hospi clin review

7/29/2019 Hospi Clin Review

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Clinical/Hospital

PharmacyMargarita M. Gutierrez, RPh, MHPEd (OnGoing)

University of the Philippines Manila


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HOSPITAL PHARMACY

It may be defined as the practice of

pharmacy in a hospital setting including its

organizationally related facilities or

services.


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HOSPITAL PHARMACY

It is the department or division of the

hospital wherein the procurement, storage,

compounding, manufacturing, packaging,

controlling, assaying, dispensing,

distribution and monitoring of medications

through drugtherapy management for

hospitalized and ambulatory patients areperformed by legally qualified,

professionally competent pharmacists.


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Clinical Pharmacy

A practice in which the pharmacist utilizes

his professional judgment in the

application of pharmaceutical sciences to

foster the safe and appropriate use of

drugs, in or by patients, while working with

members of the health care team (Francke

1969)


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Clinical Pharmacy

Health science specialty whose

responsibility is to assure the safe and

appropriate use of drugs in patients

through the application of specializedknowledge and functions in patient care


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Clinical pharmacist

Interact with the health care team

Interview and assess patients

Make therapeutic recommendations Monitor patient response to drug therapy

Provide drug information


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Pharmaceutical Care

Is the responsible provision of drug

therapy for the purpose of achieving

definite outcomes that improves a

patients quality of life (Hepler and

Strand 1990)


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Pharmaceutical Care

A patient-centered practice in which the

practitioner assumes responsibility for a

patients drug-related needs and is held

accountable for this commitment

(Cipolle 1998)


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Major Functions of

Pharmaceutical Care

- Identifying potential and actual drug-

related problems

- Resolving actual drug-related problems

- Preventing potential drug-related

problems


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Expected Outcomes of

Pharmaceutical Care

Cure of disease

Elimination or reduction of symptoms

Arrest or slowing down of a diseaseprocess

Prevention of disease or symptoms


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Knowledge and Skills Required

in Clinical Pharmacy

Knowledge

Diseases

Drug therapy Non-drug

therapy

Laboratory anddiagnostic

testing

Skills

Communication

Patient monitoring Physical assessment

Drug information

provision Therapeutic planning


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General Clinical Pharmacy

Functions

Providing drug information to physicians andother health professionals

Medication history taking

Medication profile preparation

Drug therapy monitoring

Patient education and medication counseling

Disease screening, monitoring andmaintenance care for patients with chronicdiseases


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General Clinical Pharmacy

Functions

Participation in the management of

emergency medical care

Health information source for the public

Drug use review and patient care audits

In-service education for physicians, nurses

and other health professionals Specialized functions and services (ASHP

1983)


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DRUG INFORMATION

SOURCES


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A. TERTIARY RESOURCES

>> textbooks, compendia, review articles in

journals, full text computer databases andother general information such as those that

maybe found in the Internet


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easy to use

familiar to most practitioners concise overview of info on a specific topic convenient fairly complete info

Less current info due to lagtimeInformation may not be complete

Transcription errors/incorrect infointerpretation Human bias

Lack of expertise by authors


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B. Secondary Resources

INDEXINGconsists of providing bibliographic

citation information (e.g., title, author, &

citation of the article)

ABSTRACTINGincludes a brief description (or

abstract) of the info provided by the article or

resource cited


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C. PRIMARY LITERATURE = consists of published

and unpublished clinical research studies and

reports

NOT A PRIMARY LITERATURE:reviewarticles or editorials found in journals

REVIEW ARTICLES: general overviews and meta-analyses

PRIMARY LIT: controlled trials, cohortstudies, case series & case reports


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access to more detailed information

personally assess the utility & validity of results

more recent

may provide misleading conclusions based on only 1 trial

need to have good skills in evaluationtime needed to evaluate the large volume of literature


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STUDY DESIGNS


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Descriptive versus analytic studies

Descriptive studies

report frequency of conditions and

characteristics of study population

Analytic studies

examine relation between variable

to detect risk factors and make

inferences


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Observational versus experimental studies

Observational studiesthe exposure to a factor is observed and

not manipulated

EXPOSURE versus OUTCOME

Experimental studies

Manipulation of study factor or exposure;

randomization of subjects


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Analytic studies/Observational studies

COHORT


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Analytic studies/Observational studies

PostMenopausal

women free of

Endometrial Cancer

Use Estrogens

Dont useestrogens

Cases of

endometrialcancer

Non-cases

Cases of

endometrial

cancer

Non-cases

Example: Cohort study of the risk of estrogens for endometrial cancer


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Subjects

selected

for the study

With

outcome

w/ooutcome

Onset of study-

time

No direction of inquiry

CROSS-SECTIONAL STUDY DESIGN

Question: What is happening?

Case Control Study


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Case-Control Study

Example: Case Control Study of the risk of estrogens forEndometrial Cancer

Use Estrogens

Dont use

estrogens

CASES OFENDOMETRIAL

CANCER

Use Estrogens

Dont use

estrogens

CONTROLS


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RANDOMIZED CLINICAL TRIAL

DESIGN


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EXPERIMENTALCROSSOVER DESIGN


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TYPES OF BLINDING TO ASSIGN

TREATMENT IN CLINICAL TRIALS

Knowledge of Tx Knowledge of Tx

BLINDING PATIENT INVESTIGATOR

None Yes Yes

Single No Yes

Double NO No


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Other epidemiologic study designs

Case Reports: reports of events observed

in single patients

Case Series: collections of patients, all ofwhom have single exposure, whose

clinical outcomes are the evaluated and

described


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REVIEW!!!

A. Classified by how subjects are recruited into thestudy

Case-Control studies

Cohort studies

o Experimental studies

B. Classified by how data are collected for thestudy

Retrospective studies Prospective studies

Cross-sectional studies


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To test the pharmacy-based disease managementprogram for a group of hypertensive patients andto assess its impact on patients selected outcomemeasures, selected pharmacies were randomizedto either an intervention or control group;intervention pharmacists received specific trainingto follow patients over 8 weeks while control

pharmacists continued to provide standard care.

IDENTIFY THE STUDY DESIGN


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Children with diarrhea who sought admission

to San Lazaro Hospital were chosen as cases

in the study. Controls were neighbors of thecases who were of the same age. Mothers

of both groups of children were interviewed

on sanitation practices related to child

feeding.


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Study was set-up to identifycharacteristics that are associated

with the development of ADEs inhospitalized patients through ADEreports generated and

pharmacists interviews of patients



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PHASES OF PRODUCT

DEVELOPMENT
http://localhost/var/www/apps/conversion/tmp/scratch_5/new%20chemical%20entity


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New Chemical Entity

Preclinical Studies

Investigational New Drug

Application

Clinical Trials Preclinical Studies

New Drug Application

Postmarketing
http://localhost/var/www/apps/conversion/tmp/scratch_5/new%20chemical%20entityhttp://localhost/var/www/apps/conversion/tmp/scratch_5/new%20chemical%20entityhttp://localhost/var/www/apps/conversion/tmp/scratch_5/new%20chemical%20entity


