Predictabilty and Preventability Assessment, Management of ADR, Terminologies of ADR

PREDICTABILITY AND PREVENTABILITY
ASSESSMENT
Presented By
Miss. Kshama P. Mundokar
M. Pharm Sem II (Pharmacology)
Guided By
Prof. Pranali Chandurkar
Assistant Professor
M. Pharm (Pharmacology)
Dr. Rajendra Gode, Institute Of Pharmacy, Amravati
MANAGEMENT OF ADR
TERMINOLOGIES OF ADR
D
E
P
ARTMENT
O
F
P
H
A
RMACOLO
G
Y
“Clinical Research and Pharmacovigilance”
(MPL 204T)
Pharmacy Council of India, New Delhi

CONTENTS
• Predictability
• Types of Predictability
• Preventability
• Preventability Assessment Scale
• Management of ADR
• Terminologies of Adverse Medication Events
• Regulatory Terminologies
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PREDICTABILITY
• Most adverse drug reactions are dose-related, others are
allergic or idiosyncratic.
• Dose-related ADRs are usually predictable
• ADRs unrelated to dose are usually unpredictable
• Dose-related ADRs are particularly a concern when
medications have a narrow therapeutic index (hemorrhage
with oral anticoagulants).
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➢TYPES OF PREDICTABILITY
1) Type A (Predictable):
a. Extension of pharmacologic effect.
b. Often predictable and dose-dependent.
c. Responsible for at least 30% of ADRs.
d. E.g. anti-cholinergic and dry mouth.
2) Type B (Unpredictable):
a. Idiosyncratic or immunologic reaction.
b. Rare and unpredictable.
c. E.g., chloramphenicol and aplastic anaemia, penicillin induced anaphylactic
shock.
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• By the classification of ADRs predictability can be determined. Aronson classification was
followed in this study according to which adverse drug reactions are classified into
following six types;
1. Type A : Augmented, dose-related
2. Type B : Bizarre, non-dose related
3. Type C : Chronic, dose and time-related
4. Type D : Delayed, time related
5. Type E : End of use
6. Type F : Failure of therapy
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Predictable
Unpredictable

• Anything that is preventable can be
avoided or stopped in its tracks
• ADR are considered preventable when
they occurred due to contraindication,
inappropriate dose or lack of
monitoring, interactions, ignoring
toxic serum drug concentration,
allergic reactions or noncompliance
PREVENTABILITY

• According to WHO factsheet, it is assessed that atleast 60% of ADRs are
preventable
• In several countries ADR related costs like hospitalisation, surgery and lost
productivity, goes beyond the cost of the medications
• From the previous studies it is found that 20% to 80% of ADEs are
preventable having majority of later studies showing around 60-70% of
preventability
PREVENTABILITY ASSESSMENT SCALE
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➢ SCHUMOCK AND THORNTON SCALE
PREVENTABILITY OFADRs
1. By using Schumock and Thornton scale preventability of
ADRs can be evaluated
2. Any answer of “Yes” to any question in this scale proposes
that the ADR might have been preventable
3. ADRs can be categorised as definitely preventable, probably
preventable or not preventable
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➢ MODIFIED SCHUMOCK AND THORNTON
SCALE
Definitely Preventable
1. Was there a history of allergy or previous reactions to the drug ?
2. Was the drug involved inappropriate for the patient’s clinical condition ?
3. Was the dose, route or frequency of administration inappropriate for the patient’s age, weight or disease state ?
4. Was a toxic serum drug concentration (or laboratory monitoring test) documented ?
5. Was there a known treatment for the adverse drug reaction ?
Probably Preventable
6. Was required therapeutic drug monitoring or other necessary laboratory tests not performed ?
7. Was a drug interaction involved in the ADR ?
8. Was poor compliance involved in the ADR ?
9. Were preventable measured not prescribed or administered to the patient ?
Not Preventable
10. If all above criteria not fulfilled
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MANAGEMENT OF ADVERSE DRUG REACTION
• The main and primary step in management is withdrawal of suspected
drugs
• However, in case the reaction is expected to be dose related, then dose of
the drug must be reduced, and treatment for suspected reaction must be
considered
• The drug treatment must not be unnecessarily continued for longer time
period and the patient must be reviewed regularly and simplify management
should be followed
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➢Following steps must be followed during the management of any type of suspected, or
unexpected ADR:
1. Monitoring patient who are at greater risk of developing ADRs
2. Monitoring patients who are prescribed with drugs highly likely to cause ADR
3. Assesing and documenting the patients previous allergic status
4. Assessing patients drug therapy for its appropriatenss or changing dose of drug
6. Replacement with alternate medicine
7. Use of prophylactic regimen
8. Assessing possible drug interactions in multiple therapies
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09. Assistant health care professionals in the detection and assessment of ADRs
10. Stimulating health care professionals in reporting an ADR
11. Documentation of suspected reported reactions for further references
12. Obtaining feedback about the reported reaction.
13. Educating health care professionals about the importance of reporting an ADR
14. Educating patients
15. Creating awareness about ADRs amongst health care professionals, patients and public
16. Presentation of reports in meetings and conferences
17. Conducting workshops/seminars/conferences on ADRs for health care professionals
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TERMINOLOGIES OF ADVERSE MEDICATION
RELATED EVENTS
Drug Medicine:
It is any physiological and pathological change experienced by the
beneficiary after having pharmaceutical product. It comprise of complete
formulated and registered product, including the presentation, packaging as well as
associated information.
