Walgreens sued for denying leave to pregnant worker who miscarried

Posted on September 30, 2022 by Pharmaciststeve

Walgreens sued for denying leave to pregnant worker who miscarried

https://www.reuters.com/legal/government/walgreens-sued-denying-leave-pregnant-worker-who-miscarried-2022-09-29/

Sept 29 (Reuters) – Walgreen Co has been sued by the U.S. Equal Employment Opportunity Commission (EEOC) for allegedly refusing to allow a pregnant, diabetic retail worker in Louisiana to take emergency medical leave, forcing her to quit hours before she miscarried, the agency announced on Thursday.

The EEOC filed a lawsuit on Wednesday in Alexandria, Louisiana federal court claiming a manager in December 2020 told the worker she had asked for “too many accommodations” and could not leave to see her doctor unless she found a replacement.

The EEOC said the worker identified as Jane Doe had asked to leave after she noticed that she was spotting, then quit before having a miscarriage later that day.

A spokesperson for Walgreens declined to comment.

The EEOC accused Walgreens of violating the federal Pregnancy Discrimination Act (PDA) and Americans with Disabilities Act by refusing to grant Doe a reasonable accommodation related to her pregnancy and disability.

In a 2015 case involving UPS Inc, the U.S. Supreme Court said the PDA requires employers to grant pregnant workers the same accommodations that they give to employees who are injured or disabled.

The EEOC in Wednesday’s complaint said Walgreens ordinarily permits employees to leave work if they are having an emergency.

The commission is seeking backpay and compensatory and punitive damages on behalf of Doe.

In a statement, EEOC lawyers said the case highlights that emergency leave can be considered a reasonable accommodation.

“No one should have to choose between losing a pregnancy and losing a job,” said Andrew Kingsley, a senior trial attorney.

The case is EEOC v. Walgreen Co, U.S. District Court for the Western District of Louisiana, No. 1:22-cv-05357.

For the EEOC: Andrew Kingsley

For Walgreens: Not available

(NOTE: This article has been updated to reflect that Walgreens declined to comment on the lawsuit. A previous version of the article also incorrectly identified Walgreen Co as Walgreens Co.)

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CDC 2022 Opioid Prescribing Guideline: Tapering

Posted on September 29, 2022 by Pharmaciststeve

CDC 2022 Opioid Prescribing Guideline: Tapering

https://www.practicalpainmanagement.com/resources/clinical-practice-guidelines/cdc-2022-opioid-prescribing-guideline-tapering

In this analysis, we break down the various aspects of the proposed revisions to the CDC Guideline on Opioid Prescribing for Chronic Pain to help clinicians, patients, and caretakers alike understand their nuances and to provide expert review of their applicability, potential benefits, and potential concerns. Specifically, we examine an integral part of the 2016 original and 2022 revised guidelines: recommendations on opioid tapering.

Decision-Making

The Decision to Taper an Opioid Prescription

Opioid tapering has historically been, and continues to be, one of the most controversial aspects of the original 2016 CDC prescribing guideline, and, thus, has become a crucial topic to examine in the proposed 2022 guidelines (expected to be finalized and released by the end of this year).

The concept of tapering does not exclusively apply to opioids, as it describes the general process of lowering any amount of medication in a gradual way to avoid potential precipitation of withdrawal and to ensure that a patient’s condition does not worsen without said medication. However, with opioids in particular, inappropriate reasons to taper or the use of an inappropriate tapering process can be associated with detrimental cognitive, physical, and emotional issues, all of which should be avoided when possible.

Prior to making the decision to taper an opioid, it is essential to establish an appropriate reason to taper in the first place. There could be several clinical reasons for initiating a taper:

  • lack of efficacy
  • attempt at opioid rotation
  • development of adverse events
  • abhorrent use/misuse
2016 Recommendations

Opioid Tapering in the 2016 CDC Prescribing Guideline

MME Limits

Each of the reasons to taper noted above are specifically noted in the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain,¹ however, to the dismay of several expert clinicians, researchers, organizations, and stakeholders,²⁻⁵ the recommendation seemed to emphasize achieving a dosing threshold of 90 morphine milligram equivalents (MME) or lower per day. In addition, the 2016 recommendation advised to “consider tapering opioids to a lower dosage or to taper and discontinue opioids” if the patient is at ≥ 90 MME/day.

While the authors of the CDC guideline did not outright recommend blind and blanket tapering for those on opioids at ≥ 90 MME/day, unfortunately, because of the framing of the recommendations, several states enacted legislation while third-party payers created policies revolving around cutoffs utilizing the 90 MME/day threshold.¹˒⁶ These regulations resulted in blind tapering, reductions, and, in some cases, abrupt discontinuation of opioids across many patient populations who had been maintained on stable opioid therapy.²⁻⁸

Tapering Process

Regarding the process of how to taper, the 2016 guidelines were more vague, although their recommendations were more in line with the literature and best practice of the time.⁹ The CDC guideline authors did note that clinicians should collaborate with the patient on a tapering plan and that, if the patient agreed to taper, and that taper should remain slow, gradual, and even require pauses to allow for “gradual accommodation.”¹

They also recommended patients be monitored closely for anxiety, among other symptoms that may result from a taper.¹

2022 Recommendations

Opioid Tapering in the Proposed 2022 CDC Guideline

Regarding the pending update to the CDC opioid prescribing guideline, there seems to be a greater emphasis by not only the authors but also by relevant stakeholders and the review panel, on gradual, patient-centered tapers.¹⁰

MME Limits

Despite what the authors indicate regarding MME/day cutoffs, there is a section in the draft update that discusses the plateauing of analgesia at opioid dosing of around 50 MME/day based on evidence with a level of “type 2” quality.¹⁰ While there is no mention of using 50 MME/day as a new dosing cutoff, the inclusion of 50 MME/day to describe evidence of efficacy is concerning, to say the least.

