Many pre-exposure prophylaxis (PrEP) users reported voluntarily discontinuing therapy during shelter-in-place orders (SIPOs) amid the coronavirus disease 2019 (COVID-19) pandemic due to low perceived HIV risk, according to an online survey conducted by The American Academy of HIV Medicine in partnership with Gilead Sciences HIV Medical Affairs.

The survey findings were part of the data presented online by Gilead at the 23rd International AIDS Conference on the effect of COVID-19 SIPOs and PrEP utilization on HIV prevention strategies and associated risk behaviors.

The survey, which aimed to capture the potential changes in behavior among PrEP users and prescribers during SIPOs, included 598 total respondents: 409 PrEP users and 189 PrEP prescribers.

According to the results, although the majority of prescribers reported recommending no change in PrEP regimen, approximately 33% of PrEP users discontinued therapy voluntarily, with 85% noting low perceived HIV risk associated with decreased sexual activity as the reason. The survey data indicated that of those who discontinued PrEP, only 8% cited inability to access PrEP medications. Despite limitations caused by SIPOs, 95% of prescribers were able to successfully prescribe PrEP.

Additionally, PrEP users reported changes in sexual behavior associated with HIV risk, with 90% citing no or fewer sexual partners and no or fewer sexual events during SIPOs. 

Of the providers who responded to the survey:

Sixty-eight percent implemented telemedicine practices.

Fifty-nine percent indicated refilling PrEP medications while postponing routine HIV/sexually transmitted infection (STI) and laboratory tests.

Fifteen percent opted to completely forgo testing and lab monitoring. 

Additionally, of the 20% of responding providers who encountered PrEP users with suspected STIs for which they could not obtain a test, 47% treated STIs empirically.

“Reducing the number of new HIV transmissions and ensuring access to critical HIV prevention services must remain a public health priority during this challenging time,” Bruce Packett, executive director of The American Academy of HIV Medicine, said in a statement. “These data demonstrate the crucial role that technology-enabled care can play in helping facilitate the safe and timely delivery of critical public health services. My hope is that clinics and HIV prevention providers can continue to adapt to changing circumstances by offering expanded use of telehealth services and other innovative tools to help meet the evolving needs of people at risk for HIV.”

Further, in the separate DISCOVER trial, results revealed no changes in participant behavior regarding the number of sexual partners; condomless, insertive anal sex partners; or condomless, receptive anal sex partners from baseline through 96 weeks of follow-up. DISCOVER is an ongoing multi-center randomized controlled trial evaluating the safety and efficacy of emtricitabine 200 mg/tenofovir alafenamide 25 mg (Descovy) for PrEP in men and transgender women who have sex with men and are at risk for sexually acquired HIV infection. According to Gilead, the findings suggest that an increase in risk behavior due to a reduction in perceived risk did not occur during the trial.

Gilead Sciences Presents Survey Findings on PrEP Access and Utilization in the US During COVID-19 Shelter-in-Place Orders. News Release. Gilead; July 8, 2020. Accessed July 8, 2020. 

https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/gilead-sciences-presents-survey-findings-on-prep-access-and-utilization-in-the-us-during-covid19-shelterinplace-orders

Articles

Survey results on PrEP access and utilization during COVID-19 shelter-in-place orders presented at the 23rd International AIDS Conference.

Survey: Changes in PrEP Utilization, Risk Behaviors During COVID-19 Pandemic

The American Society of Health-System Pharmacists (ASHP) announced the results of its annual survey of pharmacy directors from almost 5000 hospitals across the country, which delivered valuable insights on hospital and health system pharmacy practice.

American Journal of Health-System Pharmacy (AJHP), 

gauged prescribing and transcribing strategies used by hospital pharmacy and therapeutics (P&T) committees, with the most common tools including therapeutic interchange, evidence-based clinical practice guidelines, opioid stewardship, and comparing the efficacy of products when making formulary decisions. The survey also pointed to additional trends in areas of staffing and the use of mobile technology.

Lead author Craig A. Pederson of Virginia Mason Medical Center noted that the findings are not surprising, as these strategies have been proven to be effective. Of note, the results determined an increase in the use of therapeutic interchange since 2016.

Other noteworthy trends on the basis of formulary management from the survey:

Thirty-one percent of hospitals reported rationing medications due to expected patient outcomes and cost of therapy, up from 25% in 2016.

Seventy-three percent of hospitals has be limited strict formulary and tight restrictions on non-formulary medication use, up from 63% in 2016.

Eighty-nine percent of hospitals provide their pharmacists the authority to write medication orders; among these locations, 94% of pharmacists are able to modify or initiate therapy by policy or protocol, whereas 6% are authorized to prescribe medications.

“Seventy-two percent of hospitals use protocols that transfer authority for product selection and dosing from prescribers to pharmacy as a strategy by P&T, suggesting that pharmacists are increasingly recognized as effective stewards of the formulary system, and at implementing formulary standards,” Pedersen said. “This is significantly less than 77% of hospitals in 2016.”

Related to pharmacogenomics, a mere 5.4% of hospitals who participated in the survey reported their recommendations for or scheduling of pharmacogenomics testing for determining drug and dosage; 90% indicated that their pharmacists experience limitations in dispensing products for pharmacogenomics drugs therapy management.

