FDA Approves a New Treatment for Opioid Use Disorders

As one year ends and another begins, we look back and remember the major news events of the year: politics; entertainment; the hurricanes that devastated Louisiana, Texas, Puerto Rico, Cuba, and the Virgin Islands—and something that destroyed many people’s lives—the opioid epidemic. We all have read about or even known someone who was or is opioid dependent—like a family member, friend, neighbor, or patient.

In 2014, according to the Centers for Medicare & Medicaid Services (CMS):

  • More than 650,000 opioid prescriptions were dispensed
  • 3,900 people began non-medical use of opioids
  • Prescription opioid abuse cost the U.S. $55 billion
  • $20 billion was invested in emergency departments and inpatient care for opioid poisoning

CMS states that prevention, treatment, research, and effective responses to rapidly reverse opioid overdoses are critical. Through the StrategicHealthSolutions, LLC (Strategic) Big Hairy Audacious Goal (BHAG), we are committed to educating the public on policies for reducing opioid misuse.

On November 30, 2017, the U.S. Food and Drug Administration (FDA) approved a monthly buprenorphine injection, Sublocade™, to enhance compliance with treatment for opioid use disorders. Sublocade is for patients who have been on a stable dose of buprenorphine for at least seven days, and serves as an option for patients in recovery who may want to receive a once-monthly injection instead of taking medication daily.

Sublocade should be used as part of a comprehensive treatment program that includes counselling and psychosocial support. It should be injected by a health care professional subcutaneously as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown of the depot. Sublocade has a boxed warning that provides important safety information, including the risks of intravenous self-administration. If the product were to be administered intravenously rather than subcutaneously, the solid mass could cause occlusion, tissue damage, or embolus.

The most common side effects include constipation, nausea, vomiting, headache, drowsiness, injection site pain, severe itching at the injection site, and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents under 17 years. Clinical studies did not include participants over the age of 65 years.

Buprenorphine injection must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients. Health care settings and pharmacies that dispense Sublocade must complete an enrollment form attesting they have procedures to ensure the injection is dispensed only to clinicians and not directly to patients.

What’s Next in 2018? 

In 2018, we will continue to discuss new developments, treatments, and processes and how they can help us #RedefineHealthCare as a sustainable resource for generations to come. We look forward to continuing to share our insights with you as we work together to create change.

About the author:

Photo of Dr. Manuel PubillonesDr. Manuel Pubillones

Dr. Pubillones operated a medical technology practice for 4 years before completing medical school and becoming a practicing psychiatrist for 14 years. In the early 1990s, he joined the Puerto Rico Medicaid program before heading stateside and joining Medicare. Dr. Pubillones has witnessed the prevalence of discrimination against persons with mental health conditions. Through participating in Medicaid and Medicare, he has realized the need for improving systems to provide quality services while eliminating malpractice, fraud, and abuse. Dr. Pubillones is an advocate for providing coverage and offering mental health and substance abuse services in a similar way as for other clinical services.

Sources:

FDA: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm

HHS:
https://www.hhs.gov/sites/default/files/Factsheet-opioids-061516.pdf

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