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: I’d like to talk about some of the safety and efficacy profile of one of the common things that we use, topical calcineurin inhibitors. These are nonsteroidal agents. They’re pretty exciting. They’ve been with us since around the year 2000, and then we have a newer entry into the nonsteroidal group, our topical phosphodiesterase-4 inhibitor, crisaborole. I’d like us to think about these in terms of how they work, their safety and efficacy. Kristen, can you start us off with a little discussion of these?

: Absolutely. I’m going to start off with the safety and efficacy profiles of the calcineurin inhibitors. There are 2 topicals that are commonly used, tacrolimus and pimecrolimus. The brand names are Protopic and Elidel. They’ve been around, as you said doctor, for many years. There’s a favorable clinical efficacy proven in these calcineurin inhibitors as shown in multiple clinical trials. Furthermore, studies have shown in children and adults with atopic dermatitis, long-term maintenance therapy with these agents reduced the chance of relapse episodes, which is great because they work more for maintenance as well. Regarding their safety, they exhibit a favorable safety profile without evidence of severe adverse effects. Common adverse effects are really limited to application site reactions, such as burning, erythema, and pruritis with these agents.

A newer medication is crisaborole, and that has the trade name Eucrisa. This is a bit newer in the field, but it’s been very popular, especially among children, because it is not a steroid, and it doesn’t have all the common adverse effects that a lot of parents want to avoid with children. Especially if you’re applying this all over your body, they want something that is safe and doesn’t carry those risks. Regarding the effectiveness, it improves lesion clearing and pruritis in patients with atopic dermatitis to a greater extent than emollient treatments alone. In many studies, significantly more patients treated with Eucrisa achieved results of clear or almost clear as evaluated by investigators compared with using only emollient treatments.

These results reflected a 2-point improvement in lesion clearing on a 5-point assessment scale, which is clinically meaningful. The pruritis and symptoms were responding in a few days, which is great because especially with children, you don’t want to be waiting a very long time to achieve improvement and comfort. More patients will also experience further clearing after a week of treatment.

Regarding common adverse effects, these are also application site related, such as burning, stinging, and worsening of dermatitis. I’ve learned that with these application site reactions, they generally decrease as you continue treatment. That’s an important counseling point for patients, to continue with it, if you can get past the first 3 applications, stick with it because it will improve and those will subside, which is important to note. Hypersensitivity reactions, such as urticaria, rarely occur. There are no available data on the safety of crisaborole in women who are pregnant, breast feeding, or in children younger than 2 or adults over 65 at this point.

: That’s a great overview of our nonsteroidal agents because the typical first-line treatment for atopic dermatitis is going to be our topical steroids. They meet those 5 criteria pretty well. They’re very effective, they work quickly, they’re accessible because they’re very inexpensive, and they have good safety when they’re used correctly, of course, and really high tolerability. But as you said, sometimes they’re not going to be useful in the medium and long term if people are overusing them, and they could actually have greater risks than their benefits would allow. That’s where these nonsteroidal agents particularly help.

The biggest problem that we find with the nonsteroidal agents is 1) they’re pretty expensive compared to corticosteroids, that can be an issue. And number 2) as you really nicely discussed, the stinging and burning, which it does seem like most patients can get through or push past. For some, unfortunately, it can be a deal breaker. Crisaborole is exciting because it got its new indication at a lower age group just last year. So now it’s actually FDA approved down to 3 months of age, which is unique among those. That changes the game and makes it a little bit more favorable, because there’s so little, as you said, available for kids under the age of 2.

The last part about this whole discussion is the concept of a maintenance approach. We usually could use a topical steroid to get things better quickly, but these can be wonderful agents to help maintain atopic dermatitis in the medium to long term. That’s exactly what you talked about, how they were studied. In particular, Andreas Wollenberg, [MD] from Munich, Germany, has done some beautiful work talking about a proactive approach, using them kind of more regularly to keep things down and prevent flare-ups over time. That was really excellent, thank you for that.

