Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement

Dreischulte, Tobias; Grant, Aileen M; McCowan, Colin; McAnaw, John J; Guthrie, Bruce

doi:10.1186/1472-6904-12-5

Table 5 Safety assessment criteria generated from candidates that the RAM panel classified as 'inappropriate' (I) or 'necessary to avoid' (N)

From: Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement

Topic No.	Treatment targeted - Associated PDRM event (Medication safety category)
A. DRUGS FREQUENTLY IMPLICATED IN PDRM HOSPITAL ADMISSIONS
ANTIPLATELETS
S1	High-risk use without gastro-intestinal protection (GIP) - GI toxicity/bleeding (MS1)
	1. (N) Patient with previous peptic ulcer (PU) treated with low dose aspirin - is not prescribed GIP
	2. (N) Patient aged ≥ 65 treated with warfarin AND low dose aspirin - is not prescribed GIP
	3. (N) Patient aged ≥ 65 treated with warfarin AND clopidogrel - is not prescribed GIP
	4. (N) Patient aged ≥ 65 treated with low dose aspirin AND clopidogrel - is not prescribed GIP
	5. (I) Patient aged ≥ 75 years treated with low dose aspirin - is not prescribed GIP
NSAIDS
S1	High-risk use without gastroprotection (GIP) - GI toxicity/bleeding (MS1)
	6. (N) Patient with previous PU treated with an oral NS NSAID for > 12 weeks - is not prescribed GIP
	7. (N) Patient is aged ≥ 75 years treated with an oral NS NSAID for > 12 weeks - is not prescribed GIP
	8. (I) Patient is aged 65 to 74 treated with an oral NS NSAID for > 12 weeks - is not prescribed GIP
S1	High-risk use without gastroprotection - GI toxicity/bleeding (MS1)
	9. (N) Patient aged ≥ 65 treated with warfarin AND an oral NS NSAID - is not prescribed GIP
	10. (N) Patient aged ≥ 65 treated with low dose aspirin AND an oral NS NSAID for > 12 weeks - is not prescribed GIP
S2	High risk drug without compelling indication - General drug specific toxicity (MS2)
	11. (N) Patient aged ≥ 65 - is prescribed an oral NSAID for osteoarthritis without previous trial of full dose paracetamol
	12. (N) Patient aged ≥ 75 - is prescribed an oral NSAID for minor trauma without previous trial of full dose paracetamol
	13. (I) Patient aged 65 to 74 - is prescribed an oral NSAID for minor trauma without previous trial of full dose paracetamol
S3	High-risk selection in renal impairment - Renal toxicity (MS3)
	14. (N) Patient with CKD stage 3 - is prescribed an oral NSAID
	15. (N) Patient with CKD stage 4 or 5 - is prescribed an oral NSAID
S3	Drug-Drug interaction (additive toxicity) - Renal toxicity (MS4)
	16. (N) Patient aged ≥ 65 treated with an ACEI or ARB but no diuretic - is co-prescribed an oral NSAID
	17. (N) Patient aged ≥ 75 treated with a diuretic but no ACEI or ARB - is co-prescribed an oral NSAID
	18. (N) Patient treated with an ACEI or ARB AND a diuretic - is co-prescribed an oral NSAID
	19. (I) Patient aged ≤ 65 treated with an ACEI or ARB but no diuretic - is co-prescribed an oral NSAID
	20. (I) Patient aged 65 to 74 treated with a diuretic but no ACEI or ARB - is co-prescribed an oral NSAID
S4	High-risk drug without compelling indication - CV events (MS2)
	21. (N) Patient treated with low-dose aspirin - is prescribed an oral COX II selective NSAID
S5	High-risk selection in patients at high vascular risk- Vascular events (MS3)
	22. (N) Patient aged > 40 and CVD risk > 20% - is prescribed a COX II selective NSAID
	23. (N) Patient with a history of vascular events - is prescribed a COX II selective NSAID
DIURETICS
S6	Monitoring of U&E's - Electrolyte imbalance (MS8)
	24. (N) Patient treated with a potassium sparing diuretic -had no U&Es check before treatment start
	25. (N) Patient treated with a potassium sparing diuretic - had no U&Es check in the last 48 weeks
	26. (N) Patient treated with a loop diuretic - had no U&Es check before treatment start
	27. (N) Patient treated with a loop AND a thiazide diuretic or metolazone - had no U&Es check in the last 24 weeks
