News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Great Resignation Hits Retail Pharmacies, Causing Shorter Hours, Closures

As with clinical laboratories, worker shortage is affecting large retail pharmacy chains and independent pharmacies alike

Staffing shortages in clinical laboratories and anatomic pathology groups caused by the Great Resignation is having a similar impact on retail pharmacy chains. Consequently, pharmacy chains are reducing store hours and even closing sites, according to USA Today.

As Dark Daily covered in “Clinical Laboratories Suffer During the ‘Great Resignation,” the US Bureau of Labor Statistics reported that from August 2021 through December 2021, the healthcare and social assistance workforce saw nearly 2.8 million workers quit—an average of 551,000 people during each of those months. By comparison, in December 2020, 419,000 healthcare workers left their jobs.

Pharmacies now report similar shortages in qualified workers, partly due to the sharp decrease in revenue from COVID-19 vaccinations, but also due to worker burnout. Both developments have counterparts in clinical laboratories as well.

B. Douglas Hoey, PharmD

“I’m concerned that without the help from the COVID-19 vaccinations that everyone needed, these pharmacies that were able to tough it out for another year or two might not be able to continue,” B. Douglas Hoey, PharmD, CEO of the National Community Pharmacists Association (NCPA), told USA Today. Clinical laboratories that processed large numbers of SARS-CoV-2 diagnostics have experienced the same sudden drop in revenue causing similar difficulties maintaining staffing levels. (Photo copyright: Cardinal Health.)

Staffing Shortages Leading to Safety Concerns

According to the Washington Post’s coverage of a study conducted in 2021 of 6,400 pharmacists in various retail and hospital environments, a majority did not feel they could conduct their jobs efficiently or safely.

  • “75% of the pharmacists in [the] survey disagreed with the statement ‘Sufficient time is allocated for me to safely perform patient care/clinical duties.’”
  • “71% said there were not enough pharmacists working to ‘meet patient care/clinical duties.’”
  • “65% said ‘payment for pharmacy services’ did not support their ‘ability to meet clinical and non-clinical duties.’”

“Workplace conditions have pushed many pharmacists and pharmacy teams to the brink of despair,” said the board of trustees of the American Pharmacists Association (APhA) in a press release, the Washington Post reported. “Pharmacy burnout is a significant patient safety issue. It is impacting patients today with delayed prescription fulfillment, unacceptable waits for vaccines and testing, and potential errors due to high volume, long hours, and pressure to meet performance metrics.”

This is a sentiment that has been repeated across every facet of healthcare—including in clinical laboratories—where staff shortages are being felt.

Shortage of Pharmacists or Lack of Morale?

In “Drugstores Make Slow Headway on Staffing Problems,” the Associated Press outlined from where it believes the staffing problems originate. “There isn’t a shortage of pharmacists. There’s just a shortage of pharmacists who want to work in those high-stress environments that aren’t adequately resourced,” Richard Dang, PharmD, Assistant Professor of Clinical Pharmacy at the University of Southern California (USC), told the Associated Press.

This statement is reminiscent of the views expressed by Susanna Bator, a former clinical laboratory technician, in her personal essay published in The Daily Nurse titled, “The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic.” She previously worked at the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio.

Dark Daily covered Bator’s journey as a clinical laboratory technician working in the trenches during the COVID-19 pandemic in “Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic.”

“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” Bator wrote.

“We techs were left unsupported and unmentored throughout the pandemic,” she continued. “No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention.”

Healthcare workers feeling burnt out and under-appreciated during the pandemic led to mass resignations that produced staffing shortages throughout the industry. It appears this trend has caught up to pharmacies as well.

Workforce Wasn’t Ready

Local and chain pharmacies played an important role in the COVID-19 pandemic. Pharmacists distributed COVID-19 tests and treatment to their communities. But for many it was a struggle to keep up.