Tapering Process

There has been no significant change in recommendations for appropriate reasons to taper.¹⁰ Additionally, similar to the 2016 guideline, the 2022 draft update recommends a vague but gradual approach to opioid tapering, recommending specifically against blanket tapers or abrupt discontinuation.¹⁰ The authors of the updated document (who, of note, are the same authors of the 2016 guideline aside from one new contributor) also make a specific note, highlighted in the summary, that the guidelines are not “a law, regulation, and/or policy that dictates clinical practice or [serves as] a substitute for FDA-approved labeling.” This distinction is especially important to consider given that more than 170 policy changes made between 2016 and 2018 related to opioid-dosing cutoffs and MME/day thresholds, many of which were directly in response to the 2016 guidelines.⁶˒¹⁰

In fact, the 2022 draft update confirms the misapplication of the 2016 recommendations (specifically with regard to policies) concerning “opioid tapers and abrupt discontinuation without collaboration with patients; rigid application of opioid dosage thresholds.”¹⁰ The 2022 authors agree, as they did in a 2019 article published in the New England Journal of Medicine,⁷ that misapplying these recommendations in particular may have contributed to physical and psychological patient harm, undertreated pain, withdrawal symptoms, and suicidal ideation and behavior.¹⁰ They indeed recommend against the strict utilization of dosing thresholds based off of MME/day cutoffs.¹⁰

Table I: How the CDC Guideline Update May Alter Opioid Tapering.
2016 CDC Guideline on Prescribing
Opioids for Chronic Pain		 2022 CDC Proposed Guidelines on
Prescribing Opioids for Chronic Pain
Reasons to Taper • lack of efficacy
• attempt at opioid rotation
• development of adverse events
• abhorrent use/misuse		 no change
Tapering Process • collaborate with patient on tapering plan
• use a slow, gradual, process that allows for pauses
• monitor patient’s anxiety, among other symptoms that may result from taper		 no significant change; greater emphasis on avoiding blind tapers/abrupt discontinuations

still needed: evidence-based consensus on tapering duration, reduction amount, and/or frequency of reduction
Noted MME/day* 90 MME 50 MME
*Cutoffs are not required, but language is vague
Discussion

Expert Opinion

Like other revisions to the new guidelines, it does appear that the CDC has attempted to clarify and highlight important concerns that arose after the vast implementation of their 2016 opioid prescribing guidelines around opioid tapering. We commend the CDC for confirming the appropriate reasons to taper, for emphasizing patient-centered decisions regarding tapering, and for emphasizing that tapers be enacted with a gradual and careful approach.

However, there has not been a consensus update by pain management specialists based on clinical trials or sound scientific data regarding specific tapering recommendations such as duration, reduction amount, or frequency of reduction, and, thus, there remains significant discomfort and disparity among clinicians regarding how to adequately taper a patient off of opioids.¹¹˒¹²

Further, as noted, the CDC’s discussion that “type 2” evidence does not support dosing of opioids greater than 50 MME/day because of lack of association with significant efficacy and increased risk of adverse events when used in chronic pain.¹⁰ While the CDC recommends against the use of rigid dosing cutoffs, the language around their concerns with doses greater than 50 MME/day reads similar to the language used in 2016 guideline on 90 MME/day. The latter was a major reason cited by providers for tapering stable patients off opioids.¹¹ To reduce these concerns, it would be prudent for the CDC to specifically recommend against the use of 50 MME/day as a potential dosing cutoff going forward.

Takeaways

Practical Takeaways

Overall, opioid tapering continues to be a difficult therapeutic aspect entwined within the use of opioids, not only because of the difficulties in identifying appropriate reasons/individuals to taper, but then to develop a tapering strategy with the patient. The CDC’s draft update to the opioid prescribing guideline attempts to provide some clarity on all of these aspects, however, remains vague in tapering strategies and allows for ambiguity around potential tapering in individuals on certain opioid doses.

No matter the final language, the authors believe it is pertinent that opioid tapering occurs in only appropriate situations, where patient physical and psychological harm is minimized, and where the tapering process remains individualized.

Back to our toolkit on the CDC opioid prescribing guidelines, including analyses on Initiating Opioid Therapy, Target Patient Populations and New: Subsequent Visits

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Is this a new kind of “LEGAL CRAZY”

Posted on September 29, 2022 by Pharmaciststeve

She Wanted An Abortion. Now The Embryo Is Suing Her Doctors

The ‘wrongful death’ suit could usher in a new threat for abortion providers and women nationwide

Four years ago in Arizona, a woman had an abortion. She was not ambivalent about the decision: She was upset to learn she was pregnant, scared of giving birth, and she did not want — she had never wanted — children. Even so, Arizona law requires a pregnant person absorb a litany of information before terminating: medical information (like the risks associated with the procedure), and legal information (like the fact that the father would be liable for child support if she carried the pregnancy to term). In Arizona, a person must sign a consent form officially acknowledging receipt of that information, then wait 24 hours before she can obtain an abortion. The woman signed her paperwork and returned the next day to pick up the pills. Six days later, she came back for a follow-up visit: The abortion was successful. 

Two years later, that woman’s ex-husband, Mario Villegas, created an estate for the aborted embryo, and filed a lawsuit on behalf of the embryo against the doctors and clinic who provided the abortion. Villegas accuses the clinic and doctors of failing to obtain his ex-wife’s informed consent, thus committing malpractice, causing the wrongful death of his potential child and violating his “fundamental right” to parent.

Last week, a lawyer representing the doctors and their Phoenix practice, Camelback Family Planning, made a last-ditch effort to avoid a trial in the case, asking the judge to issue a summary judgment finding that the woman had indeed given her informed consent. In depositions, the woman and her doctors “all said the same thing: that [she] knew what she was doing, she was fully advised, and they did the abortion according to Arizona law,” the doctors’ lawyer, Tom Slutes, says. “The purpose of the statute is to make sure that the mother is properly advised, and makes an informed decision, and this young lady did.”