This transcript has been edited for clarity.

Videos

Kristen Demundo, PharmD, addresses the safety and efficacy of some topical agents used as therapy options for atopic dermatitis.

Peer Exchange

Clinical

Dermatology

Efficacy and Safety of Topical Agents for Atopic Dermatitis

be defined as the inadvertent leakage of an irritant, extravasation is defined as the inadvertent leakage of a vesicant from the vein into surrounding tissue. During cancer treatment, extravasation is the accidental leakage of chemotherapy from the vein into surrounding tissue.

 Rates are not clearly defined and no centralized database of chemotherapy extravasation events exists, but some literature reports overall incidence as ranging from 0.1% to 6.5%.

The damage potential from antineoplastic therapy extravasation ranges from mild toxicity, such as local pain and erythema, to severe toxicity including tissue necrosis. Because of the potential for severe tissue injury, it is imperative that preventive measures are taken and extravasation is identified and managed quickly.

Ensuring team members are educated about what causes extravasation, opportunities to prevent it, and how to respond when chemotherapy leakage occurs is critically important. There are a few concepts that pharmacists working in oncology need to know about extravasation involving commonly used chemotherapies.

Chemotherapy drugs are grouped according to their potential to cause tissue damage if extravasation occurs; agents may be classified as irritants or vesicants. Depending on the treatment being utilized, other categories such as nonvesicant, nonirritant, or irritant with vesicant-like properties may be used as well.

Classifications of antineoplastic drugs are not absolute. Chemotherapy agents may have characteristics of irritants and vesicants.6 Additionally, there are inconsistencies among antineoplastic agent classifications in the literature.

If extravasation of an irritant occurs, there is potential for burning, pain, and erythema. This is typically a temporary, local reaction without tissue necrosis.5,7,8 Vesicants have potential for burning, pain, and erythema, along with more severe, progressive damage including blister formation and tissue necrosis.

Vesicants can be further subclassified into DNA-binding and non–DNA-binding agents. DNA-binding vesicants remain bound to the DNA of dead cells and can be internalized by adjacent, healthy cells. This allows the agent to remain in the tissue, continuing to cause damage. The damage potential of DNA-binding vesicants is generally more severe, progressive, and permanent.

Non–DNA-binding vesicants are metabolized in the tissue and damage potential is generally mild to moderate, localized, and improves with time.

 Examples of DNA-binding vesicants are anthracyclines, whereas examples of non–DNA-binding vesicants are vinca alkaloids.

shows the European Society for Medical Oncology and European Oncology Nursing Society Clinical Practice Guideline classification of chemotherapy drugs.

Identifying and acknowledging extravasation risk factors is essential to reducing risk. Risk factors may be classified as patient-related, procedure-related, or drug therapy-related, as noted in Table 2.

Implementation of prevention measures is key to minimizing risk of extravasation and potential consequences, with education on these measures remaining crucial for the medical staff and the patient. Medical staff should be trained in risk identification, appropriate vascular access, institute protocols, and extravasation prevention, identification, management, and documentation. Additionally, patients should be educated on extravasation risk and the need to promptly report any signs or symptoms of its occurrence.

The vascular access site options include central or peripheral access, with central access being generally preferred for chemotherapy agents, especially those with more severe damage potential such as anthracyclines. A flexible cannula should be used, and large veins of the forearm are preferred when selecting a cannulation site for peripheral access.

The clinical presentation of an extravasation may present as a wide range of symptoms that are nonspecific, such as tingling, burning, discomfort, pain, swelling, erythema, and visible accumulation of fluid. Additionally, there may be a lack of blood return, resistance on the syringe plunger, or an interruption in the free flow of the drug infusion.

If an extravasation of an antineoplastic agent is identified, general management principles are as follows

Disconnect tubing while leaving the cannula in place

Without applying pressure, carefully aspirate as much drug as possible using a syringe

Assess the site and outline border of extravasation area with a pen

Dry, thermal compresses should be applied in 20-minute intervals 4 times a day for 1 to 2 days.

