FDA begins to examine the opioid epidemic

Many law enforcement agencies and fire departments now carry naloxone kits. This medication can reverse the effects of an opioid overdose.

There is no secret. All over United States we are seeing an epidemic of unprecedented opioid addictions. It began as medicine’s attempt to care for patients with pain, but has rapidly run amok. The U.S. Food and Drug Administration (FDA) is the federal agency charged with over-sight of pharmaceutical safety and effectiveness. Dr. Robert Califf, Deputy Commissioner for Medical Products and Tobacco with the FDA recently said, “Nationally, the annual number of deaths from opioid overdoses now exceeds the number of deaths caused by motor vehicle accidents.”

This opioid epidemic places a terrible burden on many people and families who have to deal with addiction on a daily basis. The FDA has recognized this issue for a while and recently announced that the agency will re-examine its approach to the use of opioid medications. The key will be how this agency enacts regulations that will contain and reverse the opioid epidemic while simultaneously maintaining access to appropriate pain medications to those who truly need them.

I am happy to see that the FDA has reached outside of its own doors and is partnering with other concerned medical groups to attack this massive problem. They are seeking the counsel of pain management and substance abuse groups. The FDA has also asked the National Academy of Medicine to help develop a better way to evaluate opioids that come to the market. Here they will examine a medication’s potential for misuse and abuse.
The FDA is also partnering with a pediatric advisory committee to make appropriate recommendations for use of opioids in the pediatric population. This has sorely been a piece of the puzzle that has been missing.

The FDA has plans to expand access to and encourage the promotion of opioids that are abuse-deterrent formulations. Advisory boards are being convened to carefully determine whether an opioid devoid of the abuse-deterrent is still appropriate for use.

Plans are also underway to improve access to naloxone, a wonderful medication that can reverse the effects of an opioid overdose and thus save lives. Many law enforcement agencies and fire departments now carry naloxone kits. Efforts are currently underway to make these kits available to family members or close acquaintances of known opioid abusers in case of overdose.

The FDA will be supporting better pain management options and promote alternative treatments which have no opioid component.

Pharmaceutical companies that make opioids will also be required to keep track of long term data on how their medications are affecting people. Such tracking should generate an extensive database that will help in the understanding of opioid misuse, abuse, overdose and death.

Dr. Califf explained that drug overdose deaths are driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally made fentanyl. These drugs are now the leading cause of injury death in the United States. Things are getting worse, not better, with the epidemic opioid misuse, abuse and dependence. It is time we all take a step back and examine that which is working and what we need to change in order to effectively address this crisis.

Veita Bland is a board certified Greensboro physician and hypertension specialist. Email Dr. Bland at ideas@blandclinicpa.com.