“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
The DEA claims that they don’t practice medicine, but… they established what they believe is a standard of care and best practices for practitioners to follow and if anyone exceeds those dosing mgs/limits must be prescribing controlled substances ILLEGALLY. Of course, the SCOTUS in June 2022, with a 9-0 vote on the Ruan/Kahn hearing that the DEA could not use objective criteria when judging a practitioner in treating pts dealing with subjective diseases. The SCOTUS in June, 2022 also told ATF & EPA that they had no statutory authority – that belonged to Congress -to create new regulations or interpretations of the laws they were charged in enforcing, but… much of what the DEA uses to charge practitioner is DEA created interpretations or new DEA regulation off of the CSA. But apparently, that SCOTUS ruling did not cause all of these new interpretations and regulations that various fed agencies have created over the existence of the law that the agency is in place to enforce those laws.
Op-Ed: Finally, some promising news on opioids for patients in severe pain
The U.S. remains in the midst of an ever-worsening drug overdose crisis. Because prescription opioids drove its earlier phases, the nation responded by drastically reducing access to those drugs — with prescriptions dropping by nearly 50% over the last decade. But it’s now clear that approach was ineffective at combating overdoses, and it left many patients with painful medical conditions stranded.
Overdose deaths have continued to soar even as fewer opioids have been prescribed. More dangerous drugs filled the gap: At least two-thirds of overdose deaths are now tied to synthetic opioids, mostly fentanyl, a powerful black market opioid. Meanwhile, physicians have had to balance the risk of criminal prosecution for prescribing opioids against their responsibility to treat patients’ pain.
Yet there is promising news amid our nation’s cycle of failed attempts to tackle the crisis. Two key shifts in federal policy this year hint that the pendulum is beginning to swing back toward more access to opioids for patients who need them.
The first is opioid prescribing guidelines that the Centers for Disease Control and Prevention updated last month. They undo a controversial feature of the agency’s 2016 guidance: the cap on opioids at 90 morphine milligram equivalents, or MME, per day. Although this number was never meant to serve as a hard line, law enforcement, regulators and healthcare providers widely interpreted it as one. The problem is that some patients need more than that amount. The validity of using any MME metric has also come under fire. Recent studies show that there is no universal standard for calculating appropriate MME, and methods to determine cutoffs vary widely; a patient who is considered “high risk” for overdose or addiction when evaluated using one method could be “undertreated” according to another.
But these arbitrary standards changed the landscape. Following the 2016 guidelines, insurance companies began to deny payment for pain management above 90 MME. Physicians faced a climate of mounting fear: Although U.S. law allows physicians to prescribe opioid medications for “legitimate medical purposes,” that definition grew more contentious. Law enforcement agencies, including the Drug Enforcement Administration, cited the 90 MME limit in investigations. While some doctors were financially incentivized to overprescribe opioids, others caught scrutiny simply for providing relief to patients in debilitating pain.
After taking higher doses for years, many patients were rapidly tapered under the limit, no matter how painful their health condition was. Some were cut off entirely, unable to find a doctor still willing to prescribe for their chronic pain.
Since then, extensive research has shown that some healthcare providers were inappropriately reducing opioid prescriptions even for cancer, palliative and end-of-life patients, who were supposed to be exempt from limits. Tragically, recent studies found that chronic pain patients who are rapidly tapered off opioids have high rates of suicide and overdose, as people turn to desperate measures for pain relief, including seeking illicit street opioids.
In a step forward for treatment, this year’s CDC guidelines avoid emphasizing specific thresholds. Recognizing the harms of excessive tapering and limits, they instead discuss ranges of dosages appropriate for different conditions and highlight the need for doctors to use their clinical judgment for each patient.
The second major shift on opioids this year was the June Supreme Court ruling in Ruan vs. United States making it more difficult for law enforcement agencies to prosecute doctors for prescribing painkillers. The decision raises the bar for criminal convictions, requiring that prosecutors prove that physicians knowingly or intentionally prescribed opioids inappropriately, not just that their practices deviated from government-defined standards. This will help give doctors more legal cover to treat pain as they see fit.
These shifts are early signs that the tides are beginning to turn back toward more access to opioids for patients who need them. But achieving that access will not be easy.
Physician willingness to prescribe opioids is a cultural phenomenon. Doctors have reduced their level of opioid prescribing not just from fear of prosecution but also based on trends in the field. Seminars, institutional guidelines and professional organization statements over the last decade have instilled the idea that prescribing opioids is something to be avoided.
Prescription opioids also remain an enemy in the public consciousness. Although the drugs have been overtaken by black market fentanyl in the overdose crisis, lawsuits against opioid manufacturers continue to command a disproportionate amount of big-swing prosecutorial attention. Of course, companies that deceptively promoted opioids in unsafe ways should be held accountable. But lawsuits against them do nothing to address the current fentanyl crisis, and they may give the false impression that prescription opioids still dominate the overdose problem.
Changing these narratives will take time. Similarly, it is not automatic that the Drug Enforcement Administration, other law enforcement, state governments or billing and insurance companies will change their protocols in line with the new CDC prescription guidance.
