EDITORIAL:CVS Pharmacist: “I am awakened by nightmares about prescription errors.”

https://pharmacistactivist.com/2023/August_2023.shtml

The Ohio Board of Pharmacy has documented errors/violations, but does pharmacy recognize the dangers for patients and our profession?

The comments provided below by a current CVS pharmacist would be alarming for CVS customers if they were aware of the working conditions in the stores in which they should be able to have confidence and trust.

“CVS opens its pharmacy at the strike of 8 am. There is already a line at the drive-thru and the phones begin to announce you have 4 (and often more) calls as the technicians and pharmacist begin to face another day of chaos. Before we even count a tablet, type a label, answer the phones, and manage the drive-thru, we are already ‘red.’ ‘Red’ at CVS means you are behind. Every step in the pharmacy is measured. Understaffing is the way of doing business at CVS.

“I am in the middle of verifying directions on a hard copy prescription and it is more than ‘Take one capsule three times daily with food.’ It is a complicated titration dosage for an antipsychotic drug. I am trying to focus on the dosage and I hear, ‘Mary (not her real name), you have a DUR at drive-thru, Mary, you have a DUR at register 5 inside, and the customer on line 4 has been on hold for 7 minutes and is angry and will call corporate if you don’t talk to her. She got home with an antibiotic and it is a powder and she does not know how to measure 5 mL.’ ‘Oh God, help me – I am going crazy,’ I think in my head. DUR stands for drug utilization review which is for the purpose of having the pharmacist counsel the patient and answer questions. I quickly respond to the DURs at both pick-up stations. It turns out that both DURs were only about trying to sell pneumonia and shingles vaccines. This is just one way in which CVS focuses on marketing rather than the most important parts of my responsibility which are providing the correct medication and instructions to the patients, and educating patients about their medications and answering their questions. I then take the call from the woman on the phone, and she is furious. I apologize and show empathy for her concern, and state that this is a rare incident and that she should please bring the prescription back and we will add the distilled water. She knows me and likes me and the other pharmacist, and I breathe a sigh of relief because she will not call 1-800 SHOP CVS and complain. Actually, not adding water to medication formulations that need to be reconstituted occurs commonly in CVS stores. I review the prescription and recognize the potential for significant overdosage if she had not called to request clarification. I say a little prayer, ‘Thank you, God.’ I finally get back to the prescription for the antipsychotic drug and verify that the dosage and instructions are accurate.

“Other pharmacists and I have been involved in meetings with CVS regional managers about how we can increase the efficiency and service in the stores. I remember one roundtable, described as an open, transparent discussion, in which the regional manager stated, ‘We are here to help you and provide total transparency in our operations, but if you came to the meeting to ask for more payroll, that is a non-issue.'”

“I am awakened by a vivid, recurring nightmare that I have dispensed hydralazine and the drug was supposed to be hydroxyzine. I keep sending it back to the techs to retype and correct the drug but it still shows up on my screen as hydralazine. I have spoken to many of my colleagues, even some who are retired, and they also have misfill nightmares. It is impossible to leave the work at the store. I have no control of my brain at night when I am asleep.”

The Ohio PBM experience!

For many years, Ohio independent pharmacists and the Ohio Pharmacists Association, with the collaboration of Antonio Ciaccia (a former lobbyist for the Association and now the CEO of 46brooklyn), have voiced strong concerns about the grossly inadequate compensation provided by pharmacy benefit managers (PBMs) and the predatory tactics of CVS. Marty Schladen is an exceptional investigative reporter for the Ohio Capital Journal and previously for the Columbus Dispatch. His investigations were very important in determining that in 2017, the PBM “middlemen” CVS Caremark and OptumRx charged Ohio $224 million more for drugs dispensed to participants in the Medicaid program than they paid pharmacies. These PBMs fought to prevent access to information they refused to release, as well as other reports that they claimed were protected by sealed confidentiality agreements. However, Schladen and several others persisted and discovered additional deception. The PBM middlemen used SECONDARY MIDDLEMEN to disguise their strategy to inflate the profits for both companies from the Medicaid prescription program. Several of the secondary middlemen with different names are owned by Centene.

