Last updated: June 5, 2023
The FDA Public Workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis” is looking for input from stakeholders—which is practically everyone in the country if we’re being honest.
The FDA hopes to hear from healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and, of course, the public.
It’s destroying our nation
Opioid addiction had already reached crisis levels prior to the onset of the pandemic. However, the drastic increase in overdose deaths since it began proves this crisis is nothing short of catastrophic. Granted, the FDA is aware of the fact that since discovering how insanely addictive these drugs are, physicians don’t hand out prescriptions lightly.
Still, word got out on the street about the effect these drugs have on the system decades ago and the black market is rampant with them. Addicts are at risk of overdosing because they build up a tolerance to the drug and the brain accepts it as being “normal.” Therefore, to obtain the desired effect, it takes a higher dose. Eventually, it reaches a deadly level.
In addition, the synthetic opioid, fentanyl is all over the streets—but no one’s telling the customers. It’s cheap and provides an added kick to boot so dealers are scooping it up and mixing it with other drugs. It increases the merchandise which means more money.
This drug is extremely potent—100 times stronger than morphine—and is being found as a related cause in overdose deaths in which the body also contained cocaine, methamphetamines, heroin, and opioids, such as oxycontin, for instance.
Prescription use declining, but still…
The FDA chose not to make opioid prescription education mandatory in the past. Instead, it made manufacturers responsible for promoting prescription education. Many entities had their staff undergo training—and the number of opioid prescriptions began to decline. Despite the fact that there were fewer prescriptions being written, multiple studies have determined that patients receive more medication than necessary following surgical procedures. The same was found to be true in adolescent and children’s prescriptions following common dental procedures.
That being the case, concerns regarding addiction are still in play. Not only is it a risk to the patient, but leftover medication tends to sit in the medication cabinet. Family members or friends with addiction problems won’t hesitate to help themselves if discovering the pills.
This dark trail leads back to the black market, of course—
And, sadly, the cycle continues.
A pathway out of the darkness
As long as we’re aware of the ongoing problem and keep working together, there is hope that our nation will overcome the plague of opioid addiction. The FDA Public Workshop is calling for you to shed some light on the path we take from here.
The public workshop takes place on October 13, 2021, from 1 p.m. to 5 p.m. Eastern Time, and October 14, 2021, from 1 p.m. to 4:05 p.m. Eastern Time.
The meetings, held virtually due to continuing concerns regarding the spread of COVID-19 and its variants, are still open for registration. Yes, we realize it’s coming up fast. So, we’re sharing that if your schedule conflicts, Duke is recording the event in its entirety. Furthermore, you can submit comments, either electronically or by mail, through December 3, 2021.
Plan to tune in between now and December 3rd, then, let the FDA know your thoughts on the matter.
And, lastly—yes, it’s short notice, but, please, share this post and encourage others to do the same. Somebody somewhere has something to say that can make a difference. We need to speak up!