Review Guidelines for the Federation of State Medical Boards

NAMA’s Comments
to the Federation of State Medical Boards

Prepared by:

National Alliance of Methadone Advocates
435 Second Avenue
New York, NY 10010
Phone: (212) 595-6262

Model Policy Guidelines for Opioid Addiction
Treatment in the Medical Office

Section I Preamble

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The second sentence should also include the fact that Medical Maintenance has been demonstrated to be effective. The sentence should read:

Because office-based opioid treatment has been shown to be effective combined with the increasing number of opioid addicted individuals and the associated public health problems, as well as the limited availability of addiction treatment programs, federal laws now enable qualified physicians to prescribe Schedule III-IV medications approved by the Food and Drug Administration for office-based treatment of opioid addiction.

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At the end of the paragraph the reader is referred to CSAT for the Buprenorphine Guidelines and we suggest that you also include the Physicians’ Guide: Opioid Agonist Medical Maintenance Treatment Prepared for the Office of Pharmacologic and Alternative Therapies (OPAT), Center for Substance Abuse Treatment (CSAT). The guidelines are excellent and contain a lot of basic material that any clinician could use. It is available from CSAT and on our website at
https://www.methadone.org/physiciansguideOBOT.html

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This paragraph regards diversion. Now the problem with diversion is that it would not exist if treatment were available. Studies have demonstrated that diverted methadone is commonly sold to either other patients who are not able to get an adequate dose or to addicts who are not able to get into treatment for whatever reason that might be. In countries where treatment is free and available to all diversion simply does not exist. NAMA’s concern is the over emphasis on diversion while at the same time protecting this advancement in the treatment of opioid addiction.

We would suggest that a page of guidelines on diversion be developed and in this section only the first sentence be used. The second would be omitted and in its place the physician would be referred to the diversion guidelines.

I must emphasize that clinics and methadone programs have been so over-vigilant on this issue that the result has been that the majority of patients are hindered and harmed because they are chained to the clinic. Many methadone patients have attempted to detox because their lives were so controlled and they could not visit family or carry on normal business without first fighting with the clinic for permission to do so. Also active addicts will not enter because of the control. The guidelines should include instructions to give patient’s more responsibility with medication as treatment progresses. This is very important to patients and can be used as a positive therapeutic tool.

Section II Guidelines

Record keeping for addiction treatment is very different from what most clinicians are use to and we recommend that generic forms be developed that can be downloaded from ASAM and other websites. (We would be glad to have them on our website https://www.Methadone.org as many physicians use the site for reference.) A basic list would include:

1. List of licenses that a physician must have to prescribe controlled substances (in your section Compliance with Controlled Substances Laws and Regulations)
2. Evaluation of the Patient:
   1. Medical History Form: nature of the addiction, the history and types of drugs taken, date of first use, previous treatment and dates.
   2. Physical Examination Form (this could be combined with the Medical History): basic medical, TB test, and co-existing disorders. A second page for the patient to sign off on could recommend testing for HCV and HIV.
   3. Family and Social History: sisters and brothers, married/single, children and ages, level of education, training undertaken or completed, employment, disabilities that would hinder work (the patient could fill this form out).
   4. Treatment Plan: place to state objectives and goals of the patient, planned counseling or other appointments with services to help the patient, family involvement section, strategies for failure.
   5. Informed Consent and Agreement for Treatment: include the form for the patient to sign and a page giving the physician guidelines as to what to discuss.
   6. Toxicology Summary: simple form to list the toxicology results, date and results.
   7. Evaluation Form: this form would be similar to the Treatment Plan and would periodically update the plan to include goals achieved, appointments made and outcome, toxicology reports,
   8. Consultation Form: to be used in cases where the patient is referred to ancillary services both medical and social and should include the name of the service, the date of appointment, a report of the initial contact and the outcome.
   9. Consent for Release of Confidential Information with guidelines.

Section III Definitions

The Definition Section needs to be revised as several of the terms are confusing as in the equating of Addiction, Drug Dependence and Opiate Dependence and other terms are quickly becoming pass and should not be used (i.e. Maintenance Treatment, Substance Abuse). We have included comments and/or alternative definitions.

Addiction

The definition of addiction and equating it to drug dependence is confusing. Drug dependence usually means some one who is dependent on a drug such as a pain patient but a person who is drug dependent does not necessarily indicate that that individual will display the symptoms of addiction. Conversely an individual can display addiction and not display the symptoms of drug dependence (i.e. cocaine). We suggest the following. (Use the definitions from the monograph)

Defining An Addiction

The formal diagnosis of “psychoactive substance dependence” is now made if at least three of the following statements are true. Note that according to these guidelines a pain or methadone patient does not fit the criteria, as most are behavioral. Conversely some non-opioid medications could fit these criteria.

• The substance is taken in larger amounts or over a longer period than the person intended.
• There is a persistent desire or unsuccessful efforts to stop.
• The person spends a great deal of time trying to get the substance (e.g., robberies to raise the money), taking it or recovering from its effects.
• Using the substance disrupts important social obligations or work activities.
• The person continues to use the substance despite knowing that it is causing problems (e.g., drinking even though it makes an ulcer worse).
• There is a marked tolerance: the person needs increased amounts of the substance to become intoxicated or has a marked reduction of the desired effect if using the same amount.
• There are withdrawal symptoms.
• The substance is taken to avoid the withdrawal symptoms.

