Recently a pt share this hyperlink https://www.drugs.com/comments/acetaminophen-hydrocodone/for-pain.html?status=1

A couple a years ago Barb had a “no efficacy ” with her C-II , when we had it fill at the Winn Dixie close to our FL condo.  It was made by Rhodes – which at the time was owned by Purdue Pharma. I talked to the PIC at the pharmacy and she stated that was the ONLY BRAND that Winn Dixie allowed them to purchase from the wholesaler.

The pt that shared that the generic company that she got  was Camber https://www.camberpharma.com/   Its parent company, Hetero of Hyderabad India,  this website   https://www.drugs.com/manufacturer/camber-pharmaceuticals-inc-219.html  had this statement  “Camber Pharmaceuticals, Inc. manufactures, markets and/or distributes more than 93 drugs in the United States. Medications listed here may also be marketed under different names in different countries. Non-US country and region specific information is not available on this page.” does that last statement mean that the same meds, in the same bottle – just has a different label/name on the  outside of the bottle ?

here is another hyperlink https://reviews.birdeye.com/camber-pharmaceuticals-inc-163457133420189 and Camber got a 2.2 overall rating with 84 out of 126 reviews was a ONE – maybe because there was no option to give them a ZERO ?

Some pt have asked me… if they could get the potency of their meds tested… of course they can, I understand such tests are $200 -$300 each time….however if the med is produced off shore … how are they going to sue someone in India or Pakistan ?  The FDA is not going to do anything… if you complain to your insurance company – for paying for “defective meds”… they will just tell you to get a med from a different pharma.

The FDA years ago created the ORANGE BOOK  https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book and in it.. the FDA has determined what medication(s) a pharma makes is bioequivalent to the brand name product and gives he generic/pharma a “grade” as bioequivalent or NOT.

It is ILLEGAL for a pharmacy to compound meds that are commercially available… but compounding a product that has been independently tested is not meeting the FDA requirement that a med must be between 95%-105% of what is stated on the label.

However, a compounding pharmacy and a doc could come to some sort of an agreement about a specific combination of meds to be compounded.  Because compounding pharmacies are allowed to do anticipatory compounding and keep 7-14 days on hand and there are ways to basically do this in a semi-automated process… not how making compounded meds and putting them in capsules – BACK IN THE DAY.

Hydrocodone is not available in a 12.5 mg dose and there use to be a commercially available product that was Demerol and Phenergan… but it was finally figured out that long term use of Demerol created some toxic by products, but Phenergan/Promethazine is known to potentiate  the effects of opiates…  same thing could be done with Oxycodone … there is no 7.5 mg or 12.5 mg commercial dose.

Insurance companies don’t like to pay for compounding meds, but if the pt clinically showed BETTER PAIN MANAGEMENT with the compounded med than the generic they were taking… could give enough valid reasons for the insurance to pay for the compounded med.  IMO, Medicare Part D & Medicare Part C… has a very well defined appeal process and following their rules on appeals, the vast majority of pts seeing a benefit out of a compounded med… perhaps at least 90% would end up getting their meds paid for..

The pt is going to have to start the discussion with their doc that has a lot of pain pts… here is a link to find a independent compounding pharmacy by zip code and radius  https://ncpa.org/pharmacy-locator  these “poor” generic meds may cause a pt to end up showing “NO OPIATES IN THEIR URINE” and could get kicked from the practice.

Maybe everyone is HAPPY… the doc because the pt is getting better pain management, so is the pt, the compounding pharmacy is happy getting more business… the pharmacy that has been dispensing the cheapest meds they can buy – loses business and so does the generic pharma

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PBM Specialty Pharmacy Requirement Hurting Patients, Specialists Say

https://www.medpagetoday.com/pharmacy/pharmacy/100359

Hassles with prior authorization, delivery make it harder to dispense needed medications

Pharmacy benefit managers (PBMs) are requiring more and more patients to use specialty pharmacies to obtain their drugs — especially for cancer and other chronic illnesses — and medical specialty groups are saying that it’s increasing paperwork and hassle for themselves and their patients without adding any value.