Stefanie Ferreri, PharmD, Distinguished Professor in Pharmacy Practice and Chair of the Division of Practice Advancement and Clinical Education at University of North Carolina’s Eshelman School of Pharmacy, told the Associated Press that she felt the expanding role of pharmacies in public health was “awesome” but stated that “the workforce wasn’t quite ready” for what took place during the pandemic.

Much like Bator recounted in her essay, pharmacy workers suddenly had new responsibilities, longer working hours, and little room for error.

“There are multiple stories about pharmacists just getting overwhelmed. The stress level and burnout is high,” Dima M. Qato, PharmD, PhD, told USA Today. Qato is Hygeia Centennial Chair and Associate Professor (with tenure) in the Titus Family Department of Clinical Pharmacy at the University of Southern California. “So, pharmacists leave, and stores have to shorten” their hours, she added.

Scheduling and Patience Can Help

What can be done to soften some of the issues staff shortages are causing? Ferreri suggests that pharmacies set appointment times for regular customers so that a pharmacist’s workload can be more predictable. An appointment system can ease stress for both the pharmacist and patient. Ferreri advises customers to be patient when it comes to their prescriptions. She suggests patients give pharmacies more than a day’s notice for refills.

“I think on both sides of the counter, we need to all have grace and realize this is a very challenging and stressful time for everyone,” said Brigid Groves, PharmD, Vice President, Pharmacy Practice at the American Pharmacists Association.

With burnout, staff shortages, and stress affecting nearly every aspect of the healthcare industry, having patience with each other will go a long way to helping clinical laboratories, pharmacies, and patients navigate the road ahead.

Ashley Croce

Related Information:

Pharmacies Are Cutting Hours and Closing Stores. What It Means for Customers.

Pharmacists Are Burning Out. Patients Are Feeling the Effects.

Drugstores Make Slow Headway on Staffing Problems

The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic

US Hospitals Continue to Be Squeezed by Shortage of Nurses, Rising Salaries

Clinical Laboratories Suffer During the ‘Great Resignation’

Clinical Laboratory Technician Shares Personal Journey and Experience with Burnout During the COVID-19 Pandemic

Data from Basket Studies Help Anatomic Pathologists Better Understand Effectiveness of Oncology Drugs

Pathologists can be paid for their role in identifying and recruiting patients for basket studies and reporting results of medical laboratory tests

Anatomic pathologists who biopsy, report, and diagnosis cancer will benefit from a better understanding of basket studies and their application in developing cancer treatment therapies. Such studies can lead to more documentation of the effectiveness of various therapies for cancers with specific gene signatures

The US National Library of Clinical Medicine defines basket studies as “a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into ‘baskets.’ Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly.”

Also known as basket or bucket trials, basket studies involve patients who have different cancers at a various sites, such as lung, breast, and prostate, but whom share a common genetic mutation, explained Ryan Chandanais, MS, CPhT, Emerging Therapeutics Analyst at Diplomat Pharmaceuticals, Flint, Mich., in an article he penned for Pharmacy Times titled, “Basket Studies: An Innovative Approach for Oncology Trials.”

The popularity of basket studies has increased in tandem with genomic medicine’s rise, stated an article in Cancer Therapy Advisor titled, “Wider Use of Basket Trials Could Hasten Development of Precision Therapies.”

“Historically, cancer clinical trials have been centered on the treatment of cancer based on the anatomic location in the body, like breast cancer or brain cancer or lung cancer. A basket study is a novel trial design that includes patients with a certain molecular aberration regardless of location or tissue of origin of cancer in the body. The genomic revolution in oncology has fueled these studies,” Vivek Subbiah, MD, Associate Professor and Medical Director, Clinical Center for Targeted Therapy ( Phase 1 trials program), at the University of Texas MD Anderson Cancer Center in Houston, told Cancer Therapy Advisor. (Photo copyright: MD Anderson Cancer Center.)

