Improving the Safety of Magnesium Sulphate Injection: A ...
Transcript of Improving the Safety of Magnesium Sulphate Injection: A ...
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A Failure Modes and Effects Analysis (FMEA)
of the use of Magnesium Sulphate injection
August 2013
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Contents
Page number
1. Executive summary 3
2. Introduction 4
• Objectives
• Scope
• Procedure/Methodology
3. Method of analysis 7
4. Findings: Significant failure modes identified 7
5. Limitations of the FMEA 8
6. Discussion 8
7. Recommendations 9
8. Conclusions 12
9. Acknowledgements 12
10. References 13
11. Further reading 14
12. Appendices 15
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1. Executive summary
High-risk medications are those that pose an increased risk of causing significant
patient harm when used incorrectly. Although mistakes may or may not be
common with these medications, the consequences of such mistakes may be
much more devastating1. Based on incident reports submitted regionally and
nationally, and from the literature worldwide, injectable magnesium sulphate is
well known to be one such high-risk medication2.
Medication incidents have occurred in Northern Ireland hospitals with injectable
magnesium sulphate, resulting in varying degrees of patient harm. While
intravenous (IV) magnesium sulphate is widely used to treat a number of
indications such as arrhythmias, asthma, hypomagnesaemia, eclampsia and
neuroprotection of the fetus in the management of preterm labour, it is very
effective when used safely, however it has the potential to cause serious harm or
death when used incorrectly.
Following a Serious Adverse Incident involving IV magnesium sulphate and with
an awareness of other related incidents, the NI Medicines Governance Team
undertook a Failure Modes and Effects Analysis (FMEA) into the use of IV
magnesium sulphate in an attempt to identify the major risks involved in its use,
and to develop recommendations that might reduce the likelihood of future
medication incidents. This was endorsed by the Heads of Pharmacy & Medicines
Management across all 5 HSC Trusts.
Failure Modes and Effects Analysis (FMEA) is a structured prospective risk
analysis tool that has been widely used within the aerospace and automotive
industries and has more recently been utilised within healthcare since the early
1990s. It involves a multidisciplinary team mapping out a high-risk process of care
and identifying the failures that can occur. Each of these failures is then
characterised in terms of likelihood of occurrence, detectability and severity of
effects, and a risk priority number assigned to each of them. The resultant score is
then used to identify those failures most in need of attention3.
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2. Introduction
• Objectives
To improve patient safety through the identification of actions to reduce
medication errors in the use of IV magnesium sulphate.
• Scope
To evaluate the risks associated with the prescribing, dispensing,
administration and monitoring of IV magnesium sulphate, and to make
recommendations to reduce those risks considered to be associated with the
highest degree of potential harm to patients.
• Procedure/Methodology
Before starting the FMEA the NI Medicines Governance Team reviewed and
collated available information regarding risks relating to the use of IV
magnesium sulphate.
The team collated and analysed all medication incidents involving IV
magnesium sulphate reported in Northern Ireland during the period 01/04/08 to
31/03/11 inclusive.
A request was then submitted to the National Patient Safety Agency for
information/data on reported incidents in the UK taken from the NRLS
(National Reporting and Learning Services) database.
Professor David Cousins, Head of Safe Medication Practice and Medical
Devices, NPSA (May 2011) shared this information with the team which
allowed for a national perspective on the problems occurring with IV
magnesium sulphate.
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Following analysis of the NI incidents, the following types of incident were
found to be the most common:
Type of medication incident Number of incidents
Incorrect dose – overdose 5
Incorrect rate – too fast 5
Incorrect patient 2
Incorrect drug 2
Incorrect route 1
Incorrect storage 1
Omitted medicine during stay 1
A literature review was also carried out by the NI Medicines and Poisons
Information Service, BHSCT, into medication incidents involving IV magnesium
sulphate.
The FMEA
FMEA is a systematic, proactive method for evaluating a process to identify
where and how it might fail, and to assess the relative impact of different
failures in order to identify the parts of the process that are most in need of
change. FMEA includes review of the following: 4
- Steps in the process
- Failure modes (What could go wrong?)
- Failure causes (Why would the failure happen?)
- Failure effects (What would be the consequences of each failure?)
The NI Medicines Governance Team (Appendix 1) met initially to map the
different steps involved in the use of IV magnesium sulphate (Appendix 2) and
the following steps were agreed as those accurately describing the overall
process:
Step 1: Decision to treat
Step 2: Prescribing IV magnesium sulphate
Step 3: Stock supply/Non-stock supply/Out-of-hours supply
Step 4: Preparation
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Step 5: Administration
Step 6: Monitoring
Step 7: Treatment of toxicity
For each step in the process, all possible ‘failure modes’ were listed, including
minor and rare problems. Then, for each failure mode listed, all possible
‘failure causes’ were identified and the ‘failure effects’ of each of these were
also recorded.
