On The Cover
APhA staff
In this year-end wrap-up to 2020—a year we will never forget—we take a look at how the COVID-19 global health crisis unfolded and the ways in which pharmacists became
frontline players.
Timeline sidebars, as well as entries marked “APhA coronavirus watch,” refer to APhA’s pharmacist.com coverage of the pandemic.
The story of COVID-19 is far from over. Pharmacy Today will continue to cover the pandemic and how it touches the pharmacy world.
01.01.20
Chinese officials close the Huanan seafood market in Wuhan, suspected to be the source of a mystery illness.
01.07.20
China identifies a new coronavirus as the cause of the outbreak.
01.09.20
China reports its first death linked to the new coronavirus, 2019-nCoV.
01.21.20
CDC confirms the first U.S. case of a man in his 30s from Washington State who had traveled to Wuhan. The World Health Organization (WHO) confirms human-to-human transmission of the virus.
01.22.20
A WHO emergency committee decides that 2019-nCoV is not yet a global health emergency.
01.23.20
China places Wuhan under quarantine.
01.30.20
WHO declares the outbreak a global health emergency as cases worldwide top 9,000, reaching 18 countries outside of China.
01.31.20
The White House announces that it will ban entry for most foreign nationals who had traveled to China within the last 14 days.
02.02.20
The Philippines reports the first death from the virus outside of China.
02.03.20
China launches the clinical trial of Gilead’s antiviral drug remdesivir.
02.06.20
APhA coronavirus watch: In a survey by the National Community Pharmacists Association (NCPA), 54% of surveyed pharmacy owners said their patients are worried about the new coronavirus, 63% said their customers are buying surgical masks as a precaution, and 96% said they’re selling masks faster than they can restock. Many pharmacists reported shortages of hand sanitizers, surface sanitizers, and gloves. On the other hand, 32% of pharmacists said the new coronavirus is a significant public threat, 42% disagree, and 26% are unsure. The news coverage is clearly affecting consumer behavior, said Brian Caswell, president of NCPA.
02.07.20
WHO tells reporters there is a severe global disruption in the market for personal protective equipment, affecting access for frontline health professionals.
02.10.20
The death toll in mainland China rises to 909—surpassing that of MERS, which killed 858 people, and the SARS outbreak in 2002 and 2003, which killed 774 people.
02.11.20
WHO assigns an official name to the disease caused by the novel coronavirus: COVID-19. The global death toll reaches more than 1,000.
02.14.20
The first COVID-19 death outside of Asia is recorded in France.
02.25.20
CDC warns of the likely spread of the virus in the United States, saying, “It’s not a matter of if, but when.”
02.26.20
California announces the first U.S. cases with no clear source of exposure. The virus has now touched every continent except Antarctica.
02.27.20
APhA coronavirus watch: FDA reports the first drug shortage brought on by the COVID-19 outbreak.
02.29.20
A man in his 50s in Washington State becomes the first recorded death from the virus in the United States. President Trump announces travel restrictions involving Iran and increased warnings about travel to South Korea and Italy.
03.02.20
APhA coronavirus watch: APhA creates a resource center for pharmacists at www.pharmacist.com/coronavirus. The web page includes the latest from federal agencies and a decision tree document that helps pharmacists talk to patients with various levels of exposure to COVID-19.
03.06.20
President Trump signs an $8.3 billion emergency spending package.
03.07.20
Cases worldwide surpass 100,000.
03.10.20
Italy issues a nationwide quarantine. CMS reminds Medicare Advantage Organizations and Part D sponsors that they have the flexibility to remove prior authorization requirements, waive prescription refill limits, and relax restrictions on home or mail delivery of prescription drugs.
APhA coronavirus watch: Kentucky Gov. Andy Beshear announces an executive order allowing pharmacists to fill prescriptions for noncontrolled medications for 30 days, including an emergency refill, so patients can stock up and avoid going out to stores.
03.11.20
WHO declares the global COVID-19 outbreak a pandemic. President Trump announces travel restrictions on foreign travelers from 26 European countries.
APhA coronavirus watch: Florida Gov. Ron DeSantis signs into law a bill that allows pharmacists to test and treat patients with chronic illnesses and those with illnesses such as influenza and strep throat. The order also allows pharmacists to set up mobile stations in locations not designated as a pharmacy to ensure that homebound older adults and others in need have access to necessary medication.
