The consent risks 
with ‘black box’ 


The consent risks 
with ‘black box’ 

Oleksandr Lysenko

So-called black box drugs carry ‘serious or life-threatening risk’ and patients need to understand what is involved in terms of risk during their treatment, says Fay A. Rozovsky, president of The Rozovsky Group.

In contemporary healthcare there is a virtual arsenal of medication at the disposal of care providers. When a health plan’s drug formulary excludes certain medications, care providers are apt to find a suitable substitute to prescribe for their patients.

Through the regulatory process the Food and Drug Administration (FDA) has promulgated rules for what must be included when labelling prescription medication and biological products [see 21 Code of Federal Regulations section 201.56(b)(1)]. However, for a select number of prescription drugs and biological products the FDA has an additional requirement.

For ‘black box’ warning drugs, the word WARNING must appear at the outset along with a concise summary. The information is to appear within a box on the labelling that is both boxed and bolded. Hence the term ‘black box warning’. As noted in the FDA Guide to Drug Safety Terms:

“This type of warning is also commonly referred to as a ‘black box warning’. It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks” [, November 2012].

For those interested in the regulatory specifics, the relevant Code of Federal Regulation requirements can be found below (see box).

Beyond the regulatory requirements for black box drugs, there are some threshold questions for care providers to consider when deciding whether to prescribe preparations that pose serious or life-threatening risks. These questions include what should be discussed in the consent communication process and how to document such discussions.

Explaining the black box warning to the patient or surrogate

As with any care provider-patient encounter, a consent ‘time out’ should be considered to make certain that the patient or surrogate has the ability to understand the rationale for prescribing black box preparations and treatment options. That the black box drugs carry ‘serious or life-threatening risk’ should be a focal point of the discussion. It is important to explain what is involved in terms of serious or life-threatening risk.

"The discussion is best geared to the patient’s demonstrated health literacy and numeracy, taking into account the need to use assistive devices."

A careful review of patient medical history, current medications and patient preferences may lead to the care provider not recommending the black box warning preparation. Similarly, the inability of the patient to adhere to a strict medication regimen may cause the care provider to decide that the patient is not a candidate for the black box warning biological agent or drug. Thus, in practical terms, the discussion is best geared to the patient’s demonstrated health literacy and numeracy, taking into account the need to use assistive devices such as electronic or electromechanical communications (TTY) and language line services.

How much detail is necessary about serious or life-threatening risks?

Some care providers may decide to rely on the patient or surrogate reading the patient packet inserts or other written document to explain the serious or life-threatening risks associated with a black box warning drug or biological. Concerned about the amount of time that might be required to engage in a discussion, care providers might combine the suggestion to ‘read this information’ with a follow-up of ‘and let me know if you have any questions’.

From a patient safety and risk management perspective it is prudent to set aside sufficient time to explain in understandable terms what are the serious and life-threatening risks. Quoting statistics—1 in 300,000—is just that: providing statistical information. It does not get at the heart of what the patient or surrogate—the reasonable person—would want to know: ‘Why are you recommending this drug or biological for me? What are my options? I want to know what is meant by serious and life-threatening risks.’

Is it acceptable to rely on the pharmacist to supply risk information?

Many pharmacies provide patients with a ‘consultation’ opportunity with the pharmacist. Often, the pharmacy will print out detailed information about prescription drugs and biologics. Such detail may be similar, or in addition, to the patient packet insert and black box warning information.

While such information may be useful, it is not a replacement for a complete consent communication process between the provider and the patient or surrogate. Indeed, when patients have very specific questions, the pharmacist is likely to encourage him or her to contact the care provider who prescribed the drug or biologic.

There are some other considerations about pharmacist-patient discussions regarding black box warning drugs or biologics. First, the fact that a patient asked a series of detailed questions better addressed by the care provider suggests that the consent communication process may be incomplete. Second, the pharmacist may share information or emphasize certain details that the care provider did not, leading to a ‘question mark’ for the patient: did my care provider really explain this all to me?

