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October 2009

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Remarks from 5th Annual Health Policy Summit

Sunday, October 25, 2009 @ 09:10 AM

Here is my speech entitled “Cross-border Prescriptions and the Impact on Canadian Health Care“, the entire document is reproduced below.

Marc Kealey’s Health Policy Summit Speech

My thanks to Insight Information for the invitation to take part in this important event, the 5th Annual Health Policy Forum. This is the place to be to get the big picture on where health care is going in Canada, and the quality and diversity of the speakers and presenters assembled here is again outstanding this year.

I’m particularly pleased to be included on a program that features organizations representing other major health care providers, our peers as major players in health care in Canada.

Pharmacists, you see, have a valuable and important perspective on many issues, local, provincial, national, international, global. I’m here today to deal with an international issue, that of cross-border prescription drugs and the threat we see looming to Canada’s health. I’ll get to that in a minute. But I want to take some time first to bring you up to speed on the situation of pharmacists and pharmacy in Ontario.

Over the last two years all of us in health care in Ontario have been involved in a massive process of change within the context of what the government calls its health transformation agenda. We were challenged as health care providers – pharmacists, doctors, nurses, hospitals and others – to put the patient at the centre of what we do.

This is by no means a change limited to Ontario; it’s truly a made-in-Canada issue as we search for ways to refine and improve our unique national health care system and ensure its continued sustainability and accessibility.

As pharmacists, we are encouraged to see significant progress in Ontario over the past two years toward integration and collaboration. But there is much left to do.

It’s clear that we and our fellow health care providers simply have to step up with a real sense of priority, put our collective thinking on the table and fix what continues to be broken in this system.

The time to do so is now, so that we can build on the gains that have occurred.

When we look at the structural changes through which integration and collaboration is best being realized among doctors, nurses, pharmacists and hospitals, we’re finding it among the multi-disciplinary Primary Care Teams now active, working and succeeding in a range of locations and settings.

And through the prism of Family Health Teams, for example, the working relationship between physicians and pharmacists around medication management is undergoing fundamental reinvention.

At the broader level, there is a parallel shift occurring in the relationship between pharmacists and our physician colleagues at the Ontario Medical Association and the College of Family Physicians.

Our interactions around medication management are poised to be productive, driving common policies and approaches that place the patient appropriately at the centre.

When Jonathan Guss, came to the OMA not too long ago, he started a fiscal realities committee where we have quickly and cohesively come to appreciate that the recurring central issue in integration and collaboration is – exactly as we’re finding with Primary Care Teams – managing patients’ medications.

That puts pharmacists squarely at the centre of what patients need.

Pharmacists are equipped and ready to respond here in Ontario. That’s a fact that patients and the public in this province clearly understand.

In a survey of 1,000 Ontarians last year for OPA found:

  • 95% of Ontarians believe their pharmacists help them better understand the medications they need to improve their health;
  • 88% trust their pharmacist to have an open discussion about their health questions, whether or not they are medication related;
  • 75% would not hesitate to seek education services and patient care from their pharmacist for smoking cessation, diabetes, asthma or another health condition;

In this context of public preparedness and expectation, we have been working with the Ministry of Health on what is frankly an important development for pharmacists. Starting April 1st of this year, Ontario pharmacists have begun to provide an expanded range of professional services to our patients as the core of our new role in front-line health care delivery.

The first professional service is a medication review called Meds Check. Since the Meds Check service became available to patients just three weeks ago, it has been provided to more than 5,000 patients and is available at nearly one-quarter of Ontario’s 3,000 pharmacies.

Through this professional services initiative, Ontario pharmacists are exercising their true professional capacities. They are applying their medication expertise to counsel patients, improve patient health outcomes, and reduce pressures on other parts of the health system – and they are being paid for it.

Each Meds Check service provided to an ODB-eligible patient earns a flat fee for the pharmacy. This is an important new revenue stream for pharmacy, backed by an initial commitment by the ministry of 50 million dollars in fiscal 2007-08.

The new role of the pharmacist is part of the truly enormous change brought about by the Transparent Drug System for Patients Act, or TDSPA, which became law in Ontario last fall.

If you are at all familiar with what’s known as “the drug file,” you will be aware that the implementation of the TDSPA has been a rocky road for pharmacists and the pharmacy sector in Ontario.

But we succeeded over the past year in winning back what might have been significant losses for pharmacy. That enabled our board, some months ago, to support outright the strategy and direction of the Act, and agree that pharmacists should move forward from it into the future as a profession and as a health care player in this province.

We’ve undertaken to communicate to the government, other pharmacy and health stakeholders, patients and the people of this province that pharmacists are ready to engage in a positive, forward-looking process to improve health care.

