Frieda Wiley, PharmD

Frieda Wiley, PharmD, BCGP, is a writer and pharmacist. 

In the wake of the novel coronavirus 2019 (COVID-19) pandemic, pharmacists face an ongoing challenge with helping patients optimally manage chronic conditions.

In HIV care, for example, pharmacists play a key role in monitoring treatments, counseling patients, and assisting with adherence challenges, all of which current social distancing measures can make more difficult. Furthermore, the potential effects of the COVID-19 virus on patients with HIV remain uncertain, even as reports indicate that other chronic conditions such as diabetes and hypertension may put affected individuals at higher risk.

“So far, there is no major report to suggest that HIV patients are more or less susceptible to COVID-19 than individuals who do not have HIV or are otherwise healthy,” Rodney Ho, PhD, professor of pharmaceutics at the University of Washington School of Pharmacy in Seattle, told 

According to a statement on Aidsinfo, a US Department of Health & Human Services website, the “limited data currently available do not indicate that the disease course of COVID-19 in persons with HIV differs from that of persons without HIV.” However, the website subsequently states that the use of effective antiretroviral therapy (ART) in the HIV population might be responsible for the current trend. Before the introduction of ART, a CD4 cell count below 200/mm3 was considered a risk factor for complications resulting from other respiratory infections. At press time, the website stated that whether HIV increases COVID-19 risk is still unknown. Until experts know for sure, the scientific consensus is that proactive measures to limit risk and exposure to COVID-19 should bear little difference to the measures taken by individuals who are generally healthy.

Health care systems have taken precautions to mitigate exposure and risk for patients with HIV. Perhaps the most significant change involves encouraging patients to stay home unless clinicians feel an office visit is medically necessary.

Clinicians are also taking proactive measures to prevent drug shortages and limit onsite visits. As a result, mail order use has surged. “We reach out to patients via phone around 5 to 10 days ahead of their next refill, so we can mail out their prescriptions to enhance adherence,” said a Houston, Texas–area HIV pharmacist who practices at an outpatient pharmacy located in a health center and wants to remain anonymous. “Sometimes we match the date with the patient’s next clinic visit and have their medications ready, making it easier for them to have access during the pandemic.”

In addition to enacting medication synchronization, the pharmacist’s organization now issues emergency fills and early refills to reduce or eliminate multiple trips to the pharmacy. Patients who pick up their prescriptions must maintain a 6-foot distance from other patients. The clinic also requires these patients to fill out a COVID-19 screening form that helps pharmacists determine who needs additional assistance or medical attention.

Physical distandistancing in the HIV community has driven a massive uptick in telemedicine services. Many patient interactions, such as follow-up visits and education, now occur remotely. Although the industry trend indicates that most services for this patient population have gone remote, exceptions may apply with at-risk populations.

For example, providers at ChristianaCare’s William J. Holloway, MD, Community Program in Wilmington, Delaware, might require a site visit for patients who are older than 60 years or have certain disease states, such as lung disease and hypertension. “We are using virtual and telephonic visits, as well as preset algorithms for COVID,” said Kelly Cantwell-McNelis, PharmD, AAHIVP, a clinical pharmacy specialist with the community program.

In the outpatient pharmacy based in Houston, Texas, pharmacists make adherence calls to patients to monitor refills while screening them for signs and symptoms of the virus. “Since HIV patients are immunocompromised, we ask them if they are experiencing dry cough, fever, or chills currently, and document them in our pharmacy software,” the HIV pharmacist at the clinic said.

Phone calls and tracking prove critical because the clinic has a high number of patients with CD4 counts falling below 200 mm3, a sign of full-blown AIDS. These patients receive regular phone calls to monitor and address adherence, as well as to screen patients for opportunistic infections. Because of the pandemic, patients are now given the COVID-19 screening questionnaire over the phone.

Although telemedicine interventions have made operations more efficient, there have been hurdles. For instance, helping patients understand why they should call the pharmacy before making a trip has become a teaching opportunity that requires vigilance. “It took us a couple of weeks to get patients to understand that they should call us first and let us triage their symptoms,”said Cantwell-McNelis.