03.13.20
President Trump declares a national state of emergency.
APhA coronavirus watch: CVS Health, Target, Walgreens, and Walmart join President Trump at the Rose Garden to announce plans to provide COVID-19 testing across the country. APhA sends a letter to the President’s Coronavirus Task Force urging it to maximize the use of pharmacists to prevent, treat, and respond to the virus. APhA releases a statement calling on the nation’s health insurers and PBMs to immediately remove administrative barriers to pharmacists and patients filling prescriptions early.
03.14.20
APhA coronavirus watch: FDA announces a temporary policy allowing pharmacists in state or federally licensed facilities to compound alcohol-based hand sanitizer.
03.16.20
San Francisco becomes the first U.S. city to impose a stay-at-home order. President Trump advises Americans to avoid gatherings of 10 or more people, going to bars and restaurants, and discretionary travel.
APhA coronavirus watch: CMS approves Florida’s request for a Section 1135 waiver, the first to be granted, giving the state flexibility in its Medicaid program.
03.17.20
West Virginia, the last U.S. state without a confirmed COVID-19 case, records its first one.
APhA coronavirus watch: APhA releases a statement on the importance of precautions to protect pharmacy personnel from exposure to COVID-19 as they care for patients and communities.
03.18.20
Canada and the United States agree to close their borders to all “nonessential traffic.” The Trump administration suspends refugee admissions, citing coronavirus concerns. President Trump signs the Families First Coronavirus Response Act, which provides free coronavirus testing and ensures paid emergency leave for people infected or caring for a family member with the illness. It also provides additional Medicaid funding, food assistance, and unemployment benefits.
03.19.20
Cases worldwide surpass 200,000. Italy overtakes China as the country with the highest death toll. California issues a stay-at-home order.
APhA coronavirus watch: APhA releases guidance for patients and caregivers on how to ensure adequate supplies of medication if they become unable to get to the pharmacy.
03.20.20
New York City becomes the country’s epicenter of the virus, with 5,151 coronavirus cases and 29 deaths. DEA issues guidance stating that a practitioner may issue a patient multiple signed and dated prescriptions for up to a 90-day supply of a Schedule II controlled substance, subject to specific conditions. Pharmacies may not dispense the substance prior to the prescription date.
APhA coronavirus watch: APhA and 11 other pharmacy organizations release a joint set of policy recommendations to Vice President Mike Pence’s COVID-19 Task Force and other appropriate agencies. Recommendations include authorizing pharmacists to order, collect specimens, conduct, and interpret tests and, when appropriate, initiate treatment for infectious diseases, including COVID-19, flu, and strep; easing operational barriers, including allowing telehealth; authorizing pharmacists to conduct therapeutic interchange and substitution without physician authorization when product shortages arise; and covering pharmacist-provided services if within their scope of practice.
03.21.20
In a tweet, President Trump promotes the use of hydroxychloroquine and azithromycin, taken together, as a potential treatment for COVID-19, despite lack of sufficient evidence for its effectiveness.
03.22.20
President Trump announces his intent to activate the federal National Guard to assist Washington, California, and New York, the three states hit hardest by the pandemic. FDA issues new guidance on patient access to REMS drugs.
03.24.20
Global COVID-19 cases surpass 400,000.
03.25.20
The U.S. Senate passes the Coronavirus Aid, Relief, and Economic Security (CARES) Act—without provider status for pharmacists. WHO warns that the United States could become the pandemic’s “global epicenter.” FDA issues an emergency use authorization (EUA) for ventilators, ventilator tubing connectors, and ventilator accessories.
03.26.20
The United States becomes the new epicenter of the pandemic, with 82,474 cases and more than 1,100 deaths.
03.27.20
President Trump signs the CARES Act into law.
03.28.20
FDA authorizes an EUA for a new, rapid coronavirus test that could give patients results in less than 15 minutes. The first known U.S. infant death from COVID-19 is reported in Illinois.
03.30.20
APhA coronavirus watch: DEA allows oral prescriptions of Schedule II controlled substances when they are needed for proper treatment, there are no appropriate treatment alternatives, and submitting an electronic or paper prescription to the pharmacy prior to dispensing is not possible.
03.31.20
FDA establishes the Coronavirus Treatment Acceleration Program to expedite the development of treatments. Hydroxychloroquine sulfate tablets and chloroquine phosphate tablets are added to FDA’s Drug Shortages list.
