Benzodiazepine Information Coalition recently responded to the FDA’s Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products. This document proposed by the FDA seeks to distinguish the difference between addiction, drug abuse and dependence. We are in full support of this proposal of these distinctions as harmful and inaccurate addiction language has muddied the message of benzodiazepine survivors for decades and resulted, for many, in forced or overly-rapid cessation for compliant patients experiencing prescribed physical dependence.
August 30, 2019
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket Number 2019-14061
Dear Food and Drug Administration:
Benzodiazepine Information Coalition (BIC) is a 501(c)(3) nonprofit organization that brings together a network of medical professionals, patients, and other volunteers to educate a broad audience about the adverse effects of prescribed benzodiazepines (BZs) and Z-drugs. Our mission is to inform the general public, media, and medical professionals about the risks of these drug classes and the resulting epidemic of patient injury. We have reviewed your document entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry,” and have the following comments:
First, we appreciate you taking the time to define the terms “abuse, misuse, addiction, dependence, and tolerance,” and are in agreement with how they are defined in the document. We also are pleased to see that you made further distinction between addiction and physical dependence, clarifying that they are “not synonymous.” These terms are often confused in clinical practice, to the detriment of the patient, as appropriate treatment plans differ between the two entities.
On this note, we recommend that in the section on physical dependence, it should be made clear that physical dependence can happen even when the medication is taken EXACTLY AS PRESCRIBED. We are aware of many patients who were shocked to find out they developed physical dependence on their benzodiazepine and/or Z-drug, because they were following their doctor’s orders, often only being warned about the risk of addiction when beginning the prescription, while the risks of physical dependence and adverse events were never properly explained.
In the section that recommends provision of “treatment and mitigation of dependence and withdrawal symptoms,” we believe this should be taken one step further. Detailed taper plans or links to tapering resources (such as “The Ashton Manual” for benzodiazepines) should be provided.
Benzodiazepine Information Coalition is dedicated to patient safety, physician education, full informed consent, and prevention of adverse events related to benzodiazepines. If we can be of further help, specifically on the future content in the benzodiazepine labels, please contact us at bic@benzoinfo.com.
Sincerely,
Benzodiazepine Information Coalition
The difference between addiction and drug-injury is so clear and has been so for decades. The UK benzo-effort is lauded as way ahead of the rest of the world as it insists that the injured are still addicts. When corrected, their benzo charity workers say that it is addiction but also involuntary addiction. This is most clearly false. Still it permeates the literature from that country.
Put simply: addiction is characterized by a compulsion to use a substance when the serious consequence of doing so is clearly harmful. I’ve worked in this arena for 13+ years now, and I never have met a benzo-addict. Every benzo-sick person took as directed and simply trusted the wrong people. That was not difficult to see. Even the “benzo-wise” docs have nothing to offer.
Why is this distinction important? An extreme benzo withdrawal syndrome can be used as grounds for involuntary commitment. Once incarcerated, a struggling benzo-patient is forced into mega drugging. What creature can overcome that? You’re not an addict, but few care.
That you BIC Board Members for taking this measure on. I am currently a patient in an out patient program at a major and world known hospital in Toronto. I also see an “Addictions Counselor.” I wish more than ever they could change their program’s name “Substance Use and Dependence Program”, as I never abused my medication!!!! Like so many of us out there, I only ever took it as prescribed by my doctor. I was never told about the fact that Benzodiazepines could cause physiological dependence, nor how difficult it would be to ween off of them. I was grossly mismanaged and kept on these drugs for a year and 5 months, until I sought help. My life has been put on hold as I suffer through these horrific side effects!!! So for me, I want acknowledgment that I developed dependence and reached tolerance on my medication, and not that I became “addicted”, as to me that word is synonymous with someone choosing to misuse their medication. There is a HIGE difference between the two phrases and for many of us that were naive and trusted our doctors had our best interests at hand, we should have the right to use the term that best describes us- physiologically dependent!!! What upsets me as well, is that my note to my employer COULD state that name! I asked that I just have the doctor sign her name and she did, but if they wanted to, they can easily look her up and see she specializes in Substance Abuse. I am a teacher am worried about that “title” will be associated with my name or that I may be red-flagged as having a substance abuse problem, which is so very far from my reality. I wish you all the best as you venture forth with these pursuits.
If I’m understanding ‘billable’ correctly with my anxiolytically cognitively impaired brain from my c/t Klonopin withdrawal, and decades taking psychotropic drugs; Doctors can knowingly prescribe a highly addictive drug to patients and then profit off the side effects, adverse effects and their withdrawal symptoms that we’re forced to endure? Am I comprehending this correctly?
ICD-10 Code F13.231 – https://icdlist.com/icd-10/F13.231
Sedative, hypnotic or anxiolytic dependence with withdrawal delirium
Long Description: Sedative, hypnotic or anxiolytic dependence with withdrawal delirium (delirium is putting it mildly. It’s utter mental torture.)
Valid for Submission: ICD-10 F13.231 is a billable code used to specify a medical diagnosis of sedative, hypnotic or anxiolytic dependence with withdrawal delirium. The code is valid for the year 2019 for the submission of HIPAA-covered transactions.
Dear Sondra
Everything you say is exactly right since I know firsthand ?
And, Dr Zel Dolinsky, it’s Sandy, not Sondra…
Actually, my bad as well: “Sandra”… I know her personally as “Sandy”
And thank you, Dr Zel Dolinsky, very much for being truthful with first-hand information
Hi Sandy,
We as patients within an industry that we as children were taught to trust, now, more than ever, somehow need to stand up against filthy medical greed and disclose — unsolence — this type of obvious outright legal corruption. This is why, in one benzoinfo comment, I brought forth one method that could prevent doctors from minimizing or denying real adversities when introducing such dangerous drugs as benzodiazepines, as you and I both know is usually learned the hard way, when, if it’s learned the hard way, it’s already too late, almost. “Almost” because, as thousands of other struggling benzodiazepine — what could easily be interpreted as victims, I too am still trying to survive and without the “almost” would be giving up and we cannot give up. Keep up the good work my friend, my very good, priceless friend. And thank you so much for sending me all that helpful information years ago when no one else was stepping up with helpful coping mechanisms.
Together we can use lost battles that we have endured and focus on the overall war against medical greed, in saving just one person from the living hell is worth our efforts, as we have, and are, surviving, even as compromised as our lives have become.
You are truly a remarkable person.
My suggestion involves a contract between a patient and a prescribing physician that discloses updated, true adversities and it suggests that minimizing drugs’ potentials should be outlawed, where this contract is signed by both, before any pill is ever taken. And this is a short, even lacking exclamation as I’ve learned long explanations are not usually read — I suspect… And yes, I realized that this isn’t just going to happen as a good idea, but it can only happen when enough people get educated and get tired of witnessing the suffering where standing up to prevent such obvious medical greed from happening becomes a priority.
We as patients need protection from filthy medical greed such as you have clearly outline in your comment/question.
Again, please let us keep up the messages of disclosing wrongdoing within this medical greed industry, and supply suggestions that can take root. And please know that I very much appreciate the good that comes from the medical industry, but as human traits will surface, even within doctors, greed will and has destroyed many lives. We need to use common sense preventive measures to prevent the destruction of so many lives as what is happening today.
Enough for now, we’ll talk soon. It turns out it’s actually a small world we’re living in after all… Your friend from Seattle, Matt