The next stage in the FMEA process was to assign a ‘Risk Priority Number’
(RPN) to each of the failure modes. This is a numerical value based on the
likelihood of occurrence, likelihood of detection and severity of effects;
assigning a numerical value allows for prioritisation of the risks identified.
The documentation used to collate the information gathered throughout the
FMEA is shown below.
Step in process
Failure mode
Failure causes
Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1-10)
RPN
In order to ensure that each failure mode was considered in the correct
context, a multidisciplinary team (Appendix 3) was invited to meet with 2
members of the Medicines Governance Team to complete the FMEA. This
collaborative approach brought together expertise from other professionals in
the medical, nursing, midwifery and pharmacy fields to help ensure all aspects
in the use of IV magnesium sulphate injection were considered.
An information resource pack was distributed to the multidisciplinary team
members explaining the methodology of FMEA including guidance on the
‘scoring’ of the 3 parameters: likelihood of occurrence, likelihood of detection
and severity of effects, with each score being assigned a value between 1 and
10 (Appendix 4).
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3. Method of analysis
The RPN for each failure mode was calculated by multiplying the scores
obtained for each parameter. Those with the highest RPN values (150 and
above) were then considered in more detail as it is these particular failures
which would be associated with most risk.
The completed FMEA can be found in Appendix 5 where the RPN values
ranged between 1 and 384, with the top 10 RPN values highlighted in yellow
(i.e. RNP ≥ 150)
4. Findings: Significant failure modes identified
When collated, those RPN ≥ 150 were used to identify the failure modes as
having the greatest potential to cause harm and these were as follows:
Failure mode Step involved RPN value (and indication for IV magnesium sulphate)
Delay in decision Step 1: Decision to treat 150 (hypomagnesaemia)
Wrong dose Step 2: Prescribing IV magnesium
288 (hypomagnesaemia)
Wrong rate 288 (hypomagnesaemia)
Wrong patient 150 (hypomagnesaemia)
Wrong product ordered Step 3b: Non-stock supply
162 (hypomagnesaemia)
Wrong product selected on ward module
162 (hypomagnesaemia)
Wrong product selected in pharmacy
162 (hypomagnesaemia)
Calculate wrong volume of magnesium prescribed
Step 4: Preparation 224 (hypomagnesaemia)
Failure to do second check
Step 4: Preparation and Step 5: Administration
384 (all indications) 256 (all indications)
Failure of second check 384 (all indications)
Wrong pump setting Step 5: Administration 288 (pre-eclampsia) 180 (hypomagnesaemia) 252 (asthma)
Failure to monitor Step 6: Monitoring 160-200 (pre-eclampsia) 200 (hypomagnesaemia) 175-200 (asthma)
Failure to treat toxicity Step 7: Treatment of toxicity
200 (pre-eclampsia, hypomagnesaemia, asthma)
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5. Limitations of the FMEA
The FMEA process uses a hypothetical approach to understanding the
risks involved in a process, compared to other risk management tools such
as Root Cause Analysis which use actual data/information to understand
the problems involved.
The FMEA did not risk assess the unlicensed use of intravenous
magnesium sulphate for the neuroprotection of the fetus in the
management of pre-term labour. This indication for the use of intravenous
magnesium sulphate was identified during the development of this report.
Nor did it address the use of magnesium sulphate injection in total
parenteral nutrition (TPN).
The FMEA did not seek to evaluate the impact of implementation of any of
the recommendations.
6. Discussion
It became apparent as the FMEA was nearing completion that certain aspects in
the use of IV magnesium sulphate carried much greater risks than others. For
example, if only those RPN values > 200 are considered from the table above,
then we can make the following generalisations from the results:
Ensuring the dose and rate are correct are the key steps in the prescribing
process. The variety of measurement units in which dosage of this
electrolyte may be expressed makes potentially fatal dosing errors more
likely5.
Calculation of the volume of magnesium sulphate solution to use in the
preparation of the magnesium sulphate infusion is crucial in the safe
preparation and administration of IV magnesium sulphate, as is the
accurate setting of the infusion device.
The importance of having an independent second check carried out at the
preparation and administration stages, regardless of who is preparing
and/or administering the preparation, adds an extra safety barrier into the
overall process, and could be the difference between the patient receiving
the correct dose and a harmful incorrect dose.
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7. Recommendations
Following consideration of all the failure modes recognised in each step of the
process where the RPN ≥ 150, and the associated failure causes identified
with these failure modes, the following recommendations are made.
Those recommendations which are specific to the use of IV magnesium
sulphate are highlighted in bold followed by other recommendations relevant to
safe medication practice.
Recommendations
Ensure all wards/clinical areas have readily available access to
clinical guidance on the safe use of IV magnesium sulphate for the
indications being treated.