Ohio attorney general Dave Yost conducted an investigation that concluded that Centene-owned PBMs had overbilled Ohio for several years and not just in 2017. He filed a lawsuit in which Centene settled the case for $88.3 million, and announced that it was setting aside more than $1 billion to settle similar claims in 21 other states. Ohio was the first state to file a lawsuit to recoup these overbilling losses, but an increasing number of other states have followed its example and have been successful in reaching settlements.

The three largest PBMs, CVS Caremark, Express Scripts, and OptumRx, are each part of a corporation that also includes a health insurance company (Aetna, Cigna, and United Health, respectively). These three PBMs control an estimated 80% of the PBM prescription market place. Subsequent investigations by Marty Schladen have revealed examples of PBM deception and fraud in the Medicare prescription program. The patent for Tecfidera that is used in the treatment of patients with multiple sclerosis expired in 2020 and generic formulations of dimethyl fumarate became available at much lower cost. The list price for Tecfidera was about $8,000 for a one-month supply but some of the generic formulations of the drug had a list price of less than $900/month. CVS Caremark, Centene, Humana, and Anthem required patients in their programs for whom dimethyl fumarate (Tecfidera) was prescribed, to obtain the far more expensive brand-name Tecfidera. The motivation for this requirement is that these companies “negotiated” large rebates from the manufacturer of Tecfidera and the amount of these rebates far exceeded any rebates that might have been available from the companies marketing the generic formulations of the drug. Although the PBMs say they pass “most of” the rebates on to the government agencies/companies that use their programs, the PBMs themselves are the primary beneficiaries of the increased profits they extract from the programs. This self-serving PBM fraud adds substantial cost to prescription “benefit” programs, but the primary victims of this are the individual patients who do not have health insurance and those with Medicare coverage who will more quickly arrive in the “donut hole” in which they must pay a higher percentage of drug costs.

A former CVS senior director of Medicare Part D prescription programs has filed a whistleblower lawsuit accusing CVS of violating firewalls between its SilverScript prescription plan, CVS Caremark, and CVS stores. Among the situations identified in the lawsuit is the accusation that these CVS entities worked together to disallow coverage of less expensive multi-source generic products for at least 15 drugs. With most, if not all, of these drugs, the pharmaceutical companies that make the original high-cost, brand-name formulations of these drugs paid the CVS PBM large rebates to secure preferred formulary status for their products. It is noteworthy that, when CVS and Caremark merged in 2007, the companies assured the Federal Trade Commission (FTC) that there would be a firewall between the operations and information transfer of the two companies. The failure to observe firewalls alleged by whistleblowers and others is a primary reason for the current FTC investigation of apparent anticompetitive practices of the PBMs and the related entities within their corporate structures.

Other PBM abuses of prescription programs include “clawbacks”/DIR fees, providing higher compensation to the pharmacies owned by their parent companies than to independent pharmacies and other chain and “big box” pharmacies, and maintaining an impenetrable veil of secrecy regarding its financial operations and terms of agreements that not even government officials and legislators can access.

Continued errors, violations, and danger at CVS stores

Like other state boards of pharmacy, the Ohio Board of Pharmacy has inspectors who investigate complaints and make periodic visits to pharmacies to assure compliance with laws, regulations, and standards of practice. The Ohio Capital Journal has used the Ohio Public Records Act to obtain the reports submitted by the inspectors following their visits to 13 CVS stores in Ohio. Marty Schladen has reported the inspection findings and other concerns in his following recent stories in the Ohio Capital Journal:

The following are just a small number of selected quotes from these articles and/or the Board inspectors’ reports; the full articles are readily accessible online:

Responses from CVS corporate

During his investigations, Marty Schladen reached out to corporate CVS on many occasions in an effort to acquire explanations and additional information regarding the situations on which he was reporting. The responses he received are very familiar to those of us who have been long-term “observers” of CVS. Some of them are identified below and each is followed by my assessment of the reality of their responses:

 

 

 

 

 

 

 

 

 

 

CVS management has sometimes tried to explain its staffing problems by stating that there is a national shortage of pharmacists. There is NOT a national shortage of pharmacists at the present time, although there probably will be within several years. CVS’s staffing challenges have occurred because prospective applicants have learned about the deplorable workplace conditions, and many current CVS pharmacists are actively seeking employment elsewhere, and resign when they can identify another position, even one that pays a considerably lower salary.

