Marchese Health Care's owner, Marita Zaffiro has been awarded the Hamilton Spectator Reader’s Choice Gold Award for favourite Pharmacist, as voted by Spectator readers. Thank you to our many great customers for voting!!
Dr. Thiessen's report on this painful incident is now available to the public. From the moment we heard about this issue we have been trying to understand what happened. As Dr. Thiessen's report points out, the entire health community needs to work together to ensure that no patients ever endure such an experience again. We are pleased that the report validated our past statements and testimony and we look forward to implementing the recommendations that relate to Marchese.
We agree with Dr. Thiessen’s statement that the incident “boils down to gaps in communication” and we are very grateful that the report makes it clear that there is no evidence of any malicious or deliberate dilution of chemotherapy drugs by Marchese. We are also pleased that Dr. Thiessen confirmed that Marchese supplied the two chemotherapy medications in accordance with the contract.
Importantly, Dr. Thiessen identifies several advantages and opportunities to be gained in outsourcing the type of services Marchese provides. We plan to continue to collaborate with our pharmacy colleagues throughout the chain, comply with any new regulatory structures and work in an environment of greater clarity of accountability to deliver the best care possible for patients.
Thank you, Mr. Chairman.
I would like to address a number of issues that have arisen since my last appearance:
As I stated when I first appeared before the committee, our belief was that the chemotherapy drugs were intended for a single patient. This was a good-faith and reasonable understanding on our part for a number of reasons.
The obvious starting point was our contract with Medbuy. The contract specified the services Marchese was to provide. As you know, the contract contained an alphabetical list of about 120 admixtures. This list of preparations was the basis of our understanding of the non-concentration-specific nature of gemcitabine and cyclophosphamide.
Medbuy listed the preparations in two basic formats: Some were listed in concentration-specific format; other, and indeed most, preparations were listed in concentration-non-specific format. This included various IV solutions of antibiotics, amino acids and stomach acid suppressants.
In listing the two chemotherapy drugs at issue in a concentration-non-specific format, this suggested to us that the contents of the IV bags for these preparations were intended for use in a single patient.
As part of the RFP process, Marchese was asked to supply a set of sample labels. Medbuy provided copies of Marchese’s proposed sample labels to the committee. Those initial sample labels submitted as part of the RFP process were exactly that: samples. They were examples of all the possible data fields on the labels which could be populated if desired, and this included concentration specificity.
After the sample label formats were approved, Marchese then focused on Medbuy’s list as contained in the contract. It described gemcitabine and cyclophosphamide in a concentration-non-specific format.
After our technical review process, we prepared a complete library of 124 labels for Medbuy’s approval. I want to emphasize to the committee that the description of admixtures on the list was prepared by Medbuy without input from Marchese.
It was not our role to review Medbuy’s list to determine whether it was clinically appropriate. We understood that Medbuy’s pharmacists and member hospitals had made that determination before the list was made a schedule to the contract. Our responsibility was to ensure that our labels and admixtures conformed to what was ordered, as specified in the list which was a schedule to the contract. The labels Marchese prepared for all admixtures, including cyclophosphamide and gemcitabine, were sent to and approved by Medbuy’s pharmacy team and their hospital members before any admixtures were shipped.
Marchese was never provided copies of Baxter’s labels or mixture breakdown formulas. We were told that they could not be provided to us for proprietary reasons. Had we seen Baxter’s labels, we would have noticed the difference. We would have inquired as to why there was an apparent change. Baxter’s labels for these two preparations specifically indicated a milligram-per-millilitre concentration statement, which we understood to be a concentration-specific admixture. Our preparations did not include this statement, as it was not included in the Medbuy admixture list.
Similarly, we understood from Medbuy that the hospitals had been given our labels for review and training purposes. Had Medbuy or one of the hospital pharmacies noticed the difference, the issue could have been raised and addressed before preparation and delivery under the contract.
As it was, we understood that the majority of preparations, including cyclophosphamide and gemcitabine, were to be supplied by Marchese in a concentration-non-specific format and that this was acceptable to Medbuy and its hospital members.
Also, in January 2012, a month before the contract commenced, there was an exchange between a Marchese pharmacist and Medbuy’s manager of clinical services and patient safety referring to the chemotherapy preparations. The email string, copies of which I have brought with me today and provided to the Clerk, concerns the attachment of various lines or tubes to the bags. We had raised with Medbuy the possibility of attaching a line to the bags as a safety precaution to protect nurses who administer them from any unintentional exposure to these toxic drugs. Medbuy’s representative said he didn’t want the lines because he expected different hospitals might have different requirements. He stated in this email, “Members will still be putting on a patient-specific label in the pharmacy and can attach a line, if desired, at that time.”
