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Dr. Jake Thiessen's Report: Findings and Recommendations

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Dr. Jake Thiessen's Report: Findings and Recommendations

Ministry of Health and Long-Term Care

Ontario remains committed to working with its health care partners to ensure recommendations of Dr. Jake Thiessen's report on the cancer drug supply system are implemented.

The report contains a detailed factual review of a recent case of under-dosing of chemotherapy drugs at four Ontario hospitals and one in New Brunswick.  Dr. Thiessen was also asked to develop recommendations that would prevent a similar incident from occurring again.  

Findings

Dr. Thiessen's report found that:

  • "There is no evidence of any malicious or deliberate drug-sparing dilution" by Marchese Hospital Solutions.
  • When awarding the contract to Marchese Hospital Solutions, the Group Purchasing Organization, Medbuy, required only the amount of active ingredient per unit of the product, rather than finished product concentrations.
  • Marchese Hospital Solutions employed a bulk reconstitution process using prefilled saline bags that had overfill. This led to an excess final fluid volume which was not accounted for when labelling the final product.
  • In the absence of clarifying patient-related instructions from Marchese Hospital Solutions to the hospitals, the hospitals did not adjust doses to factor in the overfill because the hospitals were unaware of the overfill. The resulting dilution factor was an average of 7 per cent for gemcitabine and 10 per cent for cyclophosphamide.
  • Dr. Thiessen found that while the impact on patients remains unknown there was a "relatively low degree of under-dosing" and the probability "in combination drug therapy, that a single drug factor, at the stated dosing shortfall, has had an overall serious effect is small."
  • Dr. Thiessen reported that the health care system reacted quickly and effectively to protect patients upon discovering the incident, revealing a "concerted resolve to address the issues squarely and urgently, and to avoid further complicating incidents that might threaten patients' care."  He also found that the actions of professionals including administrators, doctors, pharmacists, nurses and other personnel were "a credit to our health care system."

Recommendations

Dr. Thiessen's report contains a number of recommendations to prevent future incidents directed towards five entities Group Purchasing Organizations, Marchese Hospital Solutions, Ontario College of Pharmacists, Ontario Hospital Association and Health Canada:

Recommendation #1: 

Notwithstanding the under-dosing incident, the continued use of Group Purchasing Organizations (GPOs) to negotiate vendor product preparation pharmaceutical services shall not be discouraged. However, improvements are needed in the GPO-based processes.

Recommendation #2: 

Every GPO shall review its procurement process to ensure that risk for patients is considered an essential evaluation and adjudication criterion when considering proposals.

Recommendation #3: 

Every GPO shall develop and adopt a standardized product and/or service specification description that outlines the requirements for contracted sterile or non-sterile pharmaceutical preparation services.

Recommendation #4: 

Annually in January, each GPO shall publicize information regarding the contracted pharmaceutical services provided by all its vendors.

Recommendation #5: 

Marchese Hospital Solutions (MHS) shall review and revise its product preparation processes to ensure that all its products meet the specifications required by professionals in treating patients effectively and safely.

Recommendation #6: 

The Ontario College of Pharmacists (OCP) (and by extension the National Association of Pharmacy Regulatory Authorities [NAPRA]) shall work quickly with Health Canada to define best practices and contemporary objective standards for non-sterile and sterile product preparation within a licensed pharmacy.

Recommendation #7: 

The OCP (and by extension NAPRA) shall stipulate specialized electronic material records and label requirements for non-sterile and sterile product preparation within a licensed pharmacy.

Recommendation #8: 

The OCP(and by extension NAPRA) shall consider a special designation and licence for any licensed pharmacy engaged in large volume non-sterile and sterile product preparation. Such pharmacies shall be inspected annually.

Recommendation #9: 

The OCP shall specify credentials beyond education and licensing for personnel engaged in non-sterile and sterile product preparation practices within a licensed pharmacy.

Recommendation #10: 

Health Canada shall license all enterprises that function beyond the product preparation permitted within a licensed pharmacy; that is, all product preparation enterprises not within a licensed pharmacy shall be licensed.

Recommendation #11:

The Ontario Hospital Association (OHA) shall conduct a formal review/audit to determine the efficiency and traceability of computer-based clinic and hospital records for patients and their treatments, and report the findings to the MOHLTC.

Recommendation #12:

The OCP shall license all pharmacies operating within Ontario's clinics or hospitals.

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    Minister's Office

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