Watered down chemo treatments A call for vigilance and reassurance

The medical error

It was disturbing to learn that pre-mixed solutions of cancer drugs for chemotherapy had been given to patients in doses lower than prescribed by their medical doctors. The solutions were prepared by the Marchese Health Care company in Hamilton, Ontario on contract with four Ontario hospitals – London Health Sciences Centre, Windsor Regional Hospital, Lakeridge Health Center in Oshawa and the Peterborough Regional Health Centre, as well as with Saint John Regional Hospital in New Brunswick. It was doubly disturbing that this treatment error had continued undetected for about a year – after more than a thousand patients had already been affected.

Deep concern and shaken confidence

The disturbing news quickly spread nationwide and created deep concern among the all patients and their families, health care professionals, authorities, governments at the provincial and federal levels, and the general public. Have there been any serious adverse effects on the patients in terms of relapse of the cancer or outcome below the expected? We have yet to know the definitive answer.

Like everyone else, this columnist’s confidence in our health delivery system and relevant regulatory bodies was shaken. While this gives me reason to understand the initial political fury and finger-pointing from the opposition side in our system of parliamentary democracy, I must say that I find it difficult to comprehend the hurried launching of a class action lawsuit even before we knew the factual details surrounding this serious medical accident.

Demand for timely answers

Although my confidence has somewhat been largely restored – thanks to the swift, collaborative and appropriate response from all concerned – patient and public interests demand timely answers to several questions, broad and specific:

1. Did the error (under-dosage) occur during the preparation of the pre-mixed solutions prior to delivery to the hospitals or during the administration of the pre-mixed solutions in the hospital, or a combination of both?
2. How was the first error detected and how soon, thereafter, was action taken by those involved in the care of the patients?
3. Are there actual patient treatment records available that would allow for retrospective ascertainment of the degree of dilution that occurred among the patients affected and its possible correlation with patient outcome (occurrence of relapses and outcome below the expected)?
4. What prompted the hospitals and cancer-care agencies involved to engage the said company for the above-noted services? Was it for cost-effectiveness?
5. Who initiated the idea for such an engagement between the hospitals and the company?
6. When did the contract and actual delivery of the services begin? Was there a prior pilot or trial period?
7. What, in the interest of patient safety and security, was the extent of the due diligence taken and by whom? If done, where is the report?
8. Are there other companies offering similar services? If so, were they comparatively considered?
9. What are the specific terms of the contractual agreement?
10. Were the doctors and other health care professionals involved in actual delivery of medications to the patients properly informed of the new arrangements and appropriately prepared and given the needed orientation?
11. How is the pre-mixed solution labelled compared to some well-established medication solutions in terms of concentration (unit of the active drug ingredient per unit volume of the diluent)?
12. What are the credentials required of the company personnel doing the actual pre-mixing of the solution and subsequent labelling?
13. To safeguard against the fallibility of human factors, what supervisory mechanism is in place for both activities on the company’s side and the hospital’s side?
14. What regulatory oversight, both at the provincial and federal levels, exists for such a model of delivery of chemotherapy solutions for cancer patients?

Insights for better understanding

Chemotherapy is one major medical modality with which to cure arrest or prevent certain types of cancer from developing. As with any drug used in treating any other disease, accurate dosing is critical both for its efficacy and safety. Attention to this therapeutic truism is particularly more demanding when the doctor-nurse-pharmacist team deals with cancer chemotherapy since the window of dosage between efficacy and toxicity is very narrow; hence, the potential for fatality when overdosing accidentally occurs is very real. While under dosing – as it happened when the pre-mixed chemo solutions were given in error to the affected patients as reported in the news – is not so much about fatality from toxicity, deep concern about the error that occurred is very valid since it is very much about the relapse of cancer and poor the outcome of the treatment.

Vigilance and reassurance

Lest the disturbing news might have created unnecessary anxiety, let me conclude with my confidence that Canadian oncology teams and cancer-care institutions with their state-of-the-art facilities are at all times committed to quality assurance in the interest of patients – their purpose for being. Need for their constant vigilance cannot be overemphasized.

Indeed, this column hopes to provide cancer patients and their families, and the general public at large, with insights for better understanding of the current issue even as we collectively wait for timely answers to the questions raised above – our collective call for reassurance.

Dr. Rey D. Pagtakhan is a retired Professor of Pediatrics and Child Health and former cabinet minister and Chair of the House of Commons Standing Committee on Human Rights. He has been the recipient of awards and honours including the honorary Doctor of Laws and Doctor of Science, the Philippine Presidential Citation Pamana ng Pilipino Award, and the Governor-General Queen Elizabeth II Silver, Golden and Diamond Jubilee Medals.