MONITORING EFEK SAMPING OBAT

(MESO)
RB, M. Farm.Klin., Apt.
STIFARM Padang
 Permenkes 72 th 2016 ttg
Standar Pelayanan Kefarmasian di RS

□ Pengkajian dan pelayanan resep

□ Penelusuran RPO
□ Rekonsiliasi obat
□ PIO
□ Konseling
□ Visit
□ PTO
□ MESO
□ EPO
□ Dispensing Sediaan Steril
□ Pemantauan kadar obat dalam darah

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EFEK SAMPING?

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 Efek samping
Efek Samping Obat / ESO (Adverse Drug Reactions/ADR) adalah
respon terhadap suatu obat yang merugikan dan tidak diinginkan
serta terjadi pada dosis yang biasanya digunakan pada manusia
untuk pencegahan, diagnosis, terapi penyakit atau untuk
modifikasi fungsi fisiologis.

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 “
In the US, 3 to 7% of all hospitalizations are due to adverse drug
reactions. ADRs occur during 10 to 20% of hospitalizations; about
10 to 20% of these ADRs are severe.

ADRs resulted in approximately 250,000 admissions a year in

the United Kingdom

The majority (≥ 85%) of ADRs are type A, resulting from the

pharmacological activity of the drug in Australia

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Clinical development of medicines

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Determining Medicine Safety:
Identifying and Managing ADRs
 Premarketing clinical trials
 Animal studies, human studies—Phases I, II, III
 Cannot identify ADRs with incidence < 1%

 Postmarketing surveillance
 Spontaneous reporting
 Postmarketing clinical trials—Phase IV
 Other methods—observational studies, meta-analysis, case reports
 Determining causality
 Actions taken to manage new ADRs
Limitation in Clinical development of medicines
⊡ Populasi terbatas
⊡ Penelitian obat tidak dapat dilakukan pada pasien dlm
kondisi rentan (anak2, ibu hamil)
⊡ Pengaruh genetik seseorang, penyakit penyerta dsb yang
berpengaruh thd penggunaan obat
⊡ Efek samping yang jarang terjadi

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KLASIFIKASI EFEK
SAMPING

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 Classification - Onset

 Onset of event:
• Acute
■ within 60 minutes
• Sub-acute
■ 1 to 24 hours
• Latent
■ > 2 days
 Classification - Severity
 Severity of reaction:
• Mild
■ bothersome but requires no change in
therapy
• Moderate
■ requires change in therapy, additional
treatment, hospitalization
• Severe
■ disabling or life-threatening
 Classification - Severity
FDA Serious ADR
□ Result in death
□ Life-threatening
□ Require hospitalization
□ Prolong hospitalization
□ Cause disability
□ Cause congenital anomalies
□ Require intervention to prevent permanent
injury
Classification
– Type

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Manajamen ADR

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FLOWCHART OF ASSESSMENT AND MANAGEMENT OF AN ADR

DETECTION
OF POSSIBLE ADR

PUBLISHED LITERATURE REVIEW PATIENT-SPECIFIC DATA

COMPARE PX REACTION TO DESCRIPTION IN THE

LITERATURE

CONTINUE DRUG EVALUATE SEVERITY

DECHALLENGE

RECHALLENGE
EVALUATE PATIENT
 Managing ADRs
Step 1. Evaluate the nature of the event.

 Obtain a detailed history of the patient.

 Identify and document the clinical reaction. Look up suspected

medicines and known ADRs in the literature and match them with
the reactions described by the patient

 Classify the severity of the reaction.

 Severe—fatal or life threatening
 Moderate—requires antidote, medical procedure, or hospitalization
 Mild—symptoms require discontinuation of therapy
 Incidental—mild symptoms; patient can chose whether to discontinue
treatment or not
 Assessment – Patient/Disease
 Demographics
• age, race, ethnicity, gender, height, • End-organ function
weight • Laboratory tests and diagnostics
 • Social history
Medical history and physical exam
• Concurrent conditions or special ■ tobacco, alcohol, substance
abuse, physical activity,
circumstances
environmental or occupational
■ e.g., dehydration, autoimmune hazards or exposures
condition, HIV infection,
• family history
pregnancy, dialysis, breast
• Nutritional status
feeding
• Recent procedures or surgeries and ■ special diets, malnutrition,
weight loss
any resultant complications
■ e.g., contrast material, radiation
treatment, hypotension, shock,
renal insufficiency

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 Assessment – Medication
 Medication history
 Pharmacology
• Prescription / Non-prescription
medications  Pharmacokinetics
• Medication use within previous 6  Pharmacodynamics
months
• Allergies or intolerances  Adverse effect profiles
• History of medication reactions
• Cumulative mediation dosages  Interactions
 Current medication • drug-drug
 Indication, dose, diluent, volume • drug-nutrient
 Administration : Route, method,
site, schedule, rate, duration • drug-lab test interference
 Formulation : Pharmaceutical
excipients  Cross-allergenicity or cross-
reactivity

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 Managing ADRs
Step 2. Establish the cause.
 Use the Naranjo algorithm (or other system) to assess the
patient’s reaction.

 Evaluate the quality of the medicine.

 Check for a medication error.

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 Kausalitas ADR
⊡ Certain/highly possible
□ Manifestasi efek samping / hasil uji lab yg abnormal dilihat dr waktu kejadian dapat
diterima yaitu bahwa terjadi setelah penggunaan obat (Event or laboratory test
abnormality with plausibe time relationship to drug intake)
□ Tidak dapat dijelaskan bahwa efek samping tsb merupakan perkembangan
penyakit atau dapat disebabkan oleh penggunaan obat lain (Cannot be explained
by disease or other drugs)
□ Respon thd penghentian penggunaan obat dapat terlihat sec farmakologi dan
patologi (Response to withdrawal plausible (pharmalogically, pathologically)
□ Efek samping tsb secara defenitiv dapat dijelaskan dari aspek farmakologi atau
fenomenologi (event defenitive pharmacologically or phenomenologically)
□ Rechallenge yg positif (positive rechallenge if necessary)
 Kausalitas ADR
⊡ Probable
□ Manifestasi efek samping / hasil uji lab yg abnormal dilihat dr waktu kejadian dapat
diterima yaitu bahwa terjadi setelah penggunaan obat (Event or laboratory test
abnormality with plausibe time relationship to drug intake)
□ Tidak tampak sebagai perkembangan penyakit atau dapat disebabkan oleh obat
lain (unlikely to be attributed to disease or other drugs)
□ Respon thd penghentian penggunaan obat secara klinik dapat diterima (response
to withdrawal clinically reasonable)
□ Rechallenge tidak perlu (positive rechallenge if necessary)
 Kausalitas ADR
⊡ Possible
□ Manifestasi efek samping / hasil uji lab yg abnormal dilihat dr waktu kejadian dapat
diterima yaitu bahwa terjadi setelah penggunaan obat (Event or laboratory test
abnormality with plausibe time relationship to drug intake)
□ Dapat dijelaskan oleh kemungkinan perkembangan penyakit atau disebabkan oleh
obat lain (could also be explained by disease or other drugs)
□ Informasi terkait penghentian obat tidak lengkap atau tidak jelas (information on
drug withdrawal lacking or unclear)
 Kausalitas ADR
⊡ Unlikely
□ Manifestasi efek samping / hasil uji lab yg abnormal dilihat dr waktu kejadian dan
penggunaan obat obat adalah tidak mungkin (Event or laboratory test abnormality
with a time relationship to drug inatke that makes a connection improbable)
□ Perkembangan penyakit dan akibat penggunaan obat lain dapat memberikan
penjelasan yang diterima (disease or other drugs provide plausible explanations)
⊡ Conditional/Unclassified
□ terjadi efek samping atau hasil uji lab yg abnormal (event or laboratory tes
abnormality)
□ Data yang lebih lanjut diperlukan untuk dapat melakukan evaluasi yang baik (more
data for proper assessment needed)
□ Atau data tambahan dalam proses pengujian (or additional data under examination)
 Kausalitas ADR
⊡ Unassessable/Unclassifiable
□ Laporan efek samping menduga adanya efek samping obat (a report
suggesting an adverse reaction)
□ Tidak dapat dinilai krn informasi yang kurang lengkap atau cukup atau
adanya informasi yg kontradiksi (cannot be judged because of insufficient
or caontradictory information)
□ Laporan efek samping obat tidak dapat ditambahkan lagi informasinya
atau tidak dapat diverifikasi (report cannot be supplemented or verified)
 Management Options
 Discontinue the offending agent if:
■it can be safely stopped
■the event is life-threatening or intolerable
■there is a reasonable alternative
■continuing the medication will further exacerbate the patient’s
condition

