**Guidance**

**Useful Written**

**Consumer Medication Information (CMI)**

***DRAFT GUIDANCE***

**This guidance document is being distributed for comment purposes
only.**

Comments and suggestions regarding this draft document should be
submitted within 60 days of publication in the *Federal Register* of the
notice announcing the availability of the draft guidance. Submit
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number listed in the
notice of availability that publishes in the *Federal Register*.

For questions regarding this draft document contact Ellen Tabak at
301-827-7843.

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Drug Evaluation and Research (CDER)**

**May 2005**

**Procedural**

**Guidance**

**Useful Written**

**Consumer Medication Information (CMI)**

*Additional copies are available from:*

*Office of Training and Communication*

*Division of Drug Information, HFD-240*

*Center for Drug Evaluation and Research*

*Food and Drug Administration*

*5600 Fishers Lane*

*Rockville, MD 20857*

*(Tel) 301-827-4573*

*http://www.fda.gov/cder/guidance/index.htm*

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Drug Evaluation and Research (CDER)**

**May 2005**

**Procedural**

[]{.mark}

**TABLE OF CONTENTS**

# 

#  {#section-1 .TOC-1 .unnumbered}

# I. INTRODUCTION [1](#i.-introduction)II. Background [1](#background) {#i.-introduction-1ii.-background-1 .TOC-1}

# III. Applying the action plan criteria for cmi [4](#iii.-applying-the-action-plan-criteria-for-cmi) {#iii.-applying-the-action-plan-criteria-for-cmi-4 .TOC-1}

## A. General Considerations [4](#a.-general-considerations) {#a.-general-considerations-4 .TOC-2}

## B. Specifics for Including Each Action Plan Criterion [6](#b.-specific-recommendations-for-each-action-plan-criterion) {#b.-specifics-for-including-each-action-plan-criterion-6 .TOC-2}

## C. Summary [11](#c.-summary) {#c.-summary-11 .TOC-2}

#####  {#section-2 .TOC-5}

**Guidance on Useful Written**

**Consumer Medication Information (CMI)** [^1]

This draft guidance, when finalized, will represent the Food and Drug
Administration\'s (FDA\'s) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the
FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed
on the title page of this guidance.

# I. INTRODUCTION 

This guidance is intended to assist individuals or organizations (e.g.,
pharmacies, private vendors, healthcare associations) in developing
useful written consumer medication information (CMI). CMI is written
information about prescription drugs developed by organizations or
individuals other than a drug's manufacturer that is intended for
distribution to consumers at the time of drug dispensing. Since neither
FDA nor a drug's manufacturer reviews or approves CMI, FDA recommends
that the developers of written medication information use the guidance
contained in this document to ensure that their CMI is useful to
consumers.

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency\'s current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word *should* in Agency guidances means that
something is suggested or recommended, but not required.

# Background

Traditionally, FDA has believed that people are able to make better
decisions about their healthcare and better use of the prescription
medications available to them when they are well informed about the
medications they take. Access to useful written information about
prescription medications is important to ensuring appropriate use of
these products. Over the years, FDA has undertaken a number of efforts
to help ensure that consumers receive useful, reader-friendly written
information regarding their prescription medications. These efforts are
described briefly here.

Since 1968, FDA regulations have required that patient package inserts,
written specifically for patients, be distributed to patients when
certain prescription drugs, or classes of prescription drugs, are
dispensed (see 21 CFR 310.501 for oral contraceptives and 310.515 for
estrogens). In the 1970s, however, FDA began evaluating the general
usefulness of patient labeling for prescription drugs, resulting in a
series of regulatory steps to help ensure the availability of useful
written consumer information:

-   In 1979, FDA proposed regulations that would require written patient
    information for all prescription drugs (44 FR 40016; July 6, 1979).

-   In 1980, FDA finalized those regulations. They established
    requirements and procedures for the preparation and distribution of
    manufacturer-prepared and FDA-approved patient labeling for a
    limited number of prescription drugs (45 FR 60754; September 12,
    1980).

