Lauren Biscaldi

The FDA will be seeking public comment on changes that would require opioid analgesics prescribed in outpatient settings to be disposed of via prepaid mail-back envelopes provided by pharmacists, according to an FDA news release.

The changes would modify the current Opioid Analgesic Risk Evaluation and Mitigation strategy and would provide “a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks, and takeback events.”

It is not uncommon for patients to have unused opioid analgesics on hand after outpatient surgical procedures, creating an environment of opportunity for nonmedical opioid use. Providing a mail-back envelope with these prescriptions can, the FDA said, reduce the quantity of unused medication in patient homes. This effort, coupled with patient education about disposal options, may increase the rate of disposal of unused opioids.

“The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that have the potential to decrease unnecessary exposure to opioids and prevent new cases of addiction,” said Robert M. Califf, MD, FDA Commissioner, in the news release. “Prescribing opioids for durations and doses that do not properly match the clinical needs of the patient not only increases the changes for misuse, abuse, and overdose, but it also increases the likeilihood of unnecessary exposure to unused medications.”

“[T]he mail-back envelope requirement…would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal,” he added.

These changes support the Department of Health & Human Services Overdose Prevention Strategy,

 which focuses on primary prevention, harm reduction, evidence-based treatment, and recovery support.

Public comments are being solicited until June 21, 2022.

This article was originally published on Drug Topics®. 

FDA considers new approach to improve safe disposal of prescription opioid analgesics, decrease unnecessary exposure to unused medication. News release. FDA. April 20, 2022. Accessed April 20, 2022. 

https://www.fda.gov/news-events/press-announcements/fda-considers-new-approach-improve-safe-disposal-prescription-opioid-analgesics-decrease-unnecessary

Overdose prevention strategy. Department of Health and Human Services. Accessed April 20, 2022. 

Providing mail-back envelopes and education on safe disposal with opioid analgesics dispensed in an outpatient setting. Federal Register. Accessed April 20, 2022. 

https://www.federalregister.gov/public-inspection/2022-08372/providing-mail-back-envelopes-and-education-on-safe-disposal-with-opioid-analgesics-dispensed-in-an

Articles

The agency is considering dispensing mail-back envelopes with outpatient opioid analgesic prescriptions.

FDA explores new opioid disposal strategy

One of the problems with treating chronic pain, said Emily Leppien, PharmD, BCPS, BCPP, is that pain is a subjective disease, often without physical markers.

But more people in the United States live with chronic pain than those that live with cancer, heart disease, and diabetes, combined, said Leppien, a clinical assistant professor at the Binghamton University School of Pharmacy and Pharmaceutical Sciences and a clinical pharmacy specialist at Lourdes Pain Care in Binghamton, New York, in her presentation at the American Pharmacists Association 2022 Annual Meeting & Exposition.

“One hundred and sixteen million Americans are currently living with chronic pain,” she said, “[and] opioids should not be the default pain medication.”

Instead, Leppien said, pharmacists and prescribers should look toward both nonpharmacologic and nonopioid pharmacological analgesics before opioid therapy is initiated, a suggestion backed up by pain management guidelines.

Since the 2016 publication of the CDC guidelines on opioid prescribing for chronic pain, opioid prescription rates have gone down. However, Leppien pointed out, decreased prescribing does not equal decreased pain.

“Even though we have seen a trend downward in the number of opioid prescriptions that are being dispensed or being prescribed, [the] same number of patients still have chronic pain,” she said. “How are those patients being managed?"

A multimodal approach is the best answer, Leppien suggested, perhaps beginning with nonopioid analgesics and progressing to combination therapies, low-dose opioids plus nonopioid analgesics, local anesthetics or peripheral nerve blocks, or long-acting opioids. Each of these steps, though, should be undertaken in addition to nonpharmacologic strategies. “As pain resolves, we can start to taper or take away medication depending on whether or not that pain acute or subacute,” Leppien explained.

There are a number of options—including topical anesthetics, gabapentanoids and antiepileptic drugs, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, opioid receptor antagonists, and antipsychotics—that may be used for nonopioid analgesic pain management, although, Leppien cautioned at the start of her presentation, many of the medications suggested are being used off-label for pain management.

When considering one of these nonopioid options, it’s important for providers to understand a patient’s complete pain picture. “Most patients are not going to have just one type of pain,” Leppien explained. “There may be an overlapping pain picture [with] patients experiencing nociceptive and neuropathic pain at the same time. Our treatment approach should target both of those types of pain.”