The following are RUMORS that are NOT confirmed:

• CVS has considered washing the windshields of cars waiting in the drive-thru.
• For customers who pay for their prescriptions with a credit card, CVS is considering adding a “tipping” option to supplement the abysmal salaries it pays its pharmacy technicians (Would you like to round up several dollars?)

Ohio leads the way!

The Ohio Board of Pharmacy and Ohio Capital Journal reporter Marty Schladen have done excellent work in identifying and exposing the risks and harm for both customers and employees that result from CVS policies, metrics, and workplace conditions. Their work and example should be emulated throughout the United States, as has begun with a number of states following Ohio’s lead in challenging and recouping many millions of dollars expended because of deception and fraud of PBMs.

In 2021 Ohio pharmacists were asked to respond to a survey in which one of the questions asked whether they agreed with the statement, “I feel that the workload-to-staff ratio allows me to provide for patients in a safe manner.” Almost 90% of the responding pharmacists who worked at large chain pharmacies indicated that staffing wasn’t adequate to protect patient safety, compared with 26% of the responding pharmacists who worked at independent and small-chain pharmacies. The Ohio Board of Pharmacy has proposed comprehensive new rules to address the concerns that have been identified in the opinion survey and its inspectors’ reports. The proposed rules have been very carefully crafted to address the concerns that have been identified. However, there will be a public comment period and likely legal challenges from chain pharmacies that could result in substantial delays as well as compromises. But this is a positive step that is to be commended!

I very much dislike providing information that reflects negatively on my profession of pharmacy. However, the individuals and companies that exploit and betray patients and my profession must be exposed, held accountable, and disciplined. There is an immediate need to address the errors and violations that have already been identified by Board of Pharmacy inspectors in 13 Ohio CVS stores. The first hearing for one of these stores is scheduled for the Board’s November 7-8 meeting. Based on the admittedly incomplete information of which I am aware, it is my opinion that the Board of Pharmacy has sufficient documentation of continuing errors and violations to justify suspension or revocation of the pharmacy licenses of these stores. However, because some of these 13 stores are in rural areas in which there is no longer an independent pharmacy (perhaps as a consequence of CVS predatory tactics) or another chain pharmacy, the suspension/revocation of the license of the CVS store would create the most severe hardships on the residents of the region. Therefore, other disciplinary options need to be identified. Although pharmacists and pharmacy technicians are involved in the reported errors and violations, it is the policies, metrics, and understaffing resulting from decisions of executives/management that create the stressful and error-prone workplace environment, and it is CVS and its decision makers that should be held accountable and disciplined.

My recommendations for the Ohio Board of Pharmacy

I recommend that the Ohio Board of Pharmacy consider the following actions:

1. Continue to have its inspectors conduct investigations of additional Ohio CVS stores.
2. Obtain the strong support of Ohio Attorney General Dave Yost for the Board’s investigations and actions based on concerns about errors and violations that jeopardize the safety of Ohio residents.
3. Require verifiable documentation of the number of hours of pharmacist and pharmacy technician staffing, as well as the number of prescriptions dispensed each week for the period of 2019 to the present.
4. Based on the information requested in #3, require that the store DOUBLE the number of hours of pharmacist and pharmacy technician staffing no later than 3 months following the date of this action.
5. Require the submission of reports of errors/misfills in the 13 CVS stores for the period of 2019 to the present.
6. Require the submission of records of lawsuits against the 13 CVS stores for the period of 2019 to the present, and the financial and settlement outcomes of the lawsuits.
7. Require the submission of reports of any disciplinary actions against pharmacists and pharmacy technicians employed in the 13 CVS stores for the period of 2019 to the present.
8. Require the continued reporting of all of the above information until a date to be determined by the Board.
9. For those of the 13 CVS stores that are located in a community that is also served by independent and/or other non-CVS chain stores, consider suspending the license of the CVS store for a period of at least 3 months.
10. If the continuing investigations of Board of Pharmacy inspectors identify errors and violations that warrant disciplinary actions in more than 25 Ohio CVS stores, CVS should be required to provide all of the above information for EVERY CVS store in Ohio.
11. Require CVS to pay the costs of the Board investigations and actions pertaining to the 13 CVS stores (and any additional CVS stores in which actions are taken), as well as any additional fines the Board considers appropriate.
12. Work with the governor, legislators, and other pertinent individuals and agencies to prohibit CVS Health (i.e., all entities within its corporate structure) from using mandates and/or financial incentives that require/encourage residents of Ohio to use a pharmacy other than the one they personally choose.

