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 ZuPOO is a dietary supplement designed for gut support, and specifically for colon and gut cleansing.

ZuPOO is designed to help flush excess waste from the gut and intestines. This allows for a smoother digestion process and healthier gut.

 Patients should take 2 capsules with a full glass of water. They may notice a buildup of gas over the first 12 to 24 hours, but can expect a flushing of waste within 48 hours. Patients should continue taking zuPOO before bed for 15 days to complete a full flush of the digestive system. The manufacturer notes that they do not recommend taking zuPOO more frequently than at a rate of one full cleanse per 90 days.

The capsule is made from bovine gelatin, so the product overall is not vegan. However, the contents are vegan-friendly.

ZuPOO is dairy-free, however, it is processed in the same facility as some dairy-containing products.

zuPoo Colon Cleanse by UMZU | Cleanse Your Gut - Default Title - UMZU

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ZuPOO is indicated for gut support, and specifically for colon and gut cleansing.

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Vitamins and Supplements

® Vitamins and Supplements Resource Center is a comprehensive resource for clinical news and expert insights on issues related to OTC vitamin products and supplements.

Retail

® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to retail, community, and independent pharmacists.

Daily OTC Pearl: ZuPOO

The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo, Inc) to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC). The approval indication also noted that to be eligible for this treatment, patients with NSCLC must have tumors that activate 

 mutations and have had prior systemic therapy.

An antibody drug conjugate (ADC), trastuzumab deruxtecan was developed to treat HER2 specifically, and it was granted accelerated approval after having a successful objective response rate (ORR) and duration of response (DoR) during the DESTINY-Lung02 phase 2 trial.

“The approval of trastuzumab deruxtecan in non-small cell lung cancer is an important milestone for patients and the oncology community,” said Bob T. Li, MD, PhD, MPH, a medical oncologist and physician-scientist at Memorial Sloan Kettering Cancer Center, New York, in a press release.

 mutant non-small cell lung cancer commonly affects young patients, explained Dave Fredrickson, executive vice president, Oncology Business Unit at AstraZeneca, in the press release. With the new approval, patients could have targeted treatment options that were not available to them in the past. Frederickson added that the approval emphasizes the importance of testing predictive markers at diagnosis to provide the most appropriate care for patients.

In the phase 2 DESTINY-Lung02 trial, researchers administered trastuzumab deruxtecan at 5.4 mg/kg. Based on the results, the researchers observed that patients with 

 mutant unresectable or metastatic non-squamous NSCLC responded to the drug with a 57.7% objective response rate (ORR).

“The availability of ENHERTU as the first HER2 targeted treatment option for 

mutant non-small cell lung cancer is great news for patients,” Upal Basu Roy, PhD, MPH, executive director of research at LUNGevity, said in the press release. “We are thrilled to see a novel treatment option available that targets this group of rare mutations in lung cancer. This approval is a great reminder that access to high-quality biomarker testing will be critical to ensuring that patients whose tumors have 

 mutations have access to these new therapies.”

Within the past 3 years, the FDA approved trastuzumab deruxtecan to treat 3 different types of tumors. After successful results from the phase 2 trial for DESTINY-Lung01, the FDA granted Priority Review and Breakthrough Therapy Designation for DESTINY-Lung02 in 2020.

“We are excited that the FDA has granted accelerated approval for ENHERTU for patients with 

mutant metastatic non-small cell lung cancer,” Ken Keller, the global head of oncology business, president, and CEO of Daiichi Sankyo, Inc, said in the press release. “ENHERTU has now been approved in 3 different tumor types, underscoring its significant potential across several HER2 targetable tumors.”

ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients with Previously Treated 

Mutant Metastatic Non-Small Cell Lung Cancer. Tokyo, Japan: Daiichi Sankyo; Aug 11, 2022. Accessed on Aug 12, 2022. https://www.businesswire.com/news/home/20220811005803/en/ENHERTU%C2%AE-Approved-in-the-U.S.-as-the-First-HER2-Directed-Therapy-for-Patients-with-Previously-Treated-HER2-Mutant-Metastatic-Non-Small-Cell-Lung-Cancer

The FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu) to treat HER2 mutant non-small cell lung cancer was based on results from the DESTINY-Lung02 phase 2 trial.

Oncology

® Oncology Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to oncology pharmacists.

Lung Cancer

® Lung Cancer Resource Center is a comprehensive resource for clinical news and expert insights on issues related to cancer that begins on the lungs, including non-small cell lung cancer and small cell lung cancer.

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® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to specialty pharmacists.

Hospital

® Pharmacy Technician Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to hospital and health-system pharmacists.

FDA Grants Accelerated Approval to Enhertu for HER2 Mutant Non-small Cell Lung Cancer

Medication Pearl of the Day: Meropenem and vaborbactam (Vabomere)

Meropenem and vaborbactam (Vabomere) is a combination of meropenem, which is a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor. Meropenem and vaborbactam is indicated for the treatment of patients aged 18 years and older with complicated urinary tract infections (cUTI), such as pyelonephritis caused by designated susceptible bacteria.

