Recording adverse drug reactions in a forensic psychiatry unit: how can we improve standards?
Adverse drug reactions (ADRs) are increasingly recognised as an important cause of morbidity and mortality. Psychiatric patients, and especially those in forensic units, may be at increased risk of ADRs. Detection and documentation of previous ADRs are essential in reducing the risk of future ADRs. A baseline audit was undertaken, and subsequently the recording of ADRs on the drug cards of patients in a forensic psychiatry unit was re-audited. Poor levels of documentation of ADRs were found. Following the baseline audit, a number of simple measures were undertaken which improved performance at re-audit.
adverse drug reactions; mental health; forensic psychiatry; audit
Any drug may produce unwanted or unexpected adverse effects. The World Health Organisation (WHO) defines an Adverse Drug Reaction (ADR) as:
a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases, or for the modification of physiological fuction (WHO, 1972).
ADRs are increasingly recognised as important causes of morbidity and mortality. It is estimated that one in sixteen acute general hospital admissions is attributable to edverse drug reactions. ADRs are also responsible for up to 10,000 deaths a year in the United Kingdom, and cost the NHS around £446 million each year (Pirmohamed et al, 2004).
Psychotropic medications often have to be taken long-term, and because of their central action may produce a wide range of adverse effects. Several studies have shown that psychiatric patients’ physical health tends to be worse than that of the general population, and that they may be less able to access medical services for their physical problems. These factors may put patients with psychiatric illness at increased risk of ADRs.
Patients in forensic psychiatry units may be at still further increased risk of ADRs. In these settings, patients are more likely to have severe psychiatric illnesses and to demonstrate treatment resistance, which is thought to contribute to the high proportion of these patients who are prescribed high-dose and multiple psychotropic medications. For example, Acosta-Armas et al (2004) reported that in the forensic psychiatry unit they studied 79% of patients were on psychotropic medications. Polypharmacy was present in twelve per cent of these cases, and nine per cent were on antipsychotic medication at levels above the frnnrimiim dosage recommended by the British National Formulary.
Awareness of previous ADRs is important, in order to reduce the risk of inadvertent re-exposure to the culprit drug. While patients should be asked directly for this information. It is important that known ADRs are recorded in the patient’s casenotes. ADRs should also be documented on the drug card itself, so that this information is readily accessible at the point of prescribing. Hospital inpatients (especially those in forensic units) often have voluminous case notes, in which there is a danger that more historical information, such as that on ADRs, may become difficult to find. Recording ADRs on drug cards provides an additional safeguard against this risk.
The recording of ADRs on the drug cards of patients at a forensic unit was audited at Arnold Lodge (East Midlands Centre for Forensic Mental Health). This is a 56-bedded NHS hospital that provides psychiatric care in conditions of medium security to adults from the Trent region. It consists of three wards (one admiasion/assesment ward and two ongoing care/rehabilitation wards) for patients with mental illness, and a ward for patients with personality disorder.
Audit criteria were identified from locally agreed guidelines (Leicester Partnership NHS Trust, 1997). The audit criteria were:
* presence of any known ADR to be documented in the appropriate space on the drug card
* name of drug thought to have caused ADR to be documented in the appropriate space on the drug card
* details of ADR caused by a drug to be recorded in the appropriate space alongside the name of the culprit drug
* both name of culprit drug and ADR it causes to be written in red.
Following recommendations made after the baseline audit, a fifth criterion was introduced for the re-audit
* if there are no known ADRs this fact should be recorded on the drug card.
Approval to cany out the audit was sought first from the local audit committee. All consultants and ward managers were then sent a letter requesting their approval. A representative sample of patients was randomly selected to take part in the audit.
Patients were approached and, after agreeing to be interviewed for the audit, were asked if they had ever had any ‘side-effects, allergic reactions or
The information obtained from the patient was recorded, using a data-collection sheet designed specifically for this audit. A different investigator, who was blind to the information obtained from the patient, inspected the current drug chart of the parient. The recording of any known ADRs was compared with the audit criteria and with the patient’s own account of any ADRs, using the audit data collection tool. To protect patient confidentiality, all identifying data was coded and the subsequent data pooled so the identification of individual patients was not possible.
The baseline audit took place in July 2004, and subsequently a number of recommendations were made, although not all were implemented. A subsequent re-audit was conducted in November 2004.
For both audits, data were obtained from a random selection of 30 of the 52 current in-patients. These patients were distributed equally between all wards and clin9cal teams. All patients who were approached agreed to participate.
The results of both baseline and re-audits are shown in Table 1, opposite.
In the baseline audit, none of the known ADRs was recorded according to the full audit criteria – that known ADRs must be documented on the drug card with the name of the drug and the reaction written in red. Following recommendations from the baseline audit, there was some improvement, although overall performance remained poor. In the re-audit, seven of the nineteen known ADRs were recorded according to the full audit criteria. Of the fifteen patients who gave a history of no previous ADRs, this fact was recorded on the drug card in only five cases.
In the re-audit 15 patients gave a history of having had an ADR. Of these fifteen patients eleven told of a single ADR and four patients gave a history of two ADRs. This gave a total of 19 reported ADRs. Patients in the baseline audit reported a similar number of ADRs.