Wayne Woodbury, RPh, pharmacy director at Southern Oncology Specialists in Huntersville, North Carolina, had one patient who regularly received an IV immunoglobulin (IVIG) infusion. “Every year, at the beginning of the plan year when she would renew, [the PBM] would say, ‘This medication you get, an IVIG, you can’t fill that through the provider’s pharmacy; you’ll have to use ours.'”

Patient Pushback Required

The first year that happened, “I pushed back as far as I could; I called the insurance carrier that the PBM owned and told them, ‘This is a therapy that is weight-based and it’s therapeutic-level-based,” Woodbury said in a phone interview. “Every month, the patient comes in, she gets blood work and gets weighed, and based on the lab work and her weight, the dose is determined, so our provider would prefer that we’d be able to dispense that and dose-adjust accordingly, rather than getting the shipment from the preferred pharmacy and [risking] underdosing or overdosing.'” Woodbury said he was told that although he couldn’t make that request, the patient herself could do it, and she was able to get an override for it after several hours on the phone, he said.

That worked for 2 years, but then the patient’s employer switched insurers and a new PBM was involved, Woodbury said. Not only that, but the PBM was using a third-party intermediary to manage the prescription component — “to deal with all of the prior authorizations, deal with the prescription claims coming in and where they were sent,” he continued. “I think they use them for a clearinghouse of sorts, getting the information and ascertaining what level of treatment is this and how can we best get this medication distributed?”

Woodbury’s office tried again to get an exception for this patient “and they were an outright ‘No,'” he said. “Unfortunately we weren’t able to provide the medication for the first time in 3 years … so we had it shipped to [an approved pharmacy] and they ship it to our office every month. If it’s not here in time, we may have to change her appointment.”

The intermediary gave the patient a list of reasons why they wouldn’t allow the in-house pharmacy dispensing, “a long list of what they called negligent acts by us, saying when they initially sent the request for the prescription, we didn’t send it back in a timely manner, didn’t get prior authorizations in a timely manner, and refused to give them clinical information,” Woodbury said, adding that none of that was true. “These are all things we do as part of our process — what it takes them 7 to 10 days to do, we can do in a matter of 2 hours to a day.”

Woodbury said he does see a role for PBMs “when it comes to maintenance therapies for certain disease states, because those are disease states where the therapy is established … You know what therapy you’re going to be on, and the monitoring is not as frequent as acute indications in the oncology/hematology space. There’s a place for them there; they are able to offer medication in bulk, sometimes at a discount.”

“To Us, It’s a Person”

Laurie Dieringer, MBA, office administrator at the Lafayette Cancer Center in Lafayette, Indiana, is having similar experiences at her office’s multispecialty infusion center. One patient in particular had been on a chemotherapy drug for a while, “and he’s been filling it in-office for the last couple of years,” Dieringer said. “I went to process the refill in July and got a rejection — all of a sudden we’re out of network and he has to get it at the specialty pharmacy. There was no [prior] notification to the office or the patient.”

This is further complicated by the fact that “a lot of these patients have copay assistance or foundation assistance,” which Dieringer helps manage. In addition, when there’s a dose reduction, “I know it instantly — I don’t have to wait and send a fax” to the outside pharmacy, which otherwise autofills the refill for the same dosage, she said.

Dieringer informed the patient of the change. He was upset and pointed out that he was still working, and asked, “‘Is it going to get mailed to my house? What if somebody steals it?’ That’s a valid concern,” she said. To the PBM, “it’s just a fill. To us it’s a person, it’s a patient and you must try and do the best for the patient.”

Eventually Dieringer’s office was able to convince the specialty pharmacy to ship the medication to another nearby pharmacy so the patient could pick it up there, she said, adding that sometimes prescriptions are delayed because the specialty pharmacy needs to contact the patient about something and the patient doesn’t recognize the phone number and doesn’t answer. “It can take weeks — and I’ve even had it take months — for the patient to get their medication.” The hassles of having to use the specialty pharmacy — a process called “white-bagging” — are so great that two local hospitals have refused to do it and are now sending all their infusion patients to the center Dieringer works at, she said.

