Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis; Public Workshop; Request for Comments
OPEN Request for Comments Public Workshop in an Evolving Opioid Crisis Evaluation and Mitigation Strategy (REMS) Prescriber Education Through a Risk Reconsidering Mandatory Opioid CDER
2021-11-02 2021-12-06 2021-12-06 2021-10-25 2021-12-01 2021-11-26 2021-11-29 2021-12-02 2021-09-23 2021-10-20
FDA-2021-N-0951-0023 FDA-2021-N-0951-0038 FDA-2021-N-0951-0054 FDA-2021-N-0951-0021 FDA-2021-N-0951-0031 FDA-2021-N-0951-0027 FDA-2021-N-0951-0029 FDA-2021-N-0951-0035 FDA-2021-N-0951-0002 FDA-2021-N-0951-0020
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https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0023 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0038 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0054 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0021 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0031 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0027 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0029 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0035 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0002 https://api.regulations.gov/v4/comments/FDA-2021-N-0951-0020
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1-Mandatory education improves appropriate opioid prescribing by teaching the prescriber indications and contraindications for specific opioids. This also leads the prescriber to do their own research on the opioid to ensure they are putting these drugs in the right hands. It would also encourage the prescriber to ask more questions to the patient, to identify risk of misuse prior to dispensing the drug. For pain management and treatment of opioid use disorder, it would provide alternative methods than just prescribing a drug. While these methods might be more intense and could possibly involve therapy or collaboration with other health care professionals, it ensures the patient is getting the best quality care in the long term and not just prescribing a drug because it is easier. Mandatory education would no doubt make education more consistent, efficient, and effective. It would also allow for more innovation surrounding management of opioid use disorder and pain management. With more eyes and variety of knowledge backgrounds, research and development of opioids would improve drastically because the drug manufacturer would be under pressure to create a drug that is the next best thing. In addition to more research being done, the process would be more efficient because gold standard practices would come out of this education. Lastly, it would hold prescribers accountable, if you have standards and the prescriber is not abiding by them, it is easier to pick out the bad apples and create a network of ethical prescribers. We know overprescribing happens too often with prescription and nonprescription drugs. Education would specifically help opioid prescribing by making the prescriber more aware of the consequences of even prescribing just 1 more pill than needed. The hill to climb is that more burden is put on the prescriber to collaborate with other healthcare professionals or entities. The reality is that by overprescribing, it puts these drugs on the streets and into hands that were never meant to have it. Even with a post-op patient that is given 5 pills, if they only use 3, it takes 1 person to know the drug can be sold on the street for a lot of money. The most important point to come out of mandatory education would be the innovation of alternative treatments. When you are faced with prescribing a drug that is known to have high rate of misuse versus another drug or management plan with low rate of misuse, in most cases the latter would be chosen. Education should not only surround the opioids but also those alternative treatments such as physical therapy, trigger point injections, bioelectric therapy, etc. 2-Core competencies and knowledge gaps that should be addressed are indications/contraindications, implications of drug, side effects, and long term versus short term use. Some clinical challenges are patient compliance, cost, immediate relief, and time constrictions with patient. More intensive screening needs to be mandatory by talking to the patient about their past prescription drug and substance use. This can be used to determine if prescribing a non-opioid can provide favorable results instead of opioids, determining medical history to rule out possible adverse effects, and consider the psychological state of the patient. Spending more time with the patient to get a full picture rather than just a diagnosis will help with overall treatment plans.3-Goals should include understanding basic ethical obligations to the public and reviewing the oath they took as prescribers, consideration of innovative implementation, and understanding each drug they are prescribing. In ways of measuring the understanding of a drug, a test can be administered and if they do not pass a specific drug/section, they are unable to prescribe that drug. Systems like these seem harsh, but it will provide incentive to the prescriber to be better. 4-Many challenges will arise, but initial challenges include cost of program, personnel to run the program, and how the system will be delivered- online or in person. In cases of counting for continued education, having a system in place to determine how many credits or hours are needed to satisfy requirements. We can learn that without education programs, no standard of practice will be implemented. The same patient could go to different clinics and receive completely different care. We also will learn that patient compliance and trust would increase because they will know that it doesnt matter where they go, they will receive the best care. 5-Technology platforms can be unreliable at times but for the most part, if the platform is user friendly and keeps the prescriber in mind, I dont foresee any severe issues that couldnt be mitigated through technology support. However, with any remote work, you run the risk of dishonesty among the prescriber, but there are ways to ensure when taking knowledge assessments there cannot be any cheating.  