Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments
cder2011165 CDER Blueprint Opioid
2011-12-14 2011-11-30 2011-11-30 2011-11-30 2011-11-30 2011-12-14 2011-11-30 2011-11-30 2011-12-14
FDA-2011-D-0771-0030 FDA-2011-D-0771-0003 FDA-2011-D-0771-0010 FDA-2011-D-0771-0011 FDA-2011-D-0771-0018 FDA-2011-D-0771-0023 FDA-2011-D-0771-0015 FDA-2011-D-0771-0013 FDA-2011-D-0771-0042
05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0030 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0003 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0010 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0011 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0018 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0023 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0015 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0013 https://api.regulations.gov/v4/comments/FDA-2011-D-0771-0042
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Quest Diagnostics Incorporated appreciates the opportunity to assist the U.S. Food and Drug Administration in developing the Blueprint for Prescriber Continuing Education Program. Quest Diagnostics is the worlds leading provider of diagnostic testing, information and services that patients and doctors utilize to make better health care decisions. With over 25 years of experience in toxicology testing, we perform over nine million urine drug tests (UDTs) annually across our network of four certified laboratories. UDT is well-established and recommended as an effective tool in pain management and prescription drug monitoring by numerous provider and patient organizations as well as the Federation of State Medical Boards and the Department of Veterans Affairs. We agree that prescribers should be knowledgeable about the need for UDT as a valuable tool to enhance patient safety, ensure appropriate patient access to prescribed drugs, and to help curb the prescription drug abuse and misuse epidemic. Taking into consideration the increasing rate of unintentional drug overdose and death due to prescription drugs, the Blueprint should incorporate UDT four times a year or more as appropriate.Please contact me to further discuss the issues raised in this letter with the goal of improving patient care: Faith Cristol, 202-263-6260, faith.a.cristol@questdiagnsotics.com.  I am a pharmacist in Fredericksburg, VA and in the past 2-3 years have seen an explosion in inappropriate prescribing of controlled substances.  I am wondering why this blueprint is focusing only on long acting narcotics and not all controlled substances? I was recently a witness for the Virginia Board of Medicine in a case where a doctors license was revoked for inappropriate prescribing. As I speak with doctors on the phone when I am verifying controlled prescriptions, I realize many offices have no real procedures in place to prevent addiction and illicit distribution. First off, a signed pain contract must be in place for each patient and if they deviate, the doctor has every right to discharge the patient. Previous medical records must be verified! It is not difficult today to falsify or use someone elses records.  Personally, I would only accept records from a previous physician directly after contacting them myself.   I would not accept records handed to me by the patient.  If records can not be attained for a valid reason, the prescriber must perform an exam and any testing needed to confirm a diagnosis. PMP reports are also essential and must be done on every office visit... but be aware... patients now know about PMP reporting and will do whatever necessary to make sure their report looks acceptable.  They will travel to different states because right now state PMP websites are not linked and you can only view one state at a time. Also, healthcare professionals must register separately for each state. Another way to deceive PMP reporting is to use multiple false names and dates of birth by obtaining false state identification cards. Finally, urine testing and bloodwork should be done to confirm substance use and also detect any illicit substance use. Please contact me if I can offer any additional information because I deal with this issue on a daily basis... wesandlorimilton@comcast.net REMS are the latest in a series of oh my God we have to do something  proposals that have no scientific evidence behind them that they work.  Just as just say No, and DARE to keep kids off of drugs were massive failures because no one did any research to see if they would work to solve the problem they were aimed at, we spent billions of dollars on failed ideas.  There is a general consensus that education on utilization of these medications would be helpful, however, the particular design and pervasive nature of REMS has no scientific basis whatsoever.  It makes more sense to do some preliminary studies to help determine what types of educational approaches will work and then proceed with implementation.  Add to the mix complexity in the approach by combining more than one medication into a specific REMS, and you may end up with something that does not work at all. We already have seen that Actiq, Fentora, Abstrall, (and one other drug I cannot recall) have been lumped into one REMS, without any study as to whether putting these drugs together will be helpful or not.  