John Schieszer

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

Articles

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.

Improving Pharmacist-Physician Collaboration

Biosimilars, which offer the potential for more treatment options and less expensive alternatives, are having a good year in 2020 and may have a significant impact on the prescription product market in 2021. With the approval of more biosimilar medications, experts hope that greater competition may occur and help lower overall costs. “As intellectual property protections for biological products continue to expire in the US

, we can expect many more applications for potential biosimilar and interchangeable products, and increased uptake of approved products too,” said Sarah Yim, MD, the director of the Office of Therapeutic Biologics and Biosimilars at the FDA’s Center for Drug Evaluation and Research, in Bethesda, Maryland.

 Some of the key issues affecting biosimilar uptake involve reimbursement factors and insurance coverage, according to Yim. However, she said, business and intellectual property concerns also have contributed to the delayed launch of some FDA-approved biosimilars. In 2009, the Biologics Price Competition and Innovation Act created an abbreviated regulatory pathway for biological products demonstrating to be biosimilar or interchangeable with an FDA-approved drug. Since then, the FDA has approved biosimilar medications to treat a host of conditions, including cancer, colitis, Crohn disease, rheumatoid arthritis, and psoriasis.

Biologics are medicines that generally come from living organisms, which include animals and microorganisms (yeast and bacteria). A biosimilar is defined by the FDA as a biologic that has no clinically meaningful differences from another biologic that is already FDA approved. Biosimilars are made with the same types of natural sources as the original medication and are delivered the same way. They have the same strength and dosage and the same potential adverse effects.

The FDA has outlined 4 key strategies in its Biosimilars Action Plan (BAP) to accelerate biosimilar competition. “We continue to work on the key elements of the BAP, and we have ongoing activities that fit within all of the elements,” Yim told 

Improve the development and approval process for biosimilar and interchangeable products.

Maximize scientific and regulatory clarity for the developers of biosimilar products.

Improve the understanding of biosimilars among patients, clinicians, and payers.

Support market competition by reducing gaming of FDA requirements and other attempts to unfairly delay competition.

Right now, there are 28 FDA-approved biosimilar products, and 17 are on the market. “We have seen a jump in the past year of launched products. In addition, the biosimilars that are on the market have typically launched with initial list prices 15% to 35% lower than the list prices of the reference products,” Yim said.

Over the next 6 to 18 months, the landscape will be evolving for biosimilar and interchangeable insulin products and other transition biological products. Under new regulations, insulin and other biological products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins are regulated by the FDA in biologics license applications. This means that manufacturers can submit marketing applications for proposed biosimilar and interchangeable products that reference transitioned biological products. “If approved, these products will help bring competition to those markets, and patients may have more affordable access to the medications they need,” Yim said. “I am hopeful that we will see the FDA’s first interchangeable biosimilar product during the time period [6 to 18 months].”

Once an interchangeable product is approved and available on the market, Yim said it can then be substituted for the reference product without the intervention of the prescriber. It is hoped that this will lead to increased access and lower costs for patients. There are more than 80 biosimilars in the development pipeline. Five biosimilars have been approved in the last year, with adalimumab-fkjp (Hulio) and pegfilgrastim-apgf (Nyvepria) most recently approved (

Sandoz Inc has 8 approved biosimilars worldwide and 4 in the United States. Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz in Princeton, New Jersey, said reimbursement policies do not support the use of biosimilars, and despite progress in certain therapeutic areas, some hesitancy remains among many clinicians to switch to a biosimilar. “To realize the full promise of biosimilars in the US, we need to support policies that increase their adoption and help create a more balanced and competitive marketplace,” Frame told 

She said that within Medicare Part D, Sandoz supports reducing administrative burdens for patients and providers by removing redundant prior authorization for a biosimilar when one has been granted for the reference biologic. Widespread adoption of biosimilars in clinical practice has faced headwinds, in part because of targeted misinformation campaigns, Frame said.

A recent article examining the impact of biosimilar misinformation and disparagement campaigns suggested these campaigns can harm opportunities to increase patient access.

