Pharmacovigilance

 

                             
                                   
                                     
                                   
                                     
                                   
                                     
                               



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Pharmacovigilance

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. (WHO, 2004). Surveillance over safety of medicinal products at their medical use is one of the main directions in the implementation of national drug policy worldwide. The international and national regulatory mechanism of surveillance over safety of medicinal products is called phamacovigilance.

Main objects of observation of the pharmacovigilance system are adverse reactions to medicinal products and cases of lack of efficacy of medicinal products at their medical use. It should be noted that the proper quality of pharmaceuticals is not an absolute guarantee against adverse consequences of drug therapy. The use of medicinal products assumes their therapeutic effect but adverse reactions to them cannot be ruled out. The latter are caused by pharmacological properties of active substance of the medicinal product or peculiarities of the body response to its administration. It is these issues that pharmacovigilance deals with.

The main directions of activity of pharmacovigilance system are:

- Collection, analysis and generalization of information about safety, adverse reactions and lack of efficacy of medicinal products;

- Preparation of proposals to MoH Ukraine concerning decisions about full or partial prohibition of medical use of the medicinal product, introduction of amendments or changes into instructions for medical use of the medicinal product;

- Specialized expert evaluation of preregistration materials pertinent to safety of a medicinal product and materials submitted in support of changes;

- Control over functioning of the phamacovigilance system within the health care system and one of the applicant;

- Information and methodological provision of the health care system concerning safety of medicinal products, educational activity.

The main result of activities of the state pharmacovigilance system is a withdrawal from pharmaceutical market of medicinal products the risk of which outweighs their benefit.

In Ukraine the pharmacovigilance system has been in place since 1996. Currently it is regulated by the MoH Ukraine Order of 25.12.2006 № 898 “On Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use” as amended (registered at the Ministry of Justice of Ukraine on 29.01.2007 under № 73/13340). This document has been harmonized with international approaches to conducting pharmacovigilance (WHO) and with the European legislation (the Directive of the European Parliament and the Council 2001/83/EEC of 06.11.2001).

According to the MoH Ukraine Order of 25.12.2006 № 898 “On Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use” PE “The State Expert Center MoH Ukraine” shall be responsible for conducting surveillance over adverse reactions to medicinal products permitted for medical use. The state pharmacovigilance system is represented by a central element, the Postregistration Surveillance Board of the State Expert Center, and the Board’s regional divisions acting in all oblasts of Ukraine. In health care settings this process is coordinated by persons responsible for pharmacovigilance, mainly by deputy chief doctors for medical affairs and heads of departments.

 

The Board conducts pharmacovigilance involving staff with medical and/or pharmaceutical education of all health facilities regardless of the types of ownership, applicants, patients, and patient organizations.

Owing to the information received through pharmacovigilance MoH Ukraine took important regulatory decisions, particularly, on the prohibition of use of such products as hemodez, euphyllin, with ethylenediamine as a stabilizer, kava-kava, cimetidine, furacilin tablets for internal use, combination products of diclofenac and nimesulide with resorptive effect, rimonabant, efalizumab, sibutramine, rosiglitazone, calcitonin (in the form of nasal spray), ketoconazole because the risk of using them outweighed their benefit. In addition, the medical use of the following products was considerably limited: gentamicin, methamizole sodium (analgin), detoxification solutions with low-molecular polyvinylpirralidone, rofecoxib, thioridazine, nimesulide, oseltamivir, calcitonin, trimetazidine.

Information of the pharmacovigilance system of Ukraine, regulatory decisions taken, news of medicines safety are published in section “Pharmacovigilance” of the Center’s official website (http://www.dec.gov.ua).

Since 2002 Ukraine has become a full member of the WHO Program for Safety Monitoring of Medicinal Products coordinated by the WHO Uppsala Monitoring Center, this confirms the compliance of the pharmacovigilance system of Ukraine to the international standards of efficiency.

 

Annex 1 to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use

Report form on adverse reaction (hereinafter-AR) and/or lack of efficacy (hereinafter-LЕ) of medicinal product (hereinafter-MP) at its medical use

 

Instructions for completion of report form on adverse reaction and/or lack of efficacy of medicinal product at its medical use (to be completed by physician, pharmacist, feldscher, obstetrician, chemist, nurse, applicant)

 

Annex 2 to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use

Reporting Procedure: Reportonadversereactions and/or lack of efficacy ofmedicinalproducts atmedicaluseat health facilities

Requirements to drawing up report on adverse reactions and/or lack of efficacy of medicinal products at medical use at health facilities

 

Annex to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use

 

Reportformonadversereactionand/orlackofefficacyofmedicinalproductatitsmedicalusetobesubmittedbypatientand/

oritsrepresentativeas well as by patient organizations

 

Annex 4 to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use

Formatofperiodicsafety updatereportonmedicinalproductpermittedformedicaluse

 

Annex 5 to the Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use

Formforsubmittingbyapplicantof summary dataaboutsafety of medicinalproduct atmedical use inUkraineduringthevalidity period of the most recent registration certificate