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The Journal of the Pharmaceutical Information & Pharmacovigilance Association
Issue 45 • Sept 2014
Contents
2
President’s Report
4
From The Editors
Articles and Meeting Reports
5
Citizen Science
6
Pharmacovigilance Compliance and Market Research
8
Why Orange is the New Black
10
Outsourcing Pharmacovigilance - Pro’s, Con’s and Vendor Selection
12
How Will the EU Clinical Trial Affect You?
14
The Role of Clinical Pharmacists in Pharmacovigilance: Some Thoughts From India
17
Meeting Customer Expectations - Is There An App For That
18
How Will The Change in European Device Regulations Affect Vigilance Practises?- A Future without Scandal
20
Risk Management - How Well Are We Doing?
22
PIPA Discussion Forum
23
Diary
24
Online Learning
25
New Members
26
Noticeboard
27
PIPA Committee Members
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While all reasonable efforts are made to ensure the accuracy of the information presented in this newsletter, the editors do not accept any liability for loss arising from reliance on the
information presented.
The opinions expressed in the newsletter are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.
PIPELINE Editor:
Sanjay Motivaras and Giulia Brichetto
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1
PRESIDENT’S REPORT
Dear Members,
Sarah our President is taking well deserved annual
leave – so it has fallen to me to write the president’s
report for this issue of PIPELINE.
Christine Needham, PIPA Vice President
Despite the recent rain the weather
has been good and I hope you have
all managed to get a few days away to
enjoy the Sunshine.
The power of Social media has again
been illustrated by the success of the
ALS Ice Bucket Challenge. The challenge
has become a viral internet sensation in
the last few weeks and involves dousing
yourself with a bucket of icy water,
whilst agreeing to donate to the ALS
Association. ALS is the most common
type of motor neurone disease, which
is a progressive neurodegenerative
disease that affects nerve cells in the
spinal cord and brain. Pharmaceutical
news items have featured executives at
GlaxoSmithKline, Evotec and Biogen all
taking part in this Challenge.
Sarah described in her last report how
we have also re-organised PIPA. We
have revisited our vision continue
to redefine our structure to enable
us to play to our strengths. We have
now developed nine complementary
workstreams and will continue to focus
on these to deliver a range of services
to our members. We have now had
our first committee meeting with our
new members and it was great to see so
many new ideas bought to the table.
Vicki Page Clarke has sadly left the
committee, her role is now based in
Scotland and it has become increasingly
difficult for her to attend meetings.
Vicki led the Signal Detection working
party successfully for some years and
we would like to thank her for all her
hard work. Moving forward we have
replaced this working party with a
Pharmacovigilance Regulations and
Practice” Workstream lead by Tom
Nichols (Cancer Research UK) and deputy
John Barber (Dr Reddys).
This is a great time for you to get
involved with PIPA and help shape its
2
future. If you have feedback or would like
to join one of the workstreams, please
email me or Sarah.
The PIPA Committee has also been busy
with arrangements for this Year’s Annual
conference. We have moved from a the
traditional Summer timeslot and this
year will be holding the conference on
the 6th and 7th November, in the hope
that by avoiding the holiday season
more of you will be able to come along.
We have analysed your valuable
feedback and suggestions from last year
and are putting together a full, varied
and topical agenda for both Medical
Information and Pharmacovigilance. Full
details of the agenda will be available
shortly, but sessions are likely to include:
yy PMCPA Code of Practice changes
and their impact
yy Medical Information and
Pharmacovigilance through
acquisition
yy Interactive ‘Zinc’ workshop
yy Drug driving legislation for
pharmaceutical products
yy Medical Information and
Pharmacovigilance Standards in
practice
yy Risk Management
yy A dedicated half day Managers’
work stream
yy Patient reporting of adverse events
yy Periodic Benefit-Risk Evaluation
Reports (PBRERs)
yy Mindfulness in the workplace
yy Global Medical Information
websites
As usual the conference will also provide
a fantastic platform for networking
opportunities during discussions in the
programme sessions and through the
more informal evening social event,
The power
of Social
media has
again been
illustrated by
the success
of the ALS
Ice Bucket
Challenge
which this year promises to be as
entertaining as ever! We look forward to
seeing you there.
