A Direct Healthcare Professional Communication (DHPC) is a single, additional risk minimisation measure used to directly inform healthcare professionals about new, important information about a medicinal product. DHPCs are sent by the marketing authorisation holder of the product, to healthcare providers. The MEB publishes the DHPCs on its website, together with a news message containing advice for healthcare professionals and patients.

The initiative for distributing a DHPC can come from the European or national competent authorities, or from the marketing authorisation holder. The contents of the letter and the communication plan are determined by the marketing authorisation holder and the competent authorities.

Reasons for issuing a DHPC

Possible reasons for issuing a DHPC include:

  • Suspension or withdrawal of the marketing authorisation for a medicinal product for safety reasons
  • New and important information about the usage of a medicinal product, for example new contra-indications, important new warnings, changes in the dosage, etc.
  • New risks of medicinal products
  • Shortages or quality problems of a medicinal product

Decision making around a DHPC

The procedure for drafting and issuing a DHPC depends on the authorisation and/or assessment procedure of the medicinal product.

You can find more information about the procedures and requirements in the Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication. A template for the English version of a DHPC can be found in the Guideline on Good Pharmacovigilance Practices (GVP) Annex II – Templates: Direct Healthcare Professional Communication (DHPC).

National implementation: submitting a DHPC at the MEB

When submitting a DHPC, the marketing authorisation holder must send the following information:

  • In case the decision concerns a centralised procedure: the English version of the approved DHPC
  • A Dutch translation of the approved English version of the DHPC in 'MS Word' format
  • A distribution plan which includes the target groups for whom the DHPC is intended
  • An estimate of the number of prescribers/users of the medicinal product in the Netherlands

In addition, the MEB expects to receive an accompanying letter or e-mail which includes the following information:

  • All product names that the DHPC applies to, and all associated RVG numbers or EU authorisation numbers for products authorised via the centralised procedure
  • Case number (if available)
  • Type of procedure (National/MRP/DCP/Centralised) with - where applicable – the relevant procedure number
  • Contact person's e-mail address
  • A brief description of the subject of your message

The MEB has adopted the advice about the national implementation of a DHPC in the policy document MEB 44: Direct Healthcare Professional Communications (DHPC).

Format of envelope and letter

The letter and envelope in which DHPCs are sent must have a uniform appearance, without any commercial information. There are no logos of the marketing authorisation holder depicted on the letter or envelope. Most DHPCs are sent in a White Hand Envelope (WHE) with the message 'Belangrijke, niet-commerciële risico-informatie over een farmaceutisch product'.

In exceptional cases, when the subject of the DHPC requires extra attention, the decision can be made to send the information in an 'Orange Hand Envelope' (OHE), also containing the message 'Belangrijke, niet-commerciële risico-informatie over een farmaceutisch product'.

There is no definite list of conditions for an Orange Hand Envelope, but an Orange Hand Envelope may be required in the following situations:

  • restriction of indication
  • addition of a new contra-indication
  • change in patient's therapy
  • need for additional visit by patient to doctor or pharmacist
  • recall at pharmacy and patient level

After the decision is made whether to send the DHPC in a WHE or OHE, the marketing authorisation holder is responsible for requesting the envelopes at the Association for Innovative Medicines. This should be done as soon as possible due to the delivery time.