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James Keagy 1442

News roundup

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CDC releases updated pain management guidelines

CDC's updated guideline on pain management represents a welcome improvement over earlier guidance, according to APhA. They commend the government for including pharmacists in the multidisciplinary plan.

The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain—updated from the 2016 version—promotes tailored care for acute, subacute, and chronic pain through shared decision making between patients and their care teams.

“Pharmacists have an important role to play in pain management across the spectrum,” a statement from APhA noted. They go on to say that the new guideline, which has a multimodal focus and also addresses health inequities in the provision of pain treatment, “will be helpful to pharmacists in delivering effective pain care.”

While it appreciates CDC's effort to avoid unintended consequences stemming from the previous guideline by identifying inappropriate interpretations of use, APhA encourages the agency to pay attention to current laws, regulations, and policies that might interfere with clinicians’ ability to work within the practice recommendations.

Experts flag potential risk with Paxlovid and cardiovascular drugs

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Clinicians treating patients with COVID-19 who are at risk for progression to acute disease should be aware of potential drug–drug interactions when the oral antiviral treatment nirmatrelvir/ritonavir (Paxlovid—Pfizer) is administered to people taking common CV drugs, experts warn in a new Journal of the American College of Cardiology article. Coadministration with certain anticoagulants and antiplatelet agents, for instance, can elevate bleeding risk, while hypotension can develop in patients who take Paxlovid and blood pressure drugs. Cushing's syndrome and adrenal suppression are possible after concomitant use of the antiviral with anti-inflammatories, according to the authors. Heart transplant patients undergoing immunosuppressive therapy are also particularly vulnerable due to the toxic effects created by co-use of Paxlovid and cyclosporine, tacrolimus, or sirolimus. Because of the long list of severe adverse effects that might develop due to interactions with CV medications—including certain lipid-lowering agents, anti-anginal drugs, heart failure therapeutics, and pulmonary hypertension treatments—flagged CV medications may need to be paused or, at the very least, have the dose dialed down. In the event that a potentially interacting CV medication cannot be safely discontinued for a short time or the dose adjusted, experts recommend that providers avoid Paxlovid therapy altogether.

ISMP releases survey on pharmacists’ support during a code

A recent survey from the Institute for Safe Medication Practices (ISMP) puts the pharmacist's role during code situations into focus. Although they may be called on to assist with basic life support, defibrillation, or intubation, according to the survey, pharmacists may more often be relied upon to prepare medications, retrieve drugs and/or equipment from code carts or elsewhere, and consult on appropriate interventions and dosages. Among 410 pharmacists who completed the ISMP poll, most had some level of experience responding to codes, with only 5% reporting none. Despite the high level of exposure, more than one-third of respondents expressed feeling ill-equipped to handle code situations. More than one-half received instruction on the indications, preparation, and adult doses of medications often used during codes, and an even greater share were trained on where to find medications in the code cart. However, very few had an opportunity to shadow another pharmacist during a code or to participate in a mock event. No required training at all was reported by 7% of all respondents. The survey responses also revealed a high level of worry among pharmacists about making medication errors during a code due not only to inexperience or inadequate training, but also due to lack of clear communication, chaos in a crowded and rushed environment, lack of patient information, and other issues. In light of the poll results, ISMP offered recommendations for code preparation, including requiring pharmacy participation, conducting practice simulations, and clearly spelling out responsibilities. The organization also advised steps to follow during a code; for instance, double-checking doses as well as securing and replenishing supplies for the next episode after a code.

FDA releases draft guidance to spur development of CDI drugs

New guidance released by FDA provides advice for sponsors on developing drugs for treating Clostridioides difficile infection (CDI). The draft guidance discusses how to design trials and trial populations, efficacy and safety endpoints, nonclinical studies, and pharmacokinetic studies. CDC described C. difficile as “threat-level urgent” in its 2019 Antimicrobial Threats Report and estimates that C. difficile causes the hospitalizations of 223,900 individuals per year and 12,800 annual deaths. The guidance examines the development of CDI treatments consisting of small molecule drugs and biological products and how to reduce the recurrence of CDI, especially in at-risk patients. Clinical trials should be randomized, double-blinded, and use an active control for both CDI treatment and curbing CDI recurrence, FDA's guidance document said. To demonstrate efficacy, sponsors should supply evidence from 2 competent and well-controlled trials, with one trial demonstrating efficacy only for treatment and another trial for preventing CDI. Sponsors are advised to submit safety data from at least 300 individuals exposed to the proposed investigational drug treatment. Clinical programs for drugs developed only for preventing CDI may require a larger safety database. Sponsors should discuss a suitable size of the premarket safety database with FDA during clinical development. For nonclinical studies, applicants should test the investigational drug in vitro and in animal models prior to submitting an investigational new drug application. FDA also recommends an I.V. toxicology study in at least one mammalian species to identify possible risks, noting that CDI may increase oral drug absorption because of the disruption of the intestinal barrier.

