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RJ is a 3-year-old girl with dryness, redness, and scaling on her arms. Her mother calls the pharmacy with questions regarding atopic dermatitis (AD). She reports that RJ has been trying to scratch the itchy rash, which appears to be making the plaques thicker. RJ’s mother reports that her daughter has asthma as well. What should the pharmacist recommend to treat AD?

Advise RJ’s mother to limit exposure to all potential triggers for AD, including dyes, excessive bathing, extreme temperatures, irritating detergents and soaps, and tight-fitting clothing. Preventive measures can be implemented to reduce the symptoms of AD. RJ’s clothes and sheets should be thoroughly washed with unscented detergent, and dryer sheets should be avoided. Overall, bathing is recommended to remove bacteria and hydrate the skin, but excessive bathing should be avoided, and lukewarm water and mild, hypoallergenic cleansers should be used. RJ’s skin should be moisturized with unscented emollient products immediately after bathing. The skin barrier can be hydrated and maintained using emollient moisturizers that contain oils, petrolatum, or silicone.

If nonpharmacologic modalities do not provide relief, RJ should be treated with topical corticosteroids, which will suppress the cytokines involved in the inflammatory process. Hydrocortisone 0.5% and 1% topical creams are available over the counter and can be used for AD in ages >2 years. Hydrocortisone should be applied to RJ’s lesions twice daily before the application of her daily moisturizers.

RJ’s mother returns to the pharmacy a few weeks later regarding her daughter’s AD. She mentions that she learned from friends that fish oil and evening primrose oil are helpful for AD. She asks for your input on complementary therapies and evidence for use in AD. What information can you provide to RJ’s mother?

There is little evidence to demonstrate the efficacy of complementary therapies for use in AD. Some studies have shown, however, that phototherapy may be effective in AD after non-pharmacologic measures and topical corticosteroid use do not work. In pediatric patients specifically, ultraviolet A and B phototherapy have demonstrated efficacy and safety for AD. The guidelines now recommend phototherapy as a treatment option for refractory AD.

Other complementary therapies commonly used include borage, coconut, evening primrose, and fish oils. Despite the widespread use of oils for AD, there are insufficient data to support the use of borage, evening primrose, or fish oil. However, some data do support the use of topical coconut oil in AD.

MP is a 7-month-old boy with reddened skin under the diaper area developing over the past 3 days. The area appears wet, but there is no discharge. MP is otherwise healthy and does not appear to have any changes in body temperature, bowel movements, or energy level. His diaper is typically changed frequently, but he has a new nanny who may have a different schedule. What should the pharmacist advise for MP’s condition?

MP’s symptoms are consistent with the common presentation of diaper dermatitis. Given that he does not have diarrhea, fever, or oozing, and he has not had had the rash for > 7 days, he is eligible for treatment at home. Diaper dermatitis can occur in the setting of occlusion from the diaper and increased exposure to moisture from gastrointestinal contents and urine. Instruct MP’s nanny to increase awareness of wet diapers and change them more frequently—a minimum of 6 times per day. A modality that may be difficult but effective includes a “diaper holiday,” where MP would not wear a diaper and therefore avoid duration of contact with a wet diaper.

Additionally, the use of skin protectants with each diaper change will aid in preventing diaper dermatitis. The FDA has approved 17 skin protective ingredients for treatment of diaper dermatitis, including allantoin, calamine, cocoa butter, petrolatum, and zinc oxide. MP’s caregiver should use an OTC skin protectant after each diaper change for 7 days and observe for improvement. If the rash does not improve during that time, a medical referral is recommended. OTC antibacterial and antifungal topical agents are not recommended to treat diaper dermatitis.

PA is a 27-year-old woman who has a rash on her face. She visited the dentist earlier in the day and had a few cavities filled. Immediately following the appointment, PA noted a stinging, swollen rash at the outer corner of her mouth. She researched the material used during a filling and noted that the etching solution used contains phosphoric acid, which could cause contact dermatitis if skin is exposed to it. What advice should the pharmacist provide?

