“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Almost all U.S. hospital websites are sending patient data to third-party companies such as Alphabet, Meta and Adobe, SC Media reported April 3.
The report cited an April 3 study published in Health Affairs in which researchers analyzed 6,162 U.S. hospital and health system websites, including 3,747 identified non-federal acute care hospitals with websites, and found that 98.6 percent of them sent sensitive health information to third parties.
Alphabet, the parent company of Google, received 98.5 percent of patient data transfers, followed by Meta which received 55.6 percent of all third-party transfers.
Adobe Systems also received 31.4 percent of third-party data transfers and AT&T received 24.6 percent of all data transfers.
The researchers also found that 69 percent of all U.S. hospital homepages transferred data to third parties.
U.S. hospital and health system homepages had a median of 16 third-party data transfers.
The transfers were the highest among medium-sized hospitals, nonprofit hospitals, urban hospitals and health system-affiliated hospitals.
This comes as 14 hospitals and health systems across the U.S. are facing lawsuits that allege that their websites have embedded pixel tracking tools that send patient information to Meta, Facebook and Google.
Now I understand how the DEA is able to state with a “straight face” that they don’t control/ration controlled meds and interfere with pt’s access in getting them. I have read a couple of comments about the Walgreen, CVS, Walmart lawsuit by 50 state AG’s , native American groups and others that those three chain pharmacy chains agreed to “reduce opioid Rx dispensed”. So here was have 50 state Attorney Generals, hiring law firms on a contingency basis – so that the states are not putting any tax payer monies at risk. If the win, the states get a windfall of money from the lawsuit as does the law firms involved. Whatever is contained in the final settlement, like reduce opioid Rx dispensing… the DEA can claim that they didn’t cause that. Just like the DEA & VA had no input in the CDC 2016 opioid dosing guidelines?
This could be the “final straw”, in proving that the major drug wholesalers and major chain drug stores are complicit in discriminating against a segment of the population (disabled) and are being intentionally denying medically necessary medication, which is most likely a civil rights violation under the Americans with Disability Act. Unless these settlements are “sealed” and not available for public view, it would appear that discriminating against disabled pts. Could the community need to sue whatever corporate executive(s) that signed the agreement. I suspect that each of those large corporations have something in their policies and procedure manuals that if an employee breaks/violates the law, the corporation is not responsible for their actions.
Xanax and Adderall Access Is Being Blocked by Secret Drug Limits
Patients diagnosed with conditions like anxiety and sleep disorders have become caught in the crosshairs of America’s opioid crisis, as secret policies mandated by a national opioid settlement have turned filling legitimate prescriptions into a major headache.
In July, limits went into effect that flag and sometimes block pharmacies’ orders of controlled substances such as Adderall and Xanax when they exceed a certain threshold. The requirement stems from a 2021 settlement with the US’s three largest drug distributors — AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. But pharmacists said it curtails their ability to fill prescriptions for many different types of controlled substances — not just opioids.
Independent pharmacists said the rules force them come up with creative workarounds. Sometimes, they must send patients on frustrating journeys to find pharmacies that haven’t yet exceeded their caps in order to buy prescribed medicines.
“I understand the intention of this policy is to have control of controlled substances so they don’t get abused, but it’s not working,” said Richard Glotzer, an independent pharmacist in Millwood, New York. “There’s no reason I should be cut off from ordering these products to dispense to my legitimate patients that need it.”
It’s unclear how the thresholds are impacting major chain pharmacies. CVS Health Corp. didn’t provide comment. A spokesperson for Walgreens Boots Alliance Inc. said its pharmacists “work to resolve any specific issues when possible, in coordination with our distributors.”
Secret Limits
The “suspicious order” terminology is a bit of a misnomer, pharmacists said. The orders themselves aren’t suspicious, it’s just that the pharmacy has exceeded its limit for a specific drug over a certain time period. Any order that puts the pharmacy over its limit can be stopped. As a result, patients with legitimate prescriptions get caught up in the dragnet.
Adding to the confusion, the limits themselves are secret. Drug wholesalers are barred by the settlement agreement from telling pharmacists what the thresholds are, how they’re determined or when the pharmacy is getting close to hitting them.
The exact limit for each pharmacy is kept secret in order to prevent pharmacists from gaming the system, according to Krista Tongring, leader of the DEA compliance practice at Guidepost Solutions and a former agency attorney.
