Risk Management: Prescribing Controlled Substances: Managing the Risks

| April 1, 2018 | 0 Comments

by Donna Vanderpool, MBA, JD

Ms. Vanderpool is Vice President, Risk Management at PRMS, Inc. in Arlington, Virginia.

Innov Clin Neurosci. 2018;15(3–4):47–51

Funding: No funding was provided for the preparation of this article.

Disclosures: The authors have no conflicts of interest relevant to the content of this article.

Abstract: This ongoing column is dedicated to providing information to our readers on managing legal risks associated with medical practice. We invite questions from our readers. The answers are provided by PRMS, Inc. (www.prms.com), a manager of medical professional liability insurance programs with services that include risk management consultation, education and onsite risk management audits, and other resources to healthcare providers to help improve patient outcomes and reduce professional liability risk. The answers published in this column represent those of only one risk management consulting company. Other risk management consulting companies or insurance carriers may provide different advice, and readers should take this into consideration. The information in this column does not constitute legal advice. For legal advice, contact your personal attorney. Note: The information and recommendations in this article are applicable to physicians and other healthcare professionals so “clinician” is used to indicate all treatment team members.

Question 

With everything going on in the news about the opioid epidemic and the accusations of the prescribing practices of physicians contributing to the abuse and diversion of drugs, and even patient deaths due to overdose, I’m considering no longer prescribing controlled substances, or at least those in Schedule II. Am I overreacting?

Answer

In our current environment, it is understandable for prescribers to be wary of the increased risk of governmental scrutiny and allegations of malpractice. Fortunately, even in light of this increased scrutiny, providing appropriate clinical care remains the best way to reduce and manage risk, and there are proven strategies to assist you in providing appropriate clinical care.

Risk Management Overview—The Three Cs

Effective risk management strategies that mirror best clinical practices and decrease risk related to prescribing controlled substances are represented by the three Cs:

  • Collecting information—about the medication, patient, treatment and standard of care, and abuse and diversion
  • Communicating—with the patient and others
  • Carefully documenting—the patient’s informed consent, medication monitoring, and your decision-making process.

These three risk management strategies are not meant to oversimplify the practice of psychiatry and the complexities related to decreasing adverse drug events. Rather, they are presented as a way to organize and more easily use the strategies shown to be effective in minimizing risks when prescribing controlled substances.

Risk Management Strategy #1—Collecting Information

Collecting information about medications. Staying current about medications being prescribed is fundamental to prescribing, but it’s no small task. It is more challenging than ever to stay current about prescription drugs because of the amount of information being produced, the speed at which it develops, and the prevalence of conflicting and/or incomplete information. Important activities on which to stay up to date include, but are not limited to, the following:

  • Reading the United States Food and Drug Administration (FDA) label for the medications you prescribe
  • Subscribing to the FDA’s MedWatch E-list1 for notification of medication safety alerts
  • 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 guidance4 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 FDA5 or professional organizations such as the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry6 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) treatment7 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
  • Prohibiting early or urgent refills
  • Prohibiting the replacement of lost or stolen prescriptions
  • Prohibiting dose or frequency increases unless prescribed by physician
  • Using the state PMP
  • Performing random pill counts
  • Performing random drug screening

Treatment agreements. Treatment agreements are useful for managing patient expectations. Some states require treatment agreements, typically for pain management, but prescribers might want to consider incorporating treatment agreements into their practice, even if they’re not legally required (Appendix 2).

Communicating with others. Other providers. Consultation with colleagues is a valuable clinical and risk management approach. Obtaining consultation tends to support thoughtful decision-making, demonstrate objectivity in the choice of treatment modalities, and might provide some assurance that the quality of care delivered meets the standard of care. It is also important to communicate with other providers involved in the patient’s care, such as covering physicians and other treaters.

Family members/significant others. Communication with family members as authorized by the patient can be useful in keeping the patient adherent and safe. In emergency situations, remember that safety of the patient or others is an exception to confidentiality, so no authorization is required. Also, remember that listening to others, without confirming the person is a patient, is not a breach of confidentiality and might yield clinically significant information. You can listen to third parties without breaching patient confidentiality as long as you are not disclosing information.

