Appendix E
Adverse Event Reporting Forms



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Appendix E Adverse Event Reporting Forms 

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL MEDMARXSM Adverse Drug Reaction Data Entry Form *Required Information *Date of reaction:________________________(mm/dd/yyyy) *Source of reaction: Inpatient Outpatient *Description of reaction: ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ *Body system(s) involved: Allergy & Immune System Cardiac/Heart Gastrointestinal/Digestive Renal & Urinary System System Blood/Bone Marrow/Lymphatic Circulation/Vascular & Liver/Hepatobiliary & Reproduction & Pregnancy System Coagulation Pancreas Body as a Whole, Ears/Auditory, Nose & Mental Health & Behavior Respiratory/Pulmonary, & Thoracic General/Constitutional Throat Bones/Joints, Muscles & Endocrine System Metabolism & Nutrition Skin/Subcutaneous Tissues, Hair & Nails Connective Tissue (Hormones) Brain, Neurologic, & Nervous Eyes/Ocular & Vision Mouth & Teeth System *Reaction summary terms: Abnormal, Diagnostic test Dry skin Irregular menses Rash Abnormal, Laboratory value Dysphagia (difficulty Ischemia Red-man syndrome swallowing) Acidosis Dyspnea (shortness of breath) Keratitis Renal failure Adult respiratory distress Edema Lethargy Respiratory arrest syndrome (ARDS) Alkalosis Erectile dysfunction Leukopenias Respiratory distress/depression Allergic reaction/hypersensitivity Extrapyramidal/movement Libido alteration Rhabdomyolysis disorder Anemias Fatigue Liver dysfunction/failure Rhinitis Angina Feminization of male Loss of Rigors/chills consciousness/syncope Anorexia Fever Malignancy Salivary gland changes Apnea Fistula Masculinization of female Seizure Arthritis Flatulence Melena Serum sickness Ascites Flushing Memory impairment Somnolence/depressed consciousness level Ataxia Gastritis Mucositis/stomatitis Speech impairment Autoimmune disorder Glaucoma Multi-organ failure Stevens-Johnson syndrome Bruising Glucose metabolism disorder Muscle weakness Sweating Cardiac arrhythmia Gynecomastia Nail changes Syndrome inappropriate antidiuretic hormone Cardiac conduction abnormality Hair loss/alopecia Nausea Syndrome, Other Cardiac failure Headache Neuropathy Taste alteration Cardiac infarction Hearing changes Nystagmus Thombocytopenia Cardiac ischemia Heartburn/dyspepsia Obstruction Thrombosis/embolism Cardiac rate abnormal Hematemesis Otitis Thyroid dysfunction Cardiomyopathy Hematuria Pain Tremor Cataract Hemolysis Palpitations Tumor lysis syndrome Cerebral ischemia Hemoptysis Pancreatitis Ulcer Coagulopathy Hemorrhage Pericardial effusion Urinary electrolyte wasting Colitis Hiccups Petechiae/purpura Urinary frequency/urgency Confusion Hives Pharyngitis Urinary retention Conjunctivitis Hot flashes/flushes Phlebitis Urine color change Constipation Hypertension Photosensitivity Vaginal dryness Cough Hypotension Pigmentation changes Vaginitis Cushing’s Hypoxia Pleural effusion Vascular leak syndrome syndrome/appearance Dehydration Ileus Pneumonitis/pneumonia Vasculitis Depression/mood alteration Incontinence Pneumothorax Vision Changes Diarrhea Infection Proctitis Voice changes Dizziness Infertility/sterility Pruritus/itching Vomiting Dry eye syndrome Injection site Psychosis Watery eye reaction/extravasation Dry mouth/salivary gland Insomnia Pulmonary fibrosis Weight change ©2004 The United States Pharmacopeial Convention, Inc. All Rights Reserved. MEDMARXSM (9/04)

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 APPENDIX E *Suspected medication (generic name):___________________________*Patient age:_________(days, weeks, months, years) Circle one *Seriousness Criteria Intervention to prevent Is life-threatening Other medically important Results in death incapacity condition Is a congenital anomaly or birth Requires initial/prolonged Results in persistent/significant incapacity Not serious (none defect of the above apply) hospitalization *Patient location: Admitting Department Intensive Care Unit, Nursing (Patient Care) Physical Therapy Coronary Unit Cardiac Catheterization Intensive Care Unit, Obstetrical Recovery Post-anesthesia Care Unit Laboratory General Room Cardiovascular / Pulmonary Intensive Care Unit, Occupational Therapy Pre-Op holding Services Medical Clinic, Outpatient Intensive Care Unit, Operating Room Psychiatric, Inpatient Neonatal Dialysis Unit Intensive Care Unit, Oncology Department Psychiatric, Outpatient Pediatric Emergency Department Intensive Care Unit, Outpatient Surgery Radiology Surgical Department Emergency Transport Vehicle Labor / Delivery Patient home / Rehabilitation Care Unit Residence Endoscopy / GI Lab Long-Term Care Facility Pediatrics Transplant Unit Hospice Maternity Pharmacy, Inpatient Hospital, another Nursery Pharmacy, Outpatient *Outcome of reaction: Fatal Recovered/resolved Recovering/resolving Not recovered/not resolved