John Schieszer

Pharmacists are uniquely positioned to develop and implement chemotherapy stewardship programs that allow them to lead multidisciplinary teams for establishing treatment paradigms that promote evidence-based, cost-effective therapies, according to Jason Bergsbaken, PharmD, BCOP, pharmacy coordinator for regional oncology services at UW Health in Madison, Wisconsin. Like antimicrobial stewardship programs, chemotherapy stewardships can help improve management of a constantly changing treatment landscape.

Chemotherapy stewardship programs provide the tools needed to improve patient outcomes. Currently, the American Society of Clinical Oncology (ASCO) has no guidance on developing or implementing chemotherapy stewardship programs. According to Kristen Ward, PharmD, an oncology pharmacist based in Sacramento, California, any oncology pharmacist can help establish a formal stewardship program by working collaboratively. “The aim of these programs is to train oncology pharmacists to provide high quality, cost-effective, specialty care to patients with cancer and hematologic disorders [in a way] that promotes independent critical thinking, creativity, and a culture of mutual respect with other health care providers

Bergsbaken, a member of the National Comprehensive Cancer Network (NCCN) Pharmacy Directors Committee, said pharmacists can facilitate informed patient decision making by incorporating anticipated treatment outcomes and costs. “At the individual patient level, pharmacists may help patients navigate complex treatment authorization networks to minimize out-of-pocket burden to patients,” Bergsbaken said. “The costs associated with cancer care are increasing at unsustainable rates and are a burden for patients, health care organizations, payers, and the entire health care system.”

He said that although recent expansions in treatment options are exciting, incremental improvements in patient outcomes are often overshadowed by substantially increased costs resulting in diminishing returns for society. “It is increasingly important to improve transparency of anticipated treatment outcomes with the overarching goal of maximizing therapeutic benefit while minimizing toxicity through the appropriate, targeted, and efficient use of available resources and therapies,” said Bergsbaken.

One of the primary purposes of chemotherapy stewardship programs is to ensure that facility resources are used appropriately based on gold standard guidelines such as NCCN’s or ASCO’s. Pharmacists typically encounter situations where an option for patient care does not align with these guidelines and is denied by a third-party payer. Matthew Paliughi, PharmD, a staff oncology pharmacist who has worked in inpatient and outpatient settings in Fresno and Clovis, California, said in such situations careful case analysis between pharmacist, physician, and insurance authorization team experts can result in a decision that is not detrimental to the patient in terms of efficacy and untowardly high copayment. The interventions require reviewing phase 2 and 3 study data and reporting to prescribers. “Pharmacists are the front-runners in these scenarios as they use their knowledge of alternative therapies and bring these to the care team as an option,” Paliughi said.

“A current opportunity is the incorporation of biosimilar agents into routine prescribing, where pharmacists can be the initiators of conversation with physicians and facility pharmacy and therapeutics (P&T) committees to help provide staggering cost savings to the organization with zero clinical detriment,” Paliughi explained. Paliughi, who recently returned to an outpatient pharmacy management position that oversees 3 infusion centers, said outpatient oncology staff pharmacists are in the highly advantageous position to not only advocate for patient care but to do so in a manner that provides benefit for organizations to expand on such care.

“Oncology is a rapidly evolving field that sees a newly approved agent entering the market on a nearly monthly basis. Because of this, pharmacy can become an asset when working together with the rest of the team to ensure excellent patient care and organizational success,” he said.

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Oncology programs provide the tools needed to improve patient outcomes.

Chemotherapy Stewardships Becoming Increasingly Vital

Due to a variety of new communication and technology advances, pharmacists now are much better armed to prevent drug shortages. During the initial surge of the COVID-19 pandemic in April 2020, severe drug shortages plagued health systems. Particularly affected was the supply of sedation medications. However, this was not the case during the second surge this winter, according to Emily Pherson, PharmD, assistant director of medication use policy and clinical informatics at The Johns Hopkins Hospital in Baltimore, Maryland. “In this second surge, we are doing much better than back in the spring,” Pherson told 

Chronic drug shortages have become a much bigger issue in recent years. However, Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists (ASHP) in Bethesda, Maryland, said pharmacists now have better software technology for managing inventory control. Typically in hospitals there are seasonal changes, with more respiratory infections in the winter and a greater need for antibiotics. However, centralized inventory allows a pharmacist to better keep track of how specific drugs are being prescribed. This can allow for an immediate alert if a drug is in short supply or headed that way. “The most major thing is communication,” Ganio said, “everything from the purchasers, who may have an early signal that a shortage is going to occur, and then notifying the clinical pharmacist and the providers.”

