federal and state laws differ, the practitioner should follow the more stringent aspects of both the federal and state requirements. This principle has led to much concern related to the state legalization of medical marijuana, despite the DEA maintaining its controlled substance Schedule I status. The DEA may deny, suspend, or revoke a clinician’s DEA registration upon finding the registrant has done any of the following: ● Materially falsified any application filed. ● Been convicted of a felony relating to a controlled substance of a Schedule I chemical. ● Had their state license or registration suspended, revoked, or denied. ● Committed an act that would render the DEA registration inconsistent with the public interest. ● Been excluded from participation in the Medicaid or Medicare program. Clinicians who are agents or employees of a hospital or other institution (e.g., interns, residents, staff physicians, advanced practice providers) may, in the normal course of their duties, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution provided that the following apply: ● The dispensing, administering, or prescribing is in the ordinary course of practice. ● Practitioners are authorized by the state in which they practice. ● The hospital or institution has verified that the practitioner is permitted to dispense, administer, or prescribe controlled substances within the state. ● The practitioner acts within the scope of employment in the hospital or institution. ● The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code for each practitioner so authorized. In response to the opioid epidemic, many states have enacted policies to address the crisis yet still provide access to appropriate pain management. Procedures include guidelines for or limits on opioid prescriptions in Title 21 of the Code of Federal Regulations ( CFR ), Sections 1308.11 through 1308.15. 93 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 prescriptions in a different state for various reasons. A pharmacist who receives an out-of-state prescription may refuse to fill the prescription if unsure of the rules in the other state. 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
The DEA 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 legitimate 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 responsibility rests with the pharmacist who fills the prescription. 94 Laws and regulations vary from state to state; thus, the prescribing clinician must ensure that the prescription follows all requirements. Prescriptions for controlled substances must be written in indelible ink or typewritten. The controlled substance prescription must be dated and signed on the date issued. Additional requirements for a controlled substance prescription include the following: ● 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 prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.” 95 The CSA does not permit a prescribing practitioner to delegate 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 determine a legitimate medical purpose for a controlled substance prescription; an agent may not make this determination. all essential respects to the law and regulations” rests upon the prescribing practitioner. As noted, however, a pharmacist is responsible for dispensing controlled substances. Further, “A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.” 97 Therefore, a pharmacist must carefully review all purported controlled substance prescriptions to ensure that the drug meets all legal requirements for a valid prescription. In addition, pharmacists 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 prescription is issued for a legitimate medical
Special considerations for prescribing controlled substances While the laws vary from state to state, no prescribers should prescribe controlled substances for themselves or a family member.
Page 80
Book Code: MDCO1025
Powered by FlippingBook