.

THE FOLLOWING ARTICLE HAS APPEARED IN THE RECORD ON January 22, 2003

Pharmaceutical drugs and their side effects

Were the U.S. pilots suffering the side effects of dextroamphetamine (Dexedrine) pills when they dropped their laser-guided bomb and accidentally fired killed four Canadian soldiers in Afghanistan? The Air Force refers to the pills as a "fatigue management tool." The pilots call them "go pills." In either case, the pills were medically prescribed by U.S. government physicians to prevent the pilots from falling asleep on extended operations. Students and truck drivers have been using them for decades for much the same reason. Inasmuch as the subject of adverse reactions to prescription drugs has a solid scientific basis we can expect to receive an answer during their trial on involuntary manslaughter.

About their downside

While the benefit of prescription drugs in terms of quality of life, productivity, and longevity are beyond dispute, their downside goes well beyond the fact that we consume more than are necessary, pay more than we should and can become easily addicted. The simple truth is they can also cause serious medical complications including psychiatric disorders -and even death. While adverse reactions to prescription drugs account for countless medical complications even when they are properly prescribed by physicians, they aren't the only cause. Equally pertinent are medication errors caused by physicians prescribing the wrong drug, strength or dosage. Last but not least are the many improperly filled prescriptions by pharmacists.

Alarming statistics from the U. S.

What is an adverse drug reaction? An ADR is defined as an undesired and harmful effect of a drug properly prescribed by a physician, which is not due to a mistake such as giving the wrong drug or wrong dose. It is estimated that each year in the United States, adverse drug reactions and other, medication-related problems add more than $100 billion to their nation's health care bill. According to the Journal of the American Medical Association adverse reactions to properly prescribed drugs are a major cause of deaths among hospital patients. The report found that between 75,000 and 100,000 people die each year in the US due to harmful reactions to prescription and over-the-counter medicines even though they were used as directed by the drug companies.

Assuming these figures are not just the tip of the iceberg this would leave harmful drug reactions as the sixth leading cause of death behind heart disease, cancer, lung disease, strokes and accidents. To put this alarming finding into another perspective, each year in the US there are approximately 40,000 deaths resulting in automobile accidents including 24,000 caused by drunk drivers. The study also found that, out of the 33.6 million patients admitted to U.S. hospitals each year, an additional 2.1 million experience serious but nonfatal adverse reactions.

There can be no doubt that as Canadians we are just as dependent on pharmaceutical drugs. Each year over 280 million prescriptions are dispensed by Canada's 23,000 pharmacists. Last year, prescription medicines cost our health care system a staggering $8.306 billion or slightly more than all of the over-the- counter medicines. Together, they represented 12.5 per cent of all health expenditures in Canada, the second largest category next to hospital services and the fastest growing component of health care. Although we have yet to complete a similar ADR study in Canada it is only logical to assume that the number and severity of adverse medication reactions are directly related to the number of drugs administered to hospitalized patients.

Any attempt to objectively evaluate the level of adverse drug reactions in Canada must necessarily be measured against the approximately 112 million generic and patented drugs that are dispensed each year in hospitals alone coupled with the fact that each hospital patient takes an average of eight drugs.

When translating the US estimates to Canada 's 14 million annual hospital admissions together with the 1:10 ratio of the Canadian to American population, this could mean that as many as 250,000 people every year suffer medical complications and between 7,500 to 10,000 are killed by pharmaceutical drugs.

Such estimates are similar to the conclusions of a recent study in Australia that found that adverse effects, including death, occurred in 2 to 3 percent of hospital admissions. If such figures are indeed accurate, than twice as many people in Canada die from adverse reactions to medication compared to breast cancer and five times more than from AIDS.

One study in Ontario reached a much lower estimate when it concluded that each year an average of 680 persons die in Ontario hospitals because of adverse drug reactions. The researchers calculated the overall incidence of in-hospital mortality associated with adverse drug reactions to be 0.05 per cent. On the assumption that the rates in other provinces were similar to those observed in Ontario, they estimated that approximately 1824 deaths annually could be attributed to adverse drug reactions in Canada. Various explanations as to adverse reactions How is it possible to reconcile such alarming consequences when all drugs sold in Canada are supposed to be approved by the federal Health Protection Branch and at the same time meet the strict regulations established by The Food and Drug Act? Furthermore, aren't our pharmacists required to show a high degree of diligence by ensuring the drugs are prescribed safely and meet patient needs? Even when pharmaceutical drugs serve their purpose, the effects on a patient can be both positive and negative. Some drugs, which are very effective, often have a high risk of toxicity and therefore can also cause damage. One has only to consider the many drugs that are used to treat cancer. While they are effective at killing the cancer cells they can also damage normal organs.

The experts tell us that symptoms of adverse reactions vary, and that such reactions can be triggered by almost any drug. They include the extended use of even aspirins, birth control pills and lately, estrogen (hormone replacement therapy) pills.

According to the medical literature between 5-10% of adverse reactions are allergic, meaning that the patient's immune system overreacts to the drug. Then come the drug interactions, which we are told can occur when the effect of one drug is altered by the presence of another drug in the body. Over-the-counter medications can also interact with prescription medication. In addition to medication dosage, other factors can account for an adverse reaction, such as the rate and duration of the treatment.

Being on guard

As we grow older and our medications grow in number it is all the more important to understand what they are for and to inquire about their expected side effects. Equally important, before prescribing and dispensing a new prescription it is also important to make sure that our doctor and pharmacist are well informed about our other medicines and allergic reactions.

As for the potential side- effects of dextroamphetamines pills, which were consumed by the U.S. pilots, the medical literature refers to dizziness, blurred vision plus the risk of becoming habit-forming. Next week: Part II: Crunching the figures on medication errors