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Friday, January 3, 2020

FDA Opioid Prescribing Practices

The US Food and Drug Administration (FDA) has changed the federal minimum age of sale of tobacco products from 18 to 21 years old. The FDA website states:

“It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.” 

FDA
While tobacco use is down across every demographic, vaping both nicotine and cannabis extracts is up, especially among young people. Lawmakers hope that raising the minimum age limit will prevent and curb the use of vaping products.

Interestingly, many states and more than 530 cities across the country have already raised the age limit to 21 before the FDA mandate, according to the Campaign for Tobacco-Free Kids. California had taken upon itself to make the change on June 9, 2016.

While people do not often seek addiction treatment for tobacco use, we like to remind our readers in recovery that nicotine use is associated with an increased risk of relapse. Any mind-altering substance is best to avoid for any member of the recovery community. We have pointed out on numerous occasions that smokers face elevated relapse rates.

The FDA made headlines for another reason last week when a study found that the agency failed to oversee that a program designed to ensure proper opioid prescribing practices was effective, The New York Times reports. The research appears in JAMA Internal Medicine.

Improper Opioid Prescribing Practices


opioid prescribing practices
Now some twenty years into perhaps the most severe public health crisis regarding drug use, it’s as vital as ever to ensure doctors are part of the solution. For many years doctors overprescribed powerful pain medications with very few of them facing any repercussions. A significant number of physicians continue to ignore opioid prescribing recommendations.

Current news regarding the American opioid addiction epidemic has primarily focused on pharmaceutical companies, particularly Purdue Pharma. You have probably read some of the reports on Purdue, the makers of OxyContin, and the Sackler Family, whose members are the majority shareholders.

In recent years, plenty of blame for the epidemic has been directed towards doctors. In 2011, the FDA realized there was a systemic problem regarding opioid prescribing practices in America. At that time, the agency asked drug companies making opioid painkillers to cover the cost of safety training for doctors who prescribed opioids. Moreover, the FDA also tasked pharmaceutical companies to begin keeping tabs on the efficacy of the training courses.

However, new evidence suggests that FDA dropped the ball on several fronts. The study shows that opioid manufacturers were not gathering the right kind of data, which meant the agency was incapable of determining how efficacious the safety training was in reducing addiction, overdoses, and overdose death rates. The researchers also revealed that FDA did nothing to correct the problem upon learning of the flaw in data collection.

“What’s surprising here is the design of the program was deficient from the start,” said Caleb Alexander, the senior author of the study. “It’s unclear why the FDA didn’t insist upon a more scientifically rigorous evaluation of this safety program.” 

The FDA wanted 60 percent of opioid prescribers, some 192,000 doctors, to take safety courses, the article reports. However, only about 27 percent did so between 2012 and 2016. The report said:

“If FDA does not have comprehensive data to monitor the performance...it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks.”

California Opioid Use Disorder Treatment


Please contact Hope By The Sea if you or someone you care about is struggling with an opioid use disorder. We can significantly assist individuals dependent on prescription opioids or heroin. We provide a full continuum of care – from detox to aftercare – which utilizes evidence-based therapies. Hope Starts Here!

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