Troy Trygstad, PharmD, PhD, MBA, editor in chief

Starting that fateful week in March 2020 when everyone’s life changed, health care settings closed their doors en masse.

From primary care to ambulatory surgery, physical therapy to massage therapy, nearly every setting of care suspended operations, except for emergency departments connected to hospitals and pharmacies. Yes, pharmacies. More than 60,000 remained open to patients, and most pharmacists continued their role as a source for OTC products and the free-of-charge counseling that often goes with them.

Telemedicine grew at an unprecedented rate starting in April 2020, but it did not entirely fill the health care void. Individuals needing acute medications, dose adjustments, or treatment for chronic diseases lost direct access to practitioners, but pharmacies remaining open meant patients could still receive their lifesaving medications. Of course, foot traffic slowed, and the flu was practically nonexistent in 2020, but hundreds of millions of Americans had access to basic triage, care delivery, medications, and testing supplies.

More than 80% of adults use OTC products as first-line treatment for common ailments. With Americans making approximately 3 billion trips to purchase OTC products annually and 60 million Americans using them who would otherwise not seek treatment, patient access to these products is essential to a well-functioning health care system. It is inconceivable these days to schedule an office visit, procure a prescription, and have it adjudicated by insurance just to get ibuprofen for an ankle sprain. A prescription for loratadine? Laughable. Yet less than 2 decades ago, nonsedating antihistamines were deemed too unsafe to be sold over the counter.

Making products available without a prescription does not have to mean patients go without care. Pharmacists and other health care professionals can counsel patients on all types of accessible and affordable OTC products. Does an Apple Watch’s electrocardiograph or pulse oximetry app keep patients from seeing their cardiologists? Do pregnancy tests keep women from visiting their gynecologists? Do wetting drops prevent patients from going to their ophthalmologists?

Do niacin or omega oils keep patients from getting their cholesterol checked? The answer to all these questions is no. Pharmacists have multiple encounters with patients every day, and most are just as meaningful to a patient’s care as billable encounters.

Expanding Access Through OTCs and Testing

COVID-19 self-administered testing is approved and available. Health plans have picked up on the power of patient convenience. Waning resistance against self-empowerment, which the pandemic necessitated, has enlisted a host of home-based diagnostics providing accessible and affordable screening and rescreening directly to health plan members—without a prescription. Need to improve A1c testing and reporting? Why not look to pharmacies or even send the tests directly to patients’ residences?

Postpandemic Self-Care and OTC Product Use

We are only a summer away from what will likely be the first widely prevalent cough and cold season of asthma flare ups, influenza, middle-ear infections, and rhinovirus in nearly 2 years. As social distancing and masking disappear, we will again share microbes. Disease surveillance and patient care will still have a prime spot in the consciousness of the frontline pharmacist’s mind in all seasons. Education, triage, testing, and counseling have a greater meaning and purpose than ever before, and much of this purpose is enabled by access to OTC products.

is vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 2000 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and a PhD in pharmaceutical outcomes and policy from the University of North Carolina. He also serves on the board of directors of the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.

OTC use statistics. Consumer Healthcare Products Association. Accessed May 24, 2021. https://www.chpa.org/about-consumer-healthcare/research-data/otc-use-statistics

Articles

COVID-19 permanently changed how pharmacists recommend and sell nonprescription options.

OTC Products Are Accessible When Traditional Health Care Delivery Is Not

it is hard to believe that it has been 8 months since the US Department of Health & Human Services (HHS) sent out a notice declaring that pharmacists can order and perform coronavirus disease 2019 (COVID-19) testing nationwide.

It feels so recent, perhaps because of its gravity. Subsequent expansions of service authorizations have happened since then with testing and now vaccine administration. And why not? There are 65,000 pharmacies in communities across the United States that are perfectly capable of such activities essential to the pandemic response.

WHAT STAYED OPEN BESIDES EMERGENCY DEPARTMENTS AND HOSPITALS? PHARMACIES 

I anticipate that we will see some interesting studies and white papers produced in 2021 that analyze health care use patterns in 2020, particularly in the last 2 weeks of March. When everything else shut down, patients still went to pharmacies, and many pharmacies responded with agile innovations, from curbside pickup to rearranging foot traffic to telepharmacy, long before retailers and medical clinics initiated these needed changes. Hundreds of millions of Americans conditioned themselves during those early weeks of the pandemic to think of pharmacies as accessible, trusted services providers, not retailers.

A NO-BRAINER: PHARMACIES AS MASS VACCINATORS, SCREENERS, AND POINT-OF-CARE TESTERS 

How do we reach 350 million Americans with COVID-19 vaccinations over the course of a couple months? Ask every one of the 65,000 community pharmacies in the country to administer 90 vaccinations every day for 60 days. That is not on the hard pile. The potential scale of mass screening, testing, and vaccinating by pharmacists practicing in pharmacies is unparalleled.

