Schumer: FDA has heeded the call to tighten control of Hydrocodone

By WBNG News

Schumer: FDA has heeded the call to tighten control of Hydrocodone

October 24, 2013 Updated Oct 24, 2013 at 5:08 PM EDT

(WBNG Binghamton) U.S. Senator Charles E. Schumer on Thursday announced that the Food and Drug Administration has heeded his call and approved regulations to make it harder to access painkillers that contain hydrocodone.

According to a news release from Schumer's office:

Specifically, Schumer announced that the FDA Commissioner Hamburg has reclassified hydrocodone as a Schedule II controlled substance, which will impose greater restrictions in how doctors can prescribe hydrocodone and the quantity that can be prescribed.

Schumer has fought since January 2013 to achieve this reclassification from Schedule III to Schedule II, in an effort to help combat an unprecedented spike in prescription drug abuse in New York State and the country.

Hydrocodone is among the most widely prescribed drug in New York and the country, has rapidly increased in abuse levels, and is highly dangerous. Schumer noted that in 2011, the Upstate New York Poison Control Center reported over 12,800 cases of prescription drug abuse. Over the past year, 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.

“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” said Schumer.
“I’m very pleased that the FDA has heeded my call and will tighten up control of one of the most highly prescribed – and abused – drugs on the market.”

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 D.E.A., classifies drugs based on their medical use and their potential for abuse and addiction.

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.

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.

Prescription drug abuses cases were found in every part of the state in 2011, the most recent full year of data.  According to the Upstate Poison Control Center:

•         In the Capital Region, there were 1,452 reported cases of prescription drug abuse during 2011
•         In Central New York, there were 3,103 reported cases of prescription drug abuse during 2011
•         In the Rochester Finger Lakes Region, there were 2,063 reported cases of prescription drug abuse in 2011
•         In the Hudson Valley, there were 1,428 reported cases of prescription drug abuse in 2011
•         In Western New York, there were 2,324 reported cases of prescription drug abuse in 2011
•         In the Southern Tier, there were 1,431 reported cases of prescription drug abuse in 2011
•         In the North Country, there were 1,070 reported cases of prescription drug abuse in 2011

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