Topical anesthetics like capsaicin 1% cream and 8% patches or lidocaine 5% patches have some evidence indicating their effectiveness, and capsaicin 8% patches are currently FDA approved for conditions like postherpetic neuralgia and diabetic neuropathy. Within the gabapentanoid class of medications, gabapentin and pregabalin are approved for post herpetic neuralgia and neuropathic pain, diabetic peripheral neuropathy, postherpetic neuralgia, and fibromyalgia, respectively. While these drugs can be a good choice for the right patient—they tend to work faster and can be titrated quickly—there is an increased cost and risk of dependence.

The most studied antiepileptic drugs are carbamazepine and lamotrigine, but only carbamazepine is FDA-approved to treat trigeminal neuralgia. This class of medication can come with a number of adverse effects, ranging from anemia to thrombocytopenia.

SNRI medications do have some FDA approvals for pain—such as duloxetine, approved to treat fibromyalgia, diabetic peripheral neuropathy, and chronic musculoskeletal pain—but all come with the potential for adverse effects that include nausea, hypertension, loss of appetite, serotonin syndrome, sexual dysfunction, and urinary retention. Of these medications, duloxetine currently has the best clinical evidence supporting its use for pain management.

Tricyclic antidepressant options include amitriptyline and nortriptyline, neither of which have any current pain related FDA approval. While these drugs have a low number needed to treat—only 3 to 4 for a 50% reduction in pain—side effects may limit use. For patients with sleep difficulties, these drugs can be effective in addressing 2 problems through one prescription. Second generation antipsychotics—including aripiprazole, olanzapine, quetiapine, and risperidone—can potentially reduce the over-firing of dopaminergic neurons, which has been shown to potentially improve abnormal pain perceptions. In the research, these medications have shown the most efficacy in managing neuropathic pain, fibromyalgia, and headache.

Opioid receptor antagonists, Leppien noted, have also shown some efficacy in pain treatment. “Naltrexone for pain management is used at significantly lower doses than what is commercially available,” Leppien explained. “The lowest commercially available tablet is 50 mg; low-dose naltrexone for pain management is dosed 0.5 to 4.5 mgs per day.” But because it’s not commercially available at those low doses, this option does require compounding by a pharmacist.

When it comes to naltrexone, the analgesic mechanism remains unclear, with researchers still debating how, exactly, low dose naltrexone can target pain. The simplified version, she explained, is that as naltrexone binds to mu opioid receptors as an antagonist, endorphins begin to upregulate. Because endorphins are blocked from binding to the mu receptor, their production increases which increases upregulation of pain receptors—leading to a pain response.

Naltrexone dosing should be started at a lower dose and titrated up, and benefit is not typically seen immediately—sometimes requiring several weeks before patients notice a pain benefit. And, Leppien cautioned, one of the biggest clinical pearls to keep in mind is that naltrexone use can precipitate opioid withdrawal if initiated after a patient has recently discontinued an opioid therapy. “It’s ideal to taper the opioid, if a patient is on opioids first, before switching to naltrexone to be sure we don’t push the patient into withdrawal,” she said. There’s also a risk of unintentional opioid if naltrexone is used in addition to opioids, Leppien added. “The amount of opioid that would be needed to push naltrexone off of the mu receptors is going to be higher than what a patient may have previously used—or a normal dose if the patient wasn’t using naltrexone—and that can result in overdose once naltrexone is pushed off the opioid receptor.” This is particularly important to keep in mind when treating patients who may be using recreationally or illicitly using opioid therapies.

OTC dietary supplements can also be utilized as part of the nonopioid analgesic toolkit, but these options have the additional complication of not being FDA regulated or approved. “These drugs…have even more limited evidence than the drugs we’ve previously discussed,” Leppien noted, “but there is some efficacy in the literature that shows they may be useful.” These supplements include acetyl-L-carnitine, alpha-lipoic acid, glucosamine chondroitin, and magnesium.

When it comes to selecting treatment, Leppien had some advice: choose treatment options based on how the patient describes their pain, their comorbid diagnoses, and—perhaps most importantly—include patients in the decision-making process.

“If a patient isn’t going to take the medication because they’re not interested, well, that’s just a waste of everybody’s time. Including the patient in the treatment decision-making can certainly help to improve pain outcomes,” she said. Introducing nonpharmacologic strategies like acupuncture, cryotherapy, massage therapy, and cognitive behavioral therapy can also be a key part of a patient’s pain management plan.