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STEPS IN DRUG DEVELOPMENT

New Chemical Entity

Organic synthesis

Molecular modification Isolation from plants


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STEPS IN DRUG DEVELOPMENT1. PRE-CLINICAL RESEARCH

Chemistry

Physical Properties

Biologic Characterization

Pharmacology

Drug Metabolism

Toxicology

Preformulation Studies2. Synthesis & Purification

3. Animal Testing


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STEPS IN DRUG DEVELOPMENT

4. Investigational New Drug Application

to protect the rights and safety of the subjects

to ensure that the investigational plan is sound

designed to achieve the stated objectives

clinical hold

Investigational Review Board

5. CLINICAL STUDIES


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CLINICAL STUDIES

Phase I

o for assessing safety

o 20-100 Human subjects: healthy volunteers

(patients in some protocols)

o designed to determine: human pharmacology of

the drug, SAR, side effects (dose-dependent)


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CLINICAL STUDIES

Phase II

o evaluates the effectiveness for individual

patients with the disease/condition

o short-term side effects and risks


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CLINICAL STUDIES

Phase III

o expanded patient base

o additional data on effectiveness & safety to

evaluate overall benefit-risk relationship


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CLINICAL STUDIES

Phase IV

o continued clinical investigations and

postmarketing surveillance

o manufacturing scale up

o drug formulation may be modified slightly

o Phase V

o product development may continue

o additional clinical studies on special

populations; for new indication


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OTHER APPLICATIONS

Supplemental New Drug Application

Abbreviated New Drug Application


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THERAPEUTIC GUIDELINES


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provide clear and concise,independent and evidence-

based recommendations about

patient management that havebeen developed by experts


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Objectives of TGS

To reduce chance of error by

establishing standard protocolfor how care is carried out

To improve quality and

consistency of medicalcare


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THERAPEUTIC DRUG

MONITORING


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Therapeutic Drug Monitoring

Encompasses the measurement of serumdrug levels and the application of clinical

pharmacokinetics to improve patient care


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Clinical Pharmacokinetics

Study of the time course of the ADME ofdrugs and their corresponding

pharmacological response

Applications: Time to maximal response

Need for a loading dose

Dosage alterations Choosing a formulation


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to ensure appropriate, safe, efficacious,and economical drug therapy to the patient

Economical, Clinical and Humanistic

Outcomes of drug therapy for a specificpatient


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Drugs requiring TDM

Intensity of pharmacologic effect is proportionalto the drug concentration at the site of action

Drugs have an established therapeutic

plasma range Relationship between plasma drug

concentration and clinical effect is better

than the relationship between drug dose

and its effect Drug toxicity and disease presentation are

difficult to distinguish from clinical assessmentalone


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Commonly monitored drugs

Aminoglycosides: gentamicin, tobramycin,netilmicin, amikacin, vancomycin

Anticonvulsants: phenytoin,carbamazepine and occasionallyphenobarbital


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Commonly monitored drugs

Cardioactive agents: digoxin,procainamide, lidocaine, disopyramide,flecainide

Others: theophylline, lithium,methotrexate and ciclosporin

Th ti D M it i


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Monographs

Digoxin

Therapeutic Range: 1-2 ng/mL

Signs of toxicity:

Diarrhea, vomiting, abdominal pain, visual

disturbances, drowsiness, confusion,

arrhythmias



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Lithium prophylaxis

Therapeutic range:

Acute mania (0.6-1.0 mmol/L)


Monographs



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Lithium prophylaxis

Signs of toxicity

Blurred vision, polyuria, polydipsia, anorexia,

nausea, vomiting, diarrhea, abdominal pain,

muscle weakness, lethargy, drowsiness,

tremor, confusion, ataxia, renal impairment

Serious toxicity: disorientation, convulsions,coma and possibly death


Monographs



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Phenytoin

Therapeutic range: 5-20 ug/mL

Signs of toxicity

Nystagmus, blurred vision, ataxia, drowsiness

(> 30 mg/L): dysarthria, lethargy, coma


Monographs



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Carbamazepine

Therapeutic range: 4-12 ug/mL

Signs of toxicity

Nystagmus, diplopia, drowsiness, ataxia


Monographs



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Theophylline

Therapeutic range:

Asthma (10-20 ug/mL)

Neonatal apnea (5-15 ug/mL)

Signs of toxicity

Nausea, vomiting, cardiac arrhythmias,

seizures


Monographs


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DRUG-RELATED

PROBLEMS

Categories of Drug-related problems


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1. Medication Errors

any preventable event that may lead to inappropriate

medication use or cause harm to the patient while the

medication is in the control of a health care

professional, patient or consumer.

- National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

O O O


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TAXONOMY OFMEDICATION ERRORSNO ERROR

1.1 Category A

Circumstances or events that have the capacity to

cause error

ERROR, NO HARM

Note: Harm is defined as death, or temporary or permanent

impairment of body function/structure requiringintervention. Intervention may include monitoring the

patients condition, change in therapy, or active medical or

surgical treatment.


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1.2 Category B

An error occurred but the medication did not reach

the patient

1.3 Category C

An error occurred that reaches the patient, but did

not cause harm.

1.3.1 Medication reaches the patient and is administered

1.3.2 Medication reaches the patient but not administered

1.4 Category D

An error occurred that resulted in the need for

increased patient monitoring, but no patient harm.

CLASSIFICATION OF MEDICATION ERRORS


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1.5 Category E

An error occurred that resulted in need for treatmentor intervention and caused temporary patient harm

1.6 Category F

An error occurred that resulted in initial or prolongedhospitalization and caused temporary patient harm



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1.7 Category G

An error occurred that resulted in permanent patient

harm

1.8 Category H

An error occurred that resulted in a near-death event

(e.g., Anaphylaxis, cardiac arrest)

1.9 Category IAn error occurred that resulted in patient death



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2. Adverse Drug Events

2.1 Patient FactorsAdverse drug reactions

Patients reactions to the drug

2.2 Drug Factors

Drug-Drug interactions

Drug-Food Interactions

Drug-Disease Interactions

Other incompatibilities

Categories of Drug related problems


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SPECIAL POPULATIONS


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The Neonates
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Human Pregnancy

Normal length of human pregnancy

(TERM): 37-42 completed weeks of

gestation Preterm: 42 weeks onwards

**Earliest in pregnancy at which newborn babies can

sometimes survive is 23-24 weeks gestation.


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Neonates and Birth Weights

Neonatal Period: first 28 postnatal days

Low Birth Weight (LBW): < 2500 g

Very low birth weight (VLBW): < 1500 g

Extremely low birth weight (ELBW):


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Drug Disposition in Neonates

Placenta

Cross-section through a third-trimester placenta with baby. The placenta

(blue) consists of about 20 tree-like structures called cotyledons (see

circular magnified area). The babys blood vessels, arriving by way of

the umbilical cord, spread out within the placenta, sending a large branch

into each cotyledon. Mothers blood (darker red) intimately surrounds

the cotyledons.
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Available Routes

Enteral erratic in newborns

IV ensures maximum bioavailability

Rectal e.g. paraldehyde and diazepam

(seizures), paracetamol (analgesia)

Buccal e.g. glucose gel (hypoglycemia)


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Available Routes

(Preterm Babys) Skin extremely thinand poor barrier to water loss; permeable

to substances

E.g. alcohol (chlorhexidine in 70% methylatedspirit) chemical burn and systemic methyl

alcohol poisoning

IM avoided (except for Vitamin K) dueto small muscle bulk


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Pediatrics

International Committee on
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International Committee on

Harmonization (2000)

Preterm newborn infant

Term newborn infant (0-7 days)

Infants and toddlers (28 days to 23

months)

Children (2-11 years)

Adolescents (12 to 16-18 years)