-   In 1982, FDA revoked those regulations, in part based on assurances
    by pharmaceutical manufacturers, healthcare professional
    associations, and private-sector providers of written medication
    information for patients that the goals of the final rule would be
    met more effectively and with greater innovation without regulation
    (47 FR 39147, September 7, 1982).

FDA committed to monitor the progress of this private-sector effort.
Unfortunately, periodic FDA surveys showed that, although the
distribution of written prescription drug information increased, the
usefulness of the information was highly variable. As a result:

-   In 1995, FDA proposed a regulation entitled *Prescription Drug
    Product Labeling: Medication Guide Requirements* (60 FR 44182;
    August 24, 1995), designed to set specific distribution and quality
    goals and time frames for distributing written information.

> The regulation had the following goals:

-   By the year 2000, 75 percent of people receiving new prescriptions
    would receive useful written patient information with their
    prescriptions.

-   By 2006, 95 percent of people receiving new prescriptions would
    receive useful written patient information with their prescriptions.

The proposed rule would also require manufacturers to prepare and
distribute Medication Guides for a limited number of prescription drug
products that posed a serious and significant public health concern. In
addition, the proposed rule described criteria for *usefulness* to
permit evaluation of whether the information met the target goals.[^2]

-   On August 6, 1996, as FDA was reviewing the public comments on the
    1995 proposed rule, Public Law 104-180 was enacted.[^3]

> This law adopted goals and time frames consistent with the 1995
> proposed rule. The legislation also established a voluntary
> private-sector process through which a committee of interested
> stakeholders would develop a long-range comprehensive action plan to
> achieve the goals specified in the statute. The law prohibited FDA
> from taking further regulatory steps specifying a uniform content or
> format for written information voluntarily provided to consumers about
> prescription drugs if private-sector initiatives met the goals of the
> plan within the specified time frames.

-   In 1996, a Steering Committee was created.

> The Steering Committee, consisting of healthcare professionals,
> consumer organizations, voluntary health agencies, pharmaceutical
> manufacturers, prescription drug wholesalers, drug information
> database companies, CMI developers, and others, developed a report
> entitled *Action Plan for the Provision of Useful Prescription
> Medicine Information* (the Action Plan).[^4] The Action Plan
> delineated *criteria* for evaluating whether a particular piece of
> written medication information is useful to consumers. The Action Plan
> endorsed the elements specified in Public Law 104-180 for defining the
> usefulness of medication information. Specifically, the Action Plan
> stated materials should be:

-   scientifically accurate

-   unbiased in content and tone

-   sufficiently specific and comprehensive

-   presented in an understandable and legible format that is readily
    comprehensible to consumers

-   timely and up-to-date

-   useful, that is, enables the consumer to use the medicine properly
    and appropriately, receive the maximum benefit, and avoid harm

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-   In 1998, FDA contracted with the National Association of Boards of
    Pharmacy (NABP) to conduct CMI assessment.

> The NABP performed a pilot study to test the usefulness of the CMI
> being developed. The NABP also conducted a national study to assess
> the extent to which the year 2000 goals specified in the law had been
> achieved. The results of the study were announced in 2002. On average,
> 89 percent of the patients in the study received some form of written
> medication information. However, the average *usefulness* of the
> information was only about 50 percent.[^5]

-   On July 17, 2002, the FDA Drug Safety and Risk Management Advisory
    Committee (Advisory Committee) met to review the study results and
    public comments.