Tangible improvements for pain patients probably will happen over years, rather than days or months. They will also require attention to deep disparities in pain care and treatment access. My colleagues and I found in a 2019 study that opioid prescription rates in California varied by 300% based on neighborhood income and racial composition (with predominantly white neighborhoods being most likely to receive opioids and other controlled substances). This reminds us that medical guidelines are not neutral and need an intentional focus on equity to be implemented fairly.
Nonetheless, advocates, physicians and researchers working toward the goal of adequate pain treatment have cause for optimism. The question now is how readily doctors, insurance companies and law enforcement will respect the wisdom of current scientific evidence and legal standards.
Joseph Friedman is a substance use researcher at UCLA who studies the overdose crisis. @JosephRFriedman
This past November, CMS announced that starting January 1, 2023, Medicare will pay physicians in all states and other practitioners with prescription authority such as Nurse Practitioners (NP’s) and Physician Assistants (PA’s) in some states, to perform comprehensive pain management for their patients living with chronic pain. Medicare health insurance covers individuals over the age of 65 and disabled Americans.
CMS has created two specialized billing codes just for chronic pain management (CPM codes G3002 and G3003) that these health care practitioners can use to get paid for their time spent caring for patients and coordinating patient care with other health care practitioners like physical therapists, psychologists and even complementary practitioners such as massage therapists and acupuncturists.
Did CMS include patient input in the ruling?
Yes! CMS released a draft version of this idea in July 2022 and posed many questions asking for patient and other stakeholder input. The U.S. Pain Foundation sent an alert this summer explaining the kinds of input they were seeking. Thank you to those who took action! U.S. Pain Foundation submitted a lengthy comment to the docket answering CMS’s questions from the patient perspective. You can read our comment here. We are pleased that CMS really did incorporate our recommendations into the final rule. In fact, they quoted the organization’s comment 12 times in the final rule.
How will this improve pain care?
How will I know if my doctor is using this code?
Do the new codes allow telehealth visits with my doctor?
What about if I have already been seeing a doctor for pain management and have an on-going treatment plan?
Will any doctor regardless of specialty be able to bill these new CPM (chronic pain management) codes?
Will other public and private insurers cover monthly chronic pain management visits?
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
LESLY POMPY MD
NOTES FROM TRIAL IN FEDERAL COURT DETROIT MICHIGAN
(notes may not reflect the actual date of testimony, only the date received)
Diane Greer:
“..It’s horrible what they did to this good man!! May the ones who participated in his persecution get the same in return for their evil behavior..”
December 19
Testimony:
Dr. Moulton (The Jamaican Dermatologist) testified that she sent her daughter ( Nonaigne) to me, she described how Nonaigne wanted more pain medications. I refused, Nonaigne went to a different pain doctor, who later abandoned her. Nonaigne subsequently overdosed on Heroin and died in Maryland. Dr. Moulton cried on the witness stand, with a deep impact on the jury.
Dr. Shah testified as to to Interstitial cystitis, being incurable , and causing lifelong pain and suffering.
Former patient Jes Staten testified that his great life came to an abrupt end after a car accident. His hip exploded. Surgery wasn’t an option. I did the platelets rich plasma for his hip.
The surgeons at University of Michigan could not believe how his shattered hips was healed. I prescribed Jes the stimulant Ritalin.
Prosecutor Wayne Pratt ascribed the Ritalin as treatment of side effects of opioids.
Jes described to the Jury that after weeks of chemotherapy for brain cancer ( astrocytoma), he was week and sleeping 19 hours per day. I prescribed the Ritalin so he could stay awake.
Former patient Steve Ellison was a former nuclear technician for the U.S department of energy. Steve was involved in a car accident, became addicted to the pain pills, lost his job and his family.
One day he was suicidal, went on top of the bridge in Monroe to jump. He called his father who came to get him from the suicidal bridge. I put Steve on addiction medicine, turned his life around, and now has a job in construction and family back.
Dennis Helm testified that Dr. Pompy brought platelets rich plasma to Monroe, successfully treated his knee.
After the 9/26/2016 raid he could not find another doctor to do it for him but at 3 times the cost. Insurance does not cover platelets rich plasma and he could not pay for the added costs, per each knee.
Dennis ended up with surgery of his knees and subsequent lengthy painful recovery. Earlier in the trial one former employee who had turned witness for Wayne Pratt had accused Dr. Pompy of trading a truck with Helms for OxyContin.
However, this was a damn lie….”I had never,” Pompy writes, “prescribed Dennis Helm pain medications since he (Helm’s) was under treatment at the Ann Arbor’s Veterans hospital. Dennis is a Vietnam vet disabled by agent Orange in Vietnam.”
Prosecutor Wayne Pratt hid a column on the Medicare payments to Dr Pompy for medical services rendered to Dennis’s wife, Ines Helm. Wayne insinuated that Dr. Pompy billed Helm’s insurance for services not rendered.
My attorneys Chapman and Donnini caught the Wayne Pratt attempt to deceive the Jury. Jurors frowned at the intentional misrepresentation, sleight of hand, by Wayne Pratt as he was attempting to manufacture a health care fraud charge. ( billing for services not rendered)
The Defense Rested Closing Arguments Tuesday December 20, 2022.
