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Pharmacovigilance system in Ukraine : history , results , objectives

Pharmacovigilance system in Ukraine : history , results , objectives. Formation of pharmacovigilance in Ukraine. Formation of pharmacovigilance in Ukraine. 1996 – setting up the ADR Center of the State Pharmacological Center MoH Ukraine

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Pharmacovigilance system in Ukraine : history , results , objectives

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  1. Pharmacovigilance system in Ukraine: history, results, objectives

  2. Formation of pharmacovigilance in Ukraine

  3. Formation of pharmacovigilance in Ukraine • 1996 – setting up the ADR Center of the State Pharmacological Center MoH Ukraine • 1999 – setting up the Pharmacovigilance Department of the State Pharmacological Center MoH Ukraine • 1999 – setting up the National ADR Database • 1999 – Ukraine became an associated member of the WHO Collaborating Centre for International Drug Monitoring • 2000 – Order MoH Ukraine № 347 “On Approval of Instructions for surveillance overadverse reactions/effects of medicinal products” (registered in the Ministry of Justice of Ukraine) • 2001 – Order MoH Ukraine №51 “About Reporting Adverse Effects of Medicinal Products” (report card and procedure for ADR reporting approved) 2001 - №292 “About Improvement of Reporting Adverse Effects of Medicinal Products” (form of state statistical reporting ADR cases in health care settings and methodical recommendations on completion and submission of ADR report form approved) • 2001-2002 – workshops on pharmacovigilance in all regions of Ukraine, cities of Kyiv and Sevastopol

  4. Formation of pharmacovigilance in Ukraine • 2002 – setting up 10 regional divisions on pharmacovigilance • 2002– Ukraine became a full member of the WHO Drug Monitoring Program • 2003 – translation and publication of THE RULES GOVERNING MEDICINAL PRODUCTS IN THE EUROPEAN UNION, VOLUME 9 – Pharmacovigilance Medicinal Products for Human and Veterinary use),developed within ICH process and adopted in EC) • 2003-2004–28 studies of drug safety profile conducted • 2006 – update of the pharmacovigilance legislation. In 2007 the MoH Ukraine Order №898 is approved (provided is legal framework for pharmacovigilance performance by manufacturers, interactions between partners in pharmacovigilance ) • 2007– development and publication of “Medicines Safety” Guidelines • 2007– First scientific and practical conference “Medicines safety: From development to medical use” • 2007– publication of guidelines «The principles of formation and procedure for ADR reporting by manufacturer» • 2007 – Workshop“Current status and prospects of registration and re-registration procedure in Ukraine” • 2007 – launch of “Rational Pharmacotherapy” journal.

  5. Formation of pharmacovigilance in Ukraine • 2008 – setting up the Postregistration Surveillance and 27 regional pharmacovigilance divisions as subdivisions of the State Pharmacological Center MoH Ukraine • 2009– translation and publication of the European Guidelines on Pharmacovigilance for Medicinal Products for Human Use (Volume 9а) as a basis for national guidelines on pharmacovigilance • 2009 – launching training course on pharmacovigilance for pharmaceutical manufacturers • 2009 – Second scientific and practical conference “Medicines safety: From development to medical use” • 2009 – publication of a manual on safe use of cardiotropic medicines • 2009-2010 – pilot project on drug efficacy and safety performed in hospitals of the Zhytomyr Oblast • 2011 – elaboration of a model presentation on pharmacovigilance for physician • 2011 – launching training course “Pharmacovigilance: control of ADRs and ARV product efficacy in HIV patients” • 2011– elaboration of lecture course and tests ofthe elective course “Adverse Drug Reactions”for students of medical universities • 2011 – guide on safe use of NSAIDs elaborated • 2011 – creation of a page on the web-site of the State Expert Center where information on changes in safety section of the instructions for medical use is placed (http://www.pharma-center.kiev.ua/view/farmn)

