Reports from Investigations into Chemotherapy Under-Dosing Incident Make Recommendations to Strengthen Medication Oversight

April 28, 2014 | Alissa Raphael, Kathryn M. Frelick

In a previous Health Communiqué, Changes to Ontario and Federal drug oversight address regulatory gaps, we outlined steps taken by the Ontario and federal governments to address the regulatory oversight of a number of drug related activities. These actions were in response to the March 2013 discovery that diluted chemotherapy drugs supplied by Marchese Health Care (“MHC”) were provided to patients at four Ontario hospitals and one New Brunswick hospital.

Independent Review of Oncology Under-Dosing Incident

The Ministry of Health and Long-Term Care (“MOHLTC”) appointed Dr. Jake Thiessen to conduct an independent review of the incident. The report “A Review of the Oncology Under-Dosing Incident” was publicly released on August 7, 2013.

The report included a detailed review of the incident and examined the systemic influences and responses of professional, structural, regulatory and oversight stakeholders on the chemotherapy drugs in question. The report also highlighted the need to ensure that the entire process supports patient care; from the oversight of drug preparation activities, to group purchasing organization (“GPO”) based procurement processes, to in-hospital procedures providing patient-specific treatment.

Dr. Thiessen made twelve recommendations intended to improve patient safety and prevent future similar medication incidents. The recommendations were directed at GPOs involved in negotiating vendor product preparation pharmaceutical services, MHC, the Ontario College of Pharmacists (“OCP”), Health Canada and the Ontario Hospital Association.

The extent to which the recommendations will be accepted and implemented by regulatory authorities is not yet known. The MOHLTC introduced a bill in October 2013 that, if passed, would implement Dr. Thiessen’s twelfth recommendation that pharmacies operating in clinics and hospitals be licensed by the OCP. Currently, Bill 117, Enhancing Patient Care and Pharmacy Safety (Statute Law Amendment) Act, 2014 is being debated at the Ontario Legislature. The Bill proposes amendments to the Drug and Pharmacies Regulation Act that would expand the OCP’s authority to include the licensing and inspection of hospital pharmacies.

Report of Standing Committee on Social Policy

The Standing Committee on Social Policy (the “Committee”) presented its report  on diluted chemotherapy drugs to the Ontario Legislature on April 1, 2014. This parliamentary committee of the Ontario legislature has the authority to investigate and deliver reports on matters relating to the mandate, management, organization and operation of a number of ministries, including the MOHLTC.

The report outlined the Committee’s findings and recommendations following its investigation into “whether or not the MOHLTC effectively exercised its role into the oversight, monitoring and regulation of non-accredited pharmaceutical companies.” The Committee “generally endorses” Dr. Thiessen’s recommendations and viewed its investigation and recommendations as being complementary.

The report segregated issues identified by the Committee during its investigation into three categories: (i) procurement practices of hospitals; (ii) oversight, monitoring and regulation of non-accredited pharmacies; and, (iii) “other concerns” including the labelling of chemotherapy drugs prepared at admixing facilities, communications (between MHC and Medbuy Corporation, as the GPO) and best practices for hospitals when dealing with GPOs or shared services organizations (“SSOs”).

The Committee expressed concern with the professional conduct of pharmacists connected to the diluted chemotherapy treatments. The OCP has been asked to conduct an investigation into the activities of various pharmacists involved throughout the process.

The Committee made a number of recommendations directed at the MOHLTC, the federal and Ontario governments, Health Canada, Cancer Care Ontario, Ontario hospitals and GPOs and SSOs which obtain medications on their behalf. The Committee’s recommendations emphasized the need for increased provincial and federal medication oversight including:

  1. The MOHLTC to examine best practices related to the procurement and distribution of oncology drugs at provincial cancer centres;
  2. Health Canada and provincial governments to increase oversight, monitoring and regulation of compounding and admixing of drug products;
  3. Increased federal oversight of drug labelling through the introduction of national drug labelling standards; and
  4. Cancer Care Ontario to develop labelling guidelines for the preparation of chemotherapy drugs at provincial admixing facilities.
  5. Strict adherence to Accreditation Canada standards when obtaining medications for hospitals.

Additional Implications

The Committee’s recommendations have implications beyond drug procurement practices and encourage a broader review of the procurement practices of GPOs and SSOs that procure pharmaceuticals, goods and services on behalf of broader public sector organizations including hospitals. The Committee specifically commented on the lack of transparency surrounding the receipt and use of rebates in GPO/SSO contracts with hospitals and the inclusion and encouragement of value-added incentives in requests for proposals when procuring goods and services on behalf of hospitals. In response, the Committee recommended that the operations of GPOs and SSOs be subject to all aspects of the Broader Public Sector Accountability Act, the Public Sector Salary Disclosure Act and audits by the Office of the Auditor General of Ontario.

Miller Thomson’s Health Industry Group will continue to monitor and keep you apprised of any further related developments.

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