Adverse Drug Reactions - Katalyst HLS

Adverse Drug Reactions
Pharmacovigilance
01/08/17Katalyst Healthcares & Life Sciences
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Risk - Benefit Evaluation
Benefit/Risk Ratio
• Exposure to personal risk is recognized as a normal
aspect of everyday life.
• We accept a certain level of risk in our lives as
necessary to achieve certain benefits.
2

Any harmful effect caused by administration of
a drug at a normal dosage during normal use
Adverse Drug Reaction (ADR) =
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Type-A:
Augmented pharmacologic effects - dose dependent and predictable
(e.g. hypoglycaemia with insulin, bleeding after anticoagulants, drowsiness
after opioids)
They are common but often not severe, they are usually caused by too high
dosage or alered pharmacokinetics (genetic factors, age, reduced renal or
hepatal elimination)
most often with drugs that have a steep dose-response curve and/or a low
therapeutic index
Type-B: Bizarre effects (or idiosyncratic) - dose independent and
unpredictable are relatively rare and may occur with very low doses (e.g.
drug allergy – skin rashes – anaphylaxis, blood dyscrasias)
Types of Adverse Drug Reactions (A-B-C-D-E):
01/08/17
Katalyst Healthcares & Life Sciences
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Type-C:
Chronic effects after chronic administration
(e.g. analgesic nephropathy after some analgesics or tardive dyskinesia after
antipsychotics)
Type-D:
Delayed effects
(e.g. teratogenic effects – thalidomide , cancerogenic effects – stilbestrol
during pregnancy > vaginal carcinoma in daughters 20+years later)
Type-E:
End-of-treatment effects
(e.g. withdrawal effects opioids, antiepileptics, anxiolytics, rebound
phenomenon- hypnotics)
Types of Adverse Drug Reactions (A-B-C-D-E):
5

Examples of Adverse Effects associated with
Specific Medications
Bleeding in GIT NSAIDs
Thrombosis hormonal contraceptives
Ototoxicity, nephrotoxicity aminoglycoside antibiotics
Parkinsonism 1st generation (typical) antipsychotics
Aplastic anaemia chloramphenicol
Agranulocytosis clozapine (atypical antipsychotic)
Hair loss anticancer drugs
6

Pharmacovigilance
collecting, monitoring, researching, assessing
and evaluating information from healthcare
providers and patients on the adverse effects of
drugs
Major goal of pharmacovigilance is to detect
a signal on an unknown serious adverse drug
reaction as soon as possible
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• Pharmaceutical companies are required by law
in all countries to report ADRs during clinical
trials, testing new drugs on people before they
are made generally available.
• Because these pre-registration clinical trials
involve only several thousand patients at most,
less-common ADRs are often unknown when a
drug enters the market.
Limits of Detecting rare ADRs before
Drug Registration/Marketing
8