PA should first wash the exposed area with a generous amount of lukewarm water to remove the irritant and reduce skin contact time and exposure. To protect the skin from epidermal water loss, PA should apply copious amounts of petrolatum to the exposed area. In some cases, Burow’s solution (aluminum acetate) can be used for its antibacterial, antiinflammatory, and cooling effects. Unlike with atopic dermatitis, topical corticosteroids do not target the mechanism of irritant contact dermatitis. As such, OTC hydrocortisone would not be an appropriate treatment choice. Likewise, PA should avoid lactic and salicylic acids, propylene glycol, and topical anesthetics, which may cause more irritation and potentiate allergic contact dermatitis. Inform PA that the rash may become hyper- or hypopigmented and scaly. Given that the rash is on her face, the pharmacist should also refer her to a provider for evaluation.

Rupal Patel Mansukhani, PharmD, FAPhA, NCTTP, 

is a clinical associate professor at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, in Piscataway, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

is a clinical assistant professor of pharmacy practice and administration at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, in Piscataway, and an ambulatory care specialist at RWJBarnabas Health Primary Care in Shrewsbury and Eatontown, New Jersey.

1. Paller AS, Simpson EL, Eichenfield LF, Ellis CN, Mancini AJ. Treatment strategies for atopic dermatitis: optimizing the available therapeutic options. 

. 2012;31(suppl 3):S10-S17. doi:10.1016/j.sder.2012.07.004

2. Hon KL, Leung AKC, Barankin B. Barrier repair therapy in atopic dermatitis: an overview. 

 2013;14(5):389-399. doi:10.1007/s40257-013-0033-9

3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. 

 2014;71(1):116-132. doi:10.1016/j.jaad.2014.03.023

4. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy of atopic dermatitis. 

. 2014;71(2):327-349. doi:10.1016/j.jaad.2014.03.030

5. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. 

 2014;71(6):1218-1233. doi:10.1016/j.jaad.2014.08.038

6. Evangelista MTP, Abad-Casintahan F, Lopez-Villafuerte L. The effect of topical virgin coconut oil on SCORAD index, transepidermal water loss, and skin capacitance in mild to moderate pediatric atopic dermatitis: a randomized, double-blind, clinical trial

 2014;53(1):100-108. doi:10.1111/ijd.12339

7. Stamatas GN, Tierney NK. Diaper dermatitis: etiology, manifestations, prevention, and management.

 L, Stamatas GN, Kottner J, Garcia Bartels N. Prevention of diaper dermatitis in infants—a literature review. 

 2014;31(4):413-429. doi:10.1111/pde.12348

9. Food and Drug Administration, HHS. Skin protectant drug products for over-the-counter human use; final monograph. Final rule. 

10. Eberting CL, Blickenstaff N, Goldenberg A. Pathophysiologic treatment approach to irritant contact dermatitis. 

11. Corazza M, Minghetti S, Bianchi A, Virigili A, Borghi A. Barrier creams: facts and controversies. 

. 2014;25(6):327-333. doi:10.1097/DER.0000000000000078

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How would you respond to these patients' concerns?

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OTC Case Studies: Dermatitis

 interviewed Ken Perez, MBA, vice president of healthcare policy and government affairs at Omnicell, on the House and Senate bills, HR2759 and S1362 respectively, intended to grant pharmacists provider status for Medicare Part B.

In this discussion, Perez describes how the role of a pharmacist would change if this legislation passes. He emphasizes that much of what would be expected of pharmacists are services they already provide, and that this legislation would incentivize them to practice at the top of their license.

Videos

Ken Perez, MBA, vice president of healthcare policy and government affairs at Omnicell, discussed the changes that would take place if pharmacists were granted provider status for Medicare Part B.

The Effect of Provider Status Legislation on the Role of a Pharmacist

 encompass a broad spectrum of diseases affecting skin and underlying subcutaneous tissue, fascia, or muscle that can range in severity from mild to life threatening.

Clinical trials using this terminology leave some ambiguity in interpretation because of the use of heterogeneous, broad inclusion criteria attributed to a lack of standardized nomenclature and monitoring parameters.

