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US-derived preventable drug-related morbidity definitions: outcomes and associated patterns of care1

Outcome Pattern of care

1. Gastritis and/or upper GI bleed and anaemia NSAID (e.g. diclofenac, least one month ibuprofen, ketoprofen etc) use for at and/or GI perforation and/or GI ulcer No concurrent use of a cytoprotective agent (misoprostol) Haemoglobin/haematocrit/CBC not done at least every 3 months thereafter
2. Acute renal failure and/or renal. insufficiency NSAID (e.g. diclofenac, ibuprofen, ketoprofen etc.) use for at least three months BUN/serum creatinine not done at least every three months
3. ER visit/hospitalization due to depression and/or increase in dosage of antidepressant History/diagnosis of depression Use of long-acting benzodiazepine (e.g.; Librium, Valium, Centrax, Paxipam, Dalmane, Azaene/Tranxene etc.)
4. Fall and/or hip fracture and/or other bone fracture and/or bone break Use of tricyclic antidepressant (e.g. amitriptyline, doxepin, imipramine etc.)
5. ER visit/hospitalization due to worsening renal impairment and/or acute renal failure and/or renal insufficiency Diagnosis/history of moderate to severe renal impairment and/or history of kidney disease Use of tetracycline BUN/serum creatinine not done within 30 days of initiation of therapy and at least every 6 months
6. ER visit/hospitalization due to hyperkalaemia Use of an ACE inhibitor (e.g. captopril, enalapril etc.) Electrolytes/CBC not done at least every 6 months Should be done at baseline, 10–14 days, then prn
27. Blood dyscrasias and/or hyponatraemia and/or excessive water retention and/or syndrome of inappropriate antidiuretic hormone (SIADH) Use of carbamazepine Electrolytes/CBC not done before therapy initiated, at least weekly during the first month of therapy, at least monthly during the next five months of therapy, and at least every 6 months thereafter
8. Acute renal failure and/or renal insufficiency Use of lithium. BUN/serum creatinine not done at least every three months
9. Theophylline toxicity Use of theophylline Drug level not done at least every six months
10. Bipolar exacerbation and/or ER visit/hospitalization due to bipolar disorder Diagnosis/history of bipolar disorder Use of lithium Drug level not done at least every three months
11. Major and/or minor haemorrhagic event Use of IV heparin PTT not done at least every day
12. Gastritis and/or upper GI bleeds and/or perforations and/or GI ulcers and anaemia History/diagnosis of ulcers and/or GI bleeding NSAID (e.g. diclofenac, ibuprofen, ketoprofen etc.) use for at least one month
13. Gastritis and/or upper GI bleeds and/or GI perforations and/or GI ulcers and anaemia History/diagnosis of ulcers and/or gastrointestinal bleeding Use of an oral corticosteroid (e.g., prednisone) for at least 3 months
14. ER visit/hospitalization due to depression and/or increase in dosage of antidepressant History/diagnosis of depression Use of a barbiturate (e.g. butalbital)
15. ER visit/hospitalization due to depression and/or increase in dosage of antidepressant History/diagnosis of depression Use of a sympatholytic antihypertensive (e.g. resperine, methyldopa, clonidine etc.)
16. ER visit/hospitalization due to congestive heart failure and/or heart block History/diagnosis of congestive heart failure with heart block or advanced bradycardia Use of digoxin
17. Fall and/or hip fracture and/or other bone fracture and/or bone break Use of a long-half-life hypnotic-anxiolytic (e.g. flurazepam, diazepam, chlordiazepoxide etc.)
18. Acute renal failure and/or renal insufficiency Use of an ACE inhibitor (e.g. captopril, enalapril etc.) BUN/serum creatinine not done at initiation of therapy and at least every three months thereafter
219. Status epilepticus and/or ER visit/hospitalization due to seizure activity Use of an anticonvulsant requiring drug-level monitoring (e.g. phenytoin, carbamazepine, valproic acid) Drug level not done upon initiation of therapy and at least every six months thereafter
20. Lithium toxicity Use of lithium Lithium level not done at least every month
21. ER visit/hospitalization due to hyperglycaemia Use of an oral hypoglycaemic agent (e.g. chlorpropamide etc.) Haemoglobin A1c level not done at least every six months
22. Major and/or minor haemorrhagic event Use of warfarin Prothrombin time not done before therapy starts and at least every month thereafter
23. ER visit/hospitalization due to hyperthyroidism Use of a thyroid or antithyroid agent (e.g. levothyroxine, propylthiouracil etc.) T4/TSH not done within six weeks after initiation of therapy and at least every 12 months thereafter
224. Secondary myocardial infarction History/diagnosis of myocardial infarction No use of ASA and/or a beta-blocker (e.g. metoprolol, etc.)
25. Blood dyscrasias Concurrent use of trimethoprim/ sulfamethoxazole (Bactrim, Septra) and methotrexate WBC/platelets/CBC not done at least every four weeks