Recovered/resolved with sequelae Unknown *Result of reaction on patient level of care: A level of care not determined Dialysis Hospitalization, prolonged >10 Oxygen administered days Airway established / patient Drug therapy initiated / Laboratory tests performed Surgery performed ventilated changed Antidote administered Hospitalization, initial Narcotic antagonist Transferred to higher level of care administered Cardiac defibrillation performed Hospitalization, prolonged None Vital signs / monitoring initiated / 1-5 days increased CPR administered Hospitalization, prolonged Observation initiated / X-ray / MRI / other diagnostic test 6-10 days increased performed *Preventability assessment: Considered preventable, Other Drug inappropriate for clinical Poor compliance involved condition Documented drug interaction History of allergy/previous reaction Required monitoring/tests not performed involved Dose/route/frequency Not considered preventable Unknown/Unable to assess inappropriate *Action(s) taken: Documented ADR-other Informed patient/caregiver Policy/Procedure instituted Suspected Medication(s) Dose Increased Documented ADR-patient Informed patient's physician Provided Suspected Medication(s) Dose Reduced chart Supportive/Palliative Care Documented ADR- Other Medication(s) Dose Submitted FDA MedWatch Suspected Medication(s) Dose Unchanged prescription entry system changed/withdrawn Form Formulary changed Policy/Procedure changed Suspected Medication(s) Unknown Discontinued ©2004 The United States Pharmacopeial Convention, Inc. All Rights Reserved. MEDMARXSM (9/04)

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0 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL *Naranjo Scale Probability/Causality Assessment Question Yes No Do Not Know 1. Are there previous conclusive reports on this reaction? 2. Did the adverse event appear after the suspected drug was administered? 3. Did the adverse reaction improve when drug was discontinued or a specific antagonist was administered? 4. Did the adverse reaction appear when the drug was readministered? 5. Are there alternative causes (other than the drug) that could on their own have caused the reaction? 6. Did the reaction appear when a placebo was given? 7. Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? 8. Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? 9. Did the patient have a similar reaction to the same or similar drugs in any previous exposure? 10. Was the adverse event confirmed by any objective evidence? Brand Name:_________________________ Manufacturer:________________________ Therapeutic Classification:______________ Dosage form:_________________________ Intended route of administration:________ Labeler:_____________________________ Batch Lot number:_____________________ Investigational drug name:_____________ Compounded ingredients:______________ Strength/Concentration:________________ Indication:___________________________ Dosage:_____________________________ Dosage Interval:_______________________ Dosage Information Detail:_____________ Reaction Latency:_____________________ Medication Start Date:__________________ Medication End Date:__________________ Detection Method: Patient-Objective Evidence Patient-Subjective Complaint Chart Review ICD-9 Code Review Triggers-Medication Orders/Lab Spontaneous report Other Values Male Patient Sex: Female Unavailable Patient weight:________________________ Location detail:________________________ Duration of reaction:_________________ Pertinent medication history; medical history, including relevant pre-existing conditions; concomitant drug therapy, with dates: ______________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________ Results of relevant tests/procedures to the reaction: ______________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________ Reporter level of staff: Anesthesiologist Dentist and related specialties Dialysis Technician Dietary Personnel Emergency Medical Services Laboratory Personnel Management Personnel Nuclear Medicine Technician Nurse Anesthetist Nurse Practitioner/Advanced Nurse, Graduate Nurse, Licensed Practice Nurse Practical/Vocational Nurse, Registered Nurse, Travel Nursing Assistant/Aide Nursing Personnel, non- specific Optometrist Patient/Family Pharmacist Pharmacy Personnel, non- Member/Caregiver specific Pharmacy Technician Phlebotomist Physical Therapist Physician Physician Assistant Physician, Intern Physician, Resident Psych Tech/Mental Health Technician Radiology Technician Respiratory Therapist Student Unit Secretary/Clerk Unlicensed Assistive Personnel Action taken and recommendations to avoid future reactions: ________________________________________________________________________________________________________________________ ________________________________________________________________________________________________________________________ Internal control:___________________________________________ Serum Creatinine:_____________ milligrams per deciliter Physician Service detail:________________ Patient detail:__________________________ Reporter detail:_____________________ Patient Name:______________________________________________ Medical Record #:__________________________________________ This document is part of a quality improvement process Signature of Unit Manager:__________________________________ CONFIDENTIAL-Not to be included as part of the patient medical record ©2004 The United States Pharmacopeial Convention, Inc. All Rights Reserved. MEDMARXSM (9/04)

