We welcome Dr. Dole’s expert opinion and insight on this important topic to address the upcoming FDA Public Hearing, Impact of Approved Drug Labeling on Chronic Opioid Therapy.
Dr. Ernest Dole is Clinical Pharmacist at University of New Mexico Hospitals (UNMH), Department of Clinical Pharmacy/Pain Consultation and Treatment Center (PCTC); and Clinical Associate Professor at University of New Mexico Health Sciences College of Pharmacy. A comprehensive biosketh appears beneath blog post.
Dr. Dole writes…
“I have met the enemy and he is us”-Pogo
FDA’s Drug Safety and Risk Management Advisory Committee last week voted in favor of rescheduling hydrocodone from a CIII to a CII (1). However only a few months ago, this same committee voted to NOT reschedule hydrocodone (2). I think this flip-floping and conflicting position by the FDA’s expert panel crystalizes the debate going on within both the healthcare and legal systems. Clearly there is a prescription opioid crisis in this country (3). Andrew Kolodny, MD, chair of the psychiatry department at Maimonides Medical Center in Brooklyn, N.Y applauds the current FDA position to reclassify hydrocodone to CII, citing the fact that the first step in protecting the public from this epidemic is to “diminish the pool” of available opioids (4). The problem with this line of logic is that the usual unintended consequence is that those “public” with the least amount of resources and in need of the most “protection” are the first to be disenfranchised from “protection”. In rural and/or poor areas, those without the means to come to a clinic monthly to be given a written prescription for an opioid painkiller would tacitly be denied care. This is echoed by FDA spokesperson Shelly Burgess who states that “Areas of mutual concern [between the DEA and FDA] are the negative effects that additional controls will have on patients in acquiring this essential medicine, and whether hydrocodone’s contribution to the problem of prescription drug abuse can be meaningfully reduced by restricting patient ease of access” (4).
Many medications harm or kill our public, and need “protection”. Insulin, warfarin and blood pressure medications are just a few examples. However none of these medications elicit the same gut level emotional response as does the word, oxycodone or other opioids. Almost every healthcare practitioner remembers the last time they were lied to by a patient trying to obtain an opioid prescription. Those of you that are healthcare practitioners, I want you now to take a deep breath, count to 10 and remember the last time you saw a patient with diabetes tell you that they are exercising, following their prescribed diet and taking their medications as directed…… and their A1C comes back at 10. Do you have the same reaction as the patient who lied to you to obtain opioids? Most practitioners do not have the same reaction in these two scenarios. In the case of opioids, the reaction to being lied to by a patient is generally much more personal. In the case of the patient with diabetes, the behavior is usually chalked up to, “that’s what diabetics do”. That is why, in this epidemic of prescription opioids, the enemy is us. Oxycodone is an inanimate object; however the personal baggage we bring to the scenario involving oxycodone is not and gives an inanimate object power. There are reasons the word oxycodone has power. Even in today’s period of politically correct enlightenment, opioids carry a stigma that is a mix of a person’s morals, ethics, values, beliefs, and judgments that have been passed down for centuries. This does not exist for any other chronic medication. Add to this the personal experience that one addict effects 7-10 people, often in an unpleasant manner, plus the impact of high school students becoming addicted to and overdosing on opioids, this topic becomes both professionally and personally more passionate. Add further the fear of practitioners that if they prescribe opioids they will be retaliated against by professional boards and/or the DEA and the emotion factor goes up a few more notches. Almost everyone has a biased opinion on opioids that colors any data on this subject. Somehow we have to be able to move practitioners and the public out of the realm of emotion and into the realm of logic and data so that opioids are managed like every other chronic medication. Based on observations, opioids are currently being prescribed and managed more on emotion than data. A colleague of mine, Dr. Jennifer Strickland and I came up w/ the acronym T.H.I.N.K that gives some one sentence guidance to clinicians when prescribing and managing opioids. I chose the word “THINK” to reinforce the concept of using data rather than emotions when prescribing and monitoring opioid prescriptions.
T.H.I.N.K. stands for:
T: take advantage of all data resources
- UDS, BOP PDMP reports
- FDA REMS Guidelines
- missed appointments
- patient treatment agreements
H: have data in hand
- VAS
- UDS
- BOP PDMP reports
- Opioid screening tools?
