1. National & Trust audit findings
Topic 6:
Assessment of the side effects of long-acting injectable/depot antipsychotics
National & Trust audit findings
The Prescribing Observatory for Mental Health (POMH-UK) is a national quality improvement initiative that aims to raise standards of prescribing practice in specialist mental health services. POMH-UK is based at the Royal College of Psychiatrists Centre for Quality Improvement and does not receive any funding from the pharmaceutical industry.
POMH-UK offers member Trusts/Health Care Organisations the opportunity to participate in ‘Topics’. Each Topic focuses on a discrete area of prescribing practice. For example, the first topic focused on the prescribing of high dose and combined antipsychotics for patients on adult acute and psychiatric intensive care wards. Topics are chosen in consultation with member Trusts.
This slide set contains the results of the re-audit for Topic 6: assessment of side effects of long-acting injectable/depot antipsychotics.

2. The audit standard & relevant targets
All patients prescribed depot/long-acting injectable antipsychotic (AP) medication should have a review of side effects at least once a year.
Relevant targets
AP side effects should be ‘monitored routinely and regularly’ (NICE 2002).
‘People receiving depot preparations should be maintained under regular clinical review, particularly in relation to the risks and benefits of the drug regimen’ (NICE 2002).
The side effects associated with AP drugs should be ‘assessed using standardised methods and validated rating scales’ (Clinical Standards Board for Scotland, 2001).
A minimum standard of care was identified for the audit, derived from national practice guidelines.

3. Method Participating Trusts and clinical teams: self-selected.
Audit inclusion criteria:
Case notes of patients prescribed AP medication in a long-acting injectable/depot formulation. Patients treated in a variety of clinical settings (e.g. community, inpatient, forensic) were eligible for inclusion in the audit.
Data collected for each patient:
Basic demographic data (age, gender, ethnicity), diagnostic grouping and treatment setting.
Prescription details: name of injection, dose, injection interval, treatment duration, names of any oral APs, anticholinergic agents or other medication currently prescribed for a mental health problem.
Details of location where injection administration typically takes place.
Evidence of any reference to AP side effects (present or absent).
Evidence and nature of any side effect assessments undertaken.
Evidence of assessment of specific side effects: weight gain, movement disorders, sexual dysfunction, menstrual disturbance (females only).
Data collection & analysis:
Collected from clinical records from October 2009 to November 2009.
Data entered online & analysed using Snap and SPSS.
All member Trusts were invited to participate in the re-audit.
The method was the same as for the baseline audit as is described on this slide.
Each participating Trust chose how to select their audit sample. Local results should be interpreted in the context of the selection method used.

4. Participants
At baseline 38 specialist mental health trusts participated in the audit submitting data for patients from 500 clinical teams.
35 specialist mental health trusts participated in the 12-month re-audit in October 2009 submitting data for 5037 patients from 392 clinical teams.
Findings were presented in individual reports to Trusts.
Data was analysed at national, trust and team level.
In the baseline audit 500 clinical teams from 38 specialist mental health trusts in the UK submitted data for 5,804 patients.
At re-audit there were slightly less participants with 35 specialist mental health trusts taking part, this included 392 clinical teams and 5,037 patient case notes being reviewed
Six Trusts which participated at baseline did not participate at re-audit, while three new Trusts joined at the re-audit stage.
The national data are the ‘big picture’ data.
Data for individual Trusts are benchmarked against each other and against the national data.
Team data are benchmarked against both the Trust data (for the Trust the team is from) and the national data.

5. Nature of documented evidence in the case notes of clinical assessment of side effects in the last year at baseline & re-audit
Side effect assessment documented
in the clinical records
Baseline (n=5,804)
Re-audit
(n=5,037)
No evidence of side effect monitoring
2047 (35%)
1188 (24%)
General statement regarding side effects
3123 (54%)
2836 (56%)
Side effect checklist/rating scale used
681 (12%)
875 (17%)
Physical examination to assess side effects
629 (11%)
965 (19%)
Blood tests related to side effects
710 (12%)
1081 (21%)
This table shows the nature of the documented evidence found in the total national sample of case notes at baseline (n = 5,804) and re-audit (n = 5037) regarding side effect assessment.
At baseline more than one third of patients had no documented evidence in their case notes that any form of side effect monitoring had been undertaken in the previous 12 months. Only a minority of patients had any evidence in their case notes that some form of systematic assessment had been undertaken (e.g. use of a side effect checklist, physical examination) to check for the presence or absence of drug-related symptoms.
At re-audit less than a quarter of patients had no documented evidence of side effect monitoring, a considerable improvement over baseline. Most of this improvement was due to increased rates of physical examinations and blood tests rather than general statements about side effects. The changes seen indicate that side effects are being assessed more systematically which is very positive.

