Principles of Pharmacology

Session 2
Elizabeth Young, Pharm.D., FSVHP
Wasson Veterinary Pharmacy Resident
January 18th, 2018
Quick Review from last week

1. What are the 3 main components of a VCPR?

a) Agreement, examination, record-keeping
b) Agreement, recent examination, follow-up
c) Knowledge of patient, recent examination, follow-
up
Quick Review from last week

2. Which of the following is NOT an amendment

to the Food, Drug, and Cosmetic Act of 1938?
a) AMDUCA
b) ADAA
c) Veterinary Medicine Motility Act
d) MUMS
Quick Review from last week

3. Which of the following does NOT require a

WDT?
a) Chicken
b) Cow
c) Dog
d) Rabbit
Objectives

 Briefly introduce the naming of medications

 Discuss the differences between legend and OTC medications

 Review the contents of a package insert

 Introduce abbreviations used for prescriptions and drug regimens

 Introduce the different types of dosage forms

How are Drugs Named?
 Drug Names

There are several different names associated

with medications.
Chemical name
Non-Proprietary name
Proprietary name
Chemical Names

 Chemical names are given to drugs when they are first

discovered.
 They identify the atomic or molecular structure.
 These are usually too complex to be used in daily
conversation.

 Example:
 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-
one
 Non-proprietary Names

 These are known as the “generic” names or active ingredient

 This name is assigned by an official body known as the USAN
(United States Adopted Names) council.
 There are usually two parts to these names
Prefix: identifies the individual drug within a group
Stem: identifies the drug group
 Propranolol, atenolol, sotalol = beta blockers
 Diazepam, clonazepam, lorazepam = benzodiazepines

 Example:
Diazepam
 Proprietary Names
Brand (trademark, trade) name
These names are developed by the company that is
requesting approval for the drug from the FDA.
It identifies the exclusive property of that company.
Drugs are marketed under it’s brand name while it is
under patent protection. Once the patent has
expired, the company can market its product either
as the generic name or the brand name.

Example:
Valium
 Legend vs OTC drugs

 Legend drugs are medications that require prescriptions or must be

ordered in-house by the clinician.
 Legend Drugs are identified on their label via the ℞ symbol.
 Legend vs OTC drugs

 Legend drugs are medications that require prescriptions or

must be ordered in-house by the clinician.
 Legend Drugs are identified on their label via the ℞ symbol.

 How do you tell if a drug is FDA approved for animals?

The Green Book (aka “Animal Drugs @ FDA”)
Lists all FDA approved drugs and generics both OTC and
prescription-only
 Legend vs OTC drugs

In human medicine a “Legend drug” needs to have the

statement “Caution Federal law prohibits dispensing
without a prescription”
In veterinary medicine a veterinary only “Legend drug”
states: “Caution: Federal law restricts this drug to use by or
on the order of a licensed veterinarian.”
It also contains a valid NADA or ANADA number
Who remembers from last week what NADA
or ANADA stands for?
Legend vs OTC drugs

 OTC = “Over-the-counter” medications  no

prescription required.

 These medications are still approved by the FDA,

however they are safe enough with simple
instructions that anyone can use them
 “idiot-proof”

 There are few significant side effects/adverse

reactions.
Where can you see if a drug is FDA
approved for animals?

a)The Orange Book

b)The Index
c)The Green Book
d)Google
Package Insert
 What the Package Insert Contains

Brand Name (generic

name)
Strength of
medication
Identifies as a Legend
drug
Drug Class
Physical description
of drug form
Chemical name
Indications
Dosage and
Administration
 Only the FDA approved dosage will be
listed in the package insert
The dosage describes how to determine the
amount of drug that has been approved to be
given to any animal.
10 mg/kg (mg = drug mass in milligrams, kg =
animal’s weight in kilograms)
20 g/lb (g = drug mass in grams, lb = animal’s weight
in pounds)
The dose is the mass of drug given to a single
patient – it should be calculated.
25 mg (specifically for a 2.5 kg cat getting a dosage
of 10 mg/kg)
How to properly communicate the dose

A dose should NOT listed as a volume amount or

as a number of dose forms
4 tsp
2 tablets
5 mL
 Why Not?
The package insert also lists the
Dosage Regimen
There are 3 parts to a regimen
Dosage (can be a range: 2-4 mg/kg)
Dosing Interval (every 24 hours, twice daily)
Route of Administration (by mouth, subcutaneously)
Abbreviations: Dosing interval

 “q” = every
 ”h” = hour
 “d” = day
 ”PRN” = as needed

 SID = once daily

 BID = twice daily It’s not recommended that
 TID = three times daily these be used, WHY?
 QID = four times daily
 Abbreviations: Route of Administration
 IV = intravenous (into the vein)
 IV bolus = dose given all at once
 IV infusion = dose given slowly over time
 CRI = constant rate infusion
 IM = intramuscularly (into the muscle)
 SQ (or SC) = subcutaneously (under the skin)
 ID = intradermal (into layers of the skin)
 IP = intraperitoneal (into the abdominal cavity)
 IA = intra-articular (into the joint) or intra-arterial (artery)

