Medication error logs
As a result of recent developments and changes in
the way that single dispensing errors are to be dealt with by the Society
it is now necessary
to revise and replace the Law and Ethics Bulletin on medication
error logs issued on 26 January (PJ, 10 February, p173). The maintenance of medication error logs is seen as good practice in
pharmacy and, in line with clinical governance arrangements, should be
included in pharmacy standard operating procedures. Medication error
logs are intended to be used as a risk management tool, and information
from the logs should be regularly reviewed, analysed and discussed within
the pharmacy in order to identify risk areas associated with the dispensing
and checking process. Appropriate action to review systems and procedures
with a view to minimisation of future risk should be taken, where necessary.
Pharmacy owners and individuals may be apprehensive that information
contained in medication error logs could be used as a basis for disciplinary
action by the Society. However, the existence and regular audit and review
of such logs is considered to be indicative of good practice and robust
risk management. Their use is therefore encouraged.
In March 2007 the Council agreed that the criteria set out in Panel 1 should
be used to decide whether single dispensing errors are likely to amount
to professional misconduct and warrant referral to the Investigating
Committee. One of the criteria for referral to the committee is the failure
to maintain a medication error log. Single dispensing errors that do
not meet the referral criteria are dealt with by the Society’s
inspectorate and are not referred to the Investigating Committee for
consideration of further action to be taken. This is subject to the individual
admitting the allegations made and accepting any advice given by the
inspector in relation to the dispensing error made. Further information
on the Council’s decision (PDF 60K).
During routine pharmacy inspections, Society inspectors may ask to see
evidence that a system is in place to deal with dispensing errors, including
the maintenance and use of medication error logs. However, inspectors
will not usually need to ask to look at any of the actual records or
any of the specific information held within those logs. Further information
on the inspection of error logs during routine visits is available (PDF 90K).
If the Society receives a complaint about a dispensing error, the inspector
may, as part of the investigation, ask to see the specific error log
which relates to the complaint under investigation. Evidence of the maintenance
of an error log by the pharmacy (where the pharmacy has been made aware
of the error) can be seen as evidence of good practice.
It may be particularly helpful if the error log describes any review
of systems carried out at the pharmacy in light of the incident.
There may be occasions, where, as a result of concerns raised about a
particular pharmacy or about the fitness to practise of an individual,
it may be necessary for the pharmacy error logs to be examined. This
action would only be considered where there was genuine cause for concern
about public safety.
For further information on the handling of dispensing errors (PDF 120K).
Panel 1: Criteria for consideration of single
dispensing errors
Single dispensing errors are not likely to be referred to the
Investigating Committee unless one or more of the following statements
is true:
• There is potential for, or evidence that, the dispensing error
caused moderate or severe harm or death (the definitions of these
are from the National Patient Safety Agency definitions for grading
patient safety incidents — see Panel 2).
• There is evidence that the dispensing error was a deliberate
attempt to cause harm to patients or the public.
• There is evidence of ill health or substance abuse by the pharmacist.
• There is evidence that the individual departed from agreed safe
protocols or standards operating procedures and in doing so took
an unacceptable risk.
• There are no systems to record errors in the pharmacy (this should
result in the superintendent or pharmacy owner being referred).
• There has been a failure to make an error log (if aware of the
error).
• There are no systems to learn from errors in the pharmacy (this
should result in the superintendent or pharmacy owner being referred).
• No attempt has been made to learn from the specific error.
• The Society's inspector has previously given advice that would
have prevented the error if it had been implemented.
• There has been an attempt to cover up the alleged dispensing
error.
• There has been a failure to co-operate with an investigation
carried out by the Society’s inspector or other investigatory
body.
• There is evidence of other misconduct that would form the basis
of a complaint.
• Failure to apologise or provide an explanation to the patient
or representative (if aware of the error).
• There is relevant history within the past three years. |
Panel 2: NPSA definitions for grading patient
safety incidents
• No harm (1) Incident prevented: any patient safety
incident that had the potential to cause harm but was prevented,
and no
harm was caused to patients receiving
NHS-funded care. (2) Incident not prevented: any patient safety incident
that occurred but no harm was caused to patients receiving
NHS-funded care.
• Low harm Any patient safety incident that required extra observation or
minor treatment and caused minimal harm to one or more patients receiving
NHS-funded
care. (Minor treatment is defined as first aid, additional therapy, or additional
medication. It does not include any extra stay in hospital or any extra time
as an outpatient, or continued treatment over and above the treatment already
planned; nor does it include a return to surgery or readmission.)
• Moderate harm Any patient safety incident that resulted in a moderate increase
in treatment and that caused significant but not permanent harm to one or
more patients receiving NHS-funded care. (Moderate increase in treatment
is defined
as a return to surgery, an unplanned readmission, a prolonged episode of
care, extra time in hospital or as an outpatient, cancelling of treatment,
or transfer
to another area such as intensive care as a result of the incident.)
• Severe harm Any patient safety incident that appears to have resulted in
permanent harm to one or more patients receiving NHS-funded care. (Permanent
harm directly
related to the incident and not related to the natural course of the patient’s
illness or underlying condition is defined as permanent lessening of bodily
functions, sensory, motor, physiological or intellectual, including removal
of the wrong
limb or organ, or brain damage.)
• Death Any patient safety incident that directly resulted in the death of
one or more patients receiving NHS-funded care. (The death must be related
to the
incident rather than to the natural course of the patient’s illness
or underlying condition.) |
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The
Pharmaceutical Journal