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The FDA issued a final rule to establish a new category of OTC hearing aids, which could save consumers millions of dollars while greatly improving access to these devices.

This ruling, which will be implemented in mid-October, will allow patients with mild to moderate hearing impairment to buy hearing aids directly from pharmacies, other retail settings, or online, while eliminating the need for a medical exam, prescription, or audiologist-directed fitting adjustment.

“Reducing health care costs in America has been a priority of mine since day one and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Secretary of the US Department of Health and Human Services, Xavier Becerra, in a press release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Nearly 30 million US adults could benefit and communicate better with hearing aids, but they can be expensive and inaccessible. The action seeks to stimulate competition in the hearing aid technology marketplace by allowing for the sale of OTC hearing aids, according to an FDA press release.

The original rule was proposed on Oct. 20, 2021. Following the FDA’s proposition, more than 1000 public comments were made by consumers, professionals, hearing aid manufacturers, public health organizations, advocacy groups, members of Congress, and other stakeholders.

The FDA responded by advocating for the safety and effectiveness of hearing aids, and concurrently amended the original proposed rule. These changes included lowering the maximum sound output to prevent over-amplification, revising the aid’s insertion depth, adding user-adjustable volume control, simplifying the phrasing, and specifying performance and device design requirements for hearing aids.

The new ruling will repeal certain conditions from the state-regulated hearing aids so that the OTC version can be sold. The FDA will also issue the Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the difference between hearing aids and PSAPs, which amplify sound for consumers with normal hearing.

Finally, the rule establishes certain guidelines for OTC air-conducting hearing aids. These products can be used by adults 18 years of age and older with mild to moderate hearing impairment. However, prescription devices, especially those for severely impaired individuals or those younger than 18 years of age, will not be sold in this category.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD, in a press release. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

U.S. Food and Drug Association. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. FDA website. August 16, 2022. Accessed on August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans

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The FDA has issued a rule that will grant millions of Americans access to OTC hearing aids in pharmacies or online without a prescription or medical exam required.

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FDA Finalizes Rule For Availability of OTC Hearing Aids 

Connecting individuals who inject drugs with large-scale HIV screening and peer support was found to reduce uncontrolled HIV among users by over 40%, according to a new study from researchers in Haiphong, Vietnam.

Haiphong suffered both heroin injection and HIV epidemics in the early 2000s. A large, lower middle-income country, Vietnam put resources towards increasing HIV care, but prevention and treatment for this stigmatized community is a challenge. Treatment is barred by stigma, cost, unstable housing, confidentiality, imprisonment, incarceration, and lack of awareness regarding antiretroviral therapy.

Don Des Jarlais, PhD, co-author of this study, a professor of epidemiology, and associate director of the Center for Drug Use and HIV/HCV Research (CDUHR) at the NYU School of Global Public Health, created the DRIVE (DRug use and blood-borne Infections in ViEtnam) intervention with colleagues to identify and effectively treat HIV-positive individuals in Haiphong who use injection drugs.

“Innovative strategies are needed to overcome these obstacles and increase access to HIV diagnosis and treatment among people who inject drugs, particularly in low- and middle-income countries with fewer resources,” Des Jarlais said in a press release.

From 2016 to 2019, DRIVE enrolled 3,150 people who inject heroin into their program using 4 annual community surveys. The participants were mostly men, representing approximately two-thirds of Haiphong’s injection users.

DRIVE engaged community-based organizations to conduct interviews, provide drug and HIV screening, and give case management and peer support that connects participants with drug treatment and HIV care. These services were effective for building trust, reducing stigma, and removing structural, social, and logistical barrier to receiving care.

Widespread screening coupled with support from community-based organizations is a powerful tool for rapidly identifying untreated HIV-positive people who inject drugs and linking or reconnecting them to care,” according to senior author Nicolas Nagot, MD, PhD.

Testing revealed that 833 participants were HIV-positive and 177 had unsuppressed viral loads that, left untreated, could be fatal. In 2020, the results of the community-based initiative revealed that over 40% of participants with originally unsuppressed viral loads ended the intervention with suppressed viral loads because of antiretrovirals or improved treatment adherence.

HIV transmission potential also dropped by 60% by the end of the study. Additionally, after measuring the community HIV viral load, unsuppressed viral load in patients was reduced from 7.2% to just 2.9%.

“The approach used in Haiphong of combining HIV screening, prevention, and care for people who inject drugs can serve as an example for other low- and middle-income countries and illustrates that it is possible to end HIV epidemics in these populations,” lead author Huong Duong said in the press release.

The Global Fund to Fight AIDS, Tuberculosis, and Malaria is also helping to replicate this strategy in other provinces in Vietnam, according to Oanh Khuat, the executive director of the Center for Supporting Community Development Initiatives, a local NGO working to stop the spread of HIV.

Mass screening, peer support, and treatment reduce HIV in people who inject drugs. EurekAlert. News Release. July 19, 2022. Accessed July 20, 2022.

High rates of HIV can decrease with community-based support. 

