How long to keep all prescription records? (Includes transfers in/out)
5 years minimum
How long to keep OTC PSE purchase records?
4 years minimum
How long to keep any use of DEA 222 Forms? (includes copes)
2 years minimum
How long to keep patient records (profiles) & drug orders? (invoices/inventory)
5 years minimum
How long to keep CS inventory records?
5 years
The PIC is responsible for signing & dating CS inventory documentation
How should C2 Inventory records be kept?
Must be kept separate from all other records
How should prescription files be kept?
In three (3) separate files
CII vs CIII, CIV, CV vs Non-CS
How should electronic prescription files be put into the computer system?
Accurately - the pharmacist must sign the log
Attesting that all RX information entered into the computer has been reviewed & is accurate
All pharmacies must have effective controls against the diversion of drugs in place but specifically through…
What must the Patient Profile contain?
A pharmacy can sell legend drugs to another pharmacy as long as…
The sales do not account for more than 5% of the pharmacy’s total sales of Rx drugs
Where must expired / misbranded / adulterated drugs be located in the pharmacy?
Quarantined and separated from the other drugs
What are “Automated Pharmacy Systems” also known as?
Automated Dispensing and Storage Systems
Define “Automated Pharmacy Systems”
CAN serve as Emergency Kits or After-Hours Cabinets (but do not have to)
* Sometimes they’re just a place to store drugs at a location without a pharmacy
* To be dispensed later after RX approval by a pharmacist
When can “Automated Pharmacy Systems” be used?
Only in setting that ensure medication orders and prescriptions (THAT ARE REVIEWED BY A PHARMACIST)
Also in accordance with established policies and procedures
Are there any security and/or privacy requirements needed in place?
Must be secured to prevent unauthorized access
Must maintain patient confidentiality
How should medications be maintained?
Unit-of-use packaging (for single patient use)
For “Automated Pharmacy Systems”
Who’s in charge of documentation? What is required to be documented?
The Pharmacy
Quality Assurance Docs; and
Detailed Transaction Records
* Identification of the person (stocking/restocking)
* Pharmacist checking for the accuracy of the medications (to be stocked/restocked)
Who may access “Automated Pharmacy Systems” for the purpose of stocking/restocking medications?
Only by Interns / Technicians that are designated & trained by the PIC
For “Automated Pharmacy Systems”
What must happen before the medication can be released?
Pharmacist (at the home pharmacy) must approve the release
* The RX (written or electronic) must be obtained & verified by the pharmacist
* Kept for 5 years; like all other Rx records
Explain Hospital: Absence of Pharmacist
“After-Hours Cabinet” may be used (by Specifically Authorized Personnel)
What documentation is required for “After-Hours Cabinet(s)” in a Hospital when there is an absence of a pharmacy?
Physician’s Orders; authorizes the removal of the drug
Log Documentation
* Date & Time
* Drug
* Amount, etc.
When is an authorized nurse to enter the pharmacy to retrieve a medication? What is required?
Pharmacist is absent
Drug needed is not in the after-hours cabinet
Must leave copy of the Physician’s Order (in the container) with the nurses signature
What are Emergency Kits? Explain what they can be used for.
Usually prepared by a nearby pharmacy
Drugs contained, belong to the pharmacy (included in inventory count)
May be used for Immediate Need of Patients in an LTCF