Policy Manual sample

MDT Home Health Care Agency, Inc. 210 ADVERSE DRUG REACTION REPORTING FORM REPORT ANY REACTION OR INCIDENCE THAT MAY BE A DETRIMENTAL RESPONSE TO A MEDICATION WHICH IS UNDESIRED, UNINTENDED OR UNEXPECTED IN DOSES ACCEPTED IN THE MEDICAL PRACTICE. Date of Reaction: Known Allergies: Suspected Drug: Start Date: Concurrent Drugs: Describe Reaction: Circle all that apply: GI Nausea Vomiting Diarrhea Constipation GI Upset GI Pain SKIN Rash Itching Flushing Swelling Phlebitis Erythema CV Hypertension Hypotension Chest Pain Arrhythmias Bradycardia Tachycardia CNS Headache Confusion Anxiety Sedation Depression Malaise LABS LFTs Scr/BUN Neutropenia Anemia Electrolyte OTHER Short of Breath Wheezing Fever Chills Seizures Shock Was the Physician Notified:  Yes  No Treatment of reaction: (Circle or list drugs prescribed or actions taken.) Discontinued drug Decrease dose Obtain drug level Diphenhydramine Dextrose Epinephrine Hydroxyzine Insulin Digibind Glucagon Kayexalate Naloxone Phytadione Protamine Meclizine Benztropine Physostigmine Blood Products Romazicon Steroids Vancomycin PO Other: PREVENTABILITY ASSESSMENT 1. Was the drug involved in the ADR inappropriate for the patient’s clinical condition? 2. Were the dose, route and frequency of administration appropriate for the patient’s age, weight, organ function and disease state? 3. If the reaction was due to a drug allergy, was this allergy previously documented?  Admitting orders  Pharmacy computer  Nursing Kardex 4. Were appropriate therapeutic drug monitoring or other laboratory tests performed, which may have predicted this reaction? (include toxic serum levels) 5. Reaction involved a drug-drug, drug-food or drug-lab interaction. SEVERITY ASSESSMENT 1. An ADR occurred but required no change in treatment with the suspected drug. 2. The ADR required that treatment with the suspected drug be held, discontinued or otherwise changed. No antidote or other treatment required. No increase in length of stay. 3. The ADR required that treatment with the suspected drug be held, discontinued or otherwise changed AND/OR an antidote or other treatment was required. 4. Serious ADR, but drug’s benefits outweigh the adverse effects; drug is continued. 5. The ADR was the reason for admission. 6. The ADR treatment required intensive medical care. Increase length of stay. 7. The ADR caused permanent harm to the patient. 8. The ADR directly or indirectly led to the death of the patient. THESE TYPES OF ADR ARE REPORTABLE TO THE FDA - MED WATCH 1. The suspected drug has been on the market for less than two years. 2. The reaction is not listed in the package insert. 3. The reaction is attributed to an investigational drug. 4. The reaction contributed to the death of the patient. 5. The reaction was life-threatening or permanently disabling. This information will remain confidential. Upon completion of the form, return to the __________________ Department. Completed by: Date: