“For risks and side effects, ask your doctor or pharmacist”. We find this sentence on every package insert of a drug and also often hear it in commercials for over-the-counter drugs. But what is it actually about the side effects of medications and how must they be declared?
What are side effects?
A side effect is the effect of a drug that can occur in addition to the intended main effect. Textbooks often also use the term “adverse drug reaction” for this. According to the legal definition, adverse drug reactions are “unintended and harmful reactions to a drug.” In a broader definition of human drug law, adverse effects due to medication errors such as incorrect use and overdose are also included. Adverse effects due to the misuse of medicines must also be reported to the medicines authority on the basis of drug safety. In this context, the adverse effects listed in the package insert have been observed only when used as intended.
Classification and categorization
Side effects can first be divided into drug-typical and dose-dependent as well as dose-independent side effects. The physician must always weigh whether the benefit of the drug and the risk of side effects are in reasonable proportion to each other and whether a drug can thus be used. Under certain circumstances, side effects can also have desirable effects. For example, in some patients, certain effects on a disease may be desirable, while in others they may have the opposite effect. A classification is also made into unanticipated side effects (have not been observed to date and therefore could not be described) and serious side effects (life-threatening or fatal, usually require hospitalization, may lead to permanent disability). For these side effects, special obligations apply with regard to documentation and reporting. Side effects are further classified according to their frequency as very common (more than one treated patient in ten), common (one to ten treated patients in 100), occasional ( one to ten treated patients in 1,000), rare (one to ten treated patients in 10,000), and very rare (less than one treated patient in 10,000). In addition, there is also a classification of “not known” where the frequency cannot be estimated based on the available data.
How must medications be declared in terms of side effects?
In the context of drug safety, pharmaceutical companies are not only required to collect and evaluate all side effects that have become known, but they must also declare them in the summary of product characteristics (SmPC) and in the package insert. Causality is irrelevant here. The manufacturer of a drug is liable under Section 84 of the German Medicines Act (AMG) for all side effects not listed in the product information. However, there is also a small “problem” here: the question is always asked how a drug with obviously massive side effects and little benefit is approved for the market in the first place. The answer: pharmaceutical companies, in addition to controlling scientific research, also control the testing of new drugs. Thus, clinical trials are designed in such a way that any potential dangers are very unlikely to come to light in the first place. Furthermore, pharmaceutical companies usually determine themselves which of the research results are actually published and forwarded to the regulatory authorities. As a general rule, as soon as a patient notices an undesirable change during or after the use of a drug, he or she should inform his or her doctor or pharmacist. The adverse drug reactions (even if only suspected) are then reported by the physician or pharmacist to the Drug Commission or the responsible federal authority. However, the patient should not arbitrarily discontinue the medication or change the specified dose. Side effects can also be reported to the “Federal Institute for Drugs and Medical Devices (BfArM)” via online access since 2013. Here, patients can also obtain information about the risks of medicines. However, patients should not only consider possible side effects.Interactions with other medications or even foods should also always be considered. It is often difficult for patients: they are spoiled for choice. Either they suffer from their illness until it is cured without medication or they accept the side effects. Patients are allowed to be critical when it comes to medicines. Even if they hear the argument “side effects would really only occur in very few cases”. Every patient should keep in mind that in conventional medicine the following motto applies: “No effectiveness without side effects”.
Risks and side effects for patients
Regarding side effects, especially elderly people should be careful. Due to age, they are more likely to suffer from chronic diseases and require medication for them. However, according to scientists, the susceptibility to side effects also increases with increasing age. In principle, side effects can be very diverse: from harmless side effects such as fatigue to harmful effects that sometimes significantly exceed the benefits, anything is possible. For example, certain drugs taken during pregnancy can cause severe malformations in the embryo (thalidomide disaster in the 1960s). In the worst case, life-threatening or even fatal side effects can occur. It can now be assumed that one in two deaths from adverse drug reactions could be avoided. In the EU, it is estimated that around 200,000 people die each year from the side effects of a drug. For this reason, the European Parliament passed a resolution in 2010 to improve patient information. But side effects have other consequences: It is currently assumed that side effects occur in about five percent of patients treated with medication. In addition, a side effect is said to be the reason for admission in about three to six patients who are admitted to an internal medicine ward. But it is not only the patients who suffer from side effects. The care system is burdened economically: The costs for side effect-induced treatments are approximately between five and nine percent of total hospital costs. It can also be observed more and more that side-effect-rich drugs make for permanent patients. Thus, medications are often prescribed despite all the risks, which then in turn require certain concomitant medications and thus often also control examinations. The patient must therefore visit the doctor again and again at certain intervals in order to prevent further problems. With regard to the side effects that occur primarily in older people, a new study was conducted under the direction of Prof. Dr. Petra A. Thürmann from the Department of Clinical Pharmacology at the University of Witten/Herdecke, the “PRISCUS List” project was launched. The list is intended to help physicians find a suitable alternative drug to “potentially inadequate medication”, especially for elderly patients. The list includes 83 drugs that are prescribed to older people in particular, but should not be. Physicians can find a suitable alternative drug in the “PRISCUS list”. The list also contains information on contraindications. It is intended to help reduce the number of medications prescribed that are hazardous to health. It should be borne in mind, however, that the list only includes the most common drugs and that even the alternative substances are not entirely free of side effects.
