Abuse & Misuse Risk Assessment Tools from FDA – for Opioids, Ketamine, Adderall, Xanax, Ativan, Valium, Any Drugs of Abuse


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Risk Assessment Tools Examples from FDA.gov

page 11  (pdf)

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We must always remember, all of us, families, friends and physicians alike, the possibility of opioid use disorder (OUD) in anyone on chronic opioid therapy (COT) and those who are prescribed any drugs of abuse such as Ketamine, Adderall and benzodiazepines such as Valium, Ativan, Xanax. None of us should be taking medications that interfere with our ability to think and function. None of us should be taking more than we need. Many of us do not realize that less is more.

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Details of many tools for risk assessment are reviewed previously here.

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Keep this in mind:

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  • “Assessing risk of abuse and OUD in patients receiving COT is a dynamic, ongoing process.

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  •  Diagnosing misuse, abuse and OUD in patients with pain is complex

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  • Current screening tools do not diagnose abuse or OUD but only misuse and not intent”

     

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Tools

# of Items

 Administered

Patients considered for long-term opioid therapy:

ORT Opioid Risk Tool

5

By patient

SOAPP® Screener & Opioid Assessment for Patients w/ Pain

24, 14, & 5

By patient

DIRE Diagnosis, Intractability, Risk, & Efficacy Score

7

By clinician

Characterize misuse once opioid treatments begins:

PMQ Pain Medication Questionnaire

26

By patient

COMM Current Opioid Misuse Measure

17

By patient

PDUQ Prescription Drug Use Questionnaire

40

By clinician

Not specific to pain populations:

CAGE-AID Cut Down, Annoyed, Guilty, Eye-Opener Tool, Adjusted to Include Drugs

4

By clinician

RAFFT Relax, Alone, Friends, Family, Trouble

5

By patient

DAST Drug Abuse Screening Test

28

By patient

SBIRT Screening, Brief Intervention, & Referral to Treatment

Varies

By clinician

 

Ketamine in Bipolar Depression – A Review


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An excellent review of Ketamine, a rapid-acting antidepressant and anti-suicidal agent, in Bipolar Depression

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Efficacy of Ketamine in Bipolar Depression: Systematic Review and Meta-analysis. 

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Parsaik AK1, Singh B, Khosh-Chashm D, Mascarenhas SS.

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OBJECTIVE: To consolidate the evidence from the literature to evaluate the role of ketamine in the treatment of bipolar depression.

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METHODS: Major databases, including MEDLINE, EMBASE, Cochrane, and Scopus, were searched through October 2014, for studies reporting the role of ketamine in the treatment of bipolar depression. Only randomized controlled trials were included in the meta-analysis. We calculated standardized mean differences (SMDs) with SE for each study included in the meta-analysis. A random effect model was used to calculate the pooled SMDs. Heterogeneity was assessed using the Cochran Q test and I statistic.

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RESULTS: Of the 721 articles that were screened, 5 studies that enrolled a total of 125 subjects with bipolar depression (mean age, 44.6+/-4.3y and 65.6% females) were included in the systematic review; 3 randomized controlled trials (69 subjects) were included in the meta-analysis. The meta-analysis showed significant improvement in depression among patients receiving a single dose of intravenous ketamine compared with those who received placebo (SMD=-1.01; 95% confidence interval, -1.37, -0.66; P<0.0001). The maximum improvement was observed 40 minutes after the ketamine infusion. No heterogeneity was observed between the studies (Cochran Q test P=0.38, I=0%). The 2 studies that were excluded from the meta-analysis also showed significant improvement in depression after ketamine therapy. Individual studies also reported improvement in anhedonia and suicidal ideation after ketamine therapy. None of the subjects had serious side effects, and the side effects were similar between the ketamine and placebo groups.

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CONCLUSIONS: This study suggests that ketamine is effective in treatment-resistant bipolar depression and may reduce suicidal ideation and anhedonia.

