● Patient’s full name and address. ● Prescriber’s full name, address, and DEA registration number. ● Drug name. ● Strength. ● Dosage form. ● Quantity prescribed. ● Directions for use. ● Number of refills authorized (not applicable for Schedule II drugs). ● Prescriber’s signature. ● Date issued. The regulations provide that “the secretary or agent may prepare [a] prescription for the signature of a practitioner, but the prescrib- ing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations” (DEA, 2010b). The CSA does not permit a prescribing practitioner to del- egate to an agent or any other person the practitioner’s authority to issue a prescription for a controlled substance. A practitioner acting in the usual course of their professional practice must de- termine a legitimate medical purpose for a controlled substance prescription; an agent may not make this determination. ● Required written agreement between physician and nurse practitioner. ● Limits on the number of controlled substances prescribed. ● Limits on the daily supply of a prescribed controlled substance. ● Limits placed on controlled substances prescribed in the healthcare setting. ● Requirements for a certain number of controlled substances– oriented continuing education hours. (DEA, 2022) Self-Assessment Quiz Question #2 Interns, residents, staff physicians, and advanced practice pro- viders may prescribe controlled substances under the registra- tion of the hospital provided that: a. The dispensing, administering, or prescribing is in the normal course of practice. b. Practitioners are authorized to do so by the state in which they practice. c. The hospital or institution has verified that the practi - tioner is permitted to dispense, administer, or prescribe controlled substances within the state. d. The practitioner only acts within the scope of employ- ment in the hospital or institution. e. All of the above. not prepared in the form prescribed by DEA regulations” (DEA, 2018c). Therefore, a pharmacist must carefully review all purport- ed controlled substance prescriptions to ensure the drug meets all legal requirements for a valid prescription. In addition, phar- macists must inquire further about the satisfaction of any or all of the legal requirements for a valid prescription depending upon the particular circumstances, including the condition that the pre- scription is issued for a legitimate medical purpose by a practitio- ner acting in the usual course of professional practice. Finally, the pharmacist must be satisfied that the prescription is consistent with CSA and DEA regulations before dispensing the controlled substance to the ultimate user (DEA, 2018c). Healthcare Consideration: The number of drug overdose deaths increased by nearly 5% from 2018 to 2019 and has quadrupled since 1999. Over 70% of the 70,630 deaths in 2019 involved an opioid (CDC, 2021). Therefore, competence with both state and federal regulations should be maintained.
In response to the opioid epidemic, many states have enacted policies to address the crisis yet still provide access to appropri- ate pain management. Procedures include guidelines for or limits on opioid prescriptions in Title 21 of the CFR, Sections 1308.11 through 1308.15 (DEA, 2018c). The DEA (2010a) defines a prescription as an order for medication dispensed to or for an end user. Furthermore, to be effective, a prescription for a controlled substance must be issued for a le- gitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. The responsibility for properly prescribing and dispensing controlled substances is upon the prescribing practitioner, but a corresponding respon- sibility rest with the pharmacist who fills the prescription (DEA, 2010b). Laws and regulations vary from state to state; thus, the prescrib- ing clinician must ensure that the prescription follows all require- ments. Prescriptions for controlled substances must be written in indelible ink or typewritten. The controlled substance prescrip- tion must be dated and signed on the date issued. Additional requirements for a controlled substance prescription include the following:
Prescribing controlled substances: Nurse practitioner requirements While the CSA allows NPs to prescribe controlled substances, each state has different regulations (DEA, 2022). Nurse practitio- ners may prescribe Schedules III, IV, and V controlled substances in all states. However, state laws to determine NPs' prescriptive authority differ considerably. Some states allow full practice for NPs where they may prescribe medications with a level of auton- omy comparable to physicians. On the other hand, many states restrict NP prescriptive authority and require physician supervi- sion. The American Association of Nurse Practitioners categorizes state practices into restricted, reduced, and complete practice au- thority (AANP, 2022). Twenty-two states allow full practice, where NPs have similar prescriptive authority to physicians. In 16 states, NPs have reduced authority and work alongside physicians in joint practice agreements. States with reduced prescriptive authority have varying limitations on medications that NPs can prescribe to patients. NPs are categorized as restricted in the remaining 12 states and require physician supervision or delegation when prescribing controlled substances. Each NP should verify their state’s legal requirements and regula- tions for prescribing and dispensing controlled substances. There are a variety of restrictions imposed on NPs, including: ● Limits to the allowed controlled substance schedules pre- scribed. ● Required controlled drug substance registration or licensure.
Special considerations for nurse practitioners prescribing controlled substances While the laws vary from state to state, no prescribers, including nurse practitioners, should prescribe controlled substances for themselves or a family member. Prescribing for family members may have legal and ethical implications. Pharmacists will likely question a prescription written for the same-named individual who signs the prescription. Patients may attempt to fill prescrip - tions in a different state for various reasons. A pharmacist who receives an out-of-state prescription from a nurse practitioner may only fill the prescription if unsure of the rules in the other state. Regardless of the method of transmission of a controlled sub- stance prescription—by hand delivery, facsimile, phone call, or electronically—DEA regulations make it clear that the legal re- sponsibility for issuing a valid prescription that “conform[s] in all essential respects to the law and regulations” rests upon the prescribing practitioner. As noted, however, a pharmacist is re- sponsible for dispensing controlled substances. Further, “A cor- responding liability rests upon the pharmacist, including a phar- macist employed by a central fill pharmacy, who fills a prescription
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