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April 23, 2014
New Mexico Pharmacists First Approved to Prescribe
Overdose Drug

Santa Fe, NM—New Mexico pharmacists are the first in the nation certified to prescribe the antioverdose drug naloxone directly to patients.

In January, the New Mexico pharmacy board added the life-saving drug to a regulation providing prescriptive authority for pharmacists. Pharmacists in the state already had the authority for vaccines, emergency contraception, tobacco cessation therapy, and tuberculosis testing.

The protocol also was approved by the New Mexico Medical Board and the New Mexico Nursing Board, a process dictated by state law for pharmacists to be able to prescribe.

Completion of a training course is required to prescribe naloxone, marketed as Narcon, and several dozen pharmacists have already qualified according to the New Mexico Pharmacists Association. In fact, the demand has been so great, additional courses and teleconferences have been added.

The antioverdose medicine is administered by attaching a nasal-tip inhaler to a small vial, which is used to spray a mist into the nose, blocking the opioid effect and restoring breathing.

Dale Tinker, executive director of the New Mexico Pharmacists Association, told a local newspaper that the prescriptive authority in response to a public emergency. Per capita overdose deaths from prescription drugs and heroin are higher in New Mexico than most other states, he pointed out.

“Pharmacists have a chance to change that statistic,” Tinker said. “In our state, pharmacists can write prescriptions. No other state is structured like that.”

The FDA, meanwhile, recently approved a new prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held autoinjector that can be carried in a pocket or stored in a medicine cabinet, according to the FDA. The injector is approved for the emergency treatment of known or suspected opioid overdose involving decreased breathing or heart rates or loss of consciousness.

The FDA noted that drug-overdose deaths, driven largely by misuse of prescription medications, are now the leading cause of injury death in the United States—surpassing motor vehicle crashes.

Many existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances, according to the agency.

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” said Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a healthcare setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”

Evzio, manufactured for kaléo, Inc., of Richmond, Virginia, can be injected intramuscularly or subcutaneously. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.

The FDA reviewed Evzio under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists or that offer significant improvement compared to marketed products. The product was granted a fast-track designation and was approved ahead of the product’s prescription-drug user fee goal date of June 20, 2014.




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