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The material on this site is for informational purposes only, and is not a substitute for medical advice,

diagnosis or treatment provided by a qualified health care provider.

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Please understand that it is not legal for me to give medical advice without a consultation.

If you wish an appointment, please telephone my office.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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The advertising below is not recommended by me.

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Dilaudid & Prenisone do not work for CRPS. It must be stopped or this will fail


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There is a young woman 3000 miles away who will soon be bitterly disappointed. This therapy will fail. It will be her choice to fail because she does not want to taper off Dilaudid and high dose prednisone. She has discarded physical therapy long ago, but needs it. She narcotizes her brain with Dilaudid and high dose prednisone and has given up on life the last 6 years.

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Let me be very clear. It will fail unless you get off those drugs. I will not start new ones because I guarantee you will be bitterly disappointed. All these weeks of work and what progress coming off? Send me reports regularly. What kind of doctor sits back and watches this?

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It’s a sin to take part in guaranteeing failure. I cannot allow my conscience to do that. As time goes by and you stay on failed drugs, there is a shrinking chance this treatment could help. I said last year, get off the narcotics. They do not work for CRPS. It is a delusion to think they work: you have been housebound 6 years. Love yourself. Give science a chance. Science shows how they create pain. It also shows how to modulate inflammation they have created in the brain.

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Just because the medical system doesn’t evolve with science, does not mean you continue known harm.

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It’s magical thinking to believe you can do the opposite of what science has been teaching us.

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Calling all angels to help her. Tell her your experience. Say a prayer. Keep her in your heart. And if you can, watch the movie Pay It Forward streaming now on Netflix. You will love it. It will open your heart. Everything about it is great, the acting, music, dialogue, story, really great. Every time you think it will be dopey, it gets better.

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So be honest. It ain’t easy living with nerve pain. It is possible no treatment will work. Some things may partially work. But there are things worth doing right. This is one of them.

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I will not participate in a sham. Do not nurse stale delusions. There are reasons to choose opioids. CRPS is not one of them. Be fearless. Meditate on the heart of a lion.

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To succeed requires great inward resolution. This is not the time to leave town. Either begin the work as directed, begin the P.T. immediately or recognize you are undermining that too. You know October will postpone everything even more.

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No one can help you. You must help you. This is what we taught every patient at UCLA Anesthesiology Comprehensive Pain Center in the 1980’s.  It is still true.

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Our entire medical system has been poisoned and deluded by the multi-billion dollar opioid factories supported by FDA, Congress and NIH. They prove it by decades of action. They have done nothing for your reality.

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Addendum September 2, 2016

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I am being attacked for posting the above. This article is not about dialogue. Go to some other site. This is educational.

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There is no dialogue because you can pick any doctor in the country who will give you opioids. But when you tire of chronic severe pain despite all those opioids, and your’re ready to try something else, some case reports of remarkable people have been posted on this site. Remarkable. I’ve never seen anything like it. But it’s not uncommon. What are the chances of that when they’ve failed everything? And yes, I do prescribe opioids to a few patients. There are indications. Opioids kill. Bodies age. What if they need acute painful surgeries? When will we get something better. I think ketamine is. It is shamefully underused in favor of drugs that trigger pro-inflammatory cytokines in the brain and that causes more pain.

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We will never move pain control forward until we begin to work with the science that’s immensely changed the way I can help patients become pain free or at least markedly better. Not every patient — I see very complex, extreme pain conditions. I will keep this site on the level of science, education and real breakthroughs. These complex medications I prescribe have been a huge breakthrough. My patients have failed everything before they see me. If they are still on opioids that never helped, I ask them to taper weeks or months before they see me. You cannot continue to make war on the system when you are aiming to make peace. To restore balance. To modulate the inflammation.

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My First Ketamine Patient 

Ketamine in Outpatient Use

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I had the wonderful memory tonight of my first patient. I actually handed ketamine to someone to use at home for pain. This was about 2000, 2001. She was a very enlightened clear soul who had 7 or 8 spine surgeries with 30 years of sciatic and back pain rated 10 on scale of 10. Failed all known procedures in the greater L.A. area. Then she got a painful neuropathy evolving in less than 2 weeks, burning pain below elbows and knees.

