VigiAccess INSPIRE. ENGAGE. TRANSFORM - Find information about suspected side effects Learn more about medicines and safety Get a global ...
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VigiAccess™
INSPIRE. ENGAGE. TRANSFORM.
• Find information about suspected side effects
• Learn more about medicines and safety
• Get a global perspective on how drugs interact with people
www.who-umc.org
A vital role for all
Monitoring the side effects of medicines has long
contributed to improved patient safety. We can all make a
key contribution to this crucial activity by being more aware
of how our body interacts with the medicines we take, by
making sure we use only good quality medicines, and by
talking to our doctors about any unwanted effects.
Pharmacovigilance – monitoring following their doctor’s instructions and
the medicines we take complete their treatment, which could
Medicines may cause unexpected side lead to further serious problems. In addi-
effects that can vary from individual to tion, low quality and falsified medicines
individual. Many of these effects, also can also cause harm, or not work at all,
called adverse drug reactions, are detect- increasing our chances of experiencing
ed during drug development, but since an unwanted effect.
only a restricted number of selected pa- Reporting suspected adverse reactions
tients are treated during this phase, it is thus offers the opportunity to identify
unlikely that rare adverse reactions will and further investigate previously un-
be observed. Then, as the drug becomes known or poorly described side effects.
available on the market and more people This is of paramount importance to help
take it, previously unknown effects are ensure the safe use of medicines, and is
likely to emerge. essential as long as a medicine remains
Pharmacovigilance is the science and on the market.
activities relating to the detection, as- New initiatives are now available to
sessment, understanding and prevention help us all understand better the relation
of adverse effects or any other possible between medicines and our own well-
drug-related problems. Side effects are being within a global perspective.
a common cause for patients to stop
A global perspective
Pharmacovigilance is of in a personal relation
paramount importance VigiAccess is a user-friendly interface that
allows everyone to search VigiBase®, the
for ensuring the safe use WHO global database of adverse drug re-
of medicines. actions, and retrieve statistical data on the
suspected adverse reactions of medicines
reported to the WHO Programme for been reported as a supposed reaction to
International Drug Monitoring. the medicine we are taking. Access to
VigiAccess helps us understand how more information will give us knowledge
our bodies interact with medicines and for a better dialogue with our healthcare
enables us to learn more about possible professional. VigiAccess respects patient
side effects. The more we know about confidentiality and data protection, which
suspected adverse drug reactions and the is why the information is only available at
more information we share, the more we continental and not country level.
can contribute to better treatment effects VigiBase is an important reference
and well being. source with over 10 million reports
The interface format displays easy-to- going back to 1968. It contains reports of
understand information and helps us see suspected relationships between a drug
if our suspected side effect has previously and an adverse reaction, but it is crucial
to understand that no causal relation has A more active role for patients
been confirmed. Also, not all side effects If you suspect that you have experienced
are reported since many countries face an adverse reaction, talk to your doctor
enormous public health challenges with about the symptoms and discuss togeth-
little awareness of adverse drug reactions er the measures that you should take.
among the population. The mechanisms Your doctor has the responsibility to
to support a more active reporting role report serious unknown adverse reac-
may also be lacking. tions to your country’s national pharma-
Since 1978, UMC has been the mainte- covigilance centre as part of the WHO
nance organisation for VigiBase, provid- Programme for International Drug
ing scientific leadership and operational Monitoring. In many countries, patients
support to the WHO Programme for and consumers are encouraged to report
International Drug Monitoring and ex- adverse drug reactions themselves if they
panding the global network to more than wish. Visit the website of the National
90% of the WHO member countries. Regulatory Authority for Medicines or
UMC’s efforts have helped build the National Centre for Pharmacovigi-
global pharmacovigilance capacity and, lance for more information, or ask you
by providing access to resources and healthcare provider.
tailor-made support, encouraged local
Always discuss unexpected side effects
and regional initiatives. VigiAccess is the
with your doctor
latest tool developed by UMC to promote
pharmacovigilance and improve patient
Learn more about the medicines you
safety. Most importantly, it’s available to
take and their possible side effects
the general public.Frequently
asked questions
1. What should I do if I suspect I am ward the reports to VigiBase. Note that all
having an unexpected side effect? reports sent to VigiBase are anonymous;
Always contact your doctor if you suspect the patients, healthcare professionals or
that you are experiencing an adverse drug institutions involved cannot be identified.
reaction. Your doctor will provide the UMC regularly screens the uploaded data
advice you need and report the event to to better identify, characterise and under-
your country’s national pharmacovigi- stand the potential risks of the medicine. It
lance centre. then shares the findings with national cen-
tres, the WHO and the public via various
2. Should I stop taking a medicine if channels. More information can be found
I suspect I am having an unexpected on the UMC website: www.who-umc.org
side effect?
