A Systematic Review

[Posted 5/Nov/2024]

AUDIENCE: Family Medicine

KEY FINDINGS: Different anticoagulation-related perioperative management strategies achieve different outcomes following elective arthroplasty in patients with therapeutic chronic anticoagulation. There is contradictory evidence regarding the need for the discontinuation of therapeutic warfarin. Retrospective data showed that individual risk stratification with multi-modal prophylaxis resulted in minimal complications.

BACKGROUND: There are currently different management guidelines for patients undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA) that are on long-term anticoagulation. The timing of discontinuation and restarting the anticoagulation is challenging during the postoperative care, which often involves general practitioners and physiotherapists.

DETAILS: The systematic review followed the PRISMA guidelines and included 3 databases: PubMed/MEDLINE, EMBASE, and Web of Science Core Collection. The risk of bias assessment was performed using the Methodological index for non-randomized studies (MINORS) criteria. Six retrospective studies involving 727 patients with therapeutic anticoagulation (1,540 controls) for elective THA, TKA and revision arthroplasty have been included. The follow-up ranged from 30 days to 1 year postoperatively. All studies evaluated outcomes of warfarin therapeutic anticoagulation versus prophylactic dosages of one or more of the following: warfarin, aspirin, low-molecular-weight heparin (LMWH) and unfractionated low-dose heparin (UFH). One study did not discontinue therapeutic anticoagulation. Two studies reported no significant differences in complications between groups, whilst 3 studies had significantly higher rates of superficial wound infections, revision surgeries, postoperative haematomas, and prosthetic joint infections (PJI).

Copyright © Oxford University Press. All rights reserved.

Source: Andronic, D., Andronic, O., Ammann, E., et al. (2024). Outcomes of Different Perioperative Management Strategies of Patients on Chronic Anticoagulation in Elective Total Hip and Knee Arthroplasty: A Systematic Review. Family Practice. 2024; 41(5): 629–637. Published: October, 2024. DOI: 10.1093/fampra/cmae020.

[Posted 23/Oct/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: The study reveals that the SIS can predict status anxiety. The SIS can contribute to research regarding important phenomena such as the detrimental psychological effects of income inequality.

BACKGROUND: Although substantial research indicates that considerations about status can lead to anxiety and other negative outcomes, a valid measure of the importance individuals attribute to status is lacking.

DETAILS: The study introduces the Status Importance Scale (SIS), a mono-factorial 10-item self-report questionnaire that quantifies how important a person deems status to be. Five studies validate the scale showing that it has excellent internal reliability and acceptable test–retest reliability, it correlates with several related measures (supporting convergent validity), it shows little correlation with theoretically unrelated constructs (supporting discriminant validity), it is the best predictor of conspicuous consumption compared with other potential candidates (supporting concurrent validity), and it can help predicting which activities one gives importance to (further supporting concurrent validity).

Copyright © The British Psychological Society. All rights reserved.

Source: Rigoli, F. and Mirolli, M. (2024). The Status Importance Scale: Development and Validation of a Self-Report Questionnaire for Measuring How Much People Care About Status. British Journal of Psychology. 2024; 115(4): 683-705. Published: November, 2024. DOI: 10.1111/bjop.12716.

[Posted 17/Oct/2024]

AUDIENCE: Emergency Medicine

KEY FINDINGS:

BACKGROUND: Over several days in late September 2024, Hurricane Helene caused extensive damage to the southeastern United States. The storm affected the Baxter International's North Cove facility in North Carolina, the largest manufacturer of peritoneal dialysis and intravenous solutions in the United States, halting production.

DETAILS: CDC is issuing this Health Alert Network (HAN) Health Advisory to inform healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments of a supply disruption of peritoneal dialysis (PD) and intravenous (IV) solutions from the Baxter International's North Cove facility in North Carolina, due to Hurricane Helene.

The supply disruption may impact patient care and require adjustments to the clinical management of patients. Healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments, regardless of supply chain disruptions, should immediately assess their supply and develop plans and mitigation strategies to reduce the impact on patient care.

This Health Advisory summarizes recommendations from the Food and Drug Administration (FDA); the Administration for Strategic Preparedness and Response Technical Resources, Assistance Center, and Information Exchange (ASPR TRACIE) ; the American Society of Health-System Pharmacists (ASHP); the American Society of Nephrology (ASN); and the American Society of Pediatric Nephrology (ASPN) among others, to address supply disruptions of PD and IV solutions.

Facilities can implement strategies early to conserve their fluid supplies and avoid waste to reduce the impact on services. Strategies must ensure patient safety, timely and effective safety notifications, and education of healthcare personnel and patients. Emergency medical and outpatient services must be included in these strategies.

Additional supply disruption may occur in the aftermath of Hurricane Milton.

