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FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings

Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder

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Agency Continues to Take Steps to Reduce New Cases of Opioid Use Disorder

Today, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.

“Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of their unused opioid medications is part of the agency’s comprehensive approach to addressing the overdose crisis,” said FDA Commissioner Robert M. Califf, M.D. “We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder. We’re pleased to take this first critical step to increase mail-back envelope options in partnership with the U.S. Postal Service.” 

The FDA issued notice today to all manufacturers of opioid analgesics used in outpatient settings that they are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter. The agency anticipates approval of the modified REMS in 2024. When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics. The REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics, which outpatient pharmacies and other dispensers may also provide to patients. 

This action follows a Federal Register notice issued in April 2022 that sought public comment on a potential modification of the OA REMS to require that mail-back envelopes be dispensed and education on safe disposal be provided with opioid analgesics dispensed in an outpatient setting. 

Patients commonly report having unused opioid analgesics following surgical procedures and many Americans gain access to opioids through friends or relatives who have unused opioids. Data show educating patients about disposal options may increase the disposal rate of unused opioids and that providing a disposal option along with education could further increase that rate. 

Currently, there are multiple mail-back envelope programs operating in the U.S. and mail-back envelopes are commercially available from multiple entities. There are long-standing regulations and policies, under the Drug Enforcement Administration and United States Postal Service, in place to ensure that mail-back envelopes are nondescript, fit for purpose, and can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed.

“The U.S. Postal Service is proud to partner with the FDA to expand the use of mail-back envelopes as a safe and secure disposal option for prescription opioid analgesics,” said Postal Service Chief Customer and Marketing Officer and Executive Vice President Steven Monteith. “Serving nearly 165 million addresses each day, with more than 31,000 retail locations across the country, the Postal Service makes it convenient for Americans to dispose of unused prescription drugs to help prevent accidental exposure and overdose.” 

The FDA continues to consider additional ways to increase safe disposal of unused opioid analgesics. Specifically, the agency is exploring whether manufacturers of opioid analgesic should also be required to make in-home disposal products available to patients who are prescribed opioid analgesics. In an effort to further evaluate this potential option, the agency will participate in the workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid AnalgesicsExternal Link Disclaimer, to examine current in-home disposal options hosted by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation in June 2023. The FDA has also issued a Federal Register Notice to seek information and comments from the public to aid the agency’s assessment of in-home disposal methods.

These collective efforts are part of the agency’s implementation of the FDA Overdose Prevention Framework that aims to prevent drug overdoses and reduce deaths through impactful and creative actions. The FDA remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through the four priorities of the framework, including; supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

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Source: FDA

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Services Resume After Global Computer Outage Disrupts Valley Airports and Phoenix Police

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In a troubling turn of events early Friday morning, a massive global computer outage wreaked havoc across various sectors, including the Valley’s own Sky Harbor International Airport and the Phoenix Police Department. However, as the day progressed, many services began to return to normal, much to the relief of travelers and residents alike.

red airplane. Global computer outage
Photo by Tanathip Rattanatum on Pexels.com

Airport Chaos

Sky Harbor International Airport was one of the first institutions to report issues, posting an alert on X (formerly Twitter) about significant delays and cancellations. By mid-morning, over 50 flights had been affected, although it remained unclear how many were directly related to the outage versus other operational challenges. FlightAware, a flight tracking service, indicated that thousands of flights were experiencing delays and cancellations nationwide.

Sky Harbor urged passengers to check directly with their airlines for the most accurate information regarding their flights. They warned travelers to expect longer lines as airline staff worked diligently to check in passengers amidst the confusion. By around 11:45 a.m., the airport announced that operations had returned to normal, though the ordeal had left many travelers frustrated. One traveler recounted waiting for hours and fearing he would miss an important graduation ceremony.

Mesa Gateway Airport also felt the impact of the outage, with all flights in and out of the airport canceled until at least 11 a.m. on Friday.