The purpose, she said, is to keep pharmacies from manipulating “their ordering patterns so as to get around the thresholds.”
Caught In a Dragnet
The settlement agreement, which is public, lays out general guidelines. A Cardinal Health document reviewed by Bloomberg News says that limits are calculated on a daily, monthly, and quarterly basis. But without more detailed information, it’s impossible for pharmacists to predict when they are going to have to turn patients away.
“You don’t know what you’re going to get” when you place an order, Glotzer said. “It’s no way to do business, let’s put it that way.”
Glotzer said that he’s had trouble getting all attention-deficit/hyperactivity disorder medications including Concerta and Ritalin. Supply chain issues had already created scarcity of the drugs. Adding on to those troubles, Glotzer can’t order them even when they are in stock from one of his wholesalers, Cardinal. In February, they only sent him 100 pills because he hit his threshold, compared to about 3,700 the month before, he said. They hadn’t shipped any more by March 23, he said. He was able to get some from McKesson, but not nearly enough for all of his patients, he said.
Benjamin Jolley, an independent pharmacist in Salt Lake City, said that Cardinal stopped shipping him any controlled substances in November after the pharmacy hit its limit for fentanyl lozenges, prompting a review. So he had to turn away hundreds of patients who had prescriptions for medicines to treat ADHD, chronic pain, cancer pain and other diseases.
An ‘Ethical Tightrope’
Cardinal’s move indicated they had decided “we’re going to make this someone else’s problem,” Jolley said. “We’re going to make your patients go to other pharmacies that buy from McKesson or AmerisourceBergen and therefore it will be their problem now, and not our problem of looking bad to the DEA or the various states we signed the agreement with.”
Cardinal said in a statement that the thresholds “have caused some supply challenges” and that the company works “with each customer individually to resolve any issues with their orders.” A spokesperson for AmerisourceBergen said that distributors like the company “have been asked to walk a legal and ethical tightrope” between making medicines available and limiting diversion, and that they need more guidance from regulators. McKesson didn’t respond to requests for comment.
Pharmacies can request increases to their thresholds, but those take time to adjudicate, leaving patients scrambling to find their daily medicines elsewhere in the meantime.
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Wholesalers have always been required to identify suspicious orders from pharmacies as part of the government’s regulation of controlled substances. Federal laws and rules, enforced by the DEA, mandate that wholesalers report suspicious orders to the agency. But lawsuits alleged that the wholesalers flooded the market with pills, contributing to an addiction epidemic that has killed more than half a million people since 1999.
As a result of the settlement, distributors “updated and improved” their systems for monitoring orders, said Pete Weinberger, plaintiffs’ liaison counsel in the national opioid lawsuit. AmerisourceBergen has said publicly that the policy changes would result in more cancelled orders. Cardinal has said similarly in literature distributed to pharmacists.
Some pharmacists are finding creative solutions. Matt Weisser, an independent pharmacist near Seattle, said he sometimes buys a smaller quantity of double-strength pain pills for his patients to cut in half. He also worked with a patient’s doctor to time a prescription so it was due to be filled after the monthly limit resets.
“We’ve had to figure out clever strategies in order for us to order the product,” Weisser said.
(Adds Walgreens comment in sixth paragraph. An earlier version corrected the 16th paragraph to reflect McKesson didn’t comment.)
Aspirin, the first nonsteroidal anti-inflammatory drug or NSAID, was developed in 1897. It was not until the 1950s that non-aspirin NSAIDs became available and forever changed the treatment of pain.
As a class of drugs, NSAIDs can reduce pain, fever, and inflammation, leading some to view them as miracle drugs. Yet, from the start, their use has raised safety concerns. Specifically, NSAIDs reduce the production of prostaglandins by inhibiting cyclo-oxygenase (COX) enzymes. COX-1 inhibitors have the unfortunate effect of lowering the production of the prostaglandin that protects the lining of the GI tract, which can lead to gastrointestinal problems. COX-2 inhibitors, also known as coxibs, get around this problem because they do not interfere with the production of prostaglandin that protects the stomach. However, all NSAIDS increase the risk of a wide range of cardiovascular events, including heart attack, stroke, and other cardiovascular woes.
Nonetheless, NSAIDs, available over the counter and by prescription, are among the most commonly used medications in the world. Their high level of use is, in part, because they are especially useful as alternatives to opioids as treatments for chronic pain, particularly pain with underlying inflammation. However, using them in clinical practice requires a thoughtful and cautious approach. Balancing the benefit versus the risk of treatment is always a consideration.
RISKS BENEFITS
NSAID Risks and Benefits
“Every therapeutic decision we make in medicine has benefits and risks,” said Kevin Byram, MD, assistant professor of medicine in the division of rheumatology and immunology and associate director of the rheumatology training program at the Vanderbilt University Medical Center. “The decision not to use an NSAID has risks and benefits, too,” he said. Among the risks of eschewing NSAIDs is, of course, the need for opioids in their place. However, Dr. Byram points out other risks as well. For example, the patient might not be as mobile, and that could cause them to lose the cardio-protective effects of exercise. All of this makes the use of NSAIDs complex and, at times, confusing.
Drawing on decades of research on NSAIDs, a team of researchers from the University of Michigan and the Cleveland Clinic examined the history of this class of drugs, their risks and benefits, and offered suggestions to clinicians for prescribing these drugs to treat pain and inflammation. Their recommendations were published this February in Rheumatic Disease Clinics.¹
RECOMMENDATIONS
Research Recommendations for NSAID Use
The research team’s findings suggest that all NSAIDs pose an increased risk of adverse cardiovascular events, a fact many clinicians are not aware of, said Deeba Minhas, MD, a rheumatologist and assistant professor of medicine at the Institute for Healthcare Policy and Innovation at the University of Michigan and first author on the study. She added that nuances in side effects based on COX profiles remain widely understood.
“Because we do not know ahead of time how patients may respond to NSAIDs,” the reviewers wrote, “it may be important to monitor patients closely after initiating an NSAID.” For example, they suggested monitoring blood pressure and asking about symptoms after 1 week of use. At 2 to 4 weeks, they recommended checking blood work for potential side effects and adjusting the dose if necessary. They also pointed out that emerging factors, such as biomarkers of COX inhibition, could aid clinicians in selecting the appropriate NSAID and its proper dose for a given patient.
Other recommendations included:
using the lowest possible dose for the shortest possible time
engaging in shared decision-making with patients when making the risk-benefit calculation
creating a pain toolkit for patients that includes non-pharmacologic therapies such as TENS, physical therapy, occupational therapy, myofascial release, and mindfulness.
They also suggested asking the patient to keep a pain- and side-effect diary, or the equivalent app, and reviewing this at routine follow-up visits.
Regarding specific drug choices, Minhas et al suggested starting with ibuprofen plus a proton pump inhibitor (PPI) or naproxen plus PPI. Celecoxib might be a good alternative, although they advised against doses higher than 200 mg or twice daily regimens. In individuals taking aspirin, they recommended either naproxen plus PPI, taken two hours after the aspirin, or 200 mg of celecoxib plus PPI.
Additionally, they recommended that diclofenac be avoided in patients with cardiovascular risk factors. “Overall, it does not seem that there is a benefit to using diclofenac, though I think it is still highly prescribed,” said Dr. Minhas.
Thanks to pressure from lawmakers, government agencies and policymakers who inserted themselves into the patient-doctor relationship, patients became the victims of the never-ending war on drugs.
A decade ago, most people thought of Tylenol (acetaminophen) as a medicine for fever, malaise and minor aches and pains. Nobody imagined that it would become the go-to drug for treating moderate, let alone severe, postoperative pain.
But this is just what has happened. Thanks to pressure from lawmakers, government agencies and policymakers who inserted themselves into the patient-doctor relationship, patients became the victims of the never-ending war on drugs.
Now, doctors frequently offer only acetaminophen to treat painful conditions despite the drug’s inability to remedy them.
Lawmakers believed they had to do something about the opioid overdose crisis, which has grown exponentially since the 1970s. The crisis was driven by a growing population of nonmedical drug users accessing drugs from the black market.
But what’s really fueling overdose deaths is drug prohibition and the dangerous black market that it creates. The Centers for Disease Control and Prevention got into the act by guiding doctors in treating pain, an area not in the agency’s wheelhouse.
The evidence clearly shows that acetaminophen alone is a poor choice for treating most types of pain. Multiple literature reviews show that the drug has limited analgesic utility. Several Cochrane systematic reviews, which are highly regarded, evidence-based analyses that carefully evaluate the quality of data in numerous studies, have questioned its ability to relieve pain caused by a variety of conditions. With few exceptions, it fails miserably.