It can be expected that CVS will complain, use its political influence, and sue the Board of Pharmacy. However, the Board has the best possible defense against any such threats – you are protecting the safety and well-being of the residents of Ohio in accordance with the responsibilities that the Board is expected to fulfill. CVS would also be required to pay the Board’s costs for its successful defense against CVS lawsuits.

The above recommendations do not include, but should not be considered to exclude, any action against CVS executives/management the Board considers appropriate.

Beyond Ohio

The situations described in this commentary are not unique to Ohio, but exist in every state and warrant questions such as the following as to what is being done beyond Ohio:

1. What are individual state boards of pharmacy and the National Association of Boards of Pharmacy doing to address errors and violations?
2. What are individual state pharmacy associations and the American Pharmacists Association doing?
3. What are colleges of pharmacy doing?
4. What are individual pharmacists doing?
5. Are these questions even being asked?

A pharmacist who resigned from CVS last year and who was among those interviewed by Marty Schladen, stated that the corporate practices and her experience at CVS had made her question her career choice. “I didn’t feel that I had completed a good job. Even though I’d go in, work a 14-hour day and be working the entire time without breaks, I didn’t feel like I had accomplished anything. I didn’t feel like I had an impact. It wasn’t why I went into pharmacy. It was surviving, not thriving. A lot of times at CVS, I didn’t feel like I was doing any kind of patient care beyond hopefully checking a prescription that they needed and allowing them to have that. If I knew what I know about pharmacy now, I probably wouldn’t have made the choice to go to pharmacy school.”

The number of applications to colleges of pharmacy has declined more than 60% in less than a decade but many college of pharmacy deans and pharmacy association leaders seem oblivious to the relationship of that decline to the issues addressed in this commentary. Alumni should ask the deans of their alma mater to identify their positions on these issues and whether the college receives educational grants or other financial support from CVS. Members of pharmacy organizations should ask the same questions of their association leadership. Individual pharmacists can support “reforms” in their states by making copies of selected articles by Marty Schladen and copies of this commentary and another report that will soon be available (stay tuned!), and by providing them to family members, friends, neighbors, strangers, individuals who come into the pharmacies in which you are employed, the dean and faculty of your college of pharmacy, the members of your state board of pharmacy, the officers and directors of your local and state pharmacy associations, legislators, government officials, human resources managers of companies and union leaders who make decisions regarding the selection of prescription drug plans, other influential individuals, and anyone else who is interested.

For those who feel that the focus on CVS in this commentary lets other chain and big-box stores with pharmacies escape attention and action, they will quickly get the message and make appropriate changes, or they will face the consequences proposed here. However, I and others consider CVS “Health” to be the company that places the largest number of customers at risk, causes the greatest reduction in the number of college-age individuals who might consider pharmacy as a career but don’t because of what they have observed and learned about the toxic, stressful workplace cultures at CVS and other chain stores, and represents the greatest destructive influence on the profession of pharmacy. It is where drastic measures and reform must begin!

