Patient Management

 A psychiatrist asks a lot of expensive questions your wife will ask for free.    ----Joey Adams

Pharmacotherapy alone is rarely sufficient treatment for drug addiction (McLellan et al. 1993). Treatment outcomes demonstrate a dose-response effect based on the level or amount of psychosocial treatment services that are provided. Therefore, physicians have an additional level of responsibility to patients with opioid addiction problems; this responsibility goes beyond prescribing and/or administering buprenorphine.

For most patients, drug abuse counseling individual or group and participation in self-help programs (e.g., Alcoholics Anonymous [AA]; Narcotics Anonymous [NA]; Methadone Anonymous, a 12-Step group that supports recovery concurrent with OAT; Self Management and Recovery Training [SMART] Recovery; or Moderation Management) are considered necessary.

Self-help groups may be beneficial for some patients and should be considered as one adjunctive form of psychosocial treatment. It should be kept in mind, however, that the acceptance of patients who are maintained on medication for opioid treatment is often challenged by many 12-Step groups. Furthermore, many patients have better treatment outcomes with formal therapy in either individual or group settings.

The ability to provide counseling and education within the context of office-based practice may vary considerably, depending on the type and structure of the practice. Psychiatrists, for example, may include components of cognitive-behavioral therapy or motivational enhancement therapy during psychotherapy sessions.

Some medical clinics may offer patient education, which generally is provided by allied health professionals (e.g., nurses, nurse practitioners, physician assistants). A drug abuse treatment program typically includes counseling and prevention education as an integral part of the clinic program. In a stand -alone general or family practice, the opportunities for education/counseling may be more limited. As part of their training in opioid addiction treatment, physicians should obtain, at a minimum, some knowledge of the basic principles of brief intervention in case of relapse.  Physicians may want to consider providing to office staff some training in brief treatment interventions and motivational interviewing; this information could also enhance the effectiveness of treatment for other medical problems. A list of trainers may be found at http://www.motivationalinterview.org.

Many physicians already have the capability to assess and link substance abuse patients to ancillary services for substance abuse. Physicians considering making buprenorphine available to their patients should ensure that they are capable of providing psychosocial services, either in their own practices or through referrals to reputable behavioral health practitioners in their communities.

In fact, the Drug Addiction Treatment Act of 2000 (DATA 2000) stipulates that, when physicians submit notification to the Substance Abuse and Mental Health Services Administration (SAMHSA) to obtain the required waiver to practice opioid addiction therapy outside the Opiate Treatment Program setting, they must attest to their capacity to refer such patients for appropriate counseling and other nonpharmacological therapies.

It is incumbent on practitioners of buprenorphine treatment to be aware of the options and services that are available in their communities and to be able to make appropriate referrals. Physicians should be able to determine the intensity of services needed by individual patients and when those needs exceed what the practitioner can offer. Contingency plans should be established for patients who do not follow through with referrals to psychosocial treatments. Physicians should work with qualified behavioral health practitioners to determine the intensity of services needed beyond the medical services.

Treatment Monitoring

Patients and their physicians together need to reach agreement on the goals of treatment through a treatment plan that is based on assessment of the patient. Treatment plans should include both treatment goals and the conditions under which treatment is to be discontinued. The initial plan should contain contingencies for treatment failure, such as referral to a more structured treatment modality,(for example, Opiate Treament Program.)  For polysubstance users, it is also important for patients to set a goal of abstinence from all illicit drugs, provided that counseling to address other drug use is also available. (Abstinence from all illegal or inappropriate substances of abuse should be the goal of all patients, whether single or polysubstance users.)

Treatment contracts are often employed to make explicit what is expected of patients in terms of their cooperation and involvement in addiction treatment. Physicians may find a  contract a useful tool in working with patients in an office-based setting.

After obtaining signed patient consent (according to 42 C.F.R. Part 2), physicians should clarify assessment and treatment goals with family members. Whenever possible, significant others should be engaged in the treatment process, as their involvement is likely to have a positive effect on outcomes. Conversely, when patients refuse to involve their significant others, or when the latter refuse to become involved, positive outcomes are less likely.

