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Presentation

New legislative requirements to the pharmacovigilance system of the registration certificate holders of the Russian Federation Possibilities of pharmacovigilance
outsourcing system

MONITORING OF DRUG SAFETY


Pharmacovigilance

Pharmacological science and practical activities relating to the collection, detection, assessment, monitoring, and prevention of adverse drug reactions

Medical products that are in circulation in the Russian Federation are to be monitored of the safety in order to detect the possible negative consequences of their use, warn patients and protect them againts the use of such drugs.

(Art. 64 of the Federal Law No. 61-FZ dated April 12, 2010 "On the circulation of medicinal products").

REGULATORY AND LEGAL Database OF PHARMACOVIGILANCE

  • Federal Law No. 61-FZ dated April 12, 2010 “On the circulation of medicinal products”
  • Order of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) No. 1071 dated February, 15 2017 “On approval of the procedure for pharmacovigilance”
  • Guideline on good pharmacovigilance practices (GVP) of the Eurasian Economic Union, approved by the Council of the Eurasian Economic Commission dated November 3, 2016 No. 87
  • Good Clinical Practice (GCP), approved by the Council of the ECE dated November 3, 2016 No. 79
  • Order of the Ministry of Health of the Russian Federation No. 5539 dated September 7, 2015 “On approval of the sample quality control of medicinal products for human use”
  • Order of the Ministry of Health and Social Development of the Russian Federation No. 758n dated August 26, 2010 “On approval of procedure for the suspension of use of the medical product for human use” (Registered by the Russian Ministry of Justice dated August 31, 2010 No. 18325)
  • Russian Ministry of Health order of 26.08.2010 N 749n "On approval of the form of the documents containing the results of safety monitoring of the medicinal products for medical use with the aim of confirming its state of the  registration"
  • Russian Ministry of Health order of 07.09.2016 №682n "On approval of the form of the documents containing the results of monitoring the efficacy and safety of the medicinal product for the medical use conducted by the holder or by the owner of the registration certificate of a medical or deprived legal entity"
  • National standard “Appropriate Clinical Practice. GOST R 52379-2005”, approved by the Order of the Russian Technical Regulation System No. 232-s dated September, 2005.

Regulatory measures in detection of drug safety issues

  • Cancellation of registration (Art. 34.1 of the Federal Law “On the circulation of medicinal products”)
  • Suspension of the circulation (Art. 65.1 of the Federal Law “On the circulation of medicinal products”)
  • Changes to the instruction for human use (order of the Federal Service for Surveillance in Healthcare No. 1071 dated February 15, 2017)
  • Changes to the Protocol of clinical trial*
  • Suspension of clinical trials*
  • Request for Risk Management Plan (RMP)*
  • Suspension of the circulation or use of the medicinal product for additional study period*

  • *Order of the Federal Service for Surveillance in Healthcare No. 1071 dated February 15, 2017

Sanctions in case of absence of the pharmacovigilance system on the manufactory

  • Cancellation of state registration of the medicinal product (Art. 34.9 of the Federal Law “On the circulation of medicinal products”)
  • Suspension of use of the medicinal product (Art. 65.2 of the Federal Law “On the circulation of medicinal products”)
  • Administrative responsibility
  • Criminal responsibility (the Criminal Code of the Russian Federation, Art. 238 “Production, storage, transportation or sale of goods and products, performance of the works or services not meeting safety requirements)

ADDITIONAL REGULATORY REQUIREMENTS OF OF THE EURASIAN ECONOMIC UNION

  1. Harmonisation of the pharmacovigilance system of the Russian Federation with GVP, GCP of the Eurasian Economic Union and EU GVP;
  2. The obligation to provide the Master file by request from Federal Service for Surveillance in Healthcare;
  3. The requirement for the presence of the Pharmacovigilance Officer on Eurasian Economic Union;
  4. Requirements for screening local scientific literature;
  5. Possible laboratory control of drugs if we got adverse reactions in sample test;
  6. Requirements to training local staff on pharmacovigilance;
  7. Possible to request RMP of registered drugs before implementation of risk management measures;
  8. Requirements to create risk management programs considering specific Federal Service for Surveillance in Healthcare
  9. Impossibility of copying European PSUR
  10. Informing regulators by holders of registration certificates about important changes to the pharmacovigilance system;
  11. Planned and extraordinary inspection pharmacovigilance system;
  12. The appointment of post-marketing clinical trials;
  13. Requirements for informing doctors and consumers about the new data safety of drugs
INDEPENDENT CREATION OF THE PHARMACOVIGILANCE SYSTEM
  • Prepare pharmacovigilance system master file;
  • Appoint the Pharmacovigilance Officer and notify the Federal Service for Surveillance in Healthcare;
  • Educate Pharmacovigilance Officer and all employees;
  • Create standard operating procedures (SOP) for the main pharmacovigilance processes based on the company's quality management system;
  • Provide the implementation of the SOP leaving a documentary trace;
  • Provide a continuous and qualitative analysis of the balance of benefits and risks of drugs;
  • Organize the work of an electronic database of  adverse drug reaction;
  • Organize the collecting, analysis and evaluation of adverse drug reaction's data;
  • Provide a scientific literature screening;
  • Prepare periodic security reports in a new format (PSUR);
  • Self-detection and drug safety signal processing;
  • Independent development of drug risk management plans and strategy;
  • Provide a full and timely submission of responses to regulatory requests;
  • Providing regular audits (self-testing);
  • Preparing for inspections of regulatory organs (external audits – since 2017)

