Generic Med8cine

Let's start with a story. What a drug first comes to Market in the United States. Parent company,
can sell it exclusively under a brand name for a certain number of years, this length of time
depends, how many years are left on the drugs patent and the type of exclusivity, granted at the
time of approval by the FDA, when the patent or exclusivity Runs Out. Other manufacturers, can
begin making a generic. The generic product is sometimes cheaper than the brand name
version. This is probably why some generic products get a bad rap. There's this pervasive
missed Section. The generic things are generally not as good as the brand because they're
cheaper. While this may be true about those weird store brand Fruit Loops with no bird on the
box, the same logic can't really be applied to generic drugs. Here's one before a company can
manufacture and Market generic drug in the United States it must submit an abbreviated you A
and D A to the Say this application includes data providing the generic product is closed
pharmaceutically, equivalent and bioequivalent to the Branded product pharmaceutical
equivalents the same drug compound as the innovator drug as well as having the same
strength, same route of administration and the same dosage Twitchy bioequivalence. The
generic product must have the same effect as the brand drug meeting that the compound has
the same action in the body in the same amount of time, but make no mistake.

Because the brand and our by which women and pharmaceutically equivalent does, not mean
that they are the same in every way. That's because of excipient. Acceptance of the inactive
ingredients in a drug product or the stuff that's not the active drug molecule. Let's say it took a
10 milligram tablet, popular allergy medication. If you weigh the tablet on the scale, it will
definitely be heavier than 10 milligrams. Mmm, that's because 10 milligrams is really tiny. It
would be nearly impossible to make the drug tablets so small, let alone expect someone to take
it. For example, of quarter, teaspoon of table salt. Ways, like 1500 milligrams. 10 milligrams is
like, less than ten grains of kosher salt. Some drugs use less than a milligram of active
ingredient in there for drug manufacturers. Will use approved compounds, like lactose starch
and microcrystalline. Cellulose has died luton's to bulk up tablets.

Other excipient. Smite help, tablets disintegrate in the digestive tract or provide flavoring and
coloring. The list goes on and get a little overwhelming. When you start including dosage forms
like inhalers, patches, creams, and ointments generic and brand drugs will always have the
same active ingredients, but the recipients may vary. One of the other may have slightly more or
fewer types of an active ingredients and coloring agents. Usually also difference, the products
can distinguish themselves even though the entire Her ingredient list. May not be exactly the
same between brand and generic. The generic manufacturer must still prove the FDA product is
entirely bioequivalent. If not that an adjustment to the excipient, may be warranted in the late
1960s, an outbreak of intoxication occurred in Australia. Among patients, taking an
anticonvulsant drug phenytoin in 87 percent of patients experiencing toxicity, drug levels,
measured in the blood were well beyond the therapeutic range, putting them at risk of side.

Many patients have changed safety and some even experienced vomiting double vision. And
other abnormalities in mental function, the good news is that the majority of people return to
normal. Once their dose was lowered by were patients that have been stable. Anticonvulsant
medication, all of a sudden experiencing toxicity, you guessed it excipients after evaluating the
phenytoin, capsules investigators discovered that in 1967 one manufacturer had changed its
diluted or bulking agent from calcium. Food dehydrator, lactose the lactose formulation allowed
the phenytoin to dissolve more readily from the capsule into higher concentrations in the blood.
Thus some patients began to experience toxic side effects While others that were previously
getting little benefit from the phenytoin their seizures under control for the first time. This
incident shows that excipients aren't inured and justifies why it's so critical that brand and
generic drugs. Be both pharmaceutically and bioequivalent today.

The FDA and other regulatory bodies around. The globe are really strict about. The on
approving generic forms of drugs willy-nilly in addition to being pharmaceutically equivalent and
bioequivalent, generic drugs must have the same strength identity Purity and quality as the
Branded product, so the FDA regulates things no surprises there. But why should we take their
word for it to the research? A 2008 meta-analysis published in Jama? The clinical effectiveness
of generic and brand name, cardiovascular drugs, the study included 38, randomized, controlled
Trials of nine different subclasses.

These medications bioequivalence was seen in all studies of beta-blockers antiplatelet Agents
statins, ACE inhibitors alpha blockers, any arithmetic agents and Warfarin it was seen in 10 of
11 randomized, controlled Trials of diuretics and 71% of calcium channel blockers. So, not
perfect. But these differences were minor and did not impact clinical outcomes overall. The
aggregate effect of the meta analysis indicated that there were no significant differences
between Brandon and Janelle. Like drugs, the same study also, examined editorials. And
commentaries discussing the interchangeability of brand and generic cardiovascular, drugs. A43
editorials more than half expressed in negative view of generic drugs. Let's look deeper some
drugs have, what's known as a narrow? Therapeutic index. Meaning that the drug is only
effective within a very small dosage range to little in the drug will have no effect too much and
the drug can cause harm one. Such drug is the blood thinner Coumadin.

Also known by its generic name. Warfarin, not everyone responds to warfarin in the same way
so those taking it have their blood monitored regularly so that are appropriate dose adjustments
can be made. Because of this Physicians and pharmacists are hesitant to Interchange the
brand, the generic versions of committed and drugs like it. But what did the data say? A review
article published in 2011, in the Journal of pharmacotherapy examined, five randomized,
controlled trials and six observational studies, comparing outcomes when switching patients
from cool. Going into generic Warfarin, the observational study suggested that those switching
between brand and generic should be monitored more closely. So perhaps there's a reason to
be more cautious about switching between brand and generic. Warfarin in the randomized,
controlled trials though. There were no significant differences. Reported at all. No studies
showed that the Branded drugs were more effective than the generic similar results were seen
in systematic reviews of antiepileptic drugs. Even though National regulatory bodies require a
mountain of data Pulling bioequivalence and independent Studies. Have shown that generics
are just as effective. As innovator drugs, there's still this lingering perception. Among some
practitioners that generic drugs aren't as good. A survey of 506 Physicians. The United States
revealed that as many as 23 percent had negative opinions on the efficacy of generic drugs and
those over the age of 55 were more than three times as likely to believe that. I don't know
survey looked at both Physicians and pharmacists, while 11.8 percent of doctors Leave the
generic drugs were less effective than the brand product, only 2.3 percent of Pharmacists
shared this opinion. Why? Here's what? Rachel thought? Pharmacist spend a lot of time in
school learning about the chemical nature of drugs, and how excipient, work and Drug products,
perhaps resulting, in a higher degree of confidence in a well-formulated generic, conversely
physicians, may be more likely to hear first-hand accounts of patients, being unhappy with the
generic, making them less likely to prescribe it in the future. Ignoring this has consequences, the
2014 study compared adherence to standards,

Therapies in patients that were started on, either the brand or generic drug, a significantly
higher number of patients started on generics were compliant with their medication regimen and
those taking generics had an 8% reduction in hospitalization for acute coronary syndrome, or
stroke, why Christian? Eric's cost less and people are more likely to stick to stuff. That's not as
expensive for them. This matters chemical compound is a chemical compound and as long as
bioequivalence is assured, And generic drugs should give the same results? There may be.
Good reason to be cautious when switching back and forth between different formulations of
certain narrow therapeutic index drugs. But for the vast majority, of small molecular drugs,
there's no difference. Don't get hung up on the labels. Healthcare triage is supported in part by
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