Recommendations

Healthcare Providers, Pharmacists, and Healthcare Facility Administrators in Healthcare Facilities

• Assess inventory, supply, and conserve available IV solutions.
• Determine the type of IV solutions your pharmacy or facility uses, including expiration dates, and whether this supply disruption will impact your facility.
• Monitor current and future supplies of IV solutions at your facility.
• Report any potential shortages or interruptions to the Food and Drug Administration (FDA) at DrugShortages@fda.hhs.gov.
• Implement a facility-specific action plan to optimize the use of IV solutions using evidence-based fluid management protocols.
• Evaluate all protocols, including the clinical need to continue IV fluid replacement at every shift change, bag change, and during the transition of care unless clinically necessary.
• Ensure that advisory committees with appropriate authorities are established to determine complex issues in supply disruptions and allocation of limited resources and patient triage as needed.
• Use oral formulations when IV options are not available and when appropriate and safe.
• Identify safe and effective alternative IV options (e.g., working with a nearby facility or licensed manufacturer who is not affected by the supply disruption).
• Review standing orders, including drug records and order sets.
• Ensure thorough documentation of the situation, including consumption of IV solutions.
• See FDA's Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International's North Cove facility.
• Ensure multidisciplinary team involvement to determine and develop conservation and stewardship strategies using IV solutions in specific patient populations.
• Include providers from various expertise (including key outpatient settings such as emergency departments, hematology/oncology, ambulatory surgery centers, wound care centers, infusion centers, home healthcare, etc.), pharmacists, nurses, infection control, informatics, patient safety, supply chain leadership, and emergency preparedness.
• Provide education and training to healthcare providers regarding any changes in protocols.
• Communicate changes in current practice, disruption, new shortages, and action plan adjustments to hospital leadership and frontline staff.
• Communicate with patients to assess supplies and provide a mechanism to notify their providers of insufficient supplies.

Providers and Administrators in Dialysis Facilities

• Assess and monitor inventory of available PD solutions.
• Review current practices to identify changes that extend the PD solution supply safely.
• Monitor current and future supplies of PD solutions.
• Report any interruptions to the FDA at DrugShortages@fda.hhs.gov.

• Implement an action plan for emergency PD treatment protocols
• Assess emergency PD protocols.
• Ensure optimal PD catheter function and flow of all patients to maximize ultrafiltration and solute exchange (malposition, etc.).
• Optimize prescriptions; overall approaches should prioritize bag-sparing rather than solution-sparing.
• For example, consider changing dwell times rather than adding a PD solution bag if a prescription change is needed for a patient.
• Monitor patients closely after prescription adjustments, including phone check-ins.
• Communicate with patients receiving peritoneal dialysis at home and their care providers.
• Assess supplies and provide a mechanism to notify their provider of insufficient supplies.
• Provide education and training to patients and their care providers regarding any changes in PD bags or associated products (e.g., adaptors, tubing, etc.) used for their treatments.
• Consider options for individual patients, keeping safety in mind.
• Continuous ambulatory PD (CAPD) may be a good option for some patients.
• Transitioning to hemodialysis (HD) should be avoided as much as possible. However, if adjustment of PD prescription has been explored and exhausted, a temporary transition to HD may be necessary if the available supply is insufficient to provide adequate PD.
• Reinforce patient safety principles when not using usual products and procedures to prevent patient injury and medical errors.

State, Tribal, Local, and Territorial Health Departments

• Maintain situational awareness of the severity of the supply disruption and implement strategies.
• Where possible, facilitate communication across health systems within the jurisdictions related to acute supply needs.

Source: CDC Issues Health Alert In Light of Disruptions in Availability of PD and IV Solutions from Baxter International Facility in North Carolina. CDC. 2024; Published: October, 2024.

[Posted 2/Sep/2024]

AUDIENCE: Internal Medicine, Nursing

KEY FINDINGS: Scientists from the University of Copenhagen have detected lipid biomarkers in children and teenagers with obesity that indicate an increased risk of developing type 2 diabetes, liver and heart disease as adults. A one-year lifestyle intervention lowered the levels of these lipid biomarkers, which demonstrates the importance of early intervention for children with obesity.

BACKGROUND: The number of children and teens with obesity is increasing worldwide, with over 250 million expected to be affected by 2030. It is a major public health crisis, as children with obesity risk developing insulin resistance, fatty liver, and high blood pressure, which may lead to diseases such as cardiovascular disease, type 2 diabetes and liver disease, later in life.

DETAILS: Scientists think these diseases can be triggered by changes in the body's lipids -- a wide range of fats and oils in the body including triglycerides and cholesterol that serve many purposes including energy storage and cellular signalling. But it is still not well understood how lipid species change in children with obesity, and how they are linked to early cardiometabolic complications.

Now, scientists at the University of Copenhagen have discovered that lipid species linked to cardiometabolic disease in adults are strongly associated with cardiometabolic risk factors in children and teenagers with obesity. The findings could pave the way for tests that serve as an early warning system for cardiometabolic disease.

