Education & Labeling
The FDA has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). Continuing education and training under the modified REMS will be available to healthcare providers by March 2019. With these actions, the new Opioid Analgesic REMS will encompass 347 new opioids intended for outpatient use in addition to 62 ER/LA opioid analgesics already covered.
The FDA is also approving new safety label changes for all opioid products intended for use in an outpatient setting. The labeling will include information about the availability of education through REMS for prescribers and other healthcare providers involved in treating and monitoring pain patients.
Additionally, the new labeling includes information about REMS-compliant education in the Boxed Warning, Warnings and Precautions sections. It strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks and appropriate storage and disposal of opioids; and to consider other tools to improve patient, household and community safety. For patients and caregivers, the labeling emphasizes the importance of reading the Medication Guide every time it is provided by a pharmacist. | ← Previous | | | Next → | Single Page