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– Nobody prohibits the sale of knives just because someone can stick them in the stomach – says Dr. Jarosław Woroń, clinical pharmacologist at the Collegium Medicum of the Jagiellonian University in Krakow. Is ketonal approval for over-the-counter sale a good decision?
In Poland, unlike other EU countries, such as France, Italy, Finland, the Netherlands or Estonia, so far ketonal has been available only after being prescribed by a doctor. The Office for Registration of Medicinal Products has decided that from October 2017 it will be available at Polish pharmacies without a prescription. According to most specialists, this decision should not raise any concerns, especially since many products belonging to the same group of drugs can be purchased for a long time without visiting a doctor beforehand.
Any drug can be poison
Some doctors remind you that painkillers, the so-called NSAIDs can cause side effects, including from the digestive tract, kidneys or increase the risk of a heart attack. Pharmacologists point out that any drug can be poison, and if there are no side effects, it most likely doesn’t work. Outstanding specialist in the field of clinical pharmacology prof. Jacek Spławiński ensures that selling ketonal without a prescription is a very good decision.
– Our regulations precisely define the characteristics that such a drug must have. First of all, it is important that it does not pose a direct or indirect threat to life and health, does not contain a substance that may require further research, does not interact with commonly used drugs, and that the disease state it is to treat is easily recognizable. It is also not expected to cause severe overdose effects or unusual reactions. And ketonal meets these requirements, he says. He recalls the words of Paracelsus, known as the father of modern medicine, that it is not the substance itself, but its dose, that makes it a poison. Therefore, any drug taken in the wrong dose can be poisonous.
Pain is both an enemy and a symptom
Dr. Woroń adds that it all depends on patient education. – An uneducated patient can hurt himself with vitamin C if he eats too much of it. But that’s not a reason to ban everything, he says. He adds that the benefit of having access to effective pain medications is large. – Let’s imagine that someone went on a business trip and had a toothache. This drug will quickly benefit him therapeutically, and he will go to the dentist when he returns home, he says.
Pain can be so nagging that the suffering are ready for anything to get rid of it. So instead of swallowing six tablets that are less effective for their ailments, it is better if they take one that works effectively. Specialists warn, however, that easy access to painkillers may mean that patients, instead of going to a doctor and diagnosing the cause of pain, will eliminate it. And this, in turn, will delay treatment, reducing the chances of its success. Dr. Woroń admits that the biggest mistake in pain management is pain management. She adds that the painkiller is a reliever, and that the ailment must be diagnosed. The spokesman of the Office for Drug Registration, Dr. Wojciech Łuszczyna, reminds that such drugs are used only for short-term, at most a few days’ treatment with small doses. Prolonged symptoms or a change in their nature, e.g. fever or intensification of pain, absolutely require contact with a doctor.
Uneducated drug addicts
The fact is that pain medications are often overused. When something hurts us, we often take more than the dose recommended on the leaflet or we do it too often. Sometimes we take one tablet because we have a runny nose, another because we have a headache, and another one because of menstrual or rheumatic ailments. Meanwhile, all of them, although with different names and indications, contain the same substance. Thus, we exceed the permitted dose. – That is why more people die from these drugs than die in car accidents – says Dr. Woroń. If they are abused, it causes many side effects. These may be gastrointestinal bleeding, kidney failure, liver failure or an increased risk of a heart attack.
– Unfortunately, only 15 percent. he reads drug leaflets of us – he regrets. In his opinion, an educational campaign in the media is needed to show how to safely use the benefits of pharmacotherapy. Especially that – as Dr. Łuszczyna adds – in connection with the aging of the society, we will consume more and more drugs, because the number of various ailments, including pain, will increase. Meanwhile, the availability of doctors is unlikely to improve. Moreover, in many of these ailments their consultation is not necessary at all. Sales of over-the-counter drugs will increase. – In the past, suppositories for hemorrhoids, allergy medications or all painkillers were prescription. Today, hardly anyone questions their universal availability. I do not see anything wrong with the fact that we want to consciously decide about our own health, but after careful consideration of the pros and cons, that is, after reading the leaflet, consulting a pharmacist and, if necessary, a doctor – he says.
Ketonal in numerous company
– It would be illogical to ban the sale of ketonal without a prescription in a situation where other similar drugs containing ibuprofen, diclofenac, meloxicam, naproxen or dexketoprofen can be purchased without visiting a doctor’s office. The drug containing meloxicam has a half-life of 20 hours. This is the period from taking the drug to the moment when the body’s saturation with it is reduced by half. Meanwhile, in the case of ketonal, it is two hours – says Dr. Woroń. Ketonal does well in terms of side effects compared to other over-the-counter medications.
Research shows that it does not increase the risk of having a heart attack. As one of the few, it does not weaken the action of aspirin commonly used in the prevention of cardiovascular diseases. Due to its short half-life, it is characterized by a relatively low risk of side effects from the digestive system. Its effects on the liver and kidneys are similar to those of other over-the-counter pain relievers. Meanwhile, it works especially well in the treatment of bone, joint, muscle pain, head tension and migraine. It is highly effective in treating pain in patients with rheumatoid diseases who have been taking it intermittently for years. Studies have shown that it is faster and more effective than ibuprofen in sports soft tissue injuries.
Ketonal will be sold with the modified indications on the package insert. The maximum recommended duration of use without consulting a doctor will be 5 days. The dose will be lower than the prescription, and there will be 10 or 20 capsules in the package.