HP Systems Drug Use Process

drug

Substances that produce a change in cellular or physiologic functioning

remedy

Alleviate symptoms or eliminate disease

poisons

Alleviate symptoms or eliminate disease

magic pill

Not knowing how a drug works lends itself to a sense of magic

Medicalization

a way to name common conditions in medically diagnosable terms. For example – feelings of sadness for a prolonged period of time – depression, eating too little leading to a very low bmi– anorexia. Everything works through ICD-10 codes that correspond to a diagnosis.

Medicalization

The process by which nonmedical problems become defined and treated as medical problems.

Society’s way of making a social, political or existential problem a medical one, so that it may be “treated

Prescriber external factors

Marketing, colleagues, regulations, patients, costs, formularies

Prescriber patient factors

Cost, patient needs and demands

Prescriber factors

Education, practice setting, workload, personal preferences

Dispenser role

Assure accuracy of dispensing

Apply clinical skills

Assist prescriber in therapy selection

Serve as patient’s advocate

OTC medication

Drugs that can be sold directly to people without a prescription.

ANDA (abbreviated new drug application)

To change a drug from Rx to OTC, what is submitted for an existing drug that is reviewed by the FDA?

Non-prescription drugs

The photo describes?

Prescription drugs

THe photo describes

BTC medication

Drugs dispensed under supervision of a pharmacist without a prescription.

To limit a drug’s use by those who might misuse it, while maintaining reasonable access for legitimate use by patients.

Combat Methamphetamine Epidemic Act of 2005

bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine.

Generic substitution

Substitution of a prescribed branded drug by a different form of the same active substance

Pharmaceutical Substitution

A pharmacist replaces a patient’s prescription drug with a similar drug that is expected to have the same clinical effect.

Therapeutic Substitution

Replacing a patient’s prescription drug with a chemically different drug that is expected to have the same clinical effect when administered in therapeutically equivalent doses.

FDA

protects the public health by overseeing the safety, efficacy and security of drugs, biological drugs and medical devices

Decides if drugs can be prescribed and sold, OTC, process new drug applications

FDA

there are no provisions in the law for ____ to "approve" dietary supplements for safety or effectiveness before they reach the consumer.

Discovery & Development

Identification of compounds followed by testing for ADME, side effects, and formulation. (1st Drug step)

Preclinical research

In vitro and animal testing for toxicity.

Must follow Good Laboratory Practices.

Leads to Investigational New Drug (IND) application.

(2nd drug step)

Clinical Trials

Using multiple phases to asses & evaluate the drug.

Phase I:

Safety, dosage, side effects (small number of subjects)

Phase II

Effectiveness, dosing range, continued safety.

Phase III

Large trials comparing to placebo; long-term effects.

FDA

Submission of NDA or BLA, including all preclinical and clinical data.

Review teams evaluate sections; FDA inspects clinical sites.

Approval granted if benefits outweigh risks.

Post-marketing (Phase IV)

• Tracks long-term effects in broader populations.

• Ensures detection of rare adverse events.

• Example: Vioxx withdrawal due to increased MI/stroke risk

Patents

Granted by the U.S. Patent and Trademark Office.

Last 20 years from the filing date.

Prevent others from making/selling the invention.

Can be filed any time during drug development.

Market exclusivity

Granted by the FDA; blocks generic approval for a defined period.

May overlap or differ from patents.

Purpose: Balance innovation incentives with generic competition.

New Chemical Entity (NCE)

5 years

New clinical investigations of existing drug

3 years.

Orphan drug

7 years.

Pediatric exclusivity

additional 6 months.

Generic 180-day exclusivity

first generic applicant receives 6-month marketing advantage.