House House Energy and Commerce Subcommittee on Oversight and Investigations Hearing
On behalf of the
There is no question that we are in the midst of a public health epidemic. According to the
The numbers are sobering and the AMA is working on a number of fronts to implement specific strategies to reduce prescription opioid misuse, abuse, overdose, and overdose deaths. The AMA brings a critical perspective to this public health crisis as physicians are on the frontlines and fully understand the human cost and the toll it can take on patients and their families, as well as on whole communities. Physicians work hard to balance their ethical obligation to treat patients with legitimate pain management needs against their legal responsibility to identify patients who may be misusing or abusing drugs, and prevent abuse, misuse, overdose, and death from prescription drugs. Under the Controlled Substances Act (CSA), physicians have a legal responsibility to ensure that a prescription for a controlled substance is "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice." This legal responsibility underscores our ethical obligations to our patients, and the AMA is committed to helping physicians meet their responsibilities.
The AMA believes that it is up to physicians to be leaders in preventing and reducing abuse, misuse, overdose and death from prescription drugs through ensuring appropriate prescribing practices as one part of a multi-pronged public health strategy. At the same time, the AMA is strongly committed to ensuring that patients experiencing pain receive appropriate treatment with opioids, if necessary, and that patients with opioid use disorders have access to treatment.
We need a comprehensive public health approach to combatting the nation's prescription opioid abuse and growing heroin epidemic. These are complex problems, and the AMA is working with multiple stakeholders to effectuate change in how to address these issues. We believe the following critical components are necessary: enhancing education for physicians and patients about appropriate prescribing practices; increasing access to treatment programs for opioid use disorders, including medication assisted treatment programs (MAT); ensuring that patients in pain receive the care they need and reducing the stigma of pain; recognizing that opioid use disorder is a medical condition, reducing the stigma of this disorder, and increasing coverage for and access to medication assisted treatment and related services; increasing access to naloxone and other overdose prevention measures, and expanding Good Samaritan laws; and increasing funding and staffing for up-to-date, interoperable, at the point-of-care prescription drug monitoring programs (PDMPs) that are integrated into a physician's workflow. Each of these components is discussed in further detail below.
Enhancing education for physicians and patients
The AMA strongly supports physicians and other prescribers relying on the most up-to-date education and training when it comes to pain management, prescribing opioid analgesics, and other pain medications. We must take increased responsibility for solving this national epidemic. Enhanced education--beginning in medical, physician assistant, nursing, dental, and pharmacy schools and continuing throughout one's professional career--can help all prescribers, pharmacists, and patients identify and address the risks of prescription drug misuse and prevent diversion and overdoses. Physicians must take the lead in training and educating themselves and their colleagues to ensure they are making informed prescribing decisions, considering all available treatment options and data for their patients, reducing inappropriate prescribing of opioids, making appropriate referrals for patients with opioid use disorders, and taking other steps to address over-prescribing of opioids while ensuring appropriate treatment of patients with acute or chronic pain. The AMA is working with the
In addition, the AMA, along with several other medical organizations, is a partner in the Prescriber Clinical Support System for Opioid Therapies (PCSS-O) funded by the
Ensuring that patients in pain receive the care they need and that they are not stigmatized as "malingerers" or "drug seekers"
Patients in pain deserve compassionate care just like any other patient physicians treat, and the AMA strongly opposes stigmatizing patients who require opioid therapy. In medicine, we do not use terms such as "malingerer" or "drug seeker" because these terms carry with them damaging psychological stigma. Patients who need care are simply "patients," and we should seek to change the tone of the debate toward more attention on multidisciplinary, patient-centered approaches to pain management and ensuring that evidence-based alternative pain management treatments and strategies are covered by insurance, while supporting opioid-based therapies when clinically appropriate and effective. For example, many patients must face step therapy, fail first, and prior authorization protocols by insurers that limit a physician's ability to prescribe a non-opioid treatment such as physical or occupational therapy. Despite the substantial burden of chronic pain in the U.S., access to multidisciplinary care and reimbursement for non-pharmacologic approaches is inadequate and needs to be addressed.
Furthermore, objective tests for the presence or absence of pain or pain intensity are still at a basic stage of development, and in most circumstances, the best clinical approach is to assume that the patient is reporting a true experience. While accepting a patient's complaint of pain as valid does not demand that a specific treatment be initiated, it does provide a foundation for assessment and the basis of developing an effective patient-physician dialogue and relationship, which is key to enabling the physician to provide the best possible care.
Recognizing that opioid use disorder is a medical condition and increasing coverage for, and access to, medication assisted treatment and related services
Similar to patients in pain, we should not use terms such as "addict" or "junkie" or "user" because these terms carry with them damaging psychological stigma. Patients who need care are "patients," and deserve our care and compassion. Opioid use disorder is a chronic disease that can be effectively treated but it requires ongoing management. However, more resources need to be devoted to ensure availability of, and access to, evidence-based treatment. A public health-based approach to harmful drug use requires having both broad-based treatment services available for those with opioid use disorders, as well as MAT, and insurance coverage for such treatment. MAT is the use of medications, commonly in combination with counseling, behavioral therapies, and other recovery support services to provide a comprehensive approach to the treatment of opioid use disorders.
We are deeply concerned by the barriers faced by physicians in finding and placing patients in addiction treatment and recovery programs. Many physicians regularly face this dilemma because there is inadequate capacity to refer patients for treatment and recovery programs. A profound need exists to address the workforce limitations and the lack of accessible and affordable treatment programs.
