) is a common condition that is estimated to affect approximately 10% to 20% of the population in the Western world.

The most common symptom of GERD is heartburn, which can be described as a burning sensation in the middle of the chest or in the middle of the abdomen. Other symptoms that may be suggestive of GERD include bad breath, nausea, vomiting, painful and/or difficult swallowing, respiratory complaints, and wearing away of the teeth.

 An important element in the etiology of GERD is the abnormal reflux of gastric contents from the stomach into the esophagus, oral cavity, and/or the lung.

 Gastroesophageal reflux may be associated with defective lower esophageal sphincter (LES) pressure or function, which may be due to spontaneous transient LES relaxations, transient increases in intra-abdominal pressure, or an atonic LES; other etiologies may also contribute to the development of GERD.

The first step in managing GERD includes nonpharmacologic interventions/lifestyle modification. Patients presenting with GERD symptoms should be counseled on strategies that may address their symptoms. Patients who are overweight or those who have recently gained weight should be counseled about the importance of weight loss. It is important to note that GERD symptoms may develop even in those individuals with a normal body mass index who experienced recent weight gain.

The weight loss goal in patients suffering from GERD should be at least 10%.

 Patients, especially those who suffer from nocturnal GERD, should also be counseled about the benefits of elevating the head of the bed and avoiding meals 2 to 3 hours before bedtime.1 Head of bed elevation can be achieved by inserting a foam wedge under the mattress such that the head of the bed will be elevated by 6 to 8 inches. Traditionally, patients suffering from GERD have been counseled about the need to quit smoking and eliminate foods that are believed to trigger reflux, including chocolate, caffeine, alcohol, acidic and/or spicy foods, as these may decrease LES pressure or act as direct irritants to the esophageal mucosa. However, because clinical evidence to support the global avoidance of “trigger” foods is lacking, guidelines published in the 

 note that this strategy is not recommended in the management of GERD.

Pharmacologic management should be reserved for patients in whom non-pharmacologic interventions/lifestyle modifications were unsuccessful. The pharmacologic management of GERD is primarily aimed at acid suppression, which at times may be accompanied by adjunctive treatment with promotility agents.

 Acid suppression may be achieved with the use of non-prescription antacids, which are appropriate for treating milder intermittent GERD symptoms. Patients suffering from more severe or chronic symptoms usually require treatment with proton pump inhibitors (PPIs) or with H2 receptor antagonists (H2RAs).

 The various PPIs on the market are similar to one another in efficacy, useful in the management of moderate-to-severe symptoms, and generally produce long-lasting effects over the course of the day. When treatment is initiated, PPIs are typically dosed once daily, with the dose administered prior to the first meal of the day. Traditional delayed-release PPIs should be administered 30 to 60 minutes before a meal, but dexlansoprazole can be dosed more flexibly relative to the timing of the meal. Patients that only respond partially to PPI therapy may benefit from adjusting the timing of the dose, twice daily dosing, and/or switching to another PPI. In patients with mild-to-moderate disease, H2RAs may be appropriate. These agents, which are also similar in their efficacies to one another, are usually dosed in divided doses, but often produce suboptimal results.

 Promotility agents, such as metoclopramide, may be used as adjuncts to acid suppression therapy in patients with a known motility defect; however, these agents generally have undesirable adverse effects and their efficacy is limited.

Dr Nathan is the director at the International Drug Information Center and associate professor at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University.

Dr Grossman is a drug information specialist at the International Drug Information Center and adjunct assistant professor at Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University.

1. Katz PO, Gerson LB, Vela MF. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. 

. 2013;108(3):308-328. doi: 10.1038/ajg.2012.444.

2. The National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms & Causes of GER & GERD. November 2014. Accessed June 30, 2020.

https://www.niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-adults/symptoms-causes

3. May D, Thiman ML, Rao SSC. Gastroesophageal Reflux Disease. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V, eds. Pharmacotherapy: A Pathophysiologic Approach, 11e. McGraw-Hill; 2020.

Articles

Pharmacists can counsel patients with GERD on strategies to address their symptoms. 

