FDA Releases Alert for Amneal and Impax Epinephrine Auto-Injector Device Malfunctions

FDA Releases Alert for Amneal and Impax Epinephrine Auto-Injector Device Malfunctions

https://www.drugtopics.com/latest/fda-releases-alert-amneal-and-impax-epinephrine-auto-injector-device-malfunctions

The FDA has released an alert to patients, caregivers, and health care professionals about inspecting some lots of Amneal and Impax epinephrine auto-injector 0.3 mg to make sure the device has its yellow “stop collar.”1

The yellow “stop collar” is 1 of several components that work together to confirm proper dosing of the auto-injector but may not be present in some devices, according to an Impax Laboratories, LLC letter sent to health care providers. Without the stop collar, the auto-injector can potentially deliver an overdose of 0.6 mg instead of 0.3 mg, and may cause harm to the patient or death.2

Impax is a subsidiary of Amneal Pharmaceuticals LLC, the company that manufactures the epinephrine auto-injector.1

In a letter to health care professionals, Impax requested that pharmacists who have dispensed Impax’s epinephrine injection, USP auto-injector 0.3 mg since December 20, 2018 contact all patients who received the device and provide their consumer letter, which has instructions for inspecting the yellow “stop collar.”1

Additionally, pharmacists should inspect the products before dispensing them to patients to ensure that the yellow “stop collar” is present. Those who received the device after December 20, 2018 should immediately take the following precautions to determine if the device is missing the yellow “stop collar”:

  1. Remove the auto-injector from the carrying case
  2. Place the auto-injector on a flat surface
  3. Locate the edge of the label stating, “Peel here for further instructions.” Lift the label edge until you see the clear part of the device
  4. Look for the yellow “stop collar” inside the clear part of the device; if the yellow “stop collar” is not visible there, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to see if the yellow “stop collar” comes into within the clear part
  5. If yellow “stop collar” is there, the device is safe for use and no further action is needed. Re-wrap the label to its original position and place the device into the carrying case

If patients and health care professionals take these steps and fail to find the “stop collar,” they should contact the Amneal Drug Safety Department at 1 (877) 835-5462 for assistance in confirming malfunction and in making arrangements for returns.2

The FDA added that the devices have not been recalled; the agency urged patients to use the device they have on hand, but to be aware of potential malfunctions by taking action with the above listed steps.1

Two independent pharmacies – owned by the same family – “gutted” – restitution for Floyd George’s murder ?

Will OPTICS and huge visible demonstrations really make any difference in the future ?

A week ago I made this op-ed post

Looking at the OPTICS: bureaucrats picking winners and losers

At about the same time or shortly there after, when actions of a police officer that caused the death of George Floyd caused a lot of demonstrations and unfortunately some “bad actors” showing up and started looting and destroying businesses small and large. Mr Floyd death was in the public and of course was videoed from several angles… HIS DEATH WAS VISIBLE TO THE PUBLIC AND THE MEDIA.

Demonstrations have been going on for over a week in mostly very large cities coast to coast and border to border… some of the cable channels have been reporting on these demonstration/looting wall to wall … 24/7.

There is/was some very large protests in London England in Hyde Park. Estimates of the number of people demonstrating has been upwards of tens of thousands in each city.

When the chronic pain community – of an estimated 100 million people – has a rally/protest… and only a few dozen – at most – shows up… how many media outlets report on these rally/protest ?

When a chronic pain pt has their pain therapy reduced or eliminated and they commit suicide or die because their comorbidity issues worsens and they die from “natural causes” or ends up living being house/bed/chair confined… They are INVISIBLE to the public and the media…  Apparently those lost lives have little/no social value or importance to only their immediate family

How many chronic painers have written/called their representatives in Congress about how they are unable to get treatment from a doctor or have been dropped/discharged from a practice only to get a letter back how their member of Congress is really concerned about the OPIATE CRISIS…

The 100 million chronic pain pts are not collectively visible enough that the members of Congress have taken time to create generic paragraphs that their staff can cut/paste into a letter about pts suffering from chronic pain and not able to get adequate treatment.  The community is not even on their radar.

Apparently the community having thousands of FB pages is not getting the attention of anyone that is not in the community.  How many of the estimated 100 million chronic painers are just totally not involved ?

I just wonder when we look back at the end of this year or this time next year. If all of these demonstrations will really make a difference in some police officers using excessive force during arrests ?

