Taking opioid education seriously, doctoral students at the Albany College of Pharmacy & Health Sciences (ACPHS) currently enrolled in the Pain Management elective class were assigned the task of uploading a rebuttal to the FDA website with their opinion on opioid relabeling.
Each student received a grade on their ability to make a valid argument for or against the opioid label changes. Students were not graded on their opinion or which position they took; they were however graded on their ability to substantiate their recommendations with supportive evidence or lack thereof. In a previous assignment, this very class posted a blog that essentially verified that it’s not possible to determine an exact “morphine equivalent” dose because of a huge disparity in conversion literature and online calculators.
PY3 Student Julie Yu took this new assignment to another level when she prepared a newsletter of sorts. Because of her dedication to the topic, she was invited to write a guest blog which follows below. Ms. Yu’s classmates will have an opportunity to add their FDA submissions in the commentary area beneath her blog either anonymously or by name.
Ms. Julie Yu is an ACPHS Pharm.D Candidate, Class of 2014. She is enrolled in Dr. Fudin’s Pain Management Pharmacotherapy elective class (PHM551001).
Julie Yu writes…
Implications of Opioid Relabeling on Chronic Non-Cancer patients
Last week, the FDA finished collecting comments regarding the impact of opioid relabeling in treating chronic pain. A quick search on the internet brings up an overwhelming number of statistics completed by experts in the field. In an already busy conversation, my approach was to avoid robotically echoing studies that have been mentioned before. I thought it would be the best use of the FDA’s time to give my perspective as a pharmacy student. In the following commentary, I have briefly highlighted the main points that I have made to the FDA.
The United States has experienced a steady increase in opioid sales and related deaths every year. At first glance, this may lead some to think that opioid prescribing has become relaxed, or that opioid abuse is getting out of control. I was hesitant about taking these numbers at face value. After all, medications used to treat hypertension have also been increasing over the years. The cause of chronic pain often times cannot be predicted or prevented. Therefore, the number of opioid sales and deaths is expected to increase as the population increases. However, the diversion of opioids from one family member or friend to another can be prevented. Pharmacists have a critical responsibility as opioid educators to prevent many of these tragedies.
Out of all the proposed changes to labeling, establishing a maximum length of treatment is the one that makes the least sense to me. To illustrate my point, mood disorders and chronic pain share certain similarities. They are both conditions where treatment is heavily influenced by the patient’s perspective over laboratory values. The patient’s quality of life is significantly affected if they are inadequately treated with medication. Despite arising from different causes, many mood disorders are also treated with the same class of drugs. Patients with mood disorders are treated as individuals, and there is no rigidly defined maximum length of therapy. Why can’t we afford the same type of patient-centered approach to those with chronic pain? Chronic pain should be handled in a customized manner, as it is with every other medical condition.
Complementary and Alternative Medicine (CAM) can often be overlooked in the treatment of chronic pain, but it is a powerful adjunct to opioid therapy. Most patients in 2007 have used CAM to help alleviate pain in the neck, back, and joint areas. However, I think it is also important to be cognizant of the patient’s needs. Recommending yoga for a patient working 50 hours a week with 3 children is not practical or helpful. It is a combination of pharmacotherapy and CAM that provides the best control for chronic pain.
While reading several stories directly from patients, I cannot help but feel a kind of sadness. Unlike many other medical conditions, chronic pain patients are often met with hostility in an effort to live with diminished pain. Opioids have powerful analgesic properties, but they are also potentially addicting and life-threatening. As health care professionals, one of the best ways to get involved is to be active educators. Having an open conversation with all patients can simultaneously help prevent tragedies and appropriately help those who need it.
As always, comments are encouraged and welcomed!
Just so everyone knows, the “student jury” came back with a decision that the federal status of hydrocodone should remain unchanged based on all of the above presentations. Nice work students!
I am currently a 5th year pharmacy student at Albany College of Pharmacy and am concerned over the proposed position of PROP. PROP is a proposed plan to further regulate opioids. The main problems I have with these proposed changes is the fact that they want to limit the maximum daily dose of opioids to doses equivalent to 100mg of morphine for non cancer pain. They also want to limit the duration of opioid therapy to 90 days for non cancer patients.
First I think it is ridiculous for opioids to have a maximum daily dose. Most opioids are not toxic at dose dependent levels! This means that when you raise the opioid dose you will not see organ failure, unlike many over the counter pain medications including acetaminophen and NSAIDs. The only two opioids that have dose limiting side effects are meperidine and pentazocaine. Therefore putting a maximum daily dose on all opioids is just nonsensical. Not only is this proposed rule inappropriate but it is also very confusing. I have learned from experience in my pain management class that converting between opioids can be very difficult. For example the dosing conversion is different from a chronic opioid patient as compared to an opioid naïve patient. In our pain management class we had an assignment where we had to convert 100mg of morphine to other opioids using three different resources. The results showed just how difficult it was as many of the resources did not give the same numbers.
The other issue I have is proposition to change the duration of opioid therapy to 90 days for non cancer patient is another issue. The definition of chronic pain is that it lasts for 3 months or longer and that it does not have an identifiable pathology. This proposition would really hinder the treatment of chronic pain patients who do not have cancer. There are many patients who have chronic pain who are not cancer patients. Opioids can be very useful in the treatment of these patients. To put a limit of 90 days on the duration of therapy does not seem wise.
So why does PROP want to make these changes? They are overreacting to the increase in deaths caused to opioids so they want to decrease the prescribing of opioids. This is not a sound way of going about this issue. The key to the problem is education, for clinicians and patients. I am in my 5th year of pharmacy school, and if I hadn’t taken a pain management elective I would not understand many of the issues with opioids. For example, changing doses between morphine and methadone is really difficult. As the dose of morphine increases, the amount of methadone that you need to replace it decreases. There is not a linear dose relationship between these drugs. This education in opioids needs to be increased across the board. Doctor’s should also be very aware of what they are using. Opioids are great drugs but you don’t have to use them for every ache and pain that a patient has. Every doctor should know that there are other pain management drugs for pain that does not require the strength of opioids. Increased education in this topic is imperative and appropriate, rather than placing irresponsible laws that will end up hurting, true patient’s that have chronic pain, we should be trying to fix this issue at the source with increased education.
1. Fudin J. Opioid pain management: balancing risks and benefits Continuing Education Drug Topics 9/2011 Accessed 4/2013
2. Rowbotham, Michael C., Lisa Twilling, Pamela S. Davies, Lori Reisner, Kirk Taylor, and David Mohr. “The New England Journal of Medicine.” Oral Opioid Therapy for Chronic Peripheral and Central Neuropathic Pain â NEJM. The New England Journal of Medicine, 27 Mar. 2003. Web. 08 Feb. 2013.
The group Physicians for Responsible Opioid Prescribing (PROP) had good intentions when suggesting to re-label opioid analgesics in their letter to the FDA dated July 25, 2012. However, I believe that the way they are suggesting to re-label them is unfavorable and will not benefit those who suffer from chronic pain.
Their first point, to “strike the term ‘moderate’ from the indication for non-cancer pain” is a hard point to support. As mentioned in the response letter from the American Academy of Pain Medicine dated August 15, 2012, the only way to classify whether pain is moderate or severe is by subjective classification by the patient. There is no way to differentiate it otherwise. Another great point they brought up was that moderate to severe pain is used in many efficacy studies for opioids, not severe pain alone. PROP wanting to eliminate the “moderate” from the indication would not be able to be even considered without support from efficacy studies for opioid medications with “severe pain” as the new criterion.
