1306.04(a) “CORRESPONDING RESPONSIBILITY,” DANGERS WHEN PHARMACISTS WITHHOLDS YOUR PAIN CARE: “I DON’T FEEL COMFORTABLE,” THE STORY OF KATHERINE ROSENBURG-DOUGLAS A CHICAGO TRIBUNE REPORTER ‘WHO HAD BROKE-NED HER BACK’

Filed under: General Problems | Leave a Comment »

I normally don’t share emails from pts having problems getting their meds. This pt is having a problem he has been patronizing a particular Meijer store for 20 yrs. For those of you not familiar with Meijer, they are a “big box” store with 259 stores mostly in the mid-west. I find this statement very humorous the team of Pharmacist at this location. Most chain pharmacies function with one Pharmacist per shift and most Meijer stores are open 7 days a week with 12 hrs open Mon-Fri and shorter hours on Sat & Sun. So in most Meijer’s pharmacies the “team of Pharmacist” would probably be a COLLECTIVE OF TWO. While 60 mg is the FDA recommended max daily dose of Adderall, but that dosing was determined before there was DNA pharmacogenomics (PGx) tests and I have not heard that even these days that the Pharmas use  PGx testing in their clinical trials. Then there is the issue of the pt having a record at this pharmacy of him taking 85 mg of Adderall daily for some time, which may suggest that he is a ultra fast metabolizer of Adderall. So this team of Pharmacists is IGNORING the pt’s clinical medication records – right under their nose. One of the core functions of the practice of medicine is the starting, changing, stopping a pt’s therapy. Commonly referred to as prescriptive authority, and pharmacists – even Doctors of Pharmacy – do not have prescriptive authority. I have never heard of a pharmacy having a pt “take a pledge”, the only thing close is some independent pharmacists – that work with chronic pain pts – asking them to sign a pain contract with the pharmacy.  Apparently, this team of Pharmacists has dramatically expanded our scope of practice ?

Good Morning Steve,

I am writing you today for help with the filling of my Adderall prescription at Meijer’s Pharmacy  I have been a customer with Meijer’s Pharmacy for roughly 20 years and never had a problem filling my scripts. Now with the Adderall shortage this particular Meijer’s will not fill over 60mg per day stating the shortage and that 60mg is the recommended daily allowance, even though they have transferred my prescription to other Meijer’s Pharmacies to fill my 85mg script which they have done, they say the Pharmacists at this store have agreed not to dispense more than 60mg dosage per day. I take two 30mg tablets a day along with an extended 25mg capsule.

When they first told me about this I had the tablets that added up to 60mg per day dosage filled at their store and found another Pharmacy to fill my 25mg daily capsules. When I went back this month they told me they couldn’t fill it due to the fact that I filled my capsules else ware and they will not fill my 60mg tablets due to the fact it would put me over their 60mg a day pledge. Yes I said pledge, I was told by a pharmacist at the location that the team of Pharmacist at this location have agreed not to dispense more then the recommended amount of 60mg per day. This is a maintenance drug for me and I need this medication to maintain my day to day activities. I am wondering if you can help me out with this or direct me to someone that can help me with this situation. Thanks 

Filed under: General Problems | 2 Comments »

ended her life through intervention assisted euthanasia – suicide.

This poor intractable chronic pain pt, from a work place injury, after having lost all her pain meds,  to be able to put a end to her physical pain.  Now, the family left behind is suffering. Our politicians and bureaucrats talk about HARM REDUCTION, apparently that only applies to those dealing with mental health issues and dealing with some SUBSTANCE USE DISORDER.

This Administration, Congress, and numerous bureaucrats at city/county/state levels are all about DEI (Diversity, Equity, Inclusion). Regardless if the number is 10’s or 100’s of millions of people dealing with chronic pain. The chronic pain community is the largest minority in our country.

The Fed agency in charge of enforcing the Americans with Disability Act is part of the DOJ as is the DEA. Might be the reason that they never have the resources to handle a civil rights violation/discrimination of the chronic pain community.

How many others – like Jessica – is living/existing in a torturous level of pain – NO HARM REDUCTION HERE – NO INCLUSION HERE – NO EQUITY HERE.  How many Jessica’s are no long among us, took a similar path of Jessica and just “faded” from being part of the community.

Filed under: General Problems | 1 Comment »

Buprenorphine Initiation Rates Stall Despite Policy Efforts to Boost Uptake

https://www.medpagetoday.com/psychiatry/addictions/104181

Furthermore, just one in five patients remained on therapy for at least 180 days

Monthly initiation rates for buprenorphine increased and then flattened from 2016 to 2022, suggesting that recent efforts to increase use of the treatment for opioid use disorder have been insufficient, an analysis of prescription data showed.

