IASP Statement on Opioids

https://www.iasp-pain.org/Advocacy/OpioidPositionStatement

Opioids are indispensable for the treatment of severe short-lived pain during acute painful events and at the end of life (e.g., pain associated with cancer). Currently, no other oral medication offers immediate and effective relief of severe pain. Although opioids can be highly addictive, opioid addiction rarely emerges when opioids are used for short-term treatment of pain, except among a few highly susceptible individuals. For these reasons, IASP supports the use and availability of opioids at all ages for the relief of severe pain during short-lived painful events and at the end of life. IASP’s 2010 Declaration of Montreal states that access to pain management is a fundamental human right. In some cases, there is no substitute for opioids in achieving satisfactory pain relief.

Despite this stated value of opioids, the role of opioids in the treatment of chronic pain has come into question. Recent open-ended and indiscriminate long-term prescribing of opioids in the United States and Canada has led to high rates of prescription opioid abuse, unacceptable death rates, and an enormous burden to the affected societies. This burden has been a consequence largely of opioid prescribing for the treatment of chronic pain, where long-term effectiveness is uncertain and where harms, especially for high doses, are clear and strongly supported by cautionary data from the affected countries. Such harms include, but are not limited to, addiction and death. Increased prescribing for chronic pain is occurring in some other developed nations, while the developing world continues to struggle with lack of opioid availability for appropriate indications.

IASP strongly advocates for access to opioids for the humane treatment of severe short-lived pain, using reasonable precautions to avoid misuse, diversion, and other adverse outcomes. At the same time, IASP recommends caution when prescribing opioids for chronic pain. There may be a role for medium-term, low-dose opioid therapy in carefully selected patients with chronic pain who can be managed in a monitored setting. However, with continuous longer-term use, tolerance, dependence, and other neuroadaptations compromise both efficacy and safety. Chronic pain treatment strategies that focus on improving the quality of life, especially those integrating behavioral and physical treatments, are preferred. IASP also strongly advocates for continued research to identify ways to minimize opioid risk and find effective alternatives to opioids for the treatment of various pain problems.

Notes

  1. This statement is based on best available evidence and expert opinion. See References below.
  2. IASP recommends adherence to and promotion of local opioid prescribing guidelines, with special attention to assessing the supportive evidence with appropriate scientific rigor.
  3. IASP recognizes the importance of comprehensive educational efforts to teach safe and appropriate opioid use.

References

  1. Contextual evidence review for the CDC guideline for prescribing opioids for chronic pain – United States, 2016. CDC Stacks, Public Health Publications, March 18, 2016.
  2. Injury Prevention and Control: Opioid Overdose. Prescription opioid overdose data. Centers for Disease Control, Atlanta, GA, 2016.
  3. Attal N, Cruccu G, Baron R, Haanpaa M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol 2010;17(9):113-e88.
  4. Baron MJ, McDonald PW. Significant pain reduction in chronic pain patients after detoxification from high-dose opioids. J Opioid Manag 2006;2(5):277-82.
  5. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011;305(13):1315-21.
  6. Boscarino JA, Rukstalis MR, Hoffman SN, Han JJ, Erlich PM, Ross S, Gerhard GS, Stewart WF. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis 2011;30(3):185-94.
  7. Campbell G, Nielsen S, Bruno R, Lintzeris N, Cohen M, Hall W, Larance B, Mattick RP, Degenhardt L. The Pain and Opioids IN Treatment study: characteristics of a cohort using opioids to manage chronic non-cancer pain. Pain 2015; 156(2):231-42.
  8. Case A,Deaton A. Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century. Proc Natl Acad Sci USA 2015; 112(49):15078-83.
  9. Cherkin DC, Anderson ML, Sherman KJ, Balderson BH, Cook AJ, Hansen KE, Turner JA. Two-Year Follow-up of a Randomized Clinical Trial of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care for Chronic Low Back Pain. JAMA 2017;317(6): 642-4.
  10. Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA 2016;315(12):1240-9.
  11. Chou R, Deyo R, Devine B, Hansen RL, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The effectiveness and risks of long-term opioid treatment of chronic pain. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Sep. (Evidence Reports/Technology Assessments, No. 218). Report No.: 14-E005-EF.
  12. Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain 2016, Comparative Effectiveness Reviews, No. 169. Rockville (MD): Agency for Healthcare Research and Quality (US): 2016 Feb. Report No.: 16-EHC004-EF
  13. Cunningham JL, Evans MM, King SM, Gehin JM, Loukianova LL. Opioid Tapering in Fibromyalgia Patients: Experience from an Interdisciplinary Pain Rehabilitation Program. Pain Med 2016;17(9):1676-85.
  14. Dillie KS, Fleming MF, Mundt MP, French MT. Quality of life associated with daily opioid therapy in a primary care chronic pain sample. J Am Board Fam Med 2008;21(2):108-17.
  15. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2): 85-92.
  16. Eriksen J, Sjogren P, Bruera E, Ekholm O, Rasmussen NK. Critical issues on opioids in chronic non-cancer pain. An epidemiological study. Pain 2006;125:172-9.
  17. Finlayson RE, Maruta T, Morse RM, Martin MA. Substance dependence and chronic pain: experience with treatment and follow-up results. Pain 1986;26(2):175-80.
  18. Frank JW, Lovejoy TI, Becker WC, Morasco BJ, Koenig CJ, Hoffecker L, Dischinger HR, Dobscha SK, Krebs EE. Patient Outcomes in Dose Reduction or Discontinuation of Long-Term Opioid Therapy: A Systematic Review. Ann Intern Med 2017;167(3):181-91.
  19. Goldenberg DL, Clauw DJ, Palmer RE, Clair AG. Opioid Use in Fibromyalgia: A Cautionary Tale. Mayo Clin Proc 2016;91(5):640-8.
  20. Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug- related mortality in patients with nonmalignant pain. Arch Intern Med 2011;171(7):686-91.
  21. Han B, Compton WM, Blanco C, Crane E, Lee J, Jones CM. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health. Ann Intern Med 2017;167(5):293-201.
  22. Hooten WM, Townsend CO, Sletten CD, Bruce BK, Rome JD. Treatment outcomes after multidisciplinary pain rehabilitation with analgesic medication withdrawal for patients with fibromyalgia. Pain Med 2007;8(1): 8-16.
  23. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev 2014(9):
  24. Noble M, Treadwell JR, Tregear SJ, Coates VH, Wiffen PJ, Akafomo C, Schoelles KM. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010(1):
  25. Palmer RE, Carrell DS, Cronkite D, Saunders K, Gross DE, Masters E, Donevan S, Hylan TR, Von Kroff M. The prevalence of problem opioid use in patients receiving chronic opioid therapy: computer-assisted review of electronic health record clinical notes. Pain 2015;156(7):1208-14.
  26. Paulozzi LJ. CDC Grand Rounds: Prescription Drug Overdose, a U.S. Epidemic Morbidity and Mortality Weekly Report (MMWR), 2012; 61(01);10-13.
  27. Richmond H, Hall AM, Copsey B, Hansen Z, Williamson E, Hoxey-Thomas N, Cooper Z, Lamb SE. The Effectiveness of Cognitive Behavioural Treatment for Non-Specific Low Back Pain: A Systematic Review and Meta-Analysis. PLoS One 2015;10(8):e0134192.
  28. Schaafsma F, Schonstein E, Whelan KM, Ulvestad E, Kenny DT, Verbeek JH. Physical conditioning programs for improving work outcomes in workers with back pain. Cochrane Database Syst Rev 2010(1):Cd001822.
  29. Sjogren P. Epidemiology of chronic pain and critical issues on opioid use. Pain 2011;152(6): 1219-20.
  30. Toblin RL, Mack KA, Perveen G, Paulozzi LJ. A population-based survey of chronic pain and its treatment with prescription drugs. Pain 2011;152(6):249-55.
  31. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain 2015;156(4): 569-76.

