Prevention — the most proactive intervention for opioid abuse — often occurs at the point of care. However, the responsibility does not fall solely on the prescriber at this juncture. Each stakeholder has a role to play when it comes to ensuring appropriate prescribing and dispensing of opioid therapy.
Pain is the unfortunate result of many workplace injuries. And as many payers are aware, pain is often managed through the prescribing of opioids. Too often, however, an opioid prescription that was originally intended to manage acute short-term pain following a severe injury or surgery leads to long-term use, a practice not recommended by medical guidelines. Chronic use may lead to undesirable consequences such as misuse, abuse, dependence, and addiction. The price of opioid abuse is high, from any perspective.
55% of drug overdose deaths in the U.S. in 2011 were related to pharmaceuticals; of those, 74% were related to opioids.1
There are many drivers of opioid abuse in workers’ compensation. The inherent need to manage pain, inappropriate prescribing practices, uncoordinated care, and the lack of financial responsibility on the part of the injured workers all contribute. In most states injured workers receive their work-related prescriptions with no out-of-pocket cost, removing the financial barrier to medication misuse.
With prescription drug abuse a national epidemic impacting over 12 million people in the U.S., and opioid abuse playing a major role in workers’ compensation, many stakeholders are playing a key role in curbing abuse. The federal government, individual states, healthcare organizations, pharmacy benefit managers, physicians, and payers have all implemented strategies to address preventing drug abuse. From federal and state drug scheduling changes to Prescription Drug Monitoring Programs (PDMPs), each strategy is a step forward in reducing our nation’s prescription for abuse.
STRATEGY: HEALTHCARE MANAGEMENT AND AUTOMATION
The most logical approach to curbing drug abuse would be to ensure that powerful opioids do not even make it into the hands of patients who will abuse and misuse them. This problem is not easily solved because often the signs of drug abuse, misuse, and diversion are subtle and require close collaboration and information sharing in order to uncover.
Pharmacy benefit managers are the first line of defense in this automated process — a specific medication plan anchoring a stringent prior authorization process. At a basic level, requiring authorization for an opioid prescription can help eliminate some instances of illicit drug-seeking from the onset. A more advanced approach incorporates multiple levels of authorization based on specific patient and medication factors. This approach puts complex therapy decisions in front of the appropriate decision maker in order to make a timely and informed decision.
In instances where a complex treatment regimen is in effect, Healthesystems has demonstrated a savings of $400/script as a result of employing a multi-tiered authorization process.
Requiring a letter of medical necessity (LOMN) from the physician detailing the medical need for prescriptions can refocus the physician on his patient’s treatment plan by requiring information to support drug therapy. And when this process and valuable information is digitized and automated, accurate treatment decisions can be made in a timely manner.
STRATEGY: DRUG RESCHEDULING
Two federal agencies — the U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA) have the authority to develop and maintain the federal controlled substances drug schedule. This categorizes controlled substances into five schedules based on several factors, including:
- Accepted medical use in treatment
- Relative abuse potential
- Likelihood of causing dependence, when abused
The schedule ranges from Schedule I, which indicates high potential for addiction and abuse along with no accepted medical use, to Schedule V, which indicates the least potential for abuse. The stricter schedules limit the amount of drugs to the market and require more diligence on the part of physicians when writing the prescription. On prescriptions, drug schedules are listed as CI, CII, and so forth.
Drug schedules are in a state of constant flux and will change based on new findings, changes to the pharmaceutical market, and legislation. Drugs can be added to a schedule, upgraded to a higher schedule, or downgraded to a lower schedule. In fact, since the Controlled Substances Act was enacted in 1970, over 200 substances have been added, removed, or transferred.2
Federal and state drug schedules can have inconsistencies, with the stricter classification superseding the other. In most cases, state schedules are stricter than the federal schedule. An example seen in the workers’ compensation patient population is Carisoprodol (Soma®) which is a federal Schedule IV drug. Louisiana upgraded Soma to a stricter Schedule II drug.3
||No currently accepted medical use in the U.S.; lacks accepted safety for use under medical supervision; has a high potential for abuse.
||Heroin, LSD, marijuana, peyote, ecstasy
||A high potential for abuse which may lead to severe psychological or physical dependence.
||Hydrocodone, methadone, Demerol®, OxyContin®, Percocet®, fentanyl, morphine, codeine, hydromorphone
||A potential for abuse lower than substances in Schedules I or II; abuse may lead to moderate or low physical dependence or high psychological dependence.
||Products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®), ketamine, anabolic steroids
||A low potential for abuse relative to substances in Schedule III.
||Alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), temazepam (Restoril®), and triazolam (Halcion®).
||A low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
||Cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®) and ezogabine.
U.S. Department of Justice. Drug Enforcement Administration. Office of Division Control. Controlled Substances Schedule. http://www.deadiversion.usdoj.gov/schedules.
Drug scheduling decisions can cause controversy at times. A recent example is the rescheduling of hydrocodone combination products (HCPs) from Schedule III to Schedule II by the DEA.4 HCPs are often used to manage pain and a common example often seen in workers’ comp patients is Vicodin (combination hydrocodone and acetaminophen). The HCP schedule change occurred after 10 years of formal debate and consideration and 15 years after the initial proposal was made.
