Drug Manufacturers, Monographs, and Package Inserts Flashcards
What are National Drug Code (NDC) numbers?
unique 11-character codes that numerically identify medications.
How are the NDC numbers identified and what do they stand for?
The first five digits identify the manufacturer,
the next four digits identify the product (dosage form and strength),
and the last two digits identify the package type or size (such as 50 or 60 tablets).
NDC numbers are required only for prescription medicines but what else an they also be used for?
ome companies provide NDC numbers for products sold over the counter (OTC), such as aspirin, Tylenol, and so on.
What exactly are the NCD numbers used for?
The NDC numbers are used to process claims for payment from insurance companies and are used in computer software to select the product you’re dispensing. Since the NDC number is unique for every manufacturer, it can be used to choose the exact product you need. The number is especially useful when filling prescriptions with generic products. It prevents confusing generic and brand-name products.
Drug Nomenclature :
Most drugs are referred to by several names: (4)
- Generic
- Chemical
- Brand
- Popular Generic name.
What is Chemical name?
This is usually a very long name of the chemical composition of the drug. It can be found in the package insert. It isn’t often used in the dispensing process, but it’s important to the FDA and the offices that register the patent on the drug. It’s also important to chemists and other scientists working in the field of pharmaceuticals.
What is Brand name?
This is also called the trade name. This is the name given to the drug by the owners and sellers of the drug. The name is designed to be recognized easily. Examples of brand names are Tylenol, Lunesta, Lipitor, and Allegra.
What is Popular name?
There are many drugs that are referred to by a popular name. It’s usually nothing more than an abbreviated version of the generic or chemical name. For example, the cancer-treating drug whose generic name is etoposide and whose brand name is VePesid is often referred to by its popular name, VP-16, the name researchers used in its development. For safety reasons, the proper way to express the name of a medication in the pharmacy and medical literature is by the generic name.
what is a drug patent?
A chemical patent, pharmaceutical patent or drug patent is a patent for an invention in the chemical or pharmaceuticals industry. The concept of a patent in the drug industry is very important to continued production and discovery of new products.
Read how drug patents work :
Manufacturers spend a portion of income on research. The goal of the research is to produce new medications to be sold while there’s no competition. A patent is assigned to a product when it’s first discovered. The time from discovery to marketing may be up to 10 years. In the United States, the life of a patent is 17 years. The patent allows the manufacturer to produce and market its product exclusively, without competition, until the patent expires. Once the patent expires, other manufacturers can submit a request to the FDA for approval of an equivalent product. This product is called a generic equivalent, or an equal product. When a brand-name product has approved generic equivalents, competition drives the prices down. The result is less expensive drugs for the consumer.
What are Biologics ?
are medicinal products from natural sources and include a growing range of products that include vaccines and blood components.
Who regulates the pharmaceutical industry?
- Food and Drug Administration (FDA)
Pharmaceutical manufacturers have _______ protection after discovering a new drug.
Patent
True or False? The National Drug Code (NDC) is a series of 10 digits that identify the
manufacturer, product, and package size
False
True or False? NDC numbers are unique for every prescription product.
Ture
True or False? Generic products have exclusive marketing rights.
False
What is a drug monograph?
A drug monograph is a concise collection of information about a given drug that’s required by the Food and Drug Administration (FDA) to describe the characteristics of the drug.
what is a package insert?
A package insert is a copy of a drug monograph that accompanies the drug in its package when distributed for sale and use. Each time you open a new drug package for dispensing in the pharmacy, you’ll see the package insert for that drug. If the medicine is packaged in a box or plastic container, the package insert is folded and placed inside the box. If the medicine is available as pills or liquid in a bottle, the insert is affixed with some type of adhesive to the outside of the bottle.
Once the monograph is folded and placed into the drug package, it then becomes known as the package insert.
How many types of package inserts are there what what are they.
Types of Package Inserts
**Currently, two distinct types of package inserts can be found in the pharmacy. **
The package inserts and monographs format got updated by the FDA in January, 2006. Anything before that was not required to be revised. **The order in which information is presented is one of the areas that was changed with the revised package insert format. **
name -
This section at the beginning of the monograph lists the brand and generic names of the drug described.
Boxed Warning
This section contains material that warns of serious injury and even death when the drug is used in certain situations. Note that not all drug monographs contain a boxed warning.
Description
This section describes the chemical nature of the drug.
Clinical Pharmacology
This section describes the basic nature of how the drug works in the body and how the drug is taken up by the tissues and excreted.
This section describes the basic nature of how the drug works in the body and how the drug is taken up by the tissues and excreted.
This section describes the basic nature of how the drug works in the body and how the drug is taken up by the tissues and excreted.
Indications and Usage.
This section describes the medical conditions for which the drug is used.
Contraindications.
This section describes the medical conditions and patients for which the drug absolutely can’t be used.
warnings
This section warns about certain serious effects that have occurred in patients using the drug. It warns against using the drug in similar conditions.
Precautions.
This section describes situations and patients for which the drug should be used with caution.
Adverse Reactions.
This section lists the adverse reactions that were observed and reported during the clinical testing trials of the drug prior to FDA approval.
Overdosage
This section describes the results of and possible fatalities due to an overdose of the drug.
Dosage and Administration.
This section lists the dose and the duration of dosing for the drug in specific medical conditions.
How Supplied.
This section describes the available dose forms, the available strengths of the drug, and a physical description of each dose form.
What are some categories that are not required by the FDA to be on monographs and package inserts?
Sections that aren’t required by FDA: animal pharmacology and/or animal toxicology, clinical studies, and references
Highlights of Prescribing Information.
This introductory section of the revised package insert presents a succinct summary of the information that’s most crucial for a drug’s safe and effective use, with cross-references to more details in the full prescribing information. The Highlights section must be no more than 1/2 page in length.
