The Coronavirus resource center provides clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.

Visit Our Coronavirus Resource Center

Pharmacists will continue to become more involved in patient care, technology, and emergency preparedness next year, according to the 2022 American Society of Health-System Pharmacists (ASHP) and ASHP Foundation Pharmacy Forecast Report, which was released in advance of the ASHP Midyear Clinical Meeting and Exhibition.

The report is intended as a strategic planning tool to help pharmacists and practitioners prepare for the upcoming year and how they can best position themselves for success, according to a press release. The new report notes that the experiences of the COVID-19 pandemic may still impact the health care landscape, medication use, and the pharmacy profession over the next 5 years.

“This year’s Forecast report reflects the ongoing challenges associated with COVID-19, and the related opportunities for pharmacy professionals to continue to enhance their leadership and advance their practices in service to their patients and communities from the bedside to the home and all points throughout the continuum of care,” the report authors wrote.

Pharmacists’ roles in emergency preparedness will continue to grow, including in the development of plans for future disasters or emergencies such as pandemic outbreaks. Pharmacy leaders must operate as a go-between for both health systems’ emergency-preparedness planning and community public health teams, according to the report. Within health systems, pharmacists will also need to create contingency staffing plans in response to significant health-system patient volume shifts.

The report noted that the 2020 Public Readiness and Emergency Preparedness (PREP) Act allowed pharmacists to take on greater roles in providing vaccinations, administering COVID-19 tests, and organizing and overseeing mass vaccination programs. Pharmacy leaders and organizations should continue to advocate for the expansion of these responsibilities, according to the report.

“One of the most salient lessons of the COVID-19 pandemic is the need for pharmacy leaders to make investments in areas that will allow their organization to effectively respond to disruptions caused by unforeseen events like a global pandemic while also supporting the health system’s overall preparedness efforts,” said the report’s editor, Joseph T. DiPiro, PharmD, in the press release.

The COVID-19 pandemic had massive impacts on the supply chain, and pharmacists can also play a role in planning for and mitigating any future supply chain issues. Further analysis of the shortages early in the pandemic is needed to improve production forecasting and create flexible allocation strategies for both individual hospitals and regions, according to the report. In-house or regional continuous manufacturing processes could also help mitigate future shortages, or health systems can collaborate with manufacturers to develop demand surge strategies such as demand contracting and regional warehousing.

The expansion and development of technology were accelerated by the pandemic, increasing the ability of health systems to use digital health solutions and artificial intelligence to optimize medication management. Pharmacists will likely be key leaders in the effort to streamline digital health solutions and integrate them with current workflows. Pharmacists will also manage chronic conditions from remotely generated health data, according to the report.

Despite this accelerated technological development, a lack of technological access and literacy also negatively impacted underserved populations during the pandemic. Some technologies, such as voice-assisted technology, are being used in health care to improve information accessibility, and pharmacy leaders can advocate for equitable access to digital tools to ensure that underserved populations benefit from technological advances, according to the report.

Finally, the report predicts that new care models, including hospital at home, will continue to develop and evolve in the coming years. The pandemic necessitated quick and drastic changes in care delivery, such as delivering vaccinations to patients’ homes, at drive-through locations, and to schools. Pharmacists and health systems also pivoted to help manage patients with chronic conditions remotely when in-person appointments were too risky.

Health systems will increasingly be required to offer advanced care at home, the report predicts. Additionally, pharmacy leaders will be expected to participate in the design and implementation of remote patient care.

The report was developed using a survey of 387 pharmacy leaders from around the country. Responses were submitted by 311 survey recipients who represented a variety of leadership roles, hospital sizes, and geographic regions, according to the press release.

 Anticipates Lasting Impact from Pandemic-Related Changes to Health-System Pharmacy. News release. Email; December 3, 2021. Accessed December 3, 2021.

Articles

Pharmacy leaders and organizations should continue to advocate for the expansion of responsibilities granted by the 2020 PREP Act, according to the report. 

News

Conference

Hospital

Pharmacy Forecast Report Predicts Ongoing COVID-19 Impact in 2022

Officials with the FDA have granted approval to rituximab (Rituxan) plus chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).

The approval was based on the global, multicenter, open-label phase 3 Inter-B-NHL Ritux 2010 trial (NCT01516580), which enrolled patients at least 6 months of age with previously untreated, advanced stage, CD20-positive, DLBCL/BL/BLL/B-AL. 