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® HIV Resource Center is a comprehensive resource for clinical news and expert insights on the treatment of HIV, a virus that attacks the body's immune system and, if left untreated, can lead to AIDS.

Study: Mass Screening, Peer Support Helps Reduce HIV Transmission, Community Viral Load

Chronic lymphocytic leukemia (CLL) is a hematologic cancer characterized by proliferation and accumulation of abnormal B-cells in blood, bone marrow, and lymphatic tissue leading to progressive immune dysfunction. CLL is a common cancer with more than 20,000 new cases expected in 2022.

Traditional treatment involves standard combination chemoimmunotherapy.In recent years, research and a better understanding of CLL’s pathogenesis have led to targeted treatment options.

Several recently published clinical trials have evaluated the combination of 

 in the treatment of CLL with promising results. Both medications carry an approved indication for use in CLL but do not often lead to complete remission, and therapy routinely continues indefinitely or until disease progression.

 provides each medication's specific drug information.

 in May 2019, evaluated the combination of ibrutinib and venetoclax in high-risk and older patients with previously untreated CLL. The treatment involved lead-in monotherapy with ibrutinib, followed by combination therapy with ibrutinib and venetoclax (using the traditional ramp-up dosing to minimize tumor lysis syndrome). Complete remission was achieved in 88% of patients and 61% of patients had remission with undetectable minimal residual disease (uMRD).

The phase 2 CLARITY clinical trial studied the ibrutinib and venetoclax combination in patients with relapsed or refractory CLL. Initial treatment consisted of monotherapy with ibrutinib followed by combination therapy with ibrutinib and venetoclax (using the traditional ramp-up dosing).

The primary endpoint was eradication of MRD to fewer than 1 cell in 10,000 leukocytes. After 12 months of therapy, 53% of patients met this endpoint in peripheral blood and 36% met the endpoint in bone marrow. Additional results included an 89% patient response rate and a 51% patient complete remission rate.

The phase 2 CAPTIVATE clinical trial evaluated therapy with ibrutinib and venetoclax in patients between 18 and 70 years of age with previously untreated CLL. The study consisted of a cohort evaluating minimal residual disease (MRD) and a second evaluating a fixed-dose (FD) regimen.

In the MRD cohort, eligible patients received treatment in 2 phases. During the first phase, patients received monotherapy with ibrutinib, followed by combination therapy with ibrutinib and venetoclax (using the traditional ramp-up dosing).

Based on MRD status and tumor response assessment at the end of the first phase, patients progressed into 2 different additional treatment arms. After 12 cycles of combination therapy, 75% of patients achieved uMRD in blood and 68% in bone marrow.

The FD cohort of the CAPTIVATE study evaluated patient response to fixed-duration combination treatment with ibrutinib and venetoclax. Dosing involved lead-in monotherapy with ibrutinib, followed by combination therapy with ibrutinib and venetoclax (using the traditional ramp-up dosing). The study’s primary endpoint, progression-free survival (PFS), was met in 55% of study participants.

The phase 3 GLOW clinical trial evaluated fixed-duration therapy of ibrutinib and venetoclax compared to chlorambucil and obinutuzumab in patients 65 years of age or older or 18-64 years of age with comorbidities and previously untreated CLL. The primary endpoint of PFS was higher in patients treated with ibrutinib/venetoclax compared to treatment with chlorambucil/obinutuzumab.

Jennifer Salvon is a licensed pharmacist in Massachusetts and Connecticut and a student in UConn's Medical Writing Certificate Program.

American Cancer Society: Cancer Facts and Figures 2022. American Cancer Society, 2022. Accessed July 1, 2022. 

https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2022/2022-cancer-facts-and-figures.pdf

Imbruvica prescribing information. May 2022. Accessed June 29, 2022. 

https://www.imbruvica.com/files/prescribing-information.pdf

Venclexta prescribing information. June 2022. Accessed June 29, 2022. 

https://www.rxabbvie.com/pdf/venclexta.pdf

Jain N, Keating M, Thompson P, et al. Ibrutinib and Venetoclax for First-Line Treatment of CLL. 

. 2019;380(22):2095-2103. doi:10.1056/NEJMoa1900574

Hillmen P, Rawstron AC, Brock K, et al. Ibrutinib Plus Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia: The CLARITY Study [published correction appears in J Clin Oncol. 2020 May 10;38(14):1644]. 

Wierda WG, Allan JN, Siddiqi T, et al. Ibrutinib Plus Venetoclax for First-Line Treatment of Chronic Lymphocytic Leukemia: Primary Analysis Results From the Minimal Residual Disease Cohort of the Randomized Phase II CAPTIVATE Study. 

Tam CS, Allan JN, Siddiqi T, et al. Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort. 

. 2022;139(22):3278-3289. doi:10.1182/blood.2021014488

Kater ap, Owen C, Moreno C, et al. Fixed-Duration Ibrutinib-Venetoclax in patients with Chronic Lymphocytic Leukemia and Comorbiditites.

 2022;1(7):1-13. doi;10.1056/EVIDoa2200006

Both ibrutinib (Imbruvica) and venetoclax (Venclexta) carry an approved indication for use in chronic lymphocytic leukemia but do not often lead to complete remission, and therapy routinely continues indefinitely or until disease progression. 