But although the survey showed limited pharmacy involvement in this area of drug management, Pederson remains hopeful that the prevalence of pharmacogenomics will only improve from here.

“There are a lot of drug products with pharmacogenomic markers,” Pederson said. “So where are pharmacists in pharmacogenomics? At this point, pharmacists play a very limited role. Some might be very disappointed in that — I think there are a lot of people that are highly invested in this. But my point is that pharmacogenomics has not yet become the pharmacokinetic monitoring of pharmacy. That’s not to say that I don’t think it will.”

On the other hand, more positive trends from ASHP’s survey were found in opioid stewardship, as 47% of hospitals had active opioid stewardship programs, compared with 41% in 2018, and 65% indicated that their pharmacists function as leaders for accountability concerning the hospital’s opioid stewardship programs.

Philip J. Schneider, co-author and professor in the College of Pharmacy at The Ohio State University, lauded these trends showing increased pharmacist participation. “The good news is that if a hospital has an opioid stewardship program, which nearly half do, pharmacists are almost always involved,” he said.

Other areas of growth in this sector included the following:

Eighty-five percent of hospitals reported educations programs or guidelines, compared to 71.4% in 2018.

Eighty-five percent have been using a prescription drug monitoring database, compared to 63.5% in 2018.

Sixty-one percent limit home discharge prescription supplies of opioid medications, compared to 46.3% in 2018.

Results from the survey also included data on hospital staffing of pharmacists, as the number of full-time pharmacist positions have grown since 2016, with a mean of 19.2 positions for each 100 occupied beds. Pharmacists also showed a vacancy rate of less than 3%; pharmacy technicians had a vacancy rate of 6.5%. Despite challenges in vacancy rates for technicians, human resource commitments to support new services are increasing, and staff credentialing continues to expand for pharmacists and technicians, the authors wrote.

Encouraging results also took form in the survey’s data concerning mobile technology. The majority of pharmacists are now using smartphones, tablets, or laptops to supplement and facilitate patient care services following the nearly universal adoption of the universal electronic health records.

“Pharmacists continue to assume greater responsibility for writing medication orders, dosing, ordering laboratory tests, and monitoring outcomes,” the authors of the survey reported. “Health-system pharmacist are taking a leading role in addressing the opioid crisis, advancing safety in compounded sterile preparations through adoption of intravenous workflow technologies, and optimizing EHR applications to leverage clinical decision support tools to improve the safe prescribing and use of medications.”

The survey was conducted prior to the COVID-19 pandemic.

ASHP National Survey Reveals Trends in Pharmacy Practice. News Release. ASHP; June 26, 2020. Accessed July 7, 2020. 

https://www.ashp.org/news/2020/06/26/ashp-national-survey-reveals-trends-in-pharmacy-practice?loginreturnUrl=SSOCheckOnly#

The annual survey hit on key health-system pharmacy insights related to formulary management, pharmacogenomics, and opioid stewardship, among others. 

ASHP Annual Survey Reveals Key Trends in Health-System Pharmacy

 Tim, thank you so much for joining me today.

 So what are some of the evidence based prevention strategies amid COVID-19 that have the ability to incorporate AI?

 I think probably in terms of evidence basis of pre-loaded term, I think that, more or less, in the world of treatment because once the diagnosis is made, we can better understand and talk about science. 

I think what we're seeing a lot with AI and thinking about how it can help with treatment: going back to some of the early identification, some of these mobile devices—your smartwatch or your fitness tracker—many of them actually have an oxygen sensor in there that can measure your oxygen saturation. Oftentimes the tech changes in oxygen saturation earlier before the onset of symptoms, or, even though you may have a diagnosis, these sensors can detect that you may be going into trouble into developing a more complicated or severe case before you feel it symptomatically. That is one area where we can see a lot of potential promise, in terms of notifying the individual patient, we can say, “Hey, we notice there's been a change in your oxygenation level, maybe you should get this checked out.” 

Similarly, we certainly are seeing a lot of research interest for the patients who do have the diagnosis and get admitted to the hospital. You all may have heard that a significant portion of the mortality associated with COVID-19 are those who end up getting put on the ventilator in the ICU. What if, using AI, we're reading the records in the electronic medical records and reading those data, and then identifying patients who are about to experience these clinical demise and pick them earlier, instead of waiting until they have developed into a full blown respite failure? 

If we can't identify those patients sooner, we can do other things that may have an impact on changing the trajectory of the outcome. We're talking here in the third week of June, I don't know when people are going to encounter this information. But early this week, we've seen some very positive results from the UK talking about the use of dexamethasone in changing outcomes or improving outcomes in patients with COVID-19. 

Wouldn’t it be nice if we can actually utilize AI to identify those patients that may benefit the most from this treatment, so that we can administer them much earlier, and make sure that those patients have the best chances of surviving this?

 So AI can also help decide how to distribute the different potential treatments.

 I think that is a fair way to summarize that because right now, I think we are still in the early stages of understanding this disease. 

We're even trying to just find out what drug may work. Perhaps some of these drugs may work better in one subset of patients versus the other set of patients. So those are things that we're still trying to learn right now. Certainly, everyone who has received some of these drugs will not have a good outcome. What is the difference between those patients who didn't have a good outcome versus those who do have a good outcome? We don't indiscriminately give these medications that have potential side effects. 