PROP’s second recommended course of action was to “add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain”. This recommended change is flawed in several ways. One of the problems is that a 100mg equivalent of other opioids to morphine can vary depending on which opioid calculator is used. There are many different pharmacokinetic, pharmacodynamic, and pharmacogenetic effects, as well as different drug interactions and co-morbidities that determine what the most effective dose for a patient will be. Making 100mg morphine equivalent the cut-off is hard to support because that is not necessarily helping a patient with chronic non-cancer pain who has built up a tolerance to opioids and requires a higher dose to relieve their pain.
The last requested action that PROP mentioned was to “add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.” Like the American Academy of Pain Medicine response stated, “this change effectively eliminates the use of opioids for chronic noncancer pain”. I completely agree with their point of view and think putting a maximum duration on these medications would cause many patients to have a diminished quality of life, especially if their pain has previously been controlled for years on opioids.
As a student pharmacist, I feel very strongly about helping all patients by utilizing the medications we have to their maximum effect, provided they are still safe for the patient to use. In some chronic non-cancer pain cases, this will exceed what these requested actions offer. I do not agree with PROP’s vision because in my opinion, it is severely limiting our treatment options to patients. They will be limited based on the revised indication and proposed maximum daily dose and duration, and also based on the patient’s insurance company or financial situation.
I feel as though PROP has good intentions to try and reduce prescription misuse and abuse, but AAPM and PROMPT have some good points that truly need to be considered before any action is made on PROP’s requested actions.
Dr. fudin,
Thank you so much for educating this next generation of Pharmacists about opioids and their role in managing pain. As a patient who suffers from Intractable pain from a genetic connective tissue disorder (Ehlers-danlos Syndrome), reading Julie Yu’s post has given me some HOPE. Ms. Yu and the other students all have something that is usually lacking in regard to how medical professionals view people with pain conditions these days, and that is compassion. How refreshing to read her common sense views about opioid education, the cruelty of the 90 treatment limit, and her awareness that many patients in pain are often treated with hostility. No other chronic condition is met with the same lack of empathy and understanding. My hope for this group of bright young students is that they hang on to their views throughout their carriers and don’t become hardened by the few who will misuse their medication. The majority of us who require opioids to increase our quality of life and suffer less, have been dealt an awful sentence of daily suffering. We are just trying to survive, and can use all the compassion, empathy, and understanding they have to give. Keep up the good work. We need you!
Nancy,
Thank you for your kind comments. Yes, Julie and her student colleagues deserve kudos for their insight. You reminded me to be certain that I teach them about Ehlers-danlos Syndrome, which I will do in class tonight. Keep up the fight, as I am very doubtful at this point that any chance remains of adopting the PROP proposal.
Dr. fudin,
Thanks so much for teaching your students about Ehlers-danlos Syndrome (EDS). Many of us have suffered years of symptoms, joint dislocations, surgeries, eye & vision problems, heart issues, spine abnormalities, skin problems, debilitating pain….misdiagnosis after misdiagnosis, the list is endless, before being acurately diagnosed. In my case, it was my fourth rheumatologist who sent me to a geneticist for diagnosis at age 40. Though considered rare, EDS is extremely under diagnosed and under recognized in the medical community. Many people with EDS have been diagnosed with Psychiatric conditions and labelled as “drug seekers” because of our seemingly unrelated, exaggerated, and strange complaints….including severe pain.
EDNF.org is a great resource. Below is a link to a Medical Resource Guide for pain in EDS.
http://www.ednf.org/documents/MRGPainManagementS.pdf
Thanks for you help in spreading the word about Ehlers-danlos Syndrome.
Dear Nancy,
Thank you for your encouraging words. I was not aware of the pain that comes along with EDS, so I thank you for educating ME on this topic! I can’t imagine what it’s like to be in your shoes, but I do my best to listen so I CAN understand and make informed decisions. Take care.
This is great ! What great work and insight. Now I am going to search and understand EDS.
There has been much debate recently about opioid overdose and relabeling their usage to make them safer. There are three specific requests that have been made by the Prop group. These are 1 strike the term moderate from the indication for non-cancer pain 2 add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain and 3 add a maximum duration of 90-days for continuous (daily) use for non-cancer pain1. While I believe that their intentions are in the correct place I do not believe that the Prop group fully understands all aspects of what they are asking for.
The biggest problem I see with the first proposal is that categorization of pain is already very subjective. Taking moderate pain away from the indication may have no effect at all because when establishing pain level too many variables exist to establish a realistic threshold. When diagnosis pain, factors like patient reports and physician’s interpretation are utilized; either one of these could be easily skewed to justify a diagnosis of severe rather than moderate pain. Instead of seeing less utilization of opioids I feel this proposal may only see the increase of severe pain diagnoses.
For the second problem, having a maximum daily dose equivalent to 100 milligrams morphine brings about a myriad of issues. This arbitrary number that has been decided does not fully look at all of the mathematics behind medications. There exists numerous pharmacokinetic and pharmacodynamics properties that have not been established. For example, let’s look at the idea of an “equivalent” dose. Just try typing in opioid conversion into a search engine and you will see how variable this conversion can be. My class of fellow pharmD students undertook an exercise to do just this. We took multiple doses of multiple opioids and tried to convert into morphine.2 Even though we shared a knowledge base we still had at best a standard deviation of 20mg; you can only imagine what could happen when other practitioners become involved. The problem here is clearly not the medications themselves, as well it’s not even the providers fault; the issue lies in this system itself. Time and effort should be spent more on developing a universal opioid conversion algorithm that is significantly cautious in its conversions to and from one opioid to another.
This idea is only one of the problems with the second proposal. Other issues like interpersonal variability are not taken into account. It is well established that each person has a unique mechanics within their body3. One patient may have no effect at a dose of 50 mg of morphine where another may have toxic buildup of metabolites. I think the best was to the issue of opioid overdose is not to set a maximum daily dose but rather to hold our providers to a higher standard of care. A patient should be closely monitored on opioid therapy. They should be made aware of all the risks, fully educated on the appropriate way to take medications, and monitored for signs of abuse/improper use.
The third proposition strikes at me personally. This proposal would take away medication that has helped someone dear to me. They have been on chronic opioid therapy for almost five years now for lower back pain. I have watched them without this medication been unable to make it from the chair to standing. How can you say that taking this long term therapy away will help anything if you are decimating the quality of life for other patients? This problem is not only applicable to lower back pain, but patient who suffer from osteoarthritis, neuropathic pain, rheumatoid arthritis, along with others. There exist many patients who have chronic pain not associate with cancer; are these patients expected to have poor quality of life because they are only allowed three months of continuous treatment?
Opioids are not drugs to be feared but respected. There are clear problems that need to be addressed with the increase in overdose victims and the high abuse potential; however, the current proposals have apparent holes in their logical continuity. It is necessary to look at all proposals from every angle before determining if it is appropriate; here I believe you will see that there is need for alternative options.
Kenneth Musco, P3 Pharmacy Student
April 7th 2013
Pain Management FDA Submission
Pharm. D Candidate 2014 Albany College of Pharmacy and Health Sciences
Appropriate and Responsible Opioid Use for Chronic Pain
I am writing this letter in response to the FDA public hearing about obtaining information on issues pertaining to the use of opioid drugs in the treatment of chronic pain. I will mainly be focusing on the issue regarding the relabeling of opioids. Specifically addressing part B, the “Understanding and Adhering to the Labels of Pain-Treating Products.” One of the most controversial topics in the medical field these days is “the great opioid debate.” Before discussing the positions in this debate we must first look at why this debate is occurring now, when opioids have been used for many years and are one of the oldest medications. If one were to check a media source daily for news it would not be uncommon to see several headlines pertaining to opioid abuse or even death related to opioid use. The reason behind this is that opioids are the most commonly prescribed drugs in the United States of America. They can be addicting, cause severe side effects, and can be abused if not used responsibly. However, opioids remain one of the best classes of medications to treat chronic pain. The “fault” of these drugs lies not in the medication but in the people prescribing and using them.