Laboratory staff should ensure that reliable systems are in place to
communicate all abnormal laboratory test results to the relevant medical
practitioner looking after the patient.
Recommendations
Trusts should ensure that clinical guidelines are in place to
support the safe prescribing of IV magnesium sulphate in all
settings (e.g. hypomagnesaemia, asthma, arrhythmias, severe pre-
eclampsia, eclampsia and neuroprotection of the fetus in the
management of preterm labour) including guidance on the
required dose and rate of infusion, and conversion between
different expressions of units.
Consensus should be reached on suitable pre-prepared IV
magnesium sulphate infusions for the required indications, which
should then be prescribed.
Step in process: Decision to treat
Failure mode: Delay in decision
Step in process: Prescribing IV magnesium sulphate
Failure mode: Wrong dose/wrong rate/wrong patient
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Magnesium sulphate injection and pre-prepared infusion strengths
should be expressed in mmol and grams in all electronic
prescribing systems to reduce confusion in magnesium dosing.
Ensure treatment plans are written clearly in the patient’s medical notes,
medication charts or any other record used to document treatment
decisions/information.
Ensure all relevant laboratory results are correlated with the correct
patient before prescribing new treatment.
The kardex should always be checked against the details of the patient
before prescribing to ensure the correct kardex is used when
prescribing medication.
A clinical pharmacist check of prescribed medication should be carried
out at ward level where feasible.
Recommendations
Magnesium sulphate injection and pre-prepared infusion strengths
should be expressed in mmol and grams in all electronic
dispensing systems to reduce confusion in magnesium dosing.
All non-stock requisitions for IV magnesium sulphate should be
clinically checked by a pharmacist, against the patient’s kardex
where feasible.
Trusts should ensure that storage of IV magnesium sulphate is
risk assessed to minimise mix-ups between IV magnesium
sulphate products or other pharmaceuticals stored in the same
area, taking into consideration the product packaging.
Step in process: Non-stock supply
Failure mode: Wrong product ordered/wrong product selected on ward
module/wrong product selected in pharmacy
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Recommendations
Pre-prepared magnesium sulphate infusions should be procured
and used wherever possible in accordance with prescribing
consensus.
Magnesium sulphate injection should be removed from ward stock
and replaced with pre-prepared IV magnesium sulphate infusions
in accordance with prescribing consensus.
Where pre-prepared magnesium sulphate infusions are not
available, calculation of the volume of magnesium sulphate
solution required to prepare the IV infusion should be carried out
carefully. It is very rare that ‘more than 3’ vials/ampoules of
magnesium sulphate injection would be required to prepare an
infusion, even at the higher doses6,7. For this reason it is
imperative that all calculations are independently second checked
by another member of medical/nursing/pharmacy staff.
The second check of medicine preparation and administration
should include the following: right patient, right route, right dose,
right volume of magnesium sulphate solution required to prepare
the dose, right final volume, right infusion fluid, right rate of
administration and right rate setting on the infusion device.
Bolus doses of IV magnesium sulphate must never be
administered from an infusion preparation where both a bolus and
infusion are to be given.
Confusion between the different expressions of strength of
magnesium sulphate injection can lead to calculation errors. Staff
involved in the preparation of magnesium sulphate bolus
injections and/or infusions should check with a more senior
colleague if unsure about any aspect of the strength of magnesium
sulphate injection when preparing the dose.
Staff should avoid distractions/interruptions during the preparation of
medicines.
Step in process: Preparation and administration
Failure mode: Calculate wrong volume of magnesium sulphate solution
required to prepare dose/failure to carry out second check/failure of
second check/wrong pump setting
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Consideration should be given to the use of smart pumps in the
administration of IV medicines.
All staff must be encouraged to challenge staff regarding the
preparation of medicines where they feel has been inaccurately
prepared/administered.
Recommendations
Trusts should ensure that clinical guidelines are in place to
support the safe prescribing of IV magnesium sulphate in all
settings (e.g. hypomagnesaemia, asthma, arrhythmias, severe pre-
eclampsia, eclampsia and neuroprotection of the fetus in the
management of preterm labour) including guidance on the normal
reference range for magnesium, the monitoring requirements
when IV magnesium sulphate is prescribed, signs of toxicity, how
to treat toxicity and availability of the antidote (calcium gluconate
10%).
8. Conclusions
FMEA facilitated the identification and prioritisation of risks with the use of
injectable magnesium sulphate. Recommendations have subsequently been
developed, aimed at reducing medication errors with magnesium sulphate
injection in secondary care in Northern Ireland.
9. Acknowledgements
The Regional Medicines Information Service undertook a literature review of
medication incidents involving intravenous magnesium sulphate.
David Cousins, Head of Safe Medication Practice, National Patient Safety Agency,
provided medication incident data from the National Reporting and Learning System.
