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DRUG-RELATED

PROBLEM

dr Sufi Desrini M.Sc


Definition DRP
An undesired patient experience that
involves drug therapy and that actually or
potentially interferes with the desired
patient outcome (Cipolle et al. 2012)

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Classification
Need for additional therapy
Unnecessary drug therapy
Wrong drug
Dosage too low
Adverse drug reaction
Dosage too high
Non-compliance

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Problems
Treatment effectiveness
Adverse reactions
Treatment costs
Other

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Causes
Drug selection
Drug form
Dose selection
Treatment duration
Drug use/administration
Logistics
Patient
Other
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identification of DRP
Patient/career
Prescribed
Dispenses
Consumed/compliance
Practical handling
Knowledge
Attitude

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identification of DRP
Health Care
Records
Diagnosis
Allergies/cave
Prescription
Dispensed
Notes
Tests; lab, ADL
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Hospital Care, a supportive
process

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Hospital Care, a (non-)
supportive process

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Aim and objectives for
development of the LIMM
Develop and research a systematic model
for improved medication use during a
patient hospital stay.
Analyse problems and limitations in the
standard patient medication care process
Develop a structured team-based model
incl. Clinical pharmacy service
Study the process and outcomes (clinical,
humanistic, and economic)
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The LIMM-model

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Process for handling of DRP

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Example of tools
LIMM Medication Interview (admission)
Part 1 is focused on a correct patient
medication list
Part 2 adds questions on the patient
problems with practical handling,
knowledge and adherence
Part 3 adds questions for a deepened
assessment of adherence and beliefs

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Ester 80 years old
Found on the floor in her apartment Friday
afternoon
At hospital admission
Slightly confused
High blood sugar
Low blood preassure
Medication interview by a pharmacist
Monday morning according to LIMM

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LIMM Medication Interview
Focus correct medication list

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LIMM Medication Interview Focus Knowledge abd
compliance

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MEDICATION ERROR

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DEFINISI
A medication error is defined as any preventable event that
may cause or lead to inappropriate medication use or
patient harm, while the medication is in the control of the
healthcare professional, patient, or consumer.

- NCC MERP
National coordinating council for Medication Error Reporting and
Prevention, 1996
Psychological classification of medication errors
Tipe error/ Contoh-contoh
Mistakes
Knowledge-based Memberikan penisilin tanpa menanyakan
errors riwayat alergi.
Rule-based errors Memberikan injeksi diklofenak di paha samping
bukannya di gluteus
Applying a bad rule Memberikan captopril dosis besar pada awal
gejala)
Slips (salah comot) and lapses (lupa) Bermaksud meresepkan
Slips of action chlorpromazine, tapi yang ditulis
(skill-based errors) chlorpropamide.
Lapses of memory Memberi beta blocker, tahu, tetapi, lupa bahwa
(skill-based errors) pasien penderita asma.

Medication error that leads to manslaughter THE LANCET Vol 355 March 18, 2000
Kejadian Medication Error

Prescribing Transcription (12%) Administering


39% Dispensing (11%) (38%)
Dokter Farmasis Perawat
professional practice

health care products


events may be
related to
procedures

systems

o prescribing, o distribution,
o order communication, o administration,
o product labelling, o education,
o packaging and o monitoring,
o use.
o nomenclature;
o compounding dispensing,
Medication Error pada penderita yang dirawat di ICU
Di 2 RS Pendidikan Periode Januari-Desember 2002 (n=128)
ICU

1.7 errors/patient/day
Donchin, 1995
Medication Error pada pasien SC elektif
Di 2 RS Periode Januari-Desember 2002 (n=240)
Communicatio
n especially
System hand-offs
failures
Failure of
information,
planning
tests,
diagnoses

Use of Safety issues External


obsolete/ stimuli: crowd,
abandoned in health too many
technology care patients
BEBERAPA PENYEBAB UMUM MEDICATION ERROR

1. Kegagalan komunikasi
2. Praktek distribusi obat yang buruk
3. Dose miscalculations
4. Drug and drug device related problems
5. Pemberian obat yang keliru
6. Kurangnya informasi kepada pasien
Adverse Event
an injury caused by medical
management (rather than the
underlying disease) and that prolonged
the hospitalization, produced a
disability at the time of discharge, or
both.
19. Brennan, et al., 1991.
20. Leape, et al., 1991. See also; Brennan, et al., 1991.
Adverse drug events pada pasien rawat
inap (Classen et al., 1997).

Memperpanjang
Extra biaya Mortalitas
LOS

$8.4 juta/tahun untuk 1983-1993: naik 2 x


RS Pendidikan dengan lipat (7.391 kematian
700-bed 1993)

(Phillips, Christenfeld,
(Bates et al., 1997).
and McGlynn, 1998)
1. Informasi tentang adverse &
beneficial effect

Pasien kelompok khusus: ibu hamil, anak, usia


lanjut

Efek yang dipengaruhi oleh obat lain

Efeknya dibandingkan dengan obat untuk


indikasi yang sama
2. Informasi yang tidak dapat diperoleh
dari premarketing studies
Penemuan adverse & beneficial effect yang tidak terdeteksi
saat premarketing studies
uncommon effects
delayed effects

Pola penggunaan obat

Efek overdosis obat

Dampak ekonomi obat

Dampak kebijakan & politik


DEFINISI ERROR (IOM, 1999)

Menggunakan cara yang Gagal menyelesaikan


keliru untuk mencapai tindakan yang sudah
tujuan disiapkan

ERROR OF PLANNING ERROR OF EXECUTION

Errors dapat mencakup masalah dalam praktek,


produk, prosedur, dan sistem
ERROR

Omission Commission

Tidak melakukan sesuatu Melakukan sesuatu


yang seharusnya yang seharusnya tidak
dilakukan dilakukan

misdiagnosis Tindakan keliru


Terlambat bertindak Obat salah
Tidak melakukan Tindakan/prosedur
pertolongan yang salah
near miss
Suatu kejadian atau situasi yang
sebenarnya dapat menimbulkan
kecelakaan, trauma, atau
penyakit, tetapi belum terjadi
karena secara kebetulan
diketahui atau upaya
pencegahan segera dilakukan.
Near Misses
Death
1

Severe
0s
Minor Moderate
00s

Prevented/No harm incidents


000s
Clinical Negligence (kelalaian klinik)

Pelayanan oleh dokter/tenaga kesehatan yang


dilakukan di bawah standar yang diharapkan
(a relative standard not a gold standard)
Jury Awards $38 Million To San
Jose Family In Malpractice Suit

01/01/02 - A San Jose family has won


a 38 million dollar (342 Milyar)
malpractice award after a jury agreed
that delayed care for a newborn baby
led to serious brain damage.

Pengadilan Santa Clara County Superior memutuskan kasus San Jose Medical Group,
Doctor Ilene Newman dan San Jose Mecical center. Brandon Nunez (3 tahun) hanya
dapat tinggal di rumah bersama orang tuanya, Carmelo and Sonia Nunez.

Sonia Nunez sedang in partu, 27 September 1999. Dokter terlambat saat akhirnya
memutuskan untuk operasi Caesar. Saat itu ketuban sudah pecah dan janin menjadi
hipoksia dan akhirnya menimbulkan kerusakan otat permanen pada Nunes.
Percent of Injuries due to Negligence

California Medical Harvard Medical


Insurance Feasibility Practice Study
Study

17 28
% %

AEs AEs
Proportion of Adverse Events Involving Negligence
Type of Event Proportion of Events
Due to Negligence
Operative
Wound infection 12.5
Technical complication 17.6
Late complication 13.6
Non-technical complication 20.1
Surgical failure 36.4
All 17.0
Non-operative
Drug-related 17.7
Diagnostic mishap 75.2
Therapeutic mishap 76.8
Procedure-related 15.1
System and other 35.9
All 37.2
Source Leape, 1991
Rates of Adverse Events and Negligence by
Specialty
Specialty Rate of Rate of
Adverse Negligence
Events (%) (%)
Orthopedics 4.1 22.4
Urology 4.9 19.4
Neurosurgery 9.9 35.6
Thoracic and cardiac surgery 10.8 23.0
Vascular surgery 16.1 18.0
Obstetrics 1.5 38.3
Neonatology 0.6 25.8
General surgery 7.0 28.0
General medicine 3.6 30.9
Other 3.0 19.7
P value <0.0001 0.64

Source Leape, 1991


KATEGORI ERROR
Feinberg, JL, ed. Med Pass Survey.. ASCP 1993

Omission Terlambat/terlalu cepat memberikan obat


Error periode berikutnya

Unauthorized
Pasien membeli antibiotika tanpa resep
Drug Error

Extra Dose
Dosis ganda
Error

Wrong Dose Dosis lebih besar atau lebih kecil dari yang
Error diresepkan dokter

Wrong Route
Cara pemberian keliru
Error

Wrong rate Kecepatan tetesan obat infus kurang atau


Error berlebih
KATEGORI ERROR
Feinberg, JL, ed. Med Pass Survey.. ASCP 1993

Wrong Time Error


Interval pemberian obat keliru

Wrong Drug Preparation Error


Suspensi tidak dikocok,
sediaan slow release dijadikan puyer,
incompatible,
inadequate product packaging
Wrong Administration Technique
Injeksi tanpa metode steril,
menggerus obat secara keliru

Deteroriated Drug Error


Obat rusak,
kadaluarsa,
obat tidak disimpan di lemari es
Overview of off-label prescribing
What defines off-label specifically?
Age? Antidepressants in children
Pregnancy? Zofran for nausea
Comorbid conditions? Cancer/non-cancer
Dose ranges?
Duration?
Studies are often VERY narrow populations
i.e. Actiq/Fentora: Cancer pain!
i.e. Cymbalta/Lyrica: Diabetic neuropathic
pain

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Overview of off-label prescribing
Overall 21% of medication use is off-label
(Arch Intern Med. 2006; 166:1021-1026)

Neurontin (83%), Elavil (81%)


Study finds 90% of Actiq prescriptions are
off-label (Prime Therapeutics Jan 16, 2007)
In 2002, 94% of Neurontin sales for off-
label use (USA Today 8-16-2004)

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Common off-label medications
Medication FDA indication Off-label use

Neurontin Anticonvulsant; Shingles pain Neuropathic pain

Lidoderm Shingles pain Neuropathic pain

Actiq/Fentora Acute cancer pain Acute pain (non-cancer)

Ambien Short-term use sedative Long-term use sedative

Lyrica Anticonvulsant; diabetic Neuropathic pain


neuropathic pain
Cymbalta Antidepressant; diabetic Neuropathic pain
neuropathic pain

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STRATEGIES TO IMPROVE DRUG
USE

EDUCATIONAL REGULATORY
inform or persuade restrict decisions

MANAGERIAL
structure or guide decisions
EDUCATIONAL STRATEGIES

Multimedia warning campaign


Printed educational material

Group education Feedback of patient-level


medication profiles

Data feedback

Opinion leaders or Educationally-


influential physician
Face-to-face education
DASAR-DASAR PEMANFAATAN
PRINTED MATERIAL UNTUK PROVIDER
relevan dengan keputusan terapi
yang dilakukan
memahami konsep-konsep
prescribing behavior
orientasi pada action decission
menekankan pesan kunci
menarik perhatian melalui headline
menarik secara visual
referensi memadai dan diterima
secara ilmiah
KEUNTUNGAN DAN DASAR-DASAR
FACE TO FACE EDUCATION

Komunikasi dua arah


Prescriber participation
Menilai motivasi
Pendekatan untuk perubahan?
Untuk pengambil keputusan
Verbally reinforce improved prescribing
PRESCRIBING AUDITS PLUS FEEDBACK TO
PRESCRIBER
Establish Criteria
Comparison with Guidelines
Comparison with Peers

Audit (collect data) on prescribing

Analyze data:
are there deviations from guidelines

Notify prescribers of the result


individuals or groups
letters or patient notes or in person
Strategi untuk meningkatkan
komunikasi antara pasien dan
dispenser

Jelas, menarik sederhana,


PACKAGING
mudah, tidak berbahaya

Jelas, pesan ringkas mudah


LABELING
dipahami &dilaksanakan

SARAN Penting, efek terapi cara, dosis,


VERBAL frekuensi lama, bahasa
MANAGERIAL STRATEGIES

Clinical guideline/standard treatment


Essential drug list
Hospital Drug Formulary
REGULATORY
STRATEGIES

Pembatasan jumlah resep


Informasi ketersedian jenis dan jumlah obat
TERIMA KASIH

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