Benzodiazepine Harms Overlooked, Especially in Older Adults

https://www.medscape.com/viewarticle/892983

As attention remains focused on opioid abuse, another drug epidemic rages outside the spotlight: inappropriate prescription of benzodiazepines.

In an editorial published in the February 22 issue of the New England Journal of Medicine, Anna Lembke, MD, Jennifer Papac, MD, and Keith Humphreys, PhD, from Stanford University School of Medicine in California, point out that from 1996 to 2013, the number of adults who filled a benzodiazepine prescription rose from 8.1 million to 13.5 million, an increase of 67%. During roughly the same time (1999-2015), deaths from benzodiazepine overdose increased from 1135 to 8791.

“Despite this trend, the adverse effects of benzodiazepine overuse, misuse, and addiction continue to go largely unnoticed,” they write.

Concurrent opioid use figured in three quarters of the overdoses, “which may explain why, in the context of a widely recognized opioid problem, the harms associated with benzodiazepines have been overlooked,” the editorialists state. They cite data showing that coprescription rates nearly doubled between 2001 and 2013, going from 9% to 17%.

 

Of particular concern is benzodiazepine use among the elderly, who are especially vulnerable to adverse effects, including an increased risk for falls, fractures, motor vehicle accidents, impaired cognition, and dementia. Professional societies in several countries, including the American Geriatrics Society, have issued guidelines recommending against prescribing benzodiazepines to these patients, as has the Choosing Wisely International campaign, which aims to reduce inappropriate and low-value care.

Nevertheless, “[p]rescribing to older adults continues despite decades of evidence documenting safety concerns, effective alternative treatments, and effective methods for tapering even chronic users,” Donovan T. Maust, MD, MS, and coauthors wrote in the Journal of the American Geriatric Society in 2016. Other researchers have found that clinicians often are unaware of the dangers these drugs pose to seniors, or believe they have no other therapeutic options.

Now a new observational study of older adults in the United States, Canada, and Australia confirms that, despite a modest decline in benzodiazepine prescriptions in this population, “use remains inappropriately high — particularly in those aged 85 and older — which warrants further attention from clinicians and policy-makers,” the authors write.

Jonathan Brett, MBBS, from the Medicines Policy Research Unit at the University of New South Wales in Sydney, Australia, and colleagues published their findings online February 12 in the Journal of the American Geriatric Society.

The authors used prescription claims data from the US Department of Veterans Affairs (VA), the Ontario (Canada) Drug Benefit Program, and the Australian Pharmaceutical Benefits Scheme to analyze annual incident and prevalent benzodiazepine use among people 65 years of age or older between January 2010 and December 2016. The entire cohort included 8,270,000 people.

They observed a significant and linear decline in prevalent benzodiazepine use, defined as people with at least one prescription claim for a benzodiazepine during a given calendar year, in all three countries during the period studied. In the United States, it declined from 9.2% to 7.3%; in Ontario, Canada, it declined from 18.2% to 13.4%; and in Australia, it declined from 20.2% to 16.8%.

Incident use, defined as a new prescription in a given year for someone with no previous history of benzodiazepine use, also declined in the United States, going from 2.6% to 1.7%, and in Ontario, going from 6.0% to 4.4%. In Australia, incident use changed only slightly and nonsignificantly, going from 7.0% to 6.7%.

In all three countries, rates of incident and prevalent use were highest among women, Brett and colleagues write. In Australia and Ontario, prevalent use was highest among patients 85 years of age or older, but “decreased with advancing age in the U.S. VA population.”

