Proposed Changes to the DPRA regulations

Feedback deadline was: May 10, 2015

Summary

The Drug and Pharmacies Regulation Act (DPRA) legislation and its related regulations provide the framework for the Ontario College of Pharmacists to regulate pharmacy practice sites in Ontario. The College is currently seeking feedback on proposed revisions to the regulations related to the DPRA — Ontario Regulation 58/11.

Ontario Regulation 58/11 of the DPRA covers the following aspects of pharmacy operations:

  • Drugs
  • Certificates of Accreditation: Issuance and Renewal
  • Standards for Accreditation and Operation
  • Advertising
  • Proprietary Misconduct / Conflict of Interest
  • Information, Examination and Audit 

Background

The passing of Bill 21: Safeguarding Health Care Integrity Act, 2014 extends 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 current DPRA regulations, which only address community pharmacy practice, needed to be revised.

Pharmacy practice is changing more rapidly than ever before as new technology becomes available and scopes of practice change. Simply adding provisions for hospital pharmacies to the existing regulation framework would not provide the flexibility needed to adapt to practice change and evolving practice settings.

Aligning with government’s regulatory policy pertaining to the drafting of regulations, the College took the opportunity to propose fundamental changes to Ontario Regulation 58/11.


In drafting the regulation, the College considered the following principles:

  1. Regulations will be performance-based.
  2. Regulations will focus on high-risk practices, those that impact patient and safety.
  3. The approach to drafting regulations will be high-level rather than specific. Standards, policies and guidelines will be used to address issues wherever possible.
  4. The regulations will support practice evolution and change.
  5. The regulations will be drafted without specificity to permit the contemplation of multiple classes of certificates of accreditation.

This new approach sets out the performance expectations of pharmacy practice sites in regulation, while excluding many of the details which become irrelevant over time. It also strives to avoid duplication with other legislation and reference national standards as appropriate to maintain our authority. Through a consultative process the College will develop policies to ensure expectations of the regulation are clearly articulated.


Read the Draft Regulation to the Drug and Pharmacies Regulation Act (DPRA)


Common Questions

1. How can I better understand the rationale behind the proposed changes?

There are two documents that help explain the rationale behind the proposed changes. The first document is a general, high-level explanation by section. The second document is a specific explanation by clause.

2. Can I see a document outlining just the proposed changes?

The proposed revisions to Ontario Regulation 58/11 are broad and substantive, and go far beyond adding or changing single provisions. While we usually post a document tracking all changes we make, in this case the document itself does not provide enough clarity. That said, to assist in understanding the broad nature of the revisions, a document tracking all changes made to the original regulation is available for review. Read above for more on the principle-based approach used to develop the proposed regulation.

3. Who is the “owner” of a hospital pharmacy?

The owner of a hospital pharmacy will be the hospital corporation. The certificate of accreditation will be issued in the name of the corporation. This is consistent with community pharmacies.

4. Why does the record retention period seem so long?

The existing record retention requirement is consistent with that for other healthcare professionals in Ontario and for hospitals. Software vendors may be of assistance in developing electronic workflow. Read more on our Record Keeping, Scanning and Documentation practice tool. 

5. The requirement to include prices for 15 different drugs when advertising has been removed. Does that mean that pharmacies can now advertise a low price for one drug?

Yes. However, all other requirements related to a patient’s ability to make informed decisions based on advertising remain intact. Further details can be found in the rationale documents in question one above.


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