Why Do We Need a Single-Entity Hydrocodone?

Will the approval of Zohydro benefit patients and physicians by providing another option for pain relief for patients with legitimate chronic pain needs, or will it spark a new wave of abuse, misuse, and diversion?

How many times in the past year have you wished you could prescribe a single-entity, controlled-release form of hydrocodone for your patients?

On October 25, 2013, Zohydro was approved by the US Food and Drug Administration (FDA). Interestingly, the FDA advisory committee that reviewed Zohydro in December 2012 voted against its approval, citing the fact that it was not an abuse-deterrent formulation and expressing concerns over the potential for abuse, misuse, and diversion of a single-entity extended-release hydrocodone product.

In light of the recent focus on the dangers of liver damage from overdose of acetaminophen, I think it is quite likely that Zohydro will soon be the replacement for the older formulation of OxyContin. Currently, hydrocodone-containing products are prescribed in huge numbers in the United States, often by telephone orders.

On October 24, 2013, the FDA announced its intent to work with the Drug Enforcement Administration (DEA) to change the controlled substance scheduling of hydrocodone to CII from its current CIII status. This would prevent future telephone prescribing, require the use of written prescriptions, and limit the total amount of hydrocodone dispensed to only 90 days without an option for refill. Hydrocodone would join the ranks of fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxycodone.

I have previously written about the need for tamper- or abuse-deterrent opioid medications. I realize nothing will stop abuse completely, and that crushing, chewing, and taking more tablets than the recommended and/or prescribed dose will produce the high desired by abusers. However, do we have to make it easy? Do we have to tolerate our patients giving, selling, and/or trading their medications with their friends and family members? At what point is anyone held accountable?

Good physicians and pharmacists follow established guidelines and best practices when prescribing and dispensing opioid medications. Proper risk management requires that patients be screened for their abuse potential, which should affect how and to whom physicians prescribe opioids. However, once medications are in the community, there is no way to determine what happens. There is no way to stop someone I for whom I have prescribed an opioid from selling, trading, or giving away his or her medication. There is no way to stop them from taking more than I prescribed. The DEA can’t stop them, nor can the FDA.

Although many deaths from opioids can be attributed to schedule 2 agents, the DEA refuses to hold patients accountable for their acts of diversion. The DEA refuses to ask patients who are resuscitated by naloxone from their opioid overdoses if they even have lawful prescriptions. We fill our jails and prisons with drug abusers and dealers, but the dying doesn’t stop. Abuse doesn’t stop. So, we legalize marijuana in Colorado and Washington, and allow medical marijuana in other states. What comes next? Legal methamphetamines? Legal heroin? Legal cocaine? There is no easy answer, but again, is the point of the rulemaking by the federal government to criminalize behavior, address abuse/addiction, or have an alternative revenue source through taxation?

I am far enough along in my career to have seen the pendulum swing from complete prohibition of opioids for neuropathic and other forms of chronic noncancer pain to the profligate prescribing of opioids for many commonly painful conditions. Opioids as part of an overall plan of care can bring relief for pain sufferers. The “good old days” when physicians did not have the option to prescribe opioids were hardly so good for my patients in the 1980s, but do we really need single-entity hydrocodone to treat patients today? Do we need that so-called controlled-release formulation to easily allow for immediate release by chewing and crushing?

The FDA and DEA work at cross purposes; they have to answer to many masters. When I prescribe an opioid, I answer to my patients and to myself. The deal is done. Zohydro has been approved. Take an extra minute in each clinical encounter to remind your patients that more than 70% of all prescription drugs recreationally abused in America come directly from legitimate prescriptions through gift, sales, and carelessness leading to theft. Ask your patients to do their part to keep the privilege of opioids alive. Remind them, it is a privilege to receive opioids. Let’s not collectively blow this.