Patients were randomized 1:1 to receive Lymphome Malin B (LMB) chemotherapy consisting of corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple-drug intrathecal therapy (methotrexate/cytarabine/corticosteroid), alone or in combination with rituximab or non-US–licensed rituximab.

Patients in the investigative cohort were administered 6 infusions of intravenous rituximab at a dose of 375 mg/m.

 The main efficacy outcome measure was event-free survival (EFS) defined as progressive disease, relapse, second malignancy, death from any cause, or non-response as evidenced by the detection of viable cells in residue after the second CYVE (cytarabine/veposide) course, whichever occurred first.

Across both cohorts, 83% of patients were male and 17.5% were female with a median age of 7.5 years (range, 1-17). In the investigative arm, 0.6% of patients were 6 months to less than 3 years of age, 71.0% ranged from 3 years of age to less than 12 years of age, and 29% were aged 12 years to less than 18 years.

Forty-nine percent of patients in the rituximab arm had group B high-risk disease compared with 51.0% in the LMB chemotherapy–alone arm; 40% of patients in both arms had group C1 disease and 11% vs 10% of patients, respectively, had group C3 disease. Across both cohorts, most patients had BL or BLL, followed by B-AL, and DLBCL. Further, 45% of patients in both cohorts had bone marrow involvement and 27% had central nervous system involvement.

At a median follow-up of 3.1 years, 28 EFS events were reported in those who received LMB chemotherapy alone compared with 10 events in patients administered rituximab plus LMB chemotherapy (HR 0.32; 90% CI, 0.17-0.58; 

At the time of the interim analysis, 20 deaths were reported in the LMB chemotherapy–alone arm compared with 8 deaths in the rituximab/LMB arm. Estimated overall survival HR was 0.36 (95% CI, 0.16-0.81).

An additional 122 patients were administered rituximab plus LMB and contributed to the safety analysis of the trial. The most common adverse effects (AEs) in the rituximab combination cohort were febrile neutropenia, stomatitis, enteritis, sepsis, increased alanine aminotransferase, and hypokalemia.

Grade 3 or higher AEs noted to occur more frequently in the rituximab-containing cohort compared with the LMB-alone cohort were sepsis, stomatitis, and enteritis. Fatal toxicities were experienced by less than 2% of those in both cohorts.

FDA approves rituximab plus chemotherapy for pediatric cancer indications. News release. FDA; December 2, 2021. Accessed December 2, 2021. https://bit.ly/3djDAGe

Rituxan. Prescribing information. Biogen and Genentech USA; 2021. Accessed December 2, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf

FDA approves rituximab (Rituxan) plus chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.

Hematology

Oncology

Specialty Pharmacy

FDA Approves Rituximab Combination Across Multiple Pediatric Cancer Indications

Many health care workers struggle to understand the connection between health care and the environment, even though these entities affect each other in a reciprocal manner. Environmental conditions, such as severe weather, contaminated water supplies, and air pollution, affect health by causing injuries and fatalities, exacerbating respiratory and cardiovascular diseases, and spreading infectious diseases, such as cholera and cryptosporidiosis.

 In turn, health care can also affect the environment in cases of improper disposal of pharmaceutical waste, manufacturing and supply chain issues, and pollution from health care systems.

Recent research confirms the presence of pharmaceuticals in locations that extend beyond its intended use by patients or in the health care setting. For example, a 2014 Environmental Protection Agency water study measured municipal wastewater effluent from 50 health care facilities serving 46 million people and detected hydrochlorothiazide in every sample. Valsartan was found at the highest concentration, and lisinopril was found at concentrations that could produce 1 dose annually.

 Moreover, in 2014, 7.9% of the total national carbon footprint was attributable to health care.

As more data emerge showing how closely health care and the environment are intertwined, the roles of pharmacists and pharmacy students continue to be explored and defined. Although the climate crisis can feel overwhelming, it can be comforting to remember that no effort, regardless of size, goes to waste.

Tackling environmental issues can feel particularly paralyzing for students, given the numerous responsibilities that accompany school. For new graduates, stepping into new roles as pharmacists while striving to protect the environment can be intimidating and isolating. However, making environmental health a part of standard practice within the pharmacy can begin with just a few action steps.

Attending conferences can help support exposure to knowledge and ideas on how to make an impact. For example, the annual CleanMed Conference provides attendees with the opportunity to network and learn from experts about sustainable health care and environmental protection.

Student-led initiatives that invite discussion about the intersections of health care and the environment are an important step to identifying gaps in education. Asking peers and professionals both within and outside pharmacy about their ideas, ways to collaborate, and strategies to implement sustainability into practice can foster growth and make change approachable.

For example, the Planetary Health Report Card initiative is implemented by medical students to encourage medical schools to incorporate sustainable health care education while measuring each medical school’s “green” score. Advocating for environmental factors to be taken into consideration during the clinical decision-making process is critical because of the many links between patients’ health and the environment.

Joining student organizations and professional organizations can help maintain motivation in sustainability efforts and support the free exchange of ideas.

For example, the Sustainable Pharmacy Project, originating from Virginia Commonwealth University School of Pharmacy, provides opportunities for pharmacy students to connect, collaborate, and hold events that inspire future pharmacists to lead efforts to reduce pharmaceutical waste. Additionally, Rx For Climate is a web-based organization focused on empowering pharmacists to make sustainable decisions and enforce the idea that pharmacists have an important role in the fight against climate change.

As practicing pharmacists, opportunities to promote sustainability are numerous and diverse, and educating other health care practitioners has always been central to the pharmacist’s role. Although this has traditionally been limited to education on optimal therapeutic use of medications, it is not unrealistic to extend this scope to include guidance on therapy that considers environmental impact as well.

For example, anesthetic gases used during surgery exhibit a profound greenhouse effect, yet there are less impactful alternatives available that do not compromise patient safety. In a 2019 study, pharmacists were found to be key in implementing these alternatives and reducing their use at the University of Wisconsin, resulting in a 64% per-case reduction in carbon dioxide equivalent emissions.

Furthermore, pharmacists are aware that dry powder inhalers are the environmentally friendly choice among inhaler options because of metered dose inhalers’ higher carbon footprint.

 As medication experts, pharmacists can make suggestions like this regarding the safer choice of a medication for the environment as well as for the patient while also helping to write protocols and educate other clinicians on how to make these environmentally conscious choices and balance patient needs.

There are also databases available like Janusinfo, which categorizes the environmental hazards of different medications, allowing pharmacists to compare the environmental risks involved with prescribing a given medication. In this way, just as cost, availability, and patient preference may shape prescribing patterns, environmental harm should be among the factors that guide medication utilization.

Pharmacists are also well positioned to support sustainability on a systems level. Because they are heavily involved in the selection, procurement, distribution, and utilization of medications in hospitals and other settings, they can work to reduce the impact on environmental systems by making environmental sustainability a consideration during these processes to support patient health.

Pharmacists can promote their institutions’ medication disposal services and play an active role in reducing improper medication disposal. In a 2016 study, the most common method of household disposal of unused medications among 18,008 participants globally was the garbage.

 Proper disposal of medications is a simple and effective method that minimizes harm to ecological systems.

Pharmacists should continue to instruct patients on how to utilize medication disposal programs rather than flushing or pouring medications down the drain. Equipping patients with knowledge of these services empowers them to take an active role in keeping their environments safe and healthy.

There is also room for pharmacists to promote sustainability even further upstream within the pharmaceutical industry and drug development. A growing area of interest in pharmaceutics is utilizing green chemistry principles for new drug synthesis and implementing “benign-by-design” drug manufacturing (ie, medications that biodegrade into benign components rather than environmentally harmful pollutants) to lessen the impact of medications that reach the environment.

Opportunities for pharmacy students and pharmacists to positively affect the environment are endless. From attending environmentally centered conferences as a student pharmacist to creating benign-by-design medications as a pharmacist, no effort is too small. Through collective action, students can make a difference.

There is still a lot that remains unknown about the symbiotic relationship between pharmacy and the environment, but 1 truth remains: Health care providers play a pivotal role in affecting the climate crisis, whether through action or inaction.

To find a pharmacy offering medication disposal services near you, visit https://safe.pharmacy/drug-disposal/ and provide your zip code.

To hear more about the ways in which environmental conditions affect patient health, visit https://www.pharmacytimes.com/view/webcast-the-impact-of-environmental-conditions-on-patient-health.

