In general, this legislation limits first-time opioid prescriptions for acute pain to a supply for a certain number of days (i.e., 3, 5, 7, or 14 days) or dosage limits (i.e., morphine milligram equivalents, MMEs); most states set exceptions for chronic pain treatment, cancer pain, and palliative care. In addition, some states have also set limits for minors. 112 Under federal law, a prescriber may issue multiple prescriptions authorizing the patient to receive up to a 90-day supply of a Schedule II controlled substance based on the following conditions. • Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual professional practice. • The prescriber provides written instructions on each prescription, indicating the earliest date on which a pharmacy may fill each prescription. The first prescription does not need a fill date on it if the prescriber intends for that prescription to be filled immediately. • The practitioner concludes that providing the patient with multiple prescriptions in this manner does not create a risk of diversion or abuse. • Issuing multiple prescriptions is permissible under applicable state laws. • The practitioner complies with all other requirements of the CSA and any other provisions of state law. Generally, a valid Schedule II controlled substance prescription is not allowed to be transmitted via facsimile. The CSA requires that a Schedule II controlled substance be dispensed by a pharmacy only according to a written prescription, except in emergencies, and prohibits Schedule II prescriptions from being refilled. Thus, in most cases, a pharmacist must receive the original, manually signed paper or electronic prescription before dispensing a Schedule II controlled substance. 93 Therefore, a prescriber may transmit a Schedule II prescription to the pharmacy via facsimile to expedite the filing. However, the original Schedule II prescription must be presented to the pharmacist for review before the controlled substance is dispensed. Facsimile and Oral Prescriptions for Schedule II Controlled Substances In an emergency, a practitioner may call in a prescription for a Schedule II controlled substance to the pharmacy. The pharmacist may dispense the medication, provided the quantity prescribed and dispensed is limited to enough to treat the patient only during the emergency period. The prescribing practitioner must provide the pharmacist a written and signed prescription within seven days. The pharmacist must notify the DEA if the prescription is not received in that timeframe. The DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. As a result, the facsimile of a Schedule II prescription may serve as the original
prescription as follows. Regardless of the method of transmission of a controlled substance prescription—by hand delivery, facsimile, phone call, or electronically— DEA regulations make it clear that the legal responsibility for issuing a valid prescription that “conform[s] in all essential respects to the law and regulations” rests upon the prescribing practitioner. However, a pharmacist is responsible for properly prescribing and dispensing controlled substances. • A practitioner prescribing Schedule II controlled substances to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may transmit the prescription by facsimile. • Practitioners prescribing Schedule II controlled substances for residents of long- term care facilities may transmit a prescription by facsimile to the dispensing pharmacy. The practitioner’s agent may also transmit the prescription to the pharmacy. • A practitioner prescribing a Schedule II narcotic-controlled substance for a patient enrolled in a hospice care program certified and paid for by Medicare under Title XVIII or a hospice program licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or agent may transmit the prescription to the pharmacy and will note on the prescription that it is for a hospice patient. As electronic prescribing of controlled substances becomes more widespread, the need to fax or call in a Schedule II controlled substance (or any other controlled substance) will decrease. Schedules III–V Controlled Substance Prescribing Considerations A prescription for controlled substances in Schedules III, IV, and V may be communicated verbally, written, or by facsimile to the pharmacist. It may be refilled if authorized on the prescription or by call-in. The CSA provides that a pharmacy may dispense Schedules III and IV controlled substances according to a “written or oral prescription.” DEA regulations further specify that a pharmacist may dispense a Schedule III, IV, or V controlled substance according to “either a paper prescription signed by a practitioner [or] a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy.” Accordingly, an authorized agent may transmit such a practitioner-signed paper prescription via facsimile to the pharmacy on behalf of the practitioner. 93 Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within 6 months of the date it was issued. After five refills or 6 months, whichever occurs first, a new prescription is required. Prescriptions for Schedules III through V controlled substances may be transmitted by facsimile from the practitioner, or an employee or agent of the individual practitioner, to the dispensing pharmacy. The facsimile is
equivalent to the original prescription. 112 In addition, a pharmacist may dispense a controlled substance listed in Schedules III, IV, or V according to an oral prescription made by an individual practitioner. The pharmacist must promptly reduce to writing the oral prescription containing all information required for a valid prescription, except for the practitioner’s signature. Substance Use and Drug Diversion Drug misuse typically refers to prescription drugs and is defined as the use of drugs for a purpose other than that for which they were prescribed. Examples include taking higher doses than prescribed, taking for a longer duration than prescribed, using drugs for purposes other than prescribed, using drugs in conjunction with other medications that affect CNS or alcohol, and skipping doses/hoarding drugs. Drug diversion is defined as “any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient,” including everything from outright theft of the drug to doctor shopping, prescription forging, manufacture or sales of counterfeit drugs, and international smuggling. 132 Diversion can occur at any point—from the manufacturer’s distribution to the wholesalers to pharmacies and, in turn, to the patient. However, some drugs are more targeted than others: (1) antianxiety medications and sedatives, including benzodiazepines; (2) prescription pain medications, including opioids; (3) stimulants, including those used to treat attention deficit disorder and narcolepsy; (4) sleep aids; and (5) anesthetics, such as propofol. Healthcare providers can divert medications through false documentation, scavenging wasted medications, and theft by tampering. 132 Behavioral changes include subtle changes in appearance, increasing isolation from colleagues, inappropriate verbal/ emotional responses, and diminished alertness, confusion, or memory lapses. Many healthcare workers with substance use disorders are unidentified, unreported, and untreated. The Impaired Physician The prevalence of SUDs in physicians is thought to mimic the prevalence in the general public and has been estimated at 8 to 13 percent in the United States population. 135 In the past, physicians with SUDs were described as “impaired physicians,” a term that was also applied to physicians with psychiatric, cognitive, behavioral, or general medical problems with potential to adversely affect their ability to perform specific duties. More recently, the terminology has evolved to “physicians with potentially impairing conditions” to more accurately reflect the reality that not all physicians with a diagnosable SUD demonstrate workplace impairment. 136
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