One of the leading groups to advocate for more stringent opioid use and opioid relabeling is the Physicians for Responsible Opioid Prescribing (PROP). PROP believes the FDA indication for opioid use is too broad which can cause ineffective and unsafe treatment in patients, especially when high doses of opioids are being utilized. Currently the general FDA approved indication for opioid analgesics is for moderate to severe pain and may be used for an extended period of time. The PROP group requests three specific actions for changes to opioid analgesic labels. The first is that the term moderate be removed and that opioids should only be used for severe pain. The second is to add a maximum daily dose equivalent to 100mg of morphine for non-cancer pain. Finally, the third request is to add a maximum duration of 90 days for continuous use for non-cancer pain. Personally, I do not agree with these requests and I do not believe their claims can be adequately backed up with scientific data.
Before we look at the PROP argument it is important to realize that pain management is a very complex topic. Often times the people prescribing these opioids do not have the proper amount of knowledge. This is why many places have a pain management team that is comprised of many different health care providers such as physicians, pharmacists, psychologists, and others. By working together it can help create a more appropriate plan for chronic pain patients. Most of the “accidents” that occur with opioid use could have been avoided if a team was consulted rather than having just one medical professional handle it. The reason behind this is that there are many variables associated with opioid use. One of these variables is indication, some opioids work better than others for different types of pain. For example, most opioids do not work for neuropathic pain, however levorphanol, methadone, and a few others can work because they act on the NMDA receptor. The understanding of the mechanism of action and the pharmacokinetic profiles of these drugs is essential to their use. Not all health care providers have received this amount of knowledge. Physicians are trained to diagnose and prescribe while
pharmacists are trained to know how the medications work. This is why it is important to have a
pharmacist, especially one that specializes in pain management, as part of the pain team.
The first request for the PROP group is to get rid of the term “moderate” from the
indication of opioids for non-cancer pain. Classifying pain is a very subjective assessment tool
as there is no way to objectively classify pain. What one patient might describe as severe pain
might only be moderate pain in another patient with the same exact indication. By re-classifying
opioids to not include moderate pain, the number of patients with “severe” pain would probably
increase. It would not be fair to give one patient opioids and not give them to another if they are
having the same pain, just one patient is reporting it higher than another. One reason that PROP
might be calling for this change is to further reduce the amount of opioid prescriptions to reduce
the risk for misuse. It is worth noting that there are formulations of opioid medications that can
prevent abuse. There are also opioids that are less addicting than others. These things can be
used in patients that are more at risk for abusing opioids. For example, the product Embeda was
a combination of morphine and naloxone. The naloxone was contained in micro-beads at the
center of the capsule that would be released if the capsule was altered in any way and counteract
the potential for abuse. Although there were some problems with this product it is a step in the
right direction and more formulations are being developed with the same thought process.
The second point PROP seeks to change is adding a maximum daily dose equivalent to
100mg of morphine for non-cancer pain. One of the major problems with this change is the
amount of variability associated with dose equivalences. The equivalence of 100mg of morphine
to other opioids can have a varying range depending on which opioid source or calculator one
uses. For example, my colleagues and I have found that Hydrocodone 80mg oral correlated with
a range of 67 – 144mg of oral morphine. This is just one of the many opioids we converted using
different sources to determine how much variability we could find. Therefore setting a ceiling
dose of 100mg of morphine would allow for a range of doses to be used depending on which
source is used. Although higher doses of opioids correlate with a higher risk for death, this
association is a very complex one that must take into account the pharmacokinetic,
pharmacodynamics, and pharmacogenetic interactions. Several studies have found that it is safe
to titrate up the dose of opioids using the proper education, titration, and monitoring.
The final change requested by PROP is to add a maximum duration of 90 days for
continuous use for non-cancer pain. If this change were to be enacted it would essentially mean
that patients with non-cancer pain would not be able to utilize opioid therapy for an extended
period of time. For some patients there would not be many treatment options available for them
if they were not allowed to use opioids, especially due to the restrictions of many insurance
companies. This limitation on opioid use ignores several problems including palliative care. If a
non-cancer patient used their 90 day limit on opioids at some time in their life and was now a
candidate for palliative care it would be hard to tell that patient that they cannot receive
morphine to make them comfortable.
There is a need to address the appropriate and responsible use of opioid treatments for
patients with non-cancer chronic pain. However, I do not believe the radical points that PROP
brings up are the correct direction for this change. The assemblage of pain management centers
and teams that combine multiple, different health care providers is a viable way of reducing the
risk for opioid harm and misuse. Education and research can help improve opioid therapy by
developing different formulations that can negate abuse potential. Providers can also
individualize opioid therapy for patients, utilizing the proper opioid for the patient and providing
close monitoring and titration. In the end it comes down to providing the best care for each
patient which would not be achieved by relabeling opioids. Instead, we should be focusing our resources on educating both the general public and providers to provide the appropriate therapy for each patient.
Kenneth Musco, Student Pharmacist
References: 1. Brennan MJ, Fudin J, Perkins RJ. “Opioid Calculator.” Practical Pain Management. 2013. . (accessed 2013 Apr 7). 2. Algo. “Rapid Opiate Dose Equivalence Information”. Algo’s Research. (accessed 2013 Apr 7)
3. Kolodny A, Von Korff M, Orr R. FDA letter from physicians for responsible opioid prescribing. [homepage on the Internet]. 2013 [cited 2013 Apr 7]. Available from: https://paindr.com/wp-content/uploads/2012/08/2012-07-25_FDA-letter-from-physicians-for-responsible-opioid-prescribing.pdf
4. Fudin J, Brennan M, Passik S. PROMPT response letter. [homepage on the Internet]. No date [cited 2013 Apr 7]. Available from: https://paindr.com/wp-content/uploads/2012/08/FINAL_2012-08-17_PROMPT-RESPONSE-LETTER.pdf 5. Ballantyne JC, LaForge KS. Opioid dependence and addiction during opioid treatment of chronic pain. Pain. 2007;129(3):235-55. 6. Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at postoperative pain medication delivery, consumption and disposal in urological practice. The Journal of Urology. 2011;185:551-555. 7. Bohnert ASB, Valenstrein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305(13):1315-1321. 8. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-30. 9. Fudin, J, et al. The Answer is Morphine 100mg Equivalent Morphine Jeopardy. [homepage on the Internet]. No date [cited 2013 Apr 7]. Available from: https://paindr.com/the-answer-is-morphine-100mg-equivalent-morphine-jeopardy/.
