FDA Study Calls for More Aggressive Opioid Regulation — Pain News Network

By Pat Anson, Editor

A new report commissioned by the U.S. Food and Drug Administration is calling for a sustained and coordinated national campaign to combat the opioid crisis, including more aggressive regulation of opioids by the FDA and a “cultural change” in the prescribing of opioid medication,

The report by a special committee of the National Academies of Sciences, Engineering, and Medicine(NASEM) focuses primarily on restricting the supply of prescription opioids, not illicit opioids such as heroin and fentanyl, which are now driving the so-called opioid epidemic.

“The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin,” said committee chair Richard Bonnie, a Professor of Medicine and Law at the University of Virginia.

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel.”

The report estimates that at least 2 million people in the U.S. have an “opioid use disorder” involving prescription opioids — meaning they are addicted to prescription painkillers — and almost 600,000 have an opioid use disorder involving heroin.

Although opioid prescribing has been declining for several years and the number of overdose deaths from prescription opioids has remained relatively stable in recent years, deaths from illicit opioids such as heroin have tripled in the past decade.

Read the full article

 

Source: FDA Study Calls for More Aggressive Opioid Regulation — Pain News Network

Personal Commentary: “This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing.”

How can it help the millions of people who suffer from chronic pain if opioid prescribing is reduced or denied for said chronic pain sufferers? Who chooses which patients receive or are rejected? The physician or the government?

“The report claimed that many people who normally would use prescription opioids have transitioned to heroin because of the declining price of heroin and the introduction of abuse-deterrent formulations that make opioid medication harder to snort or inject.”

Yet the report declines to mention the many people who have never transitioned to heroin or any other type of illicit drugs.

These reports never mention the vast majority of patients who remain compliant, who’ve never failed a scheduled or random drug screen, who’s quality of life however slight was a quality enough to stay alive for.

Perhaps it’s the people who aren’t in the chronic pain they claim to be that are abusing the system and heading for heroin and perhaps it’s easier to lump us all together for political gain and ulterior motives that have little to do with helping us and everything to do with you. Just you. 

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National Pain Strategy PAINS Collaborators Meeting Recap – COMMUNITY PAIN CENTER

National Pain Strategy PAINS Collaborators Meeting Recap

By Barby Ingle, Power of Pain Foundation President

On June 29 and 30, 2015, the Pain Action Alliance to Implement a National Strategy (PAINS), a group of over 100 pain collaborators and stakeholders, came together in Washington DC to discuss the National Pain Strategy (NPS). The purpose was to provide attendees an opportunity to discuss the NPS and find areas of agreement on next steps, collaborations, priorities, and to hold accountable those responsible for implementation.As the president of the Power of Pain Foundation, I was invited to participate. I went into the meeting with some preconceived notions based on little happening since the Institute of Medicine’s report in 2011 and didn’t expect much to be accomplished. To my great surprise, the meeting exceeded my expectations. I left the meeting feeling that a path toward implementation of stronger access to care issues was clarified as a result of the meeting. I am excited to be one of the attendees present that will be helping move a chronic pain agenda forward, making a difference in the lives of those living with pain.The goals of the meeting were to encourage collaboration among key pain community leaders, to promote the NPS report and build enthusiasm for it, and to facilitate conversations about how to move forward to implementation of the strategy outlined in the report.For me, the meeting clarified the path ahead for the NPS in terms of priorities,implementation, next steps, funding,leadership and accountability. One of the unintended outcomes from the meeting was the consensus to support the messaging of the Chronic Pain Advocacy Task Force (CPATF). The CPATF is a group of 17 consumer advocacy groups convened by the State Pain Policy Action Network (SPPAN), which is a program of the American Academy of Pain Management (AAPM). As a founding member of the CPATF and the representative of one of the 17 groups involved, I was very proud to see that our work was recognized by this larger group of collaborators and stakeholders. As agreed upon, the core messages are: Chronic pain is a real and complex disease that may exist by itself or be linked with other medical conditions.Chronic pain is both an under-recognized and under-resourced public health crisis with devastating personal and economic impact. Effective chronic pain care requires access to a wide range of treatment options, including biomedical, behavioral health and complementary treatment. Denying appropriate care to people with chronic pain is unethical and can lead to unnecessary suffering, depression, disability, and even suicide.

Read the entire article at:

Source: National Pain Strategy PAINS Collaborators Meeting Recap – COMMUNITY PAIN CENTER

Prescribing Task Force Meeting | April 13, 2015

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Prescribing Task Force
The Medical Board of California
April 13, 2015

I’ve been apart of this Prescribing Task Force since it began. These are the highlights of the meeting as it pertains to current affairs.

