Pharmacy 101

PHARMACY 101
FEBRUARY 22, 2018
E L I Z A B E T H YO U N G , P H A R M . D. F S V H P
WA S S O N V E T E R I N A RY P H A R M A C Y R E S I D E N T
P U R D U E U N I V E R S I T Y V E T E R I N A RY T E A C H I N G H O S P I TA L
1
OBJECTIVES
 Review laws that apply to the veterinarian when writing prescriptions.
 List controlled substances used in veterinary medicine and their corresponding

schedules assigned by the DEA.
 Discuss the requirements of writing a prescription (controlled and non-controlled).
 Review the education most pharmacists have regarding veterinary medicine.
 Describe how to find a reliable compounding pharmacy.
2
PHARMACY LAW & VETERINARY MEDICINE
3
HISTORY OF IMPORTANT LAWS
 Food and Drug Act of 1906 – prevention of mislabeling

 Products must contain what the label says it contains
 No safety testing required
 No efficacy testing required
 This law only forbade fraudulent curative claims

4
HISTORY OF IMPORTANT LAWS
 Food, Drug, and Cosmetic Act of 1938 – requirements for safety testing
 Sulfanilamide disaster in 1937:

 Sulfanilamide – used to treat strep throat (mainly children)
 “taste of raspberries, taste of death”
>100 people died of renal failure
 Many amendments apply directly to animal drugs
5
AMENDMENTS TO THE FEDERAL FDC ACT
 AMDUCA = The Animal Medicinal Drug Use Clarification Act of 1994
 “made extra-label-drug-use an FDA-regulated veterinary medical activity, allowing

veterinarians to prescribe extra-label uses of approved animal and human drugs when
the health of an animal is threatened, or when suffering or death may result from
failure to treat animals.”
 Prior to it’s passage, extra-label drug use was illegal.

6
AMDUCA
1. Make a careful diagnosis and evaluate the conditions for which the drug is to be used.
2. Make sure there is not an approved medication that is labeled for such use in that
species, or that contains the same active ingredient in the required dosage form and
concentration
 Alternatively if an approved animal drug exists but a veterinarian finds, within the context of a VCPR, that
the approved drug is clinically ineffective for its intended use, extra label use of an alternative medication is
permissible.
3. Establish a substantially extended withdrawal period supported by appropriate

scientific information prior to marketing milk, meat, eggs, or other edible products
from the treated animals
4. In non-food producing animals, a drug labeled for use in humans can be administered 7
even if an animal-label drug for that species and medical condition exists.
EXTRA LABEL DRUG USE (ELDU)
 Describes the use of an approved drug in a manner that is not in accordance
with the approved labeling.
• If we use this in a dog, is it ELDU?

• Yes
• So, why can this legally be used in a dog?
• There are no cyclosporine
solutions approved in dogs 8
EXTRA LABEL DRUG USE (ELDU)
 ELDU of an FDA approved drug may be used if:
 There is no approved animal drug that is labeled for such use, or that
contains the same active ingredient in the required dosage form and
concentration
 An approved animal drug for that species and condition exists, but a
veterinary finds that the drug is clinically ineffective for its labeled use.
9
WITHDRAWAL TIME (WDT)
 The WDT is the estimated time that tissues can be safely consumed
following the last dose of drugs in 99% of animals treated.
 WDTs are expressed in days for meat and eggs, and hours for milk
 Meat: the animal cannot be slaughtered for food prior to that time
 Milk: the milk taken from the lactating cow must be discarded for that many hours
after the last dose of drug is given
 Drugs approved for use in food animals must contain WDT information
on their labeling 10
CONTROLLED SUBSTANCES ACT (CSA)
 Controlled Substances Act (CSA) of 1970

 Grants the Attorney General the power to classify substances based on their potential for
addiction and abuse
 The addition, deletion, or change of schedule of a medication or substance may be

requested by the DEA, Department of Health and Human Services, the FDA, or from
any other party via petition to the DEA
11
CONTROLLED SUBSTANCES ACT (CSA)
 There are five schedules/classes of medications that are used to classify drugs – these
are based on the abuse potential, medical applications, and safety.
 Schedule I: High abuse potential, NO accepted medical use

 Schedule II: High abuse potential, accepted medical use; use may lead to
psychological/physical dependence
 Schedule III: Lower abuse potential, accepted medical use; may lead to moderate or
low physical dependence or high psychological dependence
 Schedule IV: Low abuse potential, accepted medical use; may lead to limited physical
dependence or psychological dependence
 Schedule V: Low abuse potential, accepted medical use; may lead to limited physical 12
dependence or psychological dependence relative to the drugs in schedule IV.

