The U.S. Food and Drug Administration (“FDA”) has recently proposed tighter controls on the prescription of hydrocodone-containing products, such as Vicodin®. In October 2013, Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, noted “that the impact on public health caused by the abuse of the drugs as well as their medical use had reached a tipping point.” Now, almost one year later, the FDA has published its final rule reclassifying hydrocodone combination products from their Schedule III status to a more restrictive Schedule II class, resulting in tighter documentation control from pharmacists and restricting renewals and newly written prescriptions from physicians. The rule will take effect in October 2014.
Even when the drug is prescribed properly, patients tend to develop tolerance, leading them to take more pills to obtain the desired pain-killing effect.
When the Controlled Substances Act was passed in the 1970s, Congress created a classification system of narcotics, or controlled substances, based on their abuse and misuse potential, as well as their legitimate medical use. For instance, the FDA and the Drug Enforcement Agency (“DEA”) placed LSD in a Schedule I category because it did not implicate legitimate medical use. While hydrocodone itself is already a Schedule II drug, hydrocodone combination products, such as hydrocodone and acetaminophen (Tylenol®), are classified as Schedule III because of their lower abuse potential than plain hydrocodone. Nevertheless, many people become addicted to hydrocodone combination products. In some users these opioid analgesics create a feeling of euphoria. Even when the drug is prescribed properly, patients tend to develop tolerance, leading them to take more pills to obtain the desired pain-killing effect.
Additionally, greater limitations are placed on Schedule II prescriptions over Schedule III. While Schedule III prescriptions are refillable and may be called into a pharmacy via telephone, Schedule II prescriptions require a visit to the doctor and patients must bring a hard-copy script into the pharmacy. Additionally, Schedule II prescriptions are not refillable by phone. Once the pharmacist has filled the prescription, patients are required to re-visit their physician in order to obtain a new script for additional refills.
Drug overdose was the leading cause of injury death in 2011, killing a higher number of people between ages twenty-five and sixty-four than motor vehicle accidents.
Although it took the FDA one year to publish the final rule, the schedule change has been the subject of discussion for several years. The FDA initially resisted tighter rules on hydrocodone-containing products out of concern that patients with legitimate pain would face difficulty accessing the medication. However, the DEA requested the FDA to reconsider its position in light of the drug’s availability on the black market. It is not uncommon for drug addicts to obtain prescription narcotics illegally by stealing from pharmacies or relatives.
Drug overdose was the leading cause of injury death in 2011, killing a higher number of people between ages twenty-five and sixty-four than motor vehicle accidents. Over fifty-five percent of drug overdose deaths were due to pharmaceutical drugs as opposed to illegal drugs. Opioid narcotics, the class that contains hydrocodone combination products, have been the most potentially deadly of the medically useful prescription drugs. Of the 22,810 deaths implicated by pharmaceuticals in 2011, 16,917 were due to opioid narcotics, translating into three-quarters of pharmaceutical-related deaths caused by this class of drugs.
Not only are these drugs extremely lethal, they are also very popular. Since 2007 there have been more prescriptions written for hydrocodone combination products than any other drug. By 2012, prescriptions for hydrocodone combination products surpassed prescriptions for heart disease and high cholesterol.
“When the DEA put forth its notice in February 2014 of its intent to enforce the new rule, only a slight majority (fifty-two percent) of the nearly 600 comments they received were in favor of the change to Schedule II.”
The publicity of such shocking statistics on opioid-related deaths motivated the DEA and the FDA to hold an advisory meeting in January 2013 (pdf) to place all hydrocodone-containing formulations within the more restrictive Schedule II. The two-day meeting, which produced a transcript of over 400 pages, brought together pharmacists, dentists, and generic drug manufacturers who expressed their concern regarding the schedule change.
While pharmacists expressed their concern about the upkeep of maintaining extra records and documentation of Schedule II drugs, dentists worried about resorting to codeine products for pain after dental surgery since codeine-containing drugs remained one of the strongest painkillers in Schedule III. Physicians also voiced their opinion, noting the time crunch involved with increased patient visits and writing Schedule II prescriptions for refills. Generic drug manufacturers were concerned with lower sales of hydrocodone-containing products after being placed under Schedule II instead of III. Since hydrocodone combination products are less likely to be abused than oxycodone pills, the drug manufacturers feared patients would resort to oxycodone for pain over hydrocodone.
The voting results of the Advisory Committee were divided—nineteen members favored the schedule change while ten opposed it. “When the DEA put forth its notice in February 2014 of its intent to enforce the new rule, only a slight majority (fifty-two percent) of the nearly 600 comments they received were in favor of the change to Schedule II.”
Those in favor of greater restrictions on hydrocodone combination products included several government officials. Senator Dianne Feinstein (D-CA) applauded the move placing greater restrictions on hydrocodone-containing products due to the growing rates of drug abuse. She noted, “[p]ainkillers containing hydrocodone are some of the most commonly abused prescription drugs, and strengthening their regulations will help combat the growing epidemic of prescription painkiller abuse.” In Feinsten’s home state, Governor Jerry Brown signed two bills to combat reckless prescribing. Proposition 46, a ballot initiative that will likely be presented to voters this November, will require physicians to check the state’s drug prescription program, known as CURES, before prescribing power painkillers to patients.
Senator Joe Manchin III (D-WV), whose state is among those hardest hit by painkiller abuse, echoed the applause to greater restrictions on hydrocodone containing products. He called the shift, “a tremendous step forward in fighting the prescription drug abuse epidemic,” that would “undoubtedly help prevent these drugs from getting into the wrong hands and devastating families and communities.”
In Oregon, local substance abuse prevention advocates were also relieved of the shift to greater restrictions. Dwight Holton, former U.S. Attorney for the District of Oregon, called the new rules “a very important step” towards “getting [the drugs] into the hands of those who need it and limiting the risk of abuse.” In 2013, thirty-two Oregon citizens died in connection with hydrocodone use.
Finally, Senator Charles Schumer (D-NY) noted “[e]ach day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs, and we cannot continue to lose more children and young adults to this painkiller scourge.” Schumer, who has worked with the FDA since 2012 urging the agency to tighten access to hydrocodone, highlighted the significance of the policy to help strike a balance between appropriate access to pain relief medication and preventing prescription drugs from getting into the wrong hands.
The American Society of Consultant Pharmacists expressed concern over long-term care patient access to mild painkillers.
While state government officials were among the fifty-two percent in support of the tighter restrictions placed on hydrocodone containing products, numerous professional healthcare organizations opposed the change. The American Society of Consultant Pharmacists expressed concern over long-term care patient access to mild painkillers. They worried that the tighter requirements would make it more difficult for long-term care patients to receive adequate pain treatment in a timely manner.
When prescriptions such as Vicodin® were in Schedule III, elderly patients with chronic pain in nursing homes could receive up to six months of those pills with one prescription and easy refills. Instead, they will now be faced with waiting for their physicians to write numerous prescriptions for the same Vicodin® month after month without any refills.
The final rule will take effect on October 6, 2014. Prescriptions for hydrocodone-containing products that are issued prior to October 6, 2014 will be dispensed in accordance with Schedule III guidelines, as long as the dispensing occurs prior to April 8, 2015. Therefore, a prescription of Vicodin® that is written prior to October 6, 2014 with refills may continue to be refilled under Schedule III up until April 8, 2015. Hydrocodone-containing prescriptions written after October 6, 2014 will not be refillable without a visit to the doctor.