Post-Marketing Surveillance
Pharmacovigilance after
Drug
Registration/Marketing
Major sources of information on ADRs:
1.Spontaneous reporting of suspected ADRs by healthcare professionals.
2.Reporting of ADRs by pharmaceutical companies (marketing
authorisation holders).
3.ADRs reported in medical journals.
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Spontaneous reporting of suspected ADRs
by healthcare professionals
to their national pharmacovigilance center
(or to the manufacturer)
is indispensable in data-generating
system of pharmacovigilance
Spontaneous Reporting
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Spontaneous reporting of ADRs by physicians
is legally obligatory in many countries
Origin of spontaneous reporting of ADRs by physicians:
Yellow Card Scheme founded in the UK in 1964 –
forms to fill in, sent by post or electronically to the UK
pharmacoviligance center
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• ADRs that have caused death or a serious illness.
• Any ADR, however minor, if associated with a new
medicine or one that is under continued monitoring
(highlighted in the British National Formulary (BNF) with
a ▼ black triangle).
• Any ADR, however minor, if associated with a child
(under 18 years of age) or in pregnancy.
Yellow Card Scheme
The sort of ADRs that should be reported are:
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The American Food and Drug Administration:
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability - significant, persistent, or permanent change, impairment,
damage or disruption in the patient's body function/structure, physical
activities or quality of life.
• Congenital anomaly
• Requires intervention to prevent permanent impairment
or damage
The sort of ADRs that should be reported are:
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* marketing authorisation holders
Pharmaceutical companies* continually monitor and
assess ADRs in their medicines and are expected to
report of them to authorisation agencies and/or to
certain pharmacovigilance centers
Periodic Safety Update Reports (PSURs)
PSUR is an update report, at defined time points after authorization, of the
worldwide safety experience of a medicinal product. The PSUR is to be
submitted to the authorisation agency (e.g. to the European Medicines Agency)
by a marketing authorisation holder. PSUR provides succinct summary
information together with a critical evaluation of the benefit/risk balance of the
product in the light of new or changing post-authorisation information. This
evaluation should ascertain whether further investigations need to be carried
out and whether changes should be made to the marketing authorisation (e.g.
to the product information). 01/08/17
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International collaboration in the field of
Pharmacovigilance:
Spontaneous reports of suspected ADRs are sent from
national pharmacovigilance centers (n ≈100)
to the Uppsala Monitoring Centre
where they are processed, evaluated and entered into the
WHO International Database
This may lead to the detection of a signal – an alert about
a possible hazard communicated to members countries.
WHO International Drug Monitoring Programm
01/08/17
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European Medicines Agency (EMA)
EudraVigilance -
the system of collecting all suspected serious
ADRs
Pharmacovigilance in EU:
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Post-marketing surveillance is overseen by the
Food and Drug Administration (FDA),
which operates a system called MedWatch,
to which doctors or the general public can voluntarily
report adverse reactions to drugs
Pharmacovigilance in USA:
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e.g. Bulletin of European Medicines Agency (EMA):
PhVWP monthly report on safety concerns, guidelines and
general matters
SPC (/Summary of Product Characteristics: frequency
Solid sources of information on ADRs
Solid Drug Databases e.g. Micromedex, UpToDate, BNF, AISLP etc
ADRs in general:
ADRs recently reported:
PhVWP = The CHMP Pharmacovigilance Working Party
CHMP = Committee for Medicinal Products for Human Use
01/08/17
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• Very common (>10%) >= 1/10
• Common (frequent) (1-10%) > = 1/100 and < 1/10
• Uncommon (infrequent) (0,1 - 1 %) >= 1/1000 and < 1/100
• Rare (0,001-0,1%) >= 1/10000 and < 1/1000
• Very rare (< 0,001 %) < 1/10000
Frequency of Adverse Drug Reactions
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Psychiatric
Very common 1/10 Sleep disorders including abnormal dreams and insomnia
Common 1/100; <1/10 Nervousness
Nervous system disorders
Very Common 1/10 Headache, dizziness
Common 1/100;<1/10 Tremor
Cardiac Disorders
Common 1/100;<1/10: Palpitations
Uncommon 1/1000; <1/100 Tachycardia
Respiratory, Thoracic and Mediastinal Disorders
Common 1/100; <1/10 Dyspnoea, pharyngitis, cough
Gastrointestinal Disorders
Very Common 1/10 Nausea, vomiting
Common 1/100;<1/10 Dyspepsia, abdominal pain upper, diarrhoea, dry mouth, constipation
Skin and Subcutaneous Tissue Disorders
Common 1/100; <1/10 Sweating increased
Very rare <1/10000 Dermatitis allergic, dermatitis contact,
photosensitivity
Musculoskeletal and Connective Tissue Disorders
Common 1/100; <1/10 Arthralgia, myalgia
Example: Frequency of ADRs in
NicotineTransdermal Patches (from SPC):
01/08/17
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Summary – „a message to take home“:
Spontaneous reporting of suspected ADRs
by healthcare professionals
to their national pharmacovigilance center (or to the
manufacturer)
is essential in Pharmacovigilance
21

Thank YouThank You
&&
QuestionsQuestions
01/08/17
22
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com

Adverse Drug Reactions - Katalyst HLS

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