CONTROLLED SUBSTANCES
 Examples:
 Schedule I: heroin, marijuana
 Schedule II: hydromorphone, fentanyl, codeine, methadone
 Schedule III: ketamine, buprenorphine, pentobarbital (euthanasia solution)
 Schedule IV: tramadol, phenobarbital, butorphanol, benzodiazepines (alprazolam,
diazepam, etc.)
 Schedule V: diphenoxylate + atropine (Lomotil)
 A medication schedule can change at any time 13

CONTROLLED SUBSTANCES
 “A prescription for a controlled substance may be issued by one of the following
practitioners licensed in Indiana:
 physician,
 osteopathic physician,
 veterinarian,
 podiatrist,
 advanced practice nurse,
 physician assistant
 … The practitioner must hold an Indiana Controlled Substance Registration
(CSR) and a federal Drug Enforcement Agency (DEA) registration … in order to14
prescribe a controlled substance.”
PRESCRIPTION WRITING
15
HERE IN THE HOSPITAL WE USE
Non-Controlled Substances Controlled Substances

16
WHAT IS REQUIRED ON ALL PRESCRIPTIONS?
 According to Federal and Indiana law each prescription must contain the following:
1. Name of the owner & patient 9. Directions for use
2. Address of the patient 10.Quantity to dispense
3. Species of the patient 11.Number of refills (if any) authorized
4. Prescriber’s name 12.Prescriber’s DEA number (if prescribing
5. Prescriber’s address a controlled substance)
6. Drug name 13.Date of issue
7. Drug strength 14.Signature of prescriber
8. Dosage form
 There are also recommended items that can be included on a prescription

1. Weight of the patient 2. Dosage (mg/kg) 3. Length of therapy
17
Drug Enforcement Agency http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm

Indiana Code 25-26-13-2 Definition of “Prescription”
1. Name of the owner & patient 3. Species of the patient
2. Address of the patient
Dr. John Smith

625 Harrison St., West Lafayette, IN 47907
DEA# AB1234567
Jane Doe “Spot” (Canine)

Name:_________________________________Date: ________
123 Sesame St, West Lafayette, IN 47906
Address: _____________________________________________
Refill: NR 1 2 3 4 5 Void After__________
_______________________ _______________________
Dispense as Written May Substitute
18
4. Prescriber’s name
5. Prescriber’s address
Dr. John Smith


Name:_________________________________Date: ________
Address: _____________________________________________
_______________________ _______________________
19
HERE IN THE HOSPITAL…
Non-Controlled Substances Controlled Substances

20
6. Drug name 9. Directions for use
7. Drug strength 10. Quantity to dispense
8. Dosage form
Dr. John Smith


Name:_________________________________Date: ________
Address: _____________________________________________
Rimadyl (Carprofen) 25 mg caplets #14

1Give
tab 1PO
tablet
q12hby mouth every 12 hours.
_______________________ _______________________
21
DIRECTIONS FOR USE
 Must include: Dose/Units: 1, 5, 0.4

Dosage form: tablet, capsule, mL
 Dose/Units Route: PO, IV, etc.
Frequency: q12h, once daily, etc.
 Dosage form
 Route of administration
Always include leading zeros, but never
 Frequency include trailing zeros!
 Can also include: Do This Don’t do This
• 0.4 mL • .4 mL
 Duration of therapy • 5 mL • 5.0 mL
 Indication
22
11. Number of refills (if any) authorized
• Number allowed differs depending on the type of medication
you are prescribing
Dr. John Smith


Name:_________________________________Date: ________
Address: _____________________________________________
Rimadyl (Carprofen) 25 mg caplets #14

1 tab PO q12h

_______________________ _______________________
23
HOW MANY REFILLS CAN YOU PRESCRIBE?
 CII – cannot be refilled.
 Federal and State Law agree
 Indiana Code
 CIII – CV – can be refilled up to 5 times in 6 months
 Federal Law
 CIII – CIV – can be refilled up to 5 times in 6 months
 CV – may be refilled as authorized by the practitioner
24
https://www.deadiversion.usdoj.gov/faq/prescriptions.htm
https://www.in.gov/pla/3017.htm
12. Prescriber’s DEA number (if 13. Date of issue
prescribing a controlled 14. Signature of prescriber
substance)
Dr. John Smith

DEA# AB1234567

Name:_________________________________Date: 1/25/18
________ If you are typing out a
Address: _____________________________________________ prescription, you have to
actually sign the form
Rimadyl (Carprofen) 25 mg caplets #14 when you print it out.
1 tab PO q12h
_______________________ Dr. John Smith DVM

_______________________
25
DISPENSE AS WRITTEN VS. MAY SUBSTITUTE
 Dispense as Written (DAW) – the pharmacist needs to dispense the exact

medication that is written on the prescription
 May Substitute – the pharmacist can substitute a generic form of the medication that
is written on the prescription
 A clinician writes Lasix, the pharmacist can dispense furosemide
 Typically this does not apply to veterinarians.
26
WHY WOULD DISPENSE AS WRITTEN VS. MAY SUBSTITUTE
NOT APPLY TO VETERINARIANS?
 Pharmacists aren’t trained in veterinary medicine.

 Bioavailability of drugs are usually different in veterinary patients compared to
humans and between different brands/generics
 Example: Itraconazole1
27
Recommended Items to include on a Rx
1. Weight of the patient 2. Dosage (mg/kg) 3. Length of therapy
Dr. John Smith

625 Harrison St., West Lafayette, IN 47907 Why should a veterinarian include this
DEA# AB1234567 information?
Name:_________________________________Date: 1/25/18
________ So that a pharmacist can check the
Address: _____________________________________________ dose!
Rimadyl (Carprofen) 25 mg caplets #14 Pharmacists have the responsibility

1 tab PO q12h for 7 days Wt: 11kg to ensure all prescriptions filled are
Dosage: (2.2 mg/kg) accurate and safe.
_______________________ Dr. John Smith DVM

_______________________
28
IF YOU WERE WRITING A PRESCRIPTION FOR A RABBIT,
WHAT ELSE WOULD YOU NEED TO INCLUDE?
Dr. John Smith

DEA# AB1234567
Jane Doe “Hopper” (Rabbit)

Name:_________________________________Date: 1/25/18
________
Address: ___________________________________________
#1 – 15 mL
Meloxicam 1.5 mg/ml oral suspension
bottle
1.7 mL PO SID Wt: 2.5kg Dosage: (1 mg/kg)
Refill: NR 1 2 3 4 5 Void After__________ WDT: meat = ___ days
____________________ Dr. John Smith DVM

_____________________
29
HOW LONG IS A PRESCRIPTION VALID?
 Indiana law requires that a prescription for a schedule II prescription

must be filled within one (1) year of being signed.
 This varies state to state!!
 Schedule III, IV, and V controlled substances shall be filled or refilled no

more than six (6) months after the date on which such prescription was
issued.
 Medications that are not scheduled, but that require a prescription must
be filled within one (1) year of being signed.
30
 Varies, and is not always a hard and fast rule
WRITE A PRESCRIPTION
 My dog Tucker (73 lbs) has been under the

weather and you as the veterinarian decide to
prescribe metronidazole. I (Elizabeth Young) want
to get it filled at my local Walgreens.
15 mg/kg every 12 hours

Available strengths include 250 and 500 mg tablets **There is a blank Rx on the next slide
31
https://www.plumbsveterinarydrugs.com/#!/search/metronidazole
Name:_______________________________________Date: _____________
Address: ______________________________________________________
Refill: ___ times
____________________________ ___________________________
32
WRITING A LEGAL PRESCRIPTION
 Controlled prescriptions
 Same as legend prescriptions
 Must also include:
 Six quantity check off boxes
33
 Refill options
34
 Refill options
 “VOID” should appear
on photocopies
 Watermark on backside
stating “Indiana Security 35
Prescription”
IN THE STATE OF INDIANA…
 “All controlled substance

prescriptions written by Indiana
licensed practitioners must be
issued on approved security
feature prescription pad paper in
order for their prescriptions to be
accepted for filling in Indiana
licensed pharmacies.”
36
https://www.in.gov/pla/3017.htm
WHAT IF YOU MAKE A MISTAKE WHILE WRITING A
PRESCRIPTION?
 Mistakes happen,
 On a non-controlled substance and CIII-CV prescription, simply draw a
single line through your mistake, correct it, and initial your mistake.
 Don’t try to write over the mistake, it makes it harder to read.
 On the other hand, there can be NO errors on a CII prescription.
 If you make a mistake, rip up the prescription and start again.
 The whole prescription must be written with one color ink.
37
WORKING WITH
PHARMACISTS
38
HOW DOES ONE BECOME A PHARMACIST?
Undergraduate Graduate Post-doctoral Education
• Bachelor’s degree (4-years) • Doctor of Pharmacy • Human residency programs

