L17-L19 Medication Safety

Question 1

Define a “just culture”.

Answer 1

Just culture seeks to create a system of workplace justice that CONSISTENTLY fostered open reporting, while simultaneously, holding people appropriately accountable for their actions.

• To remove fear
• Creates a culture of accountability; it is NOT punitive, NOR blame-free

Question 2

Explain the tenets of a “just culture* in patient safety.

Answer 2

Just Response to 5 Behaviours:

1) Human Error:
- Unintended conduct, where actor should have done other than what they did
- Appropriate level of response: Accept/Console

2) At-Risk Behaviour:
- A choice where risk is not recognised or mistaken to be justified
- Appropriate level of response: Coach

3) Reckless:
- Conscious disregard of a substantial & unjustifiable risk of harm
- Appropriate level of response: Punish/Sanction/Dismiss

4) Knowledge:
- Knowingly causing harm (sometimes justified)
- Appropriate level of response: Punish/Sanction/Dismiss

5) Purpose:
- A purpose to cause harm (never justified)
- Appropriate level of response: Punish/Sanction/Dismiss

Each level of culpability has its own cause & its own solutions!

• (1) & (2) usually unintended, resulting in second victim of either pharmacist or staff committing the medication error
• All responses are independent of actual outcome!

Question 3

What are the benefits of promoting a “just culture” when reporting medication errors?

Answer 3

1) Creates physiological safety for staff to report errors
2) Uses common language to consistently & fairly evaluate human (staff) behaviour.
3) Shifts the focus from errors & outcomes to system design & behavioural choices.
4) Creates a culture of accountability; it is NOT punitive, NOR blame-free

Question 4

Define ‘side effect’.

Answer 4

Any unintended effect occurring at doses normally used in humans that is related to pharmacological properties of drug
- Can refer to positive or negative effect

Question 5

Define ‘adverse drug reaction’.

Answer 5

WHO definition:
Reaction that is noxious/harmful and unintended and occurs at doses normally used in man for prophylaxis, diagnosis or treatment of disease of the modification of physiological function
- Exclude overdose, drug abuse & medication errors
- Include side effects i.e. injuries that are judged to be caused by drug

Question 6

Define ‘adverse drug event’.

Answer 6

Injury due to medication that may or may not be preventable

• Preventable due to medication errors as e.g.
• Not preventable due to ADR or side-effect as e.g.
• Costly & result in significant additional healthcare resource consumption

Question 7

Define ‘medication error’.

Answer 7

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the HCP, patient or consumer (i.e. medication use process).

Such events may be related to:

• Professional practice
• Healthcare products
• Procedures
• Systems, including prescribing, order communication, product labelling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring, use etc

That may result in:

• Adverse event, in which a patient is harmed
• Near miss, in which a patient is nearly harmed
• Neither harm nor potential for harm

Question 8

Define ‘near miss’.

Answer 8

An event or situation that could have resulted in medication error, but did not.

• Either by chance or through timely intervention
• aka “close call”

Near misses, if ignored, may lead to medication errors reaching patients, since it is possible that they are at a systems level error

• Occurs 10-100x more often than adverse events
• Heinrich ratio: 1 major injury - 29 minor injuries - 300 near misses

Question 9

Which category of patient outcomes are alternatively known as “near misses”?

Answer 9

Category B

Question 10

Where do medication errors occur in the medication use process?

Answer 10

Errors & failures may occur at any point in the medication use process.

• For process to function optimally, HCP must consciously ensure that each step has been carried out properly.
• Consider safety at each step of the medication use process.

1) Prescribing
2) Preparation & Dispensing
3) Administration
4) Monitoring

Question 11

Which step of the medication use process has the highest percentage of timely interception?

Answer 11

Prescribing

Question 12

Which step of the medication use process has the lowest percentage of timely interception?

Answer 12

Administration

- Since it is almost unlikely to have a buddy to check, thus having the highest percentage of causing harm to patient.

Question 13

How can medication errors occur in the prescribing step of the medication use process?

Answer 13

• Inadequate knowledge about drug indications and C/I
• Failure to consider individual patient factors, such as allergies, pregnancy/lactation, co-morbidities, DDI etc.
• Wrong patient, wrong drug, wrong dose, wrong route, wrong time
• Inadequate communication of administration plan between patient, pharmacist, nurses, doctors etc.
• Documentation is illegible, incomplete, ambiguous
• Mathematical error when calculating dosage or total quantity
• Incorrect data entry when using computerised prescribing (e.g. duplication, omission, wrong number, typo error)

Question 14

How can medication errors occur in the preparation & dispensing step of the medication use process?

