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CLIN PHARM > Clin Pharm Exam I - Learning Objectives > Flashcards

Clin Pharm Exam I - Learning Objectives Flashcards

1
Q

What is the FDA responsible for in terms of drugs?

What types of medications does this NOT cover?

A
  • Drug safety in animals, people, the environment, and the food supply
  • Safety and efficacy (the product will consistently and uniformly perform as the label claims it will

DOES NOT COVER
- Neutraceuticals, compounded drugs, or FDA-approved drugs used extra-label

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2
Q

What government agency is responsible for regulating veterinary drug use?

A

FDA

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3
Q

Where do you report an adverse drug interaction?

A

FDA website

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4
Q

What is the definition of prescription drugs?

A

They can only be dispensed by a licensed DVM or on the written order of one.

Must be labeled with “Federal law restricts these drugs to use by or on the order of a licensed veterinarian”

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5
Q

What are the components of the veterinary-patient-client-relationship (VPCR)?

A
  • Responsible for clinical judgement about the health of patient and need for treatment
  • Client agrees to follow your directions
  • You have knowledge about the patient (recently had a PE, personally acquainted with the care and keep of patient)
  • Available for follow ups
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6
Q

What is the minimum information required to be a on the label of a dispensed veterinary drug?

A
  • Name/address of dispenser
  • Date of order/when filled
  • Name/address of veterinarian who prescribed the drug
  • Directions for use
  • Any necessary warning/precautionary statements including withdrawal times
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7
Q

Under AMDUCA, what does the FDA have the right to prohibit in food animals?

A

Extra-label drug use of certain drugs

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8
Q

What drugs are specifically prohibited for use in food animals?

A

1) Chloramphenicol
2) Clenbuterol
3) Diethylstilbestrol (DES)
4) Dimetridazole/nitromidazoles
5) Furazolidine/nitrofurazone
6) ELDU of fluoroquinolones
7) Glycopeptides
8) Sulfonamide drugs (lactating dairy cattle)
9) Phenylbutazone (Female dairy cattle >20 mo)
10) Cephalosporins
11) Adamantane/neurimidase inhibitors (ELDU in poultry)

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9
Q

What is the definition of extra-label drug use?

A

Actual or intedned use of a drug in an animal in a manner that is not in accordance with the FDA approved labeling

  • Use in different species
  • Different dosage
  • Frequency
  • Route of administration
  • Deviation from labeled withdrawal time
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10
Q

When is extra-label drug use (ELDU) permitted by the FDA?

A
  • Within the scope of a VCPR
  • When health of animal is threatened, or suffering/death may result from non-treatment
  • No animal drug approved for use
  • Animal drug is approved, but doesn’t have needed active ingredient, not required dosage/concentration, or is clinically ineffective when used as labeled
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11
Q

What are the absolute requirements for ELDU in food animals?

A
  • Diagnose and evaluate the condition for which you are prescribing
  • Ensure client maintains ID of treated animals
  • Establish an extended withdrawal time
  • Ensure no illegal drug residues will occur
  • Have thorough record keeping
  • ELDU can never be used for enhanced production
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12
Q

What is the definition of a compounded drug?

A
  • Any manipulation of an FDA approved drug
  • Drug formulated from bulk chemical that is not approved by the FDA

Includes
- Mixing formulation
- Crushing/breaking tablets
- Adding flavoring to a commercially available oral solution
- Not following label indications for prep of formulation, using different dilution factor/diluent, mixing different drug proportions

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13
Q

When does the FDA allow the use of compounded drugs?

A
  • Valid VCPR
  • Health of animal is threatened or suffering
  • No FDA commercial animal or human drug available
  • Product is made from an FDA approved human or animal drug
  • Compounded drug must be safe and effective
  • Amount of product is made on an individual basis
  • Food animals MUST be provided with an extended withdrawal time
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14
Q

What are the advantages of compounded drugs?

A
  • Discontinued FDA approved formulation
  • Patient is allergic to agents in FDA approved products
  • Tailored dosage strengths
  • Palatability/dosage form changes
  • Drug shortages
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15
Q

What are some disadvantages of compounded drugs?

A
  • No monitoring of manufacturing process
  • No inspected facilities
  • Drug stability is unknown
  • No assessment of purity or potency
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16
Q

What are some possible consequences on drug effect that are inherent with compounded drugs?

A
  • Suboptimal effect
  • Toxicity
  • Time of onset
  • Intensity/duration
  • Residue elimination/withdrawal time
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17
Q

How do you recognize if a drug is FDA approved?

A

NADA number listed on label

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18
Q

What is a controlled substance?

A

A prescription drug that is placed into a schedule based on:
- Current accepted medical use
- Relative abuse potential
- Liklihood of causing dependence when abused

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19
Q

What qualifies a Schedule I drug?

Give examples.

A
  • No currently accepted medical use in the US
  • Lack of accepted safety for use
  • High potential for abuse

Heroin, LSD

20
Q

What qualifies a Schedule II drug?

Give examples.

A
  • High potential for abuse
  • Severe psychological or physical dependence

Hydromorphone, methadone, fentanyl

21
Q

What qualifies a Schedule III drug?

Give examples.

A
  • Potential for abuse less than II
  • Abuse may lead to moderate or low physical dependence, OR high psychological dependence

Buprenorphine, products with less than 90 mg of codeine

22
Q

What qualifies a schedule V drug?

Give examples.

A
  • Low potential for abuse

Alprazolam, diazepam, lorazepam, midazolam

23
Q

What qualifies a Schedule V drug?

Give examples.

A
  • Very low potential for abuse

Preparations with limited quantities of certain narcotics
- Cough medications with no more than 200 mg codeine per 100 ml/G - Robitussin AC, ezogabine

24
Q

What are special considerations with controlled substances?

