Uneven Availability of High Dose Flu-Fighting Vaccines For Older Folks Poses a Quandry: Wait or Not? Ask a Doc

There was line of customers at the Giant Pharmacy in Maryland and when the 67-year-old asked for the “high dose” flu shot specifically for the older age group, he got a polite reply, with a smile: “Sorry we’re not going to have that for a week or two. Check back.”

For people seeking the higher dose vaccine specifically for people aged 65 or older, pharmacies may not have it available in all cases because of what pharmacists are calling delays from vaccine manufacturers. The higher dose contains four times as much flu virus antigen as other vaccines and is designed to strenghten an older person’s immune system in the face of the flu, according to the Mayo Clinic.

“Due to a manufacturer delay of senior dose flu vaccine this season, some CVS Pharmacy locations have a limited supply,” CVS spokeswoman Christine K. Cramer told HealthDataBuzz today. “We are working with suppliers to get additional doses of senior dose vaccine to our stores as soon as possible.”

Other news outlets across the country also have reported sporatic vaccine shortages for older people not only at CVS, but other pharmacies as well, including Walgreens and Payless.

Because of the shortages, senior patients are “encouraged to call their local pharmacy in advance to confirm availability,” Cramer said.

The flu shot is definitely a life saver, according to the Centers for Disease Control and Prevention.

Its Mortality and Morbidity Weekly Report notes vaccinations in the long “influenza season” in 2017-2018 is estimated to have prevented 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations and 8,000 deaths. That’s despite the fact the overall vaccine effectiveness was registered at 38 percent.

For some seniors, they may be confused what they should do. While the “regular” flu shot – the quadrivalent QIV) – is, as Cramer said, “widely available across all of our pharmacies” it’s obvious the vaccine specifically for seniors is not.

Although the special vaccination has been marketed for seniors, Cramer noted that the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices “has not expressed a preference for any specific flu vaccine indicated for people 65 and older.”

“CDC recommends a flu vaccination as the first and most important step in protecting against the flu and there is no preferential recommendation made for any flu vaccine formulation for this age group,” she added.

While seniors definitely should get a flu shot, they may feel in a quandry if they are in an area where there are shortages: should I wait for the more “powerful” vaccine, if you will, even if it takes another week or so, or not take a chance, and take a flu shot now?

The CDC didn’t respond to my question yet. Cramer quickly did.

“We’d recommend they talk to their physician,” she said.

Then again, in its study the CDC talks about when people should get the vaccine.

“Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that immunity might wane over the course of a season, it is recommended that vaccination should be offered by the end of October.” — Joe Cantlupe, HealthDataBuzz


— Joe Cantlupe, HealthDataBuzz

When You Dreamed of Baseball and the World Series Was Always in New York

When you are a little kid in northern New Jersey in the early 1960s, there was a baseball team on your mind. You think about the players as you grab your glove and go into a wind-up and lob what you think are fastballs onto a brick wall and run around to catch the grounders that come back. You play with your friends at the nearby park. You get up to bat and you feel like you have the smoothest stroke in the world, because, of course, in your mind, it’s exactly like one of your heroes.

The New York Yankees, a colossal team of superstars, win the World Series in 1961, and 1962, and those years are vivid to you. They also won a string in the 1950s, 1940s, 1930s, and 1920s. Your battered baseball cards tell the stories of those old games you never got to see. In 1961, Roger Maris’s 61 home runs that break Babe Ruth’s season record (with asterisk ), which in your mind was ancient history. You get to see on the black and white TV Maris’s smooth swing, and Mickey Mantle’s steady power. With glove in hand, I was at the Stadium for one game, and saw Mantle hit a shot that hit the center field wall 461 feet from home plate.

Depending on the day, you get up to bat in a Little League game and one day you are Roger. Another day you are the Mick. And when you go into your wind up as a pitcher, you are maybe Whitey Ford. You catch with some old mitt and you are Yogi Berra or Elston Howard. You pinch-hit with that loopy swing and you are Hector Lopez.

When you are a little kid, each year is so long. It was 1960, and no baseball memories before that. Suddenly, it just blossomed before you. You stopped at the grocery store on the way home from school and someone wrote each game’s score on a glass board. It was Game 7. The Yankees power ahead. The Pirates come back. The game is only a few innings from being completed. The Yanks emerge. You are almost giggly as you turn on the Zenith TV. Wait, something is wrong. The picture is clear. It’s Yogi Berra racing toward the grass-covered fence in left field, and the ball is clearing the wall at Forbes Field in Pittsburgh. Oh no. You can’t believe it. A guy named Bill Mazeroski of the Pirates just smashed a home-run, and is circling the bases and crowds reach in to touch him as he circles third and heads for home, as if he just won a war. He did, in a way.

In 1963, there is normalcy, one thinks in the summer of baseball, months before the death of a president.

A loss: what’s that?

That year, the Yankees steamrolled through the American League, and one figured there would be no heartbreak like 1960. After all, they were two-time repeat World Champions, and just one more team to beat, the Los Angeles Dodgers.

If you were lucky, as a kid, there was something new to watching the World Series on TV. It was in vibrant, amazing colors. The splash of the constant sun in California. The bleached white home uniforms of the Yankees and Dodgers.

Once again as the World Series started, the Yankees were powerful, the only description for them when you are 11 years old. The team had just finished with a record of 104-57, winning another ho-hum pennant.

When you are a young fan, you didn’t think much about injuries, but yes they did happen. I knew Mantle had hurt himself years earlier on a drain in center field at Yankee Stadium. Maris had wrist problems. There were no statistics to speak of, at least from the newspaper sports pages besides batting averages, home runs, and runs batted in. Not like the metrics of today.

Coping with injuries: Yes, that’s been the badge of honor for this 2019 Yankees team, a monster group of sluggers reminiscent of the Yankees of old.

It seemed week after week, some key component of this Yankee team went down, only to be reinforced by a young player you never heard of doing amazing feats. And then that player went down only to be replaced by another.

“Yes, the Yankees have been resilient. They’re also hungry. They want it more than anybody else that’s walking on this planet, said The Athletic. 

The story added: “The 2019 Yankees will be remembered as a squad that was resilient and focused in the face of adversity that refuses to let them out of its injurious maw from spring training right up until the final day of the regular season.”

“Powered to 103 wins by depth and skillful managing, the Yankees learned throughout the season a lesson that will serve them ell as they prepare to head into another October gauntlet.”

Those words were written Oct. 3.

Before last night, though, the Yankees seemed in disarray, a team that couldn’t hit or field, and were on the brink of elimination by the Houston Astros, 3 games to one.

As the Yankees warmed up, it was hard not to have visions of being a kid in 1963, thinking of the Bronx Bombers’ powerful lineup. And then running into the swooping curveballs of Sandy Koufax, and Don Drysdale’s fastballs. And more pitching. And more pitching. The Dodgers swept them 4-0.

The Houston Astros have a couple of incredible arms, future Hall of Famer (maybe) Justin Verlander and (maybe) future Cy Young Award winner Gerrit Cole.

Well, Verlander allowed four runs in one inning, almost unheard of.

And it was a guy who was sitting at home for months, injured, who instantly turned it around for the Yankees. Center fielder Aaron Hicks’ shot went high into the night and hit the right field yellow foul pole, bringing in three runs. Suddenly the Yankees were up 4-1 in the first inning and that made all the difference.

Last month, it looked certain that Hicks wouldn’t be back for the remainder of the season because of a flexor strain. It was also thought he might need Tommy John surgery.

Hicks didn’t. He underwent successful rehab. He came back and made the difference.

So the baseball drama continued at least another day. And for the Yankees, the World Series is not always something you can count on like the Mickey Mantle days. In fact, the Yankees haven’t been in a World Series since winning in 2009.

“Yankees fans between 10 and 110 years old are one defeat away from experiencing something for the first time: living through an entire decade without seeing their time: living through an entire decade without seeing their team win an American League pennant,” according to Newsday.  

And that defeat came. After the Yankees came back to tie the Astros 4-4, Houston’s Jose Altuve dramatically hit a two-run walk-off homer tonight to knock off New York, and head to the World Series.

Decades later, haunted just like Mazeroski’s blast those many years ago.

Worrisome antimicrobial resistance

from my story at Leader’s Edge Magazine

Several years ago, Aetna uncovered a major problem among more than 1,000 doctors in its network

The large insurance carrier referred to the physicians by a nickname that summed up the problem in a single word: “superprescribers.”

Tapping into its data, Aetna found that nearly 1,500 doctors inappropriately prescribed antibiotics for bronchitis at least half the time. Aetna repeatedly warned doctors not to prescribe antibiotics, which target bacterial infections, to combat bronchitis, a viral infection. In other words, the medicine was useless against the infection. Despite those admonitions, Aetna says at least 432 doctors continued to prescribe the wrong drugs.

Too often, says Dr. Dan Knecht, Aetna’s vice president for clinical strategy and policy, “it’s easier for physicians to prescribe antibiotics.” When antibiotics are overprescribed, however, they might not be effective against infections or illnesses they once easily overmatched.

Around the world, bacteria are fighting back and winning against antibiotics. The occurrence of antimicrobial resistance, or AMR—bacteria that are resistant to multiple antibiotics—is growing. That growth has been spurred by the overuse—and improper use—of antibiotics, which has enabled bacteria to build defenses against them. The result is drug-resistant infections in both animals and people.

At least two million Americans contract antimicrobial resistant infections each year, and 23,000 of those people die, according to the Centers for Disease Control and Prevention. Drug-resistant infections are said to account for 700,000 deaths annually and are projected to cause 10 million deaths by 2050 and cumulatively result in trillions of dollars in losses.

“It has become one of the great global public health challenges of the century,” says Dr. Joan Butterton, associate vice president and senior director in the Department of Clinical Pharmacology at Merck Research Laboratories. “The bacteria are smarter than we are.” Merck touts itself as one of the few large pharmaceutical companies in the country to be developing new antibiotics. It has helped initiate the Study for Monitoring Antimicrobial Resistance Trends (SMART), a large AMR surveillance study involving 63 countries that is identifying resistance patterns.