I: intuition
- does this make sense; SARS (Something Ain’t Right Syndrome)
N: “NO” is a valid answer
K: know the basics of chronic medication management
- this seems to be forgotten with opioid use
- systematic process
- federal, state & local laws
In addition to applying the above acronym, healthcare can address the phenomena of personal bias being the guiding force of prescribing and monitoring opioid prescriptions by developing a system that tries to take as much personal emotion out of the process of prescribing opioids as possible. Systems can be developed with guidelines for refilling opioid prescriptions that will hopefully ease provider’s fears and take some of the provider personal bias out of this process. A “toolkit” can be provided for clinicians that includes patient risk assessment tools, visual pain and function scales, a clinic note template, guidelines for monitoring and refilling opioid prescriptions, guidelines for the ordering and interpretation of urine drug screens, guidelines for appropriate action if a urine drug screen is inappropriate, guidelines for opioid rotation and dose conversion, guidelines for the use of prescription monitoring programs. By designing the prescribing and managing of opioid prescriptions to be as systematic and data driven as possible, the impact of personal bias will be limited.
Contrary to Kolodny’s thoughts that restricting access will begin to solve the problem, the start of turning the tide on this epidemic begins with those of us in healthcare who prescribe these medications to begin to approach them for what they are, inanimate objects that can be prescribed, monitored, adjusted and discontinued based on data; in the same manner as every other medication used in chronic conditions. It would be unconsciousable for a clinician to refuse to prescribe insulin because the clinician “feels” that insulin is too dangerous. In the same manner, it is unconsciousable to refuse to prescribe patients opioids for the same reason. Insulin is prescribed, monitored, adjusted and sometimes discontinued by data such as blood sugar, A1C and the fact that the patient is not able to use the medication in the way it was prescribed for them and/or the patient is not responding to the medication. In the same approach, opioids can be prescribed, monitored, adjusted and sometimes discontinued based on visual pain and function levels scores, urine drug screen results, data contained in prescription monitoring programs, and the fact that the patient is not able to use the medication in the way it was prescribed for them and/or the patient is not responding to the medication.. The answer is NOT to restrict access of medications to those public that need opioid medication. The answer begins with understanding that “the enemy is us”, and to realize what, as clinicians, we bring to the table in the form of personal bias when prescribing opioids and how this can give an inert medication power. The answer begins with using the same methods to prescribe and monitor opioid medications that are used when prescribing any other medication for a chronic disease that has the power to harm or kill our patients. The answer begins with letting go of emotion and using data to THINK when prescribing opioids. Dr. Kolodny is incorrect in his thoughts that restricting access to these medications will protect the “public”. Rather this is a short sighted answer that will harm the “public”.
REFERENCES
1. http://www.pharmacist.com/fda-advisory-committee-votes-favor-hydrocodone-rescheduling
2. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/10/fda-releases-its-briefing-concerning-rescheduling-of-hydrocodone-combination-products-in-advance-of-.html
3. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm
4. http://www.medpagetoday.com/Blogs/InOtherWords/29102
Ernest Dole, PharmD, PhC, FASHP, BCPS 
At UNMH PCTC, Dr. Dole manages ambulatory care patients with chronic pain, as well as participating on an inpatient Pain Service. He received his B.S. in Pharmacy from Colorado, with honors, and his Doctor of Pharmacy degree from Tennessee. He completed an ASHP accredited Clinical Pharmacy Practice residency at Memphis VAMC, 1988. Dr. Dole was the ninth Pharmacist Clinician in New Mexico in 1996, was recognized as an ASHP fellow in 1997, passed the Board of Pharmaceutical Specialties Pharmacotherapy exam in 1997, and Certified Diabetes Educator exam in 2000. Dr. Dole has twice been nominated for the NMSHP Pharmacist of the Year. He has been the Chair of American Society of Health-System Pharmacists Section of Home, Ambulatory and Chronic Care Practitioners and has served as a member on ASHP Councils and Task Forces. He has been president of the New Mexico Society of Health-System Pharmacists in 2008-2009. Dr. Dole received the Volunteer Faculty of the Year Award and Preceptor of the Year Award from University of New Mexico Health Sciences College of Pharmacy in 2009. In 2012, Dr. Dole received the Dorothy Dillon Memorial Lecture Award from the New Mexico Society of Health System Pharmacists. This is the organization’s highest honor. His research interests include the impact of culture on pharmaceutical care, substance abuse in the elderly, and obtaining federal recognition of pharmacists as healthcare providers. His research interests with respect to chronic pain control include the effect of high opiate doses on testosterone levels, the effect of opiates on sleep apnea, and the use of non-opiate medications in the therapy of chronic non-cancer pain.
