Electronic storage for transaction, compounding, or repackaging records? Yes, if you meet these requirements.
August 5, 2014
In the July 22 edition of The Link, we informed you that Health Canada approved electronic storage of written prescriptions. We have had several questions about whether this change can apply to other records.
ACP recognizes the new interpretation from Health Canada for written prescriptions. Electronically scanned prescriptions that are filed systematically and retained for up to 42 months will meet the requirements outlined in Standard 8.3 of the Standards for the Operation of Licensed Pharmacies.
ACP also recognizes electronic storage as a method of meeting the retention requirements for the other records described in Standard 8.3: transaction, compounding, and repackaging records.
You must still print these records, as you have in the past, but now when you are finished with them you may scan the final documents and retain them electronically to meet the requirements of the standard. This will ensure that any notes, labels, or other information affixed to the records are also captured.
Why do these records need to be created and then scanned for storage?
Although the Health Canada interpretation changes record retention methods, all other ACP standards in the Standards of Practice for Pharmacists and Pharmacy Technicians must be met:
Standard 7.16 requires that an audit trail be created that identifies all individuals involved in the processing of a prescription and the dispensing of the drug.
Standard 10.11 requires documentation regarding compounded drugs.
Standard 18.1 requires that a written transaction record is created each time a Schedule 1 drug is dispensed.
Standard 21.1 requires an audit trail of drugs repackaged.
Of course, if you prefer, you may choose to retain the physical copy rather than a scanned version.
Before disposing of any written prescriptions, remember:
It is your responsibility to confirm that others, such as third party payers, recognize Health Canada’s interpretation.
Disposal must be done in a way that ensures privacy is maintained, as required by the Health Information Act.
Definition: Transaction record
Each time a pharmacist or a pharmacy technician dispenses a Schedule 1 drug or blood product, the pharmacist or the pharmacy technician must ensure that a written transaction record is created that includes:
a) the name of the patient for whom the drug was dispensed;
b) the name of the prescriber of the drug;
c) the date the drug was dispensed;
d) the name, strength, and dosage form of the drug dispensed;
e) the DIN of the drug dispensed;
f) the quantity of drug dispensed;
g) route of administration and directions for use; and
h) a unique prescription and transaction number.
(Standard 18.1, Standards of Practice for Pharmacists and Pharmacy Technicians)
Additional documentation requirements for compounded drugs
In addition to the documentation requirements for dispensing a drug or blood product in Standards 18.1 and 18.2, a pharmacist or a pharmacy technician who compounds a drug or blood product must ensure that a record is created that includes the:
a) name, lot number, expiry date and quantity of each ingredient used to prepare the compounded drug or blood product;
b) formula used to prepare the compounded drug or blood product;
c) beyond-use date assigned to the compounded drug or blood product; and
d) a clear audit trail that identifies all individuals who were involved in the preparation and verification of the compounded drug or blood product, and the role of each individual.
(Standard 10.11, Standards of Practice for Pharmacists and Pharmacy Technicians)
Duty regarding audit trail when repackaging
A pharmacist or a pharmacy technician who repackages a drug or blood product must ensure that in respect of that drug or blood product there is sufficient documentation to provide a clear audit trail of the repackaging process.
The documentation required under Standard 21.1 must identify:
a) drug information from the original container including:
i. DIN, NPN or HN;
ii. lot number;
iii. expiry date; and
b) all individuals involved in the repackaging and verification process and the role of each individual.
(Standards 21.1 and 21.2, Standards of Practice for Pharmacists and Pharmacy Technicians)