Administer meropenem and vaborbactam at 4 grams—with 2 grams of meropenem and 2 grams of vaborbactam—every 8 hours by intravenous infusion over 3 hours for up to 14 days, in patients aged 18 years and older with an estimated glomerular filtration rate of 50 mL/min/1.73m2 or greater.

: Meropenem and vaborbactam at 2 grams for injection is supplied as a sterile powder for constitution in single-dose vials containing 1 gram of meropenem, which is equivalent to 1.14 grams of meropenem trihydrate, and 1 gram of vaborbactam.

 The most frequently reported AEs occurring in 3% or more of patients treated with meropenem and vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.

: The meropenem component of the combination treatment is a penem antibacterial drug. The bactericidal action of meropenem results from the inhibition of cell wall synthesis. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding protein targets. The vaborbactam component of the combination treatment is a non-suicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as Klebsiella pneumoniae carbapenemase. Vaborbactam does not have any antibacterial activity, and it does not decrease the activity of meropenem against meropenem-susceptible organisms.

Meropenem and vaborbactam is indicated for the treatment of complicated urinary tract infections for patients aged 18 years and older.

Infectious Disease

® Infectious Disease Resource Center is a comprehensive resource for clinical news and expert insights on a group of disorders caused by organisms, such as bacteria, viruses, fungi, or parasites.

Daily Medication Pearl: Meropenem, Vaborbactam (Vabomere)

The FDA approved a supplemental New Drug Application (sNDA) for baloxavir marboxil (Xofluza; Genentech), which is an acute and uncomplicated influenza (flu) treatment. Baloxavir marboxil is a single-dose oral flu medicine that is the first and only drug of its kind that has been approved for this age group.

The FDA approved baloxavir marboxil to treat healthy children aged 5 to 11 years who are symptomatic for less than 2 days with the flu. It is also approved to prevent the flu in children aged 5 to 11 years who have encountered someone with the flu. The FDA approved baloxavir marboxil following the miniSTONE-2 and BLOCKSTONE phase 3 studies.

“Today’s FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza," said miniSTONE-2 study investigator Pedro Piedra, MD, professor of molecular virology and microbiology, pediatrics at Baylor College of Medicine, in a statement.

From 2018 to 2019, more than 6 million children contracted a strain of the flu. Further, the severity of the flu can vary from mild to deadly. From 2018-2019, the flu killed more than 100 children aged 5 to 17 years. In the press release, the CDC added that recent social distancing and mask wearing during the COVID-19 pandemic significantly reduced flu cases in children.

“Despite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in the press release. “Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.”

In the miniSTONE-2 phase 3 trial, researchers compared baloxavir marboxil with oseltamivir, evaluating healthy children aged 5 to 11 years with less than 48 hours of symptoms. During the BLOCKSTONE phase 3 trial, researchers evaluated baloxavir marboxil as a preventative treatment for household members living with someone diagnosed with the flu.

As one of the largest transmitters of the flu virus, children can also play a significant role in transmission of the virus within the home, as well as beyond it.

“Historically, school-aged children have played a significant role in the community transmission of influenza. The annual influenza vaccine continues to be the most important first step to prevent illness in children, though there can still be breakthrough cases where antiviral treatment is needed,” Piedra said in the statement.

Baloxavir marboxil was shown in non-clinical studies to be effective against multiple flu strains. The FDA approved baloxavir marboxil back in 2018 to treat acute, uncomplicated flu in healthy individuals aged 12 years with less than 48 hours of symptoms. When approved in 2018, it marked the first new flu antiviral in 20 years. That same year, it was also approved as a one-dose, single tablet for individuals aged 12 years and older exposed to the flu.

Among pediatric patients, 5% reported adverse effects—of this percentage, 5% reported vomiting and 5% reported diarrhea. Researchers are now studying baloxavir marboxil in children who are aged younger than 1 year in a phase 3 development program (NCT03653364).

Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older. San Francisco, CA: Genentech; Aug 11, 2022. Accessed on Aug 12, 2022. https://www.businesswire.com/news/home/20220815005009/en

Baloxavir marboxil is the first and only single-dose oral medicine to treat influenza in children, a population who play a significant role as transmitters of influenza in the country.

Immunization

® Immunization Resource Center is a comprehensive resource for clinical news and expert insights on common immunizations, such as flu, zoster, and COVID-19 vaccines.

® Flu Resource Center is a comprehensive resource for clinical news and expert insights on the treatment of influenza, a contagious viral infection that can cause mild to severe symptoms and life-threatening complications.

