(13) Effectiveness of Risk Minimization Plan for Concentrated Insulin Lispro in France, Germany and Sweden

Publication Number: 344

Background: Concentrated insulin lispro (U-200) is a prefilled multi-dose pen injector. Direct healthcare professional communication (DHPC) beyond routine risk minimization measures have been implemented for the product to minimize the potential risk of hypoglycemia and/or hyperglycemia associated with potential insulin transfer from the pen cartridge to an alternative administration device.

Objectives: To evaluate the impact of DHPC on healthcare professional (HCP) understanding regarding the risk due to medication errors associated with administration of U-200 in Europe.

Methods: Within 18 months following U-200 launch, cross-sectional, internet and telephone surveys were administered to a random sample of HCPs who were involved in the treatment of patients with diabetes and aware of the study product. The surveys were conducted in France (FR), Germany (GE), and Sweden (SW). Countries were selected based on product launch and market uptake. The survey assessed HCP awareness of the following key safety messages communicated in the DHPC: importance of specifying insulin lispro strength on prescriptions (Message I); dose adjustment is not necessary when switching patients between different insulin lispro strengths (Message II); and U-200 should not be transferred from the pen to an alternative administration device (Message III).

Results: A total of 5,887 HCPs received invitations for participation. Of those, 180 responded (149 met inclusion criteria). A final sample of 146 HCPs completed the survey (FR, n=26; GE, n=48; and SW, n=72). About 93% were physicians and 6% were registered nurses. HCP specialty was general internal medicine (40%), family medicine (35%), endocrinology/diabetology (15%), and other (10%). The majority (57%) worked in general practice, 36% in hospitals, and 8% in other settings. About 82% prescribed U-200 in the past year. HCP responses to key safety messages were: Message I, 91.1% (95%CI=85.3%-95.2%); Message II, 59.6% (95%CI=51.2%-67.6%); and Message III, 27.4% (95%CI=20.3%-35.4%). Knowledge rates in each country for respective messages were: Message I (FR, 100%; GE, 94%; and SW, 86%); Message II (FR, 54%; GE, 60%; and SW, 61%); and Message III (FR, 19%; GE, 48%; and SW, 17%).

Conclusions: Despite their low awareness of potential medication errors associated with U-200, the majority of HCPs were knowledgeable of appropriate prescribing. In general, the DHPC effectively communicated the key safety messages to the majority of HCPs in these European countries.