Gastroesophageal Reflux Disease: A Focus on Management and Patient Education

Following a review of 2 new 2019 Federal Advisory Committee on Immunization Practices (ACIP) recommendations, the American Cancer Society (ACS) has updated its guidelines for human papillomavirus (HPV) vaccination.

Guidelines for use of the HPV vaccine were first issued in 2007; an update to those guidelines were published in 2016. The latest update addresses key concerns surrounding when routine vaccination should begin, the effectiveness of subsequent catch-up vaccinations, and whether to recommend shared clinical decision-making about vaccination. The ACS, in adapting these concerns, also provided several qualifying statements regarding their own interpretation of the new set of guidelines.

Both the ACIP and ACS recommend that girls and boys should receive 2 doses of the HPV vaccine when they are between the ages of 9 and 12.

In their qualifying statement, the ACS noted the presence of emerging evidence suggesting that series completion rates and vaccine acceptance tended to be higher when vaccination began as early as 9 instead of 11, which previous guidelines had recommended.

Parents also reported a greater sense of ease with administering vaccines early on, preferring to have fewer shots per visit. The ACS affirmed that the subsequent higher rates of completion and vaccine acceptance meant higher rates of cancer prevention, thereby increasing overall vaccine effectiveness.

The newest guidelines emphasize that children and young adults up to age 26, who have not received the vaccine, should be vaccinated, since vaccination of young adults will not prevent as many cancers as vaccination of children and teens.

The ACS qualified their statement by suggesting that providers inform individuals from the age range of 22-26 about the risk of lower efficacy. This updates the previous 2016 guidelines, which could not determine a harmonized age range between both men and women, and also reaffirms increased opportunity for college-aged individuals and those still under their parents’ household to gain access to vaccination.

The ACS does not recommend that individuals older than 26 receive the HPV vaccination.

Although the ACIP suggested that adults aged 27 to 45 years should receive the HPV vaccination, the ACS does not endorse this, due to the low effectiveness and low cancer prevention rate within this age group. The effectiveness of the HPV vaccine dramatically decreases by age 18 and minimal benefits are noted by age 20. The ACS also noted that although the vaccine is safe to receive for adults in the 27 to 45 age range, the benefits are severely limited.

Regarding the additional recommendation that the ACIP made about having shared clinical decision making for clinicians and adults, the ACS worries that such a discussion may interfere with efforts for vaccination at younger ages. Furthermore, the ACS noted that the recommendation may unintentionally suggest increased parental focus on their children’s future sexual behavior rather than on cancer prevention.

The HPV vaccination, since its 2006 unveiling, has successfully reduced the number of genital warts, recurrent respiratory papillomatosis, cervical precancers, and cervical cancers in the global population. Yet, lower rates of HPV vaccination in the United States have prompted a re-commitment to eliminating the disease as early as possible.

Combining HPV vaccination and cervical cancer screening could possibly prevent tens of thousands of cancer-related mortalities each year, the ACS concluded. Vaccination of adolescents ages 9 to 12 years will prevent almost 90% of cancers for which HPV is responsible. Given this, the ACS hopes that this will lead to the first elimination of a cancer in history.

Saslow D, Andrews KS, Manassaram-Baptiste D, Smith RA, Fontham ETH. Human papillomavirus vaccination 2020 guideline update: American Cancer Society guideline adaptation. 

ACS Updates HPV Vaccination Recommendations to Start at Age 9. News Release. American Cancer Society; July 8, 2020. Accessed July 8, 2020. https://www.cancer.org/latest-news/acs-updates-hpv-vaccination-recommendations-to-start-at-age-9.html

The American Cancer Society has updated its guidelines regarding the administration of the HPV vaccine.

American Cancer Society Updates Guidelines for HPV Vaccination

Merck announced new findings from its phase 2b clinical trial which assessed islatravir, its investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) in combination with doravirine (Pifeltro, Merck) in antiretroviral treatment-naïve adults with HIV-1 infection, as well as analyses from its phase 3 DRIVE-SHIFT trial.

The latest analyses of these 2 trials will be offered at 2 oral presentations taking place at the 

, which has been made virtual in response to the novel coronavirus disease 2019 (COVID-19) pandemic.