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Adverse Event :
AE also known as adverse experience, can be defined as any
unexpected/inappropriate or untoward medical incidence associated with drug
use in humans, with or without any relationship to the drug.
For example: Physical findings (increase in B.P. or temperature
abnormal laboratory values, symptoms (nausea, headache, dizzines etc.) and
medical errors (miscalculation. misunderstanding of verb orders, name
confusion in drugs. overdose route of drug administration etc.), transfusion
reactions accidental injuries Surgery.
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Adverse Drug Reaction:
It can be defined as, "Any unintended, noxious or undesirable effect drug
occurring at doses used normally in humans for the purpose diagnosis, prophylaxis
or therapy of disease, or for any changes to done in physiological function.’’
For example: Cough nausea, vomiting diarrhea headaches. Sk reactions
(redness, rashes, itching), anaphylaxis ancmia etc.
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Serious Adverse Event or Reaction:
It can be defined as any unintended, untoward medical intervention at any
dose resulting in significant disability or life threatening death. A serious adverse
reaction which needs hospitalization of inpatient or its prolongation.
Unexpected Adverse Reaction:
It is an adverse reaction in which the nature or severity of drug is not
constant that is mentioned in the domestic labeling or market approval or is a
known characteristic of the medicine.
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Side Effect:
It is an undesirable physical symptom caused by taking a drug or
undergoing medical treatment or therapy.
For example: Diarrhea constipation dermatitis or skin rash, dizziness,
dry mouth, headache, drowsiness insomnia, etc.
Drug Alerts:
It is an action of informing a large group of people in comparison to
the initial information holders of allerged relation between a drug and an
adverse reaction.
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Individual Case Safety Report (ICSR):
It is a document containing complete information associated to an
individual case. This is provided by a primary source to describe alleged adverse
reactions related to the administration of one or more medicinal products to a
particular patient at a certain point of time.
Lack of Efficacy:
It is a situation in which an unexpected medicine failure occur which
produce a desired effect determined by previous scientific investigation.
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Suspected Adverse Reaction:
It occurs when there is a reasonable possibility that the adverse event
is caused by the specific drug. Reasonable possibility indicates a causal
relationship between the adverse event and drug.
Prescription Event Monitoring:
It is a system that is generated to monitor adverse drug events in a
population. For identified patients who are receiving an specified medicine,
prescribers are requested to report all events irrespective to whether they are
suspected adverse events.
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Rechallenge:
It is a point at which the recipient administers repeats a medicine once
the previous dose is extracted out.
Dechallenge:
It indicates the withdrawal of a drug from a patient. It is that condition
at which the adverse effects might disappear, get reduced, or the continuity
might get broken down.
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Record Linkage:
It is a process of assembling information comprising of two or records.
For example, in different sets of medical charts, or in vital records (birth and
death certificates).
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REGULATORY TERMINOLOGIES
Adverse Event of Special Interest (AESI):
It can be a notable event for any specificied pharmaceutical product or
class of products that can be monitored carefully by the sponsor.
The event can either be serious or non-serious, for example, loss of
hair, impotence, loss of taste, etc.
It might also include conditions that could be potential precursors or
can indicate any early for causing illness or onset of any serious medical
conditions in susceptible individuals.
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Adverse Drug Reaction (ADR):
As per WHO adverse drug reaction can be defined as “Any response to
a drug which is noxious and unintended and which occurs at doses normally
used in man for prophylaxis, diagnosis, or therapy of disease, or for the
modification of physiological function."
It is however considered to necessarily have a causal relationship
between the treatment and the occurrence, i.e, judged as being at least possibly
related to drug (medical product) being administered by the reports or a
reviewing health worker.
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Absolute Risk or Incidence Rate:
It indicates the risk in exposed person's population. It is the possibility
in a particular population that any event can affect its members.
For example. 1 person in a population of 1000 individuals. It can be
measured over time (indicating incidence) or at a given time (indicating
prevalence).
Benefit:
It is a predictable gain for any individual person or a population.
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Risk:
It can be considered as the probability of developing any outcome or
that something can happen. It can be referred to as a negative term, but not
necessarily always.
Benefit Risk Analysis:
It is the analysis of the beneficial (favorable) and critical (unfavorable)
results of undertaking a specific course of action.