I am a 15 yr pain patient after being given 2 epidurals without x-ray guidance, followed by lumbar surgery, followed by more invasive tests and ESIs. Too many injections to count. I have had Arachnoiditis for many yrs, but was not diagnosed until I paid for an independent MRI review. I moved to KY in 2001 when I transferred with my company. I was in pain management, but not prepared for the unprofessional, abusive treatment of pain patients here. Lack of care left me unable to work. I have been forced to have ESIs to get treatment. That seems to be the rule here and is the worst thing you can do to a patient with Arachnoiditis. I hate taking medication because of the stigma attached to opiates. They work, but Docs just will not, or can not write them. I worked in mental health, have been to counseling, had years of physical therapy, I do yoga poses for stretching, and strength exercises at home. I have Chiari1, cysts on S1 nerve root, multiple bulging disc in cervical and lumbar, one with annular tear, facet arthropathy, stenosis, but the Arachnoiditis is a level of pain that numbers and words can not describe. It has stolen my life. I am unable to be a mother to my children, a grandmother to my granddaughters, or any benefit to my community. I do not have money to seek out Chiar, or Arach specialists, and without better pain management would not be able to travel to appointments anyway. I have psoriasis and a follicle disease cased by chronic pain. I seldom sleep. I am flexible because I work at it, but nothing I can do eases the pain of Arach. I am slightly underweight. Some days it is just too hard to go out and get food. I have had acupuncture and it gave relief for a short time. It is no longer available here…..I have put up with” the look” from drs and nurses at almost every appointment. Nurses are the worst and I refuse to talk to them about medication now. If I were going to become an addict, or criminal, I think it would have happened long ago. I walked out of the last pain clinic I was sent to due to unprofessional treatment by a nurse and the requirement that I have more injections. The number of chronic pain patients will continue to grow as long as the Pain Industry is allowed to give injections to every patient who walks through the door. Their policy of not allowing a family member, or advocate in the room with the patient has to be a violation of patient rights. Many of us need an advocate. I take less medication now than 15 yrs ago. I am never pain free and barely manage to care for myself. There is an answer. I could function better if I could get my pain level down even a little. The fact is there is no safe, effective treatment for pain. I would rather have a short time with less pain than 15 more yrs of agony. Should that not be my choice? If the FDA, DEA, and politicians had to feel the pain of Arachnoiditis for 1 day, they would sing a different tune. I urge patients to get educated before being injected. Once the damage is done, there is no going back. They will not tell you that Arachnoiditis is a risk of ESIs. Yet the FDA admits they cause it. I pray everyone suffering will find relief.
It seems as though these people who are making these decisions they are not doctors for people with chronic illnesses they dont suffer like we do every single day. Wish they could be in our shoes for about a week or two they would see what we are going through that should be treated to give us quality of life. politicians are not dr’s they do not know what we are feeling.