26. ER visit/hospitalization due to a major/minor haemorrhagic event Warfarin use NSAID (e.g. diclofenac, ibuprofen, ketoprofen, etc.) use PT not done within 10 days
27. ER visit/hospitalization due to hypothyroidism Lithium use for at least six months TSH not done at least every six months
28. ER visit/hospitalization due to a major/minor haemorrhagic event Warfarin use Antibiotic use (Bactrim etc.) PT not done within five days
29. Gastritis and/or upper GI bleed and/or GI perforation and/or GI ulcer and anemia Use of two or more NSAIDs concurrently for at least 2 weeks.
30. Blood dyscrasias/ thrombocytopenia Use of Ticlopidine (Ticlid) CBC/platelets not done at baseline, within two weeks of start of therapy and within two months
31. Rebound congestion Use of a long-acting nasal spray (e.g. oxymetazoline) for more than three days
32. Acute urinary retention Diagnosis/ history of bladder atony due to diabetes Use of imipramine
33. Acute respiratory failure History/diagnosis of severe COPD Use of a medium- to long-acting benzodiazepine
34. Acute urinary retention History/diagnosis of benign prostatic hypertrophy (BPH) Use of an anticholinergic agent
35. ER visit/hospitalization due to liver toxicity Use of troglitazone (Rezulin) Liver function tests not done at baseline and at least monthly for the first eight months of therapy and at least every two months for the remainder of the first year
36. ER visit/ hospitalization due to congestive heart failure and/or fluid overload History/diagnosis of high blood pressure (over 140/90 mmHg and/or congestive heart failure NSAID (e.g. diclofenac, indomethacin, ketoprofen, etc.) use for at least three months
37. ER visit/hospitalization due to extreme hypoglycaemia History/diagnosis of diabetes Use of a beta-adrenergic blocking agent (e.g.; propranolol, nadolol etc.)
38. ER visit/hospitalization due to depression and/or increase in dosage of antidepressant History/diagnosis of depression Use of a moderate to high lipophilic beta-adrenergic blocking agent (e.g. propranolol, pindolol etc.)
39. ER visit/hospitalization for hypokalaemia Use of a potassium-wasting diuretic (e.g. hydrochlorothiazide etc.) No concurrent use of potassium chloride supplement Electrolytes not checked at least every two months
240. Anticonvulsant drug toxicity Use of an anticonvulsant requiring drug level monitoring (e.g.; phenytoin, carbamazepine, valproic acid) Drug level not done at least every six months
41. ER visit/hospitalization due to systolic heart failure History/diagnosis of systolic heart failure Use of a beta-adrenergic blocking agent (e.g. propranolol, nadolol etc.)
42. ER visit/hospitalization due to congestive heart failure History/diagnosis of congestive heart failure Use of an antiarrhythmic agent (e.g. disopyramide, procainamide etc.)
43. Fall and/or hip fracture and/or other bone fracture and/or bone break Use of an antipsychotic (e.g. thioridazine, haloperidol, chlorpromazine etc.)
44. Asthma exacerbation and/or status asthmaticus and/or ER visit/hospitalization due to asthma Diagnosis of asthma Use of a bronchodilator No use of a maintenance corticosteroid (e.g. beclomethasone etc.)
45. Hospitalization/ER visit due to worsening renal impairment and/or acute renal failure and/or renal insufficiency Diagnosis/history of moderate to severe renal impairment/history of kidney disease Use of a select urinary antiinfective agent (nalidixic acid, nitrofurantoin, or methenamine complexes) BUN/serum creatinine not done within 30 days of initiation of therapy and at least every six months
46. ER visit/hospitalization due to congestive heart failure Diagnosis/history of congestive heart failure Not on an ACE inhibitor (e.g. captopril, enalapril etc.)
47. Aminoglycoside toxicity (acute renal failure and/or renal insufficiency and/or vestibular damage and/or auditory damage) Use of an aminoglycoside Serum creatinine not done before and after therapy (and if therapy longer than seven days, not done at least every seven days). At least one drug level not done
48. ER visit/hospitalization due to congestive heart failure History/diagnosis of congestive heart failure Use of a calcium channel blocker (e.g. diltiazem etc.)
49. COPD exacerbation and/or visit/hospitalization due to COPD Diagnosis/history of COPD. Use of a beta-blocker (e.g. propranolol, etc.).
50. ER visit/hospitalization due to hypoglycemia or hyperglycemia Use of insulin. Hemoglobin Alc level not done at least every 6 months.
51. Fall and/or hip fracture and/or other bone fracture and/or bone break Use of an anticholinergic agent
1Data reproduced with permission [19].

2These indicators were separated into the number identified below for the UK work: number 7 (two indicators), number 19 (three indicators), number 24 (two indicators), number 40 (three indicators). Therefore, this equated to 57 distinct indicators for the beginning of the UK work.





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