04.02.20
COVID-19 cases worldwide surpass 1 million, with more than 51,000 deaths.
04.03.20
The White House and CDC recommend Americans wear cloth face coverings in public. FDA says it will coordinate development of convalescent plasma and hyperimmune globulin, derived from human blood donated by people who have recovered from the virus, to treat patients with COVID-19.
APhA coronavirus watch: Pharmacists will be included in legislation creating a tax holiday for health professionals and first responders who continue to serve during the COVID-19 pandemic. The legislation, the Helping Emergency Responders Overcome Emergency Situations (HEROES) Act of 2020, initially did not include pharmacists as beneficiaries, but after a request from the APhA Government Affairs team, bill sponsor Rep. Bill Huizenga (R-MI) added pharmacists to the list.
04.05.20
Spain’s daily death toll falls for the third day in a row, and Italy’s falls to its lowest level in more than a week. President Trump advises parts of the country to brace for a peak of cases.
04.06.20
China reports its first day without deaths since the outbreak began. Pharmacy technicians are added to the HEROES Act.CDC releases pharmacy-specific guidance during the COVID-19 pandemic: “Considerations for Pharmacies in the COVID-19 Pandemic.”
04.07.20
APhA coronavirus watch: DEA allows increased production and importation of medications in high demand, including methadone, to ensure access to patients in opioid treatment programs.
04.08.20
China lifts its lockdown in Wuhan.
APhA coronavirus watch: The U.S. Department of Health and Human Services (HHS) authorizes licensed pharmacists to order and administer FDA-approved COVID-19 tests, including serology tests.
04.10.20
A New England Journal of Medicine (NEJM) report finds Gilead’s remdesivir showed improvements in two-thirds of severe COVID-19 cases.
APhA coronavirus watch: FDA issues an EUA for a blood purification system for adult patients with COVID-19 who are admitted to ICUs.
04.14.20
President Trump announces he will halt U.S. funding of WHO while a review is conducted to assess the organization’s role in “severely mismanaging and covering up the spread of the coronavirus.”
04.17.20
APhA coronavirus watch: APhA, the American Medical Association, and the American Society for Health-System Pharmacists update their March 25 joint statement to provide further clarification about inpatient use of certain medications compared with prophylaxis, the distribution and supply chain, safety considerations and adverse-event reporting, and the need for evidence to guide discussions and decisions.
04.21.20
An analysis by the Veterans Health Administration, the largest study of hydroxychloroquine to date, indicates that the two primary outcomes for patients with COVID-19 who were treated with the drug were death and need for mechanical ventilation.
04.24.20
FDA cautions against prescribing hydroxychloroquine to patients with COVID-19 outside of hospital settings or clinical trials, saying the drug could be deadly in some patients susceptible to heart conditions.
04.27.20
New York Gov. Andrew Cuomo says pharmacies can test essential workers for COVID-19.
04.28.20
APhA coronavirus watch: FDA authorizes the first at-home sample collection test for COVID-19.
04.29.20
The United States explores issuing an EUA for remdesivir after a study found it helped recovery from COVID-19. Some children with COVID-19 are experiencing symptoms similar to Kawasaki disease.
05.01.20
FDA issues an EUA for remdesivir, a potential COVID-19 treatment.
05.03.20
Researchers explore using a common blood-plasma treatment to fight COVID-19.
05.05.20
An experimental vaccine against COVID-19, developed by Pfizer and BioNTech, enters human testing in the United States and is being injected into healthy volunteers. New studies add to the evidence that children may transmit the coronavirus.
APhA coronavirus watch: FDA clarifies compounding rules for drugs in shortage during the pandemic.
05.09.20
FDA issues the first EUA for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic.
05.12.20
California Gov. Gavin Newsom announces an executive order allowing pharmacists to conduct COVID-19 tests.
05.14.20
CDC issues a warning about multisystem inflammatory syndrome in children, a condition associated with COVID-19.
APhA coronavirus watch: The Occupational and Safety Health Administration takes small but notable steps toward protecting pharmacy workers.
05.15.20
The Trump administration announces details about Operation Warp Speed, which aims to accelerate the development, manufacturing, and distribution of vaccines, medical treatments, and diagnostics for COVID-19 by January 2021.