 The observed decreases in prescriptions “are likely to be in response to safety concerns and lack of evidence of effectiveness,” the authors write.
 Still, despite these “modest changes,” and “in spite of consistent messaging about the hazards of using benzodiazepines in this population, the rates of benzodiazepine use in older adults remain high,” perhaps related to a tendency by clinicians and patients alike to minimize the risk these drugs pose.
 The finding of high use among the oldest patients in Canada and Australia was “particularly troubling,” the authors add, because of the greater potential for harm in this age group.
 They also express concern that clinicians may be prescribing “Z-drugs,” agents such as zopiclone and zolpidem, instead of benzodiazepines, in a mistaken belief that those products are safer.
 One way to begin reducing benzodiazepine prevalence might be to limit the conversion of new to chronic use by “explicitly limiting the duration of new prescriptions and not routinely providing repeat prescriptions,” the authors suggest. “For people who have been using benzodiazepines for a long time, a discussion about the risks and benefits of continued therapy and attempts to reduce the dose gradually might be the best strategy.”
 Lembke and colleagues also emphasize the need for discussions about tapering, and note numerous parallels between patterns of benzodiazepine and opioid use: “Despite the many parallels to the opioid epidemic, there has been little discussion in the media or among clinicians, policymakers, and educators about the problem of overprescribing and overuse of benzodiazepines and z-drugs, or about the harm attributable to these drugs and their illicit analogues,” they write.
 If measures designed to discourage people from using opioids divert them to benzodiazepines instead, “[i]t would be a tragedy,” Lembke and colleagues conclude in their editorial. “We believe that the growing infrastructure to address the opioid epidemic should be harnessed to respond to dangerous trends in benzodiazepine overuse, misuse, and addiction as well.”
 The authors have disclosed no relevant financial relationships.
 J Am Geriatr Soc. Published online February 12, 2018. Abstract
 N Engl J Med. 2018;378:693-695. Full text
Interesting the time frames they looked at  among people 65 years of age or older between January 2010 and December 2016 . In Jan 2011 the first baby boomer turned 65 and 10,000/day turn 65 since then and
use remains inappropriately high — particularly in those aged 85 and older this is the FASTEST growing segment of our population.. even if percentages remain the same… the raw numbers are going to increase..

Despite this trend, the adverse effects of benzodiazepine overuse, misuse, and addiction continue to go largely unnoticed,” they write. Concurrent opioid use figured in three quarters of the overdoses, “which may explain why, in the context of a widely recognized opioid problem

So there is little/few OD’s from benzo alone… so they have to put into the equation that opiates were involved… again … no suggestion that these OD could have been intentional as in SUICIDES ?  Is this another study that culled the data and the time frames to prove a preconceived conclusion ?

Lawmakers, Pharmacists Meet with CVS over Regulation of Pharmacy Benefit Managers

http://www.arkansasmatters.com/news/local-news/lawmakers-pharmacists-meet-with-cvs-over-regulation-of-pharmacy-benefit-managers/985681024

LITTLE ROCK, Ark. – Hundreds of pharmacists and patients from every corner of the state spilled out of the Old Supreme Court Room at the capitol Wednesday to fight for change. 

The nearly 750 pharmacies in Arkansas noticed cuts to their drug reimbursement rates at the beginning of the year. They have been working with lawmakers ever since to regulate who they say is to blame: pharmacy benefit managers (PBMs).

“This room is packed because this is an Arkansas issue,” Lt. Gov. Tim Griffin told the crowd. “This is every household in Arkansas. We don’t have a healthy market. We don’t have healthy competition. What we have is dysfunction because of oversized players who are basically helping themselves at your expense.”

The Arkansas Pharmacists Association obtained records of more than 270 popular drugs in the state and found CVS pays itself at least $60 per prescription more than it pays pharmacies.  

“This is an example of blatant self-dealing,” CEO Scott Pace told the crowd. 

Pace pointed to two cases in particular. While Arkansas pharmacies received about $28 for 30 tablets of Aripiprazole, a medication to treat depression, CVS received $512. The other showed the state’s pharmacists received about $909 for 20 tablets of Temozolomide, a cancer treatment. CVS received nearly $4,000. 

“When the fox guards the hen house, all sorts of games can be played and in Arkansas with the PBMs, they have been,” Pace said. “They operate behind a curtain of secrecy.”

The CEO has been working with lawmakers on the legislation to regulate these PBMs, giving the state insurance department oversight of them. 

Pace said they have trimmed the resolution from 14 to seven pages, which CVS saw for the first time Wednesday morning right before the press conference. He had another meeting scheduled with CVS representatives at 4 p.m. at the capitol. 

The Pharmaceutical Care Management Association, who represents PBMs across the country, released the following statement on the proposed Arkansas legislation: 

“This resolution would raise prescription drug costs for Arkansas’s patients, employers, state government, and taxpayers and do nothing to improve the quality of pharmacy benefits. The state should be encouraging market-based solutions to reduce drug costs, not giving special protections to the drugstore lobby.”

Arkansas pharmacists argue PBMs have forced them to cut hours and jobs, even consider closures in the near future. 

“They say it’s proprietary, but it’s affecting my business every day that I love,” said Mike Smith, the owner of Rose Drugstore in Russellville. “We are the boots on the ground. We are the ones with all the customers. We have been serving families for generation after generation that we need to take care of. We would like to have a reasonable, fair reimbursement on a level playing field.”

Gov. Asa Hutchinson plans to call a special session on this issue once lawmakers wrap up the fiscal session.

St. Rep. Michelle Gray, R- Melbourne, who is sponsoring the PBM legislation on the House side, is adamant about her colleagues addressing the issue immediately during the fiscal session. However, Gray said a meeting with Hutchinson Wednesday morning convinced her to back off.

“He assures me that this bill, which we are still working to finalize to make sure that there are no unintended consequences, will be on the special call,” Gray told the crowd. “He looked me in the eyes, and I have to trust that. If I can’t trust my governor to do what he says he’ll do, I might as well just pack up and go home.”

Rep. Gray and the legislation’s sponsor on the Senate side, St. Sen. Ron Caldwell, R-Wynne, said they would not have been able to act this fast without the help of their colleagues, pharmacists, patients and other community members across the state. 

 After CVS cuts reimbursement to independent pharmacies via their PBM ( Caremark )… then they send out solicitation letters to these same independents inquiring if they want to sell their stores to CVS Health.
For those of you who remember your history about Standard Oil.. where they would go into a area and sell gasoline below cost until all the competition had gone out of business and then Standard Oil would raise the price of the gasoline they sold above what it was before they entered the market.  That anti-competitive actions caused the Sherman Antitrust Act to be passed.
The PBM came into existence in 1969-1970 and they have never been transparent in how they operate financially. CVS Health/Caremark is just one of the many “bad actors”… here is a recent law suit where Anthem claims that Express Scripts – maybe the largest of the PBM’s… failed to share rebates on medications from the Pharmas  http://www.modernhealthcare.com/article/20160321/NEWS/160329992
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PETITION: Demand President Trump Stop the Criminalization of Kratom!

 

https://www.americankratom.org/copy-of-petitions

 

I need your help and so do 3-5 million people. In some cases this is the difference between life and death. Please help me keep Kratom Legal. I don’t want to be in agony again 24/7. We can’t fight three agencies, all at once, without your help. Chronic pain eventually will reach the majority of us. Please sign the petition to keep Kratom as an option for yourself. And please make sure you complete the form with too. Otherwise it won’t count.

Kratom has meant the all the difference in the world for my family. All of the things you see me post wouldnt be possible if it wasn’t for Kratom. I went from using a walker and wheelchair to biking or walking miles everyday. From being bedridden to tent camping road trips. I went from being prescribed fentanyl and dilaudid to taking zero opiates. I am truly afraid of what a future would look like for me without Kratom.

Looks like the government is giving each agency a turn at bat.

In 2016 the DEA took a swing at Kratom and Strrrrrrike. They tried to get to first base by trying to hit a home run by a 2-3 year emergency ban. But it was a fly ball. We caught it though so you’re OUT. Science prevailed.

Now the FDA has taken a strike at Kratom by having FDA scientists come up with a Model that predicts how Kratom may affect opioid receptors. But the scientific community at large has come out against the FDAs model. Can you imagine the fda accepting a computer model as scientific evidence that a drug is safe. No way. So Strrrrrrike.

So today the CDC came out with a warning that there were 28 salmonella cases ”associated” with Kratom. Notice how carefully they choose their words as not to be caught in an outright lie but make it sound bad. “Just last month a consumer advocacy group called on the FDA and CDC to do a better job of warning people about a romaine lettuce E. coli outbreak, which at last count had made 58 people sick in the U.S. and Canada. One person has died. However, when it came to the subject of infected vegetables that have actually resulted in a death, the CDC was hesitant to issue any serious warnings.

“Because we have not identified a source of the infections, CDC is unable to recommend whether U.S. residents should avoid a particular food.”

But when it comes to Kratom, which has caused zero deaths and has no proven correlation respective to the recent CDC Salmonella claims, it’s crystal clear what the CDC’s motives are in issuing this warning.” Washington Post and CNN just released stories on this. According to the CNN article “an estimated 1.4 million cases of salmonella occur in the US each year, according to the CDC. Of the 11 people who have been interviewed for this salmonella investigation, 8 reported consuming kratom in pills, powder or tea.” I could get my calculator but I am thinking that 8/1.4M= a pretty low %. Maybe there is some connection but this seems like a stretch.

So hopefully this is their last gov agency they will use to try to ban Kratom

WALMART TECH: extra hassle they have to go through to fill C-II Rx each month… we’re not going to do it anymore

Hi, my name is XXX, I am 60yrs old and am located in Florida. I found the site “Drug Topics” while searching for help in getting my medications. Since the article I read was written in 2014 I am wondering if the same information still applies.

I have been taking a prescribed medication for a number of years for a chronic condition I have ( approximately 15 years).  There has been an increase in dosage a couple of times during this span of time to maintain the effectiveness but there has not been an increase in years. This drug is classified as a class 2 medication. This is the only medication that has been proven to work for me and I have tried many. My prescription is written for me by my primary care physician but continued to be issued after me being seen at Mayo Clinic in Jacksonville, Florida and after many testing procedures. The physicians at Mayo Clinic advised my doctor to continue with the medication I was receiving as it was the only thing that appeared to help me. I was also advised to take it at the specified times and not try to wait longer. This medication “xxxxxxxx” is extended release in nature thus I take it at 12 hour intervals.

My problem comes in because I have been getting my medication filled for years at Wal-Mart Pharmacy.  The pharmacist has now decided she will not fill it anymore because it comes up with an alert that she has to approve. They have called my doctor and he told them that I needed this particular medication at the dosage he had written but they are now refusing to fill it for me.  I had a pharmacy tech tell me I did not need this medication and rudely tell me in some detail the extra hassle they have to go through to fill it each month while also telling me the pharmacist said they have been doing it for years and were not going to do it anymore.  I was told I could try another pharmacy and I have tried others but to no avail. I am at a loss of what to do and both my husband and myself are very worried and scared.  The added stress and fear of this situation is exacerbating other chronic issues. It is about time to refill my meds and I do not know what to do.

 

I’m hoping you get this and appreciate any advice you might could offer. Thank you for your time

 

http://www.ncpanet.org/home/find-your-local-pharmacy

Above link is to find a locally owned independent pharmacy by zip code where you will be dealing with the Pharmacist/owner and not just some employee of a large chain… who may not care less about you and your health needs

 

Image result for Walmart Uniform

The Myth of What’s Driving the Opioid Crisis

Oxycodone pain pills are pictured. | Getty Images

Doctor-prescribed painkillers are not the biggest threat

https://www.politico.com/magazine/story/2018/02/21/the-myth-of-the-roots-of-the-opioid-crisis-217034

As an addiction psychiatrist, I have watched with serious concern as the opioid crisis has escalated in the United States over the past several years, and overdose deaths have skyrocketed. The latest numbers from the Centers for Disease Control and Prevention show fatalities spiraling up to about 42,000 in 2016, almost double the casualties in 2010 and more than five times the 1999 figures. The White House Council of Economic Advisers recently estimated that the opioid crisis cost the nation half a trillion dollars in 2015, based on deaths, criminal justice expenses and productivity losses. Meanwhile, foster care systems are overflowing with children whose parents can’t care for them, coroners’ offices are overwhelmed with bodies and ambulance services are straining small-town budgets. American carnage, indeed.

I have also watched a false narrative about this crisis blossom into conventional wisdom: The myth that the epidemic is driven by patients becoming addicted to doctor-prescribed opioids, or painkillers like hydrocodone (e.g., Vicodin) and oxycodone (e.g., Percocet). One oft-quoted physician refers to opioid medication as “heroin pills.” This myth is now a media staple and a plank in nationwide litigation against drugmakers. It has also prompted legislation, introduced last spring by Senators John McCain and Kirsten Gillibrand—the Opioid Addiction Prevention Act, which would impose prescriber limits because, as a news release stated, “Opioid addiction and abuse is commonly happening to those being treated for acute pain, such as a broken bone or wisdom tooth extraction.”

