basics of pharmacology

drugs are substances that alter biological activity in a

• person to promote healing, cure disease, control or slow progress of disease, decrease risk of complications, etc.

  

pharmacokinetics: processing of

• drugs by the body

pharmacokinetics: processing of drugs by the body: human cytochrome P450 (CYP)

• play important role in metabolism

  

pharmacokinetics: processing of drugs by the body: research shows that drug-metabolizing enzyme activity

•  impacts patient response to medication

  

pharmacokinetics: processing of drugs by the body: absorption, bioavailability,

• distribution, metabolism, and execration

  

pharmacodynamics: effects of drugs on body,

• either favorably or unfavorably

  

pharmacodynamics: effects of drugs on body, either favorably or unfavorably, receptor binding,

• post-receptor effects, and chemical interactions

  

pharmacotherapeutics: use of

• drugs in treatment of disease

  

drug discounts are partnered with surescripts to allow

•  clinicians access to drug discount information

  

evolution of medications: treatment based on

•  little scientific knowledge in early history

  

evolution of medications: treatment based on  little scientific knowledge in early history, such as

• Opium, morphine or cocaine was main ingredient

  

evolution of medications: food and drug act of 1906:

evolution of medications: food and drug act of 1906: formulary, if you have a medication not on the list you

• have to bring the medication to the hospital and they will properly administer it if they can't find one similar on their list

  

evolution of medications: food and drug act of 1906: formulary is specific for every hospital, every one has one,

• they can't administer drugs that are not on the list

  

evolution of medications: food and drug act of 1906: formulary lists

• every drug, the side effect, ingredients, and when it should be taken

  

evolution of medications: food and drug act of 1906: this introduced the

• national formulary *

evolution of medications: food and drug act of 1906: 1912 amendment require accurate

• labeling of drugs to prevent substitution or mislabeling of ingredients

  

evolution of medications: food and drug act of 1906: drug mfg’s opposed drug laws but

• public outrage resulted in passage

  

1914 - harrison narcotic act

• limits indiscriminate use of addictive drugs

1938 - federal food, drug, and cosmetic act

• determines: safety of drugs before marketing; labeling specifications; ensures advertising claims are met

1951 - durham-humphrey amendment

• restricts number of prescription that can be refilled

1962 - kefauver-harris amendments

• product must be proven safe and effective before it is released for sale

1970 - comprehensive drug abuse prevention and control

• improve administration and regulation of manufacturing, distributing and dispensing controlled substances. DEA created

1983 - orphan drug act

• offers federal financial incentives to nonprofit and commercial orgs to develop/market drugs to treat rare diseases

1987 - prescription drug marketing act

• prohibits reimportation of drugs by anyone other than mnfg

1990 - safe medical devices

• users report to mnfg’s and FDA occurrences in which device caused death or illness

1990 - anabolic steroid control act

• placed anabolic steroids under ACA

1990 - omnibus budget reconciliation act

• pharmacists offer to counsel medicaid and medicare pts about drug information and potential adverse effects for all new and refilled prescriptions

1994 - dietary supplements and health and education act

• guidelines established and mnfg liable for claims against products in accordance w/ FDA guidelines

1992 - occupational safety and health act

• ensures safety or workers

1996 - health insurance portability and accountability act

• EHR standards, unique identifiers, security and electronic signature standards, privacy and confidentiality standards

1997 - FDA modernization act

• patients have increased access to experimental drugs and devices

2003 - medicare prescription drug, improvement and modernization act

• help seniors by reducing drug costs and help employers offer drug benefits

2005 - combat methamphetamine epidemic act

• designed to stop illegal use of methamphetamine and regulated trafficking or drug

HIPAA really started with

• portability

drug surveillance: includes the

• drug enforcement administration (DEA)

• federal controlled substances act (CSA)

• FDA

drug surveillance: drug enforcement administration (DEA): physician must

• renew registration every 3 years

  

drug surveillance: drug enforcement administration (DEA): any theft or loss

• must be reported

drug surveillance: drug enforcement administration (DEA): regulates and enforces

• manufacturing and dispensing of dangerous and potentially abused drugs

  

federal controlled substances (CSA) part of comprehensive drug abuse prevention and control act of 1970

• drug surveillance

drug surveillance is concerned with

• prevention and control of abuse of controlled substances

  • Administered and enforced by DOJ

  • Unit of DEA

    

food, drug, and cosmetic act (FDA) looks to fix the rules and regulations by

• which drugs are imported, manufactured, distributed and sold in U.S.

  

state regulate laws more than

• the federal

states are the main regulators of

• pharmacy practice

state laws differ

• from state to state

state laws require minimal qualification for individuals involved with

• pharmacy practice (licensing)

state laws: health care providers must use

• prescription pads

  • Must be secured at all times

    

prescription drug monitoring program (PDMP) allows prescription drug information to be

• shared across all pharmacies

• Helps with doctor hopping

  

development process of new drugs: first step is

• New compound developed by pharmaceutical company

  

development process of new drugs: New compound developed by pharmaceutical company →

• pre-clinical testing (making sure it's safe)

  

development process of new drugs: New compound developed by pharmaceutical company -> pre-clinical testing (making sure it's safe) ->

• investigational new drugs status if approved

  

development process of new drugs: New compound developed by pharmaceutical company -> pre-clinical testing (making sure it's safe) -> investigational new drugs status if approved ->

• clinical trials in humans

  

development process of new drugs: New compound developed by pharmaceutical company -> pre-clinical testing (making sure it's safe) -> investigational new drugs status if approved -> clinical trials in humans ->

• new drug application sent to FDA

  

development process of new drugs: New compound developed by pharmaceutical company -> pre-clinical testing (making sure it's safe) -> investigational new drugs status if approved -> clinical trials in humans -> new drug application sent to FDA →

