Are Generic Medications the Same?

[Guest guest]

For convenience and an apparent small price advantage, I recently switched

my prescriptions from CVS to Walgreens. I take a generic medication

(Metformin) for diabetes and a generic ace inhibitor and a generic beta

blocker for a high heart rate and high blood pressure. I've bought generics

from Canada and Mexico without noting any problems. What could go wrong?

 

 

 

As an aside, I recently d to a low cost HMO for seniors called Blue

Care 65 which reduced my medical costs although I have Medicare Parts A & B.

Blue Care provides the cost of prescriptions with a small $8 co pay. There

are many other advantages to Blue Care 65 including free diabetic supplies

from my local pharmacy rather than mail order from Medicare. Mail order

required a lot of paperwork. This does not require any.

 

 

 

I received a $40 discount on purchases by switching to Walgreen and it

seemed more convenient, is larger, well-stocked and has a drive in

prescription window. After taking my Metformin from Walgreens, I noticed

immediately than my blood glucose was higher. No other changes or

differences. When I ran out of my CVS beta blocker and ace inhibitor, I took

the prescription meds I received from Walgreen. The next day my blood

pressure and pulse rate numbers were up higher. I have two different blood

pressure machines and 3 blood glucose monitors (free supplies). I

recalibrated the glucose monitors, they check OK.

 

 

 

After several days of frequent checking, I called the pharmacy and they

assured me there could be no difference in the generics. The pharmacist

claimed theirs was better. How could that be if they are the same? I called

CVS. Same answer. Call your doctor. Doctor says there should be no

difference. Test more. Wait a few days.

 

 

 

I've worked as a chemical engineer and laboratory quality control analyst

and quality manager. I know there are differences in manufacturing standards

and processes and that the FDA does allow for certain manufacturing

differences. Generic drug manufacturers do not have to prove drug safety or

efficacy because that was already done by the original manufacturer. I did

some research and found the following within minutes:

 

 

 

(BTW: there was a slight increase in price above what I should be charged.

I'm going back to CVS.

 

 

 

 

 

Are Generic Medications the Same?

 

 

 

Generic medications can usually be purchased for a fraction of the cost of

their branded counterparts. But even generics differ in price and the

differences can be costly. Many people, especially the elderly shop around

for better deals, lower prices and convenience. Generics are assumed to be

the same. Are they?

 

 

 

.. What is a Generic Drug?

 

.. Are There Any Differences Between Different Generics?

 

.. The Bottom Line on Generic Drugs

 

 

 

WHAT IS A GENERIC DRUG?

 

 

 

The active ingredient of a 'generic' medication is chemically identical to

the active ingredient of the corresponding branded medication. Because

generic medications are often much cheaper than their branded counterparts,

very many people choose generics (whether buying discount medications online

or in traditional retail outlets), and many insurance companies actually

require that they be used.

 

 

 

According to the FDA's Office of Generic Drugs:

 

 

 

A generic drug is identical, or bioequivalent to a brand name drug in dosage

form, safety, strength, route of administration, quality, performance

characteristics and intended use. Although generic drugs are chemically

identical to their branded counterparts, they are typically sold at

substantial discounts from the branded price.

 

 

 

According to the Congressional Budget Office, generic drugs save consumers

an estimated $8 to $10 billion a year at retail pharmacies. Even more

billions are saved when hospitals use generics.

 

 

 

ARE THERE ANY DIFFERENCES BETWEEN GENERICS?

 

 

 

However, it should be noted that current regulations permit a variation of

up to 20% either way in the bioavailability of the active ingredient. (See

the Food and Drug Law Institute overview of the Hatch-Waxman Act of 1999.)

In one study (Borgheini 2003), a 31% variation was found in the blood plasma

levels of a particular medication after a patient switched from a branded to

a generic product. (Why does this happen? It may be accounted for by

differences in the manufacturing process yielding different particle sizes

that are absorbed at different rates, as well as other factors.)

 

 

 

THE BOTTOM LINE ON GENERIC DRUGS

 

 

 

This does NOT necessarily mean that switching generic medications or sources

due to cost is a bad idea -- in fact, in most cases it is probably still a

very good idea! -- but this does mean that the issue is not quite as clear

cut as it might otherwise seem.

 

 

 

In my view, provided that medications are taken under the supervision of a

qualified medical professional, and any changes are monitored, there is very

little advantage to buying branded medications if cheap generic drugs are

available. If cheaper generic exist from other sources, they should not be

overlooked. The only difficulty, of course, is that it sometimes takes many

decades before generic differences are ever noted or studied.

