discussed (Section 2.4.3.1), as well as the types of information that should be documented and steps following documentation to be followed (i.e. reporting of an ADR to other relevant healthcare professionals). Given that the aim of this study relates directly to the extent and frequency of ADR documentation, this section will present a description of ADR documentation that was observed in the pre- and post-intervention phases.
Acceptable instances of documentation of ADR to antipsychotic drugs were those that included mention of the symptom or sign experienced and implicated an antipsychotic drug (Table 4.12).
Table 4.12
Prevalence of documentation of ADR in patient medical notes pre- and post-intervention.
"ADR documentation" refers to those instances where an actual ADR was documented (such as sedation, or reversible EPSE). "No ADR documentation" refers to any instance where a nurse or doctor indicated that the patient had not experienced an actual ADR (such as was the case with 'No side effect noted').
There were 16 more instances of documentation in the post-intervention phase, compared to the pre-intervention phase. Statistical analysis found that there was a statistically significant difference between the number of patient files with and without documentation between the pre- and post-intervention phases (Pearson's
chi2 p<.05).
Presence of documentation Pre-intervention (n=102) Post-intervention (n=102)
No ADR documentation 36 20 ADR documentation 66 82
124 Table 4.13
Frequency of types of ADR documentation
Type of documentation Pre-intervention %
(n=186)
Post-intervention % (n=351)
Documentation of ADR absent 37.63% (70) 27.35% (96) Documentation of ADR present 62.37% (116) 72.65% (255)
The difference between the number of positive and negative instances of documentation pre- and post-intervention was found to be statistically significantly
different (Pearson's chi2 p<.05).
Of particular interest for this study was the incidence of ADR documentation (and thereby the incidence of ADR in general) in patients co-diagnosed with HIV (Table 4.14).
Table 4.14
Prevalence of ADR documentation in HIV positive and HIV negative patients in both phases.
Pre-intervention Post-intervention HIV Positive (n=18) HIV Negative (n=85) HIV Positive (n=9) HIV Negative (n=93) No ADR documented 10 45 5 29 ADR documented 8 39 4 64
When comparing the ADR trends in HIV positive patients (Table 4.14), the pre- and post-intervention results were not statistically significantly different (Pearson
Chi2p=.613). However, in the post-intervention phase more HIV negative patients
had some form of documentation (64 patients; n=93) in their medical records than in the pre-intervention phase (39 patients; n=85). This is at odds with the fact that fewer patients were diagnosed with co-morbid HIV in the post-intervention phase, possibly suggesting that the post-intervention HIV positive patients experienced more frequent adverse drug reactions (Pre-intervention: 8 of 18 patients; Post- intervention: 4 of 9 patients). This was not correlated with evidence, however, as
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the ratio of HIV positive patients to total ADR experienced was similar in both pre- and post-intervention (Pre: 1.06; Post: 0.89).
Table 4.15
Documentation of identified antipsychotic-related adverse drug reactions, including multiple instances of the same adverse drug reaction in individual patients.
ADR documented Pre-intervention % (n=116) Post-intervention % (n=255)
Reversible EPSE 66.38 65.49
Sedation 14.66 12.55
Irreversible EPSE 4.31 5.49 Headache 2.59
Oedema 2.59
General side effect noted 1.72 0.39 Weakness 1.72
Hypersalivation 0.86 6.67 Orthostatic hypotension 0.86 2.34 Loss of libido 0.86
Metabolic side effects 0.86 Diarrhoea 0.86
Fever 0.86
Insomnia 0.86
Cardiotoxicity 0.39
Constipation 0.39
Oculogyric crisis (EPSE) 0.78
EPSE improved 1.96 Urinary retention 0.39 Hypoglycaemia 0.39 Tachycardia 1.57 Nausea/vomiting 0.39 Galactorrhoea 0.78
Before discussing the adverse drug reactions linked to the antipsychotic drugs (Table 4.15), it must be noted that documentation recorded as an ADR was linked to antipsychotic drugs. It is possible, however, that some instances of particular adverse drug reactions could be due to other pharmacological therapy (for example sedation can be caused by multiple drugs). A total of 255 instances of adverse drug reactions were documented in the post-intervention phase, compared to 116 in the pre-intervention phase. This relates to a 2.1 fold increase in the rate of
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documentation after the intervention. However, it must be taken into account that the above figures include duplicate instances of documentation. Duplicates may include cases where more than one healthcare professional has documented the same ADR in a different place, or where the same ADR was documented in the same patient over a number of consecutive days. The data was therefore re- examined by removing the duplicates of ADR documentation (Table 4.16).
Table 4.16
Documentation of adverse drug reactions where one instance represents one patient experiencing that particular adverse drug reaction, i.e. with duplication removed.
ADR documented Pre-intervention %
(n = 66) Post-intervention (n = 105) Reversible EPSE 56.06 48.57 Sedation 15.15 18.10 Irreversible EPSE 6.06 2.86 Headache 4.55
General side effect noted 3.03 0.95
Oedema 3.03
Hypersalivation 1.52 12.38
Orthostatic hypotension 1.52 3.81
Metabolic side effects 1.52
Loss of libido 1.52 Weakness 1.52 Fever 1.52 Insomnia 1.52 Diarrhoea 1.52 Cardiotoxicity 0.95 Constipation 0.95
Oculogyric crisis (EPSE) 0.95
EPSE improved 4.76 Urinary retention 0.95 Hypoglycaemia 0.95 Tachycardia 1.90 Nausea/vomiting 0.95 Galactorrhoea 0.95
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Excluding duplicate instances of documentation (Table 4.16) 66 instances of documentation during the pre-intervention phase and 105 instances in the post- intervention phase were identified. During the pre-intervention phase the most frequently identified form of ADR documentation identified was reversible EPSE (56.06%; 37; n=66), followed by sedation (15.15%; 10; n=66).
During the post-intervention phase the results were similar, with reversible EPSE again being the most identified ADR (48.57%; 51; n=105) and sedation next most (18.10%; 19; n=105). Hypersalivation was far more frequently identified in the post- intervention phase at 12.38% of all documentation (13; n=105) compared to the pre-intervention phase (1.52% 1; n=66). Several ADR which were not identified at all during the pre-intervention phase were recognised in the post-intervention phase, including: 'EPSE improved' (4.76%; 5; n=105), tachycardia (1.90%; 2; n=105), urinary retention, constipation, oculogyric crisis, hypoglycaemia, nausea/vomiting and galactorrhoea (0.95%; 1; n=105). The increased number of ADR types which were documented could represent a greater awareness of healthcare professionals regarding the ADR to antipsychotic drugs. This could in turn be related to the educational intervention. The possibility of this finding is discussed further in Chapter Five.