Filed under: General Problems | 1 Comment »

It would seem that our healthcare system is consolidating geographically, in doing so “they” are creating “healthcare deserts” and “healthcare oases” and it also seems that chain pharmacies are at the forefront of creating a “pharmacy desert”.. Since there is a mention in their article of chains “pulling back” because DOJ/DEA fines. Could one or more of the chain pharmacies elect to stop stocking certain controlled meds? It use to be that pharmacies were required – by the state pharmacy practice act – to stock medications that are routinely prescribed in their market area. Most pts prescribed controlled meds are considered disabled or would be disabled without their medications.  If a pt, who patronizes a chain pharmacy and all of a sudden they are told that their med is on back order or unavailable.  The pt may want to lookup/read the state’s pharmacy practice act and see it they can find that requirement to stock meds routinely prescribed in their market. Federal & state law requires each pharmacy to maintain a perpetual inventory of all C-II meds.

Could pts get the inspector from the state pharmacy board to do a “check-in” with one or more chain pharmacies to verify that they are not stocking one or more C-II’s.  Getting the Board of Pharmacy (BOP) take actions against the Pharmacist in Charge (PIC) and the permit holder, for failing to stock/inventory most/many/all C-II’s. 

This could go several ways… BOP could decline to send out a pharmacy inspector, pharmacy could be found to be stocking C-II, but the BOP has no concerns that the pharmacy has stopped dispensing C-II’s or it was discovered that the pharmacy stopped stocking C-II’s and the BOP failed to take any action against the PIC and permit holder for violating the practice act.

In this article, the chains are admitting that some of the reason for attempting to reduce overhead costs and mentions the fines imposed by the lawsuit and fines imposed by 50 state Attorney Generals and others.  There is an agreement with those 50 state AG’s that the 3 major chains (CVS, Walgreen, Walmart) that they would reduce the number of controls they dispense to pts.  I have a copy of the agreement between those 50 AG’s and the three major drug wholesalers who agreed to reduce the controls that they sell to ALL PHARMACIES. 

There is a growing “pile” of evidence that these corporations are INTENTIONALLY denying pts – mostly disabled pts – of their medically necessary and legally prescribed controlled substances. 

 

It’s not just CVS. Other big pharmacy chains cut hours, close stores

https://ohiocapitaljournal.com/2023/09/01/its-not-just-cvs-other-big-pharmacy-chains-cut-hours-close-stores/

Walmart is cutting hours at its busy pharmacies, while Rite Aid — which is already selling off stores — is expected to file for bankruptcy protection, news organizations have reported over the past week.

The news comes after inspectors have found that CVS’s understaffed stores in Ohio have in some instances lacked controls to protect patients. And it raises the prospect that after buying up independent and small-chain competitors, cost-cutting large chains might not be able to adequately protect patients — when they can provide service at all.

One Tuesday, Reuters reported that Walmart was trying to reduce costs by asking 16,000 pharmacists to work fewer hours. Earlier this year, the company reduced the hours at 4,500 of its 5,000 pharmacies by two a day, the story said.

Reasons cited for the need for cuts include the $3.1 billion Walmart has to pay to settle a national opioid lawsuit, a lack of pharmacy technicians, and losses from sales of a weight-loss drug, the story said.

Meanwhile, Rite Aid is reportedly planning to file for Chapter 11 bankruptcy protection — a move that would likely involve the company closing 400 of its roughly 2,000 stores, Yahoo News reported. It also cited mounting costs from opioid settlements as part of the reason.

Also bedeviling the companies might be difficulty competing with e-commerce retailers for front-of-store sales of items such as cosmetics and shampoo. 

The outlet Digital Commerce 360 reports that online retailers sold more than $1 trillion worth of merchandise in 2022. And while its 8% growth that year was off from the 12% to 14% growth that typified the years from 2013 to 2019, it still was robust.

In 2021, CVS announced that it was closing 900 of its stores over the next three years, citing declining sales due to online competition as part of the reason.

The declines come after the big pharmacy chains in the 1990s and 2000s made a big bet that they could make money if they “sold everything, seemingly everywhere, at all hours,” as Slate put it last year.

But as the retail bet seems to be coming up lemons, it comes with a real cost to pharmacy patients.

For example, CVS bought and closed numerous smaller competitors and moved their prescriptions to its stores. Now it’s been closing its own stores and moving those scripts into its remaining stores, seemingly without adding staff to accommodate the new patients.

