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Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Appendix

Contains Nonbinding Recommendations

June 2009

V. Appendix: Instructions for Completing the MedWatch Form 3500A to Report a Serious Adverse Event Associated with a Dietary Supplement

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Form FDA 3500A (PDF format) is a two-sided form. It is for use by user facilities, distributors, importers, applicants, and manufacturers for "mandatory" reporting of adverse events and product problems associated with drugs, biologics, and devices, as designated in the applicable statutes and FDA regulations. In addition, MedWatch Form 3500A is for use by manufacturers, packers and distributors for "mandatory" reporting of serious adverse events associated with the use of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462).


How to Obtain FDA 3500A Forms and Guidance on How to Complete FDA Form 3500A Regarding Serious Adverse Event Reporting for Dietary Supplements

  1. Copies of Form FDA 3500A
  2. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
  3. Fillable Forms Software
    • If you submit reports frequently, you may download a fillable version of the FDA 3500A form for local installation on your personal computer.
    • This application does not permit electronic submission of reports.
  4. How to Submit Form FDA 3500A to FDA

    At this time, FDA requires that mandatory reports using MedWatch Form 3500A for serious adverse events associated with the use of dietary supplements be submitted in hard copy by mail only (see #5 for address). FDA does not currently accept dietary supplement serious adverse event reports electronically or by facsimile.

  5. Where to Send Mandatory Reporting Forms for Reports of Serious Adverse Events Associated with Dietary Supplements

    For Dietary Supplements Only:

    Food and Drug Administration
    Center for Food Safety and Applied Nutrition
    Office of Food Defense, Communication and Emergency Response
    CAERS Team (HFS-11)
    5100 Paint Branch Parkway
    College Park, MD 20740

  6. Questions About Mandatory Serious Adverse Event Reporting for Dietary Supplements?

    Office of Nutrition, Labeling, and Dietary Supplements
    Center for Food Safety and Applied Nutrition
    Food and Drug Administration
    5100 Paint Branch Parkway, HFS-800
    College Park, MD 20740
    ((301) 436-2375 (240) 402-2375

General Instructions

  • All entries should be typed or printed in a font no smaller than 8 point.
  • Complete all sections that apply. If information is unknown, not available or does not apply, the section should be left blank.
  • Dates should be entered as mm/dd/yyyy (e.g., June 3, 2005 = 06/03/2005). If exact dates are unknown, provide the best estimate.
  • For narrative entries, if the fields do not provide adequate space, attach an additional page(s). The following specific information is to be incorporated:
    • Include the phrase continued at the end of each field of FDA Form 3500A that has additional information continued onto another page
    • Identify all attached pages as Page __ of __
    • Indicate the appropriate section and block number next to the narrative continuation
    • Display the manufacturer, packer or distributor name and report number in the upper right hand corner as applicable
  • All submissions must be made in English.

Front Page

At the top of the front page

Enter the page number and total number of pages submitted (include attachments in the total) where the words Page __ of __ are indicated.

On the top-right corner of the front page, enter the manufacturer report number, packer report number or distributor report number in the "Mfr Report #" box. Enter all report numbers, if applicable, to cross-reference this report with a report from another source on the same event. The manufacturer, packer, or distributor report number is the unique identifier used by the manufacturer, packer or distributor for this report. The manufacturer, packer or distributor report number is also entered in block G9 on the back of the form.

Section A. Patient Information

A. Patient Information - MedWatch Form 3500A

The patient is the person who experienced the adverse event. If more than one person experienced the adverse event, complete a separate form for each patient.

Parent-child/fetus report(s) are those cases in which either a fetus/breast feeding infant or the mother, or both, sustain an adverse event that the initial reporter considers possibly associated with a product administered to the mother during pregnancy. Several general principles are used for filing these reports:

  • If there has been no event affecting the child/fetus, the mother is the patient to be described in section A.
  • For those cases describing fetal death, miscarriage or abortion, the mother is the patient to be described in section A.
  • When ONLY the child/fetus experiences a serious adverse event (other than fetal death, miscarriage or abortion), the child/fetus is the patient to be described in section A. Information concerning the mother, including the name of the product that the mother ingested, if she was the source of exposure to the product, should be provided in section C. Section B5 should describe that the mother ingested the product but the child/fetus experienced the serious adverse event.
  • When an infant is found to have a congenital anomaly/birth defect that the initial reporter considers possibly associated with a product administered to the mother during pregnancy, the infant is the patient to be described in section A.
  • If both the mother and the child/fetus experience serious adverse events associated with the mother's use of a single product, the responsible person should submit two separate reports to FDA. Each report should be linked to the other using the "Describe Event or Problem" narrative in block B5, which should give the manufacturer report number for the other report.

