The U.S. Food and Drug Administration are becoming alarmed at the increasing rate of prescription drug abuse in the United States, specifically opioid painkillers. Opioids are chemical compounds that bind to specific opioid receptors in the brain, the central and peripheral nervous system, and other tissues in the body. Opioids are found in prescription painkillers such as hydrocodone (Vicodin,) oxycodone (Oxycontin) and hydromorphone (Dilaudid) and are typically prescribed by doctors following a physical injury or surgery. Used as a painkiller, the analgesic effects of opioid use include decreased perception and reaction to pain, as well as feelings of euphoria. These affects, combined with the high potency of many of today’s opioid painkillers, gives them a high potential for abuse and dependence.
The current data on prescription opioid abuse and addiction is quite alarming. According to FDA commissioner Margaret Hamburg M.D., “More than 15,500 people died in the United States in 2009 after overdosing on narcotic pain relievers. That’s a 300 percent increase over the last 20 years. And for each death, there are an additional ten treatment admissions, 32 emergency department visits and 825 non-medical users of these drugs.” (Hamburg, 2013). These numbers represent a growing epidemic in the US, with most illicit use attributed to sharing medication with family and friends, and theft of the drug from home medicine cabinets. The pills are also commonly bought and sold illegally on the black market, fetching a high street value.
On March 1, the FDA sent out an open letter to all prescribers seeking their help in thwarting this epidemic. They called for opioid prescribers to gain further knowledge and training on the drugs they are writing prescriptions for. They must have adequate knowledge in opioid therapy and the most current prescription drug labels issued by the FDA, and it is also their responsibility to educate patients on the appropriate dosages, potential risks, and proper disposal techniques needed for opioid painkillers.
The FDA is also teaming up with American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American Academy of Physician Assistants (AAPA) and the American Academy of Pain Management (AAPM), to help implement their Risk Evaluation and Mitigation Strategy (REMS). The REMS will include new methods of prescriber training that include education to address the prescribing extended-release (ER) and long-acting (LA) opioid painkillers. FDA specially wanted the REMS for ER/LA opioids because they have the greatest likelihood of misuse, abuse, and accidental overdose. These widely-used drugs are often highly potent even in a single dose, sometimes in sufficient quantity to be lethal, especially for a child. Due to their strength and powerful effect, they are a favorite of drug users.
In 2011, 320,000 prescribers registered with the DEA wrote at least one prescription for ER/LA opioids. While this represents a large task for the FDA, Commissioner Margaret Hamburg is hopeful, writing: “…working together to ensure appropriate use of opioids, I am confident we can make great strides in reducing this epidemic.” (Hamburg, 2013). While the FDA must do their part, the patients can also do theirs. If you are taking prescription opioids, make sure you using them as prescribed and disposing of them properly. Also, if you or someone you know is currently abusing these medications, please seek help immediately. Treatment4addiction is a good place to start.
Hamburg, M. (2013, March 1). FDA joins with health professional organizations in encouraging prescribers to seek training to safely prescribe opioid pain medicines. Retrieved March 6, 2013, from FDA Voice: http://blogs.fda.gov/fdavoice/index.php/2013/03/fda-joins-with-health-professional-organizations-in-encouraging-prescribers-to-seek-training-to-safely-prescribe-opioid-pain-medicines/
Nordqvist, C. (2013, March 5). Inappropriate Use of Opioids, FDA Extremely Concerned. Retrieved March 6, 2013, from Medical News Today. MediLexicon Intl.: http://www.medicalnewstoday.com/articles/257226.php
United States Food and Drug Adminstration. (2013, March 1). Attention Prescribers: FDA seeks your help in curtailing the U.S. opioid epidemic. Retrieved March 6, 2013, from FDA: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm330614.htm
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