Answer 14

• Poor inventory control (e.g. LASA drugs placed together, expired products dispensed instead etc)
• Labelling & packaging mixed up
• Transcription errors (e.g. wrong interpretation of orders before keying into electronic systems, missing drugs in a list)
• Failure to consider individual patient factors, such as allergies, pregnancy/lactation, co-morbidities, DDI etc.
• Wrong patient, wrong drug, wrong dose, wrong route, wrong time
• Inadequate communication of administration plan between patient, pharmacist, nurses, doctors etc.
• Documentation is illegible, incomplete, ambiguous
• Mathematical error when calculating dosage or total quantity
• Incorrect data entry when using computerised prescribing (e.g. duplication, omission, wrong number, typo error)

Question 15

How can medication errors occur in the administration step of the medication use process?

Answer 15

• Failure to consider individual patient factors, such as allergies, pregnancy/lactation, co-morbidities, DDI etc.
• Wrong patient, wrong drug, wrong dose, wrong route, wrong time
• Inadequate communication of administration plan between patient, pharmacist, nurses, doctors etc.
• Documentation is illegible, incomplete, ambiguous
• Omission / failure to administer, esp. important for OD drugs (e.g. T2DM pt requiring IV contrast for diagnostics man not have taken metformin SR on schedule & after which, drug was not administered for the day

Question 16

How can medication errors occur in the monitoring step of the medication use process?

Answer 16

• Lack of monitoring for ADRs
• Drug not ceased if NOT working or course completed and yet to observe therapeutic effect
• Drug ceased before expected course completion
• Drug levels not measured or not followed up
• Communication failures

Question 17

Identify the four factors that can contribute to medication errors.

Answer 17

1) Patient factors
2) Medication/Technology design factors
3) Staff factors
4) System/Workplace factors

Question 18

Explain how patient factors can contribute to medication errors.

Answer 18

• Multiple medications (polypharmacy) or co-morbidities
• More than one doctor, requiring medication reconciliation
• Specific co-morbidities / conditions that warrant attention (e.g. renal/hepatic impairment, pregnancy/lactation, children/elderly etc.)
• Unable to communicate well
• Do not take an active role in their medication use
• Children & babies require dose calculations

Question 19

Explain how medication/technology design factors can contribute to medication errors.

Answer 19

1) Poor drug manufacturing & distribution practices
- Inappropriate packaging or design leading to dosage form confusion
- LASA drugs / products
- Appearance too similar to another manufacturer
- Appearance too similar w/in same compant’s product line
- Inaccurate and/or incomplete labels
- Distracting symbols or logo
- Similarity in color, shape, and/or size to another product
- Similarity in color, shape, and/or size to same product, but of different strength

2) Complex or poorly designed technology
- Malfunction
- Wrong device selected (e.g. not using Handihaler w/ Spiriva)
- Adapters (e.g. parenteral vs enteral, Luer connectors, oxygen tank should ONLY connect to oxygen tubing, NOT IV tubing)
- Automated distribution / vending systems / automated counting machines / compounders w/ wrong input
- Oral measuring devices (e.g. syringes, cups, spoons)
- Infusion (e.g. PCA, infusion pumps)

Question 20

Explain how staff factors can contribute to medication errors.

Answer 20

• Knowledge deficit
• Inexperience to know protocols that are in place
• Rushing
• Distracted w/ doing two things at once (may be unintentional)
• Interupptions
• Fatigue, boredom, auto-pilot (i.e. reduced alterness)
• Lack of checking & double-checking habits
• Violations to protocols and SOP
• Reluctance to use memory aids
• Poor teamwork and/or communication between colleagues
• Failed communication:
  (a) Handwriting & oral communications
  (b) Confusion w/ LASA drugs, different formulations (e.g. CR, SR, LA) or concentrations
  (c) Missing / misplaced zeros & decimal points
  (d) Confusion in units of measurement (e.g. mg, mcg, mL/min, mL/h)
  (e) Use of non-standard abbreviations
  (f) Ambiguous or incomplete orders

Question 21

Explain how system/workplace factors can contribute to medication errors.