A1: Patient Identifier

Provide the patient's initials or some other type of identifier that will allow both the responsible person and the initial reporter (if different) to locate the case if contacted for follow-up. Do not use the patient's name or social security number.

The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law.

A2: Age at Time of Event or Date of Birth

Provide the most precise information available. Enter the patient's birthdate, if known, or the patient's age at the time of event onset. For age, indicate time units used (e.g., years, months, and days).

  • If the patient is 3 years or older, use years (e.g., 4 years)
  • If the patient is less than 3 years old, use months (e.g., 24 months)
  • If the patient is less than 1 month old, use days (e.g., 5 days)
  • Provide the best estimate if exact age is unknown

A3: Sex

Enter the patient's gender. If the adverse event is a congenital anomaly or birth defect, report the sex of the child.

A4: Weight

Enter the patient's weight. Indicate whether the weight is in pounds (lbs.) or kilograms (kgs). Make a best estimate if exact weight is unknown.

Section B: Adverse Event or Product Problem

 

B. Adverse Event or Product Problem - MedWatch Form 3500A

B1: Adverse event and/or Product problem

Choose the appropriate box. For dietary supplements, product problems should be reported to FDA on Form 3500A only if the problem may have caused or contributed to a serious adverse event. In that case, both boxes should be checked. Dietary supplement product problems not associated with a serious adverse event may be reported to FDA on Form FDA 3500 the MedWatch voluntary reporting form.

Adverse event: Any adverse health-related event associated with the use of a dietary supplement. Report only serious adverse events to FDA on Form 3500A. See instructions for block B2, below, for the definition of a serious adverse event.

Product problem (e.g., defects): Any report regarding the quality or safety of any dietary supplement.

B2: Outcomes attributed to adverse event:

Dietary Supplements: Serious adverse events associated with the use of a dietary supplement must be reported to FDA. A serious adverse event, as defined in Section 761(a)(2) of the Federal Food, Drug, and Cosmetic Act, means an adverse event that:

  • Results in
    • death;
    • a life-threatening experience;
    • inpatient hospitalization;
    • a persistent or significant disability or incapacity; or
    • a congenital anomaly or birth defect; or
  • Requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

Indicate ALL outcomes that apply to the reported event:

Death: Check if death was an outcome of the adverse event, or if the cause of the death is unknown. Include the date of death, if known.

DO NOT check if:

  • The patient died while using a dietary supplement, but there was no suspected association between the death and the use of the product
  • A fetus was aborted because of a congenital anomaly, or was miscarried

Life-threatening: Check if it is suspected that:

  • The patient was at substantial risk of dying at the time of the serious adverse event.

Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a result of the serious adverse event.

Do NOT check if:

  • A patient in the hospital took a dietary supplement and subsequently developed an otherwise nonserious adverse event, UNLESS the adverse event prolonged the hospital stay.

Do check if:

  • The patient was admitted to the hospital for one or more days, even if he or she was released on the same day.
  • An emergency room visit resulted in admission to the hospital.

Note: Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., death, life-threatening experience, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or intervention required to prevent one of these outcomes)

Disability or Permanent Damage: Check if the serious adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions (i.e, a persistent or significant disability or incapacity).

Congenital Anomaly/Birth Defect: Check if it is suspected that exposure to a dietary supplement prior to conception or during pregnancy may have resulted in a congenital anomaly or birth defect in the child.

Required Intervention to Prevent Permanent Impairment/Damage (Devices): Not applicable for dietary supplements. This box is for device adverse event reporting only.

Other Serious (Important Medical Events):

Check if, based on reasonable medical judgment, the adverse event required a medical or surgical intervention to prevent one of the following outcomes:

  • death;
  • a life-threatening experience;
  • inpatient hospitalization;
  • a significant disability or incapacity; or
  • a congenital anomaly or birth defect

B3: Date of Event

Provide the actual date or best estimate of the date of first onset of the serious adverse event. If day is unknown, month and year are acceptable. If day and month are unknown, year is acceptable.

