All medications have potential side effects. Some of them are detected in mandatory clinical trials before being launched on the market. But when they go from being tested on a few thousand highly controlled patients to what can be millions of people, it is very common for new ones to emerge. After the three phases of experimentation prior to commercialization, the fourth begins, which is the test in the real world. And, to do this, it is necessary that health professionals and ordinary users get involved by reporting those suspicions that sometimes arise after taking a medicine that something has not worked well.
The word “suspicion” is key, emphasizes Edurne Lázaro, head of the pharmacovigilance division of the Spanish Agency for Medicines and Health Products (AEMPS), which participates in this week at #MedSafetyWeekan annual international awareness campaign on the importance of notifications.
We must talk about suspicion because just because something happens after taking a medication does not mean that it was caused by that medication. This was seen very clearly with the covid vaccines. Practically the entire population received it in a short period of time, so, as would have happened if it had not been inoculated, after the campaign there were people who died, who had strokes or heart attacks.
Pharmacological surveillance tries to elucidate which of these events were due to the medication, and which were due to chance. And then, gauge whether to receive the improvements that the product provides is worth risking those side effects. This is what is known as the risk-benefit balance.
These suspicions can come through various means. Each autonomous community has its own system, which collects data and sends it to the AEMPS, which in turn sends it to all EU countries. Any citizen can report adverse effects that they identify, anonymously, in the notificaRAM website.
Toilets also have their own internal system. Higinio Flores, vice president of the Spanish Society of General and Family Physicians (SEMG), explains that in his career he has only reported one that he saw very clearly. It was an anti-cholesterol medication that seemed to give one patient headaches. “It was curious, because despite having been on the market for a long time, this side effect did not appear in the technical sheet. The headaches started right when I started the medication, and subsided when I finished it,” he says.
A decisive factor in not reporting more adverse effects is the lack of time in primary consultations. Francisca González, from the Spanish Society of Family and Community Medicine (semFYC), assures that detective work must be done when a patient reports discomfort to find out if a drug could have caused it. “Most of the time we have not prescribed it, but rather a specialist,” she justifies.
In the opinion of this doctor, who was awarded the AEMPS pharmacovigilance award in its first edition (2009), not only serious effects should be reported. She gives an example: “Because we assume that antibiotics can cause diarrhea, many do not report it. But it is important, because we must not only know the severity, but also the frequency. Because maybe it causes diarrhea in 25% of cases and the package insert says that in one in a thousand. To force drug companies to change it, you need to collect as much data as possible. And it is important to know this because in the end these side effects that may seem mild end up affecting healthcare capacity and sick leave.”
González believes that there is a lack of habit when it comes to notifying alerts among the majority of health workers because it is something “that is seen in passing during the race.” “Many do not report because they are not sure that it is the medication that causes the adverse effect. But it is not necessary to be; We report suspicions and it is the agency technicians who determine it,” he adds.
More than 60,000 suspicions in 2022
There are thousands of signals received each year, but very few ultimately end up modifying the leaflets or technical sheets of the medications (to add unknown effects), their recommendations for use or, in the most serious cases, withdrawing them from the market. .
Before the pandemic, notifyRAM He received between 3,000 and 4,000 notifications monthly. With the covid vaccination, it shot up to more than 27,000 in 2021. All of these are added to those reported by the autonomous communities and the pharmaceutical companies themselves about their products. In 2022, 60,261 suspicions were collectedof which 22% were serious.
Again, this does not mean that that many adverse effects occurred. There are many that are not reported because they are minor, because they are known or because they are not identified. And, of those that are counted, a large percentage does not have to be caused by the medication, and simply occurred coincidentally during taking it.
To discriminate between one or the other, these large databases are gathered, suspicions of new risks are analyzed and evaluated jointly with all the countries of the European Union. Lázaro explains that various methods are followed to determine causality: “There are times when we make decisions with spontaneous notification. Imagine that it is very well documented, many tests rule out that there could be other alternative causes, that when the medication is withdrawn there is an improvement, and not only that, but if it is taken again the adverse effect appears again. With such clear cases, it is not necessary to modify the technical sheet much more.” Most of the time it is necessary to gather more cases, more data and do more research.
Once the agencies are sure that the adverse effect was caused by the medication, a risk-benefit assessment is made. Lázaro, from the AEMPS, explains that the new risks may be acceptable, or only for part of the population: “Maybe we will discover that we cannot give the drug to the population with kidney failure. Or it may be that when the drug was authorized there was no alternative and now there is a safer one, which changes the evaluation.” Risk-benefit is not an exact science; It is under constant review.
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