Biologicals FTags Flashcards
What are the requirements for drug labeling in healthcare facilities?
Drugs must have correct label, accessory, instructions, precautions (such as “shake well” or “take with meals”) and exp date.
How should drugs and biologicals be stored to ensure safety and compliance?
All drugs and biologicals stored in locked compartments under proper temperature controls. Only authorized personnel to have access/keys.
What measures must be taken for the storage of drugs subject to abuse or controlled substances?
The facility must provide separately locked, permanently affixed compartments for storage of drugs subject to abuse or controlled as Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976. N/A when the facility uses single unit package drug distribution in which the qty stored is minimal and a missing dose can be readily detected.
What information is required on a medication label according to healthcare regulations?
The medication label at a minimum must include the med. name (generic and/or brand), prescribed dose, strength, the exp. date when applicable, the rez’s name, and route of administration
How should medications designed for multiple administrations be labeled?
For medications designed for multiple administrations (e.g., inhalers, eye drops), the label states specific resident prescribed
What are the labeling requirements for IV medications?
IV label must show:
1. name and volume of the solution
2. resident’s name
3. infusion rate
4. name and qty of each additive
5. date of preparation
6. initials of compounder
7. date and time of administration,
8. initials of person administering medication if different than compounder
9. ancillary precautions as applicable, and date after which the mixture must not be used.
What label information must be included on OTC medications in bulk containers?
OTC meds in bulk containers’ label shall contain the original manufacturer’s or pharmacy-applied label indicating medication name, strength, qty, accessory instructions, lot number, and exp date when applicable.
How should the risk of contamination be minimized when accessing multi-use vials?
To minimize contamination, facility staff should date the label of any multi- use vial when vial is first accessed. Should only access the vial in a dedicated med. prep area.
What is the protocol for handling multi-dose vials once they have been opened or needle-punctured?
If a multi-dose vial has been opened/needle-punctured, the vial should be dated and discarded within 28 days unless the manufacturer specifies other duration.
What should be done with expired medications in healthcare facilities?
Expired meds should be discarded.
What are examples of storage areas for medications within healthcare facilities?
Storage areas may include, but are not limited to, drawers, cabinets, medication rooms, refrigerators, and carts.
How does the facility ensure security when storing medications in various types of compartments?
Depending on how the facility locks and stores meds, access to a medication room may not necessarily provide access to the meds (for example, medications stored in a locked cart, locked cabinets, a locked refrigerator, or locked drawers within the medication room).
What access restrictions are in place for areas where medications are stored without separate locked compartments?
When meds are not stored in separately locked compartments within a storage area, only appropriately authorized staff may have access to the storage area.
How is access to medications controlled in healthcare facilities?
Access to meds can be controlled by keys, codes, cards, or other tech (such as fingerprints). Schedule II-V medications must be maintained in separately locked, permanently affixed compartments. The access key used to lock Schedule II-V meds and other meds subject to abuse, cannot be same access key used to obtain the non-scheduled meds.
What system is in place to manage security access to medications?
The facility must have a system to limit -who has security access and -when access is used.