Basket Studies Get Results

During a basket study, researchers may find that a drug’s effectiveness at targeting “a genetic mutation at one site can also treat the same genetic mutation in cancer in another area of the body,” noted Pharmacy Times, which also pointed out basket studies are often starting points for larger oncology trials about drugs.

For example, it was a basket study which found that vemurafenib (marketed as Zelboraf), intended for treatment of V600E, a mutation of the BRAF gene, may also treat Erdheim-Chester disease (a rare blood disorder) in patients who have the BRAF V600 gene mutation, Pharmacy Times reported.

Additionally, the US Food and Drug Administration’s approval of the cancer drug Vitrakvi (larotrectinib), an oral TRK inhibitor, marked the first treatment to receive a “tumor-agnostic indication at time of initial FDA approval,” a Bayer news release stated. The drug’s efficacy, Pharmacy Times noted, was found in a “pivotal” basket study.

Basket Studies, a Master Protocol Trial Design

The basket study technique is an example of a master protocol trial design. The FDA defines a master protocol as “a protocol designed with multiple substudies, which may have different objectives and involves coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. A master protocol may be used to conduct the trial(s) for exploratory purposes or to support a marketing application and can be structured to evaluate, in parallel, different drugs compared to their respective controls or to a single common control.”

Other master protocols include umbrella studies and platform studies, according to Cancer Therapy Advisor, which noted that each master protocol trial design has its own unique objectives:

  • Umbrella studies look at the effectiveness of multiple drugs on one type of cancer;
  • Platform trials investigate the effectiveness of multiple therapies on one disease on an ongoing basis; and
  • Basket studies focus on the effectiveness of one therapy on patients with different cancers based on a biomarker.

“In contrast to traditional trials designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and or disease populations in multiple substudies, allowing for efficient and accelerated drug development,” states the FDA draft guidance, “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.”

Final FDA guidance on master protocols design is expected early in 2020, an FDA spokesperson told Cancer Therapy Advisor.

While master protocol studies show promise, they generally have small sample sizes, noted researchers of a study published in the journal Trials. And some researchers have ethical concerns about basket studies.

Scientist at the Jagiellonian University Medical College in Krakow, Poland, published a study in BMC Medical Ethics, titled, “Umbrella and Basket Trials In Oncology: Ethical Challenges,” in which they cite their concerns with basket studies, which are related to scientific validity, risk-benefit ratio, and informed consent.

Nevertheless, basket studies appear to hold promise for precision medicine. Anatomic pathologists may want to follow some of them or find a way to get involved through identifying clinical laboratory tests and reporting the results.

—Donna Marie Pocius

Related Information:

Basket Studies: An Innovative Approach for Oncology Trials

Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology

Wider Use of Basket Trials Could Hasten Development of Precision Therapies

FDA Approves Vitrakvi (larotrectinib), the First Ever TRK Inhibitor for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion

FDA: Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Systematic Review of Basket Trials, Umbrella Trials, and Platform Trials: A Landscape Analysis of Master Protocols

Basket Trials for Intractable Cancer

Umbrella and Basket Trials in Oncology: Ethical Challenges

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

Meet the Nation’s Top 10 Healthcare Systems for Quality

Advanced use of EHRs is one characteristic of nation’s quality leaders

It’s a new study and ranking of top-performing health systems that Dark Daily readers will find interesting and useful. Thomson Reuters announced its latest Top 10 rankings, and identified three main ingredients for attaining higher-quality outcomes. They were: 1) a corporate-level coordinating committee; 2) ample involvement in planning from front-line caregivers; and a system-wide electronic health record system (EHR).

Thomson-Reuters evaluated 252 health systems, representing 1,720 hospitals. Its findings were published exclusively in Modern Healthcare. Its rating was based on five clinical performance measures: mortality, complications, patient safety, length-of-stay and use of evidence-based medicine. No attempt was made to measure financial performance. The health systems study used 2007 information from two public databases, the Medicare Provider Analysis and Review and Center for Medicare and Medicaid Services’ Hospital Compare.
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