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. DE270 What type of medication/substance was involved? a. A1197 Medications 2. DE273 What type of medication? a. A1218 Prescription or overthe-counter (including herbal supplements) b. A1221 Compounded preparations c. A1224 Investigational drugs d. UNK Unknown 3. DE276 Please list all ingredients: b. A1200 Biological products 4. DE279 What type of biological product? a. A1233 Vaccines b. A1236 Other biological products (e.g., thrombolytic) 5. DE282 What was the lot number of the vaccine? LOT NUMBER c. A1203 Nutritional products d. A1206 Expressed human breast milk e. A1209 Medical gases (e.g., oxygen, nitrogen, nitrous oxide) f. A1212 Contrast media 6. DE285 What type of nutritional product? a. A1242 Dietary supplements (other than vitamins or minerals) b. A1245 Vitamins or minerals c. A1248 Enteral nutritional products, including infant formula d. A1251 Parenteral nutritional products e. A66 Other: PLEASE SPECIFY g. A1213 Radiopharmaceuticals h. A1214 Patient food (not suspected in drug-food interactions) i. A1216 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. A1215 Other substance: PLEASE SPECIFY STOP This form is complete. Page 1 of 5
7. DE288 Which of the following best characterizes the event? a. A1257 Incorrect action (process failure or error) (e.g., such as administering overdose or incorrect medication) b. A1260 Unsafe condition ANSWER QUESTIONS 17-25 c. A1263 Adverse reaction in patient to the administered substance without any apparent incorrect action d. UNK Unknown STOP This form is complete. 8. DE291 What was the incorrect action? CHECK ALL THAT APPLY: a. A585 Incorrect patient b. A1272 Incorrect medication/substance c. A1275 Incorrect dose(s) d. A1278 Incorrect route of administration 9. DE294 Which best describes the incorrect dose(s)? a. A1314 Overdose b. A1317 Underdose c. A1320 Missed or omitted dose d. A1323 Extra dose e. UNK Unknown e. A1281 Incorrect timing 10. DE297 Which best describes the incorrect timing? a. A1329 Too early b. A1332 Too late f. A1284 Incorrect rate 11. DE300 Which best describes the incorrect rate? a. A1338 Too quickly b. A1341 Too slowly g. A1287 Incorrect duration of administration or course of therapy h. A1290 Incorrect dosage form (e.g., sustained release instead of immediate release) i. A1293 Incorrect strength or concentration j. A1296 Incorrect preparation, including inappropriate cutting of tablets, error in compounding, mixing, etc. k. A1299 Expired or deteriorated medication/substance l. A1302 Medication/substance that is known to be an allergen to the patient 12. DE303 Which best describes the incorrect strength or concentration? a. A1347 Too high b. A1350 Too low 13. DE306 What was the expiration date? 14. DE309 Was there a documented history of allergies or sensitivities to the medication/substance administered? / / MM DD YYYY Page 2 of 5
m. A1305 Medication/substance that is known to be contraindicated for the patient 15. DE312 What was the contraindication (potential or actual interaction)? a. A1368 Drug-drug b. A1371 Drug-food c. A1374 Drug-disease d. A66 Other: PLEASE SPECIFY n. A1308 Incorrect patient/family action (e.g., self-administration error) o. A66 Other: PLEASE SPECIFY 16. E315 At what stage in the process did the event originate, regardless of the stage at which it was discovered? a. A1380 Purchasing b. A1383 Storing c. A1386 Prescribing/ordering d. A1389 Transcribing e. A1392 Preparing f. A1395 Dispensing g. A1398 Administering h. A1401 Monitoring i. UNK Unknown j. A66 Other: PLEASE SPECIFY QUESTIONS 17-27 DO NOT APPLY TO COMPOUNDED PREPARATION OR EXPRESSED HUMAN BREAST MILK FOR AN INCIDENT, ANSWER QUESTIONS 17-27 FOR A NEAR MISS, ANSWER QUESTIONS 17-26 FOR AN UNSAFE CONDITION, ANSWER QUESTIONS 17-25 Page 3 of 5
Please provide the following medication details for any medications or other substances directly involved in the event. 17. DE318 Generic name or investigational drug name 18. DE319 Ingredient RXCUI 19. DE321 Brand name 20. DE322 Brand name RXCUI (if known) 21. DE324 Manufacturer 22. DE327 Strength or concentration of product 1 2 3 4 5 23. DE328 Clinical drug component RXCUI 24. DE330 Dosage form of product 25. DE331 Dose form RXCUI (if known) 26. DE333 Was this medication/ substance prescribed for this patient? 27. DE336 Was this medication / substance given to this patient? 1 2 3 4 5 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 28-29 Page 4 of 5
28. DE348 What was the intended route of administration? a. A1440 Cutaneous, topical application, including ointment, spray, patch b. A1443 Subcutaneous c. A1444 Ophthalmic d. A1446 Oral, including sublingual or buccal e. A1447 Otic f. A1449 Nasal g. A1450 Inhalation h. A1452 Intravenous i. A1455 Intramuscular j. A1458 Intrathecal k. A1461 Epidural l. A1464 Gastric m. A1467 Rectal n. A1470 Vaginal o. UNK Unknown p. A66 Other: PLEASE SPECIFY _ 29. DE351 What was the actual route of administration (attempted or completed)? a. A1440 Cutaneous, topical application, including ointment, spray, patch b. A1443 Subcutaneous c. A1444 Ophthalmic d. A1446 Oral, including sublingual or buccal e. A1447 Otic f. A1449 Nasal g. A1450 Inhalation h. A1452 Intravenous i. A1455 Intramuscular j. A1458 Intrathecal k. A1461 Epidural l. A1464 Gastric m. A1467 Rectal n. A1470 Vaginal o. UNK Unknown p. A66 Other: PLEASE SPECIFY _ Thank you for completing these questions. OMB No. 0935-0143 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 (0935-0143) AHRQ, 5600 Fishers Lane, # 07W41A, Rockville, MD 20857. Page 5 of 5