6. Proportion of patients with documented evidence in their case notes of clinical assessment of EPS, weight gain & sexual side effects in the last year, at baseline & re-audit
Baseline
(n=5,804)
Re-audit
(n=5,037)
Evidence of assessment of EPS
1801 (31%)
1693 (34%)
Evidence of assessment of weight/BMI/waist circumference
1573 (27%)
1563 (31%)
Evidence of assessment of sexual side effects
544 (9%)
746 (15%)
The audit sought evidence of the extent to which three specific side effects associated with AP medication were assessed: extrapyramidal symptoms (EPS), weight gain and sexual dysfunction.
These side effects were chosen because they are relatively common and potentially disabling and distressing drug-related problems. Of the three key side effects that the audit focused on, EPS were the most commonly assessed at both baseline and re-audit. However, only a third of patients had evidence in their case notes that they had been assessed for EPS.
At baseline, 27% of patients in the total national sample had evidence in their case notes that their weight had been assessed in the previous 12 months. This proportion increased to 31% at re-audit.
The proportion of patients in the total national sample who had evidence in their case notes that they had been assessed for sexual side effects associated with AP use also increased between baseline and re-audit.

7. Quality of assessment of EPS, weight & sexual side effects in the TNS in the last year at baseline & re-audit
This bar chart shows the quality of the assessment undertaken for three specific side effects, namely movement disorders, weight and sexual side effects.
Weight was the side effect most frequently assessed in a standardised way (e.g. documented measurement of weight, waist circumference or BMI recorded in case notes). However, at re-audit less than 20% of the total national sample had a measurement of weight recorded in their clinical records in the previous year.
The majority of references to the assessment of EPS and sexual dysfunction were general statements regarding the presence or absence of such symptoms both at baseline and re-audit.

8. Relationship between prescription of an anticholinergic & documented evidence of assessment of movement disorder in the TNS at baseline & re-audit
Documented evidence of side-effect assessment in the clinical records
No evidence of EPS assessment
General statement that movement disorders are not present
General statement that movement disorders are present
Formal evaluation of movement disorders
TNS
Baseline
4003 (69%)
738 (13%)
871 (15%)
192 (3%)
5,804
Anticholinergic prescribed
1241 (31%)
248 (34%)
530 (61%)
105 (55%)
2,124
Re-audit
3344 (66%)
552 (11%)
745 (15%)
396 (8%)
5,037
987 (30%)
188 (34%)
430 (58%)
214 (54%)
1,819
More than one third of patients in the total national sample were prescribed an anticholinergic at both baseline and re-audit.
Despite the fact that anticholinergic medication is primarily indicated for the treatment of movement disorders, the majority (58% baseline and 54% at re-audit) of those prescribed an anticholinergic had no evidence in their clinical notes that they had been assessed for EPS in the last year.
The biggest change between baseline and re-audit is in the proportion of patients with a formal evaluation of movement disorder, which has more than doubled, whereas the proportion of patients who have a documented general statement remains almost unchanged.

9. Relationship between screening for movement disorders by depot preparation prescribed in the TNS (n=5,037) at re-audit
Depot prescribed
Re-audit n
Documented evidence of screening at re-audit (n=5045*)
No evidence
General statement EPS present
General statement EPS not present
Formal evaluation
Flupentixol
1596
1050 (66%)
259 (16%)
160 (10%)
127 (8%)
Risperidone
1237
909 (73%)
116 (9%)
148 (12%)
64 (5%)
Zuclopenthixol
957
590 (62%)
158 (17%)
117 (12%)
92 (10%)
Fluphenazine
578
392 (68%)
93 (16%)
54 (9%)
39 (7%)
Haloperidol
296
194 (66%)
40 (14%)
36 (12%)
26 (9%)
Pipotiazine
381
216 (57%)
79 (21%)
37 (10%)
49 (13%)
This table shows the proportion of patients in the total national sample prescribed particular types of long-acting injectable AP preparations who had evidence of assessment of EPS in their clinical notes. At baseline, there was little to suggest that the particular depot preparation prescribed influenced assessment of EPS, whereas at re-audit there is evidence that those prescribed the second generation antipsychotic, risperidone, were less likely to have documented evidence of assessment for EPS. The low documented assessment levels in patients who are prescribed risperidone may partly reflect clinicians’ assumptions about a low liability for EPS associated with this drug.
EPS can be distressing for patients and tardive dyskinesia, particularly, can compound the social stigma associated with a diagnosis of schizophrenia. Movement disorders may also interfere with patients’ ability to carry out everyday practical activities, e.g. feeding and shaving. However, patients may not recognise that they have developed mild EPS symptoms, e.g. tremor (Larsen & Gerlach, 1996), particularly if they have received the same treatment for a prolonged period of time, hence the need for routine assessment.

