1. Generics Vs Brand Name AED’s 2012

2. What is a generic? Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts side effectsside effects Source: Medicinenet.com

3.  So there's no truth in the myths that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. inferior  The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs.  The FDA estimates that 50% of generic drug production is by brand-name companies

4. Generic Vs Brand Brand Name Generic Tylenol Acetaminophen Valium Diazepam Dilantin Phenytoin Topamax Topirmate

5. Basic requirements for the approval of a generic drug Bioequivalence standard 90% Confidence interval Single dose studies in healthy volunteers Typical N 20-30

6. ? Generic drugs may have different dissolution characteristics FDA: true but this is an in vivo test that does not correlate with performance?

7. ? Generics drugs are not tested in children and elderly? FDA: true, but if it works in adults, it should work in other populations

8. ? Generic drugs can be associated with breakthrough sz and increased side effects? FDA: all of the support for this claims arise from patients and physician reports (anecdotes or surveys)

9. ? Brand Med Brand Med ----0---- ----0---- ----0---- ----0---- ----0---- ----0---- 85 100 125 85 100 125

10. The Problem  Professionals and patient advocacy groups do not trust generics  Regulatory agencies (FDA) consider that existing rules are adequate.

11. The Problem Why are they both wrong? Neither has provided a scientific proof of its points Both sides are susceptible to influence through “lobbying or political pressures or financial incentives.

12. Why are regulatory agencies wrong Regulatory agencies established universal bioequivalence rules and never provided scientific evidence that they are safe for diff diseases or populations. Epilepsy is different, if BP goes from 125/85 to 135/95 until next check up the consequences are negligible. A sz after a long period of sz freedom may have mayor consequences

13. Why are regulatory agencies wrong The 80% 125% bioequivalence role has real problems Generic A 125% x3 months (optimal dose at 1500mg) is getting 2000mg +. Generic X 80% 1500 x 0.64= 960 mg. This sudden change by a pharmacist is consider “Safe lawful and ethical practice” This same change by a MD would never be considered safe…

14. Why are regulatory agencies wrong Multiple preparations expose the patient to a large number of excipients or colorants, increasing the risk of an adverse reaction.

15. Why are MD and patients advocacy groups wrong? The report of patients experiencing significant problems with the substitution are all anecdotal. If 1 anecdote has no scientific value 100 or 1.000.000 have no value. The reporting is heavily biased Surveys are close to meaningless

16. Conclusions -Is there a reason for concern regarding current generic regulations? YES -Is the problem with brand to generic subs; NO/yes generic to gen YES generic to gen YES -Is the problem exaggerated and are the opinions biased due to financial interest YES

17. How can MD deal with the dilemma? -Track what ptes get from the pharmacy, ask pte to bring the bottle, -Educate consumers, other MD’s and pharmacists. Keep patients on the same formulation, either Brand or generic (same if possible)

18. How can MD deal with the dilemma?   New patient, discuss pros and cons.  Select ptes that should not be substituted -Sz free -Sz free -Hx of status. -Hx of status.