In the re-audit seven ADRs were reported by the patients but not recorded on the drug cards. These ADRs were:
* codeine associated with respiratory arrest
* carbamazepine associated with increased temperature, rash, skinn peeling
* clozapine associated with seizure
* procyclidine associated with nausea
* ranitidine associated with unpleasant taste
* risperidone associated with dyskinesia
* penicillin associated with rash.
There were no cases, in either audit, in which the patient gave a history of having had an ADR but the drug card stated that the patient had no ADRs.
Our results show that a high proportion of patients (50%) have experienced an ADR but, even on re-audit, only a minority 07%) were recorded fully on the patientas drug card. Our findings are consistent with those from other studies. For example, Krska et al (2001) found that 89% of patients taking either tramadol or venlafaxine reported at least one ADR Only 58% of these patients reported the ADR to their general practitioner, and only 22% of the ADRs were documented in the patient’s casenotes.
Before the audit our concern was that the patients would list numerous ADRs that we as clinicians would regard as trivial. However, our data do not support this. Instead patients tended to report relevant information, and four of the seven ADRs reported by patients but not recorded on the drug card are potentially life-threatening.
Moreover, a rigid classification of ADRs as ‘trivial’ or ‘not significant’ may mislead clinicians into ignoring the patient’s subjective account. An ADR which may be medically non-serious may have a drastic impact on a patient’s quality of life, such that he may not take the medication as prescribed. By taking the patient’s subjective assessment of the ADR into account, patient and clinician ran have a more useful dialogue about the relative merits of a medication, helping to increase concordance with drug therapy.
At the baseline audit none of the cases examined met all the audit criteria. This poor performance was of concern, and the result of the audit and its recommendations were discussed at the local medical audit committee. The recommendations made were:
* importance of recording ADRs to be stressed at induction of both medical and nursing staff
* specific questions on ADRs to be asked on patient admission, and this information to be incorporated into the just admitted/initial care programing approach meeting as a specific piece of information that must be elicited
* ADRs to be included on physical health form to act as reminder to clinical staff to obtain this information
* result of baseline audit to be fed back to all clinical teams so that they can examine and amend their own drug cards
* re-audit to take place in six months
* consideration to be given to redesigning the format of the drug cards.
All the recommendations made were implemented by the time of the re-audit except for redesign of the drug cards. Box 1, below, summarises some important lessons.
Performance at the re-audit was still poor, although there had been some improvement. Comparison of the results of the baseline and re-audits shows that ADRs are now being recorded on the drug cards more frequently, the ADR caused is now much more likely to be documented and this information is now more likely to be documented in red ink to increase its visibility. Clinical teams are also starting to record the absence of ADRs on the drug cards.
Shenfield et al (2001) reported similar difficulties in improving performance on recording of ADRs. In their study of a general hospital they found continued poor performance at re-audit, despite a one-month ADR education/awareness programme.
The results of the re-audit have been discussed at the local audit meeting and have been circulated to all clinical teams. Following discussion with the medical director, we are looking at the feasibility of redesigning the drug cards and other measures to improve standards further. Our preferred design for the drug cards would replace the existing blank box labelled ‘Drug Sensitivities’. Instead the entire box would be highlighted in red and labelled ‘Presence/Absence of Adverse Drug Reactions’. This would be divided into three columns headed ‘Date’, ‘Drug’ and ‘Reaction’. This would draw the prescriber’s attention to this part of the drug card and encourage fuller recording of the ADR or the absence of any ADR.
As the clinical importance of ADRs becomes increasingly recognised, services will need to examine closely how they document previous ADRs. Much of the practice of forensic psychiatry is concerned with usine information in order to assess and manage future risk. Improving performance in recording of ADRs plays an important part in reducing the risk of future ADRs. By doing this we can improve both the quality of care provided and patient concordance, and thus improve treatment outcomes.
Patients in forensic psychiatry units may be at increased risk of adverse drug reactions (ADRs). Fifty per cent of patients questioned gave a history of having had an ADR. Previous ADRs were poorly documented on the drug cards, and a re-audit showed some improvement. The need for accurate documentation of previous ADRs was emphasised and several ways to improve performance were suggested.
Acosta-Armas AJ, Cooper M, Jacob C & Churchward S (2004) High-dose antipsychotic prescription at a forensic psychiatric hospital; is there a need for implementing a monitoring form? British Journal of Forensic Practices 6 (3) 18-24.
Cosentino M et al (1996) A one-year study of drug pracriptions and adverse drug reactions in psychiatric hospital practice. Pharmacoepidemiology and Drug Safety 5 (6) 377-84.
Kraka J et al (2001) Patient self-reports of potential adverse drug reactions. International Journal of Pharmacy Practice 9 (suppl) R35.
Leicester Partnership NHS Trust (1997) The Leicesterhire medicines code. Internal publication. Pirmohamed M et al (2004) Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820 patients. British Medical Journal 329 15-9.
Shenfield GM, Robb T & Duguid M (2001) Recording previous adverse drug reactions – a gap in the system. British Journal of Clinical Pharmacology 51 (6) 623-6.
World Health Organisation (1972) International drug monitoring the role of national centres. WHO Technical Report 498.
LEICESTERSHIRE RARTNERSHIP NHS TRUST
Address for correspondence
Dr Simon Gibbon, Senior House Officer in Psychiatry, Leicestershire Partnership NHS Trust, George Hine House, Gypsy Lane, Leicester LE5 OTD, email@example.com.
Conflict of Interest
Copyright Pavilion Publishing (Brighton) Ltd. Aug 2005
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