Villegas’ lawyer, J. Stanley Martineau, doesn’t dispute that she signed paperwork consenting to the abortion. He argues her consent wasn’t informed because, among other technical faults, the clinic’s paperwork didn’t use the phrase “unborn child” when describing the embryo, as Arizona’s informed consent statute does. (He also faults the clinic for not offering a printed-out copy of the Arizona department of health services website, which the law says can be made available to pregnant person “if she chooses to review” it.) “If you interpret [the statute] literally, any slip-up in what kind of information you give is going to create a potential liability,” Martineau says. 

Superior Court Judge Bryan Chambers is considering the motion to resolve the case without a trial, and says he will come to a decision within sixty days. But Villegas and his lawyer can already claim a kind of victory: They successfully convinced the judge that Villegas should be allowed to argue that his ex-wife’s embryo, whom they call “Baby Villegas” in legal documents, is a person for the purposes of the wrongful death lawsuit. If the case goes to trial, and if a jury ultimately finds in favor of the plaintiffs, it will be the first time that an aborted embryo has triumphed in a wrongful death lawsuit, ushering in a new legal threat not just for doctors, but for anyone who can become pregnant.

“This case was brought against the abortion provider, but it is required that the pregnant person, the ex-partner, be a witness in this case,” says Dana Sussman, deputy executive director for the National Advocates for Pregnant Women. Sussman worries that future litigants could use a similar strategy — suing for wrongful death — but go even further, by targeting the woman herself. “I could see a universe in which an ex-partner, in an attempt to harass or terrorize or create fear in the pregnant person, would try to bring a wrongful death lawsuit against the pregnant person herself, in addition to the provider.”

Villegas’ lawyer calls the judge’s decision “significant” because, Martineau says, “in a way, it’s saying that an unborn fetus has rights.” And, for decades, anti-abortion activists have been trying to establish both laws and case law that say exactly that. 

The movement for fetal personhood grew out of Roe v. Wade itself, when, among other issues, the Supreme Court considered whether a fetus constituted a person with rights of its own under the Constitution. The justices ultimately concluded it didn’t, but Harry Blackmun, writing for the majority, asserted that “if this suggestion of personhood is established, [Roe’s] case, of course, collapses, for the fetus’ right to life would then be guaranteed.” Ever since, activists have been lobbying aggressively to pass “fetal personhood” laws that radically reimagine a woman’s legal rights the moment she becomes pregnant. 

Today, eleven states, including Arizona, have broad laws that have redefined the term “person” to include a fertilized egg, embryo, or fetus, paving the way for cases like the one Mario Villegas filed. Before the Dobbs decision, federal protections for abortion acted as a kind of guardrail against some of the most extreme interpretations of those laws. But “without Roe as a fundamental constitutional right,” NAPW’s  Sussman says, “we are now starting to grapple with what exactly these laws mean in practice.” 

For years, advocates have warned of the consequences fetal personhood laws could have for pregnant women, including the potential to rebrand any behavior that might pose a risk to a pregnancy as child endangerment. As anyone who has been pregnant knows, the list of activities that constitute a “risk” during pregnancy is virtually endless and can include pursuits as anodyne as consuming soft cheeses or sushi. (In many cases, admonitions around “risky” pregnancy behavior aren’t even grounded in science, but are instead based on the absence of scientific evidence, since the very idea of performing a study to quantify the risk would pose a risk of its own.) Under the legal theory that a fetus is a person with rights, even simply crossing the street can open a pregnant person up to legal liability: In one case, a court allowed a woman who was hit by a car while seven months pregnant to be sued by her future child for negligence because she failed to use “a designated crosswalk.” 

According to an analysis by National Advocates for Pregnant Women, personhood laws were already having far-reaching consequences before Dobbs, creating conditions in which pregnant women were either denied medical care or had it forced upon them against their wishes. But, without federal protections, the group warns these laws could end up outlawing or curtailing the practice of IVF in at least thirty states, or requiring the “adoption” of unused embryos; they could hamper research that involves embryonic stem cells, determine whether or not a person is entitled to use the carpool lane, and change how much they pay in taxes or child support.

There is also the potential, noted in NAPW’s report, for former partners to weaponize such laws to prevent their partners (or ex-partners) from obtaining an abortion. In the past, the group found, courts have been largely unsympathetic to the arguments men have made when trying to block their ex-partners from obtaining abortions. But, surveying the history of those failed cases, they note a marked shift in legal framing “from the man’s right to the fetus’s right, reflecting the rise of personhood ideology.”

Villegas’ lawyer argues that both the father and the embryo had rights that were violated by the woman’s abortion. (Arizona’s informed consent statute allows the “father of the unborn child” to sue if he was married to the person who sought the abortion at the time.) The complaint declares Villegas has experienced “pain, grief, sorrow, anguish, stress, and mental suffering” over the loss of his ability to parent a hypothetical child. Throughout the complaint, his ex-wife is similiarly portrayed as victim who “suffered” an abortion because the doctors “failed to obtain” her informed consent. 

In sworn testimony she was compelled to give in the case, however, Villegas’ ex-wife is crystal clear about her desire to have the abortion. She describes an unhappy and ill-conceived five-year marriage that ultimately ended with her seeking an order of protection against her ex-husband, who has a previous conviction of aggravated assault with a deadly weapon. The pregnancy came toward the end of their relationship and, she said, as a surprise, since Villegas had a vasectomy before they were married. (Villegas’ lawyer insists she was aware of her then-husband’s vasectomy reversal.) She puts it very plainly in the deposition: “I never wanted children and he knew that.” She describes fear of the “pain” of giving birth, and her disinterest in being responsible for a child: “I barely take care of myself as it is.” (The woman, who does not have a lawyer representing her in the proceedings, declined to be interviewed.) 