• Pre-pharmacy program (2- (Pharm.D.) (4-years)  emergency, internal
years) • Biochemistry, medicine, critical care,
pharmacology, pediatrics, oncology, many
pharmacokinetics, more (up to 3 years)
therapeutics in humans • Veterinary-specific
• Compounding residencies  3
• Veterinary Pharmacy programs in the US
elective courses at • Continuing education (“CE”)
select schools  required by all states for
• Veterinary Pharmacy practicing pharmacists.
Clinical Rotation (4-6
weeks)
39
EDUCATION OF A PHARMACIST
What don't we know?
What do we know? (unless we have pursued veterinary
training)
Human anatomy, physiology, pathophysiology Animal anatomy, physiology,
pathophysiology
Human pharmacology & pharmacokinetics
Animal pharmacology &
Physical exam techniques in humans pharmacokinetics
How to interpret laboratory values in
humans Physical exam techniques in animals
Calculations and conversions (both complex
and basic)
How to interpret laboratory values in
Where to get drug information animals 40
WORKING WITH PHARMACISTS
 Pharmacists have the responsibility to ensure that all prescriptions are

accurate and safe for the patient
 This includes prescriptions for animals
 Don’t hesitate to call and speak with a pharmacist if you have concerns
or questions
 We won’t hesitate to call you if we have a question!
 We like math and will double check doses for you! 41

COMPOUNDING PHARMACISTS
 Compounding
 As veterinarians you will come across many situations where a commercially
available medication is not going to work for your patient
 Strength
 Dosage form
 A product with out a specific inactive ingredient
42
COMPOUNDING PHARMACISTS
 How do you find a good compounding pharmacy?
 State Board of Pharmacy and the FDA
 Pharmacy Compounding Accreditation Board (PCAB):
voluntary accreditation program for compounding pharmacy
 https://www.achc.org/compounding-pharmacy.html
 Ask where they get their formulas
 Trissel’s Stability of Compounded Formulations
 PCCA formulations
 Ask if they follow USP Chapter <795> and USP Chapter <797> standards 43
QUESTIONS PHARMACISTS MAY ASK YOU
 Abbreviations
 SID
 Dosing
 Many medications are dosed at a much higher rate in veterinary medicine than in
human medicine.
 Levothyroxine – usually dosed in microgram increments in humans compared to milligrams in
animals
 Tramadol – most humans only take 1 tablet at a time, dogs can take multiple tablets at once
44
NUMBERS PHARMACISTS MAY ASK FOR
 NPI numbers  national provider identifier
 Only applies to providers that are performing a service billable under HHS (Medicare &
Medicaid)
 **You will NOT have a NPI number**
 License number
 Most veterinarians have a license number provided by the state
 Exception: If you are working at a veterinary teaching hospital a license number may not be
required (varies by state)
 DEA number:
 If using/prescribing controlled substances, you should have one (again may not be required if
working at a veterinary teaching hospital)
45
SUMMARY
 Know the laws in the state that you practice.

