Identification of an updated set of prescribing-safety indicators for GPs

Rachel Spencer; Brian Bell; Anthony J Avery; Gill Gookey; Stephen M Campbell

doi:10.3399/bjgp14X677806

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Figure 1.
Number of indicators at each step of the consensus process.

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Table 1

Source descriptors of indicators

Source (by age of publication, most recent first)	Indicators reviewed from source	Indicators used in round 1 of the consensus process	Source details	Relevance to prescribing safety indicators
PINCER trial:¹⁶ cluster randomised pharmacist intervention trial	11	6	Outcome measures of the trial used as indicators	Used to inform the 2009 RCGP indicators
Guthrie et al:¹⁷ Scottish general practice prevalence of inappropriate prescribing to vulnerable patients	15	12 (some crossover with other sources)	New paper published since the RCGP indicator set was developed, indicators taken from consensus	All were considered related to safety but some overlapped with the 2009 RCGP indicators
Wessel et al:⁶ prevalence of prescribing and monitoring errors	30	11 (some crossover with other sources)	Data from US GP patients, indicators developed by the research team	Some drug–disease combinations represented quality rather than safety
NORGEP:⁷ potentially inappropriate prescriptions for older people	36	5 (all of these were also found in other sources)	Based on Norwegian consensus panel	Many drugs are not relevant to the UK or are no longer prescribed
STOPP/START:⁵ Irish prescribing indicators	65	27	Many relate to appropriateness rather than safety	Used to inform the 2009 RCGP indicators
Basger et al:⁸ Prescribing Indicators Tool for Elderly Australians	48	4 (all of these were also found in other sources)	Based on the most commonly prescribed drugs to Australians aged >65 years	Many indicators reflect quality, especially secondary prevention of cardiovascular disease
Raebel et al:⁹ laboratory safety monitoring in ambulatory patients	9	3 (some crossover with other sources)	Computerised tool used on US GP records	Some recommendations were considered to have too little evidence in their favour
Zhan et al:¹⁰ Potentially harmful drug–drug and drug–disease combinations	56	No formal indicators but 3 co-prescribing statements related to warfarin	Data from elderly US outpatients, indicators from consensus	Many drug–disease combinations represented quality rather than safety
PDRM:¹⁴ Manchester indicators on preventable drug-related morbidity	29	4	Successfully tested in English GP surgeries	Used to inform the 2009 RCGP indicators
Beers 2003 update:³ US indicators of prescribing safety in older people	89	20	Although updated again in 2012 these indicators are US-specific and many cover situations not felt to be of high clinical importance	Used to inform the 2009 RCGP indicators
ACOVE:⁴ Assessing Care of Vulnerable Elders	217	2	Many process measures, minority related to safety	Used to inform the 2009 RCGP indicators
McLeod et al:¹¹ defining inappropriate prescribing practices for older people	71	6 (all of these were also found in other sources)	Canadian consensus process dating from 1997	Many indicators were outdated (new pharmacological evidence)

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Table 2.

Indicators rated as appropriate for assessing the safety of prescribing in general practice

Indicator	Risk of harm (1 = low, 2 = moderate, 3 = high, 4 = extreme)
A: Cardiovascular and respiratory disease

1. Aspirin or clopidogrel prescribed to people with previous peptic ulcer or gastrointestinal bleed without gastroprotection^a	3
2. Prescription of aspirin at a dose >75mg daily for ≥1 month in a patient aged >65 years	2
3. Prescription of digoxin at a dose >125 μg daily in a patient with renal impairment (for example, CKD 3 or worse)	3
4. Prescription of digoxin at a dose of greater than 125 μg daily for a patient with heart failure who is in sinus rhythm	3
5. Prescription of diltiazem or verapamil in a patient with heart failure^a	3
6. Prescription of a beta-blocker to a patient with asthma (excluding patients who also have a cardiac condition, where the benefits of beta-blockers may outweigh the risks)^a	3
7. Prescription of a long-acting beta-2 agonist inhaler to a patient with asthma who is not also prescribed an inhaled corticosteroid	3
B: Central nervous system (including analgesics)

8. Prescription of a benzodiazepine or Z drug for ≥21 days, in a patient aged >65 years,	3
who is not receiving benzodiazepines or Z drugs on a long-term basis
9. Initiation of prescription of benzodiazepine or Z drugs for ≥21 days in a patient aged >65 years with depression	3
10. Antipsychotics prescribed for >6 weeks in the over 65s with dementia but not psychosis^a	3
11. Amitriptyline at dose >75mg prescribed to a patient with heart failure, arrhythmia, heart block. or postural hypotension	3
12. Prescription of aspirin to a child aged ≤16 years	2
13. Bupropion prescribed to a patient with epilepsy	3
C: Anti-infective agents

14. Prescription of mefloquine to a patient with a history of convulsions^a	3
D: Endocrine and metabolic

15. Glitazone prescribed to patient with heart failure^a	3
16. Metformin prescribed to a patient with renal impairment where the eGFR is ≤30ml/min^a	4
17. Oral prednisolone prescribed at a dose ≥7.5mg daily for more than 3 months to the over 65s without co-prescription of osteoporosis-preventing treatments^a	3
18. Modified-release potassium supplements prescribed to a patient with a history of peptic ulcer disease	2
E: Women’s health and urinary disorders

19. Prescription of a combined hormonal contraceptive to a woman with a history of venous or arterial thromboembolism	3
20. Prescription of oral or transdermal oestrogens to a woman with a history of breast cancer	3
21. Prescription of oral or transdermal oestrogen without a progestogen in a woman with an intact uterus	3
22. Prescription of a combined hormonal contraceptive to a woman aged ≥35 years who is a current smoker	3
23. Prescription of a combined hormonal contraceptive to a woman with a body mass index of ≥40^a	3
F: Immunosuppression

