Inappropriate Use Of Opioids, FDA Extremely ConcernedEditor's Choice
Main Category: Pain / Anesthetics
Also Included In: Alcohol / Addiction / Illegal Drugs; Regulatory Affairs / Drug Approvals; Public Health
Article Date: 05 Mar 2013 - 10:00 PST
Inappropriate Use Of Opioids, FDA Extremely Concerned
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Overdosing on narcotic pain relievers resulted in over 15,500 deaths in the USA in 2009, the FDA informed, a 300% rise over the last two decades.
The Food and Drug Administration (FDA) says it has joined other health professional organizations in encouraging doctors to seek training in how to safely prescribe opioid pain medications.
For each person who dies from an opioid pain medication, there are:
- ten more treatment admissions
- 32 emergency department visits, and . . . .
- 825 users of these drugs for non-medical reasons
"FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the U.S., becoming a major public health challenge."
Dr. Hamburg explains that much of the problem is due to the illicit use of opioid pain-killing drugs, which may include the sharing of medications with family members, friends, or stealing them from the home medicine cabinet. However, legitimate pain medication use can also lead to addiction, unnecessary adverse events, and even death.
Investigators from the Department of Veterans Affairs, Ann Arbor, Mich. revealed in JAMA that patients on stronger prescription opioid doses have a considerably higher risk of unintentional overdose and death compared to those on smaller doses.
America's health care professionals can play a crucial role in the efforts to reduce this alarming trend.
Prescribers need to have access to education on the best uses of opioids, which must include knowing when they should be used, and for which patients, Dr. Hamburg emphasized.
On March 1st, the FDA issued an open letter to prescribers, talking about educational programs aimed at promoting responsible opioid prescribing, improving pain management, and reducing prescription drug abuse and diversion. The letter urges prescribers to take advantage of these programs.
Dr. Hamburg said:
"And I'm pleased to announce that the 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) have graciously agreed to distribute the open letter to their members. All are actively engaged in activities, including training, aimed at reducing the misuse and abuse of opioid medication, as are many others."
The open letter will also be sent to people who regularly receive the FDA's health care news. Dr. Hamburg urges health care professionals to pass the letter on to other prescribing colleagues.
Risk Evaluation and Mitigation Strategy (REMS)Approved in 2012, the REMS is a risk management plan for healthcare professionals. The aim is to address the abuse, misuse, and addiction to ER (extended-release) and LA (long-acting) opioid pain medications.
Dr. Hamburg said that the first prescriber training program became available on March 1st, 2013.
The FDA sought the Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids because these kinds of pain medications have the highest potential for harm from unintentional overdose, abuse and misuse.
Narcotic pain relievers, which are widely prescribed, contain sizeable amounts of opioids in a single dose, in some cases there is enough to kill a person, especially a child. Their potency makes them highly sought after by drug abusers. "And that's why it is so important for physicians and other prescribers to participate in these training programs to enhance their understanding of how to appropriately prescribe these powerful medications to patients that need them - while also keeping them out of the hands of those who could misuse or abuse them," Dr. Hamburg wrote.
In 2011, over 320,000 prescribers registered with the DEA (Drug Enforcement Agency) wrote at least one prescription for an ER/LA opioid pain medication. The FDA added that it needs to get in touch with all of them - that is many prescribers.
Dr. Hamburg concluded "..working together to ensure appropriate use of opioids, I am confident we can make great strides in reducing this epidemic."
The National Center for Health Statistics reported in Februrary 2013 that drug overdose deaths rose for the 11th consecutive year in 2010. Opioid analgesics have been the main drivers in these deaths.
Some politicians and lawmakers are starting to take measures in their own states and cities. New York Mayor Michael Bloomberg announced in January 2013 that his office introduced new guidelines aimed at reducing opioid prescription painkiller abuse.
The increase in opioid painkiller prescriptions is not only an American issue. In Europe, Canada and Australia, similar trends have been reported. In February 2013, researchers reported that "more and more opioids are being prescribed for pain relief in Germany".
Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Posted on March 1, 2013 by FDA Voice
By: Margaret A. Hamburg, M.D., Commissioner of the Food and Drug Administration (FDA)
24 May. 2013. <http://www.medicalnewstoday.com/articles/257226.php>
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