FDA Approves Baloxavir Marboxil to Treat Influenza in Children Aged 5 to 11

 As of December 2021, the CDC reported that 85% of adults aged 18 years and older had received at least 1 COVID-19 shot, and 15% remained unvaccinated. Among the adults not vaccinated, 75% were under the age of 50 years. Looking at what pharmacists have historically seen, we’ve always done a great job immunizing the older population and have always run into that required/recommended scenario with the 19-to-64-year-old cohort.

We’ve been discovered by a larger group of eligible patients all the way down to the 19-year-old because they’re now seeing the pharmacy as a destination for immunizations. Do you think that we could capitalize on that and continue the success? Having a larger number of patients coming to the pharmacy and looking for that service, do you think that will continue? Do you think we’ve done a good enough job? Or will we still have to market to get those patients to remember that it’s time for the next immunization and to come to the pharmacy?

 I don’t think we’ve done a good enough job, unfortunately. This is a demographic of relatively healthy people. Sometimes they do their own risk-benefit analysis. I’ve talked to a number of people who felt, “I could make it through a COVID-19 illness and I’m not sure that I need that.” It’s ironic that they’ll take better care of their pets. Their pets will be vaccinated, yet they don’t feel the need to do this. It goes back to a lot of the points that Mary made earlier around trust and that relationship with your patients.

There’s a lot of great information out there. There are social media toolkits, a way that to get a COVID-19 vaccine. You can get a text message based on your zip code of where to go, or a phone number to call, or a website to visit. There’s ways that you could quickly meet those needs. But we need to continue to have conversations around the global public health about why we’re all in this together and why it’s an important good idea. We need to counter some of the points that are continuously circulated.

I recently attended a talk where one of the points that stuck with me was, “If you hear something that’s outlandish, don’t repeat it.” That’s something that I had never thought about. Sometimes, at dinner conversation with my friends, I’ll say, “You won’t believe this one.” But you actually give this idea traction when you continue to say the idea, even though you know it isn’t something that’s based in science or something that should be out there. You’re making it more likely that someone else will hear it and perhaps believe it because you’re repeating it. Sometimes the best thing to do is not repeat misinformation and continue to have a variety of resources. Pediatricians have great resources for parents. There are great resources out there, including heartwarming stories of people who got vaccinated and it saved their life.

When we look at the vaccine hesitancy issue, a lot of times we’re trying to combat very personal stories about child illnesses that happened, or we’re debunking the autism myth—some of those things. Some of those parents have very heart-wrenching stories, and we aren’t going to combat those by using hard facts and statistics or ridiculing the person. I try to have real conversations with these individuals. I give them my perspective, I provide them information, and I try not to talk them into something. I try to be an information-giver and hope that sometime later on they’ll reap that harvest that I’ve sown.

 I want to point out that our 19-to-64-year-olds are sometimes described as sandwich generations, sandwiched between providing care for children and providing care for older adults. Sometimes you become the last person in line whom you’re thinking about from a health perspective. Anything that we can do in terms of immunization services to make things a little easier, whether it’s sharing reminders or scheduling subsequent booster doses at the time of an initial appointment, we’ve got an opportunity to do what we can to alleviate some of the burden and the challenge that this generation may be experiencing because of their circumstance in life.

There are 2 key components for educating this group. One is community immunity. Wes touched on it earlier, that you aren’t just getting vaccinated for yourself. You may be healthy and otherwise totally unaffected if you get COVID-19, but that doesn’t mean someone around you who can’t get vaccinated would be. The idea of community immunity and bringing it down to the local level [is important]. It shocked me a little when I heard that 85% had gotten 1 dose, because in the pockets I’ve been working with, it isn’t that high. Where I’m practicing directly, it’s higher, but it's much lower in some of the other groups that I work with. Talking about that local community immunity is important.

The other thing that we aren’t talking about to this age group is that they’re healthy now, but we don’t know the long-term implications of COVID-19. My mother has MS [multiple sclerosis], so I’ve been following MS research for a very long time. It has now basically been proven that Epstein-Barr virus causes MS. There was a correlation for a long time. In the last few months, this major study came out. Who’s to say what major disease may be linked in the future to having COVID-19? Talking to these people who are young and healthy and work out every day, it’s important to say, “Have you heard of long COVID? Do you know what’s happening to some people who are healthy?” And explaining some of the risks of having the illness itself, even if you do recover.

This is the generation of convenience, too. If you tell me it’s 15 minutes, I don’t have 15 minutes, I need it in 5. If you’re in a busy pharmacy, sometimes that’s difficult. Maybe we transition to asking at the drop-off instead of at pickup. Or if you’re in a clinic setting, we had a sign out front that said “Walk-in COVID-19 Vaccines” and business was booming. We got rid of the sign while still offering the vaccines, and it just shut down, because people don’t have that mental cue. Often people are willing to do it, but they’ve been at work, 9 to 5 every day, and they’re home on the weekends. They may not have the opportunity because, like Wes was saying, they aren’t sick and aren’t going to the pharmacy regularly. Think about how to draw convenience. Even though we feel like we’ve seen those signs over and over, there’s probably somebody who will benefit from it if it seems fast and easy.

