OPIOID USE AND ABUSE
As we described in Part 1 of our series on opiates, the opioid epidemic has had three phases:
- the first was dominated by prescription opioids (encouraged by “the pain movement” that began in the 1980s and 1990s),
- the second by heroin (which is far cheaper and easier to obtain than prescription drugs),
- and the third by cheaper but more potent synthetic opioids such as fentanyl (which some attribute to the large number of overdoses because of its potency).
In March 2016, a CDC Injury Center webpage stated that spike in opioid analgesic overdoses was primarily driven by fentanyl, almost entirely illicit in origin.
Similarly, a February 2017 report on Massachusetts data indicated that opioid-related deaths/100,000 residents increased 250% from 9.3 in 2011 to 25.8 in 2015.
Toxicology results in opioid OD decedents found important trends:
- fentanyl, almost all illicit in origin, was present in 42% of overdoses in 2014 vs 75% in 2016
- heroin was present in 77% of overdoses in mid-2014 vs ∼50% in 2016
- prescription opioid analgesics fell 34.68% from early 2014 to 2016
- BZD (Benzodiazepine) presence rose from 55% in 2014 to 63% in 2016.
Unlike the CDC’s study, suicides were excluded in these analyses. Thus, in 2016, 3 in 4 fatal opioid toxicities involved illicit fentanyl, approximately three in five involved BZDs, and prescription opioid analgesic fatalities continued declining.
Another result of the huge increase in illicit fentanyl (a drug so powerful that if you touch it with bare skin you could ingest some–which is why police officers often wear black gloves to make the white powder more visible), is that fentanyl is being used in other street drugs. A buyer thinks they are getting cocaine or they think they are getting methamphetamine, but it is cut or laced with fentanyl.
Deadly overdoses are occurring because the people ingesting the tainted drugs would not think to have Narcan (an overdose reversal drug) handy for a drug that is supposedly a stimulant.
THE DECLINE OF OPIOID PRESCRIPTIONS/PRODUCTION
All of these forms of opioids remain relevant to the current crisis. And there’s no denying that substance use or misuse is not a new concept and was already taking place long before opioids entered the scene. (Think: the crack epidemic of the 1980s.)
The difference between the crack epidemic and the current opioid one is that crack was never prescribed by doctors to treat pain, so there has been a different response to opiate use and misuse by critics, lawmakers, the public, and the media.
However, only 22 to 35 percent of “misusers” of pain medication report receiving drugs from their doctor, according to the Substance Abuse and Mental Health Services Administration. About half obtain pain relievers from a friend or relative, while others either steal or buy pills from someone they know, buy from a dealer, or go out looking for a doctor willing to write prescriptions.
Further, opioid prescriptions plateaued in 2014–2015, with declines in subsequent years.
Hydrocodone, oxycodone, and overall opioid prescribing have been in a multi-year decline beginning in 2012 through early 2017.
Oxycodone ER also showed steady decreases in prescribing, including a 39% decrease in a health plan with 31.3 million adult members from late 2009 to late 2012.
Nationwide data on Oxycodone ER comparing 2009 with 2013 found decreases in: national poison center surveillance system mentions (48%), mentions in a national drug treatment system (32%), prescribing using a claims database (27%), doctor shopping (50%), and fatal overdose reported to the manufacturer (65%).
Total oxycodone ER prescriptions decreased >29.7% from 2007 to 2011 and decreased by 39% from 2010 to 2015.
Prescriptions for opioids have decreased–that’s a fact and we can see that from various statistics–but what does this mean for those legitimately suffering from chronic conditions and have never used opioids to get high?
In other words, prescriptions and production have gone down…now what?
RESTRICTIONS/2020 FORECAST/API AVAILABILITY
It means changes in the market, that’s for sure.
The U.S. Drug Enforcement Administration endeavors to set production limits for opioids at a level required to meet the country’s legitimate medical, scientific, research, industrial and export needs for the year and for the maintenance of reserve stocks, without resulting in an excessive amount of these potentially harmful substances.
The DEA is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the United States this year compared with 2019. It proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent.
Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.
The five opioid substances were subject to special scrutiny following the enactment last year of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (known as the SUPPORT Act), which requires the DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions.”
MANUFACTURERS STOPPING PRODUCTION OF OXYCODONE
As a result, there are now manufacturers that are completely exiting the opioid market such as Mayne, Epic and Teva. An immediate issue of this market withdrawal is potential shortages in the market and definitive price increases. Whenever a manufacturer or manufacturers exit the market on a generic drug, a sharp increase in pricing immediately follows due to the decrease in market competition.
The reimbursement rates will not immediately (if ever) catch up to the price increase. This differential must be covered by someone, which will end up being the end-user/patient.
This may also lead to less access to proper treatment and medications. Patients with chronic pain requiring opioid analgesia increasingly encounter blocked access to pain control, stigma, and hostility in the health care system.
When an insurer boasts of a 25 percent reduction in total Morphine Milligram Equivalents prescribed, that could mean that some chronically ill patients have successfully been shifted to a nonaddictive form of analgesia—or that patients who badly need opiates aren’t getting them.
Opioid analgesic prescribing and related overdoses are in decline, at great cost to patients with pain who have benefited or may benefit from, but cannot access opioid analgesic therapy.
The negative impact of severe chronic pain is impossible to overstate. Particularly, how the negative impact of chronic pain on quality of life (QOL) is more severe than heart failure, renal failure, or major depression; it’s comparable with the QOL of patients dying of cancer.
It’s also important to note that chronic pain is second only to bipolar disorder as a medical cause of suicide. The distress, exhaustion, and hopelessness of chronic unrelieved pain can invite purposeful overdose. Death is no longer feared, but instead, becomes a welcome prospect of permanent relief from suffering and anguish.
THERE IS NO CLEAR SOLUTION
As much as we would like to wave a magic wand or pinpoint one sweeping solution, throughout this crisis we have addicted an entire generation of people.
This means any solution will likely have phases and changing the course of the opioid crisis will require a multipronged approach.
It could include implementation of screening for Opioid Use Disorder (OUD) in all relevant health care settings, improving access to medications for OUD such as methadone and buprenorphine, increasing OUD training programs at medical and nursing schools, improving access to harm-reduction services, and controlling the supply of illicit opioids.
A JAMA Network study’s findings under the Opioid Policy Model suggest that interventions targeting prescription opioid misuse such as prescription monitoring programs may have a modest effect, at best, on the number of opioid overdose deaths in the near future. But additional policy interventions are urgently needed to change the course of the epidemic.
Implementation of these strategies will require health care professionals and communities to further overcome the stigma of opioid use and OUD and to develop innovative point-of-care ways of delivering related services to those in need.