Author(s): Neil M. Ellison MD
Background Schedule II opioids (e.g. morphine, oxycodone, methadone, hydromorphone) play a major role in the management of symptoms at the end of life. Because of possible abuse, trafficking, and diversion of opioids, federal statutes mandate that appropriate safeguards be adhered to by prescribing clinicians and dispensing pharmacists. There are regulations that are important to understand for patients in hospice and long-term care settings, or who may have rapidly changing symptoms at home. This Fast Fact will review US federal regulations regarding prescribing Schedule II drugs. Note: a) some states may impose more restrictive regulations – check with your state licensing boards for specifics, and b) individual pharmacists may enforce these regulations with variable stringency.
Prescription Information Prescriptions must be dated and signed on the day issued, and include the full name and address of the patient, the drug name, strength, quantity prescribed, and directions for use. The name, address, and Drug Enforcement Agency (DEA) registration number of the practitioner must also be included.
Refills and Prescription Series Refills are not allowed on Schedule II opioids; however there are no federal regulations limiting the number of days a prescription can cover (many state or local professional standards have limited this to a 30 or 90 day supply). It is permissible to write a prescription series for up to a 90 day supply of medication. For example, at a single office visit a patient can be given 3 prescriptions, each for 30 days worth of the same drug, with two of the prescriptions noting: “Do not fill until [1 or 2 months, respectively, from the issue date].”
Emergency prescriptions Emergency prescriptions can be phoned into a pharmacist. The pharmacist must make a reasonable effort to determine that the verbal authorization came from a registered practitioner and that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. This is often interpreted as a three day supply, but there is no regulation specifying how many days or doses constitute an emergency prescription. The prescribing clinician must quickly supply the pharmacy with a written prescription (postmarked within seven days if mailed). This prescription must have "Authorization for emergency dispensing" written on it as well as the date of the verbal order.
Facsimile prescriptions A facsimile prescription is sufficient for a Schedule II opioid used for direct parenteral administration (e.g. intravenous or spinal use), or for oral opioids for patients residing in a long-term care facility (LTCF) or who are receiving hospice care (even if at home). The script must note the patient’s status (e.g. “Resides in LTCF,” “Patient in hospice”).
Partial dispensing Partial dispensing is allowed if the pharmacist is unable to supply the full quantity at one time. The remaining portion of the prescription must be filled within 72 hours. For patients in a LTCF or with a terminal illness, partial quantities up to 60 days from the issue date may be dispensed. The script must designate the patient is ‘terminally ill’ or in a LTCF.
Pharmacist changes to prescriptions Pharmacists may independently add or change the patient’s address. After consultation with the prescriber, pharmacists may also add or change the dosage form, drug strength, drug quantity, directions for use, and issue date. While the aforementioned changes are permissible, many pharmacists will request a rewritten prescription.
Patients with an addictive disease or in a drug treatment program Opioid addiction and pain can co-exist at the end of life. Clinicians approved for Schedule II prescribing by their DEA license can prescribe any Schedule II drug in the inpatient and outpatient settings for pain and symptom relief, even if the patient is enrolled in an opioid maintenance program. Clinicians are strongly advised to seek specialist help in these situations (from both pain and addiction specialists) as well as to work collaboratively with the patient’s treatment program.
Chapter II--Drug Enforcement Administration, Department Of Justice, Part 1306: Prescriptions. U.S. Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1306. Accessed November 29, 2007.
General Questions and Answers. Drug Enforcement Administration Office of Diversion Control. Available at: http://www.deadiversion.usdoj.gov/faq/general.htm. Accessed November 29, 2007.
Final Rule 2007 – Issuance of Multiple Prescriptions for Schedule II Controlled Substances. Drug Enforcement Administration Office of Diversion Control. Available at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm. Accessed November 29, 2007.
Gilson AM, Joranson DE. The Federal Drug Enforcement Administration “Prescription Series” Proposal: Continuing Concerns. J Pain Palliat Care Pharmacotherapy. 2007; 21:21-24.
Gilson AM, Joranson DE. Is the DEA’s new “Prescription Series” Regulation Balanced? Pain and Policy Studies Group. Available at: http://www.painpolicy.wisc.edu/DEA/Rx_Series_Adoption.pdf. Accessed December 10, 2007.
Fast Facts and Concepts are edited by Drew A Rosielle MD, Palliative Care Center, Medical College of Wisconsin. For more information write to: firstname.lastname@example.org. More information, as well as the complete set of Fast Facts, are available at EPERC: www.eperc.mcw.edu.
Version History: Originally published February 2008. Current version re-copy-edited in June 2009.
Copyright/Referencing Information: Users are free to download and distribute Fast Facts for educational purposes only. Ellison NM. Regulatory Issues for Prescribing Schedule II Opioids at the End of Life. Fast Facts and Concepts. February 2008; 198. Available at: http://www.eperc.mcw.edu/EPERC/FastFactsIndex/ff_198.htm.
Disclaimer: Fast Facts and Concepts provide educational information. This information is not medical advice. Health care providers should exercise their own independent clinical judgment. Some Fast Facts cite the use of a product in a dosage, for an indication, or in a manner other than that recommended in the product labeling. Accordingly, the official prescribing information should be consulted before any such product is used.
ACGME Competencies: Systems Based Practice, Patient Care
Keywords: Pain - Opioids, Ethics, Law, Policy, Health Systems