A
  • Requirements for schedules can change
  • Registration with DEA and state BOP
  • Thorough recordkeeping
  • Special Ordering requirements
  • Special prescribing requirements
  • Special security measures
25
Q

What regulatory steps are required to dispense drugs once you are a practicing veterinarian?

A
  • Know VCPR responsibilities
  • Know state laws for prescribing and dispensing
  • Know special considerations for food animals
  • Know how to report adverse drug reactions
  • Know regulations about ELDU and compounding
  • Know how to maintain records
  • Contact DEA for registration
26
Q

What is the definition of a drug-to-drug interaction (DDI)?

A

The pharmacological effects of a drug are altered by the prior or co-administration of another drug(s) that can be uni or bidirectional

27
Q

What are the three main types of mechanisms for DDI?

A
  • Pharmacokinetic
  • Pharmaceutical
  • Pharmacodynamic
28
Q

What are the five main pharmacokinetic DDI mechanisms?

A

1) Change in site of action of concentration –> change in drug effects
2) Change bioavailability
3) Change pH of GI, binding in GI, GI motility, or mal-absorption
4) Displace object drug from its binding site
5) Can induce or block metabolism of drugs

29
Q

What are the three ways a DDI can affect pharmacodynamics?

A

1) Synergistic
2) Additive
3) Antagonistic

30
Q

What are some examples of synergistic pharmacodynamic DDIs?

A
  • Nephrotoxicity with aminoglycosides and NSAIDs
  • Neuromuscular blockage w/ inhalent anesthetics and aminoglycosides
  • Amoxi-clav/TMS
31
Q

What is an example of an additive pharmacodynamic DDI?

A

Cardiovascular effects with detomidine and injectable TMS

32
Q

What is an example of an antagonistic pharmacodynamic DDI?

A

Naloxone and opioids

33
Q

What are some common DDIs seen in clinical practice?

A
  • Metaclopramide & behavioral drugs
  • Furosemide & amphotercin/gentamycin
  • Fluroquinolones & theophylline
  • Chloramphenicol & theophylline
  • Fluozetine & seligiline
  • Digoxin & quinidine
  • Ketoconazole & cyclosporin/ivermectin/digoxin/warfarin
  • Epinephrine & acepromazine
  • Atropine & alpha2 agonists
  • ECAi & digoxin
  • Phenobarbitol & mitotane/thyophylline/digoxin/lidocaine (dogs)
34
Q

What are the main ways to detect DDIs?

A

Understand the mode of action of a DDI
- Know PK features
- Is it a high risk drug?
- Is the interaction pharmacodynamic?

ID potential or real clinical outcomes
- Does the patient have new problems due to the DDI?
- Is the patient high risk?

35
Q

What are the main ways to manage DDIs?

A
  • Define true clinical consequences of DDI
  • Know how to use and have antagonist/reversal drugs on hand
  • Consider use of emergency drugs
  • Discontinue the drug suspected of causing the DDI, if possible
  • Decrease dose or change time of administration
36
Q

What is therapeutic drug monitoring?

A

A tool for guiding the design of an effective and safe regimen for drug therapy in an individual patient.

37
Q

What is drug monitoring used for?

A

To confirm a plasma drug concentration (PDC) that is above or below the therapeutic range

38
Q

What are the basic components of pharmacokinetics relevant to therapeutic drug monitoring?

A
  • Fixed dosing is intended to generate PDS within a therapeutic range
  • Marked individual variability has been confirmed due to physiologic, pathologic, and pharmacologic effects
  • Need to modify dosing when possible based on an individuals needs
39
Q

What are the general guidelines for therapeutic dose monitoring? (5)

A
  • Patient response to the drug must correlate with PDC
  • Make sure to measure that active part (parent compound vs. active metabolite)
  • Samples need to be able to measure drug at therapeutic concentrations, and be detected rapidly, precisely, and accurately
  • Monitoring is most effective when max/minimum ranges have been established
  • PDC ranges encompass 95% of all cases (5% of cases will not response to established values)
40
Q

Trial and error method for TDM works when drugs can be easily __________.

Give examples.

A

Measured

Gas inhalants
Rapidly acting anticonvulsants
Lidocaine for ventricular arrhthmias

41
Q

Trial and error method for TDM works well when the disease process:

A
  • Is not serious
  • Doesn’t require immediate resolution
  • Drugs w/ wide therapeutic windows
42
Q

When should you NOT use the trial and error approach for TDM?

A
  • Drug response cannot be easily measured
  • Drug has narrow margin of safety
  • Patient’s life is threatened
43
Q

When is TDM most useful?

A
  • Drugs that can cause serious toxicity
  • Poorly defined clinical endpoint
  • Steep dose-response curve
  • Narrow therapeutic range
  • Nonlinear pharmacokinetics
  • Combo drugs w/ potentially undesirable side effects
  • When therapeutic failure may lead to patient harm (anticonvulsants)
  • A target therapeutic range has been validated in the target species with the target drug
44
Q

When measuring TD<, when do you take a peak value?

A

If toxicity of drug is a concern

45
Q

When measuring TDM, when do you take a trough value?

A

If efficacy of drug is a concern

46
Q

What are some drugs commonly monitored using TDM?

A
  • Amikacin
  • Bromide
  • Cyclosporin
  • Digoxin
  • Gabapentin
  • Gentamycin
  • Leflunomide
  • Levitiracetam
  • Lidocaine
  • Phenobarbitol
  • Phenytoin
  • Procainamide
  • Theophylline
  • Valproic acid
  • Vancomycin
  • Zonisamide

CLIN PHARM (13 decks)

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