In the new paradigm of Ontario’s drug system, community pharmacy is finding new ways and new opportunities to secure our role as health care providers and maintain the viability of our business models. Professional services is one such avenue.

These are not simple issues; and neither is the work of the pharmacist today simple or one-dimensional. Patient needs are intricate, moreso as we age as a population, and the pharmacist-patient relationship is one of increasing complexity.

It’s fortunate in these times that pharmacists have the trust of patients.

That trust is highest at 98% versus politicians  at 7%.

But not every politician rates low on trust. When U.S. President Gerald Ford died earlier this year, I was amused to read the following tribute:

He had the look of a pharmacist. You never got the sense he was as conniving as the others.

But I have to assert today that it would be incorrect to mistake the niceness of pharmacists for complacency. Particularly when the health and well-being of our patients is at stake.

That is the case with the issue I want to focus on today:  the renewed invasion of Canada by American patients in search of low-cost prescription drugs.

When I sound a warning today about re-opening the U.S. border to prescription drugs from Canada, I’m speaking from the perspective of pharmacists who are not only trusted, but expected by their patients to get involved and to advocate in an outspoken and effective way.

Our patients want us to protect their health. So we’re speaking up to identify the issue of cross-border prescription drug importation from Canada by Americans as a threat to public health and safety, and to national security, in both our countries.

Our warning is responsible, well-considered, realistic and reasonable. We issue it because as pharmacists we put patient health, public health, and the safety and the security of the prescription drug supply at the top of our list of priorities.

Let me trace back for you what’s happened in the U.S. Back in September, a deal to once again permit so-called “foot traffic” personal importation of prescription drugs by American patients was struck in Congress and quickly signed into law by President Bush.

Events followed quickly that in effect re-opened all channels of cross-border prescription drug importation by individual U.S. patients.

Since foot traffic works only for patients in border states, another deal was needed.

So the Bush Administration intervened in October by ordering the Department of Homeland Security to cease confiscation by Customs and Border Protection agents of prescription drugs mailed from Canada.

Oversight of Canadian prescription drug imports was sent back to the Food and Drug Administration, which by its own admission lacks the capacity for comprehensive inspection and enforcement.

This climbdown on enforcement at the border expanded the permitted forms of cross-border importation to cover internet and mail-order sales.

Since October 9th, the day U.S. Customs went hands-off on prescription drugs purchased by American patients from Canadian internet pharmacies, the door to Canada’s medicine cabinet has been thrown wide-open once again.

Three months ago, on January 10th, these changes were consolidated and brought forward in a greatly-expanded form in a new legislative proposal in the new Democrat-controlled Congress.

A bipartisan bill called the Pharmaceutical Market Access and Drug Safety Act of 2007 was  introduced in both the Senate and the House of Representatives.

This bill legalizes the importation of prescription drugs from Canada by American patients, pharmacists and drug wholesalers. That means the legalization not only of personal importation by individual U.S. patients, but also of bulk importation by HMOs, state drug plans and other large entities such as high-volume retail chains.

The congressional leaders behind this bill are predicting its passage in the next two to three months, saying they have enough support in Congress to override a presidential veto.

So let’s get this straight: Here in Canada, we have built a drug supply and pricing system that meets the needs of Canadians as part of our unique marriage of social and economic policy. While in America, U.S. lawmakers are deciding it’s okay to cherry-pick the benefits of Canada’s regulated drug system as a solution to a domestic U.S. problem with unregulated drug prices.

Instead of designing a system that responds to the legitimate needs of Americans, U.S. legislators are telling their constituents to buy prescription drugs in Canada as a quick fix to high U.S. drug prices.

What does this mean? Well, picture an open floodgate. Picture a made-in-America problem being solved on the backs of Canadians.

We’ve been warning of this situation for months and months. We sent a cautionary letter to Health Minister Tony Clement on September 1st. We followed up in October and November with additional calls to action.

Our organizations believe that this American legislative proposal poses an imminent and serious threat to the security and integrity of Canada’s drug supply, and hence a serious and genuine threat to the health and well-being of Canadians.

What we’re looking at is a free-for-all on cross-border drugs…and in any free-for-all, someone is bound to get hurt.

As pharmacists, we will not stand by and allow the victims of America’s prescription drug pricing problem to be the very patients here in Canada who trust us to protect their health.

We see four dangers.

First, the so-called green light on personal drug importation is in fact a danger signal – because it encourages patients to bypass their own community pharmacists.

Patients who do so jeopardize their health and risk dangerous drug interactions by relinquishing expert consultation and pharmacist-patient interaction.

We’ve driven that message home with our patients in this country; our colleagues at the American Pharmacists’ Association have carried it forth to their patients. Pharmacists in Canada cannot provide adequate and appropriate patient counseling when they don’t have access to the U.S. medical records of a patient receiving that 90-day supply of drugs to take home. And often a patient is reluctant to share information about a Canadian-filled prescription with his or her U.S. health-care provider. This is a profoundly dangerous situation.

