A medication error reporting scheme: analysis of the first 12 months

AIMS AND METHOD

A new medication error reporting scheme (‘Safemed’)was introduced within the East Kent NHS and Social Care PartnershipTrust. All medication incidents reported using this systemin the first year were analysed by the Chief Pharmacist.

RESULTS

Over a 12-month period a total of 66 incidents were reportedthrough Safemed, compared with 55 incidents under the previoussystem. The low level of reporting made detailed statisticalanalysis and drawing meaningful conclusions problematic. Therewas a large variability in reporting between similar sites.

CLINICAL IMPLICATIONS

The low level of reporting was associated with cultural factors,in particular the failure to fully implement a ‘no blame’culture. Until such a culture is established, reporting will remainvariable and a systems approach to preventing medication errorswill not be adopted, leading to significant clinical risk.

Introduction

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Introduction

Medication errors are a major cause of injury and occur in 2-15%of hospital admissions (Leape, 1994; Bates et al, 1995).Annual costs include £400 million in claims and £2billion in hospital stays (Department of Health, 2000, 2001).The National Patient Safety Agency was established by the Departmentof Health; one of the roles of this agency is to collect andanalyse medication errors and ensure that practice is modified(Department of Health, 2001). One target is to reduce medicationerrors by 40%; however, the current rate is unknown, so reliablebaseline data must first be produced (Department of Health, 2001;Anon, 2003).

Traditionally within the East Kent National Health Service (NHS)and Social Care Partnership Trust, medication incidents havebeen reported on trust incident reporting forms. The formswere complex to complete, not designed for medication errorsand practices were not amended in response to reports, as therewas no link with clinical governance mechanisms. Furthermore,staff were reluctant to report errors owing to fear of disciplinaryaction.

Method

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Method

A Medline literature search (1966 to September 2004) using thesearch terms MENTAL HEALTH, PSYCHIATRY, MEDICATION ERROR REPORTINGand MEDICATION ERROR was conducted. Although a substantialnumber of publications on medication errors in general (Bates et al, 1993;Dean & Barber, 2001; Dean et al, 2002; Koren, 2002;Bumpus & al-Assaf, 2003; France et al, 2003; Howard et al, 2003),including systems for primary care (Dodds & Leaver, 2003)and secondary care (Furukawa et al, 2003; Smith, 2003),were identified there was little research relating to mental health. An American study on error rates for 31 patientsduring a 2-month stay in an inpatient psychiatric unit (Grasso et al, 2003)and a Japanese study on long-stay psychiatricwards (Ito & Yamazumi, 2003) were identified. The searchfailed to identify any research relating to medication errorreporting within mental health units in the UK.

The East Kent NHS and Social Care Partnership Trust introduceda medication error reporting system, entitled ‘Safemed’,based on a system developed by a community services pharmacist (Dodds & Leaver, 2003). It was designed as a ‘noblame’ system to encourage reporting and obtain reliablebaseline data, with links to the National Patient Safety Agencyand clinical governance mechanisms within the trust via theDrugs and Therapeutics Committee. The Safemed pro forma aimedto capture the details of the staff and patients involved ineach incident (details available from the authors on request).Anonymity, which might have encouraged reporting, was rejected,because it would have made individual feedback impossible (Furukawa et al, 2003).Additional details to be listed on the form includedany injury, action taken, contributory factors and suggestionsfor preventing a repeat incident.

The senior manager at each locality implemented the Safemedsystem. Awareness was raised in a number of ways. Safemed wasregularly featured in a quarterly pharmacy newsletter and inthe trust magazine (details available from authors on request).The chief pharmacist gave regular feedback, both on individualissues and any systems problems, via the Drugs and Therapeutics Committee.

Analysis of reports
We analysed all reports according to the type of error and thesite. The prescribing support pharmacy technician (A.T.) setup a database in Access to enable the fields on the form tobe recorded electronically and allow advanced data interrogationin Excel.

Results

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Results

The results of the analyses of the error reports are shown in Table 1 for type of error and Table 2 for site. Trend analysisidentified the following common threads: factors causing distraction during the administration round (n=18), unclear prescriptions (n=8), poor communication between teams (n=7), similar patientnames (n=6) and use of support workers as runners (n=5).

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Table 1. Analysis of reports according to National Patient Safety Agency categories

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Table 2. Analysis of reported incidents according to site

The chief pharmacist (I.D.M.) rated both the seriousness andlikelihood of recurrence on a Likert scale of 1-5 (1 indicatingminor significance or very low likelihood of recurrence, and5 indicating catastrophic significance or very high likelihoodof recurrence). Each incident was given a severity score obtainedby multiplying the seriousness score by the likelihood of recurrence score. Using this formula, 40 incidents had a low severityscore, 23 a moderate score and 3 a high score. The two incidentswith the highest severity scores both involved pharmacy staffidentifying potentially fatal prescribing errors. The firsterror involved a transcription error when the medicine card was rewritten and the lithium dosage was inadvertently increasedfrom 400 mg to 800 mg daily. The second involved a clinicallysignificant drug interaction - the additional prescriptionof fluvoxamine to a patient taking high-dose clozapine.

