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Introduction to Respiratory Care Pharmacology
Principles of drug action

Definitions

Drug: A drug is any chemical that alters either body functions or processes. Ex. alcohol, nicotine, vitamins, acetaminophen, etc.

Pharmacology studies drugs, including origin Natural or synthetic), properties, therapeutic and side effects as well as interactions with living organisms. It is an ever-changing science.

Most important properties are:

- Onset of action

- Peak effect

- Half life

- Therapeutic effects

- Side effects

- Clinical use

- Dosage

Naming drugs

There are five names for each FDA-approved drug!

Chemical name: it is just the chemical structure of the drug.

Code name: Alphanumeric name assigned to an experimental chemical that shows potential as a drug. Important during the research process.

Generic name: It is assigned by an official institution when there is high likelihood of clinical use and the manufacturer is willing to market the drug.

Official name: Same as generic, after the FDA has approved the drug for clinical use.

Trade, brand, commercial or proprietary name: The name given to the drug by the manufacturer, often unrelated to the generic name. For the same generic, there may be as many brand names as manufacturers. It is widely used by patients. its property is protected by law.

Sources of drug information

United States Pharmacopeia (USP)-National Formulary

- Official from 1906 (first F&D act)

Physician Desk Reference (PDR)

- Prepared by manufacturers (lack of objectivity?)

Process of drug approval in the U.S.

It may last more than 10 years (average 13-15).

Its cost may be more than $300M.

Only a small percentage of all the drugs that entered the process are finally approved.

Steps of the drug approval process in the U.S.

1- Chemical identification:

- potential for useful physiological effects.

- exact structure.

- physical and chemical characteristics.

2- Animal studies:

- general effect on the organism.

- effects on specific organs.

- toxicology studies: mutagenicity, teratogenicity, effect on reproductive fertility and carcinogenic potential.

       3- Investigational new drug approval process:

- An Investigational New Drug (IND) application is filed with the FDA. It must include all the information previously gathered and plans for human studies.

- These studies proceed in three phases and require around three years to complete.

Phase 1

Small group of healthy volunteers, for pharmacokinetic description purposes.

Phase 2

Treatment for a small group of individuals with the disease the drug is intended to treat.

Phase 3

Large, multicenter studies to establish safety and efficacy.

       4- New Drug Application

After a successful IND process, the NDA is filed with the FDA and upon approval, the drug is released for clinical use.

A detailed reporting system is in place for the first six months to track any problems that might arise with the drugs use.

Orphan and over-the-counter (OTC) drugs

Orphan drugs

An orphan drug is a drug or biological product for the diagnosis or treatment of a rare disease. It also applies to drugs used to treat more common diseases, if there is no reasonable expectation of recovering the cost of drug development.

OTC

Purchasing an OTC does not require a prescription. However, OTC may be hazardous in normal amounts if the effects are not understood and can be taken in large quantities, thereby increasing the risk. Side effects related to OTC should be taken into account.

The prescription

Patients name, address and date

Superscription (Rx)

Inscription (name and quantity)

Subscription (instructions to the pharmacist, if needed)

Transcription (instructions to the patient

Name of the prescriber

Generic substitution

Aerosolized drugs in respiratory care

Drugs delivered by nasal or oral inhalation are intended to provide a topical treatment of the respiratory tract.

Advantages:

- smaller doses

- fewer and less severe side effects

- rapid onset of action

- lower systemic bioavailability

- inhalation is painless, relatively safe and may be convenient depending on the specific delivery device used

Related drugs in respiratory care

Anti-infective agents

Neuromuscular blockers

CNS agents

Anti-arrhythmic agents

Anti-hypertensive and anti-anginal agents

Anticoagulant and thrombolytic agents

Diuretics

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