Exam 1 Content PHP 307

Pharmacy in the 1800s

- prior to 1820s, a pharmacists education consisted of apprenticeship

- first college of pharmacy was established in philadelphia in 1821

- 1850s- seek out fountain drinks to cure common ailments

John Pemberton

- pharmacist based in atlanta

- created a tonic that combined coa wine and africa kola nit

- sold as "patent medicine" in 1886 in drug store soda fountains

- claimed his tonic could cure morphine addictions, idegestion, nerve disorders and headaches

Pure food and drugs act of 1906

- prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded

- no info needed to be submitted beforehand

- paved way for FDA

adulterated drugs

changed or contaminated

misbranded drugs

Incomplete labeling

Misleading labeling

Federal Food, Drug, and Cosmetic Act of 1938

- Replaced the Food and Drug act of 1906.

- Provided better clarification about misbranding definitions.

• Provided better clarification about adulteration definitions.

- Gave the FDA authority to require adequate testing of new drugs for safety.

- akk new drugs must be proven SAFE

- certain drugs grandfathered into law

Durham-Humphrey Amendment of 1951

- amendment to FCA 1938

- established legend and OTC drug classes

- passed with hopes to increase medical supervision of certain drugs

Kefauver-Harris Amendment of 1962

- guidelines for the process of drug approval

- well controlled clinical trials

- safe and effective before marketing

- pregnancy categories

- FDA approval required

- established good manufacturing processes

Clinical Pharmacy

the area of pharmacy concerned with the science and practice of rational medication use

clinical pharmacy movement

rebranded profession as therapeutic advisors (1960s)

pharmaceutical care

responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patients quality of life

Outcomes that improve a patient's quality of life

- cure of disease

- elimination or reduction of a patients symptomatology

- arresting or slowing of a disease process

- preventing a disease or symptomatology

future issues in pharmacy

- provider status

- enhanced prescribing

- telepharmacy

- on-line pharmacists

- womens health

- pharm techs

- wellness and burnout

- PBM

- pharmacogenomics

- AI

- drug costs

- 340B pricing programs

- unionization of community pharmacists

drug shortage

a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent

why are there drug shortages?

raw and bulk materials; manufacturing difficulties; voluntary recall; manufacture decisions

manufacturing diifficulties

- FDA enforcement halts and delays

- GMP non-compliance

- usually a lengthy process to resolve

- FDA enforcement evaluated by CDER (center for drug evaluation and research)

voluntary recall

- generally a temporary manufacturing problem

- usually a minor lapse in manufacturing procedures

- not subject to FDA legal action

- Usually specific lots

- lack of assurance that the recalled product is safe or technical problem (labeling issue)

manufacturer decisions financial

- availability of generic products

- market size

- patent expiration

- anticipated clinical demand

- regulatory compliance requirements

medication use process

Prescribing

Transcribing

Dispensing

Administering

Monitoring

prescription stage

handwritten or computer prescriber order tyically entered y physician, NP, or trainee

transcription stage

clinical prescription info is transferred onto the patients medication administration record either manually or electronically

preparation and dispensing stage

pharmacist prepares, labels, and dispenses the final drug products. Many pediatric doses require extemporaneous compounding from stock containers

administration stage

The nurse or med tech administers the medication. In the outpatient setting, the patient or caregiver is responsible for drug admin. In either case the 5 rights of med admin should be achieved

five rights of medication administration

right patient, right drug, right dose, right route, right time

monitor stage

patients are monitored for drug reactions. Lab values such as plasma drug concentrations, serum creatinine concentrations, and hepatic function should be checked and drug does or admin schedule adjusted as needed

in what stage of the medication use proces is there a key difference between inpatient and outpatient treatment?

administration stage

FDA definition of a drug

-Articles intended for use in the "diagnosis, cure, mitigation, treatment, or prevention of disease" and articles (other than food) intended to affect the structure or any function of the body of man or other animals"

required information of a non controlled prescription

name, date written, drug name and strength, dosage form, directions, quantity, number of refills, prescriber signature, prescriber DEA (if controlled)

controlled substances

drugs that produce tolerance and dependence and have potential for abuse or addiction

CI drugs

illegal drugs not considered to have any medical value or use; heroin, LSD, ecstacy, ect

CII drugs

legal drugs with HIGH potential for abuse; includes opioids & amphetamines, cocaine

CIII drugs

legal drugs that have potential for abuse, but lower than CII drugs; have high potential for psychological abuse; includes anabolic steroids

CIV drugs

legal drugs with low potential for physical abuse & moderate psychological abuse; includes tranquilizers and sleep medications

CV drugs

legal drugs with LOW potential for abuse physically and psychologically; include cough medicine

SIG Codes

Certain abbreviations for directions written on prescriptions, designed to help simplify and speed up the order entry process

#

number or quantity

AAA

apply to affected area

AC

before meals (ante cibum)

PC

after meals (post cibum)

AD

right ear (auris dextra)

AM

in the morning

AS

left ear (auris sinistra)

AU

both ears (auris uterque)

AUD

apply as directed

UD

as directed

BID

twice a day

c

with

DAW

dispense as written

D/C

discontinue

gtt

drops (guttae)

h or hr

hour

hs

at bedtime, hour of sleep

IM

intramuscular

IV

intravenous

cc or mL

milliliter

g, gm

gram

mg

milligram

oz

ounce

Tbsp

tablespoon

Tsp

teaspoon

U

units

caps

capsules

tabs

tablets

susp

suspension

sol, soln

solution

sup, supp

suppository

syr

syrup

N/V

nasuea and vomiting

NEB

nebulizer

OD

right eye (oculus dexter)

ODT

orally disintegrating tablet

Oint

ointment

OS

left eye (oculus sinister)

OU

both eyes (oculus uterque)

PO

by mouth

PRN

as needed

q

every

QD

once daily

QID

four times a day

SOB

shortness of breath

SubQ, SC

subcutaneous

STAT

now/immediately

TID

three times a day

wk

week

X

times

QS

quantity sufficient

1 oz = ? mL

30 mL

1 tsp = ? mL

5 mL

1 tbsp = ? mL

15 mL

1 mL = ? drops

20 drops

dosage form

form in which drugs are manufactured; includes elixirs, tablets, capsules, suppositories, parenteral drugs, and transdermal systems

indication

conditions or symptoms for which the drug is approved to be used

adverse effect

general term for undesirable and potentially harmful drug effect

precaution

when the drug or procedure should be used or performed cautiously

contraindication

a factor in the patient's condition that makes the use of a medication or specific treatment dangerous or ill advised

controlled release

oral tablet or capsule formulations that maintain consistent serum drug levels

Chain Community Pharmacy

- part of a larger corporation

- organization consists of 4 or more stores

- traditional chain drugstores filled 55.2% of prescription in 2013

independent pharmacy

- able to practice the way you choose

- may be a single store with a sole proprietor or may consist of several stores owned by an individual or small group

- face profit struggles due to PBMs, DIR fees, claw backs and decreased reimbursement

in addition to clinical and traditional pharmacy services, independent pharmacists typically get involved in...

- merchandising

- marketing

- other general management functions

community pharmacist

The health professionals most accessible to the public. They supply medicines in accordance with a prescription or, when legally permitted, sell them without a prescription. They maintain links with other health professionals in primary health care.