In the past decade, there has been a significant increase in the use of opioids to manage chronic non-cancer pain (CNCP). Due to the increase in prescriptions, there has been an growth in the abuse of these medications. This has resulted in a health issue for the United States as the numbers opioid abuse have been significantly increasing the past decade. The danger is that these cases can result in significant adverse events such as respiratory depression and ultimately, death. Another issue is that the experimentation of these drugs are in increased occurrence amongst the youth of America. According to the article “Major increases in opioid analgesic abuse in the United States: concerns and strategies,” opioids are the “most frequently abused illicit drugs among secondary students.”1 With the pathway that addiction leads to, our youth are in significant trouble if the abuse continues. Evidence of this devastating effect can be seen in the Kroll family. Ms. Kroll, a speaker who appeared at the public hearing in regards to labeling opioids, spoke about her son. He was a successful student with the potential of accomplishing much in life. Ill struck the family when her son fell into opioid abuse which ultimately led to his death. One can imagine the heartache the family has to now go through because of this opioid addiction. 2 When it comes to the labeling of opioids, it is imperative to create stringent regulations on the marketing of these drugs. The Safe Prescribing Act of 2013 aims to change the scheduling of hydrocodone drugs from schedule III to schedule II. This can prevent the over prescribing of hydrocodone drugs from physicians which may ultimately decrease the abuse from patients. As a schedule III drug, the distribution of this drug is broader which may result in a higher incidence of being abused. As a schedule II drug, the penalty for illegally harboring this schedule of medications would be more severe. 3 Chronic pain is a very real issue that needs to be taken more seriously. With the change of scheduling, physicians can think of alternative options and make more customized therapy regimens for patients. Every patient’s pain is different. The severity of one patient’s pain can simply not equate to another even if they are both a “10” on the pain scale. This leap of scheduling change can prevent some patients from obtaining abusive drugs. Overall, if more stringent laws and classifications are placed on these medications, abuse may decrease. Labeling may be an effective way to deal with the issues that these medications potentially have. It may not resolve the issue of abuse but it would certainly decrease the growing epidemic that is taking the lives of people who abuse them.
References:
1) Compton, Wilson M., and Nora D. Volkow. “Major increases in opioid analgesic abuse in the United States: concerns and strategies.” Drug and alcohol dependence 81.2 (2006): 103-108.
2) Mcnair, Erick. United States. Federal Drug Administration. Impact of Approved Drug Labeling on Chronic Opioid Therapy Part 15 Meeting. Washington DC: Capital Recording Company, 2013. Web. .
3) “Drug epidemic — Hydrocodone reclassification a necessity.” Bluefield Daily Telegraph. 24 Mar 2013: n. page. Web. 8 Apr. 2013. .
Dear Sir or Madam,
My name is Genevieve Pelletreau and I am a P3 student attending Albany College of Pharmacy and Health Sciences. Due to your request for information on opioid medications, I have prepared a concise letter that briefly explains the different pain diagnoses and the role that opioids play in alleviating aforementioned pain. I have also briefly included a few reasons as to why I believe opioids are posing such an issue, addiction-wise, as well as two studies that have looked at physician involvement in pain management.
Section A: Pain Diagnoses
1. Pain can be diagnosed in several ways however, opioids work the best against two main types: nocioceptive and neuropathic pain.
a. Nocioceptive pain- occurs when tissues are damaged (such as a burn or cut) and is often described as sharp, throbbing, and/or achy.
i. Somatic- occurs in the skin, bones, and muscles and easily pinpointed.
ii. Visceral- occurs in the organs (such as organ cancer pain) and more of an area-wide pain and difficult to pinpoint
b. Neuropathic pain- occurs when a nerve is damaged or pinched and is often felt as numbness, tingling or a burning sensation.
2. Different Types of Pain
a. Acute: Short-term pain; can turn into chronic pain
i. When an injury occurs, a neurotransmitter called glutamate is released and attaches to a receptor called AMPA. When enough glutamate has accumulated, it continues to send the pain signal through the neurons, eventually reaching the brain.
b. Chronic: Long-term pain
i. Prolonged exposure to glutamate release and AMPA receptors being “turned on” causes the neurons to become polarized, thus activating NMDA receptors (through magnesium ions unplugging the receptors) and decreasing the pain threshold.
1. This is known as “central windup”
Section B: Opioids and How They Work
1. Opioids have three main receptors: mu, kappa, and delta.
a. Mu- responsible for analgesia, euphoria, respiratory depression, tolerance, dependence, immune suppression, and emesis (vomiting)
b. Kappa- responsible for analgesia, dysphoria, diuresis, myosis, and sedation
c. Delta- responsible for analgesia, immune stimulation, respiratory depression
2. All three receptors, when bound to by an opioid, cause an analgesic effect by inhibiting the release of neurotransmitters and preventing the pain signal from travelling through the nerves.
Opioids play an essential part in health care. They allow patients that were unable to live their lives because of chronic pain to enjoy the world again. They allow patients that are dying from cancer to do so without suffering and they provide patients who have had physical injury to heal comfortably. Yes, they are addictive; however, the benefits that opioids provide outweigh the risks that they pose. Patients need to be fully educated on the risks and not just one the side effects. Most physicians feel inadequate in their pain management abilities and many are unsure how to properly assess a patient’s risk for opioid abuse.1,2Physicians should be properly trained in pain management before they are allowed to prescribe opioids and should individualize the opioid therapy for each patient they see.2
While opioid tolerance and dependence will occur as the length of opioid treatment increases, this cannot be viewed as opioid addiction. The phrase “opioid abuse” would only occur when a patient is taking the medication for purely mental reasons and at the expense of their jobs, family and friends. This is not a result from opioid therapy so much as it is from lack of patient education, physician education, and inadequate patient monitoring. Therefore, in order to best manage opioid addiction, it is essential that we first manage opioid prescribing to ensure that patients are receiving the best care possible.
Thank you for your time,
Genevieve Pelletreau
PharmD, Class of 2014
Albany College of Pharmacy and Health Sciences
106 New Scotland Ave
Albany, NY 12208
References:
1. Colburn JL, Jasinski DR, Rastegar DA. Long-term opioid therapy, aberrant behaviors, and substance misuse: comparison of patients treated by resident and attending physicians in a general medical clinic. J Opioid Manag [Internet]. May-June 2012 [cited 2013 April 7]. 8(3):153-60. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22798175
2. Salinas GD, et al. Risk assessment and counseling behaviors of healthcare professionals managing patients with chronic pain: a national multifaceted assessment of physicians, pharmacists, and their patients. J Opioid Manag [Internet]. Sept-Oct 2012 [cited 2013 April 7]. 8(5):273-84. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23247904
As I read the responses from the Pharmacy students, I feel somewhat relieved. I was a medic in VN. I then went to Nursing School and was an RN for many years. Yes, I was hurt on the job. The staffing had been cut, and I was left alone with a new admission. His nose full of meth, and a chronic history of ‘paranoid psychotic behavior”. I had to stay alive by literally fighting with this patient for nearly an hour. Luckily I was very active, ran every day, used machines at the gym, and if it hadn’t of been for my good physical condition I would have died that night. Long story short, I was injured at L-4-5 S1. NOW, a lifelong battle with Arachnoiditis.
I have been on the same opoids for many years. It takes the edge off. Recently , within the last few months, the people from PROP have made, “THEIR” recommendations for how I should lead, or how I should limit myself in the taking of controlled medications. As I read their “crap” and don’t believe that very many took that oath that so many of us hold dear. Well, RNs take one too. How, can they deny honest people, people who have given their entire life to working, family life, etc. Every time something comes out about PROP and the FDA, I just read, and nearly get sick……..It’s the illegal dispensing of the opioids. It’s the pill mills. Its’ the people who acquire their meds illegally.