 

 

 

http://counsellingresource.com/medications/discount-drugs/generics.html

 

 

 

http://www.fdli.org/

 

 

 

http://www.fdli.org/pubs/Journal%20Online/54_2/art2.pdf

 

 

 

http://counsellingresource.com/bibliography/index.html#Borgheini_2003

 

 

 

 

 

FDA approval is typically based on small studies (20 to 30 people) of

bioequivalence. Applications to the FDA for approval of any therapeutic

equivalent must include evidence that, compared with the brand-name drug, it

is pharmaceutically equivalent and bioequivalent. Pharmaceutical equivalence

means that it contains the same active ingredient, requires the same dosage

and route of administration, and is of the same strength and concentration.

Bioequivalence means that it shows no significant difference from the rate

and extent of absorption of the reference drug.

 

 

 

[Tests of bioequivalence has been done primarily with male subjects. It is

now known that there are greater difference between men and women than among

men. This not acknowledged but just now being tested. There is no routine

testing to compare generics. It is not required by the FDA, only between a

generic and data on brand drugs.]

 

 

 

http://www.arhp.org/healthcareproviders/cme/onlinecme/lowdosecp/equivalent.c

fm?ID=59

 

 

 

According to bioequivalence data used to acquire FDA approval, one recently

approved generic levothyroxine preparation (Sandoz Levothyroxine Sodium) is

significantly more potent than the most widely used brand of levothyroxine

(SynthroidR). Information from bioequivalence studies submitted to the FDA

show that the new generic may be as much as one-eighth more potent (+12.5%)

than the widely prescribed branded product.

 

Furthermore, levothyroxine is a drug known to have a narrow

toxic-to-therapeutic ratio with significant clinical consequences of even

minor excessive or inadequate dosing. Potential adverse events include

symptoms, osteoporosis, atrial fibrillation, worsening of heart disease,

preterm delivery in pregnancy, impaired fetal brain development, and high

cholesterol.

 

" Unfortunately, this information confirms our concern that current FDA

standards defining the equivalence of levothyroxine products are too lax, "

said Carlos Hamilton, MD, AACE President. " Switching between two products

could compromise the effectiveness of treatment and even result in serious

side effects. "

 

http://www.thyroid.org/professionals/publications/news/04_08_11_fda_levothyr

oxine.html

 

 

 

Generic off-brands have the same active ingredients, strength and dosage as

their brand-name counterparts. " The only difference between the drugs is

that the manufacturer of the generic product does not have to prove to the

FDA that it is safe and effective, because that already has been done, " says

Dr. Pearson. " The approval process of a generic drug takes much less time,

usually within about two years from the time the company decides to

manufacture it. "

 

So should you always go generic? Not necessarily, says Dr. Pearson. Patients

often wonder whether it is dangerous to switch from a generic product if

they have been taking a name-brand product. Switching is usually safe - but

there are exceptions.

 

Some drugs, both brand-name and generic, have what is known as a " Narrow

Therapeutic Index (NTI). " That means the drug can produce toxic side effects

or loss of disease control if it is absorbed or released at even the

slightest changes in doses - whether too high or too low. Remember, there

are " parameters " for bioavailability that must be met, not an exact number.

 

This is why many pharmacists, including Dr. Pearson, are unwilling to

substitute generic products for drugs with an NTI. " Even the slightest

change can result in upsetting the patient's disease control, " he says.

" That's why I would recommend against switching for such drugs. There's a

real possibility that it might upset a patient's stability. It could be

absorbed differently; it could have fillers or dyes that change the

absorption or release of the dosage. While there may be side effects to

switching, I have no knowledge of it ever being fatal. If there is a switch,

it is essential to continually monitor the drug levels in the blood to make

sure there is a minimal risk of toxicity. "

 

Among the drugs known to have an NTI:

 

* Conjugated estrogen (Premarin), prescribed as hormone replacement

therapy for prevention of osteoporosis or heart disease risk.

 

* Phenytoin (Dilantin) and carbamazepine (Tegretol), anticonvulsants.

 

* Theophylline (Theo-dur), for asthma and lung diseases.

 

* Cyclosporine (Sandimmune or Neoral), used as an organ transplant

antirejection drug.

 

Aside from the NTI drugs, it's usually safe to go with a generic drug, which

is why some insurance companies will only pay for generic drugs or require

an explanation if a doctor or pharmacist insists on a name-brand product. " A

patient can say they do not want generic products, " says Dr. Pearson. " But

that means the insurance company will make them pay the difference in price,

and in many cases that can be a substantial amount. Insurance companies may

want the patient to pay the whole price. Then you will have to look for an

insurance company with a more reasonable co-payment plan. Patients should

keep a tight rein on what their insurance company is doing. Read the

material they send you in the mail to look for any changes in the policy. "

 

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