Pubdate: Sat, 03 May 2014
Source: Intelligencer, The (PA)
Copyright: 2014 The Intelligencer, Doylestown, PA.
Contact:  http://www.theintell.com/
Details: http://www.mapinc.org/media/4569
Author: Jo Ciavaglia
Bookmark: http://www.mapinc.org/find?132 (Heroin Overdose)
Bookmark: http://mapinc.org/topic/naloxone

AT-HOME OD REVERSAL DEVICE GENERATES HOPE, QUESTIONS

Later this year, Pennsylvanians should be able to purchase the first 
at-home medical device that administers a drug that reverses 
opiate-related overdoses.

The Evizo auto-injector should be available to the general public 
starting July 1, under the tentative FDA approval that was secured 
last month. The hand-held device is designed to deliver Naloxone, a 
drug that binds to the opinoid receptors in the brain to stop a 
potentially fatal overdose within minutes.

The Federal Drug Administration's approval of Evizo is significant in 
Pennsylvania and other states where Naloxone - also known under the 
brand name Narcan - can now be administered only by trained medical 
personnel, including nurses and paramedics.

A House bill under consideration in the Pennsylvania Legislature also 
seeks to give non-medically trained individuals access to Naloxone, 
but lingering questions about training and liability have stalled the 
measure. The FDA decision means Pennsylvania residents can get access 
to Nalaxone through the auto-injector, but not other delivery methods 
such as the nasal atomizer.

A doctor's prescription will be required for Evizo-delivered 
Naloxone, but it can be written to anyone, including opinoid users, 
their family and friends, said David Fialko, a prevention specialist 
with the Council of Southeastern Pennsylvania, a private nonprofit 
agency focused on substance abuse issues.

But concerns remain about whether making the drug available for home 
use could encourage addicts or families to ignore drug problems and 
discourage individuals from seeking additional emergency medical help.

"This is not a green ticket to feel you are invincible," Fialko 
warned at a recent meeting of the Bucks County Overdose Prevention 
and Education Advisory Board, during which a trainer-version of the 
Evizo device was demonstrated.

Federal officials fast-tracked the device's approval, citing its 
ability to prevent the growing number of overdose deaths, which have 
tripled since 1991 with opioid-related drugs accounting for most of 
the increase, according to a National Association of State Alcohol 
and Drug Abuse Directors' report released last year. At least 18 
states and the District of Columbia allow non-medically trained 
people access to Naloxone.

The Centers for Disease Control and Prevention estimates that U.S. 
programs for drug users and their caregivers that prescribe take-home 
doses of Naloxone and provide training on how to use it have 
prevented 10,000 opioid overdose deaths.

The Council of Southeastern Pennsylvania has no immediate plans to 
distribute Evizo when it becomes available, Fialko said. Many details 
remain unknown including how much it will cost and if insurance will cover it.

"It's not going to be cheap, I can tell you that," Fialko added. The 
Philadelphia region's largest private health insurer, Independence 
Blue Cross, is reviewing the FDA approval to determine how the 
medication will be covered, spokeswoman Ruth Stoolman said.

Medical experts describe Evizo as easy to use, similar to an EpiPen, 
which is used to treat severe allergic reactions. The device is 
pre-filled with one dose of Naloxone. Once the package is opened, 
spoken instructions explain step by step how to deliver the shot, 
which is injected into the outer thigh.

But some people, such as Newtown District Judge Donald Nasshorn, want 
more information. Nasshorn, who heads the Bucks County Overdose 
Prevention and Education Advisory Board, said that he'd like to hear 
the pros and cons of the device from medical professionals.

Naloxone has been used for 20 years and studies suggest it doesn't 
increase individual drug use, according to Robert Lichtenstein, a 
pharmacist and task force member.

Generally, the drug is considered safe, but its immediate side 
effects are related to opiate withdrawal including vomiting, 
accelerated heart rate, increased blood pressure and seizures, which 
require additional medical attention. Individuals also can become 
uncooperative or combative once the opiate is rendered ineffective, 
especially if the person has other drugs in their blood system.

But Fialko believes individuals would experience milder withdrawal 
reactions since the Naloxone concentration in the new auto-injectors 
will likely be less than what is associated with a "full shot" 
delivered at hospitals and other medical settings.

A concern among medical professionals is that Naloxone is a temporary 
fix. The drug works for 30 to 90 minutes leaving open the possibility 
it could wear off before the opioids do - triggering another overdose.

Central Bucks Ambulance and Rescue Squad Chief Charles Pressler said 
the FDA labeling on the at-home device should include a prominent 
label warning users to call 911. He has seen cases in which after 
paramedics administer Narcan an individual will refuse further 
medical treatment.

All Bucks County ambulance and rescue squads use the drug with 
suspected overdoses, Pressler said. Overall, he believes expanding 
access to the drug to the general public is a good idea since it 
could save a life, but he also worries it's the equivalent of putting 
a Band-Aid on a bigger problem.

"People have got to be smart about what they're doing with this," he 
said. "They cannot have a false sense of security."
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MAP posted-by: Jay Bergstrom