Hell, everyday I just wait for that phone call. One that says, “sorry Mr. Neeland, we can’t see you anymore.” I don’t want to die. BUT, if PROP get’s their way, then who will count the deaths, and set up the new stats regarding “HOW many deaths happened due to the new ruling by the FDA. Think about that PROP, if their are any of you reading this……..Thanks to the thoughtful, and brilliant letters that a few of the pharmacy students put here. The majority of the students really get it!!! If they take the opioids away from the honest, chronic pain patients,, non cancer, there will be a lot who die. I can’t live with what I have, without some relief. I refuse to live with that. I have tried…….thankyou, Herbert W. Neeland
Most physicians will be cautious about prescribing opiates and will only do so when they believe the benefits outweigh the risks. The vast majority of people who do use these medications never develop any problems as a result. Increasingly doctors are aware of how important it is to get the balance right between managing the pain and avoiding addiction. It is inhumane for people to be left in pain. Chronic pain makes life unbearable and to leave somebody in this state, when there is a remedy, would a form of cruelty and therefore unethical for a physician. This is why in some instances there will be justifiable reasons for prescribing opiate analgesia. Physicians will not deny people the medication they need, but they have an obligation to help the individual understand the risks involved , they also need a treatment plan that will help reduce these risks.
There has been great debate about the utilization and labeling of opioids in chronic pain care settings. This debate stirs a lot of controversy when attempting to define pain levels and types of pain when a concrete definition of these parameters may in fact not exist due to the subjectivity of their nature. Rather then focusing on these variables, it may be more valuable to our patients and us if we focused on techniques to prevent abuse in these populations by utilizing options such as Risk Evaluation Mitigation Systems (REMS) and drug level monitoring.
Joining the debate about the utilization of opioids in chronic non-‐cancer pain (CNCP) patients is a group of physicians calling themselves Physicians for Responsible Opioid Prescribing (PROP). They are imploring the FDA to limit the use of opioids in CNCP patients to those who are experiencing only “severe pain” leaving the “moderate pain” group to use only non-‐opioid pain management options. Not only do they want to limit opioid use to this population but they also want to put a cap on the use with 90 days being the maximum period an eligible patient can use opioids with no more than the equivalent of 100mg of morphine being used a day. Their reasoning for requesting such drastic and stringent restrictions is because of the increasing rates of opioid addiction, opioid related deaths and still increasing rates of opioid prescribing regardless of the lack of clinical evidence behind chronic opioid use in CNCP patients.
A group called Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT) was formed in their opposition. Their stance recognized the safety concern of opioids in these patients but found that it was more sensible to provide clinicians with adequate education, properly use the available REMS and closely monitor drug levels rather than not providing these patients with this option for controlling their pain. The argument presented by PROMPT is a strong one simply due to the fact that treatment could be extended to a larger population without a restriction to CNCP patients that fall into the severe category.
One of the most significant tools we have to fight against these increasing rates of opioid abuse and deaths is the REMS program. Through this system, safe and effective opioids can be extended to more populations with a higher assurance of proper use and less abuse. This plan is being put into effect by including medication guides, product information inserts for patients, and communication to assure safe use by patients. Another technique that can be used to deter aberrant behavior with opioids is therapeutic drug level monitoring. By testing respective levels for specifically prescribed opioids, you are able to determine if the patient is taking the medication as prescribed (Are they taking too much vs. Are they not taking it enough-‐ and if they are not then where is the remainder of their medication). For a patient that requires these medications for daily pain relief, these are two strategies that can be utilized to assure that they are not abusing their medications or distributing them throughout their community.

In closing, I feel that as healthcare providers we should have the competency to responsibly utilize opioids in chronic pain treatment groups while preventing their abuse. It is not a simple task to define different types of pain groups and their respective pain levels but society depends on us to provide them with adequate pain treatment and a balance between proper pain coverage and opioid abuse control must be struck. The argument proposed by PROP is nonsensical and will deny countless chronic pain patients the care they need to be comfortable on a daily basis.
My name is Abhishek Shrivastava and currently I am completing my fifth year (P3) of my Doctor of Pharmacy program at Albany College of Pharmacy and Health Sciences. The topic of opioid controversy came to my attention through Dr. Jeff Fudin’s pain management course I currently take. I have learned a great deal from him about pain and its pharmacotherapy involved. I have familiarized myself to PROPS arguments and the reasons they have. I understand that PROPS is proposing the relabeling of opioids and taking it as a benefit to society, however in my opinion I do not completely agree with them.
To start, pain is a universal concept that everyone has felt at some point in their life. However, the degree to which one feels pain is not universal. In other words, everybody has a different threshold for pain. It is also a fact that various cultures have different perceptions of pain. For example, the Middle Eastern culture fears pain and may exaggerate what they are feeling. Thus if the threshold for pain is varied for various people, it would not make sense to have a single universal cut off for morphine to be 100 mg or equivalent. In fact it would be immoral in my opinion to not allow a person, who is in great deal of pain, to get treatment for their suffering if he/she requires more than 100 mg morphine or its equivalent. As medical professions, we take an oath “to do no harm”, however if what PROPS is proposing gets approved, it will actually be doing more harm or have the potential to be harmful for the patient. In addition to this, it is very difficult to convert doses between opioids. There are many calculators physicians can use and even package inserts, however if one were to convert between opioids, they would realize that the answers would just give them a range and not a clear cut answer. This was demonstrated in a project my class did in Dr. Fudin’s pain management in which we were asked to convert between opioids to find equivalent dose for oral morphine. We used 2 different online sources and one primary literature. To prove my point let’s say we want to find out what is the equivalent dose of oral morphine when switching from 75 mcg/hr fentanyl patch. The lowest oral morphine equivalent dose found using the sources was 135 mg whereas the highest was 216 mg. This corresponds to a 46% percent difference! Therefore as one can see, it is nearly impossible to know for sure what the equivalent dose is when converting between these two opioids. In addition to this, I do not believe changing the label on the opioids would be beneficial either. Rather it would make it even tougher for patients that need the drug to have access. In my opinion, opioids are not the most dangerous drugs; there are drugs out there that have worse side effect profile than opioids, like the anticholinergics or even the NSAIDS for example. However, still there are no special warnings to the public about the use of these drugs. Moreover, the labeling change would make physicians unwilling to prescribe opioids for off label use which would again end up being detrimental for the patient.
Overall, I understand that the intentions of PROPS are for the good of the society, however the way they are going about it is totally inappropriate. Limiting patients that suffer from acute and/or chronic pain to just 100 mg morphine or its equivalent is just preposterous and silly. As a future pharmacist, I cannot condone this because it would be immoral to not treat a patient’s pain adequately if he/she requires more than the 100 mg morphine or its equivalent. Instead of restricting opioids, I think doctors and patients should be educated more about the use of opioids. The fact that long acting and extended release opioids are now part of the REMS program is a step in the right direction. I really hope PROPS takes a look at the big picture and realize what they propose is not really beneficial to the patients that require treatment with opioids. It is not the opioids that are the problem, it is the people who do not know how to use opioids appropriately that are the problem. Therefore it is imperative to educate the society rather than have the society suffer for their mistakes.
Thank you for your common sense response. Pain patients are exhausted, tired, worn flat out over worrying that their lives are under attack nearly daily. This PROP stuff is not heathly to them either, it just keeps continuing. Everyone is different. Each need individualized care and doses.
The population has grown very fast over the past few years so of course
Numbers are going to change and be higher every year and depending on circumstances driving this mess.
CAM may help someone in the very beginning of their pain journey but most who’ve had pain for many years have tried all that. It’s not going to do much except increase insurance premiums.
For patients having to fear of losing their quality of life every other month is taken a toll on their bodies even further. Stress of the pharmacy crawl, losing doctors due to their fear of DEA. This conversation of pain medicine has went over the TOP.