The Ohio Board of Pharmacy is proposing sweeping new rules after finding serious problems due to understaffing and high turnover. They include weeks-long waits for medicine, incorrectly filled prescriptions and a lack of controls over narcotics and other dangerous drugs.

In addition to those problems, the closure of smaller competitors — especially in rural areas — has made it much more difficult for some patients to get to the pharmacy, which for some is their only regular encounter with a medical professional. In other words, the closures have created pharmacy deserts.

In at least some cases, the problem isn’t that the companies owning big chains are losing money, it’s that they’re not making enough to keep Wall Street happy. For example, CVS Health made almost $2 billion in profit in the second quarter of this year, but that was 37% less than a year earlier, CNBC reported. 

But the corporation owns not only the biggest pharmacy retailer. It also owns Aetna, a top-ten health insurer, and CVS Caremark, the nation’s largest drug middleman. And not all of the slump was due to pharmacy operations.

In the CVS’s second-quarter earnings call, CEO Karen Lynch said, “We grew (pharmacy) revenue to $28.8 billion, an increase of nearly 8% versus the prior year. We generated $1.4 billion of adjusted operating income in the quarter, a decrease of 17% from the prior year, largely due to lower COVID-related volumes.”

Meanwhile, Walmart didn’t break out revenue from its pharmacy operation. But overall net income for the second quarter was up 53% over a year earlier, at $7.89 billion.

So at least some of the big chains are slashing stores or staffing — or both — even though their owners are making billions.

As it proposed new patient protections, the Ohio Board of Pharmacy cited numerous surveys indicating that safety is much less of a concern at the independent pharmacies and small chains that the big chains have been pushing out of business.

One was a 2021 survey asking Ohio pharmacists whether they agreed with the statement, “I feel that the workload-to-staff ratio allows me to provide for patients in a safe manner.” 

Almost 90% of those working for large chains responded that they didn’t have enough staff to keep patients safe. By contrast, almost three quarters of small-chain and independent pharmacists said they were adequately staffed to protect patients.

 

Filed under: General Problems | Leave a Comment »

 
Is this law from 1935 in conflict with the proposed bill list below ?

42 USC 1395: Prohibition against any Federal interference Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

If You Need Pain Pills, Politicians Want To Monitor Your Body Chemistry

https://reason.com/2023/09/04/if-you-need-pain-pills-politicians-want-to-monitor-your-body-chemistry/

Our political leaders envision a future in which high-tech implants snitch about our use of painkillers.

What if your medical conditions could be monitored from a distance to assess your health and adjust treatment plans based on real-time information? What if the same technology could be used to track your use of medications, such as opioids, to make sure you’re not using them in frequencies and dosages frowned upon by bureaucrats who’ve never met you? You might already have guessed that it’s that second implementation of the technology that interests politicians, who want to remotely monitor our body chemistry to stop us from getting high.

Big Brother Will See You Now

“Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate a report on the use of remote monitoring with respect to individuals who are prescribed opioids,” reads a small section inserted into the Support for Patients and Communities Reauthorization Act, which has 63 cosponsors in the House of Representatives. The program includes “identification of cohorts of individuals who stand to benefit the most from remote monitoring when prescribed opioids.”

What a future our political leaders envision, in which high-tech snitches tell unblinking overlords about our use of painkillers—or any other health data they desire.

“A government‐​sanctioned study like the proposed one by GAO will no doubt show that, given current or projected technologies, it is possible to remotely monitor how patients use opioids through their physiological responses,” warn the Cato Institute’s Jeffrey A. Singer, a senior fellow and general surgeon, and Patrick G. Eddington, a senior fellow in homeland security and civil liberties. “With such data in hand, misinformed anti‐​opioid crusaders in Congress will then take the next ‘logical’ step — legislation requiring all patients prescribed opioids for any reason to be remotely monitored (another example of ‘cops practicing medicine.’)”

“This will intimidate health care practitioners into further curtailing opioid prescribing to their patients in pain,” they add. “This simply exacerbates the misery that state and federal opioid prescribing policies have already inflicted on them that is driving many to suicide and some to homicide.”

