A leaflet is a collection of information about a drug that is presented in an understandable and comprehensive way. Despite this, patients do not read it at all or spend only a few seconds on it. And that's a mistake! Artur Fałek, an expert at the Rafał Piotr Janiszewski Advisory Office, will tell you why and how to read leaflets.
Anna Tłustochowicz:Before use, read the package leaflet or consult a doctor or pharmacist, as each drug used improperly is a threat to your life or he alth. We all know this formula, which you can read the package insert, but we don't. Why?
Artur Fałek:The popularity of drug advertising unfortunately made its content common. I am afraid that most people ignore it and do not think about its meaning.
This is bad?
This is very bad because the matter is important. Especially in terms of self-healing. According to the PEX PharmaSequence report in June, the pharmacy market in Poland will be worth around PLN 39 billion in 2022.The value of reimbursed drugs based on a prescription is slightly over PLN 13 billion.8.76 billion will be spent on fully-paid prescription drugs, and approximately 16.8 billion will be spent on drugs in the manual sale - OTC drugs ( over-the-counter drug ).
What are OTC drugs?
OTC drugs are drugs that are available to the patient without a doctor's prescription.Available to everyone.No restrictions. Each of us can buy them. Some OTC drugs can also be found in shops, kiosks and gas stations. We don't even have to look for them, because they are most often displayed on stands right next to the cash registers, next to bars and chewing gum. The most commonly purchased arepainkillers and anti-cold pills.
For me, as a doctor, it is of great importance thatgo hand in hand with the availability of positive habits . When we leave the house, we close the door and wash our hands before eating. Similarly: we buy a drug - we read the leaflet.
When a prescription is issued by a doctor, he takes into account not onlyour disease, but also general he alth and a number of other factors , such as what other medications we take. Selects the specific, I assume that always withattention and diligence - especially for us.
What to look for when buying drugs?
When we buy a drug ourselves, we have to be careful. In the case of shopping in a pharmacy, it ismuch safer than in a store or at a gas station . We can then consult the pharmacist, and if we do not do it ourselves, then he should, and most often it does, make sure that we know how to use the drug.
But the moment we take it from the stand at the self-service store? We put it in the basket, pay and nobody is interested in it. We go home, and with the packaging of the medicine we are left alone.
And drugs are not candies!
Medicines should be used consciously. Therefore, thisformula "read the leaflet before use …" is really well thought out.As director of the Department of Drug Policy and Pharmacy, I participated in its creation. The text has been edited many times, incl. in cooperation with the Chief Pharmaceutical Inspector, but, surprisingly, it was also assessed by the National Broadcasting Council, incl. in terms of how much time the teacher will need to read it. Pharmaceutical companies sounded the alarm that each additional antenna second was additional money that they would have to spend on advertising. The text was supposed to ruin the pharmaceutical industry in Poland. As you can see, it hasn't ruined. Advertisements for drugs and dietary supplements are abundant, and their supply is huge.
Ads encourage us to buy a specific drug, supplements, etc. So how to buy wisely?
We can buy drugs on our own, butI repeat like a mantra: let's read the leaflets!The ten minutes we spend on this is nothing. And the leaflets are easy to read.
The authorities responsible for the safety of drugs ensure thatthe information is understandable to everyone.This is a requirement introduced by the regulation of the Minister of He alth of April 26, 2010 on the readability of the leaflet. They are required to be carried out by the pharmaceutical company that registers the drug and is responsible, inter alia, for preparing the packaging template and information materials, including the package leaflet.
How does this process work?
First, pilot studies are carried out, and then the actual ones, in whichparticipants are people from the group corresponding to the population that will be using a given drug . People are selected from the age group for which it is intended, who have no practice in the use of medicinal products, do not work with documents, and even those who have difficulties in understanding the written information.
Everything so that the test group could help determine in the most objective way whether the content of the leaflet would be understandable.We won't find highly specialized wording there.Pharmaceutical companies reserve them for doctors who receive the characteristics of their medicinal products.
So the drug leaflet must be understandable for the patient?
The leaflet is writtenin colloquial language . In a font large enough to be read comfortably. This is not a "fine print" that requires optical aids to be used.
So why is it worth reading medicine leaflets?
First of all, to make sure if this is even a drug for me? Can you help me with my ailment? If the answer is yes - in order to answer a whole series of further important questions.
Please pay attention to the structure of any leaflet. Familiar, right? This is because all leaflets are similar to each other.The information is given in a specific order.As a result, when you pick up a leaflet, you can run your eyes over it and feel familiar, confident and safe. Anyone who has the habit of reading leaflets knows perfectly well, e.g. where to find information about dosage or storage.
Let's trace the entire text of the leaflet.
At the beginning we find an appeal to read its content carefully, and just below general information:what is this drug, what are its general properties and when to use it( the entire range of indications will be given).
The second point iskey information before taking the drug , as well aswarnings, e.g. allergies to the contained active substances or diseases , from which if the patient is ill, the drug must not be taken at all, or it is not excluded, but, for example, its effectiveness may decrease. We will read whether the drug is safe for women during pregnancy and puerperium, and a lot of other information about situations when we should be especially vigilant. Being particularly vigilant does not mean that we will not take the drug, but that we will be aware of any warning signals that we need to respond to.
Let's go further:application.
This is the part of the leaflet that most often attracts patients' attention.I regret that, unfortunately, reading is often limited to this point : when to take, or to take on an empty stomach or with food?
