BEDAH BUKU

“REPORTING AND LEARNING SYSTEMS FOR MEDICATION ERRORS: THE ROLE OF

PHARMACOVIGILANCE CENTRES”

 Buku ini memiliki tujuan utama untuk memperkuat kapasitas dan kinerja sebuah organisasi yang
bergerak dibidang farmakovigilens dalam mengidentifikasii, analisa, pencegahan atau
meminimalkan medikasi eror.
 Fakta membuktikan bahwa 1 dari 10 orang di Negara berkembang cidera dalam masa perawatan
di rumah sakit (Bates,2010)
 Definisi medication errors adalah kegagalan dalam proses perawatan yang dapat atau akan
mengakibatkan cidera (berpotensi) kepada pasien
 anak anak memiliki tingkat ME paling tinggi (Miller, et al.,2007)
 Contoh insiden ME
1. Prescribing error
- Inappropriate dose (dosis morphine)
2. Dispensing error
- Miss-selection medicine (propranolol - prednisolon)
3. Medicine preparations error
- Golongan sediaan obat yang beda (deoksikolat – lipid complex)
4. Administration error
- Time error (sejam lebih awal atau sebaliknya)
5. Monitoring error
- Monitoring penggunaan jangka panjang
 Inggris merupakan salah satu Negara dengan system pelaporan ME paling aktif
 Table 1. Examples of activities and products of some PSOs
National Reporting and Learning
Institute of Safe Medication Service ( NRLS)/ National
Australia
Practice (ISMP) (USA) Patient
Safety Agency (NPSA) England
Safety
Patient safety toolkits and Patient safety
Patient safety brochure
e-learning recommendations
and implementation resources
Improvement
National standardization,
Posters Seven steps to patient safety
e.g. National Inpatient
Medication chart
Program for RCA
Root cause analysis (RCA)
National standardization, e.g.
Teleconferences report writing tools and
National Inpatient Medication
templates
Chart
Design for Patient Safety:
Video conferences E-learning programmes
medication topics
Medication safety pocket
guide

 Proyek gabungan oleh komisi eropa

- Koleksi dan investigasi ADR’s report
- Seminar dan kursus latihan tentang ADR, ME untuk health care practitioner (praktisi
kesehatan)
- Komunikasi efektif antara PVC (pharmacovigilance centres) denganpraktisi.

 Table 3. Some terms and how they are interpreted and used by pharmacovigilance centres (PVCs)
and patient safety organizations (PSOs)

Term Meaning in PVC Meaning in PSO Comment

Event or circumstance
which could have
Patient safety PVCs could adopt this
Currently not used resulted, or did result, in
incident term
unnecessary harm to a
patient
Any undesirable
experience that has
happened to the patient
Medication PVCs could adopt this
Currently not used while taking a drug but
incident term
which may or may not
be
related to the drug
Commonly referred to as
Potential
A patient safety incident “near miss”
patient safety Currently not used
without harm PVCs could adopt this
incident
term
Any untoward medical
occurrence temporally An injury related to
Adverse associated with the use medical management, in PSO meaning not
event of a medicinal product, contrast to complications restricted to medicines
but not necessarily of disease
causally related
Any injury resulting
PVCs could adopt this
Adverse drug from
Currently not used term instead of “adverse
event medical interventions
event” (see section 4.1)
related to a drug
Potential No harm occurred even
Commonly referred to as
adverse drug Currently not used if error occurred or was
“near miss”
event intercepted
= medication error
Injury that is the result PSOs could replace this
Preventable
of an error at any stage term with “medication
adverse drug Currently not used
of the medication use error”
event
process. (see below under
“medication error”)
Event that does not result
from an error, but
Non = adverse drug reaction
reflects
preventable PSOs could replace this
Currently not used the inherent risk of drugs
adverse drug term with adverse drug
and cannot be prevented
event reaction
given the current state of
knowledge
A response to a medicine Any noxious effect
Adverse drug
which is noxious and resulting from the use
reaction
unintended, and which of the medicinal product
(ADR)
occurs at doses normally at normal doses within
 used in humans for the optimal conditions of use
prophylaxis, diagnosis, (non-preventable events)
or therapy of disease or
for the modification of a
physiological function
= medication error
This term was defined
Injury that is the result
using a Delphi method
Preventable of an error at any stage
Currently not used by PVC and PSO
ADR of the medication use
representatives. PSOs
process
could consider adopting
the term
Meaning essentially the
A failure in the treatment same
Medication process that leads to, or A preventable adverse PSOs could consider
error has the potential to lead drug event using this term instead of
to, harm to the patient preventable adverse drug
event (see above)
These definitions reflect the current understanding of terms by representatives of PVCs and PSOs.
The definitions are expected to evolve with their broader use and adaptation and should be revisited
at an appropriate time in the future

 Konklusi nya adalah standarisasi terminology dari 2 asosiasi representative bdan farmakovigilens
 Gambar klasifikasi keselamatan pasien oleh WHO


  Beberapa metode pelaporan ME
- Form kuning MESO(sejak 1964 UK)

Figure 2. A model ICSR reporting form with important data fields

to support ME detection
National Pharmacovigilance Centre
REPORTING ADVERSE EVENTS RELATED TO DRUGS AND OTHER HEALTH
PRODUCTS
Patient
Relevant
medical
history
Current
medical
condition:
Name: Comorbiditi
Age: es:
Sex: M F unknown Previous
Weight (kg): history of
If pregnant, gestation term: allergy: yes
Locality/city: no
Phone number: unknown

If yes,
please
specify to
which drug:
Adverse events(s)
Clinical and paraclinical description of adverse event:
Date of start of reaction: | | Date of end of reaction: | |

