John Schieszer

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

Articles

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

Biosimilars May Lead to Improved Competition and Lower Costs

High workloads for pharmacists increase the potential for medication errors, and during the current coronavirus disease 2019 (COVID- 19) pandemic, the pressures are greater than ever. Unions are taking unprecedented steps to protect pharmacists and their patients. Their focus over the next year will be on making significant and lasting changes to prevent the growing number of obstacles that distract pharmacists from safely dispensing drugs.

In Chicago, permanent changes are occurring. Several years ago, a 

investigation revealed that 52% of 255 Chicago-area pharmacies had failed to warn patients about drug combinations that could cause harm or death.

 Since then, Teamsters Local 727 has worked with the Illinois legislature to update the state’s pharmacy act to better reflect the issues of working in a retail pharmacy. The union is pushing for mandatory, uninterrupted breaks for pharmacists.

In 2020, Teamsters Local 727 aims to raise standards, improve working conditions, and lift the collective voice of pharmacists and members of Teamsters Local 727. In an email, Teamsters Local 727 told 

 that the union is advocating for further reforms to the Illinois Pharmacy Practice Act, and, through its 2 seats on the Illinois Pharmaceutical Task Force, this fall it will give recommendations to the state legislature regarding further reforms.

The union supports additional policy reforms, including limiting retail pharmacists’ workdays to 8 hours, requiring that at least 1 pharmacy technician be on duty at all times when a pharmacist is scheduled, and requiring a separate break room to guarantee uninterrupted breaks. In addition, Teamsters Local 727 is asking for a triple-pay penalty for days when a retail employer fails to give a pharmacist the opportunity for an uninterrupted break.

“Retail chains should be held responsible for any failure to allow pharmacists to take uninterrupted breaks. When pharmacists are unable to take breaks, it’s usually due to understaffing in the pharmacy while the duties for pharmacists continue to grow,” Teamsters Local 727 said in the email.

Protecting Pharmacists and Their Patients

Ilisa Bernstein, PharmD, JD, senior vice president for pharmacy practice and government affairs at the American Pharmacists Association in Washington, DC, said several states have rules governing pharmacist breaks, including the minimum number, based on hours worked, and where they can be taken. “In addition, some employers have begun providing breaks for pharmacists,” Bernstein told 

® in an email. “Whether by law or policy, employers should provide pharmacists with mandatory, scheduled, uninterrupted meal breaks away from the pharmacy workflow to promote pharmacist well-being and improve patient safety.”

The COVID-19 pandemic has created significant disruptions in pharmacy operations and raised pharmacist safety concerns, according to Bernstein. “Access to appropriate [personal protective equipment (PPE)] and barriers in accordance with CDC guidance, distancing issues, personnel shortages, drug supply disruptions, and more have left pharmacists in a constant state of uncertainty, and they are taking extraordinary measures to ensure consistent delivery of quality patient care,” she said.

States, federal agencies, and employers have taken steps to improve conditions, she said, but as the pandemic evolves, so do pharmacist issues and concerns. For example, she said, although pharmacists welcome the ability to provide COVID-19 testing and a potential vaccine, employers and employees need to collaborate in the workplace to mitigate pharmacy operation and safety concerns.

Veronica Bandy, PharmD, MS, past president of the California Pharmacists Association in Sacramento, said that state laws regarding staff breaks vary. “Breaks for pharmacy personnel are needed to prevent fatigue and allow for time to use the facilities. Adequate staffing, breaks, and safety would be beneficial to be addressed to ensure the ability for pharmacists to provide health care at its highest level,” Bandy told 

“With testing now and immunizations once a vaccine becomes available, community pharmacists could be the centerpiece for helping the country get back to normalcy.” 

The pandemic has changed the practice of pharmacy. Some pharmacies have placed protective partitions between patients and personnel. Individuals are encouraged to use drive-through or other social distancing methods for prescription pickup. In addition, masks need to be worn, and PPE use and social distancing between staff members must increase.“The California Pharmacists Association has been instrumental in advocating that pharmacists as health care providers have access to face masks and other [PPE]. As with many areas of health care, the practice of pharmacy is adapting on a daily basis as more scientific information becomes available,” Bandy said.

