On October 10, 2013, the Minister of Health and Long-Term Care
introduced Bill 117, Enhancing Patient Care and Pharmacy Safety
(Statute Law Amendment) Act. If passed, Bill 117 will
amend certain statutes, including the Drugs and Pharmacies
Regulation Act, in respect of the regulation of pharmacies and
other matters concerning regulated health care professionals. The
aim of the legislation is to address a gap in regulation perceived
over compounded drugs supplied to and administered in
Following the discovery of under-dosed chemotherapy drugs at
four Ontario hospitals and one New Brunswick hospital reported
earlier this year, the Ontario government appointed Dr. Thiessen, a
pharmacy expert, to review the cause of the incidences and provide
recommendations to strengthen the health care system, and in
particular the hospital drug supply system. Immediately
following the under-dosing discovery, the government implemented a
number of measures, including the requirement of drug compounders
to declare their regulatory framework, accreditation, and quality
assurance practices; and the requirement of all hospitals to ensure
quality assurance processes are in place for all drugs, whether
externally purchased or prepared in the hospital. Health
Canada also issued an interim statement which provides guidance on
compounding and admixing of medications.
The Ontario government has endorsed the recommendations of Dr.
Thiessen and this legislation was introduced in response to his
report, A Review of the Oncology Under-Dosing
Summary of the Proposed Legislation
Currently, hospital pharmacies are overseen by the individual
hospital corporations, whereas community pharmacies are regulated
by the Ontario College of Pharmacists (the "College").
The Bill will expand the College's authority to inspect,
oversee and license pharmacies within both public and private
hospitals, in addition to community pharmacies.
Among other things, the proposed legislation also seeks to:
Provide the College with the ability to conduct regular
inspections of hospital pharmacies in order to monitor compliance
and enforce licensing requirement;
Allow the College to make regulations to set out the details
and standards for licensing and inspection; and
Enhance information sharing, including complaints-related
information, between the College, other regulatory colleges,
hospitals and other public health authorities for the purposes of
administering the Health Protection and Promotion
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Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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