Please find enclosed input from the American Society of Addiction Medicine (ASAM). Federal Register CommentDocket No. FDA-2021-N-0951In Response to the Food and Drug Administrations Request for Comment and Public Workshop on Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid CrisisBoston University School of Medicine Continuing Medical/Continuing Nursing Education Office (BUSM CME/CNE) has been offering educational activities on safer opioid prescribing since 2010.  Our current opioid REMS program, entitled Safer/Competent Opioid Prescribing Education:  SCOPE of Pain, launched in March 2013 and has been operating continually since then.  To date, we have educated over 225,000 individuals  including healthcare providers (both prescribers and non-prescribers), affiliated health professionals, public health professionals, and students.We are grateful for the opportunity to provide a comment on the FDAs consideration of mandatory prescriber education.In 2017, we observed the effects of a newly enacted NY state mandate on opioid prescribing education.  We partnered with the New York Chapter of the American College of Physicians to offer our SCOPE of Pain program to satisfy the New York requirement.  Within three months, over 60,000 New York-licensed clinicians had completed our program. We compared clinicians who completed SCOPE of Pain under the New York state mandate with those who had completed it voluntarily in other states, controlling for profession and specialty.  We found that clinicians in the mandated group were less likely to report intention to improve their practice as a result of the education.  While trying to put our findings into perspective we found a lack of peer-reviewed published evidence supporting the efficacy of mandated continuing education on any topic.  We are also concerned that mandated training could decrease access to appropriate opioid therapy for patients with severe pain. This concern is based on the experience of mandated training required to prescribe buprenorphine for the treatment opioid use disorder in the Drug Addiction Treatment Act (DATA) 2000 and the Comprehensive Addiction and Recovery Act (CARA) 2016. Since the enactment of these laws, the vast majority of prescribers, including those in primary care, have chosen not to complete the required training and thus not offer the life-saving treatment for patients suffering from OUD. We fear that similarly most prescribers will opt out of an opioid prescribing education mandate and thus not be able to prescribe opioids to patients in need. This decrease in access to appropriate opioid therapy will further increase existing disparities in pain care, and will further marginalize an already highly stigmatized and marginalized patient population.Finally, if the goal of mandated education is to improve patient care, we suggest that rather than mandating a short-term educational program for everyone, consideration should be given to a mandate for demonstration of competency in safer prescribing of all controlled substances in order to maintain a DEA registration number. This competency requirement would allow those already expert to test out and for those needing education to demonstrate competency after completing the education. By including all controlled substances, it will be less likely that prescribers will opt out as maintaining a DEA registration is essential for clinical practice.  I wish to provide insight to your proposed mandatory opioid prescriber education program. Despite the noted decline in opioid prescriptions per 100 individuals, there has been an alarming increase in fatalities stemming from drug abuse. According to CDC data, 2020 witnessed a 29.4% increase in overdose deaths. This data reveals that the decrease in opioid prescriptions has not necessarily translated to fewer overdose fatalities. The proposed uniform, nationwide educational program for prescribers will prove to be a pivotal step towards addressing and reducing opioid addiction.In addition to substance abuse treatment options, the prescriber educational program should include goals for healthcare providers to initiate conversations on risks of opioid addiction with patients. For example, a patient preparing for surgery should be clearly informed of the potential side effects and risks associated with opioid prescriptions during their pre-operative appointments. They should additionally be equipped with knowledge on how to differentiate between normal, expected postoperative symptoms (including pain) and postoperative discomfort/restlessness (which can stem from either surgery or frequent, continued use of opioids). If the patient were to have difficulty in differentiating between the two, they should feel comfortable to discuss their symptoms with their healthcare provider. The program should also discuss strategies to monitor patient opioid use. Healthcare providers should always have answers to the following questions in regards to their patients: How many opioid prescriptions were given to this patient over time?How large of a prescription has been given to this patient at one time?How long has it been since this patient has been in chronic pain? What are other non-medicated strategies that can effectively manage this patients pain?Monitoring patients through frequent, routine follow-up visits to counsel and gradually reduce dependence on opioid prescriptions will be extremely beneficial towards reducing overdoses.While the consistency of such a program can be challenging, healthcare has largely evolved towards virtual platforms in just the last year; many