The antimicrobial resistance risk has cascaded across the population landscape. And business is far from immune.

“I believe that AMR/AMU [antimicrobial resistance/antimicrobial use] is a business risk that can have strategic, financial, physical, operational and reputational losses associated with it,” says Melissa Hersh, a Washington, D.C.-based risk analyst and consultant. She and other experts believe the threats posed by AMR are dangerous enough to be considered in the same breath as cyber threats.

“I would say it’s high up on the list of corporate concerns,” says Joan Buckle, a principal and consulting actuary in London for Seattle-based Milliman, an international actuarial and consulting firm. “It’s probably not high yet on the list of public concerns. It’s reasonable that big global insurers are informing their clients, but I don’t know how far down the chain it is. If it’s a local entity or national, it’s not on the agenda yet.”It has become one of the great global public health challenges of the century. The bacteria are smarter than we are.DR. JOAN BUTTERTON, ASSOCIATE VP AND SENIOR DIRECTOR, DEPARTMENT OF CLINICAL PHARMACOLOGY, MERCK RESEARCH LABORATORIES

As insurers purchase reinsurance to mitigate risk, AMR is a strategic focus, according to Yommy Chiu, vice president for life and health R&D for Zurich-based Swiss Re. Within the past year, the company held a forum about the impact of AMR. “Insurers across different product lines are at risk of being exposed to greater losses because of increasing AMR,” Chiu says. “They are starting to understand what an increased risk of AMR means for them. For example, what if you’re in the livestock business and the antibiotics you are reliant on to keep your livestock healthy become no longer effective? Or what if, in the health setting, a patient develops AMR to a treatment and therefore incurs higher medical costs because of that?”

“Risk issues—agricultural biosecurity, including antimicrobial resistance, and cyber and information risk—are seemingly unrelated at face value but are juggernauts that provide an opportunity for the insurance industry to pivot towards agility and resilience,” Hersh says. “While insurance is typically reactive versus proactive in its constitution, there is a need and opportunity for this industry to reevaluate its stance with respect to risk prevention and mitigation.”INSURANCE-LIKE MODEL

The lack of financial incentives associated with developing novel antibiotics has resulted in limited innovation in the space revolving around antimicrobial resistance, though it is critically needed, says Joan Buckle, a principal and consulting actuary for Milliman.

Milliman has issued a paper based on a study by Buckle indicating the principles of insurance may be applied to structure reimbursement models for novel antibiotics and ultimately stimulate innovation while offering financial protection to drug manufacturers.

One scenario discussed with Leader’s Edge involves the drug manufacturer in an insurer-like role and a health system (or other entity wanting access to novel antibiotics) in the policyholder role. The two would enter into a contract that would require the policyholder to make predetermined payments to the manufacturer to develop new antibiotics. The payments would be based on expected utilization of the drug and cost of resistance. Importantly, the guaranteed income is not based on volumes sold, Buckle says, thus removing a monetary incentive to flood the market with the drug, which leads to overprescribing.

Under this scenario, claims are the amount of the new antibiotic released into the market. The less antibiotic released (i.e., the lower the claims), the better it is for the manufacturer (the insurer), as they are protected from underutilization by the premium payment. The higher the claims (more antibiotic released into the market), the more risk the insurer (manufacturer) must absorb. Guidelines could also be put in place to prevent a manufacturer from withholding the drug inappropriately.

The policyholder thus incentivizes new antibiotic development and gains some control over the amount released into the market.

Government Response

How can insurers engage proactively in addressing AMR risk? Government organizations and advocacy groups that are pushing for antimicrobial stewardship programs to limit the use of antibiotics believe insurers can play a key role in tracking the use of medications and providing data to providers in efforts to roll back usage.

In a statement to Leader’s Edge, the Food and Drug Administration said it’s in discussion with other federal agencies, including the Centers for Medicare & Medicaid Services, to “explore the means for reimbursement of certain new antibacterial drugs that meet critical patient and public health needs.”

“Insurers are definitely among the stakeholders who are an important part of our plan for combating antibiotic resistance,” the agency said. “We think the financing and payment side is a very important piece of the puzzle that needs to be addressed to help ensure a robust drug development pipeline.”

In August, CMS issued a final rule on Medicare payment policies for hospitals that also focuses on antimicrobial resistance. CMS says it has revised Medicare payment policies that can open the door for more innovative medications to address antimicrobial resistance. The new formula reverses a previous mandate that officials say restricted payment for new antibiotics in hospitals. CMS officials blamed the former standard for the financial collapse of a drug maker despite FDA approval of the manufacturer’s proposed treatment for complicated urinary tract infections.

“AMR is an increasingly serious threat to America’s seniors, including Medicare beneficiaries,” CMS said in a statement. “Without effective new antibiotics, patients will have fewer choices to treat drug-resistant infections, including those related to surgery and cancer-therapy. AMR results in hundreds of thousands of additional hospital days for Medicare beneficiaries, causing billions in unnecessary health care expenses,” CMS said.