  6. International documents used for harmonization of legal framework of the pharmacovigilance system in Ukraine • Directive 2001/83/EC on the Community code relating to medicinal products for human use • Council Regulation (EEC) No 2309/93 of 22.07.1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products • VOLUME 9A. Оf The Rules Governing Medicinal Products in the European Union. Guidelines on Pharmacovigilance for Medicinal Products for Human Use

  7. Legislation on pharmacovigilancein Ukraine • Law of Ukraine“On Medicines” of 1996 as amended in 1998 • MoH Ukraine Orders: 27.12.2006 № 898 “On Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use” (harmonized with EC directives) • 24.07.2009 № 531 “On Approval of Procedure for Monitoringof Safety and Efficacy of Medicinal Products in Hospitals” • 01.09.2009 №654 “On Approval of Plan of Measures for Improving Postregistration Surveillance over Safety and Efficacy of Medicinal Products in Hospitals” • 31.08.2010 № 736“On measures for implementation of Monitoringof Safety and Efficacy of Medicinal Products in Hospitals”

  8. Founders of pharmacovigilance system in Ukraine Olexii Viktorov(1945-2011) Volodymyr Maltsev(1948-2008)

  9. Who is responsible for pharmacovigilance in Ukraine? The State Expert Center MoH Ukraine shall be responsible for conducting surveillance over adverse reactions to medicinal products permitted for medical use. (MoH Ukraine Order of 27.12.2006 №898, item 1.3)

  10. Current pharmacovigilance system in Ukraine(MoH Order № 898 of 27.12.06) Ministry of Health of Ukraine State Expert Center (SEC) Postregistration Surveillance Board Regional divisions of Postregistration Surveillance Board      Spontaneous reporting

  11. Examples of regulatory approaches to medicines circulationin different countries

  12. Regional Divisions Coordination Department Pharmacovigilance Database Department Pharmacovigilance Department Unit of ADR Reports received from Physicians Unit for Analysis of ADR Cases Recorded in Ukraine Regional Divisions Activity Organization and Coordination Unit Unit of ADR Reports received from Manufacturers Re-registration Materials Assessment Unit Monitoring Unit Regional Divisions (n=27) Structure of Postregistration Surveillance Board

  13. Chernigiv Lugansk Zhytomyr Sumy Poltava Rivne Vinnytsa Cherkasy Ternopil Lviv Lutsk Dnipropetrovsk Khmelnytskyi Kyiv Zaporizhzhia Ivano-Frankivsk Donetsk Kharkiv Uzhgorod Chernivtsi Kirovograd Kherson Crimea Odesa Mykolaiv Sevastopol Regional Pharmacovigilance Divisions

  14. Main activities of the pharmacological system in Ukraine • Health care information and methodological provision on drug safety issues (including development and conduct of specialized and general training programs, courses. For the last two years nearly 28,459 persons took part in trainings) • Collection and assessment drug safety and efficacy information received from physicians, manufacturers, international organizations • Control of PH functioning in health care and drug manufacturers • Expert assessment of re-registration materials relating to pharmacovigilance • Recommendations for marketing authorization holders to change or add information in the summary of product characteristics or package leaflets • Proposals for MoH on prohibition, suspension or renewal of the marketing authorization.

  15. State Inspectorate for Quality Control of Medicines State Expert Center Pharmacovigilance Quality control of medicines Detection of unsafe medicinal products Proposals submission to MoH Ukraine Regulatory decision Prohibition, suspension or renewal of a marketing authorization Regulatory decision Ways of detection of unsafe medicinal products

  16. Main methods of collecting information on drug safety in postregistration period • Spontaneous reports of suspected ADRs reports • Pharmacoepidemiological studies • ADR monitoring

  17. MoH Ukraine SECMoH Ukraine Regional divisions ADR reports Oblast Health Care Administrations Data collection, report - form № 69-healthy Health care settings Data collection, report - form № 69-healthy Physician Form 137/о, primary documentation (case histories, hospital records) Scheme of collecting ADR informationin Ukraine