“If we’re thinking about treating patients with nonopioid strategies, nonpharmacologic interventions should always be in addition to the use of nonopioid therapies—regardless of which step [of the pain management approach] the patient is on,” she said. “That is guideline recommended; those are guideline recommended therapies. Evidence isn’t as robust as it is with oral medication options, but it’s still worth a try.”

Leppien EE. Non-opioid options for pain management. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX

Combining nonopioid analgesics and nonpharmacologic pain management options with opioid medications can lead to better patient outcomes.

Nonopioid analgesic, nonpharmacologic options for pain management reviewed

As of February 19, there have been 78,269,789 COVID-19 cases in the United States. In the last 7 days, there have been 724,237 new cases identified. (

Across the country—and around the world—governments have begun making plans to lift COVID-19 mask mandates and as of February 21, Hawaii is the sole US state with an indoor mask mandate. (

But as these mandates relax, a more contagious version of Omicron—BA.2—has begun to spread in the United States. Infectious disease experts are watching this variant with a wary eye, noting that BA.2 may spread 30% more easily than the original version of the Omicron variant. (

A deep dive published this past weekend takes a look at the ways in which Long COVID—a chronic illness stemming from previous COVID-19 infection—“exhausts the body,” from the brain to the circulatory system and beyond. (

New York state has walked back its previous guidance that would see all health care workers required to receive a COVID-19 booster shot. According to the state, “too many” health care workers were refusing the booster, and requirements would push an already strained system past its limits. (

 further highlights the benefit of completing a 2-dose mRNA COVID-19 vaccine series while pregnant: when pregnant persons are vaccinated, there is a roughly 60% reduced risk of COVID-19 hospitalization in babies younger than 6 months. (

Check back next Monday for the latest updates and COVID-19 news you need to know.

This article originally appeared on Drug Topics®. 

COVID-19 updates and news to know as of February 21, 2022.

This Week in COVID-19: As new Omicron variant circulates, states lift mask mandates

Novavax has announced positive results of their phase 3 PREVENT-19 clinical trial (NCT04511802) evaluating the company’s recombinant nanoparticle protein-based COVID-19 vaccine, NVX-CoV2373.

The vaccine both achieved the primary effectiveness endpoint—neutralizing antibody responses noninfoerior to those seen in young adult participants of PREVENT-19—and demonstrated an 80% overall efficacy when the Delta SARS-CoV-2 variant was predominant.

The pediatric expansion of the PREVENT-19 trial enrolled 2247 adolescents aged 12 to 17 years across 73 sites in the United States. Trial investigators emphasized the importance of ensuring “well balanced racial and ethnic representation among participants.”

Results of the pivotal phase 3 primary PREVENT-19 trial were published in the 

.2 The trial enrolled 30,000 adult participants across the United States and Mexico and demonstrated a 90.4% overall efficacy, as well as high safety and tolerability.

“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19,” said Filip Dubovsky, MD, Chief Medical Officer, Novavax, in the statement. “We believe the Novavax vaccine offers a differentiated technology and option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.”

Novavax anticipates submitting regulatory findings for a pediatric indication to global regulatory authorities during the first quarter of 2022, and plans to initiate “additional studies globally evaluating younger age groups” during the second quarter of 2022.

NVX-CoV2373 has received authorization from numerous global regulatorily bodies, including a conditional marketing authorization from the European Commission and an emergency use listing from the WHO. NVX-CoV2372 is currently under review by the FDA.

Novavax announces positive results of COVID-19 vaccine in pediatric population of PREVENT-119 phase 3 clinical trial. News release. Novavx, Inc. February 10, 2022. Accessed February 14, 2022. 

https://ir.novavax.com/2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial?sf159912464=1

Dunkle LM, Kotloff KL, Gay CL, et al; for the 2019nCoV-301 Study Group. 

Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico.

 2022;386(6):531-543. Doi:10.1056/NEJMoa2116185

The NVX-CoV2373 vaccine was evaluated in adolescents aged 12 to 17 years.

Novavax pediatric COVID-19 vaccine trial yields positive results

As of January 15, there have been 65,159,554COVID-19 cases in the United States. In the last 7 days, there have been 5,588,350new cases identified. (

Results of a recent CBS News/YouGov poll show that only 49% of Americans currently approve of President Biden’s management of the pandemic. This is compared with a previous approval rate of 66% of respondents to an earlier version of the same poll in July. (

On January 13, the U.S. Supreme Court blocked the Biden Administration’s COVID-19 Vaccine mandate for private businesses, but allowed the mandate to proceed for medical facilities that receive payments from Medicare or Medicaid. (

This decision comes as the number of known global COVID-19 cases reach—and surpass—300 million. (