Other Specialties Also Affected

And it’s not just oncologists that are having this problem, according to Madelaine Feldman, MD, president of the Coalition of State Rheumatology Organizations. Rheumatologists have been having the same issue with their infusion drugs, she said in a phone interview. “We’ve been fighting against white-bagging, which has been an issue, over the last 3 years or so.”

Although PBMs say that white-bagging can save money for employer groups, oftentimes that doesn’t seem to be the case, Feldman said, noting that one member of the coalition’s Payer Issue Response Team is the office manager for her husband’s rheumatology practice, and she has found that the price that her office would “buy and bill” for a particular drug is often cheaper than the price that she is quoted by PBM pharmacy technicians or what the human resources person in a self-insured employer’s office says they are getting billed for.

Asked to comment on the issue, the Pharmaceutical Care Management Association — an industry group for PBMs — said in a statement that “Specialty pharmacy dispensing on physician-administered drugs is often much less costly and allows for claims processing to occur in real time through the drug benefit rather than through the medical benefit, where physician ‘buy and bill’ can lead to payment delays and high costs. Specialty and other high-cost medications are often misused and underutilized without PBM and specialty pharmacy management programs, support systems, and monitoring tools in place.”

The association included a comment from a 2019 Massachusetts Health Policy Commission report, which found that “clinician-administered drugs are typically high-cost, and spending for clinician-administered drugs represented almost one-quarter of all commercial drug spending and 4% of total commercial health care spending in Massachusetts in 2015. Spending for these drugs is also growing rapidly; commercial spending for these drugs grew 5.1% in 2015 and 9.5% in 2016.” MedPage Today also sought comment from one of the nation’s largest PBMs, but they were unable to respond by press time.

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15M Medicaid enrollees risk coverage loss when COVID-19 health emergency ends, HHS reports

https://www.healthcaredive.com/news/Medicaid-lose-coverage-hhs-aspe-public-health-emergency/630266/

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Two equally bad ways of treating acute pain in elderly ED patients?

https://www.pharmacyjoe.com/two-equally-bad-ways-of-treating-acute-pain-in-the-elderly/

In this episode, I’ll discuss an article comparing IV acetaminophen with IV hydromorphone for acute pain in elderly ED patients.

“Episode 740: Two equally bad ways of treating acute pain in elderly ED patients?” The Elective Rotation pharmacyjoe.com | Critical Care | Hospital Pharmacy | PGY-1 Pharmacy Residency

IV acetaminophen has been a tremendous disappointment when compared to opioids in terms of both efficacy and reducing opioid-related side effects. I have not yet seen a study demonstrating a clinically meaningful improvement of IV acetaminophen over an IV opioid for acute pain. However, there continues to be a desire to find a niche for IV acetaminophen, especially in patient populations at risk for opioid related side effects such as the elderly. To this end a Randomized Study of Intravenous Hydromorphone Versus Intravenous Acetaminophen for Older Adult Patients with Acute Severe Pain was recently published in Annals of Emergency Medicine.

The authors sought to compare the efficacy and adverse event profile of 1,000 mg of intravenous acetaminophen to that of 0.5 mg of intravenous hydromorphone among patients aged 65 years or more with acute pain of severity that was sufficient enough to warrant intravenous opioids.

The primary outcome being investigated was an improvement in a 0 to 10 pain score from baseline compared to 60 minutes after study medication was administered. The secondary outcomes included the need for additional analgesic medication and any adverse events that could be related to the study medication. The authors pre-specified a minimum clinically important difference of an improvement of 1.3 or more on the 0 to 10 pain scale.

The patients enrolled definitely represented a cohort with severe acute pain as the median baseline pain score was 10/10.

After 60 minutes, the patients who received 1000 mg IV acetaminophen improved by 3.6 and the patients who received 0.5 mg IV hydromorphone improved by 4.6 out of 10.

Overall pain relief after 1 dose however was not very good for either group. Almost half of the IV acetaminophen patients required additional doses of an analgesic, as did just over one-third of the patients who received IV hydromorphone.

Adverse events were similar between groups and minimal consisting of dizziness, drowsiness, headache, and nausea.

