And now, Class: Weed 101…(Pharmacy Students Studying Medical Marijuana)

From my story at Academic Pharmacy Now:

https://www.aacp.org/article/medical-marijuana-goes-mainstream

Ninety years ago, marijuana was widely known as the “evil weed,” prompting the 1936 propaganda film “Reefer Madness” about its dangers. In the ensuing decades, study after study gradually backed off the hyperbole about marijuana, though it is still under a spotlight of continued research. In today’s world, marijuana is sometimes used to treat what ails us. Pharmacy is keeping pace as medical marijuana goes mainstream.

Pharmacy schools are offering programs to study medical marijuana not only for student pharmacists but others seeking to learn more about it for myriad reasons, including regulatory or business purposes as well as for improved patient care. As the industry expands, more colleges are adding cannabis or marijuana courses to their portfolio. Medical marijuana is gaining traction in America with more states legalizing its use and more dispensaries opening across the country. Some educators point to the increasing need for medical professionals—including physicians, nurses and pharmacists—to properly advise patients about medical marijuana.

At last count, 33 states as well as the District of Columbia, Guam and Puerto Rico have legalized medical marijuana. Three states are already requiring that pharmacists be part of the dispensing process, according to the National Community Pharmacists Association. For instance, New York State requires a pharmacist to be on the premises and supervising the activities within a marijuana dispensing facility.

The legalization movement is expected to broaden to more states. “The number is only expected to increase in the future, fueling a demand for an educated workforce that is well-trained in both the science and therapeutic effects associated with this medicinal plant,” said Dr. Natalie D. Eddington, dean and professor at the University of Maryland School of Pharmacy.

A 2019 study from the University of Pittsburgh School of Pharmacy found that 62 percent of U.S. pharmacy schools surveyed incorporated medical cannabis into their doctor of pharmacy programs and another 23 percent planned to include courses in their programs in the next 12 months.

The University of Maryland School of Pharmacy has launched a new master of science in medical cannabis science and therapeutics, one of the first in the country to do so. The two-year program is designed for an array of healthcare professionals, scientists, regulators, dispensary owners and staff and anyone interested in the field. The program was developed “because of a knowledge gap (in medical cannabis), particularly for healthcare professionals,” said Dr. Leah Sera, assistant professor in the Department of Pharmacy Practice and Science, director of the school’s new master’s program and a clinical pharmacist.

University of the Sciences in Philadelphia has launched a medical cannabis MBA program, specifically targeting the business of cannabis, said Dr. Andrew Peterson, John Wyeth Dean Emeritus and professor of clinical pharmacy and health policy at USciences. Peterson said that the “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise will be incredibly valuable as graduates move forward in their careers.” The USciences courses are provided through the business department in conjunction with the Substance Disorders Institute at USciences and include partnerships with Philadelphia-area cannabis organizations, Peterson said.

Researching the Risks and Benefits

While much of the academic community is focusing on medical marijuana, many questions remain about the impact of the drug and where it fits into pharmaceutical treatment regimens. That’s where the University of Florida College of Pharmacy is jumping in. The university is leading a statewide consortium studying health outcomes related to medical marijuana by evaluating its benefits and risks.

The consortium will tackle safety and effectiveness outcomes but also specific intricacies of medical marijuana inherent in its dosing routes of administration and the effects of smoking versus other methods of consumption, according to Dr. Almut Winterstein, a professor and chair in pharmaceutical outcomes and policy at the University of Florida College of Pharmacy and director of the University of Florida Center for Drug Evaluation and Safety. As the demand grows in the emerging marijuana and cannabis market in Florida, she said there is an “urgent need” for evidence-based studies revolving around medical marijuana. Under the program, the consortium of academic institutions will create a statewide resource for health outcomes research related to medical marijuana, said Winterstein, who was appointed director of the consortium.

As Winterstein sees it, marijuana would be put to the test in the same way as any other drug in development. “As with any other medical treatment, providers, patients and regulators need the necessary information to evaluate its benefits and risks,” she said. “At the time of drug approval, we really don’t know much about side effects and how the new drug works in populations with multiple comorbidities” because that’s not the focus of clinical trials. That’s why post-marketing safety and effectiveness studies are pivotal, and the same applies to medical marijuana. “Really we know very little about what medical marijuana actually does, and for me this requires basically the same systematic evaluation as is in place for any other drug that is on the market.”

