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FUNGSI-PERAN

FARMASIS
IR-II

Pharmacists
Expert on drugs
Responsible for
dispensing/compounding of
medicines
Control of drugs use

THE MISSION OF PHARMACY


In 1990, the board of trustees of the
APhA
adopted the following mission
statement for
pharmacy (17):
The mission of pharmacy is to serve
society as the profession responsible
for the appropriate use of medications,
devices, and services to achieve
optimal therapeutic outcomes.

DEFINISI/ISTILAH-ISTILAH
DRUG/OBAT
A drug is defined as an agent intended for use in
the diagnosis,mitigation,treatment,cure, or
prevention of disease in humans or in other
animals

Classification of drugs?
Ethical / Prescription drugs
Use for Mx / Tx of diseases
Require prescription form

Over the counter/ Non-Rx


Use for the prevention of self-limiting or
minor ailments
No Rx form needed
Mx = managament

What is a medicine?
Drug as the active ingredient +
excipients formulated into a
suitable dosage form with
complete packaging
Pharmaceutical Dosage Form
( Sediaan Obat )
1.Sterile ( Sterile Dosage Form )
2.Non-sterile ( Non-Sterile Dosage Form )

FIGURE 4.4 Electronic tongue to assist in formulation


development. (Courtesy of Alpha MOS.)
An electronic tongue is used to aid in providing a global
taste fi ngerprint during formulation development. It
provides information on bitterness levels and the stability
of flavors in terms of taste (Figure 4.4).

Method qualification.
Preliminary methods validation
conducted during phases 1, 2, and 3
to support the drug development
process and the associated release of
clinical trial material.

FIGURE 1. The first United States Pharmacopeial Convention,held


on January 1, 1820 in Washington, DC. (Reprinted with
permission from the United States Pharmacopeial Convention)

The combined efforts of :

chemists,
biologists,
molecular biologists,
pharmacologists,
toxicologists,
statisticians,
physicians,
pharmacists and pharmaceutical
scientists, engineers,
and many others participate in drug
discovery and development.

Definition of sterile dosage forms:


A product introduced in a manner that
circumvents the bodys most protective
barriers,the skin and mucous
membranes, and, therefore, must be
essentially free of biological
contamination
Sediaan Steril ..... Injeksi = Parenteral

Tablet(European Pharmacopoeia, 5th edition,2005) , tablets are defined as :


solid preparation each containing a single dose of one or more active
ingredients and usually obtained by compressing uniform volume of particles
Tablet = ( Latin,tabuletta); small disc-like/cylindrical specimens
Tablet ( European Pharmacopoeia)= Compressi
Tablet : a.pengobatan/aksi sistemik
b.pengobatan /aksi lokal( dlm.mulut,GI,stomach/pH)
Aksi sistemik ( oabat dilepas ):Obat larut dalam saliva, stomach/intestine
diabsorbsi kedalam sirkulasi sistemik kmd sampai ketempat aksi.
Tablet digunakan dengan cara( via oral ):
- ditelan ( swallowed)
-kunyah (chewed)
-dilarutkan (effervescent)/didispersikan)sebelum diminum
-tinggal agak lama dimulut( tablet hisap)

PHARMACY
Art and science of preparing
from natural and synthetic
sources, suitable materials for
distribution and use in the Tx
and prevention of diseases
Ex. Willow bark aspirin, sennaSenokot
Tx = therapy

PHARMACY
It embraces knowledge of
identification, selection,
pharmacologic action,
preservation, analysis,
standardization of drugs and
medicines
It includes their proper and safe
distribution and use, whether
dispensed on the Rx or sold
directly to consumer

What are the scopes of Pharmacy?

Community pharmacy
Industrial Pharmacy
Hospital Pharmacy
Clinical Pharmacy
Drug Wholesaling
Education
Research
Pharmaceutical Journalism
Oraganization Management
Medical Communications
Pharmacist in Government Service

What are the scopes of


Pharmacy?
Community pharmacy
Retail Pharmacy
Activities: dispensing,
compounding, selling, storage and
handling, advising of
patients,selecting product for
inventory, identifying fast moving
products, administers, supervise
the pharmacy ( managerial
function), entrepreneural function

Scopes of Pharmacy
Industrial Pharmacy
Production
Conversion of raw materials to finished products
Supervises the operation, CGMP must be
observed, planning for production

RAW
MATERIALS

PRODUCTIO
N
PROCEDURE

FINISHED
PRODUCTS

FIGURE 2.5 A toxicologist examining research data of body


weight changes during preclinical studies in mice. (Courtesy
of Toxicology Research Laboratories, Lilly Research
Laboratories,
Division of Eli Lilly and Company.)

FIGURE 2.6 Monitoring the effects for cardiac function of an


investigational drug as a part of its clinical evaluation.
(Courtesy of Eli Lilly and Company.)

Scopes of Pharmacy
Industrial Pharmacy
Research ( R &D)

Formulation
Reformulation
Drug-excipient Compatibility Testing
Determine proper route of administration of
drug
Products stability including the proper
packaging material
Innovations
R & D : Research and Development

Scopes of Pharmacy
Industrial Pharmacy
Production
Conversion of raw materials to finished
products
Supervises the operation, CGMP must be
observed, planning for production
RAW
MATERIALS

PRODUCTION
PROCEDURE

FINISHED
PRODUCTS

B.
Highperformance
Double
rotarytabletpres
s. The Korsch
PharmapressR has a
maximum output of 1
million tablets
per hour, but for
continuous operation, it
is generally run to
produce 600,000 to
800,000 tablets per
hour. (Courtesy of
Korsch Tableting)

Scopes of Pharmacy
Industrial Pharmacy
Production
Conversion of raw materials to finished
products
Supervises the operation, CGMP must be
observed, planning for production
RAW
MATERIALS

PRODUCTION
PROCEDURE

FINISHED
PRODUCTS

Scopes of Pharmacy
Industrial Pharmacy
Quality Control
Qualitative/quantitative checks of RM,
intermediate and finished products
Tests are performed on products
Assay det the % purity of active
ingredient

Scopes of Pharmacy
Industrial pharmacy
Drug distribution or Marketing
Detailmen
contact prescribers regarding companys
products
Explain product in detail

Industrial Pharmacy

Drug establishment
manufactures, imports, repacks,
distributes pharmaceuticals
Drug manufacturers
With manufacturing facilities, engaged
Propagatiin production operations
on and
processin
g

sale

compoundin
g

Storage/distr
ibution

finishin
g

labellin
g

filling

Packing /
repackin
g

Industrial Pharmacy
Drug Trader
Registered owner of drug product
Procures the RM and packaging components
Provides production monograph, QC
standard, procedures
Subcontracts a manufacturing lab
Ex: Wyeth (Robitussin) manuf. By Interphil
Pediatrica (Dolan) - Unilab
Bristol-Myers Squibb (Tempra) Mead
Johnson
Biomedis (Biogesic) - Unilab

Industrial Pharmacy
Drug Distributor/ Importer
Imports RM, active ing, finished
product for its own use or for
wholesale distribution
Vitacolor, MDLD

Drug Distributor/ Exporter


Exports RM, active ing, finished
product to other country

Industrial Pharmacy
Drug Distributor/ Wholesale
Procures RM, active ing, finished product from
local establishment for local distribution on
whole sale basis
Zuellig Pharma, Metrodrug, Marsman &
Co.,Dyna

Small manufacturers under FIDA ( Fil. Drug


Ass) & CFDM ( Chamber of Fil. Drug Manuf)
Marginal manufacturing facilities
Serve only generic drug placed by DOH
Drugmakers, AM Europharma

Industrial Pharmacy
Federated Phar. Industry of Phil
(FPIP)
Composed of CFDM, Phil Phar
manufacturers Ass., Drug Ass of
Phil
Solve the common problems of
industry
Direct dialogue with govt agencies

