|
In the first article in this series, the National Reporting and Learning
System (NRLS) was introduced (PJ, 22 November, p719). The NRLS has been
designed to build on local reporting activity and the system has been
developed to interface with all the major commercial local risk management
systems used in most NHS organisations. This means that incident information
that was previously only collected locally can be gathered to track national
trends in a seamless way.
The system uses a standard dataset to code incident reports to enable
data pooling, analysis and learning across the NHS. During 2004 the NHS
will be requested to adopt this new dataset for use in incident report
forms and risk management software. Full details of the NRLS dataset
are available on the NPSA website at www.npsa.nhs.uk
Patient safety incidents involving medicines are defined as any unintended
or unexpected event that could — or did — lead to patient
harm while the medicine was in the control of the health care professional,
patient or consumer. Such events may be related to professional practice,
health care products, procedures and systems, including prescribing;
order communication; product labelling, packaging and nomenclature; compounding;
dispensing; distribution; administration; education; monitoring; and
use. This definition has been adopted from the National Co-ordinating
Committee for Medication Error Reporting Programmes in the United States.
There are four specific sections in the NRLS relating to medicines (see
Panel).
Panel: NRLS sections relating to medicines
1. At what stage in the medication process did an actual or potential
error occur?
a. prescribing
b. preparation of medicines in all locations or dispensing in a pharmacy
c. administration or supply of a medicine from a clinical area
d. monitoring or follow-up of medicine use
e. advice concerning any aspect of medicines use
f. supply of an over-the-counter medicine
g. other
2. In-process description of the error
a. adverse drug reaction (when used as intended)
b. contraindication to the use of the medicine in relation to drugs
or condition
c. mismatching between patient and medicine
d. omitted medicine or ingredient
e. patient allergic to treatment
f. wrong, omitted or passed expiry date
g. wrong or omitted patient information leaflet
h. wrong or omitted verbal directions to the patient
i. wrong, transposed or omitted medicine label
j. wrong or unclear dose or strength
k. wrong drug or medicine
l. wrong formulation
m. wrong frequency
n. wrong method of preparation or supply, or administration
o. wrong quantity
p. wrong route
q. wrong storage
r. other
3. Other important factors
a. failure to refer to hospital follow-up
b. failure to monitor or assess medicines therapy
c. failure of adequate medicines security (eg, missing Controlled
Drug)
d. failure of clinical assessment equipment
e. failure of compliance aid or monitored dosage system
f. failure to order laboratory test
g. handwritten prescription or chart difficult to read
h. health care practitioner undertaking supplementary prescribing
i. involving a medicine supplied under a patient group direction
j. involving an over-the-counter medicine
k. issues associated with an infusion pump or syringe driver
l. medicines with similar looking or sounding names
m. omitted signature of health care practitioner
n. patient or carer failure to follow instructions
o. poor communication between care providers (verbal or written)
p. poor labelling and packaging from a commercial manufacturer
q. substance misuse (including alcohol)
r. use of abbreviation(s)
s. variance to guidelines for sound clinical reasons
4. Details of the product(s) involved
a. approved name
b. proprietary name
c. form and strength
d. route
e. BNF classification (1–15)
f. manufacturer
g. batch number
h. is the medicine an unlicensed special?
i. is the medicine a parallel import?
j. is the medicine clinical trial material? |
The medicine product data fields (section 4) will initially be
free text, but it is planned that the NRLS will use the United Kingdom
Clinical
Products Reference Source (UKCPRS) which is being developed by the Prescription
Pricing Authority and the NHS Information Authority. This medical products
database will be continuously maintained and updated and will contain
the primary care and secondary care medicine products databases as well
as a medical devices database. The use of UKCPRS in the NRLS will enable
more accurate coding of the medicine products involved in the incident
from pull down tables when entries are being made in the reporting software.
In addition to these four sections there are data fields that identify
the type of health care setting, clinical specialty, staff type and grade
involved, patient type, age and sex, and clinical condition being treated.
There are also data fields for the date and time the incident took place.
Free text fields are provided for descriptions of the incident, measures
that prevented or minimised patient harm, and actions taken following
the incident to prevent recurrence. Optional data fields are available
to describe what were the underlying causes or events which, if rectified,
may prevent another patient safety incident.
A data field is provided to grade any actual harm to the patient using
the following scale: low (minimal harm — patient(s) required extra
observation or minor
treatment); moderate (short-term harm —
patient(s) required further treatment, or procedure); severe (permanent
or long-term harm); and death (caused by the incident).
Having described the medicine section codes of the NRLS, it will be apparent
that analysis of this data will provide useful information at local and
national level concerning the types of medicine-related patient safety
incidents that are occurring.
However, the benefits and learning from this analysis will be reduced
if incident reports submitted to the NPSA are inaccurately coded or incomplete.
When the system is rolled out throughout 2004, and as their organisation
begins participating in national reporting, pharmacists are asked to
ensure that the incidents that they report using the codes are completed
as required. It would also be helpful if pharmacists offer to assist
risk managers and clinical governance leads in trusts regularly to review
incident reports involving medicines and ensure that the coding system
is used as intended. This is particularly so concerning the details of
the medicine products involved in the incidents. Pharmacists can quality
assure and, where necessary, supplement the medicines information in
the incident report. This will ensure that the maximum learning and systems
improvement actions occur as a result of analysis of NRLS data at local
and national level. |
