When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines.

Serious safety issues relating to drugs are communicated to health-care professionals via Direct Health-Care Professional Communications (DHPCs). We explored which characteristics determined the impact of DHPCs issued in the Netherlands for ambulatory-care drugs (2001-2008). With multiple linear regression, we examined the impact on the relative change in new drug use post-DHPC of the following: time to DHPC, trend in use, degree of innovation, specialist drug, first/repeated DHPC, DHPC template, and type of safety issue. DHPCs have less impact on use of specialist drugs than nonspecialist drugs (P < 0.05). The DHPCs' impact increased after availability of a template emphasizing the main problem (P < 0.05), and for safety issues with a risk of death and/or disability (both P < 0.05) (adjusted R² = 0.392). Risk communication can be effective, specifically in case of well-structured information, and very serious safety issues. Effectiveness may improve by tailoring DHPCs and adding other communication channels, for example for drugs that are increasingly being used.

Impact of safety-related regulatory action on drug use in ambulatory care in the Netherlands.

The effect of Direct Healthcare Professional Communications (DHPCs) informing health-care providers of serious drug safety issues has been questioned. The aim of this study was to evaluate the impact of DHPCs on drug use.Nationwide dispensing data for the period 2000­2008 for new users of 46 drugs with one or more DHPCs were assessed. Impact on short-term volume of use was evaluated with regression models, and the presence of long-term changes in use was evaluated with interrupted time series analyses incorporating preexisting trends. The short-term prescription level was lower post-DHPC in 28 (48.3%) of 58 cases. Twenty (34.5%) DHPCs resulted in long-term changes in use. A long-term mean reduction in use was observed in 26.7% of cases (95% confidence interval, −15.2 to −38.2%).Long-term changes in use were not significantly related to preexisting trends in use. Although short- and long-term decreases in use were observed after only half and a third of DHPCs, respectively, the decrease was substantial.