This also suggested to us that Medbuy’s understanding, and therefore our understanding, was that these bags would be used for a single patient.
I would like to respond to questions raised by the committee as to whether outsourcing the preparation of admixtures is an appropriate practice or whether this should always be undertaken in hospitals.
Dr. Thiessen discussed this issue with the committee after visiting the MHS premises in Mississauga. He described the process for reconstituting cyclophosphamide and gemcitabine. He indicated that it can take up to four hours to prepare, which can be a burden on a busy hospital pharmacy department. Dr. Thiessen’s opinion was that it was a “big advantage” to have an outsource supplier prepare admixtures for hospitals.
I agree with Dr. Thiessen’s observations. Providing high-quality admixtures is complex and technical. It is better undertaken by specialists in sterile, state-of-the-art facilities, leaving hospital pharmacies to focus on direct clinical patient care.
I would also like to respond to general questions about the quality of Marchese Hospital Solutions’ facilities and processes, as well as any suggestion that our practices, staffing or products were somehow inferior to the previous supplier or others in the industry.
Dr. Thiessen informed this committee that, “Only quality, approved pharmaceutical products and diluents were used.” He continued, “There is no evidence of any malicious or deliberate drug-sparing dilution in preparing the bags of cyclophosphamide or gemcitabine by Marchese.”
Dr. Thiessen told the committee about the benefits MHS brought to hospitals by providing admixing services. He said we have the “finest facilities” and added that no hospital he had visited had a facility to match ours. He commented that it is “splendid in its configuration, in all the things that they have as checks and balances. They have very detailed requirements around how things are produced.”
Dr. Thiessen is not alone in his views that MHS is well-equipped to supply admixture services. Medbuy member hospitals have inspected our premises. The consistent testimony before this committee has been that our processes and standards are of the highest level. Our customers have repeatedly told us we operate at a high professional standard.
The Marchese team of pharmacists and technicians collectively bring years of professional experience to bear. However, they are only one third of the triumvirate described by Dr. Thiessen. Pharmacists at Medbuy and in the hospitals are also engaged, and each has a different role. The system is designed for the three parties to work together, but each with distinct roles. We must all ensure preparations ordered by a GPO are precisely those required by its member hospitals. Furthermore, we must communicate to ensure that the admixture service prepares exactly what is ordered by the hospital, and that the hospital pharmacists fully understand the admixture supplied to them.
The hospitals have clinical contact with patients. Marchese Hospital Solutions has no individual patient information. Therefore, our role does not include any assessment of clinical factors.
The incident demonstrates that the system did not work in this case, but the failure could have been avoided. A simple line in the contractual requirement, milligram per millilitre, would have provided the appropriate concentration specificity, and none of us would be here today. An opportunity to review and compare our label with that of our predecessor would also have prevented the problem.
I would now like to deal with the question of the pricing of our admixtures.
Last week, after Baxter Corp. appeared, concerns were raised about our pricing for the two chemotherapy admixtures. It is misleading to suggest that there is any link between the incident and any difference in price between Baxter CIVA and MHS. As specified in the RFP process, we were not required to include in our price the cost of the drugs included in the admixtures, only the cost of labour, overhead, containers, packaging materials and shipping. We believed it made sense to price based on the size of the bag that preparations would be delivered in — 50, 100, 200 or 250 millilitres — rather than pricing individual admixtures based on the type of drug, amount of processing time or value added to the hospitals.
The same meticulous quality control process was set up in our facilities to prepare all admixtures no matter what drug was admixed or what preparation steps were involved. There is no basis in fact for any suggestion that the miscommunication on concentration specificity had anything to do with pricing. There is no rational connection between pricing and this incident, in our opinion.
So what happened here? We still have to wait for your report and Dr. Thiessen’s report to understand everything, but what we now all know is that there was miscommunication and an unsuccessful transition that resulted in needless anxiety to many patients. Marchese took the position early on that we could best serve patients by only talking about things that we were certain of. We decided that we should focus our energy on working together with the other members of Dr. Thiessen’s triumvirate to understand what happened and how to prevent a recurrence.