For example, studies reveal that acetaminophen effectively reduces fever in children. But, while the drug is frequently recommended for headache pain, its efficacy is mostly imaginary. A 2016 Cochrane review examined 23 studies, including more than 8,000 people with tension headaches. While 59% of the participants experienced relief within two hours, so did 49% of the group that received a placebo.
A 2013 Cochrane review found the drug inferior to ibuprofen for reducing dental pain at all doses studied.
Perhaps most telling is a 2021 review that included 36 systematic studies of 44 painful conditions. It concluded that acetaminophen provided modest pain relief for one of them, osteoarthritis of the hip and knee. There was no sound evidence of the drug’s ability to treat any other painful condition.
The government promulgates an erroneous fear of opioids that makes patients often endure agonizing postoperative pain they never would have experienced a decade ago, a violation of basic medical standards.
The treatment and management of acute and chronic pain involve the same nuanced medical decision-making as treating hypertension, diabetes, infectious diseases and psychiatric disorders. Just as it is wrong for the government to dictate how doctors treat those conditions, it should butt out when doctors treat pain.
Doctors take an oath to ease suffering and do no harm. Government meddling is causing doctors to violate their professional credo.
Dr. Jeffrey A. Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute. Josh Bloom is director of chemical and pharmaceutical science at the American Council on Science and Health.
Every day should be Mom and Pop Business Owner’s Day
Dear Colleague,
The term “mom and pop” business had always bothered me. I thought it sounded a bit condescending and dismissive when I would hear representatives from big businesses talk about it, almost like they were giving small business owners a little pat on the head. But Wednesday was “Mom and Pop Business Owner’s Day,” and my attitude about the phrase evolved during a week in D.C. when independent pharmacies were in the spotlight.
The Hill is an inside-the-beltway media company, widely read by congressional staff and agency staff members. I was invited to be on a panel with a representative from Astellas, the National Minority Quality Forum, and PCMA. You can watch the panel discussion here on The Hill’s website.
One of the questions I was asked was:
What do you hear from patients coming to the pharmacy counter that Washington should hear more?
Washington should hear that it’s a very stressful experience because when that prescription is written by their prescriber, they’re not sure what their experience is going to be for that medication. Will their insurance plan allow them to use the drug? Will their insurance plan try to steer them into one of the health insurer’s affiliated pharmacies as PBMs have now acquired pharmacies? Patients wind up being unsure how they are going to get their medication and some, finally, just give up.
In addition to The Hill event, the Senate held another hearing on PBMs. This one, by the powerful Senate Finance Committee, was titled, “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers.” NCPA submitted comments (watch the hearing here).
The House Energy and Commerce Health Subcommittee had a hearing titled, “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care,” that once again put the PBMs under the microscope (watch the hearing here).
That brings me back to one of the last questions I was asked on The Hill panel:
What do you want to see from this Congress?
We need to see action from Congress. Some have said this is the year of the PBMs and there is a Senate hearing going on right now and a House hearing a couple of days ago. But all of this talk has to be converted into action. For example, in President Biden’s State of the Union address he talked about high drug prices, but he didn’t mention PBMs or health insurance companies. I don’t know how he can talk about reining in high drug prices and not mention reforms to PBMs and insurance companies. We need Congress to lower drug costs to patients, protect taxpayers, stimulate competition, and protect small business owners.
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There are roughly 20,000 mom and pop pharmacies across the country. As the term suggests, they are family businesses. Often, they’re run by multiple generations of the same family. Unlike the reptilian insurance companies and PBM arm-twisters, mom and pop pharmacies aren’t run for the benefit of fund managers and jet-setting executives. They’re run only for the benefit of their communities. That’s why they matter. It’s what makes them indispensable. Every day should be Mom and Pop Business Owner’s Day.
Then, when it comes to the future of work, the integration of virtual office services into business operations emerges as a forward-thinking strategy. Adopting a virtual business address and associated services can dramatically enhance a company’s flexibility and scalability. It’s a move that aligns with the evolving expectations of both clients and employees, emphasizing the importance of adaptability in today’s dynamic business landscape.
Then while exploring various tools to enhance productivity, I stumbled upon an effective solution in report generator software. The ease of use and the depth of customization available were truly impressive. Utilizing this comprehensive report generator software to streamline data analysis and reporting has been a game-changer for my team. It simplified complex data sets into understandable reports, saving hours of manual work.