 To provide consistency in the identification of infections for which a treatment effect can be reliably estimated, in October 2013 the FDA released a guidance document that introduced the term 

acute bacterial skin and skin structure infections

 (ABSSSI) and defined quantifiable efficacy end points.

ABSSSI include cellulitis/erysipelas, wound infections, and major cutaneous abscesses with a lesion surface area of equal to or greater than 75 cm

, measured by the area of edema, induration, or redness.

 Excluded from the definition are some skin and skin structure infections of very mild severity, very high severity, or those appearing from specific causes or in specific hosts. Such conditions include animal or human bites, burn wounds, chronic wound or diabetic food infections, ecthyma gangrenosum, impetigo, minor cutaneous abscesses, myonecrosis, and necrotizing fasciitis.

Suboptimal treatment of ABSSSI, resulting from failure to recognize risk factors, misclassification of severity, misdiagnosis, or using the wrong duration or type of antibiotics, may lead to infection recurrence and/or treatment failure.

This review summarizes the treatment of ABSSSI by focusing on typical pathogens expected, based on severity classification and patient risk factors, and provides associated recommendations for treatment.

Pathogens that should be suspected in various ABSSSI depend on the severity classification and patient risk factors. Abscesses and cellulitis/erysipelas are typically caused by gram-positive bacteria. However, other pathogens can be encountered depending on the location of infection and other risk factors.

 The presence of purulence typically indicates a high probability that 

, as opposed to a streptococcal spp, may be involved. In wound infections, the anatomical location of the wound plays a significant role in determining the microbiologic differential.

 For example, gram-negative organisms are typically seen in wound infections of the lower or perianal abdominal area, whereas methicillin-resistant 

 (MSSA) are more predominant in wound infections following surgery of the extremities, head, neck, or trunk.

The guideline-recommended empiric antibiotic regimens differ for nonpurulent and purulent infections, because of known differences in causative pathogens. For purulent infections, empiric oral antibiotic regimens for mild or moderate disease include oral agents with activity against 

, including MRSA and MSSA, such as doxycycline or trimethoprim-sulfamethoxazole.

 For patients with moderate or severe purulent infections requiring inpatient admission, intravenous (IV) agents include ceftaroline, daptomycin, linezolid, or vancomycin, with vancomycin representing the typical first-line agent.

 As in all infectious syndromes, special care should be given to the appropriate stewardship of antimicrobial agents when making therapy selections.

Empiric antibiotic regimens for nonpurulent cellulitis and erysipelas should primarily target streptococcal spp given the predominance of this organism in the syndrome. For outpatient management of mild or moderate infections, optimal agents include either oral first-generation cephalosporins (ie, cefadroxil or cephalexin) or a penicillin (ie, amoxicillin or penicillin). Clindamycin can be used for patients with known, severe β-lactam allergy.

For inpatient management of mild or moderate infections, the optimal first-line IV option is a first-generation cephalosporin, such as cefazolin, although such other agents as ceftriaxone, nafcillin, or penicillin also provide an appropriate empiric spectrum of activity. Clindamycin or vancomycin can be used in patients unable to tolerate β-lactams.

Patients with nonpurulent disease who have a history of MRSA infections should be considered for empiric treatment with vancomycin or another agent that will cover MRSA.

As previously indicated, treatment of wound infections varies based on the anatomical location of the wound and expected flora at the wound site. In general, oral antimicrobial regimens should include antistreptococcal agents, such as cephalexin, and anti-MRSA agents, such as trimethoprim-sulfamethoxazole. IV vancomycin provides appropriate coverage of gram-positive organisms for patients admitted to the hospital.

 Infected wounds of the abdominal, perianal, or urogenital regions should include empiric coverage for enteric anaerobes and gram-negative pathogens.

 Empiric oral regimens include amoxicillin-clavulanate or cefdinir and metronidazole. A preferred empiric IV regimen for abdominal, perineal, or urogenital wound infection consists of ceftriaxone and metronidazole.

In attempts to reduce the risk for unintended consequences of antimicrobial use, significant focus has been applied to reducing the duration of antibiotic treatment for many infections, including ABSSSI. Studies continue to emerge showing that shorter courses of antibiotics for cellulitis are just as efficacious as longer durations.