The COVID-19 pandemic created drug shortages that had not been anticipated. Ganio said in April and May 2020, pharmacists experienced a 300% to 500% increase in the use of intensive care drugs and agents for patients on ventilators. “So the whole country was affected because wholesalers made big shifts,” Ganio said. “That was a very scary time for the pharmacists.”

Artificial intelligence (AI) could be potentially useful in helping prevent drug shortages. However, limitations exist due to the inability of AI to predict a problem at a manufacturing plant or other links in the system. “When it comes down to it, there is not a lot of transparency,” Ganio said.

Most drug shortages are caused by manufacturing quality issues.

 There may be a quality issue identified during an FDA inspection, but the citation may not be posted in a timely matter. “It could be glass, the raw material, or a supply chain issue,” Ganio said. Warning letters can be delayed for months, he noted. AI use may be limited due to these factors and the fact that third parties are involved and often masked.

New drug shortages in general are declining, but the concern among pharmacists is that hundreds of drugs remain in chronic shortage. To address this issue at The Johns Hopkins Hospital, there are weekly task force meetings looking at all drug inventories and stocking practices. One task force examines weekly inventories and the areas of highest need. A second task force is dedicated solely to COVID-19–related treatments. Combined with other strategies, such as analytics solutions, pharmacists work with the providers to restrict drugs to those who are in the most need so each agent can be used the most optimally. “The keys are good management and use of dashboards that can allow for easily pulling data for monitoring and predicting shortages,” Pherson said. “It lets you be more proactive.” 

Woodcock J. To help reduce drug shortages, we need manufacturers to sell quality—not just medicine. Food and Drug Administration. Updated October 24, 2019. Accessed January 31, 2021. 

https://www.fda.gov/news-events/fda-voices/help-reduce-drug-shortages-we-need-manufacturers-sell-quality-not-just-medicine

Hospitals employ several strategies for a proactive approach to shortages. 

Leveraging New Technologies to Prevent Drug Shortages

The best practices for pill disposal are always being updated and policies vary from state to state. Opioids, in particular, are a concern and pharmacists are being called upon to educate their patients on optimal disposal practices.

Community pharmacist Elizabeth Skoy, PharmD, an associate professor at North Dakota State University School of Pharmacy in Fargo, said consumers can look for medication take-back events or drop off unused or expired medications at their local law enforcement office. Some pharmacies provide products that patients can mix with medications before disposing of them, or envelopes they can use to mail a medication to a facility for incineration. “There often is a cost to the patient for these options. There are also states that allow consumers to bring unused or expired medication to kiosks located near their local pharmacy. North Dakota allows for kiosks at the pharmacy, and tons of medication have already been collected and disposed of within the state,” Skoy told 

This issue is now at the forefront because it is estimated that more than half of individuals using prescription pain relievers for nonmedical purposes obtain the medications from a friend or relative.

Skoy said children or pets can access medications left in medicine cabinets or trash cans, which can cause unwanted, even life-threatening adverse effects. She noted that individuals looking to obtain medication for nonmedical purposes often check these areas, making proper disposal paramount.

Policies for opioid disposal vary by state. Community pharmacists should contact their state board of pharmacy to identify disposal options and what may be available for their particular pharmacy location. The FDA has a flush list, which includes opioids and other medications that the agency has identified as being suitable to flush as a method of disposal.

According to the FDA, the known risks from accidental exposure to these medications far outweigh any potential risk to humans or the environment that may arise by flushing them. “If someone is unable to properly dispose of unwanted medications through any of the above disposal options, and the medication is not on the FDA flush list, the last [option] is to dispose of [it] at home. To do this, you can mix the medication with cat litter, coffee grounds, or dirt and then place the mixture in a sealed plastic bag before discarding in the trash can,” said Skoy.

Lisa Schwartz, PharmD, who is the senior director of professional affairs at the National Community Pharmacists Association (NCPA) in Alexandria, Virginia, advises pharmacists to counsel each patient to do what works best for them to keep their household safe and to explain the importance of this issue.

“By disposing of medications in a secure drop-off bin, usually at a pharmacy or law enforcement agency, or using a prepaid medication disposal mailer, you also help protect the environment, especially the lakes and rivers,” Schwartz said.