Some of your audience of pharmacists are well aware that steroids can change your glucose metabolism. It can have a significant side effects as well. So, if the use of this drug is not likely to lead to a good outcome, why expose our patients or put them at risk for having some of these side effects. That's very important work that needs to be done in the next few weeks, as we understand this disease more and more, to identify who are likely to benefit and who are not.

You mentioned that pharmacists can use AI to identify side effects. What role do you see pharmacists having in implementing AI into their practice, during the pandemic and then going forward as well?

 Great question. Some of the issues related to COVID-19 is that some of the patients will inevitably develop what we call secondary bacterial infections, because their body is being attacked by the virus. So as a result, the immune system is weakened. So a certain subset of those patients will develop other more common [ailments], like bacterial pneumonia, for example, or things that we see in hospitals all the time, maybe bacteria in the blood, stuff like that. 

I think leveraging AI and then thinking about some of the early detection systems and natural language processing. Electronic Health Record contains a lot of data, including a lot of the laboratory results, vital signs, and a lot the patient status. A lot of human input, for example, when the nurse sees something or a doctor sees something on their physical exam, all that data is still captured in a format that is not discrete. In other words, it's not a yes, no, it is not a number. So a lot of these are just natural sentences that we will say this particular patient has a noted rash, or this patient is non-responsive, those are things that are quite tricky for what we would call a rule-based system to pick up. Using AI, using that natural language processing, where you can leverage AI to use some of that non-structured data, can drive very meaningful outcomes. 

So, you mentioned earlier, how can pharmacists use this type of technology in improving the patient care? Well, if you have a toolbox with natural language processing, that can help them understand which of their patients experienced side effects are some of the treatments. I mentioned earlier, that dexamethasone sometimes can have significant side effects. So if they go in some sort of central nervous system reactions or steroids, these are not things that you can capture in the laboratory results. 

So really, it will be dependent upon the ability of having the program algorithm to read the notes that the nurses are charting, or the doctors are recording so that the system can pick it up and notify the pharmacist: “Hey, this is a patient who may be experiencing side effects with that medication and maybe we need another pair of eyes on it, to see if there's an alternative treatment for that.” 

Similarly, looking beyond the pandemic, how would that change the way that pharmacists would utilize technology to help their patients? I think, again, going back to the way that we think about that larger framework when we first talked about this: how can we identify patients who may potentially have some of these medication-related problems? Because of genetics, pharmacogenomics is another area where we hear a lot of interest and activity. So how can we leverage some of this best technology to read very complex information in the human genome, and unlock those sequences that have been correlated with additional side effects from the medications so that we can change the utilization of those drugs? Looking at the identification of the side effects once they have occurred? Are there any early signals that we can leverage to identify a patient who's about to have a kidney failure during the antibiotics before you can see the manifestation? Even if you didn't catch it 24 hours earlier, you can stop the drug earlier and stop the continual assault on the kidneys. 

Those are areas that are very promising for pharmacists to be an advocate for the patient in managing their medication therapies.

 Are there currently any impediments or challenges in being able to expand AI capabilities?

 With regard to the obstacles and challenges, I think a lot of the health records especially, when we're going to be translating it from the hospital level to the individual clinics or outpatient areas where most of our patients are seeking the care, I think the interoperability is still a problem. We are seeing that if your primary care physician and your hospitals are not on the same electronic health records, they’re unable able to see a data element that is incomplete. That remains a challenge for the healthcare industry that we need to resolve to make sure that it doesn't matter if the information is on one brand of the electronic health record that needs to be easily translated into a second electronic health records. It's not dependent upon the patient's provider to be in the same ecosystem to get all the information. 

The other thing that we need to have a more frank conversation about is with ourselves as healthcare professionals. I think there's a lot of hesitancies and fears about using a database or data science-driven approach to some of these innovations. So how can we reduce the friction where we are not positioning the technology as a replacement or as a competition to the prescriber or pharmacist autonomy, but rather, these are tools that will help them in the clinical decision-making so that they can make the best decision based on the best data available. I think that change management will be a big hurdle for us to overcome, both on the provider side as well as on the healthcare consumer side.

How do you envision AI functioning in healthcare in the near future?

 We had talked a little bit already about the treatment and the management of these different diseases. I think precision medicine is gonna become more and more prevalent. I think people will demand that the treatment plan be tailored and be specific to you as an individual instead of, if you have this particular heart disease go through our drug 1, 2, and 3, and everyone gets put on it. I think people would expect and demand that that the treatment will be based on the best data available for your demographic, your age, your organ dysfunctions, the other diseases that you may have, other drugs that you're taking, so that the treatment will be much more personalized, and your treatment plan will be much more robust in terms of monitoring because as there are more and more events, medications become available in the marketplace. I think the management of these drug interactions and side effects are becoming more and more complex, so having that robust technology to help your pharmacists and physicians to identify any potential problems before they start, or if there is a problem that has started that they would expect that the identification will be much earlier in the course of the disease and this treatment plan. 

