Drug Name or ‘Drug Nomenclature’
Drugs are known by either their chemical, generic, or brand name. Understanding the differences between these names can be frustrating to consumers and practitioners alike who are not familiar with pharmacology.
The general process of assigning a name to a drug from the time of its discovery to its’ entry into the market place is illustrated in the diagram to the right. This is a very simplistic overview and the reader should appreciate the rigorous regulatory processes that are involved.
Generic Name
The generic name of a drug is a simple name or is sometimes described as a shorthand version of the drug’s chemical name, structure, or formula. The generic name of a drug reflects the official chemical name and structure of the drug.
In the example below the generic name diazepam is much simpler and easier to use that the official chemical name of the same compound.
Brand Name
When a drug is developed, researched, tested and produced for sale in the marketplace by a drug manufacturing company the generic formulation is assigned a ‘brand name’ or ‘Trade name’. The brand name is the registered trademark ® for a generic drug by a drug manufacturer.
For example, the generic drug acetaminophen is more commonly know by the brand name Tylenol. The generic drug ibuprofen is also known under brand names such as Advil, Motrin, and Brufen.
Why do manual therapists need to know the differences between generic and brand name preparations?
You will no doubt encounter clients who have changed their medication either from the brand named drug to the generic version or from the generic version to the brand name version. If it is a prescribed change, more than likely, the client is observed and monitored by the attending physician to ensure safety and effectiveness of the medication. If however a client voluntary changed their medication by obtaining a prescription from another doctor, or by ordering it over the internet, and this change was not professionally monitored, because of the medication switch the client may experience signs of adverse reactions.
The Food and Drug Administration defines a generic drug as:
‘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’. To obtain FDA approval a generic drug must meet the following requirements:
· contain the same active ingredients as the innovator drug (inactive ingredients may vary)
· be identical in strength, dosage form, and route of administration
· have the same use and indications
· be bioequivalent
· meet the same batch requirements for identity, strength, purity, and quality
· be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products
Although generic preparations meet the official requirements, concerns about their therapeutic effectiveness and tolerability sometimes do arise when compared to their ‘brand name’ counterparts.
All drug preparations consists of an ‘active ingredient’ and ‘excipients’ Excipients have specific properties such as improving the stability of the drug, increasing the shelf life of the preparation, assisting with the dissolution of the preparation and controlling the rate of release of the product.
Depending on the quality of the ingredients used including the excipients, the stability, dissolution, rate of release etc. of the drug can be altered, and this in turn can have an effect on the therapeutic profile of the drug.
A serious effect of this medication switch is that the client may experience variations in therapeutic effectiveness. While this point is somewhat controversial it can be life threatening depending on the client’s condition; for example, if the client had epilepsy and decided to switch versions of their medication without the appropriate medical supervision.
Massage practitioners are encourage to be alert to such medication changes by their clients, and inquire if it is medically supervised and about adverse reactions or side effects experienced since the change.
