Kristen Crossley

Officials with the FDA have approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze; Jazz Pharmaceuticals) for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric patients ages 1 month and older and adults who have developed hypersensitivity to 

-derived asparaginase. The drug is indicated for use as a component of a multi-agent chemotherapeutic regimen.

ALL occurs in approximately 5700 patients annually, about half of whom are children, and it is the most common type of pediatric cancer. An estimated 20% of patients are allergic to the standard 

-derived asparaginase and need an alternative their bodies can tolerate.

According to the FDA, there has been a global shortage for years of an alternative therapy, the only other drug approved by the agency for patients with ALL or LBL with allergic reactions.

“It is extremely disconcerting to patients, families and providers when there is a lack of access to critical drugs for treatment of a life-threatening, but often curable cancer, due to supply issues,” said Gregory Reaman, MD, associate director for pediatric oncology in the FDA’s Oncology Center of Excellence, in a press release. “[This] approval may provide a consistently sourced alternative to a pivotal component of potentially curative therapy for children and adults with this type of leukemia.”

According to Jazz Pharmaceuticals, asparaginase erwinia chrysanthemi (recombinant)-rywn) is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. The company expects this new therapy to be commercially available in mid-July.

Asparaginase erwinia chrysanthemi (recombinant)-rywn) was granted orphan drug designation for the treatment of ALL/LBL by the FDA in June 2021. The Biologics Licensing Application (BLA) approval followed review under the Real-Time Oncology Review (RTOR) program, an initiative of FDA's Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

"The accelerated development and approval of [asparaginase erwinia chrysanthemi (recombinant)-rywn)] marks an important step in bringing a meaningful new treatment option for many ALL patients—most of whom are children—who cannot tolerate 

-derived asparaginase medicine," said Dr. Luke Maese, assistant professor at the University of Utah, Primary Children's Hospital and Huntsman Cancer Institute, in a press release. "Before the approval of [this therapy]

there was a significant need for an effective asparaginase medicine that would allow patients to start and complete their prescribed treatment program with confidence in supply."

According to the FDA, the efficacy of asparaginase erwinia chrysanthemi (recombinant)-rywn) was evaluated in a study of 102 patients who either had a hypersensitivity to 

-derived asparaginases or experienced silent inactivation. The main measurement was whether patients achieved and maintained a certain level of asparaginase activity. This study found that the recommended dosage of 25 mg/m administered intramuscularly every 48 hours would provide the target level of asparaginase activity in 94% of patients.

The most common adverse effects of asparaginase erwinia chrysanthemi (recombinant)-rywn) include hypersensitivity reactions, pancreatic toxicity, blood clots, hemorrhage, and liver toxicity.

Additional data from a Children's Oncology Group retrospective analysis of more than 8000 patients found that those who did not receive a full course of asparaginase treatment due to associated toxicity had significantly lower survival outcomes, regardless of whether those patients were high risk or standard risk, slow early responders.

1. FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer [news release]. June 30, 2021; FDA. Accessed July 1, 2021. 

https://www.fda.gov/news-events/press-announcements/fda-approves-component-treatment-regimen-most-common-childhood-cancer

2. Jazz Pharmaceuticals Announces U.S. FDA Approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [news release]. June 30, 2021; Jazz Pharmaceuticals. Accessed July 1, 2021.

https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-rylazetm

Articles

Asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze; Jazz Pharmaceuticals) provides a new alternative for a therapy in long-standing global shortage. 

FDA Approves Component of Cancer Treatment Regimen for Patients With ALL, LBL

A rapidly growing elderly population needs more access to oral health care services, according to a recent report. 

But progress is being made in some areas to better care for aging teeth.

is the latest in a series published by Oral Health America (OHA) that surveys the state of oral health in older adults in the United States. 

It found that 33% of older adults have lost 6 teeth or more, and sociodemographic factors play a critical role in oral health outcomes.

“Tooth loss and poor oral health are not inevitable during the aging process,” Karen Tracy, vice president of strategic alliances and integrated communications for the Gerontological Society of America, said in a statement. 

Education, gender, income, and race all factor into oral health care, according to the report. 

Twenty-five states received poor overall scores in the report, with Wyoming, Delaware, West Virginia, New Jersey, Arkansas, Texas, Oklahoma, Louisiana, and Tennessee receiving the least favorable scores. Earning “excellent” scores for oral health in older adults were Minnesota, Wisconsin, Iowa, Connecticut, and Colorado.

“Oral health for older adults is in fragile condition,” Caswell Evans, associate dean for prevention and public health sciences at University of Illinois at Chicago College of Dentistry, said in a statement.

“Oral health for seniors is important for their diet, nutrition, self-esteem, socialization, and freedom from pain, among many other benefits.”

Many older adults regularly use several OTC or prescription medications, or both, making them more vulnerable to adverse reactions, drug interactions, and medication errors, according to the American Dental Association (ADA).

The most frequently taken OTC medications by older adults include analgesics, laxatives, vitamins, and minerals.

The typical aging patient’s baseline health state can be compromised by comorbid conditions, such as diabetes mellitus and hypertension, as well as the physiological changes associated with aging.

Dental conditions associated with aging include coronal and root caries, dry mouth, and periodontitis.

The ADA places a “seal of approval” on many OTC oral health products, including mouth rinses and toothpastes containing fluoride, and ingredients for combating bad breath, gingivitis, and plaque, as well as for teeth whitening. The organization has also placed its seal of approval on Sensodyne toothpaste for sensitivity control and on a variety of sugar-free chewing gums that help reduce cavities.

For relief of oral discomfort, the ADA recommends Benzodent Dental Pain Relieving Cream (Focus Consumer Healthcare) and Professional Strength Kank-A Mouth Pain Liquid (Blistex).

For a tooth that has been knocked out, the ADA has approved Save-A-Tooth (Phoenix-Lazarus), a device that keeps a tooth alive for 24 hours, until a dentist can replant it.

In addition to OTC products for teeth, the ADA has recommendations for dentures, including adhesives and cleansers. Efferdent Anti-Bacterial Denture Cleanser (Complete Clean and Fresh & Clean), Efferdent Overnight Denture Cleanser, and Medtech Products’ Effergrip Denture Adhesive have all received the ADA seal of approval. They are joined on the ADA’s list by Adhesadent Denture Adhesive Cream (Dr. B Dental Solutions) and Fresh’n Brite Denture Cleaning Paste (Revive Personal Products).

Adults 65 and older are expected to account for a greater patient population in dental practices in the coming years as the demographic increases in size.

Since the OHA’s previous report, in 2016, state advocates have implemented actions based on 

findings, and more states have commissioned surveys to better measure older adults’ oral health. State oral health plans (SOHPs), such as those recently implemented in Alabama, California, Iowa, and Mississippi, have increased the percentage of people in areas served by community water fluoridation and are covering a larger number of adult dental services under Medicaid.

In addition to SOHPs, some states, including California and Iowa, are offering support for all 13 common dental benefits for Medicaid beneficiaries 65 years and older.

Other entities, such as the University of Alabama (UA) at Birmingham School of Dentistry, are creating local programs to enact further oral health improvements. The UA program is reaching into some of its more rural and vulnerable communities.

“The Gerontological Society of America is pleased to see the growth in the number of states taking positive steps to advance their oral health services for older adults. And, through coordinated strategies in the education, practice, policy, and research arenas, millions of older adults can maintain their oral health for a lifetime and enjoy far-reaching benefits of overall better health and quality of life,” Tracy said in a statement.

In addition to states acting to improve oral health care, the ADA is collaborating with CVS Pharmacy to expand oral health education for consumers.

According to an announcement in January, the partners have pledged a 3-year initiative that will include public awareness and engagement programs, including a search tool that will assist consumers in finding a dentist in their area. CVS will also prominently feature dental care products that have received the ADA’s seal of approval.

the OHA has also identified areas in which federal and state policies are needed to address variables that prohibit older adults from achieving good oral health conditions.

Conduct basic screening surveys of older adults in all states. 

Establish, maintain, or reinstate a comprehensive adult Medicaid dental benefit. 

 Include specific objectives for older adults in all SOHPs.

Integrate comprehensive dental coverage in Medicare. 

Sustain or expand community water fluoridation. 

allows us to remain committed to ensuring oral health equity among all older adults, leveling the field to improve the quality of life for all,” said Michael Monopoli, DMD, MPH, MS, executive director of DentaQuest Foundation, in a statement.

“Everyrone deserves the right to oral health screenings, diagnoses, and, most importantly, access to care,” he said. “This report provides a gauge of where we are and where we need to go to meet the unmet dental needs of older adults.”

 for more information on recommended products for toothaches. 

for more information on recommended toothpaste. 

 for more information on recommended toothpaste for sensitive gums/teeth. 

 for more information on recommended therapeutic mouthwashes/oral rinses. 

1. National oral health report: a state of decay [news release]. Chicago, IL: Oral Health America; April 17, 2018. 

oralhealthamerica.org/blog/2018/04/announcing-ohas-national-oral-health-report-a-state-of-decay/

2. Oral health topics: aging and dental health. American Dental Association website. 

ada.org/en/member-center/oral-health-topics/aging-and-dental-health

. Updated January 2, 2018. Accessed May 14, 2018.

3. What is Save-A-tooth? Save-A-Tooth website. 

saveatooth.com/copy-of-what-is-save-a-tooth-1

4. American Dental Association and CVS Pharmacy collaborate to expand oral health education to consumers [news release]. Chicago, IL: American Dental Association; January, 24, 2018. 

ada.org/en/press-room/news-releases/2018-archives/january/ada-and-cvs-pharmacy-collaborate-to-expand-oral-health-education-to-consumers

More Oral Health Care Is Needed for Elderly Adults

Disaster preparedness—a necessity for specialty pharmacies and their service provid- ers, suppliers, and patients&mdash;goes well beyond stockpiling water and food supplies. The industry faces unique challenges during a disaster situation and its aftermath, according to representatives of Diplomat Pharmacy Inc, which is based in Flint, Michigan. They shared their message in a session held on the final day of Asembia’s Specialty Pharmacy Summit 2018.

“In our current environment, I think we can all agree, unfortunately, we’re experiencing a tremendous rise in domestic terrorism, cyberattacks, as well as natural disaster, all of which make disaster preparedness planning more essential to the successful recovery from these events,” Shannon Beltrand, MA, chief information security officer, said during the session, “Disaster Preparedness: Lessons Learned and Best Practices for Specialty Pharmacies.”

Hurricanes, floods, forest fires, and blizzards all created disaster situations for US communities in 2017, said Gary Rice, RPh, MS, MBA, CSP, executive vice president of operations for Diplomat. In some instances, such as hurricane recovery efforts in Puerto Rico, sustained challenges persist, underscoring the importance of long-range planning.

An effective disaster preparedness plan incorporates 3 elements, the presenters said: emergency response, disaster recovery, and business continuity. The highest priority is the lives and safety of patients and employees, followed by inventory and equipment that can be moved or rescued, and, finally, facilities.

In addition to threats to their own lives and safety, employees may face other challenges during or after a disaster. A specialty pharmacy business should consider whether a facility will be operting and if employees will be able to work, according to Rice. Prior to a disaster, he said, companies need to have human resource policies and procedures in place that address these situations, such as the amount of time off from work afforded to staff to take care of their homes and families. Finances might become an issue, as well. “Employees want to know certain things,” he said, “like ‘Am I going to get paid during a disaster?’”

Local geography should also be considered. Inaccessible roads or flooding can affect employees’ ability to get to work, as well as whether medications and supplies can be delivered. “How do we best support our patients? We have to get the product to them,” Rice said. In some cases, such as for patients living in temporary housing, it may be more efficient to provide medications through a doctor’s office or by mailing them to a post office box instead of an uninhabitable residence.

Patients and caregivers, too, should be educated on how they can best plan for an emergency. “We don’t want to alarm our patients, but we want them to be prepared,” Rice said. “Sometimes we don’t engage in those conversations early enough.”

Patient preparedness includes remembering all prescription and OTC medications and necessary medical supplies. A list of medications and a prescription card should be accessible in an emergency, and all medications should be kept together. Ordering prescriptions early can help prevent patients from running out of what they need in the midst of a disaster or aftermath.