	28. (N) Patient treated with a potassium sparing diuretic AND an ACEI or ARB - had no U&Es check in the last 48 weeks
	29. (I) Patient treated with a potassium wasting diuretic - had no U&Es check in the last 48 weeks
	30. (I) Patient treated with a potassium sparing diuretic AND an ACEI or ARB - had no U&Es check in the last 24 weeks
S7	High-risk selection in renal impairment - Renal toxicity/Treatment failure (MS3)
	31. (N) Patient with chronic kidney disease stage 4 or 5 - is prescribed a thiazide diuretic
S8	High-risk use without allopurinol - Gout (MS1)
	32. (N) Patient with a history of gout and treated with a thiazide diuretic - is not prescribed allopurinol
S9	High-risk selection in renal impairment - Electrolyte imbalance (MS3)
	33. (N) Patient with CKD stage 4 or 5 - is prescribed an aldosterone antagonist
S10	Excess duration - Electrolyte imbalance (MS6)
	34. (N) Patient treated with a potassium (KI) sparing diuretic - is prescribed a K+ supplement for ≥ 4 weeks
ANTICOAGULANTS
S11	Drug-Drug interaction (pharmacokinetic) - Bleeding (MS4)
	35. (N) Patient treated with warfarin - is co-presribed a macrolide
	36. (N) Patient treated with warfarin - is co-prescribed a sulfonamide
	37. (N) Patient treated with warfarin - is co-prescribed an azole antifungal
	38. (N) Patient treated with warfarin - is co-prescribed metronidazole
	39. (N) Patient treated with warfarin - is co-prescribed chloramphenicol
	40. (N) Patient treated with warfarin- is co-prescribed isoniazid
	41. (N) Patient treated with warfarin - is co-prescribed rifampin
	42. (N) Patient treated with warfarin - is co-prescribed griseofulvin
	43. (N) Patient treated with warfarin - is co-prescribed ribavirin
	44. (I) Patient treated with warfarin - is co-prescribed tetracyclines
S12	High risk drug without compelling indication- Bleeding (MS2)
	45. (N) Patient with atrial fibrillation - is prescribed warfarin despite CHADS2 score = 0
OPIOIDS - CONSTIPATION
S13	High-risk use without laxative - Constipation (MS1)
	46. (N) Patient treated with a strong opioid (morphine > 10 mg or equivalent) for > 4 weeks - is not prescribed a laxative
	47. (I) Patient aged ≥ 65 treated with a strong opioid (morphine > 10 mg or equivalent) - is not prescribed a laxative
BETA BLOCKERS
S14	Drug-drug interaction (additive toxicity) - Bradycardia (MS4)
	48. (N) Patient treated with a beta-blocker - is co-prescribed verapamil or diltiazem
S15	High-risk selection in asthma - Asthma exacerbation (MS3)
	49. (N) Patient with active asthma (prescribed beta agonist inhaler in last year) without COPD - is prescribed any oral BB
	50. (N) Patient with active asthma without COPD - is prescribed a non-cardio-selective oral BB
	51. (I) Patient with active asthma without COPD - is prescribed beta-blocker eye drops
ACE INHIBITORS (ACEIs) AND ANGIOTENSIN RECEPTOR BLOCKERS (ARBs)
S6	Monitoring of U&E's - Electrolyte imbalance (MS8)
	52. (N) Patient co-prescribed an ACEI AND ARB - has not had a U&Es check > 24 weeks ago
	Monitoring of U&E's - Electrolyte imbalance (MS8)
	53. (N) Patient prescribed an ACEI or ARB - has not had a U&Es check before treatment start
ANTIDIABETICS
S16	High-risk selection in renal impairment- Lactic acidosis (MS3)
	54. (N) Patient with chronic kidney disease (CKD) stage 4 or 5 - is prescribed metformin
S17	High-risk selection in renal impairment - Hypoglycaemia (MS3)
	55. (N) Patient with CKD stage 4 or 5 - is prescribed a sulphonylurea other than gliclazide or tolbutamide
DIGOXIN
S18	Excessive dose (Elderly) - General digoxin toxicity (MS5)
	56. (N) Patient aged ≥ 65 years - is prescribed digoxin ≥ 250 mcg/day
	57. (N) Patient with CKD stage 3, 4 or 5 (eGFR < 60) - is prescribed digoxin ≥ 250 mcg/day
S18	Excessive dose (DDI without dose adjustment) - General digoxin toxicity (MS5)
	58. (N) Patient treated with digoxin and amiodarone - is prescribed digoxin ≥ 250 mcg/day
	59. (N) Patient treated with digoxin and propafenone - is prescribed digoxin ≥ 250 mcg/day