On the virtual front, Dan Scales, PharmD, AAHIVP, director of collaborative care pharmacy at Vivient Health and owner and founder of Scales Pharmacy in Denver, Colorado, and his colleagues have worked diligently to get up to speed on a new technological platform. He said that he thinks the process has gone generally well but recognizes that success also depends on the patient’s resources. Scales noted major obstacles with a patient living in a rural area. “We have to use video relay because the patient’s internet connection is not stable enough to hold a conversation in real time,” Scales said. Because the patient is deaf, interaction also requires a sign language interpreter.

Historically, the health care industry has wrestled with telemedicine navigating the nebulous web of integration and reimbursement. If there is any benefit from the pandemic, it is the swift action to establish and bill for telemedicine services, according to Cantwell-McNelis. She cited a recent 

 article highlighting the near-overnight transition. “The speed of the transition has been dizzying. Changes that would typically encompass months of planning, pilot testing, and education have been compressed into days,” the authors wrote.

With no viable cure or treatment for COVID-19 yet, investigators are exploring the potential benefit of antiviral protease inhibitors (PIs) routinely used in HIV medicine. The findings’ effects on the HIV population continue to unfold with emerging data and research.

At press time, 15 studies exploring the effects of PIs on COVID-19 were found on ClinicalTrials.gov. Results from a randomized, controlled, open-label clinical trial on lopinavir-ritonavir (Kaletra) following 199 patients in China showed that the drug did not speed recovery or reduce the viral load in patients with COVID-19.

“Until we know more about how PIs affect COVID-19, people with HIV should not switch their HIV medicine in attempt to prevent or treat COVID- 19,” Scales warned.

Sources predict lasting changes in the post-COVID era of pharmacy. Scales and Cantwell-McNelis foresee telemedicine becoming a mainstay of treatment. Ho believes that the dynamics of the virus will further elevate the demand and profile of pharmacists’ contributions to the health care system by serving as a resource to the physician.

“Many physicians are emergency room doctors or heart specialists who are not trained in infectious diseases or to think about DDIs [drug-drug interactions] and how to monitor for heart conditions,” Ho said. “The pharmacist’s role is to serve as an expert when the physicians are caring for patients by looking for data to provide the best evidence available and being able to develop appropriate time-sensitive information.”

Articles

Virtual care takes center stage amid the pandemic.

Pharmacists Fight HIV

The uptick in dietary supplement use and integrative health and medicine practices in the United States creates both opportunities and concerns for pharmacists and health providers, who need to stay well informed to help patients avoid harmful effects. Some patients may seek vitamin or herbal supplements for health and wellness, often believing that these are safer than conventional OTC and prescription pharmaceutical products. However, so-called natural remedies come with their own set of health risks.

“Dietary supplements are very helpful and really needed when they are chosen correctly and properly,” said Farzana Kennedy, RPh, FACA, owner and president of Dalitso, an integrative pharmacy in Alexandria, Virginia. “Often, they can be harmful if not properly monitored or checked for interactions or contraindications in a patient who has preexisting conditions.”

Dietary supplement use has reached an all-time high, with 77% of Americans reportedly using these products, according to a 2019 survey conducted by the Council for Responsible Nutrition. The increased patient demand for non-pharmacologic health options has created unprecedented opportunities for pharmacists to expand their interactions with patients.

Many patients consider community pharmacies the ideal place to purchase vitamins and other dietary health supplements. Pharmacists can positively affect the patient experience by:

Providing supplement education Making supplement recommendations

Assessing for interactions, contraindications, and toxicities Collecting a patient’s complete medication history, including supplements

Assessing for drug-drug, drug- micronutrient, and drug- supplement interactions

Helping patients evaluate natural products for quality-related issues

Pharmacists can also educate patients about the potential effects of taking dietary supplements on laboratory test validity and results.

“In general, validating and interpreting laboratory test results can be key tools in helping health care professionals optimize clinical decisions related to their patients’ health,” said Cathy Rosenbaum, PharmD, RPh, MBA, CHC, CDP, a holistic clinical pharmacist and founder and CEO of Rx Integrative Solutions in Blue Ash, Ohio. “Pharmacists are uniquely poised to prospectively educate the public on any laboratory test interferences with medications, supplements, or micronutrients to minimize safety risks.”