HIGHLIGHTS
Dr. Murphy:
My medical expert witness, Dr. Murphy ( no relationship to Judge Murphy, of the case), began to testify. He showed how the undercover from the Blue Cross Blue Shield, fabricated medical records obtained from Dr. Robertson. Marc Moore denied he participated in the fabrication of medical records for Blue Cross Blue Shield of Michigan Mutual Insurance Company, James Stewart, aka James Howell.
Marc Moore conceded that he had no medical training, and no billing and coding knowledge. Marc Moorelacks the education, training, or experience to issue a legal opinion as to the illegal distribution of controlled substances, or insurance fraud.
My attorney played the tape of Marc Moore mocking my education. Marc Moore testified that he was keeping his cell phone on 9/26/16 so that he would see all of the drug addicts texting him to buy drugs.
December 12
Brian Bishop was the DEA agent who was actually present at the raid on 9/26/16. Bishop will not testify. Michelle Cooper of the Diversion Department of the DEA testified that the DEA helped doctors but did not do that for “Dr. Pompy.”
1)They could have helped with record-keeping ideas, but the DEA did not.
2)The DEA performed no investigation prior to the 9/26/16 raid. I was not on their radar.
3)The DEA did not check whether the number of Suboxone patients was correct, above, or below. She agreed that going over the limit of the Suboxone patients was not a criminal offense.
4)After the raid, the DEA reduced my Suboxone patients from 275 back down to 100.
5)Diversion investigator Michelle Cooper had no idea why my Suboxone limit was dropped, after the raid.
6)Chapman found it strange that the drop occurred after the raid.
7) The jury was fascinated by prosecution witness Diana Knight’s testimony: proper billing occurred and nothing was fraudulent. Diana was Dr. Pompy’s medical office biller. She maintained composure during intense, relentless attacks by AUSA Wayne F. Pratt. She won the jury’s heart.
December 8
Good day
Brent Cathey of Monroe City Police, now Police Captain after the 9/26/16 raid, saw what appeared to be medication bottles, with an expired date, at the house. Brent Cathey did not know what was in the bottles. The bottles were not chemically tested.
Tracey Lapalme, a former addiction patient testified that Dr. Pompy made her an addict. She was surprised to find out that Dr. Pompy had her on Suboxone, from the first visit, to treat any medication misuse she may have had. Suboxone can treat pain and substance misuse.
Stephanie Stine testified that her boyfriend, Scott Jones, would beat her up, and take half of her medications. She did not report either the abuse or the taking of her medications by Scott Jones to Dr. Pompy. She testified that she had interstitial cystitis ( an incurable, painful disease of the bladder that causes pelvic and abdominal pain ), and endometriosis since she was 15. She is still on medications.
..the question we now ask have these doctors done wrong???
Amid a weakening macroeconomic environment and ongoing pressure by private and public payers to reduce healthcare costs, a growing number of healthcare companies are faced with credit rating downgrades and potential defaults.
The healthcare industry’s social risk is also rising, exemplified by credit negative legislation such as the No Surprises Act and ongoing litigation around opioids, according to Moody’s Investors Service in a new report.
Among 193 rated North American-based healthcare companies, 34, or nearly 18%, were rated B3 negative or lower as of Nov. 30, up from nine, or about 4%, of rated healthcare companies as of Dec. 31, 2015. About 80% of North American healthcare companies are now speculative grade, as compared to around 73% in 2015 and 71% in 2010, Moody’s reported.
Credit stress is rising in healthcare, which has long been considered a defensive sector for credit investors. The ratings of 24 North American healthcare companies have been downgraded to B3 negative or lower, representing a “material deterioration” in the sector’s credit quality, write Moody’s analysts.
Healthcare companies now represent approximately 16% of the 207 companies on Moody’s Investors Service B3 Negative and Lower List (B3N List) as of Nov. 30.
Updated monthly, the B3N List includes all nonfinancial corporate issuers in the U.S. that meet the firm’s proprietary definition of credit stress—those with a probability of default rating (PDR) of Caa1-PD or lower, or B3-PD with a negative rating outlook or review for downgrade.
“Attracted by healthcare’s historical stability and buoyed by accommodative debt markets, financial sponsors have aggressively consolidated fragmented subsectors,” including physician practices, emergency medicine and anesthesiology, Jean-Yves Coupin, vice president, corporate finance group, Moody’s Investors Service, wrote in the report.
“The resulting roll-ups carry high levels of debt, which will pressure their cash flows and limit their ability to adapt to the changing macroeconomic environment, as well as to increasing social risk, new legislation and litigation,” Coupin said.
The 34 healthcare companies on the B3N List have nearly $65 billion of outstanding debt, an increase of 57% compared to March 2020 at the onset of the pandemic and more than double the nearly $33 billion in debt outstanding in January 2019.
The increase is largely attributable to two recent additions to the healthcare roster that together account for nearly half of its total debt: Bausch Health Companies with about $21.8 billion of outstanding debt and Envision Healthcare Corp. with about $7.9 billion. Excluding Bausch Health, Envision has the largest debt load among healthcare companies Moody’s list, accounting for 18% of total debt outstanding, followed by Team Health Holdings and Radiology Partners, each accounting for nearly 8%. Individuals who are struggling with medical and business debts should consider implementing Customized Debt Relief Strategies.