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I had been reading ketamine publications for 3 years and had a whole big stack of them. The most exciting thing I’d ever seen for almost every known pain, central pain, all pain. I attached that article on this site May 26, 2009. A review by Cousins, one of the world’s most highly rated pain specialists.

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I couldn’t bear not being able to help. I interviewed many psychiatrists who began the experiments with ketamine at NIMH in 1991, called as many researchers as I could, and a neurologist who had done work in this area ketamine/brain. He was just appointed head of an institute. He precisely spelled out the arguments against those who fear do not use due to brain issue in primates. I am very cautious with patients. No one was doing this. In fact I did get harshly attacked for giving someone ketamine.

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I instructed a very slow start. Two weeks later, she called me and said she thought she had died. I will never forget I was parked in the doctor’s parking lot, exact time, sunny morning, one of those perfect clear days of early summer when it’s not too hot, my breathing stopped. “But I hadn’t been pain free in 30 years and I didn’t remember what it felt like.”

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It is rare to get 100% with ketamine.

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The patients I see are complex. They have failed everything. The things they have been through and renowned specialists they have seen, even ketamine coma does not last. It is a short lasting drug. How much time do you want to spend on procedures vs convenience of using a medication when your body needs it. Even that is idealized.

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Chronic pain, especially nerve pain, is most difficult to treat. It is never all about medicines. Never. You must learn tools to give the power of conviction to your mind that you can be strong. You cannot afford to fall apart because that makes pain worse. Tools you use or else pain. Once we know, we can take action. Same with muscles that have been inactive for years. Tools we all learn – the entire family together can be taught what it takes for physical therapy. We cannot help all people. They need family help to bathe and dress.

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For CRPS especially, we want to prevent spread, mirroring, appearing in the other limb and areas. I like to think of it like a football game. You’ve failed everything known, that makes it potentially harder. But you’ve gotta win this game. You have one guy running down the field with a football, how many guys are you going to send after him? What if 3 or 4 guys only partially help? Add that up and you may have extra 30 or 40% relief. Hit is hard, selectively chosen glial modulators and others with mechanisms on these pathways, get it to zero – or give it the best chance to get it near zero pain. That’s the first goal.

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Nothing is perfect. Nothing in medicine is perfect. It is still an art, not a science. But it is a gift to be able to use these tools that I’ve put together the last 15 years. And thrilling to see the science come out explaining even more the power of the innate immune system, the glia. Had the practice of medicine evolved, we’d have developed the timing of the circadian clock in these cells to prevent postoperative chronic pain, or minimize sending the inflammation into overdrive. Opioids damage the balance of inflammation in a system already exploding with pain. It would be a miracle if “they” ever stop reaching for opioids first. Do they even understand they are doing the opposite of  relieving pain, or care that better choices exist? Perhaps, but it would take a multi-zillion dollar study. Pain is only taught in 3% of medical schools. It loses money for the schools.

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Veterans Suicides 20 per day – MD not paid in 12 months for 5 approved visits


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VA Conducts Nation’s Largest Analysis of Veteran Suicide

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Read the report all you want, but for 12 months I’m not reimbursed. And no explanation why. No wonder they can’t get doctors.

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Yet another call just now from TriWest asking me to treat a veteran. VA crisis lines leave vets in limbo. Calls go to voice mail. Veterans have killed themselves just after calls to crisis lines. A lot of these suicides are due to PTSD. Veterans cannot get the help they need.

 

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I believe it is TriWest who won the contract to schedule suicidal veterans who have Treatment Resistant Depression or PTSD or Bipolar Depression. I treat that. It works except in the most extreme cases, in minutes to just a couple days. It’s simple and safe for outpatient use. It has been tested at NIMH and Yale since 1991. The VA-UCSD psychiatrist referred him and then continued care.