As a Chronic Pain Patient for well over 20 years I was prescribed opiates that work very well for me and any and every time my Dr wanted to try something new I agreed and we always ended up right back were we started. In 20 + years I can so very Truthfully I have never gotten HIGH from my medication as I take it as prescribed and if there is a day that it not working as well or helping with the Pain I call my doctor and he will adjust my does just for that day. I now live in Kentucky ( moved back to this my home state from Florida In April 2012) as of today date I can NOT get a doctor to even allow me to walk in their door and I must add Pain is BY FAR my only medical condition. So Due to a Law that the state of KY Passed the HB 1 Law AKA the “Pill Mill Bill” doctors here will not write pain Medication. I have called well over 200 and only 1 agreed to see me and it was not a pretty site. With Medical records in hand and I will be brief this is what I was told, I do NOT have Epilepsy as my IQ is above 60 and I am not in a wheelchair, I did NOT have a heart attack on March 9 2012, even though he had the hospital report in hand as I was to young, and this continued with every medical condition I have. I was appalled at the way I was treated by this man. I told him I would be with out all my medication that includes, Heart, BP, Thyroid, stomach, Seizure, Lyme disease just to name a few and when I told him I would be put into withdrawals if he did not write at least the seizure meds he told me no one has ever died from withdrawals. My point to all this is since the FDA has yet again and stepped in and are playing DOCTOR there will be MILLIONS who suffer, at least now patients who can not AFFORD to go to the DR every month due to having NO INS as Millions of Americans do not will Now suffer horrible Pain as now this is NO longer something their Doctor can call in for them. If every single Patient now has to go to the doctor every time they need this medication Thousands will NOT be able to afford to and I see the suicide rate, the rate of illicit drugs and more alcohol being consumed by people to just get some form of Pain relief……I think the FDA needs to go back to the table and re think this and think about the Millions it will affect every single day. I have yet to hear when this law goes into effect, and if anyone knows please let me and others know.
Dr. Fudin I want to Thank you again for bringing light to this as so many people have NO idea that this was even being done.I also want to Thank you and tell you how much I respect what you do. It is nice to know that there are still doctors who GENUINELY CARE FOR THEIR PATIENTS AND ALL CHRONIC PAIN PATIENTS.
Michael so true! I like how you wove in the parallels with the less bad’ crigas. I was thinking the other day that with so many wheat (breakfast cereals, cakes, etc.) ads in magazines it is as if some of the tobacco people have come over to the wheat side to make a living. The ads just jump off of practically every three pages in most women’s magazines. Dr. David Kessler recently wrote a book entitled The End of Overeating. He covered the addictive nature of the layering of fats, salts & sugars.’ Interestingly, I believe he pretty much ignored the problems with grains. At any rate, he had a good start re: the nature of addiction and how it relates to foods, but he also confuses people by not helping them realize how much easier it gets once grains are removed from the diet.One can eat a bit of dark chocolate here and there and make a few grain-free desserts without many problems. One can also remove sugars completely and have only a few quality carbohydrates (which is better, of course). At any rate, getting over the withdrawal symptoms associated with grain (particularly gluten) withdrawal and omitting these filler’ foods does so many amazing things for our bodies and minds. It isn’t talked about much in mainstream media, because so many people are owned’ by grain companies. The OWN network has a new program on food addiction and I suspect that the anti-nutrients and problems associated with grains will not come up. In a program on addiction one couldn’t possibly broach the subject because well omitting grains is one of the worst and most damaging addictions out there. Thank God the Paleo people have clarified this for us and given us the data we need for strengthening our resolve when strategizing for optimal health. I, for one, (now) need ample evidence before taking a drastic step with my diet. I qualify this, because I was not savvy enough when I became a vegetarian many years ago truly one of the worst mistakes I made (as grains were a staple of every meal). Keep up the great work this is an excellent post.
There needs to be physicians rights as well as patient rights. I understand there’s supposed to be a pain patients bill of rights but I don’t see it being used anymore. It seems the government can now do whatever it feels like doing. Well I hope that they can live with thereselves hauling patients and doctors off to jail that are just trying to make life a little better and keep the suffering to a minimum. Yes there may of been a few pill mills that needed taking down but this has got out of hand. Patients need these medications. And innocent people are paying the price for what a few have done.
Dr. Dole viewpoints are all well presented. However, talking about opioids in this social climate is like talking about the Affordable Care Act after Sarah Palin said that “death panels” were going to be created. An untruth that lives on now almost four years later. The following quote is from an article in this month’s Medical Care journal about health care myths: “Unfortunately, it may be difficult to overcome “motivated reasoning”—people’s biases toward their preexisting attitudes and beliefs, which often lead them to accept proattitudinal claims uncritically while resisting counter-attitudinal information. In politics, people are more likely to accept unsupported claims that are consistent with their partisan or ideological views while resisting counter-attitudinal corrections.” – Nyhan B, et al. The Hazards of correcting myths about health care reform. Medical Care 2013;51(2):127-132. Sadly this all too often is the case in healthcare as well.
