Hi, my name is Patrick Carter, I'm the Assistant Director of the University of Michigan Injury Prevention Center. Today, we'll be talking about the opioid epidemic and guidelines for safer prescribing practices. When we think about the opioid epidemic there are many ways to address this problem, you can focus on supply and demand through prescribing practices, PDMPs, and diversion control. Harm reduction through community and patient education, naloxone availability, and needle exchange, or expanded access to treatment. Today we'll be focusing primarily around the practices of safer prescribing, in the past several years the Centers for Disease Control has developed a set of guidelines around safer prescribing practices for chronic pain management. These guidelines were developed because previous guidelines had been inconsistent, they were several years old and there was a need for clear and consistent guidelines that could be used across all states. The primary audience for the chronic opiate prescribing guidelines is primary care providers, nurse practitioners, and physicians assistants. One of the questions that often comes up is, why to focus around primary care providers? Primary care providers commonly treat non-cancer related pain and account for 50% of all prescriptions dispensed throughout the United States, for this reason the CDC chose to focus specifically around primary care providing practices. The CDC's prescribing guidelines are focused around 12 recommendations within three categories. The first category is determining when to initiate or continue opioid use in the treatment of chronic pain. The second category is opiate selection, dosage, duration, follow-up, and discontinuation, and the third category is assessing the risks and addressing all the harms of opiate related use. Recommendation one from the CDC is that non-pharmacological therapies and non-opioid pharmacologic therapies are preferred for the treatment of chronic pain to the use of opioids. This primarily stems from a systematic review that was done that showed there was not sufficient evidence to determine that there was effectiveness for a long time term opiate therapy for the treatment of chronic pain. And that evidence actually supported a dose-dependent risk for serious harms related to chronic opioid use, as such the CDC recommends that opiate therapy should be considered only if the expected benefits for pain and function are anticipated to outweigh the risks. Non-pharmacological therapies that have been shown to be effective include, exercise, behavioral therapy, such as cognitive behavioral therapy, and interdisciplinary rehabilitation. In addition, non-opiate pharmacological therapies include such medicines as non-steroidal anti-inflammatories, acetaminophen, topical medication, such as lidocaine and capsaicin, and other second line therapies, including serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants. Recommendation number two from the CDC includes establishing realistic goals for patient treatment in pain before initiating opiate therapy, and to discuss how and when opiates will be discontinued if they do not prove to be beneficial for the patient's pain. Recommendation three includes discussing the risks and the potential benefits of opiate therapy, both before beginning treatment and periodically throughout the treatment period. Thus, before initiating opioid therapy for the treatment of chronic pain, the CDC recommends determining how effectiveness will be evaluated and establishing treatment goals with patients. Often using written treatment plans where the course of treatment can be outlined, and the expectations for both monitoring and the plan for how to discontinue or tapering the medication in the long term can be determined. The treatment goals should include both pain relief, as well as improving functional status, including the ability for patients to do things such as returning to work, walking the dog, and returning to a normal functional life. Clinician should also have an exit strategy if therapy's proved to be unsuccessful, this includes a plan for tapering and discontinuing the opioid medications. These should be discussed with the patient upfront, prior to initiating treatment therapy. The CDC also recommends emphasizing the risks and the benefits of opioid treatment prior to initiating prescribing. Patients often highlight in prior studies that they feel they receive a lack of information regarding opioids, as well as the opiate related concerns and safety of medications. Clinicians should be realistic and explicit about the benefits, including the role of opiates in short-term pain management, but also be realistic that there's no evidence that opiates improve pain and function with long-term use, and that complete relief of pain is unlikely. Clinicians should focus on improving both pain and function of the patient. Clinicians should discuss with the patient both the potential for serious adverse effects, including things such as respiratory depression and opioid use disorder development, as well as the increased risk of opiate when higher doses are used, or when opioid medications are combined with other medications, such as benzodiazepines or alcohol. Clinician should also inform the patient about common adverse effects, including constipation, tolerance, and withdrawal symptoms from decreasing opiate use. In addition, clinicians should inform patients about the risks of opiates and driving, as well as the need for safe storage of medications and safe disposal of medications at the end of the treatment period. For recommendation four, that when beginning opioid therapy immediate release opioid should be prescribed instead of extended release or long-acting opioid