While there are similarities with other drugs in studying the impacts of medical marijuana, there is a major difference: for the most part, medical marijuana lacks Food and Drug Administration approval, she noted. As a result, the Florida research “is probably more important because we don’t have approval process on the front end. We really don’t know much about efficacy. And it’s being used by patients who have really serious problems.” If patients who have Parkinson’s disease or multiple sclerosis take medical marijuana, “we don’t know the degree medical cannabis interacts with other drugs necessary to control the disease,” she continued.

While the FDA has not approved marijuana as a safe and effective drug for any indication, it has approved a drug that contains purified cannabidiol, one of the more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years or older. The FDA also has approved drugs containing a synthetic version of a substance in marijuana.

At least 20 marijuana research studies have been initiated in the past five years in Florida, where as many as 200,000 people have been registered to receive medical marijuana, including people suffering from severe and life-threatening health conditions. Researchers have been examining the health benefits and risks of medical marijuana from different perspectives and include outcomes research related to HIV infection, chronic pain in older adults and cannabinol treatment for children with drug-resistant epilepsy.

The university has been involved in a medical marijuana program since 2014. It has extensive research infrastructure and a broad faculty, Winterstein said, and is well positioned to lead the Consortium for Medical Marijuana Clinical Outcomes Research, which comprises public and private universities engaged in research on clinical outcomes of medical marijuana. It will receive $1.5 million in annual recurrent funding from the state to support the research. The university proposes to:

  • Build a repository known as the Medical Marijuana Clinical Outcomes Repository or MEMORY that can track patient outcomes over time.
  • Develop a Clinical Research Core that will provide infrastructure support for studies and establish a competitive grants program offering $600,000 annually from the state appropriation to participating institutions.

The core will assemble a group of physicians and clinical partners to recruit patients for medical marijuana research studies. In addition, the core plans to conduct a survey of medical marijuana providers in Florida, engage a scientific expert group and provide opportunities for the public and industry to help inform the most urgent clinical research priorities, according to the university. The repository will be available to researchers within the consortium and create a statewide resource for real-world health outcomes research related to medical marijuana.

While pharmacy schools are beginning to tap into coursework for medical marijuana, the University of Mississippi School of Pharmacy has been involved in researching the plant for more than 50 years. A 12-acre farm run by the university has been the sole domestic source of cannabis for government-funded and approved research. Through the National Institute on Drug Abuse (NIDA), the University of Mississippi provides marijuana to researchers across the U.S. under NIDA’s Drug Supply Program. After an open competition among institutions around the country, the University of Mississippi won the first contract in spring 1968 to be the government’s provider for marijuana for research purposes.

“During our 50 years of cannabis research we have been involved in a multitude of projects involving the botanical and chemical properties of the plant as well as ongoing development of candidates for new cannabis-based drugs and novel drug delivery systems,” said Don Stanford, assistant director, Research Institute of Pharmaceutical Sciences, which is part of the school of pharmacy. After some legal challenges, the government has now opened the door for more than 30 other organizations to grow cannabis for research, although the process has yet to begin, officials said.

A Complicated Substance

While medical marijuana presents many possibilities, the plant itself is extremely controversial with questions over its legality, overall addictiveness and effectiveness. Marijuana use is legal in some states but it’s still illegal from the federal government’s perspective. About 85 percent of Americans support legalizing medical marijuana.

Because the marijuana plant contains chemicals that scientists say could help a range of illnesses and symptoms, many people argue it should be legal for medical purposes. The major thrust of medical marijuana has been for pain control. Chronic pain impacts millions of Americans.

Marijuana has more than 100 active components. THC, which stands for tetrahyrocannabiniol, is the chemical that ignites the “high” that is linked to marijuana use. CBD, which stands for cannabidiol, is derived from the hemp plant, a “cousin” of the marijuana plant, according to Harvard Medical School. CBD has been used by patients for a variety of conditions, such as pain relief, or to combat anxiety or insomnia. CBD does not have intoxicating properties (although it is also present in the marijuana variety of Cannabis sativa).

