Innovations-Magazine-September-2023 - 12

FEATURE NEWS
EXPANDED SCOPE OF PRACTICE
How Buprenorphine Access Will Affect Pharmacists
The Drug Addiction Treatment Act of 2000 waiver, also known as the DEA X-waiver, was a certification
process that allowed clinicians to prescribe buprenorphine to treat opioid dependency. Established in
2000, the legislation required physicians to undergo specific training and register with Drug Enforcement
Administration (DEA) before prescribing buprenorphine for substance use disorder (SUD) treatment.
When created, the X-waiver was intended to help increase patient
access to buprenorphine, a controlled substance medication
approved for the treatment of opioid use disorder (OUD). A
secondary goal was to improve regulation of buprenorphine to
prevent misuse. In the years since, some experts have been critical
of the X-waiver process, arguing that it was too restrictive and
has created unnecessary barriers for patients seeking treatment for
OUD amidst the ongoing opioid epidemic.
The Mainstreaming Addiction Treatment Act (MAT Act), signed
into law by the Biden Administration at the end of last year, aimed to
expand access to medication for OUD for individuals struggling with
substance abuse, thereby addressing the ongoing opioid crisis in the
country. It eliminated the federal X-waiver requirement for clinicians.
Now, if a clinician can prescribe a narcotic painkiller, they may also
prescribe buprenorphine without additional waiver requirements.
Indeed, buprenorphine therapy is a vital treatment for OUD.
Clinical research has shown that medication for OUD reduces the
likelihood of overdoses, facilitates healthier pregnancies, and decreases
incidents of hepatitis C in young people. The passage of the MAT Act
10 | SEPTEMBER 2023
also brings to light the crucial need for regulation by DEA to ensure the
safe and effective implementation of medication for OUD programs.
DEA has already passed some regulations on buprenorphine
prescriptions following the passage of the MAT Act, and more
are anticipated. For example, the following requirement is
effective as of June 27, 2023: " The Consolidated Appropriations
Act of 2023 enacted a new one-time, eight-hour training
requirement for all DEA-registered practitioners, except
veterinarians, on the treatment and management of patients
with opioid or other substance use disorders. "
Access to buprenorphine is a major issue due to wholesalers'
suspicious drug order monitoring and DEA enforcement.
Wholesalers' monitoring systems are triggered by orders of opioids
and may result in pharmacies being cut off from the supply because
of concerns about DEA enforcement. This issue has been brought
to the attention of DEA, with requests for clear regulatory guidance
regarding the supply of buprenorphine.
A recent JAMA Network Open study described the availability of
buprenorphine at retail pharmacies in the United States in 2022

Innovations-Magazine-September-2023

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