

4. Providing LGBTQ-inclusive care and services at your pharmacy. Human Rights Campaign Foundation. June 2016. Accessed May 16, 2022. 

https://assets2.hrc.org/files/assets/resources/LGBTQ_Pharmacy_Guide_2016.pdf?_ ga=2.8366962.1366100611.1652730700-400063218.1652730700

LGBTQ+ individuals can face significant hurdles when seeking health care.

Improving Care Disparities for the LGBTQ+ Community

On January 7, 2022, the FDA approved daridorexant (Quviviq) for the treatment of adults with insomnia.

 The approval was based on findings from a phase 3 clinical trial program in which the drug successfully demonstrated significant improvement in sleep onset, sleep maintenance, and patient- reported total sleep time.

Two multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trials (study 1, NCT03545191; study 2, NCT03575104) evaluated efficacy. Investigators randomly assigned 1854 patients to receive daridorexant or placebo once in the evening for 3 months. Study 1 included 930 participants who received daridorexant 50 mg, 25 mg, or placebo (n = 310 for all). Study 2 participants received daridorexant 25 mg, 10 mg, or placebo (n = 309, 307, and 308, respectively).

The primary efficacy end point was change from baseline in latency to persistent sleep (LPS)

and wake after sleep onset (WASO), measured by polysomnography at months 1 and 3. Secondary end points included patient-reported subjective total sleep time (sTST), recorded using a validated sleep diary questionnaire.

At months 1 and 3, study 1 participants who received 25 mg or 50 mg demonstrated statistically significant improvements in LPS, WASO, and sTST; study 2 results showed that 25 mg led to a statistically significant improvement vs placebo in WASO and sTST. No statistically significant improvement was noted in the 10 mg group.

The safety profile of daridorexant was established through 3 placebo-controlled studies: study 1, study 2, and a phase 3, 9-month extension study of eligible patients from the first 2 studies (NCT03679884). In the extension study, 804 participants were randomly assigned to receive daridorexant 50 mg, 25 mg, or 10 mg; placebo; or daridorexant 25 mg/ex-placebo.

The most common adverse events in the 25-mg, 50-mg, and placebo groups, respectively, were headache (6%, 7%, 5%), somnolence/fatigue (6%, 5%, 4%), dizziness (2%, 3%, 2%), and nausea (0%, 3%, 2%). Rare occurrences of sleep paralysis were reported in the 25-mg and 50-mg groups, and hypnagogic/hypnopompic hallucinations were reported in the 25-mg group.

A randomized, double-blind, placebo- and active-controlled 4-way crossover study assessed the next-day effects of the medication on driving after doses of 50 mg and 100 mg. The difference in performance after the first dose, measured by change in standard deviation of lateral position, was significant compared with placebo for both dose groups. However, the mean effect after 4 days of treatment was not significant. Patients should be cautioned about next-day driving impairment when initiating treatment.

The use of daridorexant is contraindicated in patients with severe hepatic impairment; a maximum daily dose of 25 mg is recommended in those with moderate impairment. Concomitant use with strong CYP3A4 inhibitors should be avoided. Concomitant use with moderate inhibitors of CYP3A4 may be considered, but the maximum daily dose should not exceed 25 mg.

Daridorexant is a schedule IV medication with potential for abuse due to its central nervous system depressant effects.

Daridorexant is for the treatment of adult patients with insomnia and is supplied as an arc triangle–shaped, film-coated oral tablet. The recommended dosage range is 25 mg to 50 mg taken by mouth, no more than once per night within 30 minutes of going to bed. There should be at least 7 hours remaining prior to planned awakening. Time to sleep onset may be delayed if daridorexant is taken with or soon after a meal.

1. QUVIVIQ [package insert]. Radnor, PA. Idorsia Pharmaceuticals US Inc. January 2022. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s000lbl.pdf

2. Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. News release. Idorsia. January 10, 2022. Accessed May 11, 2022. 

https://www.idorsia.com/media/news-details?newsId=2665386

Daridorexant demonstrated significant reduction in daytime sleepiness among
other measures.

Daridorexant Receives Approval for Insomnia Treatment

HIV remains a significant public health problem in the United States, with new infections frequently occurring. In 2019, a federal response—Ending the HIV Epidemic—was announced, with a goal of drastically decreasing the number of new infections by 2030.

Pre-exposure prophylaxis (PrEP) is a once-daily pill to prevent HIV infection. Although PrEP has a more than 90% efficacy rate, it is vastly underused.

 Pharmacists can provide access to PrEP services in their pharmacies, including sharing information about the therapy, helping patients enroll in a PrEP care program, and coordinating with other health care providers to ensure their patients receive the best possible care. Pharmacists can also address any concerns their patients may have about PrEP and provide support throughout the course of PrEP treatment.

Maria Lopez, PharmD, president of clinical pharmacy service for Mission Wellness Pharmacy, a specialty pharmacy in San Francisco and the first California pharmacy to initiate PrEP, explained that it’s important for pharmacies to offer PrEP because they are accessible and have highly trained medication experts on hand to help.

“The COVID-19 pandemic highlighted the ability of pharmacies...to provide access to tests and vaccines. They can utilize their expertise in similar ways for public health to address HIV and STI [sexually transmitted infection] epidemics,” she said.

Kristen Nichols, PharmD, BCPS, BCPPS, BCIDP, an infectious diseases specialist and a senior content management consultant, clinical effectiveness, at Wolters Kluwer, Health, noted there are disparities in the receipt of PrEP along age, race, sex, and geography lines. For example, women are less likely to initiate PrEP, and Black women are less likely to initiate it than White women.

“Access through pharmacies would likely increase the number of patients who are able to get started on PrEP; pharmacists are considered some of the most trustworthy and are the most accessible health care professionals,” she said. “There may be a lower barrier to care entry if a person can get engaged in care at their pharmacy as compared [with] other health care settings.”

“Pharmacies are motivated to sell prescriptions, which means that the system is already in place for encouraging adherence,” Nichols added. “For example, automated refill processes could assist with a vital component of PrEP, which is adherence and retention in therapy.”

Anthony V. Minniti, RPh, co-owner of Bell Pharmacy in Camden, New Jersey—which offers its own PrEP clinic inside—believes pharmacists can really “move the needle” with PrEP in much the same fashion as they did with COVID-19 testing and vaccination. “We came up with a business approach to PrEP as a great opportunity to expand hands-on pharmacy practice,” he said. “We set about creating open access to our patient population back in 2017. We have a big population of those who are in need of PrEP, and we knew we needed to do this to improve access and health care outcomes.”

PrEP is an effective way to fight HIV transmission, and more pharmacies are providing this important service. 

Drug Topics June 2022

Hacking Diabetes: The DIY Bionic Pancreas Is Here to Stay

Empowering Pharmacist-Physician Collaboration

How Pharmacists Can Help with Long COVID Symptom Management

Improving Care Disparities for the LGBTQ+ Community

Daridorexant Receives Approval for Insomnia Treatment

Curb HIV Spread With PrEP Access in the Pharmacy

The Future Looks Busy for Pharmacy Technicians in Immunization Programs

A Lesson From the Friendly Skies