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I will not see one more veteran until I am reimbursed for the 5 pre-approved visits for a veteran I treated 12 months ago. He was better in a few days, the first time in decades he had relief of depression. If you cannot pay me who can relieve treatment resistant Major Depression in 2 days, then honey, no wonder you can’t find docs to help. They limited me to their chosen codes for billing. I spoke to psychiatrists who work with veterans and they have never heard of those codes. I guess they just mean loud and clear: NO PAY. Fine. It was a pay cut to offer and took weeks of paper forms, months of approval – you have to really want to do it. With frequent help from a very experienced clerk and a doggedly informed veteran who knew all the ropes, it took months for paperwork to get rushed through. Plenty of doctors just graduating this month don’t know how many months paperwork takes and they won’t get paid.

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San Diego VA has the worst reputation in the nation. I understand it is the San Diego VA that has the worst lag time delays of several months before veterans can even be seen. Worst in the country. Correct me if I’m wrong. And we have a lot more veterans because warm sunny weather is easier on their bones. Is that any excuse to dis-incentivise any doctor by not paying for services?

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The new veterans suicide hotline does not even return all calls. Public Radio just had an expose’ on this one or two weeks ago.

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Twenty veterans take their life daily.

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Only 30% of people with depression respond to antidepressants.

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Based on publications from major academic centers, treatment resistant depression, it seems, is diagnosed after failing as few as 3 or 4 antidepressants.

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Compare any antidepressant to ketamine with potential relief in hours to a couple days.

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It’s not like this is new. In 1991 ketamine was first studied at NIH for depression. Yale has carried the work forward with them. But people live at home and it has to be cost effective. It is unnecessary and/or unaffordable for most people including taxparers to be paying for IV infusions when many or most patients do well on sublingual or nasal use. It is the #1 drug of abuse in China, so don’t just offer it to any person who needs it. Make sure you understand how important glial modulators are in depression. See Yale with NIMH publication on inflammation in depression, I posted on these pages about 3 or 4 years ago when it came out.

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Yale with NIMH had published that ketamine rapidly creates synapses.

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And Yale has published:


Activation of a ventral hippocampus–medial prefrontal cortex pathway is both necessary and sufficient for an antidepressant response to ketamine

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In January 2012, I posted detailed information:

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Depression PTSD – Ketamine Rapid Relief

 

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  • PTSD has a more direct link to suicide than previously thought, a current Texas A&M University study concludes – references below.

  • A high lifetime risk of suicide occurs in women who have been sexually and physically abused as young girls.

  • More than 300,000 veterans have been diagnosed with PTSD or major depression – many not yet diagnosed.

  • Risk of suicide is the highest during the first month of standard antidepressant therapy, and a significant number of patients do not have adequate improvement even after months, resulting in harm to personal and professional lives.

  • Patients are at suicide risk upon discharge from psychiatric hospitals.

  • Significant predictors of both suicide attempts and preoccupation with suicide are guilt and anger and impulsive behaviors.

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  • Ketamine is the most important breakthrough in treatment of major depression with rapid and lasting effects.

  • Ketmine can help immediately, unlike all other antidepressants that may require weeks or months to work, if they help at all. See NPR report here – that appeared soon after I posted this (skip to their last section). It is FDA approved and legal. NPR again reports ketamine’s rapid relief of depression.

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    • The medical literature on ketamine use is profoundly important. There are over 6,800 medical publications. Ketamine has potent healing powers. Karl Jansen, psychiatrist in London, believes that “ketamine has potent healing powers when used as an adjunct to psychotherapy.” There is nothing like it; however, treatment for serious depression still requires team support, not medication only.

    •  The World Health Organization reports that disability to due depression is second only to heart disease.

    • Suicide is a catastrophic medical emergency. I cannot stress this enough. Depression is treatable.

    • Your death is unnecessary. It would be a terrible loss to all who love you.