 In 1 such study of patients receiving antibiotic therapy for uncomplicated cellulitis, the results showed no significant differences in the clinical outcomes or treatment failure in those who received 5 days of therapy compared with patients receiving 10 days.

 As such, the most recent guidelines for ABSSSI recommend a duration of 5 days of antibiotic therapy. However, for those who demonstrate delayed clinical improvement (ie, delayed resolution of fever, recession of erythema, or vital sign stability), it may be necessary to extend the antimicrobial duration.

ABSSSI are commonly encountered in clinical practice. The broad scope of patient risk factors, severity of illness, and syndromes can be intimidating factors in determining suspected microbiology, empiric antimicrobial selection, and therapy duration. Key elements involved in these facets of care include the absence or presence of purulence, anatomical location, need for inpatient care or IV antimicrobials, and severity of infection. Careful consideration of these key factors will guide clinicians in their care of patients presenting with ABSSSI (see Table

is an inpatient antimicrobial stewardship pharmacist at Ascension Sacred Heart Hospital in Pensacola, Florida.

is an antimicrobial stewardship/outpatient antimicrobial therapy pharmacist at Mayo Clinic in Rochester, Minnesota.

is a PGY-2 emergency medicine pharmacy resident at Mayo Clinic.

1. Pollack CV Jr, Amin A, Ford WT Jr, et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. 

 2015;48(4):508-519. doi:10.1016/j.jemermed.2014.12.001

2. Tiwari AK, Lal R. Study to evaluate the role of severity stratification of skin and soft tissue infections (SSTIs) in formulating treatment strategies and predicting poor prognostic factors. 

 2014;12(2):125-133. doi:10.1016/j.ijsu.2013.11.014

3. Russo A, Concia E, Cristini F, et al. Current and future trends in antibiotic therapy of acute bacterial skin and skin-structure infections. 

2016;22(suppl 2):S27-36.doi:10.1016/S1198-743X(16)30095-7

4. Acute bacterial skin and skin structure infections: developing drugs for treatment. FDA. October 2013. Accessed June 18, 2021. https://www.fda.gov/files/drugs/published/Acute-Bacterial-Skin-and-Skin-Structure-Infections---Developing-Drugs-for-Treatment.pdf

5. Pulido-Cejudo A, Guzmán-Gutierrez M, Jalife-Montaño A, et al. Management of acute bacterial skin and skin structure infections with a focus on patients at high risk of treatment failure. 

2017;4(5):143-161. doi:10.1177/2049936117723228

6. Stevens DL, Bisno AL, Chambers HF, et al; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. 

 2014;59(2):e10-e52. doi:10.1093/cid/ciu444

7. Sartelli M, Guirao X, Hardcastle TC, et al. 2018 WSES/SIS-E consensus conference: recommendations for the management of skin and soft-tissue infections. 

2018;13:58. doi:10.1186/s13017-018-0219-9

8. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. 

2017;18(1):1-76. doi:10.1089/sur.2016.261

9. Spellberg B. The new antibiotic mantra—“shorter is better.” 

. 2016;176(9):1254-1255. doi:10.1001/jamainternmed.2016.3646

10. Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin-structure infections: the ESTABLISH-1 randomized trial. 

. 2013;309(6):559-569. doi:10.1001/jama.2013.241

11. Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. 

 2014;14(8):696-705. doi:10.1016/S1473-3099(14)70737-6

12. Hepburn MJ, Dooley DP, Skidmore PJ, Ellis MW, Starnes WF, Hasewinkle WC. Comparison of short course (5 days) and standard (10 days) treatment for uncomplicated cellulitis. 

2004;164(15):1669-1674. doi:10.1001/archinte.164.15.1669

13. Kannangara DW, Pandya D. Infections in injection drug users: the significance of oral bacteria and a comparison with bacteria originating from skin and environmental sources. 