	60. (N) Patient treated with digoxin and chloroquine or hydroxychloroquine - is prescribed digoxin ≥ 250 mcg/day
	61. (N) Patient treated with digoxin and quinine - is prescribed digoxin ≥ 250 mcg/day
	62. (N) Patient treated with digoxin and a calcium channel blocker * - is prescribed digoxin ≥ 250 mcg/day
	63. (N) Patient treated with digoxin and ciclosporin - is prescribed digoxin ≥ 250 mcg/day
	* lercanidipine, nicardipine, nifedipine, diltiazem, verapamil)
S8	Monitoring of U&E's - General digoxin toxicity (MS8)
	64. (N) Patient is co-prescribed a potassium wasting diuretic AND digoxin with last U&Es check before treatment start
	65. (N) Patient is co-prescribed a potassium wasting diuretic AND digoxin with last U&Es check > 48 weeks ago
CORTICOSTEROIDS
S19	High-risk use without bone protecting agent - Bone fracture (MS1)
	66. (N) Patient aged ≥ 65 years treated with an oral corticosteroid for ≥ 12 weeks - is not prescribed bone protection *
	67. (N) Patient with low trauma fracture and treated with an oral corticosteroid for ≥ 12 weeks - is not prescribed bone protection*
	*a bisphosphonate, calcitriol or hormone replacement therapy
B. OTHER HIGH RISK DRUGS
DMARDS
S20	High-risk drug without taking action to ensure patient compliance - General toxicity (MS7)
	68. (N) Patient treated with methotrexate - has not been given explicit dose instructions of weekly dosing
	69. (N) Patient treated with methotrexate - is prescribed > 1 strength of methotrexate tablets
S21	Monitoring of full blood count (FBC) - Blood dyscrasias (MS8)
	70. (N) Patient treated with auranofin - had no FBC check in the last 8 weeks
	71. (N) Patient treated with aurothiomalate - had no FBC check in the last 8 weeks
	72. (N) Patient treated with penicillamine - had no FBC check in the last 8 weeks
	73. (N) Patient treated with leflunomide - had no FBC check in the last 12 weeks
	74. (N) Patient treated with methotrexate - had no FBC check in the last 12 weeks
	75. (N) Patient treated with azathioprine - had no FBC check in the last 12 weeks
	76. (I) Patient treated with cyclophosphamide - had no FBC check in the last 24 weeks
	77. (I) Patient treated with sulfasalazine - had no FBC check in the last 24 weeks
FEMALE HORMONES
S22	Selection in patients at high vascular risk - Vascular events (MS3)
	78. (N) Patient with previous vascular disease/events - is prescribed any hormone replacement therapy (HRT)
	79. (N) Patient with an estimated 10 year CVD risk ≥ 20% - is prescribed combined contraceptives
	80. (I) Patient with an estimated 10 year CVD risk ≥ 20% and aged 50 to 59 - is prescribed combined HRT
	81. (I) Patient with an estimated 10 year CVD risk ≥ 20% and aged ≥ 60 - is prescribed (any) HRT
S23	Excess duration - Gynaecological cancer (MS6)
	82. (N) Patient aged ≥ 50 - is prescribed combined HRT for ≥ 5 years
	83. (N) Patient aged ≥ 50 without hysterectomy - is prescribed estrogens without cyclical progestogen
	84. (I) Patient aged ≥ 50 - is prescribed estrogens only HRT for ≥ 5 years
AMIODARONE
S24	Monitoring of thyroid function - Hypo-/Hyperthyroidism (MS8)
	85. (N) Patient prescribed amiodarone - had no thyroid function test in last 9 months
THEOPHYLLINE
S25	High-risk drug without compelling indication - General theophylline toxicity (MS2)
	86. (N) Patient aged ≥ 65 with COPD - is prescribed theophylline without use of a long acting beta2 - agonist or antimuscarinic
STATINS
S26	Excessive dose (DDI without dose adjustment) - Rhabdomyolysis (MS5)
	87. (N) Patient treated with simvastatin and an HIV protease inhibitor - is prescribed simvastatin > 10 mg/day
	88. (N) Patient treated with simvastatin and ciclosporin - is prescribed simvastatin > 10 mg/day
	89. (N) Patient treated with simvastatin and verapamil - is prescribed simvastatin > 10 mg/day
	90. (N) Patient treated with simvastatin and a fibrate (except fenofibrate) - is prescribed simvastatin > 10 mg/day
	91. (N) Patient treated with simvastatin and amiodarone - is prescribed simvastatin > 20 mg/day
C. PATIENT GROUPS PARTICULARLY VULNERABLE TO ADVERSE DRUG EVENTS
ELDERLY PATIENTS
S27	High-risk drug selection in the elderly - Miscellaneous (MS3)
	92. (N) Patient aged ≥ 65 with dementia - is prescribed a TCA
	93. (N) Patient aged ≥ 65 with dementia but no psychosis - is prescribed an antipsychotic
	94. (N) Patient aged ≥ 65 with dementia and psychosis - is prescribed antipsychotic other than risperidone
	95. (N) Patient aged ≥ 65 - is prescribed a long acting benzodiazepine
	96. (N) Patient aged ≥ 65 with Parkinson's disease - is prescribed an antipsychotic other than quetiapine or clozapine
	97. (N) Patient aged ≥ 65 with Parkinson's disease - is prescribed a phenothiazine antiemetic
	98. (N) Patient aged ≥ 75 - is prescribed a TCA
	99. (N) Patient aged ≥ 75 - is prescribed a short acting benzodiazepine
	100. (N) Patient aged ≥ 75 - is prescribed a Z-drug
	101. (N) Patient aged ≥ 75 - is prescribed an antihistamine with antimuscarinic properties
	102. (A) Patient aged ≥ 85 - is prescribed an antispasmodic with antimuscarinic properties
S27	Excess duration - Miscellaneous (MS6)
	103. (N) Patient aged ≥ 65 - is prescribed a TCA for ≥ 4 weeks
	104. (N) Patient aged ≥ 65 - is prescribed a short acting benzodiazepine for ≥ 4 weeks
	105. (N) Patient aged ≥ 65 - is prescribed a Z-drug for ≥ 4 weeks
	106. (N) Patient aged ≥ 65 - is prescribed an antispasmodic with antimuscarinic properties for ≥ 4 weeks
	107. (N) Patient aged ≥ 65 with dementia and psychosis - is prescribed risperidone for ≥ 12 weeks
	108. (N) Patient aged 66 to 75 - is prescribed an antihistamine with antimuscarinic properties for ≥ 4 weeks
	109. (N) Patient aged ≥ 75 - is prescribed urologicals with antimuscarinic properties for ≥ 4 weeks
PATIENTS WITH HEART FAILURE
S28	Use in heart failure - Heart failure exacerbation (MS3)
	110. (N) Patient with chronic heart failure - is prescribed a class 1 or 3 antiarrhythmics except amiodarone
	111. (N) Patient with chronic heart failure - is prescribed verapamil or diltiazem
	112. (N) Patient with chronic heart failure - is prescribed minoxidil
	113. (N) Patient with chronic heart failure - is prescribed any oral NSAID
	114. (N) Patient with chronic heart failure - is prescribed a glitazone
	115. (N) Patient with chronic heart failure - is prescribed a tricyclic antidepressant
	116. (N) Patient with chronic heart failure - is prescribed itraconazole
	117. (N) Patient with chronic heart failure - is prescribed other antifungals (e.g. ketoconazole, fluconazole)
	118. (N) Patient with chronic heart failure - is prescribed tadalafil
	119. (N) Patient with chronic heart failure - is prescribed disulfiram
CHILDREN AND YOUNG ADULTS
S29	Use in children - Miscellaneous (MS3)
	120. (N) Patient aged ≤ 20 - is prescribed a phenothiazine anti-emetic
	121. (N) Patient aged ≤ 16 who has no record of Kawasaki disease - is prescribed aspirin
	122. (N) Patient aged ≤ 12 - is prescribed a tetracycline
	123. (N) Patient aged ≤ 18 - is prescribed an antidepressant other than fluoxetine
	124. (I) Patient aged ≤ 18 - is prescribed fluoxetine

The criteria target high-risk use of (A) drugs frequently implicated in PDRM hospital admissions, (B) other drugs implicated in severe PDRM events and (C) medication use in vulnerable groups. Within each domain A to C, the criteria are organised hierarchically by the high-risk drug (group) that is the focus of each criterion, followed by safety topic scored in the Delphi study (S) and medication use safety category (MS). MS1 = Indication for risk mitigating drug; MS2 = High risk drug without compelling indication; MS3 = Drug-disease or Drug-age interaction; MS4 = Drug-Drug interaction (DDI); MS5 = Excessive dose; MS6 = Excessive duration; MS7 = Prescribing issues linked to patient compliance; MS8 = Inconsistent monitoring

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