Using data from the IQVIA Longitudinal Prescription Database, an all-payer database that includes 92% of prescriptions dispensed in U.S. retail pharmacies, the monthly buprenorphine initiation rate increased from 12.5 to 15.9 per 100,000 from January 2016 through September 2018 (monthly percentage change 0.62%, 95% CI 0.40-0.84, P<0.001), reported Kao-Ping Chua, MD, PhD, of the University of Michigan Medical School in Ann Arbor, and co-authors.

The initiation rate then became flat from October 2018 through October 2022 (monthly percentage change -0.03%, 95% CI -0.16% to 0.09%, P=0.62), they noted in a JAMA research letteropens in a new tab or window.

Of note, the median monthly retention rate was 22.2% from January 2016 to April 2022, and increased only slightly during that period (monthly percentage change 0.08%, 95% CI 0.005-0.15, P=0.04).

“Opioid overdose deaths are at a record high in the U.S.,” Chua told MedPage Today in an email. “Despite this, our study shows that buprenorphine initiation rates have been flat since the end of 2018.”

“This is disappointing, especially because there were a lot of policy and clinical efforts to maintain and expand access to buprenorphine during the COVID-19 pandemic, such as allowing buprenorphine to be prescribed via telehealth without an in-person visit and eliminating training requirements for the waiver that previously was required to prescribe buprenorphine,” Chua added. “The fact that buprenorphine initiation rates did not rise after these efforts were implemented suggests that they were insufficient to meet the rising need for this medication.”

The researchers noted that the pandemic was not responsible for the flattening of initiation rates, since the trend emerged earlier. However, the median monthly buprenorphine initiation rate during the early months of the pandemic did dip lower than the months before and after:

• January 2019 to February 2020: 15.5 per 100,000
• March 2020 to December 2020: 14.4 per 100,000
• January 2021 to October 2022: 15.0 per 100,000

Chua said that this study adds to the growing body of research that suggests clinicians have not maximized opportunities to initiate buprenorphine treatment for patients with opioid use disorder. He highlighted another study he was involved with that showed that just one in 12 patients were prescribed buprenorphineopens in a new tab or window within 30 days of an emergency department visit for opioid overdose.

Throughout the current study period, just one in five patients who initiated buprenorphine remained on the therapy for at least 180 days, which the researchers said was similar to a prior study that examined data through 2020opens in a new tab or window.

“A comprehensive approach is needed to eliminate barriers to buprenorphine initiation and retention, such as stigma and uneven access to prescribers,” Chua and colleagues concluded.

Chua said that his hope is that this “study will further underscore to clinicians how much the healthcare system is under-using a critical tool to prevent opioid overdose deaths.”

For this analysis, the researchers included 93,713,163 prescriptions. During the study period, 3,006,629 patients initiated buprenorphine, 42.9% of whom were female.

Chua and team defined initiation as a new prescription for a patient without buprenorphine dispensing in the previous 180 days. They defined retention as at least 180 days of continuous buprenorphine treatment following the initial prescription, without gaps exceeding 7 days.

Limitations to the study included a lack of data on race and ethnicity, in-clinic buprenorphine administration, and buprenorphine dispensing in methadone outpatient treatment programs. In addition, some patients may have initiated buprenorphine to treat pain instead of opioid use disorder.

Filed under: General Problems | 2 Comments »

Is this another study with  selective data to come to a predetermined outcome?

Suicide and Opioids: No Easy Answers, No Sweeping Conclusions

Almost everyone has a personal connection to the national overdose crisis that claimed over 107,000 lives last year. Many have also been touched by the rising toll of suicides in the U.S, which took over 47,000 lives in 2021. Given the pain of those losses, debates over causes and solutions are contentious, especially when they involve the real or speculative role played by prescribed opioids in suicides. In the quest for solutions, researchers and advocates sometimes make recommendations that are not supported by data.

Recently, an article in the American Journal of Psychiatry (AJP) that was widely covered in the lay press, suggested that reductions in the chronic use of prescribed opioids for patients with pain slowed an otherwise discouraging national 20-year rise in suicides. Further, the paper suggests its findings should alleviate concerns about dose reductions in pain patients who have relied on these medicines longterm. However, these conclusions were not supported by the data in the study or in any other available data.