patients and healthcare staff can now access patient information from the comfort of their homes or offices. Therefore, implementing this programs educational materials through an online platform will reach a significantly large number of healthcare providers, whilst enabling them to review the information at a time convenient for them.Given the severity of our opioid crisis, I believe the proposed plan to increase prescriber education surrounding opioid use is of utmost importance and should remain a top priority for FDA. Thank you for your time. Prescription opioid medications have contributed to positive experiences for individuals needing pain management; however, physicians over prescription of opioids to patients for decades has caused one of the most pressing issues the nation is facing today. There is no question that the push from big pharmaceutical companies to prescribe opioids for non-cancer related pain in the late 90s contributed to massive amounts of consumers addicted to prescription pain medications. Free samples were often given to individuals seeking pain relief, leading to addiction in these individuals, some of which were unable to afford the medications turning them to obtain these drugs illegally. This created an epidemic in our country that has been addressed since it was identified but continues to remain a burden on our health system. According to the HHS, more than 760,000 people have died since 1999 from a drug overdose, and appropriate prescribing of opioids is an essential way to protect the health and safety of US citizens.Education is always an effective and low-cost method of program implementation. It is only logical that prescribers be required to educate themselves on the best practices of prescribing controlled substances, especially those with high abuse potential such as opioid analgesics. If the FDA was previously concerned about implementing mandatory prescriber education programs due to placement of an undue burden on the healthcare delivery system, it should be apparent that the absence of mandatory prescriber education has prolonged an ever-concerning national crisis. The current pandemic has shown us that we are able to provide many services to individuals from the convenience of their own homes. Employment of a mandatory prescriber education program would be highly beneficial and easily conducted virtually to reach as many stakeholders as possible. To outline a few appropriate goals of a mandatory prescriber education program, we should begin creating a list of topics that should be covered. A good place to start is looking at the blueprint that has been developed by the FDA for prescriber education for ER/LA opioid analgesics. Pulling from those, some necessary topics to be included are:Federal requirements for prescribing controlled substances Assessment of the patient needs for the medicationProper patient counseling on safe use of medicationsPrevention, screening, and signs of addictionAlternative options for pain managementSpecific drug information regarding opioid analgesicsThis program should aim to educate all prescribers on these topics and ensure complete comprehension prior to completion of the program. In order to measure the effectiveness of this program, participants should be assessed on the skills they have developed. This can be accomplished through monitored breakout discussions among the participants. The proctors of the discussions can develop questions they believe incorporate the topics that the program set out to inform prescribers on and evaluate the discussion among the participants to determine what skills were learned. The program can also include a segment after educating prescribers in which they complete a self-assessment providing examples of what they learned from each topic that was covered. Another method to measure the impact of the program is one that would take place over a longer period after the program ended. This would be to monitor the prescribing behavior in the program participants and compare changes from before educating to those afterwards. This is already a common practice in some states that have established prescription drug monitoring programs, making this method of evaluation the most feasible. Common program evaluation methods can be used to determine the effectiveness of a mandatory prescriber opioid education program, and surveillance data on the numbers of opioid prescriptions given can, over time, reinforce the programs effectiveness. We can look at the success rates of private and state entities that have implemented educational programs for opioid prescribers and determine that a nationwide standard should be enforced. Unfortunately, the burden the opioid crisis is putting on the nation is of far more concern than the burden the FDA was previously concerned about with requiring prescribers to participate in this educational program. The evidence is clear that we will benefit from applying more efforts towards combating the opioid crisis, one of which is to more extensively educate prescribers of best practices when handling these highly addictive substances.  