What is required by the general record keeping requirements in s. 23.1(1) of the PODSA Bylaws?

What is required by the general record keeping requirements in s. 23.1(1) of the PODSA Bylaws?

Bylaw Reference: PODSA Bylaws s. 23.1(1):

23.1. (1) All records required to be kept under bylaws of the college or other legislation that regulates the practice of pharmacy shall be readable, complete, filed systematically and maintained in a manner that is secure, auditable and allows for easy retrieval.

This general record keeping requirement applies to all pharmacies, regardless of the type of records they keep.  The following provides more information on the terms used in s. 23.1(1) of the PODSA Bylaws.

“Readable”

  • The readability requirement applies to all records, but is particularly relevant for paper records that are converted into an electronic format.
  • When converting paper records into electronic records by scanning, registrants must ensure that the image quality is sufficiently clear, the entire record is captured in the scan (i.e. the record is not partially cropped) and that the scan is an accurate representation of the original.  

“Complete”

  • The record should be a complete account of the registrant’s interaction with the patient, including the prescription and any notes made by the registrant.
  • When creating an electronic prescription record, all notes made on prescription must be scanned into system before the original prescription is discarded.  If notes are made on the prescription after it has been scanned, it must be re-scanned before it is discarded.
  • It is recommended that both the front and back of prescription is scanned, even if nothing is written on back.  

“Filed systematically”

  • Each pharmacy is responsible for establishing its own filing system.  For example, records may be filed chronologically, by patient name, etc.
  • Since the College does not prescribe how records are to be stored and maintained, we expect that there will be significant variations in how pharmacies choose to keep records.  As a result, the pharmacy manager will be required to ensure that there is a policy in place that describes the records filing system, records format, and the method and system for storing records, and backups.  Please refer to s. 23.2 of the PODSA Bylaws, which sets out requirements for the written record keeping policy.  

“secure”

  • Records must be secure from unauthorized access, use, disclosure, modification and destruction.
  • This is consistent with the new requirement for pharmacy managers to ensure that pharmacy records containing personal information about patients are secure from unauthorized access, use, disclosure, modification and destruction. (s. 18(2)(j.1) of the PODSA Bylaws)

“auditable”

  • Records should be auditable.
  • The Canadian General Standards Board CAN/CGSB-72.34-2017 – National Standard of Canada – Electronic records as documentary evidence defines “audit” and “audit trail” as follows.
  • An audit is a systematic review of recorded information activities for compliance with policies, procedures, and controls are established and complied with to meet all financial, operational, legal, and regulatory obligations.
  • An audit trail means a log of IT system activities that enables the reconstruction, reviewing and examination of the sequence of activities relating to an operation, a procedure, or an event in a transaction.

“easy retrieval”

  • Records should be readily accessible.
  • Please also refer to s. 23.1(2) and (3) of the PODSA Bylaws, which clarifies that “valid prescriptions” must be retrievable immediately.  In practice, this means that valid prescriptions should be stored on the pharmacy premise, or in an electronic format that can be accessed immediately.

Bylaw Reference: PODSA Bylaws s. 23.1(2) and (3):

23.1 (2) Notwithstanding subsection (1), a prescription record that is valid must be retrievable immediately.

(3) For purposes of subsection (2):

(a) prescriptions for oral contraceptives are valid for a period of up to two years from the prescribing date; and

(b) prescriptions other than for oral contraceptives are valid for a period of up to one year from the prescribing date.