Principles of Pharmacovigilance


  • Self-medication:Selection and use of medications that do not require a prescription, by people, in order to treat diseases or symptoms that they themselves can identify.
  • Self-prescription:Indiscriminate and irrational use of medications that must be subject to medical supervision (5).
  • Side effect: Aneffect that does not arise as a consequence of the primary pharmacological action of a medicine, but rather constitutes an eventual consequence of this action (for example: a febrile reaction with penicillin in the treatment of syphilis, and that is due to the release of the endotoxins released by the massive destruction of treponemas, due to the antimicrobial effect of the drug; also: hypokalemia due to the use of loop diuretics).
  • Collateral effect:Any unforeseen effect of a pharmaceutical product that occurs with normal doses used in man, and that is related to the pharmacological properties of the drug (for example: constipation from the use of opioids, or dry mouth for the use of anticholinergics).
  • Medication error or medical error: Anavoidable incident caused by the improper use of a medication, and which can cause injury to a patient, while the medication is under the control of health personnel, the patient or the consumer.
  • Adverse drug event (EAM):Any unfortunate medical episode that may occur during treatment with a medication, but has no necessary causal relationship with that treatment; Although coincidence is observed over time, it is not suspected that there is a causal relationship (2).
  • Adverse event:Result of health care that unintentionally caused harm (Patient Safety Policy). Adverse events can be preventable and not preventable:

– Preventable adverse event: Unwanted and unintended result, and that would have been avoided by complying with the standards of care available at a given time.

– Adverse event not preventable: Unwanted and unintended result, and that occurs despite compliance with the standards of care.

  • Drug:Any substance administered to the human species for the prophylaxis, diagnosis or treatment of a disease, or to modify one or more physiological functions.
  • Pharmacovigilance:Science and activities related to the detection, evaluation, understanding and prevention of adverse effects of medications or any other problem related to them.
  • Incident:Event or circumstance that happens in the clinical care of a patient, and that does not generate damage, but in whose occurrence failures are incorporated into the care processes.
  • Poisoning:Manifestation of toxic effects (6) that occurs when the concentration of drugs exceeds the minimum toxic concentration, which, in turn, may be due to the use of high doses or the possible accumulation of the drug. Such definition gives continuity to that provided by Paracelsus: “Everything is toxic depending on the dose” (7).
  • Medication:Is that pharmaceutical preparation obtained from active ingredients, with or without auxiliary substances presented in pharmaceutical form, which is used for the prevention, relief, diagnosis, treatment, cure or rehabilitation of the disease. The containers, labels, labels and packaging are an integral part of the medicine, since they guarantee its quality, stability and proper use (8).
  • Drug-related problems (PRM):Those situations that in the middle of the medication use process cause or may cause the appearance of a negative result associated with the medication (9).
  • Adverse drug reaction (ADR):Any unintended harmful reaction that appears with the doses normally used in humans for prophylaxis, diagnosis or treatment, or for modifying physiological functions (2).
  • Allergic reaction to the drug (RAM):It is characterized by being independent of the dose, and which is mediated by the immune system. Allergic reactions, in turn, have been classified into four main clinical types:

– Type 1 reaction : Known as immediate anaphylactoid reaction or immediate hypersensitivity, it is mediated by the interaction of the allergen (medication) and IgE antibodies. The reactions produced by administration of penicillin are such an example.

– Type 2 reaction: Also called cytotoxic, it consists of complement fixation reactions between the antigen and an antibody present on the surface of some cells. These reactions include hemolytic anemias caused by medications, agranulocytosis and others.

– Type 3 reaction: It is mediated by an immune complex that is deposited in tissue cells or the target organ.

– Type 4 reaction: It results from the direct interaction between the allergen (medication) and sensitized lymphocytes. It is also known as a delayed allergic reaction, and includes contact dermatitis.

  • Idiosyncratic reaction: Areaction that occurs as a result of a specific genetic endowment, and that leads to the occurrence of unexpected reactions (10).
  • Negative results associated with medication (NMR):These are defined as results in the patient’s health that are inadequate to the purpose of pharmacotherapy and associated with the use or failure of medication use.
  • Patient safety: Aset of structural elements, processes, instruments and methodologies based on scientifically proven evidence, all of which tend to minimize the risk of suffering an adverse event in the health care process or mitigate its consequences (11)
  • Toxicity:Degree in which a substance is harmful. Also, harmful phenomena due to a substance or medication, and observed after administration

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