 

But this narrative misconstrues the facts. The number of prescription opioids in circulation in the United States did increase markedly from the mid-1990s to 2011, and some people became addicted through those prescriptions. But I have studied multiple surveys and reviews of the data, which show that only a minority of people who are prescribed opioids for pain become addicted to them, and those who do become addicted and who die from painkiller overdoses tend to obtain these medications from sources other than their own physicians. Within the past several years, overdose deaths are overwhelmingly attributable not to prescription opioids but to illicit fentanyl and heroin. These “street opioids” have become the engine of the opioid crisis in its current, most lethal form.

If we are to devise sound solutions to this overdose epidemic, we must understand and acknowledge this truth about its nature.

For starters, among people who are prescribed opioids by doctors, the rate of addiction is low. According to a 2016 national survey conducted by the Substance Abuse and Mental Health Services Administration, 87.1 million U.S. adults used a prescription opioid—whether prescribed directly by a physician or obtained illegally—sometime during the previous year. Only 1.6 million of them, or about 2 percent, developed a “pain reliever use disorder,” which includes behaviors ranging from overuse to overt addiction. Among patients with intractable, noncancer pain—for example, neurological disorders or musculoskeletal or inflammatory conditions—a review of international medical research by the Cochrane Library, a highly regarded database of systemic clinical reviews, found that treatment with long-term, high-dose opioids produced addiction rates of less than 1 percent. Another team found that abuse and addiction rates within 18 months after the start of treatment ranged from 0.12 percent to 6.1 percent in a database of half a million patients. A 2016 report in the New England Journal of Medicine concluded that in multiple published studies, rates of “carefully diagnosed” addiction to opioid medication averaged less than 8 percent. In a study several years ago, a research team purposely excluded chronic-pain patients with prior drug abuse and addiction from their data, and found that only 0.19 percent of the patients developed abuse and addiction to opioids.

Indeed, when patients do become addicted during the course of pain treatment with prescribed opioids, often they simultaneously face other medical problems such as depression, anxiety, other mental health conditions, or current or prior problems with drugs or alcohol. According to SAMHSA’s 2014 National Survey on Drug Use and Health, more than three-fourths of those who misuse pain medication already had used other drugs, including benzodiazepines and inhalants, before they ever misused painkillers. And according to CDC data, at least half of all prescription opioid-related deaths are associated with other drugs, such as benzodiazepines, alcohol and cocaine; combinations that are often deadlier than the component drugs on their own. The physical and mental health issues that drive people to become addicted to drugs in the first place are very much part of America’s opioid crisis and should not be discounted, but it is important to acknowledge the influence of other medical problems and other drugs.

Just because opioids in the medical context don’t produce high rates of addiction doesn’t mean doctors aren’t overprescribing and doing serious harm. The amount of opioids prescribed per person in 2016, though a bit lower than the previous year, was still considered high by the CDC—more than three times the amount of opioids dispensed in 1999. Some doctors routinely give a month’s supply of opioids for short-term discomfort when only a few days’ worth or even none at all is needed. Research suggests that patients given post-operation opioids don’t end up needing to use most of their prescribed dose.

Among people who misused prescription pain relievers in 2013 and 2014, only 22 percent said they received the drugs from their doctor.

In turn, millions of unused pills end up being scavenged from medicine chests, sold or given away by patients themselves, accumulated by dealers and then sold to new users for about $1 per milligram. As more prescribed pills are diverted, opportunities arise for nonpatients to obtain them, abuse them, get addicted to them and die. According to SAMHSA, among people who misused prescription pain relievers in 2013 and 2014, about half said that they obtained those pain relievers from a friend or relative, while only 22 percent said they received the drugs from their doctor. The rest either stole or bought pills from someone they knew, bought from a dealer or “doctor-shopped” (i.e., obtained multiple prescriptions from multiple doctors). So diversion is a serious problem, and most people who abuse or become addicted to opioid pain relievers are not the unwitting pain patients to whom they were prescribed.

While reining in excessive opioid prescriptions should help limit diversion and, in theory, suppress abuse and addiction among those who consume the diverted supply, it will not be enough to reduce opioid deaths today. In the first decade of the 2000s, the opioid crisis almost seemed to make sense: The volume of prescribed opioids rose in parallel with both prescription overdose deaths and treatment admissions for addiction to prescription opioids. Furthermore, 75 percent of heroin users applying to treatment programs initiated their opioid addiction with pills, so painkillers were seen as the “gateway” to cheap, abundant heroin after their doctors finally cut them off. (“Ask your doctor how prescription pills can lead to heroin abuse,” blared massive billboards from the Partnership for a Drug-Free New Jersey.) If physicians were more restrained in their prescribing, the logic went, fewer of their patients would become addicted, and the pipeline to painkiller addiction and ultimately to heroin would run dry.

It’s not turning out that way. While the volume of prescriptions has trended down since 2011, total opioid-related deaths have risen. The drivers for the past few years are heroin and, mostly, fentanyl, a synthetic opioid that is 50 times as potent as heroin. Fentanyl has legitimate medical use, but there is also illicit fentanyl, trafficked mostly from China, often via the Dark Web. Fentanyl and heroin (which itself is usually tainted to some extent with the fentanyl) together were present in more than two-thirds of all opioid-related deaths in 2016, according to CDC data. Painkillers were present in a little more than one-third of opioid-related deaths, but a third of those painkiller deaths also included heroin or fentanyl. While deaths from prescription opioids have basically leveled off, when you look at deaths in which prescription opioids plus heroin and fentanyl were present, then the recorded deaths attributed to prescription opioids continue to climb, too. (An especially pernicious element in the mix is counterfeiters with pill presses who sell illicit fentanyl in pill form deceptively labeled as OxyContin and other opioid pain relievers or benzodiazepines.)

Painkillers were present in a little more than one-third of opioid-related deaths in 2016.

Notably, more current heroin users these days seem to be initiating their opioid trajectory with heroin itself—an estimated 33 percent as of 2015—rather than with opioid painkillers. In the first decade of the 2000s, about 75 to 80 percent of heroin users started using opioids with pills (though not necessarily pain medication prescribed by a doctor for that particular person). It seems that, far more than prescribed opioids, the unpredictability of heroin and the turbocharged lethality of fentanyl have been a prescription for an overdose disaster.