When is it going to end? People are going to do what they want far as addicts go. But for the Legitimate pain patients taking as prescribed, getting benefit, it’s not fair to them. A very pathetic sad situation in America for the past several years. The politics of it all has my feeling of what’s driving all this . Thanks to all who are standing up for innocent Patients who are benefiting from prescription medicine.
April 7, 2013
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville MD 20852
I’m writing this letter in reference to the trial “Impact of approved drug labeling on chronic opioid therapy.” I disagree with the proposed decision to remove ‘moderate’ from prescription opioid pain medications, and I strongly disagree with the proposed idea of changing opioid dosing to a maximum of 100mg per day. I do agree that many valid points are brought up regarding this case. Yes, prescription opioids are certainly overprescribed; and yes, many times they are prescribed to people who really shouldn’t be getting them; but adding more labeling and regulations to these products is not going to solve the issue at hand. Putting a maximum daily dose of 100mg on these products is going to do nothing but hurt patients who need higher doses of these medications in order to maintain normal day to day activities. If a true addict wants their fix of oxycodone or any other equivalent narcotic, a new sticker on the label isn’t going to stop them. He/she is going to find a way to get that prescription. On the other hand, I do agree that patients need to know how serious these medications are.
Regarding the testimonials presented in the “impact of drug labeling on chronic opioid therapy therapy part 15 meeting,” although extremely sad and unfortunate, each fatal event occurred due to a medication not being taken as prescribed, or a medication not being prescribed appropriately. In one case, a girl took heroin because she was abruptly cut off from her hydrocodone, in another testimonial a boy had taken his own life while he was being prescribed hydrocodone, xanax, and cymbalta; how was the conclusion drawn that it was the opioid that caused him to commit suicide? Although these stories were devastating, there were several other factors aside from the opioids leading to these patients’ demise. For one, mixing opioids with other medications especially benzodiazepines is very dangerous. When looking at opioid related deaths 40% of deaths occur in individuals abusing the drugs obtained through multiple prescriptions, doctor shopping, and drug diversion. The girl who turned to heroin after her doctor abruptly stopped her hydrocodone after 2 years of continued use could have had a different outcome if her doctor had followed the “Opioid Treatment Guidelines, Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain” guidelines. The guidelines state, “opioid treatment may require restructuring (including weaning or discontinuation of COT) if assessments indicate reduced analgesia, function, or quality of life; aberrant drug-related behaviors; or the presence of intolerable adverse effects.” These guidelines also state, “when opioid doses reach 200 mg daily of morphine (or equivalent), more frequent and intense monitoring is often appropriate, to sufficiently inform the decision to continue therapy or consider additional dose escalations.”
All in all, there is no doubt in my mind that America is in need of some sort of opioid reform. I do not believe this is going to be done by placing restrictions on the maximum dose of opioid given, (as every person responds differently), or by removing the use in moderate pain. The heart of the issue is opioid prescribing. Doctors need to be responsible for the prescriptions they are prescribing. They need to follow the treatment practice guidelines, and ensure adequate monitoring is used in patients. Opioids should not be first line treatment for everyday aches and pains, rather other options should be explored first. Although high risk medications, when prescribed and taken correctly opioids are safe and useful medications, but it takes collaboration between not only the patient and the doctor, but also the pharmacist and any other healthcare professionals involved to get to this point.
Sincerely,
Natale Dabulewicz
PharmD Candidate, 2014
Albany College of Pharmacy and Health Sciences
References:
Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P,6 Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O’Connor PG,Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C. FOR THE AMERICAN PAIN SOCIETY–AMERICAN ACADEMY OF PAIN MEDICINE OPIOIDS GUIDELINES PANEL Opioid Treatment Guidelines, Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. The Journal of Pain, Vol 10, No. 2 (February), 2009: pp 113-130.
Manchikanti L, Helm II S, Fellows B, Janata J. Opioid Epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
Recently, there has been much debate over the relabeling of opioid prescription drugs. A group called PROP has made several recommendations to the FDA to improve patient safety. A second group called PROMPT has also made many suggestions regarding the relabeling of opioids. The big difference between these suggestions is not only the amount of reference material provided by each group, but also the deep thought that was put into the suggestions. PROMPT pointed out a number of points that are crucial to the overall care of a patient who suffers from pain, and takes opioids to help that pain. Ensuring patient safety should atop everyone’s list. There are many things that PROMPT took into consideration that would better help the patient, compared to proposal presented by PROP.
Opioids are one of the few prescription medications I knew about before I started pharmacy school. Most Americans know that opioids are used to treat pain. They also know that opioids have a reputation for addiction, abuse, high street value and even death. However, does all of this bad reputation belong solely to the opioids? There is the patient who is taking the medication, the doctor who prescribed it, the pharmacist who dispensed it, and other healthcare providers who interact with the patient. Patients may also be taking other medications or have medical conditions that could cause problems while taking opioids. It is the responsibility of all health care professionals involved to make sure the patients get the proper education. The patient also has a responsibility to make sure that he or she is using the opioids as instructed, and to ask questions if they are not sure what to do.
Opioids are not the ideal therapy for every patient who is suffering from pain. Typically, they are not first line therapy. Other options like physical therapy, occupational therapy, NSAIDs, aspirin, acetaminophen, COX-2 inhibitors and tramadol are all recommended for use before opioids. This is something to consider when looking at prescribing patterns for opioids. Are the doctors trying these other therapies first, or bypassing them and starting with opioids? Sometimes, given certain comorbid states or other patient characteristic, these other options are not possible. The doctor-patient relationship can influence what and how the doctor prescribes to the patient. The doctor is the expert. Sometimes patients do not understand this and they demand to get a certain drug. This may lead to the doctor skipping all other options and prescribing the patient opioids, in the case of pain management.
PROP has suggested establishing a MDD of 100mg of morphine or its equivalent and this therapy should be no longer than 90-days. This suggestion has the potential to negatively impact every patient who needs opioid therapy to relieve their pain, or at least make it bearable. The extent to which they are impacted can range from annoyance to death. In a recent class assignment, my classmates and I determined the morphine equivalent for the following 5 opioids: hydrocodone 80mg, fentanyl 75mcg/hour transdermal patch, methadone 40mg, oxycodone 120mg, and hydromorphone 48mg. The results showed there is a large dosage range that can be calculated. As a class, we used 16 different sources and calculators to convert each of the afore mentioned opioids to its morphine equivalent. When Hydrocodone was converted to morphine, a 20mg standard deviation was present with an average of 88mg. With Fentanyl the standard deviation of morphine equivalent was 132mg with an average of 259mg, for methadone it was 33mg with 103mg as the average, oxycodone was 37mg with 176mg as the average and Hydromorphone was found to be 48mg with an average of 199mg.
Seeing the results of our class assignment, I was shocked! I did not think that the different opioid conversion references would differ that much. These tools are used in everyday practice by physicians when they want to convert patients from one opioid to the next. These findings could be more evidence to put with the growing list that supports the need for a new, successful opioid rotation method. In a case report by Webster and Fine, the need for a new paradigm for opioid rotation was stressed. Fifty to eighty percent of patients using opioids have found an opioid rotation helpful in better treating their pain. While this may be helpful, it could also be harmful if the physician is not properly converting and gives the patient a dose that is too high or even far too low. This could lead to several adverse effects like: constipation, hyperalgesia, respiratory depression, coma and even death if the dose given was too high. If the dose given was too low the patient may self-medicate relieve the pain, or go into withdrawal.
