Summary by Andrew O’Hagan, MD
111
Based on “Principles of Addiction Medicine” Chapter by James W. Finch, MD, Theodore V. Parran, Jr., MD, FACP, Bonnie B. Wilford, MS, and Stephen A. Wyatt, DO
While there is significant variation among classes of medications which bear the potential for misuse, one common feature is the effect on dopamine reward pathways, which can lead to abuse and misuse, and ultimately long-term addictive behavior. The Drug Enforcement Agency (DEA) attempts to categorize these medications on the basis of relative risk of misuse, based on the frequency and duration of dopamine stimulation. However, it is important to recognize that what may represent high-risk use for one individual can provide beneficial or even lifesaving treatment for another. Physicians face the challenge of assessing the risk–benefit profile of prescribing medication, in which providing thorough evaluation of the patient, following the guidelines of informed consent, and patient monitoring are paramount. As prescription medication administration is tightly regulated, failure to provide the standard of care may bring regulatory and legal scrutiny from law enforcement, state licensing, and professional organizations. Due diligence should not dissuade physicians from prescribing controlled substances when clinically indicated, but they must be cognizant of the medical, psychiatric, and addiction-related factors relevant to the patient’s situation.
FACTORS THAT CONTRIBUTE TO INAPPROPRIATE MEDICATION PRESCRIBING AND USE
Inappropriate use of medications may happen when doctors do not have a full medical assessment and appropriate workup of the patient, which otherwise would lead to a reasonable differential diagnosis. Part of forming a sufficient differential is appreciation of addiction and dependence issues. Doctors are often unwilling to confront their patients who may appear to be “drug seeking.” Conversely, physicians may be overly rigid, and unnecessarily fearful of enabling addiction may be prone to undertreating patients, which is also an error in judgment. One common error in prescribing stems from the doctor having a perception of his or her responsibility to the patient as being one of complete alleviation of symptoms. This represents an oversimplification of the physician’s fiduciary responsibility, as the doctor is responsible for treating symptoms in a manner that has the least amount of acceptable risk and adverse consequences for the patient. Patient safety must be preserved.
While the physician has certain obligations to the patient, the patient is responsible for providing accurate information to the clinician and to committing to the treatment plan. Failure to abide by these objectives can stem from benign problems of communication, where the patient does not understand the parameters for treatment; unrealistic expectations of treatment; or at times outright deceptive practices. It is not uncommon for patients to engage in behaviors like sharing, using, or stealing other people’s medications or seeking out multiple prescribers in an effort to increase diversion of medications, also known as doctor shopping. It is the physician’s responsibility to provide patient education to reduce the risk of illicit diversion of medications, by monitoring patients closely, speaking directly with past providers, and utilizing state prescription drug monitoring programs.
UNIVERSAL PRECAUTIONS IN PRESCRIBING CONTROLLED DRUGS
Step 1: Conduct Initial Assessment and Risk Stratification, Differential Diagnosis
Physicians must establish a formal clear indication for treatment, against any alternative treatment options. While much information may come from the patient, it is important to obtain consent to speak with family to provide collateral information. Likewise, possible contraindications for treatment should be assessed based on risk. This evaluation should also assess nature of disease process and functional impairments (i.e., social and vocational disability) related to illness. Also of importance is a thorough clinical interview based on substance use history with the use of screening tools for both patient and family members. It is important to remember when taking a history that many patients use supplements and naturopathic treatments that are not as widely regulated. The physician should be aware of the potential for side effects, drug–drug interactions, and illicit use and abuse.
Step 2: Discuss the Proposed Treatment with the Patient and Obtain Informed Consent
Treatment plans should provide direct, clear goals and objective measures of progress or lack thereof during treatment. Treatment modalities and analysis of risk and benefit in the context of severity of symptoms, patient reliability in taking medication, and addiction potential of therapy should also be addressed in the treatment plan.
Step 3: Document Decisions in a Written Treatment Agreement
Written agreements elucidate the responsibilities between doctor and patient. The treatment plan should be explained by the doctor in a coherent manner to clarify these responsibilities. Additionally, the written treatment plan should contain documentation of patient’s agreement to allow the doctor to communicate with prior clinicians, to receive medications from one provider only, and to participate in random urine drug testing.