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Pharmacists discuss barriers contributing to vaccine reluctance among young adults, including varying degrees of education, accessibility, and convenience.

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Optimizing Immunization Schedules Among Young Adults

 Throughout the past 2 years, we’ve seen and received a lot of emergency-use privileges. Technicians have been able to immunize for flu and COVID-19. We see the PREP [The Public Readiness and Emergency Preparedness] Act and emergency decrees by the individual states. Now things are settling a bit. We aren’t feeling this emergency as we did in the beginning. There’s talk that the PREP Act could sunset. We’re already seeing some activity in states where they’re sunsetting some of those emergency decrees. With that sunset comes the potential loss of privileges for some of the things that pharmacists have been able to do, which surely will impact the technicians. Without some proactive movement on boards of pharmacy or the legislative process, technicians may lose the opportunity to immunize. It’s a passionate area for me because I truly believe that pharmacy has risen, and suddenly there’s conversation about taking pharmacy back to where we started, where we were at the beginning of the pandemic.

Without technicians jumping in and taking on some of these additional roles, it would’ve been a much longer season for us. We were slammed, and the technicians being able to administer vaccines and tests helped tremendously. If many states haven’t addressed this within their policies and regulations, and they haven’t legislated technicians being able to administer, I’m afraid that my brethren in the community pharmacy are in for a very long year of flu and COVID-19 simultaneously, depending on what happens with boosters.

I’m also concerned about the pediatric ability, because these poor pediatric offices are probably going to be completely swamped with the new approvals for children. That takes some of the burden off of those offices to be able to offer other vaccines, even down to your recommended schedule for the children’s vaccines. I’m a little concerned. I’m unclear, and you guys may know. In Tennessee, we’ve addressed this. In many other states, they’re also addressing it as far as technician administration. But I don’t know how much of the country has done this. It would be unfortunate if they were to let this sunset and not make it a standard of pharmacy practice.

 With any immunization experience building out programs, you all know that what you see in 1 state is only 1 state. There are 50 states and 50 individual immunization programs across the country. There’s no 2 alike. It was very fortunate for the profession of pharmacy to have a federal decree that said that things could be the same across all states. That has been very refreshing for the past 2 years. The loss of that federal-level authority is huge. I don’t think the states individually are picking up the ball and running forward with it. A lot of them are picking it up and going backward. Do any of you have information about what’s going on in your state?

 We’re very similar to Traci’s in the fact that our state advocacy group moved relatively quicklyand got the technicians authorized within state law to do this. It isn’t a new idea. There were a few states that were doing this before the COVID-19 pandemic. When I first heard about it, I was very much against it because I felt that it was going to take away an essential role that the pharmacist played. But then I spoke to pharmacists in those states and found that it freed them up to have the conversations that we need to be having. It’s the education and information components that the pharmacists can give. The actual task is what the technician is helping alleviate. To Tracy’s point, we need that, and we very much need it in today’s community practice. I totally agree that this is an area where we’re now getting students coming into pharmacy school who have already done hundreds of vaccines, and it’s a tremendous thing that they can bring to the table. It’s something that technicians have shown they’re capable of doing well, and it would be a tragedy to see that go backward.

 We’ve heard so much conversation about making the role of the technician a career path and not just a job. By giving them these advanced privileges and opportunities, if you take them away, that destroys the career path idea and reinforces that we don’t value the technicians. As pharmacists, if you’ve ever worked behind the counter, you know how valuable the technician is. If only those who are in the decision-making seats could experience that and see firsthand just how valuable it is to have good technicians and that career path for them. It would change all their minds.

The expert panel illustrate the changing roles of pharmacists and technicians as healthcare expands and evolves from the impact of the COVID-19 pandemic.

Shifting of Pharmacist and Technician Roles Due to the Pandemic 

Up to 5% of adults may have long-lasting distorted smell and taste after recovering from COVID-19, according to research published in the 

, which can cause distress and future neurological issues.

 Researchers also found that these symptoms manifested in womResearchers also found that these symptoms manifested in womene more than men.

More than 550 million individuals contracted COVID-19 since July 2022.1 With 50% of patients reporting smell or taste dysfunction, 15 million people (5.6%) and 12 million (4.4%) could face permanent smell or taste issues, respectively.

 This can result in certain smells or tastes being “disgusting and emotionally distressing” for patients with long COVID-19.

“This is a strong and important study, alerting us once again to the difficulties inherent in charting the scale of long-term damage caused by COVID-19,” said Danny Altmann, PhD, a professor of immunology at Imperial College London, who was not involved with the research, 

. “The authors conducted a rather rigorous meta-analysis across several cohorts, modelling the time to recovery of taste and smell. It goes without saying that problems with taste and smell are non-trivial for quality of life.”

