Melissa K. Schaefer

Fungal Infections Associated with Contaminated Methylprednisolone in Tennessee

BACKGROUND We investigated an outbreak of fungal infections of the central nervous system that occurred among patients who received epidural or paraspinal glucocorticoid injections of preservative-free methylprednisolone acetate prepared by a single compounding pharmacy. METHODS Case patients were defined as patients with fungal meningitis, posterior circulation stroke, spinal osteomyelitis, or epidural abscess that developed after epidural or paraspinal glucocorticoid injections. Clinical and procedure data were abstracted. A cohort analysis was performed. RESULTS The median age of the 66 case patients was 69 years (range, 23 to 91). The median time from the last epidural glucocorticoid injection to symptom onset was 18 days (range, 0 to 56). Patients presented with meningitis alone (73%), the cauda equina syndrome or focal infection (15%), or posterior circulation stroke with or without meningitis (12%). Symptoms and signs included headache (in 73% of the patients), new or worsening back pain (in 50%), neurologic symptoms (in 48%), nausea (in 39%), and stiff neck (in 29%). The median cerebrospinal fluid white-cell count on the first lumbar puncture among patients who presented with meningitis, with or without stroke or focal infection, was 648 per cubic millimeter (range, 6 to 10,140), with 78% granulocytes (range, 0 to 97); the protein level was 114 mg per deciliter (range, 29 to 440); and the glucose concentration was 44 mg per deciliter (range, 12 to 121) (2.5 mmol per liter [range, 0.7 to 6.7]). A total of 22 patients had laboratory confirmation of Exserohilum rostratum infection (21 patients) or Aspergillus fumigatus infection (1 patient). The risk of infection increased with exposure to lot 06292012@26, older vials, higher doses, multiple procedures, and translaminar approach to epidural glucocorticoid injection. Voriconazole was used to treat 61 patients (92%); 35 patients (53%) were also treated with liposomal amphotericin B. Eight patients (12%) died, seven of whom had stroke. CONCLUSIONS We describe an outbreak of fungal meningitis after epidural or paraspinal glucocorticoid injection with methylprednisolone from a single compounding pharmacy. Rapid recognition of illness and prompt initiation of therapy are important to prevent complications. (Funded by the Tennessee Department of Health and the Centers for Disease Control and Prevention.).

Fungal Infections Associated with Contaminated Methylprednisolone Injections

BACKGROUND Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, we initiated an investigation into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy. METHODS Three lots of methylprednisolone acetate were recalled by the pharmacy; examination of unopened vials later revealed fungus. Notification of all persons potentially exposed to implicated methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. We collected clinical data on standardized case-report forms, and we tested for the presence of fungi in isolates and specimens by examining cultures and performing polymerase-chain-reaction assays and histopathological and immunohistochemical testing. RESULTS By October 19, 2012, more than 99% of 13,534 potentially exposed persons had been contacted. As of July 1, 2013, there were 749 reported cases of infection in 20 states, with 61 deaths (8%). Laboratory evidence of Exserohilum rostratum was present in specimens from 153 case patients (20%). Additional data were available for 728 case patients (97%); 229 of these patients (31%) had meningitis with no other documented infection. Case patients had received a median of 1 injection (range, 1 to 6) of implicated methylprednisolone acetate. The median age of the patients was 64 years (range, 15 to 97), and the median incubation period (the number of days from the last injection to the date of the first diagnosis) was 47 days (range, 0 to 249); 40 patients (5%) had a stroke. CONCLUSIONS Analysis of data from a large, multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.

Adverse Events From Cough and Cold Medications in Children

BACKGROUND. Adverse drug events in children from cough and cold medications have been identified as a public health issue with clinical and policy implications. Nationally representative morbidity data could be useful for targeting age-appropriate safety interventions. OBJECTIVE. To describe emergency department visits for adverse drug events from cough and cold medications in children. METHODS. Emergency department visits for adverse drug events attributed to cough and cold medications among children aged <12 years were identified from a nationally representative stratified probability sample of 63 US emergency departments from January 1, 2004, through December 31, 2005. RESULTS. Annually, an estimated 7091 patients aged <12 years were treated in emergency departments for adverse drug events from cough and cold medications, accounting for 5.7% of emergency department visits for all medications in this age group. Most visits were for children aged 2 to 5 years (64%). Unsupervised ingestions accounted for 66% of estimated emergency department visits, which was significantly higher than unsupervised ingestions of other medications (47%), and most of these ingestions involved children aged 2 to 5 years (77%). Most children did not require admission or extended observation (93%). CONCLUSIONS. Timely national surveillance data can help target education, enforcement, and engineering strategies for reducing adverse events from cough and cold medications among children. Engineering innovations could be particularly helpful in addressing unsupervised ingestions, which is the most frequent cause of adverse events. These innovations could be applicable to other childrens medications.