  18. ADR spontaneous reporting by physicians in Ukraine

  19. Number of ADR reports received/entered in the pharmacovigilance database (2007-2010)

  20. Distribution of ADR among pharmaco-therapeutic classes (2010)

  21. TOP-10 MP (2010)

  22. Systemic ADR manifestations (2010)

  23. ADR distribution by method of MP administration, % (2010)

  24. Development of ADR by duration of therapy (2010)

  25. ADR distribution by seriousness (2010) • 79,5% – non-serious ADRs • 20,5% – serious ADRs • 7,3% involved patient hospitalization • 5,2% involved temporary disability or incapacity • 4,7% – life-threatening • 3,9% – prolonged inpatient hospitalization • 0,1% – resulted in death

  26. ADR distribution by gender and age, % (2010)

  27. At present 27% of health care settings submit ADR reports Annually all health care settings submit to MoH the summary ADR reports The pharmacovigilance database of the State Expert Center MoH Ukraine includes over 47,500 ADR reports

  28. Criteria used for evaluation of MP safety ADR frequency Ratio of unexpected and expected ADR, of serious and non-serious ADR Prevalence of ADR among cases of diseases Signal detection and confirmation Risk/benefit ratio

  29. ADR frequency Over 10% - very common ADR requiring obligatory MP safety profile or immediate appropriate regulatory actions 1-10% - common ADR requiring either study of MP safety profile or providing a risk management plan or introduction of restrictions/precautions in instruction for medical use 0.1-1% - uncommon 0.01-0.1% - rare Below 0.01% - very rare Number of registered ADR of MP for specified period Patient exposure (number of patients having used product for specified period) ADRF = ×100%

  30. Pharmacotherapy groups of MP during which use ADR were observed (2010)

  31. Prevalence of diseases according to ICD-10 per 100,000 population

  32. Prevalence of ADR among disease cases

  33. Medical errorswere observed in 2.7% of reports received in 2010. Amongthem in 10% of cases the medical error was the reason of ADR.As of 01.06.2011 the database contains 710 reports where medical errors have beendetected.

  34. Steps for evaluating risk/benefit ratio Analysis of available reliable information about adverse effects of MP Signal detection and confirmation Evaluation of alternative Regulatory decision Euphyllin with ethylenediamine, stabilizer Low molecular weight polyvinyl pyrrolidones Nimesulide- and paracetamol-containing combined MP of resorptive action Rimonabant Efalizumab Sibutramine Rosiglitazone

  35. Conducting workshops and trainings (3 workshops, 12 trainings had been conducted within 2007-2010 ); Conducting individual consultations (annually over 500); Issue of Guidelines on Principles of formation and procedure of submitting ADR information by MOH/manufacturer Cooperation in development of regulations, guidelines and publications Publication of analytical and generalized materials in 23 periodicals Issue of Rational Pharmacotherapy Journal specialized in pharmacovigilance Cooperation in pharmacovigilance with MOH/manufacturers

  36. Each company has a qualified person responsible for pharmacovigilance Trainings in pharmacovigilance are regularly conducted for companies’ staff All MOH submit PSUR with re-registration materials 47 companies submit ADR reports

  37. Submission of ADR reports

  38. During 2010 over 200 MP instructions for medical use were changed and updated based on results of expert evaluation of re-registration materials according to the current safety information and data presented in PSUR.

  39. Cooperation of formulary system with pharmacovigilance Main physician Ministry of Health of Ukraine The State Expert Center Post-registration surveillance board Central formulary committee Regional departments of Post-registration surveillance board Regional formulary committees Monitoring in-patient departments for MP efficacy and safety Clinical pharmacist (or authorized person) Pharmacotherapy committees of health care settings Spontaneous reports

  40. Participation with staff of RD, oblast physicians in workshops on implementation of formulary system Development of specific regulations on involvement of oblast physicians in regional formulary committees Cooperation of formulary system with pharmacovigilance

