original drugs (antibiotics) vs generic drugs (antibiotics) what we need to know ?? dr ankur gupta,...
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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
> 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
Brand vs. Generic
– Brand
High drug prices due
to Research &
Development costs
and Production &
Quality Assurance
Costs
Production,Quality Control
26%
Distribution,Other
2% Administration11%
R & D22%
Marketing39%
Sources of Brand Name Drug Costs
Original Drugs: Expensive to Develop, Easy to Copy
• 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
Quality of Raw material used (Raw materials
can be more than 50% of the industrial cost of a generic drug. 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)
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
WHO drug information 2000 14(2) 77- 81
GENERIC DRUGS
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?
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?
The answer to this question is less clear cut
Some doctors are reluctant to switch from a branded
drug,
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? Most difficult question to answer but most important
from patient perspective
This is where there is a conflict between the best medicine and
saving money arises
Innovative drugs are not cheap
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:
contain the same active ingredients as the innovator drug
be identical in strength, dosage form, and route of
administration
have the same use indications
be bio-equivalent
meet the same batch requirements for strength, purity
and quality
be manufactured under the same strict standards of GMP
required for innovator products.
Original Parenteral Antibiotics Vs Original Parenteral Antibiotics Vs
GenericsGenerics. . Possible implications in Possible implications in
critical care ?critical care ?
Particles, degradation products, residual Particles, degradation products, residual solvent and mineral contamination all solvent and mineral contamination all pose potential threats to patient safety.pose potential threats to patient safety.
Particulate Matter Particulate Matter Contamination Contamination (PMC)(PMC)
Where does the Where does the Contamination arise Contamination arise from?from? 1.Manufacturing process 2.Transport and storage 3. Filling process 4.Clinical dispensing process
- - microscopic glass particles when glass microscopic glass particles when glass ampoule is brokenampoule is broken
- particulate rubber or plastic from septum or - particulate rubber or plastic from septum or syringesyringe
Particulate Matter - Particulate Matter - Matters !!!Matters !!!
ARDSAdult Respiratory Distress Syndrome
MOFMultiple Organ
Failure
Particulate Contamination
Microcirculation
DysfunctionMicrocirculationDisturbances
MODSMultiple Organ
Dysfunction Syndrome
Particles < 2µm
•Glass•Latex•Polymers
Kidneys
Liver
PancreasLungs
DEATH
1 g cefotaxime sodium vials
Membrane Filter Method
Membrane Filter Method
1 g cefotaxime sodium vials
New InvestigationsNew Investigations
CARBAPENEMS
Study SummaryStudy Summary
StudyStudy designdesign: Double-blind: Double-blind
OriginalOriginal Zienam Zienam, India compared , India compared with 13 with 13 Imipenem/CilastatinImipenem/Cilastatin Products from China,Indien,Taiwan Products from China,Indien,Taiwan and Thailandand Thailand
7 Meropenem Products from 7 Meropenem Products from China,India and TaiwanChina,India and Taiwan
Filter 14 Filter 19
Filter 24 Filter 26
Filter 37 Filter 40
Filter 41 Filter 43
Link Between Number of Generics and antibiotic Resistance ???
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
RecommendationsRecommendations
More More Regulatory Control and Regulatory Control and TightenTighten the Guidelines the Guidelines
• Choice of brand should be with the prescriber and not with administration or pharmacist
• Original Research should be strongly driven.
• In critical care, for IV antibiotics, Original drugs should be preferred
• Over the counter sale of IV antibiotics should be restricted
Thankyou