Book early to secure your place and to
take advantage of our preferential earlybird booking rates.
Please go to the PIPA website for further
details and full booking information:
http://www.pipaonline.org/
Conference-2014
With Best Wishes
Christine Needham – PIPA Vice President
[email protected]
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… And a brief update from Sarah
I hope you all had a great Summer – I certainly did as our family ventured into
Asia for the first time, touring and enjoying the diverse culture, landscape
and wildlife of China. I’ll never forget the immense Terracotta Army - approx.
8000 unique warriors and horses buried for centuries and rediscovered only 40
years ago. Standing in awe on the Great Wall, I tracked it’s path snaking across
the mountain ridge in each direction – a breath-taking landmark. We were
also privileged to see five baby panda - three were only 20cm long and being
nursed in incubators while two others were sleeping in a large wooden playpen.
Thank you Christine for stepping in to prepare the Pipeline report while I was
somewhat distracted! Just a few short paragraphs from me this time….
Last Autumn, I shared the Committee
concerns regarding PIPA’s cash flow and
manpower capacity. Having critically
reviewed how we could stabilize and
sustain PIPA, we made a range of
operational changes, refocused our
efforts and announced the EGM to
consult with the membership; we were
very keen but not totally confident as
to what we could achieve in the current
climate. Almost twelve months on, I
am delighted to update on our status.
Our membership base has grown and
our cash flow has been restored (a key
milestone in August - we held >£60K
in our Current Account and decided it
was time to transfer £35K to our Reserve
Account). New committee members
have enriched our core team and the
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future looks most promising. As per
constitution, Emma and Sarah A have
recently filed our accounts for our formal
5-Year Audit with our Accountants.
I am particularly delighted with the
professional and social programme for
our November conference and hope
you can join us. While many of us feed
in suggestions, it’s the Conference
Workstream, notably Christine, Tom and
Anne, who bring this all to life. A rich
mix of personal and technical learning
opportunities through presentations,
breakout workshops and our Managers
Track, coupled with informal networking
opportunities. Please visit the website for
more details and to book your place.
Sarah Dunnett, PIPA President
Many of you have already registered
and completed the Module VI and / or
the Basic PV training courses launched
by our e-Learning Workstream (these
are continuously available through our
website). Sarah H, Ester and the team have
also been busy authoring, uploading and
quality checking a number of additional
e-learning modules so look out for
announcements regarding Module XV, I
and X.
Kind Regards,
Sarah Dunnett (PIPA President)
3
FROM THE EDITORS
Dear Readers,
Welcome to our third edition of PIPELINE. I am Giulia the
new co-editor of PIPELINE and I am delighted to have
joined forces with Sanjay to deliver a journal loaded with
hot topics that stimulate discussion. We hope you will
enjoy reading this edition as summer is a great time to
relax, enjoy the milder weather and spend time on our
wider interests.
In this edition we have the pleasure of providing you with some brilliant articles on
a variety of topics, ranging from the use of new technologies in the pharmaceutical
industry to a discussion on Pharmacovigilance compliance and marketing
regulations. There is also a very handy overview of the MHRA Orange Guide, which
we hope many of you will find useful.
Giulia Brichetto
As always if you would like to read an article on a specific topic not covered by us or
showcase your writing skills and become a PIPELINE author, please get in touch. We
would love to hear from you.
The last couple of weeks we have been very busy organising the PIPA Conference,
which is just around the corner, so hurry up and buy your tickets if you haven’t
already!
I hope to see many of you at the conference so I can introduce myself in person and
meet all the new faces.
Looking forward to hearing from you all soon
Sanjay Motivaras
Giulia & Sanjay
Contact the editors:
[email protected]
Become an Author
Fellow member,
are you a budding author with an interest in writing articles
that would be of interest to medical information and
pharmacovigilance professionals?
Would you like to impart knowledge that you have gained recently
through work or training, which you feel the membership would find
useful?
e-PIPELINE is a journal which is sent to all members electronically and is read by both members and non-members.
PIPA welcomes contributions of articles from its membership for e-PIPELINE, which is registered with the British Library.
So why not take this opportunity to see your name in print….write for us!