Step 4: Initiate an Appropriate Trial of Medication Therapy
All medication trials should have a specific end point, as well as periodic evaluation points throughout the course of treatment. The dosage, schedule, and formulation of a specific medication depend on the character of the specific illness; the patient’s weight, age, and size; loading requirements; and potential drug–drug interactions of the medication. Further, the addiction potential of the medication in the context of the patient’s own history should also be taken into account. With new patients, sometimes it is necessary to provide very specific guidelines for administration of medications and controlling the supply of medications as a means of lowering risk of diversion.
Step 5: Monitor the Patient’s Response to Therapy
Strategies for monitoring medication trials include instructing patients to provide a journal of their subjective physical symptoms in a review of systems, using pill counts to assess for diversion of medications, and periodic use of prescription drug monitoring programs to prevent the patient from seeking out multiple providers. Also, routine evaluation of behavioral changes and urine toxicology screens can be helpful for assessing comorbid addiction issues, with the caveat that many addictive substances will not appear on a standard urine drug screen, and confirmatory testing might be necessary. Positive tests should be discussed with the patient, with the goal of providing education and support. If continued concerns with issues of medication misuse persist, a consultation with an addiction specialist should be considered.
As mentioned before, every treatment should have an end point, and the goal of treatment is the reduction of morbidity and mortality. Improvement in quality of life and increased level of functioning should be considered when deciding to continue treatment. Conversely, if a medication trial results in intolerable side effects, failure to improve quality of life, or addiction issues, the physician should consider stopping the medication trial. Evidence of misuse and diversion includes early or multiple filling of prescriptions, drug intoxication and withdrawal, and threatening or pressuring behaviors by the patient. While the clinician should always be supportive of the client, the clinician has a responsibility to document these types of behaviors, confront the patient, and ultimately stop prescribing if indicated. When discontinuing medications, the clinician should assess whether immediate discontinuation could precipitate withdrawal or a clinical emergency (or warrant detox or medical admission), or if tapering of medications can be done on an outpatient basis. Outpatient detox or tapering regimens can be challenging if the patient has difficulty with adherence. Smaller medication allotments and more frequent visits may help in these instances.
Step 6: Keep Careful and Complete Records of the Initial Evaluation and Each Follow-Up Visit
Careful record keeping provides a rationale for treatment decision making and demonstrates the physician’s commitment to the patient. Since prescribing can lead to legal considerations, documentation also protects physicians from law enforcement and regulatory agencies to which they may be subject.
LEGAL REQUIREMENTS IN PRESCRIBING CONTROLLED SUBSTANCES
In order to write prescriptions, a physician must be registered with the DEA and state licensing bodies, which can have their own individual criteria for prescribing controlled substances. Prescriptions require a patient’s name, date of birth, the name of medication, strength, dosage, frequency, and number of pills prescribed. Also, every prescription should have the name of the prescribing physician and their license number, national plan and provider identifier (NPI), and/or DEA. If the prescription is for a controlled substance, the maximum daily dose should be written, as well as any supporting information (i.e., DEA X number).
KEY POINTS
1. Assessment of necessity to prescribe medication to a particular patient requires not just an understanding of the patient’s medical condition and the risk–benefit balance of a particular treatment but an understanding of the psychosocial and addictive risk factors that may come into play for a particular treatment.
2. As such, the physician is primarily responsible for delivering treatment in a safe and ethical manner. Tools such as treatment contracts, clearly written treatment plans, and providing informed consent to the patient can limit diversion of medications and provide better quality of care.
3. As part of the professional standard of care, it is the physician’s duty to follow all regulations at state and federal levels as well as guidelines from professional organizations. The best way to demonstrate following protocol is clear documentation.
REVIEW QUESTIONS
1. Your patient has for many years taken Valium for acute flare-ups of anxiety. The patient’s husband and brother both have a history of problematic drinking and cocaine use. While she has a treatment contract that specifies the frequency and dose of medications and the amount given to her, she presents to your office several days prior to her next appointment asking for more Valium. She states “she lost her prescription,” and makes poorly sustained eye contact. The best course of action is:
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