 There are some inconsistencies among thermal compress recommendations pending the resource utilized.

However, most agents will require cold compresses for extravasation management. For extravasation of vinca alkaloids, warm compresses are universally recommended.1,5 Substance-specific antidotes should also be used as appropriate (Table 3).

If dexrazoxane is being administered for anthracycline extravasation management, it must be started within 6 hours after extravasation. Additionally, cold compresses should be removed 15 minutes before and during dexrazoxane administration to maximize antidote delivery to the tissue.

The documentation of extravasation incidents should include the patient’s name, date and time of extravasation, name of extravasated drug and diluent used, signs and symptoms, IV access utilized, extravasation area, and management steps.

Best practice recommendations for documentation also include incorporating photographic documentation, because this can be helpful during follow-up. Patients should be instructed to monitor the area and report changes. Routine follow-up is recommended with more frequent monitoring within the first week post extravasation, followed by weekly review until symptoms are resolved.

Surgical debridement may be necessary if patients experience unresolved tissue necrosis or pain lasting more than 10 days, full-thickness skin necrosis, and/or chronic ulcer. For severe tissue damage, it is recommended that surgical intervention be managed by a plastic surgeon. Necrotic tissue will be excised, followed by skin grafting and reconstruction if necessary.

Antineoplastic therapy extravasation is a serious event that has the potential for severe complications. Employing strategies and preventive interventions will help ensure extravasation incidents remain rare and that staff are prepared to respond promptly and appropriately.

is a clinical pharmacy specialist at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

is a medication safety officer at Roswell Park Comprehensive Cancer Center in Buffalo, New York.

1. Perez Fidalgo JA, Garcia Fabregat L, Cervantes A, Margulies A, Vidall C, Roila F. Management of chemotherapy extravasation: ESMO-EONS clinical practice guidelines. 

2012;23(suppl 7):167-173. doi:10.1093/annonc/mds294

2. Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. 

. 2014;48(7):870-886. doi:10.1177/1060028014527820

3. Jackson-Rose J, Del Monte J, Groman A, et al. Chemotherapy extravasation: establishing a national benchmark for incidence among cancer centers. 

. 2017;21(4):438-445. doi:10.1188/17.CJON.438-445

4. Ener RA, Meglathery SB, Styler M. Extravasation of systemic hemato-oncological therapies. 

. 2004;15(6):858-862. doi:10.1093/annonc/mdh214

5. Boulanger J, Ducharme A, Dufour A, Fortier S, Almanric K; 

Comité de l’évolution de la pratique des soins pharmaceutiques (CEPSP)

Comité de l’évolution des pratiques en oncologie (CEPO)

. Management of the extravasation of anti-neoplastic agents. 

2015;23(5):1459-1471. doi: 10.1007/s00520-015-2635-7

6. Howell G, Oliai C, Schiller G. Liposomal cytarabine-daunorubicin (CPX-351) extravasation: case report and literature review.

. 2018;38(12):6927-6930. doi:10.21873/anticanres.13070

7. Kreidieh FY, Moukadem HA, El Saghir NS. Overview, prevention and management of chemotherapy extravasation. 

. 2016;7(1):87-97. doi:10.5306/wjco.v7.i1.87

8. Schulmeister L. Extravasation management: clinical update.

2011;27(1):82-90. doi:10.1016/j.soncn.2010.11.010

Articles

Extravasation is defined as the inadvertent leakage of a vesicant from the vein into the surrounding tissue.

News

Oncology

Publications

Antineoplastic Extravasation Prevention, Management

Individuals with type 2 diabetes (T2D) who were prescribed sodium-glucose cotransporter-2 (SGLT2) inhibitors lost significantly more weight than those who were prescribed glucagon-like peptide 1 (GLP-1) receptor agonists (RAs), according to the findings of a new study led by investigators at the University at Buffalo.

