1. PHARMACOECONOMICSAND SAFETY
PHARMACOLOGY
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Seminar/Assignment-I (MPL204T)
For the Subject
CLINICAL RESEARCH AND
PHARMACOVIGILANCE
Submitted to
Drs. Kiran & Pallavi Patel Global
University (KPGU)
Guided by:
Pooja Goswami
Assistant Professor
M Pharm.
KSP
Presented by:
Kaish Pathan
M. Pharm Sem-II
Pharmacology Branch
En. No. 2103314001
Krishna School of Pharmacy & Research (KSP)
Krishna Edu Campus ,Vadodara Mumbai NH#8, Varnama, Vadodara
2. INTRODUCTION
Pharmacoeconomics can be defined as “the field of study that
evaluates behavior of individuals, firms and markets relevant to use
of pharmaceutical products, services and programs and which
frequently focuses on costs (inputs) and consequences (outcomes) of
that use”.
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3. Pharmacoeconomic Analysis involves:
▪ Choosing a perspective.
▪ Identifying measuring costs.
▪ Identifying and measuring consequences.
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4. PERSPECTIVE OF EVALUATION
Common perspective involves:
▪ Patient perspective – Portion of cost not covered by insurance.
▪ Provider perspective – e.g. hospitals, direct costs.
▪ Payer perspective – e.g. insurance companies, employers or
government.
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5. COSTS
The value of resources consumed by program or drug therapy is
defined as costs.
▪ Healthcare costs are categorized as:
• Direct medical costs: Drugs, medical supplies, equipments, lab and
diagnostic tests.
• Direct nonmedical costs: Transportation and from healthcare
facilities, extra trips to emergency departments, child or family care
expenses.
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6. ▪ Indirect nonmedical cost: Morbidity cost – loss of productivity +
mortality cost – loss of years of service due to premature death.
▪ Intangible Costs: Nonfinancial outcomes of disease and medical
care such as pain and suffering.
▪ Opportunity costs: Value (economic benefit) of the alternative
therapy that was forgone.
▪ Incremental Costs: The extra costs required to purchase an
additional unit of effect.
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7. CONSEQUENCES (OUTCOMES)
▪ Consequence is defined as the effects, outputs or outputs of
programs or drug therapy.
▪ Consequences are characterized as:
- Economic outcomes – comparing direct, indirect and intangible
costs with consequences of medical treatment alternatives.
- Clinical outcomes – Medical events that occurs as result of disease
or treatment (e.g. safety and efficacy end points).
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8. ▪ Humanistic outcomes: Consequences of disease or treatment on
patients functional status such as physical function, social function,
general health and well being, and life satisfaction.
▪ Positive outcomes: Desired effect of drug.
▪ Negative Outcomes: ADR or toxicity of drug.
▪ Intermediate outcomes: Can serve as a proxy for more relevant
outcomes.
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10. COST CONSEQUENCE ANALYSIS
(CCA)
▪ Partial economic evaluation:
- Include simple descriptive tabulations of outcomes or recourses
consumed.
- Required a minimum of time and effort.
▪ Cost outcomes or cost consequence analysis:
-Describes costs and consequences of an alternative.
- Does not provide a comparison with other treatment options.
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11. COSTS OF ILLNESS (COI)
EVALUATION:
▪ COI identifies and estimates overall cost of particular cost of
particular disease for defined population.
▪ COI evaluation method is also known as burden of illness.
▪ It involves measuring of direct and indirect costs attributable to a
specific disease such as diabetes, mental disorders or cancer.
▪ COI evaluation is not used to compare competing treatment
alternatives but to provide an estimation of financial burden of
disease.
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12. COST MINIMIZATION ANALYSIS
(CMA)
▪ Cost minimization analysis is most basic technique.
▪ CMA involves determination of least costly alternatives.
▪ For example if drugs A and B are antiulcer agents equivalent in
efficacy and ADRs, then cost of using these drugs may compared
using CMA.
▪ Another example would be prescribing a generic preparation instead
of brand leader.
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13. COST BENEFIT ANALYSIS (CBA)
▪ Measures costs and benefits in monetary terms.
▪ Estimates strengths and weakness of alternatives.
▪ Both the costs and benefits are expressed as ratio ( a benefit-to-cost
(B:C) ratio).
▪ Many CBAs measure and quantify direct costs and direct benefits
only due to difficulties in measuring indirect and intangible benefits.
▪ This approach is not widely used in health economics.
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14. COST EFFECTIVE ANALYSIS (CEA)
▪ The most commonly employed method is cost effectiveness
analysis.
▪ Measure effectiveness (health benefit) in natural units (e.g. years of
life saved, disease healed) and cost in money.
▪ It compares therapies with qualitatively similar outcomes in
particular therapeutic area. For instance, in severe reflux
oesophagitis, using a proton pump inhibitor compared to using H2
blockers.
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15. ▪ The results of CEA are expressed as ratio either as an average cost –
effectiveness ratio (ACER) or as an incremental costs effectiveness
ratio (ICER).
▪ ACER = Net cost/Net health benefit.
▪ ICER = Difference in costs (A-B)/ Difference in benefits (A-B).
▪ CEA is being used to set public policies regarding the use of
pharmaceutical products (national formularies) in countries such as
Australia, New Zealand and Canada.
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18. COST UTILITYANALYSIS (CUA)
▪ In CUA, cost is measured in dollars and therapeutic outcomes is
measured in patients weighted utilities rather than in physical units.
▪ CUA can compare cost, quality and quantity of patient years.
▪ Results of CUA are expressed in ratio, a cost utility ratio (C:U ratio).
▪ CUA is complexed hence CUA can be limited in scope of
application from hospital.