Please contact the editorial team with your ideas or article, or for further information, and we would be delighted to
discuss the process for contributing an article in more detail: [email protected]
4
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ARTICLES
Citizen Science
Following the last President’s Report, we thought
we would give you more details on Cancer
Research UK’s exciting Citizen Science initiative
Citizen Science is a world-leading initiative from Cancer Research UK
that harnesses the power of the public to help scientists analyse real
cancer data, accelerating their research to beat cancer sooner.
Why it’s important
The most effective tool for analysing
cancer data is often the human eye.
Computers simply aren’t good enough
at understanding patterns or spotting
things that look a bit unusual. It can take
scientists years to look over the huge
volumes of data they need to analyse,
which delays the search for new cancer
treatments.
But what if the public could do this
analysis? With enough eyes on the data
we could analyse it in a fraction of the
time. Citizen scientists from around the
world have already joined our cause,
saving scientists thousands of hours by
helping to analyse genuine research data.
How it works
Our products visualise real cancer data
in engaging ways that make it exciting
and enjoyable for the general public to
get involved. The more people analysing
data, the more accurate the results will
be, and the faster new breakthroughs
can be discovered.
The results of their data analysis have
been consistent with the experts.
They’ve also shown that crowd sourcing
saves time. In just 3 months the public
analysed data that would have taken a
research team 18 months.
Play to Cure™:
Genes in Space
Play to Cure™: Genes in Space is the
world’s first app to incorporate the
analysis of genes into an action-packed
mobile game. As players traverse space
searching for a mysterious and valuable
substance and dodging oncoming
asteroids, they’re helping us to discover
critical clues about the genetic mistakes
which underpin cancer.
We know that faults in our genes can
lead to cancer cells forming. This can be
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linked to the amount of genes in our
cells - sometimes we have more and
sometimes we have less.
It‘s critical we recognise these patterns to
understand which cancer causing genes
to target when developing treatments.
With thousands of citizen scientists
playing Play to Cure™: Genes in Space,
the process is greatly accelerated.
Players first plot a galactic route. In the
context of the game, they’re choosing
their flight path, but these “space
coordinates” are actually a visualisation
of DNA data, and players are showing
our scientists where the genetic
variations are which may lead to cancer.
Tom Nichols
well a patient will respond to different
treatments.
Users are guided through a tutorial to
make sure they know what to do. They
are then shown real life breast cancer
data (below) and asked a few questions
to determine details about the cells in
the image.
Our scientists use this insight to answer
key questions about the type of cancer
they are studying; ultimately helping to
improve the diagnosis and treatment of
cancer.
Then they collect Element Alpha. This
mist like substance is collected as players
fly through space and can be traded
for ship upgrades. It actually represents
the same DNA data that has just been
mapped – which means our scientists
have two perspectives on the same
sample, from one player.
And we’ve added an asteroid field. This
makes the gameplay more engaging
and challenging, players need to dodge
or shoot a multitude of asteroids to
complete a stage.
Each data sample is analysed multiple
times for accuracy. Citizen scientists
don’t have to worry about making
mistakes. The more people who use
Play to Cure™: Genes in Space, the more
accurate the results will be and the faster
data can be translated into new ways to
beat cancer.
Cell Slider
Cell Slider is the world’s first online
platform that harnesses the collective
force of the public to help beat cancer
sooner. By examining tumour tissue
samples and spotting cancerous cells,
citizen scientists from all over the
world can help us understand how
5
Pharmacovigilance
Compliance and Market
Research
Ejaz Butt MRQA, MICR, Pharmacovigilance Compliance & Risk
Management Consultant
Ejaz Butt
Summary: Adverse event reporting has been closely monitored over the years and has developed into a
tighter, regulated process than ever before, not at least with the emergence of the new Legislation. With
every update in Pharmacovigilance - bringing along with it new challenges and currently one of those
new challenges is presented in the form of Market Research. The message resonating from the Authorities
would suggest that drug safety departments are to tighten their grip on marketing and provide similar, if
not exact, kind of oversight portrayed with clinical studies.
Each company is equipped with a team
of experts in the form of scientific/
medical advisors who in turn work
closely with product/brand managers to
either seek new information regarding
a therapeutic area or a particular
medicinal product, in order to try and
better understand the market or the
scientific data involved to help patients
and /or healthcare professionals
improve the management of disease
and optimisation of treatment. Along
with that however, also brings the risk
of adverse events (AE) being reported.