Technology also plays an important role during disaster recovery. In the event of an emergency, specialty pharmacy providers should be able to access a data center with patient information, a call center that allows staff to communicate with patients, and a fulfillment area that can facilitate prescriptions.

Redundancy is key for pharmacies during long-term recovery efforts, Rice said. Backup licensed facilities and pharmacists, systems, and data access can help maintain service during an emergency and aftermath. The panelists recommended running through disaster scenarios with that staff members are prepared and to identify areas that need improvement.

“This is all about being prepared. It’s not just the planning but [also] doing those desktop scenarios and challenging your team so that they really understand some of those weather conditions,” Rice said.

A business continuity plan is essential for dealing with disasters, according to Beltrand. This entails assessing a business to understand its current state, planning based on business priorities and critical systems, testing the plan with simulations, evaluating any gaps in the process, and maintaining the program. “This is a cyclical process that you’re building on,” she said.

According to the presenters, Diplomat has learned from its own experiences with natural disasters, including recent weather events in Florida and Texas. As a hurricane approached, the company prepared by sending some inventory from Florida to Michigan, Rice said, but faced an unforeseen issue returning the inventory when the delivery route became inaccessible.

Through such experiences, Diplomat recognized that its process was effective in the short term but needed to expand capabilities for longer-term recoveries, Beltrand said. A new fulfillment and distribution center now provides data redundancy capabilities for servicing operations across the country. 

Disaster preparednessâ€”a necessity for specialty pharmacies and their service providers, suppliers, and patientsâ€”goes well beyond stockpiling water and food supplies. 

How Specialty Pharmacies Can Be Prepared When Disaster Strikes

Health care industry trends affecting specialty pharmacy were the focus of a presentation on Monday at Asembia’s 2018 Specialty Pharmacy Summit. Presenter John Cervione, a managing partner of Blue Fin Group, highlighted several areas to watch in specialty, such as accreditation, digital health, and contract pharmacy’s role in integrated care.

“If you’re a payer or if you’re a manufacturer that takes these accreditations really, really serious, whether you’re going out into the market for an RFP [request for proposal] for a limited network, relooking at your limited network, or doing your business reviews, there are some critical takeaways with what’s happening with accreditation,” he said.

Accreditation is especially poised to make a big impact, according to Cervione.

“We’re doing a major overhaul of RFP,” he said.

Accreditation agencies are on the rise, with health care providers such as hospitals, health systems, and physician practices representing the fastest-growing segment. This growth expands accreditation well beyond the independent pharmacies that comprise the majority of accredited organizations. Accrediting organizations are also finding ways to differentiate the marketplace and to allow specialty pharmacy providers to identify as experts in specialized areas such as oncology, HIV, and multiple sclerosis.

Digital health is becoming more integrated with specialty pharmacy. In competitive markets, more patient support services are providing differentiated services. New technologies offer potential in addressing some of the challenges that are persistent in specialty pharmacy, including abandonment, adherence, cost, financial transparency, and diagnostic errors.

“More and more manufacturers in their requests for proposals or in their requests for information are asking about details relative to where specialty pharmacy is tracking for some of these enhanced differentiated services,” Cervione said.

Gene editing, stem cell regrowth, and consumer tools for self-testing and diagnosing are among areas of growth. As an example, Cervione mentioned a smart toilet that can tell a patient which foods are needed in a diet to produce more energy and to reduce the risk of disease.

In addition, interest is increasing for blockchain technology use with health records that would provide patients more access and control over their data. “We’re seeing that now in 2018, and we’ll see it in the near future,” Cervione said. Meanwhile, the use of artificial intelligence (AI) in health care is accelerating. Cervione noted that 106 start-ups are working on AI technologies for health care professionals that could potentially improve efficiency and reduce errors.

“Do nurses and AI become the doctors of the future? Combining an RN [registered nurse] with all the power of the data to become the doctors of the future,” he said.

In AI, Cervione noted Abilify MyCite, a tablet with a sensor that records health data. The product, which patients swallow, is expected to become available this year. “There is interest in AI, and we’ll see continued interest in funding for AI,” he said.

