Transcript Document

Original Drugs (Antibiotics)
Vs
Generic Drugs (Antibiotics)
What we need to know ??
Dr Ankur Gupta, MD (Pharmacology)
Medical Advisor, MSD Pharmaceuticals
India- The Home for generic Drugs
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> 100 Ciprofloxacins
> 125 Piperacillin-Tazobactams
> 50 Meropenems
Do we need so many ?
Do we know them all ?
What is a Branded (Original) Drug ?
The original drug for which
production and marketing are
made possible for the innovator
WHO Drug Info 2000
What is a generic drug
A copy of an original drug for which
production and marketing are made
possible by the expiry of the patent
covering the innovator product
WHO drug Int 2000
Quality is the key……..
“ In the manufacture of generic drugs, the three concepts
of quality, safety and efficacy apply to generic in the
same way as they do to the innovator product..”
“ It is a fallacy to believe that quality production and
assurance can be achieved at no great investment !!!”
WHO Drug Infor. 2000
Components of Branded Drug Cost
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Brand vs. Generic
– Brand
Sources of Brand Name Drug Costs
Sources
of Brand
Distribution,
Name Drug
Other Costs
Production,
Quality Control
26%
2%
Administration
11%
High drug prices due to
Research &
Development costs and
Production & Quality
Assurance Costs
R&D
22%
Marketing
39%
Original Drugs:
Expensive to Develop, Easy to Copy
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An average of 14 years and 800
million dollars is spent on each
discovery that reaches the public
A copy can be produced in 1 year
for less than $1 million
Tufts Center for the Study of Drug Development. 2001.
Potential difference between
Generic and Branded Drugs
WHO drug information 2000 14(2)
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77- 81
Quality of Raw material used (Raw materials can be
more than 50% of the industrial cost of a generic drug.
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Pricing pressure may cause manufacturer to target lower quality raw material
in order to offer competitive pricing. )
Method Of Synthesis
(There is a risk of toxicity from
degradation products or impurities in the event that the method of synthesis
has been changed)
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Packaging , Stability, Evaluation ( Plastic in packing
may chemically interact with drug, especially under conditions of high humidity
or heat (tropical countries) Toxic phenomena can result from the stability
modifications of the product
GENERIC DRUGS
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There are 4 main aspects to be considered
– Are generics safe?
– Is their quality as good as that of corresponding brand?
– Is doctor wise in switching branded to a generic drug?
– Are generics as effective as Innovator drugs?
Are generics safe?
Is their quality as good as that branded drug?
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The answer to this questions is Probably “YES”
…….”But only if you live in a country with
strict regulatory control of medicines…”
Is doctor wise in switching from
branded to a generic drug?
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The answer to this question is less clear cut
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Some doctors are reluctant to switch from a branded drug,
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However, doctors will be under pressure not to exceed
their budget for prescription drugs and pharmacist will be
under pressure to substitute a generic for a brand
Are generics as effective as newer,
medically innovated, more costly drugs?
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Most difficult question to answer but most important from
patient perspective
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This is where there is a conflict between the best medicine and saving
money arises
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Innovative drugs are not cheap
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They are a result of costly research and development with high risks of
product failure before it can be proven to be safe and effective
Use a Generic, But Only If……
FDA requirements for generic drugs (www.fda.gov/cder/ogd)
Thus, a generic drugs must:
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contain the same active ingredients as the innovator drug
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be identical in strength, dosage form, and route of administration
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have the same use indications
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be bio-equivalent
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meet the same batch requirements for strength, purity and quality
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be manufactured under the same strict standards of GMP required
for innovator products.
Original Parenteral Antibiotics Vs Generics.
Possible implications in critical care ?
Particulate Matter
Contamination (PMC)
Particles, degradation products, residual
solvent and mineral contamination all pose
potential threats to patient safety.
Where does the
Contamination arise from?
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1.Manufacturing process
2.Transport and storage
3. Filling process
4.Clinical dispensing process
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microscopic glass particles when glass ampoule is
broken
- particulate rubber or plastic from septum or
syringe
Particulate Matter - Matters !!!
Particulate Contamination
Microcirculation
Dysfunction
Kidneys
Particles < 2µm
•Glass
•Latex
•Polymers
Microcirculation
Disturbances
Liver
Pancreas
Lungs
MODS
Multiple Organ
Dysfunction
Syndrome
ARDS
Adult Respiratory
Distress Syndrome
MOF
Multiple Organ
Failure
DEATH
Membrane Filter Method
1 g cefotaxime sodium vials
Membrane Filter Method
1 g cefotaxime sodium vials
New Investigations
CARBAPENEMS
Study Summary
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Study design: Double-blind
Original Zienam, India compared with
13 Imipenem/Cilastatin Products from
China,Indien,Taiwan and Thailand
7 Meropenem Products from
China,India and Taiwan
Filter 14
Filter 24
Filter 19
Filter 26
Filter 37
Filter 41
Filter 40
Filter 43
Link Between Number of Generics and
antibiotic Resistance ???
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Overuse of 3rd Gen cephalosprorind linked to ESBL
production ( ESBL rate in India between 50-70%)
Overuse of Flouroquinolones and Carbapenems
leads to MDR pseudomonas and acinetobacter
infections ( MDR rate in India around 20-30%)
Overuse of Vancomycin leads to VRE and VRSA
Recommendations
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More Regulatory Control and Tighten the Guidelines
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Choice of brand should be with the prescriber and not with
administration or pharmacist
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Original Research should be strongly driven.
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In critical care, for IV antibiotics, Original drugs should be
preferred
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Over the counter sale of IV antibiotics should be restricted
Thankyou