Notes on Medication error and safety

1. WORLD ANAESTHESIA DAY
#MEDSAFE #WAD2022
BY
DR. RAVIKIRAN H M
MBBS, DNB ANAESTHESIOLOGY
ADMO, CENTRAL HOSPITAL, MALIGAON
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE

2. INDEX
• History
• Introduction
• WAD2022: Theme
• Definition
• Categories of error
• Source of error
• Reducing the risk of error
• Recommendations
• Conclusion
• References

3. HISTORY
Amphitheater-Ether dome,
Massachusetts Hospital,
Boston. On 16th October
1846, Dentist-William T G
Morton, first successful
public demonstration of
ether anesthesia, John
Collins Warren was the
surgeon, removed a tumor
from neck of patient
named Edward Gilbert
Abbott.

5. INTRODUCTION
• Unsafe medication practices and medication errors are the leading
causes of avoidable harm in health care across the world.
• It is projected that 5% of all patients who are admitted to a hospital
experience a medication error, and that an average hospital will have
one medication error every 23 hours or every 20 admissions.
• Medication errors result in severe patient harm, disability and even
death.
• Globally, the cost associated with medication errors has been
estimated at $42 billion USD annually.

6. INTRODUCTION cont…
• As recognized leaders in patient
safety, anesthesia professionals
are at the forefront of
medication safety.
• All anesthesia professionals on
a daily basis employ personal
and team-based practices and
techniques to ensure that their
patients receive the correct
medication, at the right
concentration, at the right time
and in the right place.

7. BIG TOPIC IN ANAESTHESIA
SPECIFICALLY?
1. Medications we use can be lethal
2. Narrow therapeutic window
3. Ampoules are nearly identical
4. Need of administration of multiple drug at a time
5. Critical events
6. Very less time
7. Sole individual that prescribes, dispenses, prepares,
administers and documents
8. Distracting environment: Hurrying surgeon
9. Team work

8. THEME
• WAD 2022 is about the global anesthesia community celebrating and
sharing personal and professional expertise.
• Sharing on their social media feeds the techniques that they employ
every day to ensure patient safety.
• Highlight their leadership and expertise in medication safety.
• Improving medication safety practices and reducing medication
errors.
Medication safety = Patient Safety
#MEDSAFE #WAD2022

9. TIPS/EXAMPLES ON SOCIAL PLATFORMS
• I am #MedSafe because I pre-prepare my syringes when I can.
• I am #MedSafe because I always keep my syringes colour-
coded.
• I am #MedSafe because I prioritise my wellbeing, so I’m not
overly fatigued in the operating theatre.

10. DEFINITION
• Medication errors are ‘a failure in
the treatment process that lead to, or
have the potential to lead to, harm to
the patient’.
• An ‘error’ is a failure to carry out
the plan as intended – or it’s a
deficient plan to begin with.

11. CATEGORISATION OF MEDICATION
ERRORS
Stage in the
process
Medication selection; purchase; storage; dispensing or
manipulation; distribution; prescribing; administration;
documentation; or clinical monitoring
Causative factor Supply failure; lack of clinician’s knowledge; communication
failures; or distracting work environment
Mechanism of
error
Surge in demand for a drug with low stock levels or
misselection of a syringe from a tray of drugs
Based on
psychological
theory
Errors when planning actions, errors in the execution of well-
planned actions, or deliberate violations
Clinical impact
(actual or
potential)
From no harm to life-threatening complications
Note: Commonest cause of medication related adverse events is drug misidentification resulting
in the wrong medication being in the syringe.

12. SOURCES OF ERROR
• Similar looking
ampoules/packaging or ‘look
alike’
• Similar sounding names or ‘sound
alike’ Ex: Adrenaline, Atropine
• Falsely anticipated or confounded
storage location
• Concentration of the preparation.
Ex: Midazolam, Heparin
• Intended route of administration of
the preparation

13. HUMAN FACTORS IN MEDICINES SAFETY

14. REDUCING THE RISK OF ERROR
• In 2017 the WHO identified its third
‘Global Patient Safety Challenge’ as
improving medication safety by
strengthening the systems for reducing
MEs and avoidable medication-related
harm.
• The three key priorities for safety
improvements are high-risk medication,
polypharmacy, and transition of care.
• Target of 50% reduction in number of
incidents of medication harm.

15. REDUCING THE RISK OF ERROR cont..
• Studies show that there are methods of improving medication
safety.
• For example, engagement with checklists and technology has
been shown to enhance performance, as well as pre-preparing
syringes when possible.
• It’s also important to encourage a ‘just’safety culture through
the routine reporting of medical errors, creating a fair
environment where systemic issues can be distinguished and
resolved.

16. REDUCING THE RISK OF ERROR cont..
1. Medicines management systems
2. Product design
3. Supply & storage
4. Drug loading
5. Cross checking
6. Working environment
7. Drug effect monitor
8. STAR second approach
9. Bucket of drug approach
10. Safety culture of incident reporting
11. Recommendations & Checklist

17. MEDICINES MANAGEMENT SYSTEMS
• It is the clinical, cost-effective & safe use of medicines to ensure
patients get the maximum benefit from the medicines they need, while
at the same time minimizing potential harm.
• Looks at systems surrounding selection, purchase, storage, dispensing,
prescribing and administration.
• Recommendation: the Royal College of Anaesthetists’ Guidelines for
the Provision of Anaesthetic Services (GPAS) that ‘reliable medicine-
management systems should be in place, and appropriate safety
measures should be taken to minimize errors.
• Include ensuring appropriate training for all staff, access to
appropriate & up-to-date resources, following legislation for
medications, SOP & access to a clinical pharmacy service for advice.

18. PRODUCT DESIGN
From left to right: Luer-lock syringe for intravenous use, ENFit standard
syringe for enteral use, and NRFit standard syringe for central neuraxial
and regional anaesthesia.

19. PRODUCT DESIGN cont..
• Pharmaceutical companies and procurement authority should
comply with national guidelines of packing & labeling.
• The number of syringes that are prepared in the operating
theatres is minimised to increase safety, especially of high-risk
medications Ex. Heparin, Morphine..
• Prefilled syringes are made in a system designed to ensure the
quality of the product and with enhanced labeling

20. SUPPLY AND STORAGE OF MEDICATIONS
• Facilities for medication storage that allow
– Timely access,
– Maintaining integrity of the medicines and
– Aiding organizations to comply with safe
and secure storage requirements
• Reliable medicines management, stock review,
supply, expiry checks, and access to
appropriately trained pharmacy staff to manage
any drug shortages
• In-date supply maintained for emergency drugs
• Buffer stock

21. DRUG LOADING
• Only handle one medication at a time.
• Quarantine medication preparation activities:
Whenever possible do not allow distraction or
answering of questions while preparing medications.
• Read carefully before the drug is drawn up or
injected.
• Ideally drugs should be drawn up and labelled by the
anaesthetist who administers them
• Storage: clear and distinct location. Ex: Rainbow
tray

22. All syringes containing drugs are clearly labeled, and it is recommended that the label
includes a colour as defined by international norm ISO 26825

23. Three separate trays that allow the anaesthetist to clearly
separate routine, local and emergency drugs.
Allow all syringes to sit comfortably within the sections
together with the ampoules and are less likely to be relocated
or swapped.
RAINBOW TRAY

24. CROSS CHECKING
• Double-checking medicines
• Two-person technique
• Computerized barcode-
assisted double-checking
• Intelligent computerized drug
decision-support systems were
integrated with electronic
patient records.

25. WORKING ENVIRONMENT
• Adequate rest, active supervision,
avoiding distractions, and engagement
with checklists and technology.
• Last minute changes in operating list
order to be avoided
• Senior>>Junior anesthetist will reduce
error
• Anaesthesia is provided on a
nonelective basis and outside of
normal working hours is more error
prone

26. DRUG EFFECT MONITOR
• BIS is recommended during use of TIVA: CLADS

27. STAR second
• As soon as I pick it up, I
 Stop
 Think
 Act
 Reflect: whether it
achieved the goal I
wanted.

28. BUCKET OF DRUGS APPROACH
• Drug misidentification is most common type of error.
• Strategy for addressing this is to make the packaging of different
medications as distinct as possible from one another.
• A less intuitive but often touted alternative approach is to do the exact
opposite: make the packaging of all drugs so similar that great effort
must be expended to ensure the correct medication is being given.
• Logic: providing distinctive packaging encourages clinicians to
become reliant on these cues to identify medications, rather than
concentrating on reading the label – and that this complacency may
actually promote misidentifications