Investigators aimed to evaluate the differences in weight loss caused by GLP-1 RAs and SGLT2 inhibitors, both of which are frequently prescribed for T2D. Among 72 patients, individuals receiving SGLT2 inhibitors experienced a median weight loss of more than 6 lb, compared with a median of 2.5 lb among those receiving GLP-1 RAs.

Canagliflozin was the most commonly prescribed SGLT2 inhibitor, and liraglutide was the most commonly prescribed GLP-1 RA, according to the study results.

No significant differences were found in blood pressure, blood sugar levels, or kidney function after use of the medications.

The findings suggest that SGLT2 inhibitors may be more protective
against weight gain caused by other antidiabetic drugs than GLP-1 RAs, according to a statement.

The findings also go against earlier research, which showed that GLP-1 RAs are the superior antidiabetic drug for weight loss, according to the study authors.

They added that although the weight loss caused by the drug is small, the study results warrant larger investigations that examine the medications’ impact on weight.

Antidiabetic drug causes double the weight loss of competitor in type 2 diabetes patients. News release. University at Buffalo. July 1, 2021. Accessed July 6, 2021. 

http://www.buffalo.edu/news/releases/2021/07/001.html

Diabetes

Retail

Study: SGLT2 Inhibitors Promote Weight Loss More Than GLP-1 Receptor Agonists

New data released by Pfizer and BioNTech support the companies’ application for FDA authorization of the COVID-19 vaccine in children 5 to 11 years of age, with a relative vaccine efficacy of more than 90%.

According to a briefing document released by the FDA, clinical data investigated a 10-µg vaccine dose in children 5 to 11 years of age, which is one-third of the dose used for adults and children 16 years of age and older. This dose reduction was chosen to reduce adverse effects (AEs), although it still results in a strong immune response.

The brief also noted the significant increase in COVID-19 cases among children over the past several months, especially during the widespread dissemination of the Delta variant. According to a Pfizer press release, researchers have found a 419% increase in COVID-19 cases among children 17 years of age and younger between August and September 2021, compared with June and July 2021.

Furthermore, although the mortality rate for children is significantly lower than mortality in adults, COVID-19 was among the top 10 leading causes of death for children 5 to 14 years of age between January and May 2021 in the United States.

Based on these data and the clinical trial findings, Pfizer and BioNTech are seeking emergency use authorization (EUA) of a 10-µg dose of the vaccine for children 5 to 11 years of age as a 2-dose primary series given 3 weeks apart. The EUA application is supported by safety and efficacy data, as well as a comprehensive Chemistry, Manufacturing, and Controls data package.

Efficacy of the 10-µg dose in children 5 to 11 years of age was inferred based on the immunobridging analysis, which compared SARS-CoV-2 neutralizing antibodies in a subset of participants in this age group with another group of young adult participants 16 to 25 years of age. Among study participants with no prior evidence of SARS-CoV-2 infection up to 1 month after dose 2, the ratio of 50% neutralizing geometric mean titers in children 5 to 11 years of aged compared to individuals 16 to 25 years of age was 1.04.

Furthermore, 99.2% of children 5 to 11 years of age achieved a seroresponse by 1 month after completing the 2-dose vaccine series. There was no difference in proportions of participants who had seroresponses between the 2 age groups.

In addition to these overall findings, geometric mean titers also increased for both the reference and Delta strains after 2 doses of the 10-µg vaccine dose. The titers at 1 month after dose 2 against the reference strain was 365.3, which was approximately 36.5-times the titers found pre-vaccination. Similarly, the titers at 1 month after vaccination for the Delta variant strain was 294.9, which was approximately 29.5-times the titers pre-vaccination.

Safety data were collected from 2250 participants 5 to 11 years of age, including 1518 who received the vaccine and 750 who received the placebo, with a follow-up time of at least 2 months after the second dose. Supplemental safety data were also collected from an expansion group with an additional 2250 participants. At the time of the most recent data cutoff date, the expansion group had a median follow-up time of 2.4 weeks after the second dose.

