Medicines, also called medicines or medicinal products, are known to all as preparations that can cure or prevent disease.Most of the people who use it, however, do not know in detail the composition of the tablet or syrup they use or what active ingredients are contained and how they work (read the Hoax).
There are numerous types of drugs, each suitable for treating a certain disease. For some, a doctor's prescription is mandatory, be it a family doctor or a specialist; for others, however, the recipe is not necessary.
Prescription drugs have characteristics or methods of administration that can cause risks if used incorrectly. They are sold in pharmacies and are easily recognizable as they carry the phrase on the packaging: to be sold on presentation of a prescription.
Other drugs, normally called "free sale", are used to treat milder ailments and can be sold by the pharmacist without having to show him a prescription (read the Hoax). A stamp on the package makes them easily recognizable. For some of them, defined as "over the counter" advertising is allowed.
How a drug is born
Before a drug is approved and marketed, it undergoes a long and tiring experimentation process. It is a journey that can last up to 10 years. Only a small percentage of the substances studied, in fact, reach the final goal, namely approval for human use and authorization for placing on the market.
It all begins in the laboratory where scientific research takes place. In fact, it is the researchers who, on the basis of scientific hypotheses, design and carry out experiments to verify whether a certain substance, or a preparation (combination of several substances), can have a curative effect for a given disease.
Before being able to test it on man, researchers must subject the substance, or preparation, to the so-called preclinical experimentation phase. The latter, in turn, includes "in vitro studies", carried out on cell or tissue cultures, and "in vivo studies", ie on animals.
If preclinical studies show that the test substance has the desired effect, researchers can proceed to the next step: clinical trial. Performed on humans, it involves conducting studies in which the safety and tolerability of the drug under examination are first assessed. In other words, it ensures that its administration does not induce harmful effects on health, that it is well tolerated and that it is effective.
The clinical trial consists of 3 phases:
- phase 1: the new, potential, drug is tested for the first time on humans, in order to verify its safety and tolerability. In general, studies of phase 1 they are conducted on a limited number of healthy people who voluntarily join the study. Only if the investigational drug has been designed for the treatment of a serious disease (for example cancer, AIDS) can it be studied in people who are affected by it. If the drug proves not to have toxic effects or, if they occur, that the benefit produced makes them acceptable (benefit / risk profile), it can be subjected to the next phase of the experimentation, that is to the study of phase 2
- phase 2: the therapeutic activity of the potential drug is explored, namely its ability to produce the desired curative effects on the human organism. In this type of studies, different doses of the drug under examination are often tested both to determine the minimum quantity in able to produce the desired curative effect, both to evaluate its ability to alter some parameters such as, for example, blood pressure, temperature, etc. In this phase the route of administration could also be studied. Usually, they are "enrolled "A limited number of individuals but, unlike phase 1, these are people who suffer from the disease for which the drug is designed. In this phase, therefore, in addition to investigating the safety and lack of toxicity of the drug, it is evaluated especially its curative effectiveness
- phase 3: in this phase the study is aimed at giving answers to some questions: how effective is the drug? What advantages does it offer over similar drugs already available? What is the relationship between risk and benefit? In the step 3 the number of people "enlisted" is no longer limited but includes hundreds or thousands of individuals. The study is generally designed in such a way as to treat the different groups of participants in a random way: some are administered the test substance; to others, a placebo (substance with no therapeutic efficacy); to still others, drugs with activity similar to that of the substance in question but already on the market; a last group, on the other hand, is not given any substance. At the end of the study, the effects produced by the different treatments in the various groups of people are compared with each other. The overall effectiveness of the test substance is assessed by considering its effects on the disorders (symptoms) caused by the disease, on the quality of life or on the survival of the people treated
At the end of all the testing phases, if the drug in question passes all the tests proving that it has sufficient efficacy in relation to any risks (risk / benefit ratio), it is a candidate for marketing. The process begins with the collection of all the data obtained from the preclinical and clinical trials and with the compilation of a dossier to be submitted for evaluation by the competent authority (AIFA for Italy) to request registration and marketing authorization.
No medicine is completely risk-free after administration. Even after obtaining the marketing authorization, the drugs continue to be constantly monitored. Undesirable effects (side effects) or adverse reactions that may occur after the drug enters the market, in fact, are subjected to evaluation. In rare cases, for example if there are major safety concerns or if the risk / benefit ratio is deemed no longer beneficial, drugs may be withdrawn.
In Italy, institutions such as the Ministry of Health, the Higher Institute of Health and AIFA are responsible for monitoring public health. In particular, AIFA is entrusted with the delicate task of pharmacovigilance. This is a set of activities aimed at constantly evaluating all information relating to drug safety and ensuring that all medicines on the market have a favorable benefit / risk ratio for the population.
Report an adverse reaction
When a drug is placed on the market, only the effects studied before its registration are known. This information is available on the package leaflet accompanying the packs of all medicines and is obtained in the clinical trial phase conducted on a sufficient, but still limited, number of people. Once registered, the drug is used by an ever-increasing number of individuals and this allows for a more in-depth assessment of the risk / benefit ratio.
All unwanted reactions produced by a drug must be reported to the competent authority. Every citizen can do so by communicating the side effects to the people, and / or to the reference structures (their family doctor, pharmacist or ASL clinic). appeared after taking a medicine. If, on the other hand, you wish to submit your report directly, you must fill out the form available on the AIFA website and send it to the person in charge of the pharmacovigilance of the local health authority. Anonymous reports are not allowed.
Drugs with the same active ingredient and different names
Many drugs have two different names: the trade name and the generic name. The first is an invented name given by the pharmaceutical company that first developed the drug; the second is the name of the active ingredient, that is, the substance responsible for the medicinal product's curative activity.
When a company produces a new drug, it reserves the rights of exclusivity. This means that, by holding the patent, it is the only one who can manufacture it for a certain period of time and, therefore, decide the price. Once the exclusivity period is over, other drug companies can manufacture a equivalent drug, i.e. consisting of the same active ingredient as the branded medicine that lost the patent. THE equivalent drugs they are as effective as the original drug from which they are derived and have, by law, a lower price.In-depth link
NHS. Medicines information (English)
Italian Medicines Agency (AIFA). Clinical trials of drugs
Italian Medicines Agency (AIFA). Authorization of drugs