 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
•Patient ask for a medicine/ drug product

•Present the menu card

•Allow patient to choose,

•Dispense the drug, give necessary information, direction for
use
• Patient present Rx form
• Checking/ reading of Rx form

• Present the Menu Card

• Allow patient to choose

• Dispense , give necessary information

• Recording, keep the Rx ( used in full)
 Use of Generic Terms lessens the chance of
error in dispensing
◦ Ceporex vs Leponex

◦ Diatabs vs Dia-tabs

◦ Diamicron vs Dormicum
 Cheaper Medicine Act of 2008
 The concept of Interchangeability
 Drug products with same generic names are
interchangeable
 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
◦ Either the 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?
◦ The products which are therapeutically equivalent
to a comparator
 Originator brand
◦ Developed by patent holder/ company, protected
for 20 yrs from any competition
Ex. Betaloc - Metoprolol
 Pseudo – generic
◦ Lost its patent, no protection from competition
◦ Types a. branded generic
b. unbranded ( Ritemed Metoprolol)
 Copy
◦ Products with trade and generic names
◦ Non-bioequivalent, may not be therapeutically
equivalent
◦ Made by other companies
◦ Many products in the Phil are just COPIES
 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
 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
 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
◦ Fetal risk 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
 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