> The Advisory Committee recommended that FDA take a more active role in
> advising and encouraging the private sector to meet the next target
> goal set for year 2006.[^6]

In response to that recommendation, the agency met with various groups,
held a public meeting in 2003 (see
www.fda.gov/cder/offices/ods/writtenPrescripinfo.htm), and was asked to
provide clarification on how the Action Plan should be interpreted and
implemented. This guidance is part of FDA's efforts to assist developers
of CMI. This guidance provides recommendations to developers of CMI
regarding how best to evaluate current CMI and develop future CMI to
ensure that all CMI meets the usefulness criteria provided in the Action
Plan. FDA views the *criteria* and *components* described in the Action
Plan as the minimum appropriate characteristics of *useful* CMI.
Throughout this guidance, in explaining its views about the Action Plan
criteria, FDA uses the wording of the Action Plan as much as possible.

# III. Applying the action plan criteria for cmi

## A. General Considerations

As discussed above, by 2006, 95 percent of people who receive new
prescriptions should receive useful written patient information with
their prescriptions. To determine whether CMI developers have met that
goal, FDA will evaluate CMI against the Action Plan's criteria for
usefulness. This guidance is intended to assist developers of CMI in
meeting the 2006 goal by providing specific recommendations regarding
the minimum appropriate characteristics of useful CMI.

CMI that adheres to the Action Plan criteria for a specific prescription
drug will be considered *useful* when (1) the most recent FDA-approved
professional labeling or package insert (PI) (see 21 CFR 201.56 and
201.57) serves as the source document for the information contained in
CMI,[^7]^,^ [^8] and (2) it includes the components suggested in the
Action Plan and substantially conforms to the formatting suggestions
made in the Action Plan. Specifically, written CMI should be:

-   scientifically accurate

-   unbiased in content and tone

-   sufficiently specific and comprehensive

-   presented in an understandable and legible format that is readily
    comprehensible to consumers

-   timely and up-to-date

-   useful

Critical criteria, components, and formatting suggestions are in Chapter
3 (*Guidelines for Useful Prescription Medication Information*) and
Appendix G (*Specific Language and Format Guidelines, with Samples*) of
the Action Plan. This guidance provides FDA's recommendations to the
private sector for implementing the Action Plan criteria.

The eight categories listed in the following table were developed by an
expert panel, subcontracted by NABP for FDA's evaluation of CMI in 2001,
by combining the Action Plan criteria and components. FDA believes that
this list provides the factors for determining whether written
medication information is useful. Written information that substantially
satisfies each Action Plan criterion listed in the table will be deemed
*useful* and will count toward the quantitative goals of Section 601 of
Title VI of Public Law 104-180.

**Action Plan Criteria for Defining Useful Information**

  ---------------------------------------------------------------------------
  **Criterion**   **Description**
  --------------- -----------------------------------------------------------
  1               Drug names, indications for use, and how to monitor for
                  improvement

  2               Contraindications and what to do if they apply

  3               Specific directions about how to use and store the
                  medicine, and overdose information

  4               Specific precautions and warnings about the medicine

  5               Symptoms of serious or frequent possible adverse reactions
                  and what to do

  6               Certain general information, including encouraging patients
                  to communicate with healthcare professionals, and
                  disclaimer statements

  7               Information that is scientifically accurate, unbiased in
                  tone and content, and up-to-date

  8               Information in an understandable and legible format that is
                  readily comprehensible to consumers
  ---------------------------------------------------------------------------

##  B. Specific Recommendations for Each Action Plan Criterion

*Criterion 1: Drug Name, Indications for Use, and How to Monitor for
Improvement*

> We recommend that the following information be included in the CMI to
> satisfy Criterion 1:

-   Established name and brand name (e.g., the trademark or proprietary
    name) of the drug and the phonetic spelling (pronunciation) of the
    established name. FDA recommends also including the phonetic
    spelling of the brand name.[^9]

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-   All FDA-approved indications listed in the PI for the medication.
    Information on unapproved indications should only be included in CMI
    customized for individual patients...

-   Information regarding how to monitor the effectiveness of the
    treatment by correctly interpreting physical reactions to the
    medicine, if this information is in the PI. This would include, for
    example, informing patients about when to call their healthcare
    provider if they do not notice signs of improvement.

