Transcript Pharmacovigilance System in Serbiax

Agencija za lekove i medicinska sredstva Srbije
Pharmacovigilance System in Serbia:
Current Status and Challenges
Jović Ivana, M. Pharm.
Medicines and Medical Devices Agency of Serbia
(ALIMS)
Agencija za lekove i medicinska
sredstva Srbije
TAIEX Workshop on the Implementation of EU Pharmacovigilance
Legislation
Belgrade, 20 November 2015
Overview
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Development of National pharmacovigilance (PV) system
Legal framework
Institutional framework
Existing system and achieved results
Future plans and challenges
Collaboration between National PV Centre and WHO-UMC
www.alims.gov.rs
History of PV in former Yugoslavia
1974 - National PV Centre – Clinic „Rebro“ Zagreb, Republic of Croatia
- Republic PV Centre – Pharmacy Institute of Serbia (current ALIMS)
1974- Member of the WHO
Programme for International
Drug Monitoring
www.alims.gov.rs
PV in Serbia
1994 - National PV Centre - Clinical Centre of Serbia
2000 - Member of the WHO Programme for
International Drug Monitoring
2004 - Medicines and Medical Devices
Agency of Serbia (ALIMS)
National Pharmacovigilance Centre (2005)
www.alims.gov.rs
Legal framework
Law on Medicines and Medical
Devices (OG RS No. 30/2010,107/2012)
Section 10 Pharmacovigilance
Article 158 - 162
In accordance with:
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Rulebook on the method of reporting, •
EU Directive 2001/83/EC, not
with new Directive 2010/84/EU
EU Regulation 726/2004, not
with new Regulation 1235/2010
VOLUME 9A
ICH guidelines
collecting and monitoring adverse
reactions to medicines (OG RS No. 64/2011)
Rulebook on immunisation and method of protection by drugs (OG
RS, No. 11/2006, 25/2013, 63/2013, 99/2013, 118/2013, 65/2014, 32/2015)
www.alims.gov.rs
Pharmacovigilance stakeholders
Patients
Healthcare professionals
PHARMACOVIGILANCE
STAKEHOLDERS
Agency – ALIMS
(National PV Centre)
Ministry of health
(Inspection)
Marketing authorisation
holders
(local PV responsible person)
www.alims.gov.rs
ALIMS – Organisation chart
1
12
ALIMS Pharmacovigilance: National PV
centre (12) + Coordinator of PV affairs(1)
www.alims.gov.rs
National PV Centre in 2010
Sten Olsson. Patient safety in the Balkans. Uppsala
Reports 48, January 2010 (available at: www.who-umc.org)
“The National centre has now a staff of around ten highly
qualified and dedicated professionals. A successful
twinning programme with the French regulatory agency,
Afssaps, has contributed to a high level of competence
and confidence, making the Centre prepared to take on
the challenge of joining the European Union
pharmacovigilance collaboration once the political
processes are completed.”
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www.alims.gov.rs
National PV Centre in 2015
(STAFF)
• 5 Medical doctors
• 7 Pharmacists
• 1 Technical assistant
M. Pharm
M. D.
Pharm. Techn.
• 2 PhD degree
• 4 Specialists (of which, 2 have PhD degree)
• 4 Ongoing specializations
National PV Centre staff constantly improve knowledge and
competence, in order to be fully prepared to take on the
challenge of joining the EU PV collaboration.
www.alims.gov.rs
ALIMS PV ASSESSMENTS AND ACTIVITIES
Individual safety case reports (ICSRs)
National database - VigiFlowTM;
Submisson to VigiBase®;
Signal detection
PSUR/PBRER
within procedure of marketing authorisations
(MA), if available; at regular intervals; within
renewals
Safety variations
(changes of MA)
Regulatory
actions
Risk
communication
(educational
programme/
material, DHPC
etc)
RMP
within procedure of MA;
renewals; at any point in
drug lifecycle
Educational campaigns
continuous maintenance
and improvement of the
national PV system
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www.alims.gov.rs
Reporting of adverse drug reactions (ADRs)
MAH – local PV
responsible
person
Health
professionals
Patients
ALIMS – National PV centre
ICSR assessment:
seriousness
expectedness
causal relationship
National database
VigiFlowTM
www.alims.gov.rs
PV Coordinators - PV Network
Coordinator for pharmacovigilance (PV coordinator) is a healthcare
professional employed in a healthcare institution who performs activities
related to the organization and promotion of the implementation of good
practice in the collection and reporting on suspected ADRs and
communication about the risks of medicinal product use in healthcare
institution.
PV coordinator is the contact person of the healthcare institution for the
ALIMS in the domain of pharmacovigilance and collaborates with the ALIMS.
All healthcare institution in Serbia should appoint its PV coordinator and
inform ALIMS about this.
