Update: FDA Takes Major Steps to Address Growing Opioid Crisis

Last week was a busy one for the Food and Drug Administration (FDA), as the nation’s health watchdog began taking serious action to combat the rising opioid crisis.

It has been a busy month, in general, for top health officials.

The Centers for Disease Control (CDC) calls the growing number of drug overdose deaths an epidemic. Since the year 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioid painkillers and heroin, according to the agency’s website.

People who visit the emergency room and individuals with chronic pain are going to have a more difficult time getting prescriptions for opioid painkillers like Oxycodone because of action the CDC already took earlier in March. The agency released long-awaited guidelines designed to limit the prescribing of opioids, though there is no legal mandate that requires physicians to follow them.

In the guidelines, the CDC urges doctors not to immediately prescribe opioids to treat pain. The agency recommends prescribing non-opioid painkillers and other treatments first, including exercise therapy and weight loss. When a physician does prescribe an opioid, the CDC advises starting the patient on the lowest possible dose, and prescribing immediate-release opioids for short periods of time, rather than for weeks or months.

Urine testing is also recommended, to make sure patients are following the prescription’s directions. [1]

Read: Senate Approves Bill to Tackle Nation’s Nation’s Heroin, Opioid Problem

Let’s take a look at the most recent actions taken to combat the burgeoning opioid problem.

Making Opioids More Difficult to Abuse
The current version of the drug OxyContin is difficult to crush and dissolve or snort, but other opioid medications can be easily broken down and abused. To counter the problem, the FDA published draft guidelines last week outlining testing standards for harder-to-abuse generic painkillers. Five brand-name opioids which are designed to discourage abuse have already gotten the all-clear from the agency.

Currently, generic drugs are not individually scrutinized for safety and efficacy the way brand-name drugs are. Instead, the FDA will approve a generic medication if the drug manufacturer can prove it is the bioequivalent, or the chemical equivalent of a brand-name medication.

Under the FDA’s new guidelines, however, drug makers will need to perform additional studies proving that generic opioids have the same anti-abuse properties as their brand-name counterparts. [2]

Black Box Warnings
Last week, the FDA said that all fast-acting opioid painkillers will be required to carry a Black Box Warning, the agency’s strongest warning, about the risks for addiction, misuse, overdose, and death. The warnings will emphasize that prescription painkillers should be used only when absolutely necessary, and as a last resort. The Black Box warnings will also inform women that opioid use during pregnancy has been linked to opioid withdrawal syndrome (NOWS) in newborns. [3]

While many people legitimately need strong pain medications, these actions are intended to prevent people with temporary and/or obtuse pain from getting hooked on such drugs.

The blame for the opioid crisis doesn’t fall solely on patients, who usually trust their physician’s advice, either. The results of a survey released March 25 by the National Safety Council found that when American doctors prescribe opioid drugs, 99% of them hand out prescriptions that exceed the federally recommended 3-day dosing limit. [4]

Sources:

[1] The Wall Street Journal

[2] San Jose Mercury News

[3] Canada Journal

[4] HealthDay

CDC

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