The national trend of increased government oversight of opioids continues, as New Hampshire's legislature fine-tunes new labeling regulations while the U.S. Food and Drug Administration introduces changes to current opioid label requirements.
On May 23, the New Hampshire House and Senate each passed separate but related bills that would require orange warning stickers on opioid prescription bottle lids. The orange stickers would also be accompanied by an additional label warning of the risk of addiction and overdose, along with a pamphlet handout to be developed by the Governor's Commission on Alcohol and Drug Abuse, Prevention, Treatment, and Recovery providing information on opioid risks as well as advice on how to lessen the risks for patients who are receiving the pain-relieving prescriptions.
Legislation Expected To Be Signed By Governor
According to New Hampshire Public Radio, the Senate version of the bill passed by a vote of 22-1, with some opposition from pharmacists who preferred a voluntary approach. Since the House and Senate versions contain some minor variations in wording, these will need to be ironed out first before the legislation is signed by Gov. Sununu.
This follows government action on the national level, in which the FDA issued a statement April 9 warning of the harm from sudden stoppage of opioid medications and announcing new safety-related drug labeling requirements that would improve guidance for health care professionals on the safe dosing and weaning of patients who have been prescribed opioid painkillers.
In making its announcement, the FDA cited the dangers of uncontrolled pain, serious withdrawal symptoms, psychological distress and suicide that have been associated with rapid discontinuation of the drugs. As a result, the FDA said that patients may end up seeking alternative sources for medications to treat their withdrawal symptoms, including illicit opioids such as heroin and other substances.
FDA and NH Actions Will Mean Labeling Changes
The new information required by these legislative actions will necessitate significant changes to existing packaging and labeling now being used by pharmacies.
If you're in the process of updating your product labels to keep up with government regulations, a helpful place to begin is viewing our high-quality label printers at Argon Technology's U.S. store or Canada page.