This is of course very important, but no less important is further information, for examplewhether and how the drug we buy interacts with others that we take.Drugs generally come with interact with each other. Theirthe effect may, of course, be different: weakening or strengthening the effect of the drugs. Nay! Toxic substances may also be formed as a result of the interactions.
Few people know about it… and this is important information. Where can it be located in the leaflet?
This information can be found in the leaflet in the precautions section. Here you can also read whether it will be safe to drive or operate a car after taking the drug.
What else should we pay special attention to in this section?
This section also containsseemingly neutral information about possible fillers.Contrary to appearances, for some patients it is very important. Each drug, of course, contains an active substance and at the very beginning of the leaflet we received allergy warnings. The patient may not be allergic to this substance, but to e.g. lactose, which is sometimes a filler - yes.
There is no irrelevant information in the leaflets.
When a drug is prescribed by a doctor, he or she recommends a dose that is selected specifically for the patient. In other cases, we follow the information contained in the leaflet, i.e. how it is usually taken. If we use it ourselves,in the self-healing process, we should stick to the standard dose , of course taking into account what dose is optimal for our age. We will always find this information in the leaflet.
It even gives advice when you should contact your doctor immediately. When should I do?
For example, if your symptoms persist or even get worse after a few days, contact your doctor.
Sometimes you also have to do this if you have taken too much of the drug.From the information included in the package, we will always find out what to do when we missed a dose.Sometimes you have to take two more, sometimes we go over the agenda or take too much of the drug. Sometimes it is necessary to go straight to the hospital, where toxicological treatment will be implemented, such as gastric lavage, irrigation.
I urge you not to delay self-medication.
If there is no improvement after a few days, you need to seek professional help. Not all medications, even the most popular painkillers, can handle all pain in every patient. For some, they won't work at all. That's for sure.The NNT parament specifies the number of people who need to be treated in order to have the claimed effect.Popular painkillers have high indexes: for example, three to reduce pain by 50%, and sometimes seven.Vaccines against COVID-19 are estimated to be 80-90% effective. (protection against severe disease) That's a lot!
Let's go back to the leaflet: side effects. What can we read from this point?
Many patients are terrified that so many are mentioned. All this so that we know what possibly, even with the minimal probability, may happen.That we are aware, attentive and observe our body.And if the drug causes side effects in us, we should report to the doctor and changed their treatment.
I also urge you not to sound loud,solidarity with other patients and reporting adverse drug effects.Someone waves their hand: "What does it matter that I got rashes? ? " It matters!
By collecting and passing on information, we contribute to the fact that drugs are better known, described and ineffect, leaflets are updated.They serve patients better.
Where can we report side effects of the drug?
You can also read about how to report information about side effects toof a pharmaceutical company or drug registration officein the leaflet.
How to store the drug?
This is a very important issue from the security point of view.Drugs have different properties and tolerance to temperature changes or exposure to light.That is why some of them in pharmacies are stored in the refrigerator (it is easy to imagine what would happen, for example, to glycerin suppositories left in heat on the shelf!). In supermarkets, this is not the case, as most over-the-counter products can be stored indoors, but especially in summer you need to make sure that this is the case.
Package contents and drug description. Formality?
No!Medicines are sometimes counterfeit.This is why we receive information in the leaflet about what they should look like, what form, shape and color they should have, so that we can organoleptically see if everything is correct. Thanks to this, we can also find out if they have not changed their color, e.g. due to previous bad storage, which may result in a change of properties, or if they have not crumbled. In a word: "is everything okay with them".
What information can we find at the end of the leaflet?
The leaflet ends withinformation about the responsible entity and the manufacturer.This does not always match. The MAH has the right to the drug, i.e. it is the owner of the marketing authorization document, and introduces itand supervises it. The manufacturer is the factory in which it was produced. It will take no more than ten minutes to read the entire flyer.
However, it is worth taking a moment to read the leaflet before using the drug.
It's worth it! If some people are still not convinced to read drug leaflets, I will refer to a story.
The idea of safe pharmacotherapy dates back to the middle of the last century. Thalidomide was then introduced to the market,was supposed to alleviate some ofailments, e.g. vomiting in pregnant women. The side effects were devastating. The medicine caused severe damage to unborn babies: focomelia ('seal limbs'). Children came into the world with underdeveloped hands and feet.
It was this great tragedy that drew the attention of the international community to the need to introduce mandatory testing and registration of drugs before their approval. In 1965, the European Community decided thatthe content of the leaflets must summarize all current knowledge:not only that from preclinical and clinical trials, but also feedback from patients and doctors who the pharmaceutical company receives its product after the sale begins.
Medical professionals have an obligation to report adverse reactions, andhas recently been granted this option to patients . All this so that the card attached to the package of the drug protects the patient in the best possible way.
So, for our own sake, let's read the leaflets!
Dr. Artur Fałek, doctor
He is an expert of the Rafał Piotr Janiszewski Consulting Office in the field of the organization and operation of the he alth care system, the operation of state administration, legislation in the field of he alth care, and an expert in the field of reimbursement and drug management. He worked in the Ministry of He alth as the Director of the Department of Drug Policy and Pharmacy (2007-2015), previously as the Deputy Director (2007), in the National He alth Fund Headquarters as the Director of the Drug Management Department.
From 2005 he was a member and from November 2007 the Chairman of the Drug Management Team. He is the author, co-author of many organizational solutions and legislation in the field of pharmacy and drugs, he was a Deputy Member of the Management Board at the European Medicines Agency; Senior Project Officer in the "Transparency of the National He alth System Drug Reimbursement Decisions" project (2007-2008); was a representative of Poland in the work of working groups at the European level.
Probe