James Broughel, a senior research fellow at the Mercatus Center at George Mason University in Arlington, Virginia, said that in response to the pandemic, many governors expanded pharmacists’ prescribing authority or made it easier for medical professionals licensed in another state to practice. Many states have drive-through COVID-19 testing sites at pharmacy locations; although the extent of these operations varies significantly across states, pharmacists already play a significant role, which is likely to grow over time. "Unions should anticipate that pharmacists are going to be doing a lot of COVID-19 testing and ensure that adequate precautions are taken to ensure the safety of pharmacy staff, as well as customers,” Broughel told 

Study results published in 2007 in the journal Medical Care found that high workloads for pharmacists increase the potential for medication errors.

In a retrospective study, investigators reviewed data submitted to insurance companies by 672 pharmacies in 18 metropolitan regions. The pharmacies filled an average of 17,948 prescriptions from January to March 2003. The investigators found that factors significantly related to an increased risk of dispensing prescriptions with potential drug-drug interactions included pharmacist workload (odds ratio [OR], 1.03), pharmacy staffing (OR, 1.10), and various technologies, such as sophisticated telephone systems, internet receipt of orders, and refill requests.

The pharmacies employed an average of 1.2 pharmacists for each hour the store was open, and each pharmacist filled an average of 14.1 prescriptions per hour. The risk of dispensing potentially harmful drug combinations increased by 3% for each additional prescription filled per hour. There has been little improvement since the research was done, said study investigator Dan Malone, PhD, RPh, a professor at the University of Utah College of Pharmacy in Salt Lake City. “Working conditions are worse,” Malone told 

 in an email. “I would suggest that not much has changed.” 

Mike DeAngelis, senior director of corporate communications for CVS Health in Woonsocket, Rhode Island, said the company has policies and protocols to help ensure that stores are safe for both employees and patients during the current pandemic. All employees have received protective masks, gloves, hand sanitizer, and cleaning supplies and are required to wear a company-issued mask, their own mask, or a cloth face covering. “We have installed protective panels at our pharmacy counters and front-store checkout stations in all stores. We have hourly protocols in place for cleaning hard surfaces and more frequent cleaning of commonly handled items,” DeAngelis said in an email.

B. Douglas Hoey, MBA, RPh, CEO of the National Community Pharmacists Association in Alexandria, Virginia, said community pharmacies are the safety nets helping their communities during both times of crisis and normal times. In addition, pharmacists now are on the front line in America’s fight against COVID-19, ordering and administering tests. “With testing now and immunizations once a vaccine becomes available, community pharmacists could be the centerpiece for helping the country get back to normalcy,” Hoey told 

® in an email. How smoothly that goes will depend on the rights and protections afforded pharmacists in retail stores across the nation.

Roe S, Long R, King K. Pharmacies miss half of dangerous drug combinations. 

 December 16, 2016. Accessed July 1, 2020. https://www.chicagotribune.com/investigations/ct-drug-interactions-pharmacy-met-20161214-story.html

Malone DC, Abarca J, Skrepnek GH, et al. Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions. 

 2007;45(5):456-462. doi:10.1097/01.mlr.0000257839.83765.07

Workplace conditions can affect both pharmacist and patient safety.

Pharmacy Unions Push for Improvements

Nonmedical issues are requiring pharmacists’ attention in increasingly urgent ways, especially in light of the coronavirus disease 2019 (COVID-19) pandemic. A greater focus on social determinants of health (SDOH) may lead to a much more comprehensive approach to treating patients in the pharmacy and ultimately drive improved outcomes. Overall health is often determined by social and economic issues, and understanding how these factors affect patients is key to identifying and addressing SDOH in the pharmacy setting.

The World Health Organization (WHO) defines SDOH as the conditions in which individuals are born, grow, live, work, and age. The WHO definition also states that these circumstances are shaped by the distribution of money, power, and resources at global, national, and local levels. SDOH can be directly related to health inequities contributing to unfair and avoidable differences in health status. However, the health care community is now addressing these issues in a much more formal way, with the COVID-19 pandemic placing even greater urgency on pharmacists to adopt models of SDOH.

Hannah Fish, PharmD, associate director of strategic initiatives at the National Community Pharmacists Association in Washington, DC, said pharmacists are one of the most accessible health care providers and are often the first point of care for many patients. “Pharmacists are intimately familiar with the lives of the patients in their community and often are aware of nonmedical-related concerns such as transportation, housing, and food security," she told 

Fish added that because many independent pharmacies deliver medications, they can see firsthand many of the SDOH affecting their patients. Pharmacies across the country are starting to train their pharmacy technicians as community health workers. “Pharmacists have been leveraged informally as the eyes and ears of the care team, documenting what they see in their pharmacy management systems or simply just knowing their community so well. Now we’re starting to see some formality,” she said.

