It’s Holiday Time

Its holiday time and so many people are going about their business buying gifts, wrapping them, there are holiday parties to attend, be it at work, or an individual inviting their friends over and celebrating.

Then there are those of us who live with chronic pain day in and day out. Pain does not have days off as pain seems to have a mind of its own. It seems to think that it can control us, it cannot only make us hurt; it can also make us so very tired and can help to either bring on depression or make it worse.

If I may, let me call pain “Mr. Pain” for it comes on strong, it stays with us and certainly can take on the role of the boss. Well Mr. Pain, I as a long-term chronic pain patient try not even to use your name. I do not want to dignify your name. Instead, I use the word when needed as “I am experiencing DISCOMFORT.” I have found that when the name Pain is used, it has a very negative connotation and can even make me feel worse which in turn intensifies how I feel. Please know that there are times that I do use it and usually put some profanities in front of the word. At least you may want to try it and begin during this period and do your best to go through this holiday time not thinking about your illness and perhaps this time of year can be a good period for you.

I do want to bring up another subject with you, which I will be discussing in much more detail right after the New Year. The FDA is in the process through The Federal Register of revising drug labeling. The name of the Notice is; Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing ; Request for Comments.
In addition to the possible changing of the label is a section that discusses the possibility of Limiting Opioid Prescription and Use. I have copied the section which discusses the background and purpose of holding this public hearing.

Prior to listing this, I would like to wish all of our readers a healthier and joy filled New Year.

The FDA listing is as follows;

I. Background Back to Top
Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. The July 9, 2012, approval of the Risk Evaluation Management Strategy for extended-release (ER) and long-acting (LA) opioid analgesics is a recent example of FDA’s ongoing commitment to ensuring that the benefits of these types of opioid drugs continue to outweigh their risks.
While ER/LA opioid issues have been a particular focus of public health concern, discussions continue about the proper use of opioid drugs in general. Over the past several years, the Agency has received comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain. In particular, members of the public and the regulated community have debated the presence or absence of evidence showing the safety and efficacy of these drugs as pain relievers in the various populations for whom they are prescribed. Many have raised issues specific to particular opioids, such as those pertaining to drug product composition, specific abuse-deterrence properties, and biological action. Some have raised broader issues that impact the entire class of opioid drugs or a large subcategory thereof (e.g., ER/LA opioids), such as the propriety of controls on drug dosage and duration of administration or changes in indication and prescribing practices.
II. Purpose and Scope of the Public Hearing Back to Top
In light of the ongoing interest in issues related to opioid use, FDA has decided to hold a public hearing to obtain information—particularly scientific evidence, such as study data or peer-reviewed analyses—from expert members of the public on the following questions:
A. Diagnosis and Understanding of Patient Pain
1. What methods do professionals use to accurately distinguish between different types of pain (e.g., cancer vs. non-cancer) and their respective etiologies?
2. What are the definitions of the terms “mild,” “moderate,” and “severe” when those terms are used to describe symptomatic conditions such as pain?
3. How do professionals accurately categorize a patient’s pain as mild, moderate, or severe? For example, what tests or assessments do they use?
4. What methods should and do professionals use to accurately distinguish between short-term pain and chronic pain?
a. What are and should be the time periods that characterize short-term pain versus chronic pain?
b. What are and should be considered the clinical differences between short-term pain versus chronic pain?
c. What types of pain, if any, are presumed chronic versus presumed short term?
B. Understanding and Adhering to the Labels of Pain-Treating Products
1. How are the words “indicated for the treatment of moderate to severe pain” interpreted and used by practitioners when deciding what types of treatments (including opioids) are appropriate for treating patients with pain?
2. If the indication for opioid drugs were restricted to the treatment of severe pain only, how would such a change impact:
a. Prescribing practices?
b. Patient access to pain medication and patient pain control?
c. Abuse and misuse of opioid medicines?
3. If the pain threshold described in the indication (e.g., moderate, moderate to severe, severe pain) differed based on the pain’s etiology, how would such an approach impact:
a. Prescribing practices?
b. Patient access to pain medication and patient pain control?
c. Abuse and misuse of opioid medicines?
C. Limiting Opioid Prescription and Use
1. Limits on exposure to opioid drugs.
a. What data, if any, exist that would support or oppose the establishment of a maximum daily dose for opioid drugs? FDA is interested in drug safety or efficacy data in particular.
b. What data, if any, exist that would support or oppose a difference in maximum daily dose for opioid drugs based on pain etiology (e.g., cancer vs. non-cancer pain)? FDA is interested in drug safety or efficacy data in particular.
c. What method(s), if any, should be used to establish a maximum daily dose of opioid drugs?
d. What effect(s), if any, would a maximum daily dose for opioid drugs have on the following:
i. Prescribing practices?
ii. Patient access to pain medication and patient pain control?
iii. Abuse and misuse of opioid medicines?
2. Limits on duration of use of opioid drugs.
a. What data, if any, exist that would support or oppose the establishment of a maximum duration of continuous treatment with opioid drugs? FDA is interested in drug safety or efficacy data in particular.
b. What data, if any, exist that would support or oppose a difference in maximum duration of continuous treatment with opioid drugs based on pain etiology (e.g., cancer vs. non-cancer pain)? FDA is interested in drug safety or efficacy data in particular.
c. What method(s), if any, should be used to establish a maximum duration of continuous treatment with opioid drugs?
d. What effect(s), if any, would a maximum duration of continuous treatment with opioid drugs have on the following:
i. Prescribing practices?
ii. Patient access to pain medication and patient pain control?
iii. Abuse and misuse of opioid medicines?
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