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Lymphoma

® Lymphoma Resource Center is a comprehensive resource for clinical news and expert insights on treatments for lymphoma, a cancer that begins in cells of the lymph system. Common treatments for lymphoma may involve chemotherapy, medication, radiation therapy, and stem cell transplant.

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® Hematology Resource Center is a comprehensive resource for clinical news and expert insights on the treatment of blood disorders, include blood and bone marrow cancers, anemia, hemophilia, blood-clotting disorders, and leukemia.

Oncology Overview: Treatment of Chronic Lymphocytic Leukemia with Ibrutinib, Venetoclax

 interviewed Jonathan Watanabe, PharmD, MS, PhD, BCGP, professor of clinical pharmacy and associate dean of assessment and quality at the School of Pharmacy and Pharmaceutical Sciences at the University of California, Irvine, on more effective approaches to treating opioid use disorder following the increase in opioid overdose deaths in 2021.

. Joining me is Jonathan Watanabe, PharmD, MS, PhD, BCGP, professor of clinical pharmacy and associate dean of assessment and quality at the School of Pharmacy and Pharmaceutical Sciences at the University of California, Irvine, who is here to discuss an approach to treating opioid use disorder that may be more effective than our current approach, in light of the recent uptick in opioid overdose deaths in 2021.

So Jonathan, could you explain to me a bit about your background working in the opioid use disorder, or OUD, space?

 Thank you. I've been involved in several different levels over many, many years now. So it began, I was involved as an investigator on a federal—actually it was a geriatric program—part of the Health Resources and Services Administration Geriatric Workforce Enhancement Program, that included a sub-award actually to train clinicians, specifically nurses, on the use of academic detailing via pharmacists for nurses to instruct them on Naloxone, as well as opening the door for discussions on medications for opioid use disorder, specifically talking about buprenorphine, but also familiarizing them with things like methadone and naltrexone.

Then, I led research kind of concurrently with that examining patients on opioids, benzodiazepines, and muscle relaxants, who were at elevated risk of hospitalizations and ED visits—sadly, they were. And then using some national datasets looking at that association, and then, again, there were so many things at the time that were moving into this crisis. I was asked at the skilled nursing facility that I was providing care at to look at monitoring programs for opioid use. So, looking at pain management, as well as seeing if there were mechanisms for finding out if there were ways we could reduce opioid usage in that skilled nursing facility and to examine if there were mechanisms that we could better apply for medications for opioid use disorder.

That sort of dovetailed into me being asked by the National Academy of Sciences, Engineering, and Medicine to serve on, or to speak with the Medications for Opioid Use Disorder Saves Lives consensus study and then the later report. Then that segued into probably what we’re talking now is the National Academy of Sciences methadone workshop for opioid use disorder that was sponsored by the White House Executive Office of the President of the National Drug Control Policy Office, and continue to work with an array of different folks around the country to look at what we can better do to improve assets, specifically via pharmacies, but an array of different approaches. But one consistent with a lot of that messaging is we really could do a better job of utilizing pharmacies, community-based pharmacies, to aid in trying to contain this crisis.

Absolutely. What are some of the problems that have arisen in our country's current approach to managing OUD, and what are some specific examples of how community pharmacists’ involvement might be able to address this?

You nailed that, just as we even began. I mean, for the first time ever, there was more than 100,000 deaths due to overdoses in a 1-year period. That's the most has ever been measured. There was 400,000 deaths that they've measured between 1999 and 2017. So, if you actually look at that, that's more than the total combat deaths in World War II. So this is just, in terms of lives lost, not just the mortality but also the morbidity, the lives that are affected by this crisis—it’s just startling that there actually isn't more discussion about it. I think that some of the challenges, the cracks in the system—I mean, they're more like canyons in the system—in terms of trying to improve access and availability. It continues to be a situation where patients are unable to get access or are even aware, sometimes, that access is possible.

There has been a lot of dialogue that's demonstrated that it can be more than a 2-and-a-half-hour drive from certain population areas to an opioid treatment program. So some of the challenges just in terms of the inability to access the medication, even where it is available, that many times they may not carry it. The challenge is that there was this kind of twindemic that was going on with the COVID-19 pandemic, that I was also researching, as well as these things were going on at the same time, then certainly, the COVID-19 pandemic made it more challenging for those that were coping, both I think in terms of turning to opioids, but also getting treatment for it.

So, you have this kind of twin challenge that really synergized in a bad way in the past few years to make it more challenging for patients with opioid use disorder. And I think that, as many know, there's more of a challenge with fentanyl. Not only is it that the mechanisms for getting treatment continue to be challenging, but also what's going on in terms of the illicit market is the availability of fentanyl, which explained a good chunk of the opioid deaths in the spike. I mean, they're talking about fentanyl getting into even things like cannabis and these other things. I think that the challenge of ensuring that we've got appropriate management has never been more important, because it almost seems like all of the challenges have gotten more complicated in the pandemic.