Given rising national concern about a burgeoning opioid crisis, many doctors forcibly reduced doses in long-term recipients of prescribed opioids, often under pressure from regulators and boards. Unfortunately, suicides started happening among patients who were taken off their medication. A series of state- and national-database analyses have documented, retrospectively, elevated rates of mental health crises, suicidal actions or death by suicide among those persons whose doses were reduced, compared to persons not subject to reduction. Because the risk for suicide or suicide attempt remains elevated 1-2 years after the reduction, it has not seemed likely that these tragedies are entirely due to acute withdrawal from opioids. Various authorities have called for caution, as have clinician-researchers like me.

The new article in AJP, from investigators at Columbia University, pushes back. It reports that areas of the country with the biggest declines in opioid prescriptions partly bucked a national trend toward rising suicides.

A few details make it easier to think about what such regional studies can and cannot show. The study relies on suicide data from 2009 to 2017, across 882 “commuting zones” (as devised by the Bureau of Agriculture, areas typically bigger than a county). As mentioned: suicides rose nationally over the study years 2009-2017. Opioid prescriptions dropped from a 2012 peak to the present.

Statistical models tested whether suicide rates rose less in those regions with the greater prescription declines. Of course, regions differ. The study’s models tried to control for that by assigning a single statistical term for each region called a “fixed effect.” The assumption behind a “fixed effect” is the following: As long as the regions differ from each other in “fixed” ways that did not change from 2009-2017, then the models controlled for such differences

This is not a reasonable assumption. We know that regions change in many ways likely to contribute to reductions in opioid prescribing and suicide, without one causing the other. One town might enjoy some economic development, and influx of young families, and new doctors who prescribe less; a decline in suicide might result from all these good things, without the opioid prescriptions having much to do with it. Statistical and graphical analysis could have helped readers learn whether the model’s assumptions were acceptable; but they weren’t presented.

Still, this paper does show that regions with a greater decline in opioid prescriptions (compared to all others) had a smaller rise in total suicides and in opioid-related suicide rates (compared to all others). That regional pattern merits investigation. But there were also exceptions (this pattern wasn’t evident in adults 65 or older). And, for younger persons, unintentional deaths involving opioids seemed to rise most in regions with the greatest prescription declines.[1]

There would be nothing problematic about this article if all it did was present its data and invite further discussion. The article, however, proposed to address the matter of tapering long-term opioid recipients. The introduction cited two of the studies where suicide risk rose after reduction (including one I co-authored), and attempted to refute them — an unusual approach for an introduction.

Then, the paper’s discussion argues that it is the patient who receives the prescription who is put at personal risk for suicide, citing a VA paper where opioid doses did correlate with suicide risk. But that discussion omits a much richer Australian study that looked for, and could not find, any association between opioid receipt, or opioid dose, and suicidality. Buried in the discussion, a caveat was offered, that the results “do not shed light on the clinical pathways connecting local opioid prescribing to individual opioid overdose suicide deaths.”  However, this went unnoticed by many readers. (It was an academic article version of churnalist’s fifth sin: “disclaim and pivot.”)

As a physician-researcher, I care about whether studies are used in ways that misrepresent the risks of curtailing prescriptions in patients with pain. Today, I lead a federally-funded study to examine 110-120 suicides through interviews and record review. We seek to examine them in depth, the way crash-site investigators assess airplane crashes. That’s because we don’t see suicide as simple one-cause affairs.

However, simple stories appeal to reporters. The new paper ignited a storm of inaccurate press coverage, that was seen by many as endorsing the safety of forced opioid reductions, notwithstanding CDC and FDA declarations to the contrary. Speaking to US News and World Report, for example, an associate professor of surgery announced, “for those who have wondered whether curtailing opioid prescriptions could be associated with an increased risk of suicide, this study is reassuring.”

Within days, a widely-quoted, highly-paid expert witness for the plaintiffs in our nation’s ongoing opioid litigation tweeted that the new data “debunk” a “hoax that opioid reduction caused an ‘epidemic’ of suicides” (designation of a suicide “hoax” is not a one-time affair for this expert).  Of course, no experts had claimed an “epidemic” of suicides. Rather experts and patients observed that tapering can increase the risk for suicide, and were appropriately concerned to avoid that.