Climate effects on health. CDC. March 2, 2021. Accessed September 1, 2021. 

https://www.cdc.gov/climateandhealth/effects/default.htm

Kostich M, Batt A, Lazorchak J. Pharmaceuticals in municipal wastewater Problem statement Active pharmaceutical ingredients (APIs) What are risks to humans and aquatic life? Challenges: well over 1000 APIs approved by FDA for use in the S. 2014.

Pichler P-P, Jaccard IS, Weisz U, Weisz H. International comparison of health care carbon footprints. 

 2019;14(6):064004. doi:10.1088/1748-9326/ab19e1

Zuegge KL, Bunsen SK, Volz LM, et al. Provider education and vaporizer labeling lead to reduced anesthetic agent purchasing with cost savings and reduced greenhouse gas emissions. 

. 2019;128(6):e97-e99. doi:10.1213/ANE.0000000000003771

Panigone S, Sandri F, Ferri R, Volpato A, Nudo E, Nicolini G. Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment. 

. 2020;7(1):e000571. doi:10.1136/bmjresp-2020-000571

Pharmaceuticals and environment. Janusinfo. Accessed August 23, 2021. 

https://www.janusinfo.se/beslutsstod/lakemedelochmiljo/pharmaceuticalsandenvironment.4.7b57ecc216251fae47487d9a.html#query/warfarin

Paut Kusturica M, Tomas A, Sabo A. Disposal of unused drugs: knowledge and behavior among people around the world. 

Collecting and dispensing of unwanted medicines. United States Environmental Protection Agency. March 23, 2015. Accessed September 1, 2021. 

https://www.epa.gov/hwgenerators/collecting-and-disposing-unwanted-medicines

Tucker JL, Faul MM. Industrial research: drug companies must adopt green chemistry. 

. 2016;534(7605):27-29. doi:10.1038/534027a

Gahbauer A, Gruenberg K, Forrester C, et al. Climate care is health care: a call for collaborative pharmacy action. 

. 2021;4(5):631-638. doi:10.1002/jac5.1412

Chung JW, Bang OY, Ahn K, et al. Air pollution is associated with ischemic stroke via cardiogenic embolism. 

. 2017;48(1):17-23. doi:10.1161/STROKEAHA.116.015428

Student

Considerations for Environmentally Conscious Pharmacy Students

The 2021 Industry Trend Report in Pharmacy Quality sponsored by Pharmacy Quality Solutions (PQS) focuses on COVID-19’s impact on pharmacy claims and community pharmacy access during 2020. This report tracks prescription trends from the announcement of the COVID-19 public health emergency (PHE) through the remainder of the year and highlights associated mitigation approaches that may have impacted pharmacy and medication utilization patterns.

The 3-section report covers changes in pharmacy utilization, patterns of utilization among hypothesized treatments for COVID-19, and medication utilization patterns impacted by COVID-19.

“2020 was a unique year and we needed to approach this year’s trend report differently as it’s based on 2020 measurement data,” said PQS COO Nancy Chung. “Rather than directly comparing year to year data, this analysis evaluates the change in weekly prescription claims volume, from baseline, based on date of service and number of claims for 2020. We’ve included the same trend analysis for 2019 for comparison. We hope that this report serves as a reference for how the pandemic impacted medication utilization.”

One notable chart from the Industry Trend Report highlights the change in all claims for pharmacy utilization. The graph below shows an increased pharmacy utilization for all prescription claims, starting at week 9 and reaching a peak at week 12, when the public health emergency was declared.

There is a significant decrease after week 12, with utilization dropping precipitously to levels well below the prior year of 2019. Pharmacy utilization was also low in fall 2020, which may have been due to the resurgence of COVID-19.

An excellent example of abnormal utilization of hypothesized treatments for COVID-19 is the dramatic increase in claims for hydroxychloroquine (HCQ) in March 2020. The chart below tracks an overall increase in prescription claims for HCQ with 14 days or fewer supply for those with prior use of HCQ and those without.

The only FDA-approved indication for short courses of HCQ is to treat acute attacks of malaria, typically a very rare instance in the United States. HCQ is also used as a chronic medication for the treatment of lupus and rheumatoid arthritis.

The dramatically sharp increase in utilization of this medication with a supply of 14 days or fewer suggests that it was being pursued for a non-FDA approved indication of COVID-19 therapy. Utilization takes a sharp dip after HCQ fell out of the spotlight as a COVID-19 therapy into May 2020. But prescription claims volume for HCQ, well above normal levels, indicates ongoing use in the setting of COVID-19 despite lack of evidence and recommendations against its use for COVID-19 therapy.