Answer 21

• Lighting and noise levels
• Frequent interruptions and distractions
• Absence of readily available medication & patient information
• Inappropriate storage of medications
• Inadequate staff numbers or staffing arrangement
  (a) Lack of availability of HCP
  (b) Assignment or placement of HCP or inexperienced personnel
  (c) System for covering patient care
• Breakdown of information system (computer), where multiple Rx will be affected at any one time
• Absence of safety culture in workplace
• Inadequate training & supervision

Question 22

Why do medication errors occur, despite the fact that people working in healthcare are amongst the most educated & dedicated workforce in any industry?

Answer 22

1) Most errors occur as a result of “a chain of events set in motion by faulty system design that either induces error or make them difficult to detect, rather than lack of care & concern on the part of caregivers.
- Swiss cheese model of harm, where harm is the result of layers of defence in a system failing to prevent a hazard from reaching a patient
- One of the greatest contributors to accidents in any industry is human error.
- NOT the same as assigning blame as most human errors are induced by system failures (i.e. latent errors)

2) Latent errors / system failures are the greatest threat to safety in a complex system because they lead to operator errors
- i.e. failures built into the system & present long before the active error is manifested
- Difficult for people working in the system to see, since they may be hidden in computers or layers of management & ppl become accustomed to working around the problem

Question 23

Explain the rationale for using a systems approach to modify the conditions that contribute to medication errors.

Answer 23

1) Common initial reaction is to find & blame someone for the error.
- However, even apparently single events or errors are due most often to the convergence of multiple contributing factors.
- Blaming an individual does NOT change these factors & the same error is likely to recur.

2) Errors are a form of information about a system that represent places in which the system failed & the breakdown resulted in harm.

3) Current responses to error tend to focus on active errors by punishing individuals, retraining or other responses aimed at preventing recurrence of the error
- May sometimes be appropriate, but in many cases, is NOT an effective way to make system safer.

4) If latent failures remain unaddressed, their accumulation actually makes the system more prone to future failures.
- Discovering & fixing latent failures and decreasing their duration are likely to have a greater effect of building safer systems than efforts to minimise errors at the point at which they occur

Question 24

Explain what a ‘root cause analysis’ means.

Answer 24

RCA is a systematic approach to understanding the causes of an adverse event & identifying system flaws (i.e. latent errors) that can be corrected to prevent the error from happening again.

• Focusing on these causes & vulnerabilities is much more effective way to improve quality and safety than simply blaming the individual who made a mistake.
• Focusing on the system causes means analysing ALL factors that contributed to error (i.e. patient, technology design, staff & system errors)

Usually conducted by a team of 4-6 ppl
- Team should be interprofessional & include individuals at ALL levels of organisation who are close to, and have fundamental knowledge of issues and processes involved in the incident.

Question 25

How does one conduct a simplified RCA?

Answer 25

3 questions:

1) What happened? Describe the key steps in chronological order.
2) What went wrong & why at each step? Identify the failed processes.
3) What to do to prevent incident recurrence? Suggest risk reduction strategies & their implementation, with a focus on system errors.

Question 26

List all mitigation strategies based on the hierarchy of effectiveness, to reduce medication errors.

Answer 26

High leverage (most effective):
1) System-based: Forcing functions & constraints (e.g. removal of product from use)

2) System-based: Automation or computerisation (e.g. automated patient-specific dispensing)

Medium leverage (moderately effective):

3) System-based: Simplification & standardisation
4) Person-based: Reminders, checklists, double-checks (e.g. independent double checks for high-alert medications)

Low leverage (least effective):

5) Person-based: Rules & policies (e.g. policies to prohibit borrowing doses from other areas)
6) Person-based: Education & information (e.g. education sessions on high-alert medications)

Question 27

List the ten practices that have been shown to reduce medication errors.

Answer 27

1) Reduce reliance on memory
2) Simplify
3) Standardise
4) Use forcing or constraints functions
5) Use protocols and checklists wisely
6) Improve access to information
7) Decreased reliance on vigilance
8) Reduce handoffs/handovers
9) Differentiate / eliminate look-alikes and sound-alikes (LASA)
10) Automate carefully

Question 28

Suggest some mitigation strategies to reduce reliance on memory to reduce the occurrence of medication errors.

Answer 28

Use DDI checking systems
Use computerised order entry
Use bar-coding technology on drugs, containers, medication records, patient wristbands (e.g. Swisslog)
Use computerised patient information
- Easy to access information to make informed clinical decisions
Use guided dose algorithms (e.g. CrCl calculations)

Question 29

Suggest some mitigation strategies to simplify the medication use process to reduce the occurrence of medication errors.