Amy Tiemeier, an associate professor of pharmacy practice at St. Louis College of Pharmacy at University of Health Sciences and Pharmacy in St Louis, Missouri, said the best way for a consumer to get rid of unused or expired medications would be to dispose of them in a medication drop box or at a take-back event that destroys medications in an EPA-certified incinerator. “Drop boxes can be found throughout the country and the DEA [Drug Enforcement Agency] National Prescription Drug Take Back Days use this method of destruction. The National Association of Boards of Pharmacy has an online search tool where consumers can search for a drop box near them,” she said.

The policies on opioid disposal have changed over the past 5 years and are likely to change again. The FDA has not always recommended medication disposal drop boxes. According to Tiemeier, the federal law allowing medication disposal boxes in pharmacies, hospitals, and long-term care facilities didn’t go into effect until October 2013. “It was at least 6 months after that before any large chains started putting drop boxes in some of their locations, and some states had laws that still didn’t permit it. With the addition of more medication drop boxes that were more widely available to the general public, the recommendation changed to using that method first if available instead of flushing,” she explained.

List of medicines recommended for disposal by flushing. FDA. Updated April 2018. Accessed November 10, 2020. 

https://www.fda.gov/media/109643/download

Jones CM, Paulozzi LJ, Mack KA. Sources of prescription opioid pain relievers by frequency of past-year nonmedical use: United States, 2008-2011. 

 2014;174(5):802-803. doi:10.1001/jamainternmed.2013.12809

Drug disposal. National Association of Boards of Pharmacy. Accessed November 10, 2020. 

Counsel patients on best practices for disposal of unused or expired pain medications.

Optimizing Pill Disposal Programs

Operational barriers and lack of shareable patient-specific documentation are systemic obstacles to eective collaboration between pharmacists and physicians. However, there are some simple steps that go a long way in improving collaboration between pharmacists and physicians. “I believe there often is a disconnect between the patient care that pharmacists and physicians provide, especially in the community pharmacy setting,” said Michelle Jeon, PharmD, who is an assistant professor in the department of pharmacy practice at the University of Health Sciences and Pharmacy in St Louis, Missouri.

In an email to Drug Topics®, Jeon said pharmacies have crucial patient information that most physicians don’t have direct access to, such as medication out-of-pocket costs and refill histories. Pharmacies may serve as a central repository for medications prescribed by several dierent prescribers, and pharmacists can identify potential drug interactions and duplications in therapy. However, Jeon said pharmacists often don’t have access to diagnoses and patient information, such as weight, in order to ensure optimized patient-specific medication doses.

Jeon and her colleagues have been investigating how pharmacists can improve collaboration with physicians and overcome systemic barriers. Collaborative drug therapy management (CDTM) is permitted between a physician and pharmacist in Missouri. This allows pharmacists to modify, initiate, or discontinue noncontrolled medication therapies under a written protocol. However, Jeon’s team surveyed 103 community pharmacists and 23 outpatient physicians and found that pharmacists identified operational barriers of time and reimbursement. Physicians reported concern with clinical risks, including potential disconnect between providers and inadequate pharmacist training.

Jeon said physicians need a better understanding of the clinical role of pharmacists working in the community setting. “Most pharmacies conduct adherence calls on a regular basis, providing an opportunity to uncover barriers to optimal medication habits and educate patients about their medications,” Jeon said.“If physicians tapped into these pharmacist-led services through referrals or shared documentation, patient outcomes and overall care could drastically improve.”

Brian Caswell, RPh, the 2019-2020 president of the National Community Pharmacists Association and owner of Wolkar Drug in Baxter Springs, Kansas, said that pharmacists can find it difficult to track down a physician with questions and vice versa. “If I leave a message with an oce, these questions can be so technical that the message can get lost in translation before it gets to the doctor,” Caswell said.

He would like to see pharmacists and physicians set up recurring group conversations to discuss common issues, such as prior authorizations and how to streamline processes. Caswell said the coronavirus disease 2019 (COVID-19) pandemic has compounded some issues.“Pharmacists and physicians are so busy, especially right now. In my view, time is the biggest barrier to collaboration,” Caswell said.

"There are reimbursement hurdles. On the pharmacy end, there are state and federal rules on the prescription order. You can’t assume anything,” Cliord Young, RPh, CGP, president of the California Pharmacists Association, said. “It is more complex than it appears and should be. You can go into a phone queue from hell to get a clarification.”

According to Young, the very high costs of some newer agents has added even more complexity. “Most pharmacists need to know the restraints the physician is under. The payment to physicians is a challenge, just like it is to the pharmacists. If the physicians understood that we are really the patient advocate, that would help,” Young said. “It is about relationships.”


Shared information and continued communication can build a cohesive partnership.