Right. Absolutely. That makes sense. What are some of the changes you would be advocating for especially coming from the perspective as an academic in health care specializing in this area and having a bit of a lens around some of the research in this area?

I think what we'll continue to lean on is there's, just as you mentioned, a challenge in access. If we can find ways, particularly what we looked at with methadone is can we utilize mechanisms for making it less onerous--they have to go to an OTP, sometimes they can only get literally a dose per day. They have to go to the OTP to get their daily dose of methadone. During the pandemic, that's I mean, for many, they just didn't even feel safe. So the challenge is what we can potentially do to improve access to make it less difficult to get treatment.

So some of those that we looked at, this was truly a repeating theme, was that we were finding ways to use pharmacies to better to serve as extenders for opioid treatment programs. So they're the mechanism that's—and they've literally demonstrated that in in GIS kind of heatmaps, that it's much easier to get to a pharmacy than it is to an OTP. So if we could use those as places where you could get your methadone if you needed it, and you qualify to continue or initiate your treatment generally, that would be a huge boon to patients to be able to safely access. So that really came up quite often. And, there's even some precedent because we can learn the lesson for buprenorphine, where that can be accessed at pharmacies. So try to certainly look at what we can better make available in terms of pharmacy-based access to medications for opioid use disorder. That just makes sense. And that was even repeated by many of the addiction providers, that what can we do to improve access by pharmacies? What can we do to improve access to take-home doses? What can we do to make it less difficult for patients to qualify for OTP? I think all of these came up very routinely.

And then I think some of the other elements, we'll probably get to this, is just enforcement of currently available regulatory activities. The ADA, the American with Disabilities Act, already protects people with opioid use disorder. They have the right to access; you cannot discriminate solely based on that they have opioid use disorder or they're using a medication for opioid use disorder. Similar in the prison system where, just like if they had diabetes, they are entitled to treatment. If they have opioid use disorder, they are entitled to medications for opioid use disorder. So some of these are actually just making sure that we adhere and enforce some of the rules that are presently available to help these patients get their lives back.

Absolutely. How involved are pharmacists currently in OUD treatment programs? You've mentioned some of the ways that pharmacists involvement would really aid those programs, but where is involvement currently at?

It's not occurring nearly enough. When you think, buprenorphine can be dispensed at pharmacies, so that basically even general practitioners that are waivered can prescribe a medication for opioid use disorder that can be provided by pharmacies. From that standpoint, pharmacies are currently involved in trying to treat with buprenorphine. But the challenge in that continues to be access. There have been certainly well-documented data that it is not available at pharmacies, that there's challenges certainly in stocking at certain moments, because that can trigger follow up from the DEA. There's a called corresponding responsibility, the fact that you have to discern whether you should be dispensing that, so the discretion that's left to the pharmacist sometimes gets in the way. So, even for buprenorphine, there certainly continues to be challenges for pharmacies. Now in terms of OTP extension or basically clinical services for things like methadone at pharmacies, it doesn't seem to be occurring in a high volume, at least in the United States. There's certainly some demonstration projects and some recent research that's been done, I believe in Maryland, that's looked at getting the appropriate basically sign offs that you can dispense from pharmacies for methadone, as extension from OTPs. But doesn't happen, you know, I think I can count on one hand, the number of papers I can recall where they've studied it. So, it needs certainly needs to be done a lot more. And I do know, there are an array of pharmacists in this field that are interested but getting together the right regulatory framework that's going to provide for that, I think we still need to do important work. I'm actually hoping that some of this discussion we’re doing right now will hopefully stimulate that. There are many times where you will have to get authorization from substance abuse, mental health services administration, SAMHSA, or DEA, or state regulatory bodies to sign off. Those things all need to be checked for some of these things can occur. But we need to do that, or we need to find some brave techniques of trying to reduce some of those barriers, so we can capitalize getting pharmacists more involved.

And actually, there was a lot that was noticed during the pandemic where they certainly opened up the door to more things like beginning prescription of from an OTP versus via telehealth, providing more take home doses, and the data was positive. We didn't see a massive increase in overdoses of methadone or diversion. There hasn't been any real signal to say that that poses a problem. If anything, it seems to have benefited. It met its goal which is continuing to provide care for opioid use disorder patients during the pandemic. And I think there's lessons learned that can probably be brought in, like we saw with COVID-19 treatment and what have you, that there were many lessons that we learned from during the pandemic that can aid us in treating opioid use disorder patients.

Absolutely. Do you have any thoughts on what pharmacists can do right now to advocate for some of the changes that you’re talking about in terms of bringing things further into the pharmacy and also pharmacists involvement in some of these programs? What can pharmacists do today or this year to try to make some of these changes happen?

