Canadians are paying too much for generic drugs

I am the co-author of a publication in Open Medicine today that’s getting quite a bit of media coverage. Our study “Pan-Canadian overpricing of medicines: a 6-country study of cost control for generic medicines” was published this morning online, and has since been covered by The Toronto Star and in various publications by the Canadian Press.

The conclusion of our study is quite simple: Canadians continue to overpay for generic medicines. Canada has been long-known as having generic drugs that are more expensive than peer countries, but our study is the first to evaluate a new attempt by Canada’s provincial and territorial ministers of health to reduce the cost of 6 generic medicines that comprise 20% of pharmaceutical spending through a specific program of cost reductions. This initiative, initiated by the Council of the Federation, pegged the reimbursement cost of these 6 medicines – used to treat hypertension, dyslipidemia, and depression, among others – at 18% of the cost of the brand-name drug (the on-patent price), and expected to save $100 million annually.

We have no doubt that this initiative will save Canadians millions of dollars annually, and probably already has (it’s been in effect for over a year, and has already been expanded to include a total of 10 drugs); this represents a significant price reduction for 6 commonly-used, and expensive, drugs. However, when we compared the price that Canadians pay with the price of the same drugs and strengths in 6 comparable countries, we found that Canadians continue to overpay by a median price ratio of 2.13. Or, put another way, we pay 2.13 times more for the same drugs than patients in similarly wealthy countries of a similar market size. Even drugs that are manufactured and sold by Canadian generics companies are cheaper elsewhere – one drug supplied by Apotex (a Canadian manufacturer) was 86-87% less expensive internationally than in Canada.

This points to a significant need to reconsider how Canadians are sourcing medicines and ensuring that we continue to keep on top of Canadian healthcare policy.

Read the full article on Open Medicine’s site. (It’s open access!)

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We have ignored supply chains for essential medicines and devices, and that’s fueling the Ebola epidemic

 

Jason Nickerson in El Fasher, North Darfur, Sudan

Jason Nickerson in El Fasher, North Darfur, Sudan

I recently wrote of the need to understand the Ebola epidemic from the perspective of health systems. As the epidemic continues to spiral out of control throughout Liberia, Sierra Leone, and Guinea, it’s important for us to adopt a critical perspective not only on the broad aspects of the epidemic, but on the nuances of what is contributing to the spread of the virus, and what is working effectively to contain or constrain it within these health systems.

Among the many assessments of the epidemic’s spread have been reports of the shortages of essential medical supplies: gloves, gowns, aprons, boots, etc. All too often this is portrayed with a fatalist tone of a common problem in low-income countries, but this is an incredibly important and overlooked aspect not only of the epidemic, but of the failures of the global public health systems to adequately prepare developing health systems for even minor threats.

First, let’s consider the commodities that we are discussing. Disposable medical goods like gloves and aprons are not sophisticated pieces of technology, and do not require elaborate manufacturing processes or complex supply chains in the way that something like drugs or vaccines do. As the IRC’s field director in Liberia reports “The supplies they need to contain the outbreak aren’t expensive, but there just aren’t enough available.” The bottleneck in the system is not a shortage of manufacturers, nor is it an intellectual property concern. Rather, it’s more likely the result of a supply chain that has been ignored in the grand scheme of health systems strengthening.

Regrettably, this is an all-too-common occurrence in global health. A great deal of attention has been paid within the access to essential medicines debates to discussing intellectual property and the role of patents in restricting the availability of lifesaving therapeutics, but this discussion seems to stop at the factory and restart at the bedside. In between the manufacturer and the patient lies a very complex system with many weaknesses that plays a crucial role in ensuring the availability of drugs, devices, and supplies for hospitals and clinics.

The consequences of a poorly managed supply chain extend beyond the obvious. In the absence of trained and dedicated logisticians, health care workers (often nurses and pharmacists) are the ones often left responsible for ordering supplies and ensuring they arrive and are stored properly. This has two consequences: you end up with a poor supply chain manager, and you remove a clinician from actually providing patient care. Neither is desirable, and both contribute to the fragility of weak healthcare systems.