*Criterion 2: Contraindications and What to Do if They Apply*

We recommend that the following information be included in the CMI to
satisfy Criterion 2:

-   Information about circumstances in which the medication should not
    be used for its labeled indication. Include all contraindications
    listed in the PI.

-   Directions about what to do if any of the contraindications apply to
    the patient, such as contacting the healthcare provider before
    taking the medicine or discussing with him or her situations that
    would warrant discontinuing use of the medication. Include a general
    statement such as, *Talk to your healthcare provider before taking
    this medicine if you have any of these conditions*.

-   Information on any contraindication that could result in serious
    injury or death if it is disregarded.

-   A statement of precaution about any circumstances (such as past or
    current medical conditions or use of other medications, vitamins, or
    supplements) in which the use of the medication could lead to
    serious injury or death.

*Criterion 3: Specific Directions About How to Use and Store the
Medicine and Information About Overdose*

We recommend that the following elements be addressed to satisfy
Criterion 3:

-   The CMI should be considered a stand-alone document in meeting this
    criterion. The label and packaging of the dispensed medication may
    also contain such information (e.g. name, strength, dosage, brief
    directions for use), but for the purposes of assessing usefulness,
    should not be considered as part of CMI.

-   If detailed instructions describing how to administer the medication
    (instructions for use) are included in the manufacturer's patient
    labeling for the product (for example, instructions for inhalers,
    injections, and patches), include a statement to alert the patient
    to read the instructions for use contained in the package.

-   A statement should be included in the CMI to stress the importance
    of adhering to the dosing instructions prescribed by the healthcare
    provider.

-   State the route of administration. Examples of information about the
    route of administration are *skin use only* if a patch and *do not
    swallow* if a suppository.

-   If specified in the PI, include information on how to use the
    medication, such as whether to take it with or without food or
    water, times of day to take the medication, and any other
    instructions, for example, statements such as (1) *Do not chew*, (2)
    *Do not split or crush*, and (3) *Do not lie down for 30 minutes
    after taking this medicine*.

-   Describe what patients can do if they miss a scheduled dose, if this
    information is in the PI.

-   State the risks to the patient of developing tolerance to or
    physical or psychological dependence on the drug if this information
    is included in the PI. In the case of these medicines, provide an
    explanation of tolerance, dependence, or addiction, and list the
    physical and psychological signs of addiction and withdrawal.

-   State what to do in case of an overdose. If overdose is a
    significant issue for a particular medication, include text
    describing signs of overdose so that patients can recognize the
    symptoms. In all cases, we recommend that symptoms of overdose be
    directly followed by instructions for what to do should these signs
    or symptoms occur, such as calling the doctor or other emergency
    telephone number.

-   Include storage instructions.

*Criterion 4: Specific Precautions and Warnings*

If the PI contains any boxed warnings that relate to important knowledge
the consumer should have or actions the consumer should take, we
recommend that a prominently displayed statement which is consistent
with or derived from the boxed warnings be included in the CMI. FDA
believes that most boxed warnings have information that is relevant to
the consumer.

We recommend that the CMI include all information stated in the PI
regarding what precautions the patient should take while using the drug
to avoid negative consequences. For example, the following information
should be included:

-   Drugs to avoid because of drug-drug interactions.

-   Foods and other substances (e.g., dietary supplements) to avoid
    because of the potential for interactions. Since the Action Plan was
    written, there has been increased awareness of dietary supplement
    interactions with medications. If such interactions are included in
    the PI, include them in the CMI in the same way as drug and food
    interactions.

-   Patient activities and behavior to avoid. Examples of such
    activities include smoking tobacco, drinking alcohol, being exposed
    to the sun, or driving a vehicle or operating dangerous machinery.
    Sometimes a behavioral instruction is not given in the PI, but a
    specific precaution or warning will imply that a certain behavior
    should be avoided. In this circumstance, specify the behavior to be
    avoided. For example, if the PI states that the medication has been
    shown to result in photosensitivity, then advise patients to avoid
    sun exposure. If the PI states that the product can cause
    drowsiness, then advise patients to avoid driving or operating heavy
    machinery until patients know how they will react to the medication.

