APRIL 2017 ISSUE 75

Do drugs have a puberty?

Social media in the service of pharmacovigilance History of UMCs &
WHOs drug safety efforts Community awareness & patient reporting
Pharmacogenomics Identifying medicinal products PV in Palestine
I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 1
 Directors message Contents

D
O CLINICIANS HAVE accurate expectations of the The basic principle of signal detection need not change a signal
benefits and harms of treatments, tests, and screening is a notice of an early concern or hypothesis about a possible

09.
tests? No is the answer. According to a recently medicines safety problem, with evidence and arguments to
published systematic review in JAMA, accurate support it.
expectations were rare, and clinicians more often I believe signal detection must include communicating
underestimated harms and overestimated benefits. important and relevant clinical information that
If the findings in the article are true, and adds to existing knowledge. Instead of chasing
can be generalised, one conclusion is that If I hear only new bones I suggest we spend more
our current knowledge base is skewed
towards the benefit side of treatment. We
on the radio effort adding meat to the bones we already
have. If we provide information and even
that my medicine
want treatments to work so much that we
actively search for evidence that supports
our hypotheses of effectiveness, and the
increases the risk of
headache by 20%,
suggestions about what to do when
treatment takes a negative aspect, we
properly empower health professionals
28.
ASOP 2016
ensuing promise of benefit. And we ignore and patients to do the right thing. What FOUR DECADES OF DRUG SAFETY
what does it mean?
04.
signs pointing in the opposite direction. do they tell us on airlines? What do we do
Or is it more a communication issue, when we get in a car? We think about what
talking too much about the benefits of Will I get a can go wrong and how to act to prevent
treatment relative to the risks? So many headache harm and manage it. We dont panic and we UMCS ASIA
times have we heard the argument against dont stop flying or driving or at least most PACIFIC PV
a public discussion about signals of suspected
now? of us dont because we trust the people who COURSE
adverse effects of medicines, particularly before communicate the truth more than those who hide it.
there is definite proof of causation. Signals cause Accurate expectations can only be based on sound

16.
medicine scares, jeopardise vaccination programmes, and science, open disclosure of available evidence and clear guidance
generate mistrust in the medical system in general and in from trustworthy sources. For me, this is what the WHO
medical interventions in particular. But how often do we hear Programme for International Drug Monitoring is all about.
complaints about public claims of benefits, often voiced vividly
and strongly, and rarely with evidence of the limits of benefit
one can expect from a particular treatment? READ
T. C. Hoffmann, C. Del Mar, Clinicians
Expectations of the Benefits and Harms
07.
OPINION: THE PUBERTY
VIGIBASE API:
REAL-TIME ADR
REPORTING
Whilst I agree that swift dissemination of signals of possible MOR E:
of Treatments, Screening, and Tests: OF A MEDICINE
harm can cause unnecessary public concern, it is not the timing A Systematic Review, JAMA Internal
in itself that is the main problem. If I hear on the radio that my Medicine, 2017.
medicine increases the risk of headache by 20%, what does it
mean? Will I get a headache now? And what kind of headache
are we talking about a dull ache, or a splitting pain that is
impossible to endure? Can I stop taking the drug? Should I stop
20.
SOCIAL MEDIA AND PV
taking it immediately? Fear is knowing that something is wrong
IN EUROPE
but being without control, not having any idea what to do, not
having full possession of the facts. This is the critical issue.
Knowledge is much more than numbers; it is the quality
and level of clinical detail that is paramount for the correct
interpretation and application of new medical information. Marie Lindquist, Director
06. MEDICINAL PRODUCT
DEFINITIONS 09. DOWN MEMORY LANE
As he retires from UMC, Sten Olsson 20. SOCIAL
EUROPE
MEDIA AND PV IN
Identification of Medicinal Products looks back at four decades of phar- SCOPE and MHRA raise awareness
(IDMP) sets global standards for phar- macovigilance development and the about side effects, fake medicines,
maceutical products and ingredients. growth of the WHO Programme for and the importance of ADR reporting
International Drug Monitoring. in the EU.

07. OPINION
Should medicines be allowed a
14. STRENGTHENING PV
24. AFRICA INSIGHTS
puberty in between the pre- and IN PALESTINE Community reporting in Uganda;
UPPSALA REPORTS Covering the world of pharmacovigilance post-marketing phases? How do you establish reliable health- Raising drug safety awareness in Cabo
care and pharmacovigilance practices Verde; ASoP 2016; PV in Kenya

08. FINDING
Editor-in-Chief Paula Alvarado. Editors Alexandra Hoegberg & Geoffrey Bowring. Editorial committee Supported by a team of multidisciplinary NEEDLES IN in a distressed political system?
pharmacovigilance experts. Production UMC Global Communications. Design Daniel Hansson, Zellout, Sweden. HAYSTACKS 30. IN BRIEF
Cover illustration Jan Fornhem, Zellout, Sweden.

Contact Uppsala Monitoring Centre, Box 1051, S-751 40 UPPSALA, SWEDEN | info@who-umc.org | +46-18 65 60 60. Web www.who-umc.org
Developing methods for mining social
media to find adverse drug reactions.
18. GENE TESTING FOR DRUG
METABOLIZER STATUS
Recent events and news from UMC
and the world.
Social media UMCGlobalSafety company/Uppsala-Monitoring-Centre UppsalaMonitoringCentre c/UppsalaMonitoringCentre Pharmacogenomics as a tool to identify
patients at the highest risk of serious
adverse drug reactions.

