6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC

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6. Use of DHPCs


An article from 2014 explores the DHPC system in Europe and explores consistency in safety communications across multiple European regulatory agencies [4]. Of the 185 novel medicines authorised (via CP) between January 1st, 2001 and December 31st 2010, 53 (26%) were the subject of at least one DHPC safety communication. A total of 95 DHPCs were issued by the EMA between January 1st, 2001 and April 30th, 2013, including five withdrawals. The authors come to the conclusion that among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined.