The FDA recently approved a new OTC form of naloxone nasal spray, meant to be available for people to purchase via dispensers and other less conspicuous places without the input of medical professionals. Naloxone is an opioid overdose reversal drug available by prescription and over the counter in certain states. In most localities, a user must take a training class to administer the lifesaving drug. Much debate surrounded removing the training requirements. For the FDA, the discussion centered not on using naloxone but on the importance of fine-tuning its instructions.
At a meeting involving the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, pharmaceutical giant Emergent BioSolutions presented data and newly developed labeling for an OTC form of its nasal naloxone spray. (Typically, people who are prescribed naloxone have to take a short training class or meet other requirements.)
New instructions were written to help people without healthcare training in emergency treatment. Still, FDA reviewers cited various issues, ranging from user errors like dialing 911 first (rather than administering a dose) to the possibility that each blister packaging may need to contain instructions should users discard the box.
The FDA will work closely with manufacturers to ensure the design is simple and effective for people who have never used it before. "The design of the entire user interface plays an important role in how effective the product is at reversing opioid-induced respiratory depression and preventing death and other serious outcomes," they wrote briefly before the meeting.
The FDA Committees issue opinions to the FDA, which are usually respected in final decisions. While OTC Naloxone is likely soon to be approved, there will still be barriers to access, such as cost and locality.
Naloxone (brand name Narcan) is a medication used to reverse opioid overdose rapidly. It works by blocking the effects of opioids in the brain and can quickly restore normal breathing in someone who overdosed on opioids. Narcan is typically administered by emergency medical personnel, but in recent years, some jurisdictions have made it available over the counter, meaning that anyone can purchase it without a prescription.
The benefits of Narcan being available over the counter include:
While Narcan can be a lifesaving medication, it is not a substitute for long-term treatment and support for opioid addiction. Most people need additional medical help after an overdose.
If you or someone you know is struggling with opioid addiction, seeking professional help and support is important.
If you or a loved one is looking for safe, stable housing as you continue your recovery, sober housing may be your best next step. Learn more about what we can offer by giving us a call.
Recently, a new law was added to the California books that requires public schools to keep a steady supply of Narcan, also known as Naloxone, in their emergency supplies. The opioid overdose reversal drug has become a vital public health tool as the drug supply has been inundated with fentanyl. However, schools aren’t the only way that Narcan has saved lives. People who don’t use opioids but live in California have begun to take the harm-reducing measure into their own hands. Several community members spoke recently to the LA Times to describe how they have helped save lives by carrying it on them when they’re out in their communities.
Naloxone, known chiefly by its brand name, Narcan, is an opioid-overdose reversal tool approved by the FDA. People who want to carry Naloxone on hand or keep it in their homes face few barriers thanks to California legislation.
The Department of Health Services in your county will be able to distribute fentanyl to people who want to carry it. LA County has made it a mission to hand out 50,000 doses in a year, including people living in encampments uniquely positioned to save drug-using peers.
People who don’t use drugs are still often in a position to save lives. Family members often come across an unconscious relative and try to administer CPR. Naloxone is the only thing that can reverse the effects of an overdose. Many parents and spouses of addicted persons now keep Naloxone in their homes in case of emergency.
Fentanyl has caused an uptick in deaths for Californians in the past three years. It's been found as an additive in almost every type of street drug. In 2021, 625 people died of an overdose in San Francisco, an uptick of 41%. So many people in the community see carrying Narcan as a way to help others stay alive long enough to find recovery. EMTs, people in recovery from addiction, and other empathetic people have revived overdose victims and helped them stay alive.
Narcan is just one tool to help fight the fentanyl epidemic. However, it’s a powerful one – saving a life is a priceless task. Once a person has been revived, they still need medical attention. Most likely, they will be given drug treatment options when in the ER. Some of them will take the chance and decide to get sober. Others will take a little longer.
Treatment centers and sober living homes in California stock Narcan as a preventative measure.
When a person is still alive and breathing, the chance for recovery is always there.
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Saul Caro, a San Diego resident, convicted of selling fentanyl to a man who subsequently overdosed, pleaded guilty to providing the fentanyl on June 1, 2022. At his sentencing hearing, more details of the case were revealed, showing that he was worried about the potency of the fentanyl he had acquired. The jury gave him 15 years.
When Caro pleaded guilty on June 1, 2022, he admitted that he sold the highly potent fentanyl to a man the court recorder identified only as MS. Two days later, M.S. was dead. The victim, investigators discovered, had been worried about the potency of the drugs he had previously acquired from Caro. Not only did he think the fentanyl was too potent, but he told Caro that he needed to warn people about it. Caro lied, telling the victim he was. “Yeah thanks otherwise would have been bad news for me lol” (sic) the victim replied.
