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July 22, 2019

This paper will review current practice guidelines for patient monitoring during follow-up visits for patients receiving medication-assisted treatment using buprenorphine/naloxone products for Opiate Use Disorder (MAT). Evidence-based best practice recommendations include interventions targeted specifically to enhance the doctor-patient relationship. Characteristics of doctor-patient relationship, as measured subjectively and objectively, such as personal-warmth, good-interpersonal skills, and empathy are heavily weighted in all current published practice guidelines. It follows then that any discussion the follow-up visit must include critical components of the doctor-patient interaction when treating substance use disorders and related conditions. Clinical examples will illustrate one approach to integrating all recommended guidelines into clinical practice.

Introduction

Medication-assisted treatment (MAT) of Opiate Use Disorder with buprenorphine/naloxone products is an emerging intervention borne out of the DATA 2000 Act. Led by an unusual public/private partnership between SAMSHA and Reckitt Benckiser (drug manufacturer), this law’s aim was to improve accessibility and decrease stigma for patients seeking treatment of Opiate Use Disorder in response to the worst opiate misuse epidemic in US history. Passage of this law allowed buprenorphine and buprenorphine/naloxone combination use in outpatient medical practice by qualifying licensed physicians. The DATA2000 act required physicians to complete an eight hour online course and attest to their ability to refer patients for appropriate counseling services (i.e. individual or group therapy). The Department of Health and Human Services (HHS) Secretary, Sylvia Burwell, ruled to increase the patient limit to 275 this year for wavered physicians who meet more extensive criteria. For example, qualified individuals or practices must attested to follow relevant practice guidelines for use of buprenorphine/naloxone for opiate use disorder. Leading medical organizations, the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, and the Substance Abuse and Mental Health Service Administration published practice guidelines for monitoring patients at follow-up visit. State medical boards in one state has incorporated best practice guidelines as medical board regulation (Ohio). These guidelines can be summarized by the following Federation of State Medical Boards recommendations:

“Patient monitoring during follow-up visits should address the following points:
• Whether the patient continues to use alcohol or illicit drugs, or to engage in non-medical use of prescription drugs;
• The degree of compliance with the treatment regimen, including the use of prescribed medications as directed; i.e. diversion assessment.
• Changes (positive or negative) in social functioning and relationships;
• Avoidance of high-risk individuals, situations, and diversion risk;
• Review of whether and to what degree the patient is involved in counseling and other psychosocial therapies, as well as in self-help activities through participation in mutual support meetings of groups such as Narcotics Anonymous;
• The presence or absence of medication side effects; and
• The presence or absence of medical sequelae of substance use and its remission. “
Critical interpersonal interactions occur in the delivery of the above medical service at each visit which have been linked to better patient outcome. Attributes of an effective addiction treatment provider are included in the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opiate Addiction: A Treatment Improvement Protocol TIP 40 (Figure 3-1 Page 28) are as follows:

Attributes of an Effective Addiction Treatment Provider
• Ability to establish a helping alliance
• Good interpersonal skills
• Non-possessive warmth
• Friendliness
• Genuineness
• Respect
• Affirmation
• Empathy
• Supportive style
• Patient‐centered approach
• Reflective listening

Using these recommendations as a framework, I will discuss the process of a typical medical follow-up visit. I will highlight critical junctures in the unfolding of a standard medical follow-up visit where evidence-based patient-centered interventions can enhance outcome.

PROCEDURE:
The sentinel question for the follow-up visit for Opiate Use Disorder is current use of opiate or other illicit drugs. We set the expectation in the treatment contract signed at the first visit that patients accurately report use since last visit. When the patient does not report these symptoms accurately care is compromised. Observed urinalysis provides reliable data regarding recent drug use. Since urinalysis results are not routinely available at the visit, we review the patient’s history of accuracy in reporting drug use before each visit and assign those patient’s who do not report accurately to be discussed at the next visit. When the patient demonstrates consistent problems reporting drug use between visits, the necessity of more frequent observed urinalyses and/or more intensive services becomes self-evident. Patients sufficiently distressed by continued drug use welcome accountability. They understand that our mutually agreed upon interventions are more effective when deviations from the care plan are promptly reported and corrected. They learn that accurate reporting of deviations in the treatment plan lead to a better outcome for them. They also learn that significant deviations in the care plan lead to direct consequences and unmanageability in their live. Deviations from the treatment plan also signal patients who may be at risk for diversion. Perhaps most significantly, it is the only manner in which the patient can tell us he/she has lost control of drug use and needs us to intervene.