It is interesting to me that this is an FDA workshop that I had never heard of; as an MPH student and someone that had worked in the healthcare field before, I thought it would be something that would be mentioned in class or a professional setting. I do have to say that since 2012 from 84 prescriptions per 100 residents to 67 prescriptions per 100 residents in 2016, and 52 prescriptions per 100 residents in 2018, the rate dropped to 43 prescriptions per 100 U.S. residents in 2020 the implementation of REMS has had quite a successful run, but not as successful as it could be. The issue is that the epidemic isnt over; the numbers have only been rising. Provisional data from CDCs National Center for Health Statistics indicate an estimated 100,306 drug overdose deaths in the United States during the 12 months ending in April 2021, an increase of 28.5% from the 78,056 deaths during the same period the year before. Also, In 2019, an estimated 10.1 million people aged 12 or older misused opioids in the past year. Specifically, 9.7 million people misused prescription pain relievers, and 745,000 people used heroin. (https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm). This goes into the fact that cocaine, heroin, methamphetamine, and benzodiazepines have also become a major indicator of the rise of opioid misuse. That is due to the lack of educational spread and prevention, which is clearly shown in this article and the above numbers. The purpose of the workshop is to make REMS mandatory through risk evaluation and mitigation strategies for healthcare workers that prescribe opioids. The workshop can be attended by anyone who works in healthcare but is specifically targeted to prescribers. The issues start early on with the implementation of the workshop. First, it shouldve been mandatory for any healthcare provider that even remotely works with opioids, not just prescribers. There are too many cooks in the kitchen when it comes to prescribing medication; the pharmacist, any medical provider that the patient sees other than the prescriber, mental health providers, or anyone that the patient sees that helps them with their health. Therefore, REMS should be mandatory for everyone because not every patient is the same, but the goal of healthcare is the same: to do no harm. If only a certain number of healthcare providers are getting this continuing education opportunity, why cant everyone? The other thing that couldve been mentioned here is who gets notified about the workshop. Is it well-known hospitals in well-known areas where the people can afford treatment if they become addicted, or does the notification of the workshop not discriminate? To be even a spark of equality in the healthcare system, there needs to be an accessible and affordable way to educate all. Thats where I would love to see that analytical makeup of attendance and where the statistical data presented below is kept. If someone came to the workshop, where do they work, what is their line of profession, what is the population they see compared to others. I think this information is essential to all present to the stakeholders attending the workshop because it shows the pros and cons of not only making it mandatory but also if the FDA keeps it in general care. The final thing that sparked my interest is that the blueprints currently do not include principles for managing opioid use disorder, including treatment with buprenorphine. My curiosity lies in why treatment was not part of the workshop. Its a very crucial part of lowering the number of patients that go into overdose and die. Substance use disorders can be best treated on an outpatient therapy basis or in an inpatient program dedicated to treating people with addiction. Many of these programs use medications to help patients transition from physical dependence on opioids. The medicine buprenorphine also relieves opioid cravings without giving the same high as other opioid drugs. Prescribed by many physicians from office settings, this is typically a daily dose placed under the tongue and can be delivered as a once-a-month injection or through thin tubes inserted under the skin and last six months (https://www.hopkinsmedicine.org/opioids/treating-opioid-addiction.html). Different addiction treatments should be added to the blueprints because if the healthcare provider cant prevent the addiction, they most certainly can treat it. Nevertheless, I thought this approach was fascinating, and I hope through the decisions made in October, a real change can be made in 2022.   Over-prescribing of opioid drugs in the United States has fueled the opioid overdose epidemic, contributing to 200,000 overdose deaths from 1999 to 2017 (Mathis, 2020). It is necessary for all health care providers to do their part in reducing the possibility for opioid abuse in their patients and those that their patients may influence. A mandatory REMS educational program could address the over prescribing of opioids for acute pain through teaching prescribers screening questionnaires, recognizing warning signs of drug abuse, limiting opioid prescriptions, encouraging patients to utilize non-addictive pain management strategies, and recognizing the potential consequences for over prescribing. In a REMS program, prescribers should be required to learn ways to accurately assess and detect a patients levels of pain prior to making the decision of whether to prescribe opioids.  A REMS program can address which types of acute pain may require prescription of opioid drugs, and which may not. Most surgeries and invasive procedures may generally cause more acute pain than acute injuries. Another screening tool, which is required in Massachusetts by law, that can be used is The National Institute on Drug Abuse Quick Screen (Keith, 2020). This is a quick questionnaire that can be used to assess frequency of drug use and risk for potential abuse. Surveys like this should be taught to prescribers in a mandatory program to reduce the chance of prescribing opioids to people prone to abuse. Early warning signs of prescription drug abuse can be easily detected if prescribers are properly educated on what to look for. Patient and provider communication is key to detecting these early warning signs (Mathis, 2020). Providers should be taught to look for how many providers the patient has seen in the past and if those previous providers were prescribing opioid drugs. Doctor shopping, when a patient tries to obtain multiple prescriptions from multiple prescribers at the same time, is a common sign that a patient has been abusing opioid drugs (Keith, 2020). They should note if the patient immediately asks if they can be