Pharm 1 L1

A broad description of a drug or medication that includes mechanism of action, pharmacokinetics/dynamics, drug interactions, adverse effects, and toxic effects.

Pharmacology combined with disease state and patient considerations; it involves using medication in patients with various disease states.

The study of what the body does to the drug, including absorption, distribution, metabolism, and elimination.

The study of what the drug does to the body, including its mechanism of action.

Practitioners must monitor for efficacy (whether the drug is doing its intended job) while avoiding adverse effects (toxicities).

A specific target where a medication exerts its effect, such as a membrane protein, enzyme, or nucleic acid, often described by the “lock and key hypothesis.”

Medications that bind to a receptor and activate it.

Medications that bind to a receptor but do not have the exact structural features needed to activate it.

The specific chemical name, such as atorvastatin calcium, often long, burdensome, and hard to pronounce.

An internationally recognized name, nonproprietary, with only one generic name per drug (e.g., atorvastatin).

A patented property name from the pharmaceutical company that discovered or made the medication (e.g., Lipitor®).

Tablets, capsules, ointments, creams, sprays, lotions, etc.

Oral administration of a drug (PO).

Administration involving a needle, such as intravenous (IV), intramuscular (IM), or subcutaneous (SC).

Application of medication on the skin or mucous membranes for absorption, such as skin creams, vaginal products, or patches.

The circulation of medication through the vascular space, where most medications go once absorbed orally or through IV.

The Food and Drug Administration oversees the drug evaluation process in the USA and grants approval for the marketing of new drugs.

The Drug Enforcement Agency enforces the controlled substance laws and regulations of the United States.

The DEA can bring civil or criminal charges against those involved in growing, manufacturing, or distributing controlled substances.

The addiction potential of the substance.

Schedule I drugs are not considered medically necessary and are used for research only.

Schedule I

Heroin or "Medical" Marijuana.

True

Narcotics like Morphine, fentanyl, and ADD/ADHD meds like Methylphenidate.

Safer and less likely to be abused than Schedule II drugs.

Combination products with APAP or ASA (e.g., codeine).

Safer and less likely to be abused than Schedule III drugs.

Tramadol (Ultram) and Benzodiazepines (e.g., lorazepam).

Schedule V

Expectorants with codeine.

1906

The deaths of over 100 children due to "elixir sulfanilamide."

Proof of efficacy and documentation of safety in terms of the risk-to-benefit ratio.

To identify potential human toxicities and design tests to define the toxic mechanism.

An Investigational New Drug (IND) application.

To monitor the safety of the new drug in a more realistic setting.

The FDA’s program for reporting adverse reactions, product quality problems, and product use errors.

The analysis of genetic variations that may influence a person's response to a drug.

A drug that meets unmet medical needs for patients with serious, life-threatening conditions.

Incentives for the development of drugs that treat diseases with fewer than 200,000 patients in the U.S.

Foods specifically formulated for dietary management of diseases with distinctive nutritional needs that cannot be met by a normal diet alone.

1. Be specifically formulated for PO administration (not “naturally” occurring)
2. Be labeled for dietary management of a specific medical problem with distinctive nutritional requirements
3. Be intended for use under medical supervision (“RX only”)
4. Be intended for patient receiving ongoing medical care (ie. Requires regular instruction on the use of the medical food)

"Labeled" use is FDA-approved for a specific indication, while "off-label" use refers to unapproved uses not studied by the manufacturer.

The most serious type of warning mandated by the U.S. FDA about potential adverse reactions or problems with a drug.

An FDA-mandated strategy to ensure that the benefits of a drug outweigh its risks, often requiring special training for prescribers, patients, and pharmacists.

Optometrists can prescribe hydrocodone (II), tylenol with codeine (III), and tramadol (IV)