The medical cannabis MBA program at University of the Sciences in Philadelphia offers a “combination of healthcare, pharmaceutical and cannabis business knowledge and expertise [that] will be incredibly valuable as graduates move forward in their careers.DR. ANDREW PETERSON

The marijuana plant remains classified as a Schedule I substance under the federal Controlled Substances Act. Schedule I substances are considered to have a high potential for dependency and no accepted medical use, making distribution of marijuana a federal offense. The law, however, is generally applied only when people possess, cultivate or distribute large quantities of cannabis, according to Americans for Safe Access, an organization that advances legal medical marijuana therapeutics and research. The Obama administration encouraged federal officials not to prosecute people who distribute marijuana for medical purposes. The Trump administration differs; it has allowed federal prosecutors to decide how to prioritize enforcement of federal marijuana laws.

Marijuana dispensaries have grown because federal law prohibits cannabis from being prescribed and filled at pharmacies for medical or recreational purposes. State-regulated dispensaries are designated under regulations for the growth and consumption of cannabis, noted Americans for Safe Access.

In Maryland, Strategic Advantage

As the marijuana industry began expanding, University of Maryland officials believed they needed to initiate a program to give students a “competitive advantage” in pursuing a career in the medical cannabis industry, whether working in healthcare or not. Indeed, the program is specifically designed for students with or without a background in science or medicine, said Sera.

The Maryland curriculum includes coursework in “policy and direct patient care,” with a “grounding in the basic science of pharmacology and the development of the formulation and chemistry of different cannabinoids and how we can treat different conditions,” Sera said. For students, the courses also provide a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.”

Faculty for the medical cannabis program include instructors from the pharmacy school immersed in the basic sciences, teaching pharmacology and chemistry, as well as clinicians. Besides those working in the medical field, adjunct professors who are knowledgeable in the study of cannabis will be engaged. Sera herself is a specialist in pain medicine and palliative care.

At least half of the 150 students who were accepted into the program’s first class, which began in August, have a background in science, chemistry, medicine or microbiology. Others include attorneys, educators and patient advocates, and even an art student. The classes are primarily online with an in-person symposium held once each semester.

Neil Leikach, president of a Catonsville-based pharmacy and a BSP graduate of the University of Maryland, is a student in the master’s program and is particularly interested in learning about evolving regulations around cannabis that are impacting pharmacies.

“This has been a Schedule I drug, and states are looking at this differently. There are many opportunities to help patients,” Leikach said. “States are really catching up on how to help patients with different disease states.” Leikach said he’s attended classes that have focused on regulations and drug interactions with cannabis. He’s pleased with the course offerings. “As pharmacists we need more information, and there is not enough good information out there.”

A Matter of Business in Philadelphia

As USciences officials began looking into the academic program for cannabis instruction, they believed that it should examine not only the science of the plants but also something that has not received enough focus: the business of medical marijuana, its marketing and sales. “There are many unique aspects to the medical cannabis and hemp industry,” noted Peterson.

As he examined the program and worked with experts in the field, Peterson said he was surprised by the complexity involved in the underlying business of marijuana and the horticulture process. “I learned so much about the science of growing plants,” he said. “The humidity, pest control, so many things.”

The legal aspect will also be explored. Students will be asked questions such as “what is the status of cannabis as a controlled substance in the U.S. under federal law as well as state to state?” Peterson said. USciences sought assistance in developing its program through a memorandum of understanding agreement with Franklin BioScience, a Colorado-based cannabis grower and retailer. Franklin BioScience assisted in developing educational programs about the cannabis plant and its medicinal value.

Four separate courses are being offered online as part of the Cannabis Industry Masters of Business Administration option under the pharmaceutical and healthcare business curriculum. While any student can take the courses, priority is given to MBA students, and there is no certificate for taking cannabis-related electives, school officials said.

The courses include introduction to the medical cannabis industry; finance and regulation in the medical cannabis industry; cannabis marketing and sales; and a project-based course where students will work to write a business plan or bring a product to market. Currently 14 people are enrolled; officials are still recruiting for the next cohort, all of them MBA students (some of whom are pharmacists). Like Maryland, USciences does not have an on-site cannabis lab.

Symposium attendees in discussion at round tables.
Attendees at the University of Maryland 2019 fall symposium for the MS in Medical Cannabis Science and Therapeutics Program. Photo credit: Matthew Di’Agostino

Mississippi: Ahead of the Field

The University of Mississippi has not offered an advanced degree in medical marijuana despite its research on the substance, officials said. “We could not consider doing so due to our long-standing efforts to develop new cannabis-based therapies as (Food and Drug Administration) approved products, but we are now exploring the possibilities of a cannabis program here,” said Stanford.