Dedicated pharmacy liaisons embedded into specialty clinics are becoming more common, often acting as contract pharmacies. They are interacting directly with patients and provider teams to assist with enrollment forms and prior authorizations in all clinics, not only hospitals.

A centralized board-certified specialty pharmacy team is supporting clinical management and adherence programs for all hospital partner sites and augmenting prior authorizations, benefits verifications, and financial assistance.

Cervione said the liaisons are helping to streamline and hasten the process of providing services with same-day prescription fills, which he said can otherwise take up to 3 to 5 days.

The centralized team allows for access to systems and data across the continuum of care. In addition to speed, the increasing use of integrated care offers better customer satisfaction, decreased financial toxicity, and increased persistency and adherence.

Health care industry trends affecting specialty pharmacy were the focus of a presentation at Asembiaâ€™s 2018 Specialty Pharmacy Summit. 

Digital Health, Accreditation Among Areas to Watch in Specialty

Creating and delivering an optimal patient experience was at the forefront of an educational presentation Tuesday, May 8 at Asembia’s 2018 Specialty Pharmacy Summit in Las Vegas, Nevada. Moderated by Thomas Cohn, Asembia’s chief strategy officer, the presentation focused on industry efforts to design and implement effective ways to determine the true needs of patients and the role of technology in the process.

Joining Cohn were Rahul Bhatia, senior director of commercial strategy and operations for Insmed, a biotechnology company that works to improve the lives of patients with serious and rare diseases, and Farris Ibrahim, director of Nuvera Life Science Consulting, a boutique firm that specializes in designing and implementing patient experiences.

Bhatia discussed an Insmed campaign that focused on nontuberculous mycobacteria (NTM) to raise awareness of the condition and deliver the best possible patient experiences. He said there are twice as many undiagnosed patients with NTM as there are diagnosed patients, which is typical for a rare disease. The symptoms often get confused with other conditions, such as asthma and chronic obstructive pulmonary disease. There are currently no FDA-approved treatment options for NTM, Bhatia said.

“Patients to go through a long journey before they get diagnosed,” Bhatia said. “That journey could be upwards of 2 years.”

In order to deliver effective patient experiences, Bhatia said, Insmed first sought to understand their needs and expectations, then worked to create the capabilities that would address those needs. Insmed collaborated with Asembia throughout the project, according to the presenters.

Cohn said Asembia-1, an integrated online software platform that assists with specialty phar- macy operations, prescription workflow, and overall patient management is being used by Insmed to design its patient experience. It provides real-time data and analytics, and business intelligence.

According to Bhatia, Insmed started with the data it had on approximately 45,000 patients with NTM. They used that to “connect all the dots,” by identifying the key stakeholders and where the problems are and discussing that information with patients and caregivers.

Nuvera worked with Insmed to develop a strategy for improving patient experiences. According to Ibrahim, a treatment experience blueprint was created to address the need and determine influential moments along a patient’s holistic journey.

“Where and when did they have an impact with the patients and the providers that they were going to be working with when the product came to market?” Ibrahim asked.

The blueprint incorporates a holistic understanding of patients and providers and patient support expectations—a set of complimentary services across provider workflows&mdash;and establishes boundaries of where to start and stop programs.

Nuvera also created an integrated program design model to address the need to build meaningful support for patients. 

“You have to know what is going to be meaningful to these patients,” Ibrahim said. Ibrahim noted they discovered that the stage of prescription and therapy onboarding provided the greatest opportunity to engage patients and to impact them. This includes supporting the patient through enrollment, access to resources, providing brand and disease area education, facilitating the first dose, and administering prescription coordination.

“How are you going to educate how a nebulizer works,” said Ibrahim. “It’s about keeping things moving forward and that they continue to be successful.”

Bhatia said an example is for respiratory therapists to provide at-home guidance for use of devices. “Some patients need training on how to use it,” he said.

Validating patient needs is also important, the panelists noted.

“All too often, we sit in rooms together around the table and figure out ‘this is what’s going to be best,’ and that’s what we end up going to market with, and we never actually check with the end user,” Ibrahim said.

“We worked with patients and actually checked with the services, validated their needs, walked them through what we thought their journey was, modified it, and we did that with what we call the customer co-creation process,” he added. This process starts with enrollment support, and includes reimbursement services and co-pay assistance, third-party support for caregivers, and device and adherence support.

