Comprehensive Addiction and Recovery Act of 2016

In July 2016, the Comprehensive Addiction and Recovery Act of 2016 was signed into law by President Barack Obama.¹ The act covers numerous grant programs. Specific to pharmacy, it provides “grants to states that allow the distribution of naloxone without a prescription and amendments to the CSA to allow partial filling of Schedule II medications whenever requested by patient, prescribers, or when allowed by state law.”² The focus of the law is on both education and access to opioid reversal medication and devices: recommendations for prescriber education on opioids are being addressed,² as is access to opioid overdose reversal medications and devices. In addition, this law addresses the partial dispensing of a prescription for a Schedule II substance, which, until now, was not an option for patients.

Opioid overdoses should be taken very seriously. The symptoms of an opioid overdose are described as the opioid overdose triad, which includes pinpoint pupils, unconsciousness, and respiratory depression.³ Fortunately, naloxone was developed to reverse opioid overdoses. This agent is a competitive antagonist of the mu-opioid receptor, which is used for the reversal of opioid overdoses. When the concentration of naloxone increases in the body, it displaces the opiate, allowing the patient to be revived. Administration of naloxone as soon as an opioid overdose is suspected greatly increases the chance of overdose reversal. Because of the effectiveness of naloxone, it is important to have access to it at numerous locations.

Under the Comprehensive Addiction and Recovery Act of 2016, expanded access to drugs and devices for opioid overdose reversal is being funded. This funding will go toward training and providing resources for pharmacists and other health care providers on prescribing overdose reversal drugs, purchasing overdose reversal drugs and devices, and connecting patients who have experienced overdose-appropriate treatment.² In addition, the law rec- ommends that guidelines be established regarding prescriber education on appropriate use of opioids.¹ Having standards and guidelines for proper prescribing of opioids sets a basis for decreasing occurrences of opioid overdose.

Another part of this law that greatly affects pharmacists is the ability to partially fill a Schedule II controlled substance prescription.² Until this law was passed, if a patient received a portion of the quantity originally prescribed for a Schedule II medication, the remainder of the prescription was voided. Under this new law, if certain requirements are met by patients, partial dispensing of their Schedule II pain medication is permitted and they can pick up the remainder within 30 days of the date on which the prescription was written. Section 702 of this law discusses the requirements a patient must meet to have the quantity specified in a Schedule II prescription less than completely dispensed at the initial presentation.²

END NOTE

The number of opioid overdoses is increasing at an alarming rate. The Comprehensive Addiction and Recovery Act of 2016 is addressing several issues by funding opioid reversal medications and devices. Further, the law’s authorization of partial dispensing of Schedule II controlled substances should help reduce the number of opioid overdoses by allowing patients to fill only what they need or will use. Once patients know how the medication affects them and determine how much they need, they can obtain the balance of the original quantity.² Because of more funding to address the opioid overdose problem, patients have a better chance and opportunity to receive the care and counseling they need.

Heather N. Wolf, a native of Evansville, Indiana, is a firstyear PharmD student at the University of Kentucky College of Pharmacy. Joseph L. Fink III, BSPharm, JD, is professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

References:

• Fassett WE. Controlled substances: President Obama signs S. 524, Comprehensive Addiction and Recovery Act of 2016. Pharma-Law E-News. 2016;July:1-5.
• Comprehensive Addiction and Recovery Act of 2016 (Public Law No. 114-198): a section-by-section analysis. National Association of State Alcohol and Drug Abuse Directors website. http://nasadad.org/2016/07/comprehensive-addiction-and-recovery-act-of-2016-s-524-as-passed-by-house-and-senate-a-section-by-section-analysis/. Published July 21, 2016. Accessed October 18, 2016.
• Information sheet on opioid overdose: signs of opioid overdose. World Health Organization website. www.who.int/substance_abuse/information-sheet/en/. Published November 2014. Accessed October 18, 2016.