24. Methotrexate prescriptions should state ‘weekly’	3
25. Methotrexate 2.5/10mg co-prescription	3
26. Methotrexate prescribed without folic acid	3
G: Musculoskeletal

27. Concurrent use of two NSAIDS for more than 2 weeks (not including low-dose aspirin)	3
28. Prescription of an NSAID, without co-prescription of an ulcer-healing drug, to a patient with a history of peptic ulceration^a	4
29. Prescription of an NSAID in a patient with heart failure^a	3
30. Prescription of an NSAID in a patient with chronic renal failure with an eGFR <45^a	4
31. Allopurinol prescribed at a dose of >200mg/day to patients with renal impairment (eGFR <30 or CKDA)^a	3
H: Hazardous co-prescriptions and allergy

32. Prescription of warfarin and aspirin in combination (without co-prescription of gastroprotection)^a	3
33. Concurrent use of warfarin and any antibiotic without monitoring the INR within 5 days^a,^b	4
34. Prescription of warfarin in combination with an oral NSAID	3
35. Prescription of a phosphodiesterase type-5 inhibitor, for example sildenafil, to a patient who is also receiving a nitrate or nicorandil^a,^c	3
36. Co-prescription of lithium with thiazide diuretic	3
37. Prescription of a potassium salt or potassium-sparing diuretic (excluding aldosterone antagonists) to a patient who is also receiving an ACE inhibitor or angiotensin II receptor antagonist^a	3
38. Prescription of verapamil to a patient who is also receiving a beta-blocker	3
39. Co-prescription of itraconazole with simvastatin, or with atorvastatin at a dose ≥80mg^a,^c	3
40. Co-prescription of trimethoprim with methotrexate for >7 days^a	3
41. Prescription of clarithromycin or erythromycin to a patient who is also receiving simvastatin, with no evidence that the patient has been advised to stop the simvastatin while taking the antibiotic^a	3
42. Prescription of a penicillin-containing preparation to a patient with a history of allergy to penicillin	4
I: Laboratory test monitoring

43. Patients aged >75 years on loop diuretics who have not had a U+E in the previous 15 months^a	3
44. Prescription of amiodarone without a record of liver function being measured in the previous 9 months	3
45. Prescription of amiodarone without a record of thyroid function being measured within the previous 9 months	3
46. Prescription of an ACE inhibitor or angiotensin II receptor antagonist without a record of renal function and electrolytes being measured prior to starting therapy	3
47. Patients on an ACE inhibitor or angiotensin II receptor antagonist who have not had a U+E in the previous 15 months^a	3
48. Prescription of warfarin to a patient without a record of INR having been measured within the previous 12 weeks (excluding patients who self-monitor)	4
49. Prescription of a statin without an ALT taken prior to starting treatment	3
50. Prescription of a statin without an ALT taken prior to starting treatment and within 3 months of starting treatment	3
51. Prescription of lithium without a record of a lithium level being measured within the previous 6 months^a	3
52. Metformin without yearly serum creatinine	3
53. Use of a hypothyroid agent without monitoring relevant thyroid function tests within 2–4 months of initiation or dosage change and at least every 15 months thereafter	3
54. Prescription of methotrexate without a record of a full blood count within the previous 3 months	3
55. Prescription of methotrexate without a record of liver function having been measured within the previous 3 months	3
56. Allopurinol without baseline urea, electrolytes, creatinine and eGFR	2

↵a For 23 items (19 high risk and 4 extreme risk) 80% or more of the responders rated the indicator as high or extreme risk.
↵b Consensus reached for assessing the safety of prescribing of practices, but not individual GPs.
↵c Consensus reached for assessing the safety of prescribing of individual GPs, but not practices. ACE inhibitor = angiotensin-converting enzyme inhibitor. ALT = alanine transferase. CKD = chronic kidney disease. eGFR = estimated glomerular filtration rate. INR = International Normalised Ratio. NSAID = non-steroidal anti-inflammatory drug. U+E = urea and electrolytes.

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Appendix 1.

Literature review search strategy

Setting

“Family physician” OR “primary care” OR “family practice” OR “general practice” OR “ambulatory care” OR “ambulatory health” OR “ambulatory health-care” OR “ambulatory healthcare” OR “community health” OR “community healthcare” OR “community health-care” OR “primary health” OR “primary healthcare” OR “primary physician” OR “primary health-care” OR generalist OR “family medicine”

Safety synonyms

“administration error” OR “administration errors” OR “dispensing error” OR “dispensing errors” OR “medication error” OR “medication errors” OR “medical mistake” OR “medical mistakes” OR “prescription error” OR “prescription errors” OR “prescribing error” OR “prescribing errors” OR “ prescribing fault” OR “prescribing faults” OR “medical error” OR “medical errors” OR malpractice OR safety OR “safety-culture” OR “adverse event” OR “adverse events” OR “adverse effect” OR “adverse effects” OR “adverse reaction” OR “adverse reactions” OR harm OR harms

Types of tools

“scale” OR “scales” OR “survey” OR “surveys” OR “questionnaire” OR “questionnaires” OR “instrument” OR “instruments” OR “indicator” OR “indicators” OR “outcome assessment” OR “outcome assessments” OR “patient reported outcome” OR “patient reported outcomes” OR “patient experience” OR “patient experiences” OR “practice guideline” OR “practice guidelines” OR “quality assurance” OR tool OR tools OR toolkit OR toolkits