There's a lot of promise, and certainly, a lot of applications that we have already been able to even deliver in the marketplace. One of the things that we're just wrapping up is a pilot project in being able to use an AI algorithm to identify patients who may be at risk for developing an infection that is common in a hospital called C. diff. We are so excited to see the precision and how much earlier our model can detect someone who may be at risk for having that. We can even identify those patients, even before they have symptoms. So a project that has really rapidly moved from a proof of concept to being piloted to being made available to customers as early as next month. 

We're not really talking in the abstract here, we're talking about things that are coming to market and people will have access to these tools. I think that's why it excites me to have the opportunity to talk with you about things that we are putting in the hands of our consumers and use it to improve patient care.

Steve, thanks so much for joining me today and your continued work as well.

Expert Interviews

Drug Topics interviews Steve Mok, PharmD, manager of pharmacy services and director of health outcomes and analytics fellowship at Wolters Kluwer, to break down the ways that artificial intelligence can mitigate challenges posed by the COVID-19 pandemic.

Part 2: Innovations in AI Amid COVID-19

A group of pharmacies and pharmacy organizations urged the Centers for Medicare & Medicaid Services (CMS) to formally recognize and promote medical at home pharmacy services for long-term care (LTC)—particularly in the wake of the coronavirus disease 2019 (COVID-19) pandemic.

“With medical at home pharmacy services being needed now more than ever due to the coronavirus public health emergency, long-term care pharmacy stakeholders are urging the Centers for Medicare & Medicaid Services to formally recognize and promote these services to help improve value-based patient care, increase savings, and ensure pharmacy providers are fairly and properly reimbursed,” NCPA said in a press release.

In addition to NCPA, Independent Pharmacy Alliance, American Pharmacy Cooperative, American Society of Consultant Pharmacists, Thrifty White Pharmacy, Smith Drug Company, and numerous other pharmacies, drug distributors, and organizations signed the July 2 

“This demand for at-home care was on the rise before the deadly coronavirus outbreaks in LTC facilities across the country,” they wrote.
“Looking beyond the pandemic, demand will only continue increasing as seniors who need specialized care continue to socially distance due to their increased risks and vulnerabilities.”

In order to “meaningfully address” the increasing aging population with long-term and complex health care needs and those who require assistance with activities of daily living—particularly during the COVID-19 crisis—the groups said CMS should issue guidance formally recognizing these services at the same level as other LTC services.

“Due to the risks our members’ patients may experience leaving their homes at this time, and the immediate need to keep these seniors out of LTC facilities, medical at home pharmacy services can significantly fill these gaps. However, LTC pharmacies and pharmacists need CMS to formally recognize these services at the same level as other LTC services,” the groups wrote.

1. Stakeholders to CMS: COVID-19 pandemic underscores urgent need for medical at home pharmacy services. Press release. NCPA: July 7, 2020. Accessed July 7, 2020. 

https://ncpa.org/newsroom/news-releases/2020/07/07/stakeholders-cms-covid-19-pandemic-underscores-urgent-need

2. Increasing need for medical at home pharmacy services during COVID-19. Letter. July 2, 2020. Accessed July 7, 2020. 

https://ncpa.org/sites/default/files/2020-07/joint-cms-letter-re-covid-medical-at-home.pdf

A group of pharmacies and pharmacy organizations urged the Centers for Medicare & Medicaid Services to formally recognize and promote medical at home pharmacy services for long-term care. 

Pharmacy Groups Urge CMS to Reimburse for Medical at Home Services

Herpes zoster (shingles) is considered to be one of the most 

 common medical conditions. But approximately 1 in 6 patients with shingles end up experiencing a new and enduring level of pain when they develop postherpetic neuralgia (PHN).

The condition is defined as recurring or persistent long-term nerve pain in an area of the body that has suffered an outbreak of shingles, which is caused by the varicella zoster virus (VZV). The virus initially causes chickenpox in an individual, then goes dormant in their dorsal root ganglia for decades. When it 

, it moves to the skin to resurface as a blistering rash, damaging the sensory nerves that register pain and pressure along the way.

PHN is the result of that nerve damage, and the most common chronic complication of shingles. Its onset typically begins after the shingles blisters crust over and start to heal, but it can also occur in individuals with 

. The dermatomal pain associated with PHN lasts at least 90 days after the appearance of the shingles rash, but can extend unremittingly for months or years.

Statistics show that approximately 1 out of every 3 people in the United States will develop shingles in their lifetime, or an estimated 1 million cases each year. The 

 notes that between 10% and 18% of them will experience PHN, and that the risk increases with age.

“An older adult with shingles is more likely to develop PHN and have longer lasting and more severe pain than a younger person with shingles. People younger than 40 rarely experience PHN,” according to the CDC.

DelveInsight's "Postherpetic Neuralgia - Market Insights, Epidemiology, and Market Forecast-2030"

 on PHN epidemiology in 7 major countries, including the United States. It observes that people over the age of 60 have about a 60% chance of developing PHN after having shingles. That number rises to 75% for individuals who are 70 or older.2

The level of pain associated with PHN is reflected by the types of treatments that are used. It typically requires an individualized, multi-pronged approach using a combination of options.

 containing lidocaine or capsaicin can be applied directly to the affected area of skin for temporary pain relief. Anticonvulsants like gabapentin and pregabalin are used to stabilize abnormal electrical activity caused by injured nerves. The antidepressants nortriptyline, amitriptyline, duloxetine, and venlafaxine target key brain chemicals that determine how the body interprets pain. Opioid painkillers—including tramadol, oxycodone, and morphine—can also be prescribed in low doses if closely monitored. 

