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Dear Healthcare Professional (DHCP) letters – Guidance for industry

Background
When may a DHCP letter be needed?
Process and considerations for DHCP letters
Further information

Background

The Pharmacovigilance Guideline (PDF, 521 KB, 36 pages) contains guidance on when a Dear Healthcare Professional (DHCP) letter may be needed. Information on this page provides more detail on DHCP letters, including the process that sponsors should follow.

When may a DHCP letter be needed?

A DHCP letter may be needed for any new information that significantly affects the benefit-risk balance of a medicine. This new information should be in the data sheet, so sponsors should submit a changed medicine notification (CMN) to Medsafe for consent before issuing the DHCP letter.

Sponsors may need to provide DHCP letters to healthcare professionals and relevant organisations (eg, Health New Zealand | Te Whatu Ora, pharmaceutical wholesalers, pharmacies, professional societies) to advise them of the overall impact on safety and/or use of the medicine.

Common reasons include:

• restrictions to indications due to safety reasons
• changes in the recommended dose due to safety reasons
• new contraindications
• important new warnings or precautions
• changes to the formulation or appearance of the medicine.

Sponsors may decide to disseminate a DHCP letter themselves, or following a request from Medsafe.

Process and considerations for DHCP letters

Medsafe recommends that sponsors send drafts of DHCP letters relating to pharmacovigilance issues to Medsafe for review. The final wording should be agreed prior to distribution to ensure appropriate communication and management of the safety issue.

Table 1 provides guidance on submitting DHCP letters to Medsafe.

Table 1: Guidance on submitting Dear Healthcare Professional (DHCP) letters to Medsafe

Information to provide	Considerations
1. Draft letter	The draft letter should include a succinct description of the safety issue, and clear advice on actions healthcare professionals should take. Information and advice should be aligned with the updated data sheet. Include how adverse reactions can be reported to the New Zealand Pharmacovigilance Database.
2. Communication plan	Who are the intended recipients and when is the approximate dissemination date.
3. Due date for Medsafe review	The date you need Medsafe's comments back, which we will endeavour to meet.
4. Additional information to submit for Medsafe review (if necessary)	If the data sheet has not yet been updated, please submit a changed medicine notification (CMN) to update the data sheet and email Medsafe to request an urgent review. If a CMN cannot be submitted prior to distribution because the issue is so urgent that healthcare professionals need to have the information immediately, please provide: a copy of the signal evaluation report the updated wording in the core data sheet (CDS) that aligns with advice provided in the DHCP letter.
5. Whether the letter should be published on the Medsafe website	Medsafe will publish DHCP letters on the Medsafe website with the sponsor s agreement.
6. Email Medsafe	Email the above information to medsafeadrquery@health.govt.nz
7. Finalised letter (if necessary)	If the DHCP letter is being published on the Medsafe website, email the final PDF to medsafeadrquery@health.govt.nz

Further information

Guideline on the regulation of therapeutic products in New Zealand: Pharmacovigilance (PDF, 521 KB, 36 pages)