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Please read that entire post January 2012 before you call to ask questions. The calls are very time consuming.

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There is no reason to restrict life and death matters to one drug, and then make it dependent upon only IV infusions. What kind of life is vegetating in depression for decades? It is a short acting drug. I have posted on why ketamine should never be used alone, but must be used with other glial modulators.

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Most troubling:

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Compounded Medications are Not Covered by Any Insurance

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Most people cannot afford compounded medications, especially if disabled due to Major Depression or PTSD or pain – same medications work on mood and pain.

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TAKE ACTION

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Healthy people can get back their lives. These simple steps can be taught across the nation. Millions are needlessly disabled, especially our young adults who are most vulnerable to these disorders, and several hundred thousand of our young veterans.

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An entire nation can get and breathe relief.

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DO THIS:

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Call your favorite politician and relevant organizations who care about healthcare and veterans to STOP the collusion and restraint of trade since all insurers began refusing to cover compounded medications. All these new $100,000 per year medications are paid for by the taxpayers and your insurance deductible that goes up every year. How long will you be able to afford medical care? How long can this restraint of trade be practiced under our noses unless we take action?

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Get this on the Democratic platform this presidential year. It’s a scam perpetuated by multibillion dollar pharma and their mighty rich contributions to congress who are killing affordable medical care.

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Affordable medical care

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These medications must be compounded. How many can afford $200 to $300 or more cash out of pocket just for medications? Or will this become another safe old drug that is bought by a financier, patented, and now they charge $100,000 a year? You know who pays for everything and it ain’t the 1%.

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Ketamine Survey for MD’s from RSDSA – Please Help


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Jim Broatch, Executive Director of RSDSA requests help from doctors giving IV Ketamine to treat CRPS. Please ask your doctor to do the survey. 

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 https://www.surveymonkey.com/r/ZPP9BXY

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And remember, if you shop Amazon, you can direct Amazon to contribute a portion to RSDS.org —- many thanks! 

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This site is educational, not for email.

Relevant comments are welcome.

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Advertising on this free website, below, is not endorsed or sanctioned by me.

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Complex Regional Pain Syndrome in Remission 6 years


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 Complex Regional Pain Syndrome

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Celebrating six years of complete remission

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Why ketamine should never be used alone

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I first posted her case here. 

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For years, pain below both knees was 8 to 9 on scale of 10, “like I had swallowed a fire burning.”

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She was unable to stand or walk for more than 4 years before seeing me. This week, I again saw this very healthy athletic RN who at almost 70 of age is very youthful, very energetic. She failed IV ketamine given first by Dr. Schwartzman daily for one week, then boosters for 8 months.

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After 8 months of ketamine, then no response at all. None. 

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That’s when I prescribed other glial modulators and rational polypharmacy that brought CRPS into remission. Then very very slowly tapered off all but one, leaving only low dose naltrexone (LDN) for the last 8 years. Zero pain. None. Hiking, working, fully active.

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When used in conditions with known neuro-inflammation, rats or human, LDN is a one of the most powerful, most effective glial modulators I have ever seen clinically in my patients in the last 15 years.

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Until proven otherwise clinically, LDN should be taken lifelong in those cases.

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This website is not for email.

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The advertising is not approved by me and

unrelated to anything on these pages.

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The material on this site is for informational purposes only, and

is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

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For My Home Page, click here:  Welcome to my Weblog on Pain Management!

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Ketamine Prescribed Since 1994 – My Experience


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Ketamine offers an opportunity for normal life unmatched by any medication I know of when given off-label for chronic treatment of intractable pain, treatment resistant depression, bipolar depression, juvenile bipolar disorder. It is one of the safest medications I have prescribed in 41 years of medicine. I have never seen anything more effective – it is not a cure, but remission is highly possible. Please refer to peer reviewed references since 2009 on this website on ketamine and depression or pain. Read elsewhere about street drugs, junkies, addicts and media headlines.

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Never Ketamine Alone

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Ketamine is short acting no matter how it is given.

