data that can help identify problematic trends with specific drugs, geographic regions, and patient demographics. The purpose of PDMPs is to (1) improve medication safety for opioids and other controlled substances by allowing clinicians to identify patients who are obtaining controlled substances from multiple prescribers (i.e., doctor shopping), (2) calculate the total amount of opioids prescribed per day, and (3) identify patients who are being prescribed other
substances that may increase risk of opioids, such as benzodiazepines. However, the effect of PDMPs is uncertain, as studies have reported conflicting results. Suggested improvements to prescription drug monitoring programs include improved clinician training in using PDMPs, prescriber dashboards for higher-risk patients, proactive alerts, mandatory registration, mandatory querying for specific prescriptions, improved interfaces, and integration into electronic medical records. 108
ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES (EPCS)
In June 2010, the DEA published an interim final rule allowing for the electronic prescribing of controlled substances (EPCS) in all states. States had to meet specific requirements, including certification of the electronic prescribing and pharmacy applications to sign, transmit, or process the controlled substance prescriptions; audits and certification reports for these applications; and two-factor authentication for prescribers. However, implementation of EPCS has been slow; in 2015, only 2.2% of prescribers and less than 50% of pharmacies were enabled for EPCS, while over 70% of prescribers and 95% of pharmacies could e-prescribe or accept other prescriptions. 99 Delays included necessary updates to electronic health records and pharmacy systems and changes to state legislation to allow for EPCS. As the opioid crisis worsened, the implementation of ECPS as a tool for increased security against diverted controlled substance prescriptions has been is permitted only in an emergency for Schedule II controlled substances. Written prescriptions for a Schedule II controlled substance may not be refilled. While there is no federal quantity limit for Schedule II controlled substance prescriptions, many states have enacted legislation limiting quantities for opioid prescriptions. As of 2018, 33 states passed legislation limiting it, guidance, or other requirements related to prescribing opioids. 111 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
recognized. 109 E-prescribing continued raising the bar for safe, precise prescriptions in 2021 with better data quality and more efficient communication between pharmacists and prescribers. A Centers for Medicare & Medicaid Services (CMS) rule requiring that Part D providers use EPCS took effect January 1, 2021 (according to the requirements of the SUPPORT for Patients and Communities Act), and state legislation continued moving forward throughout the year. With between 20% and 26% of U.S. adults using telemedicine every month in 2021, it is no surprise that e-prescribing use grew throughout the year. EPCS brings extra safety and security to controlled substance prescriptions, which is critical amid an opioid overdose crisis that spiked as the COVID-19 pandemic hit the United States. Already used by virtually all pharmacies, EPCS saw an 18% jump in the number of enabled prescribers in 2021. 110 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. 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 controlled substance prescribing considerations Schedule II controlled substances require a written, signed prescription, except where states have enacted laws allowing EPCS. There is no federal law limiting when a signed prescription expires. A verbal order
Facsimile and oral prescriptions for Schedule II controlled substances 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
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Book Code: MDCO1025
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