"Our study shows that the impact of cardiometabolic associated lipid species emerges early in life in children with obesity, particularly affecting liver function and glucose metabolism. These risk lipid species could potentially be explored further as biomarkers for diagnosing or predicting cardiometabolic risk in children at high risk, offering new insights for early detection and intervention," says Postdoc Yun Huang from the Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen, and co-first author of the study in Nature Medicine.

Early intervention reverses cardiometabolic disease risk

The scientists made their discoveries by drawing on the HOLBAEK Study biobank of more than 4,000 children with and without obesity. at the Children's Obesity Clinic at Holbaek Hospital. Together with scientists at Steno Diabetes Center Copenhagen, they harnessed powerful mass spectrometry technology to map hundreds of individual lipid species, each with distinct structures and functions, providing a detailed picture of lipid metabolism. By analyzing the differences in the lipid profiles of 958 children with overweight or obesity and 373 who had normal weight, they gained deep insight into obesity altered lipid profiles and their link to cardiometabolic risk, and the ability to detect excessive fat in the liver.

Copyright © ScienceDaily or by other parties, where indicated. All rights reserved.

Source: University of Copenhagen - The Faculty of Health and Medical Sciences (2024). A Simple Blood Test Warns of Possible Cardiometabolic Complications for Children With Obesity. ScienceDaily. 2024; Published: September 20, 2024. DOI: 10.1038/s41591-024-03279-x.

First Influenza Vaccine That Does Not Need to be Administered by a Health Care Provider

[Posted 4/Oct/2024]

AUDIENCE: Infectious Disease, Family Medicine, Nursing

On September 20, 2024, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age. It is the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider

"Today's approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health."

The flu is a common and contagious respiratory disease that is caused by influenza viruses that typically circulate during the fall and winter in the U.S. It can cause mild to severe illness with a range of symptoms that usually appear suddenly, such as body aches, fever, coughing, sore throat, tiredness and a stuffy or runny nose. Flu can be life-threatening and cause serious complications that can lead to hospitalization or death, particularly in high-risk groups such as the elderly, young children and people with certain chronic medical conditions. Each flu season is different and the health impacts can be substantial and vary widely from season to season, with some flu seasons being worse than others. According to the U.S. Centers for Disease Control and Prevention, flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023. Numerous FDA-approved vaccines are available each flu season to prevent influenza.

FluMist contains a weakened form of live influenza virus strains and is sprayed in the nose. A prescription is still required to receive FluMist. There are now two approved options for receiving FluMist. The vaccine may be administered by a health care provider in a health care setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older.

The most commonly reported side effects of FluMist are fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age and a sore throat in adults 18 through 49 years of age.

For those interested in self- or caregiver-administration, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy. Those who choose this option will complete a screening and eligibility assessment when they order FluMist. The third-party pharmacy determines eligibility based on the completed screening and, if it is determined that the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the address provided by the individual who placed the order. The vaccine can then be administered to the prescribed household member(s) at their convenience. A caregiver should administer FluMist to individuals 2 through 17 years of age, as individuals in this age group should not self-administer the vaccine.

A study was conducted with vaccine recipients and caregivers to evaluate whether the instructions for use were appropriately designed so that recipients and caregivers could safely and effectively use the vaccine.

Vaccine recipients and caregivers who administer FluMist will be sent the vaccine, the Prescribing Information, Information for Patients and their Caregivers and Instructions for Use. The Instructions for Use provides detailed instructions for storage, administration and disposal of FluMist.

The FDA granted this approval of FluMist (Influenza Vaccine Live, Intranasal) to MedImmune LLC.

Source: FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. FDA. 2024; Published: September, 2024. DOI: FDA.

[Posted 23/Sep/2024]

AUDIENCE: Ob/Gyn, Family Medicine

KEY FINDINGS: Veozah, a medication used to treat hot flashes due to menopause, was shown in a postmarketing report to cause serious liver injury in a patient.

BACKGROUND: The FDA has issued a Drug Safety Communication involving Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, due to its potential to cause "rare but serious liver injury."

DETAILS: This update was made "after reviewing a postmarketing report of a patient with elevated liver blood test values and signs and symptoms of liver injury after taking the medicine for about 40 days." The FDA also added new recommendations about "increasing the frequency of liver blood testing" upon starting Veozah. The FDA suggests that patients "stop taking Veozah immediately and contact your health care professional who prescribed the medicine if you experience signs and symptoms that suggest liver problems." It also suggests that healthcare professionals "conduct hepatic laboratory testing before prescribing Veozah, then every month for the first three months after patients start treatment, and then at months 6 and 9 of treatment." The patient in the postmarketing report returned to normal after stopping the medication. The agency urges patients and healthcare professionals to "report side effects involving Veozah (fezolinetant) or other medicines to the FDA MedWatch program."

Copyright © Endeavor Business Media, LLC. All rights reserved.

Source: MacKenzie, M. (2024). FDA Warns Veozah Can Cause Serious Liver Injury in Rare Cases. Healthcare Purchasing News. 2024; Published: September 16, 2024. DOI: 55140088.