New DEA rules on pain killers are coming soon

Dr. Victor Sierpina

Dr. Victor Sierpina

The US Drug Enforcement Agency, after lengthy debate and public input, has implemented a rescheduling of the most widely prescribed group of drugs in the U.S., the hydrocodone-acetaminophen combinations. These are drugs with brand names of Vicodin, Norco and Lortabs.

There are 135 million prescriptions annually for these hydrocodone combination products (HCPs), much more than for the next most common prescriptions for thyroid, blood pressure, and cholesterol lowering drugs.

Some time ago, government rules reduced the total acetaminophen (trade name Tylenol) content to 325 mg a day per pill as greater than 4,000 mg daily in combination with hydrocodone was placing patients at risk for liver damage.

Those addicted to these meds might have been taking 10, 20 or 30 pills a day, way exceeding the safe amount of acetaminophen the liver can handle.

Now, this HCP group of drugs is moving from a Schedule 3 to a Schedule 2 class, entering the same category as morphine, Dilaudid, oxycodone, Percocet, Demerol, Fentanyl and other powerful and highly addictive pain medicines.

Most people take pain medications for legitimate purposes yet the rise in opioid related deaths to over 17,000 people in 2011 makes such drugs highly concerning in terms of public safety. In fact, more people die annually of drug overdoses of all types than in car accidents.

What this will mean for you is that you will need a handwritten prescription from your doctor that you must take to the pharmacy for HCPs. Schedule 2 medications cannot by phoned or faxed except for an emergency 72-hour supply which must then be followed with a written prescription. These prescriptions are on special paper with thermochromic ink, cannot be copied (“void” appears if they are copied), and are each tracked with a discrete serial number.

If you are on these prescriptions now, your doctor can write three 30-day prescriptions with a “do not fill before date” on them so you have a 90-day supply. You’ll still need to take them to the pharmacy. I have heard of some pharmacies giving a 90-day supply of Schedule 2 drugs but do not count on this without checking with your pharmacist.

A good thing for those on these medications is that according to published rules, pharmacies can honor existing refills without the so-called “triplicate” prescription until April, 2015. Hopefully, the new rules will reduce the number of unused and potentially abusable, overdosable prescriptions lying around people’s homes and medicine cabinets.

Unscrupulous “pill-mill” physicians who provide controlled substances for cash will find it harder to ply their addictive craft. In this all too common scenario, without ever seeing a physician, patients plunk down a hundred bucks or more to get scripts for a HCP, a muscle relaxant, and a bendozdiazepine (typically Xanax) — the so called “Trinity” of substance abusers. The combination seems to give a highly coveted buzz. Switch out hydrocodone for oxycodone, and you have what is called on the streets “The Holy Trinity.”

I have been a consultant to the Texas Medical Board and in other medicolegal settings in prosecuting such pill-mill doctors. This is almost always after one of their so called “patients” died of an overdose. Perhaps this new rule will save some lives.

In any case, it will be slightly more inconvenient for UTMB patients on these medications to get their refills after Oct. 6. However, our clinics are developing a workflow process to manage this for those whose pain control needs are legitimate.

At Family Medicine, we have established a process to limit abuse of pain medicines by having those with non-cancer related chronic pain sign a controlled substance agreement, which stipulates conditions under which they can and cannot get refills.

We also have instituted random urine drug testing and require at least a biannual pain assessment visit. This has already reduced the number of inappropriate drug seekers in our clinics. This new rule may do more of the same come Oct 6.

Dr. Victor S. Sierpina is the WD and Laura Nell Nicholson Family Professor of Integrative Medicine and Professor of Family Medicine at UTMB.

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