Those most vulnerable are the American patients in the greatest need of low-cost drugs – the elderly, those most likely to be using multiple medications, and most needful of the medication management expertise their pharmacist can provide.

The second threat to public health is in our own country, with the potential for the depletion of the Canadian drug supply.

U.S. demand for prescription drugs is more than ten times the Canadian supply. Just imagine how the three million residents of the state of Iowa would react if 33 million Canadians suddenly descended on them and said, “We’re here for your prescription drugs, hand ‘em over.”

Canada simply does not have the capacity to feed America’s appetite for lower-cost drugs. Our pharmacists do not want to become America’s drug store. Our job is to provide medications and expertise to Canadian patients, not provide solutions for the shortcomings of the U.S. health care system.

The bulk importation provisions of this new U.S. legislative proposal would quickly drain the Canadian drug supply and cause a crisis in drug availability for Canadians.

One authoritative US analysis says Canada’s drug supply could withstand full-blown U.S. importation for only a little over one month.

A crisis in drug availability translates into an impending threat to public health and safety.

The practice of arbitrage – flowing U.S. prescription drugs into Canada solely for reimportation – creates a false economy that American pharmaceutical manufacturers simply will not support.

And if in response Canadian internet pharmacies import drug products from offshore, the lines can quickly blur, making it difficult for U.S. patients – and the FDA – to differentiate between drugs produced or approved in America, and those produced in India or Israel or China, even in so-called FDA-approved factories.

Unless and until a comprehensive drug pedigree regime is in place and all prescription drugs are identifiable through Radio Frequency Identification (or RFID) technology, that issue cannot simply be wished away.

The industry is telling us RFID drug pedigrees are at least two or three years off. In the interim, knowing which mail-order drugs are produced where remains a guessing game – with patient health up for grabs.

And therein lies the third threat, that of counterfeit drugs. The re-legitimizing of internet and mail-order drug traffic encourages fraud by offshore criminals posing as Canadian pharmacists and selling counterfeit drugs.

The evidence produced by U.S. Customs on this file is rock-solid, and damning. The Customs statistics on mail-order seizures show at least 10 per cent of packages purported to be from Canadian internet pharmacies in fact contain counterfeit drugs.

In one seizure last fall, 19 million dollars worth of prescriptions that U.S. patients believed were filled by a Canadian internet pharmacy were actually filled by a criminal organization located in Belize. The drugs were fake and the patients, rather than saving a few dollars, lost every penny they spent.

The physical harm that can be done to patients who believe phony drugs they take are genuine cannot be over-stated. This imperils the health and safety of those who, again, are trying to do nothing more than save a few dollars.

Last month, the reality of this danger was brought home with a tragic finding by the coroner for Vancouver Island region in B.C.

The coroner tied the death of 56-year-old Marcia Bergeron to counterfeit pills she unwittingly ordered from a purported Canadian internet pharmacy. We received from the coroner’s office the toxicology report indicating that these counterfeit pills contained dangerously high levels of the heavy metals strontium, uranium and lead, as well as other hazardous elements.

Last month, we advised the B.C. coroner that the circumstances of Ms. Bergeron’s death are disturbing to Canadian pharmacists and patients. And we urged the coroner to conduct an inquest to make public all the facts of the case.

We believe an inquest represents the best possible path whereby the issues and questions raised by Ms. Bergeron’s death may be answered and the public responsibly and fully informed and protected.

If Internet pharmacies masquerading as legitimate and Canadian are supplying counterfeit drugs to Canadian patients, we need the mechanism of an inquest to fully expose the facts surrounding this incident and to identify and hold to account those responsible. We are further concerned that the presence of poisonous heavy metals in counterfeit drugs raises additional serious questions.

A full exposure of the facts surrounding Ms. Bergeron’s death will assist Canadians to understand the dangers of circumventing the legitimate drug system and putting their health and even their lives at risk by purchasing drugs from unknown and unreliable sources.

At last report the coroner continues to weigh the case for an inquest.

The fourth and final threat I warn you about today is one I do not raise lightly.

The greatest danger posed to the United States today by the legislative and enforcement changes on cross-border drugs is a renewed national security vulnerability through the possibility of drug terrorism, with mail-order drugs used as the vehicle of attack.

Who can say with absolute certainty that the next 19 million dollars worth of phony drugs could be sent to America not by criminals in Belize, but by terrorists? That the next batch of tainted pills from a purported Canadian internet pharmacy will contain deadly substances added deliberately to cause harm or death?

Do Americans really want the hands-off policy Homeland Security has adopted? Are the Democrats and the Republicans in the new Congress prepared to live with these risks?