Answer 29

Limit choice of available drugs in pharmacy
Limit dosage strengths & concentrations for each drug
Mix IVs in pharmacy to reduce risk of contamination (limited implementation in SG)
Eliminate transcription of orders via computerised entries that goes across every system
Automate dispensing on patient care unit (e.g. Omnicell, Pyxis)
- Medication to be taken from shelf based on patient name is lighted up
- Paired w/ further bar-coding to verify correct item

Question 30

Suggest some mitigation strategies to standardise the medication use process to reduce the occurrence of medication errors.

Answer 30

Standardise prescribing conventions
- Use generic names NOT brand name, unless otherwise specified
- No error-prone abbreviations
- Use ‘units’ instead of ‘U’
Use protocols for complex medication administration
Standardise times of drug administration to improve efficiency
Store medication in same place in every medication room (i.e. familiarity = less errors)
Use standard equipment (e.g. infusion pumps, syringes)
Follow the Institute of Safe Medication Practices (ISMP)’s List of Error-Prone Abbreviations, Symbols and Dose Designations

Question 31

Based on the ISMP’s List of Error-Prone Abbreviations, Symbols and Dose Designations, which abbreviations should NEVER be used & what are their respective correction?

Answer 31

ug: Use mcg
OD, OS, OU, AD, AS, AU: Use right/left/each ear or right/left/each eye respectively (or once daily for OD)
D/C: Use discontinue and discharge
HS: Use half-strength or at bedtime
IU or U: Use units
QOD: Use daily and every other day
.5mg: Use 0.5mg with a leading zero
10.0mg: Use 10 mg w/o a trailing zero
cc: Use mL
> or

Question 32

Suggest some mitigation strategies that introduce forcing and constraints functions in the medication use process to reduce the occurrence of medication errors.

Answer 32

*Effective error-proofing methods that eliminate reliance on memory, checklists and double-check systems

Use special luer-lock syringes & indwelling lines that have to match before fluid can be infused
Use computerised order entry w/ dosage entry checks
Remove dangerous IV drugs from ward stock
Special safeguards for High-Alert Medications (HAM)
- Improve access to information about these drugs
- Limit access to HAM
- Use auxiliary labels & automated alerts (precautions)
- Standardised ordering, storage, preparation & administration
- Employ automated or independent double-checks where necessary

Question 33

Define what are ‘high-alert medications’.

Answer 33

HAM are drugs that bear heightened risk of causing significant harm to patient when used in error.

• Mistakes may or may not be more common
• Reason why they are HAM because consequences are more devastating, thus requiring special safeguards!

Question 34

Name some drugs/drug classes that fall under ISMP’s List of HAM.

Answer 34

ALL medications administered by intrathecal or epidural routes
Anaesthetic agents (e.g. ketamine, desflurane, propofol, sevoflurane)
Anticoagulants & thrombolytics (e.g. heparin, warfarin, DOACs)
Chemotherapeutic agents (IV/PO)
Concentrated electrolytes (e.g. KCl, NaCl)
Hypoglycaemic agents& insulin (IV/PO)
Inotropes (e.g. digoxin, milrinone)
Neuromuscular agents
Opiates
Radio-contrast agents
Sedatives (IV/PO)
Sterile water for injection, inhalation or irrigation in containers of 100mL or more
Vasopressors (e.g. adrenaline)

Question 35

What are the recommended guidelines for the management of HAM to minimise the occurrence of medication errors in relation to these drugs?

Answer 35

1) Eliminate or reduce possibility of error
- Removing HAM from clinical areas (forcing functions)
- Reducing number of HAM stocked by hospital
- Limit available concentrations and volumes

2) Make errors visible
- Independent double-checking for infusion pump settings for HAM to catch errors before they reach patients

3) Minimise consequences of errors
- Change practices to reduce adverse effects that do occur
- Close monitoring to improve early detection of errors and institute prompt remedial action

Question 36

High-alert medications are drugs that bear a heightened risk of causing harm to patients when used in error because mistakes in prescribing these drugs are more common. True or false?

Answer 36

False!

Reason why they are HAM because consequences are more devastating, thus requiring special safeguards!

Question 37

Suggest some mitigation strategies that utilise protocols and checklists wisely in the medication use process to reduce the occurrence of medication errors.

Answer 37

Protocols support standardisation
Checklists serve as reminders of critical tasks & implement systematic thinking/processing, especially when omission can have serious consequences
Reduce individual variation in practice, but can be a source of error w/ indiscriminate adherence
Avoid statements that contain negatives
Make sure that everyone has agreed on protocol or checklist, and is aware that it is in use
Revisit protocol or checklist regularly to evaluate and update

Question 38

Suggest some mitigation strategies that improve access to information in the medication use process to reduce the occurrence of medication errors.

