Popping Pills in America: Can the DEA Fix This?
There's no doubt about it - the U.S. is a big consumer of prescription painkillers. In fact, in 2010 enough prescription painkillers were prescribed to medicate each American adult every four hours for an entire month. A report released in March 2014 from the U.S. National Safety Council shows that prescription drug overdoses – more than car accidents – are the leading cause of accidental death among U.S. working-age adults. According to the Centers for Disease Control and Prevention (CDC), one person dies every 19 minutes from a prescription drug overdose, fueled mainly by opioids. The narcotic abuse epidemic has gotten out of control. But what is being done to stop it?
The Drug Enforcement Agency (DEA) is taking action. The medical community awaits a final DEA decision on switching hydrocodone combination products like Lortab and Vicodin from schedule III to schedule II to help curb abuse and encourage patients and prescribers to consider alternative ways to deal with pain. In addition, in September 2013 the U.S. Food and Drug Administration (FDA) instituted class-wide safety labeling changes for all extended-release and long-acting narcotic painkillers. The FDA has also added provider education on both pain management and substance abuse for extended-release and long-acting opioid analgesics through a risk evaluation and mitigation strategy (REMS) plan.
In a recent survey, researchers found that schedule III hydrocodone and schedule II oxycodone were the most popular drugs among Americans who abuse prescription painkillers. Researchers surveyed more than 3,500 painkiller abusers and found that 45 percent favored oxycodone, while 30 percent favored hydrocodone. Oxycodone may be favored because it comes in the pure form without acetaminophen, which can be toxic to the liver and cause pain when injected.
Plus, there is the nation’s youth to consider. In the National Institute of Health (NIH) 2013 Monitoring the Future Survey, acetaminophen/hydrocodone and oxycodone were two of the top prescription drugs abused by teens, although rates of abuse did show a downward trend. In the 2012 National Survey on Drug Use and Health, over 60 percent of teens said they accessed the prescription drugs they abuse from a relative or friend, either by buying (12%), stealing (4%), just getting it for free (54%).
In the U.S., controlled prescription drugs with accepted medical use fall into one of four schedules based on The Controlled Substances Act (CSA). Schedule I is reserved for controlled substances with no currently accepted medical use and lack of accepted safety. Substances in this category include marijuana, street drugs like heroin, and LSD, and designer drugs like bath salts and synthetic marijuana (K2 or Spice). Drugs with accepted medical use but the highest potential for abuse, like the single-entity hydrocodone (Zohydro ER) or oxycodone (Oxycontin), are placed in Schedule II, and medications with progressively less potential for harm and abuse are placed in Schedules III through V.
Hydrocodone combination products are regulated as schedule III drugs. These drugs, used as pain relievers or cough suppressants, contain both hydrocodone and some other substance, like acetaminophen or a cough/cold product. Well-known brand names include Vicodin, Lortab or Tussionex. Combination hydrocodone products are currently regulated as schedule III drugs, which allow a prescriber to write for up to 5 refills in a period of 6 months, and refills can be called in or faxed to the pharmacist.
More stringent prescription limits on schedule II drugs are as follows:
- A written prescription for a schedule II drug is required; a phone order is only permitted in an emergency situation. Schedule III drugs can be called in to the pharmacist.
- No refills – verbal or otherwise – are allowed for a schedule II drug. Refills are allowed on schedule III drugs.
- With schedule II, patients will need to visit the doctor to get a new prescription, although certain DEA rules allow the doctor to write multiple prescriptions for up to a 90-day supply. Refills on schedule III drugs help to avoid additional doctor visits for patients in chronic pain.
- Within industry, manufacturing quotas on schedule II drugs are enforced along with more strict storage rules. Pharmacists will have special forms, protocols, and pharmacy storage regulations to initiate, as well. Schedule III drugs do not require a locked safe in the pharmacy.
- Prescribing limits on mid-level providers are in place for schedule II drugs.
Benefits of Rescheduling
At first glance, it seems like rescheduling combination hydrocodone products could only make good sense. According to health regulators the switch of combination hydrocodone to schedule II will help lower rates of narcotic drug abuse and probably save lives.Prescribing patterns would change. Combination hydrocodones are widely prescribed according to the Office of Surveillance and Epidemiology (OSE). In 2011, roughly 131 million prescriptions were written and over 47 million patients received combination hydrocodones, far exceeding other selected opioids like oxycodone. On average, patients were prescribed a 14-day supply of combined hydrocodone drugs.
