The U.S. Food and Drug Administration approved Narcan, a 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online.

The timeline for the availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available, and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

The Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers could understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status. It was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription.

The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis, and the FDA may contact other firms as needed.

The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

“Naloxone is a critical tool in addressing opioid overdoses, and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status. Further, we will work with any sponsor seeking to market a nonprescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”

The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.

Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose, and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing the development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

The FDA granted the OTC approval of Narcan to Emergent BioSolutions.

U.S. Sen. Mark R. Warner (D-VA), released the statement below after Federal Drug Administration (FDA) authorized the over-the-counter sale of Narcan, a nasal spray drug that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Prior to today’s action by the FDA, this lifesaving medication was available by prescription only.

“This announcement is welcome news for the communities in Virginia and across the country that have been torn apart by the opioid epidemic, including deaths from fentanyl. As we continue pursuing a comprehensive range of solutions to tackle the opioid epidemic, I applaud the FDA for acting to put this lifesaving medication in the hands of more Americans – a move that is sure to fight overdose deaths and save lives.”

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On March 29, 2023, Governor Glenn Youngkin signed HB 2290, patroned by Delegate Emily Brewer, and SB 1314, patroned by Senator Siobhan Dunnavant, which provides financial support for expecting mothers.

Governor Glenn Youngkin participates in the bill signing ceremony at East End Pregnancy Center, Mar. 29, 2023. Official Photo by Christian Martinez, Office of Governor Glenn Youngkin.

“During Women’s History Month, it was an honor to stand with two extraordinary women who championed this legislation that supports women and mothers across the Commonwealth,” said Governor Glenn Youngkin. “These bills recognize that we can do more to support our expecting mothers and ensure they have the needed financial support to take that next step towards creating a family.”

Governor Youngkin signed the following bills :

HB 2290, patroned by Delegate Emily Brewer, and SB 1314, patroned by Senator Siobhan Dunnavant, provide that in the event that the initial petition for the establishment of parentage is commenced within six months of the live birth of a child, the judgment or order shall, except for a good cause shown or as otherwise agreed to by the parties, apportion between the legal parents, in proportion to the legal parents’ gross incomes, as used for calculating the monthly child support obligation, (i) the mother’s unreimbursed pregnancy and delivery expenses and (ii) those reasonable expenses incurred by either parent for the benefit of the child prior to the birth of the child.

“HB2290 is landmark legislation that will allow new mothers the opportunity to seek pregnancy and delivery-related expenses. This measure being signed into law will assist in reducing the financial burden on mothers at a time when caring for a newborn is of utmost importance. I am proud to have carried this priority bill on behalf of the Governor, and I am grateful for his commitment to such vital legislation,” said Delegate Emily Brewer.

“Children are such a wonderful blessing, and every day I witness the physical and emotional resiliency of moms. Pregnancy is really hard work. Babies are also expensive, and they need a lot of stuff even before birth. It just makes sense that child support should include the expenses of preparing for a baby. This bill will help moms have better financial resiliency by lifting a little of their load, giving them a chance to worry less, and the ability even to find more time for the joy and hope that babies bring,” said Senator Siobhan Dunnavant.

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Buying meat directly from a farmer has been around as long as farming, but these days, the grocery store is about as close as most people get to the farm.

For omnivores who want to keep their dollars local and don’t mind the upfront investment, buying a share of a cow or pig might be a great and surprisingly accessible option, with potential savings and the convenience of always having protein on hand.

1. Think about what you want and how much. If you’re interested in beef, consider that a whole cow could provide 400-600 pounds of meat, a half cow between 200 and 300, and a quarter cow between 100 and 150. A whole 250-pound hog yields about 120-140 pounds of meat, while a half will provide 60-70.

2. Assess your freezer capacity. You’ll need an additional freezer, especially if you purchase your share on your own and intend to keep all of the meat. For reference, a whole butchered hog might fill between half and two-thirds of a 10-cubic-foot chest freezer.

3. Ask friends or family if they’d like to split the purchase.

4. Set a budget, and keep in mind that you’re purchasing meat for up to a year all at once. Buying pork or beef directly from a farmer isn’t automatically cheaper than going to the grocery store — a lot of factors influence the price. Look online for local farmers who sell shares or ask around at farmer’s markets. If you want to purchase from a 4-H kid at the county fair, plan to spend more, but that extra money helps that kid participate the following year.

5. Find a pork or beef (or lamb or veal) producer who can give you what you want at the price you can afford. Remember that specialty options, like custom butchering or delivery, might add to the price.

6. Once your meat is stowed in your freezer, enjoy! Many people find that the taste alone is worth the extra work — and sometimes the extra cash — over meat from the grocery store or even a butcher.

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In this edition of Town Talk, our publisher Mike McCool speaks with Chuck Brome and Rick Logan from the South Warren Ruritan Club. On Saturday, April 15, 2023, the club is hosting its 17th Annual Spaghetti Dinner at Skyline High School. The event takes place in the school cafeteria from 4 pm to 7 pm.

Guests can enjoy unlimited spaghetti, salad, bread, beverages, and dessert. While a donation is requested, it supports a fantastic cause. All proceeds will be used to fund scholarships for local high school students. In addition to the meal, a cake auction and other baked items will be available for purchase to enjoy at home.

Passage Creek Raising will provide entertainment.

The club will also sell flower baskets, just in time for Mother’s Day.

Town Talk is a series on the Royal Examiner where we will introduce you to local entrepreneurs, businesses, non-profit leaders, and political figures who influence Warren County. Topics will be varied but hopefully interesting. Let us know if you have an idea or topic or want to hear from someone in our community. Send your request to news@RoyalExaminer.com

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You know the importance of preparing a winter emergency kit for your car, but what about a spring kit? Hot weather can be hard on your vehicle, resulting in unexpected breakdowns. Here’s how to stock your emergency kit to prepare for warmer weather.

• Visibility equipment like road flares or reflective hazard triangles
• Water bottles to stay hydrated in the heat
• Blanket to shade you from the hot sun
• Extra pair of clothing and shoes, including rain gear
• Flashlight or headlamp
• First aid kit, including ointment, gauze, bandages, adhesive tape, and tweezers
• Disinfectant wipes
• Sunscreen with SPF 30 or 50
• Booster pack or jumper cables
• Work gloves
• Paper maps
• Insect repellant
• Basic tool kit
• Phone charger or extra battery pack
• Toilet paper
• Snacks that won’t melt, such as granola, dried fruit, and nuts

Visit local stores to pick up everything you need to stock your spring emergency kit.

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Reviews and testimonials are essential to doing business in the modern world. In today’s competitive labor market, conducting an exit interview is your opportunity to learn more about the worker’s experience within your company and potentially become a more desirable workplace.

Targeted recruitment
An exit interview lets you learn more about the vacated role, which has likely evolved. This knowledge helps you elevate your job ad from a boilerplate to a targeted description of expectations. The more precise your job ad, the better your chance of identifying the most suitable hire.

Enhanced retention
When employees leave, they’re more likely to give candid feedback about their experience on the job. This information can help you make informed adjustments to your corporate culture. It can also help you identify which practices are working. It all adds up to an opportunity to improve conditions for those who remain with you.

Ask a local employment agency or counselor to advise or support your recruitment and retention, from job ads to exit interviews.

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