The creeping problem of drug shortages

The creeping problem of drug shortages
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Dozens of drugs are suddenly unavailable every year. In Canada, we read about shortages of Epipens, opioids and antibiotics and before that, it was saline. In India, it is anti-HIV drugs for children. The problem is global, but most Canadians notice only when their pharmacists cannot fill their prescriptions.

Hyped reporting of individual shortages obscures the fact that they are all connected —as symptoms of a bigger, unprecedented and poorly understood problem.

Health Canada has acknowledged the problem, but it has never measured the shortages through time or attempted to analyze the types of products affected —injection or oral, generic or innovator.

Drug shortages provoke great anxiety. For pharmacists and health-care providers, they demand time-consuming and often frustrating searches for alternatives. For patients, they result in the stress and harm of delayed treatments and surgeries. For governments, they increase health-care spending to acquire the scarce products or their replacements from other sources or innovator substitutes.

Some studies have shown that drug shortages can lead to illness and even premature death.

How big is the problem?

To measure the problem in Canada, I, together with Dr. Brian White-Guay of the Université de Montréal and two students, examined publicly available data to assess the size of drug shortages in Canada between 2010 and 2017. Our sources were the websites recommended by the federal government since 2012 (notification of shortages became mandatory only in 2016).

We discovered that the reporting was often incomplete, inconsistent and inaccurate. However, this was the only publicly available information on the problem and it was sufficient to provide a baseline minimum.

Approximately 1,000 shortages have occurred annually in Canada, affecting 1,250 different products during a recent three-year period. Indeed, the number of shortages appears to be increasing, although the apparent rise might be explained by growing pressure to adhere to the policy of mandatory notification —a policy that is not enforced.

The majority (77 per cent) of shortages involve generic drugs, although a significant proportion (23 per cent) also affect innovator drugs.

Without blaming any particular branch of industry, these figures correspond to the relative prescription volume of generic and innovator drugs in Canada.

In addition, we calculate that roughly 10 per cent of all products actively available have been affected by the shortages.

Since Canada does not maintain an Essential Medicines List, it is difficult to know how many of the affected drugs are medically necessary.

Raising awareness

Yet many people who have been affected are unaware of the shortages. If the family doctor substitutes a new drug for an old reliable product, patients might wrongly believe that "newer and more expensive" could mean "better."

If they are lucky enough to have a drug plan, the added cost is absorbed by the insurer or later the employer when the premiums rise. If they are seniors or on welfare or in the hospital, the drugs are covered through other channels, and it is the taxpayer who will pay the additional cost. If they fall ill because they cannot locate or afford the substitute drugs, they will end up in hospital, and again, it is the taxpayer who pays.

The precise causes of in Canada and all other affected countries are unknown. Little has been done to analyze root causes or explore the consequences of Canada's limited capacity to supply its own needs for medicines with locally manufactured active ingredients and finished products.

The first step in trying to uncover the cause is to measure and characterize the shortages. Our research shows that those in Canada differ from those measured in the United States and elsewhere.

A stable supply of a diversity of medicines will keep health-care costs down, avoid the expense and stress of sudden emergencies and maintain access to medications for the entire population.

Canadians should urge the government to undertake regular analysis of the drug shortage problem. Measurement will generate insight into the extent of the problem and its possible causes, and it will provide a baseline for assessing the effectiveness of policies created to manage and prevent it.

Only when the causes are identified can solutions be found.

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