Drug Use

What does pharmakon mean?

Greek term for remedy, poison, or magical charm.

• remedies = when the reduce diease or eliminates it

• poision = harmful or unpleasent expeirence

What is a drug?

A substance that changes cellular or physiological functioning.

social values which affect perception and use of drugs

• some durgs illegal

• some highly restricted

• some easily avalible

What is a magic bullet?

A drug that targets disease without harming other cells.

What is DTCA?

Direct-to-consumer advertising of pharmaceuticals.

Why can familiarity with drugs be misleading?

It masks side effects, interactions, costs, and development complexity.

What is a prescription drug?

A medication requiring an authorized provider's prescription.

What is an OTC drug?

A medication available without a prescription.

• aka non prescription

What is an approved use?

Use of a medication for an FDA-approved condition.

What is off-label use?

Use of a medication for a condition not approved by the FDA.

• ex: using ozempic for weight loss is unapproved b/c it’s approved for diabetes

What is medicalization?

Defining a personal or social problem as a medical condition.

When does medicalization happen

when previous non-medical problem becomes defined as medical problem

• ex: anticulation disorder = diffculty in pronouncing specfic types of sounds

• Obesity = need treatment such as medication or bypass surgery

• ADHD (Attention defict/ hyperactivty disorder)

What are three concerns about medicalization?

• Pathologizing differences (turn human differences into medical problems)

• medicine defining normality

• excessive medication use.

What do drug manufacturers prioritize?

Therapeutic effects with goals of:

• optimizing biochemical activity

• increasing specificity

• fewer negative effects.

What do healthcare providers prioritize in drug therapy?

Therapeutic effects and efficient patient treatment.

What do consumers prioritize when choosing drugs?

• Effectiveness

• adverse effects

• cost.

Who ultimately decides whether to take a drug?

The consumer or patient

what influences whether consumers take drugs or not?

• side effects

• confident desired treatment effect with minimal side effects

What can consumers do about a perceived health problem?

• Do nothing

• Take action.

  • use self-care

  • seek medical care.

regarding medication beliefs with consumer and health care professionals

consumer beliefs are different from beliefs of healthcare professionals

What did the patient-versus-clinician reporting graph show?

Patients reported higher rates of several adverse symptoms.

Why can prescribing have a ritualistic role?

It symbolizes healing and gives patients satisfaction

What is one of the most common and expected treatments recommended by prescribers?

Prescription drug therapy.

What four factors influence prescribing behavior?

• Education

  • includes training in pharmacotherapeutics and preceptors prescribing habits

• colleagues or other health care providers

• consumer and society demands

• promtional activities by drug manfucater

How has automation changed pharmacists' work?

More verification, therapy monitoring, and patient-centered care.

• considered a professional aspect

why is retail pharmacy spending less time filling prescriptions

• majority of prescrpition filling done by robots

• internet sales of prescription and mail order delivery

What does the FDA determine?

Which drugs can be marketed and whether they require prescriptions.

What does the Food, Drug, and Cosmetic Act regulate?

Small-molecule drugs and hormones.

What does the Public Health Service Act regulate?

Biologic drugs.

• much larger molecules and more complex than small molecule drug

What are major FDA responsibilities?

• Drug approval, labeling

• manufacturing

• bioequivalence

• safety monitoring (post marketing + monitoring safety on nations blood supply)

What is postmarketing surveillance?

Monitoring approved drugs for unexpected problems.

Non- FDA approved “on label” indications

uses products which were not approved by the FDA but show value after approval based on post marketing research (PMR or PMS)

• CANNOT be promoted by manufacturer

What is the first stage of drug development?

Discovery research to identify promising compounds.

• bench research and identifies potiental useful compounds

What is the second stage?

preclinical trails

• Animal and laboratory testing before human trials.

What is an IND?

Investigational New Drug application requesting permission for human testing to FDA.

• Manfcautures submit data about safety and efficacy

what is the thrid stage in drug devolpment process?

clinical testing

• testing on humans

• three phases of approval

what is the fourth stage in drug devolpment process?

new drug application (NDA) submitted for approval

What is the purpose of Phase I trials?

