Wednesday, November 13, 2013

More Powerful Opiods Approved

Prescription drug interactions, abuse and misuse have received a great deal of press in recent years. Since the death rate from these exceeded the death rate from automobiles, people suddenly began to notice. States have focused in recent years on pill mills, prescription practices, databases and more. There is a clear recognition on a state level that medicine intended to be a benefit to patients is killing them and the people around them (as detailed in a recent post, family members sometimes illegally use the drugs found in their homes). These drugs find there way onto the streets also.

The AMA has published stern warnings about the affect of opiods, and the dangers they present. See the AMA Guides Newsletter, April/May 2011 and January/February 2013. There is concern in the medical community about whether opiods are appropriate for many types of pain complaints.

So, the good news is that the Federal Government approved a new form of hydrocodone last week. This form is marketed as Zohydro. Ignoring the facts that other opiods have been tied to deaths around the country, those responsible for American's safety, the Food and Drug Administration (FDA) has approved Zohydro an opiod that is five to ten time more powerful than the existing opiods, like hydrocodone, oxycotin, dilaudid, and fentanyl. You did not read that wrong, five to ten times stronger.

Like most bureaucracies, the FDA has processes and committees. Relevant here is the Drug Advisory Committee, which overwhelmingly recommended against approval of this new opiod that is five to ten times stronger than existing products. The good news is that all of the deaths related to opiods have led to requirements that drug manufacturers include elements in most opiods that deter addiction and resist people tampering with the drugs. These features are presumably to help protect human beings who take these chemical compounds for pain. Presumably these features are a good idea, and that is why they are required. The bad news is that these requirements for addiction and tampering precautions will NOT be required for the new opiod, Zohydro, which, by the way, is reportedly FIVE to TEN TIMES more powerful than exiting opiods. 

The FDA is counting on labeling that describes risks associated with Zohydro. They explain the warnings required on this medicine will be stronger, and will clearly describe the risks and concerns. If labels like this solve the concerns with misuse and addiction, why not put clear, stronger labels on all opiods? Why have anti-addictive and anti-tampering formulations for those drugs, when we could simply make their labels stronger and clearer? For the dangerous opiods, they require these formulation changes, but for the really strong (did I mention Zohydro is reportedly FIVE to TEN times more powerful?) hydrocodone, our government is convinced that stronger and clearer labeling will suffice. 

Certainly this must make sense to someone in Washington. I respectfully suggest that someone else needs to review this decision, and review the person that finds it logical. Americans are dying. My car can achieve 140 miles per hour (according to the speedometer). The government has taken some interesting precautions, including requirement for my safety such as seat belts. The FDA logic would apparently be to approve the sale of automobiles that are capable of 700 miles per hour (5 times the 140), and without any requirement for seatbelts. They would instead put a clear and strong warning on the steering wheel of each car. Is this logical?

Einstein is credited with this definition of insanity: "doing the same thing over and over again and expecting different results." Allowing marketing of super-opiods without the safeguards required for existing opiods might meet this definition. 

There is some good news from the FDA. In another action, they have recommended that all hydrocodone formulations be added to the Schedule II designation. This would put restrictions such prescriptions. For example, written scripts are required for Schedule II, they cannot be phoned in to the pharmacy. Also no refills beyond 90 days are allowed for Schedule II, and there are more stringent record-keeping requirements. 

Is the FDA being consistent in their treatment of these medications? Is there any concern within the FDA that Americans are dying from prescription painkillers? Apparently, there is some concern or there would be no move to reclassify all hydrocodone to Schedule II. If there is enough concern to warrant that action, why not enough concern for the new super opiod to require formulation additions for addiction prediction and tamper prevention? 








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