As when a market research programme
(MRP) involves direct interaction with
patients, there is always the possibility
that AEs or product complaints relating
to any of the marketing authorization
holder’s (MAH) products may be
mentioned. And where there are
possibilities of AE’s - there are risks
of under-reporting - and when the
programmes are contracted out to third
party entities, the risk increases twofold, as first line safety information is no
longer in the domain of the MAH.
Market Research Programmes, according
to the Good Vigilance Practice Module
VI (VI.C.2.2.11Reports from Patient
Support Programs (PSP) and MRPs)
is defined as a “systematic collection,
recording and analysis of data and
findings concerning medicinal products,
relevant for marketing and business
6
development”. It is often conducted
by a third party on behalf of the MAH,
and can be conducted face to face, by
telephone, online and through mail
(be it in the electronic format). It may
involve fully structured questionnaires
including closed questions, or semistructured, which involve a mix of open
and closed questions. Or it could be
completely unstructured and therefore
all open questions (qualitative). When
responding to any of the questions
presented to the participant of the
research, the possibility for patients or
health care practitioners (HCPs) - who
are the participants of the research - to
report adverse events which could be
suspected adverse drug reactions.
The GVP Module VI (VI.C.2.2.11 Reports
from PSPs and MRPs), outlines the legal
requirements in the collection of safety
data, and this module also contains
requirements applicable to MAHs for
the management and reporting of
safety data arising from PSPs and MRPs,
when made aware of them. Serious
and non-serious cases of suspected
adverse reactions originating in those
programmes are required to be reported
by MAHs as solicited reports. A Patient
Support Programs (PSPs) is defined
by Module VI, as “an organised system
where a MAH receives and collects
information relating to the use of its
medicinal products. Examples are post
…where
there are
possibilities of
AE’s - there are
risks of underreporting and when the
programmes
are contracted
out to third
party entities,
the risk
increases twofold …
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authorisation patient support and
disease management programmes,
surveys of patients and healthcare
providers, information gathering on
patient compliance, or compensation/
reimbursement schemes”. The
Association of the British Pharmaceutical
Industry (ABPI) defines a PSP as “a
service for direct patient or patient carer
interaction/engagement designed to
help management of medication and/
or disease outcomes (e.g. adherence,
awareness and education), or to provide
healthcare professionals (HCPs) with
support for their patients”. A program,
therefore, falls into the category of a PSP,
if there is direct contact with patients or
patient carers. The intention of a PSP is
to support patient care provided by the
MAH or by a third party on the MAH’s
behalf. Thus, PSP research presents itself
as a “higher risk” in terms of AEs being
reported due to the direct nature of its
interactions with participants.
Further examples of activities revolving
around PSPs include (but the list is not
an exhaustive one): helping to manage
a patient’s medication and/or disease
outcomes (e.g., adherence, awareness,
education), providing healthcare
professionals with support for their
patients, compliance programmes where
consenting patients on a medication are
contacted to see how they are managing
with their medication, etc.
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It is important to note that third parties
are acting as “delegates” of the MAH,
therefore, the AE reporting clock starts
when the third party entity is made
aware of the AE and not the date the
report is passed onto the MAH. It is
therefore of paramount importance,
that those involved with carrying out
activities within the programme are
appropriately trained. As a general
guidance, there are certain factors which
should be covered when meeting your
regulatory obligations and providing
a PV compliance oversight over MRPs.
These can be summarised through a
checklist (here enlists a minimum criteria
that ought to be covered):
1. Appropriate quality assessment of
vendor involved (due diligence)
2. Adequate training (including
reporting and/or product
information related training if
applicable)
The guidance provided is rather
broad, but the message is quite clear.
So where does the responsibilities
lie? With different parties involved in
such activities, who takes the lead to
ensure compliance is met? It is clear
that the expertise of the Drug Safety
department must be utilised to develop
a system where everyone has a precise
understanding of the pharmacovigilance
requirements and compliance of market
research programmes. Drug safety
needs to be prepared to work together
with the different entities involved, be
it Medical Affairs, Marketing, Legal and
Commercial areas of the business. They
need to encourage transparency and
be open to provide advice, training and
guidance. Ultimately, the goal is to drive
the message and promote a culture
that pharmacovigilance is very much
part of the business and together can
bring quality medicinal products to the
patient.