Opposition to changing HCPs from Schedule III to II came from various pharmacy, physician, and patient advocacy organizations. Those against the change wanted the re-schedule to impact only HCPs that contain hydrocodone bitartrate of 5 mg or more. Their concerns included depriving patients of access to critically needed pain medication, with a focus on patients in rural areas who have limited access to medical facilities. A schedule change would require all patients currently taking HCPs to obtain a new written prescription from their physician for each fill. The new federal schedule limits HCP prescriptions to a 90-day supply per script, but some states have stricter guidelines in place and limit prescriptions to a 30-day supply.
Advocates of the schedule change believe it will improve physician prescribing patterns and discourage pain clinics and pharmacies that offer pain medication to patients without physician oversight.
In fact, more physician visits should foster more patient/physician interaction, closer monitoring of patients on HCPs, and deliver improved treatment outcomes.
STRATEGY: PRESCRIPTION DRUG MONITORING PROGRAMS (PDMPs)
Preventing drug abuse requires a calculated balance between ensuring medications are available for patients in need while discouraging accessibility to those who are misusing. A Prescription Drug Monitoring Program (PDMP) is a statewide electronic database containing information pertaining to medications dispensed in the state. Certain individuals, such as physicians, pharmacists, or law officers are authorized under state law to access this database of patient prescription history. Its purpose is to encourage and facilitate legitimate medical use of controlled substances and to discourage drug abuse, misuse, diversion, and doctor-shopping.5
Forty-nine states currently have PDMPs with New Hampshire slated to begin its program soon. Drug abuse in this state is particularly problematic. Between 2000 and 2011, drug-related deaths quadrupled annually. Eighty percent of those were related to prescription drugs, usually opioids such as oxycodone and methadone.6 Missouri is currently the only state without a prescription drug database, which may explain the influx of patients from neighboring states obtaining controlled substances.7
Prescription drug abuse is driven by multiple factors including inappropriate prescriber practices and patient behavior. Quite often, a small number of opioid prescribers are responsible for the majority of prescriptions. A 2012 study by the Oregon Health Authority found that 4% of prescribers were responsible for prescribing 60% of the state’s Schedule II-IV controlled substance prescriptions.8 And overall, roughly 20% of prescribers prescribe 80% of all prescription painkillers.9 PDMPs can have a profound impact on clinical prescribing. One study found that of the prescribers who participated in a PDMP, 58% indicated a reduction in either prescriptions written or number of pills dispensed.10
Barriers do exist to realizing the full potential of PDMPs. These include limited funding, interstate operability and variability of data prevent states from sharing information. A handful of states have taken steps towards interstate collaboration with New Hampshire Gov. Maggie Hassan recently announcing an agreement between other New England governors to share PDMP data. Some states such as Kentucky and Ohio already have interchange of data in place.11
Additional integration may be on the horizon for PDMPs, which may improve their overall effectiveness. The Office of the National Coordinator for Health Information Technology (ONC) along with SAMHSA and the CDC have launched a project accurately titled “Enhancing Access to Prescription Drug Monitoring Programs Using Health Information Technology.” The program aims to integrate more information and existing technologies into the PDMP such as electronic health records (EHR), health information exchanges (HIEs), and pharmacy systems. It also hopes to foster improved communication and information sharing between stakeholders through its resource center, PDMPConnect.12
Opportunities for improvement include increasing provider use of PDMPs, incorporating EHRs, and making PDMPs more accessible to providers (including incorporating them into existing systems for quick access and ease of use).
Drug scheduling changes can also appear inconsistent at times, due to the ever-changing nature of the pharmaceutical market, changes to medical guidelines, and new research findings. While the FDA recently reclassified HCPs from Schedule III to the stricter Schedule II, it conversely approved a pure hydrocodone product that currently lacks an abuse-deterrent formulation. The approval of this pure drug, called Zohydro ER (hydrocodone bitartrate extended-release capsules) has caused discordance between the federal schedule and state-specific drug schedules.
Zohydro ER is controversial for several reasons, including the fact that it does not have an abuse-deterrent formulation and therefore can be broken down for illicit intravenous and inhalation use. The FDA approved Zohydro as a Schedule II drug in 2013. It’s the first FDA-approved single-entity and extended-release hydrocodone product for pain severe enough to require around-the-clock, long-term treatment.
MEDICAL MARIJUANA MAZE
A great irony exists in the fact that state drug schedules are often stricter than the federal government’s drug schedule regarding opioid medications, yet nearly half of states have legalized the use of marijuana, which is currently listed as a federal Schedule I drug. As a Schedule I drug, marijuana sits alongside heroin and LSD as an illegal substance. But this could change in the future.
