Laws & Reg Flashcards

1
Q

Rabies PEP in previously vaccinated (after 1980) individuals

A

Human rabies immune globulin (HRIG) should NOT be given (to individuals vaccinated after 1980)
1.0mL rabies vaccine given IM in deltoid (NEVER) in gluteal area b/c of reduced Ab production

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2
Q

All animal exposures (ie, to rabies) must be reported by __ to __

A

Fax; Pinellas Co Animal Services AND Florida Dept of Health in Pinellas Co

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3
Q

Animal exposures (to rabies) are defined as

A

Bite exposure
Non-bite exposure: contamination of broken skin or mucous membranes with suspect animal’s saliva
Unknown exposure - individual’s exposure cannot be determined

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4
Q

FL requires that all cats and dogs be revaccinated against rabies __ after the initial vaccination.

A

12 months

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5
Q

After the second vaccination against rabies (to occur at 12 mos after initial dose), the interval between rabies vaccinations will conform to the ___

A

Manufacturer’s directions

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6
Q

Peak rabies Ab titers are reached ____

A

Within 28 days of the primary vaccination

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7
Q

Per Florida Administrative Code rule, an animal is considered currently vaccinated (against rabies) if s/he has received ___ prior to an exposure incident

A

The primary vaccination at least 28 days prior to the exposure incident

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8
Q

Because of expected rapid anamnestic response, an animal is considered currently vaccinated

A

Immediately after a booster vaccination

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9
Q

Immediately following exposure to a rabid animal, ____ is important to ensure adequate protection against the virus

A

Obtaining a booster (rabies) vaccination

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10
Q

Although uncommon, rabies has occurred in vaccinated animals ___

A

Who did not receive a rabies booster vaccination following exposure

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11
Q

In FL animals are not considered “currently vaccinated” if they are a

A

Dog, cat, ferret, horse, cattle, or sheep whose 1st vaccination was given < 1 month before exposure
Cat, etc, whose previous vaccination expired
Cat, etc. whose initial vaccination was not boostered 1 year later
Cat, etc, vaccinated by anyone other than a licensed veterinarian
Any wild animal, or wild and domestic animal crosses

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12
Q

Rabies titers are NOT acceptable in lieu of

A

Revaccination

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13
Q

Research has shown that cats and dogs not currently vaccinated (against rabies) but who were previously vaccinated…

A

Mount an Ab response comparable to that of currently vaccinated animals after booster vaccination. Consequently, the quarantine requirements for cats/dogs who were previously vaccinated (but not currently), exposed to rabies suspects, and IMMEDIATELY BOOSTERED, is the same as for currently vaccinated animals, at 45 days, rather than 4 mos.

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14
Q

High priority situations for rabies testing include ___.

A

Human bit by wild/stray animal (ie, animalnat moderate/high risk of acquiring rabies)
Bats found in room with unattended child or sleeping human
Human bit by sray or domestic animal with neurologic signs
Domestic animals who die during an observation period related to human exposure

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15
Q

____ is required before submitting a specimen for rabies testing.

A

Consultation with the County Health Department (CHD)

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16
Q

Rabies-related confinement should be by

A

Fence
Cage
Inside living quarters/related buildings
Leash under control of responsible human

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17
Q

Isolation and observation period refers to

A

Confinement for observation for 10 days of cats/dogs/ferrets who bite/expose human to rabies

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18
Q

A quarantine period (relating to rabies) involves

A

Cats/dogs/ferrets, when they are bitten/exposed to rabies may be confined and observed for 45 days if they are vaccinated or previously vaccinated but receive a post-exposure booster and 4 months if they are unvaccinated (6 mos for ferrets, horses, cattle, & sheep)

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19
Q

The 10-day isolation and observation period for cats/dogs/ferrets following their potentially exposing a human (or other animal) to rabies begins starting ___

A

From the time the animal bit/exposed the bite recipient

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20
Q

If a biting animal who is a rabies suspect is alive 10 days after exposure,

A

The animal was not shedding rabies virus in saliva at the time of the exposure

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21
Q

Drugs that may be removed from the original container and labeled appropriately are __

A

FDA approved

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22
Q

Drugs that may not be removed from their original packaging for the purpose of dispensing are __

A

EPA approved (eg, topical insecticides)

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23
Q

EPA approved products are exclusively administered

A

Topically

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24
Q

EPA products can only be broken up

A

If you are administering as a dose within the clinic (but individual units/doses cannot be removed for the purposes of dispensing)

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25
Q

Compounding definition

A

Combining, mixing, or altering the ingredients of 1 or more drugs or products to create another drug or product

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26
Q

A compounded sterile product is for use in

A

Parenteral or ophthalmic, administration, oral inhalation in an aqueous base, or the use of an unapproved drug required to be sterile per state/federal law

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27
Q

Compounded medications can only be used when

A

There is no commercially available (equivalent) product

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28
Q

If you are having medication compounded for office use, you must

A

Enter into a contract with a pharmacy; in your records, you must document purpose and volume of use and what lot it came from

29
Q

Describe the grey zone respecting compounding medications

A

At the state level, compounds can be re-sold and re-dispensed by veterinarians in FL under HB 1049 but, the Pharmacy Practice Act prohibits the redistribution of compounded drugs