29. BUCKET OF DRUGS APPROACH cont..
• Rationale: making all medication packaging as close as possible to
identical, the clinician is instead compelled to perform the task
required of them: vigilant checking of the medication label.
• Remove cues related to position in the storage drawer : placing all of
these identical medications into a single receptacle – a ‘bucket of
drugs’, which could only be distinguished by reading the details on
the label.
• Impractical: lack of time, various expiry date, similar drug
appearance preparation not possible

30. PROMOTING SAFETY CULTURE
• Routine reporting of MEs, ADRs, and near misses should be easy to
perform and actively encouraged.
• Root cause investigations should be fair and transparent, with
compassionate support and feedback afforded to those involved.
• Investigations should focus on the various latent factors arising from
the working environment in conjunction with the final ‘action error’.
• Analysis of individual reports and regular audit of collective reports
enables the development of quality improvement interventions.

31. PROMOTING SAFETY CULTURE cont…
• Important policy changes should
be implemented in a timely fashion
and be well publicised to the
relevant staff, and subsequently re-
evaluated.
• A ‘just culture’ model of shared
accountability between
management and staff has been
advocated.
• Although a nonpunitive approach
is appropriate for most errors,
individuals are accountable if they
deliberately or repeatedly
compromise patient safety.
JUST
CULTURE
REPORTING
CULTURE
LEARNING
CULTURE

32. RECOMMENDATIONS

33. RECOMMENDATION: PREOPERATIVE
• Confirm the drug history, allergy status, and patient weight with the
patient, clinical records and relatives/ carer’s, when relevant.
• Include relevant patient information such as allergy status in the
preoperative time-out.
• Single location for recording medications across surgery (pre, intra,
PACU)
• Automated alerts within anaesthesia information system for: Dose,
Allergy, Drug-drug interactions
• Establish weight-based dose limits: Infusion device has prompts re
limits, Computer prompted ,Paper sheet to consult

34. RECOMMENDATION: PREPARATION/CART
INVENTORY
• Minimise the risk of infection
– Effective hand hygiene.
– Limit each ampoule or vial to single patient use.
– Swab vial tops and injection ports with 70% alcohol wipes.
– Cap syringes and store them in clean trays for each patient.
• Environment for drug preparation
– Adequate lighting
– Uncluttered workspace
– Minimal distractions
• Read drug labeling carefully to check the name, concentration and
expiry date.

35. RECOMMENDATION: PREPARATION cont..
• Draw up drugs using one syringe and one ampoule at a time.
• Apply colour-coded syringe labels except when an uninterrupted
process is used for the preparation and bolus administration of single
drugs, with any remaining drug discarded immediately.
• Use a consistent process for labeling either before or after drawing up
a drug.
• If drug preparation is disrupted then discard the syringe.
• Prepared syringes should be logically ordered in an appropriate
container.

36. RECOMMENDATION: PREPARATION cont..
• Prefilled or pharmacy prepared syringes may improve safety
for high risk, compounded or diluted drugs. Otherwise
carefully double-check these types of medication during
preparation.
• Locate drugs prepared for emergency use or different routes
of administration separately in the workspace.
• Safely store all used drug ampoules and syringes until the end
of each case to facilitate investigation of suspicious adverse
events.

37. RECOMMENDATION: PREPARATION cont..
• Drug trays in anaesthesia carts:
– Standardized across all locations
– Tray divisions labeled clearly
– Drugs placed to minimize confusion
– Modular system
– Pharmacy manages drug trays
• Eliminate unusual drugs from usual locations
– Unique location or tray
– Remove at end of case
• Single use vials preferable;
• If multi-dose vial required, discard at end of case

38. RECOMMENDATION: PREPARATION cont..
• Management of high risk/dangerous drugs
– No concentrated drugs
– Only one standard concentration on cart
– Pharmacy provides diluted, high risk drugs (insulin, heparin)
– Alert label on concentrated or high risk drugs
– No large volume epinephrine
• Separate regional cart for regional drugs
• Only preservative free local anaesthetics
• SQ or topical local anaesthetics clearly labeled
• Pharmacy prepares all compounded drugs
• Regional anaesthetic solutions clearly segregated from i.v. meds