3. A safety data exchange agreement or
similar
4. Monitoring of program compliance
throughout the lifecycle of the
project involved, e.g. periodic
reconciliation for the process of
data exchange, etc – relevant forms/
templates can be obtained from the
BHBIA or ABPI website
7
Why Orange is the
New Black
A brief overview of MHRA Orange Guide 2014
– a Medical Information perspective
Perveen Kashem, Medical Information Scientist, Baxter Healthcare
Perveen Kashem
We are aware of Good Manufacturing Practice (GMP) and Good
Distribution Practice (GDP) as necessary to ensure safe and effective
products reach customers. Numerous directives, guidance and
regulatory requirements have been developed over the years which
cover a diverse range of medicines.
So wouldn’t it be useful to have the essential information in one
handy book? Well, the good news is a resource known as the Orange
Guide, ‘Rules and Guidance for Pharmaceutical Manufacturers and
Distributors.’
This rough guide to the latest edition of the Orange Guide gives an
overview of the contents, key changes and how information from the
guide may be useful from a Medical Information perspective.
I hope you will agree with me after this brief overview, that Orange is
indeed the new black!
History
The Orange Guide is divided into four major sections
First published in 1971 consisting of
just 30 pages, the original Orange
Guide was a voluntary guide to help
British manufacturers understand
the regulatory requirements for
the manufacture of pharmaceutical
products. Later editions followed
with more detailed requirements for
manufacturing sites, addition of Good
Distribution Practice (GDP) and in the
late 90’s it was harmonised to European
Legislation.
The guide is traditionally orange and has
maintained this cover, perhaps for easy
identification and to maintain continuity
in the Pharmaceutical Industry.
The latest edition, produced by the
Medicines Health Regulatory Agency
(MHRA) contains the changes since the
2007 edition. The Orange Guide is more
than a guide to GMP, as it covers both UK
and EU legislation on pharmaceuticals, as
well as GDP and Active Pharmaceutical
Ingredients and a whole lot more.
8
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MHRA
The first section of the book is an overview
of the MHRA and the work they do.
All licensed medicines available in the
UK are subjected to rigorous scrutiny
by the MHRA before they can be
used by patients. The MHRA assess
all applications for new medicines so
they meet acceptable standards on
safety, quality and efficacy. This is then
maintained by regular inspections and
testing throughout the lifetime of the
medicine.
Good Manufacturing Practice
-GMP (parts I, II and III)
GMP ensures products are consistently
produced and controlled according to
quality standards. GMP covers all aspect
of production from the starting materials,
premises and equipment to training and
personal hygiene of the staff.
The GMP section forms a large section of
the guide consisting of three parts;
Part I is for basic requirements for
Medicinal Products, which includes the
quality system, personnel, equipment,
documentation, outsourcing etc.
followed by 20 separate appendices
or annexes specific for product type,
e.g. sterile medicines, biologic active
substances for human use, medicines
derived from human plasma.
Part II is the basic requirements for active
substances used as starting materials
and
Part III is a new section which clarifies all
the regulatory documents required for
GMP.
Manufacture and Importation
The third section is about Manufacture
and Importation (includes extracts from
Human Medicines Regulation 2012).
This gives guidance on the conditions
required for Manufacturer’s licence, set
out in the Human Medicines Regulation
2012. This section also details the code
of practice for a ‘Qualified Person’, the
legal and regulatory requirements for
imported products.
Wholesale Distribution and
Brokering (Falsified Medicines
Directive)
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Manufacturers performing any
distribution activities with their own
products must comply with Good
Distribution Practice (GDP).
details on how to prepare a Site Master
File, provides a template exporting
active substances to the EU and ICH
requirements for batch certification.
This ensures products are consistently
stored, transported and handled under
the Marketing Authorisation (MA) holder
or product specification.
Application within Medical
Information
There are detailed instructions for the
wholesale distribution of medicinal
products by manufacturers, importers
or other wholesale distributors, or
pharmacists supplying medicinal
products to the public.
