Fred Gebhart

A daily fixed-dose combination polypill with 4 common cardiovascular medications can reduce the risk of primary cardiovascular disease by 21%, according to new research. Adding daily low-dose aspirin reduces primary cardiovascular risk by 31%. 

The polypill used in the study cost about $0.50 per dose per day, said Salim Yusuf, MD, DPhil, professor of medicine, clinical epidemiology, and biostatistics and director of the McMaster University Population Health Research Institute in Hamilton, Ontario, Canada. He said large-scale production could cut cost to as little as $0.10 per dose per day.

“If even half the people who were eligible took this polypill-aspirin combination, we could prevent 3 to 5 million people from getting a heart attack or stroke, or dying from heart disease or stroke every year,” Yusuf said. “Polypill could be used very effectively to reduce the impact of cardiovascular disease in every part of the world, rich or poor.”

The International Polycap Study-3 (TIPS-3) is the largest trial ever of a quadruple fixed-dose combination to prevent cardiovascular disease. The polypill includes thiazide 25 mg, atenolol 100 mg, ramipril 10 mg, and simvastatin 40 mg taken once daily.

The trial compared polypill, 75 mg aspirin, and polypill plus aspirin with placebo in 5713 participants across 9 countries for 4.6 years. The trial was planned to run for 10 years with 7000 participants, but supply problems and the coronavirus disease 2019 (COVID-19) pandemic cut the program short.

“You see these people in your clinic or pharmacy every day,” said Prem Pais, MD, professor of medicine at St. John's Research Institute in Bangalore, India.

“They were all middle-aged, men 50 or older, women 55 and older. They all had at least 1 risk factor for cardiovascular disease—overweight, high blood pressure, elevated cholesterol, elevated glucose or diabetes, smokers. But no one had any known cardiovascular disease. This was about primary prevention, reducing the risk of that first cardiovascular event. ”

At least a half-dozen companies sell polypills outside the US, Pais noted. But they are not widely used because there have been no large, international studies showing that they actually reduce heart attack, stroke, and death. Prior studies looked at surrogate markers such as blood pressure, not clinical events.

“I think this will change our practice,” Yusuf said.

Results of TIPS-3 were presented at the American Heart Association Scientific Sessions and published simultaneously in the 

The trial was complicated by logistical delays in manufacturing and distribution as well as access interruptions from COVID-19 closures. Pais noted that nonadherence was high, 43% by the end of the study, but only 5% of nonadherence was due to adverse effects.

There was no difference in gastrointestinal bleeding between the aspirin group and placebo and there were more serious adverse events in the placebo group than in the polypill group.

The primary results of the trial that made headlines were based on an intent-to-treat analysis, which includes everyone enrolled in the trial, even if they could not get the drug or placebo. A subanalysis of participants who had less than a 30-day interruption in supply showed 45% lower risk for primary cardiovascular events with the polypill plus aspirin versus placebo.

“This first-generation polypill is not magic, but it would be clinically worthwhile,” Yusuf said. “In the future, there will be polypills with greater cholesterol reduction, greater reductions of blood pressure. And my guess is that they will have a greater effect on reducing first cardiovascular events.”

The study was funded by the Wellcome Trust, Cadila Pharmaceuticals, an Indian polypill maker, and other research organizations around the world.

1. Yusuf S, Joseph P, Dans A, et al. Polypill with or without aspirin in persons without cardiovascular disease. 

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“This first-generation polypill is not magic, but it would be clinically worthwhile.”

Fixed-Dose Combination Polypill Reduces Primary Cardiovascular Disease Risk

Cannabidiol (CBD) may be the biggest business booster pharmacy has seen in years. Statista forecasts $1.9 billion in CBD sales in the US by 2022, up from $535 million in 2018.

said Tim Gregorius, RPh, vice president of operations for PRS Pharmacy 

Services in Latrobe, Pennsylvania.“There are drug interactions, there are [adverse] effects, there are dosing considerations. The clerk at the gas station 

and the nice lady at the convenience store should not be selling CBD. CBD belongs in a pharmacy.”

Don’t try to compete on price, warned Mike Bellesine, RPh, owner of El Dorado TrueCare Pharmacy in El Dorado, Kansas.

“You can buy CBD from any smoke shop, from Amazon,” he said.“ We have brought our prices down somewhat, but we focus on the professional aspect. We are the CBD specialists.”

Pharmacists can build financial suc- cess with CBD around 3 elements:

Pharmacy regulations for CBD products vary by state.

California, for example, does not explicitly permit sale of ingestibles in pharmacies, said Ken Thai, PharmD, chief executive officer of K & B Pharmacy Associates in Los Angeles.

