Shingles, or herpes zoster (HZ), is a common viral infection that affects about 1 million individuals in the United States each year. Long considered to be primarily a health concern for the elderly, 

 are on the rise in younger age groups. Approximately half of the population that reaches 80 years of age will experience shingles, sometimes with 

 that are long lasting and life changing.

Despite abundant available information about shingles, plenty of myths remain in circulation that can endanger not only individuals who are most at risk, but also the population at large. 

 addresses some of those misconceptions with the help of Jeffrey Cohen, MD, chief, Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases.

 Shingles is caused by a reinfection of the varicella zoster virus (VZV).

 Shingles occurs when the opportunistic VZV, which has laid dormant in the body’s nervous system since an earlier episode of chickenpox, 

 decades later and takes a different path. “During chickenpox, the virus spreads in the bloodstream and it infects skin potentially all over the body, as well as organs in the body,” Cohen explained. “But during reactivation in healthy people, the virus spreads from the ganglia along the nerves to the skin.”

 The shingles rash is the worst aspect of the infection.

 Although the rash is a painful and unsightly 

, it typically resolves within a few weeks. However, in up to 20% of all shingles cases, patients develop a debilitating and far more serious condition known as postherpetic neuralgia (

). “Postherpetic neuralgia is unrelenting pain for weeks to months or even a year or more,” said Cohen, who calls it the major shingles concern. “There is clear medication for postherpetic neuralgia, but just like everything else in the elderly it has more side effects and it doesn’t truly get rid of all the pain.”

 VZV can reactivate as shingles more than once.

 Cohen said the vast majority of people who experience shingles have only 1 episode, although it depends primarily on an individual’s 

. “Typically, if one gets shingles, it might be another 20 years before the immune system declines and doesn’t recognize the virus as strongly, and people can get a second episode,” he said.

 is the varicella zoster virus, which spreads easily through the air. If a person with no immunity to VZV is infected with it, they are likely to develop chickenpox. The virus will then go dormant in their nervous system, with the potential to reactivate at a later date. “If somebody in the family has zoster, keeping the lesions covered makes it less likely that it’s going to spread in the air,” Cohen advised.

 If a person already has VZV in their body, little can be done to prevent shingles.

 has been proven to drastically reduce a person’s risk of developing shingles. “Shingrix is about 90% protective against zoster in people who are 70 and above, and about 97% in people who are 50 to 69 years old,” noted Cohen.

Shingrix is recommended for use in immunocompetent individuals age 50 and older, and is administered in 2 doses given 2 to 6 months apart. It is included on the CDC’s Advisory Committee on Immunization Practices’ 2021 

Articles

Addressing misconceptions about herpes zoster.

5 Myths About Shingles

70.5 million coronavirus disease 2019 (COVID-19) vaccine doses

 administered in the US as of this article’s press time, keeping up with pandemic news is more important than ever. Check back to 

 to stay informed on the latest coronavirus-related news and research.

 Colin Banas, chief medical officer at DrFirst, illuminated the key issues surrounding the upcoming deadline for the information blocking rule, a component of the 21st century Cures Act, and its impact on community pharmacies.

Don’t miss our upcoming Over the Counter episode with Drew Hegi and Bob Graul of First Financial Bank. Hegi and Graul are seasoned experts in pharmacy lending and spoke with 

 about what it takes to succeed in pharmacy ownership.

Upcoming Webinar on Integrating CBD Into Your Pharmacy

This Wednesday, don’t miss our webinar with Chris Howard, VP, general counsel and chief compliance officer, and Mike Sullivan, director, trade marketing of E-Alternative Solutions, who will be joining 

® for this 1-hour webinar to address these concerns and equip you with the knowledge to effectively navigate the CBD industry.

 will soon be available on DrugTopics.com. In this issue, pharmacists offer advice on how to approach complementary and integrative therapies, and our cover story, in celebration of Women’s History Month, highlights the achievements from women in pharmacy practice.

In Case You Missed It: Examining Potential Mechanisms of Comorbid Bipolar Disorder and Migraine

In a systematic review, investigators aim to understand the mechanisms for comorbid bipolar disorder and migraine, as well as therapeutic targets.

Here’s a preview of the featured content to watch for this week on Drug Topics®.

This Week on Drug Topics: March 1 to 5

Approximately 50% of patients hospitalized for severe COVID-19 and with elevated troponin levels presented lasting heart damage, including myocarditis, infarction, ischemia, as well as combinations of all 3, according to a recent study.