Calling antimicrobial stewardship programs “critical,” the agency said its plans are not only to reinforce payment reform effectiveness but also to help move clinicians “towards the appropriate use of new antibiotics tailored to each patient.”

Moving clinicians toward changing prescribing practices—and consumers toward acceptance of using fewer antibiotics—are behavior changes in which the insurance community could also be involved, Hersh says.

Ultimately, “insurers can sound alarm bells and collaborate with health and policy experts to see how to create behavioral changes using both incentives and disincentives,” Hersh says. She concedes, however, that the insurance community is reluctant to “stick their necks out and raise a risk issue without having a mitigation solution or offering.”

Checking Doctors’ Pulse

One of the problems with burgeoning antibiotic resistance is that, whenever people want antibiotics, physicians are inclined to prescribe them. One troublesome setting for inappropriate prescribing is in outpatient visits. About 44% of outpatient antibiotic prescriptions in the United States target conditions such as sinus infections and viral upper respiratory infections, including asthma, allergies and pneumonia, according to the Pew Charitable Trust. Yet half those prescriptions were unnecessary, because viral illnesses do not respond to antibiotics, Pew says. A White House national action plan goal, released in 2015, focused on reducing inappropriate outpatient antibiotic use by 50% in 2020, according to Pew.

“It is estimated that up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate and makes everyone feel less safe,” says Dr. Ronald Leopold, chief medical officer for Lockton Benefits Services, in Kansas City, Missouri. “Stopping even some of the inappropriate and unnecessary use of antibiotics in people would greatly help in winding down the spread of resistant bacteria.”

Leopold says while there have been training and education efforts to mitigate antimicrobial misuse, government, nonprofit and other organizations are stepping up their tracking of provider prescription patterns and employing quality-management programs with prescription tracking being the metric.

Insurers are among those keeping watch on doctors’ prescribing practices. For the past three years, Aetna has sent 4,500 letters to providers urging them to refrain from using antibiotics when not necessary. Some letters admonish physicians for prescribing antibiotics for acute bronchitis. Other letters praise physician “champions” who never prescribe antibiotics for these conditions, Knecht says.

The approach led to a drop in antibiotic use among Aetna member patients by one-third, from 27% in 2014 to 18% in 2016.

Aetna says it is collaborating with the CDC to focus on states with the highest rates of overprescription. The company believes its actions can make a significant difference in the fight against antibiotic resistance while also cutting unnecessary healthcare spending. Acute bronchitis was chosen, Knecht says, because “it’s common and antibiotics shouldn’t be prescribed, but physicians have substantially overprescribed for this viral condition.”

Many insurance brokers seem to have taken only tentative steps to evaluate the antimicrobial issue, but Leopold says they can take significant steps to thwart antimicrobial problems. They can identify what health plan administrators and carriers are doing regarding tracking, monitoring or intervening in antibiotic usage.

Among other things, brokers can “flag” providers who have been identified as misusers or overusers of antibiotics, as Aetna does, he says. When that happens, cited providers might receive additional levels of file review, attend mandatory training and education, or face financial consequences or penalties, Leopold says. Brokers can provide independent claims data reviews of antibiotic use by providers for a client and monitor hospital-based infection rates for an employer’s health plan, Leopold says. Brokers can also help ensure that identified providers who seem to prescribe too many antibiotics receive appropriate intervention and that their activity is monitored. They also can educate employers about the issue and devise appropriate communication strategies for employees and plan members.

“It’s alarming to see that the rate of antibiotic-resistant infections has doubled since 2002 and spending to treat patients is 165% higher than for those without resistant bacteria,” says Dr. Shealynn Buck, chief medical officer at Lockton Dunning Benefits. “Insurers and pharmacy benefit managers have an important role in monitoring and ensuring provider adherence to quality standards for antibiotic prescribing.”

An opportunity for monitoring inappropriate antimicrobial use is in the outpatient setting, including physicians’ offices, telemedicine, urgent care centers and emergency departments, Buck says. Most antibiotic prescriptions, she says, are written in outpatient settings.

Brokers can partner with medical and pharmacy administrators on behalf of employers to include antibiotic stewardship measures in annual health plan reporting, Buck says. For employers who directly contract with providers, “brokers can facilitate a provider audit and ongoing review process.” Their evaluations can be based on the 2018 Quality Improvement Organization’s A Field Guide to Antibiotic Stewardship in Outpatient Settings, she says. That guide provides practice advice for reducing and monitoring inappropriate antibiotic use, Buck adds.

Employers can also play a significant role in antimicrobial resistance issues. “Employers can help raise awareness and educate their health plan members about appropriate antibiotic use so they understand why they don’t need an antibiotic and can make the right choice when they are sick,” Buck says. Generally, she adds, “providers are put in a tough spot when patients demand a prescription and then give the provider a poor rating if they don’t get what they want.”