Reactogenicity was mostly mild to moderate and short-lived, with a median onset of 1 to 4 days after vaccination and resolution within 1 to 2 days after onset. Local reactions presented mostly as injection site pain, although mild to moderate redness and swelling occurred at higher frequencies in children than was previously reported.

Systemic events included fatigue, headache, and muscle pain, and generally increased in frequency or severity with increasing dose number. However, these AEs were typically milder and less frequent than previously reported in earlier studies.

FDA Briefing Document. Vaccines and Related Biological Products Advisory Committee October 26, 2021, Meeting Document. Released October 22, 2021. 

https://www.fda.gov/media/153409/download

Data show 99.2% of children 5 to 11 years of age achieved a seroresponse by 1 month after completing the 2-dose vaccine series.

Coronavirus

Hospital

Pfizer, BioNTech Data Show High COVID-19 Vaccine Efficacy in Children Ages 5 to 11

When discussing how to address high out-of-pocket health care costs, we should focus on what matters most: the patient, particularly the one at the pharmacy counter.

This is more than an academic exercise for me. My interest in pharmacy began when I observed the health benefits that my own family members experienced thanks to medications dispensed by a pharmacist.

Medications increase life expectancy and quality of life for millions of Americans. 

 from the National Pharmaceutical Council found that physicians perceived medications as the most important contributor to improved patient outcomes for eight debilitating medical conditions over a 20-year period — more than any other medical innovation.

As a trained pharmacist, I know the success of medications also depends on pharmacists, who help the right patients get the right medications at the right time.

This commitment to ensuring patient access to needed medicines has been on full display during the COVID-19 pandemic. In the pandemic’s early days, I personally witnessed pharmacists in Florida quickly find creative ways to minimize disruption of medication regimens for patients like my parents. They installed plexiglass at pharmacy counters, set up pop-up drive-throughs in parking lots, and delivered medicines or helped patients shift to mail-order prescriptions.

Pharmacists are the most accessible health care professional and the health professional most prepared to optimize medication use to improve patient health. The broader health care delivery and payment system, especially insurance benefit design, should adopt this patient-centered mindset. Recent 

 from NPC and the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center found that almost half of health plan decision-makers surveyed said they never engaged with patients when developing drug coverage policies. Furthermore, a majority of those surveyed thought it was improbable that patient influence on coverage policy would grow in the future.

This disconnect between insurers and patients makes it more likely that health plans will fall short of helping those they are supposed to serve.

My pharmacy training made it clear to me, as it has to many others, that the barriers caused by poor insurance benefit design make life so much harder for patients who need these remarkable, life-changing treatments. Pharmacists spend precious time keeping up with benefit design changes and utilization management requirements. This time is better spent caring for patients. Of course, this is all happening against the backdrop of declining reimbursement and inexplicably increasing direct and indirect remuneration (DIR) fees.

Insurance coverage is top of mind right now for many Americans as we approach the fall open enrollment season. But as anyone who has helped a parent or loved one examine their health insurance options can attest, figuring out the quality of the health coverage and what medications will be covered, and at what cost, is quite challenging.

As a result, most people end up making their decisions based on the price of premiums and deductibles, even though medication access 

Some plans leave patients exposed to high out-of-pocket spending. A recent IQVIA report showed that 

 were abandoned in 2020 and that higher out-of-pocket costs correlated to higher rates of abandonment.

To address high out-of-pocket health care costs for patients at the pharmacy counter and beyond, we must rely on evidence-based research and data to develop real solutions. Yet some current proposals appear to miss the mark.

Take the discussion around the government directly setting prices for drugs: According to 

, a mandated drug price discount would be unlikely to reduce patient out-of-pocket costs. Only 1 in 4 health plan decision-makers surveyed said they would pass savings on to patients through lower co-pays. Most of those interviewed said no discount amount would trigger a drop in copays or coinsurance rates.

