The opioid crisis has become such a public health crisis that there is now a Prescription Opioid and Heroin Epidemic Awareness Week to focus on the dangers of opioid addiction as well as treatment options treatment – which includes access to Naloxone.
“Access to Naloxone, however, continues to be limited in some communities,” Food and Drug Administration (FDA) Acting Commissioner Norman E. Sharpless, MD, said in a statement. “There are three FDA-approved forms of Naloxone – injectable, auto-injector and nasal spray – and all three currently require a prescription, which can be a barrier for people who aren’t under the care of a health care provider or who are apprehensive about admitting to issues with substance abuse. However, in response to the crisis, most states and the District of Columbia have passed laws that allow pharmacists to dispense Naloxone under a standing order, which takes the place of an individual prescription. Some states also have given pharmacists direct authority to prescribe and sell Naloxone to consumers. Still, many pharmacists may be unaware of the standing orders and direct authority in their states or are unwilling to provide all forms of Naloxone to consumers without an individual prescription.”
Currently, the FDA is working with other federal, state and local officials to increase the availability of Naloxone, including the first generic Naloxone hydrochloride nasal spray approved in April.
The FDA is committed to getting Naloxone into the hands of those who are at risk of an overdose as well as those who are most likely to observe an overdose.
