Medication errors, types, RCA (Root Cause Analysis), Preventing Strategies

1. Medication Errors
Dr. Ankit Gaur., PharmD, MSc, MBA, RPh
Clinical Pharmacologist
Coordinator Medical Device Adverse Event Monitoring Centre (MDMC)
Coordinator ADR Monitoring Centre (AMC)
Kailash Hospital & Heart Institute
Mobile: +91-9716574979

2. 13-02-2023 2

3. How medications affect
patient safM
e
ed
tiy
ca?
tio?
n safety issues
 Adverse drug reactions
 Usage of Hazardous drugs
like chemotherapy, narcotics
 IV infusion therapy issues
 Radioactive drugs
 Medication errors

5. What is a Medication Error ?
Any PREVENTABLE event that may cause or
lead to inappropriate medication use or patient
harm while the medication is in the control of
the health care professional, patient, or
consumer.
ISMP 2001

6. Medication Errors
 Over 770,000 patients injured every year.
 USFDA - At least 1 death occurs per day and 1.3 million people injured
each year.
 For India the extrapolated figures would be:
 400,000 deaths due to Adverse Drug Reaction and
 720,000 Adverse Events per annum
 More people die then Motor Vehicle Accidents or AIDS
 Serious mistakes involving prescription drugs occur in 3% to 7% of
hospital inpatients.
 Considered worse than a crime
 Serious economic consequences like extended hospital stays, additional
treatment
 Malpractice Litigation.
Agencyfor HealthResearchandQuality,2001
FoodandDrugAdministration(FDA) website,www.fda.org last accessedon 21st August,2020

7. Global
Calculations which
include
186 countries:
IMSMIDAS,2009 and
2011; WorldBank
2009; WHO2009;
USDin2011

8. Economic burden of Medication error
 In 2007, the National Patient Safety Agency estimated that
preventable harm from medication could cost over £750 million
annually in England.
 Adverse Drug Reactions are becoming a global issue because
of:
 Increasingly complex medical needs
 Introduction of many new medications
This has led to the World Health Organization’s Third Global
Patient Safety Challenge: Medication Without Harm.
https://qualitysafety.bmj.com/content/30/2/96

9. First Challenge -2005
Clean care is safer care
WHO’s Global Patient Safety Challenges
Second Challenge -2007
Safe Surgery Save Lives
Medication Without Harm
Third Challenge -2017
Medication without Harm
Currently ongoing

10. Risk factors for ICU medication errors
Eric Camiré et al. CMAJ 2009;180:936-943

11. Risk factors for ICU medication errors
Eric Camiré et al. CMAJ 2009;180:936-943

12. Medication Errors : Indian Experience
M Parihar, G PR Passi. Medical Errors in pediatric practice. Ind Pediatrics 45
2008; 586-89.
 Prospective study in a Teaching Hospital at Indore, MP -
1286 children in PICU
 Out of the total 457 errors identified, medication errors
313 (68.5%)
 Majority were dosing errors (45.5%)
 Morbidity was nil in 375 (82%), mild in 49 (10.7%),
moderate in 22 (4.8%) and severe in 11 (2.4%) errors.

13. RCA of Medication Error
Note: Errors are more frequent during “Prescription” and “Administration” stage
Medication
Errors
Transcription
Administration
Prescription
Route not
Specified
Order without
Time Interval
Order without
an Indication
Order Illegible
Order with Dose
Inappropriate
Order without
Dose Order without
Frequency
Drug Changed without
Discontinuing Previous One
Order not at all
transcribed
Order transcribed
Incorrectly
Allergy not Documented
on Order Sheet
Drug Administered
Dispensing
Wrong Preparation
Dispensed
Diluted Drug
Dispensed
Wrong Drug
Dispensed
Dose missed because
of transcription
Incorrect Entry of Order
in Pharmacy Module
Scheduled dose not
documented as administered
without Physician Order
Drug Administered to
a Wrong patient
Infusion
rate Error
Wrong Drug
Administered
Wrong Dose, Route, Frequency,
Dosage
Storage, Packaging & Labeling
Mixing of Bottles &
Drugs that are similar
Improper Storage leading to
mixing of Drugs
Inappropriate or Illegible
Labeling of Containers
in appearance
Improper Review of
Instructions for use /
warnings/ precautions
Patient Response
Patient not following the
Physician Prescription,
Dose and Orders
Expired Drug
Dispensed
Improper Recording of Allergy not Documented on
Patient ADR Medication Adm Record
Improper Assessment
of Drug Efficacy

14. Common causes of medication errors
A. • Human-related
B. • System-related
C. • Medication-related

15. Human-Related Factors
Providers
Over-worked
Under-trained
Competence
 Distracted
 Illness
 Stressed
Patients
In a hurry
Health literacy level
Do not understand the
medication/use
Trust providers to not make
mistakes

16. System-Related Factors
Lack of communication
 Poor workflow
 Disorganized workspace
 Inadequate tools to complete work
 Lack of supervision

