How Do Pharmaceutical Companies Get Their Drug Names?

According to the Institute of Medicine, over 1.5 million Americans get sick, injured, or killed by errors in dispensing, prescribing, and taking medications every year. A study in the British Medical Journal found that about 251,000 Americans die every year because of medical errors, such as drug name and dose mixups.

Overview of Drug Naming

A branded prescription drug has three names.

1. Chemical Name: the pharmaceutical company gives the new drug this name. The organization follows the rules set by the International Union of Pure and Applied Chemistry. Chemical names describe the molecular structure of drugs. Users often struggle with these names as they are too complex for most people. Researchers reference the medication using shorthand versions of the drug's chemical name or use a code name.
2. Generic Name: once approved by the FDA, the drug gets a generic name. The United States Adopted Name (USAN) Council assigns this name for medications marketed in America. The organization clears the name via the International Nonproprietary Name Program run by the WHO.
3. Brand Name: the pharmaceutical company proposes this name to the FDA to own the drug. The organization can market off-patent drugs using either their brand names or generic names. Companies that file for permission to sell an off-patent drug use the same generic name, but they can develop their brand name. This ability causes a generic drug to have many brand names.

Drug Naming Prioritizes Safety

Pharmaceutical companies need to clear various hurdles to get permission to market their drugs under various names.

FDA's Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research scrutinize every proposed name. Each department rejects 20–35% of the proposed names. Companies submit two names to allow the departments to consider the second option if they reject the first one.

Reviewing the drug names is crucial to avoid mistakes, such as drug prescriptions or drug names confusions. According to the British Medical Journal study, medical error is the third leading killer of Americans after cancer and heart disease. Avoiding LASAs — lookalikes and sound-alikes — can reduce the fatalities of medical errors.

Research shows that computerized prescriptions do not reduce errors caused by illegible handwriting. Lookalikes cause mistakes when the prescriber chooses a similar drug name by accident.

Doctors often use the brand name of a drug because it is easier to remember. Drugs with generic names may be less expensive than those with brand names. They are of the same quality and efficacy as brand-name drugs.

How Pharmaceutical Companies Find Proposals for Drug Names

Pharmaceutical companies follow a unique process to get name proposals for their drugs. Most of them start by playing the numbers game. They create 2,000–5,000 names. Having many options is vital, as drug naming is not straightforward. The company needs to ensure that its proposal does not match any existing drug name. If their suggestion matches any existing drug, the relevant bodies will reject them.

Pharmaceutical companies eliminate most of these choices. They remain with about ten options that make it to the last selection stage. The ultimate naming picks two alternatives that the organization submits to the relevant bodies for screening and approval.

Large pharmaceutical companies have contingency plans in case the bodies reject their proposals. Other organizations follow the criteria they believe the FDA uses to scrutinize their names, such as pronouncing the names to see if they sound similar to existing drug names.

Summary

Naming drugs is a complex process. Drugs often have three names. Pharmaceutical companies submit proposals to relevant bodies to get permission for the generic names of their drugs. Coming up with these proposals is challenging.

Stakeholders ensure every drug has unique names to avoid errors caused by lookalikes and sound-alikes. Knowing the drug naming system avoids prescriptions and drug names confusions that can be fatal