2 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 3
 Updates
MYSOR E
13 nationalities learn pharmacovigilance
at the Asia-Pacific course
Lecturers and participants at the course.
Photo: JSS
In January 2017, 28 participants from 13 countries gathered in Mysore, India,
for the two-week 3rd Asia-Pacific Pharmacovigilance Training Course.
T
HE COURSE HAS BEEN given by
Uppsala Monitoring Centre and
JSS University at the universitys
College of Pharmacy campus for
the past three years. It draws upon the
experience and curriculum of UMCs
International Pharmacovigilance Training
Course its sister-course in Uppsala,
Sweden, which will happen for the 19th
time this year.
Much like the Uppsala course, the Asia
Pacific training aims at building pharma-
covigilance capacities amongst healthcare
professionals and staff of national phar-
macovigilance centres, with the additional
ambition to address the particular needs
of Asian nations and low- and middle-in-
come countries globally.
UMC has regularly organised interna-
tional pharmacovigilance training courses
since 1993 with the overall objective of
building pharmacovigilance competence
and support the establishment and
maintenance of national pharmacovigi-
lance systems, said Sten Olsson, UMCs
4 U PPSA LA R EPORTS / ISSU E 75
recently retired WHO Programme Expert
who gave several lectures during the two-
week course.
The global perspective represented by
UMC is combined with the experience
of local experts, making the training in
Mysore particularly relevant to the specific
needs of the region, he continued.
BESIDES LECTURERS FROM UMC and
JSS, the course also welcomed external
speakers from India and abroad, such as
Mr Michael Deats from WHO head-
quarters in Switzerland, and Dr V.
Kalaiselvan from the Pharmacovigilance
Programme of India (PvPI). In total, 26
speakers attended some via video link
covering topics that ranged from health
impacts of low quality medicines to effects
of inappropriate use of medicines and
adverse drug reactions.
The presence of two lecturers who
presented at the course for the first time
provided a testimony to the positive
impact and legacy of the training courses.
Group work.
Photo: UMC
Dr Urmila Thatte gave a lecture
on safety of traditional medicines.
Photo: UMC
Ms Tschering Choden, a pharmacist who
attended the course in 2016, returned
to Mysore this year to give a lecture
on the pharmacovigilance situation in
Bhutan where she has been the driving
force behind a steep increase in adverse
drug reaction reports from one of the
countrys three regional pharmacovigi-
lance centres. Dr Jyoti Joshi from Public
Health Foundation of India an alumnus
from last years course in Uppsala gave
an engaging and well-appreciated lecture
on vaccine pharmacovigilance.
Alexandra Hoegberg
Communications Officer, UMC
alexandra.hoegberg@who-umc.org
@alex.hoegberg
www.who-umc.org/education-training/
READ
MOR E: education-training
The next pharmacovigilance training course
takes place in Uppsala, Sweden, on May 8-19.
I NSPIR E. ENGAGE. TR A NSFOR M
Helena Skld, Dr Gerald Dal Pan, and Dr Rebecca Chandler at FDAs offices in Silver Spring, Maryland.
WASH I NGTON, DC
Pharmacovigilance and risk management
in Washington, DC
Uppsala Monitoring Centres medical
doctor Rebecca Chandler and product
manager Helena Skld travelled to North
America to attend the annual DIA Confe-
rence on pharmacovigilance, and to pay
visits to the national pharmacovigilance
centres in the United States and Canada.
DIA (Develop Innovate Advance)
serves as a global forum for stakeholders
in healthcare product development and
life-cycle management. Their four-day
Pharmacovigilance and Risk Management
Strategies Conference was held on 22-25
of January in Washington, DC.
The keynote address was delivered by
a senior medical officer at the European
Medicines Agency, Hans-Georg Eichler,
who spoke on innovative therapies,
processes, and the growing role of pharmaco-
vigilance. He challenged the audience with
a vision of drug regulation of the future
I NSPIR E. ENGAGE. TR A NSFOR M
in which real world data takes a place
alongside more traditional randomised
controlled trials. He emphasised the
importance of recognising heteroge-
neity as an opportunity to understand
modifiers.
Real-world data, captured in the post-
marketing phase, is present in magnitudes
large enough to allow for better appreciation
and understanding of the variety of
phenotypes of both benefits and harms of
medicines. In short, he sees a future with a
shift from pharmacovigilance to knowledge
generation.
Another interesting presentation was
by Juergen Schmider, Vice President of
Pharmcovigilance and Safety Evaluation
and Reporting, who described work at
Pfizer to incorporate applications of artificial
intelligence to case processing and analytics
in pharmacovigilance.
Updates
AFTER THE DIA CONFERENCE, the UMC
delegation visited US FDA in Silver Spring,
Maryland. They met with pharmacovigi-
lance colleagues from both the Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) units of the FDA,
including Dr Gerald Dal Pan who serves as
director of the Office of Surveillance and
Epidemiology at CDER.
A side trip to Ottawa in Canada allowed
them the opportunity to make two visits to
Health Canada; to the Marketed Health
Products Safety and Effectiveness Bureau, and
to the Canadian Adverse Events Following
Immunization Surveillance System.
Rebecca Chandler
Medical Doctor, UMC
rebecca.chandler@who-umc.org
@RebeccaChandle1
ISSU E 75 / U PPSA LA R EPORTS 5
 Research
Setting global standards for
medicinal product definitions
The Identification of Medicinal Products (IDMP) a set of international standards supports
harmonised specifications for pharmaceutical products and their ingredients in order to enhance
pharmacovigilance activities globally.
G
LOBALISATION PRESENTS
tremendous challenges and
opportunities for the pharma-
ceutical industry, regulators, and
global health as a whole. Emerging diseases
and the health impacts of catastrophic
events respect no national boundaries, nor
does the increasing volume of substandard,
contaminated, and counterfeit products
that overburden national regulators.
Ingredients for pharmaceutical products
are typically sourced on a global basis and
it is very rare that all ingredients for a single
product are produced within one jurisdiction.
To regulate the global supply chain efficiently
and to better respond to and prepare for
catastrophic events it is essential to have a
global information system for pharmaceuti-
cal ingredients. Identification of Medicinal
Products (IDMP) is a set of international
standards, developed to support harmonised
specifications for medicinal products
and their ingredients, to enhance and
standardise pharmacovigilance activities.
Working closely with the standards
authors and with regulatory authorities,
the National Center for Advancing Tran-
slational Sciences (NCATS),part ofthe
National Institutes of Health in the US, is
developing the software that will implement
6 U PPSA LA R EPORTS / ISSU E 75
this standard.The first deployment of this
software was to the U.S. Food and Drug
Administration, with participation of other
regulatory authorities currently in the
planning stage. NCATS has been colla-
borating closely with Uppsala Monitoring
Centre on this project, whose expertise and
effort have been instrumental in planning
the work, including hosting a workshop in
Uppsala in 2015 which attracted more than
100 regulatory and industry participants.
INSTEAD OF RELYING on drug or chemical
names, which vary across countries and
regions, IDMP will enable substances to
be defined by standardised, scientific
descriptions. First, the substance is classified
into one of a few categories, such a chemical,
protein, or plant substance. Then researchers
use objective criteria, for example chemical
structure or DNA sequence, to differentiate
the substances in each category. When
enough information is available, a substance
is assigned a unique identifier, which can be
used as a quick way to refer to that ingredient
in the future. The increased granularity in
IDMP will contribute to easier tracking and
faster identification of suspected substances
by allowing easy access to information about
recipients and packaging.
Photo: Shutterstock
These data standards attempt to cover
nearly all of science from nuclear chemistry
to speciation and taxonomy. As medicine
makes new advances, it continues to push
the envelope of what matter can be used as
part of a drug, which challenges our ability
to even classify what is being produced. In
the 20th century, medicines were largely
small molecules and herbal extracts. Today,
were dealing with antibody-drug conjugates
(brentuximab-vedotin), nucleic acid
therapeutics (mipomersen), autologous
cell therapeutics (carticel; sipuleucel-T),
and synthetic biology.
Instead of basing its data management
on names, the pharmaceutical community
has realised that it is essential to capture
scientific definitions of these substances,
their defining structure elements and
properties, and so be able to compare and
assign a unique identifier for each substance.
Noel Southall
Informatics, National Center for
Advancing Translational Sciences,
National Institutes of Health
southalln@mail.nih.gov
@ncats_nih_gov
I NSPIR E. ENGAGE. TR A NSFOR M
The puberty of a medicine
By breaking down the wall between the pre-
and post-marketing phases in a medications
life-cycle, the safety profile of a new product
would have more time to mature in the real
world, argues Dr Agnes Kant from Lareb.
research conditions. For instance, it is used by a wider range of age
conditions.
what the safety issues are, so that we can balance benefits and safety
I NSPIR E. ENGAGE. TR A NSFOR M
Opinion
I
N THE LIFE-CYCLE of a medicine, there is a life before and a
life after registration. This is the result of the strict separation
between the pre- and post-marketing phases in regulatory
systems. In premarketing research, there are all kinds of
controls and restrictions. You could say that the medicine is still
under the protective care of the pharmaceutical company, as a child
would be under the care of its parents. At this stage, it hardly has
any contact with the real world.
After growing up in this protected world, after registration, from
one day to the next the medicine steps out into the real world where
its existence is less controlled. Its as if the medicine is treated as an
adult already, while it would be more accurate to say that the
medicine is still in puberty. And, as we all know, adolescents still
have a lot of life lessons to learn.
Out in the real world the medicine is taken by a much larger and
more diverse group of patients, compared to the previous controlled
groups, including older people. The medicine will also be used by
patients with comorbidity in combination with other medicines.
Some patients might get pregnant while using it. And, in real life,
healthcare professionals and patients may also behave differently
in prescribing and taking medicines, compared to the research
THERE IS PRESSURE to get a medicine on the market sooner,
especially when there are patients in need. This means shortening
the pre-marketing phase of a medicine, and allowing it to enter the
real world even in a pre-pubescent phase. Of course, everyone
wants a new medicine to become available as soon as possible for all
patients who could benefit from it. But we also want to be certain
that patients do actually benefit from it, and we want to be aware of
as soon as possible.
Therefore, instead of focusing on the challenge of how to intro-
duce medicines to the market sooner, shouldnt we focus on how to
collect the necessary independent information on the efficacy and
safety of a medicine sooner?
To achieve that goal, we should start recognising that a medicine
goes through puberty. It would be better if the medicine has contact
with the real world already in childhood, under public guidance,
and makes its transition into adulthood more slowly. This approach
could lead to a new system with a more step-by-step route, where a
medicine is guided at an earlier age and for a longer period in the
real world of daily practice. In this system it will be necessary to
break down the wall between the pre- and post-marketing life
phases of a medicine.
Agnes Kant
Director, Netherlands Pharmacovigilance Centre Lareb
a.kant@lareb.nl
ISSU E 75 / U PPSA LA R EPORTS 7
 Research Interview
UMCs Advisory Group, appointed
by the WHO PIDM board, pictured

Mining social media to find

look for. In the social media context, this is in Uppsala in the mid-80s.
a very challenging task due to the amount
of data that is available and the rare

adverse drug reactions

occurrences of relevant data.
Finding medicinal products in free text
is one part of the process of analysing social
media to find new potential drug-related
safety problems. A comprehensive drug
Get data dictionary like WHODrug is needed, but
many product names in WHODrug are
Twitter user @TwitterUser . Mar 14
Twitter user @TwitterUser . Mar 14
Find medicinal product ambiguous when used in everyday
i am experiencing photosensitivity from my anti-malarial medicine
Twitter user @TwitterUser . Mar 14 language, for example Intermezzo and
Today Im not using oxycontin for fun.. Terrible headache and
3
Twitter
waiting
45
user #badexperience
for a doctor.
Twitter user @TwitterUser . Mar 14
45 oxycontin for fun.. Terrible headache and Find
3 . Mar 17Today Im not using
@TwitterUser medical event Today. To handle the ambiguity of these
3 Today Im not using45 oxycontinwaiting
for fun..
for aTerrible headache and
Twitter user waiting for. Mar
@TwitterUser a doctor.
14 #badexperience
doctor. #badexperience
words a method was developed that applies
3 45 Find adverse
Twitterheadache
Today Im not using oxycontin for fun.. Terrible
3 #badexperience Today Im
waiting for a doctor.
user @TwitterUser
and . Mar 14
45not using oxycontin for fun.. Terrible headache and event a logistic regression model to the number
3
waiting for a doctor. #badexperience
Twitter user @TwitterUser
45 . Mar 14

3
of reports relating to the product in the
My omeprazole 45
is making my stomach even worse than before! Detect
signal
VigiBase database and the frequency of the
3 19
product name as they occur in any regular
tweet. When there are more reports in
VigiBase it usually means that the word in
the social media text is a medicinal
Research staff at Uppsala Monitoring Centre is developing product, and a higher occurrence of the
text-mining methods capable of analysing millions of social word in tweets than in VigiBase usually
means that it is not a medicinal product.
media posts in the search for messages with personal With this approach UMC researchers
were able to discard roughly two out of
experiences of adverse effects caused by medicines. three search terms when extracting data

DOWN MEMORY LANE

from social media, reducing the number

O
NE OF THE MAJOR scientific could be utilised both to generate of collected posts by 78%, thus lowering
objectives of the WEB-RADR hypotheses of new safety problems as well the cost for data collection from social

FOUR DECADES
research project in which as being an aid for testing hypotheses of media. The proportion of relevant posts
UMC takes part is to explore safety problems found elsewhere. increased from 21% to 99%, while only
the value of social media monitoring for More than half a billion tweets are sent 1% of relevant posts were lost.
pharmacovigilance purposes. To do so, each day, and posts relating to consumers' Future research in the WEB-RADR
text-mining algorithms have been experiences of adverse drug reactions are project will give additional insights into
how to find the medical events, how to