Step in process: Monitoring and the treatment of toxicity
Failure mode: Failure to monitor/failure to treat toxicity
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10. References
1 Pathways for Medication Safety. www.medpathways.info
2 Implementation of a High-Alert Medication Program. The Permanente Journal.
Spring 2008. Volume 12 No.2
3 Failure mode and effects analysis outputs: are they valid? BMC Health Services
Research 2012, 12:150 NA Shebl, BD Franklin, N Barber.
4 Failure Modes and Effects Analysis (FMEA). Institute of Healthcare Improvement
2004
5 Magnesium sulphate: Is that the right dose? American Journal of Nursing (AJN).
August 1997 – Volume 97 – Issue 8 – pp12-14. Linda L. Lilley, Robert Guanci
6 ISMP (Institute for Safe Medication Practices). Medication Safety Alert, 5th Nov
1997. http://search.ismp.org/cgi-
bin/hits.pl?in=517791&fh=80&ph=1&tk=y%22vXfb%20sruC%203%22&su=qevvrT--
xxx.uibr.Q_P-%3Aqxipqvvq_i-WVCvqVW_q-W_vuVpqi-
19971105.Wir&qy=p%22p%3AFE%20JP%26b%203%22&pd=1
7 ISMP (Institute for Safe Medication Practices). Medication Safety Alert, 14th July
1999. http://search.ismp.org/cgi-
bin/hits.pl?in=517791&fh=80&ph=1&tk=zCxj%3A%20Cxj%3APd%20MFwX%20MFw
XPd%203%20j%27v%3A%20j%27v%3APd%20j%27v%3Ad&su=w%3AjjCKVVMMM
.QaiC.vxbVJLMa_LjjLxaVPudjLuPxLVPxjQu_LaVD3g99DujQvJ.PaC&qy=fKEPn%20
w-HV%203%20PLWn&pd=1
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11. Further reading
The Ten Most Common Lethal Medication Errors in Hospital Patients. Hospital
Pharmacy 2000, 35(5), 470-474. Argo AL, Cox KK, Kelly NN.
Obstetrical accidents involving intravenous magnesium sulphate: recommendations
to promote patient safety. MCN Am J Matern Child Nurs. 2004 May-Jun;29(3):161-9;
quiz 170-1. Simpson KR, Knox GE.
Preventing magnesium toxicity in obstetrics. Hospital Pharmacy 2005, 40(12), 1028-
1031. Cohen M.
Shaken, not stirred. Hospital Pharmacy 2005, 40(7), 556-557. Cohen M.
Resident training for eclampsia and magnesium toxicity management: simulation or
traditional lecture? American Journal of Obstetrics & Gynecology 2010, SMFM
Papers 379.e1
Acute magnesium toxicity in an obstetric patients undergoing general anaesthesia
for caesarean delivery. Int J Obstet Anesth, 2010, Apr;19(2):226-31. McDonnell NJ,
Muchatuta NA, Paech MJ.
Inadvertent administration of magnesium sulphate through the epidural catheter:
report and analysis of a drug error. Int J Obstet Anesth, 2006, 15, 63-67. Goodman
EJ, Haas AJ, Kantor GS.
Hypermagnesenia in a paediatric patient. Anesth Analg 2000;91:1160-2. Harker HE,
Majcher TA.
Failure mode and effects analysis: too little for too much? BMJ Qual Saf, published
online March 23, 2012. Dean Franklin B, Shebl NA, Barber N.
Design of a safer approach to intravenous drug infusions: failure mode effects
analysis. Qual SAF Health Care, 2004;13:265-271. Apkon M, Leonard J, Probst L,
DeLizio L, and Vitale R.
FMEA: a new approach to manage high risk medicines. The British Journal of
Clinical Pharmacy Dec 2009, Vol 1. Williamson S, Wake N, Donovan G.
Towards standardisation of drug infusion concentrations in UK critical care units.
Journal of the Intensive Care Society, 2009, Volume 10, Number 3. Borthwick M,
Keeling S, Keeling P, Scales K, and Waldmann C.
Managing high-risk medications: implementing medication management standard
7.10. Hospital Pharmacy 2006, 41(5), 470-476. Shlom EA, May SK.
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NI Medicines Governance Team members Appendix 1
Anna Lappin, Northern Health & Social Care Trust
Daryl Connolly, Western Health & Social Care Trust
Jillian Redpath, Southern Health & Social Care Trust
Sharon O’Donnell, Belfast Health & Social Care Trust
Aine Liggett, South Eastern Health & Social Care Trust
Angela Carrington (Team Leader) Belfast Health & Social Care Trust
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Process mapping of IV magnesium sulphate use Appendix 2
1. Decision to treat - based on lab results +/-
- clinical presentation of patient [consider Neonates & Paediatrics]
2. Prescribing - dose (mmol or gm) - rate of administration - volume of fluid - type of fluid - where to prescribe - kardex
- fluid balance chart
- recommendation in patients notes
- verbal recommendation from specialist e.g.
over the phone (does this include dose
guidance?)
