Session 5 Poll Questions Flashcards
(9 cards)
Which is NOT one of the five areas of focus when managing controlled substances?
a. Registration
b. Reverse distribution
c. Record keeping
d. Security and protection
e. Reporting losses
f. Substance disposal
b. Reverse distribution
True or False: Veterinarians who work at more than one location may administer, dispense, and prescribe controlled drugs provided they have a current DEA registration at a central place of business.
False - May prescribe controlled drugs if they are registered at some principle place of business. To administer or dispense they must be classified as an employee of a registrant, or they must register at each facility where they are employed.
Under what circumstances can a DVM dispense an adulterated drug?
a. When all ingredients are FDA/CVM approved.
b. Under no circumstances.
c. As long as there are no more than two drugs combined and both are FDA/CVM approved.
b. Under no circumstances
In regards to a DEA inspection, what can the inspector copy without the consent of the practice owner or representative?
a. All records and reports involving controlled rugs.
b. All records, reports, and financial information regarding controlled rugs.
c. They cannot copy any documents without consent.
a. All records and reports involving controlled drugs.
What are the five areas that must be focused on when managing Controlled Substances?
- Registration
- Security and protection
- Record Keeping
- Reporting losses
- Substance disposal
These drugs contain unsanitary components, lack of adequate control in manufacture, differ in strength from official compendium, or that are mixed with another substance.
Adulterated Drugs
These drugs include those in which the labeling is false of misleading, including any drug in a package form that does not bear a label that contains the name and place of business of the manufacturer/packer/distributor, and an accurate statement of quantity. Most importantly a drug is misbranded if the label does not include adequate directions for use.
Misbranded Drugs
What are the FDA label requirements for prescription drugs? 5 items
1) The statement “Caution, Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
2) Recommended dose and route of administration.
3) Quantity or proportion of each active ingredient.
4) Names of all inactive ingredients if drug is for non oral use.
5) Identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.
What are the 8 items a practice must have to be in compliance with Hazard Communication (Right to Know)?
1) A designated Safety Manager or Officer
2) An annual hazard analysis inspection
3) Safety plans in place for all identified hazards
4) A chemical list and safety plans for Immediately Dangerous to Life and Health chemicals
5) Safety Data Sheets on all chemicals and components
6) Secondary labeling as needed and explanation and training on labeling system.
7) A protocol in place for emergency evacuation
8) A training program focusing on PPE, monitoring devices, and hazards of the practice (11 or more employees).