 January 22, 2020. Accessed June 18, 2021. 

https://www.researchgate.net/publication/338836628_Infections_in_Injection_Drug_Users_The_Significance_of_Oral_Bacteria_and_a_Comparison_with_Bacteria_Originating_from_Skin_and_Environmental_Sources

14. Jenkins TC, Knepper BC, Moore SJ, et al. Microbiology and initial antibiotic therapy for injection drug users and non-injection drug users with cutaneous abscesses in the era of community-associated methicillin-resistant Staphylococcus aureus. 

2015;22(8):993-997. doi:10.1111/acem.12727

Consider key elements of acute bacterial skin and skin structure infection to help patients manage this broad range of diseases.

Hospital

Scratch Beneath the Surface: ABSSSI

A new survey conducted by The Harris Poll on behalf of the Samueli Foundation found that 29% of Americans are taking more supplements compared with before the COVID-19 pandemic, bringing the nationwide percentage of supplement-takers to 76%.

The results showed that nearly two-thirds of those who increased supplement use (65%) cited a desire to enhance their overall immunity (57%) or protection from COVID-19 (36%) as reasons for the spike. Other reasons for the increase included taking control of their own health (42%), improving sleep (41%), and improving their mental health (34%).

"The COVID-19 pandemic is a catalyst for increased supplement use," said Wayne Jonas, MD, executive director of Integrative Health Programs at Samueli Foundation, in a press release. "Supplements, when used under the guidance of health care professionals, can be beneficial for one's health. Unfortunately, however, many people are unaware of the risks and safety issues associated with their use."

Additional results showed that more than half of those surveyed taking supplements (52%) mistakenly believe that most dietary supplements available for purchase have been declared safe and effective by the FDA. Approximately 32% indicated that if a supplement could be dangerous, it would not be allowed to be sold in the United States.

"Contrary to what many believe, the FDA does not regulate supplements. In fact, many supplements are not identified as dangerous until after people are negatively affected by them,” Jonas said in the press release. "There are benefits to one's health from supplements, but also risks, so I encourage anyone who is taking a supplement or thinking of taking one to discuss it with your health care provider first."

Less than half of Americans who use supplements (47%) said they spoke with a health care provider before use, despite national guidelines that strongly recommend doing so. Further, 46% of Americans currently taking prescription medications said they have not talked to their health care provider about the possible interactions that supplements could have with their prescriptions.

There were various barriers analyzed in terms of discussing supplements with a health care provider, including:

Thirty five percent of all Americans claim they do not think their health care provider is interested in whether they are taking supplements.

Approximately 32% of Americans do not think their health care provider knows enough about supplements to advise them properly.

Other findings showed differences that are based on race and ethnicity, such as:

Only 86% of non-Hispanic Americans said they would be comfortable sharing which supplements they take with their health care provider compared to 67% of Hispanics and 75% of Blacks.

More than 1 in 3 Hispanic adults said they worry that their health care provider will make preconceived judgements based on the supplements they take, whereas 46% said they do not think their health care provider is interested versus 31% of non-Hispanic adults.

The survey was conducted online among 2053 US adults ages 18 years and older, including 1531 who are currently taking supplements. The participants were surveyed from June 15-17, 2021.

Three in ten Americans increased supplement use since onset of pandemic. EurekAlert! July 21, 2021. Accessed July 21, 2021. 

https://www.eurekalert.org/pub_releases/2021-07/trg-tit072021.php

Vitamins and Supplements

Survey Finds 3 in 10 Americans Increased Supplement Use Since COVID-19 Pandemic

New research from Lehigh University has found that students with attention-deficit hyperactivity disorder (ADHD) face substantial challenges in succeeding and completing their college education. A new paper by George DePaul, professor of school psychology and associate dean for research in Lehigh University’s College of Education, hypothesizes ways academic success can improve.

The paper, called “Academic Trajectories of College Students with and without ADHD: Predictors of Four-Year Outcomes,” highlights one of the largest, most comprehensive investigations of college students with ADHD conducted and is the first to systematically examine the functioning of ADHD students across 4 years of college.

“College students with ADHD are likely to experience significant academic difficulties throughout their college years, are at higher than average risk for dropping out of college and require academic support prior to and throughout their college years,” DuPaul said in a press release.

