Prescribing Controlled Substances: Managing the Risk

by Donna Vanderpool, MBA, JD

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

Funding: No funding was provided for this article.

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

Reprinted with permission from Innov Clin Neurosci. 2018;15(3–4):47–51. © Copyright Matrix Medical Communications, 2018.

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Answers in this column 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.

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Question

With everything going on in the news about the opioid epidemic and the accusations of physicians’ prescribing practices 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, the patient, treatment and the 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 medicine 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 due to the amount of information being produced, the speed at which it develops, and the prevalence of conflicting and/or incomplete information.  Important activities 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 of the patient 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 your state. If the report shows prescriptions not reported by the patient, you should address the issue clinically with the patient rather than automatically terminating treatment without notice as this may lead to allegations of abandonment.

Collecting information about treatment and the 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 other professional associations. Also, appropriate continuing medical education (CME) courses related to controlled substances may be beneficial, and are being required by an increasing number of states.

The Federation of State Medical Boards (FSMB) has issued the following “universal precautions” when prescribing opioids³ that may be useful when prescribing all types of controlled substances:

• 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 function
• 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 textbook symptoms
• Evasive or vague answers to questions regarding medical history
• No regular doctor; no health insurance
• Will request a specific mediation 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
• Traveling through town, visiting friends or relatives
• Feigning physical problems
• Feigning psychological problems
• States that certain medications do not work or is allergic to them
• Lost or stolen prescription
• 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 a very 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. 

You may want to consider patient medication guides, such as those from the FDA⁵ or professional organization  to augment patient education when prescribing a medication. Obviously, any 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 communication topic between patient and physician. You may want to consider a standardized assessment tool for this purpose.⁶ 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:

• Only one prescriber
• Only one pharmacy
• Policy regarding early or urgent refills
• No replacement of lost or stolen prescriptions
• Prohibition on dose or frequency increases by patient
• Use of PMP
• Random pill counts
• Random drug screening

Treatment agreements. Treatment agreements are very useful for managing patient expectations. Some states require treatment agreements, typically for pain management, but prescribers may want to consider incorporating treatment agreements into their practice, for other uses of controlled substances even if not legally required to.

Communicating with others. With 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 may 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.

With 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 may yield very 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, so your records should be written so that a subsequent treatment provider can review the record and know what happened in treatment and why. For example, documentation of your decision-making process can include diagnosis, medication chosen, 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, and by you if your work is questioned years later. Consider including the following in your records:

• Initial evaluation
• Medical indication for prescribing
• Medication log
  • Name of medication
  • Start and stop dates
  • Changes in dosages
• Treatment plan—initial and updated
• Informed consent—including patient education materials
• 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 as well as your actions based on that report.)
• Referral / consultation, if necessary
• Assessment forms, if used

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.

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 2 Apr 2019.
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 2 Apr 2019.
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 2 Apr 2019. 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 2 Apr 2019.
5. United States Food and Drug Administration site. Drugs. Drug safety and availability. Medication guides. Last updated 8 Aug 2018. https://www.fda.gov/drugs/drugsafety/ucm085729.htm. Accessed 2 Apr 2019.
6. 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 2 Apr 2019.

Tags: controlled substances, drug abuse, Risk Management

Category: Past Articles, Risk Management