** reflect biological changes


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Adverse Drug Reactions

Typically occur at lower doses than inadults, and are usually atypical

Enamel hypoplasia and permanent

discoloration of teeth: tetracyclines Growth suppression: corticosteroids

Paradoxical hyperreactivity: phenobarbital

Ad D R i


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Adverse Drug Reactions

Hepatotxicity: valproate

Reyes syndrome: salicylates (drowsiness,

coma, hypoglycemia, seizures and liver

failure)


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The Elderly

Age Related Changes in


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Age Related Changes in

Pharmacokinetic Processes

Drug

Absorption

iintestinal blood flow, surface area, & motilitydelay drug absorption; slow onset of drugaction

DrugDistribution

ibody water, lean body mass & plasmaproteins; hfat content; hplasma drugconcentrations & pharmacologic effects

Drug

Metabolism

iliver blood flow, liver organ size & enzymeconcentration; i the rate of drug

metabolism & hduration & intensity of drugaction

Drug

Excretion

irenal function & blood flow slow the rate ofdrug excretion, & hduration & intensity of drugaction

Ph d i


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PharmacodynamicsUCSF Division of Geriatric Primary Health Care Lecture May 2001

Some effects are increasedAlcohol, fentanyl, diazepam, morphine,

theophylline

Some effects are decreased isoproterenol and beta -blockers

High Risk Situations


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High Risk SituationsUCSF Division of Geriatric Primary Health Care Lecture May

2001

Patient seeing multiple providers

Patient on multiple drugs

Patient lives alone and/or hascognitive impairment

Discharge from hospital or any

change in venue


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The Pregnant

and Lactating

Problem Drugs in Pregnancy


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Alcohol

fetal alcohol syndrome

small skull (microcephaly) abnormal facial features

heart defects

impeded growth and mental retardation



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Tobacco

miscarriage or premature labor

Nicotine depresses the appetite Reduced ability of the lungs to absorb

oxygen



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Cocaine and Methamphetamine

Miscarriage

premature labor abruptio placentae

Withdrawal symptoms for babies



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Heroin and Other Narcotics

premature birth

low birthweight breathing difficulties

Hypoglycemia

intracranial hemorrhage



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PCP

(phencyclidine, or angel dust)

withdrawal symptoms (lethargy withtremors)



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Marijuana

premature birth

Low birthweight



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Other Medications

Isotretinoin

chronic malformations Phenytoin and carbamezapine

heart and face defects

mental retardation



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Other Medications

Ergotamine and methylsergide

premature labor



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Other Medications

Aspirin, ibuprofen, and other NSAIDs

increased risk of uncontrolled bleeding

delayed or extended labor

Pregnancy Category


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Pregnancy Category

an assessment of the risk of fetal injury

due to the pharmaceutical, if it is used as

directed by the mother during pregnancy does notinclude any risks conferred by

pharmaceutical agents or their metabolites

that are present in breast milk


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CategoryInterpretation

A Adequate, well-controlled studies in pregnant womenhave not shown an increased risk of fetal abnormalitiesto the fetus in any trimester of pregnancy.

B Animal studies have revealed no evidence of harm tothe fetus, however, there are no adequate and well-

controlled studies in pregnant women. OR

Animal studies have shown an adverse effect, butadequate and well-controlled studies in pregnantwomen have failed to demonstrate a risk to the fetus inany trimester.

Eg. Amoxicillin, paracetamol

C Animal studies have shown an adverse effect and there are noadequate and well-controlled studies in pregnant women. OR


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adequate and well controlled studies in pregnant women. ORNo animal studies have been conducted and there are noadequate and well-controlled studies in pregnant women.

Eg. Rifampicin, theophylline

D Adequate well-controlled or observational studies in pregnantwomen have demonstrated a risk to the fetus. However, thebenefits of therapy may outweigh the potential risk. Forexample, the drug may be acceptable if needed in a life-

threatening situation or serious disease for which safer drugscannot be used or are ineffective.

Eg. phenytoin, tetracycline

X Adequate well-controlled or observational studies in animals orpregnant women have demonstrated positive evidence offetal abnormalities or risks.

The use of the product is contraindicated in women who are ormay become pregnant.

Eg. isotretinoin, thalidomide

Drug Safety in Lactation


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Drug Safety in Lactation

Nearly all drugs transfer into breast milk to

some extent

milk (7.2) is slightly more acidic thanplasma (7.4) weakly basic drugs

transfer more readily into breast milk


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PATIENT CASE


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Generalpatientinformation

Date and time ofadmission, patients name,age, race, gender

Chiefcomplaint Reason or reasons the

patient is seeking medicalcare


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History of

presentillness

Narrative that describes the

current medical problem

Pastmedical

history

Brief description of current andprevious patient problems

unrelated to the present illness


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Socialhistory

Contains information about thepatients use of tobacco, alcohol,

and illicit drugs; patients

occupation, marital status, sexual

history, & living conditions

Family

history

Brief summary of the medical

histories of the patients first

degree relatives

Medicationhistory

Include demographic

i f ti di t


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history information, dietary

information, social habits,

current & past prescription &non-prescription medications,allergies, ADRs & compliance

Review of

systems Summarizes all patient

complaints not included in the

HPI

Physical

examination

Short description, vital signs,

systemic examination (skin,HEENT, hear, chest, abdomen,

genitalia, neurologic)


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Laboratory & diagnostic test results

Patient problem list and plans


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COUNSELING AND

COMMUNICATION

Non-compliance


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Non compliance

Non-compliance or non-adherence, is apatients failure to follow a drug regimenas instructed inadequate/excessive intake

incorrect frequency

discontinuation

intake of medication other than prescribed

Verbal Communication Skills


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Verbal Communication Skills

Includes the ability to listen, understand andrespondto other peoples statements and the

ability to interpret the nonverbal ways of other

people.

Active listening makes people feel thatthey have the full attention of the health

professional

Active Listening


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Active Listening

LISTENING FILTERSOrganizational

Role AttitudesPrevious

experiencesValues Bias, etc.

HEARI

NG

UNDERSTANDING INTERPRETING

EVALUATING

REMEMBERIN

G

RESPONDING

Body Language


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Body Language

Raising the hand

Shifting body positions

Crossed arms

Leaning toward the speaker

Raising the hands and thenletting them fall limply

Frequent throat clearing

Desire to speakor interrupt

Desire tointerrupt

Shutting out theother person

Receptiveness

Hopelessness

Disagreement


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Barriers to Verbal Communication

Physical barriers

Lack of privacy

Hindering Behaviors


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Hindering Behaviors

technical language and medical jargon frequent interruption

expressing bias

closed posture/ threatening posture

reading notes during interview Avoiding eye contact

Asking multiple questions at once

Engaging in sarcasm

Ignoring emotion of patient

mumbling


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PHARMACEUTICAL CARE

PLAN

Pharmaceutical Care Plan


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Pharmaceutical Care Plan

Assessment

Plan

Monitoring


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DRUG UTILIZATION

REVIEW

Drug Utilization Review


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Drug Utilization Review

Review of medication profiles to ensurethe appropriateness of prescriptions or

medication orders

Prospective DUR (before dispensing) orRetrospective DUR (after dispensing)


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PHARMACOECONOMIC

METHODOLOGIES

Cost of Illness (CI)


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Cost of Illness (CI)

evaluates the direct and indirect costs of aparticular disease

non comparative

serve as a baseline information

Measures of Cost


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Measures of Cost

Direct: paid directly by the health service

medical

non-medical

Measures of Cost


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Measures of Cost

Indirect: costs experienced by the patientor society

e.g. loss of earnings; loss of productivity

Intangible: impossible to measure inmonetary terms

e.g. pain, worry, distress of patient/family

Cost Minimization Analysis (CMA)


