Monday, May 12, 2014

At-home OD reversal device generates hope, questions

Posted: Sunday, May 4, 2014

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.
Evizo will become available in July
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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