  • When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth of the child.
  • When a fetus is aborted because of a congenital anomaly, or other reason, the event onset date is the date pregnancy is terminated.

If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block B5.

B4: Date of this Report

The date the report is filled out.

B5: Describe Event or Problem

For a serious adverse event: Describe the event in detail using the initial reporter's own words, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and if relevant, include synopses of any office visit notes or the hospital discharge summary. To save time and space (and if permitted by the institution), attach copies of these records with any confidential information deleted. DO NOT identify any patient, physician, or institution by name. The initial reporter's identity should be provided in full in section E.

Results of relevant tests and laboratory data should be entered in block B6 (see instructions for B6).

Preexisting medical conditions and other relevant history belong in block B7. Be as complete as possible, including the date diagnosed and duration of the preexisting medical condition (see instructions for B7).

B6: Relevant Tests/Laboratory Data, Including Dates:

Provide all appropriate information, including relevant negative test and laboratory findings, in order to most completely convey how the medical work-up/assessment led to strong consideration of dietary supplement-induced disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.

Include:

  • Any relevant baseline laboratory data prior to the administration or use of the dietary supplement
  • All laboratory data used in diagnosing the event

If available, include:

  • Any pre- and post-event medication levels and dates (if applicable)
  • Synopses of any relevant autopsy, pathology, or lab reports

If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. DO NOT identify any patient, physician or institution by name. The initial reporter's identity should be provided in full in section E.

B7: Other Relevant History, Including Preexisting Medical Conditions:

If available, provide information on:

  • Other known conditions in the patient, e.g.,
    • Hypertension
    • Diabetes mellitus
    • Renal/hepatic dysfunction, etc.
  • Significant history
    • Race
    • Allergies
    • Pregnancy history
    • Smoking and alcohol use
    • Drug abuse, etc.

Section C: Suspect Products

C. Suspect Product(s) - MedWatch Form 3500A

For adverse event reporting, a suspect product is one that the initial reporter suspected was associated with the adverse event. In block C10 enter other concomitant products (other dietary supplements, drugs, biologics, or medical devices) that the patient was using at the time of the event but that are NOT thought by the initial reporter to be involved in the event.

Up to two (2) suspect products may be reported on one form (#1=first suspect product, #2=second suspect product). Attach an additional form if there were more than two suspect products for the reported serious adverse event.

C1: Name:

Use the product or trade name as marketed in the U.S.

C2: Dose, Frequency, and Route Used:

Describe how the product was used by the patient (e.g., one tablet four times a day). For reports involving overdoses, the amount of product used in the overdose should be listed, NOT the amount recommended in the directions on the product label.

C3: Therapy Dates

The therapy dates are the dates during which the dietary supplement was consumed.

Provide the date the patient started taking the dietary supplement (or best estimate) and the date use was stopped (or best estimate). If no dates are known, an estimated duration is acceptable (e.g., 2 years) or, if usage was less than one day, then describe when the dietary supplement was taken (e.g., 1 gelcap at 5 p.m.).

C4: Diagnosis for Use

Give the reason(s) why the patient used the product.

C5: Event Abated After Use Stopped or Dose Reduced:

In addition to checking the appropriate box, provide supporting information, lab tests, and dates, if available, in block B6.

C6: Lot #:

If known, include the lot number of the suspect dietary supplement.

C7: Expiration date:

Include the expiration date of the suspect dietary supplement.

C8: Event Reappeared After Reintroduction:

In addition to checking the appropriate box, provide supporting information, lab tests, and dates, if available, in block B6.

C9: NDC # or Unique ID:

If the product has a unique or distinct identification code, such as a Universal Product Code (UPC) number, provide the identification code here.

C10: Concomitant Medical Products and Therapy Dates:

List and provide dates of use for any other dietary supplements, drugs, biologics, or medical devices that the patient was taking or using at the time of the serious adverse event. Do not include products used to treat the serious adverse event.

Section D: Suspect Medical Device is for device adverse reporting only. This section should not be completed by those submitting a serious adverse event report associated with a dietary supplement.

 

Section E: Initial Reporter

E. Initial Reporter - MedWatch Form 3500A

E1: Name, Address & Phone #

Please provide the name, mailing address, and phone number of the person who initially reported the serious adverse event to the dietary supplement manufacturer, packer or distributor, and who can be contacted to provide information on the adverse event if follow-up is necessary. If available, provide the initial reporter's e-mail address and fax number. If the initial reporter has requested that his/her name and contact information not be provided to FDA, enter "Requested Anonymity" in block E1.

