Generic Dispensing


Transcript of Generic Dispensing

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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

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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

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Generic Dispensing flowchart (OTC)

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Generic Dispensing flowchart (Rx)

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Use of Generic Terms lessens the chance of error in dispensing Ceporex vs Leponex

Diatabs vs Dia-tabs

Diamicron vs Dormicum

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RA 9502

Cheaper Medicine Act of 2008 The concept of Interchangeability Drug products with same generic names

are interchangeable

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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

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Pharmaceutical Equivalent Same generic name Same molar amount Same dosage form Same active ingredient Same route of administration

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Pharmaceutical alternative Same generic name Different dosage form Different chemical form/ salt

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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

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What are interchangeable pharmaceutical products? The products which are therapeutically

equivalent to a comparator

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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


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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

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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

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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

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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

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Generic name Drug category

Serve as reference to therapeutic action of drug

Provide generic implications, precautions, ADR Tetracycline – Doxycycline

Precaution: CI: ADR: DI:

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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

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Action How the drug will produce therapeutic

effect MOA: inhibits 30s ribosome of bacteria

inhibits protein synthesis inhibits cell wall formation, cell


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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

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Side effects Transient, non therapeutic reaction to the

drug Normally troublesome, not very dangerous Codeine- constipation Antihistamine - sedation

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Adverse effect Harmful non therapeutic reaction to drug

which may require discontinuation of drug use

Tetracycline Enamel hypoplasia, GI disturbances, rashes,


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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

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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

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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)

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Category X Absolute fetal abnormalities CI to both pregnant or unpregnant patient Alcohol in large amt, alprostadil parenteral Statins PO, coumarin

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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

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Eardrops Adult – pull ear back and up Child – pull ear back and down