“We used to carry a full line of CBD products in our stores, but have cut back 

to topicals because state board inspectors are inconsistent. Some are fine with gummies and tinctures, some are not.”

Some CBD products also contain THC, which may not be noted on the product label. Kansas allows up to 5% THC in CBD products, according to 

Bellesine. Still, employers can terminate employees who test positive for THC. Bellesine uses only manufacturers that certify their products contain no 

THC, then sends samples to a local lab for confirmation.

“The only acceptable level of THC for us is 0,”Bellesine said.“Our suppliers know it, our customers know it, their employers know it. That has brought a lot of customers to our doorsteps.”

PRS also screens manufacturers. Products can be sold only to pharmacies or similar health care outlets, and packaging cannot carry mari-

juana leaves or similar deceptive elements. All products must be free of THC, certified by the manufacturer and a third party certificate of analysis, then veri

Judy Leventhal, president of Leventhal Productions in St. Louis, Missouri, spent 3 years hammering out advertising guidelines with TV networks and streaming services. Leventhal is the only advertising agency devoted exclu- sively to independent pharmacies.

”Essentially, we can’t show products, we can’t talk benefits,”she explained. “What we can do is position the pharmacist as the CBD expert and education resource. This can be tremendously effetive, especially with older audiences.” The most successful CBD marketing focuses not on patients and customers, but on prescribers. Pharmacists can be the go-to source for CBD information, just as they are for drug information.

“We advise focusing on prescribers in town,” Gregorius said.“Tell them about your CBD knowledge and your certified THC-free products.”

Bellesine’s only CBD pitch is to local physicians. Window signs and sandwich boards advertise his THC-free product lines. Inside, products are arranged on clear shelves behind a plastic barrier that separates a technician line from the rest of the store.

“Customers can see product clearly, but they have to ask for it,” he explained. “That gives us an easy opening to talk about how CBD might help. That kind of low-key, in-store positioning is cheap, easy, and it works.”

Patients are bombarded by a bevy of purported benefits, but pharmacists may not make therapeutic claims.

“I can’t tell you that CBD is a sleep aid,” Bellesine said. “But I can tell you that other customers have told me that it helps them sleep better. And I can tell them that CBD doesn’t work for everyone, but this is what it did for me.”

CBD price may be an issue for some customers. Bellesine offers 2 options.

One is a high-dose formulation, cheaper per use but more costly at the register. The other is a low-dose formulation, which is cheaper at the register but more expensive per use.

“If CBD doesn’t help, they’re not out a lot of cash with the low-dose choice,” he said.“And if it does work, they come back for the higher dose bottle to save money. Either way, I’ve helped my customer.”

Tips for building financial success with CBD for your pharmacy.

Boosting Business With CBD

Good technicians can be the backbone of pharmacy operations. They answer the phone, ring up sales, input scripts, refill dispensing machines, and shepherd claims through adjudication, which allows pharmacists to focus on their job.

“Our analogy is the primary care provider,” explained Tripp Logan, 

PharmD, second-generation owner of L&S Pharmacy in Charleston, Missouri, and 2 other stores.

“The physician doesn’t do intake or billing or all of those other essential, nonclinical tasks. We try to replicate that in pharmacy to free up our pharmacists to do what they are really good at, clinical work, and let our techs do the work they’re really good at, which is just about everything else that keeps the store running smoothly and our patients coming back.”

So how can pharmacists best use their technicians? By helping their techs work at the top of their own jobs with plenty of training, incentives, and motivation.

“I came here from a chain store, and this approach is 100% different,” said community pharmacy resident Heather Jarvis, PharmD, MBA, who works at L&S. “So many of the things I was used to doing at the chain store the techs handle as a matter of course. I had no idea technicians could give me so much more clinical time.”

That’s no surprise for Jody McConkey, MPA/HCM, CPhT, pharmacy standards and process controls senior manager for Banner Health in Phoenix, Arizona. For too many technicians, especially in retail, pharmacy is a job, not a career.

Pharmacy technicians, like other employees, try to meet expectations. Setting low expectations, with minimal support and no career path, is a prescription for low performance.

“Providing standardized training and the opportunity for professional growth not only engages technicians, it helps them grow and develop and support the pharmacist more effectively,” said McConkey, who is the head of the Pharmacy Technician Certification 

Board Certification Council.“Developing your techs, helping them develop themselves, can add real value to the pharmacist, make the pharmacist’s job easier, and improve patient care.”

Logan adopted that kind of support-the-technician approach several years ago. He dropped his company’s annual cost of living raise to instead focus on incentive raises based on pro- fessional education and credentials.