OF BUILDING
developed to detect and encode medicinal rare in proportion to the total amount of
products and medical events, as has an tweets. How to find the needles in that classify them as related to a medicinal
algorithm for adverse event recognition. huge haystack was one of the great product, and how to use this data for
The algorithm for recognising medicinal challenges that had to be addressed when signal detection.
products is completed, and its output feeds developing the methods.
the algorithm for signal detection, which is
also under development. MANY OTHER TECHNICAL challenges in Tomas Bergvall
Data Scientist, UMC

People use social media both to search social media analytics remain for
pharmacovigilance researchers to solve.
for health-related information and to share
their own health experiences. If these One is how to handle the creative ways
online sources were to be available for people describe both medicinal products
analysis in near real-time, pharmaco and, especially, medical events. A simple
vigilance could benefit greatly. The data dictionary-based approach where a fixed
set of terms is used to match against the
words in a text will not be sufficient to
People use social capture the myriad ways people describe
media both to search their symptoms or ailments. The existence
of an adverse drug reaction might be clear
for health-related from the text, but which specific event it
information and to represents might not be.
share their own health Another obstacle is that to develop
automatic methods to detect these side
experiences. effects one often needs human-annotated
data in order to tell the algorithm what to
DRUG SAFETY
tomas.bergvall@who-umc.org
@TomasBergvall
www.web-radr.eu
READ
MOR E:
Ellenius J, et al. Medication Name Entity
Recognition in Tweets Using Global Dic-
tionary Lookup and Word Sense Disam-
biguation. Pharmacoepidemiology and
Drug Safety. Vol. 25, Abstract number
710, 2016.
Almost 40 years ago, Sten Olsson became one of the first employees
of the newly established Uppsala Monitoring Centre. As he retires,
Hedfors, S, et al. Improving the Yield
of Relevant Data for Pharmacovigilance
Analysis by Reducing Search Term Com-
he looks back at how pharmacovigilance has evolved globally
plexity-A Study on Reddit Data. Pharma-
coepidemiology and Drug Safety. Vol. and become an integral part of public health.
25, Abstract number 707, 2016.

8 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 9
 Interview
I
N 1978, the 10-year-old WHO
Programme of International
Drug Monitoring (PIDM) was
in the middle of an international
relocation. The programmes
base of operations was to move
from the hustle and bustle of
WHOs headquarters in
Geneva, Switzerland, to the
small Swedish town Uppsala.
When the final touches
were made to the agreement, a young
pharmacist at Uppsala Universitys Depart-
ment of Toxicology was approached with an
offer to apply for a position at the new WHO
Collaborating Centre for International Drug
Monitoring. His name was Sten Olsson,
and he became the first of three individuals
who dedicated the next several decades
of their lives to the centre later renamed
Uppsala Monitoring Centre (UMC) and
to the development of pharmacovigilance
across the globe. Before long, he was
joined by Cecilia Biriell and Dr Marie
Lindquist, who today holds the position as
UMCs director. During the first ten years
of UMCs operations they were the only
three employees at the centre, under the
leadership of its acting director Prof ke
Liljestrand, the head of Swedens medicines
regulatory authority.
Cecilia Biriell, Marie Lindquist,
and Sten Olsson at a national
pharmacovigilance centres
meeting in Dubrovnik, Croatia.
(1985)
1968
The pilot for WHOs
UMC drug monitoring
TIMELINE programme is
launched in
Alexandria, USA.
10 U PPSA LA R EPORTS / ISSU E 75
International co-operation is essential for the
achievement of the best possible protection against
hazards for man arising out of the use of drugs.
16th World Health Assembly, Clinical and Pharmacological Evaluation of Drugs (1963)
E
ARLY MEDICINES SAFETY
The Western world was rudely
awoken to the need for post-market
surveillance of medicines in the
wake of the thalidomide disaster that caused
birth defects in new-born children in the
1950s and 60s. The disaster heralded a
resolution at WHOs 16th World Health
Assembly in 1963, which concluded that
international co-operation is essential
for the achievement of the best possible
protection against hazards for man arising
out of the use of drugs.
The result was the launch of a pilot
project in 1968, based outside Washington
D.C., USA. In 1971 it turned into a
permanent programme the WHO
Programme for International Drug
Monitoring and moved to WHOs
headquarters in Geneva, Switzerland.
A decade later, the number of
participating countries had doubled and
more than 130,000 reports on suspected
adverse drug reactions had been collected
1971
The WHO Programme for Interna-
tional Drug Monitoring (WHO PIDM)
becomes a permanent programme
and moves to WHO HQ in Geneva,
Switzerland.
in the programmes database nowadays
known as VigiBase. Unfortunately, the
priorities of the WHO leaders had shifted
in other directions.
The secretary-general Halfdan Mahler
had a strong intention to improve WHOs
support to primary healthcare, and to the
needs of developing countries, Mr Olsson
recalled. This programme involved only
developed countries. My perception was that
they wanted to save money, and close down
this particular programme.
The programme was threatened by
termination, but Sweden one of the ten
founding members stepped in and offered
to take over the operational support of the
WHO PIDM. From the Swedish side they
felt like too much investment, too much
methodological development had happened,
too much data had already been collected,
and it would be a great pity to lose this
programme, Mr Olsson said.
TECHNOLOGICAL ADVANCEMENT WAS one
of the advantages that Sweden brought to
the table. A relational database management
system called MIMER had been developed
at Uppsala University, and thanks to a close
collaboration between key actors at the
university and the pharmacist Per Manell at
the governments Department of Drugs, the
MIMER system had been implemented in
the Swedish regulatory agency.
Their advanced development of database
technology was really one of the bases for
The Swedish offer was
to bring the WHO data-
base into a new gene-
ration of IT technology,
and we did that.
1978
The WHO Collaborating Centre for International Drug
Monitoring (Uppsala Monitoring Centre) takes over
operations of the WHO PIDM. Prof ke Liljestrand is
its acting director.
Sten Olsson and Cecilia Biriell join UMC.
I NSPIR E. ENGAGE. TR A NSFOR M
why Sweden got the task of setting up this
centre, Mr Olsson said. The Swedish
offer was to bring the WHO database into
a new generation of IT technology, and we
did that.
Despite the good intentions of those
involved, the alliance between WHO and the
Swedish government was not to be an easy
one at least not initially. Many advisors
to WHO and some of the 20 countries in
the programme were sceptical about the
capacity of the new group in the far north.
However, the centre remained in Uppsala
and new countries were steadily added as
time went on. To date, the programmes
125 full member countries and 28 associate
members represent about 78% of the worlds
independent nations. All the while, the
WHO database, VigiBase, contains around
15 million reports of suspected adverse drug
reactions collected across the globe.
Generally speaking, UMC has gained
a position as the custodian of the WHO
database we manage that database and
we provide services to WHO programme
members. I think its been extremely
1979
WHO PIDM has 20 member Dr Marie Lindquist
countries and WHOs data- joins UMC.
base of individual case safety
reports (VigiBase) contains
130,000 reports.
I NSPIR E. ENGAGE. TR A NSFOR M
Interview
WHO IS STEN OLSSON?
Mr Olsson is one of the three founding mem-
bers of Uppsala Monitoring Centre. He retired
from his position as WHO Programme Expert
in early 2017. Since October 2016, hes held
the position as president of the International
Society of Pharmacovigilance (ISoP), and even
though he has retired he will stay active in the
field of medicines safety in his capacity as ISoP
president and as a private consultant. He can
be reached on stenolssonpv@gmail.com, or
on Twitter at @StenOlssonPV.
important that we have been there for the
countries, always, if they have a question
We know that the
or if they want advice on something, vast majority of all
theyve always known that they can turn regulatory decisions
to WHO and to UMC and get advice,
Mr Olsson said.
on safety are based on
spontaneous reports,
G
LOBAL PHARMACOVIGILANCE &
PUBLIC HEALTH
on observations by
In step with UMCs advance- clinicians, by health-
ments, pharmacovigilance as
a scientific field has also developed and
care professionals, and
become increasingly important. WHOs by patients it is the
Essential Medicines Programme, which was most sensitive method
launched in 1977 and which WHO describes
as a list of medicines that satisfy the priority
we have to find rare
healthcare needs of the population in a and serious adverse
country, has come a long way to make more
of the most crucial medicines accessible in
drug reactions.
low- and middle-income countries.
In the 1980s, many of these countries
just didnt have the medicines, and if you
dont have the medicines then you dont
have the problem of adverse reactions,
Mr Olsson mused, and added: When,
in the 1990s, countries had access to
1984 1990
Prof Kjell Stranberg takes over Prof A change in its statutes allows the centre to use
Liljestrands dual role as head of commercial revenues to fund its activities.
Swedens Department of Drugs and
acting director of UMC.
Prof Ralph Edwards joins the centre as director.
ISSU E 75 / U PPSA LA R EPORTS 11
 Interview Interview

Per Manell and Prof ke Liljestrand

were both involved in setting up UMC.

