Professional Documents
Culture Documents
FARMASIS
IR-II
Pharmacists
Expert on drugs
Responsible for
dispensing/compounding of
medicines
Control of drugs use
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
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 )
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.
chemists,
biologists,
molecular biologists,
pharmacologists,
toxicologists,
statisticians,
physicians,
pharmacists and pharmaceutical
scientists, engineers,
and many others participate in drug
discovery and development.
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
Community pharmacy
Industrial Pharmacy
Hospital Pharmacy
Clinical Pharmacy
Drug Wholesaling
Education
Research
Pharmaceutical Journalism
Oraganization Management
Medical Communications
Pharmacist in Government Service
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
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
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
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
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.
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
discard date
Applications Amber fluted For external use only
4
weeks
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.
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
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
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