Practice Tips

Chances are one of the most common complaints providers see adult patients for is pain¹. It is estimated that as many as one in five adults had ongoing, chronic pain in 2019¹. Couple that with an opioid crisis that the US has been dealing with since the mid-1990's², and it is not surprising that providers are finding the treatment of both acute and chronic pain to be complex and challenging.  As the opioid crisis continues, concerns about opioid prescribing and the opioid epidemic have led to the development of federal and state laws with opioid prescribing guidelines. In 2016, two federal laws were enacted—The Comprehensive Addiction and Recovery Act (CARA) of 2016³ and The 21st Century Cures Act⁴, quickly followed by a third in 2018—The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act⁵.

Despite the oversight and resources, the same concerns with opioid prescribing and patient outcomes remain^1,2.  Providers should keep current with and follow state and federal regulations for prescribing controlled substances. A failure to follow prescribing guidelines can lead to physician investigations and actions against physicians’ licenses. Here are links to state prescribing laws and resources: Maine Law, Maine Resource, Massachusetts Law, Massachusetts Resource, New Hampshire Law, New Hampshire Resource, Vermont Law, Vermont Resource.

In addition, Congress has updated Section 1263 of the Consolidated Appropriations Act of 2023, known as MATE—the Medication Access and Training Expansion, which now has a new educational requirement for all Drug Enforcement Administration (DEA) registrants.  By June 27, 2023, all registrants must have completed at least 8 hours of opioid/substance use disordered training via an approved source⁶.

The following risk management recommendations have been developed to assist providers in maintaining the controls necessary to prescribe opioids in a manner consistent with legal requirements and accepted medical practice.

Policy

Your practice should develop a policy regarding the management of patients with chronic pain. The policy should include assessment, including whether or not opioids should be initiated, risk assessment, treatment, including dosage and duration, and follow-up protocols developed in accordance with currently acceptable guidelines. Consider any assessments that may be needed to inform tapering dosages when opioids are going to be discontinued.  Outline in the policy opioid prescribing limits that align with state and federal guidelines. Include preprinted/trigger forms or checklists to ensure documentation meets the requirements of physician licensing board regulations and current medical practice standards.  For patients with a risk of, or history of opioid use disorder or overdose, who need a risk mitigation plan, such as offering Naloxone, ensure your policy and procedures follow federal and state guidelines¹.

Medical Records/Documentation

Maintain a current medical record for each patient. Obtain the patient's past medical records and thoroughly review information received prior to seeing/treating the patient. Prior to prescribing opioids, the patient should receive a comprehensive evaluation, which should include at a minimum:

• Chief complaint and chronologic history of the development of the present pain (location; quality; severity; timing; context; modifying factors and associated signs and symptoms).
• Review of systems.
• Evaluation of the effect of pain on physical and psychological function.
• Current pharmacological and non-pharmacological treatments being used to treat the pain.
• Past history (include past experiences, illnesses, operations, and treatments).
• Family history (pain complaints, degenerative disorders, drug or chemical dependency, alcoholism, drug abuse, depression, anxiety, and other psychological disorders).
• Social history.

When considering prescribing an opioid the provider should conduct and document a risk assessment, to evaluate the patient’s risk of misuse, abuse, diversion, addiction, or overdose. Risk assessment tools are available on many state medical board sites. Document in the patient’s medical record any non-pharmacological modalities and non-opioid therapy for chronic pain patients. 

Prescription Drug Monitoring Programs

Providers should be familiar with their state-specific prescription monitoring program and follow all requirements. Failure to follow these requirements could lead to board action. When a provider or pharmacist becomes aware of a patient who might be abusing or misusing prescription medications, they must take appropriate steps to address the situation.  For specific information according to your state of practice, please utilize the following links:

Maine Prescription Monitoring Program

Massachusetts Prescription Monitoring Program

New Hampshire Prescription Drug Monitoring Program

Vermont Prescription Monitoring System

If the provider determines that opioids are an appropriate part of the patient’s treatment, they should develop and document a treatment plan. The treatment plan should:

• Document in the medical record one or more medical indications for the use of a controlled substance.
• List objectives that will be used to evaluate the success of the prescribed treatment plan, such as pain relief, and improved physical and psychosocial function.
• Indicate other recommended treatment modalities, any additional tests necessary, and any recommended referrals.
• Prescribe the lowest effective dose for a limited duration.
• Include risk mitigation strategies for patients at risk for opioid misuse.

Informed Consent/Agreement

Before beginning, the opioid prescription written informed consent should be obtained. The patient’s informed consent may be incorporated into the text of the controlled substance/chronic pain agreement. The consent should include evidence that:

• An explanation of the risks associated with opioids, including addiction, overdose and death, physical dependence, physical side effects, hyperalgesia, tolerance, and crime victimization.
• The patient, who has demonstrated capacity, has been given the opportunity to ask questions about the recommended drug therapy and had those questions answered to the patient's satisfaction.
• The patient has given consent.

The informed consent discussion should be documented in the medical record. An annual informed consent discussion with the patient is recommended. (See our practice tip Informed Consent Guidelines.) The patient should sign a written controlled substance treatment agreement, which includes the following elements:

• The organization’s policy when prescribing controlled substances for chronic pain management.
• The patient's consent to random drug screens.
• The requirement for random pill counts.
• The clinician as the single source of controlled substances.
• Agreement to use one pharmacy.
• The patient's written informed consent to release the contract to local emergency departments and pharmacies and for those clinicians to report contract violations to the treating provider.

Determine, based on the individual patient and their specific risk factors, what level of patient monitoring is necessary to achieve the required results and to avoid an adverse outcome.

• Assess the patient's progress regarding the specific/measurable goals of their treatment plan.
• Document the success, failure, or progress made toward the established goals. Include efficacy, safety, side effects, and interactions with other components of the chronic pain management plan.
• Incorporate additional information into the overall patient assessment, e.g., urine drug screens, prescription monitoring program results, pill counts, other treatments received through an emergency room or other providers, any suggestion of misuse or abuse of prescription medications, illegal drugs, alcohol use, manic or depressive behaviors including violent outbreaks or thoughts of suicide.

Patient Education

The patient should receive education on the risks associated with opioids, including addiction, overdose and death, physical dependence, physical side effects, hyperalgesia, tolerance, and crime victimization. Patients should understand that opioid therapy may be discontinued if treatment goals are met, or for contract violation and/or illegal activity.

Patient education should include prescription management and the security of their medication. According to the CDC, unused drugs in the home contribute to prescription drug abuse, with teens being particularly prone to misuse of unused prescription medication left in medicine cabinets. Patients should be reminded not to share their medication. They should understand that the practice is not only unsafe but also illegal. Patients need to be educated on the safe storage and disposal of prescription medication. When providers prescribe medications, particularly medications with a potential for abuse, they should encourage patients not to store medication in medicine cabinets, to keep medicines locked up, and to keep track of their pills. It is especially important to have this conversation with patients who might have children living in or visiting their homes.

The patient’s medical record should reflect a reassessment of the chronic pain control therapy. Reassessments should be performed based on state opioid prescribing guidelines. Does the reassessment demonstrate:

• An increase in patient overall functioning.
• Pain reduction and relief of psychological distress.
• That the pain was alleviated and progress occurred as a result of the treatment plan.
• A review of violations of the written treatment agreement.

Audit random medical records of patients receiving chronic pain management therapy. Audits should review for patient assessment, reassessment, patient progress, and medical record documentation based on the established office practice policy for the management of patients on chronic pain control therapy.

Prescription Drug Misuse

Providers play an important role in identifying and preventing prescription drug misuse. Their role is complex and at times difficult. To reduce the risk of misuse and abuse of controlled substances providers must be vigilant when prescribing these drugs.

