Friday, March 27, 2015
We’ve been hearing a lot about prescription drug shortages in recent years—and it doesn’t look like the problem will be going away anytime soon. In this article, we’ll look at how and why these shortages occur.
In the past few years, there have been a number of drug shortages, some of them severe. It’s a serious concern for everyone—healthcare professionals, patients, governments and insurers alike—because we’re often left scrambling to find last-minute alternatives.
Every year, the Canadian pharmaceutical industry experiences supply disruptions for between 250 and 500 drugs.1, 2 And it’s not just Canada—it’s a problem for industrialized countries worldwide. It also affects multiple classes of drugs, and there’s no way of identifying which ones are most vulnerable. That said, generic and injectable drugs tend to be affected the most. And since they make up a higher proportion of the market than brand name drugs, the impact is that much more noticeable.
What are the causes?
Although many hypotheses have been put forward, as surprising as it may seem, we don’t fully understand the causes of these shortages. However, we can break it down into two main problems that cause supply chain disruptions: problems acquiring raw materials, and problems with quality or quality control.
Disruption in supplies of raw materials is a serious problem. First of all, there are very few chemical companies in the world that manufacture these substances, and production has been shifted to emerging countries where costs are lower. Plus, after a series of mergers and acquisitions, the number of players left in the game isn’t enough to keep up with demand. The result: a market with high demand that few companies, if any, seem to be interested in. Given the lack of interest in this market, we should probably be questioning the price we pay for generic products. It forces us to think about the strategies used to determine generic drug prices, which have been falling over the last few years and which many provinces and countries automatically set at 18% of the original product.
Furthermore, in some provinces and healthcare facilities (such as hospitals), there’s been a move towards going to tender to get the best possible price. In these cases, the contract goes to a single supplier. But the problem with sole-source contracts is that there’s no room left in the market for anyone else. So when there’s a crisis, it’s difficult, if not impossible, to find another manufacturer.
Contributing further to the problem is the just-in-time production strategy used by most producers. Production is dictated by demand, which means stocks are kept to a minimum, and every step of the production process has to be carefully managed to keep it in balance. It’s a delicate balance: the entire process can be thwarted by a problem or delay at any one step. And there are a lot of steps, thanks to the numerous quality control procedures involved. Plus, given the global scale of these suppliers’ operations, there is no quick fix to any problem.
The other culprit in the drug shortage problem is quality control. It’s an area severely lacking in transparency from pharmaceutical companies, which makes it hard to distinguish problems with actual quality from problems with the quality control process. From media reports, we’ve learned that US Food and Drug Administration (FDA) inspections have revealed quality problems in facilities in Canada and in one facility in India.3
It has also been noted that drug shortages often affect older medications—leaving some people wondering whether that’s by chance or by design. Is it due to lower demand? Or to a lack of indexation and unprofitable prices? Or is it a strategy to promote newer drugs? As it stands, we don’t have any official answers to these questions.
Consequences and possible solutions
The consequences are wide-ranging. In the most serious cases, treatments and surgeries have been delayed—there have even been patient deaths reported. In other cases, finding an alternative drug has been the only option. Doctors and pharmacists have had to modify their patients’ treatments by finding equivalent drugs—and equivalent doses—so as not to compromise the efficacy and security of the treatment. This increases the risk of error, adds to doctors’ and pharmacists’ workloads, and causes uncertainty and difficulties for patients.
In 2010, the Canadian Pharmacists Association and various pharmaceutical and medical associations took measures to address drug shortages.4 However, we’re still waiting for results.5 And while the situation is similar in both Canada and the US, the FDA has been more proactive, adopting an action plan to better manage the availability of prescription drugs in the American market.6
A lot of work has gone into trying to better predict shortages and control the results in Canada. Most stakeholders are calling for manufacturers to announce foreseeable shortages in advance. Reporting mechanisms have been launched, including a Quebec-based initiative (www.vendredipm.ca) that has since developed into a nationwide program (https://www.drugshortagescanada.ca/
). Unfortunately, being aware of shortages can only help us prepare for them—the real question is how to avoid them altogether.
The Canadian Pharmacists Association has been lobbying to allow pharmacists to make substitutions to prevent treatment interruptions. In Quebec, this is being accomplished with Bill 41, which is expected to come into force in the first quarter of 2015. Similar steps have been taken in seven other provinces.7 This change will help pharmacists find substitutes for drugs in the same therapeutic family in the event of a shortage.
However, the only way to ensure a continuous supply of high-quality prescription drugs is to understand the real causes of these shortages. A lack of transparency makes it hard to come up with any short-term solutions.
The issue of prescription drug shortages has raised some big questions, not only about our vulnerability as a nation in terms of our healthcare needs, but also about the kind of market we represent for the pharmaceutical industry. For now, we will have to continue to rely on creative problem-solving and flexibility to protect patients from the risks of these shortages.
2 Barthélémy I. et al. Can J Hosp Pharm. 2012 Sep–Oct; 65(5): 406–407