Her absolute clarity of mind around her decision underscores the ways in which elevating an embryo’s rights instantly strips a woman of her own. The woman had a vision of her future that is incompatible with her ex-husband’s vision of her embryo’s future. Now, he’s asking the court to disregard hers entirely.

If the case goes to trial, and a jury ultimately finds that the doctors violated the statute, the doctors could be fined, forced to pay Villegas’ attorneys fees and possibly damages. Their medical licenses could be suspended or revoked as well. The case will offer a blueprint that could be replicated to re-litigate abortions in the future. While potentially devastating, those consequences seem almost quaint this week, as Arizonans wait for a different judge to issue a decision that could allow an abortion ban dating back to 1864 back into effect. The ban would make abortion illegal in every instance, except to save the life of the mother, and punish providers who violate the law with two to five years in prison.  

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ATTENTION: CALIFORNIA PTS !!!

Posted on September 29, 2022 by Pharmaciststeve

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WH Spokesperson: number of illegal fentanyl poisoning have leveled off.. Our “North Star”prgm is working

Posted on September 29, 2022 by Pharmaciststeve

It is claimed that we already spend > 100 billion/yr in fighting the war on drugs and we have spent collectively about TWO TRILLION since the Controlled Substance Act was signed into law in the early 70’s. So adding an additional couple of billion to fighting the war on drugs… is going to dramatically change the course of substance abuse of most illegal substances ?  The director of the White House Office of National Drug Control Policy seems impressed that in the last 12 months opiate poisoning killed about the same number of people as in the previous period. I guess the families/relatives of the 70K-75K that died/poisoned from using illegal fentanyl were happy that the rate of poisoning didn’t increase 🙁

More $$ On the Way to Fight the Opioid Overdose Crisis, White House Says

https://www.medpagetoday.com/psychiatry/opioids/100901

Officials also plan to keep buprenorphine prescribing flexibilities for 1 year after the PHE ends

WASHINGTON — The Biden administration announced several new actions aimed at tackling the opioid overdose crisis, including more funding for states and territories and new guidance designed to increase access to naloxone (Narcan).

“Our nation is facing 108,000 overdose deaths in just 12 months,” said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), on a phone call with reporters Thursday evening. “That’s one life lost every 5 minutes around the clock … Our North Star is to save lives and connect more Americans to treatment and recovery support services. We have already seen our efforts take effect. After a more than 35% increase in overdose deaths during the first 18 months of the pandemic, more recent 12-month rolling total overdose death counts have remained largely unchanged.”

Actions announced by the administration on Friday include:

  • $1.5 billion in funding to states and territories to address addiction and the opioid crisis. The funding, which is being given through the Substance Abuse and Mental Health Services Administration, will be used to increase access to treatment for substance use disorder, remove barriers to public health interventions like naloxone, and expand access to recovery support services such as 24/7 opioid treatment programs, according to a White House fact sheet. States can also use the funds to increase their investments in overdose education and to hire peer support specialists for emergency departments.
  • $104 million in funds to expand substance use treatment and prevention in rural areas. This funding, which will come through the Health Resources and Services Administration, will go to public, profit, and nonprofit organizations as part of the multi-year Rural Communities Opioid Response Program. The money will be spent to open new medication-assisted treatment sites, help with workforce mentorship and training, and allow communities to invest in education and outreach to prevent and treat substance use disorder, the White House said.
  • New guidance to increase access to naloxone. The FDA issued guidance Friday to ease distribution of FDA-approved naloxone products. The guidance, which is effective immediately, makes naloxone exempt from certain laws related to drug purchase and distribution under the Drug Supply Chain Security Act. Making these exemptions “helps to address some of the obstacles that have existed in obtaining access to naloxone, and may help eligible community-based programs acquire FDA-approved drugs directly from manufacturers and distributors,” the White House noted.
  • More funding for law enforcement. In April, the ONDCP announced $275 million in funding for the High Intensity Drug Trafficking Areas Program to support law enforcement officials working against drug traffickers. The agency is now adding another $12 million to that funding, which also includes money for efforts to prevent gun crimes associated with drug trafficking.

Asked during a question-and-answer session about why the opioid crisis continued to escalate during the pandemic, Gupta said that “we know that the increase in drug overdose and poisoning deaths was beginning to rise even prior to the pandemic, and it has been very clear that the pandemic has clearly exacerbated the suffering to Americans, both in terms of isolation and of early shutdown of treatment facilities.” That’s why the administration has implemented “a number of things, including telehealth provisions, that allowed some significantly increased access to care, both for rural populations but also other marginalized and underserved communities, and populations such as [prison inmates],” he added.

MedPage Today asked officials whether any thought had been given to continuing the newly loosened restrictions on buprenorphine prescribing; as part of the COVID-19 public health emergency, the administration lifted the training requirement for a buprenorphine prescribing “X-waiver” in April 2021, although doctors still have a limit of 30 patients for whom they can prescribe the drug at any given time.

“We certainly have heard from communities” that the loosened restrictions “have been so helpful,” said Miriam Delphin-Rittmon, PhD, HHS Assistant Secretary for Mental Health and Substance Use. In addition, “for individuals who are on either methadone or accessing buprenorphine, it has been helpful to be able to receive those medications through telehealth, or to receive take-home doses. We are currently looking to continue those flexibilities for 1 year beyond the end of the public health emergency,” and also considering extending them even beyond that date, she said. “That is all in process and under discussion. But currently, for at least 1 year beyond the public health emergency, those flexibilities will be continued.”

Gupta added that as an X-waivered physician himself, he knows that “it is very difficult for providers and clinicians all over the country to be able to provide that access on par with the ability to write [prescriptions for] other Schedule II drugs … We want to make sure that these flexibilities that Dr. Delphin-Rittmon’s talking about — the telehealth provision and access to methadone to take home, as well as the mobile vans for methadone that significantly increased access to people, especially in rural communities — [continues because] it is critical, and we know treatment saves lives.”