I think that trying to coordinate with, if they're interested, is reaching out to addiction specialists to find out if there are mechanisms that they could, like I said, if some of the bodies that are involved SAMHSA, DEA, Board of Pharmacy, Board of Medicine, finding out what it would entail to effectively get the waivers so they could begin some of these initiatives. Because in many places the pharmacists are knowledgeable about methadone. We use methadone for pain treatment. That's what's interesting is when I was working in long term care, we would see a good volume of methadone used for pain management. But the minute it's used, it's indicated for opioid use disorder, that's when all the barriers kind of fall down. So pharmacists are aware, and they have participated in tapering patients with methadone. So, in terms of the pharmacology, the pharmacodynamics, how to dose it, they're well equipped. So they're in a very good position for use with buprenorphine and with methadone. Just trying to find the mechanisms where they could do that becomes—I think an important step is letting them know that there is interest. And then there's things like basically some demonstration projects from CMMI that have supported potentially finding programs that could be set up to evaluate whether some of these novel approaches of getting pharmacists involved, not just in dispensing but also being involved in providing direct patient care for some of these folks, could also be utilized and potentially be reimbursed. And I think that's the other element that really becomes important is ensuring that there's actually coverage, that both for the patient and for the provider that some of that is better delineated. And there's been a lot of discussion of trying to ensure that, at least from the Medicare and Medicaid perspective, that gets better fleshed out is that there's going to be reimbursement for providers of all stripes, but certainly for pharmacists, that if they want to be integrated into this, there's going to be reimbursement that they will be paid for those paid for those services.

Absolutely. Any closing thoughts, Jonathan?

I think that most of the problems when you've got something of this magnitude, it's that it's multifactorial. I think that the barriers that we're seeing are access barriers in terms of patient awareness, access barriers in terms of providers knowing what they can be involved in and how they can they can provide treatment for these patients, barriers in terms of reimbursement to ensure that, that patients and providers feel covered. I always think it's interesting, as one of the rare moments where you have basically universal coverage before you reach Medicare age is actually for pregnant women. That's a very important moment when they can get services for opioid use disorder in terms of coverage, where they actually have it. So ensuring that these medications are covered for those for patients, when they actually have coverage becomes very, very important. I've also mentioned again, just ensuring that the laws that are already in effect are adhered to and enforced. I think that right after our meeting, there was a press release that again, indeed, the American with Disabilities Act does protect those with the opioid use disorder. They cannot be discriminated against and their services need to be offered, including within people that are incarcerated. And then finally, the one maybe we should have started with is we just have to find a way to diminish the stigma that comes with patients. The list was long in terms of those lived experience that said that they wanted to get help, but they didn't know how; when they were being treated with methadone, they were told they were still addicts even though they were living now being able to maintain a comfortable living take care of their families; these kinds of things. Some of this, we’ve just got to diminish, eradicate, I think the stigma that comes to the opioid use disorder, because I think what you even have is some providers that are interested in being evolved, they don't want to have to deal with what some of the kind of perceived baggage of providing care for these people that need help. And I think the frustration with this, that just makes it worse. So I think it almost doesn't quite matter what your exact take on how you want to characterize these folks that actually have just a brain disorder. But it's the fact that these current mechanisms clearly are not affected. And if we want to do something about it, we're going to have to kind of modify our approaches. And these things are, are very, very sound. We're not talking about medications that are unknown. We're not talking about quantities, and certainly we're talking about a patient population that really is, that their options are few. It just seems that, like any other any other disorder, that we have this duty to provide care. This is one where we could certainly do much more to enhance what we deliver.

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Pharmacies can play a key role in supporting patients with opioid use disorder and helping diminish stigma for patients treated with methadone, who are told by some they are still addicts despite trying to receive help.

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Expert: Pharmacies Serving as Extenders for Opioid Treatment Programs May Help Significantly Decrease Deaths From Opioid Use Disorder

With the combined impact of the COVID-19 pandemic on the health care workforce, consolidation of blood collection centers, and a shrinking donor pool, the nation’s blood supply its at its 

 in more than a decade.1 And with costs for blood and blood products continuing to rise, appropriate blood use by hospitals is more important than ever.

In a recent study from Columbia Healthcare Analytics and Vizient of roughly 8,900 transfused patients across 15 hospitals in the western United States, researchers found that 44% of patients could have been managed without a transfusion (whether red blood cells (RBC), plasma, cryoprecipitate, or platelets), and 92% received at least 1 transfusion that was unnecessary.

The study found that nearly all unnecessary transfusions stemmed from common misinterpretation of Association for the Advancement of Blood and Biotherapies guidelines. Many clinicians inaccurately believed that transfusion is prescribed for a hemoglobin value less than 7 gm/dL. A closer reading of the guideline finds that a hemoglobin less than 7

for good blood management. Rather, it’s a 

 level below which transfusion may be appropriate but not necessarily warranted.

Because hospitals commonly use hemoglobin values to gauge transfusion appropriateness in combination with the guideline, this pattern likely occurs daily in hospitals across the country. This costs the health care industry millions of dollars annually and wastes this precious and increasingly scarce resource.

A first step to improving blood management starts with an evaluation of pre-transfusion and discharge hemoglobin values of RBC-transfused patients, followed by an estimation of the potential discharge hemoglobin if transfusion has not occurred. Assessing the data will reveal 3 key metrics about clinical practice: patients pre-maturely transfused, over-transfused, and those who could have been managed without transfusion.