NEW AT-HOME TESTING BUT NOT WITHOUT THE ORDER AND THE SERVICE 

New FDA-authorized home testing kits for severe acute respiratory syndrome coronavirus 2 are now available. Convenience and safety are king, but the need for ordering and counseling remains. The trend toward at-tome testing (see Cologuard and others) and at-home devices (eg, remote patient monitoring) will continue long after the pandemic has abated, but the friction between easy procurement in the community and navigating a complex, expensive system of providers of care to get devices, medications, and now even computer programs (yes, there is one for children with attention disorder) remains. The procurement and use are the easy parts, but getting the prescription is the pain in the butt.

EXPANDING AND PRESERVING THE ROLE OF RAPID-RESPONSE CARE DELIVERY (UNDER PROTOCOL) 

Fortunately, pharmacists have received the authority to order COVID-19 testing and have procured blanket authorizations for initiating immunizations across the country. And consumer expectations have changed to the point of no return, despite any future expiration of emergency authorization. Pharmacies are in an ideal position for screening, testing, and triaging the most straightforward ailments and making referrals when necessary. It’s Public Health 101: accessible, engaging, trained, and trusted.

Yes, the third rail of internecine health care professional politics is the initiation of pharmacotherapy, the final frontier. It seems so silly though, right? Pharmacists can do most everything except the thing they were best trained for: selecting medications and counseling on their use. Why do we continue this charade? Physicians have been so defensive about pharmacist-initiated therapy for so long, even when involving a limited set of medications under a strict set of circumstances and criteria, that they lost sight of the tens of thousands of nurse practitioners (NPs) and physician assistants (PAs) displacing them at breakneck speed. Physicians should be partners with pharmacists, not adversaries, and the same goes for NPs and PAs.

YES, MEDICATIONS TOO. READ ON BEFORE FREAKING OUT. REMEMBER LORATADINE BY PRESCRIPTION? 

Examples abound, from the mildly counterintuitive to the patently absurd circumstances where medications come to market as prescription only, with very little risk for mis-prescribing, and yet pharmacists are not allowed to initiate them. Remember Claritin by prescription? I remember a few decades ago watching a rather large meeting of industry and provider panelists conclude that Claritin should not be moved OTC because doing so would pose a threat to public safety. The panelists argued that despite Claritin’s impeccable adverse effect profile, too many individuals would not be seen for more serious conditions that may lie beneath the sneeze if such a product were accessible without a health care professional’s evaluation. Then it went generic, immediately went OTC, and we never heard concerns again. There was no public health crisis.

AND DIPHENHYDRAMINE? WHAT IS THE EXCUSE FOR KEEPING THAT OTC? 

Meanwhile, diphenhydramine, a medication that is dangerous without proper assessment of patient risk and ongoing monitoring, remains widely available. Diphenhydramine has a long rap sheet of “do not use” advisories, such as the Beers Criteria for older adults. Yet it continues to be available to anyone, anywhere, without a health care professional’s consultation. Why was loratadine so dangerous that pharmacists could not initiate it, but diphenhydramine is not?

The health care system is long overdue for a renewed discussion of a third class of devices, medications, and tests that can be initiated or ordered by multiple health care professionals, including pharmacists. There are myriad reasons for allowing pharmacists to serve their communities in this way—the growth of health savings accounts that require a prescription for needed coverage, large swaths of the population that avoid traditional care, the loss of primary care in rural areas, underserved populations that cannot access or afford traditional care, or a pandemic. It makes economic and moral sense, and now because of COVID-19, it is making a lot more sense to the average health care consumer.

, is the vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 1800 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and his PhD in pharmaceutical outcomes and policy from the University of North Carolina at Chapel Hill. He also serves on the board of directors for the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.

The COVID-19 pandemic has shed light on the need to further expand the accessible, trusted care provided by community pharmacies.

It Is Time for a Third Category of Devices, Medications, and Tests

Americans are frustrated by high drug prices, even though 80% of the money spent on prescription drugs goes toward just 10% of prescription fills.

Increasingly, lifesaving drugs that come to the market with eye-popping price tags are fodder for advocates claiming that health care costs out of control. Americans rate high drug prices as their No. 1 health care issue in surveys, with increasing support for direct government negotiations for the Medicare program.

 (Note that money spent on prescription drugs is still less than 10% of our national health care spend after rebate).

Pharmacy benefit managers (PBMs) are having a hard time staying out of the news. Much of the public awareness of PBMs started with a May 2018 CBS “60 Minutes” investigation into Rockford, Illinois, municipal employees overusing 6-figure medications, highlighting how everyone in the supply chain makes more money, the more money that spent.

 Chief among the criticism was a lack of fiduciary duty on the part of the PBMs for not putting the clients’ best interests first. Arkansas, Ohio, and many other states since have had high-profile, publicly released findings of hundreds of millions of payments to PBMs in question, through journalistic as well as government auditors. The New York State Comptroller found in September 2020 that more than $700 million in questionable payments for pharmaceuticals had been made by the Medicaid program, affirming support for the state’s plans to move back to a transparent fee-for-service reimbursement model.

Not long ago, California became so frustrated with the lack of supply chain transparency, the state proposed group purchasing for its drug supply and then took the extraordinary step in 2020 of proposing to manufacture its own brand of generic drugs.

 When next-generation hepatitis C medications came to the market, Louisiana proposed purchasing an unlimited supply of medications for a fixed price for all the state’s Medicaid enrollees rather than use the traditional system, which would deny patients who had not progressed as far with the disease.

 It seems to make sense to pay a fixed amount and attempt to cure everyone with hepatitis C, rather than pay a little less and treat a much smaller number of enrollees, leaving the asymptomatic or latent stage patients to progress toward morbidity and mortality.

More recently, the Defense Production Act (DPA) has been dusted off and used or proposed for procuring personal protective equipment, point-of-care testing analyzers, test kits for COVID-19, and ventilators. Passed originally in 1950 in response to the start of the Korean War, the DPA authorizes the US government to compel the private sector to prioritize government purchase of products and services necessary for national defense. This year, the DPA was used to take at least 15,000 point-of-care testing analyzers off the market and to be given to skilled nursing facilities. In late August 2020, Abbott was awarded a deal for $760 million to deliver 150 million rapid result tests, which could be potentially deployed to schools and used to serve other special needs populations.

A Workaround That Has Been Around But Not Used Prior At Scale 

Oh, Canada! Your drugs are cheap and safe. Americans can still choose to travel to Canada to purchase their medications (assuming that the border is open), but reimportation is not part of the commercial supply chain. Recently, the Trump administration announced its intention to allow states to import drugs from Canada. Long discussed but heavily lobbied against, reimportation has been an active policy discussion for more than 2 decades and was arguably the final impetus to pass Part D provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 as reliable elderly voters increased the pressure for affordable medications. The announcement was short on details but precedent-setting, nonetheless.

Direct Government Subsidization of Patient Consumer Purchases 

Also in September 2020, the Trump administration announced a plan to send $200 discount cards to Medicare enrollees, ostensibly for offsetting enrollee cost sharing. Much like with reimportation, drug discounts and subsidies direct from the federal government are directives without details. Although some may dismiss the effort as simply an election-year overture, the idea of going around the traditional third-party system of health care financing and administration (PBMs and insurance plans) could gain traction. Future politicians may see this government-administered direct subsidy option as an “easy button” way to impose policy into the private marketplace.

Direct negotiation of drug prices and a national formulary seem to be on the table. Government ownership of parts and pieces of the supply chain are under way. Direct contracting for services with pharmacies has already happened through COVID-19 collection site contracts and potentially will happen in 2021 with COVID-19 vaccination. Pharmacy reimbursement could come into play. Basing reimbursement of pharmacy acquisition cost through surveys is already popular among Medicaid programs through National Average Drug Acquisition Cost pricing. Could we move in the direction of other countries, where pharmacy reimbursement is set by the government through negotiation with the private sector rather than letting the private sector determine such reimbursement? Leaving the merits aside, it is not farfetched to make the argument that community pharmacies are an essential workforce for chronic disease, national defense, and pandemics, and thus ought to have a national reimbursement floor for each prescription dispensed.

Levy NM. High drug costs outweigh ‘Medicare for all’ as top healthcare issue for voters. 

. January 21, 2020. Accessed October 4, 2020. https://www.latimes.com/politics/story/2020-01-21/high-cost-prescription-drugs-campaign-issue.

Stahl L. The problem with prescription drug prices. 

. May 6, 2018. Accessed October 4, 2020. https://www.cbsnews. com/news/the-problem-with-prescription-drug-prices/

Fries A. DiNapoli: New York paid over $700M in improper Medicaid benefits. 

. September 22, 2020. Accessed October 4, 2020. https://www.timesunion.com/news/article/DiNapoli-New-York-paid-over-700M-in-improper-15587144.php

Lin J, Aguilera E. Gov. Gavin Newsom to proposed that California manufacture its own generic drugs. 

. July 8, 2020. Accessed October 4, 2020. https://calmatters.org/health/2020/01/gavin-newsom-to-propose-california-manufacture-state-generic-drugs/

Deslatte M. Louisiana reaches ‘Netflix-model’ deal to tackle hepatitis C. Associated Press. June 26, 2019. Accessed October 4, 2020. https://apnews.com/article/bc074b5c06024926a5c58163de-8bab9d