DEA Has Approved Final Rule & Will Start Enforcing Tighter Controls on the Prescription of Hydrocodone Within 45 Days
Washington, DC - August 22, 2014 - Today, U.S. Senator Charles E. Schumer announced that the Drug Enforcement Administration (DEA) has heeded his call and will publish a final rule that changes the scheduling designation of hydrocodone from a schedule III to a schedule II, meaning there will be greater control over the prescription of the drug. The new classification will go into effect in 45 days and will impose greater restrictions in how doctors can prescribe hydrocodone and the quantity that can be prescribed. The scheduling system, which is overseen by the DEA, classifies drugs based on their medical use and their potential for abuse and addiction. Schumer has long fought to achieve this reclassification, in an effort to help combat an unprecedented spike in prescription drug abuse in New York State and the country. In October 2013, Schumer announced that the Food and Drug Administration (FDA) had approved, at his urging, regulations that would make it harder to access painkillers that contain hydrocodone. Following this major approval, the FDA requested the DEA make this final change so that it might be enforced.
“Each 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” said Schumer. “I am very pleased that the DEA has heeded my call and listened to the FDA’s suggestion to tighten up access to hydrocodone. Now, the DEA and law enforcement will have greater control over one of the most highly prescribed – and abused – drugs on the market.”
Hydrocodone is among the most widely prescribed drug in New York and the country, has rapidly increased in abuse levels, and is highly dangerous. According to the DEA, nearly seven million Americans abuse controlled-substance prescription medications, including opioid painkillers that contain hydrocodone. The DEA estimates that there are more deaths resulting from prescription drug overdoses than automobile accidents. Since 2012, Schumer has worked closely and effectively with the FDA to help stem the abuse of hydrocodone, and highlighted the importance of policy that strikes a balance between appropriate access to pain relief medications, and preventing prescription drugs from getting in the wrong hands.
Hydrocodone-containing painkillers are now Schedule II medications, instead of Schedule III. The scheduling is based on the potential for abuse and addiction. Schedule II are those with the highest potential for addiction that can legally be prescribed, and now hydrocodone joins oxycodone, Adderall and Ritalin in that classification. The scheduling system, which is overseen by the DEA, classifies drugs based on their medical use and their potential for abuse and addiction. That is why it was so important, Schumer said, that the DEA heed his call and the FDA suggestion to re-schedule this drug so that the tighter restrictions might be enforced.
In his original January 2013 letter, Schumer highlighted that on January 24 and 25th, a federally-convened drug safety panel, called the Drug Safety and Risk Management Advisory Committee, issued a recommendation to increase hydrocodone’s classification from Schedule III to Schedule II, by a vote of 19-10. Schedule II substances have a high potential for abuse, which may lead to severe psychological or physical dependence. Schedule II drugs include narcotics like oxycodone (Oxycontin) and morphine, and stimulants like methamphetamine and amphetamine. Schumer then urged FDA Commissioner Hamburg to approve these expert recommendations, which will then be sent to the Department of Health and Human Services (HHS) for a positive recommendation to the Drug Enforcement Administration. Schumer noted that approval by FDA is the greatest hurdle in reclassifying such drugs, as the DEA requested this change.
The Controlled Substances Act (CSA), which was passed by Congress in 1970, places substances with accepted medical uses into one of four schedules. Substances with the highest potential for harm and abuse are placed in Schedule II, while substances with progressively less potential for harm and abuse re placed in Schedules III through V. Schedule I is specifically reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use. While hydrocodone itself was a Schedule II drug, other drugs that contained specified amounts of hydrocodone were only classified as a Schedule III.
Schedule II controlled substances require a written or electronic prescription which must be signed by the practitioner. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited, therefore a new prescription must be issued each time a patient needs a refill. Schumer noted that in terms of issuance of multiple prescriptions for Schedule II substances, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided several conditions, including a legitimate medical purpose for each drug, written instructions on each prescription, determination that undue risk of abuse is not created, and permissibility under state law.
Hydrocodone is one of the most commonly prescribed prescription drugs in the United States, with 47 million Americans receiving prescriptions for it in 2011 alone. It is prescribed for anything from wisdom tooth extractions to broken bones, and Schumer noted that often such strong medications are unnecessary, or are prescribed in too high a quantity for certain ailments. Schumer stated that this demonstrates a critical need for better control and more appropriate distribution of this class of drugs.
Schumer acknowledged that many patients seek the legitimate use of hydrocodone for pain management, and access for those individuals should be preserved. However, it is among some of the most highly abused substances, and can cause serious health conditions, and often death, as a result. In addition to serving as a potential catalyst of chronic dependence, crime and suicide, hydrocodone spurs a number of serious health side effects, including nausea, constipation, urinary retention and in higher amounts, depressed respiration. While long term use can lead to dependence and addiction, withdrawal symptoms include restlessness, muscle and bone pain, insomnia, diarrhea, and vomiting. Severe liver damage can occur when large doses of hydrocodone in combination with acetaminophen, as is commonly practiced.