An important way that physicians and pharmacists can collaborate when the patient’s Hgb value becomes a concern is through the use of erythropoietin-stimulating agents (ESAs), which work by stimulating the production of more red blood cells, in combination with intravenous (IV) iron.

Methods to adequately manage surgical patients who are not hemorrhaging with hemoglobin laboratory values below 7 gm/dL include:

Diagnosing anemia prior to surgery and administering iron via an IV as appropriate

Normovolemic hemodilution, in which the patient’s heart is maintained during surgery using their own blood, drawn before surgery

Intra-operative cell salvage, in which a device is used to capture blood during surgery, process it, and return it to the patient via an IV

Lastly, clinicians can implement aggressive hemostatic techniques such as reducing sample sizes and frequency of sample draws and using shorter tubing.

How to Break a Pattern of Over-Transfusion With Physicians

In addition to COVID-19-induced market challenges to acquiring blood donations, the cost of blood products has dramatically increased due to FDA testing requirements that went into effect October 1, 2021. If hospitals can begin to implement better blood management and utilization practices, the reduction in unnecessary transfusions could lower costs and address much of the blood shortage the industry is currently experiencing.

Breaking a pattern of over-transfusing starts with 2 simple steps—measuring all blood use and engaging physicians.

First, hospitals should begin measuring all transfusion activity and providing that data to physicians monthly. To gain engagement, the data should show individual physician activity benchmarked against their peers’ activity. Providing benchmarking data can open the door for physicians to seek out additional decision-making skills related to transfusions that are less reliant on lab values.

The hospital’s transfusion committee should also follow up with clinicians to understand whether specific cases could have been managed without RBC transfusion. To improve physician engagement, consider offering continuing medical education (CME) credit and ongoing professional practices evaluation documentation required for certification maintenance.

An additional step to keep clinicians engaged is gamification. Monitor blood use from transfusion to credentialing. Award points for skill assessment, no committee referral, good patient management, and timely physician response. Then, reward clinicians with CME credits, certification, credentialing, or other incentives.

Engaging and rewarding clinicians through these types of activities will help effect change, and with the current shortage, the sooner the better. The real reward comes when the hospital laboratory is fully stocked with blood inventory.

 is senior principal of laboratory and blood consulting at Vizient.

Red Cross Declares First-ever Blood Crisis Amid Omicron Surge. News release. American Red Cross. January 11, 2022. Accessed August 15, 2022. 

https://www.redcross.org/about-us/news-and-events/press-release/2022/blood-donors-needed-now-as-omicron-intensifies.html

With costs for blood and blood products continuing to rise, appropriate blood use by hospitals is more important than ever.

Op-Ed: Unnecessary Transfusions in Hospitals May Be Fueling the Blood Shortage

Older patients with chronic kidney disease (CKD) who were administered fluoroquinolone at higher than recommended doses were more likely to be hospitalized, according to a study published in 

Fluoroquinolone is the most prescribed broad-spectrum antibiotic, even though the FDA has severe black box warnings about its risks. Fluoroquinolones (ciprofloxacin, levofloxacin, or norfloxacin) are typically eliminated by the kidneys, but patients with reduced kidney function excrete the antibiotic at a lower rate.

Population-based studies and meta-analyses already show an association between fluoroquinolone and rare but serious adverse events (AEs). These AEs include nervous system disorders, psychiatric disorders, hypoglycemia, and collagen-associated AEs.

Researchers analyzed these AEs and whether they were associated with a higher vs lower dose of fluoroquinolone in older patients with advanced CDK. Primary endpoints included hospitalization due to AEs during the first 14 days of taking medication. Secondary outcomes included hospital visits due to sepsis, retinal detachment, all-cause hospitalization, all-cause mortality, or sudden cardiac death.

From January 2008 to March 2020, researchers conducted a new user, population-based cohort study in Ontario, Canada, analyzing 11,917 CKD patients taken from 8 health care databases. Participants were 66 years of age and older, most of whom with an estimated glomerular filtration rate [eGFR] of less than 30 mL/min/1.73 m2.

Researchers gave participants either a single higher dose of oral fluoroquinolone—which includes ciprofloxacin (501 to 1000 mg/d), levofloxacin (501 to 750 mg/d) or norfloxacin (401 to 800 mg/d)—or a low-dose prescription of ciprofloxacin (500 mg/d), levofloxacin (250 to 500 mg/d), or norfloxacin (400 mg/d). The thresholds were determined by current patient guidelines for patients with advanced CKD.

In 2021, the team found that the higher fluoroquinolone dose associated with a higher risk of severe AEs, supporting the primary outcome. Neither the high- nor low-dose groups were associated with any secondary outcomes. Researchers also discovered that 46% of patients with advanced CDK were being prescribed higher than recommended doses.

In the study, participants taking the larger dose of fluoroquinolone also had a significantly higher risk of hospitalization for altered mental status, which was the most common AE.

The study authors further conducted 4 post hoc sensitivity analyses, showing a consistent survival analysis, low confidence of primary outcomes, insignificant risk of heart failure on the antibiotic, and overall consistent results.

