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Articles

The US government is entrusting mRNA vaccine pioneers Moderna to develop protection for the gradually increasing threat of avian influenza. 

Moderna Receives $590 Million From HHS to Develop Bird Flu Vaccine

Erin Fox, PharmD, MHA, BCPS, FASHP, discussed the 2025 Pharmacy Forecast and its perspective on managing ultra-high-cost drugs.

Q&A: Ultra-High-Cost Drugs Highlight Complex US Health Care System

Kurt Proctor, BS Pharm, PhD, CCHS, President of the NCPA Innovation Center, discussed his organization’s efforts in launching the Independent Community Pharmacy Consortium for Government Engagement.

Q&A: NCPA Announces Independent Community Pharmacy Consortium for Government Engagement

For adults with obesity but no diabetes diagnosis, researchers searched for the key factors leading to semaglutide initiation.

Sociodemographic, Clinical Factors Associated with Semaglutide Initiation in Adults with Obesity

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When investing in the future profitability of your pharmacy, here are 3 ways to help manage and mitigate the bottom line impacts of DIR fees.

Focus on DIR Fees: 3 Ways to Manage Them

Ollin Sykes, CPA, CITP, and Scotty Sykes, CPA, CFP, discuss the business landscape after COVID within pharmacies and 5 objectives for focusing on growth again.

Coming out of COVID: 5 Objectives for Boosting Rx Business and Cash Clinical Services

Is adherence packaging technology a big investment for a community or independent pharmacy? 

Maximizing Adherence Packaging for Patient Health and Pharmacy Growth 

journal explores issues within pharmacy, from the impact advocacy can have in community pharmacies to staffing shortages across multiple sectors within pharmacy. This month’s issue also explored the importance of disease awareness months and how they are opportunities to maximize valued care. Check out a preview of this month’s issue here.

download the PDF of the Total Pharmacy August 2024 issue here

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 and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.

See what’s trending in pharmacy with a preview of the Total Pharmacy August issue.

Total Pharmacy

In This Issue: Total Pharmacy August 2024

Combining sodium glucose co-transporter 2 inhibitors (SGLT2is) with glucagon-like peptide-1 receptor agonists (GLP-1RAs) may offer additional protection against cardiovascular and kidney disease in patients with type 2 diabetes (T2D), according to the results of a new meta-analysis published in 

 and presented at the 61st European Renal Association Congress in Stockholm, Sweden.

Separately, SGLT2is and GLP-1RAs have demonstrated cardiovascular benefits. However, little clinical literature has focused on outcomes associated with using the medicines together. Due to the growing prevalence of GLP-1RAs in the 

 and obesity landscape, accelerated by an increasing number of indications for the agent class, this is a crucial area for further study.

The SGLT2 Inhibitor Meta-analysis Cardio-Renal Trialists’ Consortium (SMART-C) is the largest assessment of outcomes for the combined therapeutic use of SGLT2is and GLP-1RAs. The study gathered data from 12 large-scale, placebo-controlled trials of SGLT2is involving 73,238 patients with diabetes. Of these, 3065 were already receiving GLP-1RAs.

Overall, SGLT2is lowered the risk of major adverse cardiovascular events by 11% and hospitalization for heart failure or cardiovascular death by 23% compared to placebo. Notably, this benefit was seen regardless of whether patients were also taking GLP-1RAs.

When used together with GLP-1RAs, SGLT2is reduced the risk of chronic kidney disease progression by 33% and slowed the annual loss of kidney function by nearly 60%.

The study found no additional safety concerns when SGLT2is were used in combination with GLP-1RAs.

Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

Current meta-analysis results build off positive results of the landmark FLOW trial (

). Published earlier in May, results of the international, double-blind, randomized, placebo-controlled phase 3 trial spotlighted semaglutide’s effectiveness in lowering the risk of kidney failure, decelerating worsening kidney function, and protecting against the risk of cardiovascular events and death, in patients with T2D.

“SGLT2 inhibitors have clear protective effects against heart failure and chronic kidney disease, while GLP-1 receptor agonists can reduce the risk of heart attack, stroke, and also kidney disease—as recently demonstrated in the landmark FLOW trial,” said Brendon Neuen, lead author, clinical associate professor, senior research fellow at The George Institute for Global Health, and director of kidney trials at Sydney’s Royal North Shore Hospital, in a news release.

 “Our findings support using this combination to further improve outcomes in patients with type 2 diabetes who meet guideline recommendations for both therapies.”

Elevated glucose from diabetes can damage blood vessels in the heart and kidneys, increasing the risk of 

 and kidney disease. In fact, diabetes is the most common cause of chronic kidney disease.