  41. Implementation of new methods of collecting information on ADR Pilot project on “Monitoring of MP safety and efficacy (Zhytomyr Oblast)” has been conducted (2009-2010) Planning and monitoring MP efficacy and safety in hospitals of health departments in 10 oblasts of Ukraine (2010-2011) Conducting workshops for oblast physicians and staff of RD on procedure for monitoring hospitals for MP safety and efficacy

  42. Ukraine has participated in Russian translation of WHO ADR classification (2011) and WHO recommendations “A practical handbook on the pharmacovigilance of antiretroviral medicines” Participation in international conferences conducted under aegis of WHO

  43. Participation in writing articles “State registration of MP” and “Pharmacovigilance” of new wording of Law of Ukraine “On medicines” Translation and publication of VOLUME 9A of “The Rules Governing Medicinal Products in the European Union” – Guidelines on Pharmacovigilance for Medicinal Products for Human Use) (2010) being the basic document for state guideline on pharmacovigilance Amendment of MoH Ukraine Order as of 27.12.2006 №898 related to: Involvement of nurses, pharmacists, consumers of MP (or their representatives) to ADR reporting process Pharmacovigilance and risk management systems in MP manufacturers Efficient cooperation of partners conducting pharmacovigilance Further harmonization of pharmacovigilance in Ukraine according to the amended European legislation

  44. Ministry of Health of Ukraine ADR with an established casual relationship MP manufacturers Lethal, incl. expected Serious State Inspectorate of medicines Unexpected Expected Unexpected Non-serious Expected Suspension or prohibition of registration certificate validity Development of medical and technical documents for medical care (protocols, formularies) Re-registration of medicinal product Oder Positive decision Changes in MP instruction for medical use Educational activity on safety and efficacy of pharmacotherapy Sales of MP Patients Physicians Pharmacists

  45. Practical contribution of Ukraine's pharmacovigilance system in the process of safe MP use (2009-2011) The safety information about medicinal products with the following active substances was updated through forming a signal: Thiotriazolin Quercetin L-lysine aescinate Sodium chloride Dextran (glucose solution, rheopolyglucin) Ringer’s solution, Ringer’s lactate solution Tivortin Aflubin In2010 instructions for medical use of some infusion solutions and blood substitutes were changed and updated according to the current data on MP safety and expert evaluation of re-registration materials (the model instructions were developed)

  46. Practical contribution of Ukraine's pharmacovigilance system in the process of safe MP use (2010) According to the results of post-registration surveillance over 200 MP instructions for medical use were changed and updated. Based on sufficient information and an established casual relationship between ADR and use of Glutargin (PC “Zdorovie”) and Eurespal (Servier) the “Adverse reactions” section of instruction for medical use was updated: Glutargin: rarely pain in epigastria, nausea may be observed immediately after use of medicinal product which are over on its own. In single cases allergic reactions (urticaria, hyperimia, pruritus) may be observed Eurespal – changes have been introduced both in Ukraine and all countries where this medicinal product is marketed: CVS disorders: rarely – moderate sinus tachycardia, which decreases when dose reduced GI disorders : common – dyspepsia, nausea, pain in stomach; frequency unknown – diarrhea, vomiting Nervous system disorders – rarely – somnolence; frequency unknown – dizziness Skin and subcutaneous tissue disorders: rarely – erythema, fixed pigmentary erythema, skin rash, urticaria, Quincke’s edema; frequency unknown – pruritus General disorders: frequency unknown – asthenia (weakness), fatigue

  47. The appropriate regulatory decisions on medical use of some medicinal products in Ukraine

  48. Capabilities and main objectives of pharmacovigilance system in Ukraine Detection of unsafe MP Detection of risk groups of pharmacotherapy Detection of typical medical errors being the reason for ADR and working out measures for their minimization Education healthcare professionals, MP consumersabout safety issues of MP use Implementation of MP monitoring in hospitals as optimal procedure for collecting information about ADR Involvement of nurses, pharmacists, consumers of MP in ADR reporting Further harmonization of legislation on pharmacovigilance

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