 Check the state boards of pharmacy and veterinary medicine for specifics on controlled substance
prescriptions, registration, record keeping requirements, etc.
 Be able to write a prescription using all requirements.
 Understand that the majority of pharmacists are not trained in veterinary medicine,
but are bound by oath to serve all patients to the best of their ability.
 Don’t hesitate to use pharmacists as resources for drug information, compounding,
and other questions.
46
REFERENCES
 FDA Website > Food, Drug and Cosmetic Act:
https://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/d
efault.htm
 FDA Website > AMDUCA:
https://www.fda.gov/regulatoryinformation/legislation/significantamendmentstothefdcact/animalmedicinaldruguseclarificationactamducaof1
994/default.htm
 FDA Website > Brochure on the Veterinary Feed Directive > Requirements for Veterinarians 2015:
https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/UCM455480.pdf
 Indiana Board of Pharmacy Website > Controlled Substance Prescriptions. http://www.in.gov/pla/3016.htm
 Indiana Board of Pharmacy Website > Pharmacy Laws & Regulations. http://www.in.gov/pla/2545.htm
 DEA website > Controlled Substance Regulations. https://www.deadiversion.usdoj.gov/index.html
 DEA website > List of Controlled Substances. https://www.deadiversion.usdoj.gov/schedules/index.html
 http://news.vin.com/vinnews.aspx?articleId=22939
 https://www.avma.org/KB/Resources/FAQs/Pages/Prescriptions-and-Pharmacies-Veterinarian-FAQs.aspx
 https://www.avma.org/KB/Resources/Reference/Pages/Pharmacy.aspx
 http://www.pharmacytimes.com/resource-centers/veterinary-pharmacy/understanding-the-veterinary-patient
47
 https://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm214772.htm
 samples.jbpub.com/9781284035667/9781449685362_CH02_Sample.pdf
PHARMACY 101
FEBRUARY 22, 2018
E L I Z A B E T H YO U N G , P H A R M . D. F S V H P
W A S S O N V E T E R I N A RY P H A R M A C Y R E S I D E N T
P U R D U E U N I V E R S I T Y V E T E R I N A RY T E A C H I N G H O S P I T A L
young481@purdue.edu
48

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PHARMACY 101

FEBRUARY 22, 2018

 List controlled substances used in veterinary medicine and their corresponding

 Review the education most pharmacists have regarding veterinary medicine.

 Describe how to find a reliable compounding pharmacy.

 Food and Drug Act of 1906 – prevention of mislabeling

 This law only forbade fraudulent curative claims

 Sulfanilamide disaster in 1937:

 Many amendments apply directly to animal drugs

 AMDUCA = The Animal Medicinal Drug Use Clarification Act of 1994

 “made extra-label-drug-use an FDA-regulated veterinary medical activity, allowing

 Prior to it’s passage, extra-label drug use was illegal.

3. Establish a substantially extended withdrawal period supported by appropriate

• If we use this in a dog, is it ELDU?

 Controlled Substances Act (CSA) of 1970

 The addition, deletion, or change of schedule of a medication or substance may be

 Schedule I: High abuse potential, NO accepted medical use

dependence or psychological dependence relative to the drugs in schedule IV.

 A medication schedule can change at any time 13

Non-Controlled Substances Controlled Substances

 There are also recommended items that can be included on a prescription

Drug Enforcement Agency http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm

Dr. John Smith

Jane Doe “Spot” (Canine)

Refill: NR 1 2 3 4 5 Void After__________

Dr. John Smith

Jane Doe “Spot” (Canine)

Refill: NR 1 2 3 4 5 Void After__________

Non-Controlled Substances Controlled Substances

Dr. John Smith

Jane Doe “Spot” (Canine)

Rimadyl (Carprofen) 25 mg caplets #14

Refill: NR 1 2 3 4 5 Void After__________

 Must include: Dose/Units: 1, 5, 0.4

 Can also include: Do This Don’t do This

Dr. John Smith

Jane Doe “Spot” (Canine)

Rimadyl (Carprofen) 25 mg caplets #14

Refill: NR 1 2 3 4 5 Void After__________

Dr. John Smith

Jane Doe “Spot” (Canine)

Refill: NR 1 2 3 4 5 Void After__________

_______________________ Dr. John Smith DVM

 Dispense as Written (DAW) – the pharmacist needs to dispense the exact

 Typically this does not apply to veterinarians.

 Pharmacists aren’t trained in veterinary medicine.

Dr. John Smith

Rimadyl (Carprofen) 25 mg caplets #14 Pharmacists have the responsibility

_______________________ Dr. John Smith DVM

Dr. John Smith

Jane Doe “Hopper” (Rabbit)

Refill: NR 1 2 3 4 5 Void After__________ WDT: meat = ___ days

____________________ Dr. John Smith DVM

 Indiana law requires that a prescription for a schedule II prescription

 Schedule III, IV, and V controlled substances shall be filled or refilled no

 My dog Tucker (73 lbs) has been under the

15 mg/kg every 12 hours

Refill: ___ times

 “All controlled substance

• Bachelor’s degree (4-years) • Doctor of Pharmacy • Human residency programs

 Pharmacists have the responsibility to ensure that all prescriptions are

 We like math and will double check doses for you! 41

 Know the laws in the state that you practice.

Refill: NR 1 2 3 4 5 Void After________ WDT: meat = _ days