FDA Panel hears Victims of Pain and Relatives of Overdose Victims Stories
On Feb 7th, the FDA allowed relatives of patients who had overdosed, as well as patients dealing with pain, speak at a hearing on the use of opioids. Before the FDA makes any decisions they want to hear all sides and accumulate statistics on how doctors are diagnosing. They also want to understand patients dealing with pain and how opioids are being used to treat pain, as well as how they are currently labeled. Their overall goal is to figure out the best way to limit opioid usage, but not make it impossible for those who need it to get it. This is all part of the effort to decrease the numbers of abuse and misuse of powerful narcotics.
Relatives of victims said they would at least like to see changes made to the labels on prescription drugs. Victims of pain voiced their concerns about the changes being considered; they are worried that they might be left out in the cold to suffer from their pain if these changes occur. The FDA made the statement that they are aware that opioid analgesics are beneficial to modern pain management, but their abuse has made “a serious and growing public health problem. ” They believe that the development of abuse-deterrent formulations is “a high public health priority.”
So far the FDA is considering a petition of Physicians for Responsible Opioid Prescribing, which is composed of a group of doctors and pain specialists. The petition has ideas such as a recommended upper daily dose on the medications’ labels and limit prescriptions to 90 day treatments. They would like to see painkillers used for severe pain, rather than moderate pain, except in the case of cancer patients.
This along with a few other ideas such as creating tamper resistant formulas of the opioids as well as packaging that could prevent misuse are being considered by the FDA to instate as regulations for prescription medications.
Author Information: RTPR.com
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Why is it that if someone shoots another, they want to take away all self protection? Why is it when a doctor mis-uses drugs, they want to punish ALL doctors? Why is it when patients are in pain so much, and nothing is being done to REALLY help them, that the other pain patients are punished? If you have a child who does something wrong, do you punish the whole family? Where has our logic gone?
I believe one thing that\’s missing in this discussion is the new technology of pharmacogenetics which can allow prescribers in any specialty to target the correct therapy for patients particularly with Opiates where the risks of a poor outcome are so high. And example is methadone which is metabolize through three different pathways giving the opportunity for different drug interactions that can cause increased blood levels. We all know that methadone has a variable half-life of around 20 hours to up to 120 hours and metabolism shortly has a lot to do with us. Another excellent example of this need is the FDA\’s decision on February 20, 2013 Today boxed warning their most serious warning to the package insert of Codeine To avoid its use unless the patient has been genetically typed to show that they are good metabolizers. The latest morning discusses deaths two children who took what we would consider routine doses of codeine. During my career in the both long-acting and short acting opiates around I have found that drug interactions are really discussed. We all consider codeine a benign if not ineffective opiate But if children cannot metabolize a normal dose they can actually overdose and die within 24 hours on a typical dose because they cannot excrete It so levelsl build to dangerous levels. I\’m know many readers of this will say yes \”But we don\’t use codeine in our practice with adult patients.\” If that\’s true however there are other commonly used drugs which have the same qualities such as hydrocodone tramadol oxycodone and especially methadone which can be the most dangerous of them if not used properly due to the variable metabolism. In the past year there have been at least four laboratory companies that have launched commercially pharmacogenomis typing for opiates available opiate metabolism testing so there is no reason why I cannot easily be done In approximately 2 to 3 days With nothing more than a 20 second buccal swab in both cheeks. This technology should become routine in the coming years however many physicians are pooh-poohing it now. Some good questions for certain specialist to ask is with surgeons how many times have they asked family members if the patient is a chronic illegal drug user because they are post surgery opioid requirements were higher than what is typical? How many hospice patients have hallucinated for become nonresponsive when the stock to be cancer rather than the drugs they\’re taking For pain control? Prescribers know that some patients are extremely sensitive to opiates even post surgically where is others require very high doses or what might seem more benign? I recently spoke to a director at a major medical teaching institution in my state who said that this is the number one topic that particularly pediatric surgeons should be concerned with. The FDA\’s boxed warning specifically states not using codein following tonsillectomies and adenoidectomies. The greater concern in adults are the many drugs that they take in concert with pain drugs that are Inducers, Inhibitors and Substrates which can cause major adverse outcomes including death. For a voluminous list of these interactors look up The work of Dr. David Flockhart of Indiana University Who is compiled the best list of these that can be found on the Internet. If you are at a teaching institution Use the Lexicom search engine which is best for pharmacologic information. This technology now exists. Why not use it?