The only way to avoid both shingles and PHN is through vaccination. 

 has been approved by the FDA for adults 50 years and older. It also received a preferred recommendation from the CDC’s Advisory Committee on Immunization Practices for the prevention of shingles and related complications.

Shingrix has an efficacy rate of over 90% in clinical tests, far surpassing that of the only other shingles vaccine on the market, Zostavax. It also has been shown to induce 

 in older adults who are at greatest risk.

1. CDC. Shingles (Herpes Zoster). Complications of Shingles. Page last reviewed July 1, 2019. Accessed July 6, 2020. 

https://www.cdc.gov/shingles/about/complications.html

2. Postherpetic Neuralgia Market Size & Share, Epidemiology and Forecast till 2030. Press Release. DelveInsight. Accessed July 6, 2020. 

The lowdown on shingles’ most common complication.

Postherpetic Neuralgia Overview	

Xeris Pharmaceuticals’ glucagon injection (Gvoke HypoPen) is now available by prescription in the United States for the treatment of severe hypoglycemia in adults and children with diabetes ages 2 years and older, according to a press release.

The glucagon injection is a ready-to-use glucagon in a premixed autoinjector, with no visible needle, according to Xeris. The easy-to-use pen is available in 2 doses: 0.5 mg/0.1 mL for children who weigh less than 100 pounds and 1 mg/0.2 mL for adolescents and adults who weigh 100 pounders or greater.

According to Xeris, the glucagon injection’s simple administration guarantees a reliable method of delivery, with 99% of patients who were able to use it correctly in studies. Additionally, studies also showed that 99% of adults and 100% of children had their blood sugars raised to safe levels with use.

“Gvoke HypoPen allows the diabetes community to change how we approach treating severe low blood sugar events,” Bruce Bode, MD, FACE, Atlanta Diabetes Associates, said in a statement. “Anyone can use Gvoke HypoPen in 2 simple steps. That opens the door for some patients to even give it to themselves, in certain situations. My hope is that what was once considered a crisis moment, can now become a manageable situation with Gvoke HypoPen.”

For limited time, eligible commercially insured patients may pay as little as $0 for a 2-pack of Gvoke HypoPen by using the Gvoke copay savings card. Xeris also offers a Patient Assistance Program to help those who qualify, according to the release.

Xeris Pharmaceuticals Announces Gvoke HypoPen – the First Autoinjector for Severe Hypoglycemia – Now Available. News Release. Xeris Pharmaceuticals; July 1, 2020. Accessed July 6, 2020. 

https://investors.xerispharma.com/node/7721/pdf

Xeris Pharmaceuticals’ new glucagon injection (Gvoke HypoPen), a ready-to-use glucagon formulation in a premixed autoinjector, is now available by prescription. 

Ready-to-Use Glucagon Injection for Severe Hypoglycemia Now Available 

ZosterGent Reagent, a fast fluorescent antibody test for the detection and confirmation of the varicella zoster virus (

), is now available for use with high-risk patients, including those who are immunocompromised. Its launch was announced by Georgia-based 

The 1-step, 1-solution test delivers results in less than 30 minutes, according to cellular biologist and Viro CEO Nicholas Vafai, PhD, MBA. He founded the company with his father, microbiologist Abbas Vafai, PhD, a former chief of the biologics branch at the CDC and inventor of the shingles vaccine 

“We think the Shingrix vaccine has been very effective, and we thought it was a great time to bring more attention to the actual diagnosis of shingles with a very simple, sensitive, and rapid test for the infection of the varicella zoster virus,” Dr Vafai told 

There are other tests for the detection of VZV—the virus that causes both chickenpox and shingles—such as PCR and ELISA. They can be processed in large batches, making them attractive to high-volume reference labs. "However, pathologists may be required to directly detect and observe the infected cells in skin lesions and in the patient's tissue under the microscope, which is why they would prefer ZosterGent,” Vafai noted.

ZosterGent is an immunofluorescent assay (IFA) approach that offers a mix of 6 highly unique and specific monoclonal antibodies. The process begins when a health care provider takes a sample from a patient’s lesion vesicles and sends it to a laboratory.

After preparing the sample, a lab technician views it under a fluorescent microscope. Positive samples appear with a bright green intensity that makes the specimen easy to see and recognize. The health care provider can receive test results within 24 hours.

“Immunofluorescent assays are one of the gold standards, highly specific and sensitive tests that have been used for decades now,” explained Vafai. “Research institutions and hospitals that have their own virology labs or diagnostic facilities onsite can know the result very quickly and be very confident that the result is accurate.”

Quick and accurate diagnosis of shingles is particularly important for ZosterGent’s target group, immunosuppressed individuals including patients with HIV or 

. Early treatment of shingles with antivirals can shorten the length of the illness and reduce the risk of developing serious complications like 

ZosterGent Reagent, a fast fluorescent antibody test for the detection and confirmation of the varicella zoster virus, is now available for use with high-risk patients, including those who are immunocompromised.

