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
- BOP PDMP reports
- Opioid screening tools?
- 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”.
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.