Before

After
physician

physician

Rx

interaction

R
X

pharmacist
patient
dispensing

patient
pharmacis
t

DUR

COMPOUNDING and DISPENSING


COMPOUNDING
Definisi: - Compounding
- Manufacturing
Guidelines to Distinguish between Manufacturing & Comp.
Compounding Facility and Equipment
(Personel,Duties,Qualifications,Attire)
Ingredient Standards
The Compounding Process
Step in the Compounding Process
Continuous Quality Improvement
Packaging, Storage, and Labeling
Quality Control
Stability, Expiration, and Beyond- Use Dating
Records and Reports
Patient Counseling

COMPOUNDING
Definition:
Is the act of preparing, mixing, assembling,
packaging, and/or labeling of a drug or
device as the result of a practitioners
prescription drug order or initiative based on
the practitioner-patient-pharmacist
relatioship in the course of professional
practice, or for the purpose of, or as an
incident to, research, teaching, or chemical
analysis and not for sale or dispensing.
Compounding also includes the preparation of
drugs or devices in anticipation of prescription
drug orders based on routine, regularly
observed prescribing patterns.

Manufacturing is the production,


preparation, propagation, conversion,
and/or processing of a drug or device, either
directly or indirectly, through the extraction
from substances of natural origin or
independently through means of chemical
or biological synthesis, and the term
includes any packaging or repackaging of
the substance(s) or labeling or relabeling
of its container and the promotion and
marketing of such drugs or devices.
Manufacturing also includes the
preparation and promotion of
commercially available product from bulk
compounds for resale by pharmacies,

GUIDELINES to DISTINGUISH between


Manufacturing and Compounding
1.Pharmacists may compound
2.Pharmacists may compound nonprescription
3.Pharmacists
4.Pharmacists
5.Compounding pharmacies/pharmacists

Compounding Facility and Equipment


Personnel
Duties
Qualifications
Attire
Ingredient Standards

The Compounding Process


Steps in the Compounding Process
Steps in the Compounding Process
1.Preparatory
2.Compounding
3.Final Check
4.Sign Off
5.Clean Up

A number of different preparations and expand


on their compounding using the following
subheadings:
1. Use of the product
2. Is it safe and suitable for the
intended purpose?
3. Calculation of formula for preparation
4. Method of preparation
a. Solubility where applicable
b. Vehicle/diluent
c. Preservative
d. Flavouring when appropriate

5. Choice of container
6. Labelling considerations
a. Title
b. Quantitative particulars
c. Product-specifi c cautions (or additional labelling
requirements)
d. Directions to patient interpretation of Latin abbreviations
where necessary
e. Recommended British National Formulary cautions when
suitable
f. Discard date
g. Sample label (you can assume that the name and address
of the
pharmacy and the words Keep out of the reach of children
are
pre-printed on the label)
7. Advice to patient

Storage and labelling requirements


Storage
All products dispensed extemporaneously require some
form of additional storage instructions to be detailed on the
label. This information can be the addition of just a product
expiry date through to a number of important additional
auxiliary labels.
The summary list given in Table 1.1 is to be used as a guide
in the absence of any guidance from the offi cial
pharmaceutical texts. It should be remembered that the
information in this table is to be used only as a guide. Any
information on additional labelling or expiry dates in the offi
cial texts will supersede the information provided in Table
1.1.
All suggested expiry dates included in Table 1.1 and other
sections of this book are to be used as a guide only and are
based on historical practice.
General principles

Nowadays it is common practice to assign a


maximum of a 2-week discard to any
extemporaneously prepared product.
Consideration should always be given to
assigning a shorter discard date.

The label of a pharmaceutical product has many


functions:
To indicate clearly the contents of the container
To indicate clearly to patients how and when the medicinal product should be
taken or used
To indicate clearly to patients how the product should be stored and for how
long
To indicate clearly to patients any warnings or cautions of which they need to
be madeaware.
Table 1.1 A guide to auxiliary labels and discard dates for extemporaneous
preparations.
Preparation Container Important auxiliary labels Suggested
discard date
Applications Amber fl uted For external use only 4 weeks
bottle with CRC
Capsules Amber tablet bottle See BNF for advisory labels 3 months
with CRC recommended for active
ingredient
Creams Amber

General principles of labelling


Every extemporaneously prepared preparation
will require a label to be produced before the
product can be dispensed or sold to the patient.
The accuracy of the label is paramount as it
conveys essential information to the patient on
the use of the preparation.
Although the pharmacist or other healthcare
practitioner may counsel patients when the
medication is handed over, it is unlikely that
patients will be able to remember all the
information that they are given verbally.
The label therefore acts as a permanent reminder
of the key points that patients need to know.