10. Assessment of menstrual irregularities associated with AP use at baseline & re-audit
No. of women in total national sample <50 years of age.
1,043
809
No. (%) with any documented evidence of assessment of menstrual irregularities in the last year.
152 (15%)
154 (19%)
General statement that menstruation was normal.
73 (7%)
65 (8%)
General statement that menstruation was abnormal.
42 (4%)
40 (5%)
Description of nature of the irregularity
Of the 1,043 women in the total national sample who were under 50 years of age, only 152 (15%) had any documented evidence of assessment of menstrual irregularities in the last year. Of these 1,043 women, 7% had a general statement that menstruation was normal and 4% a general statement that menstruation was abnormal.
Data at re-audit shows a modest improvement in the assessment of menstral irregularitiess.
Menstrual disturbances can be distressing to patients and prolonged absence of menstruation may be associated with an increased risk of age-related bone loss (osteopenia).

11. Association between clinical setting in which AP medication is administered & nature of side effect assessment at baseline & re-audit
Setting in which patient usually receives depot
Base
line n
Re-audit n
Evidence of assessment: percentage of patients assessed in each setting
No evidence of assessment
General side effect checklist used
Assessment of EPS
Assessment of Weight/BMI
Assessment of sexual dysfunction
Baseline
Re-audit
Home visit
2,452
2066
36%
24%
10%
17%
31%
33%
22%
27% 8%
13%
Depot clinic
1,781
1,752
38%
14%
19%
28%
34%
26%
32%
CMHT appointment
810
495
23%
11%
Inpatient ward
522
382
29%
16%
43%
48%
53%
58%
GP surgery
120
108
40%
25% 4% 6%
Other
114 72
42%
12%
15%
Prison 5 12
20%
67%
TNS
5,804
5,037
35% 9%
This table shows the proportion of patients in the total national sample who were assessed for EPS, weight/BMI, sexual dysfunction, or who were assessed for a broad range of side effects using a general side effect rating scale or checklist across the different settings in which AP medication was administered.
Between the baseline and re-audit there is little difference in the proportion of patients assessed for side effects across settings, although there is some suggestion that hospital admission may sometimes serve as a prompt for review of side effects.

12. The proportion of patients for whom side effect assessments/measures were documented, & the change in profile between baseline & re-audit
Inpatient Ward
TNS
The following figures show diagramatically the proportion of patients for whom side effect assessments/measures were documented, and the change in profile between baseline and re-audit.
The increase in the proportion of patients receiving blood tests and physical examinations to assess side effects is more evident in those patients receiving the depot at home, in a depot clinic or in an inpatient ward, with the greatest change seen in inpatient settings. There was little change in practice where patients receive their depot during a CMHT appointment.
These findings may reflect that changes in practice are easier to implement in inpatient wards and depot clinics than the other two settings, for a number of reasons.

13. Comparison between Trusts: Clinical services
This figure shows the proportion of patients under the care of different clinical services included in the re-audit. The majority of the patients whose clinical notes were audited were under the care of adult community psychiatric teams (baseline n = 4,752 (82%) and re-audit n = 4,276 (85%)), represented by the blue portion of the bars.
The Trusts on the left side of the figure included the largest proportion of patients who were on the caseload of an adult community psychiatric team, whilst the Trusts on the right included the least. The picture for the total national sample is shown on the extreme right side of the figure.

14. Comparison between Trusts: Location of depot administration
This figure shows the locations where patients included in the audit sample typically receive their AP injections.
The Trusts on the left side of the Figure included the largest proportion of patients receiving their depot at a depot clinic (shown in blue), whilst the Trusts on the right included the least. The picture for the total national sample is shown on the extreme right side of the Figure. The variation between Trusts in the setting in which depot is administered is marked. The degree to which this reflects individual Trust choice of participating teams for this audit is unknown. However it seems reasonable to conclude that there is a wide variation between Trusts in the way that services are configured for the delivery of depot medication.