In September, Moody’s has issued a scathing corporate credit rating downgrade to Envision Healthcare, assigning the physician staffing service and ambulatory surgery center operator its lowest possible junk rating and warning that a bankruptcy or major restructuring is likely on the horizon.
Many healthcare companies rated B3 negative or lower started 2022 with high financial leverage, high levels of floating rate debt and weak operating performance, according to Moody’s. With rising interest rates, these companies now have to contend with higher financing costs amid persistent inflation along with slowing economic growth that will pressure earnings well into 2023.
“Finding lenders willing to refinance will become increasingly difficult in the year ahead as the market retrenches,” analysts wrote.
Thirteen healthcare companies have defaulted since January 2020, with high leverage and weak operating performance as the two main culprits, Moody’s analysts noted. This proves the industry is not immune to the profit and cash flow pressures challenging many industries today.
Operating weakness came from a variety of sources including technological obsolescence, shortages in skilled labor or increases in labor costs, changes in the operating environment or simple mismanagement.
For some defaulters, disruption caused by the COVID-19 pandemic was the last straw.
Looking ahead amid a challenging economic environment in 2023, capital structures of the healthcare companies rated B3 negative or lower will become “unsustainable” as they contend with higher financing costs and find it increasingly difficult to find willing lenders to refinance.
“Companies with unsustainable capital structures will need to cut their cash interest expense by either seeking to convert their debt to payment-in-kind (PIK) obligations, completing debt-to-equity conversions, or through debt extensions. Lenders will likely accept these maneuvers to avoid borrowers filing for bankruptcy, which would result in greater losses,” analysts wrote.
Moody’s analysts noted that private equity activity in the sector contributed to the uptick in companies on the lower end of the ratings scale.
Nearly 90% of the North American healthcare issuers on the B3N List are controlled by private equity, reflecting “aggressive financial policies, high leverage and debt structures predominantly funded with floating-rate loans,” analysts wrote.
As credit conditions worsen and interest expense rises, these companies’ cash flow have increasingly come under pressure, which limits their ability to adapt to changing industry dynamics such as increasing social risk, new legislation and litigation.
Two of the largest healthcare companies on the B3N List are owned by private equity: physician staffing companies Envision Healthcare, which has defaulted on its debt twice since January 2020, and Team Health, which we downgraded to Caa3 in October, Moody’s noted.
Analysts warned that many of the downgraded companies face the same factors that caused 13 healthcare companies to default.
Labor costs, which have risen in most industries, have been particularly credit negative for healthcare companies, which have also been plagued by labor shortages. “Labor issues led to ratings downgrades to B3 negative or below for several healthcare staffing companies, which have struggled to find sufficient labor to provide necessary care at a cost at which they can remain profitable,” analysts noted.
Technological obsolescence is another factor that has led to recent downgrades. For instance, Lifescan Global is seeing its traditional blood glucose monitoring equipment being replaced with newer technology that is much more popular with patients. Another example is Carestream Health, which specializes in traditional medical film for X-rays—a technology that is being rapidly replaced by digital imaging.
Changing industry dynamics, including new legislation or regulations, can cause additional headwinds and drive downgrades, Moody’s said.
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
A PHYSICIANS COMMON SENSE OBSERVATION
Every person is entitled to effective pain relief. However, I continue to see articles on treatments and medication for pain relief. All of the treatments and medications fall short of their goals.
In addition, every medication has side effects that far outweigh their benefits. NSAIDs can cause GI bleeding, kidney failure, and peripheral edema. Tylenol can cause liver failure. Neurontin can cause, dizziness and mental confusion and is known to be abused. Lyrica has limited effectiveness and is used mostly for diabetic neuropathy and polymyalgia rheumatic.
The most effective medication is opiate pain medication. The side effects are even better when the opiate is not combined with other drugs. Why, then, do we continue to substitute things that are not proven to work or where the side effects are severe?
The risk of addiction. The problem with using addiction as a reason for not using opiate pain medication is that it ignores the facts and misrepresents the benefits.
We have the medication that has been proven to be effective since 1803 when morphine was synthesized. Patients deserve to have safe and adequate proven pain relief.
LOST IN THE DISCUSSION IS TOBACCO
Lost in our conversation is What substance actually causes the worse harm? What actually is a gateway drug? Let us look at the evidence. We have known for years that nicotine has harmful effects. Lung cancer and emphysema are well-known side effects but take years to develop. Death is less traumatic because although abuse starts at a young age, death occurs at an older age.
Nicotine, like opiates, is addictive because of the interaction between the drugs and receptors found in the brain and bodies of individuals. But if we look at the actual numbers, 450,000 people die from tobacco-related causes, while only 70,000 people die from opiate-related causes.
Also, individuals who die from opiate-related causes tend to be younger, thus appearing to be more tragic. After all, parent should not outlive their children. I will also argue that tobacco is a gateway drug. Tobacco and alcohol are associated with being adults, and since children want to be like their parents, young people are encouraged to use tobacco and alcohol at a younger age.
