Adverse events: additional types

Additional examples of variability in data collection (which, in turn, affects data interpretation) include questionnaires and physical exam forms. Questionnaires often utilize open-ended questions that allow great variability in the type and extent of adverse event information gathered. Physical exam forms—even when designed in a checklist format—may elicit variable collection of adverse event data what is a serious event to one clinician may not be serious to another. 

Drug interactions In a randomized, double-blind study, Zenapax or placebo was added to an immunosuppressive regimen of cyclosporine, mycophenolate mofetil, and steroids to assess tolerability, pharmacokinetics, and drug interactions. The addition of Zenapax did not result in an increased incidence of adverse events or a change in the types of adverse events reported. The following medications have been administered in clinical trials with Zenapax with no incremental increase in adverse reactions cyclosporine, mycophenolate mofetil, ganciclovir, acyclovir, azathioprine, and corticosteroids. 

In 19 patients with type 1 diabetes using regular insulin and 21 using insulin lispro, who injected pramlintide 60 micrograms or placebo before a standardized breakfast in addition to their normal insulin treatment, there was a marked reduction in the postprandial blood glucose excursion mild hypoglycemia (25%) and mild nausea (18%) were the most frequent adverse events (5). 

In subgroup analysis, it may become necessary to examine multiple, often numerous, subgroups based on baseline characteristics. This is in addition to a potentially large number of types of adverse events (e.g., MedDRA Preferred Term [PT] level. Standardized MedDRA Queries) that need to be evaluated for safety assessment. 

In this section, results obtained in a case study (Itoh and Andersen 2008, 2010) will be reviewed to illustrate the contribution of safety culture to safety outcome. In a case study, a questioimaire-based survey concerning staff reactions after the adverse event introduced in the last section, was conducted in addition to the safety culture survey. At the same time, incident reports for three years (2004-06) submitted by nurses were obtained from one of the hospitals (Hospital M) that participated in the safety culture survey. Hospital M was a private, acute-type general hospital, located in Tokyo. This hospital covered almost all clinical specialties and, at the time of the survey in 2006, it had about 500 inpatient beds, 160 full-time doctors and 360 full-time nurses. Nurses belonged to any one of 18 clinical work units 14 inpatient wards, an outpatient clinic, operating room, kidney centre, and medical examination unit. 

The standards issue becomes most problematic with patients who have multiple problems. It may be sensible to delay the treatment of pneumonia, for instance, while more urgent investigations and treatments are instituted. An additional problem is that of combining multiple treatments with the risk of adverse drug events and actually producing harm through the application of standard procedures. Wachter (2006) has argued that quality measurement is bewildered by the patient with multiple conditions, which is, of course, most people admitted to hospital and many older people outside hospital. He considers a hypothetical 79-year-old woman with five common diseases hypertension, osteoporosis, osteoarthritis, type 2 diabetes mellitus and chronic obstructive pulmonary disease ... 

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