Adverse drug reactions are any adverse and unintended effects of a medicinal product. All medications can cause side effects and side effects, although not everyone will experience them. If, after taking the drug, disturbing symptoms appear, this should be reported to the appropriate authorities. Find out what the side effects of your medications are and how to report them.

Adverse drug reactionsis any adverse and unintended effect that occurs when using the recommended doses of a drug in humans for prophylactic, diagnostic, and therapeutic purposes, and for the restoration, improvement or modification of the body's physiological functions . This is the definition adopted by the WHO. According to another definitionside effects of drugsare harmful and unintended effects of using a medicinal product that result from its authorized use, as well as: incorrect use, outside the conditions specified in the marketing authorization, misuse, overdose, medical error. All medicines can cause side effects, although not everybody gets them. If disturbing symptoms appear after taking the drug, this should be reported. Descriptions of confirmed side effects are included in the drug leaflets also thanks to patient reports.

Adverse drug reactions

1.Dose-dependent adverse drug reactions

They may be related to the basic mechanism of action of the drug, e.g. hypoglycaemia (hypoglycaemia) during treatment with antidiabetic drugs, bleeding occurring during the use of anticoagulants, or the toxic effects of medicinal substances, e.g. liver damage during paracetamol therapy. This group of complications includes unwanted drug interactions with other drugs (including herbal ones) or with food.

2.Adverse drug reactions independent of the administered dose

Adverse reactions do not depend on the administered dose of the drug, but on the patient's sensitivity to the drug. In this case, even the smallest doses of the drug may cause adverse hypersensitivity reactions, e.g. urticaria / angioedema caused by various NSAIDs. There are allergic and non-allergic hypersensitivity reactions. In the first case, the reactionoccurs after at least a second exposure to a drug or substance that causes cross-allergy. In the latter case, the reaction appears after the first contact with the drug.

This group of complications also includes idiosyncrasy - a reaction resulting from a genetically determined increased individual sensitivity to drugs.

Adverse drug reactions not related to the administered dose account for a small percentage of adverse reactions, but are often severe. They can even be life-threatening reactions, such as anaphylactic shock.

3.Adverse drug reactions depending on long-term use

For example, thrombotic disease seen in women using oral contraceptives, subcutaneous lipodystrophy of adipose tissue at the site of insulin administration.

This group also includes addictions, e.g. to opioid analgesics or hypnotics, as well as overuse of laxatives.

There are also cases of the so-called drug-induced diseases, e.g. renal failure associated with therapy with immunosuppressants.

Any drug can cause side effects, although not everyone gets them. If disturbing symptoms appear after taking the drug, report it.

4.Time-delayed adverse drug reactions

They may appear several months / years after the end of therapy with a given drug. For example, tumors of the reproductive organs in women whose mothers were treated with stilbestrol during pregnancy, or Creutzfeld-Jacob disease in patients treated with naturally-derived growth hormone.

5.Adverse drug reactions induced by drug withdrawal

Discontinuation of treatment or sudden discontinuation of some chronically used medications that the body has already accustomed to, may cause disease recurrence, even in an exacerbated form, e.g. sudden discontinuation of beta-blocker therapy may result in severe coronary heart disease symptoms .

6.Adverse drug reactions - ineffective therapy despite administering the recommended dose of the drug

Their cause is mainly drug resistance. For example, increasing bacterial resistance may render the antibiotics ineffective. This also includes the ineffectiveness of vaccines and the ineffectiveness of contraceptives.

Important

Factors increasing the risk of side effects

  • age - children and the elderly are more likely to experience side effects after taking itdrugs
  • body weight - for very short and slim people ( <40 kg) lub bardzo wysokich i otyłych (>100 kg), you should take into account sometimes large differences in the effects of drugs
  • gender - greater sensitivity of women to drugs
  • pregnancy
  • coexisting diseases, e.g. diseases of the kidneys, liver
  • genetic background

Serious side effects of drugs

This is an undesirable effect which, regardless of the dose of the medicinal product used, causes:

  • patient's death
  • life-threatening (e.g. anaphylactic shock, angioedema, intracerebral haemorrhage, myocardial infarction)
  • the need for hospitalization or its extension
  • permanent or significant damage to he alth
  • other effects of the medicinal product, which the doctor, according to his knowledge, finds severe
  • disease, birth defect or damage to the fetus

There are also some specific situations that are considered severe and are subject to the rapid reporting procedure (within 15 days). They include, among others: lack of efficacy of the medicinal product used in the treatment of life-threatening diseases, vaccines, contraceptives, suspected transfer of the infectious agent with the drug, and overdose / abuse / misuse of the drug dose when a complication was observed.

Unexpected side effects of drugs

An unexpected side effect is defined as any negative effect of a drug whose nature or degree of severity is not consistent with the statements contained in the Summary of Product Characteristics. It should also be considered a reaction not described in the "Adverse reactions" section of its characteristics, but presented in the section on clinical pharmacology, contraindications, warnings or interactions.

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Worth knowing

Adverse drug reactions - frequency of risk of occurrence

  • very common, i.e.>1/10 patients - this means that it occurs more often than in one in 10 patients
  • often - occur less often than<1/10 pacjentów i jednocześnie częściej niż>1/100 patients
  • uncommon - occur in less than one patient in a hundred, and more than one patient in a thousand ( <1/100 pacjentów i>1/1000 patients)
  • rare - occur less frequently than in 1 / 1,000 patients and more often than in 1 / 10,000 patients
  • extremely rare - they appear in one in 10,000 patients or in one patient in even more than 10,000 people surveyed

How to report an adverse drug reaction? Idiosyncrasy

The patient hasthe right to report any activity that he or she feels is inappropriate. These include harmful effects and those that cause discomfort. They should be reported regardless of whether it is a real situation or only a suspicion.

Applications should be sent to:

  • president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • of the responsible entity (company producing the drug)
  • a he althcare professional, e.g. a doctor, pharmacist, nurse or paramedic

The patient may report an adverse reaction in a form convenient for him, e.g. by letter, e-mail, fax. The application addressed to the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products can be sent using a special form, which is available at www.urpl.gov.pl.

The application must contain, among others age and sex of the patient who was (or suspected to have been) a participant in the adverse event, the patient's initials, information about the patient's weight (in the case of children and people with an unusual weight).

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Bibliography:

Wiela-Hojeńska A., Łapińs Ł., Undesirable effects of drugs - types, division, causes and economic effects, "Farmacja Polska" 2010, No. 4

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