-   Any risks to the mother and the fetus or the infant from use of the
    drug during pregnancy, labor, or breast-feeding. If the risks are
    unknown, include a statement such as, *Talk to your doctor if you
    are pregnant or breast-feeding. It is not known if the medicine will
    affect your baby*.

-   Specific risks to identifiable patient populations, such as
    children, elderly patients, people with compromised immune systems,
    or people with impaired kidney or liver functioning, if such
    information is in the PI. Provide enough detailed risk information
    for the consumer to understand the significance of the hazard
    described.

*Criterion 5: Symptoms of Serious or Frequent Possible Adverse Reactions
and What to Do*

The most serious potential adverse reactions will most likely appear in
the *Warnings* or *Precautions* sections of the PI; we recommend that
this information be included in CMI. In addition, we recommend that CMI
include a list of, at minimum, the symptoms of at least the 5 to 9 most
frequently occurring (common) adverse reactions.

We recommend including a statement telling patients that the side
effects given are not a complete list and instructing them to ask their
doctor or pharmacist for more information.

*Criterion 6: Certain General Information, Including Encouraging
Patients to Communicate with Healthcare Professionals, and Disclaimers*

We recommend that certain general information be contained in all CMI:

-   A statement that the medicine should only be used by the patient for
    whom it is prescribed and should not be given to other people.

-   The name of the publisher of the CMI.

-   The date that the CMI was published or the date of the most recent
    revision or review for adequacy and accuracy of content.

-   A disclaimer stating that the CMI is a summary and does not contain
    all possible information about the medicine.

-   A statement encouraging discussion with a healthcare professional
    about the prescription medicine. A statement that the healthcare
    professional who prescribed the medicine has additional information
    about the medicine as well as about the patient's specific health
    needs, and that the healthcare professional can provide this
    information to the patient and answer the patient's questions. An
    example of a statement that covers both recommendations could be:
    *This leaflet summarizes the most important information about
    \<insert medication name\>. If you would like more information, talk
    with your doctor*.

*Criterion 7: Information That Is Scientifically Accurate, Unbiased in
Tone and Content, and Up-to-Date*

Scientific accuracy is an essential characteristic of CMI. The entire
CMI will be assessed for scientific accuracy and bias. The information
in the CMI should be consistent with or derived from the PI, unless the
CMI is customized for individual patients.

The text of the CMI should be unbiased in content and tone and should
meet the accepted standards of scientific literature. That is, the text
should be explanatory; neutral; without comparative adjectives,
untruthful claims about the benefit of a product, or hyperbole; and
distinguished from any promotional or other information provided to the
patient.

CMI should not promote a specific brand, manufacturer, or distributor
for the purpose of economic gain.

*Criterion 8: Information in an Understandable and Legible Format That
Is Readily Comprehensible to Consumers*

To be useful, CMI should be written in wording that is understandable.
To meet the Action Plan criterion of being understandable, we suggest
that CMI be provided at the sixth to eighth grade reading level. This
can be achieved by using a validated readability instrument. We
encourage using plain language and looking at the message from the
reader's point of view.

CMI should adhere to the criteria, components, and formatting
suggestions in Chapter 3 (*Guidelines for Useful Prescription Medication
Information*) and Appendix G (*Specific Language and Format Guidelines,
with Samples*) of the Action Plan, which "reflect widely recognized
standards used by designers and publishers of written information to
ensure that the materials are legible and readable." We recommend that
CMI be designed to ensure the prominence of important information. It is
helpful to use formats that distinguish between the degree of
seriousness of cautions or warnings. Information should be written
clearly and concisely, and complex terms should be avoided. Polysyllabic
words could be replaced by shorter, simpler words (e.g., *harmful*
rather than *detrimental*), even if it takes several words to get across
a concept that can be expressed in a single, more complex term.