prescribed opioids and if they frequently ask for refills or misplace their medications regularly. Additionally, prescribers should base their decision to prescribe on evaluative measures such as special physical and diagnostic tests for pain rather than relying solely on patient reports. The ability to clinically rule out if someone is over-exaggerating or faking their pain through evidence-based measures makes the prescribers decision process easier. These strategies should all be covered in a mandatory REMS program.Education on prescribing fewer opioids in one singular prescription for acute pain rather than prescribing in excess would be beneficial to include in a REMS program. Healthcare professionals can always prescribe more pain medications if needed. For example, if prescribers are going to prescribe opioids to patients for acute pain, they should only prescribe two to three days worth of medication and then encourage use of NSAIDS or acetaminophen to manage pain. If the patient reports that they are still having unbearable pain not manageable through over-the-counter medications, prescribers should then consider an additional prescription of another two to three days of medications.There are many potential consequences that prescribers may not immediately consider when prescribing opioids to patients. Not only are patients at a higher risk for developing an addiction to the opioid themselves, but one factor that is often overlooked is the possibility of the patient abusing their excess prescription to sell and supply opioids to others. Even if a patient is not abusing their excess prescription themselves, it can still be used to harm others. Not only is selling excess opioids a possible issue, but if drugs are leftover and end up in a medicine cabinet, young adults or children in the household are more likely to abuse these drugs.It would be extremely beneficial to require a mandatory REMS education program for prescribers to reduce over-prescribing opioid drugs to patients. The simple implementation of this program will help reduce patient drug abuse, the likelihood of other family members to abuse these drugs, and repercussions for doctors if these unfortunate events do occur. Keith, D. A.,  Hernndez-Nuo de la Rosa, M. F. (2020). Special Screening Resources: Strategies to Identify Substance Use Disorders, Including Opioid Misuse and Abuse. Dental clinics of North America, 64(3), 513524. https://doi-org.proxygw.wrlc.org/10.1016/j.cden.2020.03.002Mathis, S. M., Hagaman, A., Hagemeier, N., Baker, K.,  Pack, R. P. (2020). Provider-patient communication about prescription drug abuse: A qualitative analysis of the perspective of prescribers. Substance abuse, 41(1), 121131. https://doi-org.proxygw.wrlc.org/10.1080/08897077.2019.1635956 Since the 1990s, pharmaceutical companies marketed synthetic and semi-synthetic opioids to medical providers, assuring the fact that they were nonaddictive or were less addictive than other opioid options at the time, such as morphine. The lobbying, sponsorships, and heavy marketing tactics employed by pharmaceutical companies catalyzed the increase in opioid prescriptions which has stemmed into whats now known as the opioid epidemic: the misuse and abuse of opioid drugs, leading to negative health outcomes or deaths due to overdose. The health impact of this issue is nothing less than substantial. In 2019, approximately 10.1 million Americans reported opioid misuse, 1.6 million had an opioid-use disorder related to prescription medication, and there were an estimated 70,000 opioid-related deaths in the United States that year. In addition to these health outcomes, we also see an associated economic burden of $78.5 billion each year related to this opioid epidemic. Taking a deeper look into this issue, we can see that approximately 25% of individuals who were prescribed opioids have misused them, with an average of 10% developing an opioid use disorder. The 2012 Risk Evaluation and Mitigation Strategy (REMS) was developed by the Food and Drug Administration (FDA) with the purpose of providing training to medical professionals for prescribing medications with specific risks and concerns. This program includes training on Extended Release and Long-Acting (ER/LA) opioid medications which educates healthcare professionals on appropriate opioid prescriptions and prevention of opioid misuse or abuse in patients. Ultimately, the goal was to reduce the frequency and severity of opioid-related adverse health outcomes such as addiction or overdose through an upstream, educational program for medical care providers. However, due to concerns about the burdens of this extra program, the FDA decided not to make the REMS mandatory. Instead, this program was made widely available to healthcare providers. As mentioned in the document, there were approximately 350,000 individuals who completed the REMS training program since 2013. With an estimated 1 million opioid-prescribing healthcare providers in the United States, this means that only one-third have completed this training. Although the number of prescribed opioids has decreased over the years, presumably due to the efforts of this program alongside other alternative educational interventions, studies continue to show that opioid medications are prescribed in excess following medical procedures, where up to 70% of opioid tablets were unused. These results indicate an unnecessary over-prescription of opioids. Now that the conversation of REMS training is back on the table, it is important to consider making this program mandatory so that all opioid-prescribing healthcare professionals can be equipped with the necessary knowledge and training to reduce opioid abuse and overdose.In public health, it goes without saying that prevention is always better than the cure. It is worth investing time and resources into addressing the upstream issue of opioid abuse and