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Compounding
N/A
19
Veterinary Medicine
Professional
11/29/2011

Additional Veterinary Medicine Flashcards

 


 

Cards

Term
_____________________ involves the mixing, preparation, assembling, packaging, and labeling of a drug or device in accordance with a licensed practitioner's prescription under an initiative based on one of the triads (VPCR) in the course of professional practice.
Definition
Compounding
Term
Compounding includes:

a. preparation in anticipation of Rx orders based on routine patterns
b. Reconstitution of commercial products that requires the addition of >2 ingredients as a result of Rx
c. Manipulation of products requiring addition of >1 ingredients per Rx.
d. Preparation of drugs for research, teaching, or chemical analysis
e. All of the above
Definition
e. all of the above
Term
_______________ involves the production, propagation, conversion, or processing of a drug or device either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis.
Definition
Manufacturing
Term
Manufacturing includes:

a. Packaging containers for promotion and marketing.
b. Preparation of drug for resale.
c. Distribution of inordinate amounts of compounded preparations or copying commercially available products.
d. Preparation without a PPP or VPCR relationship.
e. All of the above
Definition
e. All of the above
Term
___________________ is the preparation of small quantities for specific patients, while ___________ is the preparation of large quantities for mass distribution (not patient specific).
Definition
Compounding
Manufacturing
Term
T/F: Compounding requires FDA approval for their preparations.
Definition
False
Term
T/F: Manufacturing requires FDA approval for their products.
Definition
True
Term
Who can compound for veterinary use?
Definition
Licensed DVMs
Licensed Pharmacists
Term
In the 1930s, about ____% of prescriptions were compounded. In the 1950s, about ____% of prescriptions were compounded. In the 1970s, about ___% of prescriptions were compounded. Today, an estimated _______________ prescriptions/day are compounded.
Definition
75%
26%
1%
43,000/day
Term
What is the reason for the fall of compounded products?
Definition
Growth of the pharmaceutical industry
Term
Why has there recently been a resurgence in compounding?
Definition
Need for customized medications
Lack of commercially available products
Technology and materials
AMDUCA (for veterinary compounding)
Term
Why is there a need for customized medications?
Definition
Change the strength of a medication
Patient allergies
Change dosage form or flavor
Product discontinued/not available
Improve client compliance
Lack of approved veterinary labeled products
Term
When compounding, which of the following should be considered?

a. Rationality
b. Safety
C. Efficacy
d. Stability
e. All of the above
Definition
e. all of the above
Term
List the important factors a DVM must consider when determining whether to compound a drug:
Definition
Compounded drugs are unapproved products and their use is extralabel

Must meet AMDUCA criteria to use or prescribe a compounded drug

Need valid VCPR

Legitimate medical need based on careful diagnosis

There is a need for an appropriate dosage regimen for the species, age, size or medical condition of the patient

There is no marketed approved animal or human drug, when used as labelled or according to established criteria, in the available dosage form, or concentration

Non-food animal vs. food animal

Compounding from bulk drugs

Prohibited drugs for extralabel use in food animals

What pharmacy to use
Term
T/F: The FDA will usually defer to state authorities on the day-to-day regulation of DVM/RPh compounding.
Definition
True
Term
T/F: the FDA will become involved in DVM/RPh activities associated with manufacturing or violation of the FFDC act.
Definition
True
Term
The highest regulatory priority for compounded medications is for those used in _________________. Why?
Definition
Food animal

This is because the pharmacokinetics and residue depletion time in food animals are unknown. Extemporaneous withdrawal time could result in potentially harmful residues.
Term
Which of the following does not pose a regulatory issue?

a. Preparation of small quantities of medications for use in the presence of a valid VPCR.
b. Compounding drugs essentially similar to FDA-approved drugs except in rare instances where legitimate need can be established.
c. Substitution or recommendation by a pharmacist of a compounded drug instead of an FDA-approved product.
d. Compounding from bulk drugs for food animal use, with few exceptions (antidotes)
e. Offering compounded drugs at wholesale to other DVMs or pharmacists or other commercial entities for resale.
Definition
A.
Term
When should a compounded product be used or prescribed?
Definition
When the need is clinician driven.
When the benefits outweigh the risks.
When there are no other treatment options.
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