Moreover, estimates predicting that T2D prevalence will more than double in the next 30 years, surpassing 1 billion global cases by 2050, further strengthen the need for research into diabetes care.

 According to Neuen in an interview with 

 conducted over email, the current study offers valuable insights for developing global treatment strategies for the condition.

"These findings, which represent the largest and most comprehensive evaluation of the combined use of SGLT2i and GLP-1RA, provides the clearest evidence yet that combined use of both medicines can further reduce cardiovascular and kidney disease," said Neuen. "We anticipate that these findings will inform how people with diabetes are treated worldwide, including influencing major clinical practice guidelines.

Although current results suggest that using SGLT2is and GLP-1RAs in tandem may offer robust protection against cardiovascular and kidney disease, further research is needed to fully understand the long-term effects of the combination therapy.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our 

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1. Apperloo E, Neuen BL et al. Efficacy and safety of sodium glucose co-transporter 2 inhibitors with and without glucagon-like peptide-1 receptor agonists: A SMART-C collaborative meta-analysis of randomised controlled trials. 

. 2024. doi: 10.1016/S2213-8587(24)00183-9

2. Massaro L. Study reveals robust benefits of semaglutide in protecting against kidney, CV events in patients with T2D. 

https://www.drugtopics.com/view/study-reveals-robust-benefits-of-semaglutide-in-protecting-against-kidney-cv-events-in-patients-with-t2d

3. Combining popular diabetes drugs offers complementary heart and kidney benefits. News release. The George Institute for Global Health. July 9, 2024. Accessed July 10, 2024. 

https://www.georgeinstitute.org/media-releases/combining-popular-diabetes-drugs-offers-complementary-heart-and-kidney-benefits

4. Mayo Clinic Staff. Chronic kidney disease. Fact sheet. Accessed July 8, 2024. 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

5. Klein HE. Diabetes prevalence expected to double globally by 2050. 

https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050

When used together, sodium glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were able to lower the risk of major adverse cardiovascular events and kidney disease by 11% and 33%, respectively.

Clinical

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

Although opioids are highly effective for chronic pain, they pose significant risks of misuse, addiction, and adverse effects. Nonopioid and nonpharmacologic therapies, which are at least as effective as opioids in managing pain for a variety of conditions,

 offer safer alternatives. In response to the opioid crisis, pharmacists are increasingly advocating for nonopioid strategies to optimize pain management and minimize risks. Sometimes, these can be as simple as managing mood disorders, improving sleep hygiene, or providing empathetic patient counseling.

Melissa Durham, PharmD, MACM, brings a wealth of experience in managing chronic, non-oncologic pain. As an associate professor of clinical pharmacy and associate dean at the USC School of Pharmacy and Pharmaceutical Sciences, and a clinical pharmacist at the USC Pain Center, Durham has been at the forefront of patient care for over a decade.

By understanding the complexities of pain management and the potential benefits of nonopioid interventions, pharmacists can empower patients to make informed decisions about their treatment options. In her interview with 

, Durham shared insights on how to counsel patients who might be reluctant to discontinue opioid therapy, the value of multimodal therapy, innovations in the nonopioid landscape, and more.

 What are the most common nonopioid pain management strategies that pharmacists are currently implementing in their practice?

: Multimodal therapy is critical when it comes to pain management. We know this is the gold standard, using medications that work synergistically together. So, depending on the disease state and the disease process, you might choose a variety of different medications with different mechanisms, everything from antidepressants such as tricyclic antidepressants [TCAS] and serotonin and norepinephrine reuptake inhibitors [SNRIs] to anti-epileptic drugs like gabapentin or pregabalin, anti-inflammatory drugs, and even [adding] simple analgesics like acetaminophen [to] the mix is helpful.

Some of the more out-of-the-box things that we've been working with over the last several years are agents like ketamine, which is an n-methyl-d-aspartate [NMDA] receptor antagonist that we've been able to use pretty successfully to get opioid doses down as we taper people off. Other out-of-the-box therapies, like low dose naltrexone, are more expensive and cost prohibitive because they need to be compounded. But those are a few of the nonopioid things in our toolbox that we reach to, in addition to topicals, which can be helpful in taking the edge off, but those are some of the top ones that come to mind.

And then, of course, there's non-pharmacologic therapies. It’s not just the multimodal therapy, but it's also [taking a] multi-disciplinary approach, using physical therapy, occupational therapy, pain psychology, making sure patients' mood disorders are under control as well as sleep is under control, [that’s] another important part of it too in managing pain.

 How can pharmacists effectively educate patients about nonopioid pain management options and what challenges do they face in communicating this information to patients who may be hesitant to try alternative therapies?