Phase 2b Sub-Analysis of Investigational 2-Drug Regimen of Islatravir Plus Doravine

The international, multicenter, randomized, phase 2b clinical trial evaluated patients with HIV-1 infection by assigning them to 1 once-daily oral treatment group: islatravir 0.25 mg, 0.75 mg, or 2.25 mg in combination with doravirine 100 mg and lamivudine (3TC) 300 mg compared with doravirine 100 mg/3TC 300 mg/tenofovir disoproxil fumarate 300 mg (TDF).

After a minimum of 24 weeks of treatment, participants receiving islatravir with HIV-1 RNA less than 50 copies/mL that had not met protocol defined virologic failure (PDVF) criteria altered treatment course to receive a 2-drug treatment, including the same dose of islatravir, as well as doravirine 100 mg without 3TC.

The 48-week treatment demonstrated decreased rates of drug-related adverse events (AEs) in participants in the islatravir groups (7.8%) compared with the doravirine/3TC/TDF group (19.4%). The study found that instances of AEs were more frequent in the first 24 weeks compared with the second half of the trial.

At week 48, PDVF rates were low; all participants who discontinued due to PDVF expressed levels of HIV-1 RNA below the clinically significant level of 200 copies/mL. Observed low-level viremia was similar to those reported in previous studies that included treatment-naïve patients. Investigators stressed the importance of continuing research in this area of HIV-1 infection treatment.

Phase 3 Sub-Analysis of DRIVE-SHIFT Trial

The latest findings from the phase 3 DRIVE-SHIFT trial, which assessed patients that had shifted treatment to doravirine/3TC/TDF, found that weight changes in patients reflected the average change reported in HIV-negative adults in the United States. Following the treatment change, patients in the Immediate Switch group gained 1.4 kg, whereas those in the 2-year Delayed Switch Group gained 1.2 kg.

“The initiation of some types of antiretroviral therapy in people living with HIV has been associated with weight gain,” said Princy Kumar, MD, chief, division of infectious diseases and tropical medicine at MedStar Georgetown University Hospital and professor of medicine and microbiology, Georgetown University School of Medicine, Washington, DC. “Our post-hoc analysis of weight changes from the Phase 3 DRIVE-SHIFT trial showed weight changes with Delstrigo comparable to the average annual weight gain observed in the general adult population.”

Prescribing information for doravirine can be found 

, and prescribing information for doravirine/3TC/TDF is available 

Merck Announces New Analyses Showing Additional Safety and Efficacy Data for Investigational Islatravir in Combination with Doravirine in Adults with HIV-1 Infection. News Release. Merck; July 6, 2020. Accessed July 7, 2020. 

https://www.mrknewsroom.com/newsroom/news-releases/news-details/2020/Merck-Announces-New-Analyses-Showing-Additional-Safety-and-Efficacy-Data-for-Investigational-Islatravir-in-Combination-with-Doravirine-in-Adults-with-HIV-1-Infection/default.aspx

Both trial sub-analyses will be presented at the virtual 23rd International AIDS Conference.

Merck Announces New Trial Results for Islatravir Plus Doravirine in Antiretroviral-Naïve Adults With HIV-1

Walgreens and VillageMD announced today their commitment to making Walgreens the first national pharmacy chain to integrate physician offices at their locations on a large scale, effectively providing full-service to their patients through an integrated model.

The partnership aims to open between 500 and 700 “Village Medical at Walgreens,” a full-service clinic led by physicians, in upwards of 30 US markets within the next 5 years. Village Medical at Walgreens plans to staff an estimated 3600 primary care providers, with recruitment being led by VillageMD. Pharmacists will be uniquely integrated as critical members of the multi-disciplinary team, according to Walgreens. 

“This rollout is a major advancement of one of Walgreens Boots Alliance’s 4 key strategic priorities, Creating Neighborhood Health Destinations,” said Stefano Pessina, executive vice chairman and chief executive officer, Walgreens Boots Alliance. “These clinics at our conveniently located stores are a significant step forward in creating the pharmacy of the future, meeting many essential health needs all under one roof as well as through other channels.”

The expanded partners have been conducting a trial of this new integrated model in the Houston, Texas region, and reported favorable results since opening the test location in November; patients rated the full-service doctor office highly, with Net Promoter Scores above 90.