Unfortunately, it seems that efforts to provide analgesia with lower doses of opioids like 0.5 mg IV hydromorphone or alternatives to opioids like IV acetaminophen cannot reliably provide adequate pain relief in a cohort of elderly ED patients with severe acute pain.

To access my free download area with 20 different resources to help you in your practice, go to pharmacyjoe.com/free.

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Healthcare Has Always Been Political

https://www.daily-remedy.com/healthcare-has-always-been-political/

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Over the last year or more, I have been talking and promoting the use of PGx (pharmacogenomics) DNA testing.  We ran a PGx test that our PCP recommended only to discover that it did not cover opiates –  in discussing this test with our PCP – he was under the false impression that it did.  Not only that but I talked to a Pharmacist at this company, he shared with me some other “short comings” of their testing & reports.  So I found another company that did cover opiates and a total of 200 FDA approved meds… so we did that test  https://www.clarityxdna.com/clarityx-comprehensive-test/

It came back and it suggested that Barb may have some metabolism issues with both of her LA & IR opiates and one of her other medications.  I have shared the report – all 70 pages – with our PCP and my observations & opinions of what it revealed.

But on Barb’s report there was something that was very strange that showed up… Barb was diagnosed with Breast Cancer in 1994 – the end of this month she will be a 28 yr survivor – with breast CA, a woman is not considered “cured” until 10 yrs …

Barb was our Master Fitter/Trainer in our Mastectomy prosthetic center…  We knew that the younger a woman was when diagnosed with breast CA… the more likely it would metastasize to brain/bone/lung/liver and that was typically fatal.  Because of what she saw working with women with breast CA she did self breast exam several times a week…  Her lump became palpable between Sunday and Wednesday and she went for a follow up mammogram on Friday.. which confirmed there was a lump… one of the staff walker Barb from the mammogram center to the surgeon’s office she had used before…  he even skipped lunch – because he was scheduled to go out of town for a seminar..  A biopsy was scheduled for Monday and her lump was malignant and growing at TEN TIMES the normal rate.  A modified radical was scheduled for Wednesday.  Back then, a lumpectomy  was not believed to be a good option.  Her lump was already 1.9 Cm and no lymph nodes were involved… made it a STAGE ONE under the classification used at that time… a 2.0 Cm it would have been classified as a stage-2. She finished several doses of chemo on New Years’ eve of 1994.

Barb was prescribed the normal medication post chemo that was suppose to suppress any further metastasize of the cancer.. with breast CA , 60% of the metastasizes happen within the first 3 yrs.  For Barb this medication cause a significant – almost fatal – side effect – temporary  BLINDNESS and the first time she experienced this – SHE WAS DRIVING ALONE…

Of course, this medication was discontinued IMMEDIATELY…  of course back in 1994, the internet was nothing like it is today- as far as depth of research material.  I read all the FDA available literature… nothing showed up… I contacted our PCP … NOTHING… I contacted her Oncologist … NOTHING… I contact the pharma’s research dept that made this brand name drug … NOTHING…

Back then the pharma Glaxo, was providing a internet bulletin board for pharmacists… it was based at the St Louis College of Pharmacy.. somehow.. I was asked to be one of ELEVEN national moderators for this bulletin board.. and because of this, I was fairly active on this bulletin board.  One of the pharmacist at the St Louis College of Pharmacy was a “informational specialist”… so I was at the end of my resources trying to find out about this seemingly unknown reaction to this med that Barb had experienced.   She was able to locate a obscure article in a England Medical Journal from the 70’s that MENTIONED this side effect with this med.

Now back to where this post started, in Barb’s PGx report – which has three columns …. one column listing meds that she should normally metabolize, second column listing meds that she MAY HAVE metabolism problems with and a third column where meds  SHOULD NOT BE USED – based on the pt’s abnormal liver enzyme issues and the ONLY MED on the 70 pages there was ONE MED LISTED IN THE SHOULD NOT USE COLUMN… and it was this med that Barb had this obscure side effects that almost no literature listed it back in 1995.

Of course our DNA was not fully mapped until the early 2000’s and that is what all this pharmacogenomics testing is based on… but it clearly demonstrates how important this testing can be to some/many/all high acuity pts – sickest of the sick and taking a “boat load” of meds. Everyone needs to remember that what medical science knows about the human system is dwarfed by what it doesn’t know.

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When the first COVID-19 vaccines, came to market… two were made with a – what I considered – a process that was too new and too untested… that was the Pfizer & Moderna based on the mRNA process and the third one was being produced by J&J/Jansen using a process that we had used to make our flu vaccines for decades.  Our Congress passed a law that indemnified the pharmas from any law suits/liabilities of producing those vaccines. Over my 52 yr career, I can’t count all the “new meds” that came to market after 10+ yr of clinical trials only to see them pulled from the market from serious adverse events of people taking the meds, either with other meds the pt was taking and/or other comorbidity health issues the pt had.  I don’t ever remember Congress indemnified any pharma- against lawsuits – when they brought out a new med to market. To me, that was a red flag… and millions of doses being administered under a FDA “emergency use authorization”.  This article dated Aug, 2022, does now – does not recommend the J&J even as a booster – but we got both the initial J&J vaccination and as a booster and WE ARE STILL ALIVE…

There seems to be too much “fuzzy data” being published about the adverse events with these vaccines and they seem to LUMP all the vaccines together, when the J&J vaccine is an entirely different animal than the other two.

We always get our annual flu vaccine – during the optimum time frame – of the last of Sept thru the first couple of weeks in Oct.  Unless something that is published about the “new” COVID-19 vaccines and the only ones made available is made using the mRNA process..  I think that we are going to skip any more COVID-19 vaccines… there appears to be some very effective treatments for anyone testing positive for COVID-19. Everyone can make their own choice to take what seems like what is going to be multiple “jabs” per year in perpetuity.  To me that suggests that these mRNA vaccinations may only be providing a passive immunity that will typically last 60-90 days.

Before We Push the New Omicron Vaccine, Let’s See The Data

https://sensiblemed.substack.com/p/before-we-push-the-new-omicron-vaccine

The White House is pushing Americans hard to take a novel Covid vaccine before the studies are complete.

But where’s the data to support such a sweeping recommendation? The new mRNA vaccines expected to be authorized next month have no clinical trial results that are public. In fact, we know nothing about them. Urging the American people to blindly obey to take a novel mRNA vaccine is not only bad medicine, it’s bad policy. And it’s certainly not following the science.

We just saw this data ambush approach two months ago with the Covid vaccines for babies and toddlers. Here’s how the timeline played out. The White House and public health officials promised them and pushed them hard for children between the ages of 6-months and 5 years. Then vaccine manufacturers released data and declared them safe and effective (the media blindly parroted the message). Here’s the catch. The underlying data actually showed the study sample was too small to make safety conclusions, and most of the claimed effectiveness was statistically invalid. The Pfizer vaccine in babies and toddlers had no statistically significant efficacy. Moderna’s vaccine had an efficacy of just 4% in preventing asymptomatic children aged 6 months to 2 years. (Some European countries have restricted the use of Moderna’s vaccine for anyone under the age of 30 due to the risk of myocarditis). One frustrated CDC official told me the vaccines are so ineffective in young children it wouldn’t matter if you, “inject them with it or squirt it in their face.” Maybe that’s why after a month of pushing Covid vaccination for children under five, only 3% of them got the jab.

Supporters of pushing the new omicron vaccine might point to annual influenza vaccines that are blindly offered each year, but:

1) they use a traditional vaccine platform that has withstood the test of time. In contrast, the novel Covid vaccines have been associated with a serious adverse event rate of 1 in 5,000 doses according to a German study published three months ago by the Paul-Ehrilich Institut. While the National Institutes of health has dedicated over a billion dollars to study long-Covid (which has yielded nothing), its spent virtually no money to investigate Covid vaccine complications, like heart injury in young people.

2) There is currently no scientific consensus that a repeated Covid booster strategy is the right approach. Some scientists are concerned about what is called immune imprinting from multiple booster doses that can weaken the immune system. A recent article published in the journal Science noted a reduced immune response against the Omicron strain among people previously infected who then received three Covid vaccine doses compared to a control group that previously had Covid and did not have multiple shots.