Taste and smell dysfunction, also known as chemosensory dysfunction, occurs when receptors that send signals of tastes and odors to the brain are blocked.

 These sensorineural mechanisms are thought to facilitate the specific manifestation of COVID-19 symptoms.

 They were some of the most early and prominent symptoms of COVID-19.

The experts performed a meta-analysis of 3699 patients across 18 studies, using statistical cure models and time-to-event data to estimate the recovery of patients with chemosensory dysfunction post-COVID-19.

Individual patient data (IPD) at 30, 60, 90, and 180 days show that 96% of patients reported smell recovery after 6 months, whereas 98% of patients self-reported taste recovery.

 This aligned with scientists’ predictions that patients were most likely to recover smell within 3 months of COVID-19.

Further data at the 6-month mark revealed that many patients may not fully recover from chemosensory dysfunction, with some findings showing that at least 7% to 8% of patients dealt with a year of impaired smell and taste.

 These results were comparable to the researchers’ prediction.

Some underlying factors including heavy nasal congestion and severe chemosensory dysfunction at the onset of infection, which resulted in patients less likely to recover their sense of smell.

 Women were also more likely to face these permanent consequences.

Smell dysfunction was found to potentially predict depression and other neurodegenerative disorders, as well.

 Dysfunctional taste and smell were also associated with malnutrition, cognitive decline, and accelerated neurodegenerative disease.

Recovery could look different depending on the variant.

 Only 16% of people with the omicron variant experienced chemosensory dysfunction, compared to 44% who had these symptoms during the spread of the delta variant.

Although recovery seems unlikely for these individuals, past studies prove that it is not impossible.

 Personalized treatment and follow-up are necessary, and relevant future research should be done on the stratified recovery with different variants, according to the researchers.

Tan B, Han R, Zhao J, Tan N, et al. Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves. 

. June 14, 2022. Accessed August 8, 2022. doi:10.1136/bmj-2021-069503. 

https://www.bmj.com/content/378/bmj-2021-069503

Gregory, A. Covid study finds millions have long-term smell or taste problems. 

. July 27, 2022. Accessed August 5, 2022. 

https://www.theguardian.com/world/2022/jul/27/covid-study-finds-millions-have-long-term-smell-or-taste-problems

Hearing and vision may not be considered hierarchically superior senses anymore, as a new study sheds light on the importance of taste and smell for quality of life. 

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Coronavirus

® Coronavirus Disease Resource Center is a comprehensive resource for clinical news and expert insights on COVID-19, an infectious disease caused by the SARS-CoV-2 virus, including vaccine information and treatments for the disease.

Millions of Patients Still Lack Smell, Taste After Recovering from COVID-19

Medication therapy management (MTM) is at the heart of what pharmacists do. This is not a new responsibility, although some literature suggests otherwise. The name for this task has changed over the years and pharmacy has become more systematic in the implementation of medication management, but this has always been at the core of pharmacy.

Particular attention is rightfully paid to providing MTM services for entire populations, rather than simply to individual patients. In fact, it is the most vulnerable populations where pharmacy services might make the greatest difference. The “management” in medication therapy management is a critical piece. Without proper management, our services are inefficient and ineffective. Relying on foundational management concepts and even management theories can often make the difference between successful and unsuccessful approaches for these services.

Turner et al. examined the different factors that result in the successful implementation of community pharmacy MTM programs. Specifically, they took a closer look at organizational determinants such as implementation climate and innovation-values fit. These are part of implementation effectiveness paradigms, which were designed for complex innovations such as medication management programs, which often require coordinate efforts by multiple individuals to be successful.

A positive implementation climate would suggest that a pharmacy has formal policies to support implementation of an MTM program that includes things such as employee training and reward and recognition programs for implementation. This in turn affects employees’ shared perceptions about the extent to which the MTM program is supported and even expected.

Innovation-values fit refers to pharmacy employees’ perceptions about how well medication management programs align with the values of the pharmacy and the pharmacy profession. If the employee believes that the program is not a good fit, they will be less committed to it.

Turner et al. studied community pharmacies that participated in either the first or second year of the 3-year North Carolina Community Pharmacy Enhanced Services Network (NC-CPESN). Participating pharmacies received a survey assessing their structural characteristics, experience with NC-CPESN, and perceptions about implementation. They compared these responses across 2 outcome variables. One was implementation versus non-implementation of a comprehensive medication review (CMR) program for high-risk patients. The other was the program’s reach, which was calculated as the number of attributed high-risk patients receiving a CMR divided by the number of high-risk patients in the pharmacy’s catchment area as described from county health agencies.

In their analysis, researchers found that the implementation climate and perceptions of pharmacy had a significant impact on the success of the program and how many patients it reached. Additional analyses found that pharmacies located in rural areas were associated with lower implementation of CMRs per high-risk patient, and that pharmacies associated with the 340B program were associated with higher implementation.