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Attributable Risk:
It is also known as excess risk. It can be defined as, ‘’Percentage of difference
between the incidences among exposed population (absolute risk) and non-exposed (reference
risk) with incidence among exposed’’, it results from an absolute comparison between
outcome frequency measurements, like incidence. ADR Incidence among Exposed-Incidence
and among Non-Exposed.
For example, if the exposed persons with a specific disease (outcome) are ‘A’ and the
exposed persons without the disease (outcome) are ‘B’. The unexposed persons with disease
(outcome) are ‘C’ and the unexposed persons with disease (outcome) are ‘D’, then the
attributable risk can be calculated by,
Formula: [A/(A+B)]-[C/(C+D)]
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Potential Risk:
It can be defined as any unintended or untoward incidence for which the
pharmaceutical product can be suspected but in condition where it has not been confirmed.
For example, Pre-clinical safety concerns that have not been observed in clinical
studies, adverse effects observed but with a comparative effect (with placebo) not large
enough to suggest a causal relationship, and event known to be associated with other products
of the same class.
Biological Products:
It is a therapeutic or medical products obtained (prepared) from biological material
of animals, humans or microbiologic origin like blood products, vaccines, insulin, etc.
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Causality Assessment:
It is the evaluation of the probability that the therapeutic drug can be
the cause of an observed adverse reaction. Causality assessment is usually
made according established algorithms.
Case Reports:
They are reports of the ADR of single patients. These types of reports
describe about single patient exposed to a drug and experience a particular
disease (outcome), usually an adverse event.
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Data-mining:
In this Uppsala Monitoring Centre (UMC) uses an automated tool.
based on Bayesian logic, for the scanning of the WHO database (Vigibase) in
the process of detecting drug-adverse reaction associations.
Case Control Studies:
It is the studies that compare cases with an outcome (disease) to
controls without the outcome (disease), looking for differences in precursor
exposures.
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Case Series:
Reports of collections of patients who have a common exposure to
examine about their clinical outcomes. In these reports no control group is
present.
Cohort Studies:
It is the studies that identify defined populations and follow them
forward in time, examining their rates of disease. Cohort studies generally
identify and compare exposed patients to unexposed patients or to patients
who receive a different exposure.
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Cross-Sectional Studies:
These studies examine exposures and outcomes in populations at one
point in time: they have no time sense.
Descriptive Studies:
These studies that do not have control groups, such as case series, case
reports, and analyses of secular trends. They contrast with analytic studies.
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Development Safety Update Report (DSUR):
It is a periodic summary report of safety information for regulators that
includes any changes in the benefit-risk relationship, for a drug. biological or
vaccine under development. These are prepared by the sponsor of all its
clinical trials.
Good Clinical Practice (GCP):
It is a standard for the design. perform. conduct. monitor, audit, record,
analyses, and reporting of clinical trials that provides assurance that the data
and reported results are credible and accurate.
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Medication Errors:
It is any type of error in the medication use process, like monitoring. prescribing,
dispensing, transcribing, and administering.
Observational Study:
This study includes the investigator who does control the therapy, but observes and
evaluates the results of any medical care.
Periodic Safety Update Report (PSUR):
These reports include format content for providing an evaluation of the risk-benefit
balance of a medic product for submission by the marketing authorisation holder at defined
points during the post-authorisation phase.
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Pharmaco-epidemiology:
It is the study of the utilization and the effects drugs in large numbers of people or
population.
Randomised Controlled Trial (RCT):
It is a study where investigator assigns patients randomly to different therapies or de
treatment studies.
Suspected Unexpected Serious Adverse Reaction (SUSAR):
It is reaction which is both unexpected and serious in nature.
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Excipients:
They are all the pharmaceutical substances included to make
pharmaceutical formulation such as tablet, capsule, ointment, etc. except
active drug substance.
Formulary:
It includes a list of medicinal drugs with their methods administration,
uses, available dose forms, side effects, etc. It also sometime includes their
methods of preparation and formulas.
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Incidence:
It is the extent or rate of occurrence, especially the number new cases
of a disease in a population over a period of time.
MedDRA or Medical Dictionary for Regulatory Activities:
It is clinically-validated international medical terminology used by
regulatory authorities and the regulated biopharmaceutical industry.
The terminology used through the entire regulatory process, from pre-
marketing to post marketing, and for data entry, retrieval, evaluation and
presentation.
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Prescription Event Monitoring (PEM):
It is a System created to monitoring adverse drug events in a
population. Prescribers are requested to report a events, regardless of whether
they are suspected adverse events of identified patients receiving a specified
drug. Also more accurately name "cohort-event monitoring".
Prescription Only Medicine (POM):
The therapeutic drug or medicinal product becomes available to the
public only on showing prescription.
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Regulatory Authority:
It is the regulatory body with the legal authority any country having all
the responsibility of regulating all matters related wit the drugs.
Vigibase:
It is the name for the WHO International ADR Database.
Vigimed:
E-mail conferencing facility, exclusive to member countries of the
WHO Program for International Drug Monitoring.
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