Investigators from London, United Kingdom, utilized multi-parametric cardiovascular magnetic resonance (CMR) to diagnose causes of elevated troponin in patients who recovered from SARS-CoV-2.1 The study, published in the 

Acute respiratory infections and sepsis are often indicative of elevated serum troponin levels in hospitalized patients, which may lead to death even after a patient’s recovery, investigators explained.

The study recruited 148 patients with severe infection of the virus, defined as requiring hospitalization, and 48% of which additionally required ventilation support, who experienced troponin elevation up to June 2020 among 6 hospitals across 3 NHS Foundation trusts: Royal Free London, Imperial College Healthcare, and University College London Hospital.

COVID-19 infection was diagnosed through either:

a positive combined oro/nasopharyngeal throat swab or tracheal aspirate for SARS-CoV-2 by reverse-transcriptase-polymerase chain reaction (PCR), or

a negative SARS-CoV-2 swab with a demonstration of illness, including cough, fever, myalgia, as well as typical blood biomarkers and high likelihood of viral infection.

Following hospital discharge, the 148 patients with an abnormal high-sensitivity troponin (hsTnT14 ng/L for Royal Free and UCLH; hsTnI14 ng/L for females and 30 mL/min/m2 for males for Imperial) underwent CMR scans. All volunteer participants did not have symptoms or a history of cardiovascular disease or hypertension, and the control group was matched for age, gender, diabetes, and hypertension but with no clinical suspicion of myocardial injury, including myocardial infarction (MI) or myocarditis.

Of the 148 patients, 133 underwent a full tissue characterization protocol (LGE, T1 and T2 mapping). Investigators reported that the mean age of patients was 64 12 years, with 70% of patients being male (104). Eighty-six percent (128) of patients were PCR-positive, and 93% (138) presented typical symptoms of COVID-19. Additionally, the median length of stay in the hospital was 9 days; 32% (48) of patients required admission to the intensive care unit in order to receive ventilation support.

As for cardiac function, left ventricular dysfunction was present in 11% (17) of patients, with 9 cases a result of myocardial infarction, 6 of whom had a history of ischemic heart disease. The average right ventricular ejection fraction (RVEF) was 61% 9% and was the same in the healthy volunteers (RVEF 61% 5%, 

 = 0.85); however, RVEF was lower in the matched control group (RVEF 64% 7%, 

After follow up of at least 1 month, scarring or injury to the heart muscle was found in 54% (80) of patients, stemming from inflammation (26%), infarction or ischemia (22%), or both (6%), with 8% of patients showing ongoing heart inflammation, according to investigators.

"These findings give us 2 opportunities: firstly, to find ways of preventing the injury in the first place, and from some of the patterns we have seen, blood clotting may be playing a role, for which we have potential treatments,” said co-lead researcher Marianna Fontana, professor of cardiology at University College London, United Kingdom.

“Secondly, detecting the consequences of injury during convalescence may identify subjects who would benefit from specific supporting drug treatments to protect heart function over time.”

Study authors stipulated that it remains uncertain whether the findings demonstrate preexisting disease or that brought on by COVID-19, and more research is necessary.

“We found evidence of high rates of heart muscle injury that could be seen on the scans a month or 2 after discharge. Whilst some of this may have been preexisting, MRI scanning shows that some were new, and likely caused by COVID-19,” Fontana said.

“Importantly, the pattern of damage to the heart was variable, suggesting that the heart is at risk of different types of injury. While we detected only a small amount of ongoing injury, we saw injury to the heart that was present even when the heart's pumping function was not impaired and might not have been picked up by other techniques. In the most severe cases, there are concerns that this injury may increase the risks of heart failure in the future, but more work is needed to investigate this further."

1. Kotecha T, Knight DS, Razvi Y, et al. Patterns of myocardial injury in recovered troponin-positive COVID-19 patients assessed by cardiovascular magnetic resonance. 

https://doi.org/10.1093/eurheartj/ehab075

2. Damage to the heart found in more than half of COVID-19 patients discharged from hospital. News release. European Society of Cardiology; February 18, 2021. Accessed February 24, 2021. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Damage-to-the-heart-found-in-more-than-half-of-COVID-19-patients-discharged-from-hospital 

Investigators used MRI scans of the heart to identify whether heart injury was caused by COVID-19 infection.   

Study Results Show Half of Severe COVID-19 Patients Have Damage to the Heart 

Officials with the FDA recently announced updates to required storage and transportation conditions for the Pfizer-BioNTech COVID-19 vaccine.

