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PLEASE, PLEASE,
PLEASE- If you aren't taking your medicine the way the doctor ordered (or at
all) because you can't afford to- TELL US---- there are things we can do.
FDA's position
on drug substitution
This states that a generic drug is the same if it's bioequivalence is ANYWHERE from
80 - 125% of the original drug!
Sample drug calculation: 4 pills
each 200mg in the morning 4 pills 200mg at night
Non-generic drug
4 pills each 200mg in the
morning 4 pills 200mg at night gives
1600 mg
Generic A- Could be
(85% strength) 4 pills each 200mg +
4 pills at night gives strength of
1360 mg
Generic B-
Could be (125% strength)
4 pills each 200mg + 4 pills at night gives strength of
2000 mg
The
AARP White Paper on Generics ...... According
to the FDA, a generic drug is a “chemical clone” that has the same active
ingredients as its FDA-approved brand name counterpart. The FDA asserts that virtually all
generic drugs can be expected to have the same therapeutic effect as their brand-name
counterparts. Generic drugs need not be
exactly identical to brand-name drugs because FDA allows them to differ in shape,
scoring configuration (i.e., presence or absence of indentations in the pills), release
mechanisms, packaging, inactive ingredients (such as colors, flavors, preservatives),
expiration date/time, minor aspects of labeling (e.g., the presence of specific
pharmacokinetic information), and storage conditions.
And the Epilepsy Foundation's statement:
STATEMENT ON SUBSTITUTION OF
GENERIC ANTI-EPILEPTIC DRUGS
The Epilepsy Foundation of America (EFA) is seriously concerned about mandatory
substitution of generic anti-epileptic drugs without prior approval of the patient and
treating physician. Generic formulations of a number of widely used anti-epileptic drugs
(i.e. carbamazepine, phenytoin, primidone, and valproic acid) have recently become
available and present the opportunity to reduce costs. Some states and some institutions
(including prepaid health plans) have mandated that the pharmacist fill a prescription
with the least expensive available drug. There may be significant differences between the
characteristics of brand name and generic anti-epileptic medications, as well as among
generic anti-epileptic drugs. A generic product may be approved as equivalent to a brand
name product even if it produces varying bioavailability in some individuals.
The FDA guidelines allow for a therapeutic range that is too broad to ensure that each
individual will receive the same amount of anti-epileptic drug when switching from a brand
name to a generic anti-epileptic drug or from one generic to another. The fact that these
differences may exist could result in adverse effects, including loss of seizure control
and the development of toxic side effects. Changing from one formulation of the drug to
another can usually be accomplished, and risk minimized, if physicians and patients
monitor blood levels, seizures and toxicity.
EFA therefore strongly advised that all rule-making bodies -- including those at the
Federal and state level, as well as prepaid medical plans, institutions, such as
hospitals, correctional facilities, residential facilities and others who make decisions
about the availability of certain medications -- (be made aware of) address the potential
adverse effects of
changing from one formulation of an anti-epileptic drug to another, by requiring (without)
the prior expressed permission of the treating physician and (the agreement of) the
patient.
Approved by the Board of Directors June, 1996.-Last
updated 6/22/2001 |
There are several ways to reduce your drug costs WITHOUT going overseas.
- Membership in the Epilepsy Foundation of America (EFA) gives you access to
reduced price brand name drugs through the AARP Pharmacy Service. This is a mail order
service. You can receive information about how this service works by phoning the EFA
National Office at 1-800-332-1000.
- Many drug companies have a PATIENT ASSISTANT PROGRAM where you can apply to
recive their medications for a low or NO cost to you basis.
- We have found one of the best sites to find out which companies offer what plan
is: NeedyMeds which has
information on over 1300 items.
There are also discount plans available in many areas, sponsored BY the
drug companies themselves. Most if not all of these are FREE.
Here are links designed to help patients find government supported and
other pharmaceutical industry patient assistant program for which you may qualify:
If you click on the above and go to either of these sites, use your
"back" browser button to return here.
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