Safety information (DHPC) for doctors and other healthcare professionals
Providing timely information to doctors and other health professionals is of paramount importance whenever new information emerges about the safety of a medicine.
A direct healthcare professional communication (DHPC) serves the purpose of supporting safe and effective use of medicines, and it is sent out when new important safety information about a medicine has been obtained.
In case of important new safety information about a medicine, the marketing authorisation holder of the medicine (the pharmaceutical company) may be instructed by the European Medicines Agency (EMA) or the national authorities (the Danish Medicines Agency) to distribute safety information to relevant health professionals by way of a DHPC. The information serves the purpose of supporting safe and effective use of medicines, and it is usually distributed at the end of a regulatory procedure (e.g. a periodic safety update report (PSUR procedure)), safety study (referral) on the assessment of the safety of the medicine. However, it can also be used in connection with critical supply difficulties or product defects.
The information provided in the DHPC and the target audience are decided jointly by the Danish Medicines Agency and the pharmaceutical company. DHPCs must not contain advertising or other commercial content.
The Danish Medicines Agency distributes the information electronically and directly to the affected health professionals, thus ensuring fast communication of targeted information. The distributed safety information can be found here on our website.
The information is also distributed to relevant hospital departments, to private hospitals and to medicinal products committees and medical societies. The information will in future be made available via a link from the relevant medicine’s page at pro.medicin.dk.
To ensure the DHPC notices can be identified easily, the subject field is titled ”Sikkerhedsinformation fra Lægemiddelstyrelsen – [substansnavn/præparat] og [safety concern]” in English this means: ”Safety information from the Danish Medicines Agency – [substance name/medication] and [safety concern]”.