Refer to UStream MBC 4-13-2015 (98:02) Monday at 9:52 a.m
http://www.ustream.tv/recorded/61075030

Jason Smith- Generation Lost
Jason’s story begins at 13:00 of MBC 4-13-2015 (98:02) Monday at 9:52 a.m.

Mr. Smith begins his story by showing us photos of what a drug addict doesn’t look like, he immediately tells us that he abused the system 10 years ago. He say’s we have a preconceived notion of what a junkie looks like as he flips through slides of street bums and obvious users in dirty clothing in underground structures. He tells us that when he was 17 years old he became hooked after a car accident. He shares how he was put on Fentanyl, Norco and Soma. He believes his addiction started from Fentanyl. He said prior to the accident he was never interested in a drug “but when this hit my system, don’t get me wrong, I loved it”.

He was never honest with his doctor because he was worried his doctor would cut him off. He does say now, he has to take personal responsibility. He says his doctor didn’t know any better that he was just trying to keep him out of pain.

Additional Commentary-

I appreciate Mr. Smith’s truthfulness to come forward and tell his story. It would be honest if more patients did the same. We know they are out there. I am glad he is alive to tell his story and help the drug abuse problem. However, I can’t hold back. It is because of patients like this who make patients like me look bad. It is doctors like his that were duped that will second guess me now. I say me because I represent many pain patients who are falsely accused and judged for someone else’s deceit.

Jason appears friendly, handsome, not what society perceives an abuser to be. He’s right about the photo’s he’s shared.

Abusers are every day people, in any community, wealthy, poor, religious, strong, weak, and of any race. It is said that certain populations are at higher risk than others. We hear that over and over again. Don’t be fooled! They are in every class of people. Most dress quite well, are physically beautiful and are not just the poor folk, they are corporate managers, they are of the populations we don’t care to consider. If you think their aches and pains are more relevent then some one elses who might be on medi-cal you are misguided by your own misconceptions.

There has to be patient provider communication. There needs to be patient assessment, risk stratification, and screenings for abuse. Labeling a pain patient a potential abuser without merit because of other people who have used and abused our doctors and themselves is unjust.

Overdose means a person didn’t take a medication as prescribed, mixed it with alcohol, or another substance. Generally addiction and abuse occurs when mis using, again not taking as prescribed. Where is the personal responsibility in all of this? It is because of patients who do these things that contribute to the negative stigma and impede in the access to care and analgesic management to responsible chronic intractable pain patients. Much more work needs to be done not just in curbing abuse, but by making sure access to proper pain care on a case by case basis in ensured.

I admire Jason for sharing his story. His honesty actually brings truth and enlightenment to what many of us have been saying all along. You’re looking in the wrong place.

Dr. Rupali Das, Executive Medical Director of the Division of Workers Compensation spoke on Workers Compensation Guidelines, prescription drug misuse and overuse, and the multidisciplinary approach that the guidelines recommend. Treating providers are required to use the Evidence Based Treatment Schedule (MTUS). Opioid Treatment Guidelines- Refer to 57:00 of MBC 4-13-2015 (98:02) Monday at 9:52 a.m. http://www.ustream.tv/recorded/61075030

Dr. Das’ intentions are decent, yet early treatments such as acupuncture, physical and occupational therapy, yoga and other interventional treatments are more often than not, denied. This leads to the progression of disability and in some cases, irreversible disease. There is no wean down program when determining a modification of medication in many situations. Injured worker’s are abruptly halted leaving them in withdrawal. Even if a patient isn’t taking an opioid medication, withdrawal is dangerous. Injured worker’s continue to deal with denials and delays.

Agenda

1. Call to Order
2. The Lost Generation – Jason Smith
3. Update from the Prescription Opioid Misuse and Overdose Prevention Workgroup –
Julie Nagasako, California Department of Public Health
4. Update from Division of Workers Compensation – Rupali Das, M.D. Depart of Industrial Relations
5. Update on Controlled Substance Utilization Review and Evaluation System (CURES) –
Kimberly Kirchmeyer
6. Discussion on Statewide Best Practices
—–
Twinkle VanFleet
Executive Board Member/Advocacy Director
Power of Pain Foundation http://powerofpain.org

In attendence with
State Pain Policy Advocacy Network (SPPAN) Fellow Leader’s
Scott Clark of the California Medical Association (CMA) http://www.cmanet.org/
Maggie Buckley of the Pain Community http://paincommunity.org/

Power of Pain Foundation Co Sponsor Assembly Bill 623

california-sacramento-state-capitol-1Yesterday the Power of Pain Foundation Co-Sponsored AB 623 with Assembly Member Wood at the California State Capital in Sacramento where the bill was officially introduced.  I spoke on behalf of both pain patients and opioid abuse. In attendance with me and on behalf of POPF and the bill was Erik VanFleet, Kharisma VanFleet, Debbie Ellis, and Brandy Ellis.

Speaking at the event was: Assemblymember Wood (author), Assemblymember Levine, Mendocino County Sheriff Tom Allman,  Ralph A. Cansimbe, Chapter Commander PFC Alejandro R. Ruiz Chapter, American G.I. Forum, Representatives from bill sponsors US Pain Foundation, Power of Pain and American Chronic Pain Foundations and the CA Academy of Physician Assistants.

Legislation to Curb Prescription Drug Deaths UnveiledAB623_March242015_POPFCoSponsorWithAssemblymanWood

Published on Mar 26, 2015

(Sacramento) – California legislators, public health representatives and law enforcement officials announced new legislation at a State Capitol news conference to curb prescription drug abuse and deaths. Assembly Bill 623, authored by Assemblyman Jim Wood (D-Healdsburg), aims to reduce prescription drug abuse-related deaths by reducing their access to those most prone to abusing them. More than 60 people die every day in the United States from prescription drug overdoses. Approximately 6.5 million people in the US abused prescription drugs in 2013, more than double those that abused heroin, cocaine and hallucinogens combined. “Narcotic pain medications, or opioids, have an important role in our health care system,” said Assemblymember Wood, who is a licensed dentist. “They provide effective relief for the millions of Americans who suffer from chronic pain. But too easily they are getting into the wrong hands.” Here’s more in this Assembly Access video.http://www.asmdc.org/wood

Watch the Press Conference on Assembly Live

AB623_March242015_POPFCoSponsorWithAssemblymanWood_1

My speech-

Hello, My name is T. VanFleet, I am the Advocacy Director and Executive Board Member of the Power of Pain Foundation. I am also a pain patient myself. Through painful trial and error, my physicians and I have finally found the appropriate combination of medications to provide some relief from my debilitating symptoms. The prescription medications that I take allow me to do things that most people take for granted. Now, I celebrate small triumphs such as cooking, occasionally attending a function, and watching my grandson grow. One of the medications that helped give me my life back is a prescription opioid. A type of medication which has recently come under increased scrutiny due to heavy abuse by some.

Unfortunately, people who use prescription medications as intended can become unfortunate casualties of efforts to regulate opioid abuse, as we end up getting lumped in with those who misuse treatments. It is difficult to obtain refills,, denials and delays by pharmacists and insurance, including workers compensation leave patients in withdrawal and un-manageable circumstances including suicidal ideation.

Fortunately, there are new weapons available to help combat prescription opioid abuse which do not sacrifice the many patients who legitimately use the medications to fight pain. New “abuse deterrent formulations” (ADF) for opioids have properties that make it difficult or undesirable for someone to tamper with them. These medications are made with physical and chemical barriers, such as a special kind of coating or hardness to the pill itself, that won’t allow them to be chewed, crushed, cut, grated, ground up, or melted with water or alcohol.

The Power of Pain Foundation strongly believes that California policymakers must enact policies such as AB 623 to help develop a strong, lasting solution to the health crisis of prescription opioid abuse. We must find a balance that separates patients who truly need opioid medication to live productive lives and those who are abusing them. Responsible patients should not be punished in an attempt to crack down on prescription drug mis-use and abuse. Legislators, health care professionals and pharmaceutical companies must work together to stop opioid abuse while keeping the needs of chronic pain patients front-of-mind.

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I was honored to support this bill with Assemblyman Wood on behalf of the Power of Pain Foundation. It’s important that we assist in the prescription opioid drug abuse problem. This will help responsible pain patients get access to the care they need. Too many are denied now because of the stigma attached to their chronic pain identity. Abuse deterrent formulation’s will assist both issues.

AB623_March242015_POPFCoSponsorWithAssemblymanWood_2

Press Release Article Tuesday, March 24, 2015

Legislation to Curb Prescription Drug Deaths Unveiled by Assemblyman Jim Wood

For more information on the Power of Pain Foundation’s Policy Efforts, please visit-

Power of Pain Foundation | Policy Efforts | PatientAwareness.org

patient-awareness1-popf

-Friday March 20, 2014 Episode of

The Burning for a Cure show

With Hosts POPF President, Barby Ingle and POPF Executive Board Member & Marketing Director and Promotions Chairman – Joeygiggles and Co-Hosts Executive Board Member and Advocacy Chairwoman Twinkle VanFleet with Power of Pain Foundation Executive Director Ken Taylor.

Discussion: Legislation- Abuse Deterrent Formulation (ADF), more  Listen Here

Out in the real world, I try not to identify as a pain patient. We will be judged. You know it, and I know it. It becomes our label. As I attempt to go forward in advocacy it can sometimes be a little awkward. Not in my physical appearance, but In my inability to speak properly, delays, memory, forgetfulness, stuttering, wake-sleep, sleep-wake. I’m heading into my 15th year with CRPS type 2. My Neurocognitive deficit seemed a rapid decline. It’s part of the story that helps me fight to go on, for my family, for you.

You have to hang on to you! It’s okay to not be perfect. It’s okay to not be your “yesterday”.

The struggle is real. We are who we’ve become.  And it really is okay in all that it is. We might not like it, but we have to learn to accept it.

POPF-CoSponsor-AB623_BrandyEllis_DebbieEllis_TwinkleVanFleet_March242015PostPressConferenceCaliforniaStateCapital

Perfection is all that you can achieve in the here and the now. Getting that shower, getting dressed, combing our hair. Those are the triumphs.

There’s so much worth in the smallest things.

I believe in you! Believe in you, too.

Thank you Barby Ingle for always believing in me and my ability even when I didn’t.

POPF_AB623_KharismaVanFleet_BrandyEllis_DebbieEllis_TwinkleVanFleet_March242015
Lets try to remember to not pre-judge a chronic pain patient on appearance or preconceived notions, but instead, assess on diagnosis, and credibility. ~Twinkle V.

Power of Pain Foundation- ADF and Access to Care

 

AZ State Capitol BuildingADF

Power of Pain Foundation recognizes that Abuse Deterrent Formulations are only a step forward
toward drug diversion. We know this isn’t the final answer. It allows an option for patients to
continue to be treated with opioid analgesics and removes many of the barriers involved in non abuse
deterrent medication.

 

POPF Pain Community Needs Assessment Survey

We are not focusing on any one treatment option, we are improving upon the patient/provider
relationship.

The purpose of our survey was to determine who is having trouble getting access to quality care.
who is being dismissed, who is being cared for by a primary physician, who is being sent to pain
management and who is having difficulty receiving ongoing pain care.

We are aware of many individuals who are not receiving proper medication management or treatment
and others who had been receiving care that are now facing obstacles.

Our goal is continued access to care. Our goal is patient empowerment.

Recent Articles

INEFFECTIVE TREATMENT ASSOCIATED WITH THE CHRONIFICATION OF PAIN by Barby Ingle
http://www.lynnwebstermd.com/ineffective-treatment-associated-with-the-chronification-of-pain/

BARBY INGLE ON CHRONIC PAIN AND OPIOIDS by Barby Ingle
http://www.lynnwebstermd.com/guest-post-barby-ingle-on-chronic-pain-and-opioids/

The Unintended Side Effects of Fighting Prescription Drug Abuse by Twinkle VanFleet
http://www.californiaprogressreport.com/site/unintended-side-effects-fighting-prescription-drug-abuseTwinkleV_SB1258

 

 

 

 

 

 

Barby Ingle: Tamper-proof pain drugs deserve support

http://www.desertsun.com/story/opinion/contributors/2015/02/28/ingle-pain-medication-%20tech/24144627/
With the Power of Pain Foundation as a sponsor of the new bill AB 623 on Abuse Deterrent
Formulations, the above article  Op-Ed by our President has special significance being published 2/28/2015.
#RareDiseaseDay http://www.rarediseaseday.org/

Our President also wrote articles for for WA, NV, AZ, and CA.
She wrote letters to legislators in MD, MO, UT, CO, AZ.
BarbyIngle-FillYourPrescriptionOfHope
We are committed to you!

 

Power of Pain Foundation Advocacy Committee
Twinkle VanFleet, Board Member, Advocacy Chariwoman

Barby Ingle: Tamper-proof pain drugs deserve support

:04 p.m. PST February 28, 2015

It’s no secret that the abuse of pain medications has led to a growing public health problem across the country. The numbers are alarming, and they are growing.

But also alarming is the number of people who suffer with chronic pain, including many who come to the desert seeking the arid climate for relief.

