Risk Reduction Resources

Opioids: Avoiding Risks When Prescribing

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Pain management is among the most common reasons patients visit a provider. According to recent estimates, nearly one in four adults in the United States experiences chronic pain that frequently restricts work or life activities in the last three months (Lucas & Sohi, 2024). Following the introduction of synthetic opioids to the market in the mid-1990s to address chronic pain, concerns about over-prescribing, misuse, and overdose deaths quickly mounted. In response to the developing crisis, two federal laws were enacted—The Comprehensive Addiction and Recovery Act (CARA) of 2016 and The 21st Century Cures Act, quickly followed by a third in 2018—The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Following this legislative implementation, the United States has seen a gradual reduction in overdose deaths associated with prescription opioids from a high of 4.4 deaths per 100,000 (Hedegaard et al, 2021) in 2016 to approximately 2.3 deaths per 100,000 in 2024 (Garnett & Minino, 2026).

Despite updated oversight and resources, concerns with opioid prescribing and patient outcomes remain. Providers should remain current with and follow state and federal regulations for prescribing controlled substances. Failure to follow prescribing guidelines can lead to investigations and actions against physicians' and advanced practice providers’ 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 includes an educational requirement for all Drug Enforcement Administration (DEA) registrants. By June 27, 2023, all DEA registrants are required to have completed at least 8 hours of opioid/substance use disorder training via an approved source.

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 for managing patients with chronic pain. The policy should include assessment, including whether 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 guidelines.

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 used to treat the pain.
• Medical 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. There should be a documented discussion of risks and benefits, along with the patient's functional goals. Document in the patient’s medical record any non-pharmacological modalities and non-opioid therapy for chronic pain.

Prescription Drug Monitoring Programs

Providers should be familiar with their state-specific prescription monitoring program and comply with all requirements. Failure to comply with 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
• Vermont Prescription Monitoring System
• New Hampshire Prescription Drug Monitoring Program

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/or improved physical and psychosocial function.
• Indicate other recommended treatment modalities, any additional necessary tests, and any recommended referrals.
• Prescribe the lowest effective dose for a limited duration.
• Include risk mitigation strategies for patients at risk of 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, was discussed.
• 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 their 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 provider 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 progress or lack thereof 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 should 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 to keep medicines locked up in a secure area, 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 chronic pain control therapy. Reassessments should be performed based on state opioid prescribing guidelines. The reassessment should demonstrate:

• An improvement in the patient’s overall functioning.
• Pain reduction and relief of psychological distress.
• A review of violations of the written treatment agreement.

Audit random medical records of patients receiving chronic pain management therapy. Audits should identify patient assessments, reassessments, 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 and warrant additional investigation:

• The patient makes frequent visits to the office.
• Patients who have recently moved but refuse to provide the name of their 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 pain medications.
• 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 frequently target emergency departments for several reasons, including that 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 related to 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 based on the evaluation.

EMTALA

After a provider has had several encounters with a patient whom they believe is attempting to obtain narcotics for non-medical reasons, it can be tempting to either refuse to see them or provide 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 the patient with stabilizing treatment or to transfer the patient to another facility in accordance with the regulation's requirements. Failing to perform 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 consistent with the patient’s clinical 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 documenting statements such as "drug-seeking behavior" in a patient's medical record. These include a defamation claim, a patient's 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 the acquisition of drugs or the selling of those drugs, should be reported to the DEA or local law enforcement.

References

Centers for Disease Control and Prevention. (2025, June 10). About prescription opioids. U.S. Department of Health and Human Services. https://www.cdc.gov/overdose-prevention/about/prescription-opioids.html

Centers for Disease Control and Prevention. (2022). CDC clinical practice guideline for prescribing opioids for pain — United States, 2022 (MMWR Recommendations and Reports, Vol. 71, No. RR-3, pp. 1–95). U.S. Department of Health and Human Services. https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm?s_cid=rr7103a1_w

Congressional Budget Office. (2022). The opioid crisis and recent federal policy responses (Publication No. 58221). U.S. Government. https://www.cbo.gov/system/files/2022-09/58221-opioid-crisis.pdf

Garnett, M. F., & Miniño, A. M. (2026). Drug overdose deaths in the United States, 2023–2024 (NCHS Data Brief No. 549). National Center for Health Statistics. https://www.cdc.gov/nchs/data/databriefs/db549.pdf

Hedegaard, H., Miniño, A. M., Spencer, M. R., & Warner, M. (2021). Drug overdose death rates by selected characteristics and drug categories, United States, 1999–2020 (NCHS Data Brief No. 428: Tables). National Center for Health Statistics. https://www.cdc.gov/nchs/data/databriefs/db428-tables.pdf

Lucas, J. W., & Sohi, I. (2024). Chronic pain and high-impact chronic pain in U.S. adults, 2023 (NCHS Data Brief No. 518). National Center for Health Statistics. https://www.cdc.gov/nchs/products/databriefs/db518.htm

Substance Abuse and Mental Health Services Administration. (2024, October 11). Preventing prescription drug misuse: Data resources. U.S. Department of Health and Human Services. https://www.samhsa.gov/resource/sptac/preventing-prescription-drug-misuse-data-resources

Substance Abuse and Mental Health Services Administration. (2026, February 9). Recommendations for curricular elements in substance use disorders training. U.S. Department of Health and Human Services. https://www.samhsa.gov/medications-substance-use-disorders/provider-support-services/recommendations-curricular-elements-substance-use-disorders-training

U.S. Congress. (2016). 21st Century Cures Act, H.R. 34, 114th Cong. (enacted 2016). Congress.gov.

U.S. Congress. (2016). Comprehensive Addiction and Recovery Act of 2016, S. 524, 114th Cong. (enacted 2016). Congress.gov. https://www.congress.gov/bill/114th-congress/senate-bill/524

U.S. Congress. (2018). SUPPORT for Patients and Communities Act, H.R. 6, 115th Cong. (Public Law No. 115-271, enacted 2018). Congress.gov. https://www.congress.gov/bill/115th-congress/house-bill/6

Updated on: 3/2026