Aislinn Antrim

Investigators have found that the evolutionary sequence of insulin has become stuck at the edge of impaired production, limiting its ability to adapt to obesity and rendering most people vulnerable to type 2 diabetes (T2D).

Insulin is produced by a series of processes occurring in specialized cells, called β cells, according to the study’s authors at Indiana University School of Medicine, the University of Michigan, and Case Western Reserve University in Ohio.

The folding of a biosynthetic precursor called proinsulin is a key step in achieving the hormone’s functional 3-dimensional structure. Findings from prior studies had suggested that impaired biosynthesis could be the result of diverse mutations hindering the folding of proinsulin.

The mutant human insulin functions within the range of natural variation, though this mutation has been excluded by evolution, according to the findings of this study.

The answer to this seeming paradox is that the forbidden mutation selectively blocks the folding of proinsulin and stresses β cells, the study authors say.

Furthermore, the investigators found that even the slightest variation in the insulin-sequencing process not only impairs insulin folding and secretion but also induces cellular stress that leads to β-cell dysfunction and, eventually, permanent damage.

National experts agree that this discovery provides key insights into the development of T2D in adults and children; both groups have rising rates of diabetes, according to a statement from the investigators.

An evolutionary cul-de-sac: study suggests most humans are vulnerable to type 2 diabetes. News release. Indiana University School of Medicine. November 2, 2020. Accessed December 7, 2020. https://medicine.iu.edu/news/2020/11/study-suggests-most-humans-are-vulnerable-to-type-2-diabetes

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Investigators have found that the evolutionary sequence of insulin has become stuck at the edge of impaired production, limiting its ability to adapt to obesity and rendering most people vulnerable to type 2 diabetes.

Most Humans Are Vulnerable to Type 2 Diabetes, Study Results Show

The FDA’s Vaccines and Related Biological Products Advisory Committee has recommended an emergency use authorization (EUA) for Johnson & Johnson’s single-dose COVID-19 vaccine. The vaccine under review was developed by the company’s Janssen division.

In voting in favor of the recommendation, 22 committee members unanimously agreed that the benefits of the Janssen COVID-19 vaccine outweigh its risks in individuals age 18 years and older, based on the totality of scientific evidence currently available.

If granted an EUA, the Janssen COVID-19 vaccine would be the third approved vaccine for COVID-19, in the United States following the EUA for 

 vaccine on December 12, 2020, and the EUA for 

In his comments to the committee following the vote, Jay Portnoy, MD, said he believes the Janssen COVID-19 vaccine is as safe and effective as other vaccines currently approved by the FDA, such as influenza vaccines.

“The main thing to keep in mind is that we’re dealing with a pandemic right now….There is an urgency to get this done. We’re in a race between the virus mutating, new variants coming out that can cause further disease, and stopping it. The fewer people who are infected with the virus the less opportunity it has to emerge as a more virulent strain,” said Portnoy.

 provides strong protection against severe disease and may reduce transmission of the virus. It is a replication-incompetent adenovirus type 26 vectored vaccine with a stabilized variant of the SARS-CoV-2 S protein and is approved for adults 18 years of age and older.

“I do believe its evidence supports the safety and effectiveness,” Portnoy said.

The single-dose approach would enable vaccination of hard-to-reach populations, such as homeless individuals and those in rural communities. The vaccine is also easier to store, remaining stable at normal refrigeration temperatures for up to 3 months.

According to a joint statement by Janet Woodcock, MD, the FDA's acting commissioner; and Peter Marks, MD, PhD, director of the agency's Center for Biologics Evaluation and Research, issued following the advisory committee's meeting earlier today, the FDA will rapidly work toward finalization and issuance of an EUA. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution," said Woodcock and Marks in their statement.

Vaccine and Related Biological Products Advisory Committee—2/26/21. FDA. Accessed February 26, 2021. https://www.youtube.com/watch?v=Qd7mlCD-rEA&feature=youtu.be

FDA Analysis Finds Johnson & Johnson Single Shot COVID-19 Vaccine Protects Against Severe Illness, May Reduce Transmission. 

