Didactic Exam

drug monograph

a comprehensive, organized summary of information about a medication designed to help healthcare professionals use the drug safely and effectively

The drug monograph is written by ________ and is approved by _____

manufacturer

FDA

What law helped establish requirements for accurate and informative labeling of products

Fair packaging and Labeling Act (1966)

Code of Federal Regulations (CFR)

the collection of federal regulations/rules

divided into 50 titles representing broad areas subject to federal regulation

Which CFR title contains federal drug regulations?

CFR 21

Generic Name

US Adopted Names Council (USAN) works with manufacturers to establish names

• similar drug names often have the same stem (lisinopril, fosinopril)

Brand Name

aka trade name: pharmaceutical manufacturer proposes a proprietary name then gets approved approved by FDA

• may have slight differences in inactive ingredients, but still equivalent active ingredients

Indications

why you would use the drug

difference between labeled indications and off-label indications

labeled indications are specifically what the drug is for while off-label indications are another way the drug can be used (ex: opioid withdrawal with clonidine)

clinical data means it was conducted in ________ while nonclinical data means it was conducted in _____

humans

animals

contraindications

when to NOT use this drug

• a specific situation where the drug should not be used because the potential risk of harm outweighs any possible therapeutic benefit

absolute contraindication vs relative contraindication

DO NOT USE vs. usually avoid/use cautiously

Warnings and Precautions on a drug

when should I be especially careful?

• identifies a discrete set of adverse reactions or other potential safety hazards that are serious or are otherwise clinically significant because they have implications for prescribing decisions or for patient management

• also can show what patient populations are at risk, medical conditions that may increase risk of harm, etc.

Adverse Reactions

unwanted effects that might occur

• the rxn could be related to the pharmacological action of the drug, and therefore predictable, or it could be unpredictable

What are the FDA approved labeling for patients? (4)

Patient Package Inserts (PPI)

Medication Guides (MGs)

Patient Instructions for Use (IFU)

May 2023 proposed rule - Patient Medication Information (PMI)

Patient Package Inserts (PPI)

tells the patient about their medication

• they are developed by the manufacturer

• “What is this drug? Who shouldn’t use it? how do I take it? what are the important risks and side effects?”

• reqd for oral contraceptives and estrogen-containing products

Medication Guides

specifically focused on info FDA determines patients need to know to use certain medications safely and effectively to prevent serious side effects

• patient adherence to directions for use is crucial to the drugs effectiveness

• reqd for REMS

REMS

Risk Evaluation and Mitigation Strategy

• a drug safety program that the FDA can require for certain medications with SERIOUS safety concerns to help ensure the benefits of the medication outweighs its risks

• focuses on preventing, monitoring, and/or managing a specific serious risk by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of the event

Patient Instructions for Use (IFU)

shows the patient how to use the medication

• for products that have complicated or detailed patient use instructions

• injection pens, autoinjectors, inhalers, etc. have these

• can cover preparation, administration, handling, storage, and disposal

May 2023 proposed rule - Patient Medication Information (PMI)

gives every patient the essential info in a similar format

Required for prescription drugs used, dispensed, or

administered on an outpatient basis, as well as for blood and

blood components transfused in an outpatient setting

• When the rule is finalized, the PMI will:

• Contain essential information that patients need to

know about the prescription drug

• FDA-approved one-page document: (Indications,

Warnings, Common side-effects, serious side-effects,

directions for use)

• Standardized in format

• Written in understandable language

• Provided for outpatient prescription drugs

Schedule I (Ci)

drugs with no current medical use with high potential for abuse and/or addiction

• meth, heroin

Schedule II (CII)

drugs with some medically acceptable uses, but with HIGH potential for abuse and/or addiction. These drugs can be obtained through prescription

• adderall

Schedule III (CIII)

drugs with low to moderate potential for abuse and/or addiction, but less dangerous than CI or CII. These drugs can be obtained through prescription. Generally are not available over the counter

• testosderone

Schedule IV (CIV)

drugs with viable medical use and low probability of use or misuse

• xanax

Schedule V (CV)

drugs with low potential for abuse (lower than schedule IV)

• pregablin (lyrica)

Boxed Warning

meets one of these 3 criteria:

• An adverse reaction is so serious in proportion to the benefit of the drug that it needs to be considered before prescribing the drug.

• There is a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug

• FDA approved the drug with restrictions to ensure safe use

Beers List

a guide of potentially inappropriate medications that older adults (typically 65 and older) should use with caution or avoid

What are the five beers criteria?

• avoid if you’re over 65 years old and not in a hospice or a palliative

care setting.

• cavoid among people with certain health conditions.

• avoid that cause drug interactions when combined with other medications.

• avoid due to harmful side effects that outweigh the benefits.