However, in spite of this, we were publicly accused of:
We all owe a debt of gratitude to the people in Peterborough who very quickly and competently saw that there was a mismatch between their hospital’s expectations and the admixture in their hands. From the moment we heard about the issue, we have been trying to fully understand what went on and help fix the system so that no patients ever have this experience again.
We would be pleased to answer your questions.
NOTE – Text edited for clarity.
Thank you, Mr. Chairman.
My name is Marita Zaffiro. I am a Pharmacist and the President of Marchese Hospital Solutions and Marchese Health Care. I thank you for the opportunity of addressing your Committee on behalf of Marchese.
First, let me say my heart breaks for the patients and families trying to process and understand what they have been hearing. We are deeply distressed to learn that some patients did not receive our preparations in the manner we expected.
I also want to state that Marchese does not wish to point fingers or place blame for this unfortunate incident. We want to explain our role in the process and help this Committee understand what happened in order to make sure it doesn’t happen again.
In 1988, I left my job as a young executive to buy a storefront pharmacy in Hamilton. The store was owned by a family friend. I wanted to carry on his tradition of service, and build a more patient-focused pharmacy. I am pleased to say that, with the help of many others, I believe we’ve succeeded. Marchese is now a group of Ontario companies that have been in business for over 50 years. Jack Marchese started the pharmacy in Hamilton in 1962. We have grown substantially over the last 25 years. The Marchese companies now employ over 80 Ontarians, including 15 pharmacists and several registered pharmacy technicians.
I am proud of our company, our staff and of our service to our community. We have a long track record of leadership and recognition in the profession, and in the area in which we do business. We have received many awards for our work. Marchese Health Care now operates three accredited community based pharmacies in Hamilton, Kitchener and Mississauga. Our pharmacies deliver services to clients who live in diverse communities. We provide these services in more than 10 languages. There is also a home care services business, which includes the supply of IV medications, infusion equipment and medical supplies for home care patients.
In early 2011, we were invited to enter into a competitive bidding process to supply IV preparations, what we call “admixtures”, to Medbuy Corporation member hospitals. We were awarded the contract and, as a result, we formed Marchese Hospital Solutions (MHS) in late 2011. The contract was for the supply of IV drug preparations to a number of Ontario and New Brunswick hospitals. Among the admixtures were cyclophosphamide and gemcitabine, the two cancer drugs of concern to you.
MHS was created as a separate division to keep the operations of our community based and home care pharmacies separate from our hospital admixtures supply business. It was not created to avoid any type of regulation.
While MHS supplied admixtures directly to hospitals’ in-patient pharmacy departments, our contract was with Medbuy Corporation. Medbuy is a hospital group purchasing organization.
To increase safety, efficiency and the benefits from economies of scale, Medbuy contracts with suppliers like MHS, to supply many different products to member hospitals. These are typically hospitals for which formulation of IV preparations in the hospital pharmacy is either impractical or uneconomic. Safety is also an important factor. Some hospitals may be reluctant to have their own pharmacists and technicians preparing chemotherapy drugs. The drugs themselves are potentially toxic to any person handling them improperly. Our MHS personnel are trained to handle chemotherapy drugs and prepare them safely, without exposing themselves to potentially harmful effects. MHS prepares the IV admixtures safely and efficiently in our state of the art facility in Mississauga. They are all prepared under the supervision of an OCP registered pharmacist.
I would like to now clarify for this Committee what MHS does to prepare the two chemotherapy admixtures.
We play an important, but limited, role in the supply chain for medical treatment. Before MHS does anything, manufacturers produce the drugs, the equipment, the IV bags, and the solutions we use to prepare our admixtures. By contract, we take drugs and solutions produced by licensed drug manufacturers, and ensure they are combined in sterile conditions. We then ensure timely delivery of the admixture bags to hospital in-patient pharmacies. We withdraw a volume of saline solution from a pre-filled IV bag. The withdrawn solution is then mixed with the powder form of the chemotherapy drug. The mixture or reconstituted solution is then injected back into the bag. To be clear, no additional fluid is added by MHS.
As one of the witnesses from the Windsor Hospital stated, it is generally known in the industry that pre-filled IV bags are overfilled to account for evaporation while they are in inventory. Overfill also addresses the issue of volume remaining in IV tubing. In fact “overfill” was discussed between MHS and Medbuy.