Group photo from the national pharmacovigilance centres meeting in Canberra, Australia. (1987) Sten Olsson, Cecilia Biriell and
Marie Lindquist at UMC. (1988) Marie Lindquist (middle) took over as director of UMC in 2009. (2011)

medicines, they also had to face the

consequences. That was also when we first
started to learn about counterfeit medicines,
and all the problems that are associated
with the inappropriate management of drug
supplies and so on.
However, the scientific validity of
spontaneous reporting has long been
questioned in the wider scientific
community. Observations of potential
adverse drug reactions to medicines provide
no certain causality, and the lack of control
groups and information about the number
of people exposed may cast doubt on the
research that stems from these observations.
From the beginning, this whole issue of
collecting clinical observations, individual
observations of patients and the suspicions
of medicines being associated with harm
has been questioned by researchers, Mr
Olsson explained. But we know that the
vast majority of all regulatory decisions on
safety are based on spontaneous reports,
on observations by clinicians, by healthcare
professionals, and by patients it is the most
sensitive method we have to find new, rare,
and serious adverse drug reactions.
Generally speaking I think we have been
successful at establishing pharmacovigilance
as a major public health movement, that it
is and should be a part of any healthcare
system. I dont think that is disputed
anymore, Mr Olsson said.
IN PUBLIC HEALTH programmes specifically,
the last 15 years have brought about much
effort to establish pharmacovigilance within
programmes focused on, for example, HIV/
AIDS, malaria, and tuberculosis around the
world. Previously, adverse drug reactions
werent an indicator of success in these
programmes, according to Mr Olsson.
Public health programmes are so
focused on treating populations and
reducing the burden of disease and mortality
that they have a disregard for collateral
damage caused by their interventions. And
thats where pharmacovigilance has another
entry point, because we are concerned about
the safety of the individual patient, Mr
Olsson said.
I can accept that as a public health
programme manager, youre very concerned
about the confidence of the programme
they dont want to talk about anything that
might jeopardise confidence, because then
people might not take their medicines or
their vaccines.
Using HIV/AIDS programmes as an
example of how that attitude can cause
a backlash, Mr Olsson said: When they
started it was all about access, access, access
to medicines. They distributed medicines
to places where there were absolutely no
educated people to help support patients
receiving very toxic medicines. And in order
to protect themselves from side effects, the
patients just didnt take those medicines,
they just refused. Then adherence rates
came down, and if you dont have an
adherence to treatment of, say 90% of all
dosages, then you risk having resistance.
Generally speaking, I think we have been
successful at establishing pharmacovigilance as
a major public health movement, that it is and
should be a part of any healthcare system.
Resistance, in turn, meant that the HIV/
AIDS programme had to fall back on
second-line or third-line therapies using
patented products, which cost more and
meant that fewer patients could be treated.
In the programmes they noticed that they
really had to take the adverse reactions
seriously, because it was the only way they
could maintain their patients on the first-
line treatment, Mr Olsson said.
I think we have now managed to explain
that pharmacovigilance is part of public
health, and we are offering facilities for
public health programmes that they dont
have themselves, he said, adding: Ive
had a lot of experience of public health
programmes and pharmacovigilance coming
together. Once they come together and they
see what they can do for each other, sweet
music occurs.
Sten Olsson with Prof Ralph Edwards,
WHEN ASKED WHAT legacy he leaves who was UMCs director 1990-2009.
behind as he retires, Mr Olsson who has Photo: UNT (2008)
visited and assisted dozens of countries on
every continent over the years answered
modestly: Whatever I have done, I have
done together with a lot of other people.
Thats the important thing that weve had
here in Uppsala weve had a team that Alexandra Hoegberg
has worked very well together, and weve all Communications Officer, UMC
had different personalities complementing alexandra.hoegberg@who-umc.org
each other. @alex.hoegberg

1992 1993 2001 2004 2009 2010 2014 2017 2018

VigiBase passes The first International Pharmacovigilance A new agreement establishes Introduction of Dr Marie Lindquist Slovenia becomes the 100 th VigiBase passes the WHO PIDM has 125 full 50-year anniversary of the WHO Programme for
1 million reports. Training Course is organised in Uppsala. that UMCs board will consist Vigibase Online, becomes director country to join the WHO 10 million mark. members and VigiBase pas- International Drug Monitoring.
The three large nations China, India, of three members chosen by precursor of of UMC. PIDM. ses 15 million reports. 40-year anniversary of Uppsala Monitoring Centre.
and Russia join the WHO PIDM, drastically the Swedish government, and VigiFlow.
increasing its population coverage. three by WHO.

12 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 13
 In focus: Palestine
Strengthening
pharmacovigilance
in Palestine
Due to instability and limited import capacities in the West Bank and the Gaza Strip,
Palestine is increasingly self-reliant on locally manufactured pharmaceuticals, which
places higher demands on the establishment of a functioning pharmacovigilance system.
P
ALESTINES HEALTHCARE SYSTEM
has been plagued by political and
economic challenges to realising a
vision of providing healthcare that
is cost-effective, safe, and equitable.
The task to ensure the safety of
pharmaceutical products lies with the
General Directorate of Pharmacy (GDP)
an agency within the Palestinian Ministry
of Health responsible for regulating
medicines and vaccines. In the private
sector, the local pharmaceutical industry
and pharmaceutical distributors also play a
prominent role in ensuring the safety of
medicines that enter the market.
Palestines pharmaceutical industry
comprises five manufacturers four in the
West Bank and one in the Gaza Strip.
Primarily, they produce generic versions of
non-patented drugs, or have contracts with
multinational pharmaceutical firms to
manufacture their drugs locally. The local
pharmaceutical industry contributes 55%
of the supply needs of the population and
50% of the market value, mainly in 11 or
14 U PPSA LA R EPORTS / ISSU E 75
12 pharmaceutical categories, including
antibiotics.
Currently, these firms export to 23
countries, with Algeria being the largest
market for the past ten years. In general,
Palestinian health professionals and the
public have a positive perception of the
quality of Palestinian products, especially
in the past 15 years, as vast improvements
in facilities and manufacturing infra-
structure have been made.
Given the increased reliance on locally
manufactured pharmaceutical products
and the concurrent growing need for
pharmaceuticals for the general main
tenance of health, in early 2015 the GDP
initiated efforts to create a pharmaco
vigilance system in the country. In
particular, the Pharmaceutical Information
Department, housed within the GDP, has
taken responsibility for monitoring adverse
drug reaction (ADR) reports and
coordinating multi-stakeholder efforts
aiming to build a pharmacovigilance
programme.
A pharmacovigilance action plan was
developed in 2015 that addresses the gaps
in training and the development of
regulations, and health provider and
manufacturing guidelines are in the final
stages of promulgation. An ADR reporting
form in Arabic exists, but reporting is very
low with only five reports received in 2015.
Although there is a National Drug Policy
and a law on medicines and medical
products, there is little focus on post-
marketing drug safety surveillance
embodied in the legislation.
CONSULTATION WITH EXPERTS in the
construction of drug safety systems in
other low- and middle-income settings
was needed in order to advance pharmaco-
vigilance in Palestine and promote
understanding and education of health-
care professionals, policymakers, and
pharmaceutical manufacturers and
distributors. In particular, due to Israeli
restrictions on travel by Palestinians both
between and outside the West Bank and
I NSPIR E. ENGAGE. TR A NSFOR M
Gaza, it is useful to seek support from
international scholars with experience in
addressing challenges to health policy
construction in distressed political systems.
Against this backdrop, two experts were
invited to Palestine to assist in training
personnel at the helm of the emerging
pharmacovigilance system. Dr Syed
Rizwanuddin Ahmad, an independent
consultant, visited Palestine in July 2016
and met with GDP staff to understand the
current state of pharmacovigilance and
offer his recommendations. During his
stay, Dr Ahmad was a guest of Birzeit
University in Ramallah on the West Bank
and delivered an interactive lecture
covering the nuts and bolts of how to
establish an effective pharmacovigilance
system. Representatives from the GDP,
local and foreign pharmaceutical
companies and distributors, academia, and
non-governmental organisations attended
the lecture.
The current pharmacovigilance
structure in Palestine is rudimentary with
I NSPIR E. ENGAGE. TR A NSFOR M
Training with Dr Jaber Jaber and Dr Rizwanuddin.
a lack of trained personnel, resources and
operational budget, and is dependent on
donor funds to function and for sustain-
ability, Dr Ahmad said.
However, with support and commit
ment from the leadership of the Ministry
of Health, the General Directorate of
Pharmacy, and international donors, and
with sufficient practical training it is likely
that with time, regulation, guidelines, and
political commitment the pharmaco-
vigilance system will become strong and
effective, he continued.
Shortly after Dr Ahmads visit, a
representative from the Jordan Food
and Drug Administration, Dr Jaber Jaber,
conducted week-long hands-on training
exercises with the GDP and representatives
of the Palestinian pharmaceutical industry
as well as pharmaceutical distributors.
His visit enabled in-depth understanding
of the tools necessary for the effective
operation of a pharmacovigilance
programme, with the experiences of
neighbouring Jordan as an effective
counterpoint to frame and contextualise
concerns of the Palestinian team.
Both visits were organised and
sponsored by grant support from the Arab
Council for the Social Sciences and the
Swedish International Development
Cooperation Agency (SIDA). The grant
aimed to support pharmacovigilance in the
Arab world in partnership with
policymakers in the Palestinian Ministry
of Health.
In focus: Palestine
WHILE THERE HAS been some progress,
many challenges remain. These are
principally due to restrictions that limit
the quantity and type of pharmaceutical
products that can be imported into the
West Bank and Gaza, thus severely
constraining the health ministrys budget
as they resort to costlier options to meet the
pharmaceutical needs of the population.
These restrictions, embodied by the Paris
Protocols, have resulted in rampant drug
shortages that preoccupy the GDP and the
health ministry more broadly. While much
work remains, the stalwart efforts of the
Palestinian Ministry of Health and its
partners in promoting and prioritising
drug safety despite the political situation is
admirable and require continued support.
Danya Qato
Assistant Professor, University of
Maryland-Baltimore
Affiliate, Institute of Global Health
dqato@rx.umaryland.edu
ISSU E 75 / U PPSA LA R EPORTS 15
 Tech update
Real-time pharmacovigilance
with the VigiBase API
Modern technology with mobile apps, online reporting, and integrated pharmacovigilance
systems open up efficient medicines safety processes. The VigiBase API is an important
building block to achieve real-time reporting of adverse effects.
T
IGHTLY CONNECTED PHARMACOVIGILANCE
systems are not only possible within a country
but also on a global scale, and a quicker
reporting process has the potential for faster
intervention when adverse drug reaction (ADR) events
take place.
The sooner data is shared from the event occurring
to the report being available for analysis the sooner
we will be able to detect emerging safety issues, also on
a global level, Anki Hagstrm, the head of Uppsala
Monitoring Centres Global Services department, said.
IMAGINE THE FOLLOWING scenario: A patient
suffers from a serious adverse reaction after taking
a medicine. The patient recollects the latest TV
awareness campaign about the importance of reporting
ADRs. Via the website of the regulatory agency in
the patients country, an online ADR reporting form
is available. In addition, a medicinal dictionary is
linked to the online form for easy selection of the
specific, correct medicine that the patient was exposed
to. The completed report is automatically uploaded
in the national pharmacovigilance system with all
available information, including correct medicine
according to the dictionary. Since the reaction was
reported as serious it is automatically highlighted
and therefore quickly handled by pharmacovigilance
staff, who only have to code reactions from any free
text and to perform causality assessment. As soon as
the ADR report is completed, a copy of the report is
automatically submitted to VigiBase, the WHO global
ICSR (Individual Case Safety Report) database. Within
a week, the ADR report is available in the VigiLyze and
VigiAccess tools for signal detection and analysis.
The above scenario is already available today
with existing technology. However, to make the
process tighter, better connections between disparate
pharmacovigilance systems are required to minimise
the need for manual interventions and to integrate
international standards from the start.
16 U PPSA LA R EPORTS / ISSU E 75
One of the building blocks needed in this scenario
is the functionality that allow automatic and real-time
reporting of ICSRs from national pharmacovigilance
centres to VigiBase. This is achieved with the newly
released VigiBase API service. The API has been
developed with simplicity in mind, yet it satisfies the
demands of security and audit trail.
Connecting national pharmacovigilance systems
directly to VigiBase will eliminate the need for
error-prone manual interactions, thereby allowing
reports to be shared one by one as they are completed,
and not in batches every week, month, or quarter as is
common today.
ALL REGULATORY AGENCIES in the process of
developing a new system, re-building an old system,
or that have an old system in place that could be easily
modified, should consider connecting to the VigiBase
API. The API is already used by VigiFlow and by one
national pharmacovigilance centres system. It will also
be used by the European Medicines Agency from the
end of 2017 according to current plans. A guideline
on how to connect to the VigiBase API is available
upon request.
Real-time data sharing via the VigiBase API
will make safety data rapidly available to the
global community, thereby improving patient
safety and public health.
Magnus Wallberg
Technology Evangelist, UMC
magnus.wallberg@who-umc.org
@CMWallberg
www.who-umc.org/vigibase/vigibase
READ
MOR E:
www.vigiaccess.org
Therse Lundin, 12 million reports &
counting, Uppsala Reports 72, 2016
I NSPIR E. ENGAGE. TR A NSFOR M
Tech update
Three steps forward for VigiLyze
VigiLyze is a search and analysis tool that provides access to the
more than 14 million individual case safety reports (ICSRs) collec-
ted in VigiBase, the WHO global ICSR database. Three keenly anti-
cipated VigiLyze developments went live at the end of 2016 and
early this year.
VigiLyze is provided by Uppsala Monitoring Centre to member
countries of the WHO Programme for International Drug
Monitoring, for their staff in both national and regional centres.
The tool makes it possible to search and analyse VigiBase data statis-
The MedDRA SOC profile of tically, and to obtain a global, regional, or national view of suspected
Accupril seen in a mobile app adverse effects of a medicine. Results from VigiLyze are generated
for ADR reporting. instantly in tabular and graphical formats.
The first new development is the ability to save and monitor
searches of interest. Once the search criteria are determined, a few
simple steps enable users to save their searches and to run them again
when the dataset is updated, which usually happens on a weekly basis.
The next update is the enabling of co-reported searches for both
medications and reactions, which is interesting for example when
investigating suspected interactions or adverse effects related to drug
combinations. Another key part of this release is the possibility to
search not only for the suspected medications, but also to include
concomitantly registered drugs. This is important, as it might
not always have been suspected at the time of occurrence that the
adverse effect was caused by a specific drug, so this feature widens
the search scope.
Our goal is to continuously incorporate into VigiLyze the analytical
methods developed by the UMC Research team. The third update
is the duplicate detection algorithm vigiMatch, which has been on
the wish list for implementation for a long time, and was released
in early January. By default, statistical overviews and disproportio-
nality analysis are now based on de-duplicated data, and suspected
duplicates are suppressed in lists of reports, to minimise the impact of
suspected duplicates on all analyses made with VigiLyze.
Health Canada is one of the most active countries in using
VigiLyze. They use it routinely in all level-2 assessments by case
assessors and signal reviewers, and the information from VigiLyze is
incorporated as part of their case series evaluation. Commenting on
the benefit of the developments, Health Canadas Adverse Reaction
Information and Issues Management Coordinator, Heather Morrison,
said: One of the recent additions in functionality that has proven
useful is the ability to search for co-reported substances as either
suspect or suspect or concomitant in the same ICSR.
This new functionality provides the capacity to retrieve adverse
reaction reports where two health products have been taken at the
same time when a reaction has occurred irrespective of the role of
the health products (suspect or concomitant). This could help with
identification of potential interactions between health products,
she continued.
Helena Skld
Product Manager, UMC
vigibase@who-umc.org
@NennePennen
READ H. Taavola, Automatic detection of suspected duplicates in
MOR E: VigiLyze using vigiMatch, Uppsala Reports 74, 2017.
IINSPIR
NSPIRE.
E. ENGAGE.
ENGAGE. TR
TRAANSFOR
NSFORMM ISSU E 75 / U PPSA LA R EPORTS 17
 Research Research

