My daughter Sarah, who helped me put up this site, suggested maybe I slow down on writing blogs…
“Dad, you’ll run out of topics.”
My answer?
“Not likely!”
It seems each week something happens professionally or personally that stimulates the central neurons. This week I was reminded of hydrocodone issues because a family member needed “moderate” elective surgery and as a separate tickler, our VA Medical Center facility decided to take the high road and carry hydrocodone combinations containing acetaminophen (APAP), the only option of which will now be the 325mg APAP strength (completely excluding the 500mg option). Very soon per FDA regulation, no hydrocodone products containing 500mg APAP will be sold within the United States.
Hydrocodone is available in this country only in combination products. Until recently, it was the only Schedule III opioid not available in the United States as a single agent and is classified as a Schedule II drug only in the pure powder form for extemporaneous compounding. (The new guy on the block that changes this is transdermal buprenorphine (Butrans®), topic for another post). Hydrocodone tablet/capsule and or liquid combinations include one of the following; acetaminophen (most popular, and branded as Vicodin®, Lortab®, and Norco®), aspirin, ibuprofen, or hydrocodone bitartrate and homatropine methylbromide (Hycodan® for cough). There is no maximum daily doseof hydrocodone alone; it is however limited by the patient’s level of opioid tolerance, development of side effects, or exceeding the dose of whichever drug happens to be combined into the hydrocodone dosage unit. Online MPA Degrees has an excellent schematic of commonly prescribed medications/pharmacological classes which succinctly clarifies DEA Schedules I through V.
POTENCY
Hydrocodone, milligram for milligram is equipotent to oral morphine. It falls within the most popular of opioid classes, the phenanthrenes. Drilling down a bit, it specifically is a dehydroxylated phenanthrene. From a therapeutic standpoint, it is important to have a sizeable armamentarium of opioids from which to choose. The reasons for this are many; there are inherent biological and polymorphic patient variables, including opioid receptor differences that affect response; some patients are able to tolerate certain chemical classes and not others, and the pharmacological differences make certain opioids more or less effective for some kinds of pain (i.e. neuropathic vs. visceral vs. somatic) as opposed to others.
POPULARITY
According to Forbes magazine, hydrocodone/APAP was prescribed 128 million times last year. Why you might ask? Most probably because it’s been around for almost half a century. Prescribers are familiar with it; and it is a schedule III drug rather than schedule II (prescriptions are not scrutinized as closely by regulatory agencies and it’s refillable). Prescribing immediate release hydrocodone products chronically for pain is common and perhaps an inferior option, but a subject of another blog (pay attention Sarah, I’ll never run out of topics!).
POLITICS
According to Senator Chuck Schumer speaking on an extended release formulation of hydrocodone:
“It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the growing prescription drug crisis, new super-drugs could well be on their way, flooding the market… The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics.”
Come on… let’s not sensationalize things and scare the public unless we know what we’re talking about! “New super-drug”? REALLY?! It is an OLD drug that has been available for 40 years, not “super” in any way. Compared to hydrocodone; hydromorphone (Dilaudid®) is 10 times more potent and fentanyl is 100 times more potent; both are superseded in potency by remifentanil and sufentanil. If this post should somehow make it to Mr. Schumer’s office, I pledge to take a day off from work and teach him some pharmacology, therapeutics, and pain management skills in the appropriate patient (seriously). I will give Mr. Schumer this… hydrocodone abuse is a huge problem that needs to be dealt with (another blog topic to come Sarah).
PRACTICALITY
Dentists, dental surgeons, periodontists, endodontists, podiatrists, medical doctors and other providers often reach for hydrocodone/APAP for reasons discussed in the “popularity” section above. Often times non-opioid analgesics work better for surgical pain (beginning pre-operatively) than opioids. There is also substantial literature that supports multiple non-opioid agents (APAP, NSAIDs, anti-convulsants, NE reuptake inhibitors, and others) peri-operatively to reduce opioid needs (several anticipated blog topics here). This brings us back to square one, proper selection of analgesic therapy is important!
So, if you’re like Sarah and got lost in a bit of the medical jargon, here are some key takeaways:
- POTENCY: Hydrocodone is equipotent to morphine, milligram for milligram. It is not a “super drug”.
- POPULARITY: Substance abusers like hydrocodone and those diverting it, sell it for a nice profit. Prescribers are too comfortable prescribing it, and legitimate patients hoard it in medicine cabinets increasing accessibility to teens and unsuspecting visitors (be careful parents and grandparents)
- POLITICS: Let’s stop talking about it and spend some money on real time databases across all states and federal healthcare facilities, to avoid doctor and pharmacist shopping and multiple RX sources.
- PRACTICALITY: Hydrocodone does not work as well for every type of chronic, acute and/or post-operative pain compared to many other opioid and non-opioid options. Healthcare providers and politicians need a better education in pain management to improve analgesic outcomes for patients, to identify the unsuspecting patient/addict, and to improve public safety.
