On October 6th, 2014, all prescription medications that contain hydrocodone, such as the ubiquitously prescribed pain relief medications Vicodin® and Norco®, will be officially changed from schedule III (C-III) to schedule II (C-II) controlled medication class.
Whats the big deal? What does this mean for patients?
First, lets look at how the classification system works with pharmaceuticals. The first separation is between prescription (Rx) medications and over-the-counter (OTC) medications. This one is fairly easy to recognize. You walk through the OTC isles at your local drugstore and step up to the counter of the pharmacy. Everything behind you is OTC and doesn’t require a prescription for you to use is it, everything in front of you does.
The designation of OTC is granted by the FDA to products that they feel the general public can take safely and effectively without being overseen by a physician.
The term over-the-counter can be confusing because they are the only medications that are not passed OVER THE actual pharmacy COUNTER. To add to the confusion there are some OTC medications that are actually in the pharmacy BEHIND the counter (commonly referred to as “behind-the-counter” OTC products (huh?)). These are medications, such as pseudoephedrine (Sudafed®), that have limitations on the amounts that you can buy and for which the pharmacy must keep a record, but an actual Rx is not required for the medication to be dispensed.
What about Prescription Medications?
Prescription medications are further divided into non-controlled vs. controlled substances. Controlled medications are any drug classes with substantial abuse or addiction potential, such as morphine, while non-controlled are not thought to possess these risks, such as the blood pressure medication lisinopril.
Among the controlled substances, medications are grouped into a class schedule from I to V, with I possessing the most abuse/addiction potential and V possessing the least abuse/addiction potential. There are other distinctions between each of these classes but we will focus on what the transition from class III to class II means for this article.
Essentially, the rescheduling of all hydrocodone combination products (HCPs) means more stringent conditions with regards to how these drugs are DISTRIBUTED, PRESCRIBED, and -- ultimately -- how they are DISPENSED to and taken by patients. The rescheduling of HCPs means there will now be additional processes in place (or barriers depending on your perspective) to regulate how patients and pharmacies obtain these prescriptions and medications:
- A HARD COPY of the prescription will now be required at the pharmacy to fill HCP containing products (other classes of medications can be electronically sent to a pharmacy or called in by the MD but for C-IIs this conveyance has been slow to grant and implement)
- NO REFILLS are permitted on a C-II prescription. Consider that for patients in chronic pain it is routine to receive a Rx for hydrocodone containing pain medications with refills for 6 months of therapy
- C-II Rxs are only good for 60 days after which they expire. C-IIIs are good for 6 months. This means that a patient in chronic pain who uses HCPs on a daily basis will have to greatly increase their physician visits
- The pharmacist cannot partial-fill a C-II (other than a few special circumstances)
(Some of these rules vary slightly from state to state and many pharmacies have their own rules in addition to federal and state laws.)
The approval of this rescheduling is not without controversy and there was a near COMPLETE DIVIDE in general comments received by the DEA with regards to its ruling. The pros and cons of this rescheduling exist on both sides of the DEA’s decision but some of the more vital arguments are as follows:
The War Against Drugs
Pro
- Restricting HCP use will help curb the epidemic of prescription drug abuse that has garnered increased prevalence over the last few years
- Restricting HCP use will help drive down drug diversion since prescribers will be less inclined to prescribe it and subsequently less will be available for purchase through illegal diversion channels
Con
- This is punishing patients with actual pain for the actions of others. Additionally, this seems to be an issue of diversion which is why the medications are controlled in the first place. The rescheduling will definitely reduce the amount in circulation but it will be from reducing the amount that are prescribed, not fix the diversion of them. One of the most popular street drugs is Oxycontin® which is already scheduled as a C-II, but still has a major diversion problem
- The increased restriction on HCPs will negatively affect individuals who live in rural areas. Many of these patients live anywhere from 30-60 minutes away from their local doctor and will suffer
Overprescribing
Pro
- Restricting HCP use will help encourage physicians to be more mindful in how they prescribe opioids and re-evaluate their current therapeutic strategies
Con
- The increased restrictions on HCPs will directly damage specific patient populations, such as those with cancer and chronic debilitating pain conditions, for which HCPs and other opioid medications are their only option
Alternatives
Pro
- Restricting HCP use will encourage physicians and patients to explore alternative pain regimens such as NSAIDs (many of which are OTC options such as ibuprofen) that have been shown in large meta analysis to provide an equivalent if not better analgesic effect as compared to HCPs for relief in some pain conditions
Con
- These alternative medications are often not sufficient for treating all pain patients
What does this really mean for the BIG PICTURE?
The focus here is the rescheduling of hydrocodone containing products. What is the goal of the two sides of this controversy? Physicians aim to treat patients that are in pain, the DEA wants to ensure that these medications of abuse potential do not end up on the streets. Unfortunately, these two aims are at odds. If there were no regulations and everyone could legally obtain HCPs, there would be a lot less people in pain but a lot more people using them for recreation. Alternatively, if they were completely illegal, they would be of no use to patients.
In this imaginary scenario, the answer to the conundrum would seem to be to create a position to be filled by a professional with immense knowledge of the human body and pain disorders to decide who should and shouldn’t be prescribed these medications. Fortunately, this position has been established for much of modern culture. They are called PHYSICIANS. This is the definition of their job. The new scheduling scheme seems to just add to the paperwork necessary for them to perform these tasks, as is too often the eventual result of many top down regulations, albeit well intentioned.
Pharmacists are often saddled with the task of ensuring that people are not trying to game the system. This includes monitoring and record keeping for individual patients with regards to their controlled substance prescribing. One of the most important of these tasks is to keep people from shopping multiple physicians in order to get Rx’s written for the same condition. Many states have instituted their own programs for pharmacies to use to monitor this. For instance Kentucky has the KASPER (Kentucky All Schedule Prescription Electronic Reporting) service which allows practitioners, pharmacists, and law enforcement to track controlled substance prescriptions dispensed within the state. Hydrocodone products were already tracked via this mechanism and the new designation will not change how, or with what degree this is performed. The goal of the new designation seems literally to be to reduce the number of Rx’s written for HCPs because it will be more work for the physician to do so and more work for the patient to obtain them.
There is no doubt that a problem existed under the previous system, due to the volume of HCPs that were being prescribed and the amounts that ended up being sold, illegally, on the streets. In the decision to either retain hydrocodone as a schedule III controlled substance or switch it to a schedule II, there was no completely right or completely wrong decision...But there was a PAINFUL one, and it was chosen. And some patients will suffer the consequences.
References:
1. "Final Rule - U.S. Government Printing Office." 2014. 28 Sep. 2014 <http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-19922.pdf>
2. Maxwell, Jane Carlisle. Trends in the abuse of prescription drugs. Gulf Coast Addiction Technology Transfer Center, 2006.
3. McNicol, Ewan et al. "Nonsteroidal Anti-Inflammatory Drugs, Alone or Combined With Opioids, for Cancer Pain A Systematic Review." Journal of clinical oncology 22.10 (2004): 1975-1992.
4. "Kentucky: Cabinet for Health and Family Services - KASPER." 2008. 29 Sep. 2014 <http://www.chfs.ky.gov/os/oig/KASPER.htm>
