Health Hazards
Broadly speaking, a health hazard is damage to health caused by a thing. Causes can range from pharmaceuticals and medical devices to health foods and supplements, air pollution, and noise. In the case of pharmaceuticals and medical devices, health problems are also called side effects. Health hazards need to be addressed to prevent them from happening again. To do so, it is necessary to identify the cause. To identify the cause, we need information not only on one patient, but also on many patients. In recent years, health hazard information has been analyzed using Real-world data is beginning to be utilized for the analysis of health hazard information.
The following is a detailed explanation of the health hazards of pharmaceuticals and medical devices.
While pharmaceuticals and medical devices are expected to have beneficial effects on the body, they can also cause harm. One such case is when the effects of a drug or medical device are too strong. For example, drugs that lower blood sugar protect blood vessels by lowering blood sugar and preventing myocardial infarction, cerebral infarction, dialysis, and hemorrhage of the fundus of the eye, but in some cases, they may be too effective and cause hypoglycemia when blood sugar drops too low. Hypoglycemia can cause cold sweats and loss of consciousness.
In addition, reactions may occur that are unimaginable from the expected effect. For example, hives are one of those unimaginable reactions, and only 10 to 30% of the time, the cause can be identified. In addition, completely unanticipated situations can occur. In a past case, an ingredient that should not have been in the product was found in a pharmaceutical product, and the effect of that ingredient was produced.
Thus, while pharmaceuticals and medical devices are expected to have a positive effect on the body, the possibility that they may also cause harm cannot be completely eliminated.
Identifying the causes of health problems is difficult
In order to prevent health hazards from occurring again, it is necessary to identify the cause and take measures such as avoiding the use of the drug, being careful about how to use it, or explaining it to patients in advance in case it happens. However, identifying the cause is not so easy.
If you have a health problem after using a drug or medical device, you may think that it is caused by the drug or medical device you used. On the other hand, you will also see and hear that people who used the same drug/medical device did not necessarily have the same health problems. Also, the same amount of pharmaceuticals used for the same symptoms does not necessarily cause the same health problems. This is because there are individual and day-to-day differences in personal constitution, pre-existing medical conditions, and physical condition. You may have felt that a medicine that someone said worked well did not work, or that the same painkiller worked well some days and not so well on other days. The body reacts differently depending on the person and on the physical condition of the person that day.
Because reactions to pharmaceuticals and medical devices in this way are not completely constant, it is difficult to tell whether or not each individual case of health problems happened by chance. The way to find out if a drug or medical device is the cause is to try using it again and see if the same thing happens. However, this method cannot be used because it is not possible to use again a drug or medical device that may cause a health hazard.
You might think that the possibility of health hazards should be known before the government approves the product. In fact, most things are not known until after the product is marketed. Before a drug or medical device is approved Clinical Trials requires that a minimum number of people be tested, so any serious health hazard that is very unlikely to occur is not known until after the drug or device has been approved, clinical trial Therefore, serious health problems that are very unlikely to occur often do not occur in clinical trials.
Thus, identifying the cause of adverse health effects is not so easy.
Cause identification using information from many people
One way to identify the cause of adverse health effects is to analyze information on adverse health effects in a large number of people after the product has been marketed. This method attempts to identify the cause by comparing people who used the drug or medical device with those who did not use it. We calculate what percentage of people who used the drug and those who did not use the drug have the same health hazard symptoms. The larger the difference, the more certain it is that the use of the drug or medical device is the cause. In this way, we can move closer to identifying the cause.
Since this type of analysis requires information on people who are not using pharmaceuticals and medical devices, it is beyond the scope of what individual pharmaceutical and medical device companies can ascertain, so a wide range of patient Real-world data is needed. Real-world data is expected to help identify the causes of health problems more quickly.