Positive changes in the patient’s social, occupational functioning and support network are the hallmark of recovery. Questions about family, work and recent events lead to data-rich conversations about the patient’s recent successes and failures at work or home. Questions about primary support system functioning inform the physician regarding the resources the patient can bring to bear on their current disease burden and other psychosocial concerns. Open ended question such as, “ How is your relationship with your wife or girlfriend” and “..tell me more” teach patients the link between recovery and quality of life. Discussion of life problems is often a necessary part of evaluating need for other psychosocial services. Patients can better join us in formulating an intervention based upon the joint observations and explanation of symptoms, and help us evaluate the results of recommended interventions.

In our clinic, we enhance out ability to detect problems at work and home by gathering both subjective and objective data around quality of life. The World Health Organization (WHO) Quality of Life instruments define health as “a state of complete physical, mental, and social well-being, not merely the absence of disease.” WHO, with the aid of 15 collaborating centers, developed a shorter version of the QOL,WHOQOL-BREF, a 20 question survey Both instruments show good discriminant validity, content validity, and test-retest reliability. We include objective indicators of quality of life, months continuously employed and months current relationship.

Indicators of poor functioning in social or primary relationships signal problems which may require additional intervention. Patients suffering from Opiate Use Disorder may benefit from frequent counseling, but not all can or will comply. The majority of our patients report beneficial results from regular, supportive, informed and compassionate counseling. However, the same majority report little or poor result from mandated groups or mandated individual counseling. Commons complaints include inability to change counselors if compatibility poor, insufficient time spent in group on individual problems, lack of flexibility in scheduling appointments, and insufficient physician time. We offer counseling in addition to the physician visit at the follow-up visit. Most patients can access this service since it is available at the monthly visit. Since distance from our office is often an obstacle to weekly therapy at South Hills Recovery Project, we help patients access this service using resources available to the patient (insurance, transport, sliding scale). We find a separate visit with a counselor in necessary to address the many obstacles they may have to gathering needed resources. By centering this process towards patients strengths, priorities ,and limitations, we can engage more of our patients in this important part of their treatment.

In the case of patients who are unable to achieve or maintain expected stability (as evident by illicit drug in urinalysis, difficulty with compliance with treatment recommendations etc), individual and/or group therapy may become a necessary addition to medication-assisted treatment. The patient has the option of arranging services necessary themselves, or we can assist them in the case of co-morbid diagnosis.

Motivating patients to adopt healthier behavioral habits can be difficult. Typically, facilitating change in patients frequently becomes ongoing conversation about their mental and physical health. Patients, of course, come into treatment with different levels of understanding of their illness, how they can improve upon it, and available treatments. These point of care discussions often are opportunities to educate the patient about these matters related to illness.

Assessment of drug diversion risk is an essential part of each visit. We find that thoroughness of visit in gathering accurate indicators of diversion is more crucial than frequency of visit. Monitoring for violations in the patient contract, early refills, calls for refills of lost medication, or attempts to hide medication compliance problems are common indicators. Our policy is to document all calls, rescheduling, or request for refills in the front of the EHR to insure the doctor sees the most recent messages from the patient that may indicate diversion. Closely monitoring the patient response to treatment and other sources of data are reviewed by a physician prior to each visit to detect diversion. Patients who then show increasing indicators of diversion are placed on a pill count list. A pill count, agreed upon by the patient at intake, is initiated. A patient selected for a pill count is contacted by phone and asked to have the current supply of buprenorphine/naloxone with an appropriate time limit.

The following is a clinical example from our clinic where I cover the above elements in about 20 minutes.

A 33 year old woman with two young children came into the clinic in tears. Before I called her into my office, her electronic record indicated high PHQ-9 and GAD-7 scores, Her scores continued to be severe after her 3rd visit. All her prior urinalyses were negative for illicit drugs including her admission urinalysis. She had appropriate concentrations of buprenorphine and norebuprenophine consistent with her history of recent transfer from another clinic. She transferred because she felt the clinic could not meet her mental health needs. The visit went proceeded as described.