Where did PROP come up with the 90 day limit for opioid therapy? A patient’s pain is not going to go away, just because a patient took an opioid. As we know, medications are not magic, and in the case of opioids they are not a cure. The opioids simply work to decrease the symptoms of pain by intercepting the communication between the brain and the source of the pain. This effect will linger only as long as there is drug present in the body. It seems absurd for someone to think that after 90 days of continuous opioid therapy, a patient will no longer have pain. In fact, a patient’s pain may be worse after 90 days of therapy. While on therapy, pain will be subdued. When the patient stops taking opioids (or anything that can decrease pain) the pain will seem worse because they have gone so long will subdued pain. This could lead to patients buying opioids from street dealers to help relieve their pain or in some cases to fight off the signs of withdrawal from an abrupt discontinuation. Enforcing a 90-day limit on opioid therapy seems like a cruel and unusual torture for patients who are just looking for pain relief. Instead we should be focusing on the real problems of lack of education for both the patients and the providers.
Opioids are part of the REMS program. This program was established to make sure that high risk medications are being properly used. It aims to ensure that the patient gets proper education on their medication and to limit adverse effects. However, do we know how well this is being carried out? In a community pharmacy, the REMS paperwork (patient package insert) is printed out when the pharmacists checks the prescription. This does not guarantee that the patient will understand or even read this paperwork. If the pharmacist doesn’t take the time to talk to with the patient who is picking up the opioid, the patient may not be aware of the important aspects of the therapy. Although doctors communicate the information, many patients have no idea what their medicine is for and most do not know what to expect from the medication. With opioids, especially opioid naïve patients or a change in opioid, the patients need to be aware of the common side effects and know when to call 911 or their doctor. If the pharmacist or the doctor does not properly educate the patient, how do we expect the patient to properly and responsibly use their opioid medication?
While proper opioid use by patients is a large problem, so is proper opioid use by physicians. Webster and Fine wrote a review article “Review and Critique of Opioid Rotation Practices and Associated Risks of Toxicity”. This study concluded that the current system for opioid conversion needs to be evaluated and the flaws need to be accounted for. The problem is, we are lacking teamwork to assure that the end goal of adequate pain relief with little to no adverse effects is reached. This lack of teamwork has led to numerous publications stating ways to covert from one opioid to the next. What we really need is a set of guidelines that takes into account patient variability, opioid conversions and everything else important to pain management with opioids. Each patient is different. Not only in regards to pain and pain perception, but also when it comes to pharmacogenomics, pharmacokinetics and pharmacodynamics. These factors make it impossible to standardize a conversion method for every opioid. Instead, they make the process more complex for physicians and other health care professionals who may be involved in the process. Pharmacogenomics and pharmacokinetics, especially, can influence the effects opioids have in the body. If a patient is a “fast metabolizer” the effects of the drug will not last as long. These patients could have adequate pain relief, but it may not last as long as it should. However, if the patient is a “slow metabolizer” the effects of the drug will linger and last for a longer time. This could lead to too much drug being in the body at once, and the potential for more severe effects and overdose looms larger.
“Although most of the deaths are due to polysubstance abuse, opioids have been cited as a major factor contributing to many of the deaths.” This quote from Weber and Fine demonstrates how opioids get the blame, even when there are other substances that contributed to deaths as well. Keeping this in mind, it is shocking when patients realize that is not all the drugs fault. In a recent blog post, a patient who lost her husband to opioids and Xanax shares her views on her husband’s death. She shared her feelings about how she does not blame the drugs for her husband’s death. Instead she puts the blame where it belongs; in the hands of her late husband. She stated that she “spent nearly 8 years of my life flushing his meds down the toilet, throwing them out and pleading with him to stop using them so much.” She wondered why he took more than prescribed when his pain was under control.
It also seems like some responsibility falls on the shoulders of the doctor(s) involved in treating her husband. It was clear by what this widow described that her late husband had a problem with abusing his medications. However, when he went to the doctor to ask for more refills he was given these refills. It is prescribing practices like this that put patients at harm. If the doctor knew or even sensed that the patient he was treating had a substance abuse problem, he should have talked with the patient about it. Asked some simple questions like “how are you taking your opioid medication?” and “how well does this help your pain?” These questions could start a conversation that could enlighten healthcare providers to potential abuse of medication. This is an example of the importance of a strong relationship between patient and provider. If patients do not feel comfortable with the provider, they will not open up and tell them what is really going on.
The ultimate goal for any healthcare provider is to ensure the safety of the patients. Whether it be educating them, monitoring side effects, or making sure the dose and drug are appropriate for the patient it is all equally important. In the case of opioid prescribing, healthcare providers need to do a better job of making sure every patient has what they need to be successful with the therapy. Relabeling opioids will not help achieve this goal. The REMs program is a great addition to drug safety, but may not be doing any good if it is not properly enforced. Opioid rotation is helpful in 50-80% of cases to help the patients achieve better pain relief. Unfortunately the conversions do not always yield the best results. Opioid conversions are something that should be further studied so we can establish a universal standard for all healthcare professionals to utilize. This will not only make it easier to convert from one opioid to the next, but it will make it safer for the patients.
References
1) Kolodny A, Von Korff M, Orr R. FDA letter from physicians for responsible opioid prescribing. [homepage on the Internet]. 2013 [cited 2013 Apr 7]. Available from: https://paindr.com/wp-content/uploads/2012/08/2012-07-25_FDA-letter-from-physicians-for-responsible-opioid-prescribing.pdf
2) Fudin J, Brennan M, Passik S. PROMPT response letter. [homepage on the Internet]. No date [cited 2013 Apr 7]. Available from: https://paindr.com/wp-content/uploads/2012/08/FINAL_2012-08-17_PROMPT-RESPONSE-LETTER.pdf
3) National Guideline Clearinghouse | Pain Management Guideline. [database on the Internet].
4) 2011 [cited 2013 Apr 7]. Available from: http://guideline.gov/content.aspx?id=9744#Section420
5) Fudin J. The Answer is Morphine 100mg Equivalent – Morphine Jeopardy | Dr. Jeffrey Fudin. [homepage on the Internet]. 2013 Available from: https://paindr.com/the-answer-is-morphine-100mg-equivalent-morphine-jeopardy
6) Webster LR, Fine PG. Review and Critique of Opioid Rotation Practices and Associated Risks of 4) Toxicity. Pain Medicine 2012; 13:562-570
7) Proc. Nati. Acad. Sci. USA Vol. 91, pp. 1983-1984, March 1994
8) Fudin J. The drugs didn’t do this..he did! | Dr. Jeffrey Fudin. [homepage on the Internet]. 2013 Available from: https://paindr.com/irresponsible-drug-use/
Statistics from the CDC indicate that drug overdoses in the United States cause approximately 36,450 deaths. Of those deaths nearly 14,800 or 73.8% involved opioid pain relievers. Interestingly enough states with lower death rates also had lower rates of nonmedical use of opioids and opioid related sales.1 This trend is still currently increasing and so something must be done to address the worsening opioid abuse in the United States. To address this issue a petition from the Physicians for Responsible Opioid Prescribing (PROP) was issued by 37 physicians in pain management and other specialties. This petition was addressed to the FDA to limit drug use solely to an indication for severe pain, with a maximum of 90 days’ supply and equivalent of 100 mg of daily morphine. The petition stated that “unfortunately many clinicians are under the false impression that chronic opioid therapy (COT) is an evidence-based treatment for chronic noncancer pain…”. There may be some validity to this statement. A review journal article by Jane C. Ballantyne, MD, FRCA and Naomi S. Shin, BA addresses the efficacy of opioid use for chronic pain.2 The results from this review indicated opioid use in chronic patients is initially efficacious, however it may not be sustained during continuous and long-term opioid therapy. The authors concluded more research be done to address chronic opioid use beyond initial efficacy. Based off this review and the rising death tools related to opioid use the PROP petition may have some validity. However the stipulations such as a 90 day supply rule and equivalent of 100 mg of daily morphine are not acceptable for all patients. Exclusions such as these may be detrimental to patients who depend on these medications for pain conditions. While the PROP petition does attempt to address the rising rates of opioid related death with such restrictions, a more practical approach needs to be utilized. The benefits and risks must be weighed on an individual patient to patient basis.