However, he added, “we also need to make sure that the clinician community steps up and is providing those prescriptions, addressing the stigma that goes along [with addiction], including in healthcare, and providing people the help.”

 

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Opioid Nudges of Perceptions

Posted on September 27, 2022 by Pharmaciststeve

Opioid Nudges of Perceptions

https://www.daily-remedy.com/opioid-nudges-of-perceptions/

Optimizing Opioid Prescribing and Dosing Through Nudges

Background:

The opioid epidemic has incurred significant clinical and economic toll on the United States.  The human impact from the epidemic has adversely affected communities and many employers.  The patient-physician encounter is a microcosm of the social ramifications of the epidemic.  Physicians are concerned about clinical and legal consequences that may arise if they prescribe pain medication to Patients who may have developed a dependency or are outright abusing the medication.  Patients are concerned that their Physicians will unnecessarily reduce or outright discontinue their medication, affecting their quality of life and their activities or daily living.  As a result, there is an inherent lack of trust that builds between the Physician and Patient.  To address this lack of trust and encourage Physicians and Patients to have honest discussions about prescribing and taking opioid medications, we must encourage such discussions and open conversation.

Thesis:

If Physicians and Patients are provided a platform to anonymously express their sentiments, they will honestly convey their concerns.  Physicians will honestly state their rationale behind prescribing certain opioids to certain patients, and not prescribing certain opioids to certain patients.  Patients will honestly state their concerns around their use of opioid medications and their concerns around how they communicate with their Physicians.  The feedback will provide meaningful information on how we can bridge the trust gap that exists between Physicians and Patients regarding opioid prescriptions.

Nudges:

There are two types of nudges that exist with opioid prescribing: prospective and retrospective nudges.  In prospective nudges, the Physician and Patient are prompted to behave or converse in a specific way to encourage open discussion.  In retrospective nudges, the Physician and Patient are prompted to review a past action or past event to encourage change in future behavior.  Both nudges are necessary to optimize the Patient-Physician relationship.

Physician Prospective Nudges:

Prospective Nudges will prompt the Physician to consider why and how the Patient takes the opioid medication.  However, rather than encouraging a one-sided discussion, the nudge will prompt the Physician to encourage an open dialogue and discuss his or her concerns about the opioid epidemic with the Patient.  By revealing the Physician’s concerns, the Patient will feel more comfortable expressing his or her concerns as well.

The prospective Physician nudge will come through a computer based or mobile app-based questionnaire that will require the Physician to take 1-2 minutes to complete.  The nudges will come either monthly or quarterly.  The nudges will ask:

Do you prescribe medically indicated opioids for your patients?

Yes/No

Do you feel comfortable discussing your concerns about prescribing opioids to your patients?

Yes/No

Have you ever decided not to prescribe opioids or prescribe a lower dose of opioids to a patient?

Yes/No

How easy is it for you to obtain imaging studies and urine drug screens for your patients who are prescribed opioids?

Likert Scale – not very easy, not easy, neutral, easy, very easy

Have you ever decided not to prescribe opioids or prescribe a lower dose of opioids because you did not have access to imaging studies or urine drug screens?

Yes/No

Has your request for imaging studies or urine drug screens ever been denied by a patient’s insurance plan or because a patient cannot afford it?

Yes/No

Are you likely to continue prescribing opioids for a patient if it is difficult to obtain imaging studies or urine drug screens?

Likert Scale – not very likely, not likely, neutral, likely, very likely

Are you likely to prescribe medically indicated opioids if you have easier access to imaging studies or urine drug screens?

Likert Scale – not very likely, not likely, neutral, likely, very likely

How strongly do the opioid prescribing laws impact your willingness to manage patients who require opioid prescriptions?

Likert Scale – not very strongly, not strongly, neutral, strongly, very strongly

How strongly does your patient-physician relationship impact your willingness to manage patients who require opioid prescriptions?

Likert Scale – not very strongly, not strongly, neutral, strongly, very strongly

If you have better access to imaging studies and urine drug screens, would you feel more comfortable continuing a patient’s opioid medication?

Yes/No

How strongly do you believe better access to imaging studies and urine drug screens would improve your clinical decision making in continuing a patient’s opioid medication?

Likert Scale – not very strongly, not strongly, neutral, strongly, very strongly

How strongly do you believe better access to imaging studies and urine drug screens would improve your patient-physician relationship?

Likert Scale – not very strongly, not strongly, neutral, strongly, very strongly

The number of questions to ask per nudge and the order in which the questions will be asked can be adjusted per Physician participant.  However, all responses must be confidential and stored on a secure database.  The prospective nudges will prompt the Physician to think how he or she communicates with Patients and how he or she develops trust in his or her Patients.

Physician Retrospective Nudges:

Retrospective Nudges will prompt the Physician to review his or her prescription patterns at a broader level as opposed to the individual Patient level.  The retrospective nudges will be more informative and descriptive rather than a series of questionnaires.  We will send, either monthly or quarterly, to the Physician, statistics related to the opioid epidemic.  Statistics that will be sent in this nudge include:

Nationwide number of opioid deaths within past month and past quarter

Local number of opioid deaths within past month and past quarter

Number of overdoses among Patients seen by the Physician over the last one year within past month and past quarter

These three data points will inform the Physician about the significance of the opioid epidemic and how his or her practice and prescribing patterns compare to the local and national death statistics.  While sharing mortality rates can appear threatening, the goal is to educate the Physician and prompt the Physician to be more self-aware of how his or her broader prescription patterns compare to the statistical averages.

Local data will be limited to data within the specific county that the Physician practices.