 Intense efforts to curb prescribing are underway. Pharmacy benefit managers, such as CVS, insurers and health care systems have set limits or reduction goals. State-based prescription drug monitoring programs help doctors and pharmacists identify patients who doctor-shop, ER hop or commit insurance fraud. As of July, 23 states had enacted legislation with some type of limit, guidance or requirement related to opioid prescribing. McCain and Gillibrand’s federal initiative goes even further, to impose a blanket ban on refills of the seven-day allotment for acute pain. And watchdog entities such as the National Committee for Quality Assurance have endorsed a system that compares the number of patients receiving over a certain dose of opioids with the performance rating for a physician.

A climate of precaution is appropriate, but not if it becomes so chilly that doctors fear prescribing. This summer, a 66-year-old retired orthopedic surgeon who practiced in Northern California—I’ll call her Dr. R—contacted me. For more than 30 years, she had been on methadone, a legitimate opioid pain medication, for an excruciating inflammatory bladder condition called interstitial cystitis. With the methadone, she could function as a surgeon. “It gave me a life. I would not be here today without it,” she told me. But one day in July, her doctor said the methadone had to stop. “She seemed to be worried that she was doing something illegal,” Dr. R told me.

Dr. R was fortunate. She found another doctor to prescribe methadone. But her experience of nonconsensual withdrawal of opioids is not isolated. Last year, the nonprofit Pain News Network conducted an online survey among 3,100 chronic pain patients who had found relief with opioids and had discussed this in online forums. While not necessarily a representative sample of all individuals with chronic pain who are on opioids, the survey was informative: 71 percent of respondents said they are no longer prescribed opioid medication by a doctor or are getting a lower dose; 8 out of 10 said their pain and quality of life are worse; and more than 40 percent said they considered suicide as a way to end their pain. The survey was purposely conducted a few months after the CDC released guidelines that many doctors, as well as insurance carriers and state legislatures, have erroneously interpreted as a government mandate to discontinue opioids. In other accounts, patients complain of being interrogated by pharmacists about their doses; sometimes they are even turned away.

The most tragic consequence is suicide. Thomas F. Kline, an internist in Raleigh, North Carolina, has chronicled 23 of them. His count is surely a harbinger of further patient abandonment to come. Meanwhile, so-called pain refugeeschronic pain patients whose doctors have dropped them—search out physicians to treat them, sometimes traveling more than a hundred miles or relocating. And in a recent Medscape survey, half the doctors who were polled expressed fear of violent reactions if patients were refused the prescription.

Knowing all this, what should we do about the opioid crisis? First, we must be realistic about who is getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the people for whom they are prescribed. Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist. There is a subset of patients who are vulnerable to abusing their medication—those with substance use histories or with mental health problems. Ideally, they should inform physicians of their history, and, in turn, their doctors should elicit such information from them.

Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist.

Still, given that diverted pills, not prescribed medication taken by patients for pain, are the greater culprit, we cannot rely on doctors or pill control policies alone to be able to fix the opioid crisis. What we need is a demand-side policy. Interventions that seek to reduce the desire to use drugs, be they painkillers or illicit opioids, deserve vastly more political will and federal funding than they have received. Two of the most necessary steps, in my view, are making better use of anti-addiction medications and building a better addiction treatment infrastructure.

Methadone and buprenorphine are opioid medications for treating addiction that can be prescribed by doctors as a way to wean patients off opioids or to maintain them stably. These medications have been shown to reduce deaths from all causes, including overdose. A third medication, naltrexone, blocks opioids’ effect on the brain, and prevents a patient who tries heroin again from experiencing any effects. In 2016, however, only 41.2 percent of the nation’s treatment facilities offered at least one form of medication, and 2.7 percent offered all three medications, according to a recent review of a national directory published by SAMHSA. We must move beyond the outmoded thinking and inertia that keep clinics from offering these medications.

Motivated patients also benefit greatly from cognitive behavioral therapy and from the hard work of recovery—healing family rifts, reintegrating into the workforce, creating healthy social connections, finding new modes of fulfillment. This is why treatment centers that offer an array of services, including medical care, family counseling and social services, have a better shot at promoting recovery. That treatment infrastructure must be fortified. The Excellence in Mental Health Act of 2014, a Medicaid-funded project, established more robust health centers in eight states. In 2017, House and Senate bills were introduced to expand the project to 11 more. It’s a promising effort that could be a path to public or private insurance-based community services and an opportunity to set much-needed national practice standards.

These two priorities are among the 56 recommendations put forth last October by President Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. Indeed, there is no dearth of ideas. In Congress, more than 90 bills aimed at the opioid crisis have been introduced in the 115th session, dozens of hearings have been held and later this month, the House Energy and Commerce Committee will begin holding a week of legislative hearings on measures to fight the opioid crisis. The White House’s 2019 budget seeks $13 billion over two years for the opioid epidemic, and the president recently nominated a “drug czar” to helm the Office of Drug Control Policy, though the candidate has minimal experience in the area.

As we sort through and further pursue these policies, we need to make good use of what we know about the role that prescription opioids plays in the larger crisis: that the dominant narrative about pain treatment being a major pathway to addiction is wrong, and that an agenda heavily weighted toward pill control is not enough.

 

Patients, doctors struggle with new law aimed at reducing overdoses

http://www.lasvegasnow.com/news/patients-doctors-struggle-with-new-law-aimed-at-reducing-overdoses/985260112

LAS VEGAS – A state law barely two months old is wreaking havoc for doctors and their pain patients.

AB 474 was designed to curb opioid overdoses. The violations carry stiff penalties and something as simple as a clerical error could threaten a physician’s license.

8 News NOW spoke with pain specialist Doctor Dan Laird last fall. Now with the new regulations — we checked back in to see how its impacting his practice and his patients.

“Really, I think that this law, while well intended, it’s just has created a mess,” Dr. Dan Laird said.

A mess of confusion and controversy. The law has morphed into mountains of paperwork for physicians and pressures for pain patients uncertain if their prescriptions will be honored.