From 2005 to 2015, the University of Mississippi was involved in discovering 43 new cannabinoids, which are generally considered the most pharmacologically active compounds in the plant, according to the university. “Our contributions to the understanding of the chemical makeup and biological properties of the Cannabis sativa plant has spanned several decades,” Stanford said. “The longtime use of cannabis for the treatment of glaucoma is another example of how we have been involved in the search for new cannabis therapies.”

Dr. Leah Sera
Photo credit: Matthew Di’Agostino

The University of Maryland’s program provides a “grounding in the history of cannabis regulation in our country in order to participate in the development of well-informed medical cannabis policy moving forward.DR. LEAH SERA

In the early 1970s, studies in both humans and animals indicated that smoking marijuana might provide relief for the intraocular pressure in the eyes, according to Stanford. Taking that a step further, the University of Mississippi conducted studies and provided the standardized cigarettes used in the studies conducted in the U.S. This evidence “led to one of the earliest expanded access programs by the FDA that allow patients access to unapproved treatments,” he said. The university’s research efforts also explored cannabis-based therapies for dry eye, macular degeneration and diabetic retinopathy.

Although the University of Mississippi was the sole contractor with the government for all these years, other researchers are seeking to grow marijuana for contracts now that the process is going to open to more than 30 other organizations and academic institutions. “The University of Mississippi applies for the contract just like everyone else,” said Dr. Mahmoud ElSohly, director of the university’s Marijuana Project and professor of pharmaceutics. “Our research capability, our expertise, our knowledge in the areas of cannabis chemistry and production our personnel and facilities—everything is in place to make us very competitive.” The Drug Enforcement Administration said it “anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes.”

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.BACK TO TOP

For orthopedic surgeons, trying to get paid….can be a pain

From my story at athenaInsight https://www.athenahealth.com/insight/treating-broken-bones-without-racking-bad-deb

From the story:

Orthopedic surgery is quite literally a pain for the patient who’s having it, but there’s a major downside for surgeons as well: bad debt. Among all medical specialties, orthopedic surgeons are the most likely to be unable to collect payment from either patients or insurers, especially as deductibles skyrocket. 

In a 2019 report from Medical Group Management Association, data revealed that at least 30 percent of orthopedic surgery practices were in arrears for more than 120 days. The median bad debt is about $48,000 for orthopedic surgeons, compared to $35,000 for other single surgery practices.”  

Many orthopedic practices focused on improving bill collection practices are counting on technology to help them meet their goals. There are a variety of measures physician practices are touting, says Kumrah. Patient cost-estimators can be used based on insurance providers that physicians contract with; they’re helpful because they can seamlessly identify bills for individual patients.  

Process automation robots can take care of the mindless tasks like verifying insurance eligibility and sending out reminders for upfront payments based on schedule. “Healthcare generally is slower to adopt tools/automation as compared to other industries, so it helps to see what’s worked elsewhere from that process and perspective,” Kumrah says.  

“When you have a better-organized system, you are going to have less bad debt,” says Cristy Good, Senior Industry Advisor for Medical Group Management Associate. “You make sure all things are in place: staff training on how to do front-end collections, how to educate patients on their responsibilities, be transparent in your pricing.” 

Thwarting bad debt relies on staying on the cutting edge of health technology, but practices can’t discount the skills of people-to-people conversations. With a little automation and ingenuity, orthopedic surgery doesn’t have to be as painful for anyone involved. — Joe Cantlupe, HealthDataBuzz

Quid Pro Quo: A Part of Nature: Even for Rats

Quid Pro Quo — I’ll do something for you, if you do something for me — isn’t restricted to, well, politics.

Ok, it’s not even restricted to humans or other primates.

Rats do it too.

In exchange for food, rats will “groom” another rat’s hair, sometimes repeatedly in what scientists say is a cooperative behavior similar to humans. Researchers at the University of St. Andrew in Scotland found that rats were more inclined to engage in grooming with a fellow rat when food was received from it than not, and vice versa.

While many different animals show reciprocity for like commodities, such as food for food, primates have been known to be capable of trading goods, i.e. food, for other services, such as sex, for instance, in the case of chimpanzees. Trading of different commodities is considered a fundamental component of human interactions, with quid pro quo a part of our being and how we get along.