We as Canadian pharmacists are not the first to raise this issue. In a report to Congress in April 2005, Guiliani Partners warned:

The nation’s medicine supply is vulnerable to exploitation by organized criminals, drug traffickers and terrorists. We should not contemplate opening our borders to threats to our medicine supply when in all other aspects we are searching for ways to tighten the security of our borders.

Canadian pharmacists are asking today, why is Congress ignoring that message? And why is it ignoring other warning signs, like the court case in 2006 in Detroit in which 19 people, including five Canadians, were charged with peddling counterfeit prescription drugs and funneling the profits to a terrorist organization?

The answer, in brief, is that U.S. lawmakers are whistling past the graveyard, hoping against hope that wide-open cross-border prescription drug importation can remain safe. That the threats and dangers I’ve described will never materialize.

Our concerns extend beyond these issues of safety and security, to the bottom-line question of whether, in the face of this legislation, we in Canada can maintain the lower price differential that makes Canadian prescription drugs seem like a panacea to U.S. lawmakers and patients.

Prescription drug cost is the big issue right now for Americans, but this legislation will quickly make it a Canadian issue. The threat here is that while this legislation may incrementally reduce the price of American prescription drugs by a few percentage points, Canadian prices will go up dramatically as we deal anew with the whole range of complex issues around subsidization, trials, research and other factors underlying the enormous costs of developing and manufacturing prescription medications.

This has the makings of a serious new issue in intergovernmental affairs within Canada. If unimpeded U.S. importation drives up drug prices in Canada, each provincial ministry of health faces the prospect of staggering increases in drug costs. In Ontario, for example, the Ontario Drug Benefit program procures some $3.5 billion worth of drugs each year.

The provincial ministers of health and their premiers need to start thinking right now about how this U.S. legislative proposal could bring about fundamental change in the prescription drug pricing regimes they currently view as stable and sustainable.

It would be prescient and appropriate for the premiers to challenge the Prime Minister Harper on this issue.

To demand that he demonstrate how his government will not only prevent drug shortages in Canada if this proposal becomes law in the U.S., but also maintain price protection in Canada when American bulk buyers start pulling vast quantities of prescription drugs from our regulated market into their unregulated market.

At the root of the issue is this: American politicians and patients continue to believe that Canada will continue to offer solutions to their systemic problem of high prescription drug costs.

Canadian pharmacists will tell you that we will not, because we cannot.

It’s for that reason that we are calling on the Harper government to take immediate action to protect Canada’s prescription drug supply by banning prescription drug exports to the U.S. by all means, including foot traffic, internet and mail order, as well as through bulk importation.

As Canadian pharmacists, we cannot slake the thirst of U.S. patients for cheap prescription drugs. But wecan urge our own government to turn off the tap.

On January 12th, our organizations, representing Canadian pharmacists, patients, and members of the supply chain, called on the Government of Canada to institute an immediate ban on the export, both bulk and retail, of prescription drugs from Canada.

We asked Health Minister Tony Clement to meet with us to discuss how the government intends to protect Canada’s drug supply and ensure continued access to medications for Canadian patients.

Back in October, in response to an earlier letter, the Minister indicated Health Canada will take action if and when Canada’s prescription drug supply is affected by U.S. importation.

We told the Minister in January, and I repeat today, that we can neither counsel nor support a reactive, after-the-fact approach to the protection of public health. We believe it is incumbent on the Government of Canada to respond proactively to this threat, driven by a commitment to prevent harm and protect the public interest.

It is our firm belief that the Government of Canada can no longer simply stay silent on cross-border prescription drug exportation, particularly in light of the legislative proposal now before Congress.

It’s no secret what’s needed to avert this crisis. U.S., lawmakers must meet their own prescription drug problem head-on, and stop looking north for stop-gap measures that will quickly become unsustainable problems – or worse.

In the meantime, get ready for the cross-border free-for-all. To the Harper government, we’re writing it large:

Put the health and safety of Canadians first. Ban prescription drug exports to the U.S., and do it fast.

There is a private member’s bill, introduced by MP Carolyn Bennett on October 31st, that the government could adopt to give the Health Minister immediate power and authority to ban bulk reimportation. That bill will now be debated in the first week of May.

I will be taking this fight to Washington on May 23, a few weeks from now, as the U.S. bill regains the spotlight.

I will be presenting our position – our advocacy for patient health in both the U.S. and Canada – at a major session on cross-border drugs being mounted at this crucial time by the Center for Strategic and International Studies.

My message then will be the same as today. Faced with the threat of continued U.S. activity to permit and condone the easy answer of internet pharmacy, the solution for Canada is clear. The need for action is urgent. We will continue to press our government to do what is necessary to protect our drug supply, and the safety of Canadians.

- Marc Kealey

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