The First Line of Tamper Resistance of Prescription Pain Medications is. . . You

One of the four definitions that the Merriam-Webster dictionary offers for tampering is “to render something harmful or dangerous by altering its structure or composition.” There is nothing in the definition about intention, such as intent to break the law, intent “to get high,” or other aberrant drug-related behaviors; just the fact that something that changes structure or composition may in turn make something that is normally safe into something dangerous.

A simple and unfortunately common analogy that comes to mind is something that I have seen many times during my long career in clinical practice. I have seen many patients with accidentally-amputated fingers, resulting from power table saw injuries. The significant majority of these patients were experienced woodworkers, who removed something called a “safety guard” from the table saw. The National Consumers League estimates that there are approximately 40,000 Americans that go to hospital emergency rooms every year in the United States with injuries sustained while operating table saws. About 4,000 of those injuries – or more than 10 every day – are amputations, and in two thirds of cases, the guard had been removed and was identified as the cause of the injury.1 Additionally, table saw injuries cost the United States approximately $2 billion every year. This safeguard technology has largely been the same for 50 years; so why then are people tampering with the saws, and removing the guards, and subsequently cutting off their fingers? I have asked this question to these patients over the years, and have often received the same answers – “The guard makes it too difficult to get my work done,” “some things require the guard to be removed,” “It hampers my ‘feeling’ the wood, and the quality of my work” and lastly “I’m always careful, and nobody told me what could happen.”

Hopefully, you’re starting to see the reason for my analogy in the context of pain management. Prescription pain medications (for the purposes of this discussion, extended-release and long-acting (ER/LA opioid analgesics) can be used safely and effectively in appropriate patients, when indicated. However, patients who are prescribed these medications may unknowingly tamper with them, rendering them harmful or dangerous due to altering the medication’s structure or composition. We know that with respect to ER/LA opioids, the danger can be unintended overdose, and in many cases, death. We also know that death in the majority of these cases is due to respiratory depression.

Unfortunately, when we think about people tampering with ER/LA opioid analgesics, we may tend to only think of the people who shouldn’t be prescribed these medications, because they may have a high likelihood of abusing, misusing, diverting, or becoming addicted to them. This often conjures up images of criminal activity – people selling the medications, and people cutting, crushing, chewing, smoking, snorting, and injecting these medications to “get high.”

The Food and Drug Administration (FDA) answered the question as to why it required a Risk Evaluation and Mitigation Strategy (REMS) for all ER/LA opioid analgesics with the following statement “there are serious risks associated with patients being prescribed these drugs (ER/LA opioids) who should not take them, and with improper use [of them] (whether accidental or intentional).”2

When it comes to tampering for illicit or aberrant drug-related behavior purposes, emerging technologies, such as abuse-deterrent formulations (ADFs) or tamper-resistant formulations (TRFs) are showing promise to stem those activities to a certain degree. However, with regard to tampering of ER/LA opioid analgesics resulting from modification for “innocent” reasons, healthcare providers are the first the line of tamper resistance.

Patients may tamper with prescribed ER/LA opioids for any number of reasons. For example, they may have difficulty swallowing pills, they may be used to crushing pills and then sprinkling the resulting powder onto food to make it more palatable, or they may just be used to chewing a pill before swallowing it. They might think it’s acceptable to cut a patch in half if it’s too strong. We as healthcare providers have to educate patients about not tampering with their ER/LA opioids by not only instructing them not to do it, but also to explain why. You don’t want to confuse a patient about potency differences in ER/LA opioids, but you do want to let patients know that ER/LA opioid analgesics are designed to provide a longer period of drug release so that they can be taken less frequently. Additionally, since the amount of opioid analgesic contained in an ER/LA formulation can be much more than the amount contained in an immediate-release/short-acting (IR/SA) formulation, tampering can result in serious side effects, including overdose and death.

To complement the FDA opioid REMS education for ER/LA opioid analgesics, a patient counseling document3 has been developed to facilitate patient education about safe use, and includes the following topics:

The DO’s and DON’Ts of Extended-Release/Long-Acting Opioid Analgesics for patients

DO:

  • Read the Medication Guide for the prescribed ER/LA opioid analgesic
  • – Take medication exactly as prescribed
  • – Store medications away from children and in a safe place
  • Flush unused medication down the toilet
  • – Call a healthcare provider for medical advice about side effects

DON’T:

  • Give the medication to others
  • – Take medication unless it was prescribed for you
  • – Stop taking the medication without talking to a healthcare provider
  • Tamper with (break, chew, crush, dissolve, or inject) the medication. If the medication cannot – be swallowed whole, talk to a healthcare provider to find an alternative approach
  • Drink alcohol while taking the medication

It is our responsibility as healthcare providers, whether we are physicians, nurses, pharmacists, psychologists, or other healthcare professionals, to be the first line of tamper resistance for patients who may not understand the risks associated with tampering with their prescription pain medications. This should become a routine part of the discussion, and when we think of tampering, let’s not only think of malicious behavior, but think about this kind of “innocent” tampering as well. We need to show patients that like the one on a table saw, this “safety guard” has a purpose, and explain what that purpose is.

References

1. The National Consumers League Fact Sheet on Saw Safety. Available at http://www.nclnet.org/health/99-safety/567-facts-at-a-glance-the-inherent-danger-of-table-saws. Accessed 4/5/2014.

2. Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics. March 3, 2013. Available at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm#Q5. Accessed 4/5/2014.

3. The ER/LA Opioid Analgesics REMS Counseling Document. Available at http://www.er-la-opioidrems.com/IwgUI/rems/pcd.action. Accessed 4/5/2014.