News

Medicinal adverse events? Inform Roszdravnadzor.

03.04.2015

Federal Service for the Supervision of Public Health (Roszdravnadzor) reminds that starting from the year 2010, all medicines marketed in the Russian Federation are covered by the drug safety monitoring. The efficiency in identification of problems regarding drug safety largely depends on doctors' attention to pharmacovigilance matters, their willingness to inform Roszdravnadzor about the identified adverse reactions.

 According to the Federal Law No. 61-FZ as of 12.04.2010 "On Circulation of Medicines" (Article 64) participants of drug circulation process are obliged to inform the Roszdravnadzor about all cases of adverse events, not specified in the label claims for a drug, about serious or unexpected adverse events during drug therapy, about characteristics of drug interactions with other drugs, which have been identified in the course of clinical studies and administration of drugs.
  According to Article 64 of the Federal Law No. 61-FZ as of 12.04.2010 "On Circulation of Medicines", failure to report or non-disclosing of information to be sent to Roszdravnadzor as part of drug safety monitoring entails liability of persons, to whom this information became known in connection with their professional activities, in accordance with the legislation of the Russian Federation.
 The order of the Russian Ministry of Health demands that a report about serious or unexpected adverse events (drug reactions not described in the approved label) must be submitted to Roszdravnadzor no later than 15 calendar days from the date when this information became known to the sender.
 It is recommended to send reports as soon as possible after a minimum of information is collected about the adverse event (patient, medical symptoms and drug (trade name or manufacturer) are identified). Information about the outcome, data of examinations and laboratory tests, and other relevant data may be presented in additional reports.
 The information letter from Roszdravnadzor as of 11.04.2012 No. 04I-266/12 recommends that the report about a fatal adverse event must be sent within 24 hours after occurrence.
 Along with this, it is advisable to promptly notify Roszdravnadzor (in 15 days from the date of revealing) about the revealing of the following facts and circumstances involving possible harm to health or threat to life when using medicines:
 a) revealing information about the nature, frequency and severity of adverse events, specifics of interaction of the drug with other drugs or the information about unexpected adverse event, which do not correspond to the approved product label;
 b) revealing the threat to life and health of the mother and/or foetus when using the medicine during pregnancy and lactation;
 c) revealing of resistance of pathogens of infectious diseases when using antibacterial and antiviral drugs;
Monitoring of drug safety
 d) revealing of cases of infectious diseases transmission through the drug;
 e) revealing of information about the absence of clinical effect of vital medicines, vaccines and drugs used for contraception, when the lack of clinical effect is not due to the individual patient characteristics and/or the specifics of patient’s illness;
 f) revealing of errors of the use of drugs by health professionals and/or patients because of misinterpretation of information in its package insert;
 g) revealing of drug abuse, of deliberate drug overdose or drug use for intentional harm to the life and/or health of humans and animals;
 h) revealing of specifics of drug interaction with other drugs, having a definite or probable causal relationship with the use of the drug, which was not described in the product label and presenting a threat to human life and health, or making it impossible to use this drug with other drug(s) (pharmaceutical incompatibility);
 i) when the information is received about side effects, severe adverse events, unexpected adverse events, specifics of interaction with other drugs, caused by the use of falsified, counterfeit drugs or drugs, which quality does not meet the specified requirements.
 Recommended template for reporting about adverse drugs events is the "Notification about side effect, adverse event or the absence of expected therapeutic effect of medicine", which is available for download from Roszdravnadzor website.
(http://www.roszdravnadzor.ru/medicines/monitor_bezopasnosti_ls/map).
 The notification may be sent by fax or e-mail to the central office of Roszdravnadzor (fax +7(495) 698-15-73, E-mail: pharm@roszdravnadzor.ru) or its territorial offices (the message should be marked "Urgent"; the hardcopy should follow).
 Healthcare institutions where adverse events occur often are advised to contact the Roszdravnadzor to obtain personalized access to the information system "Pharmakonadzor" (Pharmacovigilance) of the automated information system of Roszdravnadzor.
 The procedure for obtaining a personalized access to the automated information system of Roszdravnadzor is described in the Roszdravnadzor letter as of 02.12.2008 No. 01I-752/08 published on the letteRoszdravnadzor website (in Russian only; section "Medicines", subsection "Monitoring of safety of drug in circulation in the territory of the Russian Federation", heading "Information letters", tab "2008").
It is important to note that patients who revealed adverse reactions on their own, have the right to demand that their doctor fill out the notification and send it to the Roszdravnadzor.
 
About drug safety monitoring (in Russian)