Trade Names and Generic Names

Question 1

chemical name

Answer 1

applied to a specific chemical structure using the nomenclature rules of the IUPAC

Question 2

nonproprietary names

Answer 2

• generic name
• common name
• meaningful shortened versions of the chemical name that are entirely in the public domain and may be used freely by anyone

Question 3

USAN Rule #1

Answer 3

A nonproprietary name should be useful primarily to healthcare professionals for the purposes of processing prescriptions, educational concerns, and the international exchange of information

Question 4

USAN Rule #2

Answer 4

The nonproprietary name should be simple and easily said, recognized, and recalled.

The name should preferably contain no more than four syllables

Question 5

USAN Rule #3

Answer 5

A name should reflect characteristics valuable to users.

A stem sould be used to communicate any relationship that a new drug may have with an existing class.

Question 6

USAN Rule #4

Answer 6

The proposed name should be free of confusing similarities with existing
nonproprietary and proprietary names.

Prefixes that imply a manufacturer’s
name, marketing claim, dosage form, or anatomical site won’t be accepted.

Question 7

USAN Rule #5

Answer 7

The USAN Council discourages the use in trademarks of substantial
portions of the USAN and established USAN stems.

Such use is an
impediment to USAN in devising new names in the same class of drug.

Question 8

proprietary name

Answer 8

• is owned by a company or individual and is used for describing its brand of a particular product.
• Proprietary names are developed as part of a company’s intellectual property portfolio
• Also called brand names or trademarks
• a distinctive proprietary name helps distinguish a drug from the field of competition and helps potential consumers recall its name

Question 9

property portfolio

Answer 9

includes patents, licenses, and copyrights.

Question 10

DMEPA

Answer 10

• FDA’s Division of Medication Error Prevention and Analysis
• Reviews new Trademarks (Proprietary Names of Drugs) for the following:
  
  • Misleading elements within the name
  • The potential for causing prescription errors
  • The possibility for confusion with other drug names
• Part of the IND application; is an early review and only a tentative approval is given
• 2nd review is done 90 days before the final new drug approval to check the name against other names that have come in since the early review

Question 11

PTO-FDA Oversight

Answer 11

FDA oversight of PTO is necessary bc

• PTO does not have access to the confidential medical and pharmaceutical information that’s available to the FDA – such as indication, dosage form, and dosing interval. This information may be portrayed in a misleading manner in the trademark, but the PTO would not properly be able to evaluate these confidential factors
• PTO registration examines similarity of a trademark to existing trademarks based on block print presentation. The FDA evaluation must also consider the clarity of physician handwriting
• PTO registration considers phonetic similarity of a name but only in relation to other trademarks. The FDA evaluates verbal similarity to both other proprietary names and common medical terms or abbreviations
• PTO doesn’t evaluate health or safety issues associated with a trademark. Health a safety issues are the primary concern of the FDA review process
• PTO doesn’t consider promotional aspects of a trademark. The FDA must evaluate exaggerated and unsupported claims that might be inherent in a trademark.

Question 12

Brand Name Confusion

Answer 12

• 3 billion retail prescriptions sold annually
  
  • 1.3 million injuries from various medication errors
• Thousands of deaths annually due to medication errors
• 12.5% of medication errors are attributed to sound-alike/look-alike confusion of one brand name for another by a health professional
• over 100 deaths annually due to name mix-ups

Question 13

Reduce Brand Name Confusion

Answer 13

• Clearly specify the dosage form, drug strength, and complete directions on
  prescriptions. These variables may help staff differentiate products.
• With name pairs known to be problematic, reduce the potential for
  confusion by writing prescriptions using both the brand name and the
  generic names.
• Include the purpose of the medication on prescriptions. In most cases,
  drugs that sound or look similar are used for different purposes.
• Alert patients to the potential for mix-ups, especially with known problematic drug names. Advise ambulatory care patients to insist on pharmacy counseling when picking up prescriptions and to verify that the medication and directions match what the prescriber has told them.
• Encourage inpatients to question nurses about medications that are
  unfamiliar or look or sound different than expected.
• Give verbal or telephone orders only when truly necessary, and never for
  chemotherapeutics. Include the drug’s intended purpose to ensure clarity.
• Encourage staff to read back all orders, spell the product name, and state its
  indication.
• Maintain awareness of look-alike and sound-alike drug names as published
  by various safety agencies. Regularly provide information to professional
  staff
• Whenever possible, determine the purpose of the medication before dispensing or administering drugs.
• Consider the possibility of name confusion when adding a new product to the formulary. Review information previously published by safety agencies.
• Computerize prescribing. Use preprinted orders or prescriptions, as appropriate. If possible, print out current medications daily from the pharmacy computer system and have physicians review for accuracy
• Affix “Name Alert” stickers to areas where look-alike or sound-alike products are stored. These labels are available from pharmacy label manufacturers.
• Store products with look- or sound-alike names in different locations in pharmacies, patient care units, and in other settings—including patient homes.
• Employ independent double-checks in the dispensing process. For example, prior to dispensing, have one person interpret and enter the prescription into the computer and another review the printed label against the original prescription.