The study results support the fundamental need for the “management” in MTM programs. Managers who institutionalized a culture of implementation and who provided an environment for employees to self-motivate and believe in the value of CMR services were able to successfully implement these programs and reach more patients. The pharmacy manager can do these things through such things as a rewards systems, well-defined policies and procedures, and also simply emphasizing the importance of reaching vulnerable patients as part of the pharmacy’s mission.

The Management in Medication Therapy Management 

can be found in Pharmacy Management: Essentials for All Practice Settings, 5e.

is a professor of social and behavioral pharmacy at the Touro University California College of Pharmacy.

Turner K, Trogdon JG,Weinberger M, Stoyer AM, et al. Testing the organizational theory of innovation implementation effectiveness in a community pharmacy medication management program: A hurdle regression analysis. Implementation Sci. 2018;13: 105.

Organizational determinants can play an important role in whether or not MTM programs are successful.

Pharmacy Management

® Pharmacy Management Resource Center is a comprehensive resource for clinical news and expert insights offering tips and tactics for effective management of pharmacy employees and business issues.

Tip of the Week: Focus On the “Management” in Medication Therapy Management

 interviewed Xenia Tigno, PhD, associate director for careers, Office of Research on Women’s Health (ORWH), National Institute of Health (NIH), and Reshma Jagsi, MD, DPhil, director of the Center for Bioethics and Social Sciences in Medicine, University of Michigan, on how the pandemic affected the trajectory of women’s careers in medical research and other medical fields in light of the need many women faced of shifting to provide child care and other family care and services during the shutdown in the spring of 2020.

 How might professional and societal pressures around the legitimacy of maternal leave versus paternal leave impact the trajectory of women’s careers in medical research?

 I would say that it's important for us to reflect on what our professional bodies recommend as best policies. Within medicine, which is my field, the American Academy of Pediatrics has advocated for at least 12 weeks of paid parental leave for all workers, and many other countries provide even more.

Yet, in the United States, many scientists, professionals, including medical professionals, like myself, and pharmacy professionals like the audience that may well be listening to this when we're speaking—many of us work in organizations where we have access to far less paid parental leave. This has been particularly challenging in the setting of medical training, whereby medical trainees have faced limitations both in terms of their eligibility to sit for medical board examinations, and it was only recently that we saw some very important changes on the part of the American Board of Medical Specialties and the Accreditation Council for Graduate Medical Education that have really been progressive steps towards embracing the need to ensure a civilized amount of paid parental leave for all individuals, regardless of gender, regardless of whether they're birthing parents.

The reason I want to emphasize that last bit is that we really need all parents to take leave, because if we don't do that, there develops a stigma associated with parenting and caregiving, and there also develops a group of individuals who become the de facto expert parents, because those who birth children may at least be given some amount of leave to recover from that medical experience. They have more time, and they therefore develop the skills of parenting more than their partners who are not granted that level of leave.

What that means is that for the rest of that child's life, for eternity, they become the expert parent. I joke that one of the best things that ever happened to me was my obstetric complications, which actually led to emergency C sections and were not things that one would aspire to, but it's okay, healthy mom, healthy babies—we’re all okay. In the end, what happened was my husband really had to step up and became incredibly involved. Sadly for him, to this day, he's still the expert parent, because I wasn't able to get that training. But usually those roles are reversed in terms of gender roles, and I think we have to be really mindful of including both partners or however many individuals are involved in parenting a child and ensure that they have the time to build those bonds, to build those skills to ensure greater equity in the ability to engage in the workforce later on, for all human beings.

 How has NIH looked to address internal factors that might limit new fathers from taking paternal leave, and have any of those strategies been effective?

 NIH recognizes the important role that fathers play in caregiving. NIH has several, what we call, “

” in place, which other organizations may want to emulate. As Dr. Jagsi indicated, not all organizations have this paid parental leave that we, as 

, enjoy. So not just NIH, but all federal agencies. If you're an employee, you're entitled to paid parental leave. What does that mean? It means that you can have 12 weeks of paid leave in connection with a birth of a child. Not only that, you can also claim it if you're adopting or doing foster care, so even if you're not the birth parent, as Dr. Jagsi indicated. There are no sex or gender requirements for these. You can access these family friendly leaves, and employees of either sex can do it within the first 12 months of adoption or birth. There is no requirement for you to exhaust your other leaves before tapping into this paid parental leave, making it even more accessible for employees to use. 

And if both you and your partner are feds, then each of you can take 12 weeks off as paid leave. You can do it like- one after the other, giving you not just 12 but 24 weeks of paid leave. So even our trainees, such as the fellows—and they could be of either gender—they can also receive stipends for up to 60 calendar days or even to 8 work weeks of parental leave per year for adoption or birth of a child.