Opiates, on the other hand, are not introduced until a later stage in one’s life. Bad behavior is introduced by society and in the home environment.
Walter F. Wrenn,III,M.D.
FOR NOW, YOU ARE WITHIN
YOUAREWITHINTHENORMS.COM,(WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)
A few months ago there was some confusion about some things that the DEA had published about what a Pharmacist may or may not add or change on a C-II prescription. I got this from the KY BOP, but since all C-II are now sent electronically, the ability to add/alternate data on a C-II may be limited by the pharmacy computer/software system. This may just the KY BOP restating the obvious law, while stating that the DEA is in the process of changing or creating new regulations and/or interpretations of the CSA… Which the SCOTUS made a ruling in July 2022 that told EPA & ATF that they could not do make new regulations and/or interpretation of the laws that they are in charge of enforcing. That such actions were limited to Congress to do.
Changes Pharmacists May Make to a Schedule II Paper Prescription
Drug Enforcement Administration (DEA) has issued guidance on what changes a pharmacist can make on a Schedule II paper prescription. This guidance will remain in effect until DEA codifies new regulations or until this guidance is otherwise modified or withdrawn by DEA. According to the guidance, DEA has received an increasing number of questions in the past few months concerning the ability to add or modify information – like a patient’s address – on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and is working to draft new regulations. In the interim, pharmacists should adhere to the state regulations or policy regarding those changes that a pharmacist may make to a Schedule II prescription after oral consultation with the prescriber. Kentucky has had the following policy guidance from the Drug Enforcement and Professional Practices Branch of the Office of Inspector General since 2010: •After consulting with the prescribing practitioner, a pharmacist may add or modify the following items: •date of issue – may be added, but not changed •drug strength •quantity – may be modified only in conjunction with a change of strength, and the total quantity dispensed must not exceed the total dosage authorized •quantity check-off box marked •directions for use •refill instructions (Schedules III-V) •practitioner’s name – printed (not a signature) •All consultations must be documented •The following items may be added or modified without consulting the practitioner if the information can be obtained from other reliable sources: •patient’s address
•dosage form •practitioner’s address – printed •practitioner’s telephone number •practitioner’s DEA number A pharmacist may never change or add the patient’s name, the name of the controlled substance (except generic substitution permitted by state law), or the signature of the practitioner. Both state and federal law still require professional judgment by the pharmacist on every prescription filled. Caution is advised whenever a change or addition is made to any prescription.
What’s the deal with the “discard after one year” label on pill bottles? Is it based on real science? Or, is the FDA just trying to get you to send in “outdated” medicines, especially prescription opioids?
Don’t Be Tempted to Use Expired Medicines…Out with the old! Be it the fresh start of a new year or a spring cleaning, consumers are encouraged to take stock of what has surpassed its usefulness. Medicines are no exception.
This is a size-48 waist pant load of crap. It is that wrong. More on this later.
The agency has zero credibility here, especially since it has created a monumentally dumb program where people with “excess” opioids (1) can put them in an envelope and mail them back to the FDA. What a splendid idea! I wrote about this in 2022 and 2020:
If you want to dispose of or return your unused opioids feel free to do so, but doesn’t that seem a bit like returning the unused portion of your paycheck to your employer? “Well boss, I didn’t use all the money this month, so here’s what I didn’t need.”
And here’s what I envision what the return envelope might look like:
Speaking of the drugs being stolen, I got the following comment after that story from a reader who calls himself Victor Frankenstein (presumably a pseudonym, but considering all the nutlogs that follow me, I can’t be certain) after the 2022 article: Image: licensed from Shutterstock
I had mentioned this to a good friend over a couple of beers, who is also a U S Postal Service Employee. After his beer shot out of his nose, we were able to clear his airways and get a proper response. He noted that the U S Postal Workers will ensure that any of these envelopes “clearly marked” will be properly and expeditiously delivered to the proper receiving entity. On another note: Years ago, he also informed me that a good U S Postal Service Worker can smell money in an envelope and also showed me how to remove it from the envelope without opening it. Using only a “Hair Pin”… I have a question. Is it not illegal to send narcotics through the mail? Unless of course, it’s from China.
Victor Frankenstein in rare form, 6/22. Comment after this article
Way to go, Vic! (Notice: The monster pseudonym program is now over. I don’t want to hear from any Dick Draculas or George Godzillas.)
Time for the science
Note: I’m not encouraging anyone to take any medicine after the expiration date on the bottle. This article is merely a look at the data on drug efficacy and safety of drugs over time. You can decide for yourself what, if anything, to do with this information.
Medscape thoroughly trashes the FDA’s Mr. Rogers-like advice. [Emphasis mine]
Are Drug Expiration Dates a Myth?? Note that the FDA requirement is a date at which potency is still guaranteed. In most cases, the drug in question has not been tested for efficacy or toxicity past that date. There is also no incentive in the regulations for a pharmaceutical manufacturer to look for ways to lengthen that date of expiration.
This is a blatant case of “absence of evidence vs. evidence of absence.” The FDA checks drugs after one year and finds that they are OK. This does not mean that the agency tested them after five years and determined whether they were not OK. This is where the one-year warning comes from. It means almost nothing. We can conclude from the FDA’s limited study that the real number could be one year or 1,000 years. There is no way to tell.