I am a strong supporter of education, however, it must be done in the right manner and with the right basis or we will end up with a bunch of very expensive, dust gathering documents with no help for solving the problem at hand.Richard G. Harris M.D.   Pain Management Docket No FDA-2011-D-0771As Deputy Medical Director for Addictions for the Stewart-Marchman-Act Behavioral Healthcare and the Director of the Vince Carter Sanctuary I am asking that you use the REMS process to tighten up the prescribing indications for the opioids instead of relying upon a voluntary education program by manufacturers I would like you to be aware that dentists who are Diplomates of the American Board of Orofacial Pain have had extensive training in managing patients with chronic orofacial pain.  One aspect of this training includes the basic knowledge and appropriate use of pharmacotherapeutics.  We are similarly very concerned, as is the Administration, with the epidemic of prescription drug abuse. On behalf of the American Board of Orofacial Pain (ABOP), I would like to offer our support for FDA efforts to ensure comptency in prescribing practice for opioid medications.  The ABOP is committed to assist in safeguarding the public by virtue of granting Diplomate status to those who have demonstrated proficiency in evaluation, diagnosis, and management of patients suffering with chronic orofacial pain.  Our rigorous examination process consists of both a written and oral examination, which mirrors the Core Curriculum in Orofacial Pain, (American Academy of Orofacial Pain, 2011), which has been accepted by all of the University based training programs in the United States.  All programs include, indeed emphasize, appropriate use of medication as therapy for the chronic orofacial pain patient.  Among those medications are anticonvulsants, NSAIDS, antidepressants, headache medications, various channel blockers, and opioids, among others.  The American Board of Orofacial Pain requires demonstrated proficiency in the prescription and monitoring of all of the medications used for our patients.  We would be happy and eager to assist the FDA in any way to help educate doctors on appropriate prescribing practice. Anthony H. Schwartz, DDSPresident, American Board of Orofacial Pain I think this is a commendable effort but as a pain management and addiction medicine physician, I doubt that it will do much to curb the current epidemic of prescription drug abuse. I do think that it will have a small favorable impact; however, the vast majority of prescription drug abusers that I see in my addiction practice do not obtain their drugs from licit sources. Certainly, some patients do develop drug addiction during treatment for chronic pain and detecting and treating these patients will be beneficial to society. Some patients doctor shop and scam doctors and increasing vigilance may improve detection of these patients. But it is extremely unlikely that REMS will have much impact on the pill mills and other illicit sources of prescription opioids. The criminals will not respond to REMS. It is not clear at all how much opioids are diverted from legitimate prescriptions to the street. As the vast majority of overdose deaths are in abusers, not patents, it is unclear if many lives will be saved with this effort. I am weighing in on this topic because I suspect millions of dollars will be spent on developing and implementing REMS for little actual return. I realize that everyone wants to do something to help stem the tide of opioid overdose deaths and education is always a good thing. But I would not get my hopes up with regard to this effort having a large impact as it is not targeting the source of the problem.  The use of long acting opioids does not preclude the use of short acting opioids therefore it is important to cover the aspect of breakthrough pain and the use short acting opioids and fast acting opioids.  It is not clear to me why the time to response is the factor driving in the REMS.   On behalf of the American Board of Orofacial Pain (ABOP), I would like to offer our support for FDA efforts to ensure comptency in prescribing practice for opioid medications.  The ABOP is committed to assist in safeguarding the public by virtue of granting Diplomate status to those who have demonstrated proficiency in evaluation, diagnosis, and management of patients suffering with chronic orofacial pain.  Our rigorous examination process consists of both a written and oral examination, which mirrors the Core Curriculum in Orofacial Pain, (American Academy of Orofacial Pain, 2011), which has been accepted by all of the University based training programs in the United States.  All programs include, indeed emphasize, appropriate use of medication as therapy for the chronic orofacial pain patient.  Among those medications are anticonvulsants, NSAIDS, antidepressants, headache medications, various channel blockers, and opioids, among others.  The American Board of Orofacial Pain requires demonstrated proficiency in the prescription and monitoring of all of the medications used for our patients.  We would be happy and eager to assist the FDA in any way to help educate doctors on appropriate prescribing practice.Anthony H. Schwartz, DDSPresident, American Board of Orofacial Pain