15. Percentage of patients in each Trust & the TNS with no documented evidence in case notes of formal or informal assessment of side effects in the last year at baseline & re-audit
Baseline
(n=5,804)
Re-audit
(n=5,037)
This figure shows the percentage of patients from each Trust with no documented evidence in their case notes of formal or informal assessment of side effects in the last year.
At re-audit Trust 16 (left side of the Figure) had the lowest proportion of patients with no documented evidence in their case notes of formal or informal assessment of side effects in the last year and Trust 51 (right side of Figure) had the highest. The characteristics of the total national sample are shown at the extreme right of the Figure. The numbers on each histogram bar represent actual numbers of patients and the height of each bar represents the percentage.
Overall the proportion of patients with no documented evidence improved from baseline to re-audit, with the majority of Trusts showing a reduction.

16. Proportion of patients in each Trust & the TNS at re-audit with documented evidence in their clinical records of a general statement regarding side effects in the last year
This figure shows the proportion of patients in each participating Trust and the total national sample with documented evidence in their case notes of a general statement regarding side effects in the last year.
The white portion of the bars indicates the proportion of patients with a general statement in their case notes in the last year that side effects are not present, and the blue portion represents the proportion of patients with a general statement in their case notes in the last year that side effects are present.
Trust 45 (left side of Figure) had the highest proportion of patients with documented evidence in their clinical case notes regarding the presence or absence of side effects entered in the last year, whilst Trust 69 (right side of Figure) had the least. The characteristics of the total national sample are shown at the extreme right of the Figure.

17. Proportion of patients in each Trust & the TNS at baseline & re-audit with documented evidence in their clinical records that a physical examination had been conducted to assess side effects in the last year
This figure shows the proportion of patients in each participating Trust and the total national sample who had documented evidence in their case notes that a physical examination had been undertaken to check for side effects. The characteristics of the total national sample are shown at the extreme right of the figure.
Trust 69 (left side of Figure) had the highest proportion of patients with documented evidence in their clinical case notes that a physical examination had been conducted to assess side effects in the last year, whilst the Trusts on the right side of the Figure had the least. The characteristics of the total national sample are shown at the extreme right of the Figure.
The variation between Trusts at re-audit (0-79%) was greater than at baseline (0-26%), and shows that while the samples of some Trusts showed a greater proportion of patients received physical examinations, for others the opposite was true.

18. Proportion of patients in each Trust & the TNS at baseline & re-audit with documented evidence in their clinical records that blood tests related to side effects had been carried out in the last year
This figure represents the proportion of patients in each Trust and the total national sample with documented evidence in their case notes that blood tests related to side effects had been carried out in the last year.
Trust 69 (left side of Figure) had the highest proportion of patients with documented evidence in their clinical case notes that blood tests related to side effects had been conducted in the last year, whilst the Trusts on the right side of the Figure had the least. The characteristics of the total national sample are shown at the extreme right of the Figure.

19. Proportion of patients in each Trust and the TNS at baseline & re-audit with documented evidence in their clinical records that a formal assessment of side effects had been conducted using a checklist or rating scale in the last year
This slide shows the proportion of patients in each Trust and the total national sample with documented evidence in their case notes that a formal assessment of side effects had been conducted using a symptom checklist or rating scale in the last year. For example, Trust 28 – far left hand side of figure – had the highest proportion of patients (>50%) with documented evidence in their case notes that a standardised measure had been used to assess side effects. The figure for the total national sample – just under 20% - is shown at the far right hand side.

20. Proportion of patients in each Trust & the TNS sample at re-audit with documented evidence in their clinical records of assessment of movement disorders in the last year
This slide shows the proportion of patients in each Trust and the total national sample with documented evidence of assessment of movement disorders in the last year.
Trust 28 (left side of Figure) had the highest proportion of patients with documented evidence in their clinical case notes of assessment of movement disorders, whilst Trust 70 (right side of Figure) had the least. The characteristics of the total national sample are shown at the extreme right of the figure.
The dark blue portion of the bars represent evidence of a formal evaluation of movement disorders, (e.g. use of a rating scale or physical examination).

21. Proportion of patients in each Trust & the TNS at re-audit with documented evidence in their clinical records of assessment of weight/BMI/waist circumference in the last year
This slide shows the proportion of patients in each Trust and the total national sample with documented evidence in their case notes that their weight had been assessed in the last year.
Trust 28 (left side of figure) had the highest proportion of patients with documented evidence in their clinical case notes of assessment of weight and/or BMI and/or waist circumference, whilst Trust 70 (right side of figure) had the least. The characteristics of the total national sample are shown at the extreme right of the figure.
The dark blue portion of the bars represents documentation of an actual measurement of weight (e.g. BMI, weight or waist circumference.)