In the study, there was only 1 hospitalization for every 256 patients. In total, only 1.2% of high-dose users were hospitalized for AEs.

The authors identified some limitations to the study, specifically being that it is the first of its kind to evaluate this association. Other factors such as age and disease limit the results of this drug, and researchers used multiple types of fluoroquinolones, generalizing the entire antibiotic.

The findings suggest that fluoroquinolones should be prescribed at lower doses to adults with advanced CKD due to their high-risk AEs, the authors concluded.

Muanda, Flory, Sood, Manish, Weir, Matthew, et al. Association of Higher-Dose Fluoroquinolone Therapy With Serious Adverse Events in Older Adults With Advanced Chronic Kidney Disease. 

2022;5(8):e2224892. doi:10.1001/jamanetworkopen.2022.24892.

A new study warns that fluoroquinolone could increase the risk of altered mental status and hospitalizations for advanced chronic kidney disease patients, though it is rare.

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Common Antibiotic Associated with Rare, Severe Adverse Effects for Patients with Advanced Chronic Kidney Disease

Patients diagnosed with atrial fibrillation (AF) are less likely to use non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin within 30 days of diagnosis due to insurer policies and high costs, which could result in adverse health effects, such as stroke, according to a study published in 

Warfarin is an anticoagulant long used to treat AF, a major risk factor for stroke, though it does not mix well with all food or medications. Although NOACs were found to be more effective and less burdensome than warfarin, they cost much more.

“Insurers efforts to control health spending increasingly rely on restricting access to high-cost therapies. In the case of NOACs, these policies may be penny wise and pound foolish,” said Geoffrey Joyce, Schaeffer Center senior fellow and associate professor at the USC School of Pharmacy, in a press release.

Studying fee-for-service Medicare beneficiaries, the team examined how these patients were affected by 2 insurance tools that supposedly reduce prescription drug costs.

One policy, known as step therapy, requires patients to take a generic—and often cheaper—medication first. The other policy, prior authorization, requires an insurance professional to approve the therapy before a patient can use it. These policies are intended to decrease unnecessary drug use and waste. In practice, these policies made it difficult for patients to access their medication, even the generic and cheap options, such as warfarin, according to the study.

“We tested the association between coverage restrictions and NOAC use, including initiation and compliance, and whether coverage restrictions were associated with an elevated risk of stroke and bleeding,” said 

, senior fellow at the USC Schaeffer Center and associate professor at the USC School of Pharmacy, in a press release.

Part D insurance plans for beneficiaries were divided into two. If a person had access to 1 NOAC without prior authorization or step therapy, they had an unrestricted Part D plan. If NOACs had protocols before being accessible to patients, patients had a restricted Part D plan.

All beneficiaries in the restricted Medicare Part D plan were less likely to use a NOAC, according to the findings. They were also less likely to correctly adhere to the medication instructions. Only 46% of people on restricted plans received a NOAC within 30 days of their AF diagnosis, whereas 55% of unrestricted beneficiaries received their initial prescription.

Researchers also looked at an association between formulary restrictions and clinical outcomes. They discovered that patients on a restricted insurance plan had a higher aggregate risk of death, stroke, transient ischemic attack, or systemic embolism than participants with unrestricted coverage.

The team believes that more lives can be saved with better access to NOACs. For AF patients specifically, anticoagulant therapy is an underused but effective treatment option.

“Limiting access to NOACs through step therapy or prior authorization may exacerbate the current underuse of anticoagulants and increase the risk of stroke among newly diagnosed AF patients,” Joyce explained in a press release.

Joyce concluded that “All pharmacy benefit managers and Medicare Part D plans need to continuously review their formulary policies to make sure that patients have timely access to effective medications.”

Efforts to save money on prescription drugs associated with increased stroke risk for seniors. EurekAlert! Aug 8, 2022. Accessed on Aug 9, 2022. https://www.eurekalert.org/news-releases/961270

Insurer and pharmacy benefit manager policies used to cut the cost of drugs could be so time consuming that they could put newly diagnosed atrial fibrillation patients at risk of stroke.

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Insurer Tools to Save Seniors Money on Prescription Drugs Could Put Them at Higher Risk of Stroke

The implementation of 13-valent pneumococcal conjugate vaccine (PCV13) was associated with reduction in the incidence of acute chest syndrome (ACS) among children with sickle-cell disease (SCD) in France, according to a study published in 

The findings provide evidence for the involvement of 

) in childhood ACS, the study authors noted. ACS is a specific severe complication of SCD with a complex physiopathology. Though 

has been estimated to be responsible for 4.5% of ACS, its precise involvement in ACS is difficult to determine.

PCV13 has been used in the general population since 2010 in many countries, including France, and has been shown to have a significant reduction in invasive and non-invasive pneumococcal disease, including lower respiratory tract infections. Despite its use, the public health outcomes of PCV13 implementation concerning ACS are still unknown.

To address this knowledge gap, the researchers conducted a study to assess the association of PCV13 implementation in the general pediatric population with the incidence of ACS in children with SCD. Researchers used an interrupted time-series analysis of patient records from a national hospital-based French surveillance system. Participants included children younger than 18 years of age with SCD hospitalized in France between January 2007 and December 2019.

