GENERIC SUBSTITUTION 101

Are active ingredients in generic and brand-name drugs the same?

A generic drug must come in the same strength (e.g., milligram strength of tablets or capsules, concentration of liquid) and dosage form (e.g., capsule, suspension, tablet) as the brand-name drug. Plus, the active ingredient in the generic is exactly the same as the active ingredient in the brand-name drug. In the U.S., generics only get approved by the FDA if they show that their average rate and extent of drug absorption into the body is within the statistical range of 80% to 125% of the brand product. This is referred to as bioequivalence. If drug levels vary by more than 10%, the product will likely fail the required studies. In reality, most gener -name drugs by much more than 3% to 4%.

pharmaceutical equivalence

medications that have the same active ingredients, same dosage form, same route of administration, same strength

A list of DAW codes and their meaning

0 = No product selection indicated 1 = Substitution not allowed by prescriber 2 = Substitution allowed-patient requested product dispensed 3 = Substitution allowed-pharmacist selected product dispensed 4 = Substitution allowed-generic drug not in stock 5 = Substitution allowed-brand drug dispensed as generic 6 = Override 7 = Substitution not allowed-brand drug mandated by law 8 = Substitution allowed-generic drug not available in marketplace 9 = Other

bioequivalence

A characteristic of two drugs in which all pharmacological and physiological effects are identical

What is an authorized generic?

An authorized generic is the actual brand-name drug product that has been relabeled and marketed as a generic drug. An authorized generic may be marketed by the same company that makes the brand-name drug or by its subsidiary. The brand-name drug company can also license the product to another company for marketing in return for royalties. Usually done to compete with generics.

What about "biosimilar"drugs and substitution?

Biosimilars are not a different approval process. They do still need to show that there are NO clinically meaningful differences in safety, effectiveness, purity, and potency compared to the original biologic. Biosimilars can only be substituted if FDA approves them to be 'interchangeable'. To prove interchangeability a manufactuer must perform studies showing the same clinical result as the original brand. FDA s Purple Book Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. In many cases, depending the state, biosimilar can't be substituted without involving the pharmacist and/or prescriber.

True/False: It is costly for generic drug manufacturers to get a generic drug to market due to clinical trials proving clinical outcomes.

False In the U.S., generic drug manufacturers must submit an abbreviated new drug application (ANDA) to FDA for approval. This doesn't require costly clinical trials, that were required for approval of the brand-name drugs, to be repeated.

True/False: A generic must have the exact same active ingredients in the same form as the brand name to be equivalent.

True True/False: A generic must have the exact same active ingredients in the same form as the brand name to be equivalent.

What steps are needed in the dispensing process when patients switch from a brand to a generic or from one generic to another?

o Select the correct drug product in the pharmacy computer. o Include brand and generic names on the prescription label when possible. o Use auxiliary labels to indicate that a different product is being dispensed

True/False: The generic name and the brand name should never both be on a prescription label. This causes confusion.

False Include brand and generic names on the prescription label when possible. Including the generic and brand name of the drug on the Rx label can help prevent patient confusion when dispensing generics. Generally, when a generic is dispensed, only the generic name is actually required. Some states may require both generic and brand names on the label when the brand-name drug is dispensed. Other states may require specific language when substituting a generic drug for a brand-name drug.

True/False: You should not tell the patient that you are dispensing a new generic and the color of the tablet is different. You should wait until the patient asks about it, then explain.

False Let patients know verbally or in writing when a switch is made from a brand-name drug to a generic. The same goes for when there is a switch from one generic to another generic made by a different manufacturer. Auxiliary labels can also help with getting this information across.

True/False: Generic drugs are usually available within 5 years after the brand name is marketed.

False Once a new drug is approved, the FDA provides a guaranteed period during which a generic version cannot be approved, regardless of the time remaining on the new drug's patent. This regulatory exclusivity typically runs for at least six years for new drugs. Patents usually last about 20 years after the drug is first identified. When this time period is up, the patent expires and generic versions of the brand-name drug can come to market. The first generic to come to market generally gets six months of exclusivity.

True/False: On average, prescriptions for generic drugs cost about 95% less than prescriptions for their brand name counterpart.

False prescriptions for generic drugs cost about 80% to 85% less than prescriptions for their brand-name counterparts.

When is it okay for a pharmacy to substitute a generic for a brand-name drug?

In the U.S., FDA publishes a book that is used as the standard by which many states allow generic substitution. It's called the Orange Book, r more formally, Approved Drug Products with Therapeutic Equivalence Evaluations. the Orange Book contains ratings therapeutically equivalent. The Orange Book rates each generic with a code. This and it usually begins with an AB-rated, BN-rated, etc). The first designates products that have demonstrated therapeutic equivalence. The first indicates those that have not. The second letter in the Orange Book rating code can give additional information about the product, such as its dosage form. In some states ng (e.g., AB-rated, AT-rated, AP-rated, etc) in the Orange Book can be substituted. In most cases, the pharmacist can dispense either the brand or therapeutically equivalent generic, regardless of which drug product is written on the Rx. The cost of the product or insurance co-pay will likely influence what the patient receives. However, pharmacists may not substitute when prescribers specifically indicate that substitution is not allowed.