RISKS OF CERTIFICATE HOLDERS

  • * NO EXPERIENCE, QUALIFICATIONS OF SPECIALISTS
  • * DEFICITE OF STAFF
  • * 1 OR 2 BRAND IN THE PRODUCT PRODUCTION PORTFOLIO
  • * REQUIREMENTS FOR SAFETY AND EFFICIENCY ASSESSMENT
  • * AVAILABILITY OF SOFTWARE FOR EVALUATION BENEFIT / RISK
  • * HUGE AMOUNT OF ORGANIZATIONAL WORK AND DOCUMENTATION
  • * NECESSITY OF THE USE OF ADDITIONALLY CHARGED RESOURCES OF THE INFORMATION
SERVICES OF ANO “NATIONAL PHARMACOVIGILANCE RESEARCH CENTER”
Title
Creation and maintenance of documentation of the pharmacovigilance (Master file, SOPs, instructions, positions, etc.)
Appointment of a qualified Pharmacovigilance Officer
24 hours call-center organization for adverse reaction reports receiving
Organization of the collecting of reports about side effects and non-efficacy of the medicinal products, using free and paid scientific databases of  the Russian Federation and countries of circulation including English-speaking countries
Analysis, evaluation, and storage of all the reports of adverse reactions, organization of an electronic automated system for recording, processing, and storing of drug safety information
Organization of operative collecting of additional information about a side effect in case of a serious adverse reaction, also using information collecting programs
Scientific assessment, assessment of the benefit / risk of using an automated system, including routine and 200 additional indicators
Preparing and writing of periodic safety update report (PSUR)
Preparing and evaluation of the risk management system; the risk management planning (RMP)
Development and conducting of trainings for pharmacovigilance employees
Preparing to audits and inspections of the Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor)
Organization of the system of the healthcare professionals and patients informing about the drug safety
Implementation of obligations to the authorized organs of states-member of the Eurasian Union in terms of adverse reaction information collecting, periodic reporting, inquiry answer providing

Free activities

  • Free webinars on the pharmacovigilance system organization of the drug manufacturer
  • Free audit of the current pharmacovigilance system of the drug manufacturer
  • Announcements of activities are presented on the site www.drug.safety.ru
  • Free phone numbers: 8-800-777-86-04, 8(495)799-2186
FORMAT OF COOPERATION - THE CONCLUSION OF THE OUTSOURCING CONTRACT
ICSR ASSESSMENT (STANDARD VS. NRSP METHODS)

Patient`s info (except those indicated in yellow card: age in days, months and years, diagnosis in ICD 10 codes, age categories and self-treatment cases) ADR info (duration, leading clinical manifestations, type according to WHO, Rawlins-Thompson, Will-Brawn, DoTS; severity according to Karch-Lasagna, LDS, Hartwig-Siegel and CTCAE, preventability according to Hallas, Granada test and Schumock-Tornton, MedDRA codes)

Suspected drug`s info (duration of therapy before ADR, ATC codes, presence in local formularies and recommendations, State Register of Medicinal Products, List of Life-Saving and Necessary Medicinal Products)

Info about other (concomitant) drugs (ATC codes, Causality assessment according to Horn-Hansten, interaction checker)

Reporter`s info (info about medical organization and WHO criteria for it)

Causality assessment (Naranjo and Karch-Lasagna methods)

Integral method – assessment of drug related problems (DRP, incl. local modification)

Agreement analysis for methods (during assessment of severity and preventability) and for experts

Search and evaluation of “Off Label” prescriptions (age restrictions, ignoring of contraindications, dosing, frequency and duration of therapy)

Patient`s info (gender, age, pregnancy/lactation, consequences, clinical diagnosis, allergy anamnesis, hospital stay and domestic use of medications)

ADR info (dates of beginning and finishing, description, categories, seriousness)

Suspected drug`s info (trade name, INN, manufacturer and MAH, indications, single dose, frequency, route of introduction, batch/lot number, start date for therapy and date of its end)

Info about other (concomitant) drugs (trade name, INN, dosing, routes of introduction and duration of therapy)

Information about correction

Reporter`s info (name, position, date of form filling)

Causality assessment performed by doctor (if any)

EXAMPLES OF SAFETY DATA AUTOMATIC PROCESSING
We use WHO, Rawlins-Thompson, Will-Brawn and DoTS classifications
EXAMPLES OF DATABASE RESULTS (ATC GROUPS)
We can perform analysis in different groups, incl. all levels of ATC classification
EXAMPLES OF DATABASE RESULTS
EXAMPLES OF DATABASE RESULTS (SEVERITY ASSESSMENT)

LDS points

Use NCI – CTCAE 4.03 if necessary
EXAMPLES OF DATABASE RESULTS (CAUSALITY ASSESSMENT)
For cause-and-effect relation automatized assessment different scales and algorithms are used (Naranjo, Karch-Lasagna, Horn-Hansten, RUCAM, ALDEN and others)
EXAMPLES OF DATABASE RESULTS (PREVENTABILITY ASSESSMENT)

Adverse reaction prevention assessment

WELCOME FOR COLLABORATION

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