05.19.20
APhA coronavirus watch: U.S. Health and Human Services (HHS) says pharmacists can test for COVID-19 regardless of state regulations.
Your state prohibits pharmacists from ordering and administering COVID-19 tests? Think again, said the HHS Office of the General Counsel. An advisory opinion clarified that licensed pharmacists may order and administer COVID-19 tests even in states or localities that prohibit or effectively prohibit it.
“This confirms the administration’s intent and confidence in pharmacists to provide expanded and widespread testing capacity for Americans across the entire country,” APhA said in a statement.
On April 8, 2020, the Office of the Assistant Secretary for Health (OASH) issued guidance authorizing licensed pharmacists to order and administer FDA-authorized COVID-19 tests, including serology tests, under the Public Readiness and
Emergency Preparedness (PREP) Act. OASH leads federal efforts to expand testing.
Some states issued declarations or made clear that licensed pharmacists can order and administer COVID-19 tests. Other states, however, have limited or prohibited pharmacists from performing these tests. The May 20 advisory opinion states that the PREP Act preempts state and local laws.
HHS has sent a letter condemning at least one state board of pharmacy that the agency claimed “sought to interfere unlawfully with President Trump’s efforts to provide expanded COVID-19 diagnostic testing.”
Such prohibition on testing at pharmacies is preempted by federal law and must stop immediately, the letter said.
Some questions remain—it’s still unclear if or how pharmacists can bill and be reimbursed for ordering and administering COVID-19 tests.
05.22.20
Hospitals report they are rationing remdesivir.
05.25.20
Preliminary results on use of remdesivir to treat COVID-19 are updated and published in NEJM.
05.26.20
WHO pauses its trial of hydroxychloroquine over safety concerns.
05.28.20
CDC revises its website to state that the virus “does not spread easily” from contaminated surfaces or animals.
05.29.20
Scientists question the validity of hydroxychloroquine research. The reliability of data from two recent COVID-19 studies that used the international Surgisphere database are called into question. One is a Lancet study that showed increased risks for mortality and arrhythmias with hydroxychloroquine and chloroquine. The other is a NEJM study examining the relationship between hypertension drugs and mortality in patients with COVID-19.
05.30.20
APhA coronavirus watch: New York, Ohio, and Maryland move toward allowing pharmacists to bill Medicaid for COVID-19 testing.
06.01.20
APhA coronavirus watch: CDC releases updated guidance for pharmacies during the pandemic.
APhA coronavirus watch: Patients with COVID-19 recover more quickly with remdesivir treatment, clinical trials show.
06.03.20
According to a randomized trial in NEJM, hydroxychloroquine does not prevent symptomatic COVID-19 when given to adults after a moderate- to high-risk exposure. The Trump administration selects five coronavirus vaccine candidates as finalists. After reviewing safety concerns, WHO resumes its hydroxychloroquine study for COVID-19.
06.04.20
APhA coronavirus watch: New guidance specifies data that COVID-19 testers must collect and report to HHS.
06.05.20
Authors retract studies that found risks of using antimalaria drugs against COVID-19.
06.09.20
APhA coronavirus watch: CDC releases revised vaccination guidance that will help pharmacists and other immunization providers administer vaccines to patients during the COVID-19 pandemic.
CDC notes that this updated guidance should be viewed along with specific guidance CDC issued for pharmacies in May.
CDC acknowledges the drop in routine vaccinations because of the COVID-19 crisis and states that “ensuring that routine vaccination is maintained or reinitiated during the COVID-19 pandemic is essential for protecting individuals and communities from vaccine-preventable diseases and outbreaks.” This is especially true for the upcoming influenza season. The agency goes on to say in the guidance that “influenza vaccination will be paramount to reduce the impact of respiratory illnesses in the population and resulting burdens on the health care system during the COVID-19 pandemic.”
According to CDC, immunization providers should focus influenza vaccination efforts on certain individuals such as essential health care workers (including pharmacy staff), people with an increased risk of severe illness from COVID-19, and people who are at high risk for influenza complications.
Overall, CDC encourages immunization providers to assess a patient’s vaccination status and to vaccinate when both pharmacist and patient are comfortable. In addition, patients need to be screened for fever and COVID-19 symptoms. If either is present, vaccination should be postponed until the patient no longer needs to be isolated. Patients older than 2 years who are coming into the pharmacy should wear a cloth face mask. Pharmacists and pharmacy staff need to wear a medical face mask at all times and eye protection based on the level of community transmission as outlined in any local guidance. The CDC guidance also discusses physical distancing, respiratory and hand hygiene, and surface decontamination. The key message is “vaccinate,” in accordance with local practice procedures and guidelines.
