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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

actors & performers

Remembering Louis Gossett Jr: A Trailblazing Actor and Activist

Remembering Louis Gossett Jr, the trailblazing actor and activist who made history as the first black man to win an Oscar for Best Supporting Actor. Rest in power, Louis. 🌟✨ #LouisGossettJr #HollywoodLegend #Trailblazer

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In a world where representation matters, Louis Gossett Jr’s contributions to the entertainment industry cannot be overstated. As the first black man to win an Oscar for Best Supporting Actor, his impact and talent have left an indelible mark on the film industry. With his passing at the age of 87, we take a moment to honor and remember the legacy of this trailblazing actor and activist.

Rising to Prominence
Born on May 27, 1936, in Brooklyn, New York, Gossett Jr’s journey to success began on the stage. Early on, he showcased his acting skills in school productions and made his Broadway debut in the play “Take A Giant Step” at just 16 years old. His talent and dedication eventually led him to study at New York University, where he found himself among the likes of Hollywood icons James Dean, Marilyn Monroe, and Steve McQueen.

Breaking Barriers
Gossett Jr’s breakthrough came in 1977 when he portrayed the memorable character Fiddler in the groundbreaking TV miniseries “Roots.” The series explored the horrors of slavery, and Gossett Jr’s moving performance earned him an Emmy Award. This pivotal role opened doors for future opportunities and established him as a respected and versatile actor.

Academy Award Success
In 1982, Gossett Jr’s outstanding portrayal of the formidable Marine drill instructor in “An Officer and a Gentleman” opposite Richard Gere and Debra Winger earned him the prestigious Academy Award for Best Supporting Actor. This achievement made him the first black man to receive this honor, cementing his place in Hollywood history. Gossett Jr’s Oscar win enabled him to choose a variety of compelling roles, including those in “Enemy Mine,” “Sadat,” and “Iron Eagle.”

Advocacy and Overcoming Challenges
As a vocal advocate for racial equality, Gossett Jr faced his fair share of challenges throughout his career. From enduring racism to shaping his own narrative, he consistently exhibited strength and resilience. His personal experiences motivated him to establish the Eracism Foundation, an organization dedicated to eradicating racism and promoting inclusion and understanding.

Legacy and Lasting Impact
Beyond his groundbreaking achievements on screen, Gossett Jr will be remembered for his warmth, creativity, and dedication to his craft. From his unforgettable performances to his influential activism, he opened doors for aspiring actors and contributed to a more inclusive and diverse industry. Gossett Jr’s legacy serves as a reminder that talent and determination can transcend barriers and inspire generations to come.

Louis Gossett Jr’s passing is a loss felt deeply by the entertainment industry and beyond. He will forever be remembered as a pioneer, breaking barriers and inspiring countless individuals to pursue their dreams. With gratitude, we honor his contributions and celebrate his rich legacy. As we bid farewell to a remarkable talent, we are reminded of the immense impact one person can have on the world. Rest in peace, Louis Gossett Jr.

Enemy Mine

“Enemy Mine” is a captivating science fiction, action and drama movie that was released in 1985. The talented Wolfgang Petersen directed the movie, and it was written by the skilled Edward Khmara. The film is based on an intriguing novella written by Barry B. Longyear. The storyline follows a human soldier and an alien soldier who get stranded on a hostile planet, and must work together to survive. Despite their differences and mutual distrust, they learn to cooperate and develop a bond of trust. Dennis Quaid and Louis Gossett Jr. deliver outstanding performances in the lead roles, bringing the characters to life with their exceptional acting skills.

“Enemy Mine” is an international co-production between the United States, the United Kingdom, and West Germany. The filming began in Budapest in April 1984, under the direction of Richard Loncraine. However, the director had creative differences with producer Stephen Friedman and executives at 20th Century Fox, leading to the project’s shutdown after only a week of shooting. Wolfgang Petersen then took over as director and reshot Loncraine’s scenes after moving the production to Munich.

The original budget of the film was $17 million, but the cost rose to more than $40 million after accounting for marketing expenses. Unfortunately, the film was a box office failure, earning just over $12 million during the 1985 holiday season. However, the film was a success in the former Soviet Union, as it was the first Western sci-fi film to be shown in theaters. Over time, it gained a significant cult following. (Wikipedia) https://en.wikipedia.org/wiki/Enemy_Mine_(film)

https://stmdailynews.com/category/entertainment/

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NORAD Investigates Possible Aircraft Violation in Phoenix Restricted Airspace

The NORAD F-15 intercepted an unidentified aircraft in Phoenix’s restricted airspace, ensuring safety during President Biden’s visit.

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In the early hours of Wednesday morning, the tranquility of Phoenix, Arizona was momentarily disrupted by the roar of jet engines as a North American Aerospace Defense Command (NORAD) F-15 fighter jet streaked across the sky. The reason? An unidentified aircraft had breached restricted airspace, prompting a swift response from NORAD to ensure the safety and security of the area.

According to U.S. Air Force officials, radar systems detected an aircraft operating without communication with air traffic control within the no-fly zone established due to President Joe Biden’s visit to the Valley. The incident unfolded around 7:30 a.m., triggering NORAD’s protocols for investigating potential airspace violations.