Hepatitis C Virus Infections from Unsafe Injection Practices at an Endoscopy Clinic in Las Vegas, Nevada, 2007–2008

BACKGROUND In January 2008, 3 persons with acute hepatitis C who all underwent endoscopy at a single facility in Nevada were identified. METHOD We reviewed clinical and laboratory data from initially detected cases of acute hepatitis C and reviewed infection control practices at the clinic where case patients underwent endoscopy. Persons who underwent procedures on days when the case patients underwent endoscopy were tested for hepatitis C virus (HCV) infection and other bloodborne pathogens. Quasispecies analysis determined the relatedness of HCV in persons infected. RESULTS In addition to the 3 initial cases, 5 additional cases of clinic-acquired HCV infection were identified from 2 procedure dates included in this initial field investigation. Quasispecies analysis revealed 2 distinct clusters of clinic-acquired HCV infections and a source patient related to each cluster, suggesting separate transmission events. Of 49 HCV-susceptible persons whose procedures followed that of the source patient on 25 July 2007, 1 (2%) was HCV infected. Among 38 HCV-susceptible persons whose procedures followed that of another source patient on 21 September 2007, 7 (18%) were HCV infected. Reuse of syringes on single patients in conjunction with use of single-use propofol vials for multiple patients was observed during normal clinic operations. CONCLUSIONS Patient-to-patient transmission of HCV likely resulted from contamination of single-use medication vials that were used for multiple patients during anesthesia administration. The resulting public health notification of approximately 50,000 persons was the largest of its kind in United States health care. This investigation highlighted breaches in aseptic technique, deficiencies in oversight of outpatient settings, and difficulties in detecting and investigating such outbreaks.

Infection Control Assessment of Ambulatory Surgical Centers

CONTEXT More than 5000 ambulatory surgical centers (ASCs) in the United States participate in the Medicare program. Little is known about infection control practices in ASCs. The Centers for Medicare & Medicaid Services (CMS) piloted an infection control audit tool in a sample of ASC inspections to assess facility adherence to recommended practices. OBJECTIVE To describe infection control practices in a sample of ASCs. DESIGN, SETTING, AND PARTICIPANTS All State Survey Agencies were invited to participate. Seven states volunteered; 3 were selected based on geographic dispersion, number of ASCs each state committed to inspect, and relative cost per inspection. A stratified random sample of ASCs was selected from each state. Sample size was based on the number of inspections each state estimated it could complete between June and October 2008. Sixty-eight ASCs were assessed; 32 in Maryland, 16 in North Carolina, and 20 in Oklahoma. Surveyors from CMS, trained in use of the audit tool, assessed compliance with specific infection control practices. Assessments focused on 5 areas of infection control: hand hygiene, injection safety and medication handling, equipment reprocessing, environmental cleaning, and handling of blood glucose monitoring equipment. MAIN OUTCOME MEASURES Proportion of facilities with lapses in each infection control category. RESULTS Overall, 46 of 68 ASCs (67.6%; 95% confidence interval [CI], 55.9%-77.9%) had at least 1 lapse in infection control; 12 of 68 ASCs (17.6%; 95% CI, 9.9%-28.1%) had lapses identified in 3 or more of the 5 infection control categories. Common lapses included using single-dose medication vials for more than 1 patient (18/64; 28.1%; 95% CI, 18.2%-40.0%), failing to adhere to recommended practices regarding reprocessing of equipment (19/67; 28.4%; 95% CI, 18.6%-40.0%), and lapses in handling of blood glucose monitoring equipment (25/54; 46.3%; 95% CI, 33.4%-59.6%). CONCLUSION Among a sample of US ASCs in 3 states, lapses in infection control were common.

US Outbreak Investigations Highlight the Need for Safe Injection Practices and Basic Infection Control

Current understanding of viral hepatitis transmission in United States health care settings indicates progress over the past several decades with respect to the risks from transfusions or blood products. Likewise, risks to health care providers from sharps injuries and other blood and body fluid exposures have been reduced as a consequence of widespread hepatitis B vaccination and the adoption of safer work practices. Increasing recognition of outbreaks involving patient-to-patient spread of hepatitis B and hepatitis C virus infections, however, has uncovered a disturbing trend. This article highlights the importance of basic infection control and the need for increased awareness of safe injection practices.