The guidance is expected to be updated as the pandemic evolves.
06.12.20
In two sets of guidelines, CDC encourages all individuals to wear masks as they go about their daily activities and advises on other coronavirus precautions at gatherings.
06.15.20
FDA revokes its EUA for hydroxychloroquine and chloroquine as COVID-19 treatments.
FDA warns about potential drug interactions related to remdesivir, which has received an EUA for the treatment of patients hospitalized with severe COVID-19.
FDA said it is revising the fact sheet for health care providers that accompanies remdesivir to indicate that “co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended, as it may result in reduced antiviral activity of remdesivir.”
CDC releases a report indicating that people with underlying medical conditions were hospitalized six times more often than otherwise-healthy individuals infected with the coronavirus during the first 4 months of the pandemic, and deaths were 12 times higher for this group.
06.16.20
New research indicates that dexamethasone, a widely available steroid, reduces mortality by one-third among patients hospitalized with COVID-19. The study was not published and had not undergone scientific scrutiny, but some experts felt optimistic.
06.17.20
WHO announces that clinical testing of hydroxychloroquine in a large, multinational trial of potential treatments against COVID-19 has stopped after new research indicates there was no benefit for patients.
06.20.20
The National Institutes of Health (NIH) reports that it halted its clinical trial of hydroxychloroquine after determining the drug has no benefit for patients with COVID-19.
06.25.20
APhA coronavirus watch: CDC updates and expands the list of who is most at risk for COVID-19 infection.
06.26.20
NIH’s COVID-19 Treatment Guidelines Panel adds a recommendation to prescribe dexamethasone for patients with COVID-19 who are mechanically ventilated or require supplemental oxygen.
06.29.20
APhA, along with a coalition of 12 other national pharmacy groups, sends a letter to HHS General Counsel Robert Charrow, urging the agency to act now to ensure these groups are able to provide vaccines for COVID-19 as they become available.
06.30.20
FDA releases guidance detailing its expectations for the development and licensure of a COVID-19 vaccine.
07.02.20
The daily number of new coronavirus cases in the United States tops 50,000 for the first time.
07.06.20
States mandate masks and begin to shut down again as coronavirus cases soar and hospitalizations rise.
07.07.20
The Trump administration sends a letter withdrawing the United States from WHO. Scientists warn of potential COVID-linked brain damage.
07.08.20
APhA coronavirus watch: President Trump’s decision to withdraw from WHO prompts a pharmacy response.
07.09.20
An updated scientific brief from WHO states that the coronavirus may remain in the air in crowded indoor spaces, so people should “avoid crowded places, close-contact settings, and confined and enclosed spaces with poor ventilation.” WHO also more strongly reaffirms that COVID-19 may be spread by people who are asymptomatic.
07.14.20
According to results published in NEJM, Moderna’s mRNA-1273 vaccine candidate against the coronavirus was largely safe and induced an immune response in humans in a Phase I trial.
07.15.20
WHO warns that the COVID-19 pandemic is lowering childhood vaccination rates worldwide.
07.16.20
An Annals of Internal Medicine study finds that hydroxychloroquine did not help patients with early and mild COVID-19. Major retailers such as CVS, Target, Walgreens, Kroger, and Walmart announce mask mandates for shoppers in their stores.
07.17.20
Preliminary results from a study showing a survival benefit with dexamethasone in COVID-19—previously reported by the researchers—is now published in NEJM.
07.20.20
Three of the world’s leading coronavirus vaccine developers report positive early results. Two of the vaccine developers—a partnership between Oxford University and AstraZeneca, and CanSino Biologics, a Chinese company—publish their preliminary findings as peer-reviewed research in the Lancet.
07.27.20
Moderna and Pfizer begin late-stage vaccine trials. JAMA Cardiology studies find that COVID-19 infections leave an impact on the heart.
07.29.20
FDA nears a decision authorizing COVID-19 treatment with convalescent plasma.
07.31.20
FDA authorizes the first tests that estimate a patient’s antibodies from past COVID-19 infection.