 “We are encouraged by action from the FDA and the FTC [Federal Trade Commission] to combat pervasive misinformation, but it is the responsibility of all stakeholders to challenge biosimilar disparagement and misinformation when encountered. Clear and unbiased scientific messaging is crucial to helping patients and clinicians better understand the value of biosimilars,” Frame said.

She said the cost savings from biosimilar medicines could be enormous, saving the US health care system billions of dollars over the coming years.

Andrew Powaleny, director of public affairs at the Pharmaceutical Research and Manufacturers of America in Washington, DC, said the rich pipeline of potential biosimilar products in development and market experience suggest there still is significant potential for cost savings in the marketplace.

A recent analysis of the market dynamics of 4 biologics and their biosimilars demonstrated that the net prices of all the originator biologics decreased following the entry of biosimilars. In the Medicaid program, discounts increased by between 20.1 and 35.2 percentage points.

 “As the market experience with biosimilars increases, we expect product usage to play an expanded role in options for patients and further decrease prescription drug spending. Experts have argued that the coming wave of biosimilars will penetrate the market even more quickly than those already available for patients,” Powaleny said.

COVID-19 Pandemic and Prescription Drug Costs

Currently, the coronavirus disease 2019 (COVID-19) pandemic is crippling the economy. Frame said everyone is looking toward rebuilding, so any and all cost savings are on the table. “Supporting and advancing policies that increase access and use of lower-cost biosimilars can help,” she said. 

At the University of California, San Francisco (UCSF), Health, leadership has endorsed the adoption of biosimilars for clinical care, according to Candy Tsourounis, PharmD, a professor in the department of clinical pharmacy at the UCSF School of Pharmacy. As a member of the department’s Medication Outcomes Center, Tsourounis is involved in providing evidence-based reviews of recently approved prescription medications and performing medication utilization analyses for UCSF Health. She said the endorsement of biosimilars aligns with the national adoption of biosimilars across health systems to ensure safe and cost-effective therapies are available to advance health. Now, during the COVID-19 pandemic this may be more important than ever.

“We anticipate significant cost savings while maintaining high-quality care and ensuring similar clinical outcomes. Over the next 6 to 18 months, we hope to show similar clinical outcomes but with significant reductions in drug spending, not only within UCSF Health, but also more broadly for UC Health,” which oversees and provides strategic direction across all 6 health systems, including UCSF Health, 

Brian Komoto, PharmD, past president of the California Pharmacists Association in Visalia, California, said biosimilars will could help improve patient access and reduce copays for many more individuals in the coming year. He noted that educating clinicians is vital. “Hopefully, physicians are receptive and the use of biosimilars can increase,” Komoto told 

®. “This should also allow pharmacies that are not able to get contract pricing, the ability to work with manufacturers of biosimilar products.”

Francis B. Palumbo, PhD, JD, a professor and executive director at the University of Maryland School of Pharmacy’s Center on Drugs and Public Policy in Baltimore, is a member of the biosimilars working group for the American Pharmacists Association, and he agrees that at this time clinician acceptance is vital. The trend appears positive, and it seems that biosimilars are having a significant impact in terms of patient access and lowering overall costs. “Biosimilars are now being approved at an increasing pace and have most likely reached some level of critical mass where they can exert real influence on the market,” Palumbo told 

FDA. Biosimilar product information. Updated July 7, 2020. Accessed August 7, 2020. 

fda.gov/drugs/biosimilars/biosimilar-product-information

Cohen, HP, McCabe, D. The importance of countering biosimilar disparagement and misinformation. 

 2020;34(4):407-414. doi:10.1007/s40259-020-00433-y 

San-Juan-Rodriguez A, Gellad WF, Good CB, Hernandez I. Trends in list prices, net prices, and discounts for originator biologics facing biosimilar competition. 

. 2019;2(12):e1917379. doi:10.1001/jamanetworkopen.2019.17379

How will biosimilars continue to affect the prescription product market in 2021?