In November of that same year, the victim again contacted Caro and told him he was worried that the drugs had been altered somehow. The side effect, according to the texts from M.S., said it made his heart “slam.” “Ugh why the hell did they have to put that sh-- in here and ruin it!” he texted Caro. “He told me to be careful cuz its strong,” Caro replied.
Caro continued to supply drugs to the victim and others for months before M.S.’s death. The text messages showed that other drugs could have been mixed into the fentanyl. MS, an experienced opioid user, was uncomfortable with the side effects. Yet the victim has an opioid use disorder and continued buying drugs. Caro continued to sell the drugs even though he likely knew they could be deadly.
“The defendant chose to disregard the significant risk associated with selling fentanyl and other drugs,” said U.S. Attorney Randy Grossman. “His choices had severe consequences for a family that lost a beloved son and brother. The driving factor for all of us in law enforcement is the human toll that fentanyl is taking. We see the grief and destruction in person every day. We will continue to seek justice for every victim.”
The prosecution had much tangible evidence, enough that Caro pleaded guilty on June 1, 2022. He agreed that he sold powdered fentanyl, which led to the death of one of his customers. When they arrested Caro, he had a bag of powder with a greenish tint in his pants, which tested positive for fentanyl. In addition, when they searched his house, they found several guns, ammunition, other drugs, and drug paraphernalia.
Many cases like this have been going forward across the country, and the U.S. continues to battle the opioid epidemic. Opioids have been a leading cause of death in the United States in recent years. Over 100,000 people died from opioid-related overdoses last year, with most of the deaths involving fentanyl.
If you or somebody you love wants to live in a structured, safe community after they've finished treatment, we're here to help. By the Sea Recovery has helped set high standards for sober living in California. We are an insured and certified sober living residence by the Sober Living Network and CCAPP (California Consortium of Addiction Programs and Professionals).
Learn more about our programs by calling us at 760-216-2077.
A recent letter to the Acting Director of Health and Human Services in the Biden administration urged action for expanding the availability of Medication-Assisted Treatment through the Office of National Drug Control Policy. This comes on the heels of Biden suspending the former administration's OUD (opioid use disorder) guidelines.
In response to a recent retraction of Trump guidelines, the letter announced on January 27, 2021, was written by the American Academy of Addiction Psychiatry (AAAP) and signed by representatives from seven representatives with over 150,000 members and 2200 treatment centers. The Biden administration recently decided to withdraw the previous administration's Practicing Guidelines for Administration of Buprenorphine for Treating Opioid Use Disorder to update them and provide better access.
The letter from AAAP implored the Biden administration to expand access to science-based medication. Buprenorphine, methadone and naltrexone are all medications that have been proven to help people get and stay sober.
Medications that help people addicted to opioids are crucial in assisting them to avoid the compulsion to use. Buprenorphine and methadone help people prevent painful and challenging withdrawal symptoms.
For many treatment programs, the idea of medication carries a stigma. Because of this, it's vitally important that more doctors are educated about how MAT works and how it should be administered. Many medical professionals have felt uncomfortable prescribing it because of a lack of education.
Opioids are notoriously tricky to cease using due to the problematic withdrawal symptoms they cause when a person quits using.
The letter for AAAP also says that the Biden administration needs to begin a focus on opioid addiction prevention. They say that this means requiring all prescribers of opioids to be taught about opioids dependence, addiction, and withdrawal.
Preventing opioid addiction is the best long-term strategy for ending the opioid epidemic. It's unclear what path the Biden administration will decide to take regarding new addiction recovery health policies.
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- By Philip, Milgram, MD
Worry, fear, boredom, anxiety, loneliness, escapism, insomnia; these are the emotions that plague our society. The plague that is COVID is making these human imperfections more frequent and more pronounced. There are healthy effective ways we can not only deal with these feelings and situations. But it is human tendency to take an immediate and effective way to escape: The Devil’s Drugs. They are readily (too readily) available. There is easy access to someone who can promise you the gates of heaven. You are invincible. And you want it now. From a friend or family member who has some. Or from a prescriber who will prescribe, sometimes inadvertently but often as a legitimate dealer. Hey, maybe it‘s even covered by your insurance. Maybe you know somebody who knows someone who can get it for you in a park or a parking lot. Trust me. You are not invincible. These are not your grandparent’s drugs. These synthetic drugs have a high addiction potential. I don’t think they should have ever been released to the public, like Quaaludes. You give these drugs to a thousand white mice…and a thousand whit mice will be pushing that button for more. Physiologically, we are not dissimilar from a white mouse. They use these same white mice to test the drugs and extrapolate to human consumption. WE WANT MORE OF THAT!!
These drugs cause what is known as hyperalgesia. Let’s say you stroke the hairs on your arm with a feather. These drugs make a stimulus that would be a tickle or an unpleasurable event and convert it to pain. What do you do? I WANT MORE OF THAT!!
