Direct Healthcare Professional Communications (DHPCs) (commonly called “Dear Doctor-letters” (DDL) is defined as information aims to ensure safe and effective use of medicinal products which is delivered directly to individual Healthcare Professionals by a MAH. Such DHPCs should not include any material or statement which might constitute advertising, or which is considered to be promotional or commercial by EPVC/CAPA.
A DHPC should not be used to provide safety information which does not require urgent communication or is otherwise important to be communicated to Healthcare Professionals at individual level, such as changes to the SPC which do not impact on the conditions of appropriate use of the medicinal product.
Dissemination of a DHPC is usually required in the following situations:
► Suspension, withdrawal or revocation of a marketing authorization with recall of the medicinal product from the market for safety reasons
► Important changes to the Summary of Product Characteristics (SPC), for instance those introduced by means of an urgent safety restriction (e.g. introduction of new contraindications, warnings, reduction in the recommended dose, restriction of the indications, restriction in the availability of the medicinal product)
► In other situations relevant to the safe and effective use of the medicinal product at the request of EPVC
► New data, in particular from a study or spontaneous reports that identify a previously unknown risk or a change in the frequency or severity of a known risk
► New data on risk factors and/or on how adverse reactions may be prevented
► Substantiated knowledge that the medicinal product is not as effective as previously considered
► Evidence that the risks of a particular product are greater than those of alternatives with similar efficacy
► Availability of new recommendations for treating adverse reactions
► A need for communication of other important information, in particular where the issue has been/is the subject of significant media coverage
► In cases where a regulatory agency outside Egypt independently requests dissemination of a DHPC in their territory for a product also authorized in Egypt, the MAH should notify EPVC
► Ongoing assessment of a possible significant risk, but insufficient data at a particular point in time to take any regulatory action (in this case, the DHCP should encourage close monitoring of the safety concern in clinical practice and encourage reporting, or provide information about means to minimize the potential risk)