Important Definitions in Pharmacovigilance
Summary of Product Characteristics:
A professional instruction for the doctor and the pharmacist which is an annex of the Marketing Authorisation; it contains the most important data concerning the medicinal product, conditions of its use and the possible side effects.
Individual pharmacovigilance-registration form:
This is a form used for a spontaneous report of an adverse effect, it refers to one patient and is used in urgent clinical cases. It is a so called „yellow sheet” introduced by the National Institute of Pharmacy which should be used for spontaneous reports of adverse effects and can be obtained in pharmacies. The registration forms are addressed in advance and after filling in and closing they have to be sent to the National Institute of Pharmacy for no charge by post (address: Budapest 5, Pf. 450, 1372). Side effects or adverse effects being experienced during clinical trials should be reported by the sponsor of the trial on a Hungarian or -if possible- English registration form established for that particular purpose.
Risk-benefit rate:
Conclusion coming from the comparison of the advantageous and disadvantageous effects of a medicinal product.
Pharmacovigilance:
The group of activities with the aim of the safe use of medicines. These include activities from legislative, official, Marketing Authorisation Holder's and from the public health's side.
Periodic Safety Update Report (PSUR):
Regular clinical assessment of individual reports on adverse effects experienced with medicinal products which have already had been issued a marketing authorisation.
Signal:
Information concerning possible relations between a medicinal product and an adverse effect which has been reported, is unknown or partially registered/confirmed. There are more than one report necessary for recognizing a signal depending on the severity of the effect and on the quality of the report. Information may originate from a spontaneous report, publication, epidemiologic study, it may refer to a new side effect, to a more severe extent or higher frequency of a well-known side effect, or to a new risk population (children, adults, elderly, pregnant, breast-feeding women).
Clinical report on an adverse effect:
Report on an adverse effect, side effect towards the National Institute of Pharmacy, manufacturer, or any association (e.g. Ethical Committee) which has been experienced during the clinical trial carried out on the basis of commission of the medicinal product that has not yet been issued a marketing authorisation. These include reports which refer to medicinal products with a marketing authorisation but having not been authorised for a new packaging size or a new indication.
Clinical trial:
Trials (human) carried out with the purpose of disclosing and confirming unknown pharmacological and/or pharmacodinamic effects of one or more medicinal products; furthermore identifying the side effects, study of the absorption, distribution, metabolism and elimination of a preparation with the aim to get further data concerning safety and efficacy. Investigations may be carried out with medicinal products which (i) have not yet been issued a marketing authorisation (premarketing examination); (ii) have already been issued a marketing authorisation but are tested in a new packaging size, indication, method of application (postmarketing examination); or (iii) have already been issued a marketing auhtorisation and it is necessary to know more details of the safety (postmarketing safety examination).
Clinical protocol:
Documentation with regards to a clinical trial of a preparation (medicinal product, vaccine) which includes the purpose, construction and methodology of the investigation, the aspects of assessment and instructions concerning report on adverse effects.
Risk:
Probability of a certain adverse effect or side effect.
Sponsor:
This may include natural person, economic organization, institution or any organization taking the responsibility for initiating, organizing, financial support of the clinical trial, and is in compliance with the conditions of health insurance.
Adverse reaction:
All unexpected and unfavourable reactions during the use of any dose of the examined preparation which can be brought in line with the preparation; harmful and unwanted effects during the use of a medicinal product which has already been issued a marketing authorisation and which has been used for preventing, recognizing, or treating a disease or for restoring, preparing or modifying physiological functions, it has been given in the common dose and according to the physician/supplier it can be brought in line with using the preparation. The probability of the dependence of an effect upon a cause exists in all cases when the relation cannot be totally excluded. Adverse reactions may also develop when using medicinal products for therapeutic or diagnostic purpose, furthermore hormones and preparations containing substances which are present also in the organism.
Adverse event:
All unfavourable and harmful (from clinical, laboratory or other aspect in relation with health) events manifesting themselves during the use of a medicinal product or the examined preparation – these events are not necessarily in relation with the certain preparation/treatment.
Individual case report:
Written report prepared by doctors, pharmacists or other health care professionals with regard to the possible or real adverse/side effects of a medicinal product being experienced after issuing the marketing authorisation; the report should include at least the following 4 points: identification of the announcer, identification of the patient taking the medicine, the medicinal product under suspicion, supposed adverse effect.
Serious adverse reaction:
Life-threatening side effect which makes hospitalization necessary or makes it prolonged; it may also cause irreversible harm to health, deficiencies, congenital insufficiencies, inborn defect or death.
Urgent obligation to report:
Refers to the reports of adverse effects and adverse events which have to be - according to the National Institute of Pharmacy - announced within 15 calendar days after realization/acknowledgement.
Unexpected adverse reaction:
Adverse effects which – in their characteristics and seriousness - differ from the side effects described in the informative presented to the investigators, or in case of a marketed medicinal product differ from the data described in the Summary of Product Characteristics.
Examined preparation:
Preparation used in the clinical trial primarily or in comparison with another preparation and may be an active substance or a placebo. This group also includes the marketed medicinal products which are being tested in a new packaging size, indication, method of application, or in case of collecting further data concerning the well-known effects and the safe use of the medicine.
Investigator's manual:
Assembly prepared primarily to the investigators which includes all important clinical and non-clinical data concerning the human use of the examined product.
Investigator, manager of the investigation:
Person responsible for the management of the clinical trial at the place of the investigation. If the investigation is carried out by a group, the leader of the group will take the reponsibility and control the investigation.