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Cost-Minimization Analysis (CMA)

identify the alternative with the lowest costamong various interventions with

equivalent outcomes or consequences

e.g. comparing generic drugs with theirbranded counterparts

Example: CMA


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Example: CMA

DRUG A DRUG B

Costs

Acquisition cost 250 350

Administration 75 0

Monitoring 75 25

Adverse Effects 100 25

Subtotal 500 400

Outcomes

Antibiotic Effectiveness 90% 90%

Result = Cost of Drug A > Cost of Drug B

Cost of Therapies

Note:bothinterventionsare consideredequally effective

Cost-Effectiveness Analysis (CEA)


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y ( )

compares treatment or other forms of healthintervention that yield different levels of health

benefits

Benefits can be defined and measured in the

same natural units

Example: CEA


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Example: CEA

DRUG A DRUG B

Costs


Administration 50 0

Monitoring 50 0

Adverse Effects 100 0Subtotal 500 400

Outputs

Extra years of life 1.5 1.6

Cost-effectiveness ratio 500/1.5 400/1.6

=$333 =$250

per extra year of life

Cost of Therapies

Cost-Benefit Analysis (CBA)


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y ( )

comparing the resources consumed(costs) and the output (benefit) expressed

in monetary terms

CBA: Example


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CBA: Example

DRUG A DRUG B

Costs


Administration 50 0

Monitoring 50 0

Adverse Effects 100 0

Subtotal 500 400

Benefits

Days at work ($) 1,000 1,000

Extra months of Life ($) 2,000 3,000

Subtotal ($) 3,000 4,000

Benefit to Cost ratio 3000/500 = 6:1 4000/400 = 10:1

Net Benefit 2500 3600

Cost of Therapies

Cost-Utility Analysis (CUA)


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y y ( )

assess perceived mental, physical andgeneral functioning over time of the

management of chronic diseases

outcome is a unit of utility

CUA: Example


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p

DRUG A DRUG B

Costs


Administration 50 0

Monitoring 50 0Adverse Effects 100 0

Subtotal 500 400

Utilities

Extra years of Life 1.5 1.6

Quality of life index 0.33 0.25

QALYs 0.5 0.4

Cost-to-utility ratio 500/0.5 400/0.4

= $1000 =$1000

per extra quality of life year

Cost of Therapies


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PHARMACY ETHICS

Nonmaleficence: To do no harm


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Nonmaleficence: To do no harm

Beneficence: Duty to promote good

Respecting the patient-professional

relationship

Respect for autonomy: Respect for theindividuals right to decide on issues that

affect self

Consent: right to be informed and to choose

a course of action


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Confidentiality: right to give or refuse consent

relative to release of privileged information

Respect for persons

Veracity: obligation to tell the truth, orhonesty


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CLINICAL

LABORATORYTESTS

GENERAL PRINCIPLES


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Sources of Laboratory Error

- spoiled / incomplete specimen

- Improper timing of obtaining the specimen

- Faulty reagents, technical errors, wrong

procedures

- Failure to take diet and medication into

account

GENERAL

PRINCIPLES


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PRINCIPLESClinical Performance

Sensitivity small changes or deviations from

normal can be detected

Specificity false (+) results are minimal

Laboratory Results

Quantitative ranges (e.g. 1.2 3 mEq/L)

Qualitative (+) or (-) outcomes Semi-quantitative varying degrees of (+) ,

e.g. 1+, 2+, 3+ for glucose in urine

GENERAL PRINCIPLES


133/349

Accuracy versus Precision

Accuracy extent to which mean measurement is

close to the true value

Precision reproducibility of the assay

HEMATOLOGICAL TESTS


134/349

3 Types of Formed Elements

Red Blood Cells (RBC)

White Blood Cells (WBC)

Platelets

Complete Blood Count (CBC)

Hemoglobin (Hb), hematocrit (Hct),total WBC, total RBC, mean cell volume

(MCV), and platelet count

HEMATOLOGICAL TESTS


135/349

A. Red Blood Cells (erythrocytes)

1. RBC Count

indirect estimate of the bloods Hb

content

HEMATOLOGICAL TESTS


136/349

2. Hct (Packed Cell Volume, PCV)

Low Hct: Anemia, over hydration, or blood

High Hct: polycythemia vera or dehydration

HEMATOLOGICAL

TESTS


137/349

TESTS

3. Hemoglobin estimates the oxygen carrying capacity of

the RBC

Low Hb: anemia

HEMATOLOGICALTESTS


138/349

TESTS

4. RBC Indeces (Wintrobe indices)

Mean Cell Volume (MCV)ratio of Hct

to RBC count

Low MCV: microcytic RBCs High MCV: macrocytic RBCs

HEMATOLOGICALTESTS


139/349

TESTS

Mean Cell Hemoglobin (MCH) amount of Hb in an average RBC

Mean Cell Hemoglobin Concentration

(MCHC)average concentration of Hb inan average RBC

Low MCHC : hypochromia

HEMATOLOGICALTESTS


140/349

TESTS

5. Reticulocyte Count measure of immatureRBCs with remnants of

nuclear material

Inc: hemolytic anemia, acute blood loss,response to treatment of a factor deficiency

Dec:drug-induced aplastic anemia

HEMATOLOGICAL TESTS


141/349

6. Erythrocyte Sedimentation rate

Inc: used to differentiate conditions withsimilar symptomatology

(angina pectoris vs. myocardial infarction)

HEMATOLOGICAL

TESTS


142/349

TESTS

B. White Blood Cells

5 Major Types:

Granulocytes (a) Neutrophils

(b) Basophils(c) Eosinophils

Nongranulocytes (d) Lymphocytes

(e) Monocytes


143/349

HEMATOLOGICAL

TESTS


144/349

TESTSB. White Blood Cells

Inc. WBC count (Leukocytosis): infection

(esp.bacterial), leukemia, or tissue necrosis

Dec. WBC count (Leukopenia): bone marrow

depression w/c may result from metastaticcarcinoma, lymphoma, or toxic reactions to

substances such as antineoplastic agents.

HEMATOLOGICAL TESTS


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NEUTROPHILS mature: Polymorphonuclear

leukocytes (PMNs), polys, segmented neutrophils,

or segs

- immature: bands or stabs

- NEUTROPHILIC LEUKOCYTOSIS:

e.g.pneumonia

HEMATOLOGICAL TESTS


146/349

OTHER CAUSES OF NEUTROPHILE COUNT INC

Certain viruses (herpes zoster, chicken pox) Rickettsial disease (Rocky Mountain spotted fever)

Fungi and stress (physical exercise, acute hemorrhageor hemolysis, acute emotional stress)

Inflammatory diseases (acute rheumatic fever, RA, acutegout)

HEMATOLOGICAL TESTS


147/349

OTHER CAUSES OF NEUTROPHILE COUNT INC

Hypersensitivity reactions to drugs

Tissue necrosis (MI, burns, certain CA) uremia, diabetic ketoacidosis

Myelogenous Leukemia

Epinephrine and Lithium

HEMATOLOGICAL TESTS


148/349

NEUTROPENIA

decreased number of neutrophils

- overwhelming infection of any type

- Viral infections (mumps, measles)- Idiosyncratic drug reactions

- Chemotherapy

HEMATOLOGICAL

TESTS


149/349

TESTS

BASOPHILS referred as MAST CELLS

BASOPHILIA CML (ChronicMyelogenous Leukemia)

A decrease in number is not

apparent.