3. Supply: stock supply/non-stock supply/out-of-hours (OOH) supply - ward top-up item or non-stock item - selection of correct medicine in dispensary - clinical check against kardex: Trust specific
4. Preparation - select medicines - read prescription - calculate volumes - withdraw from amps – Mg - query withdrawal of excess infusion fluid? - add Mg to infusion fluid - mix - label - 2nd check: Trust specific
5. Administration - identify patient - (2 steps) Bolus & maintenance - ensure IV access for eclampsia
- flush to ensure patency
- connect infusion – ensure correct line
- pump setting (large v small volume [bolus])
- infusion commenced
- document administration
- 2nd check: Trust specific
6. Monitoring - in accordance with requirements of guidelines or
- instructions of the prescriber (communication) - document
7. Treatment of toxicity if required - seek advice from specialist
***The FMEA did not address; the use of intravenous magnesium sulphate for the neuroprotection of the fetus in the management of pre-term labour or the use of magnesium sulphate injection
in TPN***
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Multidisciplinary Team members Appendix 3
Anna Lappin, Medicines Governance Pharmacist, NHSCT
Daryl Connolly, Medicines Governance Pharmacist, WHSCT
Dr Francis McCarroll, Registrar, Physician, NHSCT
Dr Michael Ryan, Consultant Biochemist, NHSCT
Gillian Morrow, Practice Educator, Midwifery, BHSCT
Damien Holland, Staff Nurse, BHSCT
Majella Moohan, Clinical Pharmacist, BHSCT
Dr Kevin Glackin, ST6, Obstetrics, BHSCT
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Failure Modes and Effects Analysis Resources Appendix 4
Institute for Healthcare Improvement Information and tools available at:
http://app.ihi.org/Workspace/tools/fmea/
Institute for Safe Medication Practice Canada
Training presentation available at:
http://www.ismp-canada.org/download/ISMP_Canada_FMEA_presentation.pdf
Failure Modes and Effects Analysis (FMEA)
FMEA is a tool/process that was developed outside of healthcare but has been used
widely within healthcare to identify ways in which a process can fail.
FMEA looks at any given process, identifies possible or likely errors (failure modes),
and gauges what the consequences (effects) will be, even before they take place.
The aim is to predict where and how the process may fail, the causes of such
failures, and to examine the consequences of such failures. The severity of the effect
on the patient is then examined alongside the likelihood of occurrence and the
likelihood of detection of the failures, before assigning a risk score to each failure
mode (Risk Priority Number, RPN).
The process then finishes with producing a set of prioritised recommendations to be
implemented in order to eliminate the possibility of error, detect the error before it
reaches the patient, or minimise the harmful effects of the error on a patient.
FMEA Steps
1. Choose a multidisciplinary team
2. Construct a detailed flow chart of the process
3. Decide ‘how’ and ‘where’ the process can go wrong
- The failure mode is ‘What might happen’
- The cause is ‘Why it happens’
4. Determine the ‘effect’ of each failure
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- Try to limit this to the true effect of the failure, not what the effect might be
5. For each failure ‘effect’
• Estimate the likelihood of occurrence (A)
• Estimate the likelihood of detection (B)
• Estimate the severity of effects (C)
Then calculate the Risk Priority Number (RPN)
RPN = A x B x C
6. Rank the ‘effects’ in order of RPN
7. Redesign systems to
• Decrease recurrence
• Decrease the severity
• Increase the probability of detection
8. Implement ‘new’ process
9. Audit new process for uptake
10. Repeat exercise to determine new RPN and monitor the RPN over time
against improvements in processes.
