John Schieszer

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.

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

Pharmacies Can Take Steps to Protect Against Cyberattacks

Never before have so many brilliant minds, machines, and groups come together so quickly in an attempt to develop a vaccine. The first human trial involving a vaccine product against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the novel coronavirus disease 2019 (COVID-19), began in March in Seattle, Washington. However, some experts in the field say creating unrealistic expectations may be harmful and warn that maintaining standard protocols during the pandemic is essential.

The genetic sequence of SARS-CoV-2 became available online in February. Subsequently, investigators have been able to use this information to find the protein that is critical for the virus to be able to infect humans. The hope is to use a portion of that protein to create a vaccine that will generate an antibody response to prevent the virus from infecting human cells. Some investigators are working on DNA-based vaccines that contain genes that produce the virus’ protein, whereas others are looking at vaccines that include a portion of the actual protein.

“We have never known as much as we do today [about] how to make vaccines. So if there is any bright spot to the pandemic, it is that the scientific world has many tools at hand to make an effective vaccine,” said William A. Petri, MD, PhD, a professor of medicine and vice chair for research in the Department of Medicine at the University of Virginia School of Medicine in Charlottesville. “I hope that COVID-19 will transform medicine by strengthening public support of science, public health, and medicine, and by teaching us that regardless of race, color, ethnicity, or nationality, we are all in this together.”

Petri is working with colleagues at the Infectious Disease Research Institute in Seattle to make a spike glycoprotein vaccine using novel toll-like receptor (TLR) adjuvants. Essentially they are hoping to use COVID-19’s spiked shape against the disease. His group’s vaccine is one of approximately 50 vaccines currently in various stages of development. What will take significant time is that scientists may have to study a range of virus strains in a variety of animal models before any vaccine product could even make it to a phase 3 level of testing.

At The Johns Hopkins Hospital in Baltimore, Maryland, vaccines with different approaches are under development, and scientists have been testing several avenues of crippling COVID-19 in animal studies.

 “The speed of the testing has been incredible,” said Tzyy-Choou “TC” Wu, MD, PhD, MPH, director of the Gynecologic Pathology Division at Johns Hopkins Medicine. He studied the SARS virus in 2002 and 2003 and is drawing on that experience to come up with a safe and effective vaccine.

On March 16 in Seattle, Kaiser Permanente Washington Health Research Institute’s Vaccine and Treatment Evaluation Unit launched a trial of the 

This experimental vaccine product is produced by Moderna, Inc, and the trial is expected to take 14 months. It involves 45 healthy individuals, aged 18 to 55 years, from the Seattle region. The product includes messenger RNA for the viral spike (S) protein. It does not include any form of live virus, and the trial will not expose participants to the virus.

Johnson & Johnson Announces COVID-19 Vaccine Candidate

The vaccine involves a series of 4 injections, and the investigators are testing safety and antibody production. It is an mRNA vaccine encoding for a prefusion stabilized form of the S protein, which was selected by Moderna in collaboration with the National Institute of Allergy and Infectious Diseases.

 The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle East respiratory syndrome (MERS) and SARS virus.

Coronaviruses are a family of viruses that include MERS and SARS. They are transmitted between animals and humans and can evolve into strains not previously identified. Wu and his colleagues have found that COVID-19 is continuing to evolve; consequently, it may be necessary to ensure that the portion of the protein and its genetic sequence will remain effective should the virus mutate or change.

“Several vaccines are advancing into clinical trials, [and] we are working to include our vaccine,” said Peter Jay Hotez, MD, PhD, dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston, Texas. He said it is possible that a vaccine will become available and ultimately delivered in the pharmacy. “[As] this may be an adult vaccine, we think it’s likely that in time it could be administered by pharmacists,” Hotez told 

On March 30, investigators at the University of Alabama at Birmingham announced the launch of their collaboration with Altimmune, Inc, for pre-clinical testing of a potential vaccine to prevent COVID-19 disease.

 The experimental product, named AdCOVID, would be a single-dose vaccine delivered by an intranasal spray. The investigators are examining immune responses to the vaccine in mice and are hoping to launch a phase 1 human safety and immunogenicity trial in patients in September.


																	Henry I. Miller, MD, a senior fellow at the Pacific Research Institute in San Francisco, California, was the FDA medical reviewer and head of the team that approved the first biopharmaceutical recombinant human insulin (Humulin) in 1982. He said that never before has there been such a worldwide effort to develop a safe and effective vaccine. “The good news is that the approaches are very different and varied, improving the chances that 1 or more will be successful,” Miller told 

However, he said the challenge is the nature of the vaccine products underway, all of which so far involve novel technologies. This will make regulators even more conservative in their evaluation and approval. “The facile prediction of 12 to 18 months is a pipe dream, off by at least a factor of 2, probably more,” said Miller. Getting to a phase 1 level is not a problem; however, he stated that the FDA had a significant role in a debacle surrounding a vaccine to prevent swine flu virus infections almost a half-century ago. “Of the 45 million people vaccinated against the swine flu in 1976, 450 developed a serious adverse reaction, the rare, paralytic Guillain-BarreÌ syndrome. What made the situation even more unfortunate for regulators is that the predicted epidemic never materialized, so the vaccine wasn’t needed,” said Miller.

