national university of pharmacy department of clinical pharmacology and clinical pharmacy 1...

Introduction into clinical pharmacy

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Introduction into Introduction into clinical pharmacyclinical pharmacyIntroduction into Introduction into clinical pharmacyclinical pharmacy


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• Every year increase the number of new diseases

• Unclose new pathogens

• Deciphered the human genome

• Unclose the secrets of origin and development of known diseases

• The number of diseases in modern WHO classification - more than 12000

• Introduce new brands

The ideal drug – any drug that works exactly as promised on label

Drugs and life


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ЦІЯ People and drugs

WHO annually registrate about 2 million of serious drug complications

Increase the percentage of drug complications

In the UK - die nearly two thousand of patients

5% of birth defects are due to the drugs influence on the organism of pregnant woman


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ЦІЯ PEOPLE AND DRUGS

information technologies

Global changes:

economics

system of healthcare

pharmacy

psychology

producing of drugs marketing of drugs quality control pharmaceutical

education information sphere

lead to the changes between elements of the system doctor-patient-pharmacist


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ЦІЯ People and drugs

Medical errors take the fifth leading causeof death of Americans

20032003 20072007

98 000 Americans every year

195 000 Americans every

year

20201212


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ЦІЯ Drugs, drugs, drugs …Drugs, drugs, drugs …

Innovational drugs(original design)

Generics

BRAN

D


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In the USA OTC-drugs account for 70% of the range, about 40% of sales.

Modern pharmaceutical market of drugs – 350 000.

Among them only 4 000 – original.

Arsenal of practitioner - 60-90 titles of drugs.

Modern pharmaceutical market of drugs – 350 000.

Among them only 4 000 – original.

Arsenal of practitioner - 60-90 titles of drugs.


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Clinical pharmacy and pharmaceutical carein the system of medical and biological disciplines

Pharmaceutical carePharmaceutical care

PharmacologyPharmacology

BiochemistryBiochemistry

Pharmacotherapy

PhysiologyPhysiology

PhysiopathologyPhysiopathology

MicrobiologyMicrobiology

Clinical pharmacy


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CLINICAL PHARMACY

Clinical pharmacyClinical pharmacy – – integrative applied science, integrative applied science, combining pharmaceutical and clinical aspects of combining pharmaceutical and clinical aspects of pharmacology, whose main task is to create a reliable pharmacology, whose main task is to create a reliable theoretical basis and methodological approaches to theoretical basis and methodological approaches to rational use of drugsrational use of drugs..

Clinical pharmacyClinical pharmacy – – integrative applied science, integrative applied science, combining pharmaceutical and clinical aspects of combining pharmaceutical and clinical aspects of pharmacology, whose main task is to create a reliable pharmacology, whose main task is to create a reliable theoretical basis and methodological approaches to theoretical basis and methodological approaches to rational use of drugsrational use of drugs..

DoctorDoctor

PharmacistPharmacist

PatientPatient

DrugDrug


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Rational use of drugsRational use of drugs

Increasing theIncreasing theefficiencyefficiency of therapyof therapy

Reduction theReduction thetreatment timetreatment time

Reducing the number of casesReducing the number of casesof transition the diseaseof transition the disease

into a chronic forminto a chronic form

Reducing the cost ofReducing the cost oftreatment for patientstreatment for patients

Reducing the numberReducing the numberof side effectsof side effects

Reducing the costsReducing the costson health careon health care


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MedicalMedicaland biological and biological

aspectsaspects

MedicalMedicaland biological and biological

aspectsaspects

Chemical and Chemical and pharmaceutical pharmaceutical

aspectsaspects

Chemical and Chemical and pharmaceutical pharmaceutical

aspectsaspects

Pharmaco-Pharmaco-economic aspectseconomic aspects

Pharmaco-Pharmaco-economic aspectseconomic aspects

Rational use Rational use of drugsof drugs

ClinicalClinical pharmacypharmacy


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Chemical and pharmaceutical aspectsChemical and pharmaceutical aspectsof rational use of drugsof rational use of drugs

Route of administration

DoseDosing regimenMedicinal form

Drug

Pharmacological group

Medicinalanamnesis

Pharmacogenetics


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ЦІЯ Medical and biological aspects of rational use of drugsMedical and biological aspects of rational use of drugs

Evaluation of systems that affect the pharmacokineticsEvaluation of systems that affect the pharmacokinetics

gastro-intestinalgastro-intestinal cardiaccardiac respiratiryrespiratiry excretoryexcretory

DiseaseDisease

The severityThe severity

of the diseaseof the disease

DurationDuration

of the diseaseof the disease

Assessment ofAssessment ofanatomic andanatomic and

physiological featuresphysiological features

((sexsex, , ageage, , constitutionconstitution etcetc.).)


