The opioid epidemic is a health crisis that’s taking the nation by storm.
Drug overdoses involving an opioid accounted for more than 33,000 deaths in the U.S. in 2015, according to the Centers for Disease Control and Prevention (CDC).
Kelley Waara-Wolleat, Pharm.D, MBA, associate director, medical science liaison, Purdue Pharma L.P., said our society is now challenged by two serious public health problems: the need to treat chronic pain and the abuse of opioids.
“Many people living with severe chronic pain are suffering because their pain is not effectively treated,” she said. “However, the opioid prescription pain medications can lead to tragic consequences, including addiction, overdose and death.”
As the country continues to battle this epidemic, pharmacists have an opportunity to play a pivotal role.
“Pharmacists, along with prescribers, have a corresponding responsibility to ensure that the prescription is issued for a legitimate medical purpose and by an individual practitioner acting in the usual course of professional practice,” Waara-Wolleat said.
Along with pharmacist intervention, the prescribing of Opioids with Abuse-Deterrent Properties and Claims (OADP) may be a viable option for helping to prevent drug addiction. Though not completely abuse-deterrent, OADPs are less susceptible to abuse than the opioid formulations that lack abuse-deterrent properties.
But Waara-Wolleat said abuse-deterrent technologies are only one part of a comprehensive intervention strategy to promote safe prescription opioid use. “Additional components, including governmental, community and educational initiatives, are also needed,” she said.
Opioids with abuse-deterrent properties
In 2015, the U.S. Food and Drug Administration (FDA) issued a guidance, “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” that allowed opioids to be labeled as having abuse-deterrent properties and associated claims. The labeling was based on the product’s abuse-deterrent attributes and studies demonstrating a meaningful reduction in abuse.
There are currently nine FDA-approved extended release/long-acting (ER/LA) OADPs on the market with properties that are expected to deter some forms of abuse.
But Waara-Wolleat said no opioid on the market today is completely abuse-deterrent.
“All opioids can be ingested in excess quantities resulting in adverse effects, including death,” she said. “OADP does not mean the product is abuse-proof and none of the opioids, including those with labeling indicating their abuse-deterrent properties, will prevent addiction.”
And, OADPs may not be right for everyone.
Patients who have an increased risk of developing an opioid addiction, such as patients with a personal or family history of substance abuse, need to be evaluated before an OADP is dispensed to them.
“Clinician judgment will determine whether an opioid with abuse-deterrent properties is appropriate for a patient with a past medical history of addiction and clinicians should consider consulting substance use disorder specialists and pain specialists for these patients,” she said.
Combatting the epidemic
Waara-Wolleat said OADPs will have a maximum public-health influence only when substantially all opioids have abuse-deterrent properties and claims in their Full Prescribing Information (FPI).
In the meantime, pharmacists can still work to prevent opioid abuse by educating themselves and their patients, and collaborating with prescribers.
“Pharmacists should be part of the interdisciplinary team managing patients with chronic pain by ensuring collaboration through corresponding responsibility and providing medication therapy management as appropriate for patients,” Warra-Wolleat said.
Additionally, she said pharmacists are encouraged, and in some states required, to check their state’s prescription drug monitoring program and to help identify possible doctor shopping.
Learn more about OADPs
Waara-Wolleat will discuss the use of OADPs and the pharmacist’s role in combatting the opioid epidemic in more detail during her continuing education (CE) session at the 2017 Synergy Conference in Kansas City, Mo., hosted by PBA Health, Pharmacy Providers of Oklahoma (PPOk) and the Oklahoma Pharmacists Association (OPhA) this June.
She said pharmacists can expect to learn about why OADPs are important innovations, the FDA’s direction to those developing OADPs, where to find abuse-deterrent properties and claims, and some of the technologies that are employed or under study for OADPs.
Learn more at pbahealthconference.com.
Educating pharmacists and patients about opioids
The Extended-Release and Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) is a strategy required by the U.S. Food and Drug Administration (FDA) to manage known or potential serious risks associated with ER/LA opioid analgesics. The strategy strongly encourages prescribers and pharmacists to do the following.
1. Complete a REMS-compliant education program
Pharmacists should complete an ER/LA opioid analgesics REMS- compliant education program offered by the accredited provider of continuing education (CE) for pharmacy.
2. Provide patient counseling
Pharmacists should use the REMS- provided document to discuss the safe use, serious risks, storage and disposal of ER/LA opioid analgesics with patients or their caregivers.
3. Use the medication guide
Pharmacists should encourage patients and caregivers to read the medication guide they receive when an ER/LA opioid is dispensed to them.
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