Flanders, MD; Christopher S.
Disclaimer Outbreak of acute renal failure in Panama in It is commonly used in industry and can be found in commercial products such as resins, antifreeze, inks and glues. In addition, DEG has also been found as a contaminant of raw materials used in the production of pharmaceuticals. Most recently, paediatric medicinal syrups contaminated with DEG have led to the deaths of 33 of 36 children known to be affected in India in 10 and of 85 of children known to be affected in Haiti in — Patients typically presented with abdominal symptoms, such as nausea, vomiting, epigastric discomfort and diarrhoea, followed several days later by oliguria or anuria, anorexia and fatigue.
Many patients Case study general hospital a spectrum of neurological effects, including cranial nerve palsies, acute flaccid extremity weakness and encephalopathy. Three leading hypotheses emerged. First, an infectious etiology was suspected but subsequently ruled out because there had been no known person-to-person transmission and because various bacterial cultures and viral tests for infectious causes of acute flaccid paralysis, such as enteroviruses, arboviruses, herpes viruses and Campylobacter jejuni, were negative.
Second, an antihypertensive medication was suspected. Astute clinicians recognized that many of the affected patients were taking angiotensin-converting enzyme ACE inhibitors, such as lisinopril, which resulted in a concern that the formulary change was related to the outbreak.
Finally, when two affected patients presented to a specific CSS hospital with bottles of a Panamanian-produced prescription liquid cough syrup, possible contamination of this medication was suspected.
Although features of the clinical presentation were consistent with DEG toxicity, the etiology was not confirmed and the source remained unknown.
In Octobera case-control investigation was conducted to confirm the etiology and to identify the source of the outbreak. For every case patient we attempted to enrol five matched hospitalized patients as controls. Data collection A study questionnaire was designed to collect demographic and health information and to assess potential exposures.
When a hospitalized case or control patient was unable to give consent and respond, the closest relative gave consent and completed the questionnaire. Questionnaires were administered in Spanish by health-care providers on the study team.
Blood and urine samples were collected and analysed for a variety of potential nephrotoxic and neurotoxic substances, including metals, paraquat, organophosphate metabolites that reflected potential exposure to organophosphorous parent pesticides and carbamate metabolites that reflected potential exposure to carbamate parent pesticides.
The United States Food and Drug Administration confirmed the presence of DEG in the cough syrup and determined that the lisinopril samples were within expected pharmaceutical parameters. On the basis of the positive laboratory results, the main exposure of interest was the consumption of prescription cough syrup in a specified time period before hospital admission.
This information was captured by the study questionnaire in two ways. The 3-month interval was selected to cover the period when the first suspected case was reported Fig.
Control patients were also asked to list prescription medications but, to cover the same exposure window, the timeframe used was dependent on the admission date of the matched case patient. If they had consumed liquid syrup, they were asked about the type of syrup taken and whether it was a prescription, non-prescription or traditional e.
Exposed case and control patients were those who listed prescription liquid cough syrup in the open-ended question or who responded affirmatively to the direct question by saying they had consumed prescription liquid syrup for a cough.
Eleven liquid medications in their original containers were received by the CDC laboratory for analysis, including five labelled as an antihistamine and expectorant, two as expectorants, three as antacids and one as a vitamin preparation. As part of an environmental assessment of the CSS production laboratory, samples of medications and raw ingredients were also obtained and shipped to the CDC for analysis.
The pharmaceutical products were diluted to 1: Three precursor-to-product ion transitions were monitored for both native DEG and the isotopically labelled internal standard.
Quantification was achieved using isotope dilution calibration. Detailed descriptions of these methods can be found in a separate publication. Samples were analysed using gas chromatography—tandem mass spectrometry, in which three precursor-to-product ion transitions were monitored for DEG and only one for its labelled analogue.
Using these methods, the minimum detection level for urinary DEG was 10 parts per billion. A more detailed description of this procedure and the validation parameters will be reported elsewhere. Statistical analysis Questionnaire data were analysed using SAS, version 9.
For categorical covariates, the distributions of descriptive statistics were compared between cases and controls; for continuous covariates, the means were compared. Crude and adjusted odds ratios were estimated using two sets of exact conditional logistic regression models, which represented both the open-ended and direct questions about the main exposure.
Results Forty-two case patients and control patients were enrolled in the study. The majority of cases and controls were male Most case and control patients resided in the Metropolitana region Case patients, in comparison with control patients, more often self-reported general The mean serum creatinine level was much higher in case patients than in control patients Case patients, compared with control patients, more often self-reported diabetes Hypertension was the most common self-reported pre-existing condition among case and control patients.
Case patients were significantly more likely than controls to have taken prescribed ACE inhibitors OR:North York General Hospital in Toronto is a leading community academic hospital in Canada offering acute care, ambulatory and long-term services. CASE STUDY.
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