Researchers continue to study effectiveness of ivermectin for COVID-19

Researchers wanted to find out if ivermectin compared to placebo shortened symptom duration for adult patients in the United States with symptomatic mild to moderate COVID-19. According to results of the randomized clinical trial published in JAMA on October 21, 2022, the research team found that among outpatients with mild to moderate COVID-19, treatment with ivermectin compared with placebo did not significantly improve time to recovery. The analysis included 1,591 U.S. adult outpatients age 30 years and older who had confirmed COVID-19 during the Delta and Omicron waves and presented with at least 2 symptoms of acute infection. A total of 817 participants were randomly assigned to treatment with 400 mcg/kg of ivermectin while the remaining 774 participants received a placebo. The median time to recovery was 12 and 13 days, respectively, for the intervention and control groups. In addition to having no significant effect on symptom duration, ivermectin demonstrated no benefit over placebo for secondary endpoints, including hospital admission, mortality, or acute care visits. “These findings do not support the use of ivermectin in patients with mild to moderate COVID-19,” the study authors concluded. Ivermectin is among the candidates explored as part of the ACTIV-6 trial, which aims to identify repurposed drugs that might effectively combat mild to moderate COVID-19.

One in ten older adults in the U.S. has dementia, study suggests

A new study published in JAMA Neurology estimated that in the United States, 1 in 10 adults over the age of 65 years has dementia and 1 in 5 has cognitive difficulties. The study was based on information from the Health and Retirement Study, specifically test results from 2016–2017 comprising almost 3,500 study participants age 65 years and older. They underwent tests to gauge their memory, attention, and comprehension as well as their ability to live independently and how their faculties changed over the previous decade. According to the findings, about 10% of U.S. adults aged 65 and older have dementia and 22% have mild cognitive impairment, indicating their memory and other functions are affected. About 3% of people in their 60s had dementia, rising to 35% among people in their 90s. The dementia rate was higher for older adults identified as non-Hispanic Black compared with their counterparts. The study found that 15% of older Black adults have dementia, compared with 11% of older white adults and 10% of older Hispanic adults. In addition, 13% of people with no high school diploma had dementia, compared with 9% among those who finished high school or attended college, according to the study.

Over 1 million Americans with diabetes rationed insulin, says new report

A new report published in the Annals of Internal Medicine found that an estimated 1.3 million U.S. adults with diabetes rationed their insulin in the past year, representing 16.5% of those who use prescribed insulin. The report found that people with diabetes rationed their insulin by delaying when they refill their prescription, skipping doses, or using a smaller dose. The report also indicated that rationing was more widespread among lower- and middle-income participants (15% and 20%, respectively) compared with higher income people (11%). Black participants were found to ration (23%) more frequently compared with white or Hispanic participants (16%). Rationing was most frequent among uninsured individuals, with 29% saying they had rationed insulin. Among those with private insurance, 19% rationed the drug, citing high copays, along with 14% of Medicare recipients, and 12% of Medicaid recipients. The report was based on data from an ongoing CDC health research project in which researchers were studying a nationally representative sample of 982 adults who use insulin to treat diabetes. Findings indicate the rationing is linked to the high price of insulin and “inadequate” insurance coverage.

New interactive map promotes access to pharmacy services

Dima M. Qato, PharmD, MPH, PhD, regards pharmacy access as a human rights issue. Qato, an associate professor at the School of Pharmacy at the University of Southern California (USC) and a senior fellow at the USC Leonard D. Schaeffer Center for Health Policy & Economics, developed an interactive, nationwide mapping tool that reveals the presence of “pharmacy deserts” around the country. The map identifies nearly 1 in 4 neighborhoods as being areas with pharmacy shortages. “By collaborating, we have been able to attack the problem on a national scale using faster spatial computation and spatial analysis to better understand geographic contexts, like urban versus rural areas,” said Robert Vos, PhD, in a news release. Vos is an associate professor of spatial sciences with the USC Spatial Sciences Institute who helped build the tool. The map defines a pharmacy shortage area as one where the distance to a pharmacy is greater than 10 miles in a rural area, 2 miles in a suburban area, 1 mile in an urban area, and 0.5 miles in neighborhoods where its residents have low income and low vehicle ownership. Qato hopes the mapping tool will inform federal and state policy changes that enhance health equity. “In terms of the equitable implementation of federal and state policies, it's important to ensure that local pharmacies are actually stocking essential medicines and offering essential services they are authorized to provide,” Qato said.

CDC: Antihistamines could be contributing to opioid overdoses

New CDC findings highlight the hidden dangers of antihistamines for those who have concomitant exposure to opioids. Looking at about 92,000 overdose fatalities across the nation between 2019 and 2020, investigators found that diphenhydramine—the active ingredient in Benadryl and other antihistamines—were implicated in no less than 18% of the deaths studied. The study authors suspect some opioid users may take antihistamines to enhance the effects of the narcotic, but they believe others may use them to alleviate allergies or to get relief from itching, nausea, poor sleep, and other adverse effects linked to allergies. Regardless of the motivation, antihistamines can exacerbate opioid-induced respiratory depression (the most common cause of mortality during an overdose), deepening sedation to unsafe levels. To worsen matters, naloxone by itself may not effectively reverse an overdose under these circumstances.

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