New Regulations to the Drug & Pharmacies Regulation Act (DPRA)

Revised August 1, 2016

New regulations to the Drug & Pharmacies Regulation Act (DPRA) were proclaimed — and are in effect — as of August 1, 2016. The Ontario College of Pharmacists now has the authority to license and inspect hospital pharmacies. Expectations of practice for pharmacy professionals are unchanged in the new regulations.

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As now required, Ontario hospital pharmacies, having successfully completed a baseline assessment by the College in 2015, have been issued a certificate of accreditation, which must be renewed on an annual basis. In anticipation of this authority, by-law amendments incorporating hospital pharmacy oversight (fees and filing of information) were approved by Council in December, 2015. Learn more about College oversight of hospital pharmacies.

Background

The passing of Bill 21: Safeguarding Health Care Integrity Act, 2014 extended the College’s authority to license and inspect pharmacies within public and private hospitals, as well as future authority over institutional pharmacy locations. As a result, the previous regulation to the Drug and Pharmacies Regulation Act, (DPRA) which only addressed community pharmacy practice, required amendments.

The new regulation, in addition to adding provisions for hospital pharmacies, incorporates an outcomes-based approach to the language; designed to improve the relevance of the regulatory framework over time. By removing specific expectations from the regulation and moving these into standards, policies, guidelines and processes, the College is able to respond to changes in practice and public expectations in a timelier manner.

At its meeting in March 2015, Council approved that the proposed regulation be circulated for public consultation. In addition, College staff met with major stakeholders from the hospital and community pharmacy sectors, and the Ministry of Health and Long-Term Care to gather feedback on the regulation.

There was support for the outcomes-based approach to the regulation, leaving specifics to supplemental documents such as standards, policies and guidelines that can be amended easily as practice evolves. Several stakeholders asked for clarification on how these supplemental documents would evolve over time — including the ability to be consulted on new or changing expectations of practice.

Recognizing these concerns, a Standard, Policy and Guideline Consultation Framework has been created to ensure a principle-based approach for stakeholder consultation. In addition, the supplemental documents — which capture the intent of what was removed from the regulation as a result of the revision — were created to confirm that the College’s expectations remain the same both pre and post proclamation. As proposed changes are brought forward, the College will use the Consultation Framework to ensure appropriate consultation is sought.