HEMATOLOGICALTESTS


150/349

TESTS

EOSINOPHILS

EOSINOPHILIA acute allergic

reactions and parasitic infestations

HEMATOLOGICAL

TESTS


151/349

TESTS

LYMPHOCYTES

produce antibody

B lymphocytes(antibody mediated)

T lymphocytes(cell mediated)

LYMPHOCYTOSISviral infection

LYMPHOPENIAimmunodeficiency, AIDS

HEMATOLOGICALTESTS


152/349

TESTS

MONOCYTES

phagocytic cells

MONOCYTOSIS

TB, subacute bacterial endocarditis

HEMATOLOGICAL TESTS


153/349

C. Platelets (thrombocytes)

smallest formed elements in the blood

Thrombocytopenia: idiopathic thrombocytopenic

purpura, or from drugs as quinidine and sulfonamides

COMMON SERUM ENZYMETESTS


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A. Creatinine Kinase (CK) Formerly known as Creatine Phosphokinase

myocardium, skeletal muscles and brain tissue

aids in the diagnosis of acute myocardial or skeletalmuscle damage

() vigorous exercise, a fall, deep IM injection

COMMON SERUMENZYME TESTS


155/349

B. Lactate Dehydrogenase (LDH)

LDH1, LDH2 heart

LDH3 lungs LDH4 and LDH5- liver and skeletal muscle

COMMON SERUM

ENZYME TESTS


156/349

ENZYME TESTS

C. Alkaline Phosphatase (ALP)

Inc.: partial or mild biliary obstruction,

increase osteoblastic activity (Pagetsdisease, hyperparathyroidism, or

osteomalacia)



157/349

D.Aspartate Aminotransferase (AST) SGOT (Serum Glutamic Oxaloacetic

Transaminase)

Major (heart, liver tissues); minor (skeletalmuscle, kidney tissue, pancreatic tissue)



158/349

E. Alanine Aminotransferase (ALT)

SGPT (Serum Glutamic Pyruvic

Transaminase)

Found in the liver (major), heart, skeletalmuscles, and kidney

COMMON SERUM ENZYMETESTS


159/349

TESTS

F. Cardiac Troponins (I, T, and C)

I (cardiac muscles)

C (skeletal and cardiac muscles) T (cardiac and skeletal muscles)

LIVER FUNCTION

TESTS


160/349

TESTSA. Liver enzymes (LDH, ALP, AST, ALT)

- only indicate liver damage NOT livers ability tofunction

B. Serum Bilirubin

BILIRUBIN breakdown product of Hb;predominant pigment of the bile

3 major causes of increase (jaundice)

Hemolysis Biliary obstruction

Liver Necrosis

URINALYSIS


161/349

1.APPEARANCE normal: clear, pale yellow todeep gold

Red color presence of blood or

phenolphthalein

Brownish yellow color presence of direct

bilirubin

Red, orange, yellow, brown drugs

(rifampicin)

URINALYSIS


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2. pH normal: 4.5 9

3. SPECIFIC GRAVITY normal: 1.003 1.035

() DM, Nephrosis; () Diabetes insipidus

4. PROTEIN abnormal glomerular permeability

- PROTEINURIA

- ALBUMINURIA

URINALYSIS


163/349

5. GLUCOSE GLYCOSURIA (+) DM

6. KETONES

KETONURIA uncontrolled DM, starvation,or low CHO diets

URINALYSIS

MICROSCOPIC EVALUATION


164/349

MICROSCOPIC EVALUATION

- Normal: 0 1 RBC, 0 4 WBC, occasional casts

HEMATURIA trauma, tumor, systemic

bleeding disorder

(+) squamous cell vaginal contamination(menstruation)

CASTS (+) renal disease

CRYSTALS

BACTERIA UTI

RENAL FUNCTION TESTS


165/349

A. BUN (BLOOD UREA NITROGEN)UREA end product of purine metabolism,produced by liver, excreted by kidneys

Inc.: renal disease

Dec.: significant liver diseaseB. SERUM CREATININE

CREATININE metabolic breakdown product of

muscle creatinine phosphateC. CREATININE CLEARANCE

Cockroft and gault


166/349

CLcr(male) mL/min

= [(140 -age in yr) (BW kg)]

[72 x Pcr in mg/dL]

CLcr(female) = CLcr male x 0.85

ELECTROLYTES


167/349

Sodium (Na+)

major extracellular fluid cation

Hyponatremia Total body depletion of Na

mineralocorticoid deficiency

Overhydration

CHF

Cirrhosis renal failure

ELECTROLYTES


168/349

Hypernatremia

Loss of free water

DI

Excessive Na intake

Impaired Na excretion

ELECTROLYTES


169/349

B. Potassium (K+)most abundant intracellular cation

Hypokalemia

Excessive mineralocorticoid activity Vomiting, diarrhea, laxative abuse

Diuretic use (mannitol, loop, thiazides)

Glucosuria

ELECTROLYTES


170/349

Hyperkalemia

Renal insufficciency, excessive intake, drugs

During vigorous exercise

Cellular breakdown

Metabolic acidosis

ELECTROLYTESC. Chloride (Cl-)


171/349

C C o de (C )

major extracellular anion; maintains acid basebalance

Hypochloremia Excessive loss of GI fluids, CRF

Diuretic therapy, Fasting, Adrenal Insufficiency

Hyperchloremia ARF, Dehydration, excessive salt/ Cl intake

MINERALS


172/349

C. Magnesium

2nd most abundant intra and extracellular cation

nerve conduction

muscular contractility membrane transport and integrity

MINERALS


173/349

Hypomagnesemia

- poor intestinal absorption

- excessive GI loss

Hypermagnesemia- increased intake w/ RF

- Hepatitis

- Addisons disease

MINERALS


174/349

Calcium (Ca2+) bone and tooth structural integrity

nerve impulse transmission

muscle contraction pancreatic insulin release

H+ release from stomach

cofactor for some enzyme reactions

blood coagulation

MINERALSHypocalcemia

deficiency in production or response to parathyroid


175/349

- deficiency in production or response to parathyroid

hormone- Hypoparathyroidism

- Pseudohypoparathyroidism

- Hypomagnesemia

- Low intake of vit D

- Loop diuretics

Hypercalcemia

- Hyperparathyroidism

- Pagets disease

- high intake of Ca or vit D

- Thiazide therapy

MINERALSB. Phosphate (PO4)

j i t ll l i h h t f


176/349

major intracellular anion, phosphate source for

ATP synthesis- influenced by Ca (inversely proportional)

Hyperphosphatemia- low Vit D intake

- Hypoparathyroidism

- hyperthyroidism

Hypophosphatemia

- Al containing or Ca acetate containing antacids- chronic alcoholics

- Hyperparathyroidism

- High vit D

OTHER LABORATORY

TESTS


177/349

A. Prothrombin Time (PT) Warfarin monitoring

Extrinsic Pathway: Factors II, VII, IX, X (1972)

N: 10-12 sec Inc PT

Inadequate Vit K in the diet

Drugs (coumarins)