3) The new Omicron vaccine, which is based on earlier Omicron strains, has been tested against newer Omicron strains currently in circulation—a distinct research advantage over studying flu shots. But the results have not been made public. Doesn’t the public have a right to know the results?

It may be that an omicron specific vaccine recommendation for the fall is warranted, but pushing it hard before the data is available makes a mockery of the scientific method and our regulatory process.  In fact, why have an FDA, if White house doctors feel that a new medication would likely benefit public health.

Despite the secrecy surrounding data on the new vaccine, Dr. Jha endorsed the new vaccine in his remarks.  “Based on everything we’ve seen so far, all the data suggests it should be highly effective against the new variants,” Jha said.  

Is that aspirational political talk or a scientific conclusion based on sound data? The distinction is critically important because the public has lost trust in health officials after watching them repeatedly make things up as they go and declare them as truths rather than hypotheses. We need public health leaders to show some humility, stick to the science, and be more transparent with data then they ever have been before. If Jha is following the science, we need to see the data.

Marty Makary MD, MPH is a professor at the Johns Hopkins School of Medicine, the Johns Hopkins Carey Business School, and author of the New York Times bestselling book The Price We Pay.

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When stores, like pharmacies, can’t stay open as promised, it’s time to shop elsewhere

https://www.blueridgemuse.com/node/64327

Often, Floyd’s CVS Pharmacy is closed, without notice, for days at a time . They’re not alone.

A lot of Floyd County residents found themselves without access to needed prescription medications because the pharmacy at CVS on Main Street in the town is closed for a third straight day, citing a failure to have a licensed pharmacist on the premises.

To make matters worse, those who need to save money with lower prices at the Dollar General store a few blocks north are closed as well. Unanticipated closures during normal business hours have become the norm at both stores.

An increasing number of county residents have shifted to The Pharm House, which stays open during its posted hours and provides needed prescriptions, often at better prices while honoring insurance discount cards.

Others tell us that they are now driving to Christiansburg at least once a week to obtain prescriptions at Walmart at better prices. The store is open, as is a CVS location and the pharmacy at Kroger.

“CVS is a pathetic, pitiful operation that leaves people in danger when they can’t provide needed prescriptions on time,” says one resident, who asked not to be identified. Calls to CVS’s headquarters for comment were not returned. Emails, too, were not answered.

The problem is not limited to pharmacists. Pharmacy technicians are quitting at CVS, Walgreens, Rite-Aid, and other locations around the nation, citing increased stress and an inability to keep up with an increasing backlog of prescriptions.

“It got to the point that it was just such an unsafe working environment, where you are being pulled a thousand different directions at any given time,” said technician Heidi Strehl, who worked for Rite-Aid in Pittsburgh for 16 years before quitting in disgust. “You’re far more likely to make a mistake and far less likely to catch it.”

Strehl told NBC News that low wages, few raises, and rude customers were just too much.

“I always thought I would retire from that place,” Strehl said. “But all of the parts of my job that I truly enjoyed over the years had slowly just gone away.”

She’s not alone. The more than 400,000 pharmacy technicians in America work in jobs with little training, even though they are working with serious medications where mistakes can threaten and cost lives Most are paid very little, get few if any raises and have meager benefits.

In Floyd, Dollar General is often closed early or sometimes even all day because of employee shortages, COVID-19, and other problems. Those trying to shop at Dollar General on North Main Street just outside the town limits found a hand-written sign on doors that were locked tight.

The retail chain is facing worker revolts throughout the country. One of Dollar General’s managers in Florida posted a series of Tik Toc videos

INC reports:

Employee hours were severely limited by the company, she said, leading to her or another employee often working alone in the store. Shipments arrived unexpectedly, and with no staff to unpack them, she was forced by company policy to leave boxes stacked up in the aisles, blocking the store shelves and leading to customer complaints.

Sound familiar? The aisles are often blocked in the Floyd Dollar General while some shelves are empty. A call to the company was not returned. Neither was an email request for comment.

Need a prescription or a loaf of bread? Best to call and see if the stores or pharmacy or other retail operation is open.

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