● Prescriber’s signature. ● Date issued.
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). 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 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 purpose by a practitioner 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. 93 To reduce the overall burden of opioids, clinicians should consider nonopioid treatment modalities such as regional anesthesia, massage, or physical therapy. Follow-up within three to five days of initial treatment is essential. Reevaluate any severe pain that continues beyond the expected duration to adjust the pain management regimen appropriately.
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. Consider a stepwise approach with the least invasive and least powerful pain management therapies appropriate for the patient (see Table 7 ). Counsel patients regarding common adverse effects of opioids used for acute pain. Upon initiation of opioid therapy, it is common for patients to experience sedation, nausea or vomiting, and pruritus. In most cases, these effects resolve within a few days. It is important to note that opioid-induced itching is not always indicative of an allergic reaction, as opioids induce the release of histamine. Treatment with antihistamines usually resolves the itching but may increase sedation. Ensure patients are aware of the risk of oversedation, respiratory depression, and overdose, and recommend that they not take more medication than prescribed without discussing it with their prescriber. The FDA approved the Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS), which apply to all opioid analgesics for outpatient use. The REMS program requires that training be made available to all healthcare providers involved in managing patients with pain, including nurses and pharmacists. 98 Prescribers are strongly encouraged, but not required, to do all of the following: ● Complete a REMS-compliant education program offered by an accredited continuing education (CE) provider or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. ● Use the Patient Counseling Guide (PCG) to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and their caregivers. ● Emphasize to patients and their caregivers the importance of reading the medication guide provided by their pharmacist every time an opioid analgesic is dispensed to them. ● Consider using other tools to improve patient, household, and community safety, such as patient– prescriber agreements that reinforce patient– prescriber responsibilities.
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.
Book Code: TN24CME
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