New Electronic Recordkeeping Requirements Coming Soon
New Electronic Record Keeping requirements will come into effect on November 13, 2018.
Comprehensive recordkeeping is essential to safe and effective pharmacy practice. Well-kept patient records support the provision of safe services, continuity of care, and evidence-based care, as well as good professional practice and medication management.
While the College currently enforces general record keeping requirements in s. 23.1(1) of the Pharmacy Operations and Drug Scheduling Act Bylaws, the College has received a number of requests from registrants to formally allow electronic record keeping.
In response to this, the College has developed amendments to the Pharmacy Operations and Drug Scheduling Act Bylaws and the Health Professions Act Bylaws that set out a new framework for electronic record keeping requirements. In addition, Professional Practice Policy-12: Prescription Hard Copy File Coding System and Professional Practice Policy-20: Prescription Refills will be repealed.
The bylaw amendments were approved for submission to the Minister of Health for a 60-day filing period and will come into force on November 13, 2018.
Under the new records management framework, pharmacies are permitted to continue keeping only hard copy records, only electronic records, or a combination of both. This allows the College to ensure:
- That record keeping can be completed efficiently and in a manner that promotes patient safety and the accountability of registrants
- That records are filed systematically
- That records are easily retrievable
- That registrants’ interactions with records are auditable (i.e. who did what and when); and
- That patient records and other personal and confidential information are stored securely, with appropriate back-ups
Minimum Technology Requirements
Pharmacies that keep any form of electronic record that contains personal health information must have a system that complies with the minimum technology requirements. A registrant who creates and stores electronic records must also do so using a system that complies with minimum technology requirements.
Pharmacies that do not meet the minimum technology requirements as outlined in the new Records Management Framework when the new bylaws come into force, under the new Records Management Framework will have 6 months to transition into a compliant system.
The deadline for compliance is May 13, 2019.
Electronic Record Keeping – Summary of Amendments
Apart from the new minimum technology requirements which must be complied with by May 13, 2019, pharmacies must be in compliance with the following amendments to both the PODSA and HPA Bylaws on the effective date of November 13, 2018.
Electronic Storage of Prescriptions – Repeal of Professional Practice Policy -12: Prescription Hard Copy File Coding System
PPP-12 requires that prescription hard copies must be retained in accordance with certain prescribed requirements.
The new bylaws permit all records required by the College, other than prescriptions for drugs included in the Controlled Prescription Program, to be stored electronically.
|General Record Keeping Requirements – PODSA Bylaws ss. 18(2)(j.1) and 23.1(1) and HPA Bylaw s. 65.1||
The current bylaws, apart from PPP-12, do not specify the manner in which records are to be kept.
A new general record keeping requirement will be added to ensure that records are readable, complete, filed systematically and maintained in a manner that is secure, auditable and allows for easy retrieval.
In addition, the pharmacy manager would be required to ensure that pharmacy records containing personal information about patients are secure from unauthorized access, use, disclosure, modification and destruction.
These requirements apply to both hard copy and electronic records.
|Written Record Keeping Policy – PODSA Bylaws s. 23.2||
The College believes that pharmacies should be allowed to adopt a record keeping system of their choice, provided that it meets the general requirements in s. 23.1, as well as the technology requirements in s. 23.3 of the PODSA Bylaws.
As such, the new bylaws do not prescribe a system for organizing records, the format of records, or the method of storage.
Variation in the way that pharmacies organize and file records is expected.
Pharmacies are required to have a written procedure in place that sets out how registrants would file and maintain records.
|Minimum Technology Requirements – PODSA Bylaws ss. 23.3(1) and (2)||
Pharmacies that maintain electronic records containing personal health information will be subject to minimum technology requirements.
The College believes that most pharmacies have software systems that comply with the proposed requirements, however some may need to upgrade their systems in order to comply.
The requirements do not speak to the specific technology that must be used. The language is intended to be sufficiently broad to accommodate changing technology.
Registrants must be in compliance with these requirements by May 13, 2019.
|Back Up Requirements – PODSA Bylaws s. 23.3(3)||Records would be required to be backed up at least once daily and stored securely, in a location resistant to environmental perils, and in accordance with the requirements of s. 23.1(1) of the PODSA Bylaws.|
|Electronic Signatures and Initials - Definitions in PODSA Bylaws and HPA Bylaws||
The addition of the definitions of “signature” and “electronic signature” in the PODSA Bylaws, and the definitions of “signature”, “initial” and “electronic initial” in the HPA Bylaws, clarifies that registrants may sign documents using an electronic signature or initials.
The definitions do not speak to the specific technology that must be used. The language is intended to be sufficiently broad to accommodate changing technology.
|Manner of Disposal of Records – HPA Bylaws s. 75||
Requirements for the destruction and disposal of records will be updated to remove references to out-of-date technology and to allow registrants to use their judgment to select the appropriate method of destruction, so long as records are destroyed in a manner that prevents them from being reconstructed.
This provision will apply to both hard copy and electronic records.
|Colour Scanning – PODSA Bylaws s. 23.1(5) and HPA Bylaws s. 65.1(5)||
As part of the amendments, prescriptions stored electronically must accurately reflect the original prescription, including the colour composition of that prescription. This means that pharmacies who choose to retain electronic records will have to have access to a colour scanning device.
Colour scanning is important for verifying the authenticity of a prescription and helping to identify prescription forgery and tampering.
Pharmacies that choose to retain prescription hard copies will not be required to comply with the colour scanning requirement.
|Amendments to Patient Records to Correct Errors or Omissions Must Be Auditable – HPA Bylaws ss. 69 and 70.||
In order to promote patient safety and the accountability of registrants, when a patient record is amended to correct an error or omission, the following must be identifiable:
This requirement will apply to amendments made to both electronic and hard copy records
|HPA Bylaws – Schedule F – Part 2 – Hospital Pharmacy Standards of Practice – s. 16(2)(h)||Documentation required under this provision, pertaining to the drug therapy of a patient, must include the full pharmacist’s signature.|
The following amended bylaws are being provided for reference only and will come into effect on November 13, 2018.
- What is required by the general record keeping requirements in s.23.1(1) of the PODSA Bylaws?
- Are all pharmacies required to comply with the new technology requirements?
- Are all pharmacies now required to keep electronic records?
- Are electronic equivalents acceptable for all College-required documentation, including invoices and documentation in respect of the purchase, receipt or transfer of drugs, confidentiality forms, narcotic reconciliation records etc.?
- Are all electronic records required to be maintained in a system that complies with the new technology requirements?
- Can prescriptions be destroyed after scanning and storing electronically?
- What should be included in the pharmacy's written record keeping policy?
- What is an acceptable form of electronic signature?
- Can electronic records be stored on a cloud? If yes, does the cloud need to be located in Canada?