PV coordinators present our PV network for exchange of safety
information.
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www.alims.gov.rs
Coordinators for pharmacovigilance
Healthcare
professional
Healthcare
professional
Healthcare
professional
PV
coordinator
The National PV Network
(consists of ~150 coordinators):
- established during 2006-2008
- last renewed 2015
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www.alims.gov.rs
Reporting form for healthcare professionals
Suspected ADRs may be reported:
Via email
Via post
Via fax
Individualised feedback to reporter
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www.alims.gov.rs
Reporting form for patients
Suspected ADRs may be reported:
Via email
Via post
Via fax
Војводе Степе 458, 11152 Београд
Тел: 011 39 51 145 Факс: 011 39 51 130
И-мејл: [email protected]
www.alims.gov.rs
Агенција за лекове и медицинска средства Србије
НЦФ бр:
Број:
Датум:
CЗО бр:
Регионални центар за фармаковигиланцу
Образац за пријављивање НЕЖЕЉЕНИХ РЕАКЦИЈА НА ЛЕК (НРЛ) за пацијента
Уколико сумњате да је примена лека довела до нежељене реакције, попуните овај образац и пошаљите га
поштом, факсом или и-мејлом.
1. ПОДАЦИ О ПАЦИЈЕНТУ И НЕЖЕЉЕНИМ РЕАКЦИЈАМА НА ЛЕК (НРЛ)
Иницијали*
Датум рођења
Старост*
Тежина
Пол*
M
Ž
ПОЧЕТАК НРЛ*
дан
месец година
ЗАВРШЕТАК НРЛ
дан
месец
година
НРЛ је била:
умерена
непријатна, али није
утицала на свакодневне
активности
таква да је утицала на
свакодневне активности
таква да је узроковала
посету лекару
таква да је узроковала
болничко лечење
таква да је узроковала
тешко обољење
таква да је узроковала
смрт
друго (навести):
ОПИС РЕАКЦИЈА* (знаци или симптоми, укључујући податке лабораторијских тестова):
Confirmation message to reporter
Уколико немате довољно простора, молимо Вас да приложите додатне стране овом обрасцу.
ИСХОД
НРЛ:
опоравак, нема
више симптома
опоравак
још увек су присутни
погоршање
у току
симптоми НРЛ
стања
смрт
непознато
2. ПОДАЦИ О ЛЕКОВИМА ЗА КОЈЕ СУМЊАТЕ ДА СУ ДОВЕЛИ ДО НРЛ
Начин
примене
ЛЕКОВИ ПОД СУМЊОМ*
(назив лека, произвођач)
Режим
дозирања
НЕЖЕЉЕНА РЕАКЦИЈА ЈЕ ПРЕСТАЛА НАКОН ОБУСТАВЕ ПРИМЕНЕ ЛЕКА:
ДА
НЕ
НЕПОЗНАТО
РАЗЛОГ ПРИМЕНЕ ЛЕКА
ПОЧЕТАК
ПРИМЕНЕ
КРАЈ ПРИМЕНЕ
НЕЖЕЉЕНА РЕАКЦИЈА СЕ ПОНОВО ЈАВИЛА ПОСЛЕ ПОНОВНЕ
ПРИМЕНЕ ЛЕКА:
ДА
НЕ
НЕПОЗНАТО
3. ПОДАЦИ О ИСТОВРЕМЕНО ПРИМЕЊИВАНИМ ЛЕКОВИМА
ОСТАЛИ ПРИМЕЊИВАНИ ЛЕКОВИ
(назив лека, произвођач)
Начин
примене
Режим
дозирања
РАЗЛОГ ПРИМЕНЕ ЛЕКА
ПОЧЕТАК
ПРИМЕНЕ
КРАЈ ПРИМЕНЕ
4. ВАЖНИ ДОДАТНИ ПОДАЦИ О ПАЦИЈЕНТУ
(алергије, друге болести, трудноћа са датумом последње менструације, алкохол, пушење и сл.)
5. ПОДАЦИ О ОСОБИ КОЈА ПРИЈАВЉУЈЕ СЛУЧАЈ НРЛ
НРЛ се испољила:
Име и презиме*:
Вама
Адреса*:
Телефон:
Вашем детету
И-мејл:
Потпис:
Обавезно навести податке
*
Неком другом
(навести):
Датум:
Уколико желите, упишите контакт податке Вашег
изабраног лекара:
Име и презиме:
Установа:
Адреса:
Телефон:
Хвала што сте пријавили нежељену реакцију на лек.