08.04.20
APhA coronavirus watch: Twenty-four national organizations representing patients, consumers, the medically underserved, public health advocates, physicians, and diverse health care providers send a letter to U.S. House and Senate leaders urging them to pay pharmacists for COVID-19 services to help underserved patients and make testing more accessible.
08.06.20
NIH announces the start of a randomized trial comparing remdesivir plus S.C. interferon beta-1a versus remdesivir alone in patients hospitalized for COVID-19. A study by South Korean researchers published in JAMA Internal Medicine suggests that people without COVID-19 symptoms carry as much of the novel coronavirus in their nose, throat, and lungs as those with symptoms, and for nearly as long.
08.09.20
A CDC study finds multisystem inflammatory syndrome linked to COVID-19 in nearly 600 U.S. children.
08.10.20
Gilead Sciences announces it filed for full FDA approval of remdesivir. More than 97,000 U.S. children test positive for the coronavirus in the last 2 weeks of July, more than a quarter of the total number of children diagnosed nationwide since March, according to data from the American Academy of Pediatrics and the Children’s Hospital Association.
08.11.20
Russian President Vladimir Putin announces that the country has become the first in the world to grant regulatory approval for a COVID-19 vaccine.
08.14.20
The Trump administration collaborates with McKesson for COVID-19 vaccine distribution.
08.18.20
WHO warns that COVID-19 is now driven by young people who don’t know they are infected.
08.19.20
APhA coronavirus watch: Pharmacists are authorized to provide childhood vaccinations during the pandemic.
HHS announced that it has expanded pharmacists’ authority to deliver vaccines to children ages 3 years to 18 years. The new authority includes all vaccines that are recommended by CDC’s Advisory Committee on Immunization Practices (ACIP) and authorized or licensed by FDA. The authority applies to pharmacists in all states, regardless of regulations restricting pharmacists from administering specific vaccines or limiting the age groups they may immunize.
In its authorization, HHS cited CDC data on the decline in routine pediatric vaccination rates as a reason behind the activation of pharmacists to administer vaccines during the public health emergency.
The leaders of 13 U.S. pharmacy organizations, including APhA, issued a statement praising the HHS order. “There are no greater public health priorities today than defeating the COVID-19 pandemic and protecting our nation from other vaccine-preventable diseases like the seasonal flu,” the statement read. “We need all-hands-on-deck to improve Americans’ access to life-saving vaccines during these difficult times.”
The groups were particularly pleased that the order supersedes state law. “In truth, the current patchwork of state laws makes little clinical sense and serves only to make it unreasonably difficult for parents to get their children vaccinated,” the groups wrote. “As members of the immunization neighborhood, we are committed to consistent collaboration, coordination, and communication with other health care professionals to address the public health needs of our patients and communities.”
“This is great news from HHS,” said Scott J. Knoer, MS, PharmD, FASHP, APhA executive vice president and CEO. “We have long advocated that pharmacists are uniquely positioned to address this public health emergency, and we worked with HHS to develop this strategy to engage all pharmacists. As Admiral Brett Giroir, the assistant secretary for health, said today, pharmacists have always been a trusted voice in the community, and they’re accessible. We couldn’t agree more!”
To participate in the new HHS authority, pharmacists must be licensed and have completed at least 20 hours of practical training approved by the Accreditation Council for Pharmacy Education; hold a current certificate in basic CPR; comply with their jurisdiction’s recordkeeping and reporting requirements; inform the patient’s primary care provider when available; and inform patients and adult caregivers of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate, among other requirements.
08.20.20
HHS reverses course on a change to the way hospitals report critical COVID-19 data to the government, returning the responsibility for data collection to CDC.
08.21.20
A JAMA study finds that a 5-day regimen of remdesivir may give patients with moderate COVID-19 a “modest clinical benefit.”
08.23.20
FDA issues an EUA for investigational convalescent plasma for treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.
08.24.20
Pharmacy organizations urge states to let pharmacies administer COVID-19 vaccines. The first documented case appears of an individual being reinfected with the coronavirus.
08.25.20
CDC says people without COVID-19 symptoms do not need testing.
08.28.20
FDA expands its EUA for remdesivir to now be authorized for use in all adults and children hospitalized with suspected or confirmed COVID-19, regardless of disease severity.
08.31.20
A CDC report says approximately 94% of the people who died from COVID-19 nationwide between the week ending February 1 and the week ending August 22 had other health conditions that contributed to their death.