Adverse Events From Cough and Cold Medications After a Market Withdrawal of Products Labeled for Infants

OBJECTIVE: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCM-related adverse events (AEs) among children after the withdrawal. METHODS: Emergency department (ED) visits for CCM-related AEs among children <12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal. RESULTS: After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children <2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] vs 2790 visits [28.7%]; difference: −15.4% [95% confidence interval [CI]: −25.9% to −5.0%]), whereas the overall number of estimated ED visits for CCM-related AEs for children <12 years of age remained unchanged (9408 visits [95% CI: 6874–11 941 visits] vs 9727 visits [95% CI: 6649–12 805 visits]). During both periods, two-thirds of estimated ED visits involved unsupervised ingestions (ie, children finding and ingesting medications). CONCLUSIONS: ED visits for CCM-related AEs among children <2 years of age were substantially reduced after withdrawal of over-the-counter infant CCMs. Further reductions likely will require packaging improvements to reduce harm from unsupervised ingestions and continued education about avoiding CCM use for young children. Monitoring of CCM-related harm should continue because recommendations were updated in October 2008 to avoid the use of CCMs for children <4 years of age.

Relapse of fungal meningitis associated with contaminated methylprednisolone.

A recent outbreak of Exserohilum rostratum meningitis was associated with contaminated methylprednisolone. In this report, a patient with outbreak-associated fungal meningitis had a relapse soon after completing more than 4 months of antifungal therapy.

Evaluation of International Classification of Diseases, Ninth Revision, Clinical Modification Codes for Reporting Methicillin-Resistant Staphylococcus aureus Infections at a Hospital in Illinois

BACKGROUND States, including Illinois, have passed legislation mandating the use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for reporting healthcare-associated infections, such as methicillin-resistant Staphylococcus aureus (MRSA). OBJECTIVE To evaluate the sensitivity of ICD-9-CM code combinations for detection of MRSA infection and to understand implications for reporting. METHODS We reviewed discharge and microbiology databases from July through August of 2005, 2006, and 2007 for ICD-9-CM codes or microbiology results suggesting MRSA infection at a tertiary care hospital near Chicago, Illinois. Medical records were reviewed to confirm MRSA infection. Time from admission to first positive MRSA culture result was evaluated to identify hospital-onset MRSA (HO-MRSA) infections. The sensitivity of MRSA code combinations for detecting confirmed MRSA infections was calculated using all codes present in the discharge record (up to 15); the effect of reviewing only 9 diagnosis codes, the number reported to the Centers for Medicare and Medicaid Services, was also evaluated. The sensitivity of the combination of diagnosis codes for detection of HO-MRSA infections was compared with that for community-onset MRSA (CO-MRSA) infections. RESULTS We identified 571 potential MRSA infections with the use of screening criteria; 403 (71%) were confirmed MRSA infections, of which 61 (15%) were classified as HO-MRSA. The sensitivity of MRSA code combinations was 59% for all confirmed MRSA infections when 15 diagnoses were reviewed compared with 31% if only 9 diagnoses were reviewed (P < .001). The sensitivity of code combinations was 33% for HO-MRSA infections compared with 62% for CO-MRSA infections (P < .001). CONCLUSIONS Limiting analysis to 9 diagnosis codes resulted in low sensitivity. Furthermore, code combinations were better at revealing CO-MRSA infections than HO-MRSA infections. These limitations could compromise the validity of ICD-9-CM codes for interfacility comparisons and for reporting of healthcare-associated MRSA infections.

Patient notification for bloodborne pathogen testing due to unsafe injection practices in the US health care settings, 2001-2011.

Background:Syringe reuse and other unsafe injection practices can expose patients to bloodborne pathogens (eg, hepatitis B and C viruses and human immunodeficiency virus). Evidence of such infection control lapses has resulted in patient notifications, but the scope and magnitude of these events have not been well characterized. Objectives:To summarize patient notification events resulting from unsafe injection practices in the US health care settings. Methods:We examined records of events that involved communications to groups of patients, conducted during 2001–2011, advising bloodborne pathogen testing stemming from potential exposures to unsafe injection practices. Results:We identified 35 patient notification events related to unsafe injection practices in at least 17 states, resulting in an estimated total of 130,198 patients notified. Among the identified notification events, 83% involved outpatient settings and 74% occurred since 2007, including the 4 largest events (>5000 patients per event). The primary breach identified (≥16 events; 44%) was syringe reuse to access shared medications (eg, single-dose or multidose vials). Twenty-two (63%) notifications stemmed from the identification of viral hepatitis transmission, whereas 13 (37%) were prompted by the discovery of unsafe injection practices, absent evidence of bloodborne pathogen transmission. Conclusions:Unsafe injection practices represent a form of medical error that have manifested as large-scale adverse events, affecting thousands of patients in a wide variety of health care settings. Our findings suggest that increased oversight and attention to basic infection control are needed to maintain patient safety, along with research to identify best practices for triggering and managing patient notifications.