Poorly managed and regulated supply chains are also vulnerable to the intrusion of substandard, falsified, and counterfeit medicines, which proliferate in environments where the state is either unable or unwilling to control a lucrative private pharmaceuticals market. The end result is that patients are left with drugs and devices that offer no medical benefit or, worse, will directly harm them. There are countless examples of pills being found to contain nothing more than talc or cement, and injections that contain nothing more than water.

When these supply chains fail to deliver, it should lead us to seriously question the successes of the global public health system’s architecture. The failure to be able to meet even basic medical commodity demands should surely serve as an embarrassment to us, and should prompt a few things to occur: first, and most urgently, immediate logistics support is required to replenish depleted stocks in the Ebola outbreak and to establish reliable supply chains for the continued availability of medical necessities like gloves, gowns, body bags, and other items. Second, global health programs must adopt a focus that recognizes the essential nature of supply chains in the provision of safe and reliable patient care (this is already happening and there were some great presentations at HSR2014 on this). Third, the research community must broaden its scope in discussing access to essential medicines to include the complexities of supply chain and market dynamics, and abandon this almost exclusive (and myopic) focus on intellectual property as though it were the sole determinant of access. Until we do this, we will continue to see stockouts and supply chain ruptures and the continued amplification of disease epidemics rapidly spiralling out of control at least in part because of our inattention to a basic concept.

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Health system indicators everywhere! Will we know success when we see it?

I am attending the Third Global Symposium on Health Systems Research in Cape Town this week. The central focus and theme of the conference this year is on people-centered health systems, putting patients, their families, and communities at the center of everything that we do. Intersecting this goal is, of course, a need to measure the impact of new (and old) policies and interventions that take place within the health system, from  national and international levels all the way to the bedside.

I have been interested in methods and indicators for monitoring the availability and functionality of health services across health systems for a long time. More specifically, I am interested in how we can monitor fluctuations in the availability of health services under very difficult circumstances – in fragile and conflict-affected states, natural disasters, and other humanitarian emergencies. One of the challenges that we have often run into is, however, that there are a plethora of data that are available, with a great deal of uncertainty as to how to compare them, how to integrate them, and what nuances or limitations come along with the different datasets, compiled from different tools and indicators.

One of the papers that arose from my PhD thesis was a systematic review of the existing tools for conducting health facility assessments, where we found that there were a large number of these tools in use in low- and middle-income countries. We analyzed these tools using a health systems framework, and from this we established a set of criteria that should be evaluated in a health facilities assessment – everything from the number of health workers present to the availability of essential services like surgery, pediatric care, and others. Interestingly, we found that many tools being used to guide decision-making were largely incomplete: they reflected donor or other priorities, and could offer little in the way of a broad assessment of the capacity of the health system to deliver essential functions at the health facility level. There was a general trend toward primary care services, which wasn’t surprising, but even universally-necessary services (like a morgue, or healthcare waste disposal services, or the number of healthcare workers present) were neglected by some of the tools. The large number of tools in use, and the discrepancies in what they measured and how they measured it, make the data incomparable in many instances.

Within the criteria we defined for health facility assessments, many have existing, well-defined and well-used, standardised assessments, often endorsed by the World Health Organization. For example, the Situational Analysis tool to Assess Emergency and Essential Surgical Care (PDF), evaluating the availability of drugs, equipment, human resources, and other essential items for surgical care, which is then databased for each facility around the world. This week, I also attended a session on the Workload Indicators for Staffing Need (WISN), which is also a WHO tool, used to assess the availability of health workers, identifying gaps in availability, and monitoring workload imbalances. For many other services, no standardized assessment tools exist yet, and that’s something that we really need to map out and determine where gaps are.

All of this has got me thinking: how can we practically measure progress across the health system when all of our data are so fragmented?

My experience suggests that there are a myriad of indicators and standardized assessment tools in use across all of the health system building blocks, but currently there is no way of consolidating all of this information into a big picture assessment of the relationship between them. In absence of this, will we know what success in health systems strengthening looks like if and when we get there?

