MEDICATION OR OTHER SUBSTANCE
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1 Patient Safety Event Report Hospital MEDICATION OR OTHER SUBSTANCE Use this form to report any patient safety event or unsafe condition involving a substance such as a medications, biological products, nutritional products, expressed human breast milk, medical gases, or contrast media. Do not complete this form if the event involves appropriateness of therapeutic choice or decision making (e.g., physician decision to prescribe medication despite known drug-drug interaction). If the event involves a device, please also complete the Device or Medical/Surgical Supply including Health Information Technology (HIT) form. Narrative detail can be captured on the Healthcare Event Reporting Form (HERF). Highlighted fields are collected for local facility and PSO use. This information will not be forwarded to the Network of Patient Safety Databases (NPSD). 1. What type of medication/substance was involved? a. Medications 2. What type of medication? a. Prescription or over-thecounter (including herbal supplements) b. Compounded preparations c. Investigational drugs d. Unknown 3. Please list all ingredients: b. Biological products 4. What type of biological product? a. Vaccines b. Other biological products (e.g., thrombolytic) 5. What was the lot number of the vaccine? LOT NUMBER c. Nutritional products d. Expressed human breast milk e. Medical gases (e.g., oxygen, nitrogen, nitrous oxide) f. Contrast media 6. What type of nutritional product? a. Dietary supplements (other than vitamins or minerals) b. Vitamins or minerals c. Enteral nutritional products, including infant formula d. Parenteral nutritional products e. Other: PLEASE SPECIFY g. Radiopharmaceuticals h. Patient food (not suspected in drug-food interactions) i. Drug-drug, drug-food, or adverse drug reaction as a result of a prescription and/or administration of a drug and/or food prior to admission j. Other substance: PLEASE SPECIFY STOP This form is complete. Page 1 of 5
2 7. Which of the following best characterizes the event? a. Incorrect action (process failure or error) (e.g., such as administering overdose or incorrect medication) b. Unsafe condition Event ID: ANSWER QUESTIONS c. Adverse reaction in patient to the administered substance without any apparent incorrect action d. Unknown STOP This form is complete. 8. What was the incorrect action? CHECK ALL THAT APPLY: a. Incorrect patient b. Incorrect medication/substance c. Incorrect dose(s) d. Incorrect route of administration 9. Which best describes the incorrect dose(s)? a. Overdose b. Underdose c. Missed or omitted dose d. Extra dose e. Unknown e. Incorrect timing 10. Which best describes the incorrect timing? a. Too early b. Too late f. Incorrect rate 11. Which best describes the incorrect rate? a. Too quickly b. Too slowly g. Incorrect duration of administration or course of therapy h. Incorrect dosage form (e.g., sustained release instead of immediate release) i. Incorrect strength or concentration j. Incorrect preparation, including inappropriate cutting of tablets, error in compounding, mixing, etc. k. Expired or deteriorated medication/substance l. Medication/substance that is known to be an allergen to the patient m. Medication/substance that is known to be contraindicated for the patient 12. Which best describes the incorrect strength or concentration? a. Too high b. Too low 13. What was the expiration date? / / MM DD YYYY 14. Was there a documented history of allergies or sensitivities to the medication/substance administered? 15. What was the contraindication (potential or actual interaction)? a. Drug-drug b. Drug-food c. Drug-disease d. Other: PLEASE SPECIFY n. Incorrect patient/family action (e.g., self-administration error) o. Other: PLEASE SPECIFY _ Page 2 of 5
3 16. At what stage in the process did the event originate, regardless of the stage at which it was discovered? a. Purchasing b. Storing c. Prescribing/ordering d. Transcribing e. Preparing f. Dispensing g. Administering h. Monitoring i. Unknown j. Other: PLEASE SPECIFY QUESTIONS DO NOT APPLY TO COMPOUNDED PREPARATION OR EXPRESSED HUMAN BREAST MILK FOR AN INCIDENT, ANSWER QUESTIONS FOR A NEAR MISS, ANSWER QUESTIONS FOR AN UNSAFE CONDITION, ANSWER QUESTIONS Page 3 of 5
4 Please provide the following medication details for any medications or other substances directly involved in the event. 17. Generic name or investigational drug name 18. Ingredient RXCUI 19. Brand name (if known) 20. Brand name RXCUI 21. Manufacturer 22. Strength or concentration of product Clinical drug component RXCUI 24. Dosage form of product 25. Dose form RXCUI 26. Was this medication/ substance prescribed for this patient? 27. Was this medication / substance given to this patient? IF THIS EVENT DID NOT INVOLVE AN INCORRECT ROUTE OF ADMINISTRATION STOP This form is complete. IF THE EVENT INVOLVED AN INCORRECT ROUTE OF ADMINISTRATION, ANSWER QUESTIONS Page 4 of 5
5 28. What was the intended route of administration? a. Cutaneous, topical application, including ointment, spray, patch b. Subcutaneous c. Ophthalmic d. Oral, including sublingual or buccal e. Otic f. Nasal g. Inhalation h. Intravenous i. Intramuscular j. Intrathecal k. Epidural l. Gastric m. Rectal n. Vaginal o. Unknown p. Other: PLEASE SPECIFY 29. What was the actual route of administration (attempted or completed)? a. Cutaneous, topical application, including ointment, spray, patch b. Subcutaneous c. Ophthalmic d. Oral, including sublingual or buccal e. Otic f. Nasal g. Inhalation h. Intravenous i. Intramuscular j. Intrathecal k. Epidural l. Gastric m. Rectal n. Vaginal o. Unknown p. Other: PLEASE SPECIFY Thank you for completing these questions. OMB No Exp. Date 12/31/2017 Public reporting burden for the collection of information is estimated to average 10 minutes per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer, Attention: PRA, Paperwork Reduction Project ( ) AHRQ, 5600 Fishers Lane, # 07W41A, Rockville, MD Page 5 of 5
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