Dan Laird is a Las Vegas attorney and a doctor at Flamingo Pain Specialists.

“So, the patients are sensitive and hurting and in pain to begin with and then put in this environment where under fire, hassled virtually everywhere they go. A lot feel shame, feel like they’re being treated like a criminal at the pharmacy,” Dr. Laird said.

Some patients complain the crackdown has led to pharmacy overreach with some skipping the full amount of pills or refusing to supply them at all.

“They start wondering when I go today is it going to be the good pharmacist or the bad pharmacist? Is it going to be the one who hassles me or the one who fills the prescription? It really causes a lot of suffering for them and worry,” Dr. Laird said.

AB474 targets Class 2 drugs, like Adderall, Ritalin, which treat Attention Deficit Hyperactivity Disorder. Pain suppressors like hydrocodone, Vicodin, Lortab, oxycodone, Percocet, Demerol, and more. The law also impacts Class 3 and 4 drugs: Ambien, used for insomnia. benzodiazepines, used for anxiety like Xanax and Valium. and testosterone products, like AndroGel.

So, prescribers must take numerous steps before issuing any pain medications, sleeping aids, ADHD, testosterone, and migraine medications. Steps that are time consuming and cumbersome.

Just days after the tighter restrictions went into effect, doctors gave an earful to the state medical board warning them it’s gone too far by forcing doctors to become detectives spending more time shuffling papers than taking care of people.

Pharmacies are feeling the squeeze too by making decisions on who should and should not get their meds.

Dr. Laird suspects some of his African-American pain clients are being profiled.

“I can tell you that I have about 10 percent of my patients who are African-American, maybe 20 percent. Eighty percent of problems I have at pharmacies are with African-Americans and I don’t think that’s a coincidence.”

Not only is it inappropriate, its unlawful to discriminate against patients.

Another concern is exactly what the AB 474 is trying to prevent — people dying. If patients are unable to get adequate pain control, they may be pushed to the brink and consider taking their own life.

“I ask every patient about suicide every visit because I’m very concerned about the possibility that people who have limited coping skills and they’re given severe pain they see their options as very limited. So, one of them is suicide unfortunately,” Dr. Laird said.

AB 474 is the law, but outspoken doctors are urging the state board of pharmacy to not carry out the tough enforcement and even repeal the issue all together.

Isn’t it strange that they state in this article that it is ILLEGAL to discriminate these pts… but as laws are being broken.. those in charge of enforcing these laws are turning a blind eye or sitting on their hands and DOING NOTHING.

Medicaid program limiting opioid prescriptions

https://www.news4jax.com/health/opioid-crisis/medicaid-program-limiting-opioid-prescriptions

TALLAHASSEE, Fla. As lawmakers consider proposals to limit opioid prescriptions, Gov. Rick Scott’s administration is taking steps to do the same in the Florida Medicaid program.

The Agency for Health Care Administration announced last week that, effective Monday,

prescriptions for narcotics in the Medicaid program will be limited to a maximum seven-day supply.

Medicaid also is no longer requiring prior authorization for certain medication-assisted treatments to help fight opioid addiction including monthly shots of the drug Vivitrol.

The changes, among others, are being made to “assist in the prevention and treatment of substance use disorders,” the agency said in a Medicaid alert about the decisions.

Proponents say the shifts in policy will go a long way to help the state curb the use of opioids, which are narcotic pain medications and have caused widespread overdoses. In 2016, heroin caused 952 deaths in Florida, fentanyl caused 1,390 deaths, oxycodone caused 723 deaths, and hydrocodone caused 245 deaths. Those statistics led Gov. Rick Scott in May 2017 to declare a state of emergency.

The Medicaid adjustments, in part, track legislative proposals for other patients. Those proposals would limit prescriptions for opioids to three-day supplies but also allow for up to seven-day supplies if physicians deem it medically necessary.

The new Medicaid policy also allows an exemption to the seven-day cap if physicians believe it’s medically necessary to prescribe more. Unlike the legislative proposals, though, there isn’t a limit on medically necessary prescriptions.

Supporters say limiting opioid prescriptions will help stem the use of opioids.

But many surgeons and physicians don’t like the limits. Florida Medical Association General Counsel Jeff Scott last week urged lawmakers to allow for exceptions to the limits in situations such as when patients undergo major surgery, have cancer or are in hospice.

Chris Nuland, a lobbyist for the Florida Chapter of the American College of Surgeons, said he doesn’t “like the Medicaid policy,” but said it’s better than what is under consideration by the Legislature.

“While the surgeons dislike arbitrary limits, at least the Medicaid policy acknowledges there will be cases for which a larger prescription is appropriate,” said Nuland.

Prescribing and usage guidelines for Medicaid are determined in part by panels known as the Pharmaceutical and Therapeutics Committee and the Drug Utilization Review Board, as well as the Agency for Health Care Administration, which has oversight of the Medicaid program.

The Pharmaceutical and Therapeutics Committee meets quarterly and is charged with maintaining a preferred drug list, or the list of approved medications for specific medical conditions. The Drug Utilization Review Board approves drug-use criteria and standards for drug use.

In addition to limiting prescriptions, the Medicaid program also is eliminating prior-authorization requirements for medication-assisted treatment, specifically naltrexone tablets and Vivitrol, which was added to the preferred drug list after a Pharmaceutical and Therapeutics Committee meeting in January.

Additionally, effective Feb. 5, Medicaid will reimburse for a seven-day supply of Suboxone film, which contains buprenorphine and naloxone, or buprenorphine tablets for pregnant or nursing mothers without prior authorization.

The changes impact only the Medicaid program, which provides care to about 4 million Floridians, 85 percent of whom are enrolled in managed-care plans.

In the legislative proposals for other patients, a Senate bill (SB 8), filed by Sen. Lizbeth Benacquisto, R-Fort Myers, would eliminate prior-authorization requirements for medication-assisted treatment. The House version (HB 21), filed by Rep. Jim Boyd, R-Bradenton, would not.

It can take weeks to obtain prior authorization for medication-assisted treatments, leaving patients without access to the medications that can help them recover.

Mark Fontaine, executive director of the Florida Alcohol and Drug Abuse Association, told The News Service of Florida that eliminating the prior-authorization requirements for medically assisted treatment is a step in the right direction.

The medications, he said, “help stabilize brains and move people toward a path to recovery.”

Leave it to those politicians in FL… according to THEIR OWN NUMBERS … in 2016 there was a total of 3410 opiate related deaths and abt 70% of those deaths were from ILLEGAL OPIATES… so what does the bureaucrats do… clamp down on the legal opiates and will cause those people suffering from moderate-severe intractable chronic pain.

Using national averages, would suggest that there are 2-3 million of those pts in FL and of course they are picking on those who are the poorest (Medicaid pts) who can least afford legal representation and maybe not even afford transportation to go to the state house in Tallahassee to protest.

Of course, Gov Scott is “tapped out” on running for re-election…

FDA announces recall of dietary supplements after opioid declaration

The Food and Drug Administration (FDA) on Wednesday announced a recall of dietary supplements that contain kratom, a herb the agency has classified as an opioid. There is one dietary supplement that is safe for your health and it is the alpilean, you can check alpilean reviews and complaints and there you will find all the information, customers opinion, benefits, ingredients, etc.

FDA Commissioner Scott Gottlieb also urged manufacturers to stop selling products intended for human consumption if they contain kratom.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” Gottlieb said in a statement.

“At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use.”

Last week, the FDA released findings showing kratom acts like an opioid and can be dangerous and addictive.

You get to enjoy a sense of calmness and more focus. CBD affects learning positively and it also motivates learning. It is also helpful in reversing the symptoms of the Alzheimer disease. You can get a heart that is healthier by the use of the CBD. CBD has a lot of benefits that it brings to the heart, these include the capability of lowering high levels of blood pressure. You also get relief from the stresses that are part of your daily life. CBD has been known to provide therapeutic cures for symptoms like stress and anxiety, thus helping in the reduction of psychological levels of anxious behavior. It also helps in reducing the feeling of depression and anxiety. If you want to get more about the Noopept capsules for sale, visit us here.

CBD is the acronym for cannabidiol. It has been used by people for a long time and helps to get rid of the symptoms of many common ailments. Recently it was found that a number of common problems such as lack of cognitive abilities, mental disorders, anxiety, and both internal and external pain can be relieved by the use of CBD oil in any form. CBD is extracted from the marijuana plant but it is not psychoactive in nature due to the absence of tetrahydrocannabinol (THC). Many consumers prefer the use of CBD oil over normal medications due to its quick impact and fast recovery from the troubling symptoms.While CBD oil has been shown to have potential benefits in managing anxiety, pain, and inflammation, some indirect ways in which CBD may support weight loss include reducing stress and anxiety levels, improving sleep quality, and regulating appetite. Thats why you can use some diet pills

How does CBD get to work? The body of humans contains a large network of constituent receptors, the system of endocannabinoids, which is critical to maintaining the overall wellness, along with helping the support systems for many of the physical processes in our body. Cannabinoids and CBD fit inside these receptors that help the human body with its efforts in maintaining good health.

CBD is just a molecule, not any miracle. A lot of people can reap the significant benefits if they are provided access legally to these wide variety of remedies of cannabis, not merely to no THC or low THC products. CBD by itself may not always be enough to get the trick to work. There is a lot of compelling evidence to prove that CBD functions best when it is combined with the likes of THC and the entire spectrum consisting of other components of cannabis.

 

Gottlieb said the FDA oversaw the destruction and recall of supplements containing kratom and being sold by Divinity Product Distribution, based in Missouri.

While the Sunergetic Products Apple Cider Vinegar supplements had been intended to be used to help people with weight loss, there have been reports of people using them as an alternative to prescription opioids.

“We know that some patients are using kratom because they believe it can help treat their opioid dependency, but there’s no reliable evidence to support kratom’s effectiveness for this use; and we’re deeply committed to making sure patients have access to safe, effective treatment options,” he said.

Gottlieb said there are no FDA approved therapeutic uses of kratom and the agency has evidence that it poses “significant safety issues.”

He noted that there have been 44 reported deaths associated with kratom use.

The herb is also linked to an outbreak of salmonella in 20 states.

Kratom grows in Thailand, Malaysia, Indonesia and Papua New Guinea

FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

http://fibrowomen.com/fda-warns-about-dangers-of-epidural-steroid-injections-for-back-pain/

The Food and Drug Administration has just issued what’s called a

 “Medwatch Alert” warning that Epidural steroid injections or “ESIs” for back and neck pain can be extremely dangerous. The alert says: “Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

 

Epidural steroid injections – and catastrophic injuries from them – were the subject of my debut investigation for The Dr. Oz Show almost exactly a year ago. (You can watch the video here and read the web article here.) The epidural space is an area between the spinal cord and the bony structure of the spine.

Our investigation revealed that the steroids – called corticosteroids – used for epidural injections are not even FDA approved for this purpose and yet ESIs are done nearly 9 million times a year, according to an analysis by Dr. Laxmaiah Manchikanti.

In addition to informing the public via its Medwatch Alert, the FDA said, “We are requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.”  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The new warning will be a more prominent reminder to doctors that injecting steroids into the epidural space, just outside the spinal cord, has risks. But the warning failed to list all of the possible adverse reactions. Those reactions are named in the fine print of current drug labels, and include: “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.”

In 2009, the FDA convened a group to study the safety of some types of epidural steroid injections. In its new notice, the FDA said that group’s recommendations still are not ready and will be released when they are.

Dennis Capolongo of the EDNC, a group that has been campaigning against epidural steroid injections for years, called the FDA’s new warning “bitter sweet” because it did not go further.  Capolongo wants the FDA to go beyond telling doctors that injecting steroids into the epidural space COULD have severe side effects and instead state that they MUST NOT do it.

In February of this year, Australian and New Zealand health authorities came out with exactly that stronger language, stating that steroids like this, “MUST NOT be used by the intrathecal, epidural, intravenous or any other unspecified routes.” The South African government issued similar warnings, according to Capolongo.

Since the FDA is still actively studying these procedures, it will be interesting to see if the agency takes any further steps. If and when it does, you can bet I’ll pass the information along.