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Clinical pharmacy

include

Clinical pharmacogeneticsClinical pharmacogenetics

Principles of humanPrinciples of humandiseases diagnosticsdiseases diagnostics

Pharmaceutical carePharmaceutical care

Basis of clinicalBasis of clinicalmedicinemedicine

The interpretation of the dataThe interpretation of the dataof laboratory and instrumentalof laboratory and instrumental

investigationinvestigation

ClinicalClinicalpharmacologypharmacology


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Suspension of amorphous zinc insulin

Pharmaceutical factors that influencePharmaceutical factors that influenceon the bioequivalence of drugson the bioequivalence of drugs

Physical and chemical properties of substancesPhysical and chemical properties of substances

DispersityDispersity

Crystalline powder with a size of ASA particles aboutCrystalline powder with a size of ASA particles about1680 mcm is more frequently than a small powder1680 mcm is more frequently than a small powder(about 125 microns)(about 125 microns) cause stomach and intensecause stomach and intensebleedingbleeding

2 2 mcmmcm 10-40 10-40 mcmmcm

Short term effectShort term effect Prolonged actionProlonged action


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(the ability to change the crystalloid structure)



PolymorphismPolymorphism

ААSASA – 6 – 6 crystalloid formscrystalloid forms (2 (2 -active-active)) ChloramphenicolChloramphenicol – 4 – 4 modificationsmodifications (100 (100

% % activity has only 1 formactivity has only 1 form))


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L-form of L-form of chloramphenicchloramphenicolol((laevomycetinilaevomycetini) )



Optical propertiesOptical properties

racemate of racemate of chloramphenichloramphenicolcol((syntomycinesyntomycine))

ketaminiketamini hydrochloridehydrochloride

L-formL-form ( (CNSCNS ))D-formD-form ( (CNSCNS ))


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ExcipientsExcipients

Magnesium Magnesium trisilicate and trisilicate and magnesium magnesium oxide oxide the the

destruction of destruction of

steroidssteroids

Tween-80 Tween-80 enhances the enhances the adsorption of adsorption of

vitamins A, D, Evitamins A, D, E

Lactose reduces Lactose reduces the effects of the effects of

isoniazid, isoniazid, barbiturates, barbiturates,

enhances the effect enhances the effect

of testosteroneof testosterone

Kaolin delayed the Kaolin delayed the release of alkaloids, release of alkaloids,

anesthetics, anesthetics, antibioticsantibiotics


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ExcipientsExcipients

"Activators" of dermal absorption change the structure of "Activators" of dermal absorption change the structure of epidermis due to lipids dissolutionepidermis due to lipids dissolution

Alcohols Alcohols

(ethyl, cetyl)(ethyl, cetyl) Esters (cetyl palmitate,Esters (cetyl palmitate,

tsetilmeristat)tsetilmeristat)

TurpentineTurpentine oiloil Sulfonamides, Sulfonamides, steroids, steroids,

antihistamines, antihistamines, anticoagulants, anticoagulants,

salicylic acidsalicylic acid

DimethylsulfoxideDimethylsulfoxide


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ЦІЯ BioavailabilityBioavailability

BioavailabilityBioavailability - the speed and the extent - the speed and the extentto which the active substance or activeto which the active substance or activecomponent absorbed out of thecomponent absorbed out of themedicinal form and becomesmedicinal form and becomesavailable at the placeavailable at the placeof expected actionof expected action


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ЦІЯ Bioequivalence

(the definition of WHO)

Two drugs are bioequivalent if they are pharmaceutically equivalent and have the same bioavailability and when administered at the same dose provide the adequate efficacy and safety

Two drugs are bioequivalent if they are pharmaceutically equivalent and have the same bioavailability and when administered at the same dose provide the adequate efficacy and safety


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Bioequivalence studyof sodium diclofenac tablets

Time, hour

0

0,5

1

1,5

2

2,5

С, mcg/mlTablets of diclofenac sodium of company X Tablets of diclofenac sodium of company X production (the highest maximum concentrationproduction (the highest maximum concentration ССmax)max)

Tablets of diclofenac sodium of company Y Tablets of diclofenac sodium of company Y productionproduction ((lowest maximum concentration lowest maximum concentration Cmax, long half-life period)Cmax, long half-life period)

Tablets of diclofenac sodium of company Z Tablets of diclofenac sodium of company Z productionproduction (mean of maximum concentration (mean of maximum concentration Cmax, the sharpest decline of drug concentration Cmax, the sharpest decline of drug concentration in the blood)in the blood)


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The widespread introduction of bioequivalence studies -way to guaranteed generic quality

(identity of the pharmacokinetic parameters )

Pharmaceutical marketof Ukraine

5-10% - brands90-95% - generics

95% generics need the

verifacation of therapeutic

equivalence

Two sources and two components of the generics quality

GENERIC BRANDBRAND

(equivalence of the

beginning of binding )

=


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ЦІЯ Clinical pharmacology

Clinical pharmacology – the science study the influence of drugs on the human body

TasksTasks::

Study of pharmacodynamic and pharmacokineticStudy of pharmacodynamic and pharmacokinetic features in the patients bodyfeatures in the patients body