This study adds to a growing body of evidence that shows focusing solely on drug prices will not solve the problem of patients’ high out-of-pocket costs. NPC 

 has shown that only 17% of health expenditures in the U.S. are drug costs. Further, a 

 found that while Americans on average spend about $500 more per year for medications than patients in economically similar countries, we spend nearly $4,000 more per year in inpatient and outpatient services.

Pharmacists can play a critical role in finding a solution to address high out-of-pocket costs for patients. Health care organizations have begun hiring pharmacists not to stand behind a pharmacy counter, but to help the organization learn from their patient-focused perspective: ensuring the right patients get the right medications at the right time to deliver better outcomes and reduce overall costs.

Pharmacists’ ability to think through the patient’s point of view is a tremendous asset. Other stakeholders could follow this example by coming together to forge evidence-based solutions that keep the patient at the center and help make patients healthier.

I’m proud of my fellow pharmacists for their contributions to this important work, and I look forward to working together to deliver better outcomes for patients.

Other health care stakeholders can learn from pharmacists' patient-centered perspective in addressing high out-of-pocket costs.

Help Get the Right Medications at the Right Time

The CDC Advisory Committee on Immunization Practices (ACIP) has recommended the use of a booster dose of both the Moderna COVID-19 vaccine at the 50 µg dose level as well as the Johnson & Johnson COVID-19 single-shot vaccine for eligible individuals, according to separate statements from both companies.

“Since we began this journey in January of 2020, our goal has been to protect as many people as possible from COVID-19. The ACIP recommendation is another step forward in our quest to address this devastating pandemic with a vaccine,” Stéphane Bancel, chief executive officer of Moderna, said in a press release.

 “We are grateful for the opportunity to provide individuals with another layer of protection against COVID-19.”

The Moderna booster dose is recommended for individuals 65 years of age and older, individuals 18 to 64 years of age who are at high risk of severe COVID-19, and those 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

Moderna estimated that the authorization of a booster dose could result in up to 1 billion extra doses being available by 2022.

ACIP also issued a recommendation for a booster dose of the Johnson & Johnson COVID-19 vaccine for all eligible individuals. The Johnson & Johnson vaccine booster dose was recommended for individuals 18 years of age and older who received the single-shot vaccine at least 2 months earlier. A booster dose was also recommended for eligible individuals at least 6 months following the second dose of an authorized mRNA vaccine.

“The Johnson & Johnson vaccine provided 94% protection in the US against COVID-19 when given as a booster following the single-shot Johnson & Johnson vaccine, and due to its unique mechanism of action, offers long-lasting, durable protection. We remain confident in the benefit it will provide to millions around the world,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a press release.

Both ACIP recommendations were forwarded to the director of the CDC and the US Department of Health and Human Services for review and adoption.

 for COVID-19 in eligible populations, including a single booster dose of the Moderna vaccine and a single dose of the Johnson & Johnson vaccine. In addition, FDA officials authorized each of the available COVID-19 vaccines as a heterologous booster dose following completion of the primary vaccination with a different vaccine.

1. US CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine. Moderna. News release. October 21, 2021. Accessed on October 22, 2021. 

https://www.businesswire.com/news/home/20211021006097/en

2. U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines. Janssen. News release. October 21, 2021. Accessed on October 22, 2021. https://www.janssen.com/us-cdc-advisory-committee-unanimously-recommends-johnson-johnson-covid-19-vaccine-booster-all

The CDC recommends booster doses of Moderna’s COVID-19 vaccine and Johnson & Johnson’s single-shot COVID-19 vaccine for eligible individuals.

CDC Recommends Booster Doses of Moderna, Johnson & Johnson COVID-19 Vaccines 

Pharmacy Times spoke with neurologist Dr. Tirisham Gyang and pharmacist Dr. Margaret Hansen about multiple sclerosis, including diagnosis, treatment options, and the role of the pharmacist in patient care.

Neurology

Specialty Pharmacy

What To Know About Multiple Sclerosis as a Pharmacist

The current retail pharmacy environment has relegated pharmacists to relatively mundane tasks—faxing documents, verifying medication, and answering the phone—rather than balancing those activities with the complex decision-making and patient care that pharmacists are trained to do. In fact, given today’s overburdened health care system, patients 

 pharmacists to practice at the top of their license.

