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FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia

https://www.lawofcompoundingmedications.com/2021/02/fda-issues-warning-to-acelrx-for-making.html

As part of the FDA’s ongoing commitment to combat inappropriate opioid use, the agency’s Center for Drug Evaluation and Research has issued a warning letter to AcelRx Pharmaceuticals, Inc. (AcelRx) for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic. 

AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it. The promotional communications at issue, however, promote the product as simple to administer — just “Tongue and Done.” This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.

Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is of particular use in certain special circumstances where adult patients may not be able to swallow oral medication and where access to intravenous pain relief is not possible.  

Dsuvia was approved with a Risk Evaluation and Mitigation Strategy (REMS), which reflects the serious risks associated with this product. The REMS limits distribution to certified, medically-supervised health care settings where health care professionals are trained in the proper use and administration of the product. Such settings include hospitals, surgical centers and emergency departments that are certified in the requirements outlined in the REMS. The FDA continues to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements.

Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter. In particular, the claim “Tongue and Done” severely detracts from these important conditions for safe use. Because of the potency and the small size of the tablet, the prescribing information outlines multiple administration steps including a separate, distinct step to visually confirm tablet placement in the patient’s mouth. These prescribed steps are designed to minimize the serious risk that misplaced tablets could cause to patients and others. The promotional communications at issue also omit other important risk information, further minimizing the serious risks associated with Dsuvia.  For example, the materials state that patients may retake the drug in one-hour intervals but fail to state that the maximum daily dosage is 12 tablets in 24 hours. This omission is concerning due to the serious risks associated with overdose of Dsuvia, including respiratory depression and death.

It is vitally important that promotional communications be truthful and non-misleading. Opioid products are highly addictive controlled substances and there are serious public health risks associated with their use, including addiction, abuse, and misuse, that can lead to overdose and death. False and misleading claims can negatively impact prescriber awareness and understanding about approved opioid drugs, their risks, and the actions and precautions necessary for the safe use of these products.

FDA requests that AcelRx cease any violations of the Food, Drug and Cosmetic Act and submit a written response within 15 days from the date of receipt of the letter addressing the concerns in the letter, listing all other promotional communications that contain statements such as those described in the letter, and explaining any plan for discontinuing use of such communications or for ceasing distribution of Dsuvia. If AcelRx fails to adequately address the concerns outlined in the warning letter, the FDA may take further regulatory action. The FDA is also requesting that AcelRx submit a comprehensive plan of action to distribute truthful, non-misleading, and complete corrective communications about the concerns discussed in the warning letter to the audience(s) that received the promotional communications.

The FDA encourages healthcare providers and consumers to report potentially false or misleading prescription drug promotion to FDA’s Bad Ad program.

The FDA also encourages health care professionals and consumers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

The FDA remains focused on reducing the rate of new addictions by decreasing exposure to opioids while still enabling appropriate access for those patients who have legitimate medical need for these medicines. Dsuvia, when used in a manner consistent with the FDA-approved labeling, including the REMS, can play an important role in the management of pain. The agency will continue to actively confront the opioid crisis, while also paying careful attention to the needs of patients experiencing pain and their health care providers.

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Where’s The Vaccine?

https://puttrx.medium.com/wheres-the-vaccine-cb71195ddf49

2021. So far for pharmacies, it’s been a wild ride. The much-anticipated advent of the COVID vaccine(s) has spawned additional issues with rollout and availability capabilities — many of which can be tied back to misinformation, corporate territorialism, and lack of proper planning.

Does anyone else hear a common PBM theme here?

States that are excelling in the vaccination effort are those including their local independent pharmacies in all phases of distribution. In an MSNBC interview this month, West Virginia Governor Jim Justice noted that “instead of letting vaccines sit on shelves we saw that our elderly wanted to go to their local pharmacies and clinics… We incorporated everybody together… and said we’re not going to let vaccines sit on shelves.” And, in a January interview on Face the Nation, Arkansas Governor Asa Hutchinson remarked, “Our independent pharmacies are doing a better job of getting it (the vaccine) out. They’re acting with more urgency than the chain pharmacies.”

The facts are that the CVS/Walgreens partnership was allocated more than 4.7 million doses of the Pfizer and Moderna vaccines, but as of mid-January — a month after rollout began in many states — had only administered a quarter of those vaccines. In states like Mississippi, that translated to only 5% of the state’s initially allocated shots administered to their most vulnerable populations. Statistics that abysmal can only be construed as either the chains are saving doses for second round inoculations, or incapable of doing the job they were contracted to accomplish. And while one would hope that it’s the former, not the latter, even saving doses isn’t necessary. Both Pfizer and Moderna have made clear that new shipments will cover those second rounds .. so why is there a shortage?

