Prescriber and Patient Opioid Responsibilities

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In your opinion, regarding opioid medications, what are the rights and responsibilities of the prescriber and of the patient? 

Thomas E. Quinn, MSN, RN, AOCN:

Tom Quinn has been an oncology nurse for over 25 years. Early in his career he developed a strong interest in symptom management, especially pain control. He has cared for patients in community hospitals, major cancer centers, and at home. For most of his career he has been teaching about pain in a variety of forums. He is the editor of the “Pain Relief Connection Newsletter”, distributed through the "MGH Cares About Pain Relief" program at the Massachusetts General Hospital in Boston.

One important responsibility for patients is to make sure their clinicians are communicating with each other. Patients are likely to speak to their primary care physician first about their pain. Sometimes they are referred to a pain specialist by their primary care physician or another specialist like an oncologist. Because these patients are often working with a number of specialists and clinicians, they should make an effort to facilitate coordinated care through communication. Unfortunately, some patients will develop a "don't tell me anything" attitude about their treatment. This type of approach is a dangerous one and should be discouraged. The patient must act as a "self care agent" and take a conscious and active role in his or her care. It is important for the patient to ask questions such as, "Have you spoken with my primary care physician or my oncologist about this prescription?" when he or she is meeting with another physician.

In addition to communicating with his or her clinicians, patients, especially patients who are at high risk for aberrant behavior, should speak to their family, friends, and even co-workers about their opioid treatment plan. Patients at high risk will need the support and understanding of the people around them – it is important for these individuals to be considered a part of the larger treatment team, along with the patient’s clinicians.

The responsibilities of a clinician prescribing opioids are very daunting especially for patients with co-existing addiction issues. Additionally, many patients with a primary diagnosis of pain have a psychological diagnosis among other co-morbidities. There are many resources now available for primary care clinicians to educate themselves on pain management with long-term opioids. Further, it is the responsibility of the primary care physician to educate not only the multi-disciplinary treatment team, if they are fortunate to have one, but also the office support staff. This education should include: how to recognize when someone needs help, when to make a referral and when to insist that a patient does not continue with the current treatment plan unless they also receive mental health services. Just a few "problem patients" require a lot of time, energy, and emotional reserve from a clinician and his or her support staff. Preparing your support staff with education and guidelines will prevent miscommunication and help patients get the appropriate care. Complex, especially multi-diagnosis, patients will also require the assistance of a large treatment team. It is the responsibility of the primary care physician to find partners such as mental health professionals and other resources such as 12 step programs.

Because of the regulations associated with opioid use and the potential for abuse, the issue of trust can become a challenge in a clinician- patient relationship. For instance, a patient may feel insulted and mistrusted when subjected to a urine screening. During treatment planning clinicians should prospectively explain that tests, such as a urine screen, are a common practice, as well as explain to their patients what the risks are for opioid therapy and why these regulations exist.

Monitoring patients' behavior and psychological status while they are using opioids is a major responsibility for clinicians. Taking care of these complex patients can present many challenges such as negotiating with insurers about off-label use of medications; locating scarce resources like long term care facilities for a patient taking methadone for pain, and funding the care of comprehensive pain management.

Unfortunately, a clinician may find him or herself in a position where the most appropriate action is to terminate a relationship with a patient. Developing an "exit strategy" prospectively--before it is necessary to actually implement termination with a patient—is an essential part of practice organization. This is a very loaded issue with ethical and regulatory implications. There is a risk that this may be perceived as patient abandonment. In this situation, the clinician is responsible for documenting their conversation with the patient that outlines why the relationship has been terminated, what the next steps are for the patient, and that an appropriate referral has been made.

In your opinion, regarding opioid medications, what are the rights and responsibilities of the prescriber and of the patient? 

Bill McCarberg, MD:

Bill McCarberg, MD, is the founder of the Chronic Pain Management Program at Kaiser Permanente, Escondido, California. Dr. McCarberg is also an assistant clinical professor (voluntary) at the University of California, San Diego School of Medicine, La Jolla, California. He is board certified by the American Board of Family Medicine, and the American College of Pain Medicine. Dr. McCarberg is also co-author of the soon to be published text "Managing Chronic Pain with Opioids in Primary Care".