We recommend the following formatting:

-   Use 10-point or larger type size.

-   Do not use ornate typefaces and italics. Choose a bolder type over a
    thin version of the same style.

-   Use upper- and lower-case lettering, not all capitals.

-   Use bold-face type or a box to call attention to important
    information, rather than highlighting or underlining.

-   Provide adequate space between letters, lines, and paragraphs. We
    suggest that text generally have no more than --3 *kerning* (space
    between letters). With 10-point type, 12-point *leading* (space
    between lines) is recommended (at least 2.2 millimeters). Provide
    adequate space between paragraphs and space above and below
    headings.

-   Do not use a line length that is too long. In 10-point or 12-point
    type, optimal line length is approximately 40 letters long.

-   Select text color and paper that give a strong contrast. Black, dark
    blue, or brown ink on white or pale yellow uncoated paper provides
    the best contrast. We suggest that other combinations be avoided.

-   Use short paragraphs and bullets where possible.

## 

## C. Summary

The components of useful information identified in the Action Plan are
meant to be useful "as a total package." We suggest that the information
be provided in the following order:

1.  Personalized information in a box (if customized for individual
    patients)

2.  Established name and brand name

3.  What the medicine is used for

4.  Do not take this medicine if you are...

5.  How to take the medicine

6.  Side effects include ...

7.  General information

This list is not the only appropriate headings or order in which the
headings should appear. Moreover, information pertaining to each Action
Plan criterion need not be organized under the above-specified
individual headings; they can be combined as appropriate.

[^1]: This guidance has been prepared by the Office of Drug Safety in
    the Center for Drug Evaluation and Research (CDER) at the Food and
    Drug Administration.

[^2]: FDA also specified that the usefulness of written patient
    information would be evaluated based on scientific accuracy,
    consistency with a standard format, nonpromotional tone and content,
    specificity, comprehensiveness, understandable language, and
    legibility.

[^3]: Public Law 104-180, Title VI, Sec 601 Effective Medication Guides,
    110 Stat 1593 (1996).

[^4]: Steering Committee for the Collaborative Development of a
    Long-Range Action Plan for the Provision of Useful Prescription
    Medicine Information, unpublished report submitted to The Honorable
    Donna E. Shalala, Secretary of the U. S. Department of Health and
    Human Services, December 1996, available on the Internet at
    <http://www.fda.gov/cder/offices/ods/keystone.pdf>. Secretary
    Shalala accepted the Action Plan by letter dated January 13, 1997.

[^5]: Svarstad, B.L. and J.K. Mount, *Evaluation of Written Prescription
    Information Provided in Community Pharmacies, 2001*, final report to
    the U.S. Department of Health and Human Services and the Food and
    Drug Administration, December 2001, available on the Internet at
    <http://www.fda.gov/cder/reports/prescriptioninfo/default.htm>.

[^6]: A transcript of FDA\'s Drug Safety and Risk Management Advisory
    Committee meeting on July 17, 2002, is available on the Internet at
    <http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3874T1.htm>.

[^7]: FDA-approved drug products and labeling can be found on the
    Internet at
    [[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm]{.underline}](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm).
    However, this Web site does not list all FDA-approved products and
    labeling. We are working to make all approved labeling available
    soon.

[^8]: Consistent with the Action Plan and acceptance by the Secretary,
    information beyond the FDA-approved labeling, such as
    patient-specific indications for use from scientific literature or
    provided by the prescriber is appropriate in customized patient
    information. FDA recommends that the source of such information be
    included in CMI.

[^9]: The Action Plan contained an error in reference to established
    name and brand name. All marketed products have an established name
    (also known as the generic name), while not all products have a
    brand name. Therefore, if a brand name does not exist, the phonetic
    spelling of the established name would be used.