Innovations In Clinical Neuroscience

MAR-APR 2018

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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R I S K M A N A G E M E N T 48 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE March-April 2018 • Volume 15 • Number 3–4 • Familiarizing yourself with applicable FDA Risk Evaluation and Mitigation Strategies (REMS) 2 for the medications you prescribe. Collecting information about the patient. Information should be gathered initially, as well as throughout the treatment relationship, from the following: • The patient, as part of the ongoing assessment and evaluation to develop a diagnosis, as well as to develop and implement an ongoing treatment plan • Other healthcare providers, including obtaining past treatment records • Family members and significant others, as appropriate • The state Prescription Monitoring Program (PMP). When prescribing controlled substances, the PMP is an invaluable source of information and should be checked often, even if not technically required by the state. If the report shows prescriptions not reported by the patient, you should address the issue clinically with the patient rather than abandoning the patient by terminating without notice. Collecting information about treatment and standard of care . When prescribing controlled substances, it is particularly important to stay current and follow all applicable federal and state laws and regulations, as well as guidance from regulatory agencies (e.g., the Drug Enforcement Agency [DEA] and state licensing boards) and others professional associations. Also, appropriate continuing medical education (CME) courses related to controlled substances could be beneficial and are being required by an increasing number of states. The Federation of State Medical Boards (FSMB), in an earlier version of its model policy on opioid treatment, included the following "universal precautions" that might be useful when prescribing all types of controlled substance: 3 • Make a diagnosis with an appropriate differential. • Conduct a patient assessment, including risk for substance abuse disorders. • Discuss the proposed treatment plan with the patient and obtain informed consent. • Have a written treatment agreement that sets forth the expectations and obligations of both the patient and the treating physician. • Initiate an appropriate trial of opioid therapy, with or without adjunctive medications. • Perform regular assessment of patient and his or her functioning. • Reassess the patient's pain score and level of function. • Regularly evaluate the patient in terms of the five As: analgesia, activity, adverse effects, aberrant behaviors, and affect. • Periodically review the pain diagnosis and any comorbid conditions, including substance use disorders, and adjust the treatment regimen accordingly. • Keep careful and complete records of the initial evaluation and each follow-up visit. Collecting information about abuse and diversion . The DEA has provided guidance 4 on recognizing a drug abuser, including the following: Common characteristics • Assertive personality, often demanding immediate attention • Unusual knowledge of controlled substances and/or textbooksymptoms • Evasive or vague answers to questions regarding medical history • No regular doctor or health insurance • Will request a specific medication and is reluctant to try a different one • No interest in the diagnosis; fails to keep appointments for further diagnostic tests or refuses to see a consultant • Exaggerates medical problems and/or simulates symptoms • Cutaneous signs of drug abuse Common modus operandi: • Must be seen right away • Wants an appointment toward end of office hours • Travels through town, visiting friends or relatives • Feigns physical problems • Feigns psychological problems • States that certain medications do not work or that he or she is allergic to them • Claims that prescriptions are lost or stolen • Pressures by eliciting sympathy or guilt • Utilizes a child or elderly person when seeking stimulants or opioids. RISK MANAGEMENT STRATEGY #2— COMMUNICATING Communicating with the patient. Informed consent. Informed consent is an important type of patient communication. The standard elements to cover are the nature of the proposed medication, risks and benefits of the proposed medication (including the potential impact on driving), alternatives to the proposed medication, risks and benefits of alternative treatments, and risk and benefits of doing nothing (Appendix 1). You might want to consider patient medication guides, such as those from the FDA 5 or professional organizations such as the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry 6 to augment patient education when prescribing a medication. Obviously, providing educational or informational materials are just one part of the informed consent. Some states require additional items to be covered in the informed consent discussion when prescribing controlled substances, such as the potential for tolerance, dependence, addiction, and overdose. Patient monitoring. Ongoing monitoring of the patient and his or her progress toward treatment goals is another type of communication between patient and physician. You might want to consider a standardized assessment tool, particularly for buprenorphine/naloxone (Suboxone®, Indivior Inc., North Chesterfield, Virginia) treatment 7 and pain management. 8 As part of this ongoing assessment, medications should be monitored for efficacy and side effects. Office policies. Managing patient expectations at the beginning of treatment is beneficial. You should discuss with the patient your office policies related to prescribing controlled substances, such as the following: • Restricting treatment to only one prescriber • Restricting prescriptions to only one pharmacy

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