15
www.alims.gov.rs
Online Reporting
for patients and healthcare professionals
eReporting module released and
maintained by
Allows national pharmacovigilance
centres to capture ICSRs directly from
patients and HCPs into VigiFlowTM
Gives pharmacovigilance team more
time for verifying the coding and
assessing ICSRs
eReporting with Interface and help texts translated into Serbian
available on www.alims.gov.rs since October 2015
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www.alims.gov.rs
Online Reporting
for patients and healthcare professionals
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www.alims.gov.rs
Local PV responsible person reporting
(Local MAH reporting)
CIOMS I form
(obligatory)
E2B reporting
(recommendation)
E2B reports uploaded into
national database - VigiFlowTM
manually by ALIMS PV staff
No gateway
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www.alims.gov.rs
Annual number of postmarketing ADR reports
1500
1173
1000
1018
781
423
500
102
0
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Annual reporting rate per million inhabitants
200
163
141
150
104
100
56
50
14
0
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
www.alims.gov.rs
Medicines under additional monitoring
• Medicine contains a new active substance
(authorised in the EU
after 1 January 2011)
• Biological medicine, such as a vaccine or a medicine
derived from plasma (blood) (authorised in the EU after 1 January
2011)
• Medicine has been given a conditional approval or
approved under exceptional circumstances
• The company that markets the medicine is required to carry
out additional studies, for instance, to provide more data
on long-term use of the medicine or on a rare side effect
seen during clinical trials
www.alims.gov.rs
www.alims.gov.rs
www.alims.gov.rs
Regulatory actions based on
pharmacovigilance data
ALIMS
ALIMS
ALIMS
MoH
• May require from the marketing authorisation
holders to conduct appropriate measures as part
of their risk management system
• May change the conditions of the marketing
authorisation
• May adopt a decision to revoke the marketing
authorisation or to suspend the marketing
authorisation
• May suspend or prohibit manufacturing and/or
marketing of a medicine and/or withdraw a
medicine from the market
www.alims.gov.rs
Results achieved in 2014
1018
ICSRs
590
Renewals
596
MA
642
Variations
79
Scientific
opinions
21
DHPCs
4
Restrictive
actions
17
addit. risk min.
measures
672 + 83
PSURs +RMPs
(administrative
review)
www.alims.gov.rs
ALIMS website
Legal framework
Human
medicines
Pharmacovigilance
Patients and public
Healthcare
professionals
Marketing
authorisation holders
www.alims.gov.rs
Newsletter
25
www.alims.gov.rs
ALIMS website – pharmacovigilance
Safety
information
Reporting
ADR
DHPC
Annual
reports
www.alims.gov.rs
ALIMS publications – pharmacovigilance
www.alims.gov.rs
FUTURE PLANS AND CHALLENGES
OF THE NATIONAL PV SYSTEM
• Transposing and harmonization of latest aquis
communitaire related to PV in the new Law on
medicines and Rulebook
• Development of the implementation strategy for the
new PV regulations (incorporated in the new Law on
medicines and Rulebook)
• Educational campaigns for healthcare professionals –
aiming to increase reporting rate and quality of ICSRs
• Improvement of AEFI reporting and postmarketing
surveillance of vaccines (vaccinovigilance)
www.alims.gov.rs
Collaboration between National PV Centre
and WHO-UMC
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www.alims.gov.rs
VigiBase ®
WHO Global ICSR database; it consists of reports of adverse
reactions received from member countries since 1968.
The case reports in the WHO
database do not identify the
patient or reporter.
Its purpose is to provide the
evidence from which
potential medicine safety
hazards may be detected.
www.alims.gov.rs
www.who-umc.org
www.alims.gov.rs
www.who-umc.org
www.alims.gov.rs
Communicating WHO signals
• SIGNAL is a newsletter published several times a year by UMC,
based on information derived from ICSRs available in VigiBase™
• Before signals are published, they are first clinically assessed by
pharmacovigilance experts at UMC and then reviewed by the
UMC Review Panel
• Articles in SIGNAL represent varying levels of
suspicion resulting from this assessment
• Primarily intend to inform regulatory authorities
www.alims.gov.rs
VigiAccessTM
To improve patient safety, increase
transparency and encourage the
reporting of adverse effects from
medicinal products, the WHO
launched VigiAccessTM (17/04/2015)
VigiAccessTM is a user-friendly
interface that allows everyone to
search VigiBase® and retrieve
statistical data on the suspected
adverse reactions of medicines.
http://www.vigiaccess.org/
www.alims.gov.rs
VigiAccessTM
www.alims.gov.rs
Take & Tell
http://www.takeandtell.org
www.alims.gov.rs
Take & Tell
Application
www.alims.gov.rs
CONCLUSION
• Continuous development of National pharmacovigilance system
supported by permanent international collaboration is
necessary to ensure safe and effective use of medicines.
• Harmonization with New EU PV Legislation and its
implementation in our practice is a significant contribution to
patient safety in Serbia, and small, but important step in Serbian
road to the EU.
www.alims.gov.rs
Thank you for your attention!
www.alims.gov.rs