However, the outmoded technology used in many pharmacies keeps pharmacists behind the scenes, tethered to slow, intermittent communication with the rest of the patient’s care team.

That’s why I’ve become an advocate for a tech-enabled pharmacy. Embedding technology in the pharmacy can unlock the abilities of pharmacists and technicians to help care for patients, improving their job satisfaction and health outcomes for the patient. With technology, pharmacists and technicians can—and should—be full members of the patient’s care team.

So, what exactly does a tech-enabled pharmacy look like in practice? Envision pharmacists and technicians with access to the equipment and software that better help them do their jobs so they can create the best possible experience for patients. Technology is incorporated into the role, rather than automating the pharmacist out of the role. Appropriately leveraged technology brings the pharmacist-patient interaction to the forefront.

The real value-add of any pharmacy is the people who work there, and technology can help free these experts to spend more time with patients. The highly skilled pharmacists and technicians who staff the pharmacy have knowledge that can greatly improve patient care—but only if they have the time and opportunity to share that knowledge with the patient. This is a deeper layer than most interactions between pharmacists and patients.

For example, in a tech-enabled pharmacy, pharmacists no longer have to painstakingly fill prescriptions by hand in the way they historically have in the retail setting. Instead, the pharmacist can spend their time engaging clinically with patients, answering questions and performing important tasks with a real impact on patient outcomes, such as recommending treatment for adverse effects.

A tech-enabled pharmacy also allows pharmacists and technicians to act as full members of the patient’s care team. When pharmacists can bring their pharmacological expertise together with the medical expertise of physicians and nurses, patients win. Further, pharmacists and technicians are an easily accessible point of contact. Unlike many others the patient may encounter in the health care system, pharmacists and technicians are often just a phone call away.

Software upgrades have also smoothed interactions between pharmacists and their closest partners in the medical system: Prescribers, insurers, pharmacy benefit managers, and suppliers. With these interactions increasingly migrated to the electronic space, pharmacists can manage relationships and close the feedback loop more efficiently than ever. Excellent communication between these players can make a complicated process far easier.

Traditionally, pharmacy locations have relied on outdated fax machines to communicate with doctors on everything from refill notifications to prior authorizations. But by implementing newer technology, the pharmacy shifts from a downstream recipient of prescriptions to a proactive member of the care team. 

Digital messaging, for example, allows pharmacists to communicate with providers far faster and more directly than with faxes, increasing the likelihood that the care team can solve any issues before the patient even reaches the pharmacy counter.

Over the past few decades, pharmacy has undergone a rapid shift away from the community pharmacy toward retail settings. But in the process, pharmacists have lost their role in the caregiving team.

Tech enablement is an important part of freeing pharmacists to practice at the top of their licenses and offer excellent patient care. Now, as pharmacy enters a new technological era, pharmacies have the chance to promote pharmacists once again, empowering them to act as providers integral to a patient’s care team.

The outmoded technology used in many pharmacies keeps pharmacists behind the scenes, tethered to slow, intermittent communication with the rest of the patient’s care team.

Pharmacy Technician

How Tech-Enabled Pharmacy Can Help Reinvent the Pharmacy Experience

Pregnant women with symptomatic COVID-19 are at an increased risk of poorer outcomes, which may include pre-term birth, according to a pair of studies published in 

The Journal of Maternal-Fetal & Neonatal Medicine

American Journal of Obstetrics and Gynecology

.1,2 The investigators found that the rate of preterm birth in pregnant women who tested positive for SARS-CoV-2 was a function of the severity of infection.1

“The more severe the SARS-CoV-2 infection, the greater the risk of preterm birth," said Roberto Romero, MD, DMedSci, chief of the Perinatology Research Branch and professor of Molecular Obstetrics and Genetics at the Wayne State University School of Medicine, in a press release. "There was a dose-dependent relationship between the severity of SARS-CoV-2 infection and the risk of prematurity.”1