The FDA recently agreed to study whether marijuana should be reclassified, at the DEA’s request. The agency will make a recommendation after conducting an eight-factor analysis it uses to determine the schedule classification. Factors include marijuana’s abuse potential, pharmacological effect, and risk to public health. 13
Even though marijuana use is still illegal by federal standards, 21 states and Washington D.C. have already passed legislation that varies from limited medical to recreational use to allowing medical marijuana to be used as a defense in court.14
STRATEGY: EMERGING TECHNOLOGY
National Institutes of Health (NIH) has started a real-time National Drug Early Warning System (NDEWS). The program is designed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs. Additionally, NIH hopes to identify instances of increased use of so-called designer synthetic drugs. Drug trends quickly change as abusers find new ways to possess and use them — and in many cases this information is spread online. The innovative system will review data from social media and websites to quickly uncover new drug trends. It will also utilize more traditional national and local level data resources.15 The goal is to keep up with emerging localized drug trends to keep them from spreading to surrounding areas.
As information is uncovered through NDEWS, the goal is to share information across a network of addiction experts, dispatch a team of rapid response experts to access the outbreak and collect data (including anonymous urine samples provided by criminal justice drug testing), and disseminate the information immediately to the public.
STRATEGY: RISK ASSESSMENT
Drug abuse prevention strategies address a variety of factors but perhaps one of the simplest yet often underutilized prevention methods is to screen patients for risk factors before a prescription is ever written. Quite often, risk assessments can help predict opioid abuse. Several types of screening tools are available to physicians with the most popular being DIRE (Diagnosis, Intractability, Risk, Efficacy score), ORT (Opioid Risk Tool), and SOAPP-R (Screener and Opioid Assessment for Patients with Pain — Revised).
Used in conjunction with a prescriber’s clinical assessment and incorporated into a patient’s treatment plan, these strategies deliver better patient outcomes. It is important to gain holistic insight into the full medical picture of the patient in order to consider comorbidities and other factors which may put the patient at risk for aberrant drug behavior. Even after screening has occurred and therapy initiated, it is important for the patient to be monitored closely by the prescriber for risks including: early refills requests, depression or anxiety, dose escalations, substance abuse, or unexpected urine drug screen results.
Many strategies exist to prevent opioid abuse but just as many opportunities exist for workers’ compensation patients to cross the line towards abuse. From payers to PBMs, patients to physicians, states to the federal government; all stakeholders need to engage in the prevention process in order to prevent the next opioid tragedy. Prevention is not necessarily achieved with a stepwise process. Multiple strategies employed by multiple stakeholders at the appropriate time deliver the best opportunity for breaking the opioid cycle.
WHO IS AT RISK FOR OPIOID ABUSE?
Studies suggest that up to 30% of patients who use opioids become addicted.16 Patients who are at the highest risk for opioid misuse, abuse and overdose include those who:
- possess a history of substance abuse
- doctor shop to obtain multiple prescriptions
- use high daily doses of prescription painkillers
- misuse multiple abuse-prone prescription drugs
- possess low incomes
- live in rural areas
- have a genetic predisposition for addiction
- suffer from mental illness17
Opioids are bad for business
SOURCES: Birnbaum HG et al. Pain Med. 2001;12:657-67; Centers for Disease Control and Prevention (CDC).
SOURCES: Substance Abuse and Mental Health Services Administration (SAMHSA); Institute for Pharmaceutical Outcomes and Policy 2010; Dhalla IA et al. Can Fam Physician. 2001;57:e92-6; California Workers' Compensation Institute.
General drug abuse
SOURCES: CDC; SAMHSA; Paulozzi LJ. J Safety Res. 2012;43:283-9.
Killing more than pain
SOURCES: CDC; National Center for Injury Prevention and Control.
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3 -Louisiana Board of Pharmacy Bulletin No. 14-03. July 15, 2014. Available at: http://www.pharmacy.la.gov/assets/docs/Bulletins/Bulletin_14-03.pdf . Accessed 10/22/14.
4 -Office of the Federal Register [US]. Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II. A Rule by the Drug Enforcement Administration on 08/22/2014. Available at: https://www.federalregister.gov/articles/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule . Accessed10/21/14.
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7 -Schwarz, Alan. Missouri Alone in Resisting Prescription Drug Database. NY Times. July 20, 2014. Available at: http://www.nytimes.com/2014/07/21/us/missouri-alone-in-resisting-prescription-drug-database.html?_r=0 . Accessed 10/22/14.
8 -Oregon Health Authority. Prescription drug dispensing in Oregon. October 2011-March 2012. Available at: http://www.orpdmp.com/orpdmpfiles/PDF_Files/Reports/Statewide_10.01.11_to_03.31.12.pdf .
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10 -Substance Abuse and Mental Health Services Administration. Connecting Prescribers and Dispensers to PDMPs through Health IT: Six Pilot Studies and Their Impact. 2012. Available at: http://www.healthit.gov/sites/default/files/pdmp_pilot_studies_summary.pdf . Accessed 10/22/14.
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12 -Department of Health & Human Services. Addressing Prescription Drug Abuse in the United States. Current Activities and Future Opportunities. September 2013. Page 27. Available at: http://www.cdc.gov/HomeandRecreationalSafety/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf . Accessed 10/22/14.
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14 -Office of National Drug Control Policy, The White House. Marijuana Resource Center: State Laws Related to Marijuana. Available at: http://www.whitehouse.gov/ondcp/state-laws-related-to-marijuana . Accessed 10/22/14
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