Risk Management Strategy #3—Carefully Documenting

The primary purpose of the medical record is for continuity of care, thus your records should be written so that a subsequent treatment provider can review the record, know what happened in treatment, and why. For example, documentation of your decision-making process can include diagnosis, medication choice, why this medication was chosen for this patient, and why a dosage was changed. Often, information about clinical actions not taken is as important as information about actions that were taken. Careful documentation provides subsequent readers with information about the basis for your clinical decisions and is critical to the ongoing care of patients. It also supports that you exercised thoughtful professional judgment should your treatment decisions ever be questioned by expert witnesses in litigation, by the regulators, or by yourself years later. Consider including the following in your records:

  •  Initial evaluation
  • Medical indication for prescriptions
  • Medication log
    • Name of medication
    • Start and stop dates
    • Changes in dosages
  • Treatment plan—initial and updated
  • Informed consent—including patient education materials
  • Assessment forms, if used.
  • Ongoing patient assessment
    • Adherence to treatment plan
    • Medication monitoring
    • Laboratory testing ordered and results reviewed
    • Aberrant behavior
    • Results of PMP queries (Note: Given the strict confidentiality requirements related to these PMP reports, you should not include the actual PMP report in your record unless it is required by the state. Rather, document that the query was done and what (if any) actions were taken based on that report.)
  • Referral/consultation, if necessary

Conclusion

Using the three Cs of risk management strategies—collecting information, communicating, and carefully documenting—when prescribing controlled substances supports quality patient care and can decrease the risk of improper prescribing allegations.

Appendix 1. Prescribing Controlled Substances: Informed Consent

Some, but not all states have promulgated various requirements and recommendations for components of an informed consent discussion when prescribing controlled substances.  The following is a compilation of current individual state requirements and recommendations for informed consent.  Prescribers should determine the state requirements for their state, and may want to consider incorporating these components:

  • The physician shall obtain written, informed consent and discuss the risks and benefits of the use of controlled substances with the patient; persons designated by the patient; or the patient’s surrogate or guardian if the patient is incompetent.
  • Ensure the patient does not have any absolute contraindications and review risks and benefits related to any relative contraindications with the patient.
  • The treatment plan, any alternatives to controlled substance therapy, additional therapies to be used in conjunction with controlled substances (if any) should be reviewed.
  • Inform the patient of the risks of addiction, physical dependence, and abuse; the potential for dose escalation/tolerance.
  • Inform the patient of the risk of the prescribed medication interacting with other drugs and of over-sedation.
  • Inform the patient of potential side effects (short- and long-term) of the prescribed medication.
  • Inform the patient of the risks of impaired motor skills that affect driving among other tasks and the potential for impairment of judgment.
  • Inform female patients of the risks during pregnancy and after delivery.
  • All medications from other sources, including over the counters and medical marijuana, should be discussed and documented in the medical record.
  • Inform the patient on alcohol use restrictions.
  • Inform the patient of the risks of withdrawal.
  • The patient is responsible for preventing diversion.
  • The physician’s prescribing policies, including, for example, the number and frequency of prescription refills, a policy regarding early or urgent refills, a policy regarding replacement of lost or stolen medication, etc. should be reviewed.
  • The physician should provide reasons for which drug therapy may be discontinued, such as violation of the treatment agreement. Note that compliance with all components of the overall treatment plan is expected.
  • Periodic re-evaluation of treatment is needed.
  • Provide a written warning to the patient disclosing the risks associated with taking extended release medications that are not in an abuse deterrent form, if the physician prescribes for the patient a hydrocodone-only extended release medication that is not in an abuse deterrent form.
  • Inform the patient of the limited evidence as to the benefit of long-term opioid therapy.
  • Inform the patient that one of the risks of opioid therapy is death.
  • The patient has the option to consent to the sharing of information with family members and other providers, as necessary.
  • Educate the patient and caregivers about the danger signs of respiratory depression and that someone should summon medical help immediately if a person demonstrates signs of respiratory depression while on opioids.
  • Discuss with the patient safe medication storage and disposal practices.