mass hysteria
noun Psychology .
a condition affecting a group of persons, characterized by excitement or anxiety, irrational behavior or beliefs, or inexplicable symptoms of illness.
http://en.wikipedia.org/wiki/Mass_hysteria
Sensationalism is a type of editorial bias in mass media in which events and topics in news stories and pieces are over-hyped to increase viewership or readership numbers.[1] Sensationalism may include reporting about generally insignificant matters and events that don’t influence overall society and biased presentations of newsworthy topics in a sensationalist, trivial or tabloid manner.
http://en.wikipedia.org/wiki/Sensationalism
As long as these two are involved, we will continue to fight an uphill battle. We can have all the facts to back Prompt’s suggestion to the FDA, but until we can remove the negative sensationalism and the mass hysteria it creates, we will get nowhere. I think that T.H.I.N.K is a good guide to go by, for both doctor and patient.
We were given a brain to help guide the heart with logic and fact, how do we make our detractors start using their common sense instead of emotional response to the mis-information the media and others are feeding them?
I have always thought that if you’re having to take medication every day for the rest of your life, what difference does it make that the medication can be addictive? Why give a patient an anti-seizure med, an NSAID and an anti-depressant every day (all of which have multiple serious side effects) to treat their chronic pain when they could just take something that actually works – an opiate. I have taken more medication for pain relief that was not developed for pain relief all in an effort to find something, anything besides a narcotic to appease me. THEY DON’T WORK, I TELL YOU!
Please stop making patients already suffering with chronic pain pay for the actions of drug addicts.
Kimberly:
You state ” an anti-seizure med, an NSAID and an anti-depressant every day (all of which have multiple serious side effects)” To be fair, all medications have risks and benefits. The medications you mentioned all van be beneficial if prescribed for the correct type of pain, and in fact, often are more beneficial than opioids for certain pain syndromes. The standard of care these days is to use “rational polypharmacy”. That is, it is often most beneficial to use multiple medications that work at different sites within the body in order to maximize analgesic benefit and minimize side effects,
Dr Fudin,
Thank you for the explanation. At this time, I am going through some issues with insurance denying the med prescribed for my recently diagnosed polyneuropathy and being put in a position where I have to “prove” I can’t take a cheaper drug I have already been given years ago that had terrible side effects. I know that opiates will help the pain of my FM, DJD, and the polyneuropathy, but it’s like pulling teeth now to get this type of med since Kentucky’s HB1 went into effect. I have had great success with one anti-seizure med, Zonegran (sp), which nearly wiped out my migraines.
“We have met the enemy and they are us.” Yep, read that when I was home from Nam, or it was clearly, a topic everywhere I couldn’t get a job. LOL………BUT, I can’t say anything else, that Lindsey, and Nancy haven’t covered. I have ARACHNOIDITIS. And, before I say anything else. “IT’S NOT EVEN REGARDED AS A WORD, A DIAGNOSIS, etc. WHY? HELL, they underline it as “MISSPELLED”. Come on , give me a break. I was a MEDIC in the Nam. I thought, “Hell, I will never get caught up in this drug abuse. Well, I’m a GOOD, HONEST, BY THE BOOK PATIENT, and I dare anyone to go to my Doc’s office and say otherwise. I pee in a cup every other month. I bring my meds in and they are counted. WE ARE IN CHRONIC PAIN. I belong to COFWA. “Circle of friends with Arachnoiditis>” Again, with the misspelling. AW, sets’ me on fire!!!!!!
Doctor’s need to get much more educated about this horrible , and chronic pain disease, and treat it the right way. We feel bad enough!! AND, what about that oath that was taken. “Relieve the Patient’s pain.”…..They all took that oath. I took a similar oath as an RN. I don’t want to take these drugs. I SWEAR I DON’T, I wanna work, but it’s impossible. And, if it takes’ opioids to help me get through a day, like go to the store, or visit my Grandbaby, then so be it…….I guess I did say what I meant. haha. Thanks Lindsey and Nancy, I hope I just added to your wonderful letters……..Herb OR, Doc, as they call me!!