The Falsified Medicines directive came
into force in Europe in January 2013.
This introduces measures to prevent
the entry of falsified medicines into the
supply chain.
This includes guidelines to assist
wholesale distributors in conducting
their activities and to prevent falsified
medicines entering the legal supply
chain. The legislation is not just for
wholesale distributors but also brokers
who are involved in the purchase of
medicinal products without selling or
purchasing those products themselves
and without owning and physically
handling the medicinal products.
The Orange Guide is most relevant to
colleagues in Supply Chain, Quality and
Manufacturing however the principles
GMP and GDP are important for Medical
Information. When questions are raised
around manufacturing processes,
temperature controlled delivery, product
quality, product testing etc., then the
Orange Guide may well serve as a useful
background resource. It is useful to
be able to refer to it as you research
standard answers and respond to
enquiries.
For further information please contact
Perveen Kashem at:
[email protected]
Key Changes
There have been many changes to this
latest edition, however the key changes
have been in the GMP part I ‘Quality Risk
Management’ has been harmonised with
the ICH guidelines so this is an integral
part of the quality system. The section on
document retention has been amended
to include electronic documents in
light of the increasing use of electronic
documents in GMP. Guidance on the
outsourced GMP regulated activities has
also been updated.
There have been further clarifications
in the individual annexe sections, e.g. in
‘Biologic active substances’ now includes
transgenic derived products.
The other major change has been
the addition of a new chapter in the
GMP section, part III. This section was
added in December 2010, providing
a section dedicated to GMP related
documentation and clear guidance
to Regulatory expectations. This lists
9
Outsourcing
Pharmacovigilance
– Pros, Cons and Vendor
Selection
Jonathan Hart-Smith
Historically, outsourcing drug safety and pharmacovigilance was not an option a company would
consider. The pressure to keep the expertise and responsibility in-house was powerful, coupled with
concerns over data protection, confidentiality and potential non-compliance. Companies were keen to
retain control. These reservations are still evident but a track record of successful outsourcing initiatives,
together with an increasing number of competent providers, has made it more commonplace for
companies to consider the benefits.
There are three main options available when considering outsourcing:
yy Strategic full service partnership
yy Functional Service / Business Process Outsourcing (FSP / BPO)
yy Temporary staffing / contracting
Each of these options has pros and cons:
Option
Pros
Cons
Strategic
full service
partnership
• Simplified arrangement as part of a larger
outsourcing alignment
• Reduced level of daily oversight required
• Reduced fixed costs
• Access to expertise
• A shift to low cost centres
• Reduced pressure on internal staff to recruit/train
• Access to SOPs/tools
•
•
•
•
Functional
service
provision
• Increased flexibility
• Cost reductions
• Reduced demand on internal staff for
management
• Access to capabilities/skills
• Rapid response to demand
• Reduced pressure on internal staff to recruit/train
• Fixed costs become variable
• Vendor works on the clients systems reducing data
integration challenges
• External supplier has the skills and they are now
“owned” by the company
• Investment required in training the vendor in
internal systems.
Temporary • Flexible
• Rapid response to changes
staffing
• Fixed costs become variable
• Control over work allocation and outputs
• Pay per use
10
Perceived lack of control/governance
Reduced visibility of cost allocation
Significant investment in long term relationship
Potential “them and us” relationship
• Internal staff spend time recruiting and selecting
suitable contractors
• Increased cost per hour
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Even for a company that desires keeping
responsibility in house, the demand
on pharmacovigilance departments is
increasing and the growth in demand for
both capacity and skills cannot always be
delivered by an existing workforce.
Therefore regardless of your company’s
chosen arrangement, the question of
whether to outsource or not, and how, is
likely to be raised.
If you do decide to engage a third party
vendor, there are a number of questions
to ask:
yy Is this a long term strategic goal?
What are the motivators for this
(cost, expertise, location)?
yy Is this a long or short term project?
yy Is external expertise required?
yy Will this form part of a larger
outsourcing initiative?
yy What level of control will be
retained?
yy What resources are available for this
initiative?