09.01.20
A National Academies of Sciences, Engineering, and Medicine (NASEM) committee produces a discussion draft of a preliminary framework for fair distribution of a COVID-19 vaccine.
An NIH panel says convalescent plasma should not be regarded as a standard of care for COVID-19 until more study is conducted.
09.02.20
WHO recommends systemic corticosteroids to treat patients with severe and critical COVID-19. The guidance coincides with the publication in JAMA of three randomized trials and a meta-analysis on corticosteroids.
09.03.20
A JAMA Network Open study finds vitamin D deficiency may boost COVID-19 risk.
09.04.20
APhA coronavirus watch: A letter signed by APhA and 12 other pharmacy organizations urges NASEM to prioritize the COVID-19 vaccination of pharmacists and pharmacy staff and to prominently include pharmacists in plans for the allocation and distribution of the COVID-19 vaccine.
WHO says widespread COVID-19 vaccinations are not expected until mid-2021.
09.09.20
HHS authorizes pharmacists and pharmacist interns to order and administer COVID-19 vaccines that have been approved or licensed by FDA to all individuals ages 3 years or older.
09.15.20
New CDC data reveal that COVID-19 fatalities among children and young adults are low but have disproportionately affected minorities.
09.16.20
New documents released by HHS, developed in coordination with the U.S. Department of Defense and CDC, outline a strategic distribution plan and provide an interim playbook for state, tribal, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their jurisdictions.
09.18.20
CDC reverses COVID-19 testing guidance suggesting that individuals who had close contact with an infected individual “do not necessarily need a test.” Now, the agency recommends to people who have been in close contact with a person infected with the coronavirus: “You need a test.”
09.21.20
The National Medical Association announced the formation of its COVID-19 Commission on Vaccines and Therapeutics. Lakesha Butler, PharmD, of Southern Illinois University Edwardsville is appointed as the only pharmacist to serve on the commission, which will evaluate potential treatment options for COVID-19—including vaccines currently in clinical trials—and then evaluate the clinical trial processes. The name “Operation Warp Speed” has raised concerns, especially among Black communities, that speed will be prioritized over safety and efficacy.
Countries representing about 64% of the world population signed up to expand global access to COVID-19 vaccines by funding a purchasing pool organized by WHO and other nonprofit groups. China, Russia, and the United States are not among them.
09.23.20
FDA authorizes the first point-of-care antibody test for COVID-19.
09.28.20
The global COVID-19 death toll passes 1 million, according to case counts from Johns Hopkins University.
10.2.20
President Trump and First Lady Melania Trump test positive for COVID-19.
APhA coronavirus watch: NASEM releases its final report on an allocation framework for COVID-19 vaccines and moves vaccinating pharmacists to Phase 1a priority status because they are “frontline health care workers” and “willing providers” operating in areas of higher community transmission. The report will be provided to CDC’s ACIP for consideration in its deliberations.
10.5.20
After much back and forth, CDC acknowledges that the coronavirus is only sometimes spread via airborne transmission.
10.8.20
Hydroxychloroquine use is not associated with lower mortality rates in COVID-19, according to an NEJM study. Remdesivir has a benefit over placebo for patients hospitalized with COVID-19 who are showing signs of respiratory tract infection. The final analysis, published in NEJM from the ACTT-1 study, concludes.
10.13.20
APhA coronavirus watch: A special committee of the NASEM tasked with developing a framework on the allocation and distribution of the COVID-19 vaccine agrees that pharmacists should be included in the first group to be vaccinated.
10.14.20
Pfizer intends to test its experimental coronavirus vaccine in children as young as 12 years old, marking the first vaccine trial for COVID-19 in the United States involving children.
10.15.20
Remdesivir, the only antiviral drug sanctioned by FDA to treat COVID-19, does not reduce patient mortality, WHO’s “Solidarity” study has concluded.
10.16.20
The U.S. government announces exclusive agreements with CVS and Walgreens for early-phase COVID-19 vaccine administration to residents of long-term-care facilities nationwide.
10.21.20
APhA coronavirus watch: Pharmacy interns and techs who meet U.S. Department of Health and Human Services (HHS) requirements can administer childhood, COVID-19 vaccines.