Note: There might be other requirements related to prescribing controlled substances.

Appendix 2. Prescribing Controlled Substances: Treatment Agreement

Some, but not all states have promulgated various requirements and recommendations for treatment agreements when prescribing controlled substances.  The following is a compilation of current individual state requirements and recommendations for treatment agreements.  Prescribers should determine the state requirements for their state, and may want to consider incorporating these components:

  • The treatment plan objective or the goals of the treatment.
  • Patients shall be seen by the physician at appropriate intervals, not to exceed 12 weeks to monitor the patient and evaluate progress.
  • The patient should receive prescriptions from one physician.
  • The patient should have prescriptions filled at one pharmacy.
  • The patient agrees to random drug testing (blood, urine, hair, or saliva) and pill counts when requested.
  • A female patient agrees to notify the physician if she wishes to avoid unintended pregnancy and if she becomes pregnant.
  • The physician shall specify the rules for medication use (patient take the medication as prescribed; prohibition against sharing medication with other individuals).
  • The patient is responsible for safely using medication, meaning that the patient should store the medication in a secure location and safely dispose of any unused medication.
  • The physician shall specify the consequences for misuse.
  • Reasons for which drug therapy may be changed or discontinued (e.g., violation of agreement).
  • The physician’s prescribing policies, including, for example, the number and frequency of prescription refills, a policy regarding early or urgent refills, a policy regarding replacement of lost or stolen medication, etc.
  • The physician will be available during emergencies or otherwise have a covering physician available in the event unforeseen problems arise and to prescribe scheduled refills.
  • The patient gives permission for communication between care providers.
  • The patient gives permission to share information with family members and other close contacts regarding recognition and response to overdose, including administration of an opioid antagonist, if necessary.
  • If the physician becomes concerned that there has been illegal activity, the physician may notify the authorities.

Note: There might be other requirements related to prescribing controlled substances.

Disclaimer: The content of these resources (“Content”) is for informational purposes only. The Content is not intended to be a substitute for professional legal advice or judgment, or for other professional advice. Always seek the advice of your attorney with any questions you may have regarding the Content. Never disregard professional legal advice or delay in seeking it because of the Content.

References

  1. United States Food and Drug Administration site. Safety. MedWatch. The FDA Safety Information and Adverse Event Reporting Program. Last Updated: 9 Feb 2018.  https://www.fda.gov/Safety/MedWatch/ucm228488.htm. Accessed 4 Apr 2018.
  2. United States Food and Drug Administration site. Drug databases. REMS. Approved risk evaluation and mitigation strategies (REMS). https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Accessed 4 Apr 2018.
  3. Federation of State Medical Boards.  Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain, 2013.  https://www.azdo.gov/Files/FSMBPainMgmt.pdf.  Accessed 9 Apr 2018.  Note: While the 2017 updated version of this model policy does not include the same list of 10 universal precautions, the specific recommendations from the list are included throughout the guidelines.
  4. United States Department of Justice site. Drug Enforcement Administration. Recognizing the drug abuser. https://www.deadiversion.usdoj.gov/pubs/brochures/pdfs/recognizing_drug_abuser_trifold.pdf. Accessed 4 Apr 2018.
  5. United States Food and Drug Administration site. Drugs. Drug safety and availability. Medication guides. Last updated 29 Mar 2018. https://www.fda.gov/drugs/drugsafety/ucm085729.htm. Accessed 4 Apr 2018.
  6. Parents Med Guide site. http://parentsmedguide.org/.  Accessed 4 Apr 2018.
  7. Indivior (North Chesterfield, Virginia). Suboxone® sublingual film, Suboxone® sublingual tablet, and Subutex® sublingual tablet appropriate use checklist. Expiry September 2019. ttps://www.suboxone.com/content/pdfs/App_Use_Checklist.pdf. Accessed 4 Apr 2018.
  8. National Institute of Health National Institute on Drug Abuse site. Pain assessment and documentation tool. https://www.drugabuse.gov/sites/default/files/files/PainAssessmentDocumentationTool.pdf. Accessed 4 Apr 2018.

Category: Current Issue, Risk Management

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