The agency is now allowing undiluted frozen vials of the Pfizer-BioNTech vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezer for up to 2 weeks. Previously, the preferred storage of undiluted vials were ultra-low temperature freezers between -80 degrees and -60 degrees Celsius, or -112 degrees and -75 degrees Fahrenheit.

The updated guidance is based on data submitted by Pfizer to demonstrate that the COVID-19 vaccine remains stable after storage of the undiluted vials in the standard freezer temperature. The alternative temperature for storage is not applicable to the storage of thawed vials before dilution, which can be held at refrigerator temperature or room temperature for use within 6 hours.

“This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”

The updates are reflected in the agency’s 

Facts Sheets for Health Care Providers Administering Vaccine (Vaccination Providers)

, which are available on the FDA website.

1. Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine. News release. FDA; February 25, 2021. Accessed March 1, 2021. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer

The FDA is allowing more flexible storage and transportation conditions for Pfizer-BioNTech’s COVID-19 vaccine. 

FDA Updates Storage, Transportation Guidance for Pfizer-BioNTech COVID-19 Vaccine

The FDA has granted emergency use authorization (EUA) to Johnson & Johnson for its COVID-19 vaccine following an advisory panel meeting on Friday.

The vaccine, named Ad26.COV2.S, is the first single-dose COVID-19 vaccine and the third vaccine to be authorized in the US for the virus.

The EUA is based on the phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.

As part of its authorization, the FDA noted it is mandatory for Janssen Biotech and vaccination providers to report the following to the Vaccines Adverse Event Reporting System for Janssen COVID-19 Vaccine: serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death. 

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA, through our open and transparent scientific review process, has now authorized 3 COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

 for more information on the vaccine’s efficacy and safety data. 

1. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. News release. FDA; February 27, 2021. Accessed February 27, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.

FDA Grants Emergency Use Authorization to Third COVID-19 Vaccine

A panel of advisors to the FDA voted 22 to 0 to recommend the Janssen vaccine, named Ad26.COV2.S, for emergency approval, according to the FDA Advisory Committee Meeting held on Friday. The decision moves Ad26.COV2.S one step closer to receiving emergency use authorization (EUA) by the FDA. If approved, it will be the first single-dose vaccine for COVID-19 and the third vaccine to be authorized in the US for the virus.

Although both Pfizer and Moderna utilized messenger RNA (mRNA) technology, the Johnson & Johnson vaccine is an adenovirus-based vaccine that employs a portion of genetic material from a weakened pathogen in order to induce an immune response. The company leveraged its AdVac vaccine platform that has also been previously deployed to investigate Zika, RSV, and HIV investigational vaccine candidates.

Janssen’s request for EUA for its vaccine is based on its phase 3, randomized, double-blind, placebo-controlled ENSEMBLE clinical trials, which met all primary and key secondary end points; overall, the investigational vaccine demonstrated 66% efficacy in preventing moderate-to-severe COVID-19. Johnson & Johnson submitted its EUA request on February 4.

On Wednesday, the FDA released results of its analysis of the data, confirming the safety and efficacy of the vaccine. According to the data, vaccine efficacy against moderate to severe/critical COVID-19 was 66.9% (95% CI 59.0, 73.4) when considering cases occurring at least 14 days after the single-dose vaccination and 66.1% (55.0, 74.8) when considering cases occurring at least 28 days after vaccination. The vaccine was also demonstrated to be 76.6% and 85.4% effective against severe/critical cases after 14 days and 28 days, respectively.

A post hoc analysis showed no COVID-19 hospitalizations in the vaccine group after 28 days compared with 16 cases in the placebo group.

The briefing document provided a breakdown of efficacy rates in regions where the new SARS-CoV-2 variants emerged, looking at efficacy across 3 countries: United States, South Africa, Brazil. In a subgroup analysis, there was lower efficacy against moderate to severe/critical COVID-19 observed in South Africa compared with the United States. However, efficacy against severe/critical COVID-19 was comparably high across all 3 countries.

The company has also applied for authorization of the Janssen vaccine with several health agencies outside the US on a rolling basis and plans to submit a Conditional Marketing Authorization Application with the European Medicines Agency in the coming weeks.

Johnson & Johnson recently stated that upon authorization, vaccines will be shipped out to health care facilities and pharmacies immediately.

Kaitlyn Rivard, PharmD, BCPS, BCIDP, AAHIVP infectious diseases residency director at the Cleveland Clinic, recently discussed the significance of the Johnson & Johnson COVID-19 vaccine for at-risk populations in an interview with 

Pharmacist Leads COVID-19 Vaccination Clinic

“Certainly, a single dose vaccine will be incredibly helpful from a logistic standpoint, especially for patients who have trouble coming in for 2 doses,” Rivard said.

