Direct healthcare professional communication (DHPC) is an important tool for communicating safety information about medicinal products for human use to healthcare professionals. This type of communication informs about a safety issue and provides recommendations on steps to be taken to minimize the safety issue.
DHPC is usually distributed by the marketing authorization holder for the medicine to which the DHPC refers, to certain categories of professionals to whom the respective communication is addressed (physicians, pharmacists, nurses etc.).
In Romania, the DHPC distribution is performed following approval by the National Agency for Medicines and Medical Devices in Romania – NAMMDR.
The purpose of this type of communication is to improve the safe and effective use of medicines in order to prevent adverse reactions and protect patients and public health.
The main situations in which the dissemination of a DHPC is required:
• suspension, withdrawal or revocation of a marketing authorization for safety reasons;
• a restriction in availability or discontinuation of a medicine with potential detrimental effects on patient care;
• important changes to the Summary of Product Characteristics (SmPC) or to the Patient Leaflet of a product (for example, restriction of an indication, a new contraindication, a change in the recommended dose due to safety reasons, new major warnings or precautions for use etc.);
• new recommendations for preventing or treating adverse reactions or to avoid misuse or medication errors with the medicinal product.
Safety communication should deliver relevant, clear, accurate and consistent messages. Also, the information provided in the communication should be objectively presented, must not be misleading and must not contain any material or statement which might constitute advertising, within the scope of Law 95/2006 on healthcare reform.
More information on safety communications is available in the EMA Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication.
NAMMDR has developed instructions for Marketing Authorization Holders regarding the submission of direct healthcare professional communications for approval by NAMMDR, available here.
Direct healthcare professional communications approved by NAMMDR are available here.