; February 24, 2021. Accessed February 26, 2021. 

https://www.pharmacytimes.com/news/fda-analysis-finds-johnson--johnson-single-shot-covid-19-vaccine-protects-against-severe-illness-may-reduce-transmission

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting [news release]. Silver Spring, MD; February 26, 2021: FDA. Accessed February 26, 2021. https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting-1

In voting in favor of the recommendation, 22 committee members unanimously agreed that the benefits of the Johnson & Johnson COVID-19 vaccine outweigh its risks.

FDA Committee Votes to Recommend New Johnson & Johnson COVID-19 Vaccine for EUA

With a national survey of nurses finding that more than 50% have been exposed to hazardous agents, proper safety procedures and education about handling these agents is essential. In a recent 

 video, a panel of experts discussed potential harmful effects and best practices for handling hazardous agents.

Moderator Jeffrey Lombardo, PharmD, BCOP, director of pharmacy business development at Catholic Health in Buffalo, New York, said health care workers risk exposure to hazardous agents during receipt, transport, storage, compounding, distribution, administration, and disposal of these substances. Furthermore, he said, many exposures occur in situations without monitoring requirements, making it necessary to preemptively establish best practices.

The National Institute for Occupational Safety and Health and former researcher Tom Connor, PhD, facilitated a larger understanding of these risks, with publications beginning in 1981, according to panelist Christine Roussel, PharmD, director of pharmacy at Doylestown Health in Doylestown, Pennsylvania. Roussel said the definition of a hazardous drug was established by the American Society of Health-System Pharmacists in 1999. This definition includes carcinogenic agents, which can cause cancer; genotoxic agents, which can damage DNA; teratogenic agents, which can harm a fetus; drugs with reproductive toxicity; drugs that are organ toxic at low doses; and any drugs that are structurally similar.

“Hazardous drug handling has really evolved, and we’ve known about the risks for a long time,” Roussel said. “But it’s only been within the last 3 to 5 years that really all of these guidelines and all of these recommendations are now consistent with each other.”

One potential solution for health systems may be to build alerts into their electronic medical records, alerting health care workers when anything on the hazardous drug list is ordered in the health system. Panelist MiKaela Olsen, MS, APRN-CNS, AOCNS, oncology and hematology clinical nurse specialist at the Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland, said with this system, oncology pharma- cists and nurses are alerted, allowing them to reach out to the unit where the medication was ordered to ensure proper procedures are in place.

Proper labeling is also essential to ensure health care workers know whether to wear gloves or take other precautions before touching a medication bottle, intravenous (IV) bag, or container.

“The biggest issue I worry about [hazardous agents] is contamination on the outside of packaging, of everything from unit dose medications to the IV medications that we compound,” Roussel said. “Whatever is inside is on the outside, and the biggest source of contamination is surface contamination and exposure.”

Lombardo agreed, and said proper handling procedures are important even in health systems that don’t have best practices fully implemented. Because of the opportunities for chronic, long-term exposure among health care workers, dermal exposure via surface contamination could have many risks, from skin rashes to infertility to various cancers.

“When you look at health care workers, we have more chromosomal damage—so damage to our DNA&mdash;than other people who are walking around in this country,” Roussel said. “And those health care workers who work with hazardous drugs have more genetic damage than matched controls who don’t work with hazardous drugs. So, it is a huge risk, even if we look at populations as a whole.”

Safety precautions include use of respirators, proper gowning, and appropriate gloves, panelists said. Despite research on the importance of such measures, Lombardo said, it may be difficult for some health systems to implement such practices. Consequently, panelists said, alternate duty systems are essential to ensure workers’ concerns about exposure are addressed.

In a chemotherapy infusion clinic, for example, Olsen said they have found triage roles, positions in the ambulatory clinical evaluation program, and roles in the hematology clinic where nurses administer blood and platelets. Olsen emphasized that workers should be able to choose whether they handle hazardous drugs and should have other options if they believe the risks are too high.

“There are ways to move and shift people so that they can avoid handling hazardous drugs for a time,” Olsen said. “But I really believe it’s the person’s choice.”

Finally, the panelists discussed risks involved in compounding hazardous agents. Roussel said once the compounded substance is packaged, it becomes impossible to see mistakes or miscalculations. To avoid these issues, Olsen said, barcode scanners and safety systems become essential, especially during busy hours when it’s easier to make an error.

“Manpower is always time, and the patients all come at once,” Roussel said. “So especially around lunchtime, by the time we get there, I see the value from the workflow of my staff, the amount of time my staff takes, and their exposure. But also, I think about associate safety, and I think about how [this] could possibly save a patient’s life one day.”