Looking at medication utilization patterns impacted by COVID-19, another graph from the 2021 trend report charts the change in overall antibiotic prescription utilization.

The chart above shows that overall antibiotic prescription claims decreased near the declaration of the COVID-19 PHE and continued to remain below normal levels throughout 2020 after the declaration of the public health emergency, as compared to 2019.

This may be due to the following factors:

Decreased exposure to pathogens, because more Americans were spending more time at home where exposure risk is low.

Decreased health care utilization due to anxiety around exposure to COVID and increased recommendations.

Utilization approached normal levels to some extent during summer 2020 compared to 2019, but again was suppressed into the fall of 2020, likely corresponding with the renewed wave of COVID infections in fall of 2020.

 We analyzed prescription claims and other data from a subset of health plans and pharmacy benefit managers, representing total patient counts of approximately 25.4M and 27.1M, from 2019 and 2020 respectively. Prescription claims were associated with Medicare Advantage Prescription Drug Plans (MAPD) and standalone Prescription Drug Plans (PDP) lines of business.

For more pharmacy quality insights, please download the full report, the 

Industry Trend Report in Pharmacy Quality 2021, 

We at PQS are always looking for new ideas to analyze and explore! We value your feedback and contributions for future reports. If you’d like to share your comments with us, please send us a note at 

About Pharmacy Quality Solutions, Inc (PQS)

PQS is a healthcare quality improvement company, connecting healthcare payers and providers who value measurement as the pathway to better patient outcomes. Partners of PQS represent nearly 90% of all Medicare Part D lives and 95% of community pharmacies. PQS delivers the quality insights and guidance necessary to support their customers’ efforts to optimize the quality of medication management for their Medicare, Medicaid, and commercial populations. PQS’ industry-leading platform, EQUIPP®, provides standardized measurement and reporting on key medication use quality measures and value-based reimbursement programs focused on medication adherence, treatment outcomes and patient safety. For more information on how PQS can support you, please visit 

For further information contact David Simoneaux at 919.767.9544 or dsimoneaux@pharmacyquality.com.

Pharmacy utilization, patterns of utilization among hypothesized treatments for COVID-19, and medication utilization patterns were all impacted by the pandemic.

Coronavirus

Retail

Industry Trend Report Shows COVID-19 Impact on Pharmacy Claims, Community Pharmacy Access 

GlaxoSmithKline (GSK) and Vir Biotechnology (VIR) have announced an update to bioRxiv, a preprint server, that showed preclinical data proving that retains activity against key mutations of the new Omicron SARS-CoV-2 variant, according to a statement from GSK.

“Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable,” George Scangos, PhD, CEO at VIR, said in the statement.

Sotrovimab demonstrated ongoing activity against all tested COVID-19 variants of concern and interest, as defined by the World Health Organization.

GSK and VIR are now completing in-vitro pseudo-virus testing to confirm the activity of sotrovimab against the combination of Omicron mutations and intend to provide an update by the end of 2021.

Preclinical data demonstrate sotrovimab retains activity against key Omicron mutations, new SARS-CoV-2 variant. GlaxoSmithKline. News release. December 2, 2021. Accessed December 2, 2021. 

https://www.gsk.com/en-gb/media/press-releases/preclinical-data-demonstrate-sotrovimab-retains-activity-against-key-omicron-mutations-new-sars-cov-2-variant/

Preclinical Data Show Sotrovimab Retains Activity Against Omicron COVID-19 Variant

Breakthrough COVID-19 infections in fully vaccinated individuals are considerably more common among immunocompromised individuals, according to a study published in the 

. The retrospective cohort study used data from approximately 1.2 million individuals.

“Several countries are currently experiencing a resurgence of SARS-CoV-2 infections despite the rollout of mass vaccination programs,” said Manuela Di Fusco, MSc, lead author from the Pfizer Health Economics and Outcomes Research team, in a press release. “While COVID-19 mRNA vaccines help protect people from getting infected and severely ill, the risk of breakthrough infections in fully vaccinated people is not completely eliminated.”