No. Do not discontinue your medication 5. Why can I retrieve data only at
or change the dose without seeking continental and not country level?
the advice of your healthcare provider. This ensures that patients, reporters or
VigiBase is only a reference source and treating institutions cannot be identified;
no causal relation has been confirmed. in rare cases a small number of reports in
Individual decisions must always be a specific country might lead to a breach
taken between patient and doctor. Good of privacy. If you need more information
communication is the key to balancing at country level, your national pharma-
the benefit and risk of a medicine. covigilance centre may be able to help
you, but always in compliance with local
3. Are vaccines also medicines? data protection laws.
Vaccines are also medicines and, since
they can also cause unwanted effects, are 6. What can we learn from the infor-
monitored like medicines. mation in a reporting system?
A spontaneous reporting system provides
4. What happens once an adverse very important information on potential
reaction has been reported? risks and helps identify groups of patients
The national centre for pharmacovigilance or situations in which particular attention
evaluates the report to identify potential or special monitoring might be needed.
risks. Together with the relevant authori- Since it covers all populations treated
ty, it can then take measures to minimize as long as a medicine is available on the
this risk if deemed appropriate. Countries market, the information gathered from a
participating in the WHO Programme for spontaneous reporting system is unique.
International Drug Monitoring then for- It is also very cost effective!7. What is the safety profile of Health or on behalf of them. They collect
a medicine? and evaluate spontaneous reports on
The safety profile provides information adverse reactions to medicines, advise
about the possible risks associated with a relevant authorities, and act as drug infor-
medicinal drug. Patients and healthcare mation centres for healthcare profession-
professionals need to make a benefit / risk als and the public. Their activities vary
assessment to make an informed decision greatly depending on national needs and
that best responds to patient needs and resources.
specific conditions.
10. What is a regulatory authority?
8. Can I compare the safety profile In most countries, this is the authority
of different medicines using data in charge of ensuring that only effective
from VigiBase? medicines of good quality and with a
No, this is not possible. Note also that this positive benefit / risk balance (i.e. the
reporting (so-called spontaneous report- benefits outweigh the risks) are available
ing) refers only to suspected causal rela- on the market. Well known regulatory
tionships between a drug and an adverse authorities are the US Food and Drug
event, without this relationship being Administration (US FDA) and the Euro-
proven. It is thus not possible to compare pean Medicines Agency (EMA). In some
different drugs based solely on reported countries the regulatory authority is part
information, or to conclude that one drug of the Ministry of Health, in others it is a
is safer / less safe than another. separate entity.
9. What does a national centre for
pharmacovigilance do?
National centres work either within the
local regulatory authority or Ministry of
The World Health Organization and monitors and assesses health IN BRIEF
The World Health Organization trends. It regards health as a VigiAccess simplifies retrieving and
(WHO) is the directing and co- shared responsibility, involving sharing key information from the
ordinating authority for health equitable access to essential care, VigiBase adverse reactions database
within the United Nations system. and is committed to addressing and offers a global overview of
It provides leadership on global persisting problems as well as new unexpected side effects.
health matters, shapes the health threats to public health emerging
research agenda, provides during the 21st century. For more
technical support to countries, information visit www.who.intVISIT THE VIGIACCESS WEB PAGE WWW.VIGIACCESS.ORG VigiAccess contributes to our understanding of medicines and how we interact with them; it encourages us to re- port unexpected side effects and boosts our contribution to a global safety culture. For more information, please visit www.who-umc.org
Inspire. Engage. Transform.
Photo: PhotoAlto/Johnér, Maskot, Apelöga/Scandinav, Calle Bredberg/Scandinav. Production: Matador kommunikation. Print: Kph, 2015.
Uppsala Monitoring Centre advances the science
of pharmacovigilance and inspires patient safety
initiatives all over the world. As an independent,
non-profit foundation, we engage stakeholders
who share our vision and collaborate to build
a global patient safety culture. As a leader in
the research and development of new scientific
methods, we explore the benefits and risks of
medicines to help minimize harm to patients,
and offer products and services used by health
authorities and life-science companies worldwide.
Our unique expertise makes us an organisation
with the capacity to transform patient safety from
an ambition into a reality. For almost 40 years,
we have provided scientific leadership and
operational support to the WHO Programme for
International Drug Monitoring, expanding the
global pharmacovigilance network to reach more
than 95 % of the world’s population.
Box 1051, SE-751 40, Sweden
Tel: +46-18-65 60 60 Fax: +46-18-65 60 80
E-mail: info@who-umc.org • www.who-umc.orgYou can also read