Researchers measured the monthly incidence of ACS per 1000 children with SCD. They also calculated control outcomes including the monthly incidence of hospitalization for vaso-occlusive crisis, asthma crisis, and acute pyelonephritis per 1000 children with SCD over the same period.

Researchers identified 107,694 hospitalizations of children with SCD during the study period (median [IQR] age, 9 [4-13] years; 56,264 [52.2%] boys). Of these, ACS accounted for 4007 (3.7%) cases, pneumonia for 1789 (1.7%), other LRTIs for 1153 (1.1%), asthma crises for 845 (0.8%), acute pyelonephritis for 889 (0.8%), and VOC for 69,920 (64.9%).

Results showed that PCV13 implementation in 2010 was followed by a significant decrease in the incidence of ACS (−0.9% per month; 95% CI, −1.4% to −0.4%; P < .001), with an estimated cumulative change of −41.8% (95% CI, −70.8% to −12.7%) by December 2019. The sensitivity analyses yielded the same results, including the incidence of ACS adjusted for that of vaso-occlusive crisis over time.

Results were found to be similar among different age groups. No change was found for the 3 control outcomes over the study period.

Overall, PCV13 supplementation was associated with an important reduction in the incidence of ACS in children with SCD. However, the finding that the decrease of ACS incidence following PCV13 implementation suggests an important pneumococcal involvement with this entity contrasts previous research, according to the authors of the current study.

The authors suggest that this new evidence of the key role of 

 in ACS should be considered when estimating outcomes associated with current PCVs and the potential benefit of next-generation PCVs in children. They encourage including their potential to reduce ACS in children with SCD in the assessment of potential public health benefits of such next generation PCVs.

The study faced limitations. The diagnosis of ACS relies on nonspecific criteria that allow for possible clinical overlap with pneumonia, meaning there was potential for misclassification. Additionally, the analysis may have been affected by simultaneous cointerventions targeting the same outcome.

Assad Z, Michel M, Valtuille Z, et al. Incidence of acute chest syndrome in children with sickle cell disease following implementation of the 12-valent pneumococcal conjugate vaccine in France.” JAMA 

2022;5(8):e2225141. doi:10.1001/jamanetworkopen.2022.25141

A potential public health benefit of 13-valent pneumococcal conjugate vaccine is the reduction of acute chest syndrome among children with sickle-cell disease.

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PCV13 Vaccination May Reduce Incidence of Acute Chest Syndrome for Children with Sickle-Cell Disease

Neck and shoulder pain (NSP) has been associated with 

, but the efficacy of 100-mg caffeine (IbuCaff) and 400-mg ibuprofen treatment is not substantially different in those who with NSP, according to the results of a study published in 

Investigators aimed to determine how individuals with and without concomitant NSP differ in characteristics and in their perception of treatment responses to analgesics.

There were 735 individuals with headaches and 160 with migraines in the study who used an analgesic fixed-dose combination containing IbuCaff as a non-prescription treatment. There were 538 individuals who suffered from headaches with NSP and 304 who had headaches without NSP.

Investigators found that NSP occurred in approximately 60% of individuals in the survey and found that NSP was associated with more than 1 additional day of headache per month. Those individuals also reported sedentary work more frequently than those without at 40% and 29%, respectively.

Additionally, they also reported physical tension and poor posture as perceived trigger factors more frequently than those individuals without NSP at 70% and 16%, respectively.

All other triggers, including nutrition, stress, and weather sensitivity, were reported more frequently for individuals with headaches without NSP.

Reported pain reduction was comparable in both the NSP and without NSP groups, regardless of whether assessed as mean pain rating, on a scale of about 6 to 1.5 based on 10 points, patients experiencing a greater than 50% pain reduction at 89.6% and 88.8%, respectively, or becoming pain-free within 2 hours, at 57% and 64%, respectively.

The onset of pain relief after the first dose of IbuCaff was similar in both groups and was reported to be within 6 to 15 minutes or 16 to 30 minutes.

Recurrence of pain and use of another dose within the same day occurred more frequently in the group with NSP than the group without at 53% and 36%, respectively, investigators said.

Furthermore, investigators found that individuals with headaches and NSP were more likely to recommend IbuCaff to others than those without NSP at 91% and 84%, respectively. Also, those individuals with NSP would be more willing to buy it again at 93% compared with those without NSP at 84%.

The study was conducted in 126 community pharmacies in Germany between February and June 2019. Individuals were included if they purchased a branded IbuCaff product and consented.

The individuals filled out the survey at their own discretion after taking IbuCaff to treat pain episodes. The questionnaire was sent to Winicker Norimed GmbH, which collected and analyzed the data. The survey was anonymous, with no data being collected that would allow investigators to identify the individuals. There were no exclusion criteria for the study.

Investigators noted that even though non-interventional and observational studies are useful, they cannot prove efficacy because of the lack of a control group.

However, the efficacy of ibuprofen for the treatment of headaches is undisputed, according to investigators.

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