17. Medication-Related Errors
Look-alike/sound-alike medications
Multiple dosage forms, strengths and calculations
Verbal orders

18. THE 7-R’S
• Right Drug
• Right Route
• Right Time
• Right Dose
• Right Patient
• Right Dosage Form
• Right Documentation
World Health Organization WHO, Patient Safety Curriculum Guide

19. Types of Medication Errors
1. Medication errors include
2. Prescribing Error
3. Dispensing Error
4. Documentation Error
5. Administration Error
6. Transcription Error
7. Indent Error

20. A clinically meaningful prescribing error occurs when, as a result of a
prescribing decision or prescription writing process, there is an
unintentional significant
(1) reduction in the probability of treatment being timely and effective or
(2) increase in the risk of harm when compared with generally accepted
practice” .
It includes:
•Incorrect Prescription
•Illegible Handwriting
•Drug allergy not identified
•Irrational combinations
•Out of list abbreviations
Prescribing Error:

23. Dispensing Error
A dispensing error is a discrepancy between a prescription and
the medicine that the pharmacy delivers to the patient or
distributes to the ward on the basis of this prescription, including
the dispensing of a medicine with inferior pharmaceutical or
informational quality

24. Dispensing Errors: The Numbers
98.3% accuracy in dispensing medications
Therefore, 1.7% inaccuracy rate
Over 3 billion medications dispensed per year
4 errors per day per 250 prescriptions filled
Over 51 million dispensing errors per year
Flynn E, et al. J Am Pharm Assoc. 2003;43:191–200.

25. Most Prevalent Dispensing Errors
Dispensing incorrect medication, dosage strength, or dosage form
Dosage miscalculations
Failure to identify drug interactions or contraindications

26. Sound-alike drugs
Avanza
(Mirtazapine)
Avandia
(Rosiglitazone)
Diamox
(Acetazolamide)
Zimox
(Amoxycillin)
Glynase
(Glyburide)
Zinase
(Serratiopeptidase)
Incidal
(Cetrizine)
Inderal
(Propanolol)
Brand name in black
Non proprietary name in blue
Thousands more, some reported, Most not !!

27. Look-alike drugs
Domstal
(Domperidone)
Alprax
(Alprazolam)
Zyloric
(Allopurinol)
Buscopan
(Hyoscine)
Lasix
(Fursemide)
Avil
(Pheniramine )
Veltam
(Tamsulosin)
Pantium
(Pantoprazole)
Brand name in black
Non proprietary name in blue
Thousands more, some reported, Most not !!

28. Ampoules of Bupivacaine (Sensovac Heavy) and Tranexamic acid (Nexamin) look alike

29. http://www.patientensicherheit.ch/de/publikationen/Quick-Alerts.html

30. Dispensing Errors:
Common Causes
Work environment
Workload
Distractions
Work area
Use of outdated or incorrect references
LASA drugs (Look Alike Sound Alike)

31. Example of dispensing error
A physician writes an order for primidone (Mysoline) for a 12-year old boy
with a seizure disorder. Misreading the physician’s handwriting, the pharmacist
mistakenly fills the order with prednisone. For 4 months, the boy receives
prednisone along with his seizure medications, causing steroid-induced
diabetes. The diabetes goes unrecognized, and he dies from diabetic
ketoacidosis…because the drug was LASA drug that lead to Dispensing Error

32. Administration Error:
A drug administration error may be defined as a discrepancy
between the drug therapy received by the patient and the drug
therapy intended by the prescriber.
Administration errors account for 26% to 32% of total medication
errors.
It involved wrong patient, wrong route of administration, wrong
drug, wrong dose, wrong method, wrong time.

33. CAUSES OF ADMINISTRATION
ERRORS:
Lack of perceived risk
Lack of available technology
Lack of knowledge of the preparation or administration
procedures Complex design of equipment.
CONTRIBUTING FACTORS TO DRUG ADMINISTRATION ERRORS:
Failure to check the patient’s identity prior to administration
Environmental factors such a noise, interruptions ,poor lighting
Wrong calculation to determine the correct dose

34. Example of administration error
A critical care nurse tries to catch up with her morning medications
after her patient’s condition changes and he requires several
procedures. He is intubated, so she decides to crush the pills and
instill them into his nasogastric (NG) tube. In her haste to give the
already-late medications, she fails to notice the “Do not crush”
warning on the electronic medication administration record. She
crushes an extended-release calcium channel blocker and
administers it through the NG tube. An hour later, the patient’s heart
rate slows to asystole, and he dies…because of Administration error

35. Transcription Error
Transcription is a process of making an identical copy of
prescription in the medical records. Error that occurs during this
process is known as Transcription Error.
Several sheets of paper and stages from physician’s order to
drug delivery may cause confusion and add to the possibility of
transcription errors.
Contributing factors include incomplete or illegible prescriber
orders; incomplete or illegible nurse handwriting; use of
abbreviations; and lack of familiarity with drug names.
In addition to errors associated with transcribing the drug name,
there is also opportunity for errors when transcribing the dose,
route or frequency.

