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Appendix E: Adverse Event Reporting Forms
Pages 427-434

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From page 427...
... Appendix E Adverse Event Reporting Forms 427
From page 428...
... 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.
From page 429...
... 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 *
From page 430...
... 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 Patient Sex: Male 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 CONFIDENTIAL-Not to be included as part of the patient medical record Signature of Unit Manager:__________________________________ ©2004 The United States Pharmacopeial Convention, Inc. All Rights Reserved.
From page 431...
... 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
From page 432...
... 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 RETURN this form "An agency may not conduct or sponsor, and a 10903 New Hampshire Avenue to this address.
From page 433...
... 11. Concomitant Medical Products and Therapy Dates (Exclude treatment of event)
From page 434...
... 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.


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