Editor's note: The consumption of drugs is closely related to our health, but statistics show that less than 10% of doctors in the United States will interpret drug labels and descriptions in detail, which directly affects the safety of doctors' drug prescriptions. . In order to change this phenomenon, the US FDA recently made a major revision to the US drug labeling regulations to enhance the practical value of the label.
After more than five years of review of drug labeling regulations, the US FDA made the most significant changes in 25 years. The new drug labeling regulations stipulate that the label should clearly state various information of prescription drugs, and introduce important information of drugs in a special area in a conspicuous place. With regard to the related information, this new regulation will likely cause a major change in the advertising style of drugs, and may provide certain liability protection for pharmaceutical companies.
Designed to reduce avoidable medication errors
When acting director of the US FDA, Andrew von Eisenbach, announced the new regulations on the labeling of prescription drugs at a press conference, avoiding preventable medication errors is a major issue, and the new drug label has taken an important step towards this goal .
Research shows that about 300,000 people in the United States are injured each year due to medical errors, and nearly 100,000 people die as a result. Prescription errors are one of the main reasons.
Studies also show that less than 1 in 10 doctors will read the drug label in their daily work. Even if doctors do read drug labels, they generally know very little. Although the US FDA has modified the drug label in the past, it has not been able to prevent doctors from dangerous prescribing habits.
Charles Gerson, a gastroenterologist in the Manhattan area, said: "I think the labeling of drugs is really confusing. There is a lot of fragmented information, but it is not easy to find the information you need.
Janet Wood Cook, deputy director of the US FDA, said there are several reasons for the confusion of drug labels. First, concerns about product liability and marketing have gradually led label writers to stop focusing on doctor education. Secondly, compared with two or thirty years ago, the medical community now has more understanding of how drugs work in the human body, and most of this information must be included on drug labels. Third, the existing medicines are much more than before, and doctors spend much less time on each patient than before.
FDA officials estimate that the annual loss caused by medical errors in the United States is between 4 billion and 4.8 billion US dollars. These economic losses can be avoided by taking effective measures and providing better medical information to doctors, such as through prescription drug labels The form of reform. FDA officials have not made a corresponding estimate of how many lives can be saved by a more concise and clear drug label reform.
The new standard applies to new drugs approved within 5 years
The new labeling regulations will apply to the approval of all new drugs, as well as those approved within the past five years, as well as those that are required to undergo major changes to drug labels. Old drugs can avoid these requirements because doctors are already familiar with the risks and benefits of old drugs.
The new regulations will make further efforts to make it easier for people to obtain medical information through computers. The new regulations will also encourage doctors to prescribe medicines online, because all new medicine labels are similar in structure and easy to search online.
First sighting area
According to the new regulations, a special eye-catching area will appear on the drug label for the first time. This area is used to briefly introduce some important information for the doctor to use when prescribing the medicine safely. This new area will list safety considerations for the first time, followed by a brief introduction of any recent changes. Followed by advice on how to use the medicine and how much dose to use.
In addition, a new area will appear on the drug label, where the text will tell the doctors what information they should provide to the patient.
The new regulations have affected folding drug inserts contained in some boxed prescription drugs. These inserts can also be found in medical references. These inserts are also known as "professional labels", "package inserts" or "prescription information." .
Doctor-patient information asymmetry further increases
However, the new regulations do not address information sheets that are usually provided to patients by pharmacists. Relatively speaking, the supervision of the information sheets by the drug regulatory authorities is much looser, and these information sheets often do not include important medication precautions.
Sidney Wolf, director of the public interest group Public · Citizen's Health Research Group, called on the US FDA to make similar reforms to this information sheet. He said that the information obtained by doctors is relatively better, and the information received by patients is extremely limited, and the new regulations "enlarge the gap between these two types of information."
Drug advertising style may change
FDA officials said that the introduction of the new regulations may greatly change the way drugs are advertised. The small, hard-to-read advertisements that appeared in newspapers and magazines in the past will be the most likely to disappear, and will be replaced by shorter, clearer instructions to introduce the common risks of drugs. Similarly, television commercials may also have to change their previous practices when discussing drug risks.
Once again exempting the pharmaceutical industry?
Some lawyers have reacted strongly to the preamble of the new regulations. They believe that the preamble of the new regulations transcends or replaces the liability laws enacted by the United States.
In the preface, the US FDA lists six requirements that the outside world has put forward for pharmaceutical companies. According to the newly issued regulations, these requests will be prohibited. One of the requirements is that the pharmaceutical company should put the risk considerations contained in other places on the drug label in the conspicuous area of ​​the label; the other requirement is that the pharmaceutical company should list the drug label on the drug label that the US FDA considers unnecessary Note.
The preface states that "too much warning is just like not enough warning. It will have a negative impact on patient safety and public health."
Peter Barton Hutt, the former general counsel of the US FDA, said that over the years, US FDA officials have made similar claims in some product liability trials, and the preamble of the new regulations may provide pharmaceutical companies with a wider range of Protection, which will prevent the outside world from filing liability claims.
New York State Democrat and House of Representatives Morris Singh said the liability clause in the new regulations shows that "the US FDA is defending the pharmaceutical industry again."
Chris Matthew, a spokesman for the American Lawyers Association, said the preface was partly "the most shocking example of pharmaceutical companies gaining more power in our political life." Ms. Ma Xiu said that the US FDA does not have the power to issue such exemptions.
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