7 Myths About Opioids with Abuse-Deterrent Properties
There are many misconceptions surrounding pain management, especially when it comes to opioids with abuse-deterrent properties.
There are many misconceptions surrounding pain management, especially when it comes to opioids with abuse-deterrent properties (OADPs).
To help pharmacists and other health care professionals separate the myths from the facts about OADPs, J. David Haddox, DDS, MD, and Ellen Battista, NP, led an interactive session with live audience polling on the subject at PAINWeek 2016.
Here are 7 myths and misconceptions pharmacists should debunk for their colleagues and patients:
Myth #1: Most current nonmedical users of opioids obtain the drug they abuse from a dealer.
Poll results: 93% said myth, 7% said fact
The fact is that most nonmedical opioid users obtain the drug from a friend or relative. According to combined data from the 2013-2014 National Survey on Drug Use and Health (NSDUH), half of nonmedical users received opioids from friends or relatives for free, while another 15% bought or stole them from a friend or relative. In other words, two-thirds of nonmedical opioid users obtained the drug from friends or family.
“What that tells me, as a physician and a pharmaceutical executive, is that there is a lot of unaccounted for medicine out there in our collective medicine chest just waiting to be diverted, possibly with disastrous consequences,” Dr. Haddox told Pharmacy Times.
Meanwhile, 22% nonmedical users reported obtaining opioids from one doctor. Just 0.1% said they bought them on the Internet.
Myth #2: The number of individuals abusing opioids is at an epidemic level.
Poll results: 88% said fact, 12% said myth
Believe it or not, opioid abuse is not an epidemic, but an endemic. The devil is in the definitions, as epidemic relates to a rapid spread of disease to a large population over a short period time, while endemic means a disease or condition is regularly growing or existing among a particular population or certain area.
By definition, opioid abuse is at an endemic level because the number of individuals abusing opioids has not changed much in over 12 years, according to NSDUH statistics.
“That doesn’t mean the problem isn’t serious, because there are about 4.3 million people who are doing this in any given month, but that is endemic,” Dr. Haddox explained. “What is an epidemic is the deaths that are involving opioids often with other substances. That is really an epidemic curve that is taking off in the wrong direction.”
Myth #3: Fatal overdoses involving opioid analgesics grew from 2010-2013 at a rate similar to the rate they grew from 2000-2005.
Poll results: 50% said myth, 50% said fact.
In the past decade, death resulting from unintentional prescription drug overdoses has increased steeply in the United States and is now widely recognized as a major public health problem. As Dr. Haddox put it, “This is the true epidemic with opioids.”
According to CDC figures, 18,893 deaths were related opioid analgesics in 2014, compared with just 4400 in the year 2000.
Myth #4: The most common method of abusing an opioid involves crushing.
Poll results: 50% said myth, 50% said fact
As it turns out, abuse of intact medicine by the oral route is the most prevalent method of choice for opioid abusers.
If that’s the case, then why didn’t opioid manufacturers try to deter the swallowing method first, rather than turning their attention to crushing and other manipulation methods?
“The answer is…it is the most prevalent, but it’s also exactly how patients are supposed take their medications. That makes it extremely challenging,” Dr. Haddox said. “…[Instead], let’s focus on trying to deter intranasal and intravenous abuse because those give you the most rapid rise and the highest blood levels in the shortest amount of time and therefore have the most risk of immediate lethal outcome.”
Myth #5: One approved product received ADP designation on the basis of Category 1 studies alone.
Poll results: 64% said fact, 36% said myth
Actually, no currently approved OADP received this designation on that basis alone.
In April 2015, the FDA issued guidance on OADPs to assist pharmaceutical manufacturers in creating such formulations. Within that guidance, the FDA specified that any development program for studying abuse-deterrent technologies should include data from 3 categories of premarket studies:
Category 1: Laboratory-based in vitro manipulation and extraction studies
Category 2: Pharmacokinetic studies
Category 3: Clinical abuse potential studies
All currently approved OADPs received the designation on the basis of all 3 category premarket studies, with multiple studies in each category.
Furthermore, the FDA currently recognizes 7 general approaches to formulating OADPs:
- Physical/chemical barrier: drugs with physical barriers that can prevent chewing, crushing, cutting, grating, or grinding of the dosage form. Dosage forms with chemical barriers should resist extraction of the opioid through use of common solvents including water, alcohol or other organic solvents.
- Agonist/antagonist combinations: An opioid antagonist is added to the formulation to interfere with the release of the opioid if the medication is taken in any other way than it was intended.
- Aversion: Substances are added to the dosage form to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or if a higher dosage than directed is used.
- Delivery system: Alternative delivery systems such as a depot injectable or an implant that is more difficult to manipulate.
- Prodrug: Medication contains a prodrug that lacks opioid activity until it has been transformed in the gastrointestinal tract.
- Combination: 2 or more of the above methods can be combined to deter abuse.
- Novel approaches
Myth #6: If an opioid is an extended-release (ER) formulation, it is by definition abuse deterrent.
Poll results: 100% said myth
The audience at PAINWeek got this one absolutely right: Just because an opioid is an ER formulation doesn’t guarantee it’s abuse-deterrent.
There are 2 ways pharmacists can quickly determine whether an opioid is abuse-deterrent:
- Section 9.2 (Drug Abuse and Dependence) of the drug label will list a summary of ADP claims approved by the FDA, though it notably does not mention that the drug is abuse proof.
- The opioid’s listing at Drugs@FDA will have a bullet stating that the FDA has determined that the drug has ADPs.
Myth #7: The 3 most important stakeholders in the fight against opioid abuse are policymakers, prescribers, and manufacturers.
Poll results: 56% said fact, 44% said myth
The Office of National Drug Control Policy recognizes 7 key stakeholders:
“One of the most important things a pharmacist can do is reinforce the counseling someone gets when they leave their prescriber’s office,” Dr. Haddox said. “Every time the person picks up a prescription, reemphasize the importance of safe storage, proper disposal, not sharing your medication with anyone, [and] taking it exactly as your doctor told you to take it.”