From 2010 through 2015, the percentage of fatal overdoses involving synthetic and semi-synthetic opioids like morphine, oxycodone, and methadone fell. Fatal overdoses from heroin tripled during that same time frame.

Opioid addiction, unfortunately, may start out with a routine prescription of painkillers after surgery or injury. By the time a prescription runs out, drug addiction may have already taken hold, and those who have developed dependency may turn to illicit drugs like heroin to get their “fix”.

One surprising statistic about opioid overdose deaths in recent years is that the greatest increase has been in the 55 to 64 age group. Moreover, the group with the highest overall fatal overdose rate was middle-aged adults in the 45 to 54 age group. A group of doctors, drug addiction specialists, and addiction prevention advocates recently petitioned the FDA to make changes to help curb opioid overdose rates.

What the Petition to the FDA Says

In August, a petition was made to the US Food and Drug Administration under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that so-called ultra-high-dosage unit (UHDU) opioids be removed from the market. UHDU products are ones with more than the equivalent of 90 mg of morphine per day in their formulations. Some targeted products are immediate release (IR) formulations, while others are extended release (ER) formulations. What they have in common is their high dosage.

Who Is Behind the Petition?

Representatives of the medical profession and drug addiction prevention organizations are behind the petition, including Jay Butler, MD, of the Alaska Department of Health and Social Services, and National Safety Council President and CEO Deborah A.P Hersman. Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing, and American College of Medical Toxicology President Charles McKay, MD are also authors, along with Judy Rummler, Chairperson of the FED-UP Coalition to End the Opioid Epidemic.

Opioid Prescriptions in a Public Health Framework

Opioid overdoses affect far more than the stereotypical low-income white person living in a community that has been left behind by 21st-century technology. People of every income bracket and living in every type of community are affected. In short, the opioid epidemic is a nationwide public health crisis. Physicians, pharmacists, and patients all play a role in addressing the problem. The American Academy of Family Physicians (AAFP) recommends actions for physicians, pharmacists, and patients.

Physicians should:

  • Consider all pain treatment options.
  • Stay informed on prescribing guidelines for controlled substances.
  • Screen patients for mental health and drug abuse disorders.
  • Ensure that patients are not receiving multiple prescriptions.
  • Start with the lowest effective dose, and avoid big increases in dosages.
  • Teach patients taking high doses of opioids what Narcan is and how to use it in the event of an overdose.

Pharmacists should:

  • Understand patient conditions and treatment plans.
  • Ensure patients understand proper usage and dosages.
  • Educate patients about risks, side effects, and drug interactions.
  • Inform patients on safely disposing of unused pain medication.

Patients should:

  • Feel empowered to ask questions of physicians and pharmacists.
  • Learn about risks and benefits of prescription medications, plus activity restrictions (like driving) as well as drug interactions.
  • Store prescription drugs safely and dispose of unused prescription painkillers appropriately.

Opana ER Already Pulled from Market

Earlier in 2017, pharmaceutical company Endo pulled its painkiller Opana ER from the market, despite the drug having brought in $160 million in sales in 2016. The company plans to work with the FDA to remove Opana ER from pharmacies in a manner that will minimize disruption for patients and allow them time to develop alternative treatment plans with their doctors. The FDA asked Endo to stop sales of Opana ER, because the drug’s risks outweigh its benefits, particularly during a public health crisis involving prescription drug addiction. The request to Endo was the first time ever that the FDA asked for the removal of an opioid from the market.

Physicians, drug abuse prevention advocates, toxicologists, and public health officials are joining their voices to call for better control over prescription painkillers, some of which have led to overdoses and served as gateway drugs to heroin and other street drugs. If you have a substance abuse disorder, do not be afraid to ask for help.

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