Abstract
Health Canada has changed its position on the need to amend federal laws and regulations to enable electronic prescribing.
Until recently, the federal government believed that e-prescribing could not proceed anywhere in Canada without amendments to the regulation-making authority of the Food and Drugs Act, the Controlled Drugs and Substances Act, and possibly the Personal Information Protection and Electronic Documents Act. That's because these laws stipulated that prescriptions be in handwritten or verbal form.
Following a review of the legal status of e-prescribing, Health Canada has decided that legislative and regulatory amendments are not necessary. This new opinion was communicated in a letter to the Canadian Pharmacists Association (CPhA) and the Canadian Association of Chain Drug Stores (CACDS) on May 2, 2007, from assistant deputy minister Marcel Nouvet.
“We are now of the opinion that electronically-generated and transmitted prescriptions are permissible, to the extent that they achieve the same objectives as do written prescriptions (i.e., evidence of a genuine practitioner/patient relationship and use of drugs for licit purposes),” said Mr. Nouvet in the letter.
‘A major impediment to e-prescribing has been removed’
— Joan Roch
“Definitely a major impediment to e-prescribing has been removed,” says Joan Roch, Chief Privacy Strategist with Canada Health Infoway, which has also received the official word from Health Canada. “We think this is a really positive development, as the process of regulatory change is a lot of work and time-consuming.”
E-prescribing technical standards also in place
The federal legal issues were seen as the last major hurdle to e-prescribing. The national government and Canada Health Infoway have recently completed development of a Standard for Electronic Prescribing — a pan-Canadian technical standard and protocol for ensuring the veracity of e-prescriptions.
E-prescribing has long been seen as an important complement to an integrated electronic health record (EHR), and a step forward in improving health outcomes and patient safety by helping to reduce medication errors.
All the foundations are in place to allow safe and secure electronic prescriptions, says Ms. Roch. “The technical standard for the electronic transfer of prescriptions is complete, which includes standards for what must be included in a message from one party to another.”
Additionally, the protocol has been developed for what are known as “digital certificates,” which will be issued by health authorities in various provinces to health care providers authorized to digitally sign prescriptions.
A number of provinces are moving forward with e-prescribing projects, says David Crosbie, manager of pharmacy affairs at CPhA. The most advanced are Prince Edward Island, Newfoundland, British Columbia, Saskatchewan, Manitoba, and Quebec, he says.
Both Mr. Crosbie and Ms. Roch predict that PEI will be the first to have an e-prescribing system online, potentially before the end of this year.
Meanwhile, CPhA would still like to see federal legislation eventually amended to explicitly sanction e-prescribing. “We think it's important to bring the laws in line with 21st century reality, by recognizing that a prescription doesn't have to be a piece of paper with a doctor's handwritten signature,” says Mr. Crosbie.