GENERIC DISPENSING
RA 66 75 : GENERIC ACT OF 1988
promotes, requires, ensures the production
of adequate supply, distribution, use and
acceptance of drugs and medicines
identified by their generic names.
Generic name
The following agencies are responsible in the
promotion of generic names for pharmaceutical
products
DOH – inform the public
Govt agencies/ personnel- transactions
Medical/ dental/ vet. Practitioners- generic prescribing
Manufacturing companies – generic labelling
Drug outlets – generic dispensing
Generic Dispensing
flowchart (OTC)
Generic Dispensing
flowchart (Rx)
Use of Generic Terms lessens the chance
of error in dispensing
Ceporex vs Leponex
Diatabs vs Dia-tabs
Diamicron vs Dormicum
RA 9502
Cheaper Medicine Act of 2008
The concept of Interchangeability
Drug products with same generic names
are interchangeable
Factors to consider
interchangeability among drug
products
Manufacturers: Are they CGMP
compliant?
Raw materials, machines, processes used,
lighting, packaging
Source of medicines
India, US, Europe
Prices (dictates perception of quality)
Clinical trials – high cost, checks
bioavailability, ADR
Pharmaceutical Equivalent
Same generic name
Same molar amount
Same dosage form
Same active ingredient
Same route of administration
Pharmaceutical alternative
Same generic name
Different dosage form
Different chemical form/ salt
Therapeutic equivalent
Eitherthe drug product is pharmaceutical
equivalent or alternative but of same
effect or indication
Having the same effect is checked by:
Post marketing surveillance, clinical trials,
same bioavailability
Ex: Leading Rifampicin products are not
Bioavailable, causing multiple resistance to TB
patient
What are interchangeable
pharmaceutical products?
Theproducts which are therapeutically
equivalent to a comparator
Product Types
Originator brand
Developed by patent holder/ company, protected
for 20 yrs from any competition
Ex. Betaloc - Metoprolol
Pseudo – generic
Lostits patent, no protection from competition
Types a. branded generic
b. unbranded ( Ritemed Metoprolol)
Copy
Productswith trade and generic names
Non-bioequivalent, may not be
therapeutically equivalent
Made by other companies
Many products in the Phil are just COPIES
Violation of generic
prescribing
Violative
Generic name is not written
Generic name is not legible, while brand
name is legibly written
The brand name is indicated, “ no
substitution” is indicated
Erroneous
Brand name precedes the generic name
Generic name is in the parenthesis
Brand name is not in the parenthesis
When more than two drug products are
prescribed per Rx form
Impossible
When only the generic name is written but
not legible
When generic name does not match the
brand name
Both generic name/ brand name are not
legible
When the drug product is not registered
with BFAD
EXERCISE12
INFORMATION BASIC TO
DISPENSING DRUGS
Generic name
Drug category
Serve as reference to therapeutic action of drug
Provide generic implications, precautions, ADR
Tetracycline – Doxycycline
Precaution:
CI:
ADR:
DI:
Dosage / route – to prevent medication
error, toxicity, necessary for attainment
of desired effect
Doxycycline (Vibramycin)
100 mg tab bid for 7 days – for gonococcal
infection
Action
How the drug will produce therapeutic
effect
MOA: inhibits 30s ribosome of bacteria
inhibits protein synthesis
inhibits cell wall formation, cell lysis
Indication
Approved clinical use
Tetracycline
Acne – 50-100 mg od for 2 weeks
Gonorrhea – 100 mg bid for 7 days
Syphilis – 300 mg od for 10 days
Side effects
Transient, non therapeutic reaction to the
drug
Normally troublesome, not very dangerous
Codeine- constipation
Antihistamine - sedation
Adverse effect
Harmful non therapeutic reaction to drug
which may require discontinuation of drug
use
Tetracycline
Enamel hypoplasia, GI disturbances, rashes,
hypersensitivity
Contraindication
Condition in which the use of drug outweighs
the beneficial effect
Tetracycline : CI to pregnant and children 8 yrs
old and below
Precaution
Special care in the sue of drug to be exercised by
patient
Tetracycline : not to be taken with antacids, Fe ,
Al, Ca
Protected from light
Pregnancy categories
Category A
No risk to fetus based on controlled studies
in women
Ergocalciferol PO ---- Cat. D if dose > US RDA
Folic acid PO ----Cat. C if dose> 0.8 g / day
Category B
No adverse effect in animal, but no
controlled human studies
Paracetamol , acetylcysteine, cefalexin
Category C
There is adverse effect in animals, calculated risk
to human fetus, no human studies
Aspirin PO, salbutamol PO,inhalation, parenteral
Category D
Fetalrisk exist
Alcohol, aspirin ( full dose at 3rd trimester)
Category X
Absolute fetal abnormalities
CI to both pregnant or unpregnant patient
Alcohol in large amt, alprostadil parenteral
Statins PO, coumarin
How products may be
applied ?
Powder
Sprinkle on gloved hands and apply
Use sparingly to prevent caking
Lotion, cream, ointment- pat lightly with gloved
hands
For injection
Rub skin with alcohol in circular motion from center to
out
Eardrops
Adult – pull ear back and up
Child – pull ear back and down
