Monday, July 21, 2014

Hey, got an Auto-Injector I Could Use?

There has been good news on the opiod front lately. In early July, this blog (New CDC Report on Opiods) focused on some of that regarding a report from the Center for Disease Control. The concerns remain, with about 100 people dying daily, and thousands requiring emergency room treatment, all related to drug overdose. There is a portion of these individuals who are receiving the drugs for treatment of their work-related accident. In providing these people with appropriate treatment, workers' compensation needs to be conscious of the potentials for drug interaction and errors. 

The Commissioner of the Food and Drug Administration acknowledged in April 2014 that "misuse, abuse, addiction and overdose of opiod analgesics" are at the root of "important public health problems." She notes that the most recent data "tragically" demonstrates that 16,000 lives are lost annually due to overdoses. She notes that the FDA has attempted to address the tragedy with various actions:

Revising opiod medication labeling, including safety warnings.

Requiring manufacturers to study safety of long-term use.

Providing educational materials to physicians.

Expediting FDA approval of opiod alternatives.

Studying to advance FDA understanding of the mechanisms of pain.

Recommending the reclassification of hydrocodone as a Schedule II drug.

Strengthening surveillance to monitor  prescription drug abuse.

And encouraging development of medication to treat opiod abuse and reverse opiod overdose. 

One of the achievements touted by the Commissioner is the approval of an "auto injector" designed to inject a drug called Evzio, which should "rapidly reverse the overdose of" opiods. The FDA announced the approval of Evzio in early April 2014. In announcing approval, it noted that drug overdose is a leading cause of death in America, more prevalent than automobile deaths and steadily increasing over the last decade or more. 

The announcement does not tout Evzio as much as it does the delivery system, which is simplified to allow use of Evzio without the help of "trained medical personnel in emergency departments and ambulances." The reader is left with the impression that such agents have been available, but with the help of professionals. Perhaps this is part of the drive for approximately 6,000 people visiting medical facilities daily for help with drug overdose or interaction issues.

You have likely seen the ads on television for the "EpiPen" a self-administered drug for serious allergic reactions, called "anaphylaxis." The theory is simple. If you have are prone to allergic reactions, you carry this EpiPen with you at all times. You study your situation and know your risks. You remain vigilant and prepared with your EpiPen, and in the event of a serious attack, you use it to inject yourself with epinephrine. This is a logical process of being prepared for your encounter with allergies.

The theory is the same with Evzio. The question is whether it will really matter in the drug overdose or interaction context. Will those who overdose have the foresight to have an Evzio auto injector on hand "just in case?" I am sure that some will have the foresight, and will plan for an accidental problem like this, I am not sure how many. 

Will significant numbers of those who overdose have the presence of mind while under the influence of opium to use the auto injector? I think this is less likely. I posit that those who are saved by Evzio are more likely to be saved through the quick thinking and action of a family member or friend who notes the severity of a situation and reacts for the victim. I fear that those who are a pain killer dosage level that is life threatening may be beyond the ability to help themselves with this technology.

That only addresses the users of pain killers who are in legal possession of them. Like it or not there is a secondary market for opiods in this country. Pills are being taken by those for whom they were not prescribed. Like any illicit drug use, these people are far more likely to suffer side-effects and complications because they have not had any physician advice, and since there activity is illegal they may resist the urge to call for help. They may fear prosecution and complications from asking for help. I fear that the illicit opiod user, who obtains pills on the street, is very unlikely to plan for overdose or to take steps to possess Evzio, "just in case."

I am not knocking the research and work that have gone into this new tool. I am not saying it will not save lives. I am saying that I do not think that this has the potential of the EpiPen. The mind-numbing propensities of the very drugs with which it is meant to assist will be a hurdle. Another hurdle will be that a large number of the overdose victims each year are illicit users more interested in funding their next fix than in funding the possession of Evzio to have in case that next fix goes bad. 

Time will tell if this new tool is a viable weapon in the fight against senseless death in America. In the meantime, will the other efforts of the FDA outlined above be successful in better focusing the prescription use of opium, preventing inappropriate non-prescription use of opium, or developing viable alternatives to the wide-spread use of opium?

Time will tell. 

In the meantime, we continue to hear about people having tragic results from pain medication. In June 2014, the story broke of a St. John's University pharmacy student who diet from touching Fentanyl, a synthetic opiate that can be absorbed through the skin. We also heard about 15 medical workers indicted in relation to compounding medications; an additional element of that story was the death of a 5 month old child who allegedly accidentally ingested (from coming in contact with a parent's skin after application) a compound pain cream which included Tramadol (which is not an opiod but works in a similar manner). 

There is a need for pain relief and pain management, as to that there is likely unanimous agreement. In the workers' compensation market we see a lot of pain and suffering. There are a great many cases that show us all the effects of trauma on the body and on people's lives and function. Does that relief need to come from such strong medications, and can this country do more to assure the safety of those who may come into contact with these substances? Is the Evzio injector the answer, or even an answer? 

Will the FDA step-up the requirements that such drugs include overdose and overuse inhibiting elements? There are methods to discourage the crushing of such medication (illicit users crush the pills to speed absorption). There are methods of including other substances in the formulations to discourage overuse. Will the FDA make such formulation options a mandatory part of any and all opium formulations?

The tragedy of so many deaths from overdose is a national problem. I hope that as a nation we are not paying it lip service and that  efforts will lead to success and decreases in the deaths attributed to medication. 





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