Once these questions are answered
and the scope of this work defined, it is
time to undertake vendor selection. The
contracts and outsourcing department
will often provide support. This is likely
to follow the process of identifying some
potential providers, sending a request for
information (RFI), a request for quotation
(RFQ), supplier meetings, selection and
contract negotiation. Throughout this
process you should have some core
questions to answer:
yy Does this supplier have the
expertise, track record and capacity
to deliver?
yy Can you check their references?
yy Do they have established process,
systems and tools?
yy Do they have an established
governance structure?
yy Can they integrate with your
business?
yy Will they provide the service to
meet your budget?
yy What is your budget?
yy Will they be responsive to your
demands?
yy Do you intend to use your SOPs or
the vendors?
Having selected the right vendor, take
some time at the start of the relationship
Click here to go to Contents page
to make sure you build a shared vision
for success and to establish the trust and
two-way communication that will be the
foundation of your partnership.
Summary:
Outsourcing pharmacovigilance is
becoming far more commonplace
within the pharmaceutical industry.
With careful vendor selection and a
clear definition of the work, outsourcing
provides flexibility, expertise and cost
control. Ultimately a strong working
relationship, collaborative approach
and shared common goal will lead to a
successful partnership.
CK Aspire provides dedicated teams
and departments to help businesses
do what they do best. We provide a
high quality service managing projects,
studies or functions for clients within the
pharmaceutical science and technology
sector.
For more information on how CK Aspire
can help you, contact us on +44 (0)1438
842 967 or email [email protected]
By Jonathan Hart-Smith
MD of CK Group
11
How Will The EU Clinical
Trial Regulation Affect
You?
By Tom Nichols
Tom Nichols
The current rules to regulate the conduct of clinical trials in the EU are set out in the ‘Clinical Trials
Directive’ (2001/20/EC). However, this has been criticised by patients, researchers and industry for
disproportionate regulatory requirements.
The new Regulation aims to cut red-tape
and bring patient-orientated research
back to Europe. On April 2, 2014, in was
approved by the European Parliament.
The Regulation was then formally
adopted by the European Council of
Ministers and signed into law. All that
remains is for the Regulation to be
published in the Official Journal of the
European Union Publication, which is
expected to occur by the end of June.
The Regulation will ultimately be
binding in its entirety and automatically
incorporated into the national laws for all
EU Member States and much has been
made of a new streamlined application
and review process for research
sponsors. However, what will be the
practical changes that we will see?
Many of the current issues stem from the
rules being laid out in a Directive, so are
implemented nationally, which has lead
to:
yy Lack of consistency and ultimately
divergent applications
yy Increased administration
yy Ignoring the global nature of trials
A key component of the new Regulation
is a central, web-based, Portal through
which all applications for trials in the
EU must be submitted, electronically.
However, the Portal is currently being
developed, with no deadline set. As
transition will not be complete until
six months after the EU Portal is fully
functional, full enforcement of the
Regulation is not expected until mid2016 at the very earliest.
12
Rather than submit separate applications
to each Member State (MS) for individual
approval, a single submission to the
Portal can be made, regardless of the
number of MS in which the Sponsor
intends to conduct the trial. Upon
submission, the Sponsor must identify
one of the Member States as their
preferred Reporting Member State
(RMS), responsible for coordinating and
facilitating the review of the application.
Should the Sponsor’s proposed RMS not
wish to take on the role, there is a period
during which, the MS can discuss which
is willing to assume the position. Should
there be no agreement, the Sponsor’s
proposed RMS stands. Six days after the
submission of the application, the RMS
will be confirmed.
The RMS must also validate the
application for completeness and
compliance within ten days and report
back to the Sponsor, either validating
the application; providing the Sponsor
with ten days to provide the additional
documentation; decline to validate the
application.
There will then be two parts to the
application assessment.
Part I
Part I is a harmonised, scientific
assessment of the application and is
expected to take up to 76 days (with
extended timelines for advanced
therapies). The initial assessment of the
application will occur within 26 days
of validation and will be coordinated
by the RMS. A Draft Assessment
The new
Regulation
aims to cut
red-tape
and bring
patientorientated
research
back to
Europe.
Click here to go to Contents page
Report is circulated to the other MS,
who have 12 days to respond to the
RMS on the application and Draft
Assessment Report. Within seven days
of the coordinated review, the RMS will
produce a final Assessment Report which
the Sponsor and other MS will receive
through the Portal. This report will
either accept the application; accept the
application subject to conditions; reject
the application.