That pain is undertreated is beyond question. Last year, the Centers for Disease Control and Prevention (CDC) acknowledged that opioid guidelines have been inflexibly interpreted. The CDC emphasized that “some policies purportedly drawn from the 2016 CDC Opioid Prescribing Guideline have been notably inconsistent with it and have gone well beyond its clinical recommendations” resulting in “untreated and undertreated pain.”

Physicians are leery of prescribing opioids for fear the DEA will target them and deprive them of their livelihoods and their freedom. Patients fear being labeled as drug-seekers and cut off from medication that lets them function. Remote real-time monitoring of body chemistry won’t calm anybody’s concerns about being second-guessed by bureaucrats. Resentment of and resistance to such intrusive surveillance is guaranteed given that diabetics have already told researchers that such monitoring is unwelcome.

Filed under: General Problems | 1 Comment »

STUDY BY RICHARD LAWHERN, PH.D DEBUNKS BOTH 2022 CDC, ALL DOJ ENFORCEMENT GUIDELINES: “PRESCRIPTION OPIOID CRISIS IN AMERICA HAS BEEN ONE MAGNIFICENT HOAX”

Filed under: General Problems | 2 Comments »

This ~ 40 minute video showed up in my email inbox and very informative information provided by two attorneys. Describing how they “track down” – per their criteria that is all about “numbers” and “data mining”.. your basic data “fishing expedition” in the state’s PDMP.

According to the first attorney in the video,  “they” were using the MME system as absolute to level the playing field of various opioids being prescribed. It would appear that prescribing a pt > 90 MME/day appeared to be a “pretty hard line” as being a huge red flag of prescribing “too much” & opioids without a valid medical necessity.

Of course, no mention of the pt’s pharmacogenomic metabolism tests, consideration if the pt had multiple disease issues, that were each a pain generator. It also appeared that a pt being prescribed  concurrently a opioid, benzodiazepine & muscle relaxant was a “do not cross line”.  \

The attorney reviewing what is considered suspicious activities of a pharmacy. One being when a pt is dealing with palliative care and/or cancer and PICK THEIR OWN PRESCRIPTION UP!

Maybe what these two attorney put forth about “illegal controlled meds prescribing/dispensing” might suggest why the SCOTUS in June ,2022 ruled ( 9-0 vote) in the Ruan/Kahn case that the DEA could not use objective criteria when evaluating a prescribing when treating pts dealing with subjective disease(s).

Filed under: General Problems | 1 Comment »

In my life time, it was believed that physicians PRACTICED MEDICINE. Since computers have invaded all of our lives, medicine has been sliding or evolving towards the science of medicine. Artificial Intelligence (AI) as it interfaces with medicine, the window on the “practice of medicine” may close to some degree, maybe at least try to totally close that window and fully open the “science of medicine” when it comes to treat pts dealing with subjective diseases ( pain, anxiety, depression, ADD/ADHD and multiple mental health issues).  These are diseases that have few/no medical tests to confirm that the pt is dealing with a specific disease and/or the intensity of the impact of the disease on the pt’s QOL ( Quality Of Life).  AI functions – makes decisions based on FACTS and they can be coded to have biases.

How slow or fast that this may happen, is anyone’s guess, but the pain community may be one of the first to find out!

Artificial Intelligence May Influence Whether You Can Get Pain Medication

https://kffhealthnews.org/news/article/artificial-intelligence-pain-medication-narx-score/

Elizabeth Amirault had never heard of a Narx Score. But she said she learned last year the tool had been used to track her medication use.

During an August 2022 visit to a Hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain, she said. She received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like Narx Scores are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. Narx Scores and an algorithm-generated overdose risk rating are produced by health care technology company Bamboo Health (formerly Appriss Health) in its NarxCare platform.

Such systems are designed to fight the nation’s opioid epidemic, which has led to an alarming number of overdose deaths. The platforms draw on data about prescriptions for controlled substances that states collect to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind the formulas used are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work.

Lacking the ability to see inside these systems leaves only clues to their potential impact. Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened. Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. She’d been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

Bamboo Health said that NarxCare can show providers all of a patient’s scores on one screen, but that these tools should never replace decisions made by physicians.