Except there is
The Harvard Medical School reported that the military, sick and tired of regularly throwing away expensive drugs, conducted its own study:
“[T]hey found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.
Likewise, a 2012 study reported in JAMA Internal Medicine revealed:
Eight long-expired medications with 15 different active ingredients were discovered in a retail pharmacy in their original, unopened containers. All had expired 28 to 40 years prior to analysis…Twelve of the 14 drug compounds tested (86%) were present in concentrations at least 90% of the labeled amounts, the generally recognized minimum acceptable potency. Three of these compounds were present at greater than 110% of the labeled content
More specifically:
Among the drugs that were tested that maintained greater than 90% of the labeled amount were acetaminophen, codeine, hydrocodone, and barbiturates
Well, would you look at that! Vicodin (hydrocodone plus acetaminophen) pills that have been sitting around in a bottle for about 30 years are just fine, yet the FDA wants you to return them. Based on zero evidence that the drug was no longer useable.
Likewise, the shelf-life of Dilaudid (hydromorphone) is given as three years but is probably longer, maybe by a lot.
In a more extensive study, the drug giant Sandoz analyzed 122 drugs and found that 88% of them were safe to use more than 5.5 years after the expiration date. Some of these included:
Almost all solid (tablet or capsule) drugs are stable past their expiration dates.
Solutions are less stable than solids but may still be OK if stored properly.
This does not hold true for most antibiotics, especially tetracycline, which forms a toxic isomer even when inside a capsule. Don’t use expired antibiotics. Bad idea.
Storage conditions matter. The enemies of drugs are light, heat, oxygen, and moisture. If you keep them sealed, in the dark (maybe even cold), the opioids I showed above will be useable for many years.
But keep in mind that the FDA tells you the opposite.
What to do?
My personal opinion is based on the chemical structures of a given drug and is reinforced by the studies above. I think you have to be absolutely out of your mind to return expired opioid pills because there’s an excellent chance you won’t get them back when you really need them. Don’t just take my word for it.
Should you be unfortunate enough to walk into the ER at Maimonides Medical Center in Brooklyn with a kidney stone, you’ll run into this mentality: [Emphasis mine]
Relying on opioids as the primary analgesics for moderate to severe pain is inadequate, unsafe, and costly…I am just trying to come up with a feasible, practical solution or alternative to opioid analgesia in the emergency department… For now, it is an alternative, but who knows what may happen later on. Perhaps we will be able to eliminate opioids altogether, which would be fantastic.
– Sergey Motov, MD, Maimonides Medical Center
All of you can make up your minds, but I think I’ll hang on to my small stash of 5-year-old Percocet. Ya never know when you might run into trouble, let’s say, in Brooklyn.
NOTE:
(1) The term “excess opioids” is right up there with a Model-T Ford. You are unlikely to own either of them.
Doctors across the country, especially those in primary care, have been up in arms about Medicare’s proposed cuts in reimbursement that are scheduled to go into effect on January 1. They are concerned — rightfully so — that these cuts will be ruinous to their practices and compromise the care they can provide to their patients.
As an emergency physician, I worry about the cuts for a different reason: emergency departments might soon be filled with more and more people who can’t access primary care.
In a recent commentary in the Washington Post, Shirlene Obuobi, a physician in Chicago, wrote about why patients no longer feel cared for by their physicians. Among other things, she described how Medicare and private insurers “reward procedures, imaging, tests and other diagnostics that generate revenue and have high reimbursement rates.”
Falling payments to primary care doctors and generalists have forced them to increase the number of patients they see in a day, sometimes having to schedule patients every 10 minutes to justify staying open. The inevitable burnout caused by such pressures will likely drive some away from primary care, making that kind of essential care even harder to come by.
I see the consequences of this system nearly every time I work in the emergency department: the patient with headaches who has had to wait six months for a neurology appointment, the uninsured patient with newly diagnosed diabetes, or even the patient who delayed a routine mammogram and now has cancer.
The U.S. health care system is broken and Obuobi is right to call attention to it. But as bad as things are now, they’re going to get worse if the proposed Medicare reimbursement cuts go into effect, because even more people will find themselves unable to access primary care.
As an emergency medicine doctor, I’m trained to take care of people with heart attacks, strokes, gunshot wounds, appendicitis, broken limbs, and other time-sensitive emergencies that need prompt recognition and treatment. Yet I find myself increasingly having to address problems that would better be served by a primary care physician, things like routine management of diabetes and high blood pressure.
I like to think I’m a good doctor, but I’m not the one you want adjusting your blood pressure medicine or instructing you how to dose your insulin at home, especially not after you’ve waited six hours while I was treating people with more acute and life-threatening issues. I can’t bring you back for an appointment in two weeks to see how things are going, and I can’t be available by phone if you’re not getting better. I can’t follow your progress over time and make the adjustments that keep you healthy. It’s not what I’m trained to do, and any attempt I would make would fall woefully short of what a primary care physician can do.