39. RECOMMENDATION: DRUG INFO
• Cognitive aids, checklists, rescue protocols; Infusion rate charts
• Specialized carts have protocols (malignant hyperthermia, cardiac
arrest)
• Verify high risk med and weight based doses with 2 people
• Read and verify every vial, ampoule, syringe label before
administration:
– Barcode system in use with audible and visual cues
– Use a 2 person check
– Single person check

40. RECOMMENDATION: DRUG INFO cont..
• Every medication labeled with name, date, concentration
– 3 if Barcode system used
– 2 if Preprinted, colour coded per ISO standards
• Avoid abbreviations and zero issues
• Unlabeled syringe immediately discarded
• Minimize provider prepared syringes
– Prefilled whenever possible
– Compounded and diluted drugs prepared by pharmacy
– Provider prepares dilutions of high risk meds, 2 person check
or careful double check

41. RECOMMENDATION: ADMINISTRATION
• Minimise the time between drawing-up a drug and administering it.
• For infusions use smart pumps that have guardrails and alerts, labels
at the patient end, Luer-lock connections, and one-way valves.
• During TIVA ensure that, where possible, the intravenous cannula
used for drug delivery is visible and patent at all times.
• Differentiate non-intravenous lines with coloured labels (epidural:
yellow; arterial: red) and use route specific administration sets.

42. RECOMMENDATION: ADMINISTRATION cont..
• Anyone administering medication must firstly positively identify the
patient and be aware of the relevant drug and patient information.
• Verbal prescriptions should be spoken back for verification and
announced when given.
• Use smart pumps
• Flush the catheter dead space after drug administration.

43. RECOMMENDATION: AFTER ADMINISTRATION
• Legibly document the drug name, dose, route and time for
every drug administration.
• Discard unused drugs at the end of each case.
• Unused controlled drugs should be disposed of into controlled
drug waste containers.
• Review medication at handovers.

44. RECOMMENDATION: CULTURE
• Non-punitive QA system for incident reporting, analysis, and
intervention
• Written policies for medication safety; adequate teaching of
new staff on policies
• Establish a culture of respect and collaboration that endorses
patient safety and establishes compliance (just
culture/compliance)
• Adequate supervision, teaching and in-service training

45. RECOMMENDATION: PHARMACY
• Formulary designed to avoid purchase of lookalike meds; when
unable to avoid, do not store in proximity; add alert labels to
lookalike medications
• Pharmacist assigned to support OR;
• Pharmacists available 24/7 for questions;
• Pharmacists participate in educational;
• OR pharmacists receive specialized education re OR
• Pharmacy responsible for medication flow (ordering to discard)

46. RECOMMENDATION: PHARMACY cont..
• Pharmacy stocks, tracks, delivers drug trays;
• Pharmacy prepares all compounded or diluted high risk drugs
• Pharmacy prepares infusions
• Policy for return of unused or unusual drugs - clean sweep
• Changes in drugs supplied (new labels, new concentrations) require
alerts to staff and possibly alert labels on new drugs
• Unique i.v. solutions (glucose, heparin, hypertonic, sterile water,
epidural solutions) stored separate from regular i.v. solutions

47. CONCLUSION
• Failures of medicine safety in clinical practice remain a prevalent
source of avoidable iatrogenic harm.
• In order to improve medicine safety, there is a need for effective
medicine management systems
• Embrace the principles of medicines safety culture.
• Redesign and early education of junior trainees about these processes.
• Medication handling become an explicit, core competence of early
clinical training.

48. REFERENCES
1. WFSA: World Anaesthesia Day 2022-Medication Safety
#MedSafe
2. E. Mackay J. Jennings and S. Webber. Medicines safety in
anaesthetic practice. BJA, 2019(5):151-7.
3. S. D. Marshall and N. Chrimes. Medication handling: towards
a practical, human-centred approach. Anaesthesia 2019, 74,
280–4.
4. J. A. Wahr, J. H. Abernathy III, E. H. Lazarra, J. R. Keebler,
M. H. Wall, I. Lynch, R. Wolfe and R. L. Cooper. Medication
safety in the operating room: literature and expert-based
recommendations. BJA, 2017, 118 (1): 32–43.
5. Google & social media images

49. THANK YOU