The fact that rats do it too indicates that it may be more widespread in nature than originally believed, and the reciprocal trading may not be limited to large-brained species with advanced cognitive abilities.

“The prevalence of reciprocal cooperation in non-human animals is hotly debated,” said Dr. Manon Schweinfurth of the School of Psychology and Neuroscience at the University of St. Andrew in Scotland, co-author of a study on rat behavior. “Our study suggests that either rats have this concept or reciprocity is cognitively less demanding than previously thought.”

She and Professor Michael Taborsky of the Institute of Ecology and Evolution at the University of Bern published a paper ‘Reciprocal Trading of Different Commodities in Norway Rats. on the subject earlier this year in Current Biology.

Quid Pro Quo

For humans, giving something in exchange for something else is a part of interactions with others and starts at a young age. “A key feature of human interactions is the quid pro quo: you do something for me and in exchange I do something for you and in exchange I do something for you,” Jonaton D. Crystal, Department of Psychology and Brain Sciences, Indiana University wrote about the study as a Quid Pro Quo in the journal Current Biology.

“Children 3 years onward reliably reciprocate with each other,” Schweinfurth says. “Kids most likely don’t have to learn reciprocity either but their brain is not fully developed and they lack capabilities that enable them to reciprocate.” “

Quid pro quo has been in the news constantly the last few months — maybe more so than at any time in recent memory — as investigators examine President Trump’s actions in allegedly withholding funds for Ukraine unless that government investigated former Vice President Joe Biden’s son, who conducted business there. ( The Democrats began steering the party’s narrative away from quid pro quo but a more directed allegation of “bribery.”

While quid pro quo is especially the topic of debate for political humans, some scientists believe that the action of reciprocity is definitely human, but others say the practice is not unique to us.

“The prevalence of reciprocal cooperation in non-human animals is hotly debated,” Schweinfurth writes. “Part of this dispute rests on the assumption that reciprocity means paying like with like. However, exchanges between social partners may involve different commodities and services.”

Many animals help each other such as bees managing hives seeking other bees’ assistance. And several species, particularly among primates, such as monkeys, have been known to apply such rules when exchanging food for other actions, such as protection, Schweinfurth says. Primates have been known — through observational evidence — to trade different services, such as chimpanzees trading grooming for meat.

Rats Do It

But rodents, such as rats? Indeed. Her studies show that “rats seem to follow reciprocal rules like tit-for-tat to help each other,” Schweinfurth said. Of rats, “they likely don’t memorize exact donation rates or calculate that was received but form attitudes toward their partner…like partner A was nice to me,” she added.

Rats live in burrows and form mixed social groups that might involve as many as 200 individual rats, which frequently interact with each other. As highly social animals, they often huddle together to keep warm, share food and have been known to softly pat each other’s hair.

“Rats are good model organisms because you can keep them in the lab and they learn quickly how to use experimental setup. We worked not with the classical lab rat but with descendants of wild rats,” the species known as Norway rats, Schweinfurth said.

In a series of experiments, food — oat flakes — were put into a moveable platform and rats pulled it toward other “partner” rats. The rats, which were closely studied, known as focal rats, pulled a stick connected to the moveable platform in a cage and provided food to the partner, which then in turn softly patted or groomed them. Each cage held two rats, each in its own little compartment. By pulling the connected stick, the platform moved into the cage and provided food only to the partner rat.

In an examination of more than 30 rats, the so-called focal rat continually provided more food to grooming partners than not. Rats provided more food to “cooperative” partners in test conditions, which were not previously achieved, Schweinfurth said.

The grooming occurred after saltwater was applied to the neck of the focal rat to create a situation where help was needed. Each rat’s “propensity to help the partner remove the unpleasant saltwater is enhanced by the previously experienced food donations of the partner,” the researchers wrote. “Grooming is a widespread behavior and the results might hence be more generalized to other species,” Schweinfurth said. After the experiment, the researchers took rats out into a large container where they could groom each other.

“Hitherto there is no experimental evidence that animals other than primates exchange different commodities among conspecifics based on the rules of direct reciprocity,” the researchers added in the study. “Here we show that Norway rats apply direct reciprocity rules when exchanging two different social services: food provisioning and (grooming.)