More than 400 college students were assessed through annual psychological and educational evaluations, half of whom identified with ADHD, including multiple academic outcomes including GPA by semester, progress toward graduation by academic year, self-reported study skills by academic year, and college drop-out status. The study took place over the course of 4 years with student participants from colleges in North Carolina, Pennsylvania, and Rhode Island.

The findings showed that on average, college students with ADHD received grades that were half a grade level below their peers in all 4 years. In addition, the results showed that college students with ADHD were significantly less likely to stay enrolled across semesters.

“It was somewhat surprising to see the magnitude of the academic deficits experienced by college students with ADHD because these were students who had the skills to successfully graduate from high school and matriculate in a four-year college or university,” DuPaul said in the press release. “We expected smaller declines in their educational performance in college.”

There were several variables that helped project academic success for students with ADHD, including having fewer depression symptoms, retaining better executive functioning skills such as planning and time management, and having received educational accommodations in high school and academic support services in college, according to the researchers.

The study authors hope that the findings will spark interest to college disability offices, health care and mental health professionals who work with college-aged students, higher education faculty and administrators, and individuals with ADHD and their families.

“Our findings highlight the importance of providing academic support services for students with ADHD prior to college matriculation, the vital need to improve executive functioning skills in these students, and necessity to screen for and treat depressive symptoms experienced by college students with ADHD,” DuPaul said in the press release.

Researchers find college students with ADHD are likely to experience significant academic challenges. Lehigh University. February 22, 2021. Accessed July 20, 2021. 

https://www2.lehigh.edu/news/researchers-find-college-students-with-adhd-are-likely-to-experience-significant-academic

The findings showed that on average, college students with ADHD received grades that were half a grade level below their peers in all 4 years.

ADHD

College Students With ADHD More Likely to Experience Significant Academic Challenges

In an interview with Pharmacy Times, Pamela Spicer, senior analyst with Datamonitor at Informa Pharma Intelligence, said the various controversies surrounding the FDA approval of aducanumab could impact its implementation in health systems. Although she said it's unlikely that the FDA will retract the approval, she said prescribers could be reluctant to administer aducanumab to patients.

Several major health systems—The Cleveland Clinic, Mount Sinai Health System, and Providence Health in Washington State—have already announced that they will not administer aducanumab, according to reporting 

 This interview was filmed prior to these announcements.

Walker J. Cleveland Clinic, Mount Sinai and Providence Won't Give Biogen's New Alzheimer's Drug. Wall Street Journal. July 15, 2021. Accessed July 22, 2021. 

https://www.wsj.com/articles/cleveland-clinic-mount-sinai-wont-give-biogens-new-alzheimers-drug-11626366968

Although she said it is unlikely that the FDA will retract the approval, prescribers could be reluctant to administer aducanumab to patients.

Neurology

Expert: Aducanumab Concerns Could Impact Implementation for Alzheimer Disease

Both the antibody and T cell immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were stable through 8 months following immunization, according to the interim results of a phase 1/2a sub-study published in the 

. The results indicated that T cell responses—including CD8+ T cells, which seek out and destroy infected cells—persisted over the 8-month timeframe of the study, according to the authors.

The ongoing phase 1/2a trial is a multi-center, randomized, double-blind, placebo-controlled study that aims to evaluate the safety, reactogenicity, and immunogenicity of the Janssen COVID-19 Vaccine. The vaccine is administered at 2 dose levels intramuscularly, either as a single dose or on a 2-dose schedule 8 weeks apart. The sub-study currently reporting results uses cohort 1b of the ongoing trial, which enrolled 25 adults who are 18-55 years of age.

Data from the study suggested that 1 dose of the Johnson & Johnson COVID-19 vaccine resulted in the maturation of B cell response without further booster shots. Mature B cells produce antibodies that help to fight SARS-CoV-2. In combination with the T cell responses, these dual mechanisms of protection were capable of protecting against COVID-19, including disease caused by notable variants such as the Delta, Alpha, Beta, Gamma, Epsilon, and Kappa variants. This indicates an expansion of neutralizing antibodies over the 8 months of the study, according to the authors.