The investigators found that the overall percentage of fully vaccinated individuals with breakthrough infections between December 10, 2020, and July 8, 2021, was 0.08%. However, though only 18% of the individuals studied were immunocompromised, 38% of breakthrough infections were in immunocompromised individuals, as well as 60% of all hospitalizations and 100% of deaths.

“The results supplement other real-world studies and support the introduction of a third dose of a COVID-19 vaccine to increase protection among the immunocompromised individuals,” Di Fusco said in the release.

Analyzing health care records, investigators found that 17.7% of the individuals reviewed were identified as immunocompromised. These included patients living with advanced HIV/AIDS, cancer, kidney disease, rheumatologic or other inflammatory conditions, other immune conditions, and bone marrow or organ transplant recipients. Out of the total of 978 breakthrough infections, 374 occurred in immunocompromised individuals.

“While the study leveraged a large dataset that has been previously used for healthcare research in the US, the findings should be interpreted in the context of multiple limitations, including coding accuracy and data representativeness beyond the study period,” Di Fusco said in the release. “Our study results advance the understanding of post-vaccination outcomes and support recent recommendations to provide a third primary series dose of an mRNA COVID-19 vaccine to patients with weaker immune systems after the initial two doses.”

Study on over a million people shows breakthrough COVID-19 infections occur more often and are more severe in immunocompromised [news release]. EurekAlert; November 30, 2021. Accessed December 1, 2021. 

https://www.eurekalert.org/news-releases/935977

Studies support the use of a COVID-19 vaccine booster dose to increase protection among immunocompromised individuals.

COVID-19 Breakthrough Infections More Common, More Severe Among Immunocompromised Individuals

The US Pharmacopeia (USP) announced a new general chapter <1469> about nitrosamines impurities in a new standard in the National Formulary, according to a company statement.

The new standard provides guidance for manufactures and regulators on assessing materials for nitrosamine, which will ensure the performance of analytical procedures to monitor nitrosamine levels in drug products.

“One of the things that makes nitrosamines really tricky is that they actually can be formed very simply through really simple chemistries. The building blocks that you need to create nitrosamines are all around us in nature, and so they can form very easily,” Edwin Gump, PhD, vice president of the Small Molecules Department at USP, said in an 

Nitrosamine impurities are present in some angiotensin II receptor blockers used to treat heart failure and high blood pressure, and it has the potential to cause cancer at high levels and with long exposure.

The materials are found in metformin and ranitidine, which led to recalls and an effort to eliminate or reduce these impurities in the drug supply.

“I think a really important job that pharmacists do is making sure that medicines get properly handled, teaching their patients how also to properly handle them. If medicines don't get handled properly or they're stored at conditions that might not be optimal, then there's the chance that these medicines do degrade and could produce some impurities, which if taken to an extreme, could be unsafe,” Gump said.

The USP has been developing solutions and tools to help analyze and monitor impurities in drug supplies. The USP has also led educational events on the topic and developed 8 reference standards for various nitrosamines impurities.

USP standard for nitrosamine impurities becomes official. USP. December 2, 2021. Accessed December 2, 2021. Email.

These materials are present in some angiotensin II receptor blockers used to treat heart failure and high blood pressure, and they have the potential to cause cancer.

USP Announces Approval of Chapter on Nitrosamines Impurities

In the second episode of the Psychedelic Pharmacy series, Payton Nyquvest, CEO and founder of Numinus, discussed the laboratory development and regulatory side of psychedelic research. In the interview, Nyquvest said he believes psychedelics will lead to a major shift in the mental health treatment paradigm in the next 3 to 5 years.

Podcasts

Payton Nyquvest, CEO and founder of Numinus, discussed the laboratory development and regulatory side of psychedelic research.

Pharmacy Focus Podcast: Psychedelic Pharmacy Episode 2

 (GBS) has a considerably higher global impact than previously recognized, resulting in approximately 150,000 deaths of babies each year, more than half a million preterm births, and significant long-term disability, according to a report from the World Health Organization (WHO) and the London School of Hygiene & Tropical Medicine (LSHTM). The investigators call for urgent development of maternal vaccines against GBS to reduce its impact.

“Group B strep infection poses a serious challenge to every family affected, and in every country,” said Joy Lawn, FRCPCH, FMedSci, director of the Maternal Adolescent Reproductive & Child Health Centre at LSHTM, in a press release. “Maternal vaccination could save the lives of hundreds of thousands of babies in the years to come, yet 30 years since this was first proposed, the world has not delivered a vaccine. Now is the time to act to protect the world’s most vulnerable citizens with a GBS vaccine.”

