Fast forward to today and the Center for Disease Control and Prevention has noted prescription drug abuse to be the fastest growing drug problem in the United States and overdoses involving prescription pain medications has reached an "epidemic" status. Sadly, prescription medications, such as those containing hydrocodone, are linked to > 50% of overdose fatalities.
In response to the growing epidemic, on August 22, 2014, the U.S. Drug Enforcement Administration published a final rule in the Federal Register moving hydrocodone combination products to the more restrictive Schedule II classification.
One week from today on October 6th, this final rule will be enacted and all products containing hydrocodone may only be filled according to CII requirements. I cannot help but wonder what the impact will be on patients with legitimate pain conditions.
Whenever a law or rule is put in place, there is always a need for balance--in this case--between enabling access for legitimate use, while abating misuse. Come October 6th, I wonder about the automobile accident patient, who despite years of physical therapy and multiple surgeries, still has daily pain only controlled by opioid therapy; or what about the patient under hospice care with cancer-induced pain that may have used hydrocodone/acetaminophen for break through pain; or a frail post-surgical patient in a long term care facility. These legitimate situations and care settings are likely to be significantly impacted by the rescheduling of hydrocodone combination products, resulting in poor pain control.
The CDC Grand Rounds on the topic of prescription drug overdose, published in JAMA in 2012, mentioned a number of strategies for prevention. The article included strategies to address stronger regulation and enforcement over "doctor shopping" and "pill mills", as well as enhancements for national prescription drug monitoring programs. There were strategies which focused on education of prescribers and consumers; and there was a call for better insurance coverage for alternative therapies, such as physical therapy. Interestingly, there was no mention of the rescheduling of hydrocodone to a CII. I can't help but think, it was because of the potential negative impact that this rescheduling may have on the quality of care for patients with legitimate pain conditions.
Will the rescheduling reduce the number of unintentional overdose deaths? It is possible, but now I worry that those who intend to abuse or experiment will only shift to a different drug. My guess is that we will see a drop in the number of hydrocodone deaths replaced with a surge in benzodiazepine deaths. Time will tell. Meanwhile is there more that pharmacists can do to educate and curb abuse, while facilitating appropriate pain management for those in need?
Dr. Shelton,
ReplyDeleteThank you for this insightful article on the recent changes to Hydrocodone Scheduling. I’d like to think of this decision as a step in the right direction. Physicians, pharmacists and other health care professionals will inevitably become more aware when treating their patients with Hydrocodone and Hydrocodone combination drugs. I believe this will lead to more patient education and more communication among healthcare professionals. These are key factors in successful treatment of a patient. That being said, I can see how some may think of it as more work being forced onto them however, it is something that needed to be done!
I have worked in many pharmacies in Virginia, as well as a few in West Virginia. One common theme I witnessed was lack of knowledge among pharmacists or technicians about the state prescription monitoring program. Several pharmacists I worked for did not even know Virginia had a monitoring program, and many others admitted to never using it. One step in the right direction would be education to pharmacies and pharmacist about how to use this resource that was put in place specifically to help with prescription drug abuse. Perhaps that would lower the rates of abuse of these medications.
ReplyDeleteThis regulation change will impact not only the patients but also practitioners including pharmacists. Because it is now classified as CII drug, doctors will be more cautious when prescribing hydrocodone/acetaminophen and be more conservative in choosing pain medicine to non-critical patients. On the end of pharmacists, this regulation is likely to increase their workload since all CII have to be ordered and managed separately from other drugs. One scenario is that a drive-thru patient dropping off a prescription for hydrocodone/acetaminophen has to wait longer because pharmacy technicians have to wait for pharmacists to open the safe cabinet for inventory checks. Considering the high volume of hydrocodone/acetaminophen prescription, pharmacists would likely spend more time counting for record keeping purposes. There are pros and cons. In terms of pharmacists’ workload, it is definitely bad news.
ReplyDeleteThis may be a far stretch of an option, but I can't rule out creating a wider availability of pain clinics requiring their patients to contract into a specific pharmacy. Once the patient is contracted into that pharmacy, they can pretty much guarantee that the pharmacy is going to order their medications on a monthly basis (or however often they fill their medication(s)). Contracting chronic pain patients into local pharmacies ensures that the patient will receive their medication routinely and can encourage a more all-encompassing relationship between the pharmacist and the patient. This also provides a bit more regulation for the prescribers, as they are partially responsible for the over-prescribing of pain medications for those patients who are abusing the system. By putting more pressure on the physician to be a little more restrictive in their prescribing patterns, the amount of abuse on these medications should, theoretically, be reduced.
ReplyDeleteWith the new changes, and regulations for Hydrocodone, I do feel that most people will most likely change to another different drug. However, I will say that now two months after the scheduling became effective at my pharmacy, the number of hydrocodone prescriptions are still the same. Not much has changed. However, it seems as though more and more hydrocodone prescriptions are filled, as compared to the oxycodone, but as you stated, only time will tell.
ReplyDeleteI think it's unfortunate that in order to try and limit those who are abusing the system we have to make it more difficult for those who are experiencing real and severe chronic pains. Instead of being able to have their refills filled as needed there's more hurdles they'll have to jump before receiving the medications they need. For example, with hydrocodone now a schedule II, these patients will need to receive separate prescriptions for each additional fill,which means they will have to keep up with multiple prescriptions and filling dates or need to schedule more appointments with the doctors in order to have additional prescriptions written. Personally I think patients, doctors, and especially those whom a pharmacist may suspect is abusing the drug, should all be educated on dependency and the effects of hydrocodone.
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