“If you want to become a certified pharmacy tech, we’ll cover the cost of the training and then give you a raise,” he said.“Every opportunity for training and credentialing comes with an incentive raise. Our techs can choose the courses they want, based on their own interests as well as our strategic goals for the pharmacy practice. Looking at our techs as part of the team has been very beneficial.”

Turning techs into team members gives what William Schimmel, executive director and CEO of the Pharmacy Technician Certification Board, calls a triple win.

“The pharmacist or the employer wins because they have strong performers. Individual 

technicians win by being rewarded for advancing through their careers. And most importantly, patients win by getting better 

care, which means better outcomes. The possibilities to support technicians and get more from technicians are endless as pharmacy evolves and technicians evolve with it,” Schimmel said.

Pharmacists can support technicians through training, incentives, and motivation. 

How Pharmacists Can Make the Most of Their Technician's Skills

Scope of practice and vaccination authority don’t usually grab much public attention. But when the US Department of Health & Human Services (HHS) preempted state practice acts to allow all pharmacists to order and provide coronavirus disease 2019 (COVID-19) tests and provide routine pediatric immunizations, the profession hit the headlines. What happens next in health care depends largely on COVID-19, especially in light of the breaking news at press time that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself. 

Presidential candidates regularly trade barbs on access to care, drug pricing, health insurance, and similar issues. But exactly how the 2 candidates, President Donald Trump and Joe Biden, might address health care issues is murky.

As vice president during the Obama administration, Biden was a strong supporter of the Affordable Care Act (ACA). As a candidate in 2020, he has called for broader access to health care and a national, science-based approach to the COVID-19 pandemic. Biden routinely wears a face mask in public and has called for a national policy favoring masks to reduce COVID-19 transmission.

As president, Trump has repeatedly criticized the ACA. When legislative attempts to derail ACA failed, the administration tried legal challenges. The Supreme Court will hear arguments to block the ACA in November.

On the COVID-19 front, the administration has taken contradictory positions. Trump has largely left pandemic response up to the states and said at the debate between he and Biden at the end of September, held days before this positive COVID-19 diagnosis, that he thinks masks are "ok," and that he wore them when thought they were needed. However, he has rarely appeared in public wearing a mask. 

At the same time, HHS has overruled states to expand the scope of practice for pharmacy, medicine, and other health care professions nationwide under the Public Readiness and Emergency Preparedness (PREP) Act.

Trump also appointed a science-heavy COVID-19 task force headed by veteran clinicians and Washington insiders Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Deborah Birx, MD, global AIDS coordinator for the US Department
of State. However, he has derided both Fauci and Birx while touting purported miracle cures including hydroxychloroquine and convalescent COVID-19 plasma.

administration responses to COVID-19 leave pharmacists, and everyone else, with more questions on health care policy in 2021 than answers.

“We are asking all the candidates about their positions on pharmacy 

issues, and we don’t have clear answers yet,” said Michael Jackson, RPh, executive vice president and chief executive officer of the Florida Pharmacists Association. "We do know that the status quo can't remain. We have got to change dramatically."

Change should start in the pharmacy supply chain and payment models, Jackson continued. Both presidential candidates, as well as other candidates up and down the ballot, have to recognize that pharmacy is not a cost center, but a cost container. Current payment models are driving pharmacies out of business.

Independent pharmacists have been complaining about direct and indirect remuneration (DIR) fees for years. More recently, chains and hospitals have added their objections.

“It’s pretty dire when you get the entire pharmacy industry to stand behind one issue,” said Brian Caswell, RPh, president of the National Community Pharmacists Association (NCPA) and owner of 4 pharmacies in Kansas and Missouri.

“DIR fees mean that on a quarterly basis, you have somebody reach into your bank account and pull a big chunk of money out, which totally disrupts your budget [and your] plans
to improve your business [and] make capital investments so you can step up and do a better job of taking care of your patients. Everyone is being hurt by DIR fees, including patients.”

Caswell noted that one of his stores lost $100,000 to DIR fees in 2019. That kind of unpredictable loss made him reconsider a $200,000 automated multidose strip-and-pouch packaging unit that could help meet strong patient demand for drug packaging to ease adherence. No one knows how the next president might approach DIR fees.


“We have a president [whom] we know a little bit about related to pharmacy issues, and we have a candidate who wasn’t big in the pharmacy space in his previous elected positions,” said Karry La Violette, advocacy center director and senior vice president of Government Affairs for NCPA. “We have a lot of unknowns with Biden, but he wouldn’t be a hard sell. We know what we are getting with the Trump administration, sometimes unpredictable, but we know where they’re coming from.”