Impact on Public Safety

The ramifications of the outage extended beyond air travel, affecting public safety communications as well. Early reports indicated that numerous police departments across the U.S. experienced disruptions in their 911 services. In Phoenix, the Police Department confirmed that their 911 call center systems were restored after the widespread outage began late Thursday night. They encouraged the public to use non-emergency lines during the disruption, highlighting the importance of patience as they addressed the backlog of calls.

The Phoenix Fire Department also faced challenges, having to revert to manual processes to manage calls due to impacts on their computerized dispatch center. Thankfully, technology professionals were able to restore their systems swiftly.

Healthcare Sector Strain

The healthcare sector was not spared from the disruptions. Valleywise Health reported that some of its IT systems were impacted, necessitating a return to paper for certain patient charting processes. However, the emergency departments and the Level I Trauma Center remained operational, and scheduled surgeries continued as planned.

Banner Health, on the other hand, communicated to its employees that most ambulatory services would be closing for the day to focus on acute care facilities. Their official statement confirmed that while hospitals were open for inpatient care and emergencies, many other locations would remain closed due to the outage.

A Broader Impact

The ripple effects of this global computer outage reached beyond airports and emergency services. Gas stations, retailers, and shipping companies also reported disruptions, leading to inconvenience for consumers during their daily errands.

Fortunately, as the day unfolded, Microsoft 365 announced that services were beginning to return to normal, though residual impacts continued to affect some applications. According to tech expert Ken Colburn, the underlying issue had been identified, but required technical expertise to resolve for those affected.

Protecting Personal Data

While the CEO of Crowdstrike reassured the public that this incident was not a security breach or cyberattack, it did raise concerns about personal data safety. Here are some proactive measures consumers can take to protect themselves:

  • Enhance Password Protection: Regularly change passwords, avoid reuse, and enable two-factor authentication where possible.
  • Monitor Credit: Take advantage of free annual credit reports from major bureaus to keep an eye on your credit health.
  • Consider a Credit Freeze: This adds an extra layer of security, preventing new accounts from being opened without your knowledge.
  • Be Cautious with Links: Avoid clicking on unknown links or downloading attachments unless you are expecting them.
  • Use Secure Payment Methods: Exercise caution with peer-to-peer payment platforms that may lack consumer protections.

As Valley residents and travelers breathe a sigh of relief with services returning to normal, this incident serves as a reminder of our growing dependence on technology and the importance of being prepared for unexpected disruptions. Stay informed, stay safe, and always protect your personal information.

For detailed information on this unfolding event, visit ABC News 15 Arizona’s website: https://www.abc15.com/news/local-news/sky-harbor-airport-impacted-by-global-internet-outage.

STM Daily News is a vibrant news blog dedicated to sharing the brighter side of human experiences. Emphasizing positive, uplifting stories, the site focuses on delivering inspiring, informative, and well-researched content. With a commitment to accurate, fair, and responsible journalism, STM Daily News aims to foster a community of readers passionate about positive change and engaged in meaningful conversations. Join the movement and explore stories that celebrate the positive impacts shaping our world.

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    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art.

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Remembering Shannen Doherty: A Tribute to a Fighter and Beloved Star

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Shannen Doherty, known for her iconic roles in ‘Beverly Hills, 90210’ and ‘Charmed,’ has left a lasting impact on the entertainment industry and the hearts of many. With heavy hearts, we bid farewell to a talented actress, a devoted daughter, sister, aunt, and friend who fought a courageous battle against cancer.

Doherty at the 2015 Toronto Comic-Con. By GabboT – , CC BY-SA 2.0

Shannen Doherty

Diagnosed with breast cancer in 2015, Doherty faced her illness with remarkable strength and resilience. Despite the challenges she encountered, she remained determined to live her life to the fullest and inspire others with her unwavering spirit.

