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