New Guidance Aims to Protect People Taking Prescription Opioids from Accidental Opioid Emergencies

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(BPT) - An accidental opioid overdose can happen to anyone using opioid medicines, in any community. The U.S. Centers for Disease Control and Prevention (CDC) has reported a substantial increase in opioid overdose deaths across the United States that coincided with the implementation of widespread mitigation measures for the COVID-19 pandemic in 2020.[1] The most recent provisional data available from the CDC indicates that nearly 68,000 opioid overdose deaths occurred in the 12-month period ending in November 2020, representing a worsening of the opioid overdose epidemic and the largest number of opioid overdoses for a 12-month period ever recorded.[2]

Public health leaders recognize that more must be done to strengthen and enhance the patient-physician relationship, reduce stigma, and empower health care professionals to equip patients who may be at risk of an accidental overdose.[3] [4] [5] In July 2020, the U.S. Food and Drug Administration (FDA) announced a drug safety communication that labeling for opioid pain medicine and medicine to treat opioid use disorder (commonly referred to as OUD) be updated to recommend health care professionals discuss the availability of naloxone with patients and caregivers, both when beginning and renewing these medicines.[6] Naloxone is an FDA-approved medication that is used to reverse the effects of an opioid overdose.

The FDA opioid labeling update recommends that health care professionals consider prescribing naloxone to patients being prescribed opioids who are at increased risk of opioid overdose, including those concurrently taking benzodiazepines, those with a history of OUD or prior opioid overdoses, and those who have household members, including children, or other close contacts at-risk for accidental ingestion or overdose.[7]

A Step Forward in Combatting the Growing Opioid Deaths Among Patients Taking Prescription Opioids or Suffering with OUD[8]

Importantly, the recent FDA recommendation will help to build the relationship patients have with their providers, who play an important role in addressing this ongoing public health crisis.[9] Healthcare providers can provide education to individuals who remain unaware of their risk for an accidental overdose, as well as to caregivers on how to treat potential overdoses with opioid antagonists such as naloxone.

Of the 49 million patients prescribed opioids in the United States, more than 18 million are considered at risk, but only five percent received a prescription for naloxone.[10] Our nation’s devastating rise in opioid overdose deaths before and during the COVID-19 pandemic reinforces the critical need for opioid awareness and access to opioid overdose reversal medications such as naloxone for people who may be at risk.[11]

Be prepared. Speak with your healthcare provider, pharmacist or visit the FDA website to learn more.

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[1] Centers for Disease Control and Prevention: Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic. https://emergency.cdc.gov/han/2020/han00438.asp

[2] Centers for Disease Control and Prevention: Provisional Drug Overdose Counts. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

[3] Centers for Disease Control and Prevention: Life-Saving Naloxone from Pharmacies. https://www.cdc.gov/vitalsigns/naloxone/index.html

[4] HHS, Office of the Surgeon General: U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html

[5] U.S. Food & Drug Administration: 7-23-2020 Drug Safety Communication. https://www.fda.gov/media/140360/download

[6] U.S. Food & Drug Administration: 7-23-2020 Drug Safety Communication.

[7] U.S. Food & Drug Administration: 7-23-2020 Drug Safety Communication.

[8] Centers for Disease Control and Prevention: Provisional Drug Overdose Counts.

[9] HHS, Office of the Surgeon General: U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose.

[10] Data extracted from IQVIA Pharmacy Claims Database in the retail and mail channels for the 12 months of August 2018 through July 2019.

[11] Centers for Disease Control and Prevention: Provisional Drug Overdose Counts.