• FDA approval of NDA

  

development process of new drugs: New compound developed by pharmaceutical company -> pre-clinical testing (making sure it's safe) -> investigational new drugs status if approved -> clinical trials in humans -> new drug application sent to FDA -> FDA approval of NDA ->

• post-marketing surveillance

  

1 phases of clinical trials: 10 – 100 healthy volunteers study safe dose range, evaluate side effects & establish final, correct dose for 1 – 1.5 yrs:

• Pharmacokinetics are studied

  

1 phases of clinical trials: 10 – 100 healthy volunteers study safe dose range, evaluate side effects & establish final, correct dose for 1 – 1.5 yrs: “want ads” in

•  classified section of newspapers

  

1 phases of clinical trials: 10 – 100 healthy volunteers study safe dose range, evaluate side effects & establish final, correct dose for 1 – 1.5 yrs: informed consent is

• mandatory

1 phases of clinical trials: 10-100 healthy volunteers

• study safe dose range, evaluate side effects & establish final, correct dose for 1 – 1.5 yrs

  

2 phase of clinical trials: given to 50-500 patients who have

• disease/condition on experimental basis for ~ 2 yrs

  

3 phase of clinical trials: administered to several hundred/thousand ill patients in exactly way in which it will be used once it’s on the market for ~ 3 yrs: relative

• effectiveness evaluated

  

3 phase of clinical trials: administered to several hundred/thousand ill patients in exactly way in which it will be used once it’s on the market for ~ 3 yrs: double-blind

•  studies conducted (placebo)

  

3 phase of clinical trials: administered to several hundred/thousand ill patients in exactly way in which it will be used once it’s on the market for ~ 3 yrs: ____________ studies

• gender issues

3 phase of clinical trials: administered to several hundred/thousand

•  ill patients in exactly way in which it will be used once it’s on the market for ~ 3 yrs

  

3 FDA drug classifications

1. over the counter (OTC)

2. prescription (legend)

3. controlled substances

3 FDA drug classifications: over the counter (OTC): usually

• first line of defense

3 FDA drug classifications: over the counter (OTC): may be same as

• prescription ingredients but dosage is much smaller

  

3 FDA drug classifications: over the counter (OTC): 1992 OTC Drugs Advisory Committee created to

• review drugs & determine which ones are safe/appropriate for OTC use

  

3 FDA drug classifications: over the counter (OTC): must meet following criteria - use of drug doesn’t

• require patient to have special monitoring or testing

  

3 FDA drug classifications: over the counter (OTC): must meet following criteria - low rate of

• effects/toxicity and low potential for abuse

  

3 FDA drug classifications: over the counter (OTC): must meet following criteria - patient can easily

• easily diagnose/monitor their own condition

  

3 FDA drug classifications: over the counter (OTC): must meet following criteria - indication for use is

• similar to prescription drug

  

3 FDA drug classifications: prescription (legend): must contain

• specific information

3 FDA drug classifications: prescription (legend): there has to be

• mandatory information on the label

  

3 FDA drug classifications: prescription (legend):

• Name

• When to be taken

  

3 FDA drug classifications: prescription (legend):

• Patient name

• What form given

• How much are in the container

  

3 FDA drug classifications: prescription (legend):

• Is there a refill

• Who's the manufacturer

• Expiration data

  

3 FDA drug classifications: controlled substances: drugs with potential for

• abuse and dependence

3 FDA drug classifications: controlled substances: C followed by

• class I-V

3 FDA drug classifications: controlled substances: manufacturing, storage,

• dispensing and disposal are strictly regulated by federal and state laws

  

3 FDA drug classifications: controlled substances: must register with

• DEA and be issued DEA certificate and number to prescribe/dispense drugs

  

3 FDA drug classifications: controlled substances: some states also require the

• health care provider register with state agency that controls scheduled drugs

  

half life = T_1/2 : short half life =

•  frequent dosage

• If liver/kidney isn’t functioning correctly, higher dosages of meds circulate for longer

  

half life = T_1/2 : standard method of expressing how long it take to

• metabolize and excrete 50% of a drug

• Major determinant of duration of drug action

  

half life = T_1/2 : major determinant of

• duration of drug action

  

half life = T_1/2 : because they are the same for everyone,

• it helps determine the dosage, frequency and duration needed for administration

  

half life = T_1/2 : low long it take for the body to get rid of

• 50% of the drug from the body

  

half life = T_1/2 : basing ____________ on half life

• dosing

drug patents: are

• trade name registered with US patent office

drug patents: trade name registered with US patent office: Last segment Package Code:

•  id’s package size/type

  • i.e. NDC# 00185-0144-60

    • Amiodarone 200 mg – 40 tabs – Eon Lab Manufacturing

      

drug patents: trade name registered with US patent office: NDC - Next segment Product Code:

•  id’s drug’s specific strength/dose

  

drug patents: trade name registered with US patent office: NDC - 1st 3 segment labeler code

• id’s drug company

  

drug patents: trade name registered with US patent office: ___________________ are assigned to each drug

• national drug codes

drug patents: trade name registered with US patent office: after 17 years, any drug company can manufacture

• drug under its original generic name or new trade name

  

drug patents: trade name registered with US patent office: protected by

•  17 year patent

  • Testing process included in 17 years

    

drug patents: trade name registered with US patent office: Original drug company has

• right to advertise and market

  

drug withdrawals and recalls: Post-market surveillance performed by

• FDA and drug companies

  

drug withdrawals and recalls: Certain adverse drug effects only

•  become apparent over time

  

drug withdrawals and recalls: Healthcare professionals and consumers should report through

• MedWatch Adverse Event and Safety Program

  

drug withdrawals and recalls: MedWatch

• monitor what drugs are recalled