Rats — Lots of Them

Schweinfurth said she has been studying rats since 2013, calling them “fascinating animals.”

“They are highly intelligent and billions live with us, but we really don’t know much about them,” she says. “We have a very different and interesting relationship with rats. They are very useful to us as lab rats. We hate them when we encounter them in the cities and we love them as pets.”

“There is some evidence (from another study) that rats anticipate reciprocity in the future,” she says. “If rats are hungry, they are more likely to invest in donating food to others, probably in the hope of getting more back.”

Despite the give and take, Schweinfurth said she has been restarted in her studies that she couldn’t find a “friendship” among rats.

“For the rats, they work on not an accumulative experience with a partner,” she says. “They respond to the last experience. Basically, they only consider “what have you done for me lately.”

In her recent work, Schweinfurth has moved beyond rats — to humans and other primates.

She said she wanted to “compare rats to understand how unique our form of reciprocity is and whether different species have found different ways to cooperate with each other.”

And much of that cooperation begins with the quid pro quo. – Joe Cantlupe, HealthDataBuzz

(Photo: Rats “grooming.”Courtesy of Dr. Manon Schweinfurth)

A Road to Bicycle Safety: NTSB Says “Critical Changes” Needed To Reduce Motorists’ Collisions With Cycles

Intersections, intersections.

That’s where 65 percent of bicycle and motor vehicle collisions occur.

And too many cars try to overtake bicyclists on the roads — incidents responsible for least 25 percent of fatal crashes. In many of those cases, the motorists didn’t see the cyclists.

Those are among the findings cited in the National Transportation Safety Board‘s first examination of bicyclist safety in 47 years. The board said today “critical changes” are needed to address an increase of bicycle crashes involving motor vehicles.

Among the proposals:

Improve roadway design.

Enhance visibility of bicyclists

Tap into the latest technology

Increase helmet use.

Such plans “hold the most promise for reducing the number of fatal and serious crashes,” the NTSB said.

“If we do not improve roadway infrastructure for bicyclists, more preventable crashes will happen and more cyclists will die in those preventable crashes, ” said NTSB Chairman Robert L. Sumwalt. “If we do not enhance bicyclist conspicuity, more bicyclists will die in preventable crashes.  If we do not act to mitigate head injury for more bicyclists, additional bicyclists will die.”

Figure8e_2way_Center_SBL_Vertical.jpg

Photo, taken Aug. 16, 2019, in Washington, a two-way separated bike lane with vertical barrier is shown. NTSB photo by Ivan Cheung.)

NTSB investigators said “25 percent of all fatal collisions involving bicyclists – the most frequent type – occurred while a motorist was overtaking a bicyclist in the stretches of roadway between intersections.”

At intersections, said fixes should include clearly denoted “right-of-way using color, signage, medians, signals and pavement markings would likely reduce the number of crashes in those environments,” the NTSB said.

Investigators said “about a third of the motorists involved in fatal crashes while overtaking a bicyclist did not see the bicyclist prior to the collision. “

The NTSB safety report will be available in several weeks, officials said. A text of the findings and safety recommendations, is available at https://go.usa.gov/xpTps. — Joe Cantlupe, HealthDataBuzz

A Long and Winding Road: NTSB Issues Analysis Today on Bicycle Safety — 47 Years Since Last One.

It was a mess.

Police cars parked in all directions. Ambulances rushed over. Connecticut Avenue, a major thoroughfare heading into and out of Washington DC from Montgomery County MD, was cordoned off. A bicyclist was pinned against a utility pole as a pickup truck and two cars crashed, The Washington Post reported.

The bicyclist wasn’t even on the road at the time of the collision, according to media reports. The man was standing with his bike on the sidewalk.

Bicyclists don’t have to be moving on the road to get hit. Several years ago, my son was riding with other bicyclists cross country on a gleeful trip. The joy cascaded into horror as one of the young riders in a separate group, a 24-year old woman, was killed when struck by a pick-up truck while she was changing a flat tire on the side of a road. That tragedy happened on a rural byway in Kentucky. Yet wading through traffic in urban areas is one of the biggest challenges for bicyclists, and some roads don’t seem to be a good fit no matter how enthusiastic or safety conscious the biker.  In the Connecticut Avenue crash, a bicyclist is recovering from injuries and luckily there were no fatalities.