The source, Diagnostic and Statistical Manual of Mental Disorders III (1980) is old and should be updated to the most recent DSM.

Agonists and Antagonists

First lets begin with defining an agonist, which is a substance that binds to the receptor and produces a response that is similar in effect to the natural ligand that would activate it. In contrast, antagonists bind to the receptor but block it by not allowing the natural ligand or any other compound to bind to the receptor. Antagonists do not cause the opposite effect; they merely fit into the receptor and block any other substance from binding to it. For example, narcotic antagonists such as Naloxone or its’ predecessor Naline are administered to reverse a heroin or other opioid overdose. This is achieved because antagonists have a greater affinity for the opiate receptor than agonists and in fact the affinity is so strong that narcotic antagonists can literally knock an agonist right out of the receptor. The effect is very fast and the overdose victim will wake up within minutes, or seconds even. Individuals dependent on heroin, or other opioids such as methadone can wake up in withdrawal.

Naltrexone is a long acting narcotic antagonist that is used for maintenance treatment. It works by binding to the receptor over a 24-hour period thus making any injection or administration of an opioid agonist ineffective. It must be emphasized that naltrexone does not have agonist properties it merely blocks every opiate receptor irrespective of that receptors function. Thus, long-term treatment with narcotic antagonists can also block important biological functions and various side effects have been reported, including hyper sexuality.

Narcotic antagonists have a unique pharmacological property that makes them have a stronger affinity to the opiate receptor than an agonist. This is how narcotic antagonists are able to actually “knock” an agonist out of the receptor as in the case of Naloxone’s use for emergency overdose treatment. Another important property of narcotic antagonists is that anyone dependent on any opiate, including methadone patients will be extremely sensitive to them. Some of the new analgesics are mixed agonist-antagonists drugs that have been developed to reduce their addiction potential. For a non-dependent person these medications are painkillers, however for methadone patients their use is contra indicated because the patient will be thrown into withdrawal. Talwin that is noted on the identification cards for methadone patients is the most commonly used mixed agonist-antagonist analgesic. Other common mixed agonist-antagonist drugs used in obstetrics are Nubain and Stadol.

Approved Schedule III-V Opioids

(Here I would list the current drugs and give a resource to go to for further reference and particularly as new medications are added to the schedule.)

Maintenance Treatment

The term maintenance treatment is an old one that was begun prior to the knowledge that opiate addiction was a brain condition. Thus the early methadone patients were being maintained on an opiate because it was not understood that opiate addiction was a medical condition. However in recent years with the vast knowledge of neuroscience the term maintenance has become antiquated and we would hope that the guidelines not promote these concepts which could help to continue the basic belief that opiate addiction is not a medical condition but a bad behavior. We hope that you will remove this and in its place use Opioid Agonist Treatment (OAT) that is the preferred term today.

Opioid Agonist Treatment (OAT)

OAT is the treatment of opioid addiction with opioid agonist medications such as methadone and LAAM. These treatments have been demonstrated to be the most effective treatment for opioid addiction.

Opioid Dependence

Opioid dependence is not a maladaptive pattern of substance abuse and many pain patients would be insulted with such a definition. We believe that you intended to use Opioid Addiction as below it you give the definition of addiction from the DSM. Instead in its place the definition of Tolerance and Dependence should be provided.

Tolerance/Dependence

The phenomena of tolerance and dependence are physiological phenomena that are inextricably linked. Tolerance to opiates develops with chronic use of an opioid drug, or put another way; more of the drug is needed in order to get the original effect. As tolerance increases over time an individual will become dependent on the substance in order to function and feel normal. Without the substance the individual will undergo withdrawal, which for opioids includes a specific set of symptoms called the abstinence syndrome. Dependence on a drug has nothing to do with addiction to one. Tolerance is a common problem in treating chronic pain because the patient will eventually become tolerant to the drug and need more pain medication.

Opioid Substance

The preferred term, when referring to all the peptides with opiate properties is opioid peptide. Opioids substances include all drugs that come from the opium poppy (papaver somniferum) including the semi synthetic heroin (diacetylmorphine), codeine and morphine, the synthetic opiates such as methadone (dolophine) and meperidine (Demerol) and the endogenous opiates such as endorphins, enkephalins and dynorphins. Thus, the term opioid is used to classify a family of substances whose biological action is similar to morphine. These substances produce a range of biological actions, including euphoria and the relief of pain. A common characteristic of opioids is cross-tolerance, or if one is dependent on heroin then another opioid can be substituted, such as methadone to relieve the abstinence syndrome.

Opioid Treatment Program

This definition is fine.

Partial Agonists

This definition is fine.

(Physical Dependence was defined with tolerance.)

Qualified Physician

(This definition is fine.)

Substance Abuse

Many professionals prefer the term use to abuse because there is no specific definition of abuse and what may be abuse for one person is not for another. The word itself is negative and infers that any substance use is abuse, which is not true. We would suggest that you change this to Substance Use. The bullets listed under this definition should be moved under Opioid Addiction as they were taken from the DSM and together with the list under Opioid Dependence make up the list used to define addiction in the DSM and replace it with the following definition.

Substance Use

The use of any psychoactive substance including medications and illicit substances that taken for recreational use and not under the care of a physician. Many of the substances used for recreational use include: alcohol, tobacco, steroids, inhalants, Valium, methamphetamine, marijuana, ecstasy, cocaine and heroin to name a few.

Tolerance

(Tolerance was defined previously.)

Waiver

(The definition is fine.)