On June 4, 2007, the Health System Improvement Act received Royal Assent, amending, among other things, the Drug and Pharmacies Regulation Act (DPRA) to reflect current practices.  Highlights of the Act were printed in the July/Aug 2007 issue of Pharmacy Connection. This update reviews some of the changes that have occurred and highlights additional changes taking effect on June 4, 2008 which will directly affect pharmacy operations.

In the Definitions section (s. 1), there are a number of new definitions and changes, most notably:

• The word “Licence”  has been replaced with “Certificate of Registration” for a member and “Certificate of Accreditation” with regard to a practice site, respectively.
• The term “Member” clearly refers to any member of the College.
• “Designated Manager” clearly identifies the role and designation
• “Prescriber” to refer to anyone authorized by a law in a province of Canada to give a prescription within their scope of practice.
• The term “drug” will be redefined to reflect the differences between the National Drug Schedules and new Natural Health Products Regulations.
• The term “proprietary misconduct” has been created to deal with non-pharmacist and corporate ownership issues.

• Accreditation Committee amendments now enable the Committee to refer a member, Designated Managers (DM), directors, or holder of a Certificate of Accreditation to the Discipline Committee for violations of the DPRA or proprietary misconduct.
• The Discipline Committee may now impose a fine of as much as $100,000 up from the previous $25,000.

• The Designated Manager must display his or her name and/or Certificate of Registration clearly and publicly in the pharmacy managed. 
• In addition to the requirement for a Designated Manager, the Act requires owners to designate a DM and to inform the College of the designation.

• Instead of records, the Act now refers to “documents or objects” relevant to the practice and to the Act.  This broadens the definition of what is available to an inspector during an inspection.
• Inspectors under the DPRA now have powers similar to those of investigators under the RHPA. (RHPA) 
• Obstruction of an inspector in the performance of his or her duties is prohibited.

• The first steps towards the regulation of pharmacy technicians are now in the DPRA.  “pharmacy technician” has been added to the definitions and also to the list of members who can compound, dispense, or sell any drug in a pharmacy, where they are supervised by a pharmacist who is physically present.  Regulation of Pharmacy Technicians will be completed in conjunction with changes to the Pharmacy Act and will be subject to the writing of new regulations, which will also identify terms, limits and conditions on their practice.

No person shall sell (deleted “knowingly”) any drug under the representation or pretence that it is a particular drug when the person knows or (inserted)“ought to have known” that it is not that drug, or does not contain any substance that the drug is meant to contain