Risk Management Considerations When Prescribing Controlled Substances: A Review
By Anne Huben-Kearney, RN, BSN, MPA, CPHRM, DFASHRM
Assistant Vice President, Risk Management Group, Allied World Risk Management

Dr. P. works with two nurse practitioners in a busy outpatient mental health clinic. Each morning, Dr. P. pre-signs blank prescriptions so that the nurse practitioners may dispense them to the patients they see during the course of the day. Recently, the clinic was visited by DEA agents as part of their enforcement efforts following the death of a young patient from an opioid overdose. The DEA agents audit the chart and review policies and procedures. During their investigation, they discover that Dr. P is signing blank prescriptions. As a result, they report him to the state board of medicine.

Psychiatrists and all healthcare providers with prescribing privileges play pivotal roles in the safe prescribing, administering and dispensing of prescription drugs. When prescribing controlled substances, psychiatrists should be aware of applicable ethical, regulatory and administrative considerations as well as civil and criminal penalties that may result in a loss of license for failing to comply with state and federal laws pertaining to controlled substances.1 For detailed information regarding prescribing regulations, including record keeping, storing and disposing of controlled substances, prescribers should consult their state laws and regulations and the DEA Practitioner’s Manual.2

A Note about Controlled Substances:

In addition to complying with laws and regulations, psychiatrists may also have additional liability exposures when prescribing controlled substances. The DEA under certain conditions may permit a prescriber to issue multiple prescriptions authorizing a patient to receive a ninety-day supply of a Schedule II controlled substance. However, if asked to prescribe a ninety-day supply of a medication, the psychiatrist should consider the patient’s diagnosis, as well as his/her patient’s safety concerns when deciding the amount of medication to be dispensed. For example, if you are treating a patient with a history of a suicide attempt or substance abuse, consider whether dispensing a ninety-day supply could potentially put the patient at additional risk.

Background

Generally, two regulatory bodies oversee prescribing practices for controlled substances: the U.S. Drug Enforcement Administration (DEA), and the prescriber’s state licensing board. Prescribers must ensure that their prescribing practices conform to both federal and state regulations.

By way of background, the DEA was established in 1973 to enforce the Controlled Substances Act (CSA). The DEA’s responsibilities under the CSA include, among other things, preventing the diversion and abuse of controlled substances.3 Under the CSA, every prescriber who handles controlled substances must be registered with the DEA (unless exempt by regulation) and renew their registration every three years. In certain circumstances, prescribers employed by a hospital may prescribe under the hospital’s DEA registration.

Historically, the DEA has not required separate registrations for prescribers registered at one location but also practicing at other locations, as long as the controlled substances are only prescribed and not directly dispensed. However, prescribers desiring to dispense/administer Schedule II controlled substances for maintenance and detoxification treatment must obtain a separate DEA registration as part of a narcotic treatment program.4 For information regarding prescribing controlled substances as part of a narcotic treatment program, prescribers are encouraged to consult with the DEA’s “Narcotic Treatment Programs: Best Practice Guidelines.”

Under the CSA, drugs are divided into five schedules. Placement into a particular schedule depends upon whether the drug has a currently accepted medical use, the drug’s abuse potential and the drug’s likelihood of causing dependence if abused.5 The conditions for prescribing controlled substances vary depending on the “schedule.” Schedule I drugs have a high potential for abuse and have no currently accepted medical uses in the United States. Schedule II drugs have currently accepted medical uses but also have a high chance for abuse and can lead to physiological and psychological dependence. Drugs on Schedules III through V have medical uses and a lower potential for abuse and dependence.6 In 2010, the DEA began allowing prescribers to issue prescriptions for controlled substances, electronically.7 For further discussion regarding the classification of specific drugs and corresponding prescribing regulations, prescribers are encouraged to consult with their individual state regulations and the DEA Practitioner’s Manual.