Tips
• Take small bites / keep it simple
• Think ‘what could possibly go wrong’ and/or ‘what has gone wrong frequently
in the past’
• Modifying a new process may create new risks
• Map quickly
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Scoring
(A) Likelihood of occurrence
Score Probability Description
1 1:1,000,000 Remote, no known occurrence
2 1:100,000 Very low, possible but no known data
3 1:100,000
4 1:10,000 Low, possible but infrequent documented occurrences
5 1:10,000
6 1:1,000 Moderate, documented occurrences
7 1:1,000
8 1:100 High, documented and frequent
9 1:10 Very high, documented almost certain
10 1:1 Extreme – will always occur
(B) Likelihood of detection
Score Probability Description
1 10:10 (100%) System will always detect error
2 8:10 (80%) High, likely to be detected before reaching the patient
3 7:10 (70%)
4 6:10 (60%) Moderate, moderate likelihood of detection before it reaches the patient 5 5:10 (50%)
6 4:10 (40%) Low likelihood of detection before it reaches the patient
7 3:10 (30%)
8 2:10 (20%) Very low likelihood of detection before it reaches the patient 9 1:10 (10%)
10 0:10 (0%) Detection not possible at any point within system
(C) Severity of effects
Score Description
1 Slight annoyance, may annoy the system
2 Moderate system problem, may affect the patient
3
4 Major system problem, may affect the patient
5
6 Minor patient injury
7 Moderate patient injury
8 Major patient injury
9 Terminal injury/patient death
10 Multiple terminal injury/death
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Intravenous Magnesium Sulphate FMEA (The top 10 RPN scores are highlighted in yellow) Appendix 5
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
1. Decision to treat
Decide not to treat when they should
Lack of knowledge/ experience
Deterioration of clinical state
Pre-eclampsia = 1 HypoMg = 4 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 3 HypoMg = 5 Asthma = 2 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
24 100 28 27
No decision made to prescribe:
Overlooked - no level taken or - not acted on
Deterioration of clinical state
Pre-eclampsia = 1 HypoMg = 4 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 3 HypoMg = 5 Asthma = 2 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
24 100 28 27
Decide to treat when not appropriate
Lack of knowledge/ experience. - using before other treatment maximised (asthma)
Possible magnesium toxicity
Pre-eclampsia = 1 HypoMg = 4 Asthma = 4 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 6 Asthma = 6 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2
4 48 48 8
Delay in decision
Delay in Lab results. Cannot contact specialist. Cannot find guidelines.
Deterioration of clinical state
Pre-eclampsia = 3 HypoMg = 6 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 2 HypoMg = 5 Asthma = 2 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
48 150 28 27
2. Prescribing IV Mg
Not prescribed
Forget. Decision not communicated to prescriber.
Deterioration of clinical state
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 2 HypoMg = 6 Asthma = 3 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
32 120 42 18
Delay in prescribing
Forget. Decision not communicated to prescriber.
Deterioration of clinical state
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 6 Asthma = 3 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
32 120 42 36
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Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong dose Illegibility in recommendation (notes). Lack of knowledge. Confusion with units (e.g. mmol/ml/G/%). Lack of regional/national guideline. (respiratory/ cardiology/ hypomagnasaemia). Lack of consistency between local guidelines. Failure to interpret guidelines correctly. BNF (info in different sections). Calculation. No pharmacist clinical check of prescription. Wide stock availability does not trigger further questioning of incorrect prescription.
Deterioration of clinical state (underdose) Toxicity (overdose)
Pre-eclampsia = 2 HypoMg = 3 Asthma = 3 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 6 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 6 Asthma = 4 Arrhythmias = 3 Pre-eclampsia = 4 HypoMg = 6 Asthma = 4 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
32 90 84 48
64 288 64 32
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Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong rate Calculation. Confusing guideline e.g. hours per day or per hour. Lack of knowledge. Lack of guideline. Illegibility in recommendation (notes). No pharmacist clinical check of prescription. Wide stock availability does not trigger further questioning of incorrect prescription.
Deterioration of clinical state (rate too slow) Toxicity (rate too fast)
Pre-eclampsia = 2 HypoMg = 3 Asthma = 3 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 6 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 6 Asthma = 4 Arrhythmias = 3 Pre-eclampsia = 4 HypoMg = 6 Asthma = 4 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9 Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias =8
32 90 84 54
64 288 64 32
Wrong volume
Lack of knowledge. Lack of guideline. Illegibility in recommendation (notes). No pharmacist clinical check of prescription. Wide stock availability does not trigger further questioning of incorrect prescription.
Extravasation if too concentrated
Pre-eclampsia = 2 HypoMg = 3 Asthma = 3 Arrhythmias = 1
Pre-eclampsia = 4 HypoMg = 4 Asthma = 4 Arrhythmias = 1
Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 5
40 60 60 5
24
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong type of fluid
1 1 1 1
Not documented correctly
Location as to where it is prescribed – fluid balance chart / prescription. No pharmacist clinical check of prescription.
Repeated dose (toxicity) Omitted dose Delayed dose (underdose)
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 3 Pre-eclampsia = 2 HypoMg = 5 Asthma = 3 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 3 Asthma = 3 Arrhythmias = 3 Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmias = 9
48 18 18 18
32 90 48 54
Wrong patient
Similar names. Not checking the kardex against the details of the patient to be treated. Mismatch between lab result and patient to be treated. Bed locations being quoted. Instruction on which patient to treat misheard. No pharmacist clinical check of prescription. Wide stock availability does not trigger further questioning of incorrect prescription.
Wrong patient receives Mag. Correct patient does not receive Mag.
Pre-eclampsia = 2 HypoMg = 5 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 2 HypoMg = 5 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmias = 9
32 150 32 9
25
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
3a. Stock supply Not ordered on top-up when level below top-up
Overlooked. Manual system.