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 APPENDIX E U.S. Department of Health and Human Services Form Approved: OMB No. 0910-0291, Expires: 10/31/08 MEDWATCH See OMB statement on reverse. For VOLUNTARY reporting of FDA USE ONLY adverse events, product problems and Triage unit product use errors sequence # The FDA Safety Information and Page ____ of ____ Adverse Event Reporting Program A. PATIENT INFORMATION D. SUSPECT PRODUCT(S) 1. Patient Identifier 2. Age at Time of Event, or 3. Sex 4. Weight 1. Name, Strength, Manufacturer (from product label) Date of Birth: lb Female #1 or Male kg In confidence #2 B. ADVERSE EVENT, PRODUCT PROBLEM OR ERROR Dose or Amount Frequency Route 2. Check all that apply: #1 Adverse Event Product Problem (e.g., defects/malfunctions) 1. Product Use Error Problem with Different Manufacturer of Same Medicine #2 2. Outcomes Attributed to Adverse Event (Check all that apply) 3. Dates of Use (If unknown, give duration) from/to (or 5. Event Abated After Use best estimate) Stopped or Dose Reduced? Death: Disability or Permanent Damage Doesn't (mm/dd/yyyy) #1 Yes No #1 Apply Life-threatening Congenital Anomaly/Birth Defect Doesn't #2 Other Serious (Important Medical Events) #2 Yes No Hospitalization - initial or prolonged Apply 4. Diagnosis or Reason for Use (Indication) Required Intervention to Prevent Permanent Impairment/Damage (Devices) 8. Event Reappeared After Reintroduction? #1 3. Date of Event (mm/dd/yyyy) 4. Date of this Report (mm/dd/yyyy) Doesn't #1 Yes No Apply #2 Doesn't 5. Describe Event, Problem or Product Use Error 6. Lot # 7. Expiration Date #2 Yes No Apply #1 #1 9. NDC # or Unique ID #2 #2 E. SUSPECT MEDICAL DEVICE PLEASE TYPE OR USE BLACK INK 1. Brand Name 2. Common Device Name 3. Manufacturer Name, City and State 4. Model # Lot # 5. Operator of Device Health Professional Catalog # Expiration Date (mm/dd/yyyy) Lay User/Patient Other: Serial # Other # 6. If Implanted, Give Date (mm/dd/yyyy) 7. If Explanted, Give Date (mm/dd/yyyy) 8. Is this a Single-use Device that was Reprocessed and Reused on a Patient? Yes No 9. If Yes to Item No. 8, Enter Name and Address of Reprocessor 6. Relevant Tests/Laboratory Data, Including Dates F. OTHER (CONCOMITANT) MEDICAL PRODUCTS Product names and therapy dates (exclude treatment of event) 7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, G. REPORTER (See confidentiality section on back) race, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) 1. Name and Address Phone # E-mail 2. Health Professional? 3. Occupation 4. Also Reported to: C. PRODUCT AVAILABILITY Yes No Manufacturer Product Available for Evaluation? (Do not send product to FDA) User Facility 5. If you do NOT want your identity disclosed Yes No Returned to Manufacturer on: Distributor/Importer to the manufacturer, place an "X" in this box: (mm/dd/yyyy) FORM FDA 3500 (10/05) Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL ADVICE ABOUT VOLUNTARY REPORTING Detailed instructions available at: http://www.fda.gov/medwatch/report/consumer/instruct.htm Report adverse events, product problems or product Report even if: . use errors with: . You're not certain the product caused the event . You don't have all the details Medications (drugs or biologics) . Medical devices (including in-vitro diagnostics) . How to report: . Combination products (medication & medical devices) . . Just fill in the sections that apply to your report Human cells, tissues, and cellular and tissue-based . Use section D for all products except medical devices products . . Attach additional pages if needed Special nutritional products (dietary supplements, . Use a separate form for each patient medical foods, infant formulas) . Report either to FDA or the manufacturer (or both) Cosmetics Other methods of reporting: . Report product problems - quality, performance or 1-800-FDA-0178 -- To FAX report . safety concerns such as: . 