Pain is a very subjective experience

CVS must be so proud of this pharmacist

 

 

 

 

 

 

 

 

 

Find independent pharmacy near you click here

 

 

Walgreens’ DM has no sense of humor: Fired Pharmacist For Doing Comedy

https://youtu.be/Z_aTP-G2wMk

 

Walgreens Pharmacist Fired For Doing Comedy

I was wrongfully and unjustifiably terminated from Walgreens for doing comedy. Although my new District Manager stated my comedy was gross misconduct, my previous District Managers had no issues with my comedy and members of Walgreen corporate attended my show and loved it. I do not believe I was terminated for comedy!

https://ncpa.org/pharmacy-locator

Find a local independent pharmacy with link above

CALF Med Board – declares treating chronic pain with opiates is “NEGLIGENT CARE “

Blues plans sue CVS, saying it overcharged them for generic drugs

Blues plans sue CVS, saying it overcharged them for generic drugs

https://medcitynews.com/2020/05/blues-plans-sue-cvs-saying-it-overcharged-them-for-generic-drugs/

Blues plans in six states filed a lawsuit against CVS, alleging the company inflated the cash prices of its generic drugs. They said CVS sold the drugs to consumers at a lower price using its cash discount program, while charging insurers a higher price.

Six Blue Cross and Blue Shield insurers sued CVS Health on Wednesday, claiming the pharmacy overcharged them for generic drugs. The plaintiffs — which include Blues plans in Alabama, Florida, Minnesota, North Carolina, North Dakota and Kansas City — said CVS charged them a higher price for generic prescriptions than customers paid in cash.

Pharmacies are supposed to charge insurers the “usual and customary” price for generic medications, determined in a previous lawsuit against Kmart to be the standard cash price paid by customers. The Blues plans would pay the price negotiated by their pharmacy benefit managers for drugs, unless the usual and customary price is lower than that negotiated rate.

The plaintiffs alleged that CVS misrepresented the usual and customary rate for these drugs by offering a much lower price to customers that participated in its cash discount programs. The company began offering its Health Savings Pass program in 2008, which was later transitioned to its Value Prescription Savings Card program.

By paying a $15 membership fee, customers that paid in cash would have access to more than 400 generics at the price of $12 for a three-month supply. According to the complaint, CVS frequently offered the same cash price to customers who were not enrolled in one of these programs.

The prices that the Blues plans were charged for these same medications was “significantly higher” than the cash prices paid by customers, the plaintiffs said. For example, multiple Blues plans reported overpaying for Nadolol, a generic to treat high blood pressure. BCBS of North Carolina reported paying $257 for the drug, while cash-paying customers in the savings program paid $12, according to court documents.

“Third-party payors then reimbursed CVS based on those higher, inflated prices—instead of the actual, lower, prices CVS offered to the general public, including through its Cash Discount Programs,” the complaint stated.

The Blues plans said this not only caused them to overpay for prescription claims, but it also prevented them from getting better drug prices for their members.

In an emailed statement, CVS Health denied the allegations, saying they were “completely without merit.”

“The CVS Pharmacy Health Savings Pass was a membership program intended for customers who either did not have insurance or chose not to use insurance. The Value Prescription Savings Card Program is a prescription drug card offered and administered by a third-party,” the company stated. “Generic drug prices available through these programs were not the usual and customary price charged by CVS Pharmacy, nor the price available to the general public. Neither of these programs were in any way concealed, nor fraudulent.”

The plaintiffs are seeking injunctive relief, damages, and an award of twice the amount they were overcharged.

Other pharmacy chains have recently faced similar lawsuits. In 2018, Rite Aid was hit with a class action lawsuit for allegedly charging insurers more than it charged customers under its cash membership plans. Walgreens faced a class action lawsuit for similar allegations that year.

Yesterday I picked up a Rx for one of Barb’s meds – 90 day supply – and the copay was $0.00. This year our part D is with Humana… Looking back to last year when we had Silver Scripts/Caremark – owned by CVS Health – the copay on this particular med ranged from $3 to $9 – depending if we had it filled in Indiana or in Florida – when we were at our condo.

Maybe this can explain how CVS reported a 8% increase in gross revenue and a 48% increase in net profits for 1st quarter 2020 vs 2019.  I don’t have a MBA but I owned/ran several of my own business for 20+yrs and have been buying stocks for twenty years and it highly unusual for a mature company – CVS has been in business for 60 yrs – to be able to increase their bottom line – as a percent -about FIVE TIMES what their gross revenue increased.