Throughout her journey, Shannen Doherty shared her struggles and triumphs with the world, becoming a beacon of hope for those fighting similar battles. Her openness and honesty touched the lives of many, showcasing bravery in the face of adversity.

In 2017, Doherty’s announcement of her cancer’s return shed light on the harsh reality of the disease. Despite the difficult news, she continued to face each day with courage and grace, demonstrating incredible fortitude in the midst of uncertainty.

As we reflect on Shannen Doherty’s legacy, we remember a woman who embodied resilience, positivity, and compassion. Her impact on both the entertainment industry and the cancer community will be remembered for years to come.

Our thoughts are with Doherty’s family, friends, and fans during this difficult time. May her memory live on as a symbol of strength and perseverance, inspiring us to cherish each moment and embrace life’s challenges with courage and grace. Rest in peace, Shannen Doherty.

Link related to the story: https://people.com/tv/shannen-doherty-dead/


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Remembering Richard Simmons: Fitness Guru Dies at 76

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The world of fitness and wellness mourns the loss of Richard Simmons, the iconic fitness guru, who passed away at the age of 76. His longtime publicist, Tom Estey, confirmed the news to PEOPLE, stating that Simmons died at his Los Angeles home one day after celebrating his 76th birthday. The initial report was made by TMZ, which noted that law enforcement responded to a call from a housekeeper on Saturday, July 13, and no foul play was suspected.

Richard Simmons
By John Mathew Smith & www.celebrity-photos.com from Laurel Maryland, USA – Richard Simmons, CC BY-SA 2.0, https://commons.wikimedia.org/w/index.php?curid=76508363

Estey expressed the profound impact Simmons had on the world, saying, “The world has truly lost an angel.” Despite retreating from the public eye since 2014, Simmons continued to connect with his fans through social media. His final posts were made on the morning of his passing and the day before, thanking fans for their birthday wishes and sharing his gratitude for life.

Richard Simmons

Born Milton Teagle Simmons on July 12, 1948, in New Orleans’ French Quarter, Simmons had humble beginnings. He was the son of vaudeville performers and worked various odd jobs to support his family. As a child, Simmons struggled with his weight, reaching 270 lbs by the time he graduated high school. A pivotal moment came when he received an anonymous note on his car windshield, urging him to lose weight to avoid an early death. This led him to embark on a drastic and unhealthy weight loss journey that landed him in the hospital. Determined to find a sustainable path to health, Simmons moved to Los Angeles in the 1970s, where he delved into nutrition and fitness.

In 1975, Simmons opened Ruffage and Anatomy Asylum, a health food store and exercise studio that quickly gained popularity, attracting celebrities and launching Simmons into the spotlight. Over the next four decades, Simmons became a beloved fitness icon, known for his infectious energy and dedication to helping others. He released five bestselling books, produced over 50 workout videos, hosted weight loss cruises, and taught countless classes at his Slimmons studio in Beverly Hills.

Simmons’ vibrant personality and genuine compassion made him a fixture on talk shows and speaking tours. However, in early 2014, he stepped back from the public eye, citing the need to recover from a knee injury. His last public appearance was in January 2014, and he taught his final class at Slimmons in February of that year. Despite rampant speculation about his well-being, Simmons reassured fans in a 2016 interview with the Today show that he was in good health and simply taking time for himself.

“I do what I want to do as I’ve always done,” Simmons said. “I’ve taught, like, thousands and thousands of classes and, you know, right now I just want to sort of just take care of me. I just really don’t want to do anything. I just don’t want to be traveling anymore. It certainly has taken its toll on me.”

Richard Simmons’ legacy is one of inspiration, perseverance, and unwavering dedication to helping others achieve their fitness goals. His impact on the fitness world and the lives of countless individuals will be remembered and cherished. As we reflect on his life, we celebrate the joy and positivity he brought to so many and honor his enduring spirit.

Link related to story: https://people.com/richard-simmons-dead-76-7503091


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