Biotin: A Lesson in Disclosing Supplement Use

Through their frequent interaction, patients and pharmacists often build a strong rapport and a trusting relationship in which patients feel comfortable discussing supplements. Pharmacists should advise their patients to also report all dietary supplement and natural product use to physicians prior to any blood testing, Rosenbaum said.

A laboratory-testing interaction involving biotin illustrates several important ways pharmacists can help keep patients safe through counseling. Many patients who pick up a bottle of biotin, a water-soluble B vitamin, view it as a harmless supplement to enhance physical appearance (eg, skin, hair, nails). Rosenbaum warns that this assumption can be problematic because of the lack of clinical research with standardized biotin dosing to support these claims. The scientific community has long known that biotin functions in the body as a cofactor for enzymes involved in carboxylation reactions, and it plays a role in fatty acid and carbohydrate oxidation. Daily amounts of biotin needed for general health is defined in different ways because there is no standardized recommended dietary allowance or nutrient intake for this nutrient. A generally suggested intake for adults is between 30 mcg and 100 mcg a day.

OTC biotin products come in many doses that are significantly higher than the amount provided in adequate nutrition, some as much as 10,000 mcg per dose for therapeutic indications.

Several reports link high-dose biotin supplementation to falsely elevated levels of the thyroid hormones triiodothyronine and levorotatory thyroxine and falsely low thyroid-stimulating hormone levels, all used to diagnose and monitor thyroid disease. Taking supplemental biotin at 20 mg or more on a daily basis may interfere with thyroid bioassays that use streptavidin–or avidin–biotin systems.

Excessive biotin intake can lead to misdiagnosis, inappropriate treatment, or even death. For example, biotin supplementation can produce altered levels of troponin, one of the biomarkers elevated during acute myocardial infarctions. According to a November 28, 2017, FDA statement on biotin concerns, a patient who took high doses of biotin died because of complications related to falsely low troponin levels found in a test that relied on biotin technology. Because patients may be unaware of biotin interference, they may not report taking biotin supplements, and may even be unaware they are taking the supplement at all, according to the FDA.

CBD and Medical Cannabis: Countering Ads that Overpromise

The challenges of providing patient guidance in integrative medicine are not exclusive to biotin. The recent explosion of cannabis and cannabidiol (CBD) products presents more issues because these products are routinely promoted as completely safe, with no risks. Buying into this hype could have deleterious consequences for patients.

“Pharmacists providing direct patient care by providing medical cannabis or hemp-based CBD products must know and understand patient diagnoses, treatment plans, and how to monitor patients for interactions,” Kennedy told Drug Topics®.

“One big problem is that cannabis dosing is not standardized, and therefore, pharmacists should educate themselves to help patients receive optimal care regarding the product and dose that will sit well with them without [adverse] effects or other undesired feelings.”

Kennedy also stated that the ubiquitous deluge of CBD products from companies draws increasing concern about quality. She urges pharmacists to practice due diligence, vetting ingredients and confirming that there has been third-party testing for impurities, heavy metals, and other substances.

CBD products are often erroneously advertised as devoid of drug interactions. Evidence shows that CBD is well tolerated sans psychotic effects, provided doses do not exceed 600 mg. However, CBD potently inhibits CYP3A4 and CYP2D6 enzymes, which could cause higher-than-normal increases in serum concentrations of calcium channel blockers, benzodiazepines, antihistamines, antiretrovirals, statins, cyclosporine, and other drugs cleared through these enzymes.

For more information and to stay up-to-date on issues in dietary supplements and integrative health, visit 

Patients seeking vitamin or herbal supplements for health and wellness often believe that these are safer than conventional OTC and prescription pharmaceutical products; however, so-called natural remedies come with their own set of health risks.

Integrative Medicine Presents Opportunities, Poses Challenges

Heart disease is so common among Americans that it claims 1 life every 37 seconds. That number accounts
	for approximately 647,000 deaths annually, according to the CDC. As health care providers often serving on the front lines, pharmacists have potentially underused opportunities to help keep patients’ tickers in tip-top shape.