Stock not available – delay in treatment or wrong product selected
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmia = 9
32 54 32 36
Ordered but not supplied
Overlooked at picking and checking stage. Manual system.
Stock not available – delay in treatment or wrong product selected
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmia = 9
32 54 32 36
Wrong product supplied
Similar packaging with other medicines or wrong size ampoule. Poorly labelled product. Poor product description on computer. Wrong product ordered on top-up. Overlooked at picking and checking stage. Manual system.
Stock not available – delay in treatment or wrong product selected
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmia = 9
32 54 32 36
Expired product supplied
Overlooked at picking and checking stage. Manual system. Lack of routine expiry date checks.
In date stock not available – delay in treatment or expired product administered
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmia = 9
32 54 32 36
26
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
3b. Non-stock supply
Unclear requisition (minijet vs 2ml vs 10ml ampoule vs oral)
Unaware of different products. No clinical check against prescription in Pharmacy. No pharmacist screen on non-stock orders.
Delay in supply or wrong product supplied
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 54 4 4
Wrong product ordered
Confusion. No clinical check against prescription in Pharmacy. No pharmacist screen on non-stock orders.
Delay in supply or wrong product supplied
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 9 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 162 4 4
Wrong product selected on ward module
Pick-list. Products poorly described on computer. Unaware of different products. Poorly documented prescription. No clinical check against prescription in Pharmacy. No pharmacist screen on non-stock orders.
Delay in supply or wrong product supplied
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 9 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 162 4 4
27
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong product selected in Pharmacy
Similar packaging. Wrong storage – another product in bin location. Manual check fails. Manual check not done. Non-ACT final checking requisitions (cf to stock request where only top-items can be ordered, NB not all hospitals label non-stock). Wrong product requested from robot. Lack of training of staff to check. Distraction.
Stock not available – delay in treatment or wrong product selected on ward
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 9 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 162 4 4
Sent to wrong ward
Misread/unclear/wrong ward on requisition. Placed in wrong pigeon hole. Pneumatic delivery fault.
Stock not available – delay in treatment or wrong product selected on ward
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 8 HypoMg = 6 Asthma = 8 Arrhythmia = 9
32 54 32 36
3c. Out of hours supply
Select wrong product from emergency cupboard
Single check on selection from emergency cupboard.
Stock not available – delay in treatment or wrong product selected on ward
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 54 4 4
28
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong product borrowed from another ward
Ward don’t realise pharmacist input into non-stock supply. Have been told to borrow previously.
Stock not available – delay in treatment or wrong product selected on ward
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 54 4 4
Wrong product supplied
Single check on supply by EDC pharmacist.
Stock not available – delay in treatment or wrong product selected on ward
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmia = 2
Pre-eclampsia = 1 HypoMg = 6 Asthma = 1 Arrhythmia = 1
4 54 4 4
4 Preparation Read medicine name and dose incorrectly
Illegible prescription / handwriting (e.g. decimal point).
Delay Underdose Overdose
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 1 Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 2 Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9 Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
32 80 28 36
32 40 28 16
32 64 32 16
Wrong selection
Incorrect storage of similarly packaged ampoules.
Underdose of magnesium or toxicity due to an unintended medicine
5
3
7
105
29
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Calculate wrong volume of magnesium prescribed
Calculation error. Misunderstanding of ampoule contents on label. Confusion between expression of units (mmol/ml/ G/ml/%). Unaware of ‘more than 3’ rule.
Underdose Overdose
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 1 Pre-eclampsia = 4 HypoMg = 7 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 1 Pre-eclampsia = 3 HypoMg = 4 Asthma = 3 Arrhythmias =1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
32 40 28 8
96 224 48 8
Withdraw wrong volume from ampoules
Slip or lapse. Distracted Interruption.
Underdose Overdose
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 1 Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 2 HypoMg = 4 Asthma = 2 Arrhythmias = 2 Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
32 40 28 16
48 48 48 8
Withdraw wrong volume of excess infusion fluid
Slip or lapse. Distracted Interruption.
Pre-eclampsia = 1 HypoMg = 1 Asthma = 1
Pre-eclampsia = 5 HypoMg = 5 Asthma = 1
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2
10 10 2
Failure to mix thoroughly
Not aware of need. Overdose Extravasation
Pre-eclampsia = 4 HypoMg = 3 Asthma = 1
Pre-eclampsia = 3 HypoMg = 3 Asthma = 1
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2
24 18 2
Unlabelled or incorrectly labelled infusion
Forget. No labels. Not routine practice.
Toxicity (Think just dealing with NaCl or glucose) Administered to wrong patient
Pre-eclampsia = 5 HypoMg = 4 Asthma = 4
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8
120 96 96
30
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Failure to do Second Check
Not routine practice. Medical cf nursing staff.