Occurrence delay: hours days months

Relevant laboratory test:
Differential diagnosis eliminated:
Action taken: drug withdrawn dose reduced treatment of reaction (please specify):
...............................................................
Other:
...................................................................................................................................................................
.............................
Seriousness: hospitalization prolonged hospitalization
Outcome: favourable sequelae not recovered death unknown
Drugs and other health products administered by patient
Date Status of
Dosage and Date Actio
Suspected/ Batch thera dispensi
Name and route of thera Indicati n
concomitant numb py ng
form administrat py on taken
drug er starte and
ion ended (**)
d use(*)
Please specify if it is:
(*) medical prescription 1; self-medication 2; medication error 3; defective product 4; drug
interaction 5.
(**) drug withdrawn a; dose reduced b; dose increased c; dose not changed d; unknown e.
If vaccine: Number of administration:
Setting of administration: public sector private sector vaccination drive
If herbal medicine: Quantity:
Part used: Preparation: infusion decoction soaking other
Rechallenge with drug or health product: yes no which one :
Recurrence of adverse event: yes no please describe:
Reporter
Name: ......................................................... phone no.: ........................................ email:
.................................................................
Postal address:
...................................................................................................................................................................
.................
physician specialist dentist pharmacist nurse other health-care professional:
Workplace: teaching hospital public sector private sector
City:
...................................................................................................................................................................
...................................
Receive more information about this reporting? yes no
Signature
To be transmitted by post, phone, fax or ema

- The P method
 Hanya menggunakan semacam pertanyaan tertutup (ya atau tidak) dari 20 kriteria untuk
melaportkan ADR

Table 4. Criteria for assessment of the preventability of ADRs

Factors related to Preventability criteria Yes No UK NA
Professional
1. Incorrect dose?
practice “Pr”
2. Incorrect drug administration route?
3. Incorrect drug administration duration?
4. Incorrect drug dosage formulation
administered?
5. Expired drug administered?
6. Incorrect storage of drug?
7. Drug administration error (timing, rate,
frequency, technique, preparation,
manipulation, mixing)?
8. Wrong indication?
9. Inappropriate prescription according to
characteristics of the patient (age, sex,
pregnancy, other)?
10. Inappropriate prescription for patient’s
clinical condition (renal failure, hepatic
failure …), or underlying pathology?
11. Documented hypersensitivity to
administered drug or drug class?
12. Labelled drug–drug interaction?
13. Therapeutic duplication? (prescription
of 2 medicines or more with similar
ingredient)
14. Necessary medication not given?
15. Withdrawal syndrome? (due to abrupt
discontinuation of treatment)
16. Incorrect laboratory or clinical
monitoring
of medicine?
Product/drug
17. Poor quality drug administered?
“Pd”
18. Counterfeit drug administered?
Patient “Pa” 19. Non-compliance?
20. Self-medication with non over-the
counter drug?
UK: unknown; NA: Not app
 Beberapa investigator cenderung berfikir bahwa p method lebih memakan waktu dan sumber
daya. Sehingga mereka lebih memilih metode alternative lain dalam pelaporan ADR (Kunac &
Tatley., 2011)
 Deteksi ME dalam praktik nya
- Incident report review
Paling sering digunakan.berdasarkan laporan dari praktisi-keluarga-pasien
- Patients chart review
Hanya dapat dilakukan oleh beberapa praktisi kesehatan tertentu saja.tidak semua orang
dapat melakukannya
- Direct observation
Metode paling reliable , dan efektif.karena dapat mengetahui kuantitas dan kualitas dari
tingkat kesalahan (adminiastarion error, dispensing error, dll)
- Intervensi farmasis
Melakukan audit (CPPT) lagsung mengetahui permasalahan pada tingkat prescribing
error. Alias pencegahan sejak dini
 - Adverse drugs event trigger tools
Klinisi mencoba suatu obat ke pasien dan dilakukan review. Apabila hasil baik ,maka
lanjut.bila tidak, stop. Dokter obat-lab-good/bad-go/stop.
 Perbandingan metode deteksi ME
 Table 5. Comparison of the methods to detect medication errors (MEs)
in practice
Efficacy/explored
Method Advantages Disadvantages Feasibility
stage
* underreporting * reports and * easy to set up
* captures actual
* no quantitative alerts * inexpensive
Spontaneous ME
data * feedback and * necessity for
reporting * promotes a
* data incomplete corrective a culture of
culture of safety
and inaccurate actions notification
* good quality
data about
* accurate administration
Direct * captures actual * time-consuming errors * nurse training
observation and potential * training difficult * does not explore * labour intensive
error prescription
and monitoring
stage

* gold standard to
detect adverse
events
* fewer MEs * depends on the
* retroactive
* difficult detected training of the
* available data
* time-consuming * does not detect reviewers
* commonly used
* labour intensive potential * depends on
standardized
Chart review * planning adverse drug quality of
criteria
criteria/ events documentation
* captures more
indicators * less effective of medication
than incident
necessary for detecting incidents in the
reporting
errors in the clinical history
dispensing and
administration
processes

* not all * detects

interventions prescribing,
are usually transcribing
* detects actual
Pharmacist recorded and monitoring
and potential
intervention * time-consuming errors * time needed to
MEs
reporting * pharmacists * less effective make records
* improves
system do not always in detecting
prescription
have access to dispensing and
patients or to administration
clinical notes errors
* computerized
documentation
* allows detection system needed
* limited detection
ADE trigger of actual ME * detection bias
according to the
tools * automatic depending upon
triggers used
detection triggers used:
only certain ADEs
are detected

 Penyebab terjadinya mediksai eror

- Human error
- Kontribusi berbagai pihak