It has long been reported by even their own employees that major chains like CVS and Walgreens are understaffed to the point of patient danger, and large numbers of what they themselves call “retail locations” (as opposed to ‘pharmacies’) obviously do not translate into the amount of trained medical personnel necessary to effectively administer vaccines to the single portion of the population they were contracted to vaccinate. Whether or not this factors into their ongoing vaccination rollout issues, we may never know.

The truth is that if CVS/Walgreens were not either “holding back” doses for second round inoculation or caught in a web of their own ineptitude with regards to their LTC government contract, far more shots could have gone into arms — and far more shots would be available to our swiftly dying population. Look at the independent pharmacy rollouts in West Virginia, North Dakota, and Louisiana. They’re not holding back doses, or lacking the ability to get doses administered. They’re getting them into the arms of the population that needs them most — and receiving the doses for second rounds. The statistics prove it. West Virginia alone has achieved a 50% drop in hospitalizations and a 45% drop in deaths since the inception of their vaccine rollout — a substantial difference over states who choose to rely solely on giant corporation-driven control.

Patients trust their local independent pharmacies, and have for generations. When it comes to easily accessible advice on medication-related questions and issues, their local pharmacy is a patient’s preferred go-to. Not a chain ‘retail’ store that places more importance on superstore mentality than individualized patient care — which may explain CVS and Walgreens’ claims that lack of consent is a large part of the reason they’ve been unsuccessful.

The PBM-owned pharmacies at the helm of America’s vaccine effort are, in essence, proving the necessity of PBM reform. Independent pharmacies nationwide are licensed, willing, Trusted partners in the ‘arms race’ on one of the most important vaccines in history. Giant corporations playing territorial hardball are not the answer. As The Washington Post recently wrote, “The strong performance by local pharmacies in distributing lifesaving vaccines makes that clear.”

Jeremy Counts, PharmD

Main Street Pharmacy

Blacksburg, VA

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Steve – The House is holding a hearing today on H.R. 40 – a bill that would set up a commission to examine the institution of slavery and its impact and make recommendations for reparations to Congress. We need your help to push this critical legislation forward: Please send a message to your representative and tell them to support H.R. 40 now. Today’s hearing will feature one of the Japanese Americans who successfully pushed for redress after their family was rounded up by the U.S. government and locked in prison camps, and will enforce an important message: That our country has provided reparations in the past, and H.R. 40 is a realistic mechanism to begin discussion on addressing the fundamental injustices of institutional slavery in the U.S. We cannot adequately repair harms that we have not fully examined and discussed as a national priority. It’s time our country accounts for hundreds of years of brutal mistreatment of Black people during chattel slavery, Jim Crow segregation, and the enduring structural racism endemic to our society. H.R. 40 would create the framework for that necessary process of atonement. And if the latest rise of white supremacist expression shows us anything, it’s that this crucial conversation must happen now. We must pass H.R. 40. During slavery, Black people were ripped from their families and nations and forced to labor for the enrichment of America. After its “abolition,” the emancipated were left to face the terrorism of widespread lynchings and targeted massacres. Those who survived were denied dignity in nearly every arena of life from criminal justice to economic security to health care – all harmful disparities that continue to pervade our systems and society to this day. Reparations are not a symbolic act in response to these atrocities. Passing H.R. 40 provides a real and necessary demand for justice that has support and momentum. Steve, if we ever hope to achieve racial justice in America, we must examine the impact of slavery and its legacy and make strides toward reparations. With a new Congress and new President, we have the opportunity to make this happen – through H.R. 40. Please, urge your representative to support this important bill now. Thanks for taking action, Jennifer Bellamy Pronouns: She, her, hers ACLU Senior Legislative Counsel, fighting for racial justice P.S. If you’ve already contacted your member of Congress about H.R. 40 and reparations, thank you. Your consistent support and advocacy on this issue is so important to this fight – and the more your representative hears from you, the more they’ll listen. So please, send another message now.

Donate Now

This email was sent to: steve@steveariens.com Sign up for ACLU texts | Unsubscribe Please note: If you forward or distribute, the links will open a page with your information filled in. We respect your right to privacy – view our policy. This email was sent by: American Civil Liberties Union 125 Broad Street, 18th Floor New York, NY 10004, USA

This bill (HR 40)  was introduced by https://www.congress.gov/member/sheila-jackson-lee/J000032

Interesting … ACLU sent out this letter and DIDN’T MENTION WHO INTRODUCED THIS BILL.