It is important to understand that the labels we place on the IV bags describe the contents only. They do not provide instructions or directions for use. They cannot contain the name of a specific patient as this is not known to us. We deliver the IV bags to hospital in-patient pharmacies. It is the hospital pharmacist who labels a bag for use in the hospital and dispenses the medication at the direction of the treating physician. Hospital staff administer the contents of the bag to individual patients.
The labelling of our admixtures was discussed in detail with Medbuy both during the RFP process and before any of our preparations were supplied to hospitals. We were told by Medbuy that one of the reasons our response to the RFP was successful was that Medbuy’s review team regarded our labelling as superior to that of its previous contract-supplier. Medbuy approved all MHS labels before any product was shipped.
After we began to supply Medbuy hospitals in February, 2012, we continued to have discussions with them and some of the hospitals. At all times, our labels complied with Medbuy’s requirements as specified in our contract or as amended at their request.
Until this incident no issue was raised by anyone that our chemotherapy drug labels were unclear.
If Medbuy or the pharmacist at any hospital had identified any problem with our label, we would have addressed it immediately.
Types of Solutions
There are two types of labelled intravenous solutions provided by MHS under the Medbuy contract.
First, there are “concentration-specific” solutions that contain a defined amount of drug and solution.
The “concentration” of the drug, expressed as mg/ml (milligram per ml), and the volume of solution are specified on the bag label.
Second, there are admixtures intended to be administered in their entirety to only one patient. These are non-concentration specific solutions and they contain a defined amount of drug. The amount of solution in the pre-filled bag is not measured to a precise volume. A variance in solution amount is not material in a non-concentration specific bag because the patient receives the precise amount of the medication. Whether a particular patient receives slightly more saline solution, including the overfill I mentioned earlier, with the medication, makes no difference.
I would like to stress for the members of this committee, that our contract with Medbuy required us to supply cyclophosphamide and gemcitabine preparations only in non-concentration specific form.
We were not told how the previous supplier of cyclophosphamide and gemcitabine prepared its IV bags – whether the bags were in concentration specific or non- concentration specific form. Nor were we provided a copy of the previous supplier’s labels. We supplied the type of product Medbuy requested, with the labels they approved.
I now want to turn to some of the questions that have been raised about the regulation of MHS.
Our role, our quality controls, and our boundaries of responsibility have always been known to Medbuy, the Ontario College of Pharmacists and Health Canada.
Marchese’s community pharmacies are regulated by the Ontario College of Pharmacists. Our home care business is accountable under contract to the Community Care Access Centre (CCAC) and ultimately the Ministry of Health.
A number of companies similar to MHS have emerged in the Canadian medical supply landscape over the past several years. Government authorities have always been fully aware of our presence and of the kind of work we do.
MHS has never attempted to operate without regulatory control. I want this Committee to know that before this issue arose, and indeed, before we began to service this contract, we went to both the Ontario College of Pharmacists and to Health Canada to inquire about the appropriate regulatory approval. Both the College of Pharmacists and Health Canada declined to regulate MHS.
MHS also approached the New Brunswick Pharmaceutical Society about regulation in New Brunswick. They declined to regulate MHS.
Even though there was no specific regulation of our admixture preparation services, we still instituted the most stringent quality control measures we could devise. I have always ensured that our organization operated according to the highest levels of quality. It is a core value from which I would never deviate.
My entire career has been devoted to improving patient care. I have worked collaboratively with hospitals, home care providers and pharmacists. I am deeply committed to preventing incidents like the one that brings us here.
But, regulation alone does not ensure best practices.
Training, strong quality controls, constantly reinforced corporate values and a management that practices what it preaches, can. That is how I have tried to build my company.
This Committee heard from one witness that Health Canada is planning to regulate MHS and others. Health Canada will require that all admixtures be prepared under the direct supervision of a licensed pharmacist. This is what we have always done. The admixtures at issue were all prepared under the supervision of a licensed pharmacist.
I want to conclude by speaking about Marchese’s response to the investigations as a result of this incident.
We have spent countless hours responding to inquiries from Health Canada, the College and the Ministry of Health and Long-Term Care. We have also met with Dr. Thiessen and are co-operating with him to the fullest extent. Health Canada, the College and Dr. Thiessen have been given full access to our premises, our people and our processes. They are being provided with all of the documents they have requested. Dr. Thiessen has met with me and my employees. All of us have been and will continue to be open.