In a coordinated effort to assess the situation, NORAD dispatched an F-15 jet to intercept the unauthorized aircraft. Flying at approximately 7,000 feet, the fighter pilot initiated a visual inspection, while observers on the ground may have caught a glimpse of the high-speed pursuit unfolding above.

Despite the prompt response and visual confirmation by NORAD, military officials remained tight-lipped about the nature of the intruding aircraft and its outcome following the F-15’s intervention. This reticence is common in matters of national security, where disclosing sensitive information could compromise ongoing operations or reveal defense capabilities.

NORAD’s ability to swiftly detect and respond to airspace violations underscores the importance of its sophisticated network comprising radars, satellites, and fighter jets. This multi-layered system enables NORAD to identify rogue aircraft and determine the appropriate course of action, whether it involves interception, communication, or other measures to mitigate potential threats.

In an emailed statement to Arizona’s Family, an Air Force official emphasized the critical role of NORAD in safeguarding the airspace of the United States and Canada. “The identification and monitoring of aircraft demonstrate how NORAD executes its aerospace warning and aerospace control missions,” the official stated, highlighting the organization’s commitment to maintaining air sovereignty and protecting against unauthorized incursions.

The incident over Phoenix serves as a reminder of the constant vigilance required to ensure the safety and security of airspace, particularly during high-profile events or visits by dignitaries. While most flights operate within established protocols and communicate effectively with air traffic control, occasional deviations or breaches necessitate swift and decisive action to prevent potential risks to public safety.

For NORAD, responding to airspace violations is part of its broader mission to provide aerospace warning and control capabilities, not only during times of crisis but also in routine operations to uphold national defense objectives. Through continuous monitoring and rapid response capabilities, NORAD stands ready to defend North American airspace against any threat, whether accidental or deliberate.

While the details of Wednesday’s incident remain shrouded in secrecy, the successful interception by NORAD underscores the effectiveness of its protocols and the professionalism of its personnel. By leveraging advanced technology and strategic coordination, NORAD maintains a robust defense posture, deterring potential adversaries and ensuring the safety of airspace for all.

As the investigation into the unauthorized aircraft continues, NORAD’s vigilance remains unwavering, ready to respond to any future threats with precision and determination. In a world where security threats evolve rapidly, organizations like NORAD play a crucial role in safeguarding the skies and preserving peace and stability for generations to come.

The incident over Phoenix serves as a testament to the tireless efforts of NORAD and its partners in maintaining air sovereignty and protecting against potential threats. By remaining vigilant and responsive, NORAD ensures that the skies above North America remain safe and secure for all who inhabit and traverse them.

NORAD’s advanced technology and strategic coordination enable them to maintain a strong defense posture, deterring adversaries and ensuring airspace safety. As the investigation into the unauthorized aircraft continues, NORAD remains vigilant and ready to respond to future threats with precision. In a rapidly evolving security landscape, organizations like NORAD are crucial for protecting the skies and preserving peace for future generations. The incident over Phoenix highlights NORAD’s tireless efforts in maintaining air sovereignty and defending against potential threats. By remaining vigilant, NORAD ensures the safety and security of the skies above North America.

Source: AZ Family

https://www.azfamily.com/app/2024/03/21/norad-sends-f-15-jet-suspicious-aircraft-over-phoenix/

https://stmdailynews.com/

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Crisis in the Texas Panhandle: Battling the Devastating Wildfires

“Wildfires ravage Texas Panhandle, prompting evacuations, power outages, and a nuclear facility shutdown. Community resilience shines amid the chaos.”

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A cluster of wildfires scorched the Texas Panhandle on Wednesday, including a blaze that grew into one of the largest in state history, as flames moved with alarming speed and blackened the landscape across a vast stretch of small towns and cattle ranches. (Feb 28) (AP video by Julio Cortez and Ty O’Neil) (AP production by Javier Arciga)

A series of wildfires wreaked havoc across the Texas Panhandle early Wednesday, unleashing chaos and destruction in their wake. The Smokehouse Creek Fire, now the second-largest wildfire in Texas’s history, has left a trail of evacuations, power outages, and a temporary shutdown of a nuclear weapons facility.

Governor Greg Abbott’s declaration of disaster for 60 counties underscores the severity of the situation. The cause of these ferocious blazes remains a mystery, as they rage through sparsely populated counties characterized by vast plains, cattle ranches, and oil rigs.

In the midst of this turmoil, residents like Adrianna Hill from Borger share harrowing tales of survival. Hill’s account of the fire encircling her town paints a vivid picture of the fear and uncertainty that gripped the community. With roads closed and flames closing in, the resilience of individuals like Hill and the protective force of nature itself offer a glimmer of hope in the face of adversity.

As firefighters battle against the infernos, the weather forecast brings a ray of optimism with cooler temperatures, reduced wind, and the possibility of rain on the horizon. Yet, the immediate reality remains dire in many areas, emphasizing the urgent need for support and solidarity in the ongoing fight against these catastrophic wildfires.

In times of crisis, it is in the unity of communities, the courage of individuals, and the dedication of emergency responders that resilience shines brightest. Let us stand together in support of those affected by this disaster, offering our thoughts, prayers, and assistance as they confront this formidable challenge in the Texas Panhandle.

Source: Associated Press

https://apnews.com/article/texas-panhandle-fire-evacuations-2cad37f14581bac74a3691969aaaf956

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