Then understanding the local business environment is critical when looking to purchase a business. This was where my collaboration with Truforte Business Group proved to be invaluable. They had a profound understanding of the Fort Myers market, offering tailored advice that suited my specific needs and goals. Their approach was thorough, covering every aspect from valuation to final negotiations.
I have read where 5% of pts that get ESI ( Epidural Spinal Injections) will end up with arachnoiditishttps://en.wikipedia.org/wiki/Arachnoiditis.. it is very painful – irreversible disease – These type of ESI are ILLEGAL in just a few countries, but our FDA and Pfizer that makes the most used med in these injections – DO NOT RECOMMEND this med to be used in ESI – apparently our FDA has neither the chutzpah nor cojones to ban these dangerous procedures
After the DEA loosen what could be done via tele-video office visits….below are hyperlinks of two of the major players – there were also many more – in tele-video office for diagnosing and prescribing controlled substances – especially ADD/ADHD meds without the pt being seeing for an in person exam – as required by the Controlled Substance Act.
Prescriptions for Stimulants Jumped During the Pandemic
Data might signal improved adult ADHD awareness, but questions remain about pandemic prescribing
Prescriptions for stimulants have risen in recent years, with the sharpest increases seen during the pandemic, according to the CDC.
In an analysis of claims from employer-sponsored insurance, the percentage of enrollees with one or more prescription stimulant fills rose from 3.6% in 2016 to 4.1% in 2021, Melissa Danielson, MSPH, of the CDC, and colleagues reported in Morbidity & Mortality Weekly Reportopens in a new tab or window (MMWR).
The largest single-year increases were seen during 2020-2021, with the annual percentage change exceeding 10% in many groups, Danielson and colleagues reported.
“Although improved access to ADHD care through telehealth during the pandemic might have benefitted some persons with ADHD symptoms, it might have also introduced the potential for inadequate ADHD evaluations and inappropriate stimulant prescribing,” the researchers wrote.
Using employee-sponsored insurance claims from the MarketScan database, Danielson and colleagues found that across all years, prescription stimulant fill rates remained stable or decreased among females ages 24 and under and rose modestly among those ages 25-64. However, during 2020-2021, prescription stimulant fills rose substantially among women in most age groups, with the largest annual percentage changes seen among those ages 15-44 and 50-54, ranging from 14.3% to 19.2%.
For males, the pattern was similar, decreasing slightly among those age 24 and under and remaining stable or increasing modestly among those ages 25 and up. But during 2020-2021, prescription stimulant fills rose substantially among those ages 25-44 and 50-54, with annual percentage changes ranging from 11.1% to 14.7%, the researchers reported.
Danielson and colleagues wrote that there are a host of factors at play regarding the uptick in prescription stimulants in 2020-2021. The pandemic had negative effects on mental health, which might have exacerbated ADHD symptoms. Changes in healthcare policy and reimbursement, including expansion of telehealth and easing requirements around in-person visits prior to prescribing stimulants and other schedule II substances might have also played a role, they said.
ADHD among adults has also been increasingly recognized over the years, Danielson and colleagues wrote. Most people in the study with one or more prescriptions for stimulants met the case definition for the receipt of ADHD care in the preceding or current calendar year, suggesting most were receiving ongoing care for ADHD, they noted.
Thus, the study calls attention to the need for clinical practice guidelines for ADHD in adults, they said. While guidance exists for treating children and adolescents, adult ADHD is a public health concern because of “challenges associated with the differential diagnosis of ADHD and general inadequate access to mental health providers trained to diagnose and manage” the condition in adults.
In an editorialopens in a new tab or window published in the Journal of Attention Disorders in conjunction with the MMWR report, Margaret Sibley, PhD, of the University of Washington in Seattle, and colleagues called attention to a lack of knowledge and support for research on adult ADHD.
The NIH RePORTER funding databaseopens in a new tab or window lists just under $5.5 million in active funding for adult ADHD research, whereas it lists over $42 million in pediatric ADHD research and at least 10-fold greater support for depression research compared with ADHD research overall, “despite only slightly higher population prevalence of depression,” they wrote.
“ADHD needs to now take its rightful and more central place in adult mental healthcare,” Sibley and colleagues wrote.
At the same time, they acknowledged that, during the pandemic, digital startups “recognized a mounting demand for adult ADHD treatment” and companies capitalized on relaxed regulations.