I also find it interesting that the three largest chain pharmacies have all been accused and sued for similar “bad behaviors” now and in the past.

Representative Buddy Carter’s office in Georgia is taking patient stories of issues with CVS Caremark, Optum RX, and Express Scripts

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Representative Buddy Carter’s office in Georgia is taking patient stories of issues with CVS Caremark, Optum RX, and Express Scripts. If you just want to ensure that your children and your loved ones will be able to access the pharmacy that best meets their needs then please stand up. Your voice can be heard. Our voice can be heard with your help!
Please help us win this fight and share your story!

Independent community pharmacists are among the most capable and readily accessible providers of essential healthcare services during the COVID-19 pandemic

Community pharmacies are under siege

https://www.lockportjournal.com/opinion/community-pharmacies-are-under-siege/article_4cb5b289-a875-5b90-80d7-0ffb4786b395.html

Independent community pharmacists are among the most capable and readily accessible providers of essential healthcare services during the COVID-19 pandemic.

Even though over 90% of Americans live within five miles of a community pharmacy, we are being overlooked in the news media and by policy makers and being squeezed out of business by a greedy group of corporate middlemen.

Our pharmacies are open and here to serve the community. We provide more than just medications. In normal times and especially in a time of crisis, we are one of the first sources of critical and accurate information and support. My staff and I are continuing to take this crisis full on, we are certainly not running away from it.

But, our ability to deliver personal, professional care is under attack, because our ability to make even a small profit on prescriptions is being siphoned off by a group of middlemen known as pharmacy benefit manager corporations or PBMs.

Buddy Carter, U.S. Representative for Georgia, is a trained pharmacist. He is a strong voice for community and independent pharmacies in Washington, D.C., and says, “Without support from the community, and in particular from legislators who must step in and fix the PBM problem, community pharmacies will struggle to keep the doors open. We can’t allow this to happen. We must make sure we do not lose the irreplaceable care, guidance and reassurance they give patients.”

According to a report published this year by a top pharmacy industry analyst, “DlR pharmacy fees (direct and indirect remuneration paid to PBMs) overall have skyrocketed by 1,600% in the last five years, totaling 58.58 since 2013.”

In response to the report by XIL Consulting, B. Douglas Hoey, a pharmacist and National Community Pharmacy Association CEO, said, “It should be shocking to state and federal lawmakers and regulators that pharmacy benefit manager corporations are using a government loophole to squeeze billions of dollars in fees from pharmacies, that those fees are driving up the cost of prescription drugs for patients, and that the sickest people in the country are subsidizing insurance premiums.”

Citing 2017 as an example, the report shows PBMs squeezed over $4 billion out of pharmacies which, according to a recent NCPA survey, is why 58% of local pharmacists are not sure they can survive the next two years.

Now more than ever, it is vital for everyone to not forget about their community pharmacy. Given a fair chance, we will keep fighting on the front lines of the COVID crisis and for the future of the communities we serve. We need the support of our patients, our communities, the press and government now more than ever.

Stephen L. Giroux is president and CEO of the community pharmacies in Middleport, Depew, Medina, Oakfield, Hilton, Niagara Falls, North Tonawanda and Lockport.

WAGS R.Ph’s.: being trained to spot signs of anxiety, depression, addiction

Pharmacists being trained to spot signs of mental health issues during pandemic

https://www.10news.com/newsanational/coronavirus/pharmacists-being-trained-to-spot-signs-of-mental-health-issues-during-pandemic

There’s a new first responder on the lookout for anyone who may be experiencing mental health issues.

“Most people probably see their pharmacists more than their primary care physicians or certified therapists, so pharmacists are in a really good position to be able to notice these early warning signs or risk factors,” said Chad Cadwell, a Walgreens pharmacist.

Walgreens pharmacists just finished the first phase of mental health first aid training. The program was developed by the National Council for Behavioral Health.

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They’re taught to look for risk factors and red flags in patients, everything from anxiety and depression to addiction.

Pharmacists can connect those people with the right resources, support groups, or may just lend an empathetic ear.

“Really listening to their needs, spending those extra couple of minutes, instead of trying to get the work out, but also spending that time talking and listening to your patients, right now with everything that is going on with the pandemic, everything is so busy,” said Cadwell.

This training initiative was actually put into place pre-pandemic.

Mental Health America has already seen significant increases in the number of daily screenings for depression and anxiety since the beginning of the year.