Table 1.1 A guide to auxiliary labels and discard dates


for extemporaneous preparations.
Preparation Container Important auxiliary labels
Suggested

discard date
Applications Amber fluted For external use only
4
weeks

bottle with CRC


Capsules Amber tablet bottle See BNF for advisory
labels 3
months
with CRC recommended for active ingredient
Creams Amber glass jar or For external use only 4
weeks
and Gels collapsible metal tube

Dusting Plastic jar preferably For external use only 3 months


Powders with a perforated, Not to be applied
reclosable lid to open wounds or
raw weeping surfaces
Store in a dry place
Ear Drops Hexagonal amber For external use only 4 weeks
fl uted glass bottle
with a rubber teat
and dropper closure
Elixirs Plain amber medicine 4 weeks
bottle with CRC
Emulsions Plain amber medicine Shake the bottle 4 weeks
bottle with CRC
Enemas Amber fl uted bottle For rectal use only* 4 weeks
with CRC Warm to body temperature
before use
Gargles and Amber fl uted bottle Not to be taken* 4 weeks
Mouthwashes with CRC Do not swallow in large
amounts
Inhalations Amber fl uted bottle Not to be taken* 4 weeks
with CRC Shake the bottle
Linctuses Plain amber medicine 4 weeks
bottle with CRC
Liniments Amber fl uted bottle For external use only 4 weeks
and Lotions with CRC Shake the bottle
Avoid broken skin
Mixtures and Plain amber medicine Shake the bottle 4 weeks
Suspensions bottle with CRC
Nasal Drops Hexagonal amber Not to be taken* 4 weeks
fl uted glass bottle with
a rubber teat and
dropper closure
Ointments Amber glass jar For external use only 3 months
Pastes Amber glass jar For external use only 3 months
Pessaries Wrapped in foil and For vaginal use only* 3 months
packed in an amber
glass jar
Powders Wrapped in powder Store in a dry place 3 months
(individual) papers and packed in Dissolve or mix with
a cardboard carton water before taking
See BNF for advisory
labels recommended
for active ingredient
Suppositories Wrapped in foil and For rectal use only* 3 months
packed in an amber See BNF for advisory
glass jar labels recommended
for active ingredient
BNF British National Formulary; CRC Child Resistant Closure
* See General principles of labelling below
Preparation Container Important auxiliary labels Suggested
discard date
Pharmaceutical Compounding and Dispensing

Dusting Plastic jar preferably For external use only 3 months


Powders with a perforated, Not to be applied
reclosable lid to open wounds or
raw weeping surfaces
Store in a dry place
Ear Drops Hexagonal amber For external use only 4 weeks
fl uted glass bottle
with a rubber teat
and dropper closure
Elixirs Plain amber medicine 4 weeks
bottle with CRC
Emulsions Plain amber medicine Shake the bottle 4 weeks
bottle with CRC
Enemas Amber fl uted bottle For rectal use only* 4 weeks
with CRC Warm to body temperature
before use
Gargles and Amber fl uted bottle Not to be taken* 4 weeks
Mouthwashes with CRC Do not swallow in large
amounts
Inhalations Amber fl uted bottle Not to be taken* 4 weeks
with CRC Shake the bottle
Linctuses Plain amber medicine 4 weeks
bottle with CRC
Liniments Amber fl uted bottle For external use only 4 weeks
and Lotions with CRC Shake the bottle
Avoid broken skin
Mixtures and Plain amber medicine Shake the bottle 4 weeks
Suspensions bottle with CRC
Nasal Drops Hexagonal amber Not to be taken* 4 weeks
fl uted glass bottle with
a rubber teat and
dropper closure
Ointments Amber glass jar For external use only 3 months
Pastes Amber glass jar For external use only 3 months
Pessaries Wrapped in foil and For vaginal use only* 3 months
packed in an amber
glass jar
Powders Wrapped in powder Store in a dry place 3 months
(individual) papers and packed in Dissolve or mix with
a cardboard carton water before taking
See BNF for advisory
labels recommended
for active ingredient
Suppositories Wrapped in foil and For rectal use only* 3 months
packed in an amber See BNF for advisory
glass jar labels recommended
for active ingredient
BNF British National Formulary; CRC Child Resistant Closure
* See General principles of labelling below
Preparation Container Important auxiliary labels Suggested
discard date
Pharmaceutical Compounding and Dispensing