Gene testing for drug

it easier for our busy doctors to put proven
tests into everyday practice, so our patients
can get effective doses safely all while
saving the hospital money.

metaboliser status as an
Clinical decision support tools, when
built into electronic prescribing software,
offer an opportunity for systematic alerts to
prescribers. For example, a prescriber may
be prompted to undertake TPMT testing

azathioprine safety tool

during immunosuppressant or transplant
workup; a warning may also appear at the
first azathioprine prescribing episode. With
or without an e-prescribing infrastructure,
formal hospital guidelines can support best
practice.
Pharmacogenomics can be used as a tool to identify patients at the TPMT genotype testing for azathioprine
is a practical example of where
highest risk of serious adverse outcomes of medicines, and help inform pharmacogenomics can be used as a tool
to minimise severe adverse drug reactions
decisions regarding dose changes or treatment alternatives. and their medical consequences, such as
prolonged hospital stays and invasive tests.

G
ENE TESTING FOR drug
metaboliser status, known
as pharmacogenomics,
has been heralded as an
avenue to improve drug
safety. In Australian
tertiary healthcare,
pharmacogenomic testing
has begun to occasionally penetrate wider
practice, for example as an aid to selection
of psychiatry medicines (including selective
serotonin reuptake inhibitors SSRIs) in
difficult-to-stabilise patients. Drug
metabolic status testing has also been
marketed directly to the public. It has
been offered in a limited fashion through
selected community pharmacies as an
add-on service, without insurance subsidy.
ANOTHER OPPORTUNITY is the screening
of patients on azathioprine as an immuno-
modulator. Azathioprine, a prodrug of
mercaptopurine, is a low-cost drug that
appears on the WHO Model List of Essential
Medicines: Complementary List. When used
with caution, it is a useful choice from the
range of immuno-suppressant agents. It is
prescribed across various medical
specialities, but not all. Some doctors may
be unfamiliar with its routine use and the
monitoring required, which increases the
risk of poor outcome. As well as being used
for prevention of solid organ transplant
rejection, azathioprine
is prescribed for common autoimmune
diseases such as inflammatory bowel
disease and systemic lupus erythematosus.
It is also used off-label for rare diseases,
including Behets syndrome and
dermatomyositis.
The enzyme thiopurine methyl-
transferase (TPMT) is important in the
metabolism of azathioprine. It minimises
the formation of cytotoxic metabolites,
which in excess can cause unwanted bone
marrow suppression. There are many
different polymorphisms of the genes that
determine TPMT function. Amongst
Caucasians, around 0.3% of individuals
are homozygous, with markedly reduced
enzyme activity; 11% are heterozygous,
probably displaying lowered but
intermediate enzyme activity. Regardless of
metaboliser status, any patient prescribed
azathioprine still requires routine full
blood examination and liver function test
screening. Normal metaboliser status does
not entirely avert the potential for serious
adverse effects including blood disorders
(or hepatotoxicity).
AUSTIN HEALTH IS a tertiary referral
hospital in Melbourne, Australia, which is
considering a systematic approach to
pharmacogenomic testing for the TPMT
enzyme in patients prior to starting
azathioprine. The approach is still in the
early stages, and not yet implemented.
Genetic testing can prospectively identify
patients at the highest risk of serious adverse
outcomes (such as severe neutropenia).
Such information can lead to dose changes
or consideration of treatment alternatives.
Formal guidelines and clinical decision
support software may aid prescribers in
this pre-screening process. The academic
research group PharmGKB in the US
publishes a detailed open access TMPT
testing guideline for azathioprine dosing.
TPMT pathology testing is relatively
cheap in Australia, at a government
reimbursed price of 52 AUD (ca. 40
USD; 38 EUR ). In the context of the
countrys health system, this is considered
comparably low cost and a useful safety
tool. The formal health economic cost
benefit of this test globally appears as yet
unproven. The potential benefits versus
risks may differ significantly in low- and
middle-income countries.
AUSTIN HEALTH HAS a long-established
pharmacovigilance programme. Aligned
with the World Health Organization model,
the institution seek that lessons learnt
whether local, national or international
drive process change. Dr David Liew,
one of the doctors in the hospitals drug
stewardship team, said: We are making
Other drugs where pharmacogenomic
testing can have a broadly comparable
role prior to drug initiation include
abacavir (hypersensitivity reactions)
and carbamazepine (severe cutaneous
reactions).
Claire Keith
Pharmacist, Medicines Information and
Adverse Drug Reaction Committee,
Austin Health
claire.keith@austin.org.au
@ce_keith
READ PharmGKB: www.pharmgkb.org
MOR E:
A.J. Thompson et al, The Cost-
Effectiveness of a Pharmacogenetic
Test: A Trial-Based Evaluation of TPMT
Genotyping for Azathioprine, Value
in Health, 2014.
L. Lennard, Implementation of TPMT
testing, British Journal of Clincial
Pharmacology, 2014.
About Austin Health
Austin Health is a 980-bed tertiary referral
hospital service in Melbourne, Australia.
Specialities include management of liver
disease, spinal cord injury, and cancer. The
Pharmacy Medicines Information Centre is
responsible for co-ordination of the
institutions pharmacovigilance program.

