Cancer Drug Supply

Top Ten Questions and Answers

Can you confirm that all affected individuals/family members have been contacted?

Yes. When this issue arose, the four hospitals involved contacted all of the affected patients or their families.

Each hospital arranged for patients or their families to meet with oncologists to discuss their plan of care, either individually or in group sessions.

How can patients be sure that outsourcing is not putting their chemotherapy or other treatment in danger?

Upon learning of this situation, Cancer Care Ontario confirmed that all 77 hospitals in Ontario that provide cancer treatment have verified the safety and integrity of their chemotherapy drugs.

The Ontario government has posted a new regulation under the Public Hospitals Act to ensure that hospitals purchase drugs only from accredited, licensed or otherwise approved suppliers.

The Ontario College of Pharmacists has posted a regulation to give the College the power to inspect premises where pharmacists and pharmacy technicians practice, including where drugs are prepared.

The Ontario government wrote drug compounders requiring them to declare their regulatory framework, their accreditation, and their quality assurance practices.

The Ontario government wrote our hospitals to confirm that quality assurance processes are in place for all drugs either purchased externally or prepared in hospital.

We are also working with Health Canada to determine the proper long-term oversight over these types of premises.

How do hospitals purchase drugs?

Ontario's public hospitals are not-for-profit, community based corporations. They are responsible for making their own procurement decisions which must be consistent with the Broader Public Sector Accountability Act, 2010.

Hospitals make decisions about the use of resources with the best interest of patients in mind.

How many hospitals contract services for chemotherapy drugs, and how many prepare drugs themselves?

The Ontario Hospital Association recently conducted a survey of members regarding chemotherapy and third-party pharmaceutical preparation. The survey results are available on the Ontario Hospital Association's Website.

Upon learning of this situation, Cancer Care Ontario worked with the province's hospitals to ensure that quality assurance processes were in place for all cancer drugs purchased externally or prepared in hospital.

On April 11, Cancer Care Ontario was able to confirm that all 77 hospitals in Ontario, that provide cancer treatment, had verified the safety and integrity of their chemotherapy drugs.

What are the roles and responsibilities of the Ontario College of Pharmacists?

The Ontario College of Pharmacists regulates and accredits community pharmacies under the Drug and Pharmacies Regulation Act and regulates the practice of pharmacists and pharmacy technicians under the Pharmacy Act, 1991.

More specifically, the Ontario College of Pharmacists has two main oversight roles:

  • Accrediting and inspecting community pharmacies to ensure that they are meeting relevant standards under the Drug and Pharmacies Regulation Act. All community pharmacies must meet certain standards for operations and be accredited by the College. In addition to setting standards, the College ensures ongoing adherence to the professional and operational standards.
  • Regulating the practice of pharmacists and pharmacy technicians. All persons within Ontario who wish to practice as a pharmacist or pharmacy technicians must be registered with the College. The College sets entry to practice requirements for the profession and ensures that all pharmacists/pharmacy technicians participate in continuous quality improvement through its quality assurance program.

The recent discovery of chemotherapy underdoing at four Ontario hospitals identified a "grey area" when it comes to the inspection of non-pharmacy premises where drugs are compounded.

In response to this issue, the Ontario College of Pharmacists has posted a regulation to give the College the power to inspect certain premises where pharmacists and pharmacy technicians practice, including where drugs are prepared.

What are the roles and responsibilities of Cancer Care Ontario?

Cancer Care Ontario and its regional cancer programs are committed to the safety of cancer  treatment for both patients and providers to ensure a consistent level of high-quality care across the province.

Cancer Care Ontario is the provincial agency responsible for continually improving cancer services. As the government's cancer advisor, Cancer Care Ontario:

  • Directs and oversees investments to hospitals and other cancer care providers to deliver high quality, timely cancer services;
  • Implements provincial cancer prevention and screening programs designed to reduce cancer risks and raise screening participation rates;
  • Works with cancer care professionals and organizations to develop and implement quality improvements and standards;
  • Uses electronic information and technology to support health professionals and patient self-care and to continually improve the safety, quality, efficiency, accessibility and accountability of cancer services;
  • Plans cancer services to meet current and future patient needs, and works with health care providers in every Local Health Integration Network to continually improve cancer care for the people they serve, and
  • Rapidly transfers new research into improvements and innovations in clinical practice and cancer service delivery.
What are the roles and responsibilities of Health Canada?

Health Canada regulates the manufacture, packaging, labelling and sale of drugs, and also licenses drug manufacturers, all under the Food and Drugs Act.

This act also provides Health Canada with broad inspection powers in connection with places where drugs are manufactured, prepared, packages or stored.

Health Canada has recognized their responsibility in this issue by putting in place a new policy requiring drug facilities to be regulated under either:

  • the federal Food and Drugs Act,
  • the supervision of a provincially licensed pharmacist, or
  • in a hospital.

Ontario will continue to work with Health Canada to develop a long-term solution to this national issue.

What are the related roles and responsibilities of hospitals?

Ontario's public hospitals are not-for-profit, community-based corporations. They are subject to a number of pieces of legislation, including the Public Hospitals Act, the Local Health System Integration Act, 2006, Excellent care for All Act, 2010 and the Broader Public Sector Accountability Act, 2010.

Hospitals are responsible for making their own procurement decisions. Hospitals make decisions about the use of resources with the best interest of patients in mind. Hospitals are required to follow the Broader Public Sector Procurement Directives made under the Broader Public Sector Accountability Act, 2010.

Some hospitals have chosen to use outside suppliers to safely prepare drugs so that hospital staff can focus on patient care. The Ontario Hospital Association recently conducted a survey of members regarding chemotherapy and third-party pharmaceutical preparation. The survey results are available on the Ontario Hospital Association's Website.

Drugs prepared on site within a hospital pharmacy are subject to multiple process checks throughout the compounding process including calculation checks, visual inspection, volume checks and formula checks.

Cancer Care Ontario confirmed that all 77 hospitals in Ontario that provide cancer treatment have verified the safety and integrity of their chemotherapy drugs.

The Ontario government wrote our hospitals to confirm that quality assurance processes are in place for all drugs either purchased externally or prepared in hospital.

What work is being done by the Cancer Drug System Quality Assurance Review Working Group?

The Ministry of Health and Long-Term Care has brought together a working group chaired by the Assistant Deputy Minister, Health System Accountability and Performance Division with representation and clinical expertise from the affected hospitals, the Ontario Hospital Association, Cancer Care Ontario, the Ontario College of Pharmacists, the Province of New Brunswick, Health Canada, and others as necessary.

The Working Group is a reference group for Dr. Thiessen and able to provide technical and operational information, documents and resources, to assist the hospital inspector's review of the under-dosing incident.

The entire working group has met almost daily since April 8.

When is Dr. Thiessen expected to provide his recommendations?
The report of Dr. Thiessen's independent  review is due no later than July 12, 2013.
For More Information

Call ServiceOntario, Infoline at:
1-866-532-3161 (Toll-free in Ontario only)
In Toronto, (416) 314-5518
TTY 1-800-387-5559.
In Toronto, TTY 416-327-4282
Hours of operation : 8:30am - 5:00pm