OTHER LABORATORY

TESTS


178/349

B. Activated Partial Thromboplastin Time (aPTT) Intrinsic Pathway : Factors VIII, IX, XI, XII

Common Pathway: Factors II, V, X

MONITORS Heparin Therapy N: 21- 45 sec

Inc aPPT

Severe liver dysfunction

Inadequate vit K Poor or inadequate nutrition


179/349

Clinical Pharmacy for

Common Diseases

1. Hypertension


180/349

1. Primary/ essential

2. Secondary/ underlying disease


181/349

Stages of hypertension


182/349

Systolic (+19) Diastolic (+9) Remedy

normal 100

Other types


183/349

Emergency HPN (BP 180/120) with targetorgan damage

Gestational HPN (BP 140/90) Pregnancy induced

-no underlying Dx

DOC: Methyldopa

Non pharmaceutical treatmentin HPN


184/349

1.stop smoking2. limit sodium intake

3. limit alcohol intake

4. exercise

5. healthy diet

6. loose weight

-every 10kg lost in weight BP drops


185/349

CHOICE OF ANT

HYPERTENSIVE DRUGS

BASED ON PATIENT

CHARACTERISTIC

1. DM + kidney disease


186/349

Ace inh and aRBSC/I: thiazide diretics

S/E: hyperuricimia (incuric acid and TGA)

Hypertriglyceremia

Hyperglycemia

2. CHF ( congestive heart failure)


187/349

-signs and symptoms edema bipedaledema

- ace inh + diuretics

CCBs only severe oxidation

Effects: vasodilaton


188/349

3.) Miocardial infarctionAce Inh + b-blockers

4.) asthama or with pulmonary disease

Asthma- not for b-blockers

Selective BEAMS dec sensitivity to high

dose- bronchoconstriction

DIABETES MELLITUS


189/349

Risk factor: obese

BMI: kg/m2

Based on BMI


190/349

30 Obese II

Complication


191/349

a. macrovascular (CAD, MI)b. microvascular

1. retinopathy

2. neuropathy

3. nephropathy


192/349

Post prandialInsulin will be released

-to utilize glucose ( glycogen storage)

Obese: always eat

-receptors become insensitive to insulin

-glucose accumulate

Diagnosis


193/349

1. Fasting blood sugar

6-8 hrs fasting

-screening of fat

2. RBS-(randomized blood sugar)


194/349

N (mg/dL)impaired DM

FBS 126

RBS 200


195/349

Type I Type IICauses Insulin dependent Non insulin

dependent

autoimmune Increase

glucose uptake

Antibodie are

againsta beta cell

Insulin

resistance

Impaired insulinsecretion

T I vs T II

age early Delayed


196/349

age early Delayed

FMH - +

body thin obese

sy - +

symptoms Polyphagia-

Polydipsia

Polyuria

Asymptomatic

Ketone bodies (+) (-)

Gestational diabetes


197/349

When pregnantinsuin resistant DM screening 50g glucose

challenge(interferes with release of insulin)

Confirmatory test- 100glucose/ tolerance

Test (3 hrs ,140 RO)

DOC: insulin sq lipid

Inhibitors of insulin


198/349

a. glucosan b. epinephrine

c. NE

d.cortisol e. growth hormone

TX for DM type II


199/349

Step 1

SI: lifestyle modification, diet, exercise,

Step II: OHA


200/349

a.) sulfonyl urea( glipizide, glibenclamide) Adv: most fast blood glucose reduction

AE: weight gain, hypoglycaemia

b.) biguanide (metformin)

-obes patient

- adv: good lipid profile

AE: metabolic acidosis


201/349

c. Alpha-glucosidae inhibitor (acarbose)Ae: gi flatulence

d. insulin sensitizer ( thiazolidine)resiglitazone

step III


202/349

insulin

a.) rapid acting (insulin aspo, aspu, gluco)

b. slow acting (reg insulin, pregnant IV)c. intermediate (NPH) neutral protein of

hagedorn

d.) long acting- glargne (lantus)

BRONCHIAL ASTHMA

SEVERITY MILD MID/MODERATE SEVERE


203/349

SEVERITY MILD MID/MODERATE SEVERE

Daytime sy


204/349

Sx/Sy: dyspnea ( diff in beam)

Orthopenea ( diff in breathing in supine)

Paroxysmal nocturnal dyspnea (sudden and

nightly)

New York heart association

CI Within the limit of normal


205/349

CI Within the limit of normal

CII Ordinary extraction (dyspnea)

CIII Less than ordinary exertion

CIV At rest

DOC ACE inh delivered first line


206/349

HOSPITAL PHARMACY

THE HOSPITAL


207/349

A hospital has been defined in terms of itsform, that is, its physical make up and the

quantitative nature of its services.

Clinic


208/349

a facility or area where ambulatorypatientsare seen for special study and

treatment bya group of physicians

practicing together, andwhere the patient

is not confined in a hospital.

Classification of hospital


209/349

Type of service

General

Special

- patient w/ any type of illness

- ex: cancer, psychiatric, pediatric



210/349

Length of stay

Short-term -

Long-term

< 30 days

- 30 days



211/349

- federal & state hospitals

(county & city hospitals)

- non-profit oriented: church

operated

- profit oriented: individual,

partnership & corporation

Ownership Governmental

Non-governmental



212/349

Bed capacity Under 50 beds

50-99 beds

100-199 beds 200-299 beds

300-399 beds

400-499 beds

500 beds & over

Supporting Services


213/349

1. Nursing service

2. Dietary service

3. Central supply

service

- nursing care

- procurement, planning &

preparation of food for the

patient & hospital staff

- supplies sterile linen, OR

packs & other medicalsurgical supplies

Supporting Services


214/349

4. Medical recordservice - serve as basis for planning& continuity of patient care

- provide data for use in

research education

- serve as basis for review&evaluation of the care

rendered to the patient

Supporting Services


215/349

5. Blood bank

6. Pathology

- generally under thesupervision of a licensed

physician who has a basic

interest in hematology

- cytological & gross anatomical

analysis

- clinical laboratories

Supporting Services


216/349

7. Radiology

8. Anesthesia

9. Medical social

service

- diagnostic & therapeuticapplication of radiant energy

- anesthesia care

- very important liaison

between the hospital & the

patient & his community

Main type of Medical Staff


217/349

OPEN STAFF - one in which certain

physicians, other than

those on the attending or

active medical staff, areallowed to use the private

room facilities

These physicians are

termed members of the

courtesy medical staff.

CLOSE STAFF - one in which all

professional services,

private & charity are

provided and controlledby the attending or active

medical staff

Specific Types of Medical Staff


218/349

1. Honorary staff

- consists of former staff members, retired

or emeritus, & of other practitioners whomthe medical staff chooses to honor



219/349

2. Active staff- responsible for the delivery of the

pre-ponderance of medical service within

the hospital

- most involved in the organizational &

administrative duties pertaining to themedical staff



220/349

3. Associate staff

- consists of individuals who are being

considered for advancement to the activemedical staff

- appointed & assigned to the various

services in the same manner as aremembers of the active medical staff



221/349

4. Courtesy staff- consists of practitioners who are

eligible for staff membership, who are

given privileges to admit an occasionalpatient to the hospital

- may neither vote nor hold office in the

medical staff organization



222/349

5. Consulting staff

- consists of medical practitioners of

recognized professional ability who are notmembers of the preceding categories of

staff membership



223/349

6. Resident staff

- receiving specialized clinical training

in a hospital, usually after completing aninternship

Hospital PharmacistsResponsibilities


224/349

I. Central pharmacists responsibilitiesA. Dispensing Area

1. Ensures that established policies and

procedures are followed2. Checks for accuracy of dose prepared:

a) IV admixture

b) unit dose



225/349

3. Provides for proper drug control:a) Ensures that drugs are stored and

dispensed properly and

b) ensures that all drug laws arefollowed

4. Ensures that good techniques are used in

compounding IV admixtures andextemporaneous preparations



226/349

5. Provides for proper record keeping andbilling:

a) patient- medication records,

b) extemporaneous compounding records,c) IV admixture records and billing

d) investigation- drug records

e) reports



227/349

6. Maintains professional competence,particularly in knowledge of drug stability

and incompatibilities

7. Ensures that new personnel are trainedproperly in the policies and procedures of

the dispensing area

8. Coordinates the activities of the area with

the available staff to make the best

possible use of personnel and resources



228/349

9. Keeps the dispensing area neat andorderly

10. Communicates with all pharmacy staffregarding new developments in the area

and assists in employee evaluations



229/349

11. Provides drug information as necessaryto the pharmacy, medical, and nursing

staffs

12. Coordinates the overall pharmaceutical

needs of the patientcare areas with the

dispensing area



230/349

B. Patient- Care Area1. Supervision of drug administration:

A. reviews and interprets each unit dose

and IV admixture medication order toensure that it is entered accurately into the

unit dose or IV admixture system



231/349

B. confirms periodically that administereddoses are noted correctly on the patients

chart

C. ensures that records from administerednarcotics are kept correctly and that the

physician is informed of all automatic stop

orders

D. ensures that proper drug administration,

techniques are used



232/349

E. acts as liaison between the pharmacistand the nursing and medical staffs

F. communicates with nurses and

physicians concerning medication-administration problems

G. periodically inspects the medication

areas on the nursing units to ensure that

adequate levels of floor stock drugs and

supplies are maintained



233/349

H. ensures that drugs and supplies areprocured from the dispensing area as

required

I. ensures that the other supportiveservices performed by the department of

pharmacy are carried out correctly

J. coordinates all pharmacy services on the

nursing- unit level



234/349

K. ensures that the medication area is neatand orderly

L. ensures that proper security is maintainedin the medication area to prevent pilferage



235/349

2. Direct patient careA. identifies drugs brought into the

hospital by patients

B. obtains patient medication historiesand communicates all pertinent

information to the physician

C. assists in drug- product and entityselection



236/349

D. assists in drug- product and entityselection

E. assists the physician in selecting dosageregimens and schedules, then assigns

drug- administration times for these

schedules



237/349

F. monitors patients total drug therapy foreffectiveness/ uneffectiveness, side

effects, toxicities, allergic drug reactions,

drug interactions, and appropriate

therapeutic outcomes

G. counsels patients on:

a) medications to be self- administered in

the hospital

b) discharge medications



238/349

H. participates in cardiopulmonaryemergencies by:

a) procuring and preparing needed drugs,

b) charting all medications given

c) performing cardiopulmonary

resuscitation, if necessary



239/349

II. Ambulatory pharmacistsresponsibilities

A. Dispensing Area

1. Ensures that established policies andprocedures are follow

2. Checks for accuracy in the work ofsupportive personnel



240/349

3. Ensures that proper techniques are usedin extemporaneous compounding

4. Provides for adequate record keepingand billing: patient medication records,

investigational drug records, outpatient

billing, reports, and prescription files



241/349

5. Maintains professional competence

6. Ensures that new personnel are trained

properly in the policies and procedures ofthe ambulatory pharmacy



242/349

7. Coordinates the activities of the area withthe available staff to make the best use of

personnel and resources

8. Keeps the ambulatory pharmacy area

neat and orderly at all times



243/349

B. Patient Care Area1. Inspects the medication areas on the

nursing unit periodically to ensure an

adequate supply of stock drugs and their

proper storage

2. Identifies drugs brought into the clinic bypatients



244/349

3. Obtains patient-medication histories andcommunicates pertinent information to the

physician

4. Assists in drug product and entity

selection

5. Assists the physician in selecting dosage

regimens and schedules


6


245/349

6. Monitors the patients total drug therapyfor effectiveness, side effects, toxicities,

allergic drug reactions, drug interactions,

and appropriate patient outcomes

7. Counsels patients on the proper use of

their medication


8 P di i f IV


246/349

8. Prepares medications for IVadministration

9. Provides medications and/ or supplies forpatient home care

DivisionsAdministrative Services

1 Pl & di t d t t l ti iti


247/349

1. Plan & coordinate departmental activities.2. Develop policies.

3. Schedule personnel & provide

supervision.4. Coordinate administrative needs of the

Pharmacy & Therapeutics Committee.

5. Supervise departmental office staff.

Education & Training

1 C di t f d d t &


248/349

1. Coordinate programs of undergraduate &graduate pharmacy students.

2. Participate in hospital wide educationalprograms involving nurses, doctors, etc.

3. Train newly employed pharmacydepartment personnel.

Pharmaceutical Research

1 D l f l ti f d


249/349

1. Develop new formulations of drugsespecially dosage forms not commercially

available & of research drugs.

2. Improve formulations of existing products.

3. Cooperate w/ the medical research staffon projects involving drugs

In-patient Services

1 P id di ti f ll i ti t f


250/349

1. Provide medications for all in-patients ofthe hospital on a 24-hour per day basis.

2. Inspection & control of drugs on alltreatment areas.

3. Cooperate w/ medical drug research.

Out-patient Services

1 C d & di t ti t


251/349

1. Compound & dispense out-patientprescriptions.

2. Inspect & control all clinic & emergency

service medication stations.

3. Maintain prescription records.

4. Provide drug consultation services to staff

& medical students.

Drug Information Services

1 P id d i f ti d & d


252/349

1. Provide drug information on drugs & drugtherapy to doctors, nurses, medical &

nursing students & the house staff.

2. Maintain the drug information center.

3. Prepare the hospitals pharmacy

newsletter.

4. Maintain literature files

Departmental Services

1 C t l & di IV fl id


253/349

1. Control & dispense IV fluids.

2. Control & dispense controlled substances.

3. Coordinate & control all drug delivery &

distribution systems.

Purchasing & Inventory Control

1 M i t i d i t t l


254/349

1. Maintain drug inventory control.

2. Purchase all drugs.

3. Receive, store & distribute drugs.

4. Interview medical service representatives

Central Supply Services

1 D l & di t di t ib ti f


255/349

1. Develop & coordinate distribution ofmedical supplies & irrigating fluids.

Assay & Quality Control

1 P f l d t


256/349

1. Perform analyses on productsmanufactured & purchased.

2. Develop & revise assay procedures.

3. Assist research division in special

formulations

Manufacturing & Packaging

1 Man fact re ide ariet of items in


257/349

1. Manufacture wide variety of items incommon use at the hospital.

2. Operate an overall drug packaging &

prepackaging program.

3. Undertake program in product

development.

4. Maintain a unit dose program

Sterile Products

1 Produce small volume parenterals


258/349

1. Produce small volume parenterals.

2. Manufacture sterile ophthalmologics,

irrigating solutions, etc.

3. Prepare aseptic dilution of lyophylizal &

other unstable sterile injections foradministration to patients.

Radiopharmaceutical Services

1 Centralize the procurement storage &


259/349

1. Centralize the procurement, storage &dispensing of radioisotopes used in clinical

practice

IV Admixture

1. Centralize the preparation of IV solution


260/349

admixture.