This becomes particularly problematic when health systems begin to collapse – we rapidly need to know where the health facilities are, what services they provided prior to the emergency, how many staff are available, and how well they are functioning. Taking the example of the ongoing Ebola epidemic, it’s been difficult to know what capacities existed at the outset of the outbreak in these now very disruptedhealth systems, which makes planning very difficult. This information needs to be rapidly synthesized in a way that is usable and easily updatable. When this isn’t consolidated (as was the case during the Haiti earthquake) a large number of databases tend to emerge, often providing limited assessments of the health system (we have a paper forthcoming on this).

I think that an extremely useful contribution to health systems research would be to establish a system capable of consolidating the outputs of all of the assessments currently in use to allow us to conduct analyses and syntheses of these data in a format that’s usable for making decisions and evaluating outcomes. We need to understand how these data could become interoperable and comparable. This seems like a massive undertaking, but would undoubtedly be of incredible value to the health systems research community, and health systems themselves. Any collaborators out there?

References

  • Nickerson JW1, Adams O2, Attaran A3, Hatcher-Roberts J2, Tugwell P2. Monitoring the ability to deliver care in low- and middle-income countries: a systematic review of health facility assessment tools. Health Policy Plan. 2014 Jun 3. PMID: 24895350.

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Why did it take an Ebola outbreak to realize the importance of health systems?

I work in an area of research and practice that garners immense public interest when terrible things happen: wars, famines, disease outbreaks, natural disasters. There are far too many overlooked crises, and any opportunity to shed light on the needs of people affected by these events should be welcomed; But all of these events are incredibly complex, and there are no templates for how they are going to unfold. Regrettably, nuance often gives way to brevity in reporting and public discussions of these events, and the images that are presented are far too often simplistic representations of overly complex problems.

Take the current Ebola epidemic that is currently spreading across west Africa. As others have correctly pointed out, the current outbreak is yet another example of the failures of the global research and development architecture to prioritize the needs of low- and middle-income countries in drug and vaccine development. My colleague Steven Hoffman and co-author Julia Belluz write that:

Right now, more money goes into fighting baldness and erectile dysfunction than hemorrhagic fevers like dengue or Ebola

I certainly agree that global priorities are skewed for developing new drugs, and there is ample evidence that this is a train that has gone well off its rails. Furthermore, Hoffman and Belluz also note that healthcare spending in countries affected by Ebola is among the lowest in the world, a nod to the need for stronger health institutions. Other authors have also correctly pointed out the faults in the global research and development systems with regard to Ebola, and the ethical minefield that is the current landscape for testing the drugs in development. But, I disagree that the single biggest contributor to the spread of Ebola is the lack of new drugs; rather, I agree with Karen Grepin that:

Simply put, I think we are overestimating the “substantial” public health benefits and that they are not likely large enough to justify the relatively large fixed costs associated with developing any new medicine (which are at least a few billion a drug)

This statement should not be taken to mean that we should not be working to develop new treatments for Ebola; quite the contrary. Where I differ in my opinion is that I believe that the most effective treatment for Ebola likely does not lie in new drug development, but in establishing and maintaining well-functioning, accessible health systems in low-income countries.

The central features of health systems require strong leadership, drugs and technologies, health information, health human resources, service delivery, and mechanisms for financing all of the above. Within each of these, communicable disease control plays a strong role, whether it be through the establishment of an effective disease surveillance system, hospital-based infection control procedures, providing essential medical care, the handling of medical waste, or community-based education. Regrettably, health systems in most countries affected by Ebola are weak, and suffer longstanding shortages of health workers and other important resource constraints, in part due to low spending on the health system. Until this outbreak, few (if any) cases of Ebola had ever been treated in high-resource health systems where access to critical care medicine was possible, which limits our understanding of what proportion of the Ebola virus disease mortality can be attributed solely to the virus itself, and what proportion is attributable to a lack of comprehensive medical care.

The emergence of the ZMapp antibodies for the treatment for Ebola has prompted a focus on the drug and development process for rare and neglected tropical diseases. This scrutiny should be welcomed, as should the public attention that this often byzantine process is getting. At the same time, there is a need to bring the broader issue of weak health systems to light through more robust reporting than pictures of small hospitals or delapidated clinics. The Ebola outbreak is a necessary opportunity to report on the inequalities in access to healthcare around the world as a result of weak institutions and inequitable policies that can decimate or stall health systems, and to reflect on the interconnectedness of global health. For anyone from a high-income country seeking a justification for why international development and building of stronger institutions in low-income countries ought to be of concern to them, here you go.