Patient Prospective Nudges:

Prospective Nudges will prompt the Patient to consider why and how the Patient takes the opioid medication.  However, rather than coming across as if we are interrogating the Patient, we want the Patient to feel comfortable discussing their opioid use.  The questions will explain the Patient’s rationale for taking pain medications and how comfortable the Patient feels communicating that rationale.

The prospective Patient nudge will come through a computer based or mobile app-based questionnaire that will require the Patient to take 1-2 minutes to complete.  The nudges will come either monthly or quarterly.  The nudges will ask:

Why are you taking pain medications?

Acute pain, Chronic pain

Do you take it regularly or as needed?

Regularly, As Needed

How often do you take your pain medication as prescribed?

Likert Scale – not very often, not often, neutral, often, very often

How often do you skip a dose?

Likert Scale – not very often, not often, neutral, often, very often

How often do you take more than prescribed?

Likert Scale – not very often, not often, neutral, often, very often

Do you give extra medications to friends/family?

Yes/No

Have you asked for additional pain medication from friends/family?

Yes/No

Based upon your last doctor visit, do you feel comfortable that you will have the same medication dose as before?

Yes/No

Do you feel comfortable discussing your pain medication use with your doctor?

Yes/No

Have you ever asked your doctor for additional pain medications?

Yes/No

Have you ever asked your doctor for less pain medications?

Yes/No

How honest can you be with your doctor about your pain medications?

Likert Scale – not very honest, not honest, neutral, honest, very honest

How concerned are you that your doctor will reduce your pain medications without discussing with you?

Likert Scale – not very concerned, not concerned, neutral, concerned, very concerned

Do you store extra pain medications?

Yes/No

Does your pain medication help with anxiety and stress?

Yes/No

Do you have other symptoms with your pain?

Yes/No

Will you have withdrawals if you suddenly stopped your pain medications?

Yes/No

Do you need to take your medications to function?

Yes/No

How important are the pain medications to your daily livelihood?

Likert Scale – not very important, not important, neutral, important, very important

If you took less pain medications, would you still be able to function?

Yes/No

Do you believe you have a dependency to your medications?

Yes/No

Do you believe you have an addiction to your medications?

Yes/No

The number of questions to ask per nudge and the order in which the questions will be asked can be adjusted per Patient participant.  However, all responses must be confidential and stored on a secure database.  The prospective nudges will prompt the Patient to think how he or she communicates with Physicians and begin to self-analyze how and why the Patient takes the pain medication.

Patient Retrospective Nudges:

Retrospective Nudges will prompt the Patient to review his or her opioid use at a broader level.  The retrospective nudges will be more informative and descriptive rather than a series of questionnaires.  We will send, either monthly or quarterly, to the Patient, statistics related to the opioid epidemic.  Statistics that will be sent in this nudge include:

Nationwide number of opioid deaths within past month and past quarter

Local number of opioid deaths within past month and past quarter

Number of prescriptions dispensed at local pharmacies in the area

Number of Schedule I, Schedule II, and Schedule III prescriptions dispensed in the area

These three data points will inform the Physician about the significance of the opioid epidemic and how his or her practice and prescribing patterns compare to the local and national death statistics.  While sharing mortality rates can appear threatening, the goal is to educate the Physician and prompt the Physician to be more self-aware of how his or her broader prescription patterns compare to the statistical averages.

We will limit local data and prescription patterns to the specific county that the Patient sees his or her Physician.

Data Collection:

The data will be collected over a HIPAA certified platform confidential to all participants.  Physicians and Patients will be able to complete the prospective prompts either on their desktop or mobile platform.  We will use existing HIPAA certified platforms for this study.

Data for the retrospective prompts will be obtained from publicly available national databases.

Subject Recruitment:

Recruitment will be at random and voluntary.  We will randomly select primary care physicians and randomly select people within a local community.   We will begin by recruiting physicians in a specific region and then recruit patients within that region to ensure that we get both Physician specific and Patient specific data within a specific locality.

Data Analysis:

The duration of this program should last roughly two years.  Most clinical recommendations state that opioid tapering should begin after six months, and a two year benchmark will allow, at a maximum, four data points in which to review how the nudges affect opioid prescribing rates and opioid mortality.

All responses should be aggregated and de-identified, at a local level and at a national level.  The aggregated and de-identified nudge responses should be shared.  All Physician prospective nudges should be shared among other local Physicians.  All Patient prospective nudges should be shared among other local Patients.  The purpose in sharing the aggregated nudge responses is to inform individual Physicians or Patients of any major deviations or outlier responses they may have provided.  Such outlier events show sub-optimal prescribing patterns or sub-optimal medication use.

Overall, we hope the data will serve two purposes: (1) inform Patients and Physicians how their responses vary from the local and national averages, (2) reduce excessive prescriptions without harming the patient and reduce opioid related mortality.

 

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How many more years are we going to just “tread water” in fighting the war on drugs

Posted on September 27, 2022 by Pharmaciststeve

Why do “we” allow some groups to determine that a certain category of pts with valid medical issues be viewed as a group who is not worthy of receiving treatment. we opened out independent pharmacy in 1976 and in the early 80’s as the DRG pricing for hospitals came into play we saw a growing need for home medical equipment… as this DRG hospital pricing system was causing pts to be discharged sicker and quicker. Providing home oxygen and related respiratory equipment and medication because a solid part of our overall business. Many/most of the pts requiring home oxygen supplementation was former smokers, some continued to smoke while using their oxygen. Insurance companies paid for these therapies because there was two different objective test that determined how poorly a pt’s lungs were able to convert ambient air into a adequate percent of their blood.

However, our health insurance system and to some degree our medical healthcare system seems to be reluctant and/or discourage to treat those pts dealing with subjective diseases. ( Pain, Anxiety, Depression, ADD/ADHD, various mental health issues ).  I remember earlier in my career that health insurance companies had very poor/little coverage for treating mental health issues.

