Not enough data
– A survey of Latvian residents conducted in December last year showed that over the past 20 years, a total of 22% of respondents had experienced side effects from medications, and 72% of respondents who experienced side effects indicated that they reported side effects to a doctor or pharmacist , a nurse, ZVA or a pharmaceutical company,” says Zane Neikena, medicine safety specialist at ZVA, Latvia’s representative on the European Committee for the Safety of Medicines.
Although part of the population knows that medications can cause side effects, the number of reports received from residents of Latvia makes it seem that people do not report all such cases to ZVA. This raises concerns that important new drug safety information might potentially go unidentified. For example, last year we received only 61 (!) reports of side effects from medications! This clearly does not reflect the real situation. Meanwhile, reporting the side effects of certain medications to the Agency is very important. This applies to doctors, but first of all to the residents themselves. And that’s why.
Collection of information
When registering any medicine, reports of side effects that it may cause are always taken into account. Summarizing such messages, we can conclude: in which cases some symptoms appear, in which others – others. It is also possible to estimate the frequency and prevalence of symptoms in different groups based on gender, age and other characteristics.
Source: Press photo
Thanks to this information, you can receive new information regarding specific medications and find out what side effects are possible from them. This information is subsequently included both in the description of the drug, intended for doctors and pharmacists, and in the instructions for use, intended for patients.
However, it is important not only to learn regarding the potential consequences of taking a particular medication, but also to find out what preventive measures need to be taken to reduce the likelihood of negative consequences from taking a particular medication: how to recognize the first symptoms, what to do if they appear, etc.
Therefore, by reporting side effects you experience while taking any medication, you are not only helping yourself, but also those around you by providing valuable information on how to reduce the risks of side effects from taking any medications. If we are not informed, we naturally cannot find out regarding it – accordingly, we cannot do anything to reduce or eliminate these risks.
Let’s say a person started taking a certain medicine, and he began to experience some unpleasant sensations – say, dry mouth, rash, drowsiness, weakness… But it is not at all a fact that all this is a side effect of taking this particular medicine! This may well be due to the reaction of a particular organism to a particular drug, while another person, with different individual characteristics and with a different medicinal “set” for chronic diseases, will not experience any side effects… Also, “side effects” can be caused by an unsuccessful combination of this medicine with other drugs that a particular patient is taking… Many people think that they are not sure that it is worth signaling to the ZVA that negative side effects were caused by taking a specific drug, since they cannot distinguish in which case the undesirable consequences are an individual reaction of a particular body, and where the side effect is associated precisely with the influence of a specific drug.
In fact, the effect of the medicine, as well as the side effects, directly depends on the specific characteristics of the body of each person who takes this medicine. However, regardless of whether the negative consequences are associated with the individual reaction of a particular organism or is due to the properties of the drug itself, it is still a side effect that we, as specialists, need to be aware of. It is clear that due to the fact that side effects occur in some cases, one cannot conclude that the medicine is fundamentally bad and EVERYONE should refuse it. And not a single drug will be recognized as bad and subsequently abandoned in principle only because patients share information that following taking this or that drug they had some kind of negative reaction.
If a person experiences side effects following taking any medication, they should consult a doctor to evaluate the therapy and may be prescribed other medications. However, if there are a number of reports of serious side effects of a particular drug, then following evaluating the entire body of evidence, it is concluded that the risk of such side effects does not outweigh the benefits of that drug in treating a particular disease. In this case, distribution of this drug is no longer permitted.
When collecting information and drawing certain conclusions based on it, we take into account many different factors.
Personal data protection
When reporting side effects from a particular medicine to ZVA, a person will also have to provide more detailed information regarding themselves. We have a standard, specially designed form that we ask you to fill out. It contains questions based on the answers to which we can establish certain cause-and-effect relationships.
Among the information that we ask you to provide is your first name, last name, gender, age, weight, chronic diseases (if any), medications that are taken on an ongoing basis, a disease for which the medication that caused a negative reaction was prescribed, etc. Further. It is very important for us to know all this in order to fully analyze and evaluate each specific case and draw conclusions regarding the cause-and-effect relationship between taking a specific medicine and the reaction that the patient reported to us.
It is clear that in our time, when we have to be careful in everything related to the dissemination of personal data, people are not too willing to share information regarding themselves…
But we need such information so that if any additional questions arise, we can contact a specific person and clarify some nuances. Sometimes, in rare cases, if the patient does not object, we may ask him to provide the contact information of his family doctor in order to obtain important additional information regarding the results of laboratory tests…
But residents need not worry: we work in strict accordance with the requirements of the Personal Data Protection Law, and all data that comes to us is restricted information, is used exclusively for specific purposes, and their personal data does not go anywhere outside the Agency’s database come out.
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2024-04-14 21:31:35