“I think it'll also depend on the federal government and where they allocate that product. I could see them focusing that product in areas where cold storage is a bigger concern, such as rural areas and underserved areas. I think there's still a lot more to learn about where Johnson & Johnson is going to fit in from a logistics standpoint,” she said.

For pharmacists, the Johnson & Johnson vaccine also means pivoting in terms of strategy in order to make room for additional products.

“I would encourage anyone who is currently working through the mRNA vaccines to begin planning for the next round of vaccines that are coming as well,” Rivard said. “We’re going to need as many products on hand as possible to get the population vaccinated to have the impact we’re aiming for.”

The FDA is not required to follow the committee’s advice, but it is expected to do so.

1. US Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee – 2/26/2021.

2. FDA. FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccine and Related Biological Products Advisory Committee Meeting, February 26, 2021. Accessed February 24, 2021. 

https://www.fda.gov/media/146217/download

On Friday, a panel of advisors to the FDA voted to recommend Johnson & Johnson's COVID-19 vaccine, named Ad26.COV2.S, for emergency approval.

FDA Panel Endorses Johnson & Johnson's COVID-19 Vaccine for EUA

This week marked 500,000 coronavirus-related deaths in the United States. The COVID-19 vaccination effort is well underway in the US, with over 68.27 million administered doses and 6.8% of the population fully vaccinated against the virus as of press time.

This week, an FDA advisory board confirmed the safety and efficacy of Johnson & Johnson’s COVID-19 vaccine candidate, and experts weigh in on how pharmacists can effectively tackle vaccination programs.

Here’s a roundup of the latest coronavirus-related news:

The Impact of COVID-19 on Pharmacy Management and Compliance

Pharmacy leaders have leveraged their experience, their role in interdisciplinary teams, and technology to quickly reinvent approaches to manage long-standing issues exacerbated by the pandemic.

FDA Analysis of Johnson & Johnson COVID-19 Vaccine Confirms Safety, Efficacy

On Wednesday, the FDA released results of an analysis for Johnson & Johnson’s COVID-19 vaccine candidate that supports its authorization for emergency use.

Regulation and Cost Considerations for Pharmacists Administering COVID-19 Vaccines

In our final interview segment, Lee Rosebush dives into improving vaccine distribution, addressing costs, and maintaining records while vaccinating for COVID-19.

Part 2: Pharmacist Leads COVID-19 Vaccination Clinic

In part 2 of our interview, Kaitlyn Rivard, PharmD, leads an insightful discussion on the practical side of administering COVID-19 vaccines.

MJH COVID-19 Coalition Provides Perspectives on Vaccine Rollout, Double Masking

Members of the MJH Life Sciences™ COVID-19 Coalition recently weighed in on the latest COVID-19 pandemic news.

Avoid Regulation Issues With This State-By-State COVID-19 Vaccination Guide

Lee Rosebush of BakerHostetler law firm discussed how pharmacies can avoid regulatory and compliance issues amid their COVID-19 vaccination programs.

AAP letter urges the start of COVID-19 vaccine trials in young children

A safe COVID-19 vaccine that can be administered to most of the pediatric population is a necessity for ending the pandemic, but trials for younger children have not occurred. The president of the American Academy of Pediatrics (AAP) wrote to key COVID-19 officials about the need to change this.

Here’s a roundup of the latest coronavirus-related news.

Coronavirus News Roundup: FDA Reports Safety and Efficacy for Johnson & Johnson Vaccine, Pharmacist Leads COVID-19 Vaccine Clinics

Tezepelumab reduced exacerbation rates in patients with severe, uncontrolled asthma, according new results from the phase 3 NAVIGATOR clinical trial.

Tezepelumab is an investigational treatment in severe asthma that blocks the action of thymic stromal lymphopoietin, an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. It is the only biologic to consistently and significantly reduce annualized asthma exacerbation rate (AAER) in a broad population of patients with severe asthma, irrespective of the baseline eosinophil counts across phase 2 and phase 3 trials.

The phase 3 NAVIGATOR trial included 1061 adults and adolescents with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroid plus at least 1 controller medication with or without oral corticosteroids.

