ER/LA Opioid Analgesics REMS: Overview of Ongoing Assessments of Its Progress and Its Impact on Health Outcomes

Autor: Laura Wallace, Jean-Yves Maziere, M. Soledad Cepeda, Paul Coplan, Gregory P Wedin, Nathan W. Kopper
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Drug Utilization
medicine.medical_specialty
Epidemiology
media_common.quotation_subject
03 medical and health sciences
0302 clinical medicine
Patient satisfaction
Patient Education as Topic
medicine
Humans
030212 general & internal medicine
Original Research Article
REMS
Practice Patterns
Physicians'

Intensive care medicine
Psychiatry
media_common
business.industry
United States Food and Drug Administration
Addiction
Public health
Health Policy
General Medicine
Patient counseling
Opioid-Related Disorders
United States
Opioids
Analgesics
Opioid

Anesthesiology and Pain Medicine
Outcome and Process Assessment
Health Care

Opioid
Opioid Abuse
Education
Medical
Continuing

Neurology (clinical)
OPIOIDS
SUBSTANCE ABUSE & ADDICTIONS SECTION

Opioid analgesics
business
030217 neurology & neurosurgery
medicine.drug
Zdroj: Pain Medicine: The Official Journal of the American Academy of Pain Medicine
ISSN: 1526-4637
1526-2375
Popis: Objective. Opioid abuse is a serious public health concern. In response, the Food and Drug Administration (FDA) determined that a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids was necessary to ensure that the benefits of these analgesics continue to outweigh the risks. Key components of the REMS are training for prescribers through accredited continuing education (CE), and providing patient educational materials. Methods. The impact of this REMS has been assessed using diverse metrics including evaluation of prescriber and patient understanding of the risks associated with opioids; patient receipt and comprehension of the medication guide and patient counseling document; patient satisfaction with access to opioids; drug utilization and changes in prescribing patterns; and surveillance of ER/LA opioid misuse, abuse, overdose, addiction, and death. Results and Conclusions. The results of these assessments indicate that the increasing rates of opioid abuse, addiction, overdose, and death observed prior to implementation of the REMS have since leveled off or started to decline. However, these benefits cannot be attributed solely to the ER/LA opioid analgesics REMS since many other initiatives to prevent abuse occurred contemporaneously. These improvements occurred while preserving patient access to opioids as a large majority of patients surveyed expressed satisfaction with their access to opioids.
Databáze: OpenAIRE