![[Vic Terry, P.C.]](../../Images/lovt.gif){kind=small}
Dallas, Texas USA
Specializing in helping people since 1961
Dangerous Prescription Drug Errors - A Silent Epidemic
The number of people needlessly hurt or killed by prescription drugs has become astonishing. The FDA and others, including the American Medical Association and the Harvard School of Public Health, have recently reported that prescription drugs cause an enormous number of preventable injuries and deaths. Preventable injuries result because of anything from a drug reaction, to carelessness, to incompetence, to outright greed. Mistakes can occur at any point in the prescription drug delivery process, from the manufacturer all the way to the sales clerk or nurse assistant that actually hands the drug to the patient. Experts estimate that two-thirds of the deaths and injuries caused by prescription drugs could be prevented.
Adverse drug reactions in hospital patients alone account for an estimated 106,000 deaths and 2.2 million injuries each year, according to a study published in the Journal of the American Medical Association. This study did not even include deaths and injuries caused by errors. Another study at the Harvard School of Public Health found that 6.5 percent of the patients at two Boston teaching hospitals had been injured by their medications. One-third of these injuries was the result of a mistake.
These numbers alone tell us the number of people unnecessarily killed and injured by prescription drugs has reached epidemic proportions. These numbers vastly eclipse the number of people killed or seriously injured in car accidents each year. These numbers also raise some alarming questions: Why is this happening? Who is responsible? Why aren't those responsible doing more to stop it? What can we do about it?
More Drugs than Time
One reason so many people are being needlessly hurt and killed by prescription drugs is because, as a society, we are using so many drugs. The National Association of Chain Drug Stores reported that in 1992, 2.03 billion prescriptions were dispensed in retail pharmacies. By 1998, the figure was 2.78 billion. By the year 2005, it is expected to be 4 billion. That means America´s retail pharmacies alone are now processing well over 90 prescriptions per second, 24 hours a day, every day of the year. By 2005 they will have to dispense over 126 prescriptions per second.
If retail pharmacists can hold the injury or death due to error rate to one-tenth of one percent, one in every thousand prescriptions, there will be over 4 million deaths or injuries from pharmacy errors. The industry itself estimates that errors occur about one half of one percent of the time. This would translate into 8 million errors annually by the year 2005.
These numbers do not take into account any of the prescription drugs given to patients in hospitals, or in the doctor´s office. All together, the number of prescriptions being filled far exceeds the amount of time necessary to safely administer the drugs. It may be impossible for the health care community to eliminate all deaths and injuries caused by prescription drugs. However, given the enormous scope of this problem, something must be done. We cannot tolerate hundreds of thousands of unnecessary deaths every year. At some point we must conclude that the cure is worse than the disease.
Bad System
Responsibility for this problem lies with the overall health care delivery system. At every step there is more that can be done, and must be done, to improve the system. Pharmacies are under increasing pressure to fill more prescriptions in less time. Is this because Americans need the drugs? Partly. Is it because pharmacies must reduce prices and increase sales to stay competitive? Partly. Is it because the pharmaceutical industry is undertesting and overmarketing drugs to create markets for them to drive their profits ever higher? Partly. Is it because doctors are overwhelmed, and failing to read the information they must keep up with in order to adequately care for their patients? Partly. Whatever the reasons, the results have been predictable: more errors, more needless injuries, more needless deaths.
The Pharmacies
Pharmacies have tried to cope with the situation in a number of ways. Some have installed a computer system that warns of common prescription errors, such as overdoses or potentially harmful drug interactions. Others have turned to using pharmacy "techs", to help the pharmacist. However, both of these solutions have been grossly inadequate. The problem is much deeper than either of these solutions can solve.
The computer system has not solved the problem. The Institute for Safe Medication Practices recently tested the computer system in use by many pharmacies. Their study asked 307 hospital pharmacies to fill 10 different drug orders that had killed patients in 1998. Some contained an overdose. Others called for two drugs that were deadly in combination. Only four of the 307 pharmacies detected all 10 unsafe orders; a success rate of less than 2 percent, far from tolerable.
Hiring unskilled "technical assistants" has also failed to help, and in many cases is responsible for causing more errors in dispensing drugs. The problem of hiring "techs" to assist pharmacists has recently come under heavy scrutiny. News sources have revealed that many of these "techs" are nothing more than high school students willing to work for minimum wage, who have very little or no training. In some cases these people have been expected to completely process entire drug prescriptions, even though this is illegal and extremely dangerous.
The Doctors
One of the overwhelming problems that only gets compounded by the current systems is the lack of standardization by doctors in the way they order prescriptions. For example, the vast majority of prescriptions are still hand written by the doctor. In a world where drug names can be frightfully confusing, it is ridiculous that pharmacists must decipher handwritten scribbles when their misinterpretation could mean a death sentence for some innocent consumer. For instance, the arthritis drug "Celebrex" is frequently mistaken for the anti-seizure medication "Cerebyx", and the anti-depressant "Celexia."
While there are available methods for physicians to use automated programs for writing prescriptions, few physicians use them even when they are readily available. While the ultimate responsibility for making sure that the drug dispensed is the same as the drug the doctor intended to prescribe lies primarily with the pharmacist, the doctor bears some of the responsibility to communicate clearly.
