Nurse practitioners vital in spearheading opioid REMS

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FDA issues draft guidance on abuse-deterrent opioids
FDA issues draft guidance on abuse-deterrent opioids

Las Vegas – Achieving compliance with new FDA guidelines for extended release (ER) and long-acting (LA) opioid medication risk evaluation and mitigation strategies (REMS) is a top priority for nurse practitioners, according to speakers at the American Association of Nurse Practitioner's 2013 National Conference.

In 2009, drug poisonings accounted for 39,147 deaths in the United States, nearly 14,800 of which involved prescription opioids, according to data from the CDC and National Center for Health Statistics. For every one death there are 825 nonmedical opioid users.

“You may not be prescribing opioids to your patients, but another healthcare provider may be, or they could be getting them from another patient. Friends and family are the biggest source of opioid pain pills, either as gifts or through theft,” pain management specialist Deborah Kiley, DNP, ANP, NP-C, FNP-BC, FAAN, told an audience here. “Our goal is to be sure our patients who need pain management get access to medications, and that people who should not be using them, do not.”

In 2011, 34.2 million Americans aged 12 years or older used an opioid for a nonmedical purpose at some point in their life, and many for the first time. Nonmedical prescription pills came in second behind marijuana as the drug of choice among first-time recreational drug users, results from the 2011 National Survey on Drug Use and Health indicate.

As the opioid pain pill problem continues to balloon in the United States, NPs must be prepared to protect their patients from the health risks these medications pose, as well as themselves from potential litigation due to inappropriate prescribing.

“It is more important than ever for clinicians to balance the risk of ER and LA opioids versus the benefits,” speaker Brett Badgely Snodgrass, MSN, APRN, FNP-BC, a pain management and palliative care specialist practicing in Tennessee said. “So how do we do that?”

The answer is three-fold: performing thorough pain evaluation and assessment, analyzing a patient's risk for abuse by obtaining a complete substance use and psychiatric history, and completing thorough documentation in the patient record.

Who is an appropriate candidate for ER or LA opioid trial?

Patients with moderate-to-severe pain who have failed to adequately respond to nonopioid and nondrug interventions, and who require continuous around-the-clock opioid analgesics for an extended period of time are appropriate candidates for ER or LA opioids, according to Snodgrass.

Although a history of substance abuse, psychiatric disorder or sexual abuse may raise red flags, these factors do not necessarily rule out ER or LA opioid therapy.

“High-risk patients may require additional monitoring, so refer these patients to pain management or addiction specialists and be sure to check your state regulations for requirements,” Snodgrass said. “If you're in family practice it is important for you to be in contact with other specialist providers and referrals. We all need each other to do this work.”

When initiating an ER or LA opioid trial, it is paramount for NPs to know the specific characteristics of the product prescribed, including the drug substance, formulation, strength, dosing interval, conversions and drug interactions. Good online sources for accurate detailed drug information include the National Institute of Health DailyMed website or the Drugs@FDA website.

Periodic reassessment

Remember the therapeutic risks and benefits of opioid management do not remain static, and may be affected by changes in the underlying pain condition, coexisting disease or psychological and social circumstances.

Speaker Randall Hudspeth, PhD, MS, APRN-CNP, FAANP, said the frequently recommended, but often underused patient-prescriber agreement (PPA) remains the gold-standard for monitoring the risks and benefits of opioid therapy over time and documenting patient and prescriber responsibilities.

The PPA is a document signed by both the patient and the prescriber at the time an opioid is prescribed, and enables healthcare providers to clarify treatment plans with the patient and other clinicians involved in his or her care, Hudspeth explained.

Although PPAs can help clinicians monitor adherence to the treatment plan and recognize aberrant behaviors that fall outside of the boundaries of the agreed-on treatment plan, it is not the only tool available to clinicians.

Currently, 49 states and 1 territory have legislation authorizing a prescription drug monitoring programs (PDMPs), and 43 states have operational PDMPs.

“In most cases you will need to create an account and login with your own user information, but once you sign up for these programs you can identify what medications patients are on without having to trust often unreliable self-reported drug histories, and identify if a patient has been doctor shopping,” Hudspeth said.

If a patient has existing prescriptions that he or she has not reported, multiple prescribers and/or pharmacies listed or multiple drugs that increase overdose risk when taken together it is a good indication of potential misuse or abuse.

Individual state laws determine the specifics of how PDMPs are implemented including who has access to PDMP information, which drug schedules are monitored, which agency administers the PDMP, whether prescribers are required to register with the PDMP or if they are required to access PDMP information in certain circumstances.

Urine Drug Testing

Urine drug testing is an important tool to help identify drug misuse and addiction, but it can be a difficult topic to broach with patients, particularly those a provider knows well and has treated for a long time.

“When you do the initial contract with your patient, clearly set the expectation that urine drug testing will be a component of the pain management plan. Whether testing is performed regularly or intermittently can be decided on a case-by-case basis, but it is important to make sure the patient understands it will be part of treatment,” Hudspeth said.

In order to be affective, urine testing should be performed prior to starting opioid therapy and then at intervals throughout treatment depending on whether a patient displays aberrant behavior and also to document adherence to the treatment plan. Be sure to check state regulations and requirements regarding urine drug testing, Hudspeth added.

Document, document, document!

It is especially important to document patient counseling efforts in case a criminal investigation or lawsuit is ever filed in the event of opioid misuse or death. Patient counseling documentation sheets are available for download through the FDA REMS program.

Documentation sheets consist of educational material, such as the “Dos and Don'ts” of ER and LA opioid medication, and patient-specific prescription information.

Also be sure to engage patients who are prescribed ER and LA opioids in the informed consent process. “This really outlines all the components of side effects, expectations, potential harms and benefits, and alternatives to care,” Hudspeth said.

Caution patients that sharing opioid medications with others can result in serious adverse events or death and that selling or giving away opioids are against the law.

Emphasize the importance of storing ER/LA opioids in a safe and secure place away from children, family members, household visitors and pets, and encourage then to read product-specific disposal information for when opioids are no longer needed.

The AANP will be hosting a in-depth four-hour seminar for conference attendees interested in meeting the full requirements for the FDA REMS Blueprint. “ER/LA Opioid REMS Workshop: Achieving Safe Use While Improving Patient Care,” will take place from 8 AM to 11 AM on Saturday, June 23 in Marcello 4402 at the Sands Expo and Convention Center.

Those unable to make it to the meeting, can find more information at www.core-rems.org.


References

  1. #13.3.10. “Approved Risk Evaluation and Mitigation Strategies (REMS).”
  2. #13.5.10. “ER/LA Opioid REMS Workshop: Achieving Safe Use While Improving Patient Care.”

Both presented at: American Association of Nurse Practitioners 2013 National Conference. June 19-23, 2013; Las Vegas.

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