Urgent Care Consumers

Dr. Cindy Liu, chief medical officer at George Washington University and the Antibiotic Resistance Center at the Milken Institute School of Public Health at GWU in Washington, D.C., says urgent care centers, which are growing rapidly as the go-to place for patients who don’t want to go to the emergency room, reflect the problem of patients being treated with antibiotics when they shouldn’t be. Often, the patients have a co-pay with an insurance company for their urgent care visits.

Many urgent care centers treat a disproportionately high number of coughs, earaches and sore throats that may be the result of viral, not bacterial, infections. “Often in the urgent care setting, patients are treated as consumers,” Liu says.

On the other side, the urgent care practice is often seen more like a business than a doctor’s office. The urgent care centers want to optimize their visits, want shorter visits, and aim for quicker turnaround time, Liu says. “There’s no time to build that relationship and educate the patient. They may also be at the mercy of patient satisfaction. And patients want an antibiotic.”

A study by Pew and CDC found nearly half of patients at urgent care and other healthcare clinics diagnosed with acute respiratory conditions were given antibiotic prescriptions. “We know that often patients demand antibiotics from their care providers even if a prescription is not warranted and, if they don’t receive it, they will search out someone who will give them the prescription,” Liu said in a statement.

To reduce antimicrobial use at urgent care centers, the Antibiotic Resistance Action Center and the Urgent Care Association, which represents urgent care centers, teamed up to develop patient education programs, implement training for healthcare workers, and collect data on antibiotic prescribing.It is estimated that up to half of antibiotic use in humans and much of antibiotic use in animals is unnecessary and inappropriate and makes everyone feel less safe.DR. RONALD LEOPOLD, CHIEF MEDICAL OFFICER, LOCKTON BENEFITS SERVICES

Lack of Data

A major gap in combating AMR involves the lack of data—not only the wide range of drugs impacted but also the ability to calculate potential losses from widespread antimicrobial resistance impacting human and animal life, researchers say.

“I believe that reinsurers and insurers should be using data analytics to assess the current state of claims related to AMR or AMR-associated losses across agricultural, human and life policies,” Hersh says. “More data are needed to make better decisions. Such data should be compared to models that forecast loss and impacts if AMR goes unchecked. I think that on the organizational level the issue needs to be elevated to the C-Suite, as this is not an issue that pertains only to the risk management point of contact.” In that way, she says, it’s similar to cyber-security concerns.

Among the problems is a “lack of specificity of data,” Milliman’s Buckle says.

“There are disease registries of AMR in certain countries that are thorough survey data on what the level of drug resistance actually is. But it’s still very difficult to look at medical claims data to pick up a reasonably accurate prevalence rate” of a specific case of antimicrobial resistance, Buckle says. “If you are an insurer trying to quantify AMR and trying to understand the different contributors, the lack of data is going to be a problem.

“Medical claims data has poor coding of antibiotic resistance, and as a result, the prevalence of AMR is potentially understated if trying to measure. For example, medical claim information may contain information to indicate that a patient had pneumonia but potentially not that they also had antibiotic resistance.”

Hersh says in the agricultural sector, in particular, “there’s a need to collect more robust and reliable data related to the use of antimicrobials in animal production and their impact on public health.” That can be difficult, in part, because of the practice of illicit or even off-label use of antimicrobials related to animal farming, she says. “Healthcare providers and clinical epidemiologists need to cooperate with the agricultural industry as well as include patient questionnaires about food consumption,” Hersh says, “even if most people don’t know or care about food supply chains.”

Ultimately, Hersh says, the insurance issue may eventually not only affect health insurance claims but also property/casualty and general liability losses.

Infections, Infections

As each day goes by, there are more dreadful stories of bacteria and resultant infections gone amuck. People who are stricken with staphylococcus aureus, considered the most dangerous of the many common staphylococcal bacteria, can get skin infections, pneumonia, heart valve infections and bone infections. Staphylococcus is a group of bacteria that has more than 30 types. It is estimated that 30% of the population carries staph on the skin or in the nose.

And people with MRSA (methicillin-resistant staphylococcus aureus) are 64% more likely to die than people with a non-resistant form of the infection, according to the World Health Organization. Escherichia coli (E. coli) is the leading cause of urinary tract infections and is becoming increasingly resistant to medications, according to the WHO. In 2016, 490,000 people developed multi-drug resistant TB around the world, and drug resistance is starting to “complicate the fight” against HIV and malaria, according to the WHO.

Earlier this year, a woman in her 70s died in Reno, Nevada, after contracting a superbug that could fend off 26 different antibiotics—that’s an extreme example, but not so far-fetched for what may be ahead. Officials say surgery and cancer chemotherapy can also be threatened with drug resistance.

Full Circle

The current situation involving antibiotics is ironic. “Antibiotics are the most important health breakthrough of the 20th century,” Knecht, from Aetna, says. “Antibiotics certainly reduced illness and led to longer life. In the early part of the 18th century, people were dying in their 40s from pneumonia because of bacteria. Now the leading cause of death is heart disease and cancer. I cannot overstate the value that antibiotics bring to society.”

While antibiotics boomed and were the heart of fighting sickness, they became “a victim of their own success,” Knecht says. “It’s the perfect storm of overuse.”