Ultimately, reporters repeated the fallacy that regional data can tell us how to care for individual patients. But it was the way the paper was written — most notably its introduction and discussion — rather than its data, that drew that interpretation. I suspect that public mockery of suicide risk was not the outcome desired by the authors, given that the final lines of the paper urged caution with opioid dose changes. Speaking with senior author Dr. Mark Olfson confirmed that sense. He readily offered the following condemnation:

The results of our recent study indicate that regions of the country that experienced the greatest declines in opioid prescribing also tended to have the greatest declines in regional suicide rates. It would be a mistake, however, to assume that this ecological observation informs the daily clinical management of individuals receiving opioids for chronic pain or refutes clinical research demonstrating risks attending forced opioid tapers.

Commonsense care of individual patients requires nuance. The best practice is not to force opioid reductions without consent, save when the justification is exceptionally compelling. Even then, the clinician must have a plan to protect the patient from harm, and reverse course if their dose reduction harms the patient. Individual clinical decisions should not be based on findings from geographic analysis of populations. Clinicians and researchers alike might best avert suicide by seeking a careful understanding of the particular patient, their history, and their context.

Stefan G. Kertesz is a Professor of Medicine and Public Health at the University of Alabama at Birmingham School of Medicine, and physician-investigator at the Birmingham Alabama Veterans Healthcare System. His views are his own, and do not represent positions of his employers. On Twitter he is at @StefanKertesz. His team’s study is at https://sites.uab.edu/csiopioids.

[1] Perhaps this was because young persons with opioid use disorder involving diverted prescriptions switched to more dangerous illicit opioids. However, this is pure speculation, we can’t tell from this study.

Filed under: General Problems | Leave a Comment »

America’s problem with managing chronic pain and the addiction crisis

https://www.axios.com/2023/04/21/americas-problem-chronic-pain-addiction-crisis

The Food and Drug Administration’s attempts to manage the overdose crisis by reining in on the use of narcotics are weighing on patients with chronic pain, who say the result has been harder-to-fill prescriptions and heightened withdrawal and suicide risks.

The big picture: The FDA for years grappled with criticism it helped fuel the opioid epidemic by approving products like OxyContin and a tablet 1,000 times more powerful than morphine.

• Now, patient groups are concerned the agency is proposing a large study of opioids’ long-term effectiveness in treating chronic pain without enough of their input.
• Addiction experts say its clinical trial design could be tilted toward benefiting manufacturers.
• And while the FDA has encouraged the development of alternative pain control methods, safety concerns and insurer resistance to covering them have hindered adoption.
• The result is more opioids have been approved in the last five years than non-opioid options.

Driving the news: FDA outside advisers this week slammed the agency’s proposal and, without a vote, recommended the agency reconsider pursuing the study.

• Pain care specialists criticized how the plan wouldn’t address addiction potential or improve care for the millions of Americans managing chronic pain.
• The National Council of Independent Living, a disability rights organization, also noted that these decisions are being made and discussed without patients involved.
• The nine-hour meeting on Wednesday came a week after the FDA announced it’s now requiring both instant and extended-release opioid pain medicines to carry warnings about overdose risk and potential for increased sensitivity to pain.

Details: The study’s design would have participants shifted from prescription opioids to extended-release morphine while a randomly selected group would be switched to a placebo without being told.

• There would then be an eight-week period where the placebo group would be weaned off opioids — a factor agency officials acknowledged could result in high dropout rates and challenges in recruitment.
• Diana Zuckerman, president of the National Center for Health Research, questioned the ethics behind the FDA’s proposal during public comment, saying that, “In addition to withdrawal, won’t that potentially make them even more desperate and more reliant on opioids?”
• Andrew Kolodny, medical director of the Opioid Policy Research Collaborative, asked why administering non-opioid alternatives wasn’t considered.

• “Wasn’t it the practice of switching patients from [instant release] opioids to [extended release] opioids what got us into this mess in the first place?”

Between the lines: A crackdown on opioid prescribing hasn’t stopped overdoses from rising in recent years as the epidemic becomes defined more by fentanyl-laced counterfeit pills than painkillers prescribed in clinical settings.

• But some chronic pain patients say the agency’s latest moves have made physicians more likely to deny needed pain relief out of fear of regulatory scrutiny.
• In an online public comment, Earenya Chapman wrote that “this has left patients with no alternative but to suffer in silence.”
• The policies to limit prescribing have also led to “life-altering harms” including overdose, unemployment and death, said Theo Braddy, executive director of the National Council of Independent Living.
• Some studies have found chronic patients may have an elevated suicide risk following discontinuation of opioid therapy.

The bottom line: The U.S. continues to grapple with how to slow the addiction crisis while helping millions of Americans with conditions causing chronic pain, leaving both public health issues at risk of getting worse.

Filed under: General Problems | 3 Comments »