It’s a shame that primary care physicians are so undervalued by the U.S. health care system’s reimbursement structure, because the work they do is so important. More than any other physicians, they are tasked with keeping us healthy. I focus on treating decompensated disease; primary care doctors spend a lot of their time working to ensure their patients never get the disease in the first place and, if they do, it is well controlled. In addition to being important for patients, this work is also incredibly cost-effective. Ensuring that a patient with diabetes is controlling their blood sugar is far less expensive than having that patient be rushed to an emergency department in a diabetic coma.
I realize that physicians complaining about pay might not generate much sympathy from the public. But please hear me out. Many primary care physicians are in private practice, meaning they’re responsible for their own overhead. Medicare physician reimbursements are set to be cut by approximately 4% on January 1. When factored in with other projected Medicare cuts, the total cuts physicians can expect to see are closer to 8.5%. And that’s not even accounting for inflation. If reimbursements fall that dramatically, these physicians may have no choice but to stop accepting Medicare patients in order to keep their lights on. And given that most insurance companies set their reimbursement rates based on Medicare’s, it’s reasonable to expect that reimbursement will fall across the board, meaning that primary care doctors may be forced to accept only patients who can pay out-of-pocket.
The downstream effects of Medicare’s cuts would be devastating. People who are shut out of primary care will increasingly turn to emergency departments to meet their needs, needs these departments and their practitioners were never designed to meet. This January and beyond, in the middle of Covid-19 and flu season and the rise in RSV infections, the last thing hospitals need is more people crowding emergency departments. Yet that is exactly what will happen if the reimbursement cuts go into effect.
There is still time to act. Congress has the power to avert these pay cuts and there is currently a bill in the U.S. House of Representatives, the Supporting Medicare Providers Act of 2022 (H.R. 8800), aimed at doing just that. Yet the clock is ticking and, with under a month before the new year, I am rapidly losing hope that these cuts can be avoided.
Even if Americans don’t like to admit it, health care is a business and businesses need to be adequately paid so they can continue to offer their services. Ringing in the new year by slashing Medicare payments will hit primary care physicians the hardest, but it will be disastrous for the entire health care system. My colleagues and I in emergency departments across the country will be forced to try and fill the void, and we will do our absolute best to do that. But people would be much better served by readily available primary care, a business that should be rewarded for the important work it does to keep people healthy and out of emergency departments and hospitals.
2022 may go down in history as many of the shenanigans of those within our judicial/politicians at the federal level comes out of the shadows and into the daylight and perhaps even under a microscope. As outlined in this article the federal prosecutor had gathered a number of Dr Pompy’s current & former employees and a number of pts that the prosecutor believed would testify on how poorly Dr. Pompy practiced medicine.
Apparently prosecuting witness after witness testified how Dr Pompy was doing everything “by the book”. What did the prosecuting attorney promise all these witnesses ? Immunity from being prosecuted themselves for being “active participants” in the alleged “pill mill” that Dr. Pompy was running.
Over the years, I have read where the DEA would find pts within a practitioner’s office that doesn’t have a “clean rap sheet” and would convince these people that if they testified that the targeted practitioner was doing exactly what the DEA wants them to testify to, in exchange for a “get out of jail card”
Obviously, these prosecutor’s witnesses if they tell the truth and Dr. Pompy is found NOT GUILTY… they have not risk of being charged or jailed for helping Dr. :Pompy prescribing controlled substances “too loosely” and without “valid medical necessity “
It may only be a matter of time that state and federal bureaucrats step up and pay attention to how far off the rails some parts of the various agencies have strayed. People in under/untreated pain can be ignored, because there is no real lab test that will determine the intensity of the pt’s pain. Suicides from under/untreated pain should not be ignored. I don’t encourage or condone suicide, BUT… should pts leave behind suicide videos and/or suicides notes and should the pt’s family or friends share this with the local prosecutor to press charges against practitioners that have ignored the pt’s routine sharing what the intensity of their pain really is. Should pts who have extremely high blood pressure due to their under/untreated pain continue to ask the practitioner why they are allowing their BP to stay in a hypertensive crisis level of the physical damage (eye & kidneys) or stroke or heart attack the pt is at risk of.
Likewise, should pts continue to remind their practitioner of the liver & kidney & GI bleeds from routinely taking Acetaminophen ( Tylenol ) & NSAIDS ( Motrin/Aleve)… they claim that 15,000/yr deaths associated with the use/abuse of NSAIDS. The number of liver failures caused by the use/abuse apparently is not really track or the numbers are not disclosed
This came after Diana Knight, a witness for the prosecution, stated, “proper billing occurred and that nothing was fraudulent.” Ms. Diana Knight was Dr. Pompy’s medical office biller and her testimony was strongly in Pompy’s favor. She further addressed the EMR-coded visits.
“Blue Cross acknowledged that time is not of the Essence for billing unless more than 50% of the visit Time was spent on counseling or coordination of care.”
The Prosecution grew visibly angry and lashed out as Ms. Knight was asked (by the prosecutor), “whose side are you on, the truth or Pompy’s?” Stoically, holding her composer, and with resolve in her voice, she said:
“I am on the side of Dr. Pompy because Dr. Pompy is the truth.”