The CDC has recognized the importance of SDOH to public health and has established programs that partner with communities to provide a greater health impact. The CDC programs include the National Program to Eliminate Diabetes-Related Disparities in Vulnerable Populations, which helps 6 organizations plan, develop, implement, and evaluate multisector, community-based interventions.

Fish said some community health workers can assist with screening and assessing patients adversely affected by SDOH. These health workers can serve as a referral source to connect patients with the resources they need, such as food banking services, transportation services, and more. “A pharmacy might have helped a patient with finding these resources in the past, [and] community health workers are able to expand and expedite this service,” said Fish.

Richard Logan Jr, PharmD, Logan & Seiler, Inc L&S Pharmacy, Medical Arts Pharmacy, Charleston, Missouri, echoed Fish’s recognition of the pharmacist’s role in patient’s health care: “This relationship has been for years the cornerstone of clinical pharmacy services. From addressing access to medications for reasons clinical or financial to acting as a triage and referral site into the health care system, no one spends more eyeball-to-eyeball time with the patient than their pharmacist,” he said.

Logan noted that the best health care system in the world is of no use to a patient who cannot access it. If an individual has an appointment with a physician but has no way to get to the office, that appointment is pointless. “People who have poor access to food are worrying about their next meal, not their [high-density lipoprotein] levels,” said Logan. SDOH in various forms can create a significant barrier to health care. “[The Centers for Medicare & Medicaid Services] has recognized this and legitimized it with a whole series of ICD-10 [

International Classification of Diseases, Tenth Revision

] codes addressing SDOH as a barrier to care," said Logan.

A patient with a chronic disease usually has 35 or more visits to a pharmacy in a year, making the pharmacy the logical “go-to place” to delve into how SDOH are affecting a patient’s care, according to Logan. Often the pharmacy is the canary in a coal mine for patient access to health care. “We see patient struggles first, either through conversations in the pharmacy or when we deliver to their home and step into their lives. In our practice, and others of which I’m aware, we employ trained community health workers to interact with patients, interview patients, refer patients to services, and assist them in any way possible to address their SDOH [and] access to care in a caring, compassionate, effective way,” said Logan. Logan said by focusing on SDOH, his group has had great success, in both positive patient outcomes and increased professional awareness among local health care colleagues.

Linn Gould, MPH, executive director of Just Health Action in Seattle, Washington, said the term SDOH has existed for more than 20 years. Yet many pharmacists have never even heard of it. “From 2001 to 2003, the jargon started being adopted more widely. So it is fascinating that there are so many people who have never heard of it,” said Gould.

Medical and pharmacy schools appear to be failing in addressing SDOH. One recent article suggested that major structural and cultural transformations in medical education are warranted to address social and economic issues. The authors wrote that educators need to discuss not only poverty but also oppression, racism, sexism, and homophobia. One local pharmacist in Seattle told 

® that he had never heard much about SDOH. He said he is surprised by how little attention SDOH receive and that most pharmacists have a total lack of awareness of SDOH. Yet most pharmacists would probably adopt a model if they had the knowledge and were given the opportunity, he added. Unfortunately, the current operational model for retail pharmacies is now extremely transactional and, for the most part, does not allow pharmacists to take into account SDOH.

Currently, the COVID-19 pandemic is requiring that pharmacies address SDOH in many areas. Mass unemployment, for instance, has led to myriad new needs. “Pharmacies delivering medications are calling their patients to see whether they need anything else, such as groceries, before going to the home,” said Fish. She said during the current period of social distancing, calling patients once a week to check on their general well-being and mental health may be appropriate. “In addition to employing community health workers, we’ve seen pharmacies partner with local farmers’ markets to provide fresh produce for patients coming to the pharmacy. Further, insurers are recognizing the impact SDOH have on health outcomes and are expressing a desire to work with pharmacies to address these concerns,” said Fish.

Logan said pharmacists are rising to meet the challenge of remote patient care via enhanced deliveries, curbside services, expanded personal patient outreach, and an increase in those patient touch points even as patients shelter in place. Many older patients in particular are now unable to make physician visits, putting them at risk of uncontrolled chronic comorbidities. “Our pharmacies are checking in regularly with our patients with chronic conditions to make sure they are not ignoring other conditions for the sake of COVID-19,” Logan told 

Gould works in Seattle’s Duwamish Valley, a community with environmental justice concerns as a result of significant air pollution problems. “It has one of the highest childhood asthma hospitalization rates in the city of Seattle, and now we have evidence that the higher air pollution [is], the higher the COVID-19 death rate [is]. We have also learned that there is a link between asthma and COVID-19 rates," said Gould.