18 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 19
 Communications
ADR reporting
C
OMING TOGETHER is
a beginning. Keeping
together is progress.
awareness on social
Working together is
success, Henry Ford the
founder of the Ford Motor
Company said. In the
same spirit, 21 European
media
National Competent Authorities (NCAs)
and their national pharmacovigilance
and regional monitoring centres, worked
together for the first time to launch a
coordinated adverse drug reaction (ADR)
awareness campaign on social media. The
campaign took place during a week in
November 2016 to encourage increased
reporting of suspected ADRs.
The idea originated from the
Strengthening Collaborations to Operate
Pharmacovigilance in Europe (SCOPE)
Joint Action project, which is nearing
completion. One topic, led by the UKs
Medicines and Healthcare Products Agency
(MHRA), focuses on raising awareness
about national ADR reporting systems to
tackle the unknown level of underreporting,
which is a problem for all spontaneous
adverse reaction reporting systems.
A SCOPE survey of 28 NCAs found
that only five used social media for ADR
promotion; 60% of them have not run a
public campaign since 2003; only one in five
of these campaigns were ever measured; and
there was little benchmarking of awareness
levels. These findings were reinforced in
a study by the European Organisation for
Rare Diseases (EURORDIS), concluding
that 57% of the authorities did not work
with patient organisations to promote or
support patient reporting.
SCOPE has provided
an invaluable oppor-
tunity allowing the
development of a new
21 National Competent Authorities came together in the ADR web form and
the launch of an ADR
first-of-its-kind EU-wide social media campaign during an campaign, which were
adverse drug reaction awareness week in 2016. both a great success.
20 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M
Interestingly, their study results about
sharing information on social media on side
effects showed that 16% of patients did not
know they could report; 12% did not know
who to report to; 18% were told the effect
would not last long or not be too severe;
15% did not see the connection between the
drug and the adverse event; 11% assumed
the effect would not last long; and 16%
preferred to wait and see.
SCOPE SET OUT to deliver a media toolkit
to support the efforts of NCAs to raise
awareness, which became the core campaign
materials. Planning was facilitated through
SCOPE meetings and coordinated by the
MHRA via the Heads of Medicines Working
Group of Communications Professionals,
consisting of representatives from several
EU authorities.
Not every NCA has the resources to
develop their own material, so the campaign
enabled them to adapt materials to their
local circumstances while using the same
key messages and social media assets.
These assets included infographics and an
animation, and each authority decided what
would work best in their countries.
At the centre of the campaign was an
animation developed by the SCOPE team,
supported by infographics and clips from the
animation containing key ADR messages.
The animation highlighted what a patient
needs to do if they suffer from a suspected
adverse reaction, leading on to highlight
One of SCOPEs patient reporting campaigns. Image: SCOPE
Communications
the wider benefits of reporting. One of the
main challenges was producing 24 different
versions of the material to accommodate EU
languages. Tailored versions were produced
for each NCA and for stakeholders such as
the European Medicines Agency, European
Commission and WHO, and a generic
version for EU-wide patient organisations
and charities.
It was encouraging to see more NCAs
participating than was anticipated,
considering only five had used social media
to promote reporting previously. Suspected
ADR reporting increased by 13% (1,056
reports) during the campaign week, and the
messages reached 2,562,071 people through
Twitter, Facebook, LinkedIn, and YouTube.
A range of stakeholders were also engaged
with the task to disseminate messages,
including patient organisations, healthcare
professional bodies, national health systems,
academia, government, clinical networks,
general and trade press, and media
organisations. In the evaluation, all NCA
respondents indicated it was worthwhile
running and none indicated they would not
support or run another similar campaign
themselves.
Dr Nicolae Fotin, President of National
Agency for Medicines and Medical Devices
(NAMMD) of Romania, said: SCOPE
has provided an invaluable opportunity
allowing the development of a new ADR
web form, and to launch an ADR campaign,
which were both a great success. It is the
ISSU E 75 / U PPSA LA R EPORTS 21
 Communications Communications

A cultural shift is needed, and

21
Campaign highlights
continuous communication to
patients and consumers such as
the Awareness Week, repeated
each year, together with other
media, is the cornerstone of
that change.
first extensive action to promote the importance of
ADR reporting in Romania and leading TV and radio
channels manifested the utmost interest to cover the One of MHRAs social media campaigns to raise awareness of falsified diet pills. Image: MHRA
campaign.
We are confident that the core messages reached
the general public to great extent. NAMMD saw a
350% increase for ADRs from all sources, noting a 67%

MHRAS
(700 reports) increase in direct ADR reporting from

T
consumers and healthcare professionals, he continued.
HE CAMPAIGN, which aims to change the
BASED ON THE SUCCESS and lessons learnt, NCAs are behaviour of UK consumers, employs
being encouraged to consider further building on the an integrated, multi-channel marketing
NCAs participated with common messages approach to promote key messages to
benefits and momentum by:
to promote reporting of suspected ADRs. MHRAs identified target audience, which shifts

13
Using social media frequently, to raise awareness
about adverse reactions, and to run similar national depending on the product in focus. The campaign

%
campaigns in the future. SCOPE is creating a centres around online behaviour and includes
45-minute e-learning module on raising awareness different media, but is primarily led by digital

CAMPAIGN
which includes case studies from the authorities that advertising. Significant support is provided by
will be accessible on SCOPEs website soon. partners such as the National Health Service, Get
Using the campaign materials to further promote Safe Online, and UK Anti-Doping organisations.
and educate reporter groups in different settings, The initial priority has focused on the overall
including patient organisations. issue of falsified medical products and changing
Making this an annual EU-wide campaign or global behaviour, specifically in the context of slimming
ADR awareness week. pills. To this end, the campaign has focused on
Franois Houez, Treatment Information and 18-30 year olds with a bias towards women, and
Access Director and Policy Advisor at EURORDIS, UKs Medicines and Healthcare Products Agency used a light-hearted approach to convey serious
increase in suspected ADR reporting health and financial side effects. Early work has
said: Educating the public to play an active role in
(1,056 reports). (MHRA) launched its FakeMeds campaign in garnered positive results, with the campaign
the surveillance of authorised medicines is key to
ensure medicines offer the maximum benefits and August 2016, seeking to reduce harm caused to public reaching over 25 million people. Additionally,

2,562,071
the minimum harm. A cultural shift is needed, and health by the purchase online of falsified, unlicensed, the perception of the issue of falsified medical
products increased by around 7% in the target
continuous communication to patients and consumers
such as the Awareness Week, repeated each year, and counterfeit medicines and medical devices. audience. There have also been quantified shifts
together with other media, is the cornerstone of in planned behaviours around online shopping as
that change. a result of the campaign, which demonstrate its
Any joint future campaigns would need to consider success.
planning and coordination, including how another In 2017 the campaign will expand to include
people were reached through social media. other products such as condoms and anti-
media toolkit is developed.
depressants. Over the next two years MHRA aims

337,781
Mitul Jadeja to give a range of audiences the tools to identify,
Special Projects Manager, Vigilance Intelligence avoid, and report fake medicinal products.
& Research Group, Medicines and Healthcare
Products Agency (MHRA)
mitul.jadeja@mhra.gsi.gov.uk
Lucy Cooke
READ www.scopejointaction.eu Campaigns Lead, Medicines and Healthcare
MOR E:
Products Regulatory Agency (MHRA)
www.yellowcard.mhra.gov.uk/downloadable- lucy.cooke@mhra.gov.uk
information/animations-and-vidoes/animations-
people viewed the animation. @mhragovuk
and-infographics-on-the-yellow-card-scheme