Bhatia said the process was important for each patient. “What is relevant to a physicians’ office is different than what is relevant for a patient and caregiver,” he said.

Overall, the speakers said the patient experience was critical to treatment and adherence. According to Cohn, technology has the potential to assist in that area.

“It’s important to have a system that’s flexible, and can provide support for unique journeys,” he said. “It needs to be personalized to meet the individual needs of the patients.”

Creating and delivering an optimal patient experience was at the forefront of an educational presentation Tuesday, May 8 at Asembiaâ€™s 2018 Specialty Pharmacy Summit in Las Vegas, Nevada.

How Technology Can Boost the Specialty Patient Experience

Millions of individuals in the United States are misusing opioids or have developed substance use disorder in recent years. The huge financial and human costs make the opioid epidemic a timely and significant topic of discussion among pharmacists—and for a presentation at Asembia’s Specialty Pharmacy Summit 2018.

Opioid use disorder costs a collective $78.5 billion each year, according to Dick Creager, MD, MPA, medical director for CVS Health, who discussed effective strategies to fight widespread opioid abuse.

“A person who has opioid use disorder has medical costs that are about $15,500 year greater than a person who does not have opioid use disorder,” he said. Beyond the financial costs, Creager said, is the “incredible human cost” of opioid use disorder, such as incarceration, broken dreams, and death. The misuse and abuse of prescription opioids is outpacing all other illegal drug use, including cocaine, heroin, and methamphetamines combined. According to the US Department of Health and Human Services, 11.8 million people reported misusing opioids in 2016, and 36.8% obtained them through a prescription. “The vast majority of recreational users get them for free from family and friends,” Creager said.

Better management of opioid distribution and decreasing prescriptions can help curb the epidemic, according to Creager.

One example: the size of a patient’s first prescription. Research findings reveal that an individual’s likelihood of developing opioid use disorder significantly rises along with the size of the first supply. Investigators have found that a patient given a 5-day supply has about a 10% risk of becoming a chronic opioid user, whereas patients with a first prescription for 30-day supply have a 45% chance of developing an opioid substance use disorder within 1 year. The most recent CDC guidelines advise prescribers to assess whether the benefits of prescribing opioids outweigh the risks of abuse, addiction, and dependence, Creager said. Prescribers should first consider nonopioid alternatives and prescribe opioids just when necessary and then “start low, go slow,” using the lowest possible dose for the shortest period of time.

After a prescription is filled, prescribers should continue to monitor the patient and help reduce risks, according to Creager. “Once [a patient is] on opioids, a doctor should stay on top of it,” he said. “Is the patient getting opioids from another MD?”

For its part, CVS Health has aligned its standards to complement the CDC guidelines, Creager said. The company’s pharmacy benefit manager, CVS Caremark, and its retail business, CVS Pharmacy, are also making efforts to fight the opioid epidemic.

CVS Health initiatives include prevention education, proper medication disposal, increased access to opioid overdose reversal medication, and ongoing advocacy efforts. One program sends pharmacists into schools to talk with students and show a video that addresses the destructive impact of bad decisions.

Collection units placed at CVS pharmacy locations give consumers a way to safely dispose of unneeded medications, Creager said. In addition, pharmacists are being trained to spot warning signs of opioid use disorder and provide clinical counseling. “Pharmacists should be looking for patients with continued use of opioids,” he said.

In October 2017, the company launched programs designed to decrease inappropriate opioid use while allowing access to patients with genuine chronic pain needs.

"We're already seeing very significant impact," Creager said. "We saw a 70% decrease in the number of patients new to opioid therapy with an acute condition who receive more than a 7-day supply."

CVS Health also attemps to assist patients with opioid use disorder, according to Creager. The company offers the opioid reversal drug naloxone to patients in 46 states without requiring prior authorization and with no limit on duration. Signs posted in stores aim to reduce the stigma associated with opioid use disorder and encourage patients to speak with a pharmacist about naloxone. 

The huge financial and human costs make the opioid epidemic a timely and significant topic of discussion among pharmacists.