Reporting Adverse Side Effects: If You Don’t Tell, Who Will?

Report ADROn April 2nd, on behalf of PharmaWatch, I appeared before the Senate Committee on Social Affairs, Science & Technology, which is conducting a four-part investigation into prescription pharmaceuticals. I was on a panel with Sholom Glouberman, President of Patients Canada and the issue that the Committee asked us to address was “the nature of unintended consequences in the use of prescription pharmaceuticals.”

Some might say that the only intended consequences of prescription drug manufacturing, from the point of view of Pharma, are the profits earned from marketing and promotion. However, what the Committee was referring to are the harms that can result from using prescription drugs. In our view, the term “unintended consequences” minimizes the potential harms of prescription drugs by suggesting that harm just sort of happens, that no one is at fault, there was nothing that could have been done to prevent it (particularly by the manufacturer) and that there is little that can be done to stop it in the future. This is the wrong way to frame serious adverse drug reactions which can result in significant harm to Canadians — harms they are by and large unaware of.

Adverse drug reactions — also known as side effects, adverse effects or iatrogenesis — are a leading cause of death in Canada and the United States. In some cases an ADR may be considered acceptable when weighed against the benefits someone derives from a prescription drug. On the other hand, about 80% of all ADRs reported to Health Canada are considered serious. Serious is defined by the World Health Organization as a “response to a drug that occurs at any dose and that requires in-patient hospitalisation or prolongation of existing hospitalisation, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.” It is estimated that, globally, two million people die each year using medicine exactly as prescribed, and many more people — most of them under the age of 60 — are hospitalized or seriously injured.

Terence Young, a Conservative MP had a daughter Vanessa who died suddenly of a heart attack at the age of 15 after being diagnosed with bulimia and being prescribed a drug called cisapride. The drug was contraindicated for use in patients with bulimia and was not approved for use by children at all (off-label prescribing). The drug had already been withdrawn because of safety reasons in the United States.

A coroner’s inquest into the young woman’s death criticized the federal government for not acting sooner on the information it had about the cardiac risks associated with cisapride. The jury made 14 recommendations regarding the collection of information about serious ADRs and its distribution to patients and health care providers. But many years and dozens of public consultations later, Canadians still know too little about the harmful effects associated with the drugs prescribed to them, nor do they know what steps to take when an adverse drug reaction occurs.

Health Canada is, at least in theory, the agency responsible for monitoring consumer experiences when a drug has been tested and authorized to be sold. In 1965, Canada, along with most industrialized countries, introduced a formal collection of ADR reports, largely in response to the thalidomide disaster. Thalidomide was prescribed to pregnant women in Canada from 1959–1962 to prevent morning sickness. Its use in North America and Europe prompted a wave of regulatory reform after the drug was found to cause peripheral neuritis, resulting in severely malformed limbs in newborns. In 1995, our system of ADR reporting was modernized with the introduction of regional reporting centres, expert advisory committees and a communications strategy.

Today, this monitoring and regulatory system is severely hampered by an infrastructure that is under-resourced and inadequate for the task of gathering, analyzing, and acting on information about the harmful effects of approved medicines including those that are used off-label. In fact, Health Canada spends far more on the infrastructure to approve drugs as quickly as possible than it does to monitor and address potential harms. Monitoring is never a one-time event as new risks and harms can be discovered after a drug has been on the market for years or even decades.

Pharmawatch believes that the elements of an effective monitoring program should include:

• collecting and analyzing data on drug effectiveness and adverse reactions collected not just by drug companies but by Health Canada itself through reporting by consumers and health professionals;
• disseminating information about drug effectiveness, safety, and harms to consumers, government agencies, physicians, pharmacists, and other health professionals through effective communication strategies that are continuously evaluated in terms of whether they reach their targeted audience;
• taking steps to improve the quality and effectiveness of prescription medicines by influencing physician prescribing practices through the provision of information from objective sources;
• requiring further testing of drugs and/or conducting further analysis of existing administrative data, in some cases through user registries, where indicated;
• monitoring the prevalence and type of off-label prescribing on a systematic basis to identify the evidence-base and exposure to harm and ordering safety testing when necessary; and
• withdrawing drugs from the market when necessary in a proactive way rather than relying on industry to do so.

In 2003, Health Canada changed the rules so that people could report directly rather than have to rely on their physicians, pharmacists or even manufacturers to report ADRs. For the past ten years Pharmawatch has advocated strongly in favour of the value of consumer reporting, believing that these reports often provide a more meaningful and richer picture of early and more serious problems with drugs than the large datasets that are currently provided by the pharmaceutical industry.

Since 2003, when the reporting gates opened up to consumers, the number of reports that originate with patients has increased from 331 (7.1%) in 1997 to over 16,000 today — about 31% of the total which includes health care professionals. Consumers are now more active reporters than physicians, who contribute 25% of all ADR reports, and pharmacists, who contribute 10.4%. Over-all, however, ADR reporting rates are still too low and represent no more than 1–5% of all ADRs.

Over the last ten years we have learned that consumers whose lives have been changed by serious side effects are highly motivated to share information with others. This motivation comes from three places: the first is a natural desire to ensure that no one else goes through what they have experienced; the second is that sharing the story is an important part of their recovery; thirdly, support for consumer reporting is a way of prioritizing a culture of safety in relation to pharmaceuticals and empowering citizens.

All drugs, even those that are beneficial carry risks. As Sir Frances Bacon said, “knowledge is power,” and the more knowledgeable we are about the drugs that we are prescribed the safer we are. That includes information about the experiences other consumers have had and the track record of the manufacturer.
Pharmaceutical manufacturers will often go to any lengths to minimize the harm that can occur when people use drugs as prescribed and to describe ADRs as unintended consequences. Instead of speaking of harm, drug companies prefer to speak of risk.
There is so much more that Health Canada needs to do to increase reports from all sources. Specific strategies are needed to encourage and educate consumers about the importance of their experiences and what role this information can play to help ensure we are safe and achieving the highest benefit from prescribed medicines.

There is also more that Health Canada must do to ensure that pharmaceutical manufacturers don’t control the narrative. Drug companies will often go to any lengths to minimize the harm that can occur when people use their products as prescribed, including depicting harms arising from ADRs merely as a result of “unintended consequences” about which little can be done.

About the Contributor

Colleen Fuller is a co-founder of PharmaWatch and sits on the Steering Committee of Women & Health Protection. She is a co-author of Push to Prescribe: Women and Canadian Drug Policy (2010). She is a researcher for Canadian Doctors for Medicare and has written extensively about Canada’s health care system.

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