If you screwed up at work but no one discovered the problem, would you admit your mistake? Most people have a hard time accepting blame for their errors. Not surprisingly, doctors and other health professionals are no different.
In the last few weeks several studies have revealed that up to 100,000 people die each year as a consequence of medical mistakes. But errors and adverse drug reactions are rarely noted.
When someone dies in an automobile accident, a report must be filed. The police investigate and records are kept. But if that person dies because he got the wrong medicine, or the right medicine at the wrong dose, there is a good likelihood the blunder will be ignored. And that means a similar tragedy could happen again.
Physicians, nurses and pharmacists are not required to disclose drug complications. If anything, there is a disincentive to acknowledge problems because of a fear of legal action.
According to the FDA, only about one tenth of the deaths attributed to medications come to the agency's attention each year. Experts estimate that two million people are hospitalized because of their medicines, but only 33,500 cases are reported.
The forms that the FDA does receive are dry, impersonal summaries. The stories we get break your heart. A doctor we knew once said, "statistics are people with the tears wiped away."
One mother wrote to tell us about her daughter who was engaged to be married. The medicine she had been taking to suppress an overactive thyroid gland wiped out her white blood cells, but no one warned her about this complication. Her doctors treated her for a series of throat infections without checking her blood count. When she was admitted to the hospital, it was too late to save her life.
A man shared his grief about his wife's tragic death. The pharmacist tried to warn the family that the heart medicine quinidine was dangerous in combination with the blood thinner Coumadin and the heart drug Lanoxin. Despite the pharmacist's objections, the physician maintained that the prescription was safe.
The reluctance of doctors and pharmacists to report drug reactions means that serious problems may be overlooked for years. When the antihistamine Seldane was marketed in 1985 it was hailed as one of the safest and most effective allergy drugs in history. It took five years for the FDA to discover that people were dying while taking this "safe" drug in combination with other medicines, and another seven years for the agency to force the drug's removal.
Such a lag is inexcusable. We need a better system for detecting serious side effects and drug interactions. Nurses, pharmacists and physicians need incentives rather than punishment for reporting problems. Without knowing where the pitfalls lie, it is virtually impossible to establish safeguards.
Until reforms overcome passivity at the FDA, patients will have to take responsibility for their own safety. This requires information and assertiveness.