Underdose Overdose Extravasation
6
8
8
384
Failure to do Second Check
Not routine practice. Medical cf nursing staff.
Underdose Overdose Extravasation
4
8
8
256
Failure of second check
Knowledge. Distraction. Interruption. Incomplete. Culture. Cursory Check. Failure to challenge.
Underdose Overdose Extravasation
6 8 8 384
5 Administration
Failure to identify correct patient
Similar names. Not checking the kardex against the ID braclet. Bed locations being quoted.
Wrong patient receives Mag. Correct patient does not receive Mag.
Pre-eclampsia = 4 HypoMg = 4 Asthma = 4 Arrhythmias = 1
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
96 60 84 9
No IV access
Venflon tissued. Lack of trained staff to cannulate.
Delay in treatment.
Pre-eclampsia = 4 HypoMg = 3 Asthma = 3 Arrhythmias = 2
Pre-eclampsia = 1 HypoMg = 1 Asthma = 1 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
32 15 21 18
Failure to check patency
Forget. Unaware of policy.
Unable to administer Mag. Extravasation
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 1 HypoMg = 1 Asthma = 1 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
16 10 14 18
Non-patent line
Poor line care. Patient related factors.
Unable to administer Mag.
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 1 HypoMg = 1 Asthma = 1 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
16 10 14 18
31
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Wrong line Lack of line labelling process. Failure to trace line back to patient.
Magnesium administered via wrong route.
Pre-eclampsia = 4 HypoMg = 4 Asthma = 4 Arrhythmias = 4
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
96 96 96 96
Wrong pump setting
Adjusted/set rate for another drug. Bolus rate continued. Operator error on pump. Lack of ‘smart’ pumps. Calculation error.
Magnesium administered at the wrong rate – Too Fast Magnesium administered at the wrong rate – Too Slow
Pre-eclampsia = 6 HypoMg = 6 Asthma = 6 Arrhythmias = 1 Pre-eclampsia = 6 HypoMg = 6 Asthma = 6 Arrhythmias = 1
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 1 Pre-eclampsia = 6 HypoMg = 6 Asthma = 6 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
144 144 144 8
288 180 252 9
Infusion not commenced
Distraction. Unfamiliar with pumps.
Magnesium not administered
Pre-eclampsia = 5 HypoMg = 5 Asthma = 2 Arrhythmias = 1
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 1
Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 9
120 75 42 9
Administration not documented
Forget. Documented on wrong document.
Dose administered again (bolus)
Pre-eclampsia = 5 HypoMg = 3 Asthma = 3 Arrhythmias = 3
Pre-eclampsia = 3 HypoMg = 3 Asthma = 3 Arrhythmias = 3
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
120 72 72 72
Failure to do Second Check
Not routine practice. Medical cf nursing staff.
Wrong patient Wrong route Underdose Overdose Extravasation
6
8
8
384
Failure to do Second Check
Not routine practice. Medical cf nursing staff.
Wrong patient Wrong route Underdose Overdose Extravasation
6
8
8
384
32
Step in process
Failure mode
Failure causes Failure effects
Likelihood of occurrence
(1-10)
Likelihood of detection
(1-10)
Severity (1 – 10)
RPN
Failure of second check
Knowledge. Distraction. Interruption. Incomplete. Culture. Cursory Check. Failure to challenge.
Wrong patient Wrong route Underdose Overdose Extravasation
6 8 8 384
6. Monitoring Not done Forget. Lack of guidelines. Prescribers requirements not clearly documented.
Toxicity not detected Lack of effect not detected Incorrect rate not detected – overdose Underdose
Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 2 Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 2
Pre-eclampsia = 4 HypoMg = 5 Asthma = 5 Arrhythmias = 2 Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8 Pre-eclampsia = 8 HypoMg = 5 Asthma = 7 Arrhythmias = 8
160 200 200 32
200 125 175 32
Not acted on
Lack of knowledge. Lack of clear guidance.
Toxicity/lack of effect not recognised
Pre-eclampsia = 2 HypoMg = 3 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 4 HypoMg = 5 Asthma = 4 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
64 120 64 32
Not documented
Forget. Document in wrong document.
Toxicity/lack of effect not recognised by others
Pre-eclampsia = 2 HypoMg = 2 Asthma = 2 Arrhythmias = 2
Pre-eclampsia = 4 HypoMg = 4 Asthma = 4 Arrhythmias = 4
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
64 64 64 64
7. Treatment of toxicity
Not treated Unaware of how to treat. Unaware of need to treat (severity of magnesium toxicity). Not seeking specialist advice.
Toxicity not treated
Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 2
Pre-eclampsia = 5 HypoMg = 5 Asthma = 5 Arrhythmias = 2
Pre-eclampsia = 8 HypoMg = 8 Asthma = 8 Arrhythmias = 8
200 200 200 32