A panel of experts discusses alert systems, surface contamination, and PPE as methods for minimizing exposure to dispensing pharmacists.

Proper Procedures Are Essential for Handling Hazardous Agents

As the coronavirus disease 2019 (COVID-19) pandemic continues, pharmacists and other health care professionals have had to contend simultaneously with the continuing substance use epidemic.

® webinar titled “The Impact on Substance Misuse During the COVID-19 Pandemic

,” participants discussed specific challenges for pharmacists and best practices for tackling the 2 problems.

Alcohol sales have increased, and data have shown the growing use of nonprescribed fentanyl, methamphetamine, and cocaine across the country, according to moderator Tyler Davis, PharmD, a senior advisor of pharmacy professional practice standards at CVS Health.

Jeffrey Bratberg, PharmD, FAPhA, agreed that this is a major issue, adding that there were more than 72,000 opioid overdose—related deaths in 2019, many of which were related to polysubstance use.

“[Among] people who are surveyed during the pandemic who use drugs, we’ve seen a 13% increase in the number of people who have increased their use of substances,” said Bratberg, a clinical professor at the University of Rhode Island College of Pharmacy in Kingston. “While we can’t really correlate or put [the] causation of COVID-19 and opioid use or opioid deaths, [they’re] definitely correlated.”

Pharmacies offer a major opportunity to intervene with these patients because of pharmacists’ accessibility and the long hours that many pharmacies are open.

During the pandemic, pharmacies have been deemed essential businesses, whereas methadone maintenance programs and physician offices have been either closed or operating with drastically limited hours, Bratberg said.

Pharmacists should work to meet the unmet needs of this population by offering harm-reduction strategies, naloxone, and other services, he said.

“One study from the CDC showed 3 out of every 5 people who died of an opioid-related overdose had a touchpoint with some part of the health care system, and I think pharmacy made up a great proportion of those touchpoints,” Bratberg said.

Pharmacy teams play a major role in preventing drug diversion and misuse, because many patients still need continued access to opioids for chronic pain and other controlled substances, according to Amanda Glover, PharmD, vice president of regulatory affairs at Rite Aid in Camp Hill, Pennsylvania.

Although the Code of Federal Regulations places the responsibility of proper prescribing and dispensing on the prescriber, a corresponding responsibility rests with the pharmacist, she said.

“Pharmacists are trained to look for certain red flags, such as patients filling prescriptions at multiple pharmacies from multiple prescribers, as well as pain [medication] and refill trends,” Glover said.

Ensuring that patients with opioid prescriptions have access to naloxone is a major goal that pharmacists can fulfill amid the opioid epidemic, although she noted that there is a general lack of awareness among the public about this option.

However, pharmacists can continue to promote awareness by keeping naloxone constantly in stock and working to destigmatize its use in accidental overdoses, as well as through pharmacy signage.

Research is underway to determine how substance misuse is related to the COVID-19 pandemic.

Bratberg described this research as being like “paddling down a very, very fast stream and … you don’t know where it’s going.”

Fortunately, many states have reliable data on opioid overdoses, which is how investigators know there is an increase across many parts of the country. Despite these findings, Bratberg said that there are some encouraging signs.

In addition to the widespread adoption of telehealth that has increased patients’ access to counseling, the Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration have both made regulatory changes to increase access to evidence-based and mortality-reducing drugs, such as buprenorphine and naloxone.

“They’ve allowed states lots of leeway to continue to do what we do as pharmacists in the methadone perspective and what we do from the community pharmacy perspective with buprenorphine, and we can mail the drugs,” Bratberg said.

“We can have curbside pickup,” he said. “We can have drive-through pickup, so that not only are pharmacists and their staff safe in the pharmacy but patients are kept safe.”

Although the effects of the COVID-19 pandemic have been alarming and wide-reaching, Bratberg said that there are many opportunities for pharmacies to take a leadership role in both the pandemic and the substance-abuse epidemic.

Pharmacists’ accessibility offers many opportunities to intervene with patients who may be at risk of substance misuse.

“We’re really recognized as public health nodes, right?” Bratberg said. “We’re accessible; we’re essential.”

As the COVID-19 pandemic continues, pharmacists and other health care professionals have had to contend simultaneously with the continuing substance use epidemic.