When it comes to treating pain in patients with opioids, it is reasonable to expect that both parties (physician and patient) have rights and responsibilities, which in some cases are distinct, yet in others, are actually quite the same.

From the clinician's perspective, as in any situation, the responsibility starts with a thorough history and physical. This serves to be the foundation of laying out a strategy for effective and successful treatment. Given the opportunity, patients will generally tell you what’s bothering them, and what they are looking for with respect to treating pain. In my opinion, there is nobody better to do this than the primary care physician. The ability to rely on the relationship that exists between the patient and the primary care clinician provides the longitudinal history of the patient, and this knowledge, coupled with the comfort of treating chronic conditions positions fortifies that.

Key to the clinician's responsibility is the need to arrive at a credible diagnosis prior to treatment with an opioid. Regardless of whether it means further testing, or additional history from family members or caregivers, whatever needs to be done to make that happen rests squarely on the clinician’s shoulders.

The clinician also has the responsibility as well as the right to give informed consent to the patient about the risks associated with, and appropriate use of opioids prior to prescribing them. This is the beginning of a dialogue that will include topics such as realistic expectations, methods that may be employed for the purpose of monitoring of appropriate usage, and appropriate approaches with respect to storage and disposal of opioids.

From the patient's perspective, there is a right to have an informed consent, and the responsibility to understand what they are giving consent to. Effective communication is not only the responsibility of the clinician. The patient needs to assert their thoughts and feelings as well.

After prescription, adherence to the treatment plan surfaces as the main patient responsibility. The significance of this is multifaceted. First of all, the patient needs to understand the treatment plan, and everything that goes along with that. This would include the amount of time that may be needed to achieve successful control of the painful condition. Secondly, the patient has to also clearly understand the mutually (patient and clinician) determined goals of treatment, and these need to be both achievable and realistic in nature. Lastly, and most importantly, adherence to the medical regimen as prescribed is critical to safe and responsible use of opioids for treating pain.

Additionally, I think another important responsible party with regard to this topic is that of the regulatory agencies. I believe that instead of creating a feeling of fear in clinician's minds with respect to prescribing opioids for pain, they should be working to increase the comfort level in the clinician's minds. Support in clinical decision-making could potentially improve the quality of care. Certainly, fear of retribution will not.

Ultimately, I think a very effective way to ensure a reproducible methodology with regard to the responsibilities and rights of the patients and primary care physicians is with a treatment agreement. This serves to be documentation that can be the "glue" that aligns these issues tangibly, as well as mentally for all parties involved. If this document is utilized as something that can be referred back to as necessary, it can be a very valuable tool to ensure that both parties clearly understand everyone's rights and responsibilities.

In your opinion, regarding opioid medications, what are the rights and responsibilities of the prescriber and of the patient? 

Jennifer E. Bolen, J.D.:

Jennifer E. Bolen, J.D. owns and operates a medico-legal consulting firm specializing in the development and implementation of risk management programs and practice standards for the use of controlled substances to treat pain and office-based treatment of opioid addiction. She develops educational material and educates clinicians about state and federal controlled substance and pain act guidelines, laws, policies, and regulations. Additional information about Ms. Bolen's work is available at her website www.legalsideofpain.com.

A prescriber has an ethical duty to care, to do no harm, to be a good steward of his/her licenses and registrations, to the pain community, and to his/her patients, and to not abandon patients. A prescriber must only prescribe controlled substances for a legitimate medical purpose in the usual course of professional practice, and with an eye to minimizing the potential for abuse and diversion of controlled substances. A prescriber has the right to say no when treatments requested exceed the scope of his/her practice, but this comes with a duty to help the patient find providers who might be able to help the patient.

Similarly, patients owe a duty of communicating accurate and complete information to providers and to be a good steward in terms of putting forth a genuine effort to attain treatment plan goals and responsibly handle any medications. A patient has a right to have his/her pain assessed and treated, but a patient cannot force a prescriber to treat outside the scope of his/her practice. Of course these rights and responsibilities are much more specific in terms of subtopics, but these are the topline issues.

Both prescribers and patients have should discuss their respective roles openly and honestly, and work together to achieve the best patient outcome. Pharmacists have similar responsibilities as prescribers. Unfortunately, the different information available to help clinicians, provided by federal agencies and legal entities, and individual state and legal entities, and advocacy groups and professional medical organizations, can lead to confusion and anxiety. A common example is the variety of information relating to and potential confusion surrounding the issue of whether there are quantity limits on the amount of controlled substances that can be prescribed in a single prescription. The Federal government has not set any limitation on quantities, but some states have set specific limits.

Health care clinicians need to understand the interplay of law and medicine or they can get in trouble. State and federal guidelines are available at no cost via the Internet to everyone. There are often educational audio "town halls" on my website (above). Good resources for information are the Pain & Policy Studies Group at the University of Wisconsin and my columns in back issues of Pain Management News.

Prescribers need to learn how to incorporate key phrases from state and federal regulations into the medical record. Forms are not magic, but the intent of any form should be to communicate the relevant clinical information in a manner that demonstrates compliance with federal and state legal/regulatory materials. When prescribing opioids, it is important that the clinician review minimal requirements outlined by his/her medical licensing board and determine whether his/her documentation reflects knowledge of and compliance with these terms. One area that is especially critical relates to the evaluation of the patient and whether there is indeed a legitimate medical reason for the use of a controlled substance to treat the patient's pain. If there is, then the prescriber should engage in an informed consent discussion with the patient to ensure the patient understands the potential risks, expected benefits, available treatment alternatives, and special issues associated with the use of the recommended medication. The prescriber should make a note (or use a form) to reflect the informed consent discussion.

Patients need to be honest with themselves as well as to their clinicians, about when they need to take medication and when they can manage with less. Unfortunately, most patients think they have to complain in order to assure that their medication will continue to be prescribed. Management of pain works best when the patient and prescriber have a relationship with good communication. It is very helpful for a patient to keep a good record of how they are balancing their pain medication, managing side effects, and achieving their goals. Patients should understand that while it makes sense to ask their doctor for a few days leeway between prescriptions, to account for life events and schedules, it is not wise to "stockpile" medication, as this may pose a threat that knowledge about this may jeopardize the relationship with their clinician.

At the same time, the clinician needs to reassess the patient at every visit, which may or may not require a physical examination, to understand whether there is an ongoing clinical need for the medication and whether the patient is working toward treatment plan goals. For example, a patient who finds it helpful to use a new rapid onset medication for breakthrough pain may be able to decrease their usual prescription of breakthrough medication, and information like this is significant and should be documented in the medical record.

I believe the physician-patient relationship as it relates to the use of controlled substances to treat pain is about trust and working together in a way that balances the patient’s legitimate need for controlled substances with the prescriber's responsibility to minimize the potential for abuse and diversion in relation to his/her duty to care/treat and to do no harm, etc.

Everyone in the medical practice should understand and follow the same consistent policy for management and communication, including front desk staff. The practice where I get medical care asks patients to receive all of their medications at one pharmacy. I have no trouble complying with this request. However, on at least three occasions, the pharmacy I chose did not have the medications I take and I needed to obtain my medications before I left town for an extensive period. I called my doctor's office and left a message on the nurse's line stating that I wanted to switch to a new pharmacy in the same pharmacy chain, because the new pharmacy regularly stocked the medication I use. I also told the individual who answered the phone at the front desk. Despite my efforts, I was told that I could only do this "once" and that if I did it again I could be discharged from the practice. I informed my doctor of this event and it was quite clear that he had no problem with my switching pharmacies or with the way I informed his office. In the end, it was also clear that he did not realize that a member of his staff was communicating with patients in a way that was perceived as punitive.

The prescriber and his/her staff should discuss issues like switching pharmacies and work to minimize the potential for miscommunications and behaviors that may erode the physician-patient relationship. It is important to remember that both parties have a duty of stewardship as it relates to the responsible prescribing and use of controlled substances and strive to keep communication lines open throughout the treatment period.