The investigators reported that the excess rate of premature birth was largely due to medically induced preterm birth, initiated due to concerns for the health of the mother. These concerns included preeclampsia, a sudden increase in blood pressure after the 20th week of pregnancy. The condition results in 76,000 maternal deaths and more than 500,000 infant deaths per year.1

“The principal finding is that there is a dose-response relationship between the severity of SARS-CoV-2 infection and the risk of subsequent development of preeclampsia and preterm birth," Romero said in the release. "Patients with severe COVID-19 have a 5-fold greater risk of preeclampsia than asymptomatic patients. Moreover, the relative risk of developing preeclampsia in women with moderate or severe COVID-19 was 3.3-fold higher than in those with asymptomatic or mild infection.”1

A similar study, evaluating 2471 women in the third trimester of their pregnancy, found that there were significantly higher rates of gestational diabetes, lower white blood cell counts, and heavier bleeding during delivery for patients with symptomatic COVID-19. Further, respiratory complications were witnessed in the babies of these patients. They did not, however, encounter any association between COVID-19 and preterm delivery.2

“Our analysis finds there were no significant increase in cesarean delivery in women, who were COVID-19 positive and the incidence of preterm deliveries was not significantly different among the three groups (healthy, COVID positive asymptomatic, COVID positive symptomatic),” said Dr Elior Eliasi in a press release. “Most pregnancy and delivery outcomes were similar between COVID-19-positive and -negative parturients.”2

On average, the increased risk of adverse outcomes was 13.8% higher for patients with asymptomatic COVID-19 and 19.6% higher for those who were symptomatic.

“More data is now needed to better delineate the differences between pregnancy outcomes seen in certain populations, potentially related to different viral characteristics (subtypes, viral load), patient epigenetics, or other factors,” the authors said in a prepared statement. “Additionally, the effects of maternal infection on the fetus both in terms of symptomatic maternal illness and vertical viral transmission remain to be further investigated.”

More severely COVID-19 infected mothers more likely to have preterm birth, study finds [news release]. ScienceDaily; October 8, 2021. Accessed October 21, 2021. 

https://www.sciencedaily.com/releases/2021/10/211008160455.htm

Adverse complications for COVID positive pregnant women and their newborns [news release]. ScienceDaily; October 11, 2021. Accessed October 21, 2021. 

https://www.sciencedaily.com/releases/2021/10/211011091314.htm

The investigators found that the rate of preterm birth in pregnant women who tested positive for SARS-CoV-2 was a function of the severity of infection.

Women's Health

Symptomatic, Severe COVID-19 Infection Associated With Pregnancy Complications

The FDA has approved a new low-dose tablet of bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg (Biktarvy; Gilead Sciences, Inc) for pediatric patients weighing between 30.8 lbs and 55.1 lbs who are virologically suppressed or new to antiretroviral therapy, according to a Gilead press release.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in the release. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The [supplement New Drug Application (sNDA)] approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world.”

The low-dose tablets were effective and well-tolerated through 24 weeks. There were 22 patients who continued treatment for 48 weeks and through the extension phase.

After switching to Biktarvy, 91% of patients remained virologically suppressed at week 24.

Common adverse events (AEs) are diarrhea, nausea, and headache, with no new AEs observed.

Biktarvy is a complete regiment for the treatment of HIV-1 infection in adult and pediatric individuals. The approval was based on data from cohort 3 of a phase 2/3 open-label, single-arm study.

The approval of the sNDA expands the indication for Biktarvy to include younger patients with HIV-1 infection.

US Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations. Gilead. News release. October 18, 2021. Accessed on October 21, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/10/us-food-and-drug-administration-approves-expanded-indication-of-gileads-biktarvy-for-treatment-of-hiv1-in-pediatric-populations

After switching to Biktarvy, 91% of patients remained virologically suppressed at week 24 in a cohort study.

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