Generics Vs Brand Generics Vs Brand Name AED’sName AED’s

20122012

What is a generic?What is a generic?

Generic drugs are copies of brand-name Generic drugs are copies of brand-name drugs that drugs that have exactly the same dosagehave exactly the same dosage, , intended use, effects, intended use, effects, side effects, route of , route of administration, risks, safety, and strength administration, risks, safety, and strength as the original drug. In other words, their as the original drug. In other words, their pharmacological effects are exactly the pharmacological effects are exactly the same as those of their brand-name same as those of their brand-name counterparts counterparts

Source: Medicinenet.comSource: Medicinenet.com

So there's no truth in the myths that generic So there's no truth in the myths that generic drugs are manufactured in poorer-quality drugs are manufactured in poorer-quality facilities or are facilities or are inferior in quality to brand-name drugs.

The FDA applies the same standards for all drug The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacturing facilities, and many companies manufacture both brand-name and generic manufacture both brand-name and generic drugs. drugs.

The FDA estimates that 50% of generic drug The FDA estimates that 50% of generic drug production is by brand-name companies production is by brand-name companies

Generic Vs Brand Generic Vs Brand

Brand Name GenericBrand Name Generic

Tylenol AcetaminophenTylenol Acetaminophen

Valium DiazepamValium Diazepam

Dilantin PhenytoinDilantin Phenytoin

Topamax TopirmateTopamax Topirmate

Basic requirements for the approval Basic requirements for the approval of a generic drugof a generic drug

Bioequivalence standardBioequivalence standard

90% Confidence interval90% Confidence interval

Single dose studies in healthy volunteersSingle dose studies in healthy volunteers

Typical N 20-30Typical N 20-30

??

Generic drugs may have different dissolution Generic drugs may have different dissolution characteristicscharacteristics

FDA: true but this is an in vivo test that does FDA: true but this is an in vivo test that does not correlate with performance?not correlate with performance?

??

Generics drugs are not tested in children Generics drugs are not tested in children and elderly?and elderly?

FDA: true, but if it works in adults, it should FDA: true, but if it works in adults, it should work in other populationswork in other populations

??

Generic drugs can be associated with Generic drugs can be associated with breakthrough sz and increased side breakthrough sz and increased side effects?effects?

FDA: all of the support for this claims arise FDA: all of the support for this claims arise from patients and physician reports from patients and physician reports (anecdotes or surveys)(anecdotes or surveys)

??

Brand MedBrand Med

----0--------0---- ----0--------0---- ----0--------0----

85 100 12585 100 125

The ProblemThe Problem

Professionals and patient advocacy Professionals and patient advocacy groups do not trust genericsgroups do not trust generics

Regulatory agencies (FDA) consider that Regulatory agencies (FDA) consider that existing rules are adequate.existing rules are adequate.

The ProblemThe Problem

Why are they both wrong?Why are they both wrong?

Neither has provided a scientific proof of its Neither has provided a scientific proof of its pointspoints

Both sides are susceptible to influence Both sides are susceptible to influence through “lobbying or political pressures or through “lobbying or political pressures or financial incentives. financial incentives.

Why are regulatory agencies wrongWhy are regulatory agencies wrong

Regulatory agencies established universal Regulatory agencies established universal bioequivalence rules and never provided bioequivalence rules and never provided scientific evidence that they are safe for diff scientific evidence that they are safe for diff diseases or populations.diseases or populations.

Epilepsy is different, if BP goes from 125/85 to Epilepsy is different, if BP goes from 125/85 to 135/95 until next check up the consequences 135/95 until next check up the consequences are negligible. are negligible.

A sz after a long period of sz freedom may have A sz after a long period of sz freedom may have mayor consequencesmayor consequences

Why are regulatory agencies wrongWhy are regulatory agencies wrongThe 80% 125% bioequivalence role has real The 80% 125% bioequivalence role has real

problemsproblemsGeneric AGeneric A 125% x3 months (optimal dose at 125% x3 months (optimal dose at

1500mg) is getting 2000mg +.1500mg) is getting 2000mg +.Generic X 80%Generic X 80% 1500 x 0.64= 960 mg. 1500 x 0.64= 960 mg.This sudden change by a pharmacist is consider This sudden change by a pharmacist is consider ““Safe lawful and ethical practiceSafe lawful and ethical practice””

This same change by a MD would never be This same change by a MD would never be considered safe…considered safe…

Why are regulatory agencies wrongWhy are regulatory agencies wrong

Multiple preparations expose the patient to a Multiple preparations expose the patient to a large number of excipients or colorants, large number of excipients or colorants, increasing the risk of an adverse reaction.increasing the risk of an adverse reaction.

Why are MD and patients advocacy Why are MD and patients advocacy groups wrong?groups wrong?

The report of patients experiencing significant The report of patients experiencing significant problems with the substitution are all anecdotal.problems with the substitution are all anecdotal.

If 1 anecdote has no scientific value 100 or If 1 anecdote has no scientific value 100 or 1.000.000 have no value.1.000.000 have no value.

The reporting is heavily biasedThe reporting is heavily biasedSurveys are close to meaninglessSurveys are close to meaningless

ConclusionsConclusions

-Is there a reason for concern regarding -Is there a reason for concern regarding current generic regulations? current generic regulations? YESYES

-Is the problem with -Is the problem with

brand to generic subs; NO/yesbrand to generic subs; NO/yes

generic to gen generic to gen YESYES

-Is the problem exaggerated and are the -Is the problem exaggerated and are the opinions biased due to financial interest opinions biased due to financial interest YESYES

How can MD deal with the How can MD deal with the dilemma?dilemma?

-Track what ptes get from the pharmacy, ask -Track what ptes get from the pharmacy, ask pte to bring the bottle,pte to bring the bottle,

-Educate consumers, other MD’s and -Educate consumers, other MD’s and pharmacists.pharmacists.

Keep patients on the same formulation, either Keep patients on the same formulation, either Brand or generic (same if possible) Brand or generic (same if possible)

How can MD deal with the How can MD deal with the dilemma?dilemma?

New patient, discuss pros and cons.

Select ptes that should not be substitutedSelect ptes that should not be substituted

-Sz free-Sz free

-Hx of status.-Hx of status.