Pharm Developments And Laws

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Pure food and drugs act of 1906

Back 1

prevented interstate commerce in misbranded or adulterated drugs

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Federal Food, Drug and cosmetic Act of 1938 (FFDAC)

Back 2

1. drugs must be proven safe
also required labeling to include directions and warnings
Also known as the copeland act
2. strict liability statute
3. intent is not a requirement (criminal law you have to prove both intent and action)
4. contains penalties for violations and empowers the FDA to seize product and obtain a court injunction against marketing and distribution.
5. violations can be either midsemeanors (first offense) or felonies (repeater)

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1962 Amendments to FFDAC

Back 3

Safe and effective
2. in response to thalidomide disaster.
3. stricter labeling requirements

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Orphan Drug Act of 1983

Back 4

allowed minor use

Front 5

Hatch-Waxman Act 1984

Back 5

allowed for Generic Drugs

Front 6

Animal Medicinal Drug Use Clarification Act (AMDUCA)of 1994

Back 6

Allows extra label drug use
2. Codifies responsibility

Front 7

Animal Drug Availability Act of 1996

Back 7

Vet Feed directive: 21CFR
Efficacy
minor species (draft proposal)
drug combinations (pending)

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Drug - Definition

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Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals

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New Drug - Definition

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A drug that is not generally regarded as safe and effective under the conditions prescribed and recommended or suggested in the labeling

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Adulterated - definition

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Something is wrong with the product, ie. it is contaminated, has the wrong ingredients, missing ingredients, or the incorrect proportions or it was not made under cGMP

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Misbranded - definition

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Something is wrong with the label (false and/or misleading in any way)

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The Code of Federal Regulations - 21CFR

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Expands on the act and provides the regulatory infrastructure
Written by regulators and lawyers
code adopted in 1996

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The guidelines

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1. Written by FDA
2. provides further interpretation of the regulations (21CFR)
3. help the sponsor navigate the regulations
4. many of these Guidelines are activity and species specific

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Development of pharaceutics

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1. has to be proven safe in the target animal
2. has to be proven safe for the environment
3. has to be prove safe in human food if target animal is a food animal.
4. has to be proven effective in the target animal

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Prescription Drug - definition

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A drug or device that is required by state or federal law to be dispensed on prescription only, or is restricted to use by a practitioner only.
Labeled as: "Caution: Federal law prohibits dispensing without a prescription" OR "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" OR "Rx only"

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Prescription - definition

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An order for medication (or device) issued by a licensed medical practitioner. This is a legal document.

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Required info on a prescription

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1. Date of issue
2. Patient name and address, or the owner of the animal for which the drug is dispensed, address, animal species, ID
3. Name, strength, qty of drug/device prescribed
4. Directions for use
5. Name, address, and signature of prescriber
DEA number for controlled substances.
OPTIONAL info: Number of refills permitted (if not listed defaults to 0)

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Medication Errors

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Errors of Omission
Errors of Commission
Other sources - Drug allergies and/or interactions

Front 19

Errors of Omission

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Prescriptions missing essential info.
Most common include:
1. quantity to dispense or duration of therapy not listed
2. dose or dosage regimen not specified
3. not written legibly
4. failure to provide all legally required info

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Errors of Commission

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Prescriptions with incorrect drug therapy info or duplication of existing therapy.
for example:
1. incorrect drug or indication for use
2. therapeutic duplication
3. incorrect patient name
Prescription orders containe durg interactions

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Prescription Writing

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1. minimize or eliminate abbreviations
2. avoid vague instructions
3. include what medication is for
4. use metric system
5. print
6. careful with drug names that are similar

Front 22

Prescriptions can be transmitted via:

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1. oral
a. reduced to written form by pharmacist

2. written
3. electronic
a. requirements vary by state
b. FAX - all but C-II drugs
c. Computer to computer all but controlled drugs
d. PDA devices... being hashed out.

Front 23

Controlled substance Act of 1970

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consolidated over 50 pieces of previous regulations to imporve the administration and regulation of manufacturing, distribution, and dispensing of controlled substances in order to reduce the diversion of these drugs.
2. Enforced by the DEA
3. practitioner's must be registered.
4. if practitioner has drugs at more than one location, must have certificates for each location.