Appearance
Correct position
Medicine bottles: The label should be on the front of a
medicine bottle about a third of the way down the container.
The front of an internal bottle is the curved side and the front
of a fl uted bottle is the plain side.
Cartons: The label should be placed on the large side of the
carton. If there is not enough room on a single side of the
carton for the entire label, it should be placed around the
carton, ensuring that all the information is visible.
Ointment jars: The label should be placed on the side of the
jar, ensuring that the contents of the label are visible when the
top is placed on the jar.
Ensure that the patient can open the container without
destroying the label (e.g. when labelling cartons).
Ensure the label is positioned with care and is straight, not
crooked.
Clean
Ensure the container is clean before packing the product, then
clean the outside before affi xing the label. Never pour any
liquids into a pre-labelled container as this risks spoiling the
label with drips of the medicament.
Secure
Ensure that the label is secure before dispensing the product to
the patient. The main reason for labels not sticking to product
containers is because of a dirty or greasy container.

Information
Legible
Always check label print size and quality to ensure that it can
be read clearly. If there is too much information to place on
one label, consider placing the additional information on a
secondary label, rather than reducing the size of the print or
trying to include too much information on one label.
Concise
Although it is important that suffi cient information is placed
on the label, it must be remembered that it is important not to
confuse the patient by placing too much information on the
label. If the label contains too much information, rather than
assisting patients, they may feel overwhelmed and as a result
they may read none of the information.
Adequate
Ensure that suffi cient information is given. For example, the
term when required raises the questions how much? How
often? When required for what?
Intelligible
The wording of the information on the label must be in plain
English, be easily understandable and use unambiguous
terms. It must always be remembered that patients may feel
embarrassed to ask for further clarifi cation on the meaning of
complicated words used on the label.
Accurate
It is important that the title is accurate, the instructions are
accurate and that the patient name is complete and accurate.

Remember, the label of a pharmaceutical product must


be
in the right place and contain the right information. The
following need to be taken into consideration:
-Appearance
-Correct position
-Clean
-Secure
-Information
-Legible
-Concise
-Adequate
-Intelligible
-Accurate

Dispensed type labels


In the UK, detailed requirements for labelling of medicinal products are contained in the Medicines Act
1968 and in amendments to that Act made by Statutory Instrument. The legislation distinguishes
between labelling of a medicinal product for sale and labelling for a dispensed product when lesser
requirements apply.
1. All labels for dispensed medicines must have the name of the patient preferably the full name, not
just initials and if possible the title of the patient (Mr, Mrs, Miss, Master, Ms etc.) as this helps to
distinguish between family members. The date and the name and address of the pharmacy are also
legally required.
This will normally automatically appear on most computer labelling systems with the date being reset
automatically. The words Keep out of the reach of children are also legally required, but most labels
used for dispensing purposes are already pre-printed with these words. Remember, the label of a
pharmaceutical product must be in the right place and contain the right information. The following
need to be taken into consideration:
2. All labels must state the name of the product dispensed, the strength where appropriate, and the
quantity dispensed.
3a. Products for internal use The title of an extemporaneous preparation should be given if it is an offi
cial product (i.e. one with an accepted formula that can be found in an offi cial text). The title should be
as quoted in the offi cial text (for example, Ammonia and Ipecacuanha Mixture BP). If it is an unoffi
cial product (that is, a product made from an individual formula, for example, a doctors own formula) it
may be labelled The Mixture or The Solution etc. Unoffi cial products must state the full quantitative
particulars on the label (i.e. the formula must be stated on the label). For preparations
intended for internal use, this is expressed as the amount of ingredient per unit dose.
For example, the quantitative particulars for a Sodium Chloride BP solution 4% with a dose of 10 ml bd
could be labelled as:
The Solution
Each 10 ml dose contains:
Sodium Chloride BP 400 mg
Freshly boiled and cooled purifi ed water to 10 ml
3b. Products

