Safety and efficiency of a new generic package labelling: a before and after study in a simulated setting.

BACKGROUND: Medication errors are frequent and may cause harm to patients and increase healthcare expenses. AIM: To explore whether a new labelling influences time and errors when preparing medications in accordance with medication charts in an experimental setting. METHOD: We carried out an uncontrolled before and after study with 3 months inbetween experiments. Phase I used original labelling and phase II used new generic labelling. We set up an experimental medicine room, simulating a real-life setting. Twenty-five nurses and ten pharmacy technicians participated in the study. We asked them to prepare medications in accordance with medication charts, place packages on a desk and document the package prepared. We timed the operation. Participants were asked to prepare medications in accordance with as many charts as possible within 30 min. RESULTS: Nurses prepared significantly more medication charts with the generic labelling compared with the original 3.3 versus 2.6 (p=0.009). Mean time per medication chart was significantly lower with the generic labelling 6.9 min/chart versus 8.5 min/chart (p<0.001). Pharmacy technicians were significantly faster than the nurses in both phase I (6.8 min/chart vs 9.5 min/chart; p<0.001) and phase II (6.1 min/chart vs 7.2 min/chart; p=0.013). The number of errors was low and not significantly different between the two labellings, with errors affecting 9.1% of charts in phase I versus 6.5% in phase II (p=0.5). CONCLUSIONS: A new labelling of medication packages with prominent placement of the active substance(s) and strength(s) in the front of the medication package may reduce time for nurses when preparing medications, without increasing medication errors.

Package Design Affects Accuracy Recognition for Medications.

OBJECTIVE: Our aim was to test if highlighting and placement of substance name on medication package have the potential to reduce patient errors. BACKGROUND: An unintentional overdose of medication is a large health issue that might be linked to medication package design. In two experiments, placement, background color, and the active ingredient of generic medication packages were manipulated according to best human factors guidelines to reduce causes of labeling-related patient errors. METHOD: In two experiments, we compared the original packaging with packages where we varied placement of the name, dose, and background of the active ingredient. Age-relevant differences and the effect of color on medication recognition error were tested. In Experiment 1, 59 volunteers (30 elderly and 29 young students), participated. In Experiment 2, 25 volunteers participated. RESULTS: The most common error was the inability to identify that two different packages contained the same active ingredient (young, 41%, and elderly, 68%). This kind of error decreased with the redesigned packages (young, 8%, and elderly, 16%). Confusion errors related to color design were reduced by two thirds in the redesigned packages compared with original generic medications. CONCLUSION: Prominent placement of substance name and dose with a band of high-contrast color support recognition of the active substance in medications. APPLICATION: A simple modification including highlighting and placing the name of the active ingredient in the upper right-hand corner of the package helps users realize that two different packages can contain the same active substance, thus reducing the risk of inadvertent medication overdose.

Risk of fetal death after pandemic influenza virus infection or vaccination.

BACKGROUND: During the 2009 influenza A (H1N1) pandemic, pregnant women were at risk for severe influenza illness. This concern was complicated by questions about vaccine safety in pregnant women that were raised by anecdotal reports of fetal deaths after vaccination. METHODS: We explored the safety of influenza vaccination of pregnant women by linking Norwegian national registries and medical consultation data to determine influenza diagnosis, vaccination status, birth outcomes, and background information for pregnant women before, during, and after the pandemic. We used Cox regression models to estimate hazard ratios for fetal death, with the gestational day as the time metric and vaccination and pandemic exposure as time-dependent exposure variables. RESULTS: There were 117,347 eligible pregnancies in Norway from 2009 through 2010. Fetal mortality was 4.9 deaths per 1000 births. During the pandemic, 54% of pregnant women in their second or third trimester were vaccinated. Vaccination during pregnancy substantially reduced the risk of an influenza diagnosis (adjusted hazard ratio, 0.30; 95% confidence interval [CI], 0.25 to 0.34). Among pregnant women with a clinical diagnosis of influenza, the risk of fetal death was increased (adjusted hazard ratio, 1.91; 95% CI, 1.07 to 3.41). The risk of fetal death was reduced with vaccination during pregnancy, although this reduction was not significant (adjusted hazard ratio, 0.88; 95% CI, 0.66 to 1.17). CONCLUSIONS: Pandemic influenza virus infection in pregnancy was associated with an increased risk of fetal death. Vaccination during pregnancy reduced the risk of an influenza diagnosis. Vaccination itself was not associated with increased fetal mortality and may have reduced the risk of influenza-related fetal death during the pandemic. (Funded by the Norwegian Institute of Public Health.).