By the end of both parties’ conventions, neither candidate had staked 

out positions on DIR fees, pharmacy benefit manager (PBM) regulation, drug pricing, scope of practice, the 340B drug pricing program, or other key pharmacy issues. Nei

ther the Trump nor Biden campaigns responded to repeated information requests for this article. But the two have very different perspectives on how health care should be delivered.

“You could have a President Biden focused on public options,” explained Tom Krause, JD, MHS, vice president of Government Relations for the American Society of Health-System Pharmacists (ASHP).“You could have a President Trump preserving some selected aspects of the ACA but overall oppos- ing it. Trump has a preference for a very state-based approach to managing response to the COVID-19 pandemic. Signals we’re seeing from Biden would be a more nationally focused response. Those are fundamental contrasting visions of health care.”

If current trends continue, more than 200,000 Americans will have died from COVID-19 by election day on November 3. There are endless, unsolvable arguments over how many deaths might have been avoided had the federal government taken a different approach to the pandemic. But from the health care perspective, the pandemic has brought a few positives changes.


When the federal government declared a public health emergency on January 31, HHS was able to make sweeping changes to the provision of and payment for health care services under the PREP Act.

HHS authorized physicians and other clinicians to practice in states in which they were not licensed under some circumstances and allowed pharmacists to order and administer COVID-19 tests. HHS later authorized pharmacists to provide point-of-care testing for influenza and COVID-19, expanded pharmacists’ authority to provide pediatric immunizations, and adapted reimbursement mechanisms to pay pharmacists directly for some COVID-19–related services.

“With the pandemic, pharmacists and pharmacies have been able to work as providers,” said Ilisa Bernstein, PharmD, JD, FAPhA, senior vice president of Pharmacy Practice and Government Affairs for the American Pharmacists Association (APhA). “There have been a lot of flexibilities and gains that have been achieved for pharmacists and for patients during [COVID-19]. In the next administration, whether it’s the same party or a different party, we’re going to watch and push for those flexibilities and gains to be maintained [and] move to further gains that can continue to make a difference in patient care.”

The problem is that COVID-19– related improvements in patient care all depend on the public health emergency. Once the emergency expires, state regulations take over. And not all states changed their regulatory approaches.

“There have been national mandates, but the actual changes to practice acts have not been uniform,” said Ken Thai, PharmD, president of the California Pharmacists Association and chief executive officer of 986 Pharmacy Corporation. “The next administration needs to get rid of the barriers, the handcuffs, to allow everyone to pitch in as part of the provider team—nurses, doctors, pharmacists— to give patients the best possible care and the best possible outcomes.”

Provider status has been on the pharmacy wish list for years. Bipartisan provider status legislation has been introduced in Washington but has never moved out of committee. California pharmacists gained provider status in 2014.

“Even 6 years later, recognizing that if we perform a service, we need to get paid for it, hasn’t happened to the extent that we have been able to unleash pharmacists’ true powers to help their patients,” Thai said. “With DIR fees, pharmacists are paying to provide services because there is negative reimbursement because of actions taken by the PBMs. I’m hoping this election highlights what we have been doing and the outcomes we have provided. For too many people, we haven’t just been the most available health care provider, we have been the only provider because so many physician practices were closed or limiting visits.”

None of these changes will happen on their own. Political candidates don’t respond to stakeholders they don’t hear from. Pharmacists have to make 

their own case, time and again, until change happens.

APhA, ASHP, NCPA, and other pharmacy groups are lobbying both candidates, Krause said. ASHP has pointed out that a public option for health coverage has the potential to increase covered populations. That could expand government negotiating power when it comes to issues such as patient access and drug pricing.

APhA is emphasizing the improved patient outcomes that pharmacists and pharmacy have produced from the expanded flexibility and practice that authorities put into place during the pandemic.

Caswell at NCPA is pushing the need for pharmacists to speak individually as well as through their organizations.

“We have a pandemic that has become political, and pharmacists have to get involved,” Caswell said. “A Republican mantra for a long time has been local control. And a Democratic mantra has always been patient choice. That’s a perfect combination of working with the patient-provider decision-making process and we pharmacists have to be part of that discussion. Pharmacists have to speak their mind, talk to every one of their candidates at the local, state, and federal levels, [and] utilize their contacts to get our message out there. If we can move our solutions, our personal relationships with patients, to be unencumbered by the payment system, we’re going to see better outcomes, happier patients, and happier pharmacists.”

What happens next in health care depends largely on
COVID-19, especially in light of the breaking news that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself. 