It is for this reason that the FDA’s regulation of vaccines is especially conservative, he continued, and the bar has remained high for the approval of vaccines administered to millions of healthy people. According to Miller, the first rotavirus vaccine, RotaTeq, was tested in 72,000 healthy infants and the first human papillomavirus vaccine, Gardasil, was tested in more than 24,000 people.

Immunologist Adrian Liston, PhD, a senior group leader at the Babraham Institute and head of the VIB Translational Immunology Laboratory in Cambridge, England, disagrees with Miller. He said that how soon a vaccine becomes available will be dictated by how many thousands of deaths occur in the next 6 months. Liston told 

® that he expects a vaccine to be rolled out within the next 12 months and it may come with more risks than previous vaccines. He said a vaccine that is only 50% efficacious and causes minor adverse effects in up to 10% of people may be acceptable.

“It will skip a lot of the normal safety and efficacy steps, and it will likely be a much poorer vaccine than we are used to seeing, but it will likely have utility. Then, toward the end of 2021, I would expect to see the rollout of better vac- cines, with higher levels of efficacy and fewer adverse effects. At some point in the future, every child will likely be given a vaccine for COVID-19 as part of their routine vaccination schedule, but that is much more likely to be a third- or fourth-generation vaccine, with the optimal properties that we expect,”said Liston.

David J. Prelutsky, MD, medical director and founder of Southampton Healthcare and an associate professor of clinical medicine at Washington University School of Medicine in St Louis, Missouri, said there are many similarities between the spread of HIV and SARS-CoV-2. He highly suspects that a vaccine will be approved within the next 6 to 12 months. “I believe, [as] with HIV, therapeutic agents will be the answer and not a vaccine in the immediate future,” Prelutsky said. “There may be a vaccine, but that will take longer to develop.”

1. Shapiro M. New coronavirus vaccine in development at Johns Hopkins. Johns Hopkins Medicine. March 21, 2020. Accessed April 7, 2020.  

https://www.hopkinsmedicine.org/coronavirus/vaccine-development.html

2. NIH clinical trial of investigational vaccine for COVID-19 begins. News release. National Institute of Allergy and Infectious Diseases; March 16, 2020. Accessed April 7, 2020. 

https://www.niaid.nih.gov/news-events/nih-clinical-trial-investigational-vaccine-covid-19-begins

3. Altimmune and The University Of Alabama at Birmingham to collaborate on development of single-dose, intranasal COVID-19 vaccine. News release. Altimmune; March 30, 2020. Accessed April 7, 2020. 

https://ir.altimmune.com/news-releases/news-release-details/altimmune-and-university-alabama-birmingham-collaborate

Never before have so many brilliant minds, machines, and groups come together so quickly in an attempt to develop a vaccine.

A Flurry of COVID-19 Studies Are Underway, but Scientists Warn a Vaccine Will Take Time

Osteoarthritis is the most common type of arthritis, affecting nearly 54 million people. The condition causes a great deal of pain and distress, as well as limitations in daily activities and mobility, says Marcy O’Koon, senior director of Consumer Health at the Arthritis Foundation.

While opioids might seem to be an obvious solution, O’Koon says opioids are now discouraged-not just because of the nation’s opioid crisis and tightening access, but because there is a new recognition that they don’t work all that well. “Staying physically active and losing weight, if needed, are at the top of the list,” O’Koon says.

O’Koon recommends taking a 5- to 10-minute walk throughout the week and incrementally increasing the time and/or pace. Endurance will increase and the pain may recede over time. 

It’s also helpful to look at risks in groups. O’Koon points to CDC population surveys that have found that 50% of adults with heart disease and 50% of adults with diabetes have arthritis. “Those groups have double reason to be physically active. If they are over- weight and sedentary too, then overall health suffers.”

Pharmacists can help older adults who have osteoarthritis as well as heart disease. A major concern is that many of these individuals may be taking a lot of over-the-counter NSAIDs without their doctors’ knowledge.

A new study recently published in Arthritis Care & Research suggests there is a great need for improvement for man- aging older patients with arthritis. The study examined 2,297 physician visits for knee osteoarthritis and found rates for visits to orthopedists and physical ther- apists declined from 2007 to 2015. At the same time, prescriptions for NSAIDS and narcotics or opioids increased.

Lead author Samannaaz Khoja, PT, PhD, research assistant professor at the University of Pittsburgh School of Health and Rehabilitation Sciences’ Department of Physical Therapy says physicians tend to be more focused on helping patients manage their pain with medications, without considering the long-term benefits of exercise for mitigating declines in physical health. “Pain control should be just one aspect of treatment. The focus is mainly on pain medications; there should be greater emphasis on nonpharmacological approaches,” Khoja says.

