FDA Required Opioid Label Changes: An Effort to Reduce Perscription Analgesic Abuse

Prescription opioids cause 75% of the deaths associated 
with prescription drug overdoses in the United States.

Opioid analgesics, such as morphine, fentanyl, hydrocodone and oxycodone are now under new labeling scrutiny by the Food and Drug Association in effort to control the misuse and abuse of these powerful drugs.  Could this change impact the quality of care registered nurses are able to provide patients?

 

 Among one of the oldest drug classes known to man, opioid medications have long been used to effectively control pain in many patient populations.  Opioids are an essential part of palliative care, chronic pain control, and often used in adjunct with other medications during cancer treatments.  Even though opioid analgesics may have clear indications, controversy surrounds this potent medication due to the dangers associated with its use.

   
 Prescription drug abuse has many devastating effects on patients, their families and their communities.  According to National Public Radio (NPR), substance abuse is quickly becoming one of the main causes of nonfatal illness globally.  Disability and illness due to substance abuse has increased by over 50% since the 1980’s, with prescription opioid drugs (second only to heroin) topping the list of most abused drugs (Knox, 2013).  Since 1990, deaths in the United States related to prescription drug overdoses have more than tripled- with opioid painkillers causing three-quarters of those deaths. 

With the increasing number of Americans becoming addicted to and overdosing on perscription opioids, federal health officials are beginning to take notice.  On September 10, 2013, the FDA implemented new safety labeling changes and post-market study requirements for extended-release (ER) and long–acting (LA) opioid pain killers.  This preventive measure is an effort to combat the misuse, abuse, addiction and death associated to ER/LA opioid use.  Previously, opioids were indicated for patients with moderate to severe pain.  According to the new guidelines, ER/LA opioids are only intended to be prescribed to patients for symptom relief of severe pain requiring around- the-clock, long-term pain control, only after other methods, including immediate- release formulas, have failed.

With the significant abuse potential opioid medications have on certain individuals, it seems reasonable for health officials to be concerned.  However, is this form of primary prevention really an effective intervention to control for the substance's abuse potential? 

Pain level interpretations vary greatly from patient to patient.  Effective pain management for many requires tailored medication regimens prescribed by specialists.  Will the new labeling language really better enable prescribers to make decisions based on a patient's individual needs, as the FDA claims it should?  If prescription ER/LA opioids are perscribed on a more limited basis, patients may supplement with other analgesics.  Patients have the potential to self-medicate with toxic amounts of acetaminophen without realizing the adverse implications related to this over-the-counter medication. 

Those in-patient individuals used to receiving opioid medications for treatments that may no longer qualify run the risk of going through withdrawal.  This could impede healing rates and alter their perception of  quality nursing care.  With adequately managed pain being a primary indicator of hospital-stay satisfaction, this change could also impact hospital ratings.

 For those not suffering from the burden of chronic pain,  it may be hard to imagine these new guidelines being anything but helpful.  In theory, tighter prescribing guidelines means reduced potential for dependence, addiction and substance abuse related to the use/misuse of prescription opioids.  However, for their price point, ER/ LA opioids provide the comfort many patients need at a more affordable price range.

For nurses, these new changes should not affect medication administration, patient assessment or patient education.  However, in addition to vigilant pain assessments, nurses may need to “sharpen” their skill-sets in regards to offering and implementing non-pharmacological pain interventions as well as enhancing their communication skills to accurately advocate for patients and their needs.