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Table 3 Summary of final safety assessment criteria designed from candidates accepted in the modified RAM study as inappropriate (InApp) or necessary to avoid (NecAv)

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

High-risk drug/patient group

Final safety assessment criteria

 

Medication safety category (MS):

Targeted prescribing/monitoring

Associated PDRM event

Count

   

InApp

NecAv

Total

Drugs frequently implicated in PDRM hospital admissions

ANTIPLATELET

MS1: Use without gastroprotection

GI toxicity/bleeding

1

4

5 (4%)

DIURETIC

MS1: Unmet need for allopurinol in thiazide users

Gout

-

1

11 (9%)

 

MS3: Use of thiazides in CKD

Renal toxicity

-

1

 
 

Use of aldosterone antagonist in CKD

Hyperkalaemia

-

1

 
 

MS6: Excess duration of potassium supplement

Hyperkalaemia

-

1

 
 

MS8: Inconsistent monitoring of U&E's

Electrolyte disturbances

2

5

 

NSAID

MS1: Unmet need for gastroprotection

GI toxicity/bleeding

1

4

18 (15%)

 

MS2: Use of COX II selective agents in aspirin users

CV events

-

1

 
 

Paracetamol not tried first

General NSAID toxicity

1

2

 
 

MS3: Use in CKD

Renal toxicity

-

2

 
 

Use of COX II selective agents in high CV risk

CV events

-

2

 
 

MS4: Co-prescription with diuretic and/or ACEI or ARB

Renal toxicity

2

3

 

ANTICOAGULANT

MS2: Use of warfarin in AF and low risk of stroke

Bleeding

-

1

11 (9%)

 

MS4: Co-prescription of high-risk anti-infectives

Bleeding

1

9

 

OPIOID

MS1: No laxative co-prescribed in strong opioid users

Constipation

1

1

2 (2%

BETA BLOCKER

MS3: Use in asthma

Asthma exacerbation

1

2

4 (3%)

 

MS4: Co-prescription with verapamil/diltiazem

Bradycardia

-

1

 

ACEI/ARB

MS8: Inconsistent monitoring of U&E's

Hyperkalaemia

-

2

2 (2%)

ANTIDIABETIC

MS3: Use of long acting sulphonylureas in CKD

Hypoglycaemia

-

1

2 (2%)

 

Use of metformin in CKD

Lactic acidosis

-

1

 

DIGOXIN

MS5: Excessive dose in CKD or the elderly

Digoxin toxicity

-

2

10 (8%)

 

Excessive dose in patients on interacting drugs

 

-

6

 
 

MS8: Inconsistent monitoring of U&E's

 

-

2

 

ORAL STEROID

MS1: Unmet need for bone protecting agents

Bone fracture

-

2

2 (2%)

Other drugs implicated in severe adverse drug events

   

DMARD

MS7: Lack of dose instructions/Use of 2 strengths

Miscellaneous

-

2

10 (8%)

 

MS8: Inconsistent monitoring of FBC

Blood dyscrasias

2

6

 

FEMALE

MS3: Use of estrogens in women w/o hysterectomy

Gynaecological cancer

-

1

7 (6%)

STEROIDS

MS3: Use in women with CVD or CVD risk > 20%

Vascular events

2

2

 
 

MS6: Excess duration in postmenopausal women

 

1

1

 

AMIODARONE

MS8: Inconsistent monitoring of thyroid function

Thyroid disturbances

-

1

1 (1%)

THEOPHYLLIN

MS2: Use without inhaled anticholinergics/steroids

Theophylline toxicity

-

1

1 (1%)

STATIN

MS5: Excessive dose in patients on interacting drugs

Rhabdomyolysis

-

5

5 (4%)

Particularly vulnerable patient groups

ELDERLY

MS3: Miscellaneous drugs to be avoided

Miscellaneous

1

10

18 (15%)

 

MS6: Miscellaneous drugs for excessive duration

Miscellaneous

-

7

 

HEART FAILURE

MS3: Miscellaneous drugs to be generally avoided

HF exacerbation

-

10

10 (8%)

CHILDREN

MS3: Miscellaneous drugs to be generally avoided

Miscellaneous

1

4

5 (4%)

Total

  

17

107

124 (100%)

Medication Safety (MS) categories

 

1. INDICATION

MS1: Unmet need for risk mitigating drug

3

12

15 (12%)

2. SELECTION

MS2: High risk drug without compelling indication

1

5

64 (52%)

 

MS3: Drug-disease or Drug-age interaction

5

37

 
 

MS4: Drug-Drug interaction (DDI)

3

13

 

3. INTENSITY

MS5: Excessive dose

-

13

23 (19%)

 

MS6: Excessive duration

1

9

 

4. COMPLIANCE

MS7: Issues related to patient compliance

-

2

2 (2%)

5. MONITORING

MS8: Inconsistent laboratory monitoring

4

16

20 (16%)

Criteria restricted to the elderly

   Aged ≥ 65

  

3

21

24 (19%)

   Aged ≥ 75

  

2

9

11 (9%)

   Aged ≥ 85

  

1

-

1 (1%)

  1. MS 1 to 8 refer to medication quality categories as specified in the bottom half of the table.
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BMC Clinical Pharmacology

ISSN: 1472-6904