“Did these companies drive 2021’s spike in stimulant fills and subsequent 2022 stimulant shortage?” they wrote. “Start-ups may have shouldered an urgent need for adult ADHD care during the pandemic. However, their purported methods (widespread online advertising, quick assessments, and one-size-fits-all prescription of stimulants) may have oversupplied stimulants to U.S. adults.”
The study included several important limitations, including the fact that it might not be generalizable outside of people with employer-sponsored insurance; it did not include extensive demographic information; it didn’t capture stimulants procured through other means; and it couldn’t discern whether stimulants were prescribed for conditions other than ADHD.
Some Mexican pharmacies that cater to U.S. tourists are selling medications that appear safe but are laced with deadly fentanyl and methamphetamine.
That’s the conclusion of new research that examined medications purchased legally in four cities in northern Mexico where travelers from the U.S. often seek low-cost health care and pharmaceuticals.
“For pills sold as oxycodone, we tested 27 and found 10 or 11 of them contained either fentanyl or heroin,” said Chelsea Shover, a researcher at the UCLA School of Medicine.
She said the behavior by retail pharmacies in Mexico puts unsuspecting people at high risk of overdose and death.
“When I see there are fentanyl pills somewhere that look like [prescription drugs], I know there have to have been people who’ve died from that,” Shover said.
Her team also found medications sold at Mexican pharmacies laced with methamphetamines.
While these drug stores sell medications to Mexican consumers, Shover says their main customers appear to be Americans.
“Similar products are available at a much lower price in Mexico, so Americans do travel to save money.”
“We should be absolutely very concerned,” said Rep. David Trone (D-Md.), one of the authors of the letter. “We have almost 12 million Americans visiting Mexico every year.”
According to Trone, pharmacies boosting profits with the high-risk practice are located in communities where Americans travel seeking relief from high-cost prescription medications sold in the U.S.
“There’s literally a pharmacy on every corner, they’re everywhere down there, because the price of drugs is cheaper.”
On Saturday, the Los Angeles Times reported State Department officials apparently knew about the danger posed by Mexican pharmacies as long ago as 2019 but failed to issue a high-profile alert to travelers.
According to the newspaper’s investigation, at least one U.S. traveler is known to have overdosed and died after taking medications purchased at a drug store in Cabo San Lucas, Mexico, in 2019.
Rep. Trone said if U.S. officials knew about unsafe medications being sold at legal outlets in Mexico, they should have warned travelers sooner.
“We’ve heard nothing back [from the State Department] and it’s very frustrating,” he added.
The State Department sent a statement to NPR saying it wouldn’t comment on the letter from lawmakers.
Many of the devices for knees, ankles, and hips — which were manufactured by Exactech from 2004 to August 2021, and recalled in 2021 and 2022 — were packaged in bags that were missing one of the oxygen barrier layers that protect devices from oxidation, which can degrade the plastic component before it’s transplanted into the patient.
Proper packaging features multiple oxygen barrier layers to protect the device from air, the agency noted in their safety communication.
Oxidation of this polyethylene component may cause a slew of issues for patients, such as pain, bone loss, component fracture, device failure, premature device wear, or swelling of the area, all of which may result in the need for revisional surgery.
Exactech first recalled only certain hip replacement devices due to premature wear without a known cause. This was labeled as a Class II recall — the second most serious grade indicates that the “product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.”
By February 2022, the manufacturer expanded a voluntary recall for certain knee replacements and total ankle replacements packaged in the defective bags, regardless of the device’s label or shelf life. An estimated 80% of knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.
Later that year, the company expanded its hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags.
“The FDA is working with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks,” the agency said.
The FDA recommended that no future implant surgeries be performed with any of the recalled knee, ankle, and hip devices. The agency also advised that healthcare providers monitor patients who have any of these implanted devices for possible wear, failure, and resulting bone loss. If there is a device failure suspected, providers should consider performing x-rays.
For patients who are experiencing pain, revisional surgery should be discussed on a case-by-case basis. That being said, it’s currently not recommended that joint replacement devices be removed from patients who aren’t having any new or worsening pain.
Patients are recommended to contact their healthcare providers about any pain, swelling, weakness, grinding, noise, or inability to bear weight on the device.
The term “mom and pop” business had always bothered me. I thought it sounded a bit condescending and dismissive when I would hear representatives from big businesses talk about it, almost like they were giving small business owners a little pat on the head. But Wednesday was “Mom and Pop Business Owner’s Day,” and my attitude about the phrase evolved during a week in D.C. when independent pharmacies were in the spotlight.