overdose, starting at the source. Though implementing a mandatory program may increase the burden on healthcare workers, the downstream effects of reducing opioid-related misuse and reducing opioid abuse and death is substantial and will outweigh the costs. Patients trust their providers to prescribe them with the appropriate type and necessary amount of medication to help them with their health issue. This is based on patient-provider trust and the position that healthcare providers are in to treat health conditions with the necessary resources. Thus, doctors, physician assistants, and nurses, have the due diligence to be aware of the ramifications of opioid over-prescription as well as inform their patients of the risks associated with any opioid analgesic they may be prescribed. The REMS program will ensure that physicians are equipped with this knowledge and skillsets to empower their patients to prevent drug abuse and overdose, while maintaining accessibility to these controlled substances. It is time for the federal government to step in and make this a mandatory training, ensuring that medical providers have a standardized knowledge and practice across the country to combat the opioid epidemic.  According to the National Institute of Health (NIH), Americas medical research agency, prescription opioids are often a springboard into addiction.  The National Institute on Drug Abuse (NIDA, under the NIH) reports that  75% of opioid abusers started with medically prescribed opioids, and nearly 80 percent of heroin users reported using prescribed opioids prior to beginning their heroin use .There can be little argument that a poorly considered prescription, even for an understandable reason, can derail a persons life. Countless testimonials showcase the reality of how a life can be horribly altered for the worst because of innocent and valid opioid prescriptions.  Obviously, patient pain is a horrible thing, and should be limited where possible. However, broad and unconsidered opioid prescriptions can lead to killing a demon today, and facing the devil tomorrow. In these situations the few days of pain that may have been avoided by opioid use are surpassed by a lifetime of suffering, loss, and self-harm. Yet early marketing for drugs such as OxyContin made explicit promises that their drug was non-addictive, leading to mass-misinformation in patients and doctors alike. Although this misinformation regarding the addictiveness of opioids is being re-dressed, the epidemic continues and some doctors may still struggle to see how an understandable prescription to ease a patients very real pain can result in such a painful an addiction.It is true that, particularly during this Pandemic, our healthcare system is highly burdened, and healthcare practitioners should devote their time to saving lives. However, education will help save lives in the long run by stopping addiction before it starts. Furthermore, doctors are already required to continue their education. Most States require Continuing Medical Education Credits (CME) to maintain ones medical license because medicine is an ever-evolving field and great harm can come to patients if doctors do not keep up to date with new findings and methods. Requiring a class on the risks of opioids is a low burden, particularly when the statistics come to light. Since 1999, 760,000 people have died of a drug overdose. In 2018, two thirds of all drug overdoses involved opioids. Given the majority of opioid addictions begin with a prescription, can we really afford not to educate doctors? Not only should the FDA require education, the education should include alternative treatments that should be considered before opioid pain killers where possible, better steps to address post-prescription care, weening schedules, and care/check in protocols for when the prescription ends.Opioids have a place in society, and can be of enormous benefit to suffering people, but opioids should be a last resort, not a first option. With better education, perhaps the early marketing false information can be eliminated from the medical conscious and replaced with a deeper understanding of how to balance pain management with a happy addiction-free life.Thank you for taking the time to read my comment.  THe 3 stooges would better serve our Nation, in regulating opioids, then the administrative epistocratic narcissists who believe their statistical positivism and quick and dirty simple minded evidentialism is beyond good and evil and any and every moral consideration that the public and private citizens have. It is as Aristotle indicated- educating the mind and not educating the heart- is no education at all. Clearly FDA staff and their thick as theive rubberchickendinnered friends in academia lack moral engagement on pain care and they believe that all use of opioids are unwarranted. It is a terrible thing to see and have no vision. THE FDA anf their immoral friends in academia clearly have no vision to improve pain care or cure pain. It wasnt any of them who called for curing pain in the NPS- it was yours truly. Since you dont have a heart to care and have no clue that happiness id the aim of government as Jefferson indicated- go work slinging burgers at mcdonalds- your simple minded machine robopathic machine logic is unfit for serving humans and your unfit to serve in government. Your carelessness cannot be squared with any theory of government, management or morality. You are clueless about the care ethics of Tronto, Nussbaum, Sen, Sandel, Gilligan, Watson, Butler- to name a few. YOur heartless robopathic narcissists who care nothing for people in pain. You can debate me anytime in public- your vast darkness will be unobscured.And your immorality is legion- belongs in dystopian novels or theater of cruelty. Your claim to expertise are as thin as your cartoon thin morality.Kindly put an egg in your shoes and beat it.