The FDA recently cleared the way for giving hydrocodone combination products a CII status, so pharmacists should be prepared for the consequences of this potential change.
A situation that has been debated over and over again finally seems to be becoming a reality for those who have wanted hydrocodone combination products put into CII status. It seems that the FDA recently cleared the way for this to happen, a move the Drug Enforcement Administration has endorsed for some time.
Of course, pure hydrocodone has always been a CII product, but it is found only in compounding pharmacies. That’s about to change, too, as Zogenix Pharmaceuticals obtained approval for an extended-release hydrocodone pain reliever called Zohydro. Understandably, it was placed into the CII category since it has no acetaminophen or ibuprofen combination.
When you take a look at what makes a prescription drug a CII, the most restrictive prescription schedule, it is the propensity for addiction and abuse. A CII drug is at the top of the food chain, and purely by that definition, hydrocodone combinations clearly fit the bill. Hydrocodone has long been the most abused pharmaceutical, representing half or more of the caseload for those who work in the law enforcement field combating drug diversion.
Many would argue that with hydrocodone combinations being in the CIII category, fake call-ins and refill alteraions are possible, unlike with their CII cousins. The combinations are bunched together with the CIV and CV pharmaceuticals, unlike the CII drugs, which have the distinction of being in their own files. Criminal penalties with CIII drugs are typically less in state courts and require a tractor trailer load to generate any interest by US attorneys in federal court!
Ohio, for example, requires a person to possess at least 30 extra-strength hydrocodone combination pills illegally to generate a low-level felony charge while it stays a CIII. Once the schedule changes, possession of just 1 of these same pills becomes a felony, with more stringent felony charges for a larger number of doses. Other states will be looking at similar changes in charging suspects with the illegal possession of hydrocodone combination products.
Another aspect to look at in this debate is the fact that hydrocodone is also the #1 prescribed prescription drug in the United States. With these overwhelming numbers in mind, a certain percentage of controlled substances will be abused, and with hydrocodone’s numbers, a fair amount is bound to be headed for abuse in our society.
Although many want hydrocodone combination products to be CII because it takes away the ability to call them in to the pharmacy and give patients refills, this is the very reason some prescribers and patients want hydrocodone to remain a CIII. The biggest argument is that legitimate patients will have to visit their prescriber each time they want a refill or request a call-in, adding the inconvenience and expense of additional office visits to the already rising costs of health care.
However, some pain management experts stress that prescribing hydrocodone combination products long term is likely not a sound treatment for those with chronic or cancer pain who need pain relief opiates for extended periods of time—or the rest of their lives. Many experts will recommend an extended-release product void of acetaminophen and other combination drugs for these types of patients. In addition, once they are a CII, combination products could be prescribed for up to 90 days at 1 visit, as long as all of the prescriptions are dated the day of issuance with the indication of “do not fill until” on the script.
Of course, it is likely that the other contingency not excited about hydrocodone combination products becoming a CII is the dozens of generic companies that manufacture the drug. By placing this drug in CII, it will likely result in a reduction in the prescribing of hydrocodone combination pharmaceuticals. It can definitely be argued that making this drug a CII seriously impacts the prescriber’s ability to have an optional pain reliever for patients when the prescriber feels that a CII drug is not necessary or appropriate.
Years ago, the state of Florida made hydrocodone combination pharmaceuticals a CII, but that ended up being rescinded almost immediately after incredible pressure. In this case, once it is placed into this elite category of abuse and addiction, it will almost surely never return to the CIII status it enjoys today.
I am very interested to know how our nation’s pharmacists view this potential change. Is it a good idea that is a long time in coming, or do you think it negatively impacts patients? Drop me an e-mail at firstname.lastname@example.org or burke@ naddi.org and let me know how you feel.
Cmdr Burke is a 40-year veteran of law enforcement and the current president of the National Association of Drug Diversion Investigators. He can be reached by e-mail at email@example.com or firstname.lastname@example.org, via the website www.rxdiversion.com, or by telephone at 513-336-0070.