Some patients say the tools have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

Filed under: General Problems | 2 Comments »

 

 

 

This is what is happening in Colorado …

I’m looking for help with having a PBM trying to deny
coverage because of a MME. My state (Colorado) has 
passes a law that says these pbm cannot deny coverage
because of a predetermined mme. The pbm doesn’t feel
that they are under that same law. I am denied
getting coverage because of this. 
For the record the name of he law for my state is called
The act senate bill 23-144 in case you would
like to see what Colorado has done for its
chronic pain patients. Here is a hyperlink to the text of the Colorado law 
https://pluralpolicy.com/app/legislative-tracking/bill/details/state-co-2023a-sb23144/1266204
Here is an excerpt from the law:The act also prohibits a pharmacy,
health insurance carrier, or pharmacy benefit manager from
having a policy in place that requires a pharmacist to refuse
to fill a prescription for an opiate issued by a
health-care provider solely because the prescription 
is for an opiate or because the prescription order
exceeds a predetermined morphine milligram equivalent
dosage recommendation or threshold. 

Apparently this particular PBM believes that they are exempt from state law, even though most all PBM’s are licensed insurance companies and would have to have a state license to furnish product/services within states they are operating in.

Under this law, any/all PBM’s would be under the over sight of the state Insurance Commissioner and since this state has a state law that in particular denotes that PBM’s are covered under the law, the state Attorney General may come into play on enforcing the law.

Some times state legislators, are not happy when they pass laws that none of the state agencies will enforce the law. A lot of tax dollars going to waste, first on the legislators passing the bill and then all the state agencies failing to do their job.

Filed under: General Problems | Leave a Comment »

If you are a pt that has been on what has been called the “pharmacy crawl” going from pharmacy to pharmacy to find one that has in stock the controlled med that you have been prescribed. I would recommend that don’t get too excited, expecting to see this new DEA rule to be in place with all the various pharmacy software companies and the “switch” Sure Scripts where all E-Rx data goes thru and it was brought on line abt 20 yrs ago and I don’t know if they provided for pharmacies to pharmacy communications. I know when the DEA first granted the ability for prescribers to be able to send controlled Rxs electronically, all the mandatory protocol that was required by the DEA to get a pharmacy software certified was really a challenge to software programmers. As I remember, many pharmacy software companies, it took months to get their software certified. If we take a recent example of DEA waiting until about 4-6 weeks before prescribers were told to renew their DEA licenses to created the mandate for them to complete the 8-12 hr training program to meet the old X-wavier exemption to be able to prescribe SUD meds in treating addiction to be able to renew their DEA license.

In effect: DEA final rule on transfer of EPCS in schedules II–V between pharmacies for initial filling

https://ncpa.org/newsroom/qam/2023/08/30/effect-dea-final-rule-transfer-epcs-schedules-ii-v-between-pharmacies

A new DEA final rule, which became effective August 28, states that an electronic prescription for a controlled substance (EPCS) in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient. The DEA also clarified that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription.

The final rule requires that the transfer of EPCS in schedule II-V must be communicated directly between two licensed pharmacists, the prescription must remain in its electronic form, and the contents of the prescription must be unaltered during the transmission. The final rule also stipulates that the transfer of EPCS in schedule II–V for initial dispensing is permissible only if allowable under existing state or other applicable law. In addition, the final rule describes the information that must be recorded to document transfer of EPCS in schedule II–V between pharmacies for initial dispensing. The electronic records documenting EPCS transfers must be maintained by both pharmacies for two years from the date of the transfer

Filed under: General Problems | 1 Comment »

 

CRIES OF THE USELESS EATERS: NEO-EUGENICS, SUB-HUMANIZATION, AMA- “CRIMINALIZATION OF MEDICINE MUST STOP,” MICHIGAN BLUE CROSS-DOJ-DEA, TARGETTING PAIN CENTER OF WARREN MI., (SZYMAN, BOTHRA, POMPY et al. TRIALS)

 

Filed under: General Problems | Leave a Comment »