The federal government says that beginning next year it will significantly reduce the amount of prescription painkillers that can be manufactured in the United States.

The Drug Enforcement Administration, which serves as the gatekeeper for such medicines, announced this week that it will lower aggregate production quotas for nearly all Schedule II prescription opioids by 25 percent or more beginning in 2017.

The agency’s decision comes in the midst of a national opioid addiction epidemic that has fueled a surge of overdose deaths in Maine and nationwide.

Maine’s Sen. Angus King said the reductions represent the largest decrease in opioid production quotas in two decades. A few of the affected drugs include oxycodone, fentanyl, morphine and hydrocodone, the most frequently prescribed opioid in the U.S., according to the DEA.

The agency said it based the reductions on data collected from several sources, including estimates of legitimate medical need; retail consumption based on prescriptions that were dispensed; manufacturer’s data on actual production, sales, inventory, and exports; and product development needs.

About 16,000 Mainers are currently prescribed high doses of opioids for chronic and acute pain. A new state law – most of the provisions went into effect July 29 – means that many patients will have their prescriptions reduced. Shutterstock photo

About 16,000 Mainers are currently prescribed high doses of opioids for chronic and acute pain. A new state law – most of the provisions went into effect July 29 – means that many patients will have their prescriptions reduced. Shutterstock photo

Aggregate production quotas represent the total amount of a controlled substance necessary to meet the estimated medical, scientific, research, industrial and export needs for the year, the DEA said in its statement.

“Demand for these opioid medicines, represented by prescriptions written by DEA-registered practitioners, has decreased,” the agency said.

King, several other U.S. senators and the Maine Medical Association praised the DEA’s decision. Attempts to reach a spokesman for the Maine Pharmacy Association were unsuccessful Wednesday night.

“The size and scope of the U.S. opioid epidemic requires immediate, sweeping action from federal and local governments, health care professionals, and drug companies,” King and his senate colleagues said in a joint statement issued Wednesday. “We commend the DEA for using its authority to significantly reduce the quantity of addictive painkillers that are flooding the market. This action will help prevent individuals from becoming addicted in the first place.

“We must now continue to use all the tools at our disposal to enhance federal oversight of prescription opioids, improve prescribing practices, and address barriers to addiction treatment. Failure to act will result in more heroin and opioid overdose deaths and more Americans becoming addicted,” the senators said.

King, an independent, and his Senate colleagues – Dick Durban, D-Ill., Sherrod Brown, D-Ohio, Edward J. Markey, D-Mass., Amy Klobuchar, D-Minn., and Joe Manchin, D-W.Va. – began lobbying the DEA last summer to limit the production of certain medications.

In a letter dated July 19, the senators contacted the DEA’s acting administrator, Chuck Rosenberg, calling on the agency to use its power to more aggressively “combat the opioid epidemic ravaging communities” in Maine and throughout the nation by setting lower manufacturing quotas.

The senators’ statement said under the DEA’s new quotas three powerful, addictive painkillers will see the largest reductions in production from what is currently allowed for Schedule II drugs. They are hydrocodone, which will be reduced by 34 percent, oxymorphone by 45 percent and hydromorphone by 38 percent. The DEA defines Schedule II drugs as substances or chemicals with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.

“Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by the DEA,” the senators said.

Drug overdose deaths in Maine are on pace this year to exceed last year’s record by almost 40 percent. There were 189 drug overdose deaths in Maine through June 30, according to the Maine Attorney General’s Office.

In 2015, the AG’s Office said a record 272 people died from drug overdoses in Maine, compared to 208 overdose deaths in 2014. This year’s deaths are on track to reach a new record of 378, based on an analysis by Marci Sorg, a University of Maine anthropologist, a consultant hired by the AG’s Office. Sorg said the increase in deaths is being driven by fentanyl, which is mixed with heroin.

In 2014, 28,647 people across the nation died from an opioid overdose.

The Maine Medical Association was holding its annual board meeting Wednesday and reacted favorably to the DEA’s decision. More than 20 physicians who were at the meeting were informed about the reductions in opioid production.

Gordon Smith, the MMA’s executive vice president, said he did an informal poll and most doctors say the action by the DEA fits in well with a relatively new Maine law that requires doctors to prescribe lower doses of pain medication to their patients.

About 16,000 Mainers are currently prescribed high doses of opioids for chronic and acute pain. The new state law – most of the provisions went into effect July 29 – means that many patients will have their prescriptions reduced. Maine’s new law is regarded as being one of the strictest opioid prescribing laws in the nation.

“The DEA’s announcement follows our Maine law very well,” Smith said. “We don’t see anything alarming in it. It’s highly unlikely that we will see an increase in opiate manufacturing anytime soon. These medications have proven to be very, very risky.”

A decade ago, physicians in Maine and across the nation were misled into believing that they were under-prescribing for pain symptoms. Smith said.

“It wasn’t until later on that we came to realize these drugs are highly addictive,” he said.

Maine physicians must find a better way to treat pain and need to start focusing on alternative medicine such as acupuncture, physical therapy and cognitive behavioral therapy, Smith said.

“We’ve got to find a way to change patient expectations,” he said. “The days of prescribing pain medication after you’ve seen the dentist are over.”

 


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