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 |
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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 |
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