From 2002-3 to 2003-4 the mean number of reports per month increasedfrom 4.6 to 5.5. The t-test found that the association betweenthe introduction of Safemed and the increase in reporting hada very low significance (P=0.308).

The results were analysed statistically to see if there wereany relationships between incident type, unit and severity.Moderate or severe incidents occurred disproportionately onolder adult in-patient wards ( ${chi}$ ²=6.1, d.f.=1, P=0.014). Therewere too few reports to establish any other relationships.The mean and median delays in the chief pharmacist receivingthe report were 13.4 days and 11 days respectively. In over27% of incidents the chief pharmacist did not receive the reportuntil at least 16 days after the incident. There appears tohave been a trend for reporting more severe incidents morequickly, as could be expected. However, the Kruskal-Wallistest found that the differences in the delay between low, moderateand high severity groups had very low significance ( ${chi}$ ²=2.2,d.f.=2, P=0.333).

Discussion

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Discussion

Safemed allowed a number of medication errors to be identifiedand policies and procedures to be amended to prevent similarerrors. In response to the most frequently identified factor,the trust administration policy (published on the East KentNHS and Social Care Partnership Trust intranet, 2004) was amendedto state that the medicine round should not be interrupted exceptin emergencies. Other changes included amending the pharmacycomputing system to identify potentially fatal drug interactions,modifying the layout of a supplementary prescribing chart andestablishing a procedure for cancelling prescriptions.

The observation that more severe incidents were more commonon older people’s wards is of interest. A possible reasonfor this could be the complexity of treatment regimens, includingboth physical and psychotropic medications.

There are a number of problems with the system. First, althoughSafemed has been implemented within the mental health trust,it has not been implemented by the acute trust who providethe dispensing service under a service-level agreement. Dispensingerrors are, therefore, significantly underreported. Second,the trend analysis relied upon nursing staff to identify causative factors on the open-format questionnaire. Third, the delayin the chief pharmacist receiving the report raises clinicalgovernance concerns. An electronic system that listed commoncauses of errors in a tick box format could overcome both theseproblems. Fourth, a more robust severity rating system wouldhave used a number of people to rate severity. Finally, themain flaw of the new system was the low level of reportingidentified. Implementing Safemed had little effect on the levelof reporting and it is likely that many errors are still goingunreported. On five wards there was no report of any error,near-miss or potential incident over the 12-month period. Therewas a particularly low level of reporting near-misses and potentialincidents (see Table 1).

Both administrative and cultural factors may create a barrierto adverse event reporting (Department of Health, 2003). Administrativebarriers include a complex reporting system with which staffare unfamiliar, staff feeling too busy to report errors, and lack of feedback (Department of Health, 2003). Safemed minimisedadministrative barriers. The form was simple to complete, consistingof two sides of A4 paper, and placed no additional workloadon staff because it replaced existing paperwork. Regular feedbackwas provided both individually and globally. Although staffmight have been unfamiliar with the system initially, mainlybecause a training programme was not funded, awareness wasraised over the 12-month period. This had no effect on reporting,suggesting that lack of familiarity was not a significant barrier.

Cultural barriers include failure to implement a ‘no blame’ system and an existing culture in which staff who admit mistakesfear losing the respect and esteem of colleagues (Department of Health, 2001).The NHS has a deeply ingrained culture; thusremoving any barriers is likely to be challenging (Hannagan, 2002).Furthermore, mental health services appear to be particularlydriven by the existing blame culture within the NHS (Lelliott, 2004).To remove cultural barriers, a clear and consistentmessage must be delivered to all staff (Hatch, 1997; Department of Health, 2003).Although senior managers appeared to supportthe cultural change, evidence suggested that this message wasnot consistently communicated to front-line staff (publishedon the East Kent NHS and Social Care Partnership Trust intranet,2003). This lack of consistency appears to be confirmed by alarge variability in reporting between sites. For similar wardson different sites, there was up to an eight-fold variationin the number of reports per in-patient bed (see Table 2).

Conclusion

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Conclusion

The implementation of Safemed was only partially successful.Safemed was successfully incorporated into the governance structure,allowing a number of practices to be modified in an attemptto prevent error repetition. However, the new system had nosignificant effect on the level of reporting. The number ofreports received was very low, suggesting that underreportingis a huge issue. Evidence would suggest that this is a culturalproblem and the trust has not fully moved to a ‘no blame’culture. Until such a culture is fully implemented, error reportingwill remain erratic and a systems approach to error preventionwill not be developed. This failure to implement a ‘noblame’ culture could be confirmed by a future qualitative study involving focus groups.

References

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