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DHCP/DHPC

A marketing authorisation holder may send a direct healthcare professional communication (DHPC/DHCP) to healthcare professionals to inform them of important new safety information about the medicine and any actions they should take.

DHCP/DHPCs serve to inform healthcare professionals of, for example:

  • a suspension, withdrawal or revocation of a marketing authorisation for safety reasons;

  • an important change, for example, a restriction of indication, a new contraindication or a change in the recommended dose;

  • a medicine supply shortage;

  • quality problems with medicine.

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FDA Guidance - Dear Health Care Provider Letters: Improving Communication of Important Safety Information

This guidance provides recommendations to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence ― often in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic or from FDA ― intended to alert physicians and other health care providers about important new or updated information regarding a human drug or biologic (hereafter “drug” and “product” refer to both biologic and small molecule drug products). DHCP letters may also be distributed by email and are often made available on the Internet (e.g., on company Web sites or through patient advocacy groups).

This guidance provides recommendations on

(1) when to issue a DHCP letter,

(2) the types of information to include in a DHCP letter,

(3) how to organize that information so that it is communicated effectively to health care providers, and (4) formatting techniques to make the information more accessible.

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Content:

• important new information on any authorised medicinal product which has an impact on the medicine’s risk-benefit balance under any conditions of use;
• the reason for initiating safety communication clearly explained to the target audience;
• any recommendations to healthcare professionals and patients on how to deal with a safety concern;

• when applicable, a statement on the agreement between the marketing authorisation holder and the competent authority on the safety information provided;
• information on any proposed change to the reference safety information (e.g. the summary of product characteristics (SmPC) or package leaflet (PL));
• any additional information about the use of the medicine or other data that may be relevant for tailoring the message to the targeted audience;
• a list of literature references, when relevant or a reference to where more detailed information can be found, and any other background information considered relevant;
• where relevant, a reminder of the need to report suspected adverse reactions in accordance with national spontaneous reporting systems.

§ 200.5 Mailing of important information about drugs.

Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required to mail important information about drugs to physicians and others responsible for patient care. In the public interest, such mail should be distinctive in appearance so that it will be promptly recognized and read. The Food and Drug Administration will make such mailings in accordance with the specifications set forth in this section. Manufacturers and distributors of drugs are asked to make such mailings as prescribed by this section and not to use the distinctive envelopes for ordinary mail.

(a) Use first class mail and No. 10 white envelopes.

(b) The name and address of the agency or the drug manufacturer or distributor is to appear in the upper left corner of the envelope.

(c) The following statements are to appear in the far left third of the envelope front, in the type and size indicated, centered in a rectangular space approximately 3 inches wide and 214 inches high with an approximately 38 inch-wide border in the color indicated:

(1) When the information concerns a significant hazard to health, the statement:

IMPORTANT DRUG WARNING

The statement shall be in three lines, all capitals, and centered. “Important” shall be in 36 point Gothic Bold type. “Drug” and “Warning” shall be in 36 point Gothic Condensed type. The rectangle's border and the statement therein shall be red.

(2) When the information concerns important changes in drug package labeling, the statement:

IMPORTANT PRESCRIBING INFORMATION

The statement shall be in three lines, all capitals, and centered. “Important” shall be in 36 point Gothic Bold type. “Prescribing” and “Information” shall be in 36 point Gothic Condensed type. The rectangle's border and the statement therein shall be blue.

(3) When the information concerns a correction of prescription drug advertising or labeling, the statement:

IMPORTANT CORRECTION OF DRUG INFORMATION

The statement shall be in four lines, all capitals, and centered. “Important” shall be in 36 point Gothic Bold type. “Correction,” “Of Drug,” and “Information” shall be in 36 point Gothic Condensed type. The rectangle's border and the statement therein shall be brown.

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