It can be difficult to differentiate between patients with legitimate health issues and patients who are seeking drugs for misuse. The following situations may indicate that a patient is attempting to obtain prescription drugs for non-medical reasons:

• The patient makes frequent visits to the office.
• Patients who recently moved, but refuse to give the name of his/her previous physician.
• Patients who pay cash for their visit.
• Patients who are very familiar with prescription drugs and state only a specific drug is effective.
• Patients who report allergies to multiple prescription painkillers.
• The patient is specific about providers they want or do not want to see.
• The patient reports loss of medications.

These scenarios should raise concerns that the patient might be abusing or diverting medications. The provider should take steps to address these concerns, as outlined in their policies and state and federal guidelines.

In the Emergency Department

Individuals seeking to divert drugs for non-medical purposes oftentimes target emergency departments for several reasons including they are always open, the visit might be brief and might not include an attempt to verify the patient's history, and the possibility that frequent visits could go unnoticed. In recent years, many hospitals have enacted stricter policies around prescribing narcotics in the emergency department. Many EDs now post signs informing patients that they do not routinely prescribe narcotics or will not replace lost or stolen medications. Providers should carefully evaluate all patients presenting to the emergency department and develop a treatment plan appropriate to that evaluation.

EMTALA

After a provider has had several encounters with a patient who they believe is attempting to obtain narcotics for non-medical reasons, it can be tempting to either refuse to see them or give them an abbreviated exam before discharging them. Federal regulations require that all patients presenting to an emergency department receive an appropriate medical screening exam (MSE) to determine if they have an emergency medical condition. If an emergency medical condition exists, the hospital is obligated to provide treatment until the patient is stable or to transfer the patient to another facility following the regulation's requirements. Not performing an appropriate MSE is a violation of EMTALA regulations. If the MSE does not support a prescription for narcotics, the provider should develop a treatment plan that is appropriate for the presentation. It is important to document the complete MSE, any treatment plans made, and the provider's conclusions.

Flagging Patients with Drug-seeking Behaviors

There are several ramifications associated with noting statements such as "drug-seeking behavior" in a patient's medical record. These include a defamation claim, a patient claim of interference with insurance coverage, and the possibility of misdiagnosis. Medical Mutual generally discourages documenting this in the medical record and instead encourages providers to document the facts of the encounter including the patient's request for specific medications, requests to replace lost medications, etc.

Reportable Acts

Questions frequently arise regarding what constitutes a reportable act and when law enforcement should be notified about a patient's possible illegal activity. Information gained as a part of the patient/physician relationship, including disclosure of possible criminal acts, remains confidential. However, a patient who attempts to use a provider to perpetrate illegal acts, such as acquisition of drugs or selling those drugs, should be reported to the DEA or local law enforcement agency.

Resources

¹ CDC Clinical Practice Guideline for Prescribing Opioids for Pain- United States, 2022 (2022). Recommendations and Reports, 71(3), p. 1-95.  DOI: https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w

² U.S. Congress Congressional Budget Office (2022). The Opioid Crisis and Recent Federal Policy Responses, p. 1-38.  DOI: https://www.cbo.gov/system/files/2022-09/58221-opioid-crisis.pdf

³ U.S. Congress (2016). The Comprehensive Addiction and Recovery Act (CARA) of 2016. DOI: https://www.congress.gov/bill/114th-congress/senate-bill/524

⁴ U.S. Congress (2016). The 21st Century Cures Act. DOI: https://www.congress.gov/bill/114th-congress/house-bill/34/text/pl

⁵ U.S. Congress (2018). SUPPORT for Patients and Communities Act. DOI: https://www.congress.gov/bill/115th-congress/house-bill/6

⁶ SAMHSA (2023).  Recommendations for Curricular Elements in Substance Use Disorders Training.  DOI: Recommendations for Curricular Elements in Substance Use Disorders Training | SAMHSA

SAMHSA: Prescription Drug Misuse and Abuse https://www.samhsa.gov/topics/prescription-drug-misuse-abuse

Misuse of Prescription Drugs: National Institute on Drug Abuse https://www.drugabuse.gov/publications/research-reports/misuse-prescription-drugs/summary

National Quality Foundation Opioid Stewardship Action Team: http://www.qualityforum.org/National_Quality_Partners_Opioid_Stewardship_Action_Team.aspx