The problems are complex and multi-layered and I always applaud solutions that help to balance pain management with the cost that prescription drug abuse has on society. Promising technological advancements in recent years are proving to be an important part of the battle. Among these are so-called “abuse deterrent formulas” of commonly prescribed narcotic painkillers that are being developed to prevent some of the most deadly forms of pain pill abuse.

Since 2002, I have been battling Reflex Sympathetic Dystrophy (RSD), a progressive neuro-autoimmune condition that affects multiple systems in the body. I know firsthand how difficult the journey for relief can be, particularly the sidelong glances and disbelief from medical professionals. One in three people (116 million) in the United States are affected with a condition that causes pain.

But what if there were medications that can offer pain sufferers relief, while also protecting those who might be prone to abuse them?

There are. These little known, new tamper proof formulas of strong narcotic pain medications provide patients with the same pain relief as conventional opioids, while incorporate breakthrough technology designed to protect against tampering and abuse.

Several states are considering legislation this year to improve and safeguard patient access to these new formulas of painkillers.

Abuse-deterrent formulations have received widespread support as part of a comprehensive effort to combat prescription drug abuse and promote appropriate pain management, including from the Office of National Drug Control Policy, the Community Anti-Drug Coalitions of America, members of Congress, and the National Association of Attorneys General — including California Attorney General Kamala Harris.

Abuse of pain medications has led to a growing public health problem in California and nationwide. Each year approximately 4.5 million Americans use prescription pain medications for non-medical purposes, contributing to more than 16,000 deaths annually.

This technology is only part of the solution; but it is a solution nonetheless. Patients that have struggled with addiction or substance abuse in the past, those who live with others who are current or recovering addicts and those who live with teens or young adults who may seek opioids for recreational use can all benefit from ADFs.

Abuse-deterrent formulations have received widespread support as part of a comprehensive effort to combat prescription drug abuse and promote appropriate pain management, including support from the Office of National Drug Control Policy, the Community Anti-Drug Coalitions of America, members of Congress and the National Association of Attorneys General.

To date, the Food and Drug Administration (FDA) has approved abuse-deterrent labeling for four drugs, with other abuse-deterrent opioids in various stages of development.

For the sake of those with legitimate, life-altering pain and for the safety of those prone to use these medications for non-medical use, I urge our lawmakers to stand up for policies that preserve and improve patient access to this new technology. Failing to do so would be failing to do all we can to protect our residents.

Barby Ingle is a chronic pain educator, patient advocate and chairman of the board for the Power of Pain Foundation.

via Barby Ingle: Tamper-proof pain drugs deserve support.

Another excellent article “urging our lawmakers to stand up for policies that preserve and improve patient access”. With the Power of Pain Foundation as a sponsor of the new bill CA AB623 on Abuse Deterrent Formulations addressing Opioid Abuse, this Op-Ed by our ‪#‎POPF‬ President has special significance being published today, ‪#‎RareDiseaseDay‬

How should U.S. regulate powerful painkillers?

American Academy of Pain Management’s Executive Director, Bob Twillman, PhD discusses opioid prescribing and regulations on PBS’s Newshour

Forty-six people die every day in the U.S. after overdosing on prescription painkillers, causing some states to crack down. Are tighter laws creating new problems? Judy Woodruff gets views from Bob Twillman of the American Academy of Pain Management and Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing.

TRANSCRIPT (Partial)

JUDY WOODRUFF: Each day, 46 people die in this country after overdosing on prescription painkillers.  In 2012 alone, the CDC says 259 million prescriptions were written for painkillers, enough to supply every American adult with a bottle of pills.

Now many states are pushing back, including New York, Tennessee, Kentucky, Florida, and Washington State.  Three of those states now require doctors to check a patient database before writing a prescription.  This year, Massachusetts, Rhode Island, Georgia, and Texas are also considering tighter laws.

But some physicians and patient advocates say this crackdown is creating new problems.

We get two views now.

Dr. Andrew Kolodny is the director of Physicians for Responsible Opioid Prescribing.  He’s also chief medical officer for the Phoenix House Foundation.  It’s a national nonprofit addiction agency.  Bob Twillman is the executive director of the American Academy of Pain Management and also a clinical psychologist at the University of Kansas Medical Center.  Mr. Twillman was caught in a traffic jam tonight.  He couldn’t make it to the studio, so he joins us by telephone.

Read the rest of the transcript and listen to the podcast-

via How should U.S. regulate powerful painkillers?.