1-800-FDA-1088 -- To report by phone . . Suspected counterfeit product www.fda.gov/medwatch/report.htm -- To report online . Suspected contamination If your report involves a serious adverse event with a . Questionable stability device and it occurred in a facility outside a doctor's . Defective components office, that facility may be legally required to report to FDA . Poor packaging or labeling and/or the manufacturer. Please notify the person in that Therapeutic failures (product didn't work) -Fold Here- -Fold Here- facility who would handle such reporting. Report SERIOUS adverse events. An event is serious If your report involves a serious adverse event with a when the patient outcome is: . vaccine call 1-800-822-7967 to report. . Death . Life-threatening Confidentiality: The patient's identity is held in strict . Hospitalization - initial or prolonged confidence by FDA and protected to the fullest extent of . Disability or permanent damage the law. FDA will not disclose the reporter's identity in . Congenital anomaly/birth defect response to a request from the public, pursuant to the Required intervention to prevent permanent Freedom of Information Act. The reporter's identity, . including the identity of a self-reporter, may be shared with impairment or damage the manufacturer unless requested otherwise. Other serious (important medical events) The public reporting burden for this collection of information has been estimated to average 36 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Department of Health and Human Services Please DO NOT OMB statement: Food and Drug Administration - MedWatch "An agency may not conduct or sponsor, and a RETURN this form 10903 New Hampshire Avenue person is not required to respond to, a collection of to this address. Building 22, Mail Stop 4447 information unless it displays a currently valid Silver Spring, MD 20993-0002 OMB control number." U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FORM FDA 3500 (10/05) (Back) Please Use Address Provided Below -- Fold in Thirds, Tape and Mail NO POSTAGE DEPARTMENT OF NECESSARY HEALTH & HUMAN SERVICES IF MAILED IN THE Public Health Service UNITED STATES Food and Drug Administration OR APO/FPO Rockville, MD 20857 Official Business BUSINESS REPLY MAIL Penalty for Private Use $300 FIRST CLASS MAIL PERMIT NO. 946 ROCKVILLE MD MEDWATCH The FDA Safety Information and Adverse Event Reporting Program Food and Drug Administration 5600 Fishers Lane Rockville, MD 20852-9787

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 APPENDIX E Form Approved: OMB No. 0910-0291, Expires: 10/31/08 See OMB statement on reverse. U.S. Department of Health and Human Services For use by user-facilities, Mfr Report # Food and Drug Administration importers, distributors and manufacturers for MANDATORY reporting UF/Importer Report # MEDWATCH Page ____ of ____ FORM FDA 3500A (10/05) FDA Use Only A. PATIENT INFORMATION C. SUSPECT PRODUCT(S) 1. Patient Identifier 2. Age at Time 3. Sex 4. Weight 1. Name (Give labeled strength & mfr/labeler) of Event: #1 lbs Female or or Date #2 Male kgs of Birth: In confidence 2. Dose, Frequency & Route Used 3. Therapy Dates (If unknown, give duration) B. ADVERSE EVENT OR PRODUCT PROBLEM from/to (or best estimate) #1 #1 Adverse Event Product Problem (e.g., defects/malfunctions) 1. and/or #2 #2 2. Outcomes Attributed to Adverse Event (Check all that apply) 4. Diagnosis for Use (Indication) 5. Event Abated After Use Stopped or Dose Reduced? Death: Disability or Permanent Damage #1 (mm/dd/yyyy) Doesn't #1 Yes No Apply Life-threatening Congenital Anomaly/Birth Defect #2 Doesn't Other Serious (Important Medical Events) Hospitalization - initial or prolonged #2 Yes No 6. Lot # 7. Exp. Date Apply Required Intervention to Prevent Permanent Impairment/Damage (Devices) 8. Event Reappeared After #1 #1 Reintroduction? 3. Date of Event (mm/dd/yyyy) 4. Date of This Report (mm/dd/yyyy) Doesn't #2 #2 #1 Yes No Apply 9. NDC# or Unique ID 5. Describe Event or Problem Doesn't #2 Yes No Apply 10. Concomitant Medical Products and Therapy Dates (Exclude treatment of event) PLEASE TYPE OR USE BLACK INK D. SUSPECT MEDICAL DEVICE 1. Brand Name 2. Common Device Name 3. Manufacturer Name, City and State 4. Model # Lot # 5. Operator of Device Health Professional Catalog # Expiration Date (mm/dd/yyyy) Lay User/Patient Other: Serial # Other # 6. If Implanted, Give Date (mm/dd/yyyy) 7. If Explanted, Give Date (mm/dd/yyyy) 6. Relevant Tests/Laboratory Data, Including Dates 8. Is this a Single-use Device that was Reprocessed and Reused on a Patient? Yes No 9. If Yes to Item No. 8, Enter Name and Address of Reprocessor 10. Device Available for Evaluation? (Do not send to FDA) Yes No Returned to Manufacturer on: (mm/dd/yyyy) 11. Concomitant Medical Products and Therapy Dates (Exclude treatment of event) 7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) E. INITIAL REPORTER 1. Name and Address Phone # 4. Initial Reporter Also Sent Submission of a report does not constitute an admission that medical 2. Health Professional? 3. Occupation Report to FDA personnel, user facility, importer, distributor, manufacturer or product Yes No Yes No Unk. caused or contributed to the event.