The prudent approach is not to rely on the pharmacist as a surrogate for the care provider to supply risk information. It is good practice to ask pharmacists to refer the patient back to the care provider when there are unanswered or follow-up questions about the need for and risks associated with black box medications or biologics.

Is it acceptable to utilize a nurse educator or nurse practitioner to complete the black box warning consent communication process?

Care providers often express frustration that they do not have the time that they would like to spend with patients when discussing medication, lifestyle changes, and dietary requirements. In an effort to maximize patient encounter time, the care provider may enlist the assistance of a nurse educator or nurse practitioner to meet one-on-one with the patient and surrogate. The nurse educator or nurse practitioner then takes the time needed to explain how to use the black box drug or biological.

However, since it is the care provider who is prescribing black box warning drugs and biologics, he or she is accountable for the consent communication. When asking a well-qualified nurse educator or nurse practitioner to assist with counseling the patient, it is not a replacement for the care provider fulfilling responsibilities reserved for the person prescribing black box warning medications and biologics.

Should care providers use a patient consent form with black box warning drugs or biologics?

Care providers should confer with legal counsel to determine if there are any required consent documents that must be used when prescribing black box warning drugs or biologics. Some manufacturers may also furnish documents to be distributed to patients that may look like but may not be recognized as a consent document under applicable state law.

In the absence of a required consent form, it is prudent to document the consent communication process with the patient or surrogate regarding a black box warning drug or pharmaceutical. Some care providers may use their own consent forms that are signed by the patient or surrogate. Still other care providers may complete a detailed note in the patient record that captures the elements of the consent communication process. Some may use a consent form and a detailed note in the record.

The documentation should substantiate that the consent conversation was complete and that the patient was presented with understandable information about the indications for and use of the black box drug or biologic. The documentation should also describe the discussion about possible benefits and the details of black box warning risks. Treatment options and attendant benefits and risks would also be noted along with any questions from and answers provided to the patient or surrogate. If assistive devices or interpreters were included in the communication process, this too, would be noted in the documentation.

Should a language other than English be used in the discussion, the document should reflect the language used. Further, if the patient was provided with instructive information—brochures, booklets, or website resources—the titles and versions or web addresses should be included in the consent documentation to reflect what tools were used to facilitate the communication process.


Black box warning drugs and biologics are an important part of the array of preparations available to care providers and their patients. Recognizing that these drugs and biologics include serious and life-threatening risks reinforces the importance of completing consent communications that reinforce informed patient decision-making. 


From 21 Code of Federal Regulations Section 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in 201.56(b)(1).

(a)     Highlights of prescribing information. The following information must appear in all prescription drug labeling:

(4)     Boxed warning. A concise summary of any boxed warning required by paragraph (c)(1) of this section, not to exceed a length of 20 lines. The summary must be preceded by a heading, in upper-case letters, containing the word ‘WARNING’ and other words that are appropriate to identify the subject of the warning. The heading and the summary must be contained within a box and bolded. The following verbatim statement must be placed immediately following the heading of the boxed warning: ‘See full prescribing information for complete boxed warning.’

(c)     Full prescribing information. The full prescribing information must contain the information in the order required under paragraphs (c)(1) through (c)(18) of this section, together with the headings, subheadings, and identifying numbers required under 201.56(d)(1), unless omitted under 201.56(d)(4). If additional subheadings are used within a labeling section, they must be preceded by the identifying number assigned in accordance with 201.56(d)(2).

(c)(1)      Boxed warning. Certain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be presented in a box. The boxed warning ordinarily must be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. The box must contain, in uppercase letters, a heading inside the box that includes the word ‘WARNING’ and conveys the general focus of the information in the box. The box must briefly explain the risk and refer to more detailed information in the ‘Contraindications’ or ‘Warnings and Precautions’ section, accompanied by the identifying number for the section or subsection containing the detailed information.


Fay A. Rozovsky, JD, MPH, is president of The Rozovsky Group, a firm specializing in healthcare enterprise risk management and patient safety. She is the author of Consent to Treatment: A Practical Guide, 5th Edition (2015) published by Wolters Kluwer Law and Business. She can be contacted at:

Fay A Rozovsky, The Rozovsky Group. US