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19. HUMANISTIC EVALUATION
METHOD
▪ Method for evaluating impact of disease and treatment of disease on
patients HRQOL, patient preferences, and patient satisfaction are all
growing in popularity and applications to pharmacotherapy decisions.
▪ HRQOL is defined as the assessment of the functional effect of
illness and its consequent therapy as perceived by patient.
▪ These effects are often displayed as physical, emotional and social
effect on patient.
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20. IMPORTANCE OF
PHARMACOECONOMICS
▪ Pharmacoeconomic analysis helps to achieve maximum benefit in
minimum cost.
▪ Clinicians wants their patients to receive best care and outcome
available.
▪ Pharmacoeconomics combines objectives of both clinicians and
payers by estimating value of patient outcomes for expenditure spent
on medications and other healthcare services.
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21. APPLICATIONS
▪ Healthcare practitioners can benefit from applying principles and
methods of Pharmacoeconomics to their daily practice settings.
▪ Pharmacoeconomics aid clinical and policy decision making.
▪ Complete pharmacotherapy decision should contain assessments of
three basic outcome areas whenever appropriate: economic, clinical
and humanistic outcome (ECHO).
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22. REFERENCES
1. Textbook of clinical pharmacy practice, Pharmacoeconomics:
theory, research and practice, by Duska franic, Anandi V Law and
Dev S Pathak; Page: 507-523.
2. Pharmacotherapy: A Pathophysiologic approach, Chapter 1
Pharmacoeconomics: Principles, Methods and Applications by
Lisa Sanchez Trask.
3. https://en.wikipedia.org/wiki/pharmacoeconomics
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23. SAFETY PHARMACOLOGY
▪ CONTENTS
➢ INTRODUCTION
➢ OBJECTIVES
➢ GENERAL CONSIDERATIONS
➢SAFETY PHARMACOLOGY STUDIES:
- CVS - RESPIRATORY - GI SYSTEM
- CNS - RENAL SYSTEM
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24. SAFETY PHARMACOLOGY
STUDIES
▪ Safety pharmacology (SP) is an essential part of drug development
process that aims to identify and predict adverse effects prior to clinical
trials.
▪ It identifies “potential undesirable pharmacodynamic effects of substance
on physiological functions in relation to exposure in therapeutic range and
above”.
▪ AIM:
To characterize pharmacodynamic/ pharmacokinetic (PK/PD)
relationship of drug adverse effects using continuous evolving methodology
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25. OBJECTIVES
▪ SP studies described in the International Conference of
Harmonization (ICH) S7a and S7b guidelines.
▪ According to guideline ICH S7a:
o To identify undesirable pharmacodynamic properties of substances.
o To evaluate adverse pharmacodynamic and pathophysiologic effect
of a substance.
o To investigate mechanism of action of adverse pharmacodynamic
effect.
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27. GENERAL CONSIDERATIONS
1) Effects related to therapeutic class of substance, since mechanism
of action may suggest specific adverse effect.
2) Adverse effects associated with members of chemicals or
therapeutic class.
3) Ligand binding or enzyme assay data suggesting a potential for
adverse effect.
4) Results from previous safety pharmacology studies, from
secondary pharmacodynamic studies, for toxicology studies, or
from human.
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28. USE OF INVITRO AND INVIVO
STUDIES
▪ Ex INVIVO and INVITRO studies involves:
❑ Isolated organs and tissues
❑ Cell cultures
❑ Receptors
▪ INVITRO systems can be used in supportive studies (e.g. to obtain a
profile of activity of substance or to investigate mechanism of effect
observed INVIVO).
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29. SAFETY PHARMACOLOGY
STUDIES
• The core battery SP studies, performed according to GLP standards
as per ICH guidelines involved investigation of major vital
organisms.
:- Tier 1- CORE BATTERY :- Tire 2- SUPL STUDIES
1. CVS 1. RENAL
2. CNS 2. GI TRACT
3. RESPIRATORY 3. OTHERS
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30. CVS
▪ In last few decades, a large number of drugs have been withdrawn
from market due to adverse CVS effects, which were responsible for
45% of post approval withdrawals.
• PARAMETERS TO BE ASSESSED:
o Cardiac output.
o Ventricular contractility.
o Vascular resistance.
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33. CNS
▪ ADRs involved in CNS represent major cause of concern for
pharmaceutical companies.
▪ A variety of drug exhibits CNS side effects including sedation,
ataxia and nausea.
▪ More importantly 10% of drugs withdrawn from market between
1960-1999 due to severe CNS side effects.
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35. RESPIRATORY
▪ Drugs of various pharmacological classes are known to have
deleterious effects on respiratory functions including life threatening
conditions.
• CORE BATTERY TESTS:
o RESPIRATORY RATE.
o TIDAL VOLUME
o Hg O2 saturation.
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36. ▪ Follow up studies:
o Airway resistance.
o Pulmonary arterial pressure.
o Compliance.
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38. GI system
▪ Gastrointestinal complications are common side effects with varying
degrees of severity, observed during and drug development and are
associated with drug induced morbidity.
▪ Drug induced GI complications includes nausea, emesis,
constipations and may affect the absorption of other drugs.
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39. TECHNIQUES
▪ ESTABLISHED TECHNIQUES:
o Gastric emptying.
o Intestinal motility.
o Gastric secretion.
▪ EMERGING TECHNIQUES:
o Endoscopy.
o Radioelemetry
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40. REFERENCES
▪ Review – FRONTIERS OF PHARMACOLOGY Principles of
safety pharmacology MK Pugsley 1, S Authier 2 and MJ Curtis 3.
▪ Toxicology and Applied pharmacology.
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