“These peer-reviewed data provide further and deeper insights into the durable humoral and cellular immune responses elicited by the single-shot Johnson & Johnson COVID-19 vaccine, thus offering potentially a dual mechanism of protection against COVID-19 disease, including against the Delta variant and other variants of concern,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development, in a press release. “The study showed that variant-specific neutralizing antibodies increased over the eight months examined after vaccination which suggests the maturation of B-cell responses. In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”

The data complimented results previously published in 

 providing evidence of the Johnson & Johnson vaccine’s ability to elicit a response from multiple components of the immune system in individuals. Further, preclinical data demonstrated efficacy against SARS-CoV-2 infection caused by the Beta variant in non-human primates.

Additional data from analyzing blood samples obtained from a subset of participants in the phase 3 ENSEMBLE study demonstrated that the single-shot vaccine resulted in neutralizing antibody activity against the Delta variant at higher levels than was previously observed for the Beta variant.

Johnson & Johnson single-shot COVID-19 vaccine demonstrated a durable immune response and elicited dual mechanisms of protection against delta and Other SARS-CoV-2 variants of concern in data published in New England Journal of Medicine [news release]. Johnson & Johnson; July 14, 2021. Accessed July 22, 2021. 

https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-demonstrated-a-durable-immune-response-and-elicited-dual-mechanisms-of-protection-against-delta-and-other-sars-cov-2-variants-of-concern-in-data-published-in-new-england-journal-of-medicine

The results indicated that T cell responses—including CD8+ T cells, which seek out and destroy infected cells—persisted over the 8-month timeframe of the study, according to the authors.

Coronavirus

Johnson & Johnson Single-Shot COVID-19 Vaccine Elicits Both Humoral and Cellular Response, Protects Against Delta Variant

During a presentation at the 2021 annual meeting of the American Association of Colleges of Pharmacy, the presenters broke down how best to engage colleges of pharmacy to help in establishing payer-provider relationships. Todd Sorensen, PharmD, one of the session’s presenters, emphasized the importance of these relationships and what they can accomplish.

“I like to think of partnerships as creating scenarios where 1 plus 1 equals 3,” Sorensen said during the presentation. “We can accomplish more in partnership than we can individually.”

According to the panel, creating a successful innovation in pharmacy relies on 3 factors: first, the intervention must be well-defined and have a solid base of evidence behind it. Second, the implementation needs to use evidence-based approaches that support the adoption of the innovation. Finally, the environment in which this innovation is implemented needs to help enable that implementation through policy and socio-economic factors.

“If we’re missing 1 of these 3 elements, it’s very difficult to achieve a positive outcome,” Sorensen said.

Through providing example scenarios, presenter Nicholas Cox, PharmD, BCACP, explained how colleges of pharmacy can take an active role in facilitating this kind of working relationship. At the University of Utah, the Clinical Innovation Fellowship serves both to provide education and scholarship to students while providing the payer organization with targeted, integrated, in-person pharmacist engagement for high-cost patients.

The program is a 1-year fellowship that is 50% funded by the University of Utah College of Pharmacy and 50% funded by the local payer organization SelectHealth. It focuses on ambulatory care, practice implementation and development, teaching and academia, and research and scholarship. For 3 days each week, the fellow provides proactive patient identification on SelectHealth patients at the Granger Medical Clinic, identifying the most medication-complex patients and providing comprehensive medication management.

The speakers also discussed the importance of shared responsibility between payer organizations and provider organizations. They said that in a successful payer-provider partnership, the provider organizations invest in services that generate value for the health plan, take on risk, commit to performance measurement, and create or join communities of practice. Payer organizations, on the other hand, should establish specific standards of service delivery, provide incentives, and invest in provider network development, according to the panel.

Kyle Turner, Todd Sorensen, Nicholas Cox. Strengthening our ties: college of pharmacy engagement in establishing payer-provider relationships. Presented at: 2021 AACP Annual Meeting; on-demand; virtual. Accessed July 21, 2021.

During a presentation at the 2021 annual meeting of the American Association of Colleges of Pharmacy, the presenters broke down how best to engage colleges of pharmacy to help in establishing payer-provider relationships.

