Who is responsible for the unexpectedly diluted chemotherapy cocktail that more than a 1,000 cancer patients received since February 2012? And will we ever know when aspects of the story are being treated as safely guarded secrets?
The issue has been making headlines this week with fingers pointing in all directions.
At least two of the hospitals involved have now taken back the preparation of the drug cocktail – both Durham Region’s Lakeridge Health and the Windsor Regional Hospital have said they are able to prepare it themselves.
London Health Sciences also says they have the capacity to prepare the drugs internally, but LHSC Vice-President Tony LaRocca told the London Free Press that they contract out the work because it is “more practical and efficient.”
Did he really say that with a straight face, especially after knowing the questions London patients and their families must now have?
All of the hospitals involved do group purchasing through Medbuy, which is owned by its member hospitals in three provinces. That group purchasing includes pharmaceuticals.
On Medbuy’s website, it claims that “members are highly engaged and have worked to develop specific criteria for the safe handling and administration of chemotherapy drugs as well as packaging and labelling requirements.”
The question is, were these requirements part of the Medbuy contract with Marchese Hospital Solutions? Marchese is the source of the diluted chemotherapy drug cocktails.
Like many public health care contracts with the private sector, the details remain a secret.
Marchese is saying they are not to blame, telling the Toronto Star that the drugs were administered in a way that was “not consistent with the contract” — the same contract the public conveniently cannot see.
Yet media reports suggest the issue was one of mislabelling and miscommunication. If so, did Marchese need to have it in writing that the contents on the label had to match the contents of the mix?
The hospitals are all pointing fingers at Marchese for the failure, as are two Southern Ontario law firms that have been retained to engage in a class action suit against the company.
Yet nobody can say for certain whether these patients were affected by the lower doses. Lakeridge Health maintains their relationship with Marchese was too short to have any impact – at most their 34 affected patients would have only had two doses of the cocktail.
In London, where 665 patients received the cocktail since March 2012, or in Windsor where 290 patients were impacted since February 2012, families are openly wondering if the lower doses played any role in the outcome of the treatment.
The Health Minister, as usual, has said she has ordered an investigation by the College of Pharmacists and will “take whatever steps we need to make sure it never happens again.” Given all the recent failures around private provision of public health care, she may want to permanently record this response on her voicemail.
The NDP meanwhile are calling for a ministerial investigation with a full public report.
If there is one undisputed hero in all this, it is the Peterborough Pharmacy Tech who spotted the difference when Peterborough started using the Marchese-prepared cocktail this March. As a result, only one Peterborough patient was administered the low dose. Incidentally, the Peterborough Pharmacy Techs are represented by OPSEU.
The diluted drugs are sharing headline space with a new Senate Committee report that is calling for Health Canada to step up drug oversight.
The Senate Committee particularly noted problems with secrecy regarding what Health Canada learns about whether the drugs are harmful, fatal, or fail to work.
And if that isn’t enough, the Toronto Star has been reporting this week on a strange case of a baby pronounced dead at Humber River Regional Hospital. The baby started wiggling a short time later while its body was covered under a sheet. The hospital’s report – you got it – is secret, protected under the Quality of Care Information Protection Act.
As much as politicians like to talk about accountability, it might be a little difficult when private for-profit and not-for-profit health care providers are so protected by secrecy laws. It also does not bode well for the public as we face increased privatization of public health care services.
I think you can find the answers to many of the questions you raise in the statements made by Dr. Bill Evans (head of Juravinski Hospital and Cancer Centre and regional vice-president for Cancer Care Ontario) to the Hamilton Spectator. http://www.thespec.com/news/local/article/913659–botched-chemo-drugs-a-question-of-measurement Liquid cyclophosphamide is diluted with saline solution to a specified grams per litre or millilitres per litre. The question is: is that per litre of saline, or per litre of total mixture? Dr. Evans remarks make it clear that his hospital’s practice (and perhaps most hospitals’) is per litre of mixture, while Marchese’s was per litre of saline. Dr. Evans characterizes this as “not altogether wrong” — but different from what hospitals might expect. With Medbuy being the middle man in these purchases, there was no direct communication between the hospitals and Marchese. Now, it is possible that Medbuy gave Marchese a very clear specification, and Marchese just got it wrong. Possible — but unlikely, I think. Somewhat more plausible is that Medbuy wrote a specification that was unclear, and Marchese interpreted it in a reasonable manner. But one would think that a supplier would flag a specification that seemed ambiguous and get clarification from the customer. So the most likely scenario is that Medbuy provided Marchese with a very clear specification, which Marchese followed, resulting in a dilution that was slightly different than what the hospitals’ expectation; the error was Medbuy’s.
In the two most likely scenarios the IV bags were accurately labelled in g/l or ml/l, but to a different method of specification.
The real problem is not that we, the public, do not have access to the specifications stated in Medbuy’s contract with Marchese. (We will probably know the facts eventually.) The problem is the hospital staff using the product either did not have access to the procurement specification, or did not consult it.
Dr. Evans’ comments also confirm that the IV bags contained the correct total dose, so no harm at all was done when the bags were used as intended: administered as an entire pre-measured dose. Where the problem apparently ocurred (and we don’t know to what extent it did) is where hospital staff removed some portion of the contents of a bag to measure for some mixture of their making. In such cases, the misunderstanding of the dilution specification would cause a small error in their calculations.
We need an inquiry, but I’ll predict the two most important recommendations can be written today. 1) Make sure hospital staff have access to procurement specifications for the materials they are given to administer. 2) Use pre-mixed Iv bags only as complete pre-measured doses. Do not attempt to re-mix the contents into different formulations.
Beyond this specific issue, we need to look more broadly at what sorts of communication problems we must guard against as quantity buyers are inserted into the relationship between hospitals and suppliers.