Also, doctors tend to rely far too heavily on drug salespeople. Instead of reading and understanding the available literature on a drug, doctors frequently prescribe medicine based only on their conversations with the drug manufacturer´s detail person. Doctors many times fail to do their own research to understand the drugs they prescribe, the potential side effects, or the consequences of one drug being taken with another. The inevitable result is more needless suffering by the patients the doctors set out to help.
Drug Manufacturers Share the Blame
Drug manufacturers share the blame for this state of affairs. The manufacturers have a duty to make sure the drugs they put on the market are safe, and that the drugs effectively do what the manufacturer says they will do. The manufacturer must also adequately warn of known side effects and adverse drug interactions. In recent years the pharmaceutical companies have been bringing drugs to the market with ever less testing, with ever less assurance that the drugs are safe. And, most importantly, even with knowledge of dangerous side effects, some drug manufacturers are choosing to lie to the FDA, lie to doctors, and lie to the public in order to reap ever increasing profits.
The Fen-Phen fiasco well illustrates the greed and irresponsibility of the drug manufacturing industry. In that case, American Home Products (AHP), the maker of the dangerous drug Fenfluramine [the "Fen" part of Fen-Phen], had more reports of heart valve problems by 1995 than it did of hair loss. However, AHP chose to warn of hair loss, but did not even report the findings of heart valve damage to the FDA. This was because AHP knew that a warning of hair loss would probably not affect sales dramatically. However, if AHP were required to warn physicians and the public about the potential for serious heart valve damage, such a warning would drastically hurt sales. Therefore, AHP consciously elected to withhold vital information that would have saved lives. Thousands of people now have confirmed, serious heart valve problems because of AHP´s dishonesty.
Increasing numbers of drugs have had to be recalled because of their serious, often deadly side effects. The FDA is simply not big enough to keep track of all of the new drug applications sent in by drug manufacturers. The economic and political pressure on the FDA to approve new drugs is immense. Buildings full of well paid lobbyists for the drug industry line the streets of Washington D.C., all of them with one goal: increase profits, decrease liability. The result is shoddy drugs with inadequate warnings of side effects. This, in turn, leads to more needless death and injury.
Blame the Patient
One of the reasons this problem has not gotten more publicity is that there is a tendency among manufacturers, doctors, hospitals and pharmacies to blame the patient. This is both a natural knee-jerk response, and a calculated effort to avoid liability. "It´s not our fault, it´s the patient´s." They argue that the patient should have reviewed the prescription better. Or the patient should have noticed the pills were a different color than usual. Or the patient should have told them more information. Or, the patient was sick anyway, otherwise they wouldn't have needed medicine. Or, simply, "Mistakes will happen, if we had to pay for all of them, we couldn't stay in business, so go away."
These forms of "blame the patient" ignore the fact that it is the manufacturer´s duty to make the drug safe and to warn of known side effects; it is the doctor´s duty to read and understand the literature relevant to the drugs her patient takes; and it is the pharmacist´s duty and the doctor´s duty to get the prescription right, and to take reasonable steps to know any relevant patient information that might affect the prescription or dose.
Many states require the pharmacy to keep a patient profile, listing known drug allergies, other medications, and other relevant information. Pharmacists have an independent duty to make sure the drugs they dispense are the drugs the doctor prescribed, and that they are not dangerous because of some other drug the patient is taking, or because of the dose prescribed by the doctor.
The patient is most often the least educated, least informed link in the health care chain. It is unconscionable to expect the patient to bear the weight of all of the bad decisions made throughout the health care system. Patients should have a right to expect the other health care professionals to do a reasonable job. We must all trust health care professionals with our lives from time to time. However, increasingly, this trust is hard to justify.
Accountability
Holding doctors, hospitals, pharmacies, and drug companies accountable for the injuries and deaths they cause is part of the solution. Liability alone will not fix the problem. However, if it starts costing the health care industry more money to "do it wrong than to do it right," maybe the industry itself will start working harder to solve these problems. As long as the industry continues to reap huge profits despite the horrendous number of mistakes, the problem will continue.
No civilized society should tolerate the carnage we are currently experiencing because of prescription drug mistakes. The number of those killed and injured annually is probably four to eight times the number of people hurt or killed in traffic accidents. This means we are all four to eight times more likely to be hurt or killed by a misfilled prescription drug than in a car accident. And this is based on numbers put out by the medical community and the pharmaceutical industry itself. The real numbers may even be higher.
The first step is to report all adverse drug events to the FDA. The next step is for those seriously injured, and the families of those killed by prescription drug errors to file claims against those responsible. This kind of pressure is what finally forced car manufacturers to install seatbelts, the makers of baby beds to put the bars closer together so babies don't strangle, and the maker of at least one brand of guns to install child safety locks. Our system of justice is not perfect. Some say it is the worst justice system in the world - until you compare it to the rest. Accountability is at the root of our justice system. Why? Because, while freedom entails responsibility, accountability is our only civil means of coercing responsible, just behavior.
