COVID-19 VACCINES
Guidelines released for managing rare complication
The American Heart Association and American Stroke Association have issued recommendations for management of cerebral venous sinus thrombosis (CVST) with vaccine-induced immune thrombotic thrombocytopenia (VITT), a very rare but potentially fatal adverse reaction to COVID-19 vaccines that use adenoviral vectors rather than mRNA technology, such as those produced by Johnson & Johnson and AstraZeneca. The purpose of the report is to heighten awareness of the association between these vaccines and CVST with VITT, help clinicians recognize signs and symptoms promptly, and suggest approaches to management. Recommendations include the following:
* Use MRI or computed tomography with venogram to detect CVST in suspected cases.
* Acute management should follow that for heparin-induced thrombocytopenia.
* Heparin products should not be given; instead, clinicians should administer an alternative to heparin or a direct oral anticoagulant at therapeutic dose intensity.
* Anticoagulation is recommended, even in the presence of secondary intracranial hemorrhage, but platelet transfusion should be avoided.
* After full platelet recovery, most patients can transition to an oral anticoagulant if not contraindicated.
Access the full report at http://www.ahajournals.org/doi/pdf/10.1161/STROKEAHA.121.035564.
Source: American Heart Association/American Stroke Association Stroke Council Leadership. Diagnosis and management of cerebral venous sinus thrombosis with vaccine-induced immune thrombotic thrombocytopenia. Stroke. [e-pub April 29, 2021]
SMART INFUSION PUMPS
Making use of error-prevention software
The Joint Commission has issued a Sentinel Event Alert to describe actions healthcare organizations can take to reduce the risk of errors caused by the misuse of smart infusion pumps. Such errors are caused by a combination of human and technical risk factors, including fatigue, distraction, and drug library overrides. Many of these errors could be avoided by the correct use of built-in dose error reduction software (DERS). Most healthcare facilities in the US have invested in smart infusion pumps that include DERS, according to The Joint Commission.
DERS computer software is intended to help prevent infusion programming errors and warn users of potential over- or underdelivery of a drug or fluid by checking programmed doses/rates against facility-configurable preset limits specific to a medication/fluid, and by checking clinical applications (for example, epidural administration) and/or clinical location (for example, the neonatal unit). The most common programming errors involve dose-rate confusion; mistakes with a decimal point, weight, or unit of measure; and selection of the wrong drug or dosing method in the drug library. Barriers to optimal use of DERS include alarm fatigue, limited pump availability, and deficiencies related to library use and updates, such as the omission of certain drugs and fluids from the library.
In this Alert, The Joint Commission lists a detailed six-point blueprint for overcoming barriers to the optimal use of DERS for clinicians in all healthcare settings who use smart infusion pumps, especially nurses, physicians, pharmacists, anesthesia providers, and clinical leadership personnel. Access it at http://www.jointcommission.org.
Source: The Joint Commission. Optimizing smart infusion pump safety with DERS. Sentinel Event Alert. Issue 63. April 14, 2021.
mRNA VACCINES
Little or no risk of facial paralysis found
During phase 3 clinical trials of the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines, several cases of facial paralysis were observed in the vaccine groups. Although no causal relationship could be established, the FDA recommended monitoring vaccine recipients for facial paralysis.
Using the World Health Organization pharmacovigilance database, researchers performed four analyses with two control groups (all other viral vaccines and restricted to influenza vaccines) and two facial paralysis definitions. All analyses were adjusted for gender and age.
Among the 133, 883 cases of adverse drug reactions reported with mRNA COVID-19 vaccines in the database, researchers identified 844 (0.6%) facial paralysis-related events: 749 cases with the Pfizer-BioNTech vaccine and 95 cases with the Moderna vaccine. About 68% of those experiencing facial paralysis-related events were female. The median age was 49 and the median time to symptom onset was 2 days.
Discussing their results, the study authors note that facial paralysis is seen in the context of many conditions, such as viral infections, traumatic injury, cancers, or hormonal changes during pregnancy, and may also be idiopathic. Isolated facial paralysis after vaccination has been reported for decades with almost all viral vaccines and is thought to be immune-mediated or induced by viral reactivations. However, research has so far failed to establish a higher risk of facial paralysis after vaccination. The authors of this study conclude that "the reporting rate of facial paralysis after mRNA COVID-19 vaccination found in the present study is not higher than that observed with other viral vaccines... If an association between facial paralysis and mRNA COVID-19 vaccines exists, the risk is likely very low, as with other viral vaccines."
Source: Renoud L, Khouri C, Revol B, et al. Association of facial paralysis with mRNA COVID-19 vaccines: a disproportionality analysis using the World Health Organization pharmacovigilance database. JAMA Intern Med. [e-pub April 27, 2021]
USPSTF GUIDELINES
Beta-carotene and other supplements not recommended
The US Preventive Services Task Force (USPSTF) has issued a draft recommendation advising against the use of vitamin E supplements and beta-carotene to prevent cardiovascular disease (CVD) and cancer. The recommendation is based on an extensive review of multiple databases conducted through January 2021. The conclusions include the following:
* Vitamin and mineral supplementation provides little to no benefit in preventing cancer, CVD, and death, with the exception of a benefit for cancer-related mortality and a possible small benefit for all-cause mortality with vitamin D use.
* Beta-carotene increases the risk of lung cancer and other harmful outcomes in persons at high risk of lung cancer.
* Data were absent or insufficient to draw conclusions for any of the B vitamins, iron, zinc, or magnesium.
These findings do not apply to pregnant women, for whom the USPSTF has recommended folic acid supplementation in a previously issued statement.
Sources: O'Connor EA, Evans CV, Ivlev I, et al. Vitamin and mineral supplements for the primary prevention of cardiovascular disease and cancer: a systematic evidence review for the US Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2021. USPSTF advises against vitamin E, beta-carotene supplements for CVD, cancer prevention. Healio. May 4, 2021.