E2: Health Professional?:

Indicate whether or not the initial reporter is a health professional (e.g., physician, pharmacist, nurse, etc.). If not a health professional, complete block E3 by filling in NA.

E3: Occupation:

Indicate the initial reporter's occupation (type of health professional, if applicable, or "NA" for non-health professionals). For health professionals, include specialty if appropriate.

E4: Initial Reporter Also Sent Report to FDA:

Indicate whether the initial reporter also reported the serious adverse event to FDA.

Back Page

At the top of the back page, enter the page number and total number of pages submitted (include attachments in the total) where the words Page __ of __ are indicated.

Section F: For Use by User Facility/Importer (Devices Only) should not be completed by those submitting a serious adverse event report associated with a dietary supplement.

 

Section G: All manufacturers

This section is to be filled out by the dietary supplement manufacturer, packer or distributor submitting the serious adverse event report to FDA.

G. All Manufacturers - MedWatch Form 3500A

G1: Contact Office - Name/Address:

Enter the full name and address of the manufacturer, packer or distributor reporting site [contact office], including contact name.

G2: Phone Number:

Enter the telephone number of the contact office or a representative knowledgeable about the serious adverse event report.

G3: Report Source:

Check the box(es) that most accurately describe(s) how the manufacturer, packer or distributor [contact office] became aware of the reported serious adverse event or from where the information about the serious adverse event originated.

  • Foreign: Foreign sources include foreign governments or foreign affiliates of the manufacturer, packer, or distributor. The country of origin should be included.
  • Literature: If the report source is the scientific literature or an unpublished manuscript, a copy of the article or manuscript should be attached. Foreign language articles should be translated into English. Record the date of the article as the date of the event (block B3), and provide a full literature citation in block H10. A separate 3500A form should be completed for each identifiable patient described in the article or manuscript.
  • Consumer (including attorneys or family members of the patient): Additional information, whenever possible, should be sought from the treating healthcare provider. A determined effort should be made to obtain additional detailed information from health professionals for all serious adverse events initially reported by consumers.
  • Health professional: Physician, pharmacist, nurse, etc.
  • Company representative: This check box would be selected if a company representative reported the event to the contact office based on information received from a health professional. The health professional box should also be checked, and the health professional should be listed as the initial reporter in Section E on the front page of the form.
  • Distributor: This check box would be selected when the dietary supplement manufacturer or packer who is submitting the serious adverse event report to FDA received the report from a distributor of the product. In this situation, the health professional or other reporter (e.g., patient) who reported the serious adverse event to the distributor should be listed as the initial reporter in Section E on the front page of the form.
  • Other: Any source not covered by the previous categories.

G4: Date received by manufacturer:

This means the date when the responsible person (i.e., the manufacturer, packer or distributor whose name is listed on the label of the dietary supplement associated with the serious adverse event) receives the minimum data elements (i.e., identifiable patient, initial reporter, suspect dietary supplement, serious adverse event) to submit a serious adverse event report to FDA.

Blocks G5 and G6 do not have to be completed by those submitting a serious adverse event report associated with a dietary supplement.

G7: Type of Report:

For dietary supplement serious adverse event reports that a manufacturer, packer or distributor is submitting for the first time, check the "15-day" box and the "Initial" box. As specified in Section 761(c)(1) of the Federal Food, Drug, and Cosmetic Act, serious adverse event reports associated with the use of a dietary supplement must be submitted to FDA no later than 15 business days after the report is received through the address or phone number on the label of the product. If the report is received through other means, it should still be submitted to FDA within 15 business days.

Because FDA recommends that follow-up reports of new medical information related to a dietary supplement adverse event report be submitted by attaching a photocopy of the initial serious adverse event report to the new medical information, rather than by completing a new Form 3500A, the "follow-up" box does not apply to dietary supplements.

Block G 8 (Adverse Event Term(s)) should not be completed by those submitting a serious adverse event report associated with a dietary supplement

G9. Manufacturer Report Number

For all manufacturers, packers and distributors:

Enter the Manufacturer, Packer, or Distributor report number exactly as it appears in the "Mfr Report #" field in the upper right corner of the first page.

Section H: Device Manufacturers Only should not be completed by those submitting a serious adverse event report associated with a dietary supplement