Consequences?

The drug shortage is a creeping problem that is not noticed by the majority of patients and practitioners, even when they have been affected.

The biggest consequence, so far in Canada, is on the taxpayer. No one is measuring the extent or impact of the crisis. Death certificates require the cause of death to be a disease — not a shortage of treatment for that disease.

The problem is also hidden by silo-ing in disease categories of drugs. The Media page shows how a flurry of public attention has emerged when a certain category of drug disappears–antidepressants, anesthetics, anticonvulsants, antibiotics, and cancer chemotherapy. Those affected do not realize that their own painful shortage is part of a more serious problem affecting all drugs worldwide.

No substitutes

Sometimes no substitutes are available, especially in the realm of cancer treatment. Good intentioned people strive to devise formulae for rationing, for choosing who gets what. Inevitably, someone must go without.

Substitutes

Problems with substitutes include increased expense and danger–either through contamination or because the substitute is not equivalent.

Expense. Drug substitutions often pass unnoticed. A newer, more expensive drug might actually be thought of as better. But that is not always true. See Story 15 at this site for an example. A New England Journal report in April 2017 confirmed that a shortage of BCG for bladder cancer provoked a hike in price for less suitable substitutes (see also here). Patients should always demand an explanation from doctors and pharmacists if their drugs are changed.

Seniors, people in hospital, and people on welfare, all have their drugs paid for by the Canadian taxpayer. As long as they are receiving necessary treatment, they are unlikely to complain about a more expensive substitute.

People fortunate enough to have drug plans through their employers will similarly not notice, although eventually their insurance premiums will rise.

The working poor are most likely to be affected in terms of their health, because they may be unable to afford more they expensive substitutes. If they stop taking (for example) their blood pressure or diabetes or antidepressant medications, they will end up sick and in hospital. In Canada, that again means that the taxpayer and the economy will suffer.

An early 2012 report in the CMAJ shows that about 10 per cent of Canadians do not fill their prescriptions because they cannot afford the medications. Those most affected are people in poor health, the working poor, those without drug plans, and residents of British Columbia.

An acute crisis in February-March 2012, has led to a search for replacements and fast-tracking of approvals, but the replacement drugs will inevitably cost us more.

Danger–contamination and deaths. In the United States, the outbreak of meningitis resulting in dozens of deaths was caused by a injectable made by compounding pharmacies and laced with fungus; it was a direct consequence of the drug shortage (see here).

A study released in December 2012 shows that children with leukemia treated with substitute drugs owing to the drug shortage have a higher rate of relapse (see here and here). In 2010 Dr. William Schubert in Utah died of a shortage of the enzyme used to treat his rare condition, Fabry’s disease (see here). More recently, Jennifer Lacognata of Florida went partially blind, was unable to work and lost her home, when Hospira the only manufacturer of injectable Vitamin A stopped making it (see here).

In March 2017, a Canadian study published in JAMA revealed that a shortage of drugs to treat low blood pressure in 2011 was associated with an increase in deaths. See Emily Vail et al., or media reports, by Reuters, or here and here.

In April 2017, two children died in Papua New Guinea for lack of malaria drugs. See here.

Substitute drugs also lead to errors–sometimes fatal– because concentrations, doses, and volumes change (see here). But beyond the fatal side effects, considerable suffering arises from the stress and anxiety of losing effective remedies or being given inadequate substitutes (see here and here). A nurse in a psychiatric hospital in Ghana was beaten by an agitated patient when a shortage of drugs arose in that hospital (see here).

In July 2016, a shortage of cancer drugs caused the American FDA to approve use of substances from a Chinese plant, the products of which had been banned a few months earlier (see here). It is an obscure lottery choosing between no chemotherapy — or potentially contaminated chemotherapy.

Danger–non-equivalence. Substitute drugs are not always identical to each other even when they contain the same molecule. This fact leads to problems for people with chronic conditions — such as epilepsy or bipolar disease. If they have been stable on a certain version of a medication, a substitute can destablize this situation and provoke illness.

Danger – threatened democracy. The shortage has made drug supply a political tool. See this 2017 example from Liberia.

 

Saving Lives?

1. Treatment holidays

In 2011 an Australian shortage owing to viral contamination of an orphan drug for Gaucher’s disease resulted in the discovery that patients can actually benefit from treatment holidays. See here. The shortage produced a natural experiment that allowed deviation from treatment guidelines. It is important to remember that treatment guidelines may have pharmaceutical company influence. See here.

2. Death penalty effects

Ethical objection to the death penalty has led to shortage of drugs used in execution cocktails used in the United States. These deliberately constructed shortages differ from the majority — and perversely they could save lives. The purpose is to pressure governments to abolish the death penalty. Instead some states (eg Arkansas) have retrenched, rushing to execute clusters of prisoners, and some have used inhumane methods. Others (eg Mississippi) are resorting to hiding their sources — possibily illegal–to maintain the death penalty. See Kendall Grove, here. Other reports found on page Media-United States.

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While activity around solving access to certain types of drugs is important for individuals, it does not address the root causes of the problem and serves to perpetuate it. It raises further questions.

With its technology and its wealth, why is Canada not an attractive location for a new Canadian-owned manufacturer of generic drugs to replace those in chronic short supply? Why must we be buffeted about by shortages, mostly originating in other countries, within an industry that largely does not belong to Canadians, concerning products, the recipes for which are neither secret nor protected?

Perhaps rather than asking Health Canada, these questions should be addressed to ministries of Industry and Foreign Affairs.

Ask your MP.