22. Proportion of patients in each Trust & the TNS at re-audit with documented evidence in their clinical records of assessment of sexual side effects in the last year
This slide shows the proportion of patients in each Trust and the total national sample with documented evidence in their case notes of assessment of sexual side effects in the last year.
Trust 28 (left side of figure) had the highest proportion of patients with documented evidence in their clinical case notes of assessment of sexual side effects, whilst the Trusts on the right side of the figure had the least. The characteristics of the total national sample are shown at the extreme right of the figure.
The dark blue portion of the bars indicates a formal evaluation of sexual side effects involving the use of a sexual dysfunction rating scale, or a clinical assessment covering each phase of the sexual response cycle.

23. Team level results
Trust Code: 40

24. Proportion of patients side effect assessments/measures were documented, & the change in profile between baseline and re-audit in the TNS & your Trust
TNS
Trust 40
This slide shows the proportion of patients for whom side effect assessments/measures were documented, and the change in profile between baseline and re-audit in the TNS and your trust.
As the proportions of patients with specific side effect assessments increase, the proportion with only a general statement documented is seen to decrease, as may be expected.

25. Proportion of patients in each service, your Trust & the TNS with no evidence in their clinical records of assessment of side effects

26. Proportion of patients in each Trust & the TNS with documented evidence in their case notes of a general statement regarding side effects

27. Proportion of patients in each service, your Trust & the TNS at re-audit with documented evidence in their clinical records that a physical examination had been conducted to assess side effects in the last year
This figure shows the proportion of patients in each service, your Trust and the total national sample with documented evidence in their case notes that a physical examination had been undertaken to assess side effects in the last year.

28. Proportion of patients in each service, your Trust & the TNS at re-audit with documented evidence in their clinical records that blood tests related to side effects had been conducted in the last year
This figure shows the proportion of patients in each service, your Trust and the total national sample with documented evidence in their case notes that blood tests related to side effects had been undertaken in the last year.

29. Proportion of patients in each service, your Trust & the TNS at re-audit with documented evidence in their clinical records that a formal assessment of side effects had been conducted using a checklist or rating scale in the last year
This figure shows the proportion of patients in each service, your Trust and the total national sample with documented evidence in their case notes that a formal assessment of side effects had been conducted using a checklist or rating scale in the last year.

30. Proportion of patients in each service, your Trust & the TNS at re-audit with documented evidence in their clinical records of assessment of movement disorders in the last year
This figure shows the proportion of patients in each service, your Trust and the total national sample with documented evidence in their case notes of assessment of movement disorders in the last year.

31. Proportion of patients in each service, your Trust & the TNS at re-audit with documented evidence in their clinical records of assessment of weight/BMI/waist circumference in the last year
This figure shows the proportion of patients in each service, your Trust and the total national sample with documented evidence in their case notes of assessment of weight/BMI/waist circumference in the last year.

32. Summary Audit standard:
All patients prescribed depot/long-acting injectable antipsychotic (AP) medication should have a review of side effects at least once a year.
No evidence of any assessment: BL = 35% RA = 24%
Evidence of EPS assessment: BL = 31% RA = 34%.
Evidence of weight assessment: BL = 27% RA = 31%.
Evidence of assessment of sexual side effects: BL= 9% RA = 15%.
In summary:
35% of patients in the total national sample had no evidence of any form of side effect assessment in their clinical notes in the previous year, this dropped to 24% in the re-audit
One third of patients in the total national sample had any evidence in their notes that they had been assessed for EPS (drug-related movement disorders) in the previous year both at baseline and re-audit
There was a modest increase between baseline and re-audit in the proportion of patients in the total national sample who had evidence in their case notes that their weight had been assessed in the previous year.
The proportion of patients who had any reference to the assessment of sexual dysfunction in the previous year increased from 9% at baseline to 15% at re-audit.

33. www.rcpsych.ac.uk/pomh/members Next steps…
Change interventions, informed by qualitative work.
All Trusts who participated in the re-audit have received a benchmarked re-audit report with their local data. This powerpoint slide set summarises the benchmarked findings and is customised for each trust.
Trusts should also have received an educational slide set/awareness-raising session that was made available soon after the baseline audit.
A qualitative research study, which was undertaken to explore potential barriers to monitoring antipsychotic side effects in routine clinical practice, has informed the development of a further change intervention. This is a folder containing a series of laminated information sheets, designed to facilitate discussion between clinical staff and individual patients about side effects and possible solutions. The folder also includes leaflets about individual side effects that are suitable for giving to patients.
Copies of the information sheets and leaflets can be viewed, downloaded and printed free from the ‘Members Area’ of the POMH website ( Hard copies of the folder, including laminated information sheets, will be available to order from POMH.