We want to prevent these types of incidents as much as anyone else involved. We remain committed to assisting in any way we can, to improve patient care and confidence in our health care system. We are proud of the role Marchese employees play, every day, in providing quality health care to thousands of citizens.
Thank you. I welcome the opportunity to respond to the Committee’s questions.
Let me say, Marchese Hospital Solutions (Mississauga) deeply regrets the patient concerns and uncertainty regarding the administration of some of the chemotherapy solutions we supply. These concerns have arisen as a result of a difference between the manner of administration used in some hospitals that was not aligned with how the standardized preparation had been contractually specified.
We must emphasize, despite some media characterizations to the contrary, there was never any question of a “defective” medication. This issue involves only the volume and concentration of a high quality preparation, and those exist within very narrow boundaries of variation. Those variations were the result of the use of our preparation, which according to our current understanding was not consistent with the contract, the preparation or its labelling.
We are confident that we fully met all of the contract requirements including both volume and concentrations for these solutions. However, we share responsibility to ensure that patients and their families are not given any reason for concern about their treatment. We take this responsibility very seriously.
We therefore will continue to work collaboratively with all of our clients and partners to ensure that we all learn the lessons of this deeply regrettable miscommunication. We are committed to always meeting the expectations of our client hospitals and those of their patients.
Resolving this issue is my very highest priority. Our first priority was to ensure that the right treatments reached patients. That has been done. Secondly, we need to understand how assumptions about product use which were not consistent with the contractually supplied preparation and labelling led to this issue.
We have worked closely with the affected hospitals since we were alerted to the issue and we will continue to work to address the problem.
April 2, 2013
A story appeared in the media today referencing the services of Marchese Hospital Solutions (Mississauga). The story alleges that lower than intended doses of medication in saline solutions were administered to patients in Ontario and New Brunswick. Marchese immediately responded with the following statement:
Marchese Hospital Solutions (Mississauga) has built its reputation on meeting the high standards of our industry. We are, of course deeply concerned whenever any question is raised about the quality of our work. We are collaborating closely with our partners to address the issues which have been raised. Our preliminary investigation of this issue leads us to be confident that we have met the quality specifications of the contract we are honoured to have been awarded. Following further inquiries, by our partners and Marchese, we will have more to report in a few days' time.
Marchese Health Care has served our community with pride for more than 50 years!
You can depend on us for award-winning pharmacy care, superior medical supplies, innovative wellness programs, and expert health counselling and education.
We thank you for your ongoing patronage and look forward to continuing to serve you.
Marchese Health Care is an independent community-based health care provider dedicated to the delivery of compassionate, client-focused care. We provide a wide variety of medication, supplies and equipment; clinical knowledge; and specialized services to meet your health and wellness needs.
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Marchese Health Care is a provider of health-care services to clients of the Waterloo Wellington CCAC in southwestern Ontario. (Click here for more information.) We supply high-quality medical supplies and pharmacy services to CCAC clients with a strong commitment to client-centred care.
Marchese Health Care's
New ISO Registrar
Marchese Health Care is pleased to announce that we recently engaged with BSI to become our new ISO registrar. Marchese's switch to BSI was driven by our desire to align ourselves with a renowned, world class registrar possessing global scale as well as close proximity to our sites in Hamilton and Kitchener. BSI's combination of local offices with a global presence and excellent reputation was clearly a perfect fit!
Marchese is currently ISO 9001:2008 registered for the management and administration of pharmacy service, infusion service and medical supplies at our locations in Hamilton and Kitchener. To view our certificate of registration, Click Here.
Changes to Pharmacy
We have made changes to our pharmacy delivery services so we can continue to provide you with the customer service you have come to expect from Marchese Health Care.
• Prescriptions without refills require a minimum of 48 hours notice.
• All refill orders require a minimum of 24 hours notice.
• Saturday orders must be received by our Pharmacy by 11:00 a.m. for same-day delivery.
Marchese Health Care
50th Anniversary Legacy Fund
Marchese Pharmacy on James Street North has been a crucial neighbourhood resource for five decades. To mark the milestone, owner Marita Zaffiro established the Marchese Health Care 50th Anniversary Legacy Fund at Hamilton Community Foundation in 2011. Click here to read more in the Hamilton Community Foundation Annual Report 2011-2012
New Narcotics Safety
Regulations in Effect
Ontario is taking action to reduce the abuse of prescription narcotics and controlled substances. Click here for more information, including acceptable pieces of identification, or visit the Ontario Ministry of Health and Long Term Care website.