Other benefits may include:
- Health care providers are likely to reconsider prescribing combined hydrocodones, and use alternate methods of pain control, including less addictive medication.
- Fewer leftover medications will lower risk for abuse, overdose, or diversion.
- Physicians may prescribe longer-acting opioids that require greater monitoring, which may result in less addiction and abuse.
- Less nonmedical use, fewer overdose deaths, and related cost savings.
- Patients may be less likely to request combined hydrocodone, knowing it is more strictly controlled.
Concerns About Rescheduling
Although there are predicted benefits, what are the potential risks involved with the rescheduling of combination hydrocodone? According to the American Academy of Pain Medicine and other professional organizations, potential consequences may include:
- More frequent patient visits to doctors with added costs.
- Added barriers for legitimate patient access leading to delayed or inadequate pain control.
- Increased prescribing of other schedule II drugs.
- Greater penalties to health care providers for improper prescribing.
- Additional paperwork for health care providers.
- Added requirements and costs to secure pills.
- Higher costs for insurance companies and Medicare.
- More barriers to pain medication access for the elderly, those in rural areas, and residents of long-term care facilities.
- Physicians may stop of chronic pain management.
Professional medical groups are split on whether combination hydrocodones should be placed into schedule II. Some organizations, for example the American Society of Health-System Pharmacists (ASHP) and the American Society of Pain Medicine support the switch, stating “this schedule change is necessary to address the public health crisis associated with abuse of hydrocodone combination therapies.”
Other groups, including the American Pharmacists Association (APhA), the American College of Clinical Pharmacy (ACCP), and the Academy of Managed Care Pharmacy (AMCP) oppose rescheduling, as outlined in their letter submitted to the DEA on April 28, 2014.
What Can States Do?
States vary in their prescription painkiller abuse problem. In the 2010-2011 National Survey on Drug Use and Health past year nonmedical use of prescription painkillers in those 12 years and older ranged from 3.6 percent in Iowa to 6.4 percent in Oregon. The highest rates of abuse were in the West region, and the lowest were in the midwest and south. However, a 2014 CDC report states that Alabama – the state with the highest number of narcotic painkiller prescriptions – issued about three times as many of those prescriptions as doctors in Hawaii, the lowest state. Ten of the highest prescribing states for narcotic painkillers are in the south, with Alabama, Tennessee and West Virginia leading the nation.
Florida is a good example. Drug overdose deaths in Florida skyrocketed by 61 percent between 2003 and 2009, as reported by the CDC. Some pain clinics were widely suspected of dispensing high volumes of painkillers. Between 2010 and 2012, after Florida took legislative and legal action to limit availability and dispensing of narcotics in the clinics, fatal prescription drug overdoses in the state declined by 23 percent. Florida closed approximately 250 pain clinics by 2013, and lowered the number of high-volume oxycodone-dispensing prescribers from 98 in 2010 to zero in 2013. Actions taken by Florida to limit prescription painkiller abuse included:
- Greater regulation of pain clinics.
- Limiting physician dispensing of narcotic painkillers.
- The initiation of a statewide reporting system for narcotic dispensing.
- Expanded regulation of wholesale drug distributors.
Some states have now adopted measures similar to those initiated in Florida. As noted by the CDC, two key practices that states can use to reduce prescription drug overdose are:
- Implementing state pain clinic laws
- Implementing prescription drug monitoring programs that follow selected best practices
As of July 2013, 11 states had a pain clinic laws meeting selected criteria (with 40 states have no pain clinic law), and 46 states had a prescription drug monitoring program meeting at least one best practice. Some health care professionals are calling for a nationwide prescription monitoring system. While it remains to be seen if stricter federal regulations on hydrocodone combination products will be adopted and lead to lower national rates of prescription opioid abuse, individual states should consider taking swift action.
On January 25, 2013, the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of reclassifying hydrocodone combination products to Schedule II. Ironically, a major player in the overdose deaths in Florida was oxycodone, a schedule II narcotic. The final decision, which will be handed down by the DEA at a later date, is still under review. The DEA has received over 650 public comments on this action. For now, the medical community and the public await the final DEA ruling.
Posted: July 2014