□Continue the medication (modified as needed) if:

■it is medically necessary
■there is no reasonable alternative
■the problem is mild and will resolve with time
 Management Options

□Discontinue non-essential medications

□Administer appropriate treatment
■e.g., atropine, benztropine, dextrose, antihistamines,
epinephrine, naloxone, phenytoin, phytonadione, protamine,
sodium polystyrene sulfonate, digibind, flumazenil,
corticosteroids, glucagon

□Provide supportive or palliative care

■e.g., hydration, glucocorticoids, warm / cold compresses,
analgesics or antipruritics
□Consider rechallenge or desensitization
 Follow-up and Re-evaluation

• Patient’s progress
• Course of event
• Delayed reactions
• Response to treatment
• Specific monitoring parameters
 Managing ADRs
Step 3. Take corrective and follow-up action.
Corrective action will depend on cause and severity

 Severe ADRs
 Educate and monitor prescribers.
 Change the formulary or standard treatment guideline if necessary to
substitute a medicine that is safer or that is easier to use by staff.
 Modify patient monitoring procedures.
 Notify drug regulatory authorities and manufacturers.

 All ADRs
 Educate and warn patients.
Pelaporan MESO

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Pharmacovigilance
The science and activities relating to the detection,
evaluation, understanding and prevention of
adverse drug reactions or any other drug-related
problems
 Background

⊡ Kasus thalidomide1950-an  menimbulkan efek

samping phocomelia
⊡ Dr Frances Kelsey (FDA) menahan pemberian
izin thalidomide krn resiko keamanan
⊡ Th 1961 thalidomide mulai dihentikan
peredarannya di beberapa negara

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 Background

⊡ WHO bekerja sama dengan Centre for

International Drug Monitoring  mengawasi
penggunaan obat sbg respon dr kasus
thalidomide
⊡ Tujuan : profil risk benefit dr suatu obat

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 Pharmacovigilance

⊡ Laporan adverse drug reaction

⊡ Off label use
⊡ Misuse
⊡ Abuse
⊡ Medication erros
⊡ Occupational exposure

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Pelaporan MESO
Pelaporan MESO

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Pelaporan MESO

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 Pelaporan MESO

⊡ Voluntary reporting
⊡ Untuk mendeteksi kejadian ESO yang serius dan
jarang
⊡ Offline  form kuning
⊡ Online https://e-meso.pom.go.id/ADR
 Siapa yang dapat melaporkan?

Tenaga kesehatan, dapat meliputi:

dokter,
dokter spesialis,
dokter gigi,
apoteker,
bidan,
perawat, dan
tenaga kesehatan lain

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 Pelaporan MESO
⊡ Reaksi efek samping yg dicurigai akibat obat, terutama yg
jarang terjadi
⊡ Efek samping akibat interaksi obat
⊡ Reaksi efek samping serius yg menyebabkan : lematian,
mengancam jiwa, cacat permanen, memerlukan
perawatan/perpanjangan perawatan RS. Kelainan
kongenital
⊡ Reaksi ketergantungan
⊡ Lack of efficacy  obat sub standar

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 Components of an ADR Report

 Product name and manufacturer

 Patient demographics
 Description of adverse event and outcome
 Date of onset
 Drug start and stop dates/times
 Dose, frequency, and method
 Relevant lab test results or other objective evidence
 De-challenge and re-challenge information
 Confounding variables
 Manfaat pelaporan

⊡ Perubahan Kebijakan Nasional

⊡ Perubahan Kebijakan Lokal (rumah sakit)
⊡ Praktisi waspada dalam farmakoterapi
⊡ Mencegah timbulnya efek samping berulang
⊡ Informasi munculnya efek samping yang baru dan
membahayakan
 Manfaat untuk FRS

⊡ Informasi penting dalam pengambilan keputusan

: Rasio manfaat terhadap resiko
⊡ Informasi terkini untuk pendekatan kondisi
pasien terhadap respon obat
⊡ Mencegah kejadian kembali pada kasus serupa
⊡ Menurunkan morbiditas dan mortalitas
 👆👆👆

Thank you,
any question?

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