FDA to Host Meeting on Opioid Prescribing Information Implementation

On January 30, 2018, the United States Food and Drug Administration (FDA) will host a public meeting entitled, “Opioid Policy Steering Committee: Prescribing Intervention – Exploring a Strategy for Implementation.” The FDA hopes to receive stakeholder input on how the agency can improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit the misuse and abuse of opioids, under the FDA Risk Evaluation and Mitigation Strategy (REMS). Recent studies suggest that prescriptions for opioid analgesics are frequently dispensed for a number of tablets that exceed those needed for adequate pain control, particularly for acute pain. The Steering Committee is considering whether current prescribing patterns are contributing to the development of new addiction in patients, and whether the excess unused pills are a gateway to misuse, abuse, and addiction among family members and others who might have access to the unused pills. Therefore, the Steering Committee is exploring the option of simplifying prescribing by requiring sponsors to implement a prescriber intervention at the point when the prescriber determines an opioid analgesic prescription is necessary for a patient. The Steering Committee's view is that sponsors could implement this type of prescribing documentation requirement through an electronic system incorporated into the prescriber's workflow to minimize the burden on patient access and on the health care...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs