Transcript Follow up - Ministry of Health

FOLLOW-UP,
REFERRAL &
COMMON ADR OF
ANTITB TREATMENT
by
Assoc. Prof. Dr. Tengku
Saifudin Tengku Ismail
Ms. Rahela Ambaras Khan
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LEARNING OBJECTIVES
• To learn about follow-up schedule of newly
diagnosed PTB patients
• To learn on type of cases required to be
referred to specialists
• To learn of the common ADRs of antiTB drugs
& their management
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FOLLOW-UP
• All patients on antiTB treatment should be
monitored to assess their response to
treatment & to identify problems associated
with it.
• All patients should be aware of symptoms
indicative of PTB & adverse drug reactions.
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NEW PATIENTS WITH PTB
• WHO recommends daily dosing throughout
the course of antiTB treatment.
• A daily intensive phase followed by thrice
weekly maintenance phase is an option.
• A maintenance phase with twice weekly
dosing is not recommended since missing one
dose means the patient receives only half the
total dose for that week.
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MALAYSIAN CPG TB 2002
• Follow-up was recommended at 2, 4 & 6
months during treatment. Sputum smear &
chest radiograph were recommended to be
done during each follow-up clinic visit.
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MALAYSIAN CPG TB 2012
• Follow-up is recommended at 2, 4 & 6 months
during treatment.
• In order to detect early adverse drug reactions
& to enhance compliance, follow-up within
1 month of starting treatment is advisable.
• Sputum smear & chest radiograph should be
done at 2 & 6 months if patient is clinically
improving.
•
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FLOW CHART FOR 6 MONTHS
TREATMENT OF PTB
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FOLLOW-UP
• Patients with initial sputum smear negative
should have repeat sputum smear at 2 months
of antiTB treatment. If still negative, no
further sputum sample is required.
• If sputum smear remains positive at 2 months,
refer to specialists with experience in TB
management & repeat sputum AFB & sputum
MTB C&S at 3 months.
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FOLLOW-UP
• Patients with initial sputum positive should
have repeat sputum smear at 2 & 6 months of
antiTB treatment.
• Patients who remain sputum smear positive
should be referred to specialists with
experience in TB management.
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FOLLOW-UP AFTER COMPLETION
OF ANTITB TREATMENT
• Follow-up clinic visits should not be conducted
routinely after treatment completion.
• Patients should be told to watch for symptoms
of relapse & how to contact the TB service
rapidly through primary care or a TB clinic.
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DEFINITION OF
ADVERSE DRUG REACTION (ADR)
• A response to a medicine which is unintended
or harm which occurs at a normal dosage
during normal use.
ONSET OF ADR FOR ANTITB
• ADRs occur within early stage of the
treatment compared to the later stage.
Kishore PV et al., Pa J Pharm Sci, 2008
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CLASSIFICATION OF ADR FOR ANTITB
Troublesome but
NOT SERIOUS
• Nausea
• Tiredness
• Pruritus
• Minor rashes
Treat
symptomatically
WITHOUT
treatment
interruption
• Severe skin reaction (StevenJohnson Syndrome, Toxic
Need IMMEDIATE
Epidermal Necrolysis & Drug
DISCONTINUATION
Rash with Eosinophilia &
Systemic Symptoms)
• Hepatitis
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RISK FACTORS OF ADR FOR ANTITB
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•
•
•
•
•
Age >40 years
Overweight/obesity
Smoking
Alcoholism
Anaemia
Baseline ALT more than
twice upper limit of normal
• Baseline aspartate
aminotransferase more
than twice upper limit of
normal
•
•
•
•
•
•
•
EPTB
MDR-TB medication
HIV infection
CD4 count <350 cells/mm3
Hepatitis B virus infection
Hepatitis C virus infection
Concomitant use of other
hepatotoxic drugs
1Chung-Delgado
K et al., PLoS ONE, 2011
AS et al., Rev Port Pneumol, 2010
3Khalili H et al., Factors DARU, 2009
4Marzuki OA et al., Singapore Med J, 2008
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2Vilarica
SYSTEMS MOST AFFECTED BY
ANTITB DRUGS
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•
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•
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Hepatobiliary
Skin
Gastrointestinal tract
Skeletal system
Renal
1Shang P
2Teleman
et al., PLoS ONE, 2011
MD et al., Int J Tuberc Lung Dis, 2002
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DRUG-INDUCED RASHES
Pyrazinamide (MOST)
Drug-Induced
Algorithm
Severe Cutaneous ADRs
Discontinue antiTB until the rashes subside
Reintroduce individual drug sequentially to identify the offending drug
Provide suitable regimen when an offending drug is identified
(If possible, regimen should include 2 most potent drugs namely
isoniazid & rifampicin )
Yee D et al., Am J Respir Crit Care Med, 2003
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DRUG-INDUCED RASHES (cont.)
Desensitisation?
 If the offending drugs are both isoniazid &
rifampicin
 If a suitable drug combination is available, it is not
necessary to perform desensitisation
 It is done by careful administration of increasing
doses of the drug under close supervision
 Attempted in HIV patients*
 Complex Cutaneous ADRs requires specialists
consultation
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DRUG-INDUCED HEPATITIS
Risk Factors1,2
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Slow acetylators
Old age
Extensive TB disease
Malnutrition
Alcoholism
Chronic viral hepatitis B & C
infections
• Pregnancy until 90 days
postpartum
• HIV
• Organ transplant recipients
Drug-Induced
Pyrazinamide (MOST)
Isoniazid
Rifampicin (LEAST)
Monitoring
At least for the first 2 - 4 weeks is
recommended among all patients with
antiTB treatment as DIH usually occurs
within the initial 2 months of treatment.
1Yew
2Blumberg
WW et al., Respirology, 2006
HM et al., Am J Respir Crit Care Med, 2003
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DRUG-INDUCED HEPATITIS (cont.)
Restarting?
• Depends on whether hepatotoxicity sets in
during the initial or the continuation phase
of treatment & the amount of treatment
received prior to the onset of such toxicity.
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DRUG-INDUCED HEPATITIS (cont.)
When to Stop AntiTB?
• Serum transaminase level reaches 3
x ULN for patients with symptoms
suggestive of hepatitis
• Serum transaminase level reaches 5
x ULN for those without symptoms
Restarting
The patient can then be retreated with a
regimen containing fewer potentially
hepatotoxic drugs such as streptomycin,
ethambutol, isoniazid & fluoroquinolones.
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DRUG-INDUCED HEPATITIS (cont.)
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WHEN TO REFER
The following conditions should be referred to
specialists with experience in TB management:
• Unsure of TB diagnosis
• Retreatment of TB
• Adverse events following antiTB drugs
• MDR- & XDR-TB
• EPTB except TB lymphadenitis
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WHEN TO REFER
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Renal &/or liver impairment with TB
HIV-TB co-infection
Smear negative TB
Smear positive TB after 2 months of antiTB
treatment
• All children diagnosed as TB
• Maternal TB
• Complex TB cases requiring surgical
intervention
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TAKE HOME MESSAGES
• All patients on antiTB treatment should be
monitored to assess their response to treatment & to
identify problems associated with it.
• All patients should be aware of symptoms indicative
of PTB & adverse drug reactions.
• WHO recommends daily dosing throughout the
course of antiTB treatment.
• Follow-up clinic visits should not be conducted
routinely after treatment completion.
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THANK YOU
[email protected]
[email protected]
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