Class A Pharmacy Records

Question 1

How long should records be kept?

Answer 1

Generally 2 years
C2s should be separate
C-3, C4, C5 records shall be maintained separately or be readily retrievable from other records. Readily retrievable means that the controlled substances records are asterisked, redlined, or in some other manner readily identifiable from other items in the records
Texas law allows imaging of original records for C2, C3, C4, C5 controlled substances but DEA requires the hardcopy original records be kept for two years*****

Question 2

Patient Medication Record

Answer 2

Required for all new patients
Must provide for the immediate retrieval of information for the previous 12 months to conduct a drug regimen review
PIC must ensure that reasonable effort was put forth to retrieve: name, address, telephone number, age and gender, known allergies, drug reactions, idiosyncrasies, chronic conditions/disease states, other active drugs, a list of all prescription drug orders dispensed to patient by the pharmacy during the last 2 years and pharmacist comments

Question 3

Computer System Requirements

Answer 3

Must be backed up monthly
Must maintain any information/records purged from computer for 2 years from the date of final entry of data
Daily hard copy printout shall be produced within 72 hours of the date dispensed
Each pharmacist who dispensed or refilled a prescription shall verify that the information is correct by signing and dating within 7 days***
Pharmacy may maintain a log book that pharmacist may sign in lieu of daily hard copy printout, But the computer system must be able to produce an audit trail within 72 hours for dangerous drugs and controls
Document all changes

Question 4

Computer systems must have the capacity to produce a daily hard copy printout consisting of:

Answer 4

Prescription number
Date of Dispensing
Patient name
Prescribers
Name
Name and strength of drug dispensed
Quantity dispensed
Initials or identification code of Dispensing Pharmacy and pharmacy technician
Any changes made to a record of Dispensing
If not immediately retrievable, must also include patients address, prescribers address, prescribers DEA number if a controlled, quantity dispensed if different from quantity prescribed, date of issuance of the prescription, and total refills dispensed to date

Question 5

Identification Codes***

Answer 5

Pharmacies must maintain a log of the unique initials or identification codes which will identify each pharmacist, pharmacy technician, and pharmacy technician trainee, who is involved in the dispensing process, and the pharmacy data processing system.
MAINTAIN THIS LOG FOR 7 YEARS! (Only rule that requires records for 7 years)

Question 6

Transfers of Prescription Drugs

Answer 6

Transfers must be communicated verbally or via fax or electronically between to pharmacists OR a pharmacist and an intern
TWO INTERNS MAY NOT TRANSFER FROM EACH OTHER
Controls can be transferred one time unless real-time database
The prescription that is transferred must be voided in the computer system
Electronic transfer of multiple or bulk prescription transfers is permitted.
AN INDIVIDUAL MAY NOT REFUSE TO TRANSFER A PRESCRIPTION, AND ALL TRANSFERS MHST BE COMPLETED WITHIN 4 BUSINESS HOURS OF A REQUEST***