HHS releases guidance that expands the immunization authorities of state-licensed pharmacy interns and “qualified” pharmacy technicians during the public health emergency. Interns and technicians who meet conditions set forth by HHS will be allowed to administer childhood vaccines (ages 3–18 y) recommended by the Advisory Committee on Immunization Practices (ACIP) and FDA-authorized or licensed COVID-19 vaccines and tests (ages 3 y and older), including serology tests. They will also be granted liability coverage for these duties during the public health emergency.
According to the new guidance, to be deemed a “qualified person” under federal law—that is, authorized and granted liability coverage to administer these vaccines and tests—qualified pharmacy technicians and state-authorized pharmacy interns must satisfy and practice under the following requirements:
- The pharmacy intern must be authorized by the state or board of pharmacy in the state in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the state board of pharmacy.
- To be a “qualified pharmacy technician,” pharmacy technicians working in states with licensure and/or registration requirements must be licensed and/or registered in accordance with state requirements; pharmacy technicians working in states without licensure and/or registration requirements must have a CPhT certification from either the Pharmacy Technician Certification Board or National Healthcareer Association.
- The vaccination must be ordered by the supervising qualified pharmacist.
- The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
- The vaccine must be FDA authorized or FDA licensed.
- COVID-19 vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendations.
- Childhood vaccines must be ordered and administered according to ACIP’s standard immunization schedule.
- The qualified pharmacy technician or state-authorized pharmacy intern must complete an Accreditation Council for Pharmacy Education (ACPE)–approved practical training program. This program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
- The qualified pharmacy technician or state-authorized pharmacy intern must have a current certificate in basic CPR.
- The qualified pharmacy technician must complete a minimum of 2 hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant state licensing period.
- The supervising qualified pharmacist must comply with record-keeping and reporting requirements of the jurisdiction in which they administer vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system—for example, a vaccine registry.
- The supervising qualified pharmacist is responsible for complying with requirements related to reporting adverse events.
- The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or state-authorized pharmacy intern.
- The qualified pharmacy technician and state-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.
- The supervising qualified pharmacist must comply with any applicable requirements or conditions of use as set forth in CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccines.
The guidance applies to all states, even those where state and local laws prohibit or effectively prohibit pharmacists, pharmacy interns, and pharmacy technicians from administering tests and vaccines. States and local laws that permit health care providers beyond pharmacists, state-licensed pharmacy interns, and qualified pharmacy technicians are not preempted—HHS guidances do not affect such laws.
10.22.20
FDA approves the first treatment for COVID-19. The agency approves remdesivir for use in adult and pediatric patients ages 12 years and older who weigh at least 40 kg (about 88 lb) for treatment of COVID-19 requiring hospitalization.
10.23.20
APhA and NASPA get HHS clarification to overcome state barriers to pharmacist vaccinations. AstraZeneca and Johnson & Johnson announce that their respective trials of potential COVID-19 vaccines are ready to resume, after each was temporarily halted to investigate serious adverse events in study participants.
10.26.20
An independent panel finds that combination therapy with Gilead Science’s remdesivir and Eli Lilly’s antibody drug does not help patients hospitalized with COVID-19, prompting NIH to end a trial testing the intervention.
10.27.20
CMS says Medicare and Medicaid will cover costs of future COVID-19 vaccine under new policy.
10.28.20
CMS releases a comprehensive plan announcing that new providers are now able to enroll as “Medicare mass immunizers” through an expedited 24-hour process. Providers wishing to participate in the expedited process must call the agency’s provider enrollment hotline. The ability to easily enroll as a mass immunizer applies to some pharmacies and other entities that may be nontraditional providers or otherwise not eligible for Medicare enrollment.
10.30.20
CDC enlists CVS Health, Walgreens Boots Alliance, Walmart, Kroger, Publix Super Markets, and several other pharmacy chains to be COVID-19 vaccination partners.
10.31.20
The United States reports more than 100,000 COVID-19 cases in a single day, setting a new world record.
11.2.20
CDC adds pregnancy to the list of conditions that elevate the risk of morbidity and mortality in patients with COVID-19.
11.9.20
Pfizer and BioNTech report that the first analysis of its COVID-19 vaccine indicates it’s 90% effective.
President-elect Joe Biden’s transition team announces the members of its
COVID-19 task force.
11.10.20
U.S. reports a total of 10,111,077 COVID-19 cases and 238,256 deaths.
This timeline is current as of press time.