How do generic drugs come to market?

A brand-name drug is patented product and patents usually last about 20 years after the drug is first identified. The first generic to come to market generally gets six months of exclusivity. This means that no other generic for the brand-name drug can be marketed during that time period (this usually means the generic isn't cheaper). But after six months are up, other generics can be marketed and this competition causes prices to fall. In the U.S., generic drug manufacturers must submit an abbreviated new drug application (ANDA) to FDA for approval. The generic drug manufacturer has to show that their drug acts similar to the brand. But manufacturers of generics prove clinical outcomes, such as preventing a disease or decreasing a lab value. The idea is that if the generic has the same active ingredient(s), strength, dosage form, quality, purity, and stability and acts similarly, it will have the same clinical outcomes as the brand drug.

What steps are needed to dispense a brand-name drug when a generic is available?

Indicate the reason why a brand was chosen over the generic when entering a prescription order into the computer. In the U.S., this is usually done using "dispense as written" or DAW codes in the pharmacy computer system. The DAW code tells the insurance provider if there are special circumstances that affect product selection for the prescription. In most cases, you are not required to enter DAW codes with every prescription and most pharmacy computers default to DAW code 0. Don't use code 1 if the prescriber hasn't requested the brand name. Document reasons and explanations for codes 2 through 9.

How do generic drugs benefit patients?

Since generic drug manufactures don't have the same development costs as brand name drug manufacturers, generics can be sold at a lower price. This cost savings ultimately gets passed on to the patient. For example Fixed co-pays are lower because the insurance company assigns lower co-pays for generics to encourage using them over brands.

What can I tell patients who ask when their brand-name drug will be available as a generic?

Sometimes this is hard to find out, since patent laws can be complicated and legal battles over rights to produce a generic drug are not uncommon. Generally, generics are available earlier in Canada than in the U.S. We have a chart, Anticipated Availability of First-Time Generics, that can give you an idea of when generics will be available for different brand-name drugs in the U.S. Also, brand manufacturers often provide coupons and other types of co-pay assistance for their drugs. Check out our U.S. chart, Guide for Helping Patients Afford Their Medications, for more cost saving tips.

Why do generic drugs look different from the brand-name drug?

The company that makes a brand-name drug will trademark or patent the appearance of the drug. The exception to this rule is seen with "authorized generics". Generics can have different inactive ingredients (e.g., colors, fillers, flavors, etc) than the brand-name affect the amount of drug in the body, the way the drug works, or the safety of the drug. However, rarely a patient may be allergic or intolerant to a specific inactive ingredient in either a generic or brand-name drug. Having different-looking products can help lessen confusion and mix-ups between generic and brand-name products but can be confusing to patients.

How do generic drugs benefit pharmacies?

The cost of the medication for the pharmacy and the insurer goes down. Often both the pharmacy and insurance company make better profit margins off of generic drugs. Pharmacies also benefit from having less money tied up in inventory since lower drug costs mean a smaller investment.

True/False: Generic drugs cannot look exactly like the brand name drug, with one exception, authorized generics.

True

True/False: The bioequivalence between a generic and a brand name refers to the rate and extent of the drug absorption.

True Two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.

True/False: For information on interchanging biosimilar drugs, it may be helpful to refer to the DFA "Purple Book" instead of the "Orange Book"

True Unlike generic drugs, information on interchangeability with biosimilars can be found in the FDA's Purple Book Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.

True/False: An authorized generic is the actual brand-name drug product that has been relabeled and marketed as a generic drug.

True often done to compete with generics

Therapeutically equivalent

Two formulations of a drug have an equal therapeutic effect. That mean it is both bioequivalent and pharmaceutically equivalent.

Biological drugs (or biologics)

come from a natural source, and are generally of human, animal, or microbiological origin. Biologics are made of proteins, nucleic acids, and/or sugars, and may even be living things, such as cells or tissues. Biologics are much larger and more complex molecules than a traditional drug.

DAW codes

dispense-as-written or DAW codes are a nationally recognized code set that are transmitted with the pharmacy claim to the insurance provider. In most cases, you are not required to enter DAW codes with every prescription and most pharmacy computers default to DAW code 0. DAW codes may affect insurance reimbursement, audits, and co-pay determination for a prescription if a brand-name drug is dispensed when a generic is available.

authorized generic

drug produced by the brand rx company and marketed at generic prices during and after the 180 exclusivity period that is identical to brand alternative in both active and inactive ingredients

Common situations that cause confusion when looking for an acceptable generic substitute.

o Extended- and immediate-release brand and generic forms of the same drug are available. ex: Lopressor is a brand name for metoprolol tartrate, a short-acting form of metoprolol. Toprol-XL is thebrand name for metoprolol succinate, a long-acting form of the same drug, in the U.S. A prescription for metoprolo is vague. o Multiple brand and generic forms are available, but only some are equivalent. some generics are equivalent to one brand, but not another, even though both brands contain the same drug entity. o The same ingredient exists but as different salts.