Maybe the chronic pain community and the mental health community should seek  reparations for all the abuse/discrimination that has been inflicted on these communities since Pres Nixon signed into law the Controlled Substance Act in 1970.  The Civil Rights Act – which includes/covers disabled people – was signed into law in 1965.

Over the years, how many chronic pain pts have reached out to the ACLU for assistance to stop the discrimination that those in the community has have to endure and how many pts have been told by the ACLU that they don’t have the resources – or just doesn’t have the interest – in how some specific groups – are being discriminated against…  NOT CENTURIES AGO, but here and now.

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The assumption is feckless doctors not knowing what they are doing have overprescirbed and this has caused more overdose deaths and addiction so CDC has told us what to do, to make it safe and cut down on these problems.

It did not work. Deaths are up. Addiction is the same as always.

But millions of very tragic consequences have occurred with people forcibly discontinued from the the control of their permanent painful diseases to solve the Heroin multidrug overdose problems, Ask CDC who exactly is dying and why they separated multidrugs to make it look like it was prescription drugs- a terrible mistake,

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This Burger King commercial was very popular at a time when our daughter was in early grade school… you know when a parent can “easily embarrass” kids in this age group… I use to sing along with the commercial modifying the end of the commercial  “NAKED BURGERS DON’T UPSET US !” 

Every week, I get contacted by chronic pain pts … typically concerning their inability to get their pain management medication. Sometimes it is denied by their insurance/PBM company, sometimes it is the pharmacy that they have patronized for years, sometimes it is their doctor.

In this country we are use to patronizing where/whom we wish  to purchase products/services from.  When I started working in a pharmacy as a pharmacy student (1967), there was no DEA, no PBM/drug cards, bank charge cards were in their infancy. There was a Federal Narcotic Bureau that only dealt with Opiates, that were not prescribed in quanities as they are today.  Transaction at the Rx counter was CASH or STORE CHARGE   The physician that we use, when I was a kid, was paid in CASH for a office visit.

The vast majority of pts that reach out to me, want me to tell them how they can make “them” prescribe, fill, or paid for their prescription. When the Pharmacist tells the pt that “they are not comfortable”…  that is not a valid reason.. that is an EXCUSE.  When the Pharmacist tell the pt that they are “out of stock” or they have a order coming arriving in a few days and when the pt returns in a few days and is told that “supplier didn’t send the medication” ..  is most likely a LIE.

Often the best – quickest – way to get a resolution is to switch providers…. if you are on Medicare/Medicaid you can file a complaint by calling 800- MEDICARE… you may or may not get  resolution, but the more pts that complain about a vendor the more likely the dollars that they are reimbursed will be reduced and they can have their “star rating” reduced.

If you are going to file a complaint against a medical practitioner or Pharmacist/pharmacy… some states let pts file the complaint directly with the AG office and may eliminate the particular board from “filing” the complaint and no really doing anything about the pt’s complaint.  These medical boards only have “legal authority” over the practitioner’s license, everything else is handled by the state’s AG office.

Do not expect anything to be done promptly from a complaint to the medical licensing board and/or AG’s office… normally action/response takes 6 to 24 months.

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How Deadly Is the U.K. Variant?

https://www.medpagetoday.com/infectiousdisease/covid19/91202

Updated analyses support worse clinical outcomes

Evidence continues to mount that the so-called U.K. variant is “likely” deadlier and results in more hospitalizations than non-variant COVID-19 cases, according to data released on a British government website.

The report compiled research from major universities and studies and found “increased severity” of COVID-19 cases from the B.1.1.7 variant compared to “non-variants of concern,” with B.1.1.7 cases anywhere from 30% to 70% deadlier than the original wild-type strain.

These concerns were initially raised in January, when the British government’s New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) presented initial data, suggesting cases with B.1.1.7 were likely deadlier than non-variant cases, but they noted then that “data will accrue in coming weeks, at which time the analyses will become more definitive.”

The report detailed why these updated analyses were indeed more definitive, noting earlier reports using linked community testing and mortality data were all based on the same datasets, and thus the same biases.

“More recent analyses have added a wider range of data sets and been able to control for additional confounders, increasing confidence in the association of the [variant of concern] with increased disease severity,” they wrote.

Of note, London School of Hygiene & Tropical Medicine found a relative hazard of death within 28 days was 1.58 (95% CI 1.40.1.79) for variant-infected individuals versus non-variant-infected individuals, while Imperial College London found the mean ratio of case fatality for variant cases was 1.36 with a case-control weighting method.

