Direct Health Care Professional Communication (“Dear Doctor Letters”, DHPC)

Direct Healthcare Professional Communication (DHPC) is defined as a communication intervention by which important safety information is delivered directly to individual healthcare professionals by a marketing authorisation holder or by a competent authority, to inform them of the need to take certain actions or adapt their practices in relation to a medicinal product. DHPCs are not replies to enquiries from healthcare professionals, nor are they meant as educational material for routinerisk minimisation activities.

Situations where a DHPC should be disseminated:  

• suspension, withdrawal or revocation of a marketing authorisation with recall of the medicine from the market for safety reasons.
• an important change to the use of a medicine due to the restriction of an indication, a new contraindication, or a change in the recommended dose due to safetu reasons; 
• a restriction in availability or discontinuation of a medicine with potencial detrimental effects on patient care.

Other situations:

• new major warnings or precautions for use in the product information,
• new data identifying a previously unknown risk or a change in the frequency or severity of a known risk,
• substantiated knowledge that the product is not as effective as previously considered,
• new recommendations for preventing or treating adverse reactions or to avoid misuse or medication error with the medicinal product, 
• ongoing assessment of an important potential risk, for which data available at a particular point in time are insufficient to take regulatory action.

Revipharm can help your company with the necessary actions regarding the creation and processing of Direct Health Care Professional Communication (“Dear Doctor Letters”, DHPC) and notification of safety issues to the Competent Authorities: 

- the proposed Communication Plan,

- the proposed communication text of the DHPC,

- the proposed text of any related communication documents.

For more information: info@revipharm.es