New Opioid Initiatives And Laws Seek to Curtail Access

With a burgeoning opioid addiction epidemic that has claimed thousands of lives, the U.S. government is beginning to change drug laws to restrict access and stop the mounting public health crisis.

One big change occurred in late 2014, when the federal government rescheduled hydrocodone combination medications, such as Vicodin, from Schedule 3 to Schedule 2.

The change made it more difficult to access the drug by tightening prescription requirements. Doctors are now required to handwrite prescriptions, which patients must physically deliver to the pharmacy. The drug orders can’t be called in or faxed. No refills are permitted, which means a new prescription must be written every time, and supplies are limited to 30 days.

Drug scheduling is a way of classifying drugs by the danger they pose, including risk of addiction. Schedule 2 drugs are those with a high risk for addiction, both psychologically and physically. They’re also considered highly dangerous, according to the Drug Enforcement Agency (DEA).

Other drugs in the same class include cocaine, oxycodone, and methadone. Hydrocodone by itself has been in Schedule 2 since 1971; the new rules affect medications containing the opioid in combination with other substances, like ibuprofen.

The Food and Drug Administration (FDA) says hydrocodone is the most commonly prescribed opioid, with 137 million prescriptions written in 2013. FDA Dr. Douglas Throckmorton says:

“While (hydrocodone) is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States.”

The move had been in the wings for years, reports USA Today, and required approval from the FDA, Department of Health and Human Services, and long hearing processes.

DEA had long pushed for the change, arguing that too many people had unfettered access to the drug, resulting in addiction and a plentiful black market supply. The FDA initially resisted, saying that hydrocodone combination drugs weren’t ripe for abuse like other Schedule 2 drugs, but changed its stance as the opioid epidemic has grown, reports USA Today.

Top federal health officials urge action against opioid addiction

Meanwhile, the medical community is also taking action to save lives and prevent more patients from developing addictions. In spring 2014, the New England Journal of Medicine published commentary by top federal health and substance abuse officials, calling on doctors to prescribe medicines like methadone to help patients with opioid addiction.

These medicines should be used in concert with behavioral therapy and other treatments to help patients end the cycle of opioid abuse, the paper said.

Although drugs like methadone have been found effective against opioid addiction, the paper’s authors said they’re underused because health care providers often misunderstand them, believing that using methadone is exchanging one addiction for another. Research does not currently show that patients develop new addictions to the treatment drugs, the paper said. Paper co-author Dr. Tom Frieden says:

“Prescription drug overdoses in the U.S. are skyrocketing. The good news is we can prevent this problem by stopping the source and treating the troubled.”

Saving lives on the ground

Other efforts to stop opioid-related deaths are being implemented at the ground level, with programs to train patients to save them themselves.

Known as community opioid overdose prevention programs (OOPPs), the effort involves distributing life-saving kits to those most at risk for overdose. The kits contain a drug called naloxone that has the ability to reverse the effects of opioids. Recipients are trained how to use the kits, which are often distributed at needle exchange programs.

A review of research published in the Journal of Addiction Medicine found the kits may save lives. Researchers reviewed 18 studies, and in 11 of those studies, survival rates were 100%. The remaining research reported survival rates as high as 96%. In some of the unsuccessful situations, naloxone didn’t work to reverse the opioid overdose effect.

In most of the cases reviewed, the person administering naloxone—either as an injection or nasal spray—was also an opioid user. Although the OOPPs programs appear to be successful, the study authors said more research is need to confirm potential benefits.

The paper also mentioned several difficulties implementing programs, including gathering support from addiction center staff who may question the program’s merit.

Checklist could save lives

It sounds simple, but using a compliance checklist has been shown to identify patients most at risk for misusing opioids, according to a study conducted by the American Pain Society.

A compliance checklist would be a big step in the war against opioid addiction and overdose since there are no commonly used assessments available to monitor people taking opioids long term. The study, completed at Boston’s Brigham and Women’s Hospital, used the 12-item opioid compliance checklist for 157 patients taking the medications to treat chronic pain. The patients were followed for six months.

Five questions in particular were found to heavily predict whether a person would misuse opioids. They involved determining if a person:

  • Loses medications
  • Runs out of medications before the time for refill
  • Misses doctors’ appointments
  • Uses illegal substances or those not prescribed to the patient
  • Lied about personal drug use

Researchers said focusing on learning the answers to those five questions could help predict whether a patient would misuse prescriptions. Dr. Robert Jamison, lead study author, says:

“We were surprised at how powerfully a brief checklist that reflects how patients comply with parts of an opioid agreement can predict the future misuse of opioids.”

Chronic pain patients using opioids more likely to die

Driving home the importance of reducing opioid dependence is a study published in the journal Pain that showed chronic pain patients who use opioids are more likely to die, although those most at risk were patients who obtained the pills from the black market or other illicit sources. Lead investigator Ola Ekholm says:

“Our study provides the first evidence that directly links legally prescribed opioids to risk of deaths.”

Do you think opioid laws should tighten?

Image by James~Quinn via Flickr