For issues pro and con regarding hydrocodone scheduling, see Dr. Lynn Webster’s blog on LifeSource at http://yourlifesource.org/yourpainstories/2012/06/an-amendment-to-reclassify-hydrocodone/
It’s hard to believe! Pittman D, Fiore K. FDA: Don’t Tighten Vicodin Regulation. Medpage Today, October 25, 2012.
Dr. Fudin I wanted to ask does methadone block all other opiates from working, reason I ask is I’ve tried break through medications and they don’t seem to work.
This makes me think the methadone is blocking any other opiate from entering a persons opiate receptors in the brain. Seems the methadone fills these receptors blocking other opiate from working.
Mark,
Methadone does not block other opioids from pharmacological analgesia. But, if methadone is occupying the receptors it is possible that euphoria can be blunted.
When I first saw this Super Drug, time released hydrocodone I laughed.
I was called and asked to be in the clinical trial of this medication.
I drove all the way across Houston signed a lot of papers and I asked what was this new time released pain medication. When the doctor said time released hydrocodone I stood up and walked out.
He ran outside and asked why are you leaving, I told him I cant be in any clinical trial of any pain medication. I was in a contract with my Pain Specialist and I knew it was a big waste of time.
Then the stories hit a new Super Drug 50 times stronger than vicoden.
So you see how the media blows things out of proportion.
He asked me to come back in and I told him I cant do the program, he asked why again and I told him I’m already on a long lasting opioid.He said we will do a wash out and I had to laugh.
I thanked him for his time and got paid for my gasoline and he wanted me to come back but I never did.
What is the mentality of someone in a position of high public trust who uses superlatives like “new super-drug”?
Reminds me of the WWII era term “Nazi Super Men”. Were they?
Lets save these terms for comic books and not public discourse about serious matters….as best we can.
T Sachy
Thanks Jeff! The more pharmacology and guidelines I learn (or relearn) the more moral issues become a mysterious entity in the retail world, and a confounding factor. To be, or not to be, the pharmacist who dares to inquire on the protocols of our pain docs? In my neck of the woods I found myself upsetting some very fragile ecosystems of pain management, in that self medicating patients were loosing access in some respects. In one case, 1 patient with 2 docs, multiple pain/anxiety scripts and when each doctor found out about the other they both dropped the patient. I believe after some careful deliberation the patient was re-evaluated and treated by one of them, but close call! Wilkes county, NC has some of the highest overdose rates in the state (and sadly volunteering for child advocacy group abandonment due to drug use is incredible). Any suggestions on how to approach this delicate subject matter on a local (retail) pharmacist -to- doctor level?
Hi Gregg,
Thanks for your comments! There are a lot of things you can do in the community setting both directly with physician prescribers and the community at large. Prior to connecting with the physicians, you could make it your personal goal to connect with local community groups including school administrations, PTA organizations, and even students; teach them about the issues with opioid diversion and abuse. Ohio State University College of Pharmacy has premade slide presentations and a ton of information that you can use; the project is called Generation RX.
After you become a community expert on the matter, make sure you are well-versed on opioid management, the pharmacology, therapeutics, etc. You can start by doing a couple of the CE programs listed in my RESOURCES section. Specifically, to start, focus on Opioid pain management: Balancing risks and benefits and Update on Risk Evaluation and Mitigation Strategies (REMS) associated with long-acting opioids. Also, I find that the following QUICK REFERENCES available on my site are of immense help to prescribers:
Opioid Serum Predictabilities – This comprehensive table provides expected serum predictabilities in patients receiving commonly prescribed opioids.
Opioid Chemistry – Lists various opioids in columns by their chemical class beneath the chemical structure of the prototypical agent. For example, morphine is the prototypical phenanthrene of which all others are measured against. This also indicates which opioids are more or less likely to have cross-sensitivity to others based on similarity between and among chemical structures.
Urine Drug Screen (UDS) Algorithm – A schematic diagram offering a step-by-step decision tree from the time an opioid is considered through the prescribing process. For example, if a patient is positive for amphetamine, it alerts you on which agents might cause a false negative or positive (methylphenidate will not cause a false positive for amphetamine). Another example is that most UDS tests do not include fentanyl, therefore you should expect a negative opioid analysis if your patient is prescribed only oxycodone.
This is a great article on a very pressing issue. I recently just completed my Institutional IPPE where I saw first hand a patient suffering from hepatic failure due to an APAP overdose. I think it is great the FDA is limiting the amount of APAP in Vicodin because often times patients unknowingly take other medications that contain APAP. Just the other day at work I had a patient pick up a prescription for Percocet and a bottle of extra strength APAP. This shows the importance of the role of the pharmacist in counseling patients on the medications the receive. Even with the FDA limiting the amount of APAP in these products we need to make each patient aware of other medications they should avoid.
Well said!
