Drug Names and Classifications

• Drugs can have multiple names as it progresses through the approval process.
• The manufacturer must comply with FDA requirements
• Eventually drugs will have different names as it becomes officially approved

Naming Drugs

• Chemical name describes the chemical structure and identifies the compound.
• Code name is assigned by a manufacturer to experimental chemicals showing drug potential.
• Generic name identifies drugs by their active ingredients and is recognized internationally.
• Official Name is the generic name when the experimental drug is approved for general use and admitted to the US Pharmacopeia-National Formulary (USP-NF).
• Trade Name is a manufacturer's proprietary name distinguishing its product from competitors.
• Example: Benadryl’s chemical name is 2(Diphenylmethox)-N, N-dimethylethylaminehydrochloride

Drug Naming Examples

• Zafirlukast, code name ICI204, 219 is marketed as Accolate (astrazeneca)

Sources of Drug Information

• USP-NF contains medication, supplement, and medical device information and is considered as drug market standards by the FDA
• The Physician’s Desk Reference (PDR) includes identifiers like color charts and lists manufacturer and general drug action

Other References

• Useful information can be found in general pharmacology texts
• Drug Facts and Comparisons provides monthly updates on drug products and releases.

Sources of Drugs

• Naturally occurring drugs were recognized by civilizations like Egyptian, Chinese and American
• Animal sources include thyroid hormone, insulin, pancreatic dornase
• Plant sources include Khellin (Ammi visnaga), atropine (belladonna alkaloid), digitalis(foxglove), and reserpine (Rauwolfia serpentina)
• Mineral sources include copper sulfate, magnesium sulfate (Epsom Salts), mineral oil (liquid hydrocarbons)

Drug Approval Process

• It is a long, costly, and complex procedure.
• In the 1980's it could take 13-15 years from chemical synthesis to marketing approval, costing around 350 million USD

Drug Marketing Steps

• Isolation and identification of the chemical takes place first
• Animal studies include general effects
• Special effects on organ system
• Toxicology studies
• Investigational New Drug (IND) approval happens next
• Phase 1 studies involve small numbers of healthy subjects
• Phase 2 studies involve small numbers of subjects with the disease
• Phase 3 studies involve large multi-center studies
• A New Drug Application (NDA) is made
• There is a reporting system for the first 6 months

Orphan Drugs

• It is for diagnosis or treatment of a rare disease
• Rare = affects < 200,000 persons in the US or affects > 200,000 persons, with no expectation of recovering drug development costs

Orphan Drug Examples

• Acetylcysteine is used intravenously to treat acetaminophen overdose
• α₁-Proteinase inhibitor (Prolastin) is a replacement therapy for congenital α₁-proteinase (α₁-antitrypsin) deficiency
• Beractant (Survanta) prevents or treats RDS in newborns
• Dornase alfa (Pulmozyme) is used to treat cystic fibrosis
• Nitric oxide gas (INOmax) treats persistent pulmonary hypertension in newborns or acute distress in adults
• Tobramycin solution for inhalation (TOBI) treats Pseudomonas aeruginosa in CF or bronchiectasis
• Pentamidine isethionate prevents Pneumocystis carinii (jiroveci) pneumonia in high-risk patients

Prescriptions

• It is a written order for drugs with compounding, dispensing, and usage instructions
• It can be written by physicians, osteopaths, dentists, veterinarians, etc
• While there are Latin and English terms still being used, metric and apothecary measures are used for drug orders

Prescription Elements

• Patient name, address and date it was written
• Superscription indicates to take the listed drug and prepare
• Inscription lists the name and quantity of the drug
• Prescriber will include directions to pharmacist on preparing drug
• Sig (signa) means write. The transcription/signature shows how to use the drug
• The physician signs the prescription

Over-the-Counter(OTC) Drugs

• They can be hazardous in normal amounts, if their effects are not understood
• Taken in large quantities, there can be increased risk

Ibuprofen Example

• Used to relieve pain from headaches, dental pain, menstrual cramps, muscle aches, or arthritis
• Adults can take 200-400mg every 4-6 hours, with a maximum of 1200mg a day
• Taking more can lead to adverse effects
• Long term use can lead to complications like gastrointestinal issues, kidney/liver problems

Common OTC Respiratory Drugs

• Antihistamines
• Decongestants
• Mucolytics
• Antitussives

Generic Substitution

• Physician can allow a pharmacist to provide any version of the prescribed drug
• Intended to save the consumer money because they have not invested considerable time and money in developing product

Brand Name

• Usually thought of as the Original versions.
• Pioneer drug brand names are the first on market and effective
• Drugs have gone through testing
• Rare to absorb better version of drugs
• Recognition is higher from marketing spend

Generic brand vs Cost

• Usually more expensive than generic
• Health insurance coverage may not be used due to high cost
• Generic drugs work same quality, strength, dosage, intended use, route of administration, effects, and side effects
• The price does not determine value of drug
• Developed and marketed for less expense than brand names

Quality and Regulation of Generic Drugs

• drugs are the exact same to counterparts
• generics are cheaper
• it is available due to having access to ingredients
• it is made by the FDA standard

Disadvantages of Generic brand

• Due to the appearance you can switch up what you are taking
• Rate of absorption: people may not do well with it. It also can vary
• May be dangerous to use
• Decision boils down to the needs of the consumer
• better to consult with a doctor
• Consider the cons before purchases