Conference

Student

Reimbursement

Engaging Colleges of Pharmacy to Assist Establishing Payer-Provider Relationships 

If a patient has diabetes, with metformin onboard as a treatment option, and GFR (kidney function) is below <30, metformin should be discontinued.

Do not use metformin among patients with an eGFR less than 30.

Do not start metformin among patients with an eGFR between 30 and 45.

Stop metformin if a patient’s eGFR drops less than at any point during therapy.

Complete a risk-benefit analysis of metformin if a patient’s eGFR drops to less than 45.

Because metformin is renally cleared, it may cause some concern about nephrotoxicity, especially lactic acidosis, in patients with impaired renal function.

Metformin and Renal Function (diabeteseducator.org)

How should pharmacists manage a patient with diabetes on metformin with GFR  below 30?

Diabetes

Chronic Kidney Disease

Pharmacy Clinical Pearl of the Day: Metformin and Kidney Function in Diabetes

Individuals with a higher intake of ultra-processed foods may have a higher risk of inflammatory bowel disease (IBD), according to new research published in 

IBD is most common in industrialized countries and researchers believe that dietary factors may play a role, according to the study. Ultra-processed foods include packaged baked goods and snacks, carbonated drinks, sugary cereals, ready-to-eat meals containing additives, and reconstituted meat and fish products. All of these products often contain high levels of added sugar, fat, and salt, but lack vitamins and fiber.

To investigate the link between ultra-processed foods and IBD, investigators analyzed detailed dietary information from 116,087 adults between 35 and 70 years of age and living in 21 low-, middle-, and high-income countries. These adults were taking part in the Prospective Urban Rural Epidemiology (PURE) study, which is examining the impact of societal influences on chronic diseases.

These participants were enrolled in the study between 2003 and 2016 and were assessed at least every 3 years. Investigators recorded new diagnoses of IBD, including Crohn disease or ulcerative colitis, over an average follow-up of 9.7 years. During this period, 467 participants developed IBD, 90 of whom were diagnosed with Crohn disease and 377 with ulcerative colitis.

After accounting for other potentially influential factors, the research team found that a higher intake of ultra-processed foods was linked to a greater risk of IBD. For example, they found an 82% increased risk of IBD among individuals who consumed 5 or more servings of ultra-processed foods per day compared to those who consumed less than 1 serving. They found a 67% higher risk of IBD among those who consumed between 1 and 4 servings per day.

Different subgroups of ultra-processed foods, such as soft drinks, refined sweetened foods, salty snacks, and processed meat, were associated with higher risks of IBD. In contrast, white meat, red meat, dairy, starch, fruit, vegetable, and legume intake were not associated with IBD, according to the study.

These results were consistent for both Crohn disease and ulcerative colitis and were similar after researchers conducted further analysis to test the risk of developing IBD based on age and region. According to the study authors, this suggests that the findings are robust.

Notably, however, the study cannot establish causality because it was an observational study. The researchers also noted that their results relied on self-reported diagnoses and did not account for dietary changes over time. They also said they cannot rule out the possibility that other unmeasured factors could have affected the results.

Still, the authors said their findings suggest that intake of ultra-processed foods could increase the risk of IBD. They hypothesized that because white meat, unprocessed red meat, dairy, starch, fruit, vegetables, and legumes were not associated with the development of IBD, the way that the food is processed may confer this risk of IBD, rather than the food itself.

“Further studies are needed to identify specific potential contributory factors among processed foods that might be responsible for the observed associations in our study,” the authors concluded in the press release.

Ultra-processed food linked to higher risk of IBD. News release. EurekAlert. July 14, 2021. Accessed July 21, 2021. 

https://www.eurekalert.org/pub_releases/2021-07/b-ufl071221.php

Because white meat, unprocessed red meat, dairy, starch, fruit, vegetables, and legumes were not associated with the development of IBD, the way that the food is processed may confer this risk of IBD, rather than the food itself.

Digestive Health

Study: Ultra-Processed Food Associated With Higher Risk of Inflammatory Bowel Disease

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