Lecture 1: Introduction and Prescriptions Flashcards
What is pharmacology
Study of agents used to treat, diagnose and prevent disease
What are the two major subdivisions or pharmacology
Pharmacodynamics and pharmacokinetics
What is pharmacodynamics
Biochemical and physiological mechanism- what the drug does to the body
What is pharmacokinetics
Absorption, distribution, metabolism and elimination, what the body does to the drug
Are over the counter drugs labeled or off labeled use
Labeled use
if off labeled use should prescribe the OTC drug
What are the 4 classes or prescription drugs
- Labeled use
- Extra-label use
- Compounded
4, controlled
What are the 3 groups of drugs
- Over the counter
- Prescription/legend drugs
- Vaccines and biologics
What are the 2 central philosophies for drug regulation use for animals regarding OTC drugs
- To protect the public from inadvertent consumption of harmful amounts of drugs given to livestock
- To allow livestock producers to protect the health of their animals with minimal oversight
What must be defined for an OTC labeled use drug
Dose, frequency, duration, route of administration, in a given species, and to treat a specified disease
In order for a drug to be considered over the counter all of the information for labeled use must be…..
Written down in a manner easily understood by a lay person
When is a prescription required
- The labeled use can’t be easily understood by a lay person
- Professional (veterinarian) is needed to diagnose the disease and monitor the patient for a response to the drug or adverse effects
T or F: labeled use only applies to prescription drugs
False, applies to prescription and OTC
Use of a drug in some manner other than the label or use of a drug for which there is no label is considered
Extra label drug use (ELDU)
What act/law defines labeled use
Federal food, drug and cosmetic act
In 1958 the FD&CA made ____ illegal and why
Extra labeled drug use because there were problems with drugs ending up in food chain
In 1994 what act/law was passed to overturn the decision of FD&CA in making ELDU illegal in 1958 and why
Animal Medicinal Drug use Clarification act
More people started having pets in their homes and therefore we needed to use certain ELD to treat diseases
What are the regulations for prescription ELDU
- Veterinarians must adhere to the labeled use, unless they judge it is ineffective
- ELDU is ONLY allowed for FDA approved animal or human drugs
- A human drug can’t be used if an animal drug can be used for the indication
- Requires veterinary supervision and an active VPCR
- Can’t be administered in food but can be in water
- Particular restrictions for food animals (see separate card)
- Use of an OTC in a way that isn’t labeled is ELDU- consider prescribing
What are the particulars/specifics for regulating prescription ELDU in food animals
- Only for therapeutic use, not for production
- Can’t result in any tissue residue that may be a risk to public health
- In the absence of scientific data on human food safety, the animal must be kept out of the food supply
Why can’t prescription ELDU be administered in food or liquids OTHER than water
Considered compounding
Who is responsible the vet or producer for monitoring food animals being kept out of food system if prescribed an ELDU that either has residue in tissues and/or was on a medication that has no scientific data on human food safety
VETERINARIAN
Who legalized compounding
AMDUCA
Is compounding ELDU
Yes
What is compounding
Alteration of the original dosage form for ease of administration or because the labeled form is inappropriate for the intended purpose or because an approved drug does not exist
Who determines what drugs can be compounded
FDA
Who can produce a compounded prescription
Veterinarian or pharmacist
Can production of a compounded drug be from bulk drugs, why or why not
No because bulk drugs aren’t under the same regulatory control
What act defined the classes of controlled substances
Comprehensive drug abuse prevention and control act (CDAPCA)
What drugs are considered class 1
LSD, marijuana, heroin
Do class 1 drugs have any medical use
No
What class of drug are phenobarbital, diazepam, butorphanol
Class IV
What class of drug are hydromorphone, fentanyl, and pentobarbital
Class II
What class of drug are ketamine, Telazol, zolazepam
Class III
How long must a hospital keep records of controlled substance prescriptions
Minimum of 2 years
What class/schedule of drugs must be kept separate from other classes
Class 2
What class/schedule of drugs requires a special order form (DEA-222) or online access (DEA CSOS)
Class 2
How must controlled substances be stored at faiclity
Must be secured in a locked container, preferable fixed to foundation, prescription pads should be kept secure
Loss or theft of controlled substances or prescription pads should be reported to who
DEA and state pharmacy board
What agency regulates pesticides
EPA
What department regulates controlled substances
USDOJ—> DEA
Who regulates drugs, feeds, and medical devices
USDHHS—>FDA—>CVM (FD&CA and AMDUCA)
Who regulates vaccines and biologics
USDA—>APHIS—>CVB
What are the 3 methods of issuance for prescriptions
Preprinted forms handed to client, electronically submitted to pharmacy, phoned to a pharmacy
What is the required information for prescriptions
- Facility name, address and phone number
- Your name and credentials
- Clients name, pets name
- Date
- Drug name and strength
- Quantity, refill instructions
- Directions
- DEA # if controlled
- Signature
Which class of drugs can’t have refills on same rx
2
Which class MUST be written prescription
Class 2
What is the refill maximum for schedule III-V controlled substances
5
How long is the prescription good for schedule III-V
6 months
How to prevent errors by pharmacist
Use prescription software or write legibly, be specific about drug names and use generic names, include diagnosis, indication for drug and any supplemental instructions
What units should be used in prescription s
Metric units (ex: mL not tsp)
Which abbreviation: q24 or SID
Q24
Which abbreviation: q12 or BID
Both fine, q12 better
When do you use decimal points in writing drug dose on prescription and when do you not use them
You use a decimal point when the dose is <1 (ex: 0.1 not .1). Don’t use a decimal point when > 1 (5 not 5.0- can be mistaken for 50)
How to prevent errors by client for prescription drugs
Write directions for use in plain English, specify how often and how many, do not use abbreviations
A practice can fill a prescription but under a state pharmacy law they are required to do what
Provide a prescription if requested
What is required when for prescription label
- Prescription #
- Label with valid legend
Is Rx only a valid legend
No, only used in humans
What is the valid legend for veterinary medicine on prescription label
“Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian”
“For animal use only”
For veterinary use only”
In addition to the required prescription information what must be on the label
- Manufacturer
- Form (pill, powder, liquid, capsule)
- Important warnings
- Date of issue