The Prescription
The use of Latin as the language of the prescription
has four outstanding advantages :
1. Latin is a dead language, therefore the meaning
of its words is not subject to continual change as
is the case with a language in everyday use.
2.Latin is a the language of medical science
throughout the world
3.The latin names of drugs are definite and do not
lend themselves to misinterpretation as do
colloquial or vernacular names
4.Oftentimes it is desirable that the nature and
ingredients of a mixture remain unknown to a
patient, and Latin affords a certain amount of
secrecy.

I.Parts of a Prescription
Name of the Patient
Superscription
Inscription
Subscription
Signatura
Name of the Prescriber

II.Receiving the Prescription


Consulting the Physician
III.Checking the Prescription
Legibility
Dose
IV. Labeling the Product
V.Checking the Product
VI.Pricing the Prescription
VII.Ownership of the Prescription
VIII.Information to Be Placed upon the
Prescription
IX.Filing the Prescription


POSOLOGY
Posology( dari Greek, posos = how much, and logos=
science , berhubungan dengan dosis ).
Fakator-faktor yang mempengaruhi penentuan doses :
1.Age
2.kondisi pasien
3.the severity of the
desease
4.Genetic makeup
5.Acquired tolerance
6.Idiosyncracy
7.Route of administration
8.Rate of elimination
9.Drug interactions
10.Formuation(Cooper and Gunns Disp.for
Pharm.Studnts).

Dose Frequency
Pharmacopoeial doses (e.g. Aspirin 0.3
to 1 g) represent the average range of
quantities suitable for adults when
administered by mouth)
PAEDIATRIC DOSAGE
1.UMUR
a.Youngs RULE
Age in Years/(Age in years + 12) =
proportion of adult dose,
Contoh, for a child of 6
6/(6+12)= 1/3 dari doses dewasa.

b.Dillings Rule
Age in years/20= proportion of adult dose
Contoh, a child of 6
6/20= 3/10 of adult dose
c.Cowlings Rule
(Umur anak dalam tahun + 1)/24= dari dosis dewasa
Misal anak umur 3 tahun=(3+1)/24= 1/6 dari doses dws.
d. Frieds and Clarks Formulas
Romus dosis obat ini digunakan pada anak usia kurang dari satu
tahun
2.BERAT BADAN
Misal, Dosis kloramfenikol untuk anak 25 50 mg per kg body
weight, daily in divided doses.
Bila tertulis 30 mg per kg BB anak dengan Berat 4 stones 12 lb,
1 stone 6,5 kg( 4x6,5=26); 1 lb6,5/14 kg
4 stones 12 = 26 +(12x6,5/14)= 31,571 kg x 30 mg=947,14 mg

(Ansel) , Faktor-faktor yang


mempengaruhi dosis obat:
1.Umur
2.Berat badan
3.Luas Permukaa Tubuh
4.Jenis kelamin
5.Status patologi
6.Toleransi
7.Terapi dengan Obat yang diberikan
bersamaan
8.Waktu Pemakain
9.Bentuk sediaan dan Cara pemakaian

3. Surface Area ( Luas permukaan


badan)
Catzels Rule ,
Surface area of child x 100/Surface area
of adult= percentage(%) of adult dose.

Product : I. Steril
II. Non-Steril
Equipment and Facility
Facility
1.design
2.Construction
Equipment:
1.Bahan dasar
2.Peralatan : a.kalibrasi
b. Qualifikasi
Supplier : A. Bahan baku
B. Peralatan

Pengobatan Rasional
Medication Error
Dispensing Error