Public Health England performed a matched cohort analysis, and found a “death risk ratio” of 1.65 (95% CI 1.21-2.25) for variant individuals versus non-variant individuals.

Several other studies examined the effect of the variant on hospitalization, with Public Health Scotland using the S-gene target failure as a proxy to determine variant cases. They found risk of hospitalization was higher among S-gene target failure cases versus S-gene positive cases (risk ratio 1.63, 95% CI 1.48-1.80). Research from Intensive Care National Audit and Research Centre (ICNARC) and QRESEARCH also found a higher risk of ICU admission for variant versus non-variant cases (HR 1.44, 95% CI 1.25-1.67).

However, the consensus was not unanimous, and the government included data from COVID-19 Clinical Information Network (CO-CIN), which found no evidence suggesting variants are linked with higher in-hospital case fatality rates. An analysis from Office for National Statistics (ONS) noted that while the hazard ratio suggested higher risk of all-cause mortality, “the number of deaths are too low for reliable inference.”

The report also noted several limitations to the data, including representativeness, power, potential biases in case ascertainment, unmeasured confounders, and secular trends. They added that the majority of studies tried to control for confounding by nursing home status, but there was a potential for residual confounding due to unidentified nursing home residence in hospital datasets.

“There are potential limitations in all datasets used but together these analyses indicate that it is likely that … B.1.1.7 is associated with an increased risk of [hospitalization] and death compared to infection with non-[B.1.1.7] viruses,” the authors concluded.

CDC modeling in mid-January estimated the U.K. variant would become the dominant strain of COVID-19 in the U.S. by the end of March. Another recent modeling study suggested incidence of variant cases are doubling every 10 days in this country.

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Chain Pharmacy Greed is Damaging the COVID-19 Immunization Program, And Increasing Prescription Errors!

https://pharmacistactivist.com/2021/February_2021.shtml

The efforts to develop, distribute, and administer COVID-19 vaccines are a race against time in reducing the number of deaths and other consequences. Problems have and will continue to occur, but some are preventable. The federal government awarded huge contracts to CVS and Walgreens to immunize residents of nursing homes and assisted-living facilities in deals that are potentially so lucrative that one financial analyst estimated that CVS could make $1billion in gross profits over the next year. Although CVS and Walgreens moved very quickly to obtain the federal contracts, they have not given the same priority to distributing and administering the vaccines on a timely basis. Their greed and management failures have resulted in chaos in their programs and substantial delays in providing life-protecting immunizations for the most vulnerable patients in nursing homes. Their ineptitude in providing adequate staffing and resources, and adequate workplace protections for their pharmacists and other front-line employees must not be tolerated. Now you can get medicines and essentials like La Roche-Posay Ireland get delivered online. You might also be familiar with other cosmetic products online like the inkey list.

News releases from CVS and Walgreens have stated that they are hiring tens of thousands of new employees (pharmacists, technicians, etc), the vast majority of whom are technicians. The lack of commitment and respect of CVS for its pharmacists is evident in its advertisement: “Staff Pharmacist Floater Part-time Temporary Seasonal Jobs Hiring.” To be completely clear, this commentary is NOT a criticism of the front-line pharmacists and other employees at CVS and Walgreens. Rather it is directed at management that is responsible for the understaffed, stressful workplace environment that often does not provide sufficient protections for its employees, and increases the risk of vaccine and medication errors.

There has been an avalanche of social media posts and news stories that are highly critical of CVS and Walgreens. Examples include the following:

A great program in W. Virginia

“W. Virginia a vaccine success story,” is the title of a recent news story (Cuneyt Dil; Associated Press/The Philadelphia Inquirer, Jan. 18, 2021). It provides an inspiring account of the excellent leadership and immunization services of the independent pharmacists in West Virginia Excerpts are provided below:

Congratulations and thank you to the pharmacists, government officials, and residents of West Virginia! This is a wonderful example for those of us living in the other 49 states to emulate!

Addendum

I wrote this editorial on Tuesday, February 2. Soon after I completed it, I looked at today’s issue of the Wall Street Journal and the story, “Retailers To Take Key Role in Vaccine,” (Sharon Terlep and Jaewon Kang; pB1). It includes the following comments:

CVS and Walgreens were entrusted with this responsibility already and they failed. They can’t be trusted to do it right this time and they should not be permitted to participate. Our national pharmacy associations must send a strong message to the CDC promoting the West Virginia experience in using independent pharmacies. Pharmacists should do the same with their legislators and state health departments. Like West Virginia, other states should reject the federal partnership with chain pharmacies and work with their independent pharmacists who know so many of the residents of their communities.

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