This was a great post and I just had to share with the pharmacists I work with since we were actually talking about this last week. I am a 5th year pharmacy student (Albany College of Pharmacy and Health Sciences) and although the college does a great job at giving us a significant amount of knowledge about each drug class (usually through 1-2 month modules), it definitely isn’t easy retaining every bit of the information due to it being condensed into a short amount of time. The condensed modules are understandable since there is a vast amount of drug knowledge that must be taught before a student graduates, but I feel that more electives such as the “Pain Management Pharmacotherapy” elective at ACPHS and all colleges of pharmacy would definitely benefit a student by lengthening his/her knowledge or at least giving them a more specific understanding of certain drug classes. Each time I annoy a pharmacist with the “how do you remember it all?” question, they always give me the same response. “You just never stop learning, you learn new things even after you graduate.” With new drugs/drug information coming out all the time, there will always be new topics pharmacists and other health care professionals need to be informed about. The “annoyed” pharmacists also state how hepful it is to read certain journal articles, newsletters, or even blog posts like this one in order to “keep certain drug info fresh in their minds”. I’m a strong believer of the saying “if you don’t use it, you lose it” so I definitely feel like posts such as this one would be of great help even after I hopefully graduate one day (knocking on wood). Keep up the great work informing readers about significant topics such as this one.
Almedin; Thank you for your insightful comments. Perhaps I’ll see you in my pain elective class next spring. Keep up the good work!
The truth is, people with chrnoic debilitating pain will be able to get their medications if the pain is documented and being followed by appropriate medical care. The idea that deserving people will be damaged because criminals and addicts are curbed is fear based and reactionary. So, we should continue to do nothing to address the increased addiction and criminal behaviors around us because someone, who is probably also technically addicted to their medications albeit necessary for quality of life, is afraid they might have to prove they are in real pain? No. Not logical.
I work with complicated patients with marked decrease in Pulmonary function due to neuromuscular disease. Many times it is necessary to have Gastrostomy tubes inserted either endoscopically or via intereventional radiology. There procedures can be painful and we need to avoid opioid or sedative medications so we don’t impair their respiratory drive. Can you suggest non opioid perioperative management for this group of patients.
Thank you for this excellent blog.
Dr. Miller,
Thank you for your comments! You pose an excellent question that correlates nicely with my statement, “There is also substantial literature that supports multiple non-opioid agents (APAP, NSAIDs, anti-convulsants, NE reuptake inhibitors, and others) perioperatively to reduce opioid needs.”
To keep it simple, perhaps the best alternatives here would be perioperative use of acetaminophen or ibuprofen intravenously. Although all of the pivotal trials with ibuprofen failed to show increased risk of bleed perioperatively, in the specific gastrointestinal cases you mention, I would lean towards acetaminophen.
The intravenous form of acetaminophen here is particularly useful because of the achievable Cmax. A single dose of 1g acetaminophen IV reaches twice the Cmax compared to 1g acetaminophen orally. But, the total area under the curve (AUC) is almost identical. The quick peak to Cmax is particularly beneficial in blunting the “wind-up” pain seen immediate postoperatively.
After completion of the procedure, continued use of acetaminophen and/or an NSAID with COX-2 specificity should be beneficial. A little known fact is that etodolac (Lodine®) is actually more COX-2 specific than celecoxib (Celebrex®). Etodolac is available in 200mg and 300mg capsules (easily emptied for PT administration) or 400, 500, and 600mg tablets.
For more extensive procedures, both IV acetaminophen and IV ibuprofen have been shown in several studies to decrease opioid needs by 32-34%. Some of these procedures have included orthopedic surgery (hip and knee replacement), single-site abdominal or orthopedic surgery, and abdominal hysterectomy.
Lawmaker involvement in the regulation of opioids like hydrocodone without proper education is perhaps the biggest hurdle to appropriate patient pain management. No opiate I can think of is spared of being abused, and hydrocodone will be no different once available as hydrocodone alone. It is important to remain cognizant of abuse potential, however the day we prevent medications from reaching market out of fear instead of other, more valid reasons, is a day we let our patients down.
Educating these politicians (or perhaps the public) to remove the power from their words may be of great benefit. Adequate pain management pre-op, peri-op, and post-op may improve outcomes in certain scenarios, and limiting our repertoire seems counter intuitive.
From the Mayo clinic..
Although research has clearly shown that prompt and effective pain treatment improves outcomes, a surprising number of trauma patients don’t receive it. In one study, up to 15 percent of patients received no pain medication in the trauma bay, and the mean time to administration after arrival stretched to well over an hour.
Seen here – http://www.mayoclinic.org/medicalprofs/managing-trauma-pain-put0512.html
This is from a limited patient population, but it shows that we are squeamish with the use of opiate analgesia, even in the patients who it is absolutely indicated in, such as trauma patients who may be in a great deal of pain.
Please don’t slow down on the posts Jeff, they provide a lot of great insight on relevant topics
Owen, Thanks for the comments. I’ll keep them coming as long as you keep reading; you have my word!