22 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 23
 Awareness
M
ANY COUNTRIES
are now facilitating
direct patient
reporting, as fewer-
than-expected
spontaneous reports
are sent in by
healthcare
professionals. When patients are allowed to
report suspected adverse drug reactions
(ADRs), the extra detail they give in their
reports can enhance our knowledge about
the medicines as well as clinical decision-
making.
Local communities have ready access to
medicines for common ailments through
community medicine distributors. For
example, the Ugandan governments
strategy of integrated community case
management of childhood illnesses has
handed anti-malarials and antibiotics to
community members with very limited
medical training. Self-medication is widely
practiced in Uganda, and for this reason
patient reporting of suspected ADRs
should be encouraged as far as possible.
UGANDAS NATIONAL pharmacovigilance
centre decided to assess the effectiveness of
the community dialogue and sensitisation
(CDS) approach to improving community
knowledge, perceptions, and participation
Community-led
in reporting suspected ADRs.
A baseline survey of local peoples
attitudes regarding patient reporting of
suspected ADRs was conducted in the
reporting of adverse
two predominantly rural districts Iganga
and Mayuge in eastern Uganda. This
survey took place in 1,034 randomly
selected households in collaboration with
drug reactions
Makerere Universitys Centre for Health
and Population Research (MUCHAP),
which runs the Iganga-Mayuge Health
in Uganda
and Demographic Surveillance Site
(IMHDSS). This site works closely with
the communities, health facilities, and
the district health office, and routinely
collects individual and household data from
about 86,000 people in 65 villages. The
To improve the safer use of medicines and boost direct population here is young, with about half
under 15 years of age.
patient reporting of adverse drug reactions in Uganda, Based on the results of the baseline
the national pharmacovigilance centre has joined survey, a CDS toolkit was developed
that included a facilitators guidebook,
with local stakeholders to engage communities through videos, pictorial flash cards, key talking
points, and a monitoring and feedback
dialogue and pharmacovigilance sensitisation. tool. Community dialogues aim to provide
people with opportunities to discuss newly
available healthcare services like patient
ADR reporting within their villages, and
24 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M
how local people can best benefit from
and support it. An end-line survey will
be conducted to assess the effectiveness
of the CDS intervention.
In preparation for the baseline survey,
the field researchers and supervisors
attended a two-day training course
covering data collection tools, field
procedures, and interview techniques.
Interviews were carried out by IMHDSS
field researchers, using a pre-tested
structured questionnaire translated
into Lusoga, the local language. The
questionnaire, training materials for the
field team, and the community sensitisation
materials were jointly developed by the
National Drug Authority (NDA) and
MUCHAP.
PRELIMINARY RESULTS show that members
of the community receive minimal infor
mation about the drugs that they are taking.
Of the 1,034 households interviewed, 46%
knew the name of the drug prescribed, and
about 56% knew why it was prescribed.
Almost all of them 96% agreed to having
received a prescription. This prescription in
many cases meant an envelope with some
pills inside it and two scribbled figures, one
for the number of tablets and the other for
the number of times a day a patient should
take the medicine.
Three-quarters of the community
receive their medicines from the private
sector health outlets 59% from drug
shops and 15% from private clinics and
therefore returning patient reports to the
drug sellers was considered the best way
Helen Byomire Ndagije from Ugandas
National Pharmacovigilance Centre.
I NSPIR E. ENGAGE. TR A NSFOR M
Awareness
1 % Phone call to NDA
2 % Phone call to DHO
2 % SMS
67.4 % Returning
to the drug seller
7 % Phone call
to the clinic
Best
8 % Local
authority
way to
report
13 % Other ways
According to the survey respondents, these are the best
places and methods for reporting adverse drug reactions.
to collect the feedback. Other ways of HAVING SOME knowledge that medicines
reporting included phone calls to either the may potentially cause harm, the
clinics or relevant authorities (such as the community shows willingness to report the
district health office and NDA), telephone occurrence of adverse events through the
short message systems, community health preferred community channels, as well as
workers, and to community leaders. to their healthcare providers. Some
Of those who had experienced an community members have experienced and
adverse event, 34% had reported it. After reported ADRs to their healthcare
reporting the event, 43% confirmed that providers, who in turn are aware of the
the drug was changed; 31% mentioned that presence of negative effects due to the
they were counselled about the effects of drugs but tend not report them.
the drug; 11% were told to continue taking Given the relatively moderate levels of
the drug; 6% mentioned that they were ADR reporting there is a need to engage
given specific treatment for the adverse communities through dialogue and
event; 5% were told to discontinue their sensitisation about drug safety monitoring,
treatment; while 4% were ignored. and a need for future pharmacovigilance
The remaining two-thirds of the and pharmacoepidemiological studies to
respondents had never reported a suspected evaluate the drug utilisation patterns and
ADR, mainly because they could not
tell if the event they were experiencing
rational use of medicines.
was attributable to the drug or not, as
was the case for 38% of them. 33% of
the respondents thought that it was not
necessary to report an ADR; 12% hoped
that the events would disappear shortly; Helen Byomire Ndagije
11% feared being victimised; and 6% had Head of Drug Information, National
the impression that the health workers had Pharmacovigilance Centre Uganda
no time to address their issues. ihbyomire@nda.or.ug
ISSU E 75 / U PPSA LA R EPORTS 25
 Communications
CABO VERDE
A
MONITORING SYSTEM for
adverse drug reactions
(ADRs) is vital for patient
safety, and patients should
TACKLES PATIENT
play an active role in it.
The experiences gathered
from patient reports show
that they are a good source
of information on adverse effects, both in
SAFETY ISSUES
qualitative and quantitative terms. However,
getting consumers involved in their
healthcare requires them to be sufficiently
well-informed to make rational decisions.
In Cabo Verde, despite the remarkable
WITH INFORMATION
progress in overall health indicators, a
recent study showed that one in four
Cabo Verdeans purchase medicines in
unauthorised stores, and over 60% are not
aware of the risks that it entails. A survey
was therefore carried out to further explore
CAMPAIGN
consumers knowledge and attitudes
towards the rational use of medicines, in
order to encourage them to participate in
the pharmacovigilance system in Cabo
Verde. Improving patient knowledge about
medicines is important in preventing
Black-market medicines, self-medication, and a low negative outcomes related to treatment.
general knowledge of the safe use of drugs motivated DURING ONE WEEK in August 2015 a
questionnaire was distributed to a sample
Cabo Verdes national pharmacovigilance centre to of 75,257 people aged 18 years and above in
all urban areas of Praia, the countrys
boost public awareness with a TV and radio campaign. capital with a total population of 132,000.
The questionnaire was created by a
multidisciplinary team with pharma
ceutical, biomedical, and statistical
backgrounds at the national pharmaco
vigilance centre. It consisted of questions
about age, gender, marital status, school
level, income and working status, and a
section related to respondents knowledge
of rational use of medicines and their
reporting attitudes.
The results showed that consumers
lack knowledge in some critical aspects,
such as the perception of medicine-risk,
A frame from ARFAs televised of which 29.3% were not aware; 78.3%
campaign. Image: ARFA
were not clear about the quality of generic
medicines; 34% were not sure about how
drugs interact with food and medicinal
herbals; and only 35.2% knew about the
ADR reporting system.
26 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M
AS A RESPONSE to these findings,
awareness campaigns were launched to
promote public knowledge of medicines.
Ten episodes of Responsible Medication
ran on TV and on the radio, with two
episodes per week during one month and
each episode repeated at the weekend. The
campaign aimed to inform the public about
general concepts regarding medicines, risks
of self-medication, generic medicines, and
risks associated with the purchase of
medicines sold illegally, as well as to
sensitise consumers to report adverse
effects and other drug-related problems.
To assess the impact of the programme,
a second survey was conducted. The
questionnaire was almost the same as the
first, but with additional questions about the
audience and performance of the TV and
radio programme. The survey was carried
out among 73,343 respondents one week in
November 2015 in urban areas of Praia.
These results showed that the perception
that medicines can have risks had a slight
Survey takers and respondents in the
capital Praia in 2015. Photo: ARFA
Communications
improvement of 0.7%, compared to the first
study. Knowledge that generic medicines
can be of as good quality as a branded
medicines increased by 11.6%. With regard
to the national pharmacovigilance system,
there was an increase of 8.7% in the
number who understood the concept of an
adverse effect, and the knowledge that they
can report them increased by 14.2%.
The programme was well accepted by the
public, with 53% of the respondents rating
the educational programme as very good,
and 38% as good. Data collected showed
that 31% of those surveyed had watched the
programme, although a bit more than half of
those interviewed knew of the programme's
existence. Moreover, the respondents
considered the campaign important for the
promotion of individual and public health,
with 71% of respondents intending to
follow the programmes recommendations
regarding the use of medicine.
EDUCATIONAL CAMPAIGNS for consumers
on the appropriate use of medicines are of
crucial importance, and well-tailored
campaigns can increase general knowledge.
The risks associated with the use of drugs
and a positive perception regarding the
quality of generic medicines are still issues
that cause doubts among the surveyed
population. Therefore, it is recommended
that the TV and radio programme
continues to be transmitted, particularly in
schools and in tandem with sensitisation
activities. It is important to plan, develop,
implement, monitor, evaluate, and reassess
effective consumer education programmes
on knowledge and attitude change
regarding the rational use of medicine.
Djamila Reis
Head, National Pharmacovigilance Centre,
Food and Drug Regulatory Agency (Agncia
de Regulao e Superviso dos Produtos
Farmacuticos e Alimentares, ARFA)
djamila.reis@arfa.gov.cv
Educational campaign: www.youtube.com/
WATC H
MOR E: watch?v=rvBVJrZ2tYU
ISSU E 75 / U PPSA LA R EPORTS 27
 ASoP 2016 In focus: Kenya

African and international pharmacovigilance stakeholders

met at ASoP 2016 to discuss drug safety on the continent.
Photos: Sharp Focus Productions_Kenya

Key recommendations from the conference
included:
Integration and/or inter-connection
of pharmacovigilance programmes
in countries are crucial for
institutionalisation of medicines safety
activities, resilient
Collaboration and cooperation is needed,
especially through regional platforms.
Effective use of pharmacovigilance
data for decisionmaking fosters
communication at all levels.
Health authorities should ensure that
Marketing Authorization Holders are
aware of the national legislations and/or
regulations on pharmacovigilance.
Pharmacovigilance stakeholders should
support initiatives Christabel N. Khaemba
aimed at securing resources.
Stakeholders should advocate for the
establishment of a global trust fund
dedicated to the advancement of
pharmacovigilance in Africa.
Strengthen pharmacovigilance in the
African region through innovative
approaches in training and enhancement
of infrastructure for pharmacovigilance.
Head of Pharmacovigilance and
Post Market Surveillance, Pharmacy &
Poisons Board Kenya
khaemba@pharmacyboardkenya.org
READ
MOR E: www.asop2016.com