But this begs the question of why it has taken this long for the world to realize the importance of strong health systems. By many accounts, health facilities in all of the affected countries are struggling, with some public services having collapsed, with little access to essential supplies such as gloves. Fundamentally, this collapse and the challenges in containing the spread of the virus is about weak health systems, and not solely the absence of a vaccine or treatment. As a thought experiment, consider the possibility that ZMapp was already shown to be effective, had regulatory approval, and was available at an affordable cost for low-income markets: would these health systems be able to distribute and administer it effectively?

We need better evidence and interventions to guide the treatment of Ebola patients. This likely includes the development of new drugs, but it unquestionably includes stronger health systems. We simply can not focus only on the interventions without acknowledging the systems that must be in place to guide them.

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We Need to Break Out of the Bubble – My Response to the HCC Report “How do Canadian Primary Care Physicians Rate the Health System?”

This article appears on the Health Council of Canada‘s blog Canada Values Health and can be viewed, along with several other commentaries on this report (here and here), on their site.

Because of our need to strengthen capacity within the primary care system, it is of extreme importance that we pay attention to the perspectives of those working within it. Today, the release of the report “How do Canadian Primary Care Physicians Rate the Health System?” provides such a perspective, and should signal our need to evolve not only discussion, but innovation, on how to ensure that Canadians continue to see value for money spent on healthcare.

For decades, Canadian health policy experts and practitioners have wrestled with the question of how to improve Canadians’ access to primary health care. This debate has taken place within a fractured and fragmented health care delivery system, which by all rights can hardly be characterized as a national system at all. Rather, high quality health care is frequently delivered within confined bubbles, few of which are connected in any pragmatic way that is easily navigable for patients or caregivers. An effective health care system must have seamless linkages between community care, primary care, acute care, and continuing care, something that today’s report finds is lacking in Canada. We need to focus more on systems, rather than on individual problems.

Regrettably, progress has been lamentably slow. As today’s report notes:

“Canada ranks poorly compared to other countries on many factors related to access to primary care and coordination of care between primary and specialist providers.” This is not a new problem, nor is it one that has suffered from a lack of investment. Rather, a considerable number of projects and alternative models of practice have been initiated throughout Canada, some with considerable success, and many that have lacked scalability outside of the confines of the practices where they have been initiated.

What we must acknowledge is that many of the constraints faced in accessing primary care must be addressed through considerable structural reforms to the governance and organization of Canada’s health systems (and they are a plurality, rather than one cohesive system). Far too few clinicians are able to practice to the full extent of their scopes of practice, limiting the “bang for our buck” in training and deploying them; effective referral networks and procedures are often lacking in many systems or are stymied by bureaucratic and procedural constraints that make referrals or collaboration impractical; health information systems have been deployed to collect large quantities of health information, yet frequently fail to manage information in a meaningful way across different providers and care systems.

While much has been written with regard to our need to improve healthcare in Canada, we need to move beyond simplistic solutions that have largely focused on change, rather than reform. Proposals such as interprofessional education or electronic charting have arguable potential to enact these changes, but have been poor at actually reforming the structural, regulatory, or institutional barriers that impede the optimal roll-out of these innovations. Clinicians who are not empowered (or allowed) to initiate, titrate, or discontinue treatments or refer patients to colleagues in different professions are unlikely to provide optimal interprofessional care nor see the benefits of interprofessional education. Computerized charting or imaging that offers no ability to transfer records in a useful way across health authorities or clinics offers no advantage to patients nor health systems. What’s more is that front-line clinicians identify inefficiencies and deficiencies within these systems and develop work-arounds to them, which may directly undermine investments made.

Considerable work remains if we are to see Canada’s primary health care systems ranked among the best in the world. However, this cannot be achieved in absence of coordinated reforms to link innovations and ensure the constructive evolution of Canada’s healthcare delivery systems. We currently have pockets of innovation and excellence, and what we need is a coordinated scaling-up of modern systems geared toward prevention, treatment, and accountability.

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