The physical distancing measures required to slow the spread of COVID-19 are substantially more difficult for those with adverse social determinants. According to Denise Fu, PharmD, clinical programs manager in Patient Care Services at Johns Hopkins Home Care Group Pharmacy Services in Baltimore, Maryland, although many pharmacists can identify SDOH issues, they need more education regarding available resources to help them address the barriers. “For example, pharmacists may be able to assist the patient with access to prescription medication but would need to refer the patient to other resources for employment, food insecurity, or housing instability,” she said.

Fu also said that improving information technology can help by filling in the gaps with SDOH data. One published study suggested that a lack of policy standards around SDOH data may be hindering adoption. However, commercial vendors are interested in collaboratively discussing policy solutions such as standards and guidelines. The investigators evaluated the development of electronic health record (EHR) software products that allow health care providers to identify and address patients’ SDOH. They conducted interviews with 6 EHR vendors with large market shares in both ambulatory and inpatient settings. The study results showed that SDOH appear to be an area for growth and that vendors offer a wide range of SDOH-related products with various levels of sophistication.

“If health care providers are able to collect and document SDOH risk factors, technology can help by seeing how many and to what extent of the 5 SDOH domains a particular patient is experiencing. If a patient is unable to keep the water on in their house or food on the table for their family, they are most likely not going to be able to afford and take their medicines,” said Fu.

A century ago, helping individuals with SDOH made a significant impact against tuberculosis, another highly infectious disease. At that time, better housing, a reduction in overcrowding, and improved nutrition saved countless lives. Now pharmacy is stepping up to formally address SDOH to help lower both morbidity and mortality during the current pandemic and beyond.

Enhanced pharmacy services such as home delivery, curbside services, and expanded personal patient outreach create opportunities to address social determinants of health during the pandemic.

Social Determinants of Health: Tackle Disparities From the Pharmacy

When it comes to cybersecurity threats related to the Health Insurance Portability and Accountability Act (HIPAA), pharmacists are in a unique and rather unenviable position.

Joey Mattingly, PharmD, PhD, MBA, an associate professor and vice chair of academic affairs of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy in Baltimore, teaches a pharmacy management course that examines practical implications of HIPAA. Like all businesses, pharmacies are susceptible to cyberattacks, he said, so it is important to have an information security plan that covers everything from training to what to do if a breach occurs.

“Many large chain pharmacies have well-established policies and procedures, but a start-up pharmacy or smaller organization may not have as large of an infrastructure in place,” Mattingly told Drug Topics®.

Recent data breaches with large companies and potential interference in major political elections have heightened attention to cybersecurity concerns, and it is paramount that pharmacists understand their existing company policies, Mattingly said. Pharmacists starting their own businesses should consider hiring information technology experts to establish detailed standard operation procedures specific to security.

“Err on the side of caution. One large data breach could [affect all] your patients, your employees, and yourself. The fallout from a data breach could be devastating and potentially ruin your business, particularly since it involves our patients’ personal health information,” he said.

Investing in proper training is key. Mattingly advocates taking the time to teach, review best practices, and make sure all employees practice what they learned. “Test your processes and systems for security gaps,” he said. “Many retail stores use secret shoppers to test customer service, [and] a pharmacy can use this technique to see if any of your employees would fall for a basic hacking ploy [such as a phishing email].” Mattingly advises focusing on best practices rather than failures: “You should provide incentives for your pharmacists and technicians who do things right.”

Pharmacists now have more tools and technologies to protect their data, but cyber criminals have also developed new strategies, and the risk continues
	to evolve, according to Mattingly. Protecting against a cyberattack should be viewed as a business expense or op- erating cost, he noted. “Pharmacies are already pressured with decreasing margins on pharmacy sales, so it is important that pharmacists advocate for either increased revenues for pharmacies or other financial support [such as low-interest loans and tax incentives] for technology and training investments,” he said.

Neil Edillo, PharmD, assistant direc- tor of pharmacy services and information management and medication safety at Oregon Health & Science University (OHSU) in Portland, said that as far as he knows, no cyberattacks have targeted only the pharmacy community.