Educating Patients And Caregivers

Patient Education

Basic information about nuprenorphine should be conveyed at the outset and reinforced throughout the course of treatment.  Face-to-face conversations, supplemented by written fact sheets, are helpful.  Important instructions for patients include:

*  Let Subutex or Suboxone tablets dissolve under your tongue; they are much less effective is swallowed.
*   Take no more than two tablets at a time; otherwise you may swallow them by mistake.
*   Wetting the mouth before placing the tablets under your tonguecan help the tablets dissolve faster.
*   Don't smoke for 10 to 15 minutes before you take your medication.  Not smoking seems to help the tablets disove much faster.
*   Be sure to tell your Doctor or other health care professional about any discomfort you feel.  He or she may be able to give you medication that will help.
Before you have any medical or dental treatment that involved anesthesia or pain -relieving medication, besure to tell your physician or dentist taht you are taking buprenorphine.  The medications may interfere with one another.
*   Do not drive a car or operate machinery until you are sure you can do it safely.

Preparing patients for the possibility of some temporary discomfort during the transition process and developing a trusting patient-doctor relationship are extremely important. It is especially inportant to encourage patients to tell their health care provider about any effects they feel, because temporary side-effects can often be alleviated with over-the-counter medications like Tylenol for headache or Benadryl for sleep or anxiety.

Warn patients if they continue to use illicit opioids, they may have difficulty stabilizing on buprenorphine, and that if they take their buprenorphine dose shortly after use of an illicit opioid, they may experience transient withdrawal symptoms.  Because of buprenorphine's potential to block the effects of other opioids, it is critical to advise patients to alert other treatment providers (such as dentists and emergency room personnel) that they are taking buprenorphine before undergoing any medical procedure or receiving treatment for injury or illness that involves the use of opioids to control pain (see SAMHSA's Web site at http://www.buprenorphine.samhsa.gov or the manufacturer for guidance.)

In addition, patients should be cautioned against using buprenorphine in combination with other central nervous system depressants such as alcohol and benzodiazepines.  And they should be counseled that the side effects of buprenorphine
are similar to those of other opioid agonists; the most common are headache, withdrawal syndrone, nonspecific pain, nausea, and constipation.  These side effects are not unexpected, are generally mild and mangeable, and often resolve within three weeks.   

Patients are to be made aware that misuse of of buprenorphine can have serious results.  Just as with methadone (Ernst et al., 2002) injecting buprenorphine or using larger doses than those prescribed in combination with benzodiazepines can cause death  (kintz,2002; Reynaud et al., 1998; Singh et al., 1992).

Patients who have a history of liver disease need to be informed about the need for routine monitoring, as increased liver enzyme levels have been  reported  during  buprenorphine
therapy (Lange et al., 1990; Petry et al., 2000b). And finally, warn all patients that injecting Subutex may cause liver damage(Berson et al., 2001a,2001b).
 

Frequency of Visits

During the stabilization phase, patients receiving maintenance treatment should be seen on at least a weekly basis. Part of the purpose of the ongoing assessment is to determine whether patients are adhering to the dosing regimen and handling their medications responsibly (e.g., storing it safely, taking it as prescribed, not losing it). Once a stable buprenorphine dose is reached and toxicological samples are free of illicit opioids, the physician may determine that less frequent visits (biweekly or longer, up to 30 days) are acceptable. Visits on a monthly basis are considered a reasonable frequency for patients on stable buprenorphine doses who are making appropriate progress toward treatment objectives and in whom toxicology shows no evidence of illicit drugs.

However, physicians should be sensitive to treatment barriers, such as geographical issues, travel distance to treatment, domestic issues such as child care and work obligations, as well as the cost of care.

Patients' progress in achieving treatment goals should be reviewed periodically. Various goal-attainment scales, which can be administered by a nurse or case manager, can assist in monitoring and documenting patients' progress.

Measures used to evaluate maintenance treatment with buprenorphine are similar to those used for other areas of addiction treatment:

* No illicit opioid drug use occurs and no other ongoing drug use (including problematic alcohol use) is found that might compromise patient safety (e.g., ongoing abuse of alcohol and/or benzodiazepines).

Toxicity is absent.

Medical adverse effects are absent.

*  Behavioral adverse effects are absent.

Patient is handling the medication responsibly.

