Patient safety challenges in treprostinil therapy.

Treprostinil (Remodulin) is a new therapy for pulmonary hypertension. A multidisciplinary plan for safely managing the drug is described, and includes a flow chart to guide practice through high-risk issues.

Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit.

OBJECTIVE: To determine the incidence, type, and stage of occurrence of medication errors and potential and actual adverse drug events (ADEs) in a pediatric intensive care unit (ICU) using trained observers. The preventability and severity of ADEs and the system failures leading to medication error occurrence were also investigated. DESIGN: Prospective, direct observation study. SETTING: A 16-bed pediatric medical/surgical ICU at a tertiary care academic medical center. PATIENTS: One enrolled nurse caring for at least one pediatric ICU patient age <18 yrs was randomly chosen during each observation period. INTERVENTIONS: Observers would intervene only in the event that the medication error would cause substantial patient harm or discomfort. MEASUREMENTS AND MAIN RESULTS: Medication errors and potential and actual ADEs were identified throughout the entire medication use process. The 26 12-hr observation periods included 357 reviewed written orders and 263 observed doses. The study observers identified 58 incidents, which were subsequently classified by the evaluators according to clinical importance, severity, and preventability. Fifty-two of these incidents were considered medication errors; six incidents were determined to be nonpreventable ADEs. Of the 52 medication errors, 42 (81%) were considered clinically important. Potential ADEs comprised 35 (83%) of these important medication errors; the other seven (17%) were classified as actual, preventable ADEs. Overall, the actual and potential ADE rate occurred at 3.6 events and 9.8 events per 100 orders, respectively. CONCLUSIONS: Our medication error rate was similar to that of previous pediatric ICU studies that used the direct observation method for reporting but higher than the rates in previous studies using other detection techniques such as voluntary incident reporting. Periodic direct observation and other ongoing data collection methods such as voluntary incident reporting have the potential to be complementary approaches to medication error and ADE detection.

Medication errors and adverse drug events in an intensive care unit: direct observation approach for detection.

OBJECTIVE: To determine the incidence and preventability of medication errors and potential/actual adverse drug events. To evaluate system failures leading to error occurrence. DESIGN: Prospective, direct observation study. SETTING: Tertiary care academic medical center. PATIENTS: Patients in a medical/surgical intensive care unit. INTERVENTIONS: Observers would intervene only in the event that the medication error would cause substantial patient harm or discomfort. MEASUREMENTS AND MAIN RESULTS: The observers identified 185 incidents during a pilot period and four phases totaling 16.5 days (33 12-hr shifts). Two independent evaluators concluded that 13 of 35 (37%) actual adverse drug events were nonpreventable (i.e., not medication errors). An additional 40 of the remaining 172 medication errors were judged not to be clinically important. Of the 132 medication errors classified as clinically important, 110 (83%) led to potential adverse drug events and 22 (17%) led to actual, preventable adverse drug events. There was one error (i.e., resulting in a potential or actual, preventable adverse drug event) for every five doses of medication administered. The potential adverse drug events mostly occurred in the administration and dispensing stages of the medication use process (34% in each); all of the actual, preventable adverse drug events occurred in the prescribing (77%) and administration (23%) stages. Errors of omission accounted for the majority of potential and actual, preventable adverse drug events (23%), followed by errors due to wrong dose (20%), wrong drug (16%), wrong administration technique (15%), and drug-drug interaction (10%). CONCLUSIONS: Using a direct observation approach, we found a higher incidence of potential and actual, preventable adverse drug events and an increased ratio of potential to actual, preventable adverse drug events compared with studies that used chart reviews and solicited incident reporting. All of the potential adverse drug events and approximately two thirds of the actual adverse drug events were judged to be preventable. There was one preventable error for every five doses of medication administered; most errors were due to dose omission, wrong dose, wrong drug, wrong technique, or interactions.