Current Concerns and Proposed Solutions:
Important information for everyone to know~!
DEA GUIDANCE AND DEMANDS FOR PHYSICIANS WHO PRESCRIBE CONTROLLED SUBSTANCES
THE PRACTITIONER’S MANUAL OF 2006*
Stated in 2 sentences on page 19: “A prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances.
“ACCEPTABLE MEDICAL PRACTICE”
Stated on page 30: “The legal standard that a controlled substance may only be prescribed, administered, or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice has been construed to mean that the prescription must be “in accordance with a standard of medical practice generally recognized and accepted in the United States”.
Federal courts have long recognized that it is not possible to expand on the phrase “legitimate medical purpose in the usual course of professional practice” in a way that will provide definitive guidelines to address all the varied situations physicians may encounter.
While there are no criteria to address every conceivable instance of prescribing, there are recurring patterns that may be indicative of inappropriate prescribing:
An inordinately large quantity of controlled substances prescribed or large numbers of prescriptions issued compared to other physicians in an area; No physical examination was given; Warnings to the patient to fill prescriptions at different drug stores; Issuing prescriptions knowing that the patient was delivering the drugs to others; Issuing prescriptions n exchange for sexual favors or for money; Prescribing of controlled drugs at intervals inconsistent with legitimate medical treatment; The use of street slang rather than medical terminology for the drugs prescribed; or, No logical relationship between the drugs prescribed and treatment of the condition allegedly existing.
Each case must be evaluated based on its own merits in view of the totality of circumstances particular to the physician and patient.
For example, what constitutes “an inordinately large quantity of a powerful Schedule II opioid might be blatantly excessive for the treatment of a particular patient’s mild temporary pain, yet insufficient to treat the severe unremitting pain of a cancer patient.
*This is the only written guidance from DEA published in the last 11 years.
Is prescribing medication for pain, at non-standard levels, or off label, a violation or not?
California Pain Patients Bill of Rights: PART 4.5. PAIN PATIENT’S BILL OF RIGHTS [124960 – 124961]
( Part 4.5 added by Stats. 1997, Ch. 839, Sec. 1. ) 124960.
The Legislature finds and declares all of the following:
(a) The state has a right and duty to control the illegal use of opiate drugs.
(b) Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem.
(c) For some patients, pain management is the single most important treatment a physician can provide.
(d) A patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain.
(e) Due to the complexity of their problems, many patients suffering from severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of clinicians in order to address the associated physical, psychological, social, and vocational issues.
(f) In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute pain and severe chronic intractable pain can be safe.
(g) Opiates can be an accepted treatment for patients in severe chronic intractable pain who have not obtained relief from any other means of treatment.
(h) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her pain.
(i) A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve pain as long as the prescribing is in conformance with Section 2241.5 of the Business and Professions Code.
(j) A patient who suffers from severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as the prescribing is in conformance with Section 2241.5 of the Business and Professions Code.
(k) The patient’s physician may refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who treat severe chronic intractable pain with methods that include the use of opiates.
(Amended by Stats. 2011, Ch. 396, Sec. 2. (AB 507) Effective January 1, 2012.) 124961.
Nothing in this section shall be construed to alter any of the provisions set forth in Section 2241.5 of the Business and Professions Code. This section shall be known as the Pain Patient’s Bill of Rights.
(a) A patient who suffers from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her pain.
(b) A patient who suffers from severe chronic intractable pain has the option to choose opiate medications to relieve that pain without first having to submit to an invasive medical procedure, which is defined as surgery, destruction of a nerve or other body tissue by manipulation, or the implantation of a drug delivery system or device, as long as the prescribing physician acts in conformance with the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.
(c) The patient’s physician may refuse to prescribe opiate medication for the patient who requests a treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who treat pain and whose methods include the use of opiates.
(d) A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve the patient’s pain, as long as that prescribing is in conformance with Section 2241.5 of the Business and Professions Code.
(e) A patient may voluntarily request that his or her physician provide an identifying notice of the prescription for purposes of emergency treatment or law enforcement identification.
(f) Nothing in this section shall do either of the following:
(1) Limit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, or the regulations adopted thereunder.
(2) Limit the applicability of any federal statute or federal regulation or any of the other statutes or regulations of this state that regulate dangerous drugs or controlled substances.
(Amended by Stats. 2011, Ch. 396, Sec. 3. (AB 507) Effective January 1, 2012.)
Update on the Opioid Crisis:
During the past year, deaths have continued to rise from illicit drug use, even as prescriptions for opioid medications have declined.