In addition to these leave credits, we also have a number of funding opportunity announcements, such as 

 which are sometimes called critical life events supplements, which include birth of child or adoption. These are accessible to both mothers and fathers. So, again, we do not distinguish by sex for those who want to apply for these leaves.

But what is more advantageous at NIH is that we have an 

 for those who have already exhausted their other leaves, you can tap on those as well, and that is open to both sexes. These are just some of the measures that NIH has taken to start fostering work-life balance.

 What are some effective ways of acknowledging and addressing societal norms within health care organizations that may be causing gender inequalities to persist within professional career trajectories?

 I really like to think about interventions to promote gender equity in buckets based on the categories that I think of as the mechanisms or the challenges that have led to those gender inequities. When I think about one class of challenges, I think about overt incivility, harassment, microaggressions—to address that, we really need, as organizations, to embrace effective practices to promote civility within the workplace. We need clear policies, and that includes beginning with monitoring behavior with surveys. One of the strongest predictors of the incidence of sexual harassment in organizations is whether the organization is perceived by the employees to tolerate harassment. Not only does surveying a workforce allow an organization to gain insights about the unique nature of the incivility that is occurring within it, but it also gives it an opportunity to send a very visible signal that those behaviors are not tolerated.

So, clarifying policies also with respect to reporting systems. There is an unfortunate assumption that individuals who experience inappropriate behaviors are going to report them. In fact, our own research—and groups have certainly done this in other contexts as well—has shown that individuals who are harassed are actually very, very unlikely to report. And we can all understand why—by the time we become professionals in fields like pharmacy or medicine, we have dedicated a lot to our careers. We don't want to be identified on the basis of an inappropriate experience that has occurred, but rather, we want to be known for our scholarly contributions. We don't want to be marginalized. We don't want to be stigmatized. We don't want to be victimized, and we sure as heck don't want to face retaliation. Unfortunately, the evidence does suggest that when individuals do report, sometimes they do face experiences of institutions minimizing those experiences or allowing retaliation to occur. So, we really need policies that do not allow that. We need for institutions to be transparent about the range of complaints that have been filed, the nature of the investigations, and the range of the sanctions applied, even if it's not possible to detail in individual situations the exact nature of what transpired.

And we need to encourage allyship, because ultimately, all of us are present and see behaviors that are unwanted and wonder sometimes what we can do. We need to be empowered and enabled and develop the skills to stand up for one another. So, it's this “upstanding” idea—we shouldn't be bystanders, we should be upstanders.

We should learn that even those who are not particularly powerful in a given hierarchy can intervene in some way. For example, by removing the target of the aggression from the situation or by creating a distraction—there are effective things that can be done, and in addition, providing support to the target. If one does have sufficient power within the organization, then also potentially confronting the aggressor or engaging in reporting.

That's one category of behaviors, but we also know that much of what goes on is not intentional. It’s my firm belief that the vast majority of people in the world do not wake up in the morning and think to themselves, how can I oppress people who are not like me? It's really not that common to have people who are intentionally trying to hurt others, but far more common to have unconscious biases. We know that this exists. We've seen CV studies that have shown that if you send out the exact same resume, and you just change the name at the top of it [to] Karen Miller instead of Brian Miller, that all of a sudden, people will be more likely to hire the candidate who fits their presumptions of who belongs in that role. Brian Miller is more likely to be hired than Karen Miller for an academic psychology entry level position, and is given higher ratings for his merit, for his teaching, his service, his scholarship on the basis of the same CV. And if you think that's bad, there was another study that shows that an individual named Lakeisha or Jamal needs 9 extra years of experience on their CV to get job interviews at the same rate as individuals named Emily and Greg.

We know these unconscious biases exist. We also know that we all harbor biases, this is not just certain groups harboring biases. We all have this. It's an efficient heuristic that evolved in human beings. We make snap judgments, and they're habits we need to learn to break.

 has been funded by the NIH to do some really revolutionary work to develop interventions that are effective. Not all unconscious bias training interventions are effective, some of them actually backfire. But she has actually discovered some forms of training that really do appear to be quite effective.

Then finally, there's another whole category that we've talked about in the earlier part of this discussion about the gendered expectations of society, particularly with respect to family caregiving. My very first R01 grant from the NIH actually funded me to study physician scientists about how they were spending their time. What 

 was that the women in our sample, which was actually some really high achieving NIH-funded researchers, individuals who had career development awards in the K-series at the national level, that are incredibly hard to get. Even in this elite population, the women were spending—even after adjustment for spousal employment status and many other factors—8 and a half more hours per week on parenting and domestic tasks. And that's before the pandemic. We saw that the women in that sample were 4 times as likely to stand up and step in if their usual childcare arrangements were disrupted. Again, this is before the pandemic, but we've seen it play out during the pandemic.