According to the findings, tezepelumab plus standard of care demonstrated a 56% reduction (p<0.001) in annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, compared with placebo and standard of care. Tezepelumab also achieved a statistically significant and clinically meaningful 41% reduction (

<0.001) in AAER in a pre-specified analysis of patients with baseline eosinophil counts less than 300 cells per microliter. Clinically meaningful reductions in AAE were also observed in 2 additional subgroups: a 39% reduction in patients with baseline eosinophil counts less than 150 cells per microliter and a 70% reduction in patients with greater than or equal to 300 cells per microliter.

Investigators noted additional clinically meaningful reductions in AAER compared with placebo in tezepelumab-treated patients irrespective of allergy status and fractional exhaled nitric oxide level. Statistically significant improvements were observed in every key secondary end point as well, including lung function measurements, asthma control, and health-related quality of life.

The most frequently reported adverse events with tezeplumab in the trial were nasopharyngitis, upper respiratory tract infection, and headache.

“These are ground-breaking results for the many patients with severe asthma who continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics,” professor Andrew Menzies-Gow, director of the lung division, Royal Brompton Hospital, London, United Kingdom, said in a statement.

1. Tezepelumab Is The First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma. News release Amgen; February 25, 2021. Accessed February 26, 2021. 

https://www.amgen.com/newsroom/press-releases/2021/02/tezepelumab-is-the-first-biologic-to-significantly-reduce-exacerbations-in-broad-population-of-patients-with-severe-uncontrolled-asthma

Tezepelumab is an investigational biologic for the potential treatment of severe, uncontrolled asthma. 

Tezepelumab Significantly Reduces Exacerbations in Severe Asthma

The coronavirus disease 2019 (COVID-19) pandemic not only introduced rapid-fire changes to care delivery, but it also exposed the health care system’s weak links. We learned just how fragile the current health care infrastructure is as frontline pharmacy staff and leaders were forced to navigate new medication and supply shortages as well as rapidly adapt to this once-in-a-century global public health emergency.

COVID-19 Presents Additional Challenges for Pharmacists

While pharmacists have expanded their clinical scope and become increasingly resilient amid a multitude of regulatory storms over the last decade, COVID-19 has served as a major tipping point. The virus hit the pharmaceutical supply chain, intensifying existing drug shortages, complicating inventory management, and presenting new considerations for USP compliance. Pharmacy leaders have leveraged their experience, their role in interdisciplinary teams, and technology to quickly reinvent approaches to manage long-standing issues exacerbated by the pandemic. 

Annie Lambert, PharmD, BCSCP, clinical program manager of Simplifi 797 at Wolters Kluwer Health

Addressing Inventory Management and Drug Shortages During Disruption

Challenges in medication inventory management and drug shortages are not new, and in fact the pandemic in some cases offered an unusual opportunity for pharmacists to proactively prepare as the initial case surge was not widespread. However, weaknesses in the supply chain are raising concern that the next drug or supply shortage could become a daily event. 

Fortunately, there are proven strategies hospital pharmacists can consider employing when facing a shortage:

Make a list of critical drugs and supplies and take inventory regularly.

 Understand baseline usage rates and re-assess when changes in practices or acuity occur. Using technology, like inventory management systems or shared databases, can help increase visibility into what is available across multiple locations and create opportunities for consolidation.

 Initiate approvals for clinical substitutes and research/line up alternate vendors proactively. Based on the list of critical drugs, prepare alternative therapies and get approval for bi-directional interchanges based on the products available. 

Consider operational impact of changes on the interdisciplinary team

. Sometimes a change to benefit pharmacy may have an offset on nursing or vice versa. There is not always a choice when making changes but if a choice is presented, consider the ripple effects and communicate the rationale behind the decision whenever possible. 

Traditionally, when certain medications are cost prohibitive or otherwise not available, pharmacists look to compounding to prepare those medications, either through a 503B outsourcing vendor or internally. Throughout the pandemic, health system pharmacies have had to balance the increased need for compounded products with the decrease in drug and equipment supplies. But outsourced vendors are increasingly unavailable, either due to their own COVID-related closures or because they are already at capacity. In these cases, in-house compounding may be the only option, but the following should always remain priorities:

. Have regular conversations with 503B outsourcing facilities and take inventory of what products they have available as well as their criteria for adding new items to a contract. Also be wary of alternative vendors and new entries to the market – use only trusted sources for compounded medications.

. When insourcing compounding during drug shortages, be mindful of products that may be different from standards. Mix-ups in strengths and concentrations can have serious impacts to patient safety.