Do you all know that feeling you get when it comes time for your appointment and you think something bad is going to happen today.The day before your appointment you begin to worry my Pain Specialist is going to say I need to find another doctor because he is closing his practice in fear of prosecution from Medical Boards and the DEA . I get that feeling every time I see my doctor and after my appointment when I walk out of his office I think to myself I worried for no good reason. And each month the same thing happens.
Thing is I’ve been keeping a close eye on my doctor and I can tell he is getting impatient with all these uncertainties. If any changes take place this Thursday and Friday when these decisions are made I have a feeling he will just give up on pain management. This doctor has done nothing but help those in chronic pain and I can see the fear in his eyes and I just cant believe this guy went to medical school to become a Pain Specialist now he is concerned about his job.
Dr. Kolodny and his group PROP does not know the mess they are causing and he doesn’t care about those that suffer from chronic pain. He is just trying to make a name for himself . I’m glad I’m not him because if things change I don’t want to be the one looking over my shoulder each day. With all the crazy things that have happened in the past I would fear retaliation from some crazy guy wanting to get revenge because he lost his pain care.
I don’t wish bad luck or chronic pain upon Dr. Kolodny or anyone for that matter but if indeed things change and people go to suffering the outcome will be more pain patients just giving up on life. It will be a sad day in America for all that suffer from chronic pain and the doctors that treat them.
But then again I just don’t think the FDA will do this to all that suffer, there might be some changes and we will adapt to them. To change things so drastic like PROP wants them would be too much for all that suffer to handle and the doctors that prescribe for them.
This situation with prescribing opioids can be done without fear and with care and understanding like Dr.Dole has explained. Too much emotion has gone in to the prescribing of opioids and when all is said and done opioids are just another pill in the arsenal to gain control over chronic pain. When I look at the medications I have in my cabinet opioids are just another pill that helps with the chronic pain I suffer from just like the medication I take for blood pressure and anxiety.
Any medication can kill , its strange you mention warfarin Dr. Dole, just 6 months ago I lost my best friend to the over prescribing of warfarin and he bled in to his brain. The last few times I saw my buddy his nose bled for no apparent reason and I asked him why is this happening. Three days later he complained of headaches but the hospital thought he was complaining about pain so he could get more pain medication. They didn’t care to check his chart and it was too late, he died from too much blood thinner in his system. And just like that I lost my last best friend of 25 years, from too much warfarin, it sickens me each time I think of how he died.
Thank you so much for writing an informed, thoughtful piece on this topic. People that suffer from chronic pain will seek relief, but that is not the same as an addict seeking a drug. With a proper pain management plan and monitoring of effectiveness of medications I don’t see why opiods should be different from other medications that are prescribed. These medications have a purpose which helps people to live lives less inhibited by the pain they experience. Having an across the board negative response to prescribing a ‘narcotic’ is fear based and as we know most fear stems from ignorance. I hope other clinicians read this and adopt the T.H.I.N.K. plan. Furthermore, operate out of compassion. If doctors put themselves in patient shoes from time to time they would have a kinder
approach.
I like the comparison of the diabetic patient and the pain patient. I believe if there were definitive markers to indicate a patients pain like there are with diabetic testing, opioid medication wouldn’t be an issue. It appears that there are far more drug abusers than there are chronic pain patients. This is an uphill climb for the chronic pain patient. Also, genetics now plays a part. Patients who’ve been lucky enough to have a physician order genetic testing have found that they have a defective gene. This defect processes opioid as less effective requiring higher doses. I think this too plays a part in chronic pain. Hopefully the FDA will take everything into consideration and understand that by banning (changing schedule of opioids, 100mg/day for 90 day max,..etc.) they sentence chronic pain patients to an intolerable life. I see many lawsuits in the future if this comes to pass. Thank you Ernest for this insightful article.
Great post, Dr. Dole!
It is terrifying to me, as a patient with severe chronic pain, that these hearings, meetings, and POLICIES regarding the use of opioids….. are being driven by EMOTION. I understand that addiction is a powerful disease that touches the lives of many people. I also understand that some of the anti-opioid crowd may have good intentions. Unfortuneatly, people are judged on their ACTIONS, not their intentions. If these label changes are enacted, the FDA will be responsible for ruining countless lives. Then again, chronic pain patients have been so beaten down, judged, discriminated against, neglected, and shamed….that maybe no one will notice.