Pharmacovigilance progress in Kenya

99 pharmacovigilantes at The Pharmacy and Poisons Board (PPB) since 2010. PPB has also collaborated pharmacovigilance in the East African
established Kenyas national pharma- with the University of Nairobi, HCSM, community under the Medicine Regulation
covigilance centre in 2004. The nation- the University of Washington, and SIAPS Harmonization Project.
wide pharmacovigilance system was to implement a Master of Pharmacy Currently the pharmacovigilance

ASoPs annual meeting

Kenya hosted the 3rd African Society of Pharmacovigilance in Africa; and global trends and
efforts to coordinate and harmonise
(ASoP) conference inDecember 2016, focusing on successes, best pharmacovigilance strengthening for
optimal results.
practices, and innovation in medicines safety on the continent.
launched in 2009 and PPB became the
98th member of the WHO Programme for
International Drug Monitoring in 2010.
To promote innovation, cost-
effectiveness, and sustainability, the
Pharmacovigilance Electronic Reporting
System the first VigiFlow-compatible
e-reporting system in Africa was
developed and implemented by PPB, with
support from Management Sciences for
degree in pharmacoepidemiology and
pharmacovigilance (EpiVigil). More than
15 graduates of EpiVigil are currently
implementing medicines safety activities
in public health programmes, at PPB, and
at national and county levels. PPB has four
EpiVigil specialists.
The multi-pronged approach to
pharmacovigilance-system strengthening
in Kenya has led to increased reporting of
department in collaboration with the HIV
Program are carrying out cohort event
monitoring of antiretroviral medicines
with support from the Global Fund. With
financial support from MSH and technical
support from Uppsala Monitoring Centre,
PPB is finalising the development of an
active surveillance data management tool
for collecting and analysing all active
surveillance studies in Kenya.

T
A total of 99 participants from Africa Healths Health Commodities and Services adverse events, up from 1,459 in September
and the international medicines safety Management (HCSM) programme. 2011 to over 10,000 today. These reports
HE THEME of ASoP 2016 The focus areas of the conference community attended, representing Through technical assistance from have informed several decisions, including
which was organised by were: achievements and lessons learned public and private sectors, academia, HCSM, WHO, and other stakeholders, a review of Kenya ART guidelines in 2011. Christabel N. Khaemba
Kenyas Pharmacy and in pharmacovigilance; pharmacovigilance the pharmaceutical industry, donors, Kenyas pharmacovigilance system has, The PPB is a designated Regional Head of Pharmacovigilance and
Post Market Surveillance, Pharmacy &
Poisons Board (PPB) data and use for decision-making at all research institutions, development and for example, implemented national Centre of Regulatory Excellence in
Poisons Board Kenya
was Pharmacovigilance levels; emerging areas, new ideas, and implementing partners. pharmacovigilance guidelines and a Pharmacovigilance and continues to
khaemba@pharmacyboardkenya.org
in Africa: Successes, best opportunities for pharmacovigilance in training package. Over 15,000 healthcare strive to serve as a hub for good pharmaco-
practices, innovations and Africa; challenges, unmet needs, and providers and undergraduate students vigilance practices on the continent and READ www.pv.pharmacyboardkenya.org
have been trained in pharmacovigilance MOR E:
lessons learned. strategies to advance pharmacovigilance as the technical lead country for

28 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 29
 In brief In brief

Representatives from WHO headquarters and the

WHO Collaborating Centres in pharmaocvigilance
Join the conversation on social media!
in Ghana, the Netherlands, and Morocco met up at
UMC in February.

From top left to bottom right: Agnes Kant (WHO CC Netherlands), Inass Hassan (WHO consultant),
Niklas Norn (UMC), Clive Ondari (WHO HQ), Emer Cooke (WHO HQ), Linda Hrmark (WHO CC
Netherlands), Hilda Ampadu (WHO CC Ghana), Houda Sefiani (WHO CC Morocco), Shanthi Pal (WHO
HQ), Pia Caduff (UMC), Rachida Soulaymani (WHO CC Morocco), and Marie Lindquist (UMC). Alex Dodoo (WHO CC Ghana)

Sten Olsson retired from UMC in February. He was given a warm send-off by UMCs director Marie Lindquist and the colleagues in Uppsala, as well as from
many pharmacovigilance friends from around the world who had sent in short video clips wishing him a happy retirement.

Uppsala Health Summit 2017

A One Health Approach to Emerging Infectious Diseases: New design | New ideas | New Year
Prevent, Detect, Respond NEW WEBSITE
10 - 11 October 2017 www.who-umc.org
Uppsala Castle, Sweden
Apply for a seat:
info@uppsalahealthsummit.se
www.uppsalahealthsummit.se

30 U PPSA LA R EPORTS / ISSU E 75 I NSPIR E. ENGAGE. TR A NSFOR M I NSPIR E. ENGAGE. TR A NSFOR M ISSU E 75 / U PPSA LA R EPORTS 31
 Pharmacovigilance Meetings 2017
19-21 April 2017
Congrs annuel de la Socit Franaise
de Pharmacologie et de Thrapeutique
Rouen, France Socit Franaise de
Pharmacologie et de Thrapeutique (SFPT)
www.congres-sfpt.fr
6-8 June 2017 10-14 September 2017
9th Biennial Signal Detection and 77th FIP World Congress of Pharmacy
Interpretation Conference and Pharmaceutical Sciences 2017
London, UK Drug Safety Research Unit (DSRU) Seoul, Republic of Korea FIP
www.dsru.org www.fip.org/seoul2017
@DSRUDrugSafety @FIP_org

27 April 2017 20-22 June 2017 25-27 September 2017

An Essential Overview of Pharmacovigilance Advanced Pharmacovigilance
Pharmacovigilance London, UK Management Forum Ltd London, UK Management Forum Ltd
London, UK Management Forum Ltd www.management-forum.co.uk www.management-forum.co.uk
www.management-forum.co.uk
12-14 July 2017 26-28 September 2017
3-5 May 2017 XI Congreso de Farmacovigilancia y 4th Annual Risk Management and
Medical Aspects of Adverse Drug Tecnovigilancia de la AMFV Pharmacovigilance Summit
Reactions Len, Guanajuato, Mxico Asociacin Mexicana Vienna, Austria Allan Lloyds
London, UK Drug Safety Research Unit (DSRU) de Farmacovigilancia (AMFV) www.AllanLloyds.com
www.dsru.org www.facebook.com/farmacovigilanciamex
@DSRUDrugSafety 10-11 October 2017
26-30 August 2017 Uppsala Health Summit
8-19 May 2017 33rd International Conference on Uppsala, Sweden Uppsala University
19th International Pharmacovigilance Pharmacoepidemiology & Therapeutic www.uppsalahealthsummit.se
@Ua_HealthSummit
Training Course Risk Management
Uppsala, Sweden Uppsala Monitoring Centre Montreal, Canada International Society for
(UMC) Pharmacoepidemiology (ISPE) 15-18 October 2017
www.who-umc.org www.pharmacoepi.org 17th Annual Meeting of ISoP
@UMCGlobalSafety @ICPE Liverpool, UK International Society of
Pharmacovigilance (ISoP)
8-19 May 2017 4-6 September 2017 www.isoponline.org
@ISoPonline
11me Cours Francophone de 4th ISoP UMC Pharmacovigilance
Pharmacovigilance Training
Rabat, Morocco Centre Anti Poison et de Panama City, Panama International Society of
Pharmacovigilance du Maroc (CAPM) Pharmacovigilance (ISoP) & Uppsala Monitoring
www.capm.ma Centre (UMC)
www.isoponline.org; www.who-umc.org Psst! Follow us on social
21-24 May 2017 @ISoPonline @UMCGlobalSafety media for news and updates.
6th FIP Pharmaceutical Sciences
World Congress 2017 4-15 September 2017
Stockholm, Sweden FIP Vaccine Pharmacovigilance Fellowship www.linkedin.com/company/
www.pswc2017.fip.org Accra, Ghana WHO Collaborating Centre for Uppsala-Monitoring-Centre
@FIP_org Advocacy and Training in Pharmacovigilance
www.who-pvafrica.org
@who_acc
25-26 May 2017 www.facebook.com/
ISoP Mid-Year Training Course UppsalaMonitoringCentre
Bangkok, Thailand International Society of
6-7 September 2017
Pharmacovigilance (ISoP) Back to Basics in Pharmacovigilance
www.isoponline.org Fareham, UK Drug Safety Research Unit (DSRU)
www.twitter.com/
@ISoPonline www.dsru.org
UMCGlobalSafety
@DSRUDrugSafety
5-23 June 2017
Pharmacovigilance Fellowship www.youtube.com/c/
Accra, Ghana WHO Collaborating Centre for
UppsalaMonitoringCentre
Advocacy and Training in Pharmacovigilance
www.who-pvafrica.org
@who_acc

Uppsala Monitoring Centre (UMC) is an independet non-profit foundation and centre

for international service and scientific research. Our vision is a world where all patients
and health professionals make wise therapeutic decisions in their use of medicines.
Our mission is to support and promote patient safety through effective global
pharmacovigilance practise.
32 U PPSA LA R EPORTS / ISSU E 72
75 I NSPIR E. ENGAGE. TR A NSFOR M