30
Q

At the federal level, redistribution of a compounded drug could be considered

A

Could be considered redistribution of an unapproved drug wholesale

31
Q

With respect to compounding, the FDA takes enforcement discretion when

A

When Rx is written for an individual patient
When the patient is not food
Office stock that derives from FDA approved Bulk Drug Substances (BDS) list

32
Q

The FDA recognizes that copies of drugs may be

A

Required; for example, a drug may need to be compounded to reduce the concentration for a small patient, or the drug may need to be made a liquid for patient administration
COST is NOT considered a rationale
*The rationale must be documented

33
Q

Compounding pharmacy should be able to provide

A

Stability data (where do they get their expiration date from?)
Sterility data
QA protocols
Certificates of origin and analysis for all active ingredients
503B (a federally permitted facility) 483 issued? = warning from FDA (most have) resolution?

34
Q

BUD stands for

A

Beyond use date

35
Q

Non sterile BUD USP defaults

A

Aqueous = 14 days refrigerated
Non-aqueous = 6 months
Aquesous-based topical = 30 days

36
Q

Potency study data

A

May not distinguish drug from degradation products
Considered insufficient

37
Q

Stability study is

A

A potency study over time
Separating impurities, degradation products, and excipients
Is considered accurate

38
Q

In order for a drug to work as a transdermal medication, the drug molecule

A

Has to have both lipophillic and -phobic properties

39
Q

Poor drug choices for transdermal delivery are

A

Narrow therapeutic index (NTI) drugs
Require a minimum dose to reach therapeutic level
Require too large a mg dose

40
Q

For transdermal drug delivery, the cat ear will hold

A

About 25 mg of drug maximally

41
Q

Some drugs (eg, enrofloxacin) photooxidize in light so that when compounded into a transdermal drug

A

Form crystals and the cat has a dermal reaction (can lose ear, have scar tissue)

42
Q

Child resistant containers must be used

A

If the drug format permits (ie, Gastroguard may not, but a set of pills does)

43
Q

If the owners decline use of a child resistant medication container,

A

It must be documented in the patient file

44
Q

When calling a prescription into a pharmacy, only owners can

A

Request that no child-proof container be used

45
Q

A prescription label must have

A

Your (Dr) name, address, and phone #
Owner first and last name and address
Animal’s name (if available)
Patient species
Medication name, strength, Qty, refills, directions, exp date

46
Q

A drug expiration date in FL can default to 2 terms:

A

1) Expiration date as provided by the manufacturer, repackager, or other distributor
2) Beyond use date which must not exceed the expiration date and cannot be > 1 year from the date the Rx was filled

47
Q

Which do you use: expiration date or BUD?

A

Default to the stricter definition

48
Q

All prescription products must bear the legend

A

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian

49
Q

When prescribing human OTC drugs for an animal

A

Human OTC products are not considered animal OTC products and the pharmacist should fill the product (and not refer the client to an aisle)

50
Q

Human OTC products for animal patients require

A

A full prescription label (associated with your practice)

51
Q

Products that are medicated feeds (as per the veterinary feed directive[VFD]) can only

A

Be dispensed under the order of a veterinarian

52
Q

A veterinary feed directive (VFD) product must bear the directive

A

Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian

53
Q

If a practice has many vets but only 1 with a DEA license, the non-DEA licensees

A

May function as agents of the registrant

54
Q

DVMs who are agents of a DEA license holder may __ but cannot __

A

Dispense or administer controlled substances on the premises but cannot prescribe

55
Q

The transfer of controlled substances is not permitted

A

Between veterinary licensees (or veterinary practices) in FL; controlled substances can only be transferred from a DEA license to a reverse distributor or from a supplier

56
Q

Schedule 2 controlled substance logs and records must be kept

A

Separately from other records

57
Q

All schedule III, IV, and V controlled substance records must

A

Be kept separately from other records (but can be maintained together with each other)

58
Q

Refills are not permitted for __

A

C-IIs; a written Rx is required

59
Q

For CIII-V substances, __ refills are permitted in __

A

5 refills are permitted in 6 months

60
Q

CIII-V refills can be called in

A

By a DEA registrant or their agent

61
Q

Oral prescriptions for CIIIs

A

May not be filled for > 30 days after the oral prescription

62
Q

In FL, counterproof prescription pads are

A

Not required for veterinarians

63
Q

Any CS prescription label leaving your clinic must bear the caution that

A

Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed

64
Q

Federally, deregulated hemp is defined as

A

Containing < 0.3% THC (dried plant mass)

65
Q

In FL DVMs cannot ____ hemp & CBD, etc

A

Stock, prescribe, or dispense

66
Q

Schedule II CS drugs

A

Fentanyl
Hydromorphone
Morphine
Methadone
Pentobarbital

67
Q

Schedule III CS drugs

A

Buprenorphine
Ketamine
Telazol (tiletamine + zolazepam)

68
Q

Schedule IV CS drugs

A

Alfaxalone
Butorphanol tartrate
Diazepam
Midazolam
Phenobarbital
Tramadol

69
Q

Schedule V CS drugs

A

Pregabalin