New Test Available for Varicella Zoster Virus Detection 	

Officials with the FDA recently issued an emergency use authorization (EUA) for the third diagnostic test for the detection and differentiation of the viruses that cause influenza and coronavirus disease 2019 (COVID-19), according to a press release.

The Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay is a real-time reverse transcriptase polymerase chain reaction (PT-PCR) test that detects and differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens. The assay provides a sensitive, nucleic-acid-based diagnostic tool for evaluation of specimens from patients in the acute phase of infection.

The agency previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in additions to the viruses that cause flu and COVID-19.

States Slowly Ease Barriers to Pharmacist-Provided COVID-19 Testing

Combinations tests work by testing a single sample from a patient for multiple respiratory diseases. The dual test allows for ongoing flu surveillance while also testing for COVID-19. Information about both viruses will help public health officials to control the spread of influenza and COVID-19 in the community and may help health care providers manage treatment of influenza and COVID-19, according to the CDC.3 Additionally, combination tests alleviate the need for multiple samplings, which helps facilitate faster and more comprehensive results. Combination tests also require fewer supplies and reduce pressure on the supply chain for reagents, according to the FDA.

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during COVID-19 pandemic, which might be especially worrying for some Americans,” FDA Commissioner Stephen Hahn, MD, said in a statement.

 “With just 1 swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

The Flu SC2 test kit was evaluated in CDC laboratories and 3 other public health laboratories to ensure that the test works as intended. Test kits will be shipped to public health laboratories when production, including quality control and assembly, has been assembled.

1. Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season. News Release. FDA; July 2, 2020. Accessed July 6, 2020. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-covid-19-combination-diagnostic-test-ahead-flu

2. CDC. CDC’s Diagnostic Multiplex Assay for Flu and COVID-19 Supplies. Updated July 3, 2020. Accessed July 6, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/lab/multiplex.html

3. CDC. CDC Diagnostic Tests for COVID-19. Updated July 3, 2020. Accessed July 6, 2020. 

https://www.cdc.gov/coronavirus/2019-ncov/lab/testing.html

The FDA has granted emergency use authorization to an additional combination diagnostic test for influenza and COVID-19. 

FDA Authorizes Third Combination Diagnostic Test for Flu and COVID-19

 Your research has focused on antimicrobial stewardship and infectious disease, and also on artificial intelligence. Can you provide a little bit of your professional background in antimicrobial stewardship and your interest in artificial intelligence (AI) as well?

 My background is pharmacy, and I had spent 16 years in the world of infectious disease, establishing an antimicrobial stewardship program in a variety of settings and health systems prior to joining in Wolters Kluwer 2017.

Since I joined Wolters Kluwer, I've been engaging in quite a few projects on collaborating with our data science team on how we can leverage technology to improve the delivery of pharmacist-based patient care interventions to improve and optimize patient outcomes.

Even though my background is on infectious disease and antimicrobial stewardship, a lot of the hands-on experience in the world of AI have been my collaboration projects with a lot of the data scientists to gain experience in the past few years and seeing some of the exciting developments in terms of what we can do when you put clinicians and technologists together that can derive the biggest benefit for patients.

 How do we currently see AI being used in healthcare?

 That is a loaded question, and I will try to address that briefly. In my humble opinion, if you could look at the human body and pathophysiology, the 3 major areas where we see the biggest promise in terms of AI would be in the prevention, diagnosis, and treatment of diseases. If you allow me briefly, I will touch on a few of these.

For example, prevention is getting better and better in understanding what some risk factors are that lead to the development of certain disease states, and this is near and dear to my heart. For a lot of infections, we have a good understanding of what can lead to an increased risk for developing some of these bacterial viral infections.

If we can leverage AI to identify these patients earlier, we may have an opportunity to remove some of those risk factors or change people's behaviors that may result in a low rate of infection, if you will.

In terms of diagnosis, I'm sure some of you have heard, even in the in the general news, a lot of the AI algorithm has now been deployed to read some of the radiology records, look at CT scans, stuff like that, to help physicians with clinical decision making using an AI to see if there's a disease process that they may have missed, or to confirm some of the diagnosis that they have already made.

Similar applications of AI can be used in the world of laboratory testing. There are other records that are in the patient's charts, where the technology can help identify patients with diseases a little bit earlier. That’s where we see AI being applied for the diagnosis part of human diseases being the most promising.

Finally, the last part I mentioned, treatment is another area. If we can prevent and then diagnose a patient with disease, we’re interested in what treatment can help patients we cover or manage with these disease states. In the world of treatment, we're seeing a lot of the researchers in the academic or in the commercial setting, leveraging AI to help them with drug discovery, looking at new molecular entities and identifying targets or agents that may be of interest and may have promise in terms of accelerating the path into becoming a usable human drug.

Closer to the pharmacists heart: some of these treatments also can have side effects. We're talking a lot about precision medicine these days. How can we leverage technology to understand a patient's specific characteristics, such as their organ function, their genomics, and other characteristics to help identify some of those patients who may be at risk for having adverse outcomes or side effects in some of these treatments, and that may change some of the prescribing decisions. A first line drug that may be good for you may not be so good for me because of the differences that are inherent between us as 2 different human beings.

Using technology has a lot of promise, instead of having - I hesitate to use the term cookbook medicine to describe what is the first-line treatment - the first-line treatment may look different based on the patient’s individual characteristics.

 How can AI be used to identify individuals at risk for contracting COVID-19?

Mok: That's a great question. In terms of what we're seeing with COVID-19, I think some of the things that we're learning a lot about the disease since it was first identified at the end of 2019: we're learning how it is impacting the human body, and then we're also learning a lot about what treatment works and what treatment doesn't work. I think the greatest area of interest right now is identifying patients who may have been exposed or who may have been at high risk for contracting the virus. We recognize that a significant portion of patients may be asymptomatic, and they don't even know they are carrying the virus, and yet at the same time, they can be transmitting the virus or other people who may be more vulnerable or at a higher risk or having complications.

Some of the technology that we've seen so far: using your phone to identify whether you've been exposed to somebody who might have been identified as a carrier. That can facilitate contact tracing, which is such a buzzword now. It warms my heart, as an ID specialist, this is a term that I know, but now has become a common lingo in the in the lay community.

How can we use technology to do this very labor-intensive contact tracing? If we could have the ability to actually put in a magical number that said, “Oh, this person is diagnosed with COVID-19 and then using the technology to roll back the 10 days, 7 days before, where the individual had interacted with other people and then notifying them that they may have been exposed or that they can take the proper precautions as far as getting tested.” That is very, very exciting and promising.

Certainly, we're not just talking about proof of concept. This type of technology has already been used in the United States, and we see that recently Europe has reopened, and they have certainly enabled some of this technology in European countries, where people can opt in to be notified as well as opt in to be made aware of the chain of folks that may have been exposed to the infection.

 You mentioned Bluetooth can be used. Could AI take the form of applications on people's phones for COVID-19?

 Absolutely. Some of the things that we've seen, AI can actually be used without diagnosis. There's certainly a possibility as people do searches, right? If you have a headache or you lost a sensation, we see that searching symptoms is often the first thing people do. Thinking about these symptoms, you have to go through an internet search engine and type in those keywords to look for those things. Mobile device search history can help at the macro level for local governments for better understanding how many people or how many citizens in our locality are searching for these terms.

Even though we may not be able to contact trace 100% of our citizens for this disease, we can leverage some of those searches to help local government agencies understand how often people are searching for these types of terms to have a better understanding of the impact of the disease in your local community.

 Steve, thanks so much for joining me today and your continued work as well.

Drug Topics interviews Steve Mok, PharmD, BCPS, BCIDP,
manager of pharmacy services and director of health outcomes and analytics fellowship at Wolters Kluwer, to break down the ways that artificial intelligence (AI) can mitigate challenges posed by the COVID-19 pandemic.

AI Innovations Amid COVID-19

the Journal of the American Heart Association

 discovered that women living with HIV (WLWH) who have persistent levels of depression may exhibit a greater risk of heart disease.

The goal of the study was to identify reasons for why women with HIV tend to have increased atherosclerotic risk, the risk of plaque building up in arteries, which is a key contributor to heart attacks and strokes.

The study consisted of data collected from a sample of 700 women from a sub-study of the Women’s Interagency HIV study. Participants were divided into 2 latent classes for determining their psychosocial risk: high and low. Of the 700 women, 163 were identified as having high psychosocial risk, and 637 as having low psychosocial risk. The prevalence of depression, high stress, and probably post-traumatic stress disorder was also evaluated.

Compared with HIV-negative women, who respectively held 9% for plaque prevalence for both high and low psychosocial risk classes, WLWH had a plaque prevalence of 23% and 11% in their high and low psychosocial risk classes. The prevalence of plaque continued to build as symptoms of depression persisted.

Matthew Levy, lead investigator of the study and a research scientist in the epidemiological department at the Milken Institute School of Public Health at George Washington University in Washington, DC, said that previous studies had already found that women and men with HIV were at higher risk for heart disease, regardless of whether they exhibited high levels of depression or stress. “What our results show is that mental health factors may be further contributing to this risk,” he said.

Levy also suggested that HIV care providers screen patients for symptoms of depression and stress.

Dr Matthew Feinstein, a cardiologist and assistant professor of medicine at Northwestern University’s Feinberg School of Medicine in Chicago, concurred. “What this study tells us to do is consider the whole patient, consider the broader social context in which the patient exists. We have to ensure patients get all the support that they need, not just medically.”

The study concluded that while the psychosocial factors chosen were independent atherosclerotic risk factors among WLWH, they still supported furthering research into developing interventions for depression and stress in order to potentially mitigate and treat the increased risk.

Levy ME, Anastos K, Levine SR, et al. Depression and psychosocial stress are associated with subclinical carotid atherosclerosis among women living with HIV. 

Journal of the American Heart Association.

American Heart Association News. Persistent Depression might increase heart disease risk for women with HIV. News Release. American Heart Association; June 22, 2020. Accessed June 30, 2020. 

https://www.heart.org/en/news/2020/06/22/persistent-depression-might-increase-heart-disease-risk-for-women-with-hiv

A new study found increased plaque buildup levels in women with HIV who also suffered from persistent depression and stress. 

Women With HIV and Persistent Depression May Experience Greater Risk for Heart Disease

 Hi, this is Gabrielle Ientile with Drug Topics®. Today I'm going to be speaking with Dr. Cheryl Wisseh, PharmD, MPH, and zone 5 director of the National Pharmaceutical Association (NPhA) about their commitment to racial equality and dismantling racism within healthcare.

This interview was prompted by the joint statement that was made by 14 national pharmacy organizations that came out in support of protests for the end of police brutality. But the protests also represent how many different sectors, including the healthcare sector, must actively work towards ending racism within their system.

To start out, would you highlight some of the key messages from this joint statement and what the statement means to your organization and NPhA?

So some of the key messages and coming directly from this statement is the unity within the organizations that were standing in unity to advocate for the dismantling of systemic racism that have historically marginalized and oppressed Black Americans in this country.

So advocating for measures that eliminate these inequities that result from this discrimination and systemic racism, and working together to provide opportunities to address healthcare disparities, in every facet of our profession, including patient care, pharmacists, pharmacy technicians, continuing education, student pharmacists’ education, workplace practices,  pharmacy school admissions, leadership opportunities, and even the organizational policies.

So it's a multifaceted approach from all of these organizations to dismantle the system, if you will, using different tools, initiatives, and intentional training and programs to look at this and finally move forward with it and create a generation of pharmacists that will be better equipped to fight this kind of second pandemic, and advocate for equity and actually create a more equitable world.

 So what do you see as the importance of pharmacies and pharmacists in addressing racism in health care and supporting the Black Lives Matter protests?

 It has to do with our code of ethics as pharmacists. And 1 of the tenants in our code of ethics is that a pharmacist serves individual community and societal needs.

Pharmacy and public health do have an intersection in their shared goals to promote the health of individuals, communities and society overall. Racism in all its forms – structural, institutional, interpersonal, or even internalized – is a public health issue. Since it has negative impacts on the health of individuals and communities of color and society overall, then that means it becomes a pharmacy issue, because pharmacy has that shared goal with public health.

And there's another tenant within our code of ethics that also says, as a pharmacist, we seek justice in the distribution of health resources. Delving a little bit deeper into structural racism, for instance: in order to understand structural racism, you need to know that American society in and of itself has racial discrimination built into the foundation. That includes all of the social structures and systems, so housing, education, employment, wage, earnings, credit approval, entertainment, media, and most importantly, healthcare.

Over time, you have this discrimination that is compounded within these systems and leads to that reinforcement of discriminatory beliefs and values that are discriminatory and then an equitable distribution of the resources that are within the system.

In thinking of all of that as pharmacists, we're seeking justice like that tenant says, in the distribution of healthcare resources, since structural racism also affects the healthcare system, we need to address these forces of structural racism. Because it places 1 group, which is white Americans at an unfair advantage, and then Black Americans and other non-Black People of Color at disadvantage.

For instance, you have the example of the medication availability and pharmacy deserts, so you have the literature in pharmacies showing that there's limited access to community pharmacies, the actual establishment, services, and commonly used medications based on racial segregation. In recognizing that there's this unearned privilege that in this system, pharmacists must empathize with the plight of Black Americans and strive to truly understand what it means when it is said that all Black lives matter because for centuries, there has been human suffering on the part on Black Americans in the United States, and that also leads to another part of our oath that we take as pharmacists that I will consider the welfare and humanity and relief of suffering, my primary concern, so it kind of is built into our code of ethics and our oath and we should aim, and must live up to that oath, when we take it, because we do take it.

 I just wanted to swing back around to the systemic structural factors. I know you did a great job of explaining that I was just wondering if there were other examples that you wanted to bring to light?

 Definitely. There is quite a bit I actually wanted to talk about with that.

In general, those systemic and structural factors are the social determinants of health (SDOH). So these are the conditions, those environments, that populations of people are born, live, work, play, worship and age – and this is the definition of course by Healthy People 2020 – given by that framework.

In a nutshell, they're tangible and also intangible resources that can affect the quality of life and health outcomes. Depending on which side you fall on those tracks, whether it's privilege, or it's disenfranchisement and lack, they can be life damaging, but they can also be life enhancing.

In regards to thinking about that systems approach, the social determinants in of themselves, include your economic stability, your education, the social context, the community context in which you live in, health and healthcare as we've been discussing, the neighborhood, and just that overall built environment, and to tie it back to structural racism, is shaped – the social determinants in of themselves what we see in people's lives – those conditions are shaped by how money is distributed, how power is distributed, and resources just throughout the communities and within in the world.

So, the social determinants are somewhat of like a playing field, if you will, and on the social determinants, this foundation, health disparities are built on this. Health disparities, or those inequities, are in and of themselves built by the structural inequity that comes from structural racism and other structural biases. These domains include race, and then it could be ethnicity, it could be gender, gender identity, or class or sexual orientation, but it always is a systemic disadvantage between 1 social group when compared to the other social group with whom they coexist, so you juxtapose power and privilege with lack and disenfranchisement.

Dr. Cheryl Wisseh, PharmD, zone 5 director of the National Pharmaceutical Association (NPhA) discusses the ways that the current pandemic is displaying and doubling down on long standing disparities in our health care system.