Then you develop tolerance to the drug. Until you rapidly, sometimes within days, need more to get you to that place where you want to be. And you then know. I NEED MORE OF THAT!!
We have been very successful treating alcoholism and drug addiction to heroin, opiates with our innovative and experienced team and the magical molecule of NAD+ (Nicotinamide Adenine Dinucleotide), which detoxifies and fixes your brain, relieving withdrawal symptoms and cravings with much greater regularity than your neighborhood rehab center. But these are The Devil’s Drugs. And they require an all out and effective therapeutic approach to avoid the gates of hell; loss of you job, your family, your money, your home. And finally you lose yourself and then you lose hope. Benzodiazepines (Xanax, Klonipen, Ativan, Ambien and the sort) are not a good solution. You solve a problem by creating another problem. But prescribers too readily whip out their prescription pads to give you a stopgap that may be as bad or worse than the original problem. Please don’t take Kratom either. Often the addiction to Kratom is worse than heroin. Unfortunately, it is readily available and touted as “natural”. When you are addicted to Kratom, you may be suffering such terrible withdrawals that you have to use through the night every two hours.
The best way to avoid this whole situation is to not allow these drugs into your body. Avoid them all-knowingly because I have here told you of their power, their danger, and the high percentage for your physiologic tendency as a normal human being to succumb to the power of these drugs. But it is human tendency to think you are different, stronger, better, even invincible. I WANT TO FEEL IT, NOW!!
We have an alternative therapy here in Carlsbad, with the magic molecule (NAD+) that is already present in every living animal and plant cell. And that the body naturally uses to detoxify, heal, pump up immunity, and create new neural pathways that results in less cravings, less withdrawal symptoms and a high degree of long-lasting sobriety, health, longevity and wellness. We help restore restful sleep, use additional therapies, and get you on the road to a new life free from the influence of these drugs.
NAD+ is the magic. There is an art to the administration of it—starting with the best NAD+. Then there are therapies that enhance and propagate the NAD+ effect. Then, once off the drugs, you need to deal with the emotional, physical, depression, anxiety, any underlying mental disease, situation, and establish an ongoing program of healthy nurturing lifestyle.
There is such a thing as recovery, let us show you.
Phillip Milgram MD
San Diego has kept in line with a disturbing trend; overdoses and opioid use is up among younger people, and overdoses are a frequent cause of 911 calls. In fact, according to the San Diego Police Department, officers responded to 100 more overdoses in 2020 than the prior year. And although people are staying home more, addiction isn’t taking a break.
Arrests of people on opioid-related offenses related to overdose phone calls are up by nearly fifty percent. (Police sometimes arrest users who remain with a person who has overdosed if they possess drugs or if they or the overdose victim has outstanding warrants.)
Opioids are a popular street drug but also highly addictive. There has been a surge in addiction as the pandemic has drawn on. Users of opioids may have evolved from other addictions or gateway drugs. Some people become addicted to a prescription from a doctor, while others purposefully will misuse a drug to numb or entertain themselves. Some people who overdose have relapsed from a long-term stint in recovery.
Boredom, loneliness, and anxiety during the pandemic have caused an uptick in almost all addictive behaviors. People are using more drugs to self-medicate troubling feelings. Many people have felt despair and depression with economic loss. All of the above can be factors contributing to substance use disorders.
People in their 20’s and 30’s have been dying at a higher rate during the pandemic, however, experts note that these numbers were already rising in late 2019. Overdose victims from opioids in the past year usually have had fentanyl in their bloodstream, a drug that is fifty to one hundred times as strong as morphine.
While some people use fentanyl on purpose, many users are unknowingly exposed to it through illicit drugs. Some dealers will add it to cocaine or pass it off as Oxycontin. Because it is harder for drugs to flow across borders due to the COVID-19 pandemic, drug dealers have been fentanyl to add “punch” to the drugs they sell.
People who relapse on opioids and other narcotics are statistically more likely to overdose. There are many reasons for this. For one thing, many people, especially during COVID-19, are using opioids all alone. If they overdose, nobody can call for help for them. People who have abstained for years will also use the amount of the drug they used to use, believing they will still tolerate it. Instead, they overdose because the drug is too strong.
Preventing relapse saves lives. A good aftercare program or sober living program can help you or your loved one stay sober in the long-term and learn to live life on life's terms without the use of substances.
If you or somebody you love has a problem with alcohol or drugs, help is available! While COVID has changed some procedures for starting the treatment process, recovery is still very much open to everyone!
Relapse prevention is another important component of staying sober. A structured, caring, sober living environment helps many people get sober and achieve long-term recovery.
At By The Sea Recovery, we offer the best sober living experience in California, creating a place of growing, learning, and respect for everyone who walks through the doors. We want to help you stay sober and offer camaraderie, structure, and tools for your journey. Get in touch by calling us at 760-216-2077. We’re happy to answer questions!