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 USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL FDA USE ONLY MEDWATCH FORM FDA 3500A (10/05) (continued) Page ____ of ____ F. FOR USE BY USER FACILITY/IMPORTER (Devices Only) H. DEVICE MANUFACTURERS ONLY 1. Check One 2. UF/Importer Report Number 1. Type of Reportable Event 2. If Follow-up, What Type? User Facility Importer Death Correction 3. User Facility or Importer Name/Address Serious Injury Additional Information Malfunction Response to FDA Request Other: Device Evaluation 3. Device Evaluated by Manufacturer? 4. Device Manufacture Date (mm/yyyy) Not Returned to Manufacturer 4. Contact Person 5. Phone Number Yes Evaluation Summary Attached 5. Labeled for Single Use? No (Attach page to explain why not) or provide code: 6. Date User Facility or 7. Type of Report 8. Date of This Report Yes No Importer Became (mm/dd/yyyy) Aware of Event (mm/dd/yyyy) Initial 6. Evaluation Codes (Refer to coding manual) Follow-up # Method 9. Approximate 10. Event Problem Codes (Refer to coding manual) Age of Device Patient Results Code Device Conclusions Code 11. Report Sent to FDA? 12. Location Where Event Occurred 7. If Remedial Action Initiated, Check Type 8. Usage of Device Outpatient Hospital Initial Use of Device Yes Recall Notification Diagnostic Facility (mm/dd/yyyy) Home Reuse No Repair Inspection Ambulatory Nursing Home Unknown Surgical Facility 13. Report Sent to Manufacturer? Replace Patient Monitoring Outpatient Treatment 9. If action reported to FDA under Modification/ Relabeling Yes Facility 21 USC 360i(f), list correction/ Adjustment removal reporting number: (mm/dd/yyyy) No Other: Other: (Specify) 14. Manufacturer Name/Address Additional Manufacturer Narrative Corrected Data 10. and / or 11. G. ALL MANUFACTURERS 1. Contact Office - Name/Address (and Manufacturing Site 2. Phone Number for Devices) 3. Report Source (Check all that apply) Foreign Study Literature Consumer Health Professional User Facility 4. Date Received by 5. Manufacturer (mm/dd/yyyy) Company (A)NDA # Representative Distributor IND # 6. If IND, Give Protocol # Other: STN # PMA/ 7. Type of Report 510(k) # (Check all that apply) Combination 30-day 5-day Yes Product Periodic 7-day Pre-1938 Yes Initial 10-day OTC Product Yes Follow-up # ____ 15-day 9. Manufacturer Report Number 8. Adverse Event Term(s) OMB Statement: The public reporting burden for this collection of information has been estimated to average 66 Department of Health and Human Services "An agency may not conduct or sponsor, minutes per response, including the time for reviewing instructions, searching existing data Food and Drug Administration - MedWatch and a person is not required to respond sources, gathering and maintaining the data needed, and completing and reviewing the 10903 New Hampshire Avenue to, a collection of information unless it collection of information. Send comments regarding this burden estimate or any other aspect of Building 22, Mail Stop 4447 displays a currently valid OMB control this collection of information, including suggestions for reducing this burden to: Silver Spring, MD 20993-0002 number." Please DO NOT RETURN this form to this address.