TY - JOUR
T1 - When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines
T2 - A retrospective analysis of determinants of impact of safety warnings
AU - Reber, K.C.
AU - Piening, S.
AU - Wieringa, J.E.
AU - Straus, S.M.J.M.
AU - Raine, J.M.
AU - de Graeff, Pauline
AU - Haaijer-Ruskamp, F.M.
AU - Mol, Peter G. M.
PY - 2013/4
Y1 - 2013/4
N2 - 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 R-2 = 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.
AB - 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 R-2 = 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.
KW - ADVERSE DRUG-REACTIONS
KW - REGULATORY ACTION
KW - EUROPEAN-UNION
KW - SAFETY
KW - WARNINGS
KW - NETHERLANDS
KW - SPECIALISTS
U2 - 10.1038/clpt.2012.262
DO - 10.1038/clpt.2012.262
M3 - Article
SN - 0009-9236
VL - 93
SP - 360
EP - 365
JO - Clinical Pharmacology & Therapeutics
JF - Clinical Pharmacology & Therapeutics
IS - 4
ER -