wk 9-11 quiz Flashcards
FDA
food and drug administration
CVM
center for veterinary medicine
FFDCA
federal food, drug, and cosmetic act
NADA
new animal drug application
Rx drug
prescription drug
VFD drug
veterinary feed directive drug
Define a “drug” using the FFDCA definition
articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in man or other animals AND articles intended to affect the structure or any function of the body of man or other animal
What government agency approves and regulates drugs? What act gives this
agency the authority to do so?
FFDCA gives the FDA authority
Define a drug sponsor and give examples of drug sponsors
the entity responsible for collecting all the information about a new animal drug and submitting this information to CVM for review
Understand the NADA process
- drug sponsor collects info about the safety and effectiveness of a new animal drug
- then decides if their is enough proof that the drug meets the requirements for approval
- if yes then the drug sponsor submits a new animal drug application to CVM
- CVM team review the NADA and if they agree then they can approve and the drug sponsor can legally sell the drug
List the 7 major species of animals as determined by the CVM
horses
dogs
cats
cattle
pigs
chickens
turkeys
Understand what a minor species is and list 3 examples
fish
ferrets
goats
*infrequently and in only a small number of animals each year - in a limited part of the country and in only a small number of animals each year
Who initiates the process of starting a new animal drug application?
drug sponsors
List the 4 things needed for a dosage regimen in a NADA.
dose
frequency
duration
route of administration
Name the 5 major technical sections of drug approval
- target animal safety
- effectiveness
- human food safety
- chemistry, manufacturing, and controls
- environmental impact
Describe the 2 goals of a target animal safety study
- to identify any harmful side effects of the drug
- establish a margin of safety for the drug (inc dosage until side effects are so bad you have to force dosage down)
Discuss aspects of the target animal safety studies
- examining animals
- observing behavior
- results of blood tests
- tissues and organ both with the naked eye and under microscope
Define drug effectiveness and field study
conducting a field study; all the animals have the disease the drug will be used for - see if drug performs well under normal conditions
Explain the food safety piece of the NADA puzzle
only for food producing animals to get withdrawn times - where products won’t be affected by the drug anymore
- toxicology
- residue chemistry
- microbial food safety
- analytical method
Explain antibiotic resistance
no longer work against certain bacteria
Identify important aspects of drug manufacturing
- what ingredients will be used
- where the ingredients will come from
- where drug will be made
- how it will be made
- how it will be packaged
- how it will be stored
- how long it can be stored
Discuss the importance of the environmental impact a drug has
figure out how much drug is expected to get into the environment and its potential effects
Discuss the similarities and differences between OTC, Rx, and VFD drugs
- over the counter (can get whenever)
- prescribed (by doctor permission)
- VFD: written order issued by licensed vet in the course of the vet’s professional practice that authorizes the client to obtain and use a VFD drug in or on animal feed
Explain what a generic drug is
the approved brand name animal drug that’s been through the ANADA process
Discuss ELDU and associated advantages and disadvantages
- Anytime a drug is used in a manner other than the FDA approved usage
ADVANTAGES: - Allows us more options
- Allows for potentially better quality of care
- Advancement of medicine
- Better options for minor species
DISADVANTAGES: - Could potentially be harmful if not well known
- Can run into issues in food animals
- Withdrawals- FARAD
- It is actually illegal to use some drugs extra label in food animals
Define a controlled drug
a drug or substance that could become habit forming, be abused, or cause addiction in humans
Identify the controlled drug schedules and briefly describe what they mean
Schedule I: no currently accepted medical use and a high potential for abuse
Schedule II: high potential for abuse, with use potentially leading to severe psychological or physical dependence
Schedule III: moderate to low potential for physical and psychological dependence
Schedule IV: low potential for abuse and low risk of dependence
Schedule V: lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics
Describe the process of record keeping for controlled drugs
- diligent records must be kept of all controlled drugs ordered and used
- bottles must be labeled and documented from the time they arrive to the time they are empty or disposed of in the correct manner
- there is some hub loss if frequently using 1 ml syringes to draw up the drugs
- logged in ml for liquid drugs or tablets for tablet forms
- must be inventoried at least every 6 months to ensure the logs are correct
- schedule 2 drugs must be logged separately from schedule 3-5 drugs
- must keep controlled substance logs for:
-federal law: 2 years
-illinois law: 5 years
Explain the procedure for reporting theft or abuse of controlled drugs
- report to the clinic owner/supervisor/person in charge (unless that is the suspect)
- report to the dea by filling out dea form 106 within 24 hours
- report stolen drugs to the local authorities
- report suspected drug tampering to the criminal investigation’s unit of the fda
- if the suspect is a healthcare professional report them to their respective state licensing board
Prescription
Require a prescription written by a veterinarian
dispensing
Veterinary clinics dispense drugs to be given both in and out of a clinic setting
over the counter
Do not require a prescription but can still be prescribed. Do not require a VCPR
Define the use of prescription drugs in veterinary medicine
-Veterinary prescription drugs are those drugs restricted by federal law to use by or on the order of a licensed veterinarian
-need: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
How long must medical records be kept in veterinary medicine federally? What
about in the state of Illinois?
2; 5
Discuss how to avoid drug residues and describe how to document drug withdrawal times
- Keep track of drug withdrawals
- Keep track of any extra label drug use (ELDU) and the additional associated withdrawal times
Explain the documentation needed for drug dispensing and prescribing
- Name, address, and telephone number of veterinarian(s)
- Name, address, and telephone number of client(s)
- Identification of animal(s) treated, species and numbers of animals treated
- Date
- Name, active ingredient, and quantity of the drug (or drug preparation) to be prescribed or dispensed
- Drug strength (if more than one strength available)
- Dosage and duration
- Route of administration
- Number of refills
- Cautionary statements, as needed
- Expiration date if applicable
- Slaughter withdrawal and/or eggs or milk withholding times, if applicable
Describe proper drug handling, storage, and disposal
- Inform clients about the proper handling, storage, and disposal of drugs that are being dispensed
- Strongly recommended that all drugs are placed in a child safe container when being dispensed to clients. Some states mandate this
- Over the counter drugs should be distinguished from prescription drugs
List some drug storage considerations
- Drugs need to be organized!
- Controlled drugs are kept in locked safe away from other drugs.
- Check for expired drugs- recommended to do so monthly!
- Check that all drugs are being store properly- look at label.
* Temperature
* Light exposure
* Refrigeration
* Expiration dates
* Reconstitution date
Pill vials
- Most commonly used for dispensing tablets and capsules
- Come in different sizes and colors
- Protect from light
- Most have child-safe lids
- Label goes on the vial
Blister packs
- Pill is enclosed in a plastic bubble (blister) with a foil backing or is completely enclosed in foil
- Offer protection from humidity and
contamination and light if completely enclosed - Many drugs that come in blister packs are easy-dose and come with a sleeve for easy packaging and labeling
Individual dose syringes
Whole bottles/boxes
- Sometimes an entire bottle or box of medication is dispensed
- The label can be placed directly on the box/bottle in that instance
- Often done for chronic/long-term medications
- Anything that is a prescription medication still needs a label
List and explain the information needed for a prescription
- Veterinarian’s name, address, telephone number and license number
- DEA number is needed for controlled substances
- Patient’s name and species
- Client’s name and address
- Drug info: name of drug, strength/concentration, quantity
- Instructions for use: dose, frequency, duration, route
- Additional instructions: give with food, shake well, keep refrigerated, etc.
- Refills permitted
- Date and signature (paper or electronic) of Veterinarian
- Withdrawal information for large animal
Explain what is needed to call in a prescription
everything needed for a prescription
Explain what is needed for a written prescription
same; everything needed for a prescription
What are some considerations with online pharmacies?
- Many clinics have there own online pharmacy that is through a larger company
- Stand- alone online pharmacies
- Client must place the order and then the pharmacy contacts the veterinarian to sign and fax or approve online the prescription
- DVM should only approve a request if it is justified and there is a VCPR
- just double check that it is valid and legal
What does the AVMA say about prescriptions?
-Veterinarians shall honor client requests to prescribe rather than dispense a drug
-The client has the option of filling a
prescription at any pharmacy
State safety precautions that can be taken to prevent dispensing errors
- Need to focus and exercise caution when dispensing medications!
- Very important to not mix up medications or strengths of drugs!
- Double check all medications that are being dispensed
- Every single medication that is dispensed needs to have an accurate dispensing label on it
List and explain the information needed for a drug label
- Name and Address of Dispenser (Veterinary clinic or individual DVM)
- Date
- Client’s name, Patient’s name and species
- Drug name, strength/concentration, quantity
- Directions for use: Dose, Duration, Frequency, Route, special instructions
- Withdrawal information for food animals
Define and explain compounding
- process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient
- not FDA approved in their compounded form
- Extra risk: may not be safe, effective, pure, etc.
- Legitimate medical need
ordering controlled drugs
must have vet with a DEA license and state controlled license
storing controlled drugs
in a locked safe that is bolted to the ground or wall or in an omnicell; need two keys or a combination and a key
dispensing controlled drugs
must be limited amount of time; dispense only amount needed in syringe to send with client - never a lot or whole bottle
disposing controlled drugs
logged and disposed in a non retrievable method; two witnesses
