Generic Substitution

By: Binu Thapa

• Generic substitution is the term applied to the substitution of a
prescribed branded drug by a different form of the same active
substance.
• The generic is usually unbranded; it is often a parallel imported
product, which is regarded as ‘essentially similar’ by the EU
Commission.
• Generic substitution becomes possible when the patent life of the
active substance has expired.
 • Generic prescribing is the prescribing of a drug by a
physician using the generic name. This leaves the choice of
brand to the dispensing pharmacist. A generic substitution
is a pharmacist-initiated act by which a different brand or
an unbranded drug 0 product is dispensed instead of a
drug brand that was prescribed by the physician.
 What is Generic substitution?
• When a new drug is discovered, the company that discovered it would apply for patency to prevent other companies
from producing and selling the drug. This patency may take up to 20 years and during this period, the company will
produce and sell the drug under a brand name to recover its investment and make a profit. With time, this name
becomes synonymous with the drug. But after the patency expires, other companies are allowed to produce a similar
drug. It is what gave rise to brand and generic names in drugs.
• Examples of brand name and generic drugs can be cited with the following diabetes and hypertension drugs.
Metformin is a generic drug for diabetes, but its brand name is Glucophage. Similarly, Metoprolol is a generic drug
for hypertension but its brand name is Lopressor. These drugs will be known by different names in different
countries, but the generic name remains constant.
What is the difference between brand name and
generic drugs?
• The difference between brand name and generic drugs is in the circumstances of producing the drugs. While brand
name drug refers to the name giving by the producing company, generic drug refers to a drug produced after the
active ingredient of the brand name drug. Generic drugs will, however, be sold under different brand names, but will
contain the same active ingredients as the brand-name drug. But with regards to the effectiveness of the drugs,
generic drugs have the same quality active ingredient as brand name drugs.
• All drugs must comply with strict directive and supervision of the Food and Drug Administration (FDA) in the US
and equivalent institutions in other countries.
• For branding purposes, generic drugs are not exactly the same in look, color, tastes and shape as the brand name
drugs and must have its unique brand name.
• These areas of differences are noticeable between brand name and generic drugs and among generic drugs as well. It
means you will get different drugs names with the same active ingredients, and this active ingredient is what refers to
the generic drug.
 • How brand name and generics drugs differ?
• · Different inactive ingredients: In a brand name and generic drugs relationship, the difference is the inactive
ingredient contained in the drugs. Since what the FDA is particular about is the active ingredients, generic and brand
name drugs’ inactive ingredients are different. It is why it is important to look through the ingredient list on the drug
label to see if there is any ingredient not good for you.
• · Cheaper than the brand name drugs: the cash price and insurance co-pay is typically lower. The cost can be lesser
between 20 and 80 percent. It is meant to be because generic drugs companies do not bear the same investment costs
as the brand name company.
• · Different manufacturers: Different manufacturers produce generic drugs, and you will receive your type of drug
depending on which manufacturer your drug store uses.
 • Why do generic drugs are different in colors and flavors?
• Trade laws forbid generic drugs to look exactly like the brand-name drugs but must all have the same active
ingredients for the same medicinal effects. These differences often come from non-active ingredients used such as the
dyes, fillers, and preservatives, which help to determine the size, shape and color.
• This is the reason why patients are advised to follow doctor’s prescription because your doctor is able to match your
history and some inactive ingredients in a particular generic drug that may cause adverse reaction in your body,
whereas the branded or some other generic version of the same drug might not.
 • How to know you are getting the right drug at the pharmacy?
• If your prescription is for a brand name, but your doctor permits generic substitution, the drug label will indicate the
active ingredient. So despite differences between brand name and generic drugs, active ingredients are the same,
effectively. However, talking to your doctor before filling your drug list will guarantee you are getting the right drug.
You are not to assume a drug is the same just by looking; it takes an understanding of active ingredient composition
to decide.
 • Generic drugs are cheaper than brand name drugs; will this not affect the quality of the drugs?
•If you are concerned that generic drugs are cheaper and may affect the quality, you are not alone. But it won’t, that is
the truth! The food and drug administration (FDA) works to make generic drugs as safe and effective as brand name
drugs. Imagine the world without enough and affordable essential drugs. It is why generic drugs are allowed to make
more drugs available and affordable to people who need them.
• Generic drugs are cheaper since the costs of production do not include the cost of development and marketing for
the brand name drugs. Usually, new drugs expenses will include the cost of research, patency, development,
marketing, and promotion. But none of these costs are involved in generic drugs. It is why the law allows the brand
name company to recoup its investment before allowing generic drug manufacturers to produce and sell the same
drug.
• In a way, the reason generic drugs are allowed is to bring down cost and make drugs available to more people at
affordable prices.
 • How do I know it’s the same drug?
• The law requires drug manufacturers to list active and inactive ingredients of a drug on its label. While drugs may
have different brand names, the generic name describes the active ingredient of the drug and this is a way to identify
the type of drug. The same active ingredient will have different brand names in different countries. The law also
demands that all active drugs must have the same active content and quality. However, you should talk to your doctor
or pharmacists if in doubt.
• Effectiveness of Generic Drugs
• Generic drugs are identical to their brand-name comparison drugs in terms of active
ingredients, but their inactive ingredients can vary. Inactive ingredients do not affect
the chemical activity of a drug and are added during manufacturing for stability and
preservation purposes or to achieve a certain consistency, form, color, or taste. Generic
drugs are approved by the US Food and Drug Administration based on testing
demonstrating the drugs’ safety, purity, and effectiveness. This means that a generic
drug is interchangeable with a brand-name drug. A study that compared a group of
generic heart medications with their brand-name counterparts found no evidence that
brand-name drugs were superior to generic drugs
 Advantages and Disadvantages

• The most significant advantage of using generic drugs is the cost, which can be up to 85% less
than that of a brand-name drug. Lower-cost generic drugs have been shown to increase the
likelihood that patients take essential medications prescribed by their doctors and to improve
patients’ health outcomes. If you are using a brand-name drug, ask your doctor whether a
generic form of that same medication—or a generic form of another medication in the same
class—is available. A disadvantage of generic drugs is that their appearance may change if the
manufacturer supplying your pharmacy changes, although variations in appearance should not
affect the effectiveness or safety of the drug. Some people report new or different symptoms
when they switch from a brand-name drug to a generic form or from a generic drug to another
generic drug. Although such experiences may not be related to the generic drug, you should
consult with your doctor to discuss any symptoms.