Tom Bateman, PharmD, clinical assistant professor Ernest Mario School of Pharmacy Rutgers, The State University of New Jersey, New Brunswick, says because acetaminophen has a favorable safety profile when compared to alternatives like NSAIDs or opioid analgesics, it is considered the gold standard for treatment of osteoarthritis. The general principle of “start low, go slow” when dosing should be applied when recommending acetaminophen, says Bateman.

“If patients require additional pain control or if high doses of acetaminophen are not appropriate due to reduced hepatic function or alcohol use, then multimodal pain strategies can be used,” Bateman says. “Some would consider cannabis as a newer therapy. “

The Arthritis Foundation recently released the first CBD guidance for adults with arthritis. While there are no established clinical guidelines for CBD use, medical experts who worked in partnership with the Arthritis Foundation agree that CBD may help with arthritis-related symptoms; however, this has not been confirmed in clinical studies.

Osteoarthritis is the most common type of arthritis, affecting nearly 54 million people.

Encouraging Healthy Habits in Patients with Osteoarthritis

The development of oral therapies for a host of oncology diagnoses in the last five years has not altered the institutional oncology pharmacist, but rather changed the pharmacist’s practice to be inclusive of both oral and infusion therapies, according to Michael P. Kane, RPh, director, Oncology Pharmacy Services, Rutgers Cancer Institute, New Brunswick, NJ. He says the development of oral therapies for patients to self-administer has been a logistical and safety challenge, but every challenge is an opportunity.

“Our knowledge in combining small molecule oral oncolytic agents with infusion monoclonal antibodies (MABs) and/or chemotherapy has launched the concept of an integrated, closed-loop specialty pharmacy practice that works in tandem with both the physicians and APNs (advanced practice nurses) in the clinics as well as the pharmacists and nurses in the infusion center,” says Kane.

Designed around the patient’s needs, the concept of integrated, closed-loop specialty pharmacy services allows pharmacists to be embedded within the clinics as well as in the infusion areas. Kane says this type of collaboration improves the patient experience and reduces risk of complications because it improves cross-communication between clinics, outpatient and inpatient infusion, and specialty pharmacy.

“Non-Hodgkin’s lymphoma (NHL) may well be an example to show the progression of target therapies and immune therapy MABs, in addition to classic infusion chemotherapy, to demonstrate the need for such integrated, closed-loop specialty pharmacy practices,” Kane tells 

There are more than 60 distinct subtypes of NHL, and a wide array of therapies has been developed and combined to improve patient outcomes. However, many therapy combinations also include an increased risk of toxicities, pseudo-progressions, and risk of tumor flares.

Working with outpatient APNs, infusion pharmacists and infusion nurses were able to support the outpatient initiation of venetoclax. Kane says this can improve the patient’s quality of life (QOL) by preventing the need for inpatient services. “Establishing the guidelines for toxicity risk specifically tumor lysis syndrome (TLS) and tolerance for rescue response, this team approach is able to navigate the patient’s escalation of their venetoclax dose and manage the risk of TLS with adequate hydration, timing of laboratory assessments and preventive allopurinol and rescue rasburicase,” says Kane.

He says working with patients at key intervals and providing them with blood pressure monitoring equipment, supportive loperamide, and overall adherence education can help patients remain on therapy to the important 6-month mark to ensure maximum potential benefit and response. Once therapy is completed, community pharmacists often are relied upon. M. Scott Thompson, DPh, clinical oncology pharmacy manager, Vanderbilt University Medical Center, Nashville, TN, says when the patient is no longer receiving therapy, they will also lose consistent direct access to their oncology pharmacist’s care or at least have a very limited interaction.

Thompson says a community pharmacist can help to continue the oversight of care. For example, the pharmacist can ask about appetite, nutritional wellbeing, and energy levels. “This care could be made even more personalized, if there are opportunities for the community pharmacist to have interactions with the specialty pharmacy during the patient’s care, as well as the patient’s care team during the time of treatment,” Thompson tells 

Newer combination therapies have greatly changed patient care and where that care is given. Moving from solely infusional or oral therapy to a mixture of both has changed outcomes and where the patient can be treated. Patients are no longer tethered to a hospital bed or a clinic infusion chair. “Many infusion treatments that were once treated as an inpatient or-more recently-clinic infused therapy, are now being administered via home infusion, allowing the patient to retain a more normal/balanced home-life. The vast improvement of supportive care has propelled better outcomes,” says Thompson.

The role pharmacists have in helping cancer patients.

Author | John Schieszer

Articles

Pharmacies Can Take Steps to Protect Against Cyberattacks

A Flurry of COVID-19 Studies Are Underway, but Scientists Warn a Vaccine Will Take Time

Encouraging Healthy Habits in Patients with Osteoarthritis

Pharmacists See Major Changes in Managing NHL Patients