PHAR 9941 EXAM 2

crunk

providing entertainment, amusement, excitement, or enjoyment

Drug information

dispensing of information of about drug or health-related topics in order to improve patient care

Drug informatics

use of technology as an integral tool in effectively organizing, analyzing, and managing medication use in patients

importance of drug knowledge and role in patient care

traditional sources of drug information

drug reps

mail

continuing education

colleagues

goals of drug information questions

accurate
concise
patient-specific - gender, age, ethnicity, and physiology
timely - when is the info needed by

primary literature

bottom of the triangle
randomized controlled clinical trials = GS
original research
includes case reports, cohort studies, open label trial, randomized - controlled clinical trials
ADV: original research, written BY researchers
DISADV: narrow perspective, quantity

secondary literature

condense information from primary research

includes databases and review articles

ADV: review articles, meta-analyses, and databases

DISADV: cost, out of date, biased - must retrieve primary literature to assess validity

tertiary literature

top of the triangle

textbooks

DISADV: not all peer reviewed, 5 years out of date at time of publication, and may not be detailed enough

evidence based medicine

Uses outcomes-based research that assesses: mortality, morbidity, and quality of life

steps:
1. formulate clear clinical question - PICO
2. search literature for relevant info
3. evaluate evidence
4. apply evidence to the patient

evaluate evidence

usefulness - (relevance X validity)/work

validity - is it true

3 questions:
1. direct bearing on the health of my patient
2. problem common in my practice
3. will new info require me to change my current practice

EBM gold standard

Cochrane

PICO

P: patient population
!define the patient
I: intervention
!new treatment being considered
C: comparison
!guideline or standard of care
O: outcome
!define desired outcome

janky

undesirable, intensely repellant in general

off the hook

fun and enjoyable

identification and availability GS

identidex or micromedex

foreign drugs GS

martindale's

therapeutic use GS

micromedex drugdex

dosage and administration GS

micromedex drugdex

bioequivalency GS

electronic orange book

information to clarify before answering drug questions

diagnosis
medications that have been tried
age, heigh, weight
renal function - creatine clearance
liver function tests
other disease states
current medications

pharmaceutical equivalence

have the same active ingredients, the same dosage form and route of administration, and identical strength or concentrations
!!! does not mean they are therapeutic equivalents

therapeutic equivalents

pharmaceutical equivalents, expected to have the same clinical effect - means it is bioequivalent

bioequivalency

Rate or extent of absorption differ by -20%/+25% or less

The generic drug absorbed ranges 80-125% of trade name

bioequivalency codes: first letter

A: generic is bioequivalent
B: generic is not bioequivalent

bioequivalency codes: second letter

dosage form

A: no BE problem between active ingredients and dosage form
B: multisource drug products under same heading with same strength
P: parenteral
N: aerosol or nebulizer
T: topical
R: suppository or enema

bioequivalency codes: number

Used when there is more than one RLD (referred listed drug) of same strength which are not bioequivalents

Generic that passes bioequivalency studies will be given the same three-character code as the RLD

hoopy

Old beaten-up dilapidated car

drug-drug interaction GS

drug interaction facts

drug-food interactions GS

drug interaction facts

drug-lab interaction GS

basic skills in interpreting lab data

drug-herbal interaction GS

natural medicines

ADR GS

micromedex drugdex

rare reactions GS

pubmed

type A interactions

extension of the drug’s pharmacological effect
therapeutic effect carried beyond a desired limit
pharmacological result of therapy unrelated to the objective
pharmacologically predictable
dose-dependent
high incidence and morbidity
low mortality
treatment - adjust dose

type B interactions

idiosyncratic reactions to a drug – unexpected (allergies or anaphylaxis)

low incidence and morbidity
high mortality
discontinue treatment

FDA prescription drug labeling requirements

summary for safe and effective use
informative and accurate - not promotional, false, or misleading
no implied claims or suggestions for use if evidence is lacking
based on human data if possible

purpose of prescription drug labeling

Provide healthcare professionals with information needed to prescribe drugs appropriately

off-labeled use

requires EBM - check databases and PubMed

used for a disease/condition not approved to treat

given in a different dosage from than approved

given in a different dose

package inserts GS

DailyMed

PDR - physician's desk reference

pharmacokinetics GS

winter's basic clinical pharmacokinetics

poisoning GS

micromedex poisondex

compatibility GS

handbook on injectable drugs - trissel's

pregnancy and lactation GS

drugs in pregnancy and lactation - Brigg's

therapeutic drug monitoring

measurement of specific drugs at timed intervals in order to maintain a relatively constant concentration of the med in the bloodstream

