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ADR Part 2

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6 views19 pages

ADR Part 2

Uploaded by

sabrina.sarwar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Muhammed Mahfuzur Rahman

Assistant Professor
Department of Pharmaceutical Scineces
 Animal experiments  Prescription event
monitoring
 Clinical trials
 Cohort studies
 Epidemiological  Intensive hospital
methods monitoring
 Observational
studies
 Case-control studies
 Case reports
 Case series
 Record-linkage
 Post-Marketing
Surveillance
(PMS)  Meta-analysis
 Pre-clinical Evaluation (Animal Studies)

 Acute toxicity studies

 Sub-acute toxicity studies

 Chronic toxicity studies

 Studies for
mutagenesis/carcinogenesis
 Studies for teratogenesis
 Clinical Evaluation

Phase-1 (Clinical Pharmacology Phase-2 (Clinical investigation)


Studies)  Conducted on patients
 Limited sample size (20-50)  Larger sample size (50-300)
 Healthy Volunteers (or selected patients)  Pharmacokinetic studies
 Pharmacokinetic studies  Pharmacodynamic studies for efficacy &
 Pharmacodynamic studies for efficacy & safety

safety

Phase-4 (Post-marketing Phase-3 (Formal therapeutic trials)


surveillance)  Large scale trials in patients
 Surveillance for efficacy & safety  Randomized / controlled
 Comparison with other drugs  Efficacy & safety on a larger scale

 Comparison with other drugs


 Too few

 Too simple

 Too narrow

 Too brief

 Too median
 Spontaneous ADR reporting
 Doctor
 Patient

 Post-marketing Clinical Trials


 Studies the side effects caused over time by a new
treatment
 Look for side effects that were not seen in earlier
trials
 How a new treatment works over a long period of
time
 May include thousands of people.
 Identify the suspected drug

 Identify factors contributed to ADRs-


 Multiple drug therapy
 Drug-drug interactions
 Drug-herbal interactions
 Drug – food interactions
 Excipients

 Increase information on use in “at-risk” population


 Identify unlabeled, rare, delayed ADRs

 Identify abuse potential

 Follow-up cases regrading pregnancy

 Monitor outcome of pregnancy

 Effect of drug to the foetus/baby

 Make changes to product information


Drug administered

Pt develops a new condition/symptoms

Drug suspected?
Yes
Check literature

Documented? (for the product


or similar class of products)
Yes
Highly suggestive of ADR
Documented? (for the product
or similar class of products)
No

Drug continued Drug discontinued

Worsening of symptoms Symptoms improve


(+ve dechallenge)

Any other possible causes?


• Concomitant therapy Drug restarted
• Underlying conditions

Symptoms recur
(+ve rechallenge)
 Depending on the organ system involved

 Liver functions tests

 Blood Urea nitrogen

 Blood Creatinine

 Complete blood picture (Eosinophilia)

 Urine analysis

 Biochemical immunological markers which confirms

the activation of certain immunopathological pathways


 Depending upon the reaction type

 Hemolytic complement concentrations

 Antinuclear antibodies (LE cells)

 24 hour urine histamine metabolites

 Biochemical markers for disorders that involve


systemic mast cell activation
 Skin testing
 Case study

You are treating a patient with acute pyelonephritis with the


aminoglycoside antibiotic gentamicin. While your patient is
taking gentamicin, acute tubular necrosis develops that
requires intermittent dialysis before recovery.
Should this incident be reported?

Nephrotoxicity including acute tubular necrosis is a well-


recognised and well-documented adverse effect of gentamicin and
other aminoglycoside antibiotics

Therefore, reporting this adverse event


would not provide any new or useful
information.
 Never use any drug unless there is good indication. If the patient is

pregnant, do not use the drug unless the need is imperative.

 Allergy and idiosyncrasy are important causes of ADRs. Ask if the


patient had previous reactions.

 Ask if the patient is already taking other drugs including self-

medication.

 Age, hepatic and renal disease may impair clearance of drugs so

smaller doses may be needed. Genetic factors may also predispose


to certain ADRs.
 Prescribe as few drugs as possible and give clear instructions.

 Where possible use familiar drugs. With new drugs be


particularly alert for ADRs and unexpected event.

 If serious ADRs are liable to occur, warn the patient about that.

 Charting all medications when ordered and refilled– drug

allergies, types of allergy etc.


 Pay close attention to the written prescription– correct

dosing, proper dosage form, avoid abbreviations, cautious of


drugs with similar names.

 Being familiar with all potential side effects, interactions.

 Choosing the oral route when possible.

 Taking careful history of patients esp. elderly pts.


 Initiate a committee of Post-Marketing Drug Risk
Management at hospital level.

 Initiate active surveillance (rather than relying on


spontaneous reporting).

 Assess whether physicians are following recommended DCA

warnings.

 Having a high index of suspicion for ADRs.


 Availability of safe and quality drugs

 Rational use of drugs

 Individualization of therapy

 Continued Medical Education

 Role of Health Authorities


 Type A

 Reduction in dose or withdrawal of medication altogether

 Type B

 First step: immediate withdrawal

 If mild: no further intervention

 If moderate to severe: antihistamines + steroids + adrenaline

 Type C and D

 Irreversible/partially reversible by withdrawal by the time of

detection

 Type E

 Re-introduction and more gradual withdrawal

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