Making certain prescription drugs less accessible, however, does not stop prescription drug misuse, abuse, diversion, overdose, and death. In fact, making these drugs less accessible without policies and strategies to provide treatment and recovery merely changes the drug of choice from legal prescription drugs to illegal drugs that have no legitimate medical use. If the ultimate goal is to provide comprehensive care to our patients and ensure we are doing everything we can as a profession and a society to stop addiction, overdose, and death, a far greater effort is needed to focus on the treatment and recovery side of this crisis.
For example, the AMA strongly supports increased access to treatment for drug addiction and physician office-based treatment of opioid addiction. The Drug Addiction Treatment Act of 2000 provided for an office-based option for opiate treatment utilizing buprenorphine (a potent synthetic compound that acts on the same opiate receptors as morphine and methadone). However, limits remain on the number of patients a physician may treat utilizing buprenorphine, a drug that can be used to facilitate recovery from opiate addiction. There is broad consensus in the medical community that buprenorphine is a major tool to fight addiction. Lifting the cap would enable physicians to treat more patients with this highly-effective drug.
In addition, suboxone, a combination of buprenorphine and naloxone (an inhibitor of the opiate receptor), is very safe to be administered on an outpatient basis and is available to be prescribed by any licensed practitioner after completing a training curriculum that focuses on the pathophysiology of opiate addiction, screening of patients, symptom identification and management, and prescribing of the medication. Becoming certified as a prescriber for suboxone requires a fee for completion of the training, registration with governmental entities, and after a waiting period, the ability to prescribe suboxone to 30 patients for the first year. The prescriber may submit a waiver request to treat up to 100 patients after the first year.
The regulatory process for becoming a prescriber and the patient limits serve as barriers to increase capacity to treat opiate addiction and the availability of suboxone to opiate-addicted patients, particularly those patients in jurisdictions that have adopted a law enforcement approach (as opposed to a public health approach) to combat prescription drug abuse. The advantages of reducing the regulatory burdens to prescribing suboxone would not only increase the availability of suboxone treatment for patients with opiate addiction, but would also increase clinical identification, awareness, and acceptance of opiate addiction as a disease and reduce the stigma associated with opiate addiction.
Several options exist to expand the current capacity to treat opiate addiction. First, suboxone training could be offered free-of-charge to prescribers with either renewal or initial application of a prescriber's DEA number. Second, the initial patient cap could be increased with a waiver option after 6 months instead of one year. In addition,
Increasing access to overdose prevention measures such as naloxone and enhancing Good Samaritan protections
The AMA strongly supports the national trend of states enacting new laws to increase access to naloxone, which is a safe and effective
Modernizing and fully funding prescription drug monitoring programs
We acknowledge that physicians and other prescribers must take charge of this epidemic by carefully examining prescribing practices. Physicians need to be sure that they are prescribing appropriately and taking necessary precautions, including consulting PDMPs when clinically indicated. PDMPs have the potential to serve as a helpful clinical tool in the fight against prescription drug misuse.
As a result of years of concerted advocacy from the AMA and other national medical specialty societies, the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER) was signed into law. Although
PDMPs can provide reliable and actionable information. It has been only in the past several years that almost all states (e.g., with the exception of
Modernized PDMPs can provide physicians with a basic tool to make treatment decisions based on patient-specific needs. This not only includes helping detect so-called "doctor shoppers," but also providing information on whether a patient might need counseling for a potential opioid use disorder. In short, PDMP data can be helpful to form a diagnosis and treatment plan, but it is not a stand-alone solution.
However, full funding for PDMPs is needed to ensure that physicians across the country have this effective tool at the point-of-care to combat prescription drug abuse while ensuring that patients with legitimate need for pain management continue to have access. Unfortunately, the appropriations to fully fund, modernize, and optimize the PDMPs have not kept pace with the rapid escalation in abuse and diversion of prescription drugs. We support full appropriations with a continued strong emphasis on the public health focus of NASPER.
Working with stakeholders at the federal and state levels
The AMA has worked closely with federal and state policymakers and with a diverse array of stakeholders for many years to address this growing public health crisis. At the federal level, the AMA is a founding member of the Alliance to Prevent the Abuse of Medicines (the Alliance), a non-profit partnership of key stakeholders in the prescription drug supply chain--e.g., manufacturers, distributors, pharmacy benefit managers, pharmacies, physicians--established to develop and offer policy solutions aimed at addressing the prescription drug abuse epidemic. In addition, the AMA participated in a diverse coalition of stakeholders convened by the
Over the past year, the AMA has brought together representatives from more than 40 medical specialty and state medical associations, as well as the
At the state level, the AMA and our state medical societies have worked closely to ensure that new policies have a direct impact on this national epidemic. Nearly every state legislature is considering one or more pieces of legislation concerning prescription drug abuse, misuse, overdose, and death, including bills on PDMPs, continuing medical education requirements for licensing, restrictions on prescribing opioids, and electronic prescribing of controlled substances. It is important to note, as recognized by
One of the most promising interventions has been new laws focused on overdose prevention, increased access to naloxone, Good Samaritan protections, and treatment of opioid use disorders. The AMA has worked hand-in-hand with many state medical societies to help enact these laws throughout the nation, and our goal is for every state in the land to support this life-saving approach.
But we can't stop there. In addition to state legislative advocacy, the AMA remains engaged with the
Conclusion
As the foregoing initiatives demonstrate, the AMA is strongly committed to combatting opioid drug misuse, abuse, overdose, and death while simultaneously ensuring access to treatment for pain and opioid use disorders. The AMA appreciates the opportunity to provide our comments on this critical health policy matter, and we look forward to working with the Subcommittee, Committee, and
Read this original document at: http://docs.house.gov/meetings/IF/IF02/20150423/103367/HHRG-114-IF02-Wstate-HarrisP-20150423.pdf
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