• use at limited doses or avoided due to their effects on kidney function (renal

impairment).

ectomy

removal

oma

tumor

pathy

disease

osis

abnormal condition

genic

producing

graph

recording instrument

stasis

stopping/controlling

qs

quantity sufficient

mcg

microgram

PO

by mouth

IV

intravenous

SC/SQ

subcutaneous

SL

sublingual

PR

per rectum/rectal

PV

per vagina/ vaginal

IM

intramuscular

INH

inhalation

TOP

topical

ung

ointment

crm

cream

gtt

drops

inj

injection

RR

respiratory rate

Hgb

hemoglobin

Hct

hematocrit

WBC

white blood cell

CBC

complete blood count

SCr

serum creatinine

CrCl

Creatine Clearance

eGFR

estimated glomerular filtration rate

INR

International Normalized Ratio

A1C

measures your avg blood sugar levels over the past 2/3 months

NPO

nothing by mouth

QD

daily

QID

four times a day

QOD

every other day

qHS

at bedtime

ac

before meals

pc

after meals

aa

in equal parts or of each

UD

use as directed

what is a sig

will appear right before directions on the prescriptions

• means write on label

What is Bloom’s Taxonomy?

• Create – Develop a patient-specific plan

• Evaluate – Determine whether therapy is

appropriate

• Analyze – Identify drug-related problems

• Apply – Counsel and educate a patient

• Understand – Explain what a medication

does

• Remember – Know the medication

What is the foundation to think like a pharmacist?

remember and understand - Brand/generic names, spelling, dosage forms, FDA-approved indications, common adverse rxns, contraindications, precautions, and key counseling info

What info do you need to know for each drug regarding drug cards?

● Brand/Generic name (Recognize and correctly spell)

● Therapeutic Drug Class (found on top right card)

● Common Dosage Forms

○ Formulations only, not specific dosage strengths (e.g., tablet, suspension, cream, injectable, powder,

etc.)

● FDA Indications/Dosages

○ For indications, focus on major categories of indications (e.g., pain, treatment of infections,

treatment of hypertension, etc.) *Some drugs may have multiple indications

○ For dosages, focus on highlighted dosing information only (if there is no highlighted dosing

information on the drug card, do not need to know dosing information)

● Monitoring Parameters

● Contraindications/Precautions

○ Focus on information that is all capitalized in bold face

○ Medications that are pregnancy category X

● Adverse Effects

○ Focus on most common adverse effects or ones associated with significant patient harm

● Patient Consultation

○ Focus on major counseling points related to medication administration or patient safety

● REMS/BEERS List

● CII – CV Control Scheduled medications

What is Lab testing used for?

detect disease

guide treatment

monitor treatment response and/or disease progression

When should labs be ordered? (7)

• To discover disease

• Confirm suspected diagnosis

• Differentiate among possible diagnoses

• Determine stage, activity, or severity of disease

• To detect disease recurrence

• To assess the effectiveness of therapy

• To guide the course of therapy

accuracy

extent to which the mean measurement is close to the true value

precision

reproducibility of the assay (ability to produce the same result repeatedly)

specimen

sample used for lab analysis (whole blood, venous blood, urine, sputum, tissue, etc.)

plasma

water acellular portion of blood

serum

liquid that remains after fibrin clot removed from plasma

qualitative test

results are reported as positive or negative without characterization of degree of positivity or negativity

quantitative test

results are reported as an exact numeric measurement and assessed in context of a reference range of values

semiquantitative test

results are reported as either negative or with varying degrees of positivity without quantification

screening vs. diagnostic tests

screening: Individuals WITHOUT signs/symptom of disease, high sensitivity, and requires confirmation with other tests

diagnostic: individuals WITH signs/symptoms of disease and high specificity

sensitivity

ability to identify positive results in patients who have disease (true positive)

specificity

percent of negative results in people without the disease (true negative)

reference range (normal range)

statistically-derived numerical range obtained by testing a sample of healthy individuals

when should lab errors be suspected?

• Inconsistent result with trend in serial results

• Magnitude of error is great

• Result does not coincide with a confirmatory test

• Result is inconsistent with patient’s clinical status

lab erros are usually caused by __________ errors

processing or equipment

lab results must be interpreted in context of…

what is known about the patient

When interpreting Lab Results

-consider baseline results, if available

-compare lab value to reference range

-assess rate of change of lab value

-identify isolated result vs. trend

spurious lab value

false lab value

• difficult to differentiate spurious result and real lab value

  • must consider patients clinical picture

  • consider possibility of lab error or other interfering factors

• repeat testing may be needed to rule out actual abnormality

Centralized Lab testing Advantages and Disadvantages

adv:

• ability to perform variety of tests

• automation of testing and result reporting

• higher quality care standards

• accuracy of results

disadv:

• costly

• turn around time may be slower

• must be done in one location

Point-of-Care testing (POCT) advantages and disadvantages

adv:

• portability

• quicker turn around time

• per test typically higher, but overall cost may be lower (aka the machine may be cheaper, but the test strips could be more expensive)

disadv:

• misuse of misinterpretation of results

• documentation errors

• inappropriate test material disposal

Clinical Lab Improvement Ammendments of 1988

Home Testing Adv and Disadv

Adv;

• convenient,

• less costly

• rapid turn around time

• privacy

Disadv:

• misinterpretation of test results

• delays. in seeking medical advice

• lack of pre- and post-test counseling/pyschological support

Complete test kits

obtain own sample, tests sample, and reads results

Collection kits

obtain own sample, mails sample to lab, receives result by mail or telephone

What are the three major areas a central lab is divided into?

chemistry profile analyzers

complete blood count instruments

automated microbe identification systems

What is the Basic Metabolic Panel (BMP)?

basic electrolytes plus renal function

Comprehensive Metabolic Panel (CMP)

everything from a BMP plus a few more to assess liver profile