Scientists from the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine have developed a patent-free COVID-19 called Corbevax, hailed as “the world’s COVID-19 vaccine.” Corbevax uses decades-old technology—similar to that used to produce hepatitis B vaccines—and can be manufactured by anyone capable of producing microbial-based proteins like bacteria or yeast. Clinical trial data has not yet been released, but researchers say that the vaccine was 90% and 80% effective against the original COVID-19 strain and the Delta variant, respectively. (

Some infectious disease experts have found the silver lining to the current Omicron surge: a potential “blanket of enhanced immunity” that renders the virus “easier to live with.” (

The Omicron variant has reached Beijing—just 3 weeks before the Winter Olympics are poised to begin. City authorities imposed an immediate lockdown and mass testing—a totalof 2430 samples—in an effort to stamp out the outbreak before it begins. (

Novak Djokovic has made headlines in the last few weeks—but not for his tennis game. The tennis star has faced a slew of recent issues stemming from his decision to not be vaccinated against COVID-19. After a tumultuous saga (

)involving a medical exemption to Australian vaccination policy, detainment, and visa cancellation, Djokovic was deported from the country this morning “on public interest grounds.” (

It’s not just international tennis stars who are facing repercussions to remaining unvaccinated, however: in Greece, adults aged 60 or older who remain unvaccinated will face monthly 100 euro ($114 USD), according to a new policy implemented in a country with a vaccination rate below the European Union average. (

And all across Europe, the unvaccinated are being locked out of public life, being denied entry to schools, grocery stores, restaurants, and gyms. Despite widespread public protest, European leaders are prepared to stand their ground as a measure to fight the COVID-19 pandemic. (

This post was originally published on Drug 

COVID-19 updates and news to know as of January 17, 2022.

This week in COVID-19: A patent-free COVID-19 vaccine may be on the horizon

As of December 30, 2021, there have been 53,795,407COVID-19 cases in the United States. In the last 7 days, there have been 2,213,940new cases identified. (

COVID-19 case counts are up globally as well: As of January 1, cases were up by 61%—for an average of 14 cases per second. (

The FDA has made multiple amendments to the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine, including expanding booster access to adolescents between 12 and 15 years of age, shortening the time between primary vaccination and booster dosing to 5 months, and allowing a third primary dose for "certain immunocompromised children” between 5 and 11 years of age. (

On December 28, 2021, the FDA announced a collaboration with the National Institutes of Health RADx program with the goal of studying the performance of current COVID-19 antigen tests against the Omicron variant. (

During the last week of December, 2 new COVID-19 therapies received EUAs from the FDA: Merck and Ridgeback’s investigational oral antiviral molnupiravir, for treatment of high-risk adults with mild to moderate COVID-19, and Pfizer’s Paxlovid for the treatment of mild to moderate COVID-19 in adults and chidlren 12 years or older. (

The CDC also made waves last week, announcing on December 27 that the recommended isolation and quarantine period following COVID-19 infection is now only 5 days, followed by 5 days of mask wearing for asymptomatic individuals—with no negative COVID-19 test required. The decision was widely criticized, both by the general public and by public health officials, one of whom referred to the decision as “reckless.” 

During an appearance on CNN’s State of the Union on January 2, Anthony S. Fauci, MD, said that he “anticipates ‘further clarification’” on the new CDC isolation guidelines, in response to the “number of questions” generated about the new quarantine protocols. 

Fauci also stated that he is more concerned about the current strain on hospitals than the soaring—and record—number of infections. 

Modeling conducted by researchers at Columbia University projects a peak in COVID-19 cases during the week of January 9, with a minimum of 2.5 million confirmed infections during a 7-day period, followed by a drop-off in new infections but a rise in hospitalizations among individuals susceptible to severe COVID-19 outcomes. 

But despite these data, the rapid Omicron spread has, thus far, shown no signs of slowing down. (

Concerned about the continued spread of COVID-19, some immunocompromised individuals have begun to work around government guidelines and receive unauthorized fourth—or fifth—COVID-19 vaccines. 

Officials in South Africa have announced that the country appears to have weathered its Omicron peak, without a spike in associated deaths, according to health department data. One official likened it to a flash flood, rather than a wave, leading to extremely cautious optimism from some epidemiologists. 

WHO Director-General Tedros Ghebreyesus, MS, PhD, is optimistic that the COVID-19 pandemic will be “defeated” in 2022—if there is global cooperation to contain the diseases’ spread. 

 article was originally published on Drug Topics®.

COVID-19 updates and news to know as of January 3, 2022.