medications. Recommendation five suggest that when beginning opioid treatment clinicians should start with the lowest effective dose, and use caution with any increases in dose. Reassess the patient frequently regarding their pain and function, and increase the frequency of follow-ups as the dosage is increased. The evidence for recommendation four from the CDC is based on a study that looked at immediate release acting opioids versus extended-release opioid therapy. That found that the risk of opioid overdose was higher in patients who initiated with longer-acting opioid medications, as opposed to those who began with immediate release acting opioids, especially during the first two weeks of therapy. The study also found that there was no evidence that extended release or long-acting opioids were safer or more effective for the management of chronic pain. As such, the current recommendation is that extended release and long-acting medications should be reserved for those with severe continuous pain in opioid tolerant patients, when alternative treatment options are not effective. Initial opioid choice should start with immediate release acting agents. The rationale behind recommendation five, that clinicians should start with the lowest effective dose and increase slowly, has to do with a number of studies that have examined the overall dosage of opioid therapy and the risk of overdose. These Studies have found collectively that the risk of overdose increases significantly as patients are prescribed above 50 morphine milliequivalents per day. And that the risk even increases even more once patients are prescribed above 100 morphine milliequivalents per day. In fact, doses that are at, or above, the 15 morphine milliequivalents per day dosage, double the risk of overdose. Recommendation number six from the CDC is regarding the treatment of acute pain, the CDC recommends that for acute pain treatment with opioids the lowest dosage should be used with the shortest duration of time. They recommend approximately three to five days or less will be sufficient for the treatment of an episode of acute pain, and more than seven days will rarely be needed. Recommendation seven from the CDC is regarding follow-up, this recommendation states that clinicians should evaluate the benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or of a dose escalation. They should continue to re-evaluate the use of the therapy with patients every three months, and determine whether or not the patient is experiencing any potential harms. And whether if the benefits do not outweigh the harms, whether additional alternative treatments, or lowering the dosage, or tapering the medication should be considered. When considering the use of opioids for acute pain there were two retrospective studies that found that in patients who received an opioid prescription for the acute treatment of pain, including for low back pain and post-surgical pain, there was a greater risk of long-term use of opioid therapy once you succeeded five to seven days. Based on these studies, the CDC recommends that non-opioid related therapies, such as non-steroidal anti-inflammatories, and non-pharmacological therapies should be used as first line treatment for acute pain. However, if opioids are used for the treatment of acute pain, short-acting opioids should be used for a duration of less than three to five days and rarely for longer than seven days. If patients are requiring treatment for longer than a three to five day period, clinicians should consider re-evaluating the patient and confirming the initial diagnosis, and, or, adjusting management accordingly. Clinicians should also consider several additional recommendations, they should not prescribe extended-release or long-acting opioids for the treatment of acute pain. For patients who are already on opioid therapy they should consider the co-prescription of Naloxone to avoid opioid related harm, such as overdose. They should avoid co-prescribing opioid therapy for acute pain in the setting where the patient is already on a course of benzodiazepines, and they should utilize their states PDMP in accordance with their state laws regarding opioid prescribing. With regards to the CDC's recommendation regarding the frequency of follow-up, there is no good evidence regarding how often to monitor patients. What is known is that at three months of therapy there's a significant increased risk for developing an opioid use disorder. And that the risk of overdose with extended-release and long-acting opioids is highest during the first two weeks of therapy, and that patients without significant relief at one month are unlikely to experience any relief at six months. Thus, the CDC currently recommends re-evaluating patients within one to four weeks of starting long-term therapy or of changes in a dosage. The greatest potential to mitigate the risk for an opiate use disorder is if follow-up is in that first three month period. Clinicians should also consider sooner follow-up for extended-release and long-acting opioids and particularly for Methadone. Clinicians should re-evaluate opioid therapy every three months, at these follow-up time points they should continue to assess whether the opioids are meeting the patient's treatment goals, that is whether the benefits are continuing to outweigh the risks. They should assess whether or not the patient has experienced any common or serious adverse events related to their opioid use, and they should assess whether or not the opioid dosage can be reduced or discontinued. Recommendation eight from the CDC states, that before starting and periodically during the continuation of long-term opioid therapy, clinicians should evaluate for risk factors for opioid related harms, including overdose. Specifically, clinicians should consider who to co-prescribe naloxone for, patients at potential risk for opioid overdose and opioid related harms should receive a prescription for naloxone at the time that they receive their opioid prescription. This includes patients with a prior overdose history, patients who have had substance abuse disorders, patients who are on higher doses of opioids, including those above 50 morphine milliequivalents per day due to the risk of overdose. Patients who are being prescribed long-term opioid therapy and have underlying medical diseases, including things such as severe obstructive sleep apnea, poorly controlled respiratory diseases, renal or hepatic dysfunction. Underlying alcohol and benzodiazepine use or abuse, poorly controlled depression, or special populations that are at higher risk, including elderly patients and patients who are pregnant. Clinicians should also consider co-prescribing naloxone in the setting where patients are resuming their opioid use after a period of abstinence, or if patients have recently had a period of abstinence, such as incarceration in prison. Clinicians should also consider co-prescribine naloxone to patients who live in rural settings where access to EMS services may be more difficult. Naloxone comes in three formulations, including an auto-injector format, intra-nasal, intra-muscular, and often is available in kits that include instructions on use and training for both the patient and their family member. Recommendation nine from the CDC, includes reviewing the patient's history of controlled substance prescriptions using the state's PDMP. This should occur both at the beginning of opioid therapy and periodically throughout the course of therapy. Recommendation ten includes, when prescribing opioids for chronic pain to utilize urine drug screening before initiating opioid therapy, and to consider utilizing urine drug screens at least annually to assess for other prescribed medications and the use of illicit drugs. PDMPs are prescription drug monitoring programs, these are electronic systems that digitally store, monitor, and analyze controlled substance dispensing data. There are currently PDMPs in 49 states, the PDMP collects data both on the patient and the prescriber, and the medication that is prescribed. PDMPs can be accessed by prescribing clinicians, pharmacies, law enforcement, and State Medical Boards. PDMPs are used throughout the states as a both a surveillance and evaluation tool, and to identify both outlier prescribers and patients who are receiving excessive doses of opioids. PDMPs have been shown to have effectiveness in reducing excessive opioid prescribing in several states. However, findings regarding the effect on overdose mortality are somewhat more mixed, and further evidence is needed to assess their overall impact on mortality. One question that often comes up with regards to prescription drug monitoring programs is, what information are clinicians looking for when they access the system? We know that most fatal overdoses are associated with patients who receive opioids from multiple providers, and who are on high doses of opioid therapy chronically. Thus, clinicians when they access the PDMP should be assessing whether or not the patient is currently on a high dosage of medication already, whether they're receiving opioid therapies from multiple providers. And, or, whether or not there is the potential for the opioids to interact with other medications, such as benzodiazepines, to increase the risk of overdose. In fact, recommendation 11 from the CDC, specifically around co-prescribing opioid medications with benzodiazepines, and avoiding the co-prescribing of these two medications whenever possible, given the increase risk of overdose. The CDC recommends considering possible other alternatives for pain control, including cognitive behavioral therapy, specific anti-depressants that are approved for anxiety, or other non-benzodiazepine medications. CDC recommends coordinated care with other mental health professionals when possible to avoid co-prescribing these medications with increased risk of overdose. The final recommendation from the CDC, involves clinicians offering or arranging evidence-based treatment, including medication-assisted therapy with buprenorphine or methadone, in combination with behavioral therapies for patients who have an opioid use disorder. Medication assisted treatment is a comprehensive method of addressing opioid use disorders by combining medications, behavioral counseling, and care management or case management services. Medications that are used in medication assisted treatment, include Methadone, Buprenorphine, and naltrexone. Medication assisted treatment has been shown to improve retention in substance use treatment programs, has been shown to reduce opioid use and misuse, to reduce co-occurring criminal activity. To reduce the risk of overdose and overdose deaths, to reduce the risk of HIV, Hep B, and Hep C infections from intravenous drug use, and increase overall social functioning and rates of employment. Thus, clinicians should consider the use of medication assisted treatment or a referral to medication assisted treatment programs in any patient who they suspect of having an opioid use disorder, or meets diagnostic criteria for an opioid use disorder. In addition to the materials we've discussed today in the video, the CDC has more information regarding safer opioid prescribing guidelines on their website. This information can be found in the supplemental materials for this video. We feel it's important for both clinicians and non-clinicians to be aware of the CDC prescribing guidelines, especially as they interact with patients.