There are two very separate problems going on that involve the same substances
The use of medically prescribed opioids to treat painful conditions
The misuse and abuse of illegally obtained opioids often resulting in death
In March 2017, Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, stated that heroin and illicit fentanyl were primarily to blame for the soaring rate of drug overdoses. “Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. Importantly, the available data indicate these increases are largely due to illicitly manufactured fentanyl,” Houry said in her prepared testimony before the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee. The CDC blamed over 33,000 deaths on opioids in 2015, less than half of which were linked to pain medication.
Latest information is that the majority of deaths are now due to heroin and illicit fentanyl being shipped into the U.S. from Mexico and China, often purchased via the “dark web” on the internet
The conflating of the two very separate issues – the use of prescribed opioids to treat painful conditions and the abuse of illicit drugs – is causing unintended consequences on chronic pain patients. Both chronic pain and addiction are very serious medical problems that deserve compassionate care.
Media and political attention to the opioid abuse and overdose problem have failed to acknowledge the existence of severe intractable pain patients
The CDC Guideline for Prescribing Opioids for Chronic Pain issued in March 2016 were intended to be voluntary guidelines applicable to primary care physicians
Misinterpreted as imposing mandatory dose ceilings
Incorporated by Congress into Veterans Affairs spending bill in Dec 2015 before finalized by CDC
Some state legislatures and medical boards have followed with laws and regulations imposing mandatory limits on doses and quantities
CMS planned to impose “hard edits” at 200 MED doses to stop fill of prescriptions at pharmacies in April 2017; backed off based on comments
In May 2017 FDA announced public meeting to discuss plans for prescriber training to be modeled on CDC guidelines; no acknowledgement of severe chronic pain patients or requirement to train prescribers to meet their needs
President’s Commission on Combating Drug Addiction and Opioid Crisis working now:
Stacked with anti-opioid activists and addiction experts
No voice for hands-on pain care clinicians who treat patients
No voice for chronic pain patients or advocates
No assessment of unintended consequences of CDC Guideline or other legislative and regulatory actions
Myths and misinformation about prescription opioids abound
Unintended consequences of actions to combat drug addiction and overdose are having a tremendous impact on chronic pain patients:
Sudden extreme reductions in dose with no warning
Patients abandoned by doctors as healthcare systems impose restrictions
Doctors leaving pain care practice due to fear of prosecution
Pharmacies refusing to fill scripts
Insurance companies denying payment
Suicides of chronic pain patients increasing
Under-treated pain causes serious physiological impacts including death
Increased cardiac work, increased metabolic rate, reduced oxygen levels, impaired wound healing, impaired immune function, severe insomnia, hypertension, hormone abnormalities
Can bring about death due to cardiac arrest, stroke, or adrenal failure
In the June 2002 issue of Hospital Physician, B. Eliot Cole spoke to the significance of untreated pain. “The axiom ‘No one ever died from pain’ is clearly incorrect…”
Well-funded anti-opioid lobby continues to carry out a tremendous, multi-faceted campaign to limit the availability of opioid medications:
Influencing Federal agencies, state agencies, Congress, state legislatures
Some have expressed the desire and intent to see opioid medications abolished in the United States
Our issue today: Find a compromise solution that provides for acknowledgement of severe intractable pain patients and access to the care they require
Families for Intractable Pain Relief (FIPR) will ramp up our educational campaign to combat the myths and misinformation about properly prescribed opioid medications.
We recommend establishment through legislation of a Federal program similar to the buprenorphine addiction treatment program that would allow interested qualified physicians to take special training and be certified to prescribe high doses of opioids for severe intractable pain patients for whom all other treatments have failed, or special exemptions be made for their unique and complex medical care that often involves non-standard medication regimens
Consider special identification for these patients
We must have a say in all policies going forward that affect pain care, and treatment of pain patients at the federal, state and local level. A patient or patient advocate needs to provide expert information about the needs of Intractable Pain patients. A special certification program, or special exemptions could serve their complex medical needs to the satisfaction of all concerned regulators, medical boards and federal state and local jurisdictions.
Take our concerns and proposals forward to the Senate HELP Committee and other relevant legislative Committees to introduce legislation to address the pain care needs of citizens whose lives are at risk due to unforeseen consequences of the war on opioid drugs.
We must have a say in all policies going forward that affect pain care, and treatment of pain patients at the federal, state and local level. No more about us without us. A patient or patient advocate needs to provide expert information about the needs of Intractable Pain patients at every policy meeting going forward. A special certification program, “exemptions” or “carve outs” could serve Intractable Pain patients and their doctors going forward. This would address their complex medical needs to the satisfaction of the patients and all concerned regulators, medical boards and federal state and local jurisdictions.
Families for Intractable Pain Relief 2017
We advocate for: Access to health care that includes: Non-standard and opioid medications, when indicated, to treat patients with rare diseases and injuries causing Intractable Pain. We need qualified doctors who are willing to treat these complex patients, who suffer with Intractable Pain- in every state.