The underutilization of pharmacists in wellness and disease-state management may come from the lack of recognition they receive for the value they add to the patient care equation, according to Andrew M. Freeman, MD, FACC, FACP, a cardiologist, cochair of the Nutrition & Lifestyle Work Group of the American College of Cardiology, and director of cardiovascular prevention and wellness at National Jewish Health in Denver, Colorado.

“For a long time, pharmacists have been very much underappreciated in day-to-day care,” he told Drug Topics®. “From a cardiovascular perspective on the inpatient side, they are an essential part of the team to make suggestions for things we doctors may not readily know offhand.”For example, Freeman appreciates having pharmacists give recommendations on tailoring drug therapy based on their assessments of electrolytes, allergies, and various interactions such as drug-drug, drug-nutrient, and drug-herbal interactions.

However, the diverse ways in which pharmacists can alter the patient experience transcend the support they offer physicians in drug therapy.

Twenty percent of hospital readmissions are linked to inefficiencies in the coordination of care. These challenges highlight additional gaps in the health care systems that pharmacists can help fill.

“Pharmacists have become essential to preventing readmissions because they provide education to patients at discharge,” Freeman said. “They help keep them from returning to the hospital and out of the clinic.”

Patients with recent cardiovascular events may require education on as many as 4 to 6 new medications that were started during hospitalization, according to Alison M. Walton, PharmD, BCPS, associate professor of pharmacy practice, ambulatory care clinical pharmacy specialist, and director of Healthy Horizons at Butler University College of Pharmacy and Health Sciences in Indianapolis, Indiana.

Patient education has also become extremely important in managing cardiological conditions such as hyperlipidemia and hypertension. Topics include healthy lifestyle habits as well as disease-state and drug information. Helping patients understand the importance of medication adherence and solving adherence-related problems is another element in the patient education spectrum.

“Since patients can’t feel their cholesterol or blood pressure levels, it’s difficult for [them] to realize the impact medications have on their heart numbers,” said Walton.

For that reason, educating patients on their medications is extremely important-especially as they transition through the health care system from different settings.

Additionally, the coronavirus disease 2019 (COVID-19) pandemic has created another much-needed opportunity for pharmacists to provide information to patients with cardiac conditions, especially as having preexisting conditions increases the risk of developing complications. Altered lifestyle habits as a result of the COVID-19 lockdown also pose further risks to such patients.

“As a result of COVID-19, our daily routines have significantly changed, and this may impact the lifestyle choices of our patients with disease,” said Walton.

The COVID-19 crisis has created some conditions that may limit some outdoor physical activities or force some patients to alter their eating habits in a potentially unhealthful way. A more sedentary lifestyle could negatively affect blood pressure and cholesterol. Further, with fresh produce now hard to come by, many patients may increase their consumption of frozen or canned products; as a result, they may also inadvertently increase their sodium intake.

“Throughout their career, a pharmacist may have multiple roles in the prevention and management of cardiovascular disease,” said Walton.

Pharmacists’ frequent interactions with patients create recurring opportunities to help optimize patient care. One illustration of a productive interaction is a pharmacist initiating a referral after an encounter in which a patient describes signs and symptoms of cardiovascular disease.

From Freeman’s perspective, one of the most critical ways in which pharmacists enhance patient care is by serving as an intermediary or conduit of sorts. “The role of the pharmacist is to make sure patients understand their therapies and appropriately utilize their drugs,”he said. “But sometimes the pharmacist is the link when other providers don’t speak to each other.”

As health care continues its massive overhaul, the links, or bridges, that pharmacists build with their unique blend of skills should only continue to grow.

Heart disease is so common among Americans that it claims 1 life every 37 seconds.

The Pharmacist's Role in Heart Health

When many think of nonsteroidal anti-inflammatory drugs (NSAIDs), adverse effects (AEs) such as gastrointestinal bleeding, nephrotoxicity, and cardiovascular challenges frequently come to mind. These drugs fall among the world’s most commonly used medications, but 1 AE, hepatotoxicity, gets little fanfare.

