New Requirements for Reporting Dispensed Controlled Substances

Due to the growing addiction to opioids and other prescription medicines in the U.S., providers must now follow a more intense process when prescribing controlled substances. Fentanyl, a strong Opioid, has been found to be very helpful in managing patient pain, especially in cases of adult cancer. However, Fentanyl has also been found in “street drugs” causing a rise in drug-related deaths. In the effort of trying to contain the misuse of Fentanyl and other prescribed controlled substances, the U.S. Food and Drug Administration (FDA) has implemented new opioid prescribing guidelines.

Starting on January 1, 2021 any controlled substance prescriptions must be reported to CURES. The dispensing of controlled substances must be reported within one working day after the medication is released. All security prescription forms will be required to have a 12- character serial number and corresponding barcode. Electronic prescriptions are not subject to the security feature related to paper forms. Prescribers also have the option to utilize electronic prescribing, which will become mandatory in 2022. All prescribers must be able to electronically transmit prescriptions for both controlled and non-controlled substances. Prescribers will also need to use a complaint form to fill any prescription for a controlled substance.

This process is intended to help patients access proper chronic pain treatment, to prevent drug misuse or overdose, and to help monitor how providers are prescribing controlled substances. In 2016, opioid use or opioid-caused-death affected 11.2 million Americans. Although these drugs are used to help patients manage their pain, many providers worry about their patients becoming addicted; this is especially prevalent in long term use patients.

In July of 2016, President Obama signed into law the Comprehensive Addition and Recovery Act (CARA) which authorized over $181 million in funding to help address the opioid epidemic. CARA aims to address the opioid epidemic, expand prevention and education, and promote treatment and recovery.

CARA authorized a $5 million grant program in the Office of National Drug Control Policy for current and former Drug-Free Communities (DFC) grantees to apply for additional funds of up to $50,000 for 3 years to help cope with their community’s prescription drug and methamphetamine epidemic. The FDA Opioid Action Plan requires any application for an opioid drug to be referred to an FDA advisory committee for recommendations prior to FDA approval.

There are many fact sheets and guidelines to help guide provider on how to properly prescribe controlled substance and how to look out for patient misuse and addiction signs.

For more information about CURES, reporting requirements, and prescribing guidelines, visit these resources:

Medical Board of California CURES

Fact Sheet: CDC Guideline for Prescribing Opioids for Chronic Pain

CDC Guideline for Prescribing Opioids for Chronic Pain

Medical Board of California AB 528 Bulletin

References:

OSHA Review - CA Reminder: New Prescription Mandates for Controlled Substances to Begin 2021

California Medical Association: New Prescribing and Reporting Rules for Controlled Substances Coming January 1, 2021

Medical Board of CA: New Prescribing and Reporting Rules for Controlled Substances Coming January 1, 2021

CDC Guideline for Prescribing Opioids for Chronic Pain

Opioid Prescribing Guidelines: A State-by-State Overview

Comprehensive Addiction and Recovery Act (CARA)