Front 24

controlled drug schedules

basics

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1. five schedules
2. classified by abuse or addiction potential, medicinal value, and harmfulness.

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Schedule 1 drugs

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1. highest potential for abuse/addiction and NO legitimate medical use in the US. May be authorized for research purposes only.
2. heroin, LSD, marijuana

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Schedule 2 drugs

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1. highest abuse/addiction potential, but have some legitimate medical use. Includes: narcotics, stimulants, and depressant drugs.
2. broken down into Schedule 2 (narcotics) such as morphine and Schedule 2N (non-narcotic drugs)such as fentanyl and pento

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Schedule 3 drugs

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1. less abuse potential than Schedule 2.
2. Broken down into Schedule 3 (narcotics mixed with other non-narcotic drugs) such as hydrocodone with homatropine and Schedule 3N (non-narcotics , depressants, and anabolic steroids) such as telazol, ketamine.

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Schedule 4 drugs

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lower abuse potential than Schedule 3 drugs. Includes narcotic/non-narcotic combos, depressants and stimulants such as butorphanol and diazepam

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Schedule 5 drugs

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lowest abuse potential of scheduled drugs. Includes limited dose narcotes with non-narcotic products, stimulants such as phenylpropanolamine. many cough syrups with codeine.

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Controlled drugs recordkeeping

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1. ACCOUNTABILITY
2. kept for 2 years including invoices, credit memos, dispensing transactions, and admin records.
3. C-II records must be kept separately from others as well as the others separately from other business transactions.
4. inventory must be made at least every 2 years.
5. perpetual inventory system is recommended.

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Controlled drug ordering

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C II drugs have their own order form. Must be in triplicate. Numbered in consecutive order and need to be used in that order. Do not toss any. No mistakes or alterations are permitted.
3. practitioner keeps the blue copy and records when items arrive and attaches suppliers invoice with it.

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Prescribing controlled substances

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1. alter proof prescription.
2. prescribe minimal amounts.
3. Use ink
4. no alterations
5. use both numerical and written numbers.
6. must affix DEA number.
7. No refills allowed. Need a new prescription.

Front 33

the Durham- Humphrey Amendment to the FFDAC 1951

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Created and defined the category of prescription drugs for human use and helped establish the prescription only category for veterinary drugs though it did not become a statute until 1988

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Food Additive Amendment to the FFDAC - 1958

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Food animal drugs now considered food additives.
Extra label use of drugs illegal.
most new food animal drugs were given OTC status as long as the labeling could be understood by a layperson so labeling was specific and limited for indications and dose with very limited flexibility as how the drug could be used.

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Controlled Substances Act 1970

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Passed to regulate the manufacturer, distribution, and dispensing of controlled substance.

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AMDUCA - 1994

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allows for extra-label use of drugs

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VCPR

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Valid Client Patient relationship (mandated by AMDUCA).
1. DVM has assumed responsibility for medical judgements and caretaker has agreed to follow vets instructions.
2. DVM has sufficient knowledge of the animal to make at least a general diagnosis of the animal's med. condition.
3. DVM readily availiable in case of treatment failure or adverse reactions.

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ELU recordkeeping

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must be kept for 2 years and readily retrievable.
Must contain:
1. ID
2. drug name and active ingredients
3. condition treated
4. species
5. dose
6. duration
7. # of animals treated
8. Withdrawal/discard time for food products from treated animal

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ELU in food animals

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1. must have VCPR
2. no approved drug available
3. careful diagnosis made
4. withdrawal time established
5. Procedures to assure identity of animal treated.
6. measures taken to ensure withdrawals times are met.

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ELU drug use prohibited in food animals of which drugs:

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1. chloramphenicol
2. clenbuterol
3. diethylstilbestrol
dimetridazole, ipronidazole, other nitroimidazoles
4. furazolidine (except for topical use)
5. sulfanomides in lactacting cattle
6. fluoroquinolones
7. Glycopeptides
8. Phenylbutazone