During the period of coordinated review
and production of the final Assessment
Report, the RMS can request additional
information from the Sponsor, extending
the overall deadline by up to 31 days.
Part II
Part II is a national review by each
MS, ensuring that the trial complies
with domestic laws and regulation.
Application for this stage of review can
be done in parallel with Part I, but must
occur within two years of Part I. This
also includes review by an Independent
Ethics Committee (IEC), for which the
process of coordination with must
be determined by individual MS. As
with Part I, there is a 45 day timeline
for national assessment, with up to
an additional 31 days to clarify any
questions. It is not clear whether the IEC
review will be via the Portal, or whether a
separate submission will still be required.
Potential Problems
yy Big IT projects are always risky. Nearly all communication around the
conduct of a trail will be conducted via the portal (e.g. notification
that the trial has started recruiting, suspended, DSUR submission etc.),
so must be fit for purpose. As previously mentioned, no deadline has
been set for the portal to Go-Live and is expected to take at least two
years.
yy Coordinating IEC approvals within MS. It is down to individual
countries to determine how the Part II assessments are carried out.
Within the UK, the MHRA and Health Research Authority are working
closely to implement a system of single approval. This should lead
result in an efficient review process, but is not guaranteed to be the
norm across Europe.
yy Workloads for some MS if frequently chosen to the RMS. Even if an MS
does not wish to be the RMS, they cannot refuse is no other MS accepts
the position. This could lead to unsustainable workloads for certain
authorities. Hopefully, applicants will be smart with their submissions
and ensure a healthy spread.
A final decision as to whether the trial
has been authorised, authorised with
certain conditions attached, or not
authorised will be communicated to
applicants via the portal. This notification
will take place within five days of the Part
II reporting date, or the last day of the
Part II assessment, whichever is later.
Click here to go to Contents page
13
The Role of Clinical
Pharmacists in
Pharmacovigilance:
Some Thoughts from India
Subashchander Krishnamurthy – Pharmacovigilance Associate,
Oviya MedSafe
Ganesan Ramakrishnan – Senior Drug Safety Manager, Oviya MedSafe
Subashchander Krishnamurthy
Dr J Vijay Venkatraman – Managing Director & CEO, Oviya MedSafe
Summary:
The fraternity of Pharmacy has encountered noteworthy advancements in
the recent years, across the globe. It has seen a movement from product focus
to patient centredness. With India being the fourth largest manufacturer of
pharmaceuticals in the world and with newer medications getting introduced
through clinical trials continually, the dire need to strengthen and structure the
drug safety system in the country is evident. Pharmacists, especially the ones
working in developing countries like India, are gradually coming to terms with
the fact that their jobs are no more mere assignments to be completed behind
the curtains. This article acquaints aspiring pharmacists with one such calling
where they can widen their horizons as key service providers as opposed to just
being handlers of prescription, in the value chain.
The Past and The Present
The discipline of Pharmacy is concerned
with but not limited to the planning
or administering of medications. The
professional practice has always shown
its commitment to serving community.
Ever since the inception of the concept
“pharmaceutical care” coined by C. D.
Hepler and L. M. Strand, the profession
has seen itself extending far beyond
dispensing. It emphasises and recognises
the role of pharmacist as an integral part
of the healthcare system. WHO explains
pharmaceutical care as “a philosophy
of practice in which the patient is the
primary beneficiary of the pharmacist’s
actions. Pharmaceutical care focuses on
the attitudes, behaviours, commitments,
concerns, ethics, functions, knowledge,
responsibilities and skills of the
pharmacist on the provision of drug
therapy with the goal of achieving
definite therapeutic outcomes toward
patient health and quality of life”.
Speaking globally, the role of
pharmacists has changed or grown:
perhaps now, it has become more
14
patient-focused. Pharmacists have an
important responsibility in monitoring
the ongoing safety of medicines as
part of their professional practice. The
agreed common aspect known about
pharmacists is counselling patients
on potential unfavourable impacts
of medications. This one-on-one,
two-way interaction can be utilised
further by asking them to report any
undesirable occurrence which can
serve as an effective feedback system.
Adding to this