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Helpful MCN Healthcare Resources
The US Food and Drug Administration (FDA) is informing health care professionals that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems. Tecfidera is a drug used to treat relapsing forms of MS.
The FDA recommends that health care professionals do the following:
- Prescribers should tell patients to contact them if they have any symptoms that may be suggestive of PML including, but not limited to, progressive weakness on one side of the body or clumsiness of the limbs; disturbance of vision; changes in thinking, memory and orientation, leading to confusion and personality changes. The progression of deficits can lead to severe disability or death.
- Stop Tecfidera immediately at the first sign or symptom suggestive of PML and perform an appropriate diagnostic evaluation.
- Monitor lymphocyte counts in Tecfidera-treated patients according to approved labeling.
CDC Issues Health Advisory about Fatal Gastrointestinal Mucormycosis in an Infant Following Ingestion of Contaminated Dietary Supplement
The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Connecticut Departments of Public Health and Consumer Protection are investigating a fatal case of gastrointestinal (GI) mucormycosis caused by Rhizopus oryzae in a premature infant. The infant received ABC Dophilus® Powder, a dietary supplement product containing viable microbial ingredients purchased from Solgar, Inc., Leonia, New Jersey. The product claimed to have "probiotic" properties and is marketed for infants and children. Subsequent testing of the same lot of unopened Solgar ABC Dophilus® Powder revealed contamination with Rhizopus oryzae.
The purpose of the CDC's Health Advisory is to provide awareness about this fatal case of GI mucormycosis following ingestion of a contaminated dietary supplement and to provide guidance to state health departments and health care providers. The CDC is requesting that all of the information in the Health Advisory be disseminated to healthcare workers in neonatal intensive care units, hospital pharmacies, pediatricians, and primary care providers, as well as to microbiology and pathology laboratories. A link to the Health Advisory is provided below. The following is a summary of key recommendations:
- Solgar ABC Dophilus® Powder should not be used, especially in infants who may be especially susceptible to infection.
- In considering the use of any dietary supplement, clinicians should consider that the FDA does not regulate these products as drugs.
- Clinical Care:
- Clinicians evaluating either of the following should review whether Solgar ABC Dophilus® Powder was used as part of the infant care.
- Preterm infants for necrotizing enterocolitis OR
- Infants who have signs or symptoms of gastrointestinal mucormycosis such as abdominal pain, abdominal distension, nausea, or vomiting.
- If Solgar ABC Dophilus® Powder was consumed by the patient within the previous 30 days, clinicians should consider consultation with an infectious disease physician to assist in an assessment which may include the following:
- Aggressive evaluation for a source of infection, including surgical exploration.
- Empiric treatment with antifungals active against mucormycete infections.
Clinicians and public health officials are asked to notify their state or local health departments if they learn of cases or deaths in the following categories that have occurred since November 1, 2013:
- Confirmed or suspected cases of infants with gastrointestinal mucormycosis (diagnosed via culture or histopathology) OR
- Unexplained infant deaths within 30 days after ingestingSolgar ABC Dophilus® Powder
CDC Issues Interim Guidance for Managers and Workers Handling Untreated Sewage from Individuals with Ebola in the United States
The Centers for Disease Control and Prevention (CDC) has issued interim guidance for workers who handle untreated sewage that comes from hospitals, medical facilities, and other facilities with confirmed individuals with Ebola. According to the CDC, the guidance is based on current knowledge of Ebola virus, including detailed information on Ebola virus transmission, recommendations from the World Health Organization (WHO), and scientific studies of wastewater treatment and workers who handle wastewater. Updates will be posted as needed on the CDC Ebola webpage (link below).
The CDC states that there are some workers who might come into contact with untreated sewage before it enters the wastewater treatment plant and could be at very low risk of exposure to Ebola virus. These workers include:
- Plumbers in hospitals that are currently treating an Ebola patient
- Sewer maintenance workers working on the active sewer lines serving the hospital with an Ebola patient
- Construction workers who repair or replace active sewer lines serving the hospital with an Ebola patient
Key points included in the guidance:
- Ebola virus is more fragile than many enteric viruses that cause diarrheal disease or hepatitis.
- The envelope that covers Ebola makes it more susceptible to environmental stresses and to chemical germicides than non-enveloped viruses, such as hepatitis A, poliovirus, and norovirus.
- To protect workers against Ebola, educate them on:
- What PPE to use to protect broken skin and mucous membranes and,
- How to properly use the PPE, including how to put it on and take it off.
- Develop and fully implement routine protocols that ensure workers are protected against potential exposures (i.e., prevent contact with broken skin, eyes, nose or mouth) when handling untreated sewage.
- Ensure all workers always practice good personal hygiene, including frequent hand washing to reduce potential exposures to any of the pathogens in sewage.
Included with today's notice is a policy reflecting the interim guidance.
Featured Policy Library Manuals
MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.Read more »
MCN's Central Service Policy and Procedure Manual provides over 200 proven, up-to-date policies and procedures in a ready-to-customize format. This manual is cross referenced to federal regulations, as well as Joint Commission and NIAHO standards. References used include AAMI Recommended Practices, IAHCSMM Central Service Technical Manual, ASHCSP Training Manual for Health Care Central Service Technicians and AORN Recommended Practices.Read more »
MCN's Post Anesthesia Care Policy and Procedure Manual is a comprehensive resource that covers the latest "hot topic" regulatory and patient safety issues that are relevant to PACU! This manual includes administrative, operational, functional and patient-centered policies and procedures. Policies and procedures are cross-referenced to CMS regulations, Joint Commission standards and NIAHO standards.Read more »