Elderly residents are particularly prone to antimicrobial infections because of their vulnerability to drug-resistant infections and greater exposure to pathogens. As antimicrobial resistance builds, it gets harder to find new drugs. “Physicians who reach for another antimicrobial arrow are finding their quivers empty,” wrote Seema Verma, director of CMS, “with the exodus of large companies and the bankruptcy of small firms contributing to the diminishing pipeline of drug development.”

Indeed, many large pharmaceutical companies and startups have declined to work on antimicrobial resistance drugs, citing costs, both in time and money. Former FDA administrator Scott Gottlieb observed in a statement: “Large pharmaceutical companies have, for the most part, exited from antibiotic research. And while some small, venture-backed, start-up companies remain engaged, these companies are not as well-positioned to fund the larger confirmatory trials required for regulatory approval.” As large companies reduce their efforts, Gottlieb says, “the funding pool available for commercializing innovative projects is shrinking.”

Merck is one of the few pharmaceutical companies that continues to pursue research and develop new medicines and vaccines that prevent and treat bacterial infections, says Butterton, from Merck Research Laboratories. “We’re committed to antimicrobials. We are an infectious disease company,” Butterton says. “It’s part of our mission, and we recognize the incredible public health importance.” Since 2014, Merck has introduced two novel antibiotics to reduce the recurrence of Clostridium difficile infections in adults receiving antibacterial treatment. It is also working on other pharmaceutical products designed to fight antimicrobial resistance. Merck says it has collaborated with more than 1,100 hospitals throughout the world to implement AMR-related programs, including training 10,000 healthcare providers. Its animal health unit also is developing vaccines for various animal-related diseases.

Butterton concedes the path toward developing drugs in the fight against antimicrobial resistance is not easy. “It gets harder and harder, and we have put in a lot of capital risk for years without a guarantee of success,” she says. “Companies have a real hard time. They bring medicines to market and then go out of business.”

A Fight Not Over

Through various partnerships and mandated programs in health, major steps are being taken to reduce antibiotic resistance, such as in infection control within healthcare facilities, says Michael Craig, senior advisor for the antibiotic resistance coordination and strategy unit at CDC. “We have made big strides as a country in the past decade, such as with healthcare-associated infections, and making improvements with infection control,” Craig says.

Yet he concedes there is a long way to go. “It’s still not where it needs to be in terms of mortality or the number of resistant infections,” he says. “The patient population is sicker, and the challenges we face will continue to be great. It is something you need to be vigilant about. You can’t take the day off.”

Hersh says a holistic approach to vigilance must be practiced by everyone involved in the issue—from doctors and patients to insurers and regulators. Hersh recalls that years ago, when she was living in London, she felt sick and went to a hospital emergency department. As an asthmatic, Hersh was concerned she had pneumonia, but as a knowledgeable professional, she also wanted to know if her condition was bacterial or viral.

After checking her, a physician didn’t think it was bacterial. He offered her antibiotics anyway. “You can imagine the mouthful that the tired young doc received from me,” she says.ON THE FARM

In agriculture, antibiotics have provided farmers and ranchers with an important tool to help sick animals, leading to improved livestock productivity. But these drugs can also be transmitted to consumers through the animals’ meat and may also wash off into streams as runoff. Antimicrobials also have been used as pesticides.

In the United States, however, major efforts have been made to reduce the number of antimicrobials in agriculture, with much success, says Dr. Paul Plummer (DVM), director of the National Institute of Antimicrobial Resistance Research and Education, based at Iowa State University.

In 2015, the Food and Drug Administration amended the Animal Drug Availability Act of 1996, revising the veterinary feed directive (VFD) drugs section. A VFD drug is intended for use in animal feeds, and use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian.

Under the revised rule, antibiotics for animals that also make up human medicine can no longer be used for growth promotion in cows, pigs, chickens or other food animals. And their remaining therapeutic uses must be done under the supervision of licensed veterinarians and cannot be purchased over the counter.

The FDA released data in December that shows “domestic sales and distribution of all medically important antimicrobials” intended for food-producing animals decreased by 33% between 2016 and 2017. The agency’s 2017 “Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals” also showed that domestic sales and distribution of the antimicrobials decreased 41% from 2015, a peak year, and also decreased 28% since the first year of reported sales in 2009.

“The reduction in sales volume observed in 2016 and 2017 is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact,” the FDA said in a report.

Food producers also have embraced marketing and branding that “designates whether or not their products used hormones or antibiotics,” says Melissa Hersh, a Washington, D.C.-based risk analyst and consultant. “The food supply issue is gaining more traction” in getting the message across about antimicrobial resistance, Hersh says.

Similar to cyber breaches that can result in losses, economic or otherwise, the antimicrobial issues on the farm reveal “smaller farms or large-scale production has a role to play in mitigating the risk to their assets,” Hersh says.

Otherwise, Hersh and others say, antimicrobial resistance in agriculture could result in a ripple of supply-chain disruptions, as grain and feed producers also absorb consequences as livestock die.