GS = Winter's

pregnancy categorization: A

controlled studies in pregnant women fail to demonstrate a risk to the fetus in the 1st trimester and possibility of fetal harm appears remote

!!!no evidence of risk in later trimesters
!!!most likely ok

pregnancy categorization: B

either animal reproduction studies have not demonstrated fetal risk but there are no controlled studies in pregnant women OR
animal reproduction studies have shown adverse effect that was not confirmed in controlled studies in women in the 1st trimester (assumed safe for others)

pregnancy categorization: C

either studies in animals have revealed adverse event on the fetus and no controlled studies in women

OR

studies in women and animal are not available


!!!Only give if benefit > risk

pregnancy categorization: D

positive evidence of human fetal risk but benefits from use in pregnancy may be acceptable despite the risk

!!!Life-threatening situation
!!!Safer option is not effective

pregnancy categorization: X

fetal abnormalities
!!!Risk > benefit
!!!Drug is contraindicated

dietary supplement classification

complementary and alternative medicines (CAM)
!complementary: natural product used in addition to conventional meds
!alternative: natural products used in place of conventional meds
integrative health (IH)
!combines natural and conventional approach in coordinated and purposeful way

structure and function claims

how a product may maintain normal structure/function of the body WITHOUT discussing specific disease states

Ex: supports healthy cholesterol levels (not reduce!)

disease claims

reduction in risk of a disease or health related condition

Ex: a diet low in saturated fat and cholesterol and includes 25g of soy protein may reduce heart disease

Requires FDA approval

quackery

medical practice and advice based on observation and experience in ignorance of scientific findings

ineffective products being promoted and used

common dietary supplments

Adult: fish oil, glucosamine, chondroitin, probiotics, melatonin, and CoQ10

children: fish oil, melatonin, probiotics, echinacea, and garlic

Guidelines

help make decisions regarding patients with certain disease states

includes diagnosis, clinical management, and treatment

GS: medical org webpage - AHA etc.

limitations - guidelines are GS until they are out of date, liability issues

ABC of literature evaluation: A

Applicability

Address practice or professional needs and applies to appropriate patient population

ABC of literature evaluation: B

Bias

systemic or induced error leading to data distortion

selection bias

error in selection or sampling of individuals for a study

Data collection bias

error in design or experiment

Investigator bias

hard to detect and includes manufacturer funded data – not always biased

ABC of literature evaluation: C

confounding

Did investigator fail to do something that would influence outcome or other factors that explain results

Prospective studies

data collection after the study onset, follow individuals over a period of time

forward

Retrospective studies

evaluation of data from past events or existing data to achieve research objective

backwards -> relationship between cause and event

Includes medical records

Controlled trials

experimental drug or procedure is compared to another drug or procedure OR a placebo/previously accepted therapies

Uncontrolled trials

experience with drug is described BUT treatment is not compared to other treatments

Meta-analyses

Combines results to develop conclusions with greater statistical power than individual smaller studies

Includes quantitative assessment and summary of findings

Important for studies with small number of subjects or come to different conclusions