Answer 38

*Multi-pronged approach required!

Have a pharmacist available on nursing units and at rounds (e.g. DI pharmacists)
Use computerised order entry systems that include pop-ups and alerts
Use computerised laboratory data to alert abnormal laboratory values
Place laboratory reports & medication records at bedside
Place protocols & ordering information on patients’ chart and in medication room where they are easily accessible
Colour-coded wristbands for patients with allergies for visual identification cue
Provide patient with list of medications, dosage & frequency
Track errors or near misses & provide regular feedback via medication reconciliation

Question 39

Suggest some mitigation strategies that decrease reliance on vigilance in the medication use process to reduce the occurrence of medication errors.

Answer 39

• Limits to human attention span:
• Difficulty to maintain vigilance in situations of fatigue, repetitive tasks and infrequently occurring events

Use double-check system at multiple points of medication use process
Use automatic drug dose checking in high-risk situations (e.g. hepatic/renal impairment, pregnancy etc.)
Use electronic monitors that raise alert when parameters are exceeded
Rotate staff when performing repetitive functions
Limit shift durations for HCP

Question 40

Suggest some mitigation strategies that reduce handoffs in the medication use process to reduce the occurrence of medication errors.

Answer 40

*Many errors occur during transfer of materials, information, people, instructions or supplies

Provide ready-to-administer products
Reduce transcription of medication orders
Use unit-dose systems w/ individual bar codes for pick & pack
Use automated drug dispensing/filling systems
Use computerised prescriber order entry integrated with pharmacy

Question 41

Suggest some mitigation strategies that differentiate LASA products in the medication use process to reduce the occurrence of medication errors.

Answer 41

Store similar-looking medications in separate places
Repackage or re-label look-alikes to differentiate them
Alert staff and post information of medications w/ similar names (including sound-alikes)
Avoid stocking look-alike packages
Use striking caution stickers on stock containers to alert staff to look-alikes
Use TALL-MAN lettering to differentiate LASA drugs

Question 42

What are some considerations when using careful automation in the medication use process to reduce the occurrence of medication errors?

Answer 42

Automation can reduce errors that occur in repetitive tasks or in tasks requiring attention to details

• Can become hazardous when it leads staff to feel less responsible for the task
• Can also multiply an error if the error was made in generating inputs to the system

Use computerised order entry systems (CPOE) w/ dose range checkers & ovveride capacity
Train staff to double-check automation regularly by conducting daily (preferable) audits
Use bar-code technology to identify drugs

Question 43

Suggest some mitigation strategies that involve the use of careful automation in the medication use process to reduce the occurrence of medication errors.

Answer 43

Use computerised order entry systems (CPOE) w/ dose range checkers & ovveride capacity
Train staff to double-check automation regularly by conducting daily (preferable) audits
Use bar-code technology to identify drugs

Question 44

What are some advantages of using computerised order entry to reduce the occurrence of medication errors?

Answer 44

• Elimination of handwriting discrepancies
• Immediate error checking for dosage, frequency, ROA etc.
• DDI & allergy checking
• Serve as drug information databases if tied to formularies, policies and external data sources
• Immediate transmission of orders to multiple disciplines
• Providing data to analyse drug utilisation and workflow
• Increase formulary adherence & compliance to prescribing guidelines
• Allow price comparisons
• Links to other databases (e.g. laboratory data) to provide complete patient information
• Intelligent prescribing (e.g. automatic dose calculators)

Question 45

List the ISMP’s key recommendation for Safe Electronic Communication of Medication Orders.

Answer 45

1) Use generic names
- List products as primary drug nomenclature, ensuring each matches a standardised nomenclature so that all package labels agree with medication records.

2) Avoid including salt of chemicals
- Do NOT include salt of chemical when expressing generic name, unless multiple salts available.

3) Differentiate generic names from brand names
- Present brand names in uppercase letters.
- Trademark symbols should NOT be used.

4) Standardised inclusion of suffixes
- Express suffixes that are part of brand name (e.g. SR, CR, LA) within both generic name & brand name field.

5) Standardised use of mnemonics or short names
- Allow practitioners to access particular medication listing without entering full name.
- Less of an issue nowadays.

6) Standardised fonts (size & style) and colours
- Facilitate clarity of information presented on computer screens and in printed materials derived from electronic databases (e.g. labels, reports).