To put things in perspective, in the last 12 months we have had more young Americans died/poisoned by illegal fentanyl via China & Mexico than all the young lives lost in America’s 24 yrs of involvement in the Vietnam war.   Of course, we did declare the War on drugs abt 50 yrs ago.  I guess when you look at history the last war that we actually won or brought it to a end – was WW-II and that two TWO A-BOMBS

Filed under: General Problems | 5 Comments »

When a person claiming to be a chronic pain advocate ends up being a saboteur

Posted on September 24, 2022 by Pharmaciststeve


When Bob’s refers to “my kids”.. he is really referring to the END OF LIFE PEDIATRIC CANCER PTS in Vanderbilt Hospital in Nashville, TN. Nearly a year ago, Bob started advocating for proper pain treatment for these end of life pediatric cancer pts..  Apparently Vanderbilt is one of those “no opiate hospitals”..  These “kids” when they were in the hospital, that would get some decent pain management, but when discharged back to home… told to take a NSAID and/or Tylenol (Acetaminophen) …  Bob was getting very good results in getting these kids some serious pain management when they were at home.  At one point the “shirts” at Vanderbilt decided that Bob was not a valid/bonafided pt advocate and told Bob that he could not advocate for these end stage pediatric pts…  Bob took Vanderbilt to court and the representative & attorney for Vanderbilt …. lost in court and Bob got to advocate once again for those kids.

Everything was going well with Bob getting these pediatric cancer pts good pain management…  Until someone who claims to be a chronic pain pt and a chronic pain advocate got a “friend”  in law enforcement to do a background check on Bob and uncovered a incident from a couple  of year back when Bob was loading some bails of hay into his pickup truck. in 100+F ambient and his implanted pump malfunctioned and increased the rate at which his pump was programmed to infuse in to spinal fluid.

Apparently Bob became “intoxicated” and was pulled over by one of the local “boys in blue” .. the state that Bob lives in has a ZERO TOLERANCE and Bob lives in a fairly rural area and this particular local law enforcement … can be described as having a “Barney Fife” personality…  Bob pickup truck was not air conditioned and as soon as he got into the police car – that had air conditioning and Bob quickly “sobered up”…  After this incidence the “Barney Fife” … anytime that he saw Bob driving… he would arrest him… and apparently they had to use gas chromatography to get any measurement of opiates in his blood, because opiates infused into the spinal fluid.. very, very little will cross the blood brain barrier and go systemic.  “Barney Fife” caught Bob driving with his two preteen daughters in the vehicle… so he also got charged with endangering minors with a DUI. Bob ended up suing the company that made his implanted pump and got a sizeable settlement.

Bob ended up going to the state legislature to get the state’s DUI law changed to allow some flexibility when handicapped/disable people are driving.  This “deep dive background check “that this pain advocate’s friend pulled up a national wide using Bob’s first, middle, last name… and apparently someone in the country back in the 80’s with the same first, middle, last name – no birth date match had some possible trouble with law enforcement.

This person who claims to be a chronic pain advocate, shared this information and someone along the line … came to the conclusion because Bob was charged with a DUI with preteens in the vehicle – endangering kids – that jumped to the conclusion that Bob was a pedophile.  Once again Bob was banned from advocating for these end of life pediatric cancer pts. At this point in time, Bob was advocating for kid #35.

How does someone who claims to be a chronic pain advocate and intentionally goes out of their way – spreading half truths and LIES to cause these poor little end of life pediatric cancer pts to lose their end of life pain management. At least Paul Harvey would tell … “the rest of the story”…  Below is a picture of one of Bob’s earliest kids… that was able to celebrate her last Halloween with Bob’s two preteen Daughters last year. Part of the reason that this sweetie was able to smile was because of Bob’s advocacy on her behalf.

 

 

 

 

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Woman With Severe Chronic Pain Was Denied Medication for Being ‘Childbearing Age’

Posted on September 24, 2022 by Pharmaciststeve

Woman With Severe Chronic Pain Was Denied Medication for Being ‘Childbearing Age’

https://jezebel.com/woman-with-severe-chronic-pain-was-denied-medication-fo-1849569187

The woman, Tara Rule, told Jezebel she’s being blacklisted by local hospitals for sharing her story.

A New York woman says she was denied highly effective medication for a chronic, painful condition that’s caused her to contemplate suicide because her neurologist told her she could become pregnant, and the medication might cause birth defects—even though she never plans on having children. In a series of TikTok videos, Tara Rule (@pogsyy) included audio, in which the doctor explains to her that despite the facts that she uses protection, her partner would be willing to get a vasectomy, and she would have to get an abortion anyway (her hypothetical pregnancies would be high-risk), the risks to her hypothetical fetus trump her debilitating pain.

In the audio in one video, Rule asks if the issue preventing her from getting medication is solely that she’s of “childbearing age,” and, “if I were like through menopause, would this be effective for cluster headaches?” When the doctor says “yes,” Rule asks, “So the only thing that’s kind of stopping this is the fact that at some point in my life, I could get pregnant?” In response, the doctor changes the subject and asks, “How’s your sleep?”

Since sharing her story along with the recorded audio on Wednesday, Rule posted a TikTok in which she alleges that Glens Falls Hospital, where the incident happened, warned all hospitals in Albany County that Rule had livestreamed her visit (which she denies). This prompted doctors, who confronted her during a later visit to Malta Med Emergent Care, to “berate” and “threaten [her] with legal action.” Rule includes audio of some of this conversation in the video. On its website, Glens Falls Hospital doesn’t appear to have any policy against recording oneself in the hospital.

The threat of legal action, of course, is on top of the fact that Rule still can’t get medication to effectively manage her debilitating chronic pain. “It was frustrating to be in so much pain and just hear ‘no,’ for that hypothetical reason,” Rule told Jezebel in a phone interview, adding that she’s “pretty sure I can’t even get pregnant” because of several “reproductive issues” she’s had. “It’s already hard enough to deal with this condition. It’s already so misunderstood, it took me 10 years to even get a diagnosis, because it’s a very rare condition and the symptoms are all over the place,” she said.

In her first TikTok last week, through tears, Rule explained that she suffers from painful, chronic cluster headaches and Ehlers-Danlos syndrome—which, she told Jezebel, causes several excruciating comorbidities. Despite the severity and life-threatening risk factors accompanying her condition, Rule told me that doctors who confronted her at her Wednesday visit to Malta Med Emergent Care warned her that she was on a “tracker” and is essentially blacklisted from hospitals in Albany County for the alleged “livestreaming.” Rule has filed a complaint to Glens Falls Hospital and received confirmation that it’s being processed, but it could be up to 45 days before she receives any update.

Jezebel reached out to Glens Falls and Malta Med Emergent Care for comment about Rule’s allegations and will update this story if we hear back. New York is a one-party consent state, meaning only one party must consent to the recording of an in-person or telephone conversation.

Since the overturning of Roe v. Wade, we’ve seen horrifying ripple effects like what Rule says she experienced across the health system. As Jezebel has previously reported, several people say they’ve been denied life-saving medications from pharmacists, because these medications could supposedly double as miscarriage-inducing abortifacients. Rule told Jezebel that since she shared her story, numerous people have reached out to her about issues they faced getting medications due to pregnancy-related concerns, even before the overturning of Roe. Just last summer, a pregnant woman in Alabama was arrested and prosecuted for trying to pick up pain medications to manage a chronic back condition.

While Rule said the Glens Falls neurologist she consulted repeatedly cited the overturning of Roe for why he couldn’t prescribe her the medication, she believes it’s more likely he was pushing his “personal agenda.”

Our health system has prioritized fetuses and even hypothetical fetuses over women and pregnant people’s health and safety in plenty of documented cases, and the rise of anti-abortion fetal personhood laws post-Roe could worsen all of this.

On her TikTok, Rule details the most eyebrow-raising parts of her conversation with the Glens Falls Hospital neurologist: “I said, ‘Well, I’m not having kids, I wouldn’t do that to someone, it’s not a life. I’m in pain every single day.’ He said, as long as I am of childbearing age, regardless of birth control method, I can’t take the treatment because there’s a possibility I could get pregnant.”

In another video that includes audio of the visit, we hear the doctor ask: “So you’re not having intercourse?” When Rule clarifies that she is, he responds: “Well, you could get pregnant. The point is, if you get pregnant, what are you gonna do? You can’t deny the fact that you could get pregnant, ‘even if I’m not planning on it, the risk is low, this is my plan of action.’” Further, he added that for any treatment Rule is considering that could affect potential pregnancies, if she’s “with a steady person, you’d have to bring him in as well.” Prior to when Rule started recording, she says the doctor told her she could also experience unplanned pregnancy from rape—a comment that was “retraumatizing” for her as a survivor of sexual violence. Most state abortion bans that passed since the fall of Roe lack rape exceptions.

In a later video last Monday, Rule revealed the identity of her neurologist and pointed to a number of reviews from women accusing him of sexism and making them cry. In the video, Rule explained that she decided to identify him out of concern for other patients, explaining that his actions—for example, prescribing her an alternative, high-risk medication, solely because it wouldn’t cause birth defects to a hypothetical fetus—could “kill someone.”

Rule has since started a petition demanding policy change to prevent doctors from denying treatments to patients who are women or people with uteruses and of “childbearing age.”

“I think doctors often, in my experience, bank on the fact that people don’t know their patients’ rights,” Rule said. “We need policy change to reprimand any physician or insurance company that chooses to prioritize a hypothetical life that does not exist over the wellbeing of a suffering human being who actually exists.”

Filed under: General Problems | 3 Comments »

FTC Commissioner Bedoya calls out PBM games

Posted on September 23, 2022 by Pharmaciststeve

FTC Commissioner Bedoya calls out PBM games

https://ncpa.org/newsroom/qam/2022/09/22/ftc-commissioner-bedoya-calls-out-pbm-games

On Thursday, FTC Commissioner Alvaro M. Bedoya delivered remarks in Minneapolis calling out the unfair games PBMs play. Bedoya cited an example where a pediatric cancer patient in West Virginia was denied readily available, behind-the-counter medication as the PBM insisted that the medicine can only be dispensed by the PBM’s own mail-order specialty pharmacy. The PBM then told the family to go home and wait two weeks to receive the medication via mail order, according to written remarks from Bedoya. He added that this is a product of vertical integration, which took the pharmacy benefit landscape from about 39 companies including pharmacies, PBMs, and insurers down to just three main PBMs. “And so today, when most people fill a prescription, just one of three entities mediates what medicine they get, what they pay for it, and how they will get it – and that corporate entity makes money by making sure that prescription is filled by its own pharmacy,” Bedoya said. “Even, apparently, when it is cancer medicine. And even, apparently, when doing that will force a child to wait for two weeks.” In closing, Bedoya said, “… Antitrust is about: your groceries, your prescriptions, your paycheck. I want to make sure the commission is helping the people who need it the most.” NCPA staff attended the forum.

A health care panel discussion featured community pharmacists Jessica Astrup Ehret (Owner, Astrup Cos.) and Steve Simenson (treasurer and managing partner, Goodrich Pharmacies), in addition to Tracy Jones of the AIDS Task Force of Greater Cleveland and John Farina of the AIDS Healthcare Foundation. Astrup Ehret discussed the many pitfalls of PBM’s “take-it-or-leave-it” contracts. Simenson discussed how PBMs under-reimburse drugs and how community pharmacies are negatively affected by vertical integration. Farina and Jones discussed PBMs negatively affect access to AIDS medication. Minnesota Attorney General Keith Ellison provided keynote remarks along with Bedoya.

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