Systematic review

Summary of clinical literature

question followed by literature search

sometimes includes meta analysis to synthesize results

Methods must be reproducible and transparent

blind studies

Non-blind: everyone is aware who is given active or control

Single-blind: subject OR investigators are unaware of assignment

Double-blind: both are unaware

Triple-blind: subject, investigator, and analyzers are unaware

in vitro/animal studies

#1

is an idea viable or safe before moving onto human models

commentaries/editorials: new questions or questions with too little data available

case report

unusual event in a single patient

outcome already known

case series

unique characteristic observed in a group of patients

outcome already known

case-control

particular outcome has already happened (case) compared to those without the outcome (control) and prior risk is compared

cross-sectional

risk factors and health status is studies at one specific point in time

what is happening right now

aka prevalence studies

cohort

two groups (exposed and non-exposed) followed until development of an outcome of interest

what will happen

forward

prospective and retrospective studies

generalizability

extent to which findings in a study are applicable to other settings

aka external validity

requires internal validity and applicability

hierarchy of research design

****bottom to top

1. animal/laboratory studies
2. case report of case series
3. case control studies
4. cohort studies (primary)
5. randomized controlled trial (primary)
6. meta-analysis and systematic review (secondary)
7. clinical practice guidelines (GS) (secondary)

journal club importance

1. outdated irrelevant guidelines or

2. too much literature for one person to read

3. multiple perspectives improve comprehension

Parts of a journal club

1. citation
2. purpose/objective of the study
3. background
4. study design
5. patient demographic
6. inclusion/exclusion criteria
7. outcome variables
8. procedures
9. statistical methods
10. results/author's conclusions
11. your conclusions - including strengths, weaknesses, and your recommendations

p-value

describes strength of a result

level of significance

smaller = more statistically significant
!not necessarily clinically relevant

usually p < 0.05
!less than 5% likelihood the result is due to chance

clinical significance

results are important enough that they would change the way we practice

relative risk

risk of an outcome in one group with exposure compared to a group without

RR = 1: no association
RR > 1: positive association
RR < 1: negative association

intervention/placebo

relative risk reduction

percent decrease in risk

RRR = (1 - RR) x 100

absolute risk reduction

absolute difference in rates of results between treatment and control groups

control - intervention

number needed to treat

how many patients need to be treated in order for one patient to have desired outcome/benefit

1/ARR (as a decimal)

smaller = more significant

odds ratio

odds of exposure in cases divided by odds of exposure in controls

case-control studies

=1: no difference in risk
>1: exposed group has greater risk of outcome

confidence interval

estimate of the range within which the true treatment effect lies

usually 95%
!95% certain effect lies within range

>1 is insignificant

intention to treat analysis

results of a trial include all patients who were randomized for the study regardless of whether they finished the study

journal club 2x4 method

first sentence = study type, number and type of participants, and treatment (IV)

second sentence = duration, outcome (DV), results, and p-value

third sentence = dosing, AE, etc.

hipatitis

disease of terminal coolness

OBRA-90

omnibus budget reconciliation act

address projected budgetary shortfalls

OBRA-90 goals

1. appropriate prescriptions
2. prescriptions are medically necessary
3. prescriptions do not cause AE

counseling

communication by a pharmacist of info - defined by state board of pharmacy - to a patient or caregiver to ensure proper use of meds to medical devices

pharmacist responsibilities under OBRA-90

1. maintaining proper patient records
2. performing prospective DUR
3. patient counseling

proper patient records

full name
address
current number
DOB
age
gender
history

Drug utilization review

systematic review of drug regime
1. therapeutic use - dose and duration
2. duplication
3. interactions and contraindications
4. ADR
5. abuse and misuse

SOLER

S: squarely face the patient
O: open posture
L: lean toward patient to show interest
E: eye contact
R: relax - no fidgeting

high performance patient communication

open ended Q
active listening
empathy
verification of understanding
remove distractions

openness in patient-centered communication

listen
acknowledge
wonder
recognize
question
reflect

magic 8 steps to counseling

1. name and description of med
2. dosage form, dose, route, and duration of therapy
3. special directions or precautions
4. side effects
5. techniques for self-monitoring
6. storage
7. refill info
8. missed dose actions

quest scholar

Qu: question SCHOLAR
E: establish
S: suggest
T: talk

S: symptoms
C: characteristics
H: history
O: onset
L: location
A: aggravating factors - makes it worse
R: remitting factors - makes it better