While DEA registration grants prescribers federal authority to handle controlled substances, the prescriber may only engage in those prescribing activities that are also authorized under the laws of the state where the practitioner is licensed. When federal and state laws differ, the practitioner must adhere to the more restrictive of the federal and state law regulations.8

Disciplinary Actions

Federal-controlled substances laws are constructed to work in conjunction with state-controlled substances law. As an example, if a state board revokes the license of a prescriber, the DEA will request a voluntary surrender of the prescriber’s DEA registration. If the voluntarily surrender is refused, the DEA will pursue administrative action to revoke the DEA registration. The DEA may also begin judicial action if there is sufficient proof of illegal distribution or significant recordkeeping violations. Corrective actions pursued by the DEA can include a letter of admonition, informal hearing or civil/criminal action.9

Prescriptions for Controlled Substances

Under federal law, a prescription for a controlled substance must be issued for a “legitimate medical purpose by a practitioner acting in the usual course of professional practice.” To minimize the risk of theft, loss or unauthorized use, prescribers should employ adequate security measures when storing blank prescription pads, restrict patient access to areas where the prescription pads are stored, and destroy all unused pads when they are no longer needed for practice. In addition, the prescription must be typed or written in indelible ink, dated and signed on the date issued and include the following information:10

  • Date of issue
  • Patient’s name and address
  • Practitioner’s name, address, and DEA registration number
  • Drug Name
  • Drug Strength
  • Dosage Form
  • Quantity Prescribed
  • Directions for Use
  • Number of Refills Authorized (if permitted by law)
  • Manual Signature of Prescriber

Note: Some states limit the quantity of Schedule II controlled substances dispensed to a thirty-day supply. In 2007, the DEA began allowing prescribers to issue multiple prescriptions totaling a ninety-day supply if permissible under state law and provided that certain conditions are met. Prescribers should not interpret this change as an endorsement of issuing multiple prescriptions or seeing their patients only once every ninety days. Rather, prescribers must continue prescribing in accordance with the applicable standard of care and exercising sound medical judgment.

In an effort to prevent drug diversions, states have developed Prescription Drug Monitoring Programs (PDMPs). These programs are state-wide electronic databases that are designed to detect and prevent prescription drug abuse by identifying individuals seeking to obtain prescriptions from multiple providers. PDMPs track information collected by pharmacies regarding dispensed controlled substances. These state programs vary widely with regard to who is permitted to receive the data, who is permitted to access the data, and under what circumstances. Prescribers should be aware of and comply with their specific jurisdiction’s PDMP requirements. For example, in some states physicians are mandated to check the PDMP database prior to prescribing a controlled substance.11

Risk Management Considerations for Prescribers:12

Although not exhaustive, some considerations for prescribers of controlled substances include:

  • Write out the actual amount prescribed in addition to using numbers.
  • Use prescription pads for prescribing and not for writing notes.
  • Do not sign blank prescriptions in advance.
  • Use tamper resistant prescription pads.
  • Assist the pharmacist when he/she is looking to verify prescription information. It is important that you consider HIPAA or state privacy rules within this context. Should you have questions concerning this issue, contact a risk management professional at your insurance company.
  • Contact the nearest DEA field office upon retirement or cessation of activities related to prescribing controlled substances.
  • Do not prescribe or dispense controlled substances outside the scope of your practice or in the absence of a physician-patient relationship.
  • Dispose of out-of-date, damaged, otherwise unusable or unwanted controlled substances, including samples, by transferring them to a registrant who is authorized to receive such materials. Information on safe medication disposal and “take back” locations can be found on the “FDA: Drug Disposal: Drug Take Back Locations”.13

Conclusion

Proper prescribing, administering and dispensing of controlled substances is critical to safeguarding your patients’ health. By understanding and adhering to the federal and state laws governing the prescribing of controlled substances, and practicing in accordance with the requisite standard of care, psychiatrists may reduce the likelihood of abuse and potential drug diversion by their patients and reduce their medical malpractice liability risk.

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About the Author

Anne Huben-Kearney is an Assistant Vice President of the Risk management Group. Anne provides risk management consulting services to Allied World’s medical professional liability policyholders and insured psychiatrists, psychologists, psychiatric nurse practitioners and physician assistants. She works directly with policyholders to develop individualized action plans to mitigate potential loss based on their unique exposures and risk management needs. Additionally, Anne assists these clients with ongoing medical educational programs as well as policy and procedure review and development.

1 “Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians”

2 United States Drug Enforcement Agency, “Practitioner’s Manual” (2008), http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf (last accessed 1/8/2014).

3 Id.

4 “Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians”

5 Id.

6 “Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians”

7 Id.

8 “Practitioner’s Manual”

9 Id.

10 Id.

11 “Prescription Drug Abuse: Executive Summary of a Policy Position Paper from the American College of Physicians”

12 “Practitioner’s Manual”

13 US Federal Drug Administration. “Drug Disposal: Take Back Locations” https://www.fda.gov/drugs/disposal-unused-medicines-what-you-should-know/drug-disposal-drug-take-back-locations

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