Determine the optimal drug for the concrete patientDetermine the optimal drug for the concrete patient

Determination of effective doses and regimesDetermination of effective doses and regimes

of administration for the concrete patientof administration for the concrete patient

Study of clinical efficacy and safety of new drugsStudy of clinical efficacy and safety of new drugs

TasksTasks::

Study of pharmacodynamic and pharmacokineticStudy of pharmacodynamic and pharmacokinetic features in the patients bodyfeatures in the patients body

Determine the optimal drug for the concrete patientDetermine the optimal drug for the concrete patient

Determination of effective doses and regimesDetermination of effective doses and regimes

of administration for the concrete patientof administration for the concrete patient

Study of clinical efficacy and safety of new drugsStudy of clinical efficacy and safety of new drugs


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Pharmaceutical care

Pharmaceutical carePharmaceutical carePharmaceutical carePharmaceutical care

Clinical pharmacyClinical pharmacyClinical pharmacyClinical pharmacy

ClinicalClinicalpharmacologypharmacology

PharmacoeconomicsPharmacoeconomics

ClinicalClinicaltoxicologytoxicology

ClinicalClinicalbiopharmacybiopharmacy

PharmacokineticsPharmacokinetics

ClinicalClinicalchemistrychemistry


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Pharmaceutical carePharmaceutical care – – complex programmer of complex programmer of pharmacist-patient and pharmacist-doctor interaction pharmacist-patient and pharmacist-doctor interaction during all the period of drug therapyduring all the period of drug therapy

Pharmaceutical carePharmaceutical care – – complex programmer of complex programmer of pharmacist-patient and pharmacist-doctor interaction pharmacist-patient and pharmacist-doctor interaction during all the period of drug therapyduring all the period of drug therapy

Doctor

PharmacistPharmacist

PatientPatient

DrugDrug


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Pharmaceutical care – responsibility of pharmacist before concrete patient for the result of therapy


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ЧН

ОЮ

О

ПІКОЮ

20041993

КЛ

І НІ Ч

Н А Ф А Р МА

ЦІЯ Drugs and decreed groups of patients

Pharmaceutical careof pregnant women –

guaranty of safetyand effective

pharmacotherapy

RISK

BENEFIT

• Pregnant women• Newborns• Children• Elderly and senile patients• Patients with chronic diseases


Nat

ion

al u

niv

ersi

ty o

f p

har

mac

yD

epar

tmen

t o

f cl

inic

al p

har

mac

olo

gy

and

clin

ical

ph

arm

acy

29

КЛІН

ІЧН

А

ФА

РМ

АК

ОЛ


ЕВ

ТИ

ЧН

ОЮ

О

ПІКОЮ

20041993

КЛ

І НІ Ч

Н А Ф А Р МА

ЦІЯ Biopharmacy and effectiveness of drugs

Chinini hydrochloride1 : 800

Chinini sulphate1 : 34

Overdose

Effectivetherapeutic

concentration

Insufficientconcentration 20 min 90 min 24-48 hour Hour

Drops Ointments Ophthalmic drug films

Con

cent

ratio

n


Nat

ion

al u

niv

ersi

ty o

f p

har

mac

yD

epar

tmen

t o

f cl

inic

al p

har

mac

olo

gy

and

clin

ical

ph

arm

acy

30

КЛІН

ІЧН

А

ФА

РМ

АК

ОЛ


ЕВ

ТИ

ЧН

ОЮ

О

ПІКОЮ

20041993

КЛ

І НІ Ч

Н А Ф А Р МА

ЦІЯ Drugs and food

N

SCH

O

NH

NH2 O

O

ONa

CH3

CH3

N

S

O

O

ONa

CH3

CH3

CH

O

NH2

NH2

Ampicillinsodium salt

inactivation

SO2NH2 NR

H

SO2NH2 NR

H

Sulfonamides


Nat

ion

al u

niv

ersi

ty o

f p

har

mac

yD

epar

tmen

t o

f cl

inic

al p

har

mac

olo

gy

and

clin

ical

ph

arm

acy

31

КЛІН

ІЧН

А

ФА

РМ

АК

ОЛ


ЕВ

ТИ

ЧН

ОЮ

О

ПІКОЮ

20041993

КЛ

І НІ Ч

Н А Ф А Р МА

ЦІЯ Drugs and food

Calcium channel antagonistsThe

rape

utica

l effe

ct

The increasing of toxicity


Nat

ion

al u

niv

ersi

ty o

f p

har

mac

yD

epar

tmen

t o

f cl

inic

al p

har

mac

olo

gy

and

clin

ical

ph

arm

acy

32

КЛІН

ІЧН

А

ФА

РМ

АК

ОЛ


ЕВ

ТИ

ЧН

ОЮ

О

ПІКОЮ

20041993

КЛ

І НІ Ч

Н А Ф А Р МА

ЦІЯ

national university of pharmacy department of clinical pharmacology and clinical pharmacy 1...

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