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Posted 22 January 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has released a final guidance that aims to clarify the agency's requirements for information contained within "Dear Healthcare Provider" (DHCP) letters.
The letters-so-named because they often begin with that exact salutation-are usually bulk mailings sent out by a manufacturer when it has been made aware of a serious problem with a drug or biologic, or when there is a need to provide updated information to the healthcare provider about the drug or biologic's use.
Despite the name, some DHCP letters are sent via email, and FDA notes that many are available on the Internet on the manufacturer's website.
But as FDA notes, three factors have been problematic for manufacturers:
"FDA regulations describe the process for mailing important new information about drug products (21 CFR 200.5), but do not provide instructions on the format and content of the actual letter," FDA explained. "Nor do the regulations provide information on electronic or other means of communication."
The result, FDA said, has been a wide gap in the quality of the letters with respect to how well they communicate their intended information. Regulators said they believed guidance on the format and content of the letters would "help improve the effectiveness of DHCP letters in communicating drug information," thereby benefiting patient safety.
To bridge the gap between regulations and best practices, FDA has released a final guidance, Dear Health Care Provider Letters: Improving Communication of Important Safety Information.
The guidance recommends that manufacturers work closely with the appropriate FDA review divisions to determine the need for a DHCP, the presentation of information within the DHCP, the target audience for the DHCP and the timeframe for distribution of the DHCP. For example, a manufacturer of an innovative pharmaceutical product would work with the Office of New Drugs (OND).
"In addition to providing a broader range of input into the content of the letter, such consultation could help ensure FDA's concurrence that the content of the letter is not in some way false or misleading," regulators wrote in the guidance.
When would a DHCP need to be sent? FDA's guidance explains that, "In most cases, the information relates to an important safety concern that could affect the decision to use a drug or require some change in behavior by health care providers, patients, or caregivers to reduce the potential for harm from a drug." Other DHCPs may be sent as part of a Risk Evaluation and Mitigation Strategies (REMS) plan, or to notify a healthcare provider about a pending drug shortage or to correct misleading advertising.
Three types of letters are available to manufacturers, depending on the type of information that needs to be conveyed.
Important Drug Warning Letters are those required under 21 CFR 200.5(c)(1), and are those concerning "a significant hazard to health" requiring a change in the way in which a drug is used. FDA notes that information in these letters would typically be added to the drug's WARNING, CONTRAINDICATIONS, or WARNINGS AND PRECAUTIONS portions of its labeling.
Important Prescribing Information Letters are those under 21 CFR 200.5(c)(2), and are used to communicate important changes that are less serious in scope than those communicated in an Important Drug Warning Letter. "An Important Prescribing Information letter ordinarily is used to convey important changes to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information," FDA wrote. A DHCP letter should not be used to announce new indications, "even an important one," FDA added.
Finally, Important Correction of Drug Information Letters are those required under 21 CFR 200.5(c)(3) to correct false or misleading advertising or promotional information
The guidance goes on to explain the various content recommendations for DHCP letters.
FDA said it recommended a six-part outline for writing DHCP letters:
Letters should be clear, concise and no more than two pages while containing "sufficient detail to meaningfully inform the target audience," FDA said. It should also avoid discussion of "noncritical information," it added. Contact information for the manufacturer should also be contained within the DHCP letter
Other recommendations include:
The same recommendations also apply to DHCP letters distributed electronically, FDA said.
Other recommendations made by FDA include:
Specific examples of an approved DHCP letter are included within the guidance.
Dear Health Care Provider Letters: Improving Communication of Important Safety Information
Focus: Communicating Important Drug Safety Messages: the Dear Health Care Provider Letter
Tags: Dear Healthcare Provider, DHCP
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