 These are all parenterally administered : any non-GI tract means of

administration
Abbreviations: Route of Administration

 PO = by mouth
 SL = sublingual (under the tongue)
 OU, OS, OD = both eyes, left eye, right eye
 AU, AS, AD = both ears, left ear, right ear
 PR = per rectum
 Topically = administered onto the skin
 Aerosolized = medication inhaled into the lungs
 The process of turning a drug into a mist = nebulization
Indications
Dosage and
Administration

Contraindications
Contraindications

 These are conditions under which a drug should not be

given to a patient
 2 types:
 Relative contraindications: caution should be used when
deciding to use the medication. Need to weigh the
benefits vs. the risks of using the medication.
 Absolute contraindications: using the medication could
cause life-threatening situations. The medication should
never be used, period!
 Warnings and Precautions
 These two sections are
sometimes lumped together
by the FDA – but they
indicate different levels of
concern.
 Warnings: reactions to drugs
that may require medical
intervention; there are
significant safety issues
 Precautions: milder reactions
or safety issues; these
typically do not warrant
medical intervention
Warnings vs. Precautions

Warnings Precautions
 “Not for use in humans”  “Appetite should be
 ”All cats should undergo monitored”
a thorough history and  ”Use of this drug has not
physical…before the been evaluated in cats
initiation of NSAID younger than 4
therapy” months…”
 ”Do not administer Onsior  “The use of Onsior in cats
tablets or injection in with cardiac disease has
conjunction with any not been studied...has
other oral or injectable been shown to prolong
NSAID or corticosteroid.” the QT interval”
 Adverse Drug Reactions vs. Side Effects

Adverse Drug Reaction (ADR, adverse drug

event):
“an undesired occurrence that results from taking a
medication correctly”
The event is not expected.
Side Effect:
“an undesired effect that occurs when the
medication is administered regardless of the dose.”
Usually known about before taking the medication
How to report an Adverse Drug
Reaction

If you observe an ADR, it needs to be reported.

You should contact the manufacturer of the
medication and report the event.
If you want to report directly to the FDA – fill out
form 1932a - "Veterinary Adverse Experience,
Lack of Effectiveness or Product Defect Report"
Black Boxed Warning

 This is a warning that is designed to call attention to a serious or life-

threatening risk.
 It is the strictest warning that can be on the labeling.
 Has a black box around the warning = Black Boxed Warning
Information for
Owners
Clinical
Pharmacology
Absorption
Distribution
Metabolism
Elimination
Safety and Effectiveness

Safety studies
Efficacy studies
Storage Conditions and How Supplied

Storage
Conditions
How the
medication is
supplied
Translate the following so that a client
would understand:

 5 mg/kg PO q12h (10 kg dog, 50 mg tablets)

 10mg/kg SC SID (20 kg dog, 100mg/ml solution)

Dosage Forms
 Describing Medications

Dosage forms or dose formulations are the

physical appearance or description of a
medication “form”

Capsule Caplet

Tablet
Why do we have so many different
dosage forms?
To protect the drug
From moisture, from sunlight, from stomach acid
Ease of administration
Patients may take a liquid better than a tablet
Different routes of administration
PO vs. SL vs. IV vs. SQ
 Identification
 Pharmacokinetic reasons
 Solid dosage forms
 Don’t use the word “pill” – this is inaccurate and is broadly
misinterpreted

 Tablets
 Powders that are compressed into a round form
Active ingredient = drug
Excipients = all other ingredients
Binders – hold the tablet together
Disintegrants –allows the tablet to dissolve properly
Colors, diluents, flavoring agents
Solid Dosage Forms

Caplets
Elongated, oblong shaped tablet
Why? – To make it easier to slide
down your throat

It’s important to note that there are

resources to identify medications via
their markings
https://www.drugs.com/imprints.php
Tablet and Caplet Coatings

Often tablets and caplets are coated.

Purpose of coatings:
Easier swallowing
Protects from breakage
Covers taste
Protects from moisture or light
Marketing purposes – color
Tablet and Caplet Coatings

Enteric coated tablets are made to

remain intact while passing through the
acidic environment of the stomach (pH 2-
3), then dissolve when they reach the
more alkaline intestines of a human (pH 6).
Many medications are degraded/denatured
by acidic environments
There are also medications that can be
absorbed “too well” from the stomach – which
can lead to inflammation of the gastric
mucosa (aspirin)
 Tablet and Caplet Coatings

Sustained Release or Controlled Release

 Releases drug over time as it passes through the GI tract
 Based on many factors including pH, time in the GI tract, etc
Thus, these types of medications often don’t work as well in
animals compared to humans
Human GI tract = 20 ft, Canine GI tract = 3 ft (Chihuahua), 12 ft
(beagle), 18 ft (German shepherd)

**These extended release medications

should never be split, crushed, or
chewed.
Molded Tablets (Chewable tablets)
Tablets can come in chewable or non-
chewable forms
Chewable tablets contain:
Active ingredient, mixed with binders and
lactose, sucrose, or dextrose and a flavoring
agent
They are meant to be chewed and swallowed
Problem: there has been reports that dogs
like the flavoring so much that they break
into the bottles and eat the entire contents
– which can lead to overdose.
Gel Caps or Capsules

Powdered drug
surrounded by a capsule
made of gelatin, modified
starch, or cellulose
Microencapsulation can
make capsules sustained
release
Other Solid Dosage Forms

Lozenge or troche (“TROH-key”) – hard candy-

like tablet that is meant to dissolve in the mouth.
Implants – solid polymer material that dissolves
and releases medication over a period of
months.
Suppositories – administered per rectum to
dissolve and be quickly absorbed.
Other Solid Dosage Forms
Powder - formulation in which a drug powder is
mixed with other powdered excipients to
produce a final product
Dissolve faster than tablets or capsules because
disintegration is not an issue.
Granules - consisting of powder particles that
have been aggregated to form a larger mass
granules must deaggregate before dissolution
and absorption.
Semi-solid dosage forms

Ointments and creams liquefy at body

temperatures
This helps the medication flow into cracks and
crevices better

Ear canals
can close up
with chronic
inflammation
Cream Ointment
Semi-solid dosage forms

Pastes
Designed to retain solid form at body temperature
(compared to creams and ointments)
Administered with a large syringe
Often used as orally administered medications
Deworming medications
Pain medications
 Transdermal Dosage Forms
Transdermal Delivery Gel
most commonly pluronic lecithin organogel (PLO gel)
delivers drug via the transdermal route to the bloodstream
The dose is applied to the inner surface of the pinnae,
thereby offering ease of administration, especially in cats.
Transdermal Patch
Consists of: drug incorporated into a reservoir, a protective
backing layer, a rate-limiting release membrane, and an
adhesive layer to secure the patch to the skin.
You should always wear gloves while applying or removing
patches
Aerosolized Dosage Forms
These medications are designed to be
inhaled into the lungs
Metered Dose Inhalers (MDI) and aerosol
chambers

MDI
Liquid Dosage Forms

Solutions – drug dissolved in a medium – usually

a liquid solvent
Can be given IV – however, not all solutions are
Aqueous solution  medium = water
Syrup  medium = sugar solution
Suspensions – drug not dissolved
Drug settles out over time
ALL SUSPENSIONS MUST BE SHAKEN BEFORE
ADMINISTRATION
Can be given PO, IM, SC, - NEVER IV
Caution with syrups

Often human drugs (and other products) are

made with artificial sweeteners.
What artificial sweetener is toxic to dogs?
__________
Causes hypoglycemia (hyperinsulinemia) and
liver necrosis in dogs
Liquid Dosage Forms

Emulsions: system consisting of two immiscible

liquid phases, one of which is dispersed
throughout the other in the form of fine droplets
Drug is dissolved in a liquid solution….
...then mixed (won’t dissolve) with an oil-
based medium to form an emulsion
Tend to settle out and need to be shaken
 Injectable Dosage Forms

 Solutions
 Suspensions

 Can come in what is called an ampule

 glass bottles meant to deliver 1 measured
dose
 Are opened by snapping off the top at the
narrow glass neck
 Make sure to use a gauze to protect yourself
when opening – it can cut you
 Make sure to filter the contents (with a filter
needle or filter straw)
 Injectable Dosage Forms
 Multidose vials vs. Single dose vials
 Multidose  can be used multiple times
 Has a rubber stopper that should be kept clean (using an alcohol
wipe) to prevent introduction of bacteria
 Usually contains a preservative
 Unless otherwise stated on the product, these should be discarded 28
days after opening.
 Single dose  should only be punctured once/used
immediately
 Do not contain preservatives
 Example – vaccines
 Often times they are in a powered form, and need reconstitution with
a diluent.
Bottom line on Dosage Forms

There are many different dosage forms to allow

for different delivery methods.
Modification of a dosage form can alter it’s
ability to be delivered adequately.
Know the vocabulary so that you understand
how a product should be used.
Which of the following needs to be
shaken before administration?
a)Solutions
b)Suspensions
c)Emulsions
d)Both b & c
Summary

Learn generic names and commonly used

brand names of medications (Lasix, Banamine,
Rimadyl)
Understand the differences between OTC and
Legend drugs
Know the abbreviations used for drug regimens.
Be able to recognize what a package insert
contains.
Principles of Pharmacology
Session 2
Elizabeth Young, Pharm.D., FSVHP
Wasson Veterinary Pharmacy Resident
January 18th, 2018
young481@purdue.edu