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. |
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Definition
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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 |
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Definition
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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. |
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Definition
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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 |
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Definition
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Term
| ___________________ is the preparation of small quantities for specific patients, while ___________ is the preparation of large quantities for mass distribution (not patient specific). |
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Definition
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Term
| T/F: Compounding requires FDA approval for their preparations. |
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Definition
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Term
| T/F: Manufacturing requires FDA approval for their products. |
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Definition
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Term
| Who can compound for veterinary use? |
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Definition
Licensed DVMs
Licensed Pharmacists |
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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. |
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Definition
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Term
| What is the reason for the fall of compounded products? |
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Definition
| Growth of the pharmaceutical industry |
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Term
| Why has there recently been a resurgence in compounding? |
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Definition
Need for customized medications
Lack of commercially available products
Technology and materials
AMDUCA (for veterinary compounding) |
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Term
| Why is there a need for customized medications? |
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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 |
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Term
When compounding, which of the following should be considered?
a. Rationality
b. Safety
C. Efficacy
d. Stability
e. All of the above |
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Definition
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Term
| List the important factors a DVM must consider when determining whether to compound a drug: |
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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 |
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Term
| T/F: The FDA will usually defer to state authorities on the day-to-day regulation of DVM/RPh compounding. |
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Definition
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Term
| T/F: the FDA will become involved in DVM/RPh activities associated with manufacturing or violation of the FFDC act. |
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Definition
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Term
| The highest regulatory priority for compounded medications is for those used in _________________. Why? |
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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. |
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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. |
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Definition
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Term
| When should a compounded product be used or prescribed? |
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Definition
When the need is clinician driven.
When the benefits outweigh the risks.
When there are no other treatment options. |
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