Legislative References:
- Food and Drug Act
- Controlled Drugs and Substances Act
- Drug and Pharmacies Act Regulations
- Personal Health Information Protection Act
Additional References:
College Contact: Pharmacy Practice
Principles
- A registrant’s responsibility to confirm the authenticity of a prescription may be fulfilled through the existence of a unique identifier for the prescriber. Where authenticity is questioned, confirmation with the prescriber must occur.
- A registrant considers the content of the prescription specific to the patient when evaluating the prescription for authenticity.
Guidance to Registrants Regarding Prescriptions Using Unique Identifiers
‘Signing’ a prescription no longer refers to only a pen-and-ink signature on either a traditional prescription pad or a computer generated prescription. A prescriber can utilize a number of unique identifiers which can be considered equally appropriate to ‘sign’ a prescription such as;
- a traditional pen-and-ink signature, or
- an electronically captured image of a unique signature (generated on a signature pad), or
- a unique prescription authorization process which ensures that the prescriber has reviewed and authorized each individual prescription.
Many prescribers, in advance of a province-wide e-prescription and related electronic medical record (EMR), are contracting with third-party software providers to implement a ‘unique prescription authorization process’ which permits the secure attachment of a prescriber’s unique identifier and transmission of the prescription to a pharmacy with no paper-based intermediaries.
A unique prescription authorization process acts similarly to a password and creates a digital signature on each individual prescription as it is being electronically generated by the prescriber. Mechanisms to authenticate a prescriber using a unique prescription authorization process include:
- hardware tokens – may be a physical device such as a key fob and can be used in addition to or in place of a password, or
- biometric identification – which refers to the identification of humans by their characteristics or traits such as a thumbprint reader, DNA, or voice recognition and does not require a traditional password.
Regardless of which mechanism is used the result is a secure step in the process whereby the individual prescriber consciously affixes their digital signature to each individual prescription.
In contrast, the process of ‘cutting and pasting’ a digitized image of a prescriber’s signature onto a prescription does not constitute a unique authorization. Rather, it functions as the electronic equivalent of a rubber stamp. The establishment of a unique authorization process is required to ensure each prescription is individually authenticated by the prescriber.
The Responsibility of the Registrant
As always, when determining whether to dispense a prescription a registrant must evaluate the prescription as a whole. In addition to assessing the prescriber’s method of authorizing the prescription, registrants must consider the content of the prescription and its appropriateness, given the patient’s condition and prescription history. If, upon assessing the prescription as a whole, registrants are unsure of a prescription’s authenticity or appropriateness, it is the responsibility of the registrant to confirm the prescription with the prescriber.
With respect to determining the authenticity of the prescription utilizing a unique prescription authorization process, the registrant is not responsible for assessing the specific details of the unique identifier, only that a unique prescription authorization process is in place (e.g., the registrant might confirm that the prescriber’s authorization process requires a biometric identifier but the registrant is not required to ensure that a specific biometric identification system is acceptable). Once initial confirmation has been established with the prescriber that a unique prescription authorization process is in place, it should be documented in the pharmacy. Subsequent prescriptions from that prescriber can then be received and processed in accordance with Standards of Practice.
Definitions
Electronic Prescribing (e-Prescribing)
Electronic Prescribing is the process of generating, authorizing and transmitting prescriptions from doctors and other prescribers to pharmacists and other dispensers. It eliminates hand-written prescriptions by physicians and facilitates the electronic delivery of prescriptions to pharmacies.
Electronic Prescription
An electronic prescription is a prescription that does not involve paper-based intermediaries such as prescription pads, or faxed copies.
Digital Signature
A digital signature is a secure means of electronically signing an electronic document. For example, digital signatures can make use of digital certificates from a certification authority, hardware tokens or biometric identification.
Digitized Image
A digitized image is from the same as a digital photo image of a pen-and-ink signature. The image of the pen-and-ink signature can be readily cut from one electronic document and pasted into another.
Authentication
Authentication is a process that ensures that the prescription is authorized by the prescriber at the time the prescription is generated by the prescriber’s computer-based system.
Transmission
Transmission is the process where the prescription is sent by the prescriber’s computer-based system to a pharmacy.