PROP has less than five pain management physicians who signed the original petition. In fact, I think Dr. Jane Ballantyne is the only pain management physician who signed the original petition. A majority of the doctors who signed the PROP petition are psychiatrists, addiction specialists, or epidemiologists.
Andy,
Thank you for pointing this out. Also of important note is that both Dr. Ballantyne and Dr. Chou were authors with me on the 2009 APS – AAPM Guidelines; Opioid Treatment Guidelines, Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. Moreover, there is a statement within that document, ““Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain.”
I support and agree with Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT) position. We should educate healthcare professionals on the use opioids as opposed to accepting Physicians for Responsible Opioid Prescribing (PROP) goal to regulate the prescribing of opioids. Currently I am a P3 student at the Albany College of Pharmacy and Health Sciences with limited experience on the use of opioids. However after listening to the FDA panel, coined the “Great Opioid Debate”, and reading several papers about the efficacy and adverse effects of opioids one thing is certain, PROP’s intentions are good but maybe the way of bringing awareness and change needs a bit of guidance. As healthcare professionals, we have to realize if the change we are presenting to the FDA will make a difference long term. In my opinion education is a huge factor that needs to be addressed. Also is it ethically correct to regulate prescribing opioids to patients?
Education is a huge part of the controversy and problem that have been going on the past years. There is no doubt that the rate of prescribing opioids as well as opioid-related addictions and deaths have increased in this nation. However rather then regulating the amount and restricting the number of days a patient is on an opioid should we not educate our prescribers and patients more? As a pharmacy student I can say that pain management, as part of the main curricula of the Pharm D program is not detailed at all. I am currently taking a Pain management elective and I can honestly say my colleagues and I have learned a great deal about this topic. With this knowledge I can understand the importance of this topic and state that education is a huge factor at least for pharmacy students. PROP is requesting the FDA that no more than the equivalent of 100 mg of morphine daily should be given. After almost finishing a semester of pain management, I have seen different variations of dose conversion charts from multiple reliable resources. It is safe to say that there is no consistency in opioid conversion. I understand that PROP is trying to create a universal standardized guide for pain management. Pain, however, is not a clear-cut disease state but rather therapy approaches must be individualized based on the patient’s pain threshold, condition, financial status and lifestyle. In addition, PROP wants to restrict the amount of opioids to a maximum of 90 days. This is not reasonable or realistic especially if patients suffer from chronic pain. I think the FDA’s risk evaluation and mitigation strategy (REMS) is a good step to the right direction rather then PROP proposal. REMS brings awareness to the issue and allows prescribers to understand their actions.
Ethically the PROP proposal, in my opinion, causes more harm then good. As healthcare professionals we have sworn to care for our patients to the best of our abilities. By regulating opioids we are restricting patients to drugs that are effective in treating pain. If we hypothetically create a scenario in which a patient needs pain medication for longer then 90 days, can we refuse giving them treatment that has the potential to improve their quality of life? I can understand that adverse effects (constipation, dry mouth, etc.) and addiction potential from chronic pain medication therapy is a burden however they can be treated and avoided. The question that we should instead focus on is: can we justify restricting therapy to our patients? As a future pharmacist, I vote no! If PROP’s proposal goes into effect, we will create a greater issue of incorrectly treating our patients. I fear that patients will resort to illicit drugs if we deprive them of opioids.
I support PROMPT goals to educate prescribers about opioids. On the other hand, PROP’s proposal has good intentions but it’s ethically wrong and does not fix the root of the problem. Opioids can be dangerous drugs if not handled appropriately but on the other hand, they can be effective in treating pain. Rather then restricting the use of opioids, healthcare providers should learn more about opioid effects on the human body.
As a pharmacy student, I am taught on a daily basis to treat the whole patient rather than the disease. Building on that idea, professors drill in our minds that there are genetic variations between patients. Hence, the birth of pharmacogenomics. It seems backwards to put such strict restrictions on opioids when other fields of medicine are advancing forward with the idea of personalized therapy especially when the basis of adequate pain management relies on individual patient responses to therapy.
Untreated pain can be a debilitating condition. Often many of these patients cannot work and forced to depend on social assistance. How can it possibly be fair that opioid use be limited to patients suffering from severe pain and/or cancer? Additionally, every person has a different pain threshold so a maximum daily dose may be used as a guide but should not be conclusive. The conversion between different opioids is not simple and often relies on an understanding of pharmacokinetic and pharmacodynamics properties which are often misunderstood leading to incorrect dose conversions1,2. Many references are not consistent when it comes to equivalent dosing and therefore, a conclusive maximum daily dose can be truly limiting and even life-threatening. In fact, I completed an assignment for my pain management class that showed inconsistencies of opioid conversions. All of my classmates found similar results when completing their assignments3.
Arguments for changing the labeling on opioid medications state that prescribing of opioids has increased since the 90s and that the CDC noted a 94% increase in emergency department visits between 2004 and 2009 linked to these drugs4. The solution to this evident epidemic lies within modifying the medical, pharmacy, and nursing school curricula. A focus on proper pain management is often left behind with the slim possibility of briefly being touched upon. Many health professionals graduate and enter the workforce with no understanding on proper pain management meanwhile, they are recommending, prescribing, and administering opioids frequently. There is wholesome evidence for the use and efficacy of opioids in non-cancer pain patients1. Pain also will never cease to be a leading complaint of patients. Some sort of complaint of pain provokes most physician visits whether it is minor or major. Until I voluntarily chose to take an ELECTIVE class in pain management, I was utterly clueless about how to properly treat pain. It should be noted that my elective class has about 20 students. The FDA should ideally concentrate its efforts in advocating educating healthcare professionals about pain management and proper opioid prescribing practices.
The last point I’d like to bring up is that the patient needs to take responsibility for their opioid use. If the practitioner is prescribing an appropriate opioid dose and thoroughly explains the consequences of taking more than what is recommended but the patient still makes the conscious choice to misuse their opioid regimen, the responsibility is on the patient. The practitioner has the responsibility of ensuring that the opioid dose prescribed is correct for the specific patient meanwhile the patient is also responsible for adhering to the prescribed regimen. It is vital to understand that the addicted patient will demonstrate one or more of the 4Cs: impaired Control over drug use, Compulsive use, Continued use despite harm, and Craving1. The addicted patient is more concerned with obtaining opioids than with treating their pain. A change in labeling of opioids will not change this type of attitude but may actually increase creative efforts to obtain opioids. It is unfair to the majority of patients who actually need opioid medications to treat their untreated pain because minorities of patients have made an intentional decision to abuse their medications.
In conclusion, I do NOT agree that opioid labeling should be changed. I recognize that opioid addiction, overdose, and diversion are serious and occurring increasingly more frequently. I also empathize with families of loved ones who were lost opioid misuse. However, I believe that opioids can truly help patients manage their pain if BOTH the practitioner and patient enter an appropriate agreement that addresses correct dosing prescribing and adherence. Finally, I believe that increasing the education of proper pain management practices can train healthcare professionals how to prescribe opioids safely while also being able to recognize signs of opioid abuse and misuse.