COVID-19 workflow changes can impact compounding

. Adjustments in workflow, such as changing medication administration times to reduce exposure time for nursing, may cause a shift in demand for compounded preparations and pharmacy workload. Adapt by assessing staffing levels and non-essential work in the IV room during these peak times. 

There is no higher priority for hospitals and health care workers than to engage in care delivery that promotes the highest level of safety for patients and maintains the health of the workforce. The 

United States Pharmacopeial Convention (USP)

 compounding chapters serve as the guardrails for patient and worker safety. While anticipated revisions were put on hold in 2020, the pandemic forced regulatory bodies such as the FDA and 

The pharmacy department’s responsibility is to understand which versions and standards apply to their operations. Regulatory bodies will be looking for how hospital pharmacies responded to the challenges as well as how they implemented interim practices – applicable to their facility – from a compliance perspective.

As the COVID-19 vaccine rolls out and facilities continue to navigate 

, hospital pharmacists should work within the ebbs and flows of the “new normal” and consider the following:

Focus on what is controllable and unchanging.

 Ensure compliance with the current and official chapters of USP 795 (2014) and USP 797 (2008), with temporary adjustments in line with the interim guidance. Continue to work towards compliance with USP <800> which has not changed since published in 2016 and is the best practice for worker safety. 

Document practice changes due to the pandemic.

 Regulatory bodies will be looking for evidence of how facilities adopted interim guidance including assessment criteria for returning to standard operating procedures and communication to staff.

. Review documentation for routine compounding tasks, competencies, and certification. Identify any gaps, initiate corrective action plans, and prepare to explain the cause if related to interim practices. 

Central to regulatory compliance and reducing risk is arming the pharmacy with the tools to develop standard operating procedures, building pharmacy staff competency and expertise, and adopting workflow technologies that help ensure accuracy in the compounding of CSPs. A comprehensive compliance management system is invaluable to establish the training, risk management, and quality assurance practices necessary for a safe and efficient sterile compounding environment.

When it comes to medication safety and ensuring compliance over sterile compounding, there is no one more knowledgeable than a pharmacist. In the face of increased pressure due to the COVID-19 pandemic and rapidly evolving shortages, new technology and interdisciplinary work teams can ensure patient care and employee satisfaction do not suffer. Pharmacists certainly have the strength and adaptability needed to meet existing — and as of yet unforeseen — challenges and can do so with the right tools to support evolving patient care initiatives.

Pharmacy leaders have leveraged their experience, their role in interdisciplinary teams, and technology to quickly reinvent approaches to manage long-standing issues exacerbated by the pandemic.  

The Impact of COVID-19 on Pharmacy Management and Compliance 

On Wednesday, the FDA released results of an analysis for Johnson & Johnson’s coronavirus disease 2019 (COVID-19) vaccine candidate that supports its authorization for emergency use.

Results of an FDA analysis of Johnson & Johnson’s coronavirus disease 2019 (COVID-19) candidate, known as Ad26.COV2.S, confirm the safety and efficacy of the single-dose vaccine.

On Friday, an advisory panel will meet to evaluate the vaccine and vote on whether to recommend it for emergency use authorization (EUA). The FDA will then decide whether to issue the EUA. 

To support its EUA request, Janssen submitted safety and efficacy data based on the ongoing multi-national phase 3 randomized, double-blind, and placebo-controlled trial of approximately 40,000 participants. The coprimary efficacy end points included molecularly confirmed, moderate to severe/critical COVID-19 with onset of at least 14 and 28 days, respectively, after vaccination in participants without evidence of severe acute respiratory infection coronavirus 2 (SARS-CoV-2) prior to vaccination.

According to the data, vaccine efficacy against moderate to severe/critical COVID-19 was 66.9% (95% CI 59.0, 73.4) when considering cases occurring at least 14 days after the single-dose vaccination and 66.1% (55.0, 74.8) when considering cases occurring at least 28 days after vaccination. The vaccine was also demonstrated to be 76.6% and 85.4% effective against severe/critical cases after 14 days and 28 days, respectively.

A post hoc analysis showed no COVID-19 hospitalizations in the vaccine group after 28 days compared with 16 cases in the placebo group. 

Moreover, the analysis supported a favorable safety profile for the vaccine, with no specific safety concerns.

If approved for EUA, Ad26.COV2.S would be the third COVID-19 vaccine authorized for use in the US.

FDA. FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccine and Related Biological Products Advisory Committee Meeting, February 26, 2021. Accessed February 24, 2021. 

On Friday, an advisory panel will meet to evaluate the vaccine candidate and decide whether to recommend for emergency use authorization. 