Patient is adhering to all elements of the treatment plan (e.g., seeing a psychotherapist or attending groups as scheduled, participating in recovery -oriented activities).

Unstable Patients

Given these evaluations, physicians need to decide when they cannot appropriately provide further management for particular patients. For example, if a patient is abusing other drugs that a physician does not feel competent to manage, or if toxicology tests are still not free of illicit drugs after 8 weeks, then the physician may want to assess (1) whether to continue to treat that patient without additional evidence of ongoing counseling or (2) whether to refer the patient to specialists or to a more intensive treatment environment. Decisions should be based on the treatment plan to which the patient previously agreed.

Toxicology Testing for Drugs of Abuse

During opioid addiction treatment with buprenorphine, toxicology tests for all relevant illicit drugs should be administered at least monthly. Urine screening is the most common testing method, although testing can be performed on a number of other bodily fluids and tissues including blood, saliva, sweat, and hair. A comprehensive discussion of urine drug testing in the primary care setting can be found in Urine Drug Testing in Primary Care: Dispelling the Myths & Designing Strategies (Gourlay et al. 2002).

Methadone and heroin metabolites are each detected by commercially available urine-testing kits. Buprenorphine does not cross react with the detection procedures for methadone or other opioids; therefore, it will not be detected in a routine urine drug screen. Both physicians and patients should be aware of this fact.

Buprenorphine and its metabolites are excreted in  urine.  Urine testing for  buprenorphine can  be  performed   at   a    medical laboratory, but at the time of this document's publication, there are  no  CLIA -waived, in -office buprenorphine  urine  test kits commercially available.

There are two primary reasons to consider testing for buprenorphine: (1) in new patients to confirm that they do not already have buprenorphine in their system, (2) to assist with evaluating adherence in patients on buprenorphine treatment.  As new testing procedures and protocols are recommended for use in addiction treatment with buprenorphine, SAMHSA will be making additional information available through the Division of Pharmacologic Therapies.  http://www.dpt.samhsa.gov/

Discontinuation of Medication

Under ideal conditions, discontinuation of medication should occur when a patient has achieved the maximum benefit from treatment and no longer requires continued treatment to maintain a drug-free lifestyle. Once this goal is achieved, buprenorphine should be tapered slowly and appropriately while psychosocial services continue to be provided. Patients should be assessed for continued stability in maintaining their drug-free lifestyle. Patients should then be followed with psychosocial services and/or the reintroduction of medication, if needed, for continued progress.

Certain situations undoubtedly will arise,  however, in  which  a physician may feel that a patient is not progressing satisfactorily. For example, a patient may not be in compliance with the treatment plan or with office procedures (e.g., timely payment). Under some conditions, physicians may consider involuntary termination of treatment, but must be careful to not abandon patients. Physicians can and should take a variety of actions to prevent this situation. Physicians should have written policies in place regarding patient behavior, office procedures, and adherence to treatment. These policies should be discussed with patients before initiating buprenorphine treatment, and patients should agree to comply with these policies.

Physicians  should  develop  practices  for  dealing  with  minor infractions of rules or policies and with minor nonadherence to treatment plans. Clearly defined points should be identified at which patients will be notified that they are not adhering to treatment plans, and they should be given the opportunity to improve in this regard. In the event of involuntary termination of treatment, it is necessary for physicians to make appropriate referrals to OTPs, to other physicians who are willing to prescribe buprenorphine, or to other appropriate treatment facilities.

If a patient will not be receiving Opiate Agonist Treatment in another treatment setting, the physician must manage the appropriate withdrawal of buprenorphine so as to minimize withdrawal discomfort. A patient may or may not be willing to accept referrals made on his or her behalf, but physicians must make good faith efforts to ensure that their patients have an appropriate level of care available after their own therapeutic involvement is ended.

References (1) Clinical Guidelines For The Use of Buprenorphine In The Treatment Of Opioid Addiction (TIP 40) Chapter 4 pp. 63-67

                    (2) Perspectives Vol. 2 No. 2 Practical Considerations For The Clinical Use of Buprenorphine Hendree' E. Jones pp. 4-19

Written and Edited:  Deborah Shrira           Dated:  14 April 2007