As reported earlier Diana Knight maintained her composure during intense, relentless attacks by prosecutors She won the jury’s heart literally. Ms. Knight writes:
“I am beyond proud of Dr. Lesly Pompy’s legal team. They are doing an amazing job for all of us, .standing up for our rights.I have smiled, I have cried, and I have felt overwhelmed during this trial, but most importantly, I have felt grateful. They are truly a blessing right now. I could never thank them enough for all they are doing.”
Prosecution ARRAY OF fumbling Witnesses
One former employee Abby Higgins turned against Dr. Pompy. She had worked for Pompy years earlier while in high school. After graduation, she went on to nursing school (never worked for Pompy in a nursing capacity) but hadn’t worked for Dr. Pompy since leaving high school nearly 12 years ago.
Ms. Higgins claimed that the visits, when she had worked for Pompy as a high school student, were, “too fast.” Abby Higgins’s testimony was impeached thoroughly after it was revealed that her aunt worked at the Detroit US Attorney’s Office.
PROSECUTION DROPS FIVE CHARGES
The lack of evidence was so severe that even the prosecution medical expert (smcs), Dr. Christensen, stated that these counts should be dropped. *
Dropped were Counts 26, 30, and 31,34,39. Pompey’s medical expert witness Dr. Murphy testified that :
1) our patients had real problems;
2) our patients were billed appropriately;
3) Dr. Pompy acted like a doctor; 4) no drug dealing occurred; 5) our patients received medications most likely to help them.
Prosecutor Wayne Pratt’s cross-examination of Dr. Murphy and Pompy’s Medicare Expert appeared reshuffled and confusing.
“It’s horrible what they did to this good man!! May the ones who participated in his persecution get the same in return for their evil behavior!!”
Diana Knight:
“I really miss Dr. Pompy. Not for my pain management but as a physician in general. He always found my problem and helped to correct it, or at least an answer to it.
I miss the days when he’d sit down and discuss your labs and such while the entire time critically thinking of what to do about it. Then dig deeper if needed. He always saw me as a whole picture, not just arm pain. Just wanted it put out there.”
Pamela Hoard:
To: Michael Ney, MD.
“On and on it goes. There is an assembly line of fake patients and another of unlawfully arrested doctors, in my opinion. I worked for four years with the detectives of a police dept in a large county. I pick up a few things and don’t know it all. Then there’s an assembly line coming with bedridden patients in sheer agony.
These assembly lines come out of the DEA factory with judges overseeing everything. Thank you, Michael, for keeping us alert and educated about these trials. When I was a Federal Court expert witness for six judges for three years on drug-related cases I also got an education on judicial practices.
Michael, you are a valuable person in the Chronic pain community. Your work is appreciated.”
Law Enforcement’s Achilles heel : House Passes New Bill To Abolish Qualified Immunity for all local, state, and federal law enforcement officers
On a largely party-line vote, the U.S. House of Representatives on Wednesday night approved the George Floyd Justice in Policing Act (H.R. 1280), a massive overhaul of American policing that would make it much easier to sue rogue officers. Among its many provisions, the bill would eliminate “qualified immunity” for all local, state, and federal law enforcement officers. Under qualified immunity, government officials escape any legal liability for civil rights violations unless the victim can show that their rights were “clearly established” at the time.
“We as a country have a choice: We can either choose police accountability, or choose qualified immunity, but we cannot choose both,” one of the act’s original cosponsors, Congressman Ritchie Torres (D-NY), said on the House floor. “The purpose of the George Floyd Justice in Policing Act is not to second guess officers who act in good faith, the objective is to hold liable officers who repeatedly abuse their power and who rarely, if ever, face consequences for their repeat abuses.”
A nearly identical version of the bill passed the House last summer but never got a floor vote in the Senate. Though the Justice in Policing Act still faces an uphill battle this session, prospects are brighter. Ending qualified immunity is backed by around two-thirds of Americans, including many prominent celebrities like Tom Brady and the co-founders of Ben & Jerry’s.
While this only passed the House during the current Congressional session …BUT… a new Congressional session starts in a few weeks. It was just reported today that another patient ( Jessica Fujimaki ) died from losing their pain management resulting from the DEA’s raiding Dr. Bockoff office last month. Not from suicide because their pain meds were eliminated… BUT… from WITHDRAWAL and fatal complication of her existing diseases.
More police – especially locally – are being taken to trial and found guilty for harming/killing people that were otherwise innocent. George Floyd’s death was seemingly the trigger of a lot of social/civil unrest, followed by Breonna Taylor death in Louisville, KY over a no-knock warrant – at the wrong house.
We all know that the vast majority of cops – especially at the state level – are pretty good/honest people.
Unfortunately, we cannot say the same for those who are part of our Federal Judicial system. Just read in the blog link below, towards the end of the text. How much – or little – the DEA did to help all those pts of Dr. Bickoff when they raided/closed his office and threw all those pt to the curb.
I always thought that it would take some sort of legal activity to protect the community. I never considered revoking law enforcement’s “qualified immunity” but The House Representative Rep Karen Bass (D) is now mayor of Los Angles to replace the mayor that got recalled.
However, the community has a bill already written to try and get passed by both Houses of Congress in the next 2 yr session that starts in Jan.