In 2010, nearly 43 million of adults living in the United States, or approximately 20%, took aspirin a minimum of 3 times per week for 3 months or more. Additionally, 29.1% used NSAIDs on a regular basis.

Jason Varin, PharmD, assistant professor and director of alumni relations at the University of Minnesota College of Pharmacy, shed some light on the state of affairs. “Based on a number of issues, people think of acetaminophen causing liver damage and NSAIDS causing kidney damage,”he said. “This can be true, but they are not mutually exclusive.”

NSAID-induced hepatotoxicity is relatively uncommon, occurring in approximately 4 of every 100,000 patients per year. Individuals who have certain chronic illnesses, including existing compromised liver function, have a higher incidence of additional liver injury. Genetics can also contribute to a person’s risk. Rather than pronounced liver failure, NSAID-induced hepatotoxicity is more likely to manifest through elevated liver enzymes, such as alanine transferase. Patients who have NSAID-induced liver failure are also less likely to face the invasive consequences frequently associated with acetaminophen-induced hepatotoxicity. Varin said that acetaminophen is responsible for upwards of 20% of liver transplants and is the leading cause of liver failure in the United States.

 found that only 18 of 698 studies conducted through July 30, 2016, on 9 different NSAIDs were randomized controlled trials. Of those 18 studies, 8 contained data supporting the hepatotoxic potential of diclofenac, etoricoxib, and celecoxib, based on criteria for hepatoxicity.

Of those 3 NSAIDs linked to hepatotoxicity in the randomized control trials, diclofenac was found to have the higher number of liver-damaging incidents (0.015 to 4.3x10

). Celecoxib trailed behind with 0.13 to 0.38x10-2, followed by etoricoxib, which ranged from 0.005 to 0.930 x10

Although these studies help shed some light on the potential dangers associated with NSAID use, more data is needed to paint a clearer picture.

“We definitely need more studies, since post-marketing results are very important to determine if long-term use or dosages higher than recommended would lead to more dangerous or unwanted toxicities,” explained Farzana Kennedy, RPh, FACA, owner and president of Alexandria Compounding Company in Alexandria, Virginia.

Until additional studies are conducted, Kennedy and Varin offer the following tips for pharmacists to help them lessen the burden of NSAID-induced hepatotoxicity for their patients:

Take NSAIDs with food, as some can cause stomach upset, even with a single dose.

Educate patients to take only the minimum amount necessary and to never exceed recommended dosage.

Always read the ingredient list, as NSAIDs and acetaminophen may be present in other medicines. Ibuprofen is available as a single ingredient in Advil, Motrin, and as a generic, but you will also find it in other medicines, such as several cold and influenza preparations.

Encourage patients to check with their pharmacists or physicians prior to taking any OTC medications.

Educate patients when dispensing NSAIDs or any medications that may have liver- or alcohol-induced toxicity. When NSAIDs are used in long-term treatment, make sure the patient’s liver enzymes are checked periodically.

1. Wondrakpanich S, Wongrakpanich A, Melhado K, Rangaswami J. A comprehensive review of nonsteroidal anti-inflammatory drug use in the elderly. Aging Dis. 2018;9(1):143-150. doi: 10.14336/AD.20170306.

2. Zhou Y, Boudreau D, Freedman A. Trends in the use of aspirin and nonsteroidal anti-inflammatory drugs in the general U.S. population. 

 2014;23(1):43-50. doi: 10.1002/pds.3463.

3. Sriuttha P, Sirichanchuen B, Permsuwan U. Hepatotoxicity of nonsteroidal anti-inflammatory drugs: a systematic review of randomized controlled trials. 

. 2018;2018:525623. doi: 10.1155/2018/5253623.

In 2010, nearly 43 million of adults living in the United States, or approximately 20%, took aspirin a minimum of 3 times per week for 3 months or more.

Author | Frieda Wiley, PharmD

Articles

Pharmacists Fight HIV

Integrative Medicine Presents Opportunities, Poses Challenges

The Pharmacist's Role in Heart Health

NSAID-Induced Hepatotoxicity Rare, but Still Important to Note