36. Indent Error
Error that occurs during the process of indenting
It includes wrong drug, wrong strength, Wrong dose,
Wrong route and frequency.

37. Categorization of medication Errors:
Category Event
A Circumstances or event that has a capacity to
cause error.
B Error occurred but didn’t reach the patient.
C An error occurred that reached the patient but
did not cause any harm.
D An error occurred that reached the patient and
required monitoring to confirm that it resulted in
no harm to the patient and /or required
intervention to preclude harm.
E An error occurred that may have contribute to or
resulted in temporary harm to the patient and
required intervention.

38. Category Event
F An error occurred that may have contribute to or
resulted in temporary harm to the patient and
required transfer to other unit/critical care.
G An error occurred that may have contribute to or
resulted in permanent harm of the patient.
H An error occurred that required intervention to
sustain life.
I An error occurred that may have contribute to or
resulted in patient.

39. Medication Errors signify faulty systems and not faulty professionals
Swiss Cheese Model of Risk analysis & management

40. Human factors that lead to medication
errors
 Mental Slip
 Having the knowledge, but
not using it
 Lack of knowledge
 Poor handwriting
 Lack of understanding
 Stress
 Improper label reading
Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

41. Look-alike or sound-alike (LA/SA) drugs
 Tens of thousands of drugs currently in the market, the
potential for error due to confusing drug names is significant
 Look-alike or sound-alike (LA/SA) health products refer to
names of different drugs that have orthographic similarities
and/or similar phonetics (i.e. similar when written or
spoken).
 These similarities may pose a risk to health by contributing
to medical errors in prescribing, documenting, dispensing or
administering a product
 The increasing potential for LASA medication is recognized
by NABH and requires each accredited organization to
identify a list of look-alike or sound alike drugs.

42. Abbreviations can kill!!
Abbreviations
 Although widely used in prescription writing,
abbreviations can kill!!
 Most of the time, prescribers invent their own.
 Secondly, different individuals/pharmacists may
assume or interpret abbreviations differently.
 Please stick to standard abbreviations

43. Abbreviations must be avoided
Some examples that illustrate the pit falls are-
HCT 250mg intended drug hydrocortisone but
dispensed hydrochlorthiazide.
AZT – intended drug was zidovidine but mistaken
for azathioprine.

44. Recommended strategies for prevention

45. Preventing Medication Errors
At Doctor level
 Ensuring prescription legibility through “Write in Capital Letters”
policy
 Medication orders and prescription to include both generic and
brand name along with dose, strength, directions for use
 Implementation of “Verbal order policy” for oral orders
 Protocols for High risk Medication ( e.g Anticoagulant) usage
 Usage of standardized abbreviations & acronyms through out the
organization
 Active surveillance by the Dedicated Clinical Pharmacologist
 Introduction of Hospital Formulary
 “Tall man” (mixed case) lettering to emphasize drug name
differences
( example RABEprazole and ARIPiprazole)
Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

46. Preventing Medication Errors
At Nursing Level
 Labeling all medications before preparing
 All medicines and labels to be verified by two qualified nursing
professionals before administration
 Not more than one medication is labeled at one time
 All medications found unlabeled should be discarded
immediately
 Continuous training and updation on LASA and High risk
medication and Medication Error reporting
 Separate storing of LASA and High risk medication
 Active surveillance by Dedicated Clinical Pharmacologist &
Nursing Educators
Bhowmick et al. Medication errors reported in tertiary care private hospital in Eastern India : 3 years experience. IJBCP 2020

47. Checking by 2 nurses
Medication Reconciliation

48. Proper labeling of all infusions

49. Drugs Labeled in Medication Racks

50. Preventing Medication Errors
At Pharmacist level
 Ensuring dispensing in carried out by competent individuals
 Separate storing of LASA and High risk medication
 Implementation of Medication error reporting culture
 Continuous training and updation on LASA and High risk
medication
 Training on Hospital Formulary and Good Pharmacy Practices
 Active surveillance by Dedicated Clinical Pharmacologist

51. Preventing Medication Errors
At Management level
 Development of a blame free & punishment free culture of
medication error reporting
 Punitive action is not an effective way to prevent recurrence
 Medication error does not signify faulty personnel
 It signifies faulty systems that need to be made safer
 Establishment of an active reporting system which does not
lead to blaming and shaming of the individual care provider
 Dedicated personnel (Clinical Pharmacologist)/ Team to
lead, collect and analyze Medication errors & device
strategy for process improvement

52. Summary
 Medication errors are common entity in hospitals
including ICUs.
 There is gross under-reporting of MEs.
 Active Pharmacovigilance activities can detect
Medication errors and prevent them
 Safety improvement activities include identification,
reporting and analysis of the errors by dedicated team
lead by the Clinical Pharmacologist.
 Goal is to develop a culture of patient safety and “fault
tolerant” health care system