That’s not always the case. Bicycle accidents involving motor vehicles are increasingly leading to fatalities.  They come against the backdrop of the tremendous growth of biking, whether it for fun, exercise or commuting to work. It’s not just the nine-year-old steering his or her bike on a sidewalk going to a friend’s house. The bicyclist is more likely a middle-aged person navigating a street.

While state legislators scheduled a meeting today to look at the Connecticut Avenue crash and figure out the problems of the biking accident and others along that stretch of road, the National Transportation Safety Board will be meeting a few miles away this morning in Washington DC to consider findings and recommendations of a major report about bicycle safety, crashes with motor vehicles and what can be done about it.

Usually you think of NTSB and airplane accidents. It’s true. But the agency covers bicycle and pedestrian safety too. The bicycle report is the first NTSB analysis of bicyclist safety in 47 years, and none too late, with the board mentioning the “growing use of bicycles as a means of transportation and resulting safety issues.” It will be releasing findings and recommendations in its “Safety Research Report: Bicyclist Safety U.S. Roadways: Crash Risks and Counter Measures.” The board says it will “examine the prevalence and the risk factors of bicycle crashes involving motor vehicles and assessing the most applicable countermeasures.”

NTSB officials declined to specifically identify what will be discussed in the report, but Dr. Ivan Cheung, a lead investigator, and Dr. Jana Price noted generally the board will focus on a wide-range of issues, ranging from alcohol use to speed among motorists, helmet use among bicyclists, traffic regulations,road engineering improvements – adjusting traffic signals or building islands for exclusive bicycle or pedestrian lanes, or new sidewalk overpasses and underpasses, and technological changes such as collision avoidance systems that are becoming more of a mainstream in new vehicles.

In its last report – in 1972 — the board said the majority of deaths and injuries were among children 5 to 14 years old, surely, a different world of bicycling from today, where much older people frequent the bike lanes.

In 2018, while overall traffic fatalities were down, more pedestrians and bicyclists were killed on U.S. roads last year, accounting for nearly 20 percent of all traffic deaths, according to the National Highway Traffic Safety Administration, The Washington Post said.

According to the NHTSA’s Fatal Analysis Report System data, 6,283 pedestrians and 857 people on bikes or similar nonmotorized vehicles were killed in 2018, an increase of 3.4 percent and 6.3 percent respectively, mostly in urban areas, the paper reported.

Other figures in recent years foreshadowed growing problems.  In 2017, 783 bicyclists, considered “vulnerable road users as they are more vulnerable to injury or death in the event of a crash” died as a result of crashes with motor vehicles, the National Highway Transportation Safety Administration reported.

“Safety is a growing concern. Although bicyclists represent only about 2 percent of road fatalities, bicyclist deaths have increased 25 percent since reaching their lowest point in 2010,” according to the

Insurance Institute of Highway Safety.

“Crash avoidance features and other vehicle improvements may also make pedestrians and bicyclists safer,” according to the IIHS. “Modifying the front structures of vehicles may reduce the severity of pedestrian injuries. Regulators in Europe and elsewhere have been encouraging pedestrian protection in vehicle design through their vehicle testing programs.”

It’s not always easy, whatever changes are made. the IIHS adds: “Bike lanes separated from the roadway by physical barriers make cyclists feel safer and encourage more people to ride, but IIHS says protected bike lanes vary in terms of injury risk.”

For bicyclists there are mostly two types of crashes: falls or, the most serious, collision with cars. And the NTSB has a breakdown of when they most likely occur (between 6 p.m. 9 pm.) and of those who die on a bike – males were eight times as likely as females. Among a majority of bicyclists killed in crashes, head injuries are the most serious, but helmet use can drastically reduce them.

The NTSB says: “A large percentage of crashes can be avoided if motorists and cyclists follow the rules of the road and watch out for each other,” the board says.

It seems like a no-brainer.

Many complicated issues converge, however.

In 2016, a pickup truck driver plowed into nine cyclists  in Michigan who were properly riding single file along a paved road shoulder. Five were killed.

For the bicyclists, an NTSB official said: They wore reflective material, had reflectors, flashers, helmets high visibility clothing. “They were doing everything right, nevertheless they were all struck and killed or injured by a driver who was impaired by a variety of substances,” said T. Bella Dinh-Zarr, an NTSB member.

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

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— 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.