Keeping Up With Clinical Trends — Abuse Deterrent Opioids

Scott Desmond
Clinical Fellow, PharmD

Our clinical pharmacists are passionate about educating our clients surrounding trends in opioid prescribing practices. Our pharmacists have been receiving questions about products that are meant to help combat the opioid epidemic. These products can impact patient safety as well as drug abuse and diversion. In this issue of Keeping Up with Clinical Trends, we discuss abuse deterrent opioids – the what, the how and the why.

I am seeing an increase in brand only opioids being prescribed that say abuse-deterrent, what is meant by abuse-deterrent?

An abuse-deterrent opioid is an opioid product that is formulated with properties or ingredients that make the drug harder to administer by any route other than oral ingestion. These alternative routes of drug administration considered to be abuse include intravenous, nasal and smoking. This is a practice that can be referred to as “dose dumping”. In order to be administered by any of these alternative methods, the drugs are tampered with. As a consequence, some of these new abuse-deterrent formulations (ADFs) are designed to protect against cutting, crushing, grinding or breaking and extraction for intravenous injection. These drugs take the design approach of incorporating what the industry refers to as physical and chemical barriers. Alternatively, some ADFs combine naloxone or naltrexone with an opioid. Naloxone and naltrexone are drugs that block the effects of opioids but are inactive or not absorbed when taken orally.

 

Why would a drug need to be snorted, injected or smoked to be abused?

It doesn’t. In fact, the most common way to abuse a drug is to take it orally. When a drug is taken for any reason other than its intended therapeutic purpose, the drug is considered abused or misused. Opioids are abused or misused for their euphoric effects. However, tolerance to these euphoric effects can build up rapidly requiring higher doses of opioids. A higher dose can simply be achieved by orally ingesting more or by using an alternative method. Those without access to more drugs may be inclined to seek an alternative route of administration. This is because different routes result in different levels of drug absorption leading to a different level of systemic bioavailability. Generally, the proportion of the drug that enters circulation is lowest with oral administration and highest with intravenous administration. This is because when taken orally, a proportion of a drug is broken down by the liver into compounds, some of which are inactive. The absorption of some drugs are affected by food intake and drug interactions as well. Whereas with intravenous use, the drug enters the blood stream directly.

 

Is there a need for abuse-deterrent formulations?

According to the Food and Drug Administration (FDA), there is a need for ADFs. In April 2015, the FDA issued recommendations to drug manufacturers to develop ADF opioids stating that the development of these products is, “a high public health priority.”¹ This intended need is tied directly to the U.S. opioid epidemic, which continues to plague the nation. As the opioid epidemic is a multifaceted problem, ADFs represent one way in which manufacturers are responding by making opioids safer.

 

Do you have any suggestions about which injured workers should be on abuse deterrent opioids?

The patients most likely to benefit from the use of ADFs are those where abuse or diversion are suspected, or where limiting access to children or others in the claimant’s household might be needed. A recent survey by the Substance Abuse and Mental Health Services Administration (SAMHSA) reports that greater than 50% of those who misused prescription pain relievers in the past year said they obtained the drugs from a friend or relative for free.² It is much easier to crush and snort a generic oxycodone tablet than to spend time and energy trying to do the same with abuse-deterrent OxyContin® (oxycodone ER). If half of users are obtaining their opioids from friends or relatives, it stands to reason that putting abuse deterrent opioids in these households might prevent new and continued abuse.

 

CONCLUSION

As more and more research continues to show, opioids do not necessarily relieve chronic pain or improve functioning any better than non-opioid medications. Even when taken as prescribed, opioids carry a risk of abuse and overdose, whether they are abuse deterrent or not. The answer to the opioid epidemic is not likely to be MORE OPIOIDS, at least on their own. Opioid misuse and abuse are complex problems that require a multifaceted approach, involving all stakeholders from the Federal government down to the local community level. As part of our commitment to our clients and the patients they serve, myMatrixx utilizes clinical programs to prevent acute use of opioids from becoming chronic use, to intervene with prescribers when doses of opioids escalate and to work with prescribers to safely and effectively taper and discontinue opioids in patients when the risks of therapy outweigh the benefits that a patient is deriving.

 

 

¹ https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf
² https://www.samhsa.gov/data/sites/default/files/report_2686/ShortReport-2686.html