E-prescribing (e-Rx) is a means of streamlining the prescription process by enabling prescriptions to be created, signed and transmitted electronically. There are significant benefits associated with the implementation of e-Rx including the potential to reduce the incidence of medication and dispensing errors caused by illegible prescriptions, a potential decline in adverse drug reactions and the timely transmission of prescription information from practitioner to pharmacist. Health Canada recognizes these benefits and supports the implementation of e-Rx.
Until recently, it was the position of Health Canada that, to allow for e-Rx,amendments to Part C of the Food and Drugs Regulations made under the Food and Drugs Act, regulations made under the Controlled Drugs and Substances Act and possibly regulations made under Personal Information Protection and Electronic Documents Act would be required.
After further review, Health Canada has concluded that there are currently no regulatory impediments to moving ahead with electronically generated and transmitted prescriptions and that these are permissible to the extent that they achieve the same objectives as written prescriptions.
Provinces and territories wishing to proceed with e-Rx are obligated to ensure that electronic prescriptions meet existing regulatory requirements and achieve the same objectives as written prescriptions. For example, there must be evidence of a genuine practitioner/patient relationship, and in the case of controlled substances, pharmacists filling prescriptions must verify prescriptions are signed1 by the practitioner before selling or providing drugs containing controlled substances to a patient.
Health Canada has collaborated with Canada Health Infoway on the development of a technical document entitled Ensuring the Authenticity of Electronic Prescriptions, in order to provide advice about how to ensure the authenticity of electronic signatures. Although this document (and annexes) was not subject to widespread consultation, it could be of use to provincial and territorial Ministries of Health in moving forward with e-prescribing.
Health Canada has also initiated discussions with provincial and territorial pharmacy and medical regulatory authorities in order to determine how it can be of assistance in facilitating collaboration between provincial and territorial stakeholders regarding e-Rx implementation.
1 Sign: whatever is determined to be necessary to authenticate and validate the order in that pharmacists must have a high degree of certainty that the identified practitioner (in the electronic message) has ordered the prescription.