 This is a big challenge, especially in my patient population. I have a lot of patients who are still on opioids [and] who have been on opioids for a very long time. It can be a bit of a hard sell to broach the subject about tapering when the medications that they've been on are viewed as enabling [them] to take part in their life the way that they want to, whether it be with work, social activities, intimate activities, things like that.

So, the way that I do it is that I say [to them], “Listen, you've been on this medication for a long time. It's probably not necessarily working the way that we hoped it [would], you've probably built up a tolerance to it.”

Taking the angle around tolerance is a good way to start talking to them about how opioids can potentially predispose them to developing chronic pain, because—I don't say this to the patient—they cause neural inflammation. They activate our toll-like receptors and our glial cells, and we know that that is bad for patients’ long term, especially if they have neuropathic type pain or mixed type pain.

I’ll tell them, “You know, opioids can actually maybe even worsen your chronic pain.” I often say, “You might feel better as we take you down,” because a lot of times they do, “[and] we're going to add these other therapies so that way we can bring down your dose. Overall, it's going to allow you to have less side effects from the opioids and you might feel a cloud lifting. You might feel more energy. You might feel better,” because I've seen that a lot. Bringing [up] experiences with real-life patients that we've had success with is another really good way to do it, too.

Saying that these other nonopioid therapies are tools that we can use to optimize their pain management [is helpful]. Just like I mentioned before, how using multimodal therapy is the gold standard, I counsel a lot on [how] combination therapy and working synergistically [together] really does help from all angles of their pain management.

 What role can pharmacists play in collaborating with other health care providers to develop comprehensive pain management plans that minimize the use of opioids?

 We play a significant role in this. I do this every day that I see patients and throughout the week as well. We are the medication experts. We have a very different lens when approaching patient care than other folks who might be more focused in other areas. 

I'm sort of a general practitioner pharmacist who specializes in pain management, which is kind of interesting. So, when my team sees a patient, we review the medications very thoroughly. Every single one of them. We're not just focused on the ones that are for pain. We end up catching a lot of things that might have gone missed by other providers who have a narrower focus, or different focus, other than just medications. And then, as you said in the question, to develop a comprehensive plan that involves a multi-disciplinary approach, is something that can be really valuable for optimizing patient care outcomes.

 Are there any innovative nonopioid pain management strategies or technologies that pharmacists should be aware of?

 Any time that we do anything innovative, there's going to be barriers to access for a lot of patients. But putting that aside, some of the things that interventional pain management specialists do are pretty innovative things like injections. We have epidurals and joint injections and trigger point injections. I mean, that's not that groundbreaking, those are things [that we’ve had] for a long time, but it might not be something that pharmacists think of.

A lot of things like implantable peripheral nerve stimulators and spinal cord stimulators—an interventional pain physician can get creative with things that may be outside the bounds of what we reach to normally. With pharmacotherapy, and then some of the therapies I mentioned previously, like using ketamine in unique ways, or low dose naltrexone, those are some things that not everyone is doing. Buprenorphine has been become much more popular. I don't think everyone is necessarily doing it as much as they should but using that as another alternative for the traditional opioid therapies as well.

Those are some things that your run-of-the-mill pharmacist might not necessarily think of right off the bat, and I think other strategies or technologies that pharmacists should be aware of—I don't even know how innovative this is, but I don't know if everyone's necessarily doing it—but trying to remove the stigma around patients with chronic pain. [It’s important] to remove the stigma around those who are taking opioid therapy, especially if they've been on [the medication] long term, and trying to really talk to patients and figure out what's going on with them. 

I think that if we're looking, from even a community pharmacy perspective, a lot of doubts that we have or a lot of lack of information that we have can be solved by getting out and talking to people and figuring out what's going on.

One of the big barriers that we have is lack of information. So, using that as a strategy—again, not super innovative, but that doesn't mean people are doing it—can be very impactful and solve a lot of the problems that we think that we have.

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1. Nonopioid therapies for pain management. CDC. May 2, 2024. Accessed November 7, 2024. https://www.cdc.gov/overdose-prevention/hcp/clinical-care/nonopioid-therapies-for-pain-management.html

Melissa Durham, PharmD, MACM, reveals how pharmacists are uniquely positioned to counsel patients on nonopioid pain management. 

Q&A: Pharmacists Champion Nonopioid Pain Management Strategies

A self-management intervention may be an effective intervention in people with HIV experiencing chronic pain, according to research results published in 

 have a high prevalence of chronic pain, researchers conducted a randomized clinical trial set out to evaluate the efficacy of the Skills to Manage Pain (STOMP) behavioral self-management intervention compared with enhanced usual care (

The study cohort included eligible adults with HIV who reported at least 3 months of moderate chronic pain. Participants were recruited from the University of Alabama at Birmingham and the University of North Carolina-Chapel Hill, between August 2019 and September 2022.