Patient: “I can’t take it anymore. It’s too much.”

Physician: “What is too much?,” I asked.

Patient: “LIKE, I can’t even point to one problem. In fact, I realize I don’t have any ‘bad’ problems, but that makes me feel worse.”

Physician: “Worse?

Patient: “Yeah, like I shouldn’t feel this way”

Physician: “How about we look at why you should feel this way? I stood up to go to my whiteboard in the wall opposite her on the wall. “ Let’s make a list of all those things in your life that you should feel good about or grateful.” I drew a blue #1 and circled it, standing expectantly while glancing her direction.

Patient: “My kids, they could not be better, I love them even though they are a lot of work and yet i feel guilty because I feel like I fail them too often.”
Physician: “So you love them”

Patient:“Yes”.

Physician: “And you always loved them, even through the worst of your addiction”

Patient: “Yes.”

Physician: “What would you imagine to be the most important thing a parent can do for their children”

Patient: “I don’t know”

Physician: “How about love them unconditionally?”

Patient: “Sure, that’s most important. I do love them unconditionally.”

Physician: “.and how about you? Do you feel they love you unconditionally?”

“Patient: YES. I KNOW THEY DO.”

Physician: “So can we say that the number one and number two items on you positives list is the unconditional love of your children, and your unconditional love of them?”

Patient:“Yeah, exactly”

Physician: “OK, good start. What else?”

Patient:“I don’t know, everything else is overwhelming, I can’t enjoy anything”

Physician:“How about your relationship with your husband?”

Patient: “It’s good, he is real supportive, helps me when he can, but he works a lot.”

Physician: “OK. so supportive husband is #3?

Patient: “Yes.”

Physician: “So you are saying that life is generally good, but you feel blah or deadened
inside, life has lost its shine.”

Patient: “Exactly, nothing is fun. I can enjoy time with my kids, and husband, I have in the past, I just can’t get out of this hole.”

I switched my line of questions at this point to assess her Mood Disorder. She had a long history of moderate but debilitating depressive episodes since she was 14.

Physician: “Speaking of the hole, How we doing with the antidepressant I prescribed last month to get you out of the hole.”

Patient: “I’m taking it every morning like you said, but I don’t notice anything yet.”
Physician: “Are you having new, uncomfortable physical symptoms since you started the medication?”

Physician: “No nausea, headaches, stomach pain?”

Patient: “No”.

Physician: “Any worsening insomnia, irritably, anger outbursts?”

Patient: “No.”

Physician: “How about increase in suicidal thinking?”

Patient: “No, I never think of that because I have to young kids who need me.”

Physician: “OK, good., so you have been in this depressive episode now for some months, and you worry it is not getting better?”

Patient: “Exactly. I can’t get out of this slump.”

Physician: “We talked last time about giving the antidepressant 4 weeks to work properly, and I started you on the lower dose to avoid side effects. Today we can increase your dose to 75mg. This dose is more likely to give the results we discussed last time. Perhaps that all we need to do right now is increase your daily dose of Effexor XR, and allow you another month to get well and heal. The best thing you can do for yourself right now is self-care. Take it easy on yourself. You are healing from 2 disease processes that take extra energy to heal. You have a tendency to take care of everyone else, get exhausted, and resentful that your efforts aren’t appreciated, Perhaps the problem is that you don’t appreciate what you do for others. How valuable a person you are for being just you, a loving mother and wife trying to recover.”

Patient: “That’s always been my problem. I come last. I have been doing what you said and taking time for me. I said no to my sister who wanted me to help her with a graduation party. I just had too much on my plate. I getting back to gardening again. The weather has been great. I enjoy watching things grow, feeding them, watering..it’s peaceful.”

Physician: “You feel a peace and calmness despite all the trouble surrounding you?”

Patient: “Yes”
Physician: “So while we are waiting to see how well the antidepressant works, you can spend more time in the garden. Do the kids like to help you in the garden?”

Patient: “Yeah, they dig around in the dirt, seems to keep them occupied.

Physician: “Fantastic. I’ll see you next month.”

Conclusion:

Best practice guidelines form the foundation of the follow-up visit for patients taking buprenorphine/naloxone products for Opiate Use Disorder. At the same time, cultivation of characteristics of an effective addiction treatment provider is often critical to the success of the provided interventions.

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