Determine safety, dosage, pharmacokinetics, and possible toxicities.

• last around 1-1.5 years

Who participates in Phase I trials?

Usually fewer than 100 healthy volunteers.

What is the purpose of Phase II trials?

Evaluate safety and effectiveness in patients with the disease.

• last about 2 years

Who participates in Phase II trials?

Patients with the disease or symptom; typically fewer than 300.

What is the purpose of Phase III trials?

Confirm efficacy, safety, dosage, and longer-term adverse effects. Under market conditions and montiors

• last 3-3.5 years

Who participates in Phase III trials?

Larger patient groups, often up to about 3,000 participants.

What is an NDA?

New Drug Application submitted for FDA marketing approval.

• FDA has 60 days to decide to review or refuse for completeness

What does CDER stand for?

Center for Drug Evaluation and Research.

What are the FDA's routine and priority review targets?

10 months for routine review; 6 months for priority review.

What is Phase IV testing?

Postmarketing studies of safety, effectiveness, and missed adverse effects.

• happens when approved for market

What is a supplemental NDA?

Application to FDA to approve changes to an already approved drug.

• ex: want to alter ingredients, dosage, manufacturing, or labeling

What is an ANDA?

Abbreviated New Drug Application for generic drug approval.

generic products or biosimliars

same as existing brand name drugs which were already approved

• FDA DONT require any pre clinical or clinical data

• just needs to prove their drug is the same as the original

for genetics or biosimliars what needs to be submitted

abberivated NDA to show bioequivalent with brand name drugs

copied drug

generic small molecule meaning OG drug is small molecule

biosimliar

OG drug is biologic

pharmaceutical equivalence

• same active ingreident, same dosage form, and same strength.

• only difference: color, taste, and other features may differ

What is bioequivalence?

Same rate and extent of drug absorption as the reference product.

What establishes therapeutic equivalence?

Pharmaceutical equivalence plus bioequivalence.

• drug is therapeutically equivalent to comparable brand when the FDA says generic is safe and effective

What is the largest drug-cost component emphasized in the slides?

Research and development (R&D).

What factors influence drug prices?

Manufacturer, wholesaler and retailer costs/profits, discounts, supply and demand.

What are risks of counterfeit drugs aka fake medicine?

• Wrong ingredients

• incorrect doses (wrong or no active ingredient)

• contamination

• illegal b/c harmful

• delayed treatment.

what % of drugs are considered conuterfeit sold

30%

What is one benefit and one concern of foreign clinical trials?

Diverse participants, but variable standards and limited FDA inspections.

Can drugs manufactured outside the U.S. be sold in the U.S.?

Yes, if they meet FDA requirements.

What must the FDA approve for foreign-manufactured prescription drugs?

The manufacturing process and facility where the drugs are produced.

Can individuals purchase prescription drugs from another country for use in the U.S.?

Generally prohibited, but exceptions exist

consumer risk

• consumers recive no benfit from drugs when there is no active ingredient

• consumers expierence adverse effects or even death from drugs with harmful an toxic chemicals

• drug can delay consumers access to effective treatment

about foregin clinical trails

• FDA not equipped to inspect foregin clinical trail sites

• can be hard to tell why patients outcomes differ between sites

• each site may have different standards + limiting ablity to interpert data

IPRs

Intellectual propert rights

• laws and regulations to protect ideas and products of innovators

Which laws govern small-molecule protections

• Hatch-Waxman (1984)

• data exclusivity period and patent protection to innovators

• copies considered generics

biologic drug protections

• PPACA (2010) AKA Patent Protection and Affordable Care

• data exclusivity period and patent protection to innovators

• copies considered biosimliars

patent

protects chemical structure, maufacturing and underline tech and formulation

Compare patent terms and data exclusivity periods.

• Both: 20-year patent term with US PTO (US patent and trademark office) and interchagble with OG drug.

• Small molecules: 5 years exclusivity and no new clinical trails required for biosimliars/ generics

• biologics: 12 years. yes but limited new clinical trials for generics/ biosimliars