Post on 18-Nov-2014
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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 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
Product Types
Originator brand Developed by patent holder/ company,
protected for 20 yrs from any competitionEx. 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
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 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
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