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I never prescribe ketamine by itself – a fools errand; the religion of ketamine is like the religion of opioids. Decades of intractable conditions and chronic neuroinflammation require more than one short acting drug and usually require a multi-disciplinary approach. I work with psychologists or psychiatrists and other specialists when indicated.

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Entourage effect 

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DRUGS ARE LIKE POLITICIANS. A FAMOUS POLITICIAN MAY WALK UNRECOGNIZED, BUT WHEN YOU SURROUND HIM OR HER
WITH MANY PEOPLE, EVEN OF LESSER STATUS, THE POLITICIAN HAS A FAR MORE POWERFUL EFFECT.

Mechoulam

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1994 – I first prescribed IV when teaching cancer pain at MD Anderson Cancer Center.

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2001 – prescribed for outpatient care of chronic intractable pain

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2011 – prescribed for treatment resistant depression, bipolar depressed, juvenile bipolar/fear of harm phenotype often diagnosed as oppositional defiant disorder.

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2009 – writing about ketamine, neuro-inflammation and glial modulators on this site, with classic references to publications from the foremost peer reviewed journals, including low dose naltrexone, oxytocin.

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Dosing

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Depression, Bipolar Disorder, Juvenile Bipolar/FOH, treatment resistant – may need a dose only twice daily or every 3 days. The dose and frequency of use cannot be predicted – it is idiosyncratic – look up that word.

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Intractable pain – dosing and frequency of medications is very different than for depression.

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My work with these medications, these glial modulators, is too extensive to annotate on these pages. This website since April 2009 has references for context and guidance with active links to peer reviewed publications. Example:

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Clinical experience using intranasal ketamine in the treatment of pediatric bipolar disorder/fear of harm phenotype. D Papolos et al, J Affect Disord. 2013 May;147(1-3):431-6.

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RESULTS:

Ketamine administration was associated with a substantial reduction in measures of mania, fear of harm and aggression. Significant improvement was observed in mood, anxiety and behavioral symptoms, attention/executive functions, insomnia, parasomnias and sleep inertia. Treatment was generally well-tolerated.

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CONCLUSIONS:

Intranasal ketamine administration in treatment-resistant youth with BD-FOH produced marked improvement in all symptomatic dimensions. A rapid, substantial therapeutic response, with only minimal side effects was observed. Formal clinical trials to assess safety and efficacy are warranted.

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mTOR-Dependent Synapse Formation Underlies the Rapid Antidepressant Effects of NMDA Antagonists. R Duman et al, August 2010, Science, Science 2010 Aug: Vol. 329, Issue 5994, pp. 959- 964. [this article free with registration]
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ABSTRACT:

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We observed that ketamine rapidly activated the mammalian target of rapamycin (mTOR) pathway, leading to increased synaptic signaling proteins and increased number and function of new spine synapses in the prefrontal cortex of rats. Moreover, blockade of mTOR signaling completely blocked ketamine induction of synaptogenesis and behavioral responses in models of depression. Our results demonstrate that these effects of ketamine are opposite to the synaptic deficits that result from exposure to stress and could contribute to the fast antidepressant actions of ketamine.

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“The resulting protein synthesis and neuronal alterations in the medial prefrontal cortex are the opposite of those produced by chronic stress….”

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Read elsewhere about street drugs, junkies, addicts and media headlines.

If that is you, see an addictionologist, not me.

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Some medications can be drugs of abuse but every patient and every medication that I dispense is followed meticulously. If any sign of misuse or abuse, that unfortunate person is immediately discharged and referred elsewhere.

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For my Home Page, click here: 

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Welcome to my Weblog on Pain Management!

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This site is not for email or medical advice.

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It is not legal for me to give medical advice

unless you are my patient which means I have done a medical history and examination.

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I generally accept only those who have failed most or all known treatments, and only those who I feel I can help.

 

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I interview each patient before accepting.

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Any advertising below is not recommended or condoned by me.

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