The investigators note that multiple GBS vaccine candidates are in development, but none are yet available, despite development efforts spanning multiple decades. The primary method of preventing GBS disease in newborns is currently antibiotic prophylaxis administered to a woman during labor if the bacterium is detected during pregnancy. However, this intervention is unlikely to prevent most GBS-associated stillbirths, preterm births, or GBS disease that occurs later after birth, according to the investigators.

“This new research shows that Group B strep is a major and underappreciated threat to newborn survival and wellbeing, bringing devastating impacts for so many families globally,” said Philipp Lambach, PhD, MBA, medical officer from WHO’s Immunization, Vaccines and Biologicals department, in the release. “WHO joins partners in calling for urgent development of a maternal GBS vaccine, which would have profound benefits in countries worldwide.”

An average of 15% of all pregnant women globally carry the GBS bacterium, typically without symptoms. According to the report, estimates suggest that if a GBS vaccine reached more than 70% of pregnant women, more than 50,000 GBS-related deaths could be averted annually—as well as over 170,000 preterm births.

“A new maternal vaccine against GBS would be a game-changer in the reduction of newborn and maternal deaths for the most affected countries—especially sub-Saharan Africa where the burden of these deaths is alarming,” said Martina Lukong Baye, MD, MPH, in the release. “We plead to all stakeholders to treat this as a matter of moral priority.”

Urgent need for vaccine to prevent deadly Group B streptococcus [news release]. EurekAlert; November 2, 2021. Accessed December 2, 2021. 

https://www.eurekalert.org/news-releases/933337

Multiple GBS vaccine candidates are in development, but none are available despite development efforts spanning multiple decades.

Pneumococcal

Group B Streptococcus Major Source of Preterm Births, Disability, Infant Mortality

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new fixed- duration treatment option for ibrutinib in combination with venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL), according to a press release. The application is based on the results of the phase 3 GLOW and phase 2 CAPTIVATE studies.

"Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past 7 years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,” said Edmond Chan, MD, MSc, in a press release. “This latest submission is a testament to our unwavering commitment to meeting patient needs and a noteworthy step towards an innovative, non-chemotherapy treatment regimen in the first-line setting that will allow healthcare professionals the flexibility to use ibrutinib either in a fixed-duration combination treatment regimen or as continuous therapy, depending on patient needs.”

According to Janssen, the submission is supported by positive data in the GLOW study, which investigated the efficacy and safety of first-line fixed-duration ibrutinib and venetoclax combination therapy compared to chlorambucil plus obinutuzumab in elderly or unfit patients with CLL. Further, positive data from the CAPTIVATE study evaluating ibrutinib plus venetoclax in previously untreated CLL patients 70 years of age or younger, including patients with high-risk disease, was found to support this new indication.

“Ibrutinib and venetoclax have demonstrated positive outcomes when used together for a fixed duration of treatment and this milestone highlights our commitment to developing more convenient treatment regimens for people living with complex blood cancers, such as CLL,” said Craig Tendler, MD, vice president of Late Clinical Development and Global Medical Affairs in the Oncology department of Janssen Research & Development, in the release. “We now look forward to working in partnership with health authorities to bring this promising treatment option to patients who may benefit from it as soon as possible.”

CLL is a typically slow-growing blood cancer that affects the white blood cells, with an overall incidence in Europe of approximately 4.92 cases per 100,000 persons per year. The median age of patients diagnosed with the disease is 72 years.

According to the investigators, although patient outcomes have improved in recent decades, the disease is still characterized by consecutive episodes of disease progression. As a result, patients are frequently prescribed multiple lines of therapy as they relapse or become resistant to treatments, the researchers noted.

Janssen seeks approval of Imbruvica®(ibrutinib) in a fixed-duration regimen for patients with untreated chronic lymphocytic leukaemia (CLL) [news release]. Janssen; November 30, 2021. Accessed December 2, 2021. 

https://www.jnj.com/janssen-seeks-approval-of-imbruvica-ibrutinib-in-a-fixed-duration-regimen-for-patients-with-untreated-chronic-lymphocytic-leukaemia-cll

Ibrutinib in combination with venetoclax shows promise in patients with previously untreated chronic lymphocytic leukemia.

Latest Clinical News