Mission: Prevent Lapses in Care

from my story at Academic Pharmacy Now

The more than 1,200 recently hospitalized patients had been discharged and sent home. For many, it was a time of confusion and uncertainty: patients missed taking their medications or were uncertain about their dosage, had been reluctant to make follow-up appointments and also may have wondered if a return trip to the hospital was in their near future.

One by one, these patients were getting phone calls from about two dozen University of Buffalo School of Pharmacy and Pharmaceutical Sciences fourth-year advanced pharmacy practice experience (APPE) students who worked vigorously to prevent lapses in care. The calls lasted only a few minutes, but the discussions were focused and powerful for the patients who had complex medical histories. The student pharmacists asked questions before the calls ended: Did they understand what their medications were for? Did they know the kind of diet they were on? The callers counseled patients and urged follow-up care with their doctors.

After many months of working with the patients, there were huge successes, including a significant reduction in the number of patients returning to the hospital as readmissions within 30 days. Of 1,200 patient encounters examined, 67 percent had decreased odds of all-cause 30-day readmissions and decreased odds of related readmissions. The program included patients contacted from June through November 2017.

The outreach by these student pharmacists working in tandem with community pharmacists made a “significant impact on reducing hospital readmission rates,” according to a study of the program published earlier this year by the Journal of the American Pharmacists Association.

“Post-discharge follow-up by community pharmacists has the potential to dramatically affect the rate of 30-day hospital readmissions,” the study noted. “Integration of student pharmacists or residents can provide a low-cost strategy to facilitate implementation and expansion.”

That period between the time when patients are discharged from hospitals and the time they are recovering is sensitive, wrought with potential problems. The transitions of care (TOC) stage is a continued target in a burdened healthcare system in the effort to reduce costs and improve quality.

Student Pharmacists Smoothing Transitions

Transitions of care are well documented as one of the most vulnerable times for patients, whether they experience a medication error, adverse event or other complications, the researchers said. And high readmission rates have imposed a significant clinical and economic burden on the U.S. healthcare system. About 20 percent of Medicare patients are unexpectedly readmitted within 30 days of hospital discharge, amounting to a cost of $41.3 billion, according to figures reported in 2011. The result also could be huge penalties against hospitals.

“Transitions of care is something we’ve been developing the past four or five years, how pharmacists are impacting transitions of care,” said Rebecca Brierley, assistant dean of external affairs, director of communications and alumni relations for the University at Buffalo School of Pharmacy and Pharmaceutical Sciences. “We are doing some creative things within the TOC model and are excited to share with the academic community.”

Dr. Amy Shaver, now a post-doctoral research fellow, was in rotation at the High Street Prescription Center as an APPE student and became curious about the TOC program at the pharmacy located in the lobby of the hospital. She thought it was terrific but wondered what kind of data was behind it. It was then she began working on the study along with other officials.

“They had this wonderful program that on its face looked like it was helping people, but they had no proof and I didn’t know it was statistically significant,” Shaver said. “You could tell they were doing good but you couldn’t prove it unless you studied it. I already completed my MPH and had a feel for study design and thought we should publish this.”

The Buffalo study demonstrates the role that student pharmacists can play in multifaceted transitions of care plans, university officials said. “To our knowledge, this is the first published study to evaluate the impact of a TOC program that is driven primarily by APPE-level student pharmacists. The use of student pharmacists is a low-cost and effective strategy for staffing a TOC program,” according to the study.

Using one to three APPE-level student pharmacists working full time on the calls, at an average of less than five minutes each, “allowed for a further-reaching intervention than would have been possible” with a TOC pharmacist alone, which contributed to a significant reduction in readmission rates, researchers added.

The students’ phone calls were made to patients within two to seven days after discharge and focused on medication counseling as well as promoting physician follow-up visits. Although the length of calls ranged from one to 40 minutes, the average counseling session required less than five minutes. The pharmacists worked with outpatient providers to resolve any medication-related problems such as inappropriate therapy, duplicative therapy and potential drug interactions. Patients were also advised to schedule post-hospitalization follow-up appointments as recommended in their discharge paperwork. A TOC pharmacist was available to answer questions or concerns raised by the student pharmacists.

Whistling in the Wind

While Donald Trump is a Queens native, a councilman in the neighboring borough of Staten Island is already thinking of a presidential library for him.

“I believe you have a certain affection for our borough and its residents and I believe that in many ways it is shared,” councilman Joe Borelli wrote to Trump, according to the New York Post

About 57 percent of the residents in Borelli’s’ district voted for Trump in 2016.

Hmmm. A presidential library? An ex-New Yorker friend of mine scoffed: “My dear friend in Staten Island says he has a one-car garage that would be perfect!”

Some may think of other places for President Trump and his belongings. Ryker’s Island?


As each day goes by, each hour, Donald Trump keeps making the case for impeachment. And possibly conviction.

He goes off the rails. Again. And again.

The disaster that is Donald Trump keeps giving.

It is nearly 1,000 days, America held hostage.

I thought Trump might be in bunker mode by now. That’s not his style. He’s in retaliation, tweet-in-your-face mode. What we’ve learned about Trump since the beginning of his presidency is a constant: a liar, a braggart, misleading (if not lying), angry, vengeful.

