The concern was highlighted this year when a manufacturing problem depleted Pfizer's stock of naloxone and the company couldn't fill orders for harm-reduction groups. "We need to pull out all the stops and consider a bunch of different avenues to address this issue of supply." It can't do harm," said Thomas Stopka, an epidemiologist and substance use researcher at Tufts University School of Medicine. "Having more naloxone on the street can only do good. Other advocates have suggested that the Department of Health and Human Services issue an order allowing manufacturers to sell naloxone to organizations buying in bulk without a prescriber's signoff. The product has long been deemed safe and effective for community use, harm-reduction groups say, even by the FDA. So harm-reduction groups are calling on the FDA to allow naloxone to be sold over-the-counter so they can order it more easily and distribute it to the people at the greatest risk of overdosing. The cost of the medication, requirements to show ID, a fear of discrimination from pharmacists and an inability to find a pharmacy that stocks naloxone are all barriers, said West Virginia University researcher Robin Pollini, who studies naloxone distribution. Indeed, as overdose deaths surged in 2020, pharmacy sales of naloxone decreased. Those clients won't necessarily turn to pharmacies. When these groups can't order naloxone, the people they serve can die, Wheeler and Doe-Simkins said. But they can be onerous for smaller, grassroots groups, many of which are led by volunteers and operate out of makeshift home or car offices, said Eliza Wheeler and Maya Doe-Simkins, co-founders of the Buyers Club and co-authors of a paper with Dasgupta on this subject. Hospitals and health departments can easily fulfill these requirements.
#Over the counter antibiotics license#
The organization must also have an address that is not a private home to receive shipments, a medical or pharmacy license and the ability to comply with regulations for storing and dispensing the drugs.
#Over the counter antibiotics series#
As a result, the companies impose a series of requirements on buyers.įor example, an organization that orders naloxone must have a doctor sign for the order, and that doctor must be someone who has not signed for another group. When a hospital, harm-reduction group or any other organization orders naloxone from pharmaceutical companies, the companies are required to treat naloxone the way the federal government sees it: as a prescription medication, Dasgupta said. But these workarounds don't apply to organizations that purchase naloxone in bulk from drugmakers. States don't have the authority to designate it as an over-the-counter medication, but they've created workarounds - such as a state health official writing one prescription that can be used for every resident. The rules make accessing the lifesaving medication difficult for those at high risk of overdosing.Īll 50 states allow individuals to buy naloxone at the pharmacy without a prescription. Though all 50 states allow individuals to buy naloxone, often known by the brand-name drug Narcan, organizations that order the medication from drugmakers are subject to federal rules that designate the drug as prescription-only.
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