“Pharmacists can fall victim to the same schemes that are applied broadly to everyone. There are quite a few ways that hackers can attempt to gain unlawful access to our systems, and as a health system, we have instituted a number of interventions at the individual level to help safeguard login information,”Edillo said. All systems should require strong passwords with special characters, and all employees should be required to change passwords every 90 days, he said, underscoring the importance of 2-factor authentication.

“The primary threat to obtain user log-in credentials is phishing. As great as our email servers are, some of these email attempts are able to find their way through to our end users. Our health system has provided education about what phishing attempts look like and what to do with them,”Edillo said. OHSU has instituted test programs in which they internally generate a phishinglike email that is distributed to all users across the university and health system from an outside mail server. “If the user clicks on the links contained in the email, they are immediately provided instruction on phishing attempts and to maintain their vigilance against cybersecurity threats,” Edillo told 

Pharmacists interested in protecting themselves and their customers from cyberattacks need to invest in vendors that handle their data, according to investigators at American University in Washington, DC. They conducted a study and found that a data breach due to a third-party supplier was more likely to lead to an underinvestment in cybersecurity measures. The study authors wrote that all companies need to look at every entity that handles their data-just 1 weak link and the system is compromised. Study coauthor Jay Simon, PhD, an associate professor of information technology and analytics at American University’s Kogod School of Business, said there is a huge range of cybersecurity threats, depending on the systems, data involved, and the attackers’ goals. “A computer needs to have adequate security settings and software, but the user also needs to understand how to avoid installing malware or falling for phishing scams. Pharmacists face the added legal and ethical ramifications of having sensitive personal data compromised, which makes all these measures even more crucial,” Simon told 

A few years ago, Merck was hit with a serious ransomware attack, which is a common issue for health care providers, according to Simon. Last June, 5 US health care organizations reported ransomware attacks, with some having to pay to regain access to files.

“Keep your security software up- to-date, and understand the common techniques that attackers use. Good password management and not clicking on anything suspicious goes a long way. Be restrictive about who’s allowed access to your computers and network, both physically and electronically,” he said.
	Lisa Schwartz, PharmD, senior director of professional affairs at the National Community Pharmacists Association in Alexandria, Virginia, said that like any business, pharmacies face the threat of having digital records hacked. However, these vulnerable data include not just personnel and financial records of the business, but also patient health information, which opens pharmacies up to scrutiny by the US Department of Health & Human Services Office for Civil Rights, which enforces HIPAA.

“It makes sense for pharmacists and pharmacy owners to use many of the tools that are available to HIPAA-covered entities and organizations trying to improve cybersecurity. These include virtual private networks, firewalls, and antivirus software,” Schwartz said. “[Although] those tools help protect the pharmacy management system from cyberattacks, inappropriate access by employees of the pharmacy is another concern.” Pharmacy owners should seek advice from software vendors about the access controls and the best method of monitoring, according to Schwartz. “For example, the pharmacy’s privacy officer could have an alert in place anytime a high-profile patient’s record is accessed to prevent unauthorized use or disclosure,” Schwartz said.

Today’s tactics are more subtle than those of the past, Schwartz said. Cyber criminals often try to collect bits of personal data to trick individuals into replying to an email or clicking a link they would normally discard if it snuck though a spam filter. “Pharmacists and pharmacy staff can do their part to minimize cybersecurity threats by only using pharmacy computers to access trusted websites and to be careful about opening attachments or clicking links in email,” Schwartz said. “For example, if a technician receives an email that appears to be from a familiar vendor but contains an unexpected invoice, call the sender and ask if it is legitimate.” Fred H. Cate, JD, vice president for research and a professor of law at Indiana University, said pharmacists are seeing more desperate requests for help to provide a drug without a prescription or help a patient with shipping or supply chain delays related to the pandemic. “Most of these requests are almost certainly legitimate, but that is just how a criminal would approach a pharmacy, as well, whether in a classic fraud attack or in an effort to find access information [or] an unlocked machine or other ways to infiltrate the system,”Catesaid. In recent years, he said, many attacks originated from people sitting in cars in parking lots using wireless access through the payment or other systems. Cate added that because of the pandemic, pharmacists need to be vigilant. “These types of attacks are more likely to succeed and less likely to be noticed when there are other stresses on the system,” Cate said.

“Err on the side of caution. One large data breach could [affect all] your patients, your employees, and yourself.”

Author | John Schieszer

Articles

Biosimilars May Lead to Improved Competition and Lower Costs

Pharmacy Unions Push for Improvements

Social Determinants of Health: Tackle Disparities From the Pharmacy

Pharmacies Can Take Steps to Protect Against Cyberattacks