“As I learn more and more each day, I am coming to the conclusion that what is taking place is not an impeachment, it is a COUP,” Trump tweeted tonight.

George Washington calling?

Adults leaving the room are becoming a cliche when the conversation turns to some Trump aides who offered a steady course. As an anonymous author wrote in the New York Times just over a year ago: “I Am Part of the Resistance Inside the Trump Administration. The author said “many of the senior officials in his administration are working diligently from within to frustrate parts of his agenda and his worst inclinations.”

Picture school children learning about the Presidents: Yes, Donald Trump chopped down the cherry tree. He stole the cherries, eat them all himself. He bulldozed that tree, sent it to a scrap heap.

Children – we don’t know the real story of Donald Trump or how it unfolds – yet.

Trump as president: People are stressed. Every day is the longest of the year. The news cycle is old in two minutes. Frazzled. People are stuck in front of their TVs. Breaking News. Breaking News. And it is breaking news.

The weird thing with Trump is that he’s been a steady dose of overdose since the beginning. Think back to shortly after the election when the White House lied about the crowd size during the inauguration. A few weeks ago, Trump brought out his Sharpie pen and lied about a storm heading into Alabama. Between then there have been so many lies, so much misinformation, so much twisting of facts. Dog eat dog eat dog. Loyalists are showed the door and despised. Remember Tillerson? Remember Scaramucci?

“I would like you to do us a favor”

The Don—there’s been lots of Mob stories around Trump these days, too, from his parsing of the language, his talk to the Ukrainian president. Mob guys usually aren’t too blunt at least until, well, the final instruction. Trump isn’t much of a mumbler but he likes a few syllables. His sentences veer off into collisions with words that don’t make sense. Beautiful, beautiful, beautiful, no?

That whistleblower, let me have a few words with him, Trump seems to say. C’mon, send him to the Oval Office. Robert De Niro, who has played a few mobsters, calls Trump a “wannabe gangster.”

After the whistleblower disclosed his concern about the President’s talk with Ukraine president Zelensky, the political avalanche has begun, at least among Democrats. I can’t tell if Trump loves this stuff, in part, because his campaign coffers are bolstered, and he believes he’s impervious. In the meantime, Trump raises the volume of his attacks and the nonsense: accused political opponents of treason and even invoked the prospect of a civil war if he is removed from office, according to the Associated Press. 

A history of nonsense

“During the 2016 campaign, I received a phone call from an influential political journalist and author, who was soliciting my thoughts on Donald Trump,” says Peter Wehner in the Atlantic. Trump’s rise in the Republican Party was still something of a shock, and he wanted to know the things I felt he should keep in mind as he went about the task of covering Trump.

“At the top of my list: Talk to psychologists and psychiatrists about the state of Trump’s mental health, since I considered that to be the most important thing when it came to understanding him. It was Trump’s Rosetta stone.”

“Donald Trump’s disordered personality – his unhealthy patterns of thinking, functioning and behaving – has become the defining characteristic of his presidency. It manifests itself in multiple ways: his extreme narcissism; his addiction to lying about things large and small, including his finances and bullying and silencing those who could expose them: his detachment from reality, including denying things he said even when there is video evidence to the country; his affinity for conspiracy theories; his demand for total loyalty from others while showing none to others and his self-aggrandizement and petty cheating.”

Geez, that’s a long time in the Confessional…..

That loyalty thing. “I need loyalty. I expect loyalty,” Trump once said. The Republicans have been mostly in line.

Code Orange

Is this all catching up to this bizarre businessman turned politician turned instant President? Should we say Orange Head? What name hasn’t he called people?

Carl Bernstein, the Pulitzer Prize winning reporter who exposed Watergate with his partner Bob Woodward at The Washington Post, said that Trump was “unraveling.” He’s not the only one who says Trump is unraveling.

Unraveling from what? The guy has been a ball of wrapped up crazy quilt mess for a long time. More unraveling?

In the Mueller report, many of his aides described an array of anger, anger, anger surrounding Trump and things he didn’t like. Mr. Sessions are you listening? And more anger.

Loyalty vs. Real Leader

Presidential historian Doris Kearns Goodwin found that Trump lacks several traits of an effective leader, such as “humility, acknowledging errors, shouldering the blame and learning from mistakes, empathy, resilience, collaboration, connecting with people and controlling unproductive emotions.”

Er, Trump says: “I need loyalty. I expect loyalty.”

Republicans: Is this the guy you want as president?

Excuse me, I’m checking out what Kearns Goodwin said in researching Lincoln on what it takes to be a great leader.

Among the attributes:

Share Credit for Success.

Ready Willingness to Share Blame for Failure

Awareness of Own Weakness

Ability to Control Emotions.

Lincoln 100, Trump 0.

Hmm. Trump’s not there and may never be.


Eventually, Trump’s most infamous words may be a reflection of what mobster Joey Gallo once said: “I respectfully decline to answer because I honestly believe my answer might tend to incriminate me.” – Joe Cantlupe, Health Data Buzz