OBJECTIVES: To evaluate the impact of additional risk minimization measures (RMM) on healthcare professional (HCP) and patient understanding and behavior regarding the risk of hypoglycemia and/or hyperglycemia due to medication errors associated with administration of insulin lispro 200 units/ml (U-200) in US and EU.

METHODS: The additional RMM for U-200 included a direct HCP letter, and a patient communication. Web and telephone cross-sectional surveys were administered to HCPs involved in the treatment and management of patients with diabetes who are aware of U-200, and adult patients with diabetes who have been prescribed U-200 in France, Germany, Sweden, and US.

RESULTS: A total of 424 HCPs (278 in US, 146 in EU) and 307 patients (300 in US, 7 in EU) completed the surveys. Among HCPs, 46% (US=56%, 95%CI=50%-62%; EU=27%, 95%CI=20%-35%) were aware U-200 is not approved for transfer to different insulin delivery device; however, HCPs knowledge of appropriate U-200 prescribing was high: 95% indicating correct strength on prescription (US=98%, 95%CI=95%-99%; EU=91%, 95%CI=85%-95%); and 73% answered that dose conversion is not necessary when changing patients between insulin lispro strengths (US=80%, 95%CI=75%-84%; EU=60%, 95%CI=51%-68%). The vast majority of patients in US (97%, 95%CI=94%-99%) were aware that U-200 should only be injected using the prefilled pen in which it is supplied. In US, 78% (95%CI=73%-83%) of patients and 92% (95%CI=88%-95%) of HCPs indicated it is always necessary to carry a backup pen.

CONCLUSIONS: This study showed in general that the additional RMM effectively communicated the key safety messages to the majority of HCPs. Patient recruitment in EU was challenging due to the stringent data protection regulations which makes the collection of meaningful data for patients in EU very difficult.