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Enhancing Patient Care and Pharmacy Safety


Enhancing Patient Care and Pharmacy Safety

Ministry of Health and Long-Term Care

Ontario's Bill 21, the Safeguarding Health Care Integrity Act, 2014, has passed third reading in the legislature.  Bill 21 strengthens the safety of drugs that are provided in the province's hospitals and further enhances patient care.

The government is following through on its commitment to implement recommendations contained in Dr. Jake Thiessen's report, "A Review of the Oncology Under-Dosing Incident," which was publicly released in August 2013. Dr. Thiessen was appointed by the government to determine the cause of the under-dosing of chemotherapy drugs at four Ontario hospitals, and to provide recommendations to prevent future incidents. 

Expanding Ontario College of Pharmacists' Inspection Powers

This new legislation implements recommendation 12 of Dr. Thiessen's report by making amendments to the Drug and Pharmacies Regulation Act in order to give the Ontario College of Pharmacists the authority to inspect and license hospital pharmacies. 

Currently, pharmacies in the community are overseen by the Ontario College of Pharmacists, whereas hospital pharmacies are the responsibility of individual hospital corporations.   Expanding the college's authority to regulate hospital pharmacies will ensure that they meet consistent standards across the province.

Specifically, the government's legislation:

  • Provides the Ontario College of Pharmacists with the authority to license and inspect pharmacies within public and private hospitals, in the same manner it currently licenses and inspects community pharmacies.
  • Provides the College with the ability to enforce licensing requirements with regard to hospital pharmacies.
  • Allows the College to make regulations to establish the requirements and standards for licensing, operation and inspection of hospital pharmacies.
  • Provides government with the ability to extend the College's oversight to other institutional pharmacy locations in the future, as appropriate.

As a result of these changes, the Ontario College of Pharmacists will be able to conduct regular inspections of hospital pharmacies so they can monitor compliance with operational standards and licensing requirements.

Other provinces including British Columbia, Newfoundland and Labrador, Prince Edward Island and New Brunswick require their pharmacy regulators to license and inspect hospital pharmacies.

Improving the Health System's Ability to Identify and Respond to Incidents

The legislation also improves the health system's ability to quickly identify and respond to any future incidents that could affect patient care and safety. In particular, the legislation:   

  • Enables health regulatory colleges to more readily share information with:
    • Public health authorities as may be required for the purposes of administering the Health Protection and Promotion Act;.
    • Public hospitals, as well as with other prescribed persons, in relation to a college investigation of a regulated health professional employed by or who receives privileges from a public hospital.
  • Requires entities such as hospitals and employers to report to health regulatory colleges where:
    • A regulated health professional has resigned or voluntarily relinquished or restricted his or her practice or privileges because of concerns regarding the professional's potential professional misconduct, incompetence or incapacity, or
    • Where the member's resignation or relinquishment occurs during the course of, or as a result of, an investigation undertaken into allegations of profession misconduct, incompetence or incapacity on the part of the professional. 
  • Allows the government to more quickly appoint a college supervisor, where the Minister of Health and Long-Term Care considers it to be appropriate or necessary, in order to address any serious concerns regarding the quality of a health regulatory college's governance and management.

Implementing the Thiessen Report's Recommendations

An Implementation Taskforce was struck in August 2013 to oversee the implementation of Dr. Thiessen's recommendations.

The taskforce included representation from a variety of health and government sector partners, including the Ontario Hospital Association, the Ontario College of Pharmacists, Health Canada and the Ministry of Government Services. 

As of April 28, 2014, all of Dr. Thiessen's recommendations were either complete or well under way of being implemented. As a result, the Implementation Taskforce was disbanded. Ongoing oversight to ensure Dr. Thiessen's recommendations continue to be implemented has since been provided through existing relationships with the Ministry of Health and Long-Term Care (MOHLTC) and its partners.

Immediate Actions Taken by the MOHLTC in Response to the Under-Dosing Incident

In addition to appointing Dr. Thiessen following the discovery of under-dosing of chemotherapy drugs, the government took immediate action by:

  • Requiring drug compounders to declare their regulatory framework, and their quality assurance practices.
  • Requiring all hospitals to attest that quality assurance processes are in place for all drugs either purchased externally or prepared in hospital.
  • Working with the Ontario College of Pharmacists, to amend Ontario Regulation 202/94 under the Pharmacy Act, 1991 to allow the college to inspect drug preparation premises where pharmacists and pharmacy technicians engage in or supervise drug preparation activities (such as reconstituting, combining, and mixing two or more substances). 
  • Amending Regulation 965 under the Public Hospitals Act to require hospitals to purchase or obtain drugs only from regulated or approved entities.

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