2. Review each IV admixture for physico-chemical incompatibilities.


261/349

PHARMACY AND

THERAPEUTICS COMMITTEE

Objective

To achieve optimal patient care and safety

th h ti l d th


262/349

through rational drug therapy

Primary Purposes

Policy development


263/349

- formulates policies regarding

evaluation, selection, and therapeutic useof drugs and related devices

Primary Purposes

Education


264/349

- recommends or assists in the formulation

of programs designed to meet the needsof the professional staff for complete

current knowledge on matters related to

drugs and drug use

Organization

The PTC should be composed of at least

th ff ti b h i i


265/349

the ff. voting members: physicians,

pharmacists, nurses, administrators,

quality assurance coordinators, and others

as appropriate.

Organization

A chairperson from among the physician

t ti h ld b i t d


266/349

representatives should be appointed.

A pharmacist should be designated assecretary

Functions and Scope

To serve in an evaluative, educational,

d d i it t th di l t ff


267/349

and advisory capacity to the medical staff

and organizational administration in all

matters pertaining to the use of drugs

To develop a formulary of drugs accepted

for use in the organization and provide for

its constant revision

Functions and Scope

To establish programs and procedures

th t h l f d ff ti d


268/349

that help ensure safe and effective drug

therapy

To establish programs and procedures

that help ensure cost- effective drug

therapy

Functions and Scope

To establish or plan suitable educational

f th i ti


269/349

programs for the organizations

professional staff on matters related to

drug use

To participate in quality assurance

activities related to distribution,

administration, and use of medications

Functions and Scope

To monitor and evaluate ADRs in the

health care setting and to make


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healthcare setting and to make

appropriate recommendations to prevent

their occurrence

To initiate or direct (or both) drug use

evaluation program and studies, review

the results of such activities, and make

appropriate recommendations to optimizedrug use

Functions and Scope

To advise the pharmacy department in the

implementation of effective drug


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implementation of effective drug

distribution and control procedures

To disseminate information on its actions

and approved recommendations to all

organizational healthcare staff

Formulary System

Definition: A method whereby the medical

staff of an institution working through the


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staff of an institution, working through the

PTC, evaluates, appraises, and selects

from among the numerous available drug

entities and drug products those that areconsidered useful in patient care

Formulary

Definition: A continually revised compilation

of pharmaceuticals that reflects the current


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of pharmaceuticals that reflects the current

clinical judgement of the medical staff

Main Parts of a Formulary

Part I. Information on hospital policies and

procedures concerning drugs This


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procedures concerning drugs. This

includes:

1. categories of drugs

2. brief description of the PTC

3. hospital regulations regarding prescribing,

dispensing, and administration of drugs

4. pharmacy operating procedures5. information on using the formulary

Part II. Drug Product Listing

This is the heart of the formulary and

consists of descriptive entries for each


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consists of descriptive entries for eachformulary item plus one or more indices to

facilitate use of formulary. The entries may

be arranged in any of the ff. ways: alphabetically by generic name

alphabetically within therapeutic

class combination of the two systems

Those entries must contain the ff.

minimum information:

generic name of the basic drug entity

common synonyms and brand names


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common synonyms and brand names dosage form/s, strength/s, packaging/s

and size/s stocked by the formulary

formulation (active ingredients) of acombination of product

additional information such as: unusual

pediatric and adult dose, special cautionsand notes, controlled substances symbol

Part III. Special Information

This varies from hospital to hospital and may

include:


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include:

list of hospital- approved abbreviations

rules of calculating pediatric dosages dosing guides for patients with renal

impairment

lists of dialyzable poisons, etc.


Turnover rate:

t f d ld


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cost of good sold

--------------------------------------------------------

average of beginning & ending inventory


Low turnover causes:

d li ti f t k


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duplication of stocks

large purchases of slow moving items

dead inventoryHigh turnover causes:

small volume purchasing

Satisfactory turnover rate: 4 times a year

Dispensing

In-patient Dispensing

1 U f h l t f l ti


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1. Use of charge plate - use of a plastic or

metal card prepared on patients

admission

2. Envelope system - used to dispense

drugs to the nursing station & at the same

time is also used as a charge ticket

Dispensing

3. Drug basket method - used by hospitals

for stocking non-charge floor stock drugs


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for stocking non charge floor stock drugs& related products on the nursing station

4. Mobile dispensing unit - utilizes aspecially constructed stainless steel truck

5. Mechanical dispensing - Ex. Brewersystem


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I. Erroneous Prescription

The brand name precedes the generic

name


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name.

The generic name is the one in

parenthesis.

The brand name is not in parenthesis.

Prescription 1


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Erroneous prescription

II. Violative Prescription

The generic name is not written.

The generic name is not legible and a


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The generic name is not legible and a

brand name that is legible is written.

The brand name is indicated andinstructions added (such as the phrase

No substitution) that tend to obstruct,

hinder, or prevent generic dispensing.

Prescription 3


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Violative prescription

III. Impossible Prescription

Only the generic name is written but is not

legible


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legible.

The generic name does not correspond to

the brand name.

Both the generic name and the brand

name are not legible.

Prescription 5


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Impossible prescription

Procedures to be followed for each

incorrect prescription:

Erroneous prescriptions shall be filled. Such

prescription shall be kept and reported by


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prescription shall be kept and reported by

the pharmacist to the nearest DOH office

for proper action.

Violative or impossible prescriptions shall

not be filled. They shall be kept and

reported to the nearest DOH office forappropriate.

Drug Distribution Systems

The pharmacy department makes drugs

available at the nursing unit for patient use


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available at the nursing unit for patient use

usually in one of four ways:

1. a complete floor- stock system

2. individual prescription medication for each patient

3. a combination of 1 & 2

4. unit dose dispensing, either centralized in the pharmacyor decentralized at the nursing unit level

. Floor-stock System

used in small hospitals where pharmacists

are not available to dispense individual


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are not available to dispense individual

doses for patients.

2 classes

Free floor stock- consists of a

predetermined list of medications that are


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predetermined list of medications that are

available on every nursing unit of the

hospital for use at no specific charge to

the patient.

Charge floor stock- is medication available

at each nursing unit of the hospital and for

which a charge is made to the patient

Advantages:

ready availability of the required drugs

elimination of drug returns


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elimination of drug returns

reduction in number of drug order

transcriptions for the pharmacy

reduction in the number of pharmacy

personnel needed

Disadvantages possible increase in medication errors due to

elimination order review


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increased drug inventory on the pavilion

greater opportunity for pilferage

increased hazards associated with drugdeterioration

possible lack of proper storage facilities on the

ward

greater in roads are made upon the nurses time

II. Individual Prescription Order System-

used predominantly in small hospitals

where a pharmacist is not on the premises


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p p

all the time.

Advantages: reduced manpower requirements

individualized service


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individualized service

all medications directly reviewed by the

pharmacist

provides interaction of pharmacist, doctor,

nurse, and patient

provides closer control of inventory

Disadvantages: possible delay in obtaining required

medication


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increase in cost to the patient

III. Combination of I & II-

use the individual drug order system as

the primary means of dispensing but also


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p y p g

utilize a limited floor stock; most commonly

used, incorporates unit-dose dispensing

as well.

IV. Unit Dose Dispensing-

the pharmacist prepares every dose of

medication ready for administration


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y

Advantages: improved pharmaceutical service 24 hours

a day and patients are charged only those


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y p g y

doses which are administered to them

all doses are prepared in the pharmacy

giving nurses more time for direct patientcare

allows checking or interpreting of the

doctors original order thus reducingmedication error

Advantages

eliminates excessive duplication of orders

and paper works at the nursing station and

hospi clin review

Documents