A total of 278 participants were randomly assigned 1:1 to receive either STOMP or enhanced usual care (n=139 each). Patients in the STOMP group received a total of 12 sessions, 6 individual and 6 group, alternating weekly for 12 weeks. During the one-on-one individual sessions, participants worked with pain coaches to build pain self-management skills. During group sessions, participants received peer support related to chronic pain.

 Individuals in the enhanced usual control group received the STOMP manual and a brief staff-led program overview, but no group or individual sessions.

The primary study outcome was pain severity and the impact of pain on function, measured via the Brief Pain Inventory summary score.

Pharmacists Champion Nonopioid Pain Management Strategies

At baseline, sociodemographic characteristics, pain characteristics, history of long-term opioid use, and primary and secondary outcome scores were similar across both groups. A majority of participants identified as Black or African American (81%); the mean age was 53.3±10 years, and 53% were men. At the time of study enrollment, 78% of participants reported multisite pain and 23.5% self-reported long-term use of opioids. The average pain rating was moderate (average Brief Pain Inventory score, 6.4±1.1 points), and the most common pain locations were lower back (75.5%), knee (54%), and numbness or tingling in the hands and feet (52.5%).

The STOMP intervention was associated with a statistically significant mean difference in Brief Pain Inventory Score compared with enhanced usual care (-1.25; 95% CI, -1.71 to -0.78) immediately after the intervention. At 3 months after the intervention, the mean difference in Brief Pain Inventory score remained statistically significant in favor of the STOMP intervention (-0.62; 95% CI, -1.09 to -0.14).

Investigators also noted differences in Brief Pain Inventory-pain severity score (-1.10), Brief Pain Inventory-functional interference score (-1.52), Pain, Enjoyment of Life, and General Activity scale (-1.34), Patient Health Questionnaire Depression Scale (PHQ-8; -2.27), Pain Self-Efficacy Questionnaire (4.10), and Pain Catastrophizing Scale (-4.22). Between-group differences persisted at 3 months for Brief Pain Inventory-pain severity, Brief Pain Inventory-functional interference, Pain, Enjoyment of Life, and General Activity scale, and Pain-Self Efficacy Questionnaire.

Study limitations included the specificity of the patient population, limiting generalizability to individuals with chronic pain without HIV; the short postintervention follow-up period; and that less than half of the study participants were women, also potentially limiting generalizability.

“STOMP may be an efficacious chronic pain intervention for people with HIV,” the investigators wrote. “STOMP…also has the potential to be tailored to other highly affected groups including cancer survivors, older adults, or veterans who frequently experience chronic multisite pain.”

Nonopioid Pain Management Resource Center

Jones KF, Long DM, Bair MJ, et al. Efficacy of a pain self-management intervention tailored to people with HIV: A randomized controlled trial. 

2024;184(9):1074-1082. doi:10.1001/jamainternmed.2024.3081

Merlin JS, Westfall AO, Long D, et al. A randomized pilot trial of a novel behavioral intervention for chronic pain tailored to individuals with HIV. 

2018;22(8):2733-2742. doi:10.1007/s10461-018-2028-2

Researchers evaluated the efficacy of a self-managed intervention vs enhanced usual care. 

Self-Management Behavioral Interventions May Improve Pain Outcomes in HIV

Adult trauma patients between the ages of 18 and 64 exhibited higher pain scores and more frequent pain assessments after surgery than participants over 65, according to data from a 

 Authors of the study suggested that older adults reported less pain and at lower frequencies to avoid medical procedures and costs, ultimately with the goal of maintaining sole control of their pain management.

“Poor pain control can limit or prevent participation in rehabilitation both inpatient and after hospitalization. Older adults have been shown to receive inadequate pain management. In a study of pain-related visits to the emergency department, older patients (≥75 years) received less analgesic treatment than middle-aged patients,” wrote authors of the study.

While not age-specific, the management of pain has become an increasingly worrying issue within the US. According to CDC statistics from 2019 to 2021, a total of 51.6 million patients reported chronic pain in the US, with 17.1 million experiencing high-impact chronic pain.

 Compounded with rising prescription drug costs and a national opioid crisis spurred on by the prominence of acute pain in the country, pain management has been a mystery clinical experts have tried to solve for decades, if not centuries.

Researchers aimed to determine the frequency of pain assessments and the extent of pain scores by age for patients undergoing traumatic surgery. 

Ollin Sykes, CPA, CITP

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