So, we need to consider more creative policies that provide support. For example, the Doris Duke Charitable Foundation has a fund to retain clinical scientists that provides funding for helping hands in the workplace, specifically for individuals who articulate a need related to family caregiving demands. Of course, NIH has done some really revolutionary work in this regard, as well, and so I'll turn it over to Dr. Tigno to speak to the kinds of interventions that NIH has had in that area, and in all of these areas—NIH has really been an exemplar in so many ways.

Yes, you did mention the Doris Duke Foundation and the NIH, which I think I mentioned prior,has the Continuity and Retention supplements. As Dr. Jagsi had mentioned, K-awardees are also very vulnerable, because of that 

. Although there are so many women who are K awardees—they predominate in the K-series, when it is time for them to apply for the R01- equivalent awards, which usually will ensure their tenure if they are in an academic institution, then that's where the cliff starts to become very steep. Because despite the fact that there are more women than men who have these career training awards, not as many women as men get the RO1- equivalent awards. And that's really a problem. 

With this continuity supplement, what we try is that if a woman, or even a man, has additional caregiving, due to what we call “critical life events”, such as childbirth, then they can apply for additional funding; so then they can, for instance, hire a technician or a grad student during the time that they are on parental leave to do some of the work, so that their productivity is not sacrificed at that point, and give them more opportunities to be able to apply for the R01 equivalent awards.

The other vulnerable place for men and women, but especially for women, is when you're applying for your second R01 award or you are trying to extend your first R01 award. We have this continuity and retention supplements for our awardees as well who are trying to get their second award—and say experience childbirth, or have to provide caregiving for parents, or children, or even spouses—they can apply for the supplements as well. Those are just some of the measures that we have done, but in addition, the whole 

 is day and night trying to find ways and means to achieve gender equity, either at the institutional level or at the individual level.

Further information on NIH’s antiharassment policies and information can be found here: 

Xenia Tigno, PhD, and Reshma Jagsi, MD, DPhil, discuss how professional and societal pressures around the legitimacy of maternal leave versus paternal leave can impact the trajectory of women’s careers in medical research. 

Women's Health

® Women's Health Resource Center is a comprehensive resource for clinical news and expert insights on issues related to health conditions that affect women, including gynecological health and maternal health.

NIH Expert: Stigma Around Paternal Leave Contributes to Gender Inequity in Medical Research Field

Claims of Lyme disease diagnoses in rural areas rose by 357% between 2007 and 2021, according to a study by FAIR Health. Urban areas saw a 65% increase of private insurance claim lines for the disease.

“Lyme disease remains a growing public health concern,” said Robin Gelburd, JD, president of FAIR Health, in a press release.

Lyme disease is a bacterial illness caused by a tick. It is treatable with antibiotics, but some patients develop conditions post-treatment, which can be linked to chronic Lyme disease (post-treatment Lyme disease syndrome). Symptoms of chronic Lyme disease can include fatigue, cognitive issues, joint pain, and muscle pain.

To further understand trends in Lyme disease, FAIR Health analyzed the prevalence of Lyme disease health insurance claims over 15 years. To conduct this analysis, researchers consulted a database of more than 36 billion privately billed health care claims for the condition.

In addition to this information, investigators also identified late Lyme disease diagnoses. All age groups reported symptoms of malaise, fatigue, and soft-tissue-related issues, which were more common among Lyme patients than the control patients in the general population.

Between 2016 and 2021, rural areas had a 60% increase in their claim lines for Lyme disease diagnoses. Urban areas reported a 19% increase in Lyme disease diagnoses. During each year, data showed that June and July saw the largest uptick in diagnosed cases. In general, claim lines in rural areas exceeded those in urban areas during summer months, whereas urban areas filed more claim lines from November through April.

New Jersey, Connecticut, North Carolina, Rhode Island, and Vermont (percentage ranked highest to lowest) all hosted the highest proportions of Lyme disease claims in 2017. Historically, Lyme disease was associated with the Northeast and Midwest. The claim lines of 4 of the top-ranking states support this, but the percent of claim lines pushing North Carolina to third suggests that Lyme is spreading beyond its historical territory, according to the study.

In 2021, New Jersey again led the ranks for highest percentage of claim lines of Lyme disease. It was followed by Vermont, Maine, Rhode Island, and Connecticut. Maine took the position of North Carolina, which suggests cases in North Carolina have decreased but also moved much further north.

The analysis for this study builds on a previous infographic published by FAIR Health, who studied 10 years of Lyme disease data, as well as a white paper published in 2019. FAIR Health is a national, independent nonprofit organization with the goal of making health insurance costs and information transparent.

Lyme disease diagnoses increased 357 percent in rural areas over past 15 years, according to private insurance claims. FAIR Health; Aug 2, 2022. Accessed Aug 3, 2022. 

https://www.fairhealth.org/press-release/lyme-disease-diagnoses-increased-357-percent-in-rural-areas-over-past-15-years-according-to-private-insurance-claims

Lyme disease has reportedly spread geographically and increased in rural and urban populations during the past 15 years.

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