The prevalence of multiple chronic conditions in the United States, and thus increasingly complicated maintenance of these conditions, renders the full-service model critical in its ability to offer expanded and accessible health care options to Americans. Six in 10 Americans live with at least 1 chronic condition requiring multiple daily medications, and data stemming from Village Medical clinics have demonstrated the importance of integrating primary and pharmacy care, as it supports medication adherence and improved patient outcomes.

“In the US, we spend $4 trillion per year on health care, over 85% of that is tied to patients with chronic diseases. To improve our healthcare system and reverse the trajectory of health spending, we must meet the needs of all patients. This partnership allows us to unleash the power of primary care doctors and pharmacists, enabling them to work in a coordinated way to enhance the patient experience,” said Tim Barry, chairman and chief executive officer, VillageMD. “The results of our initial pilot clinics highlight that these outcomes are infinitely achievable.”

The clinics will accept a wide range of health insurance options, as well as comprehensive primary care across a broad range of physician services, according to Walgreens. Continual care will be available through telehealth and at-home visits. 

Walgreens and VillageMD to Open 500 to 700 Full-Service Doctor Offices within Next Five Years in a Majoir Industry First. News Release. Businesswire; July 8, 2020. Accessed July 8, 2020. 

https://www.businesswire.com/news/home/20200708005320/en/Walgreens-VillageMD-Open-500-700-Full-Service-Doctor

Village Medical at Walgreens will staff a multi-disciplinary team, with pharmacists functioning as key members of the integrated model. 

Walgreens to Offer Large-Scale, Full-Service Physician Offices At Stores

Lack of fluctuations in the abundance of gut bacteria over a 24-hour time period can indicate that an individual has type 2 diabetes, according to a study published in the medical journal 

“When certain gut bacteria do not follow a day-night rhythm, so if their number and function does not change over the course of the day, this can be an indicator for a potential type 2 diabetes disease,” explained chronobiologist Silke Kiessling, co-contributor to the study. “Knowing this can improve diagnosis and outlook of type 2 diabetes.”

Alongside lifestyle, genetics, and obesity, the gut microbiome is an important risk factor for predicting metabolic disorders and nutrition-related diseases. Changes in the microbiome can correlate to changes in the metabolic health of an individual. Gut bacteria are evaluated by taking fecal samples for research purposes.

The study observed 2 population cohorts, 1 from a German population called KORA, and 1 from an independent population in England called FoCus. In the German population, 1976 individuals demonstrated a positive correlation between oscillations in the number of microbiota members and the abundance of type 2 diabetes among the population. In the independent population, 1363 confirmed positive correlations between microbial oscillations and type 2 diabetes prevalence. An additional 699 individuals from the German population were successfully predicted to be diagnosed with type 2 diabetes 5 years after the initial sampling.

In these cohorts, arrhythmic bacteria—those that do not change in the 24-hour cycle—are considered markers for potential disease, and the investigators refer to these markers as risk signatures. A change in the number therefore represents an increased possibility of contracting a nutrition-related disease.

The study placed special importance on registering the time of day that gut bacteria samples were taken, and posited that changes in the gut bacteria may affect other microbiome-associated diseases, such as Crohn disease or intestinal cancer. Further research is required to verify this, according to investigators.

The use of cohort studies also warranted future work, as the investigators offered the possibility of re-examining the individuals in the population over time. From these observations, investigators may then be able to ascertain typical signs that lead to future disease occurrences.

Reitmeier S, Kiessling S, Clavel T, et al. Arrhythmic Gut Microbiome Signatures Predict Risk of Type 2 Diabetes. 

https://doi.org/10.1016/j.chom.2020.06.004

Gut bacteria improve type 2 diabetes risk prediction. News Release. Technical University of Munich; July 6, 2020. Accessed July 7, 2020. https://www.tum.de/nc/en/about-tum/news/press-releases/details/36118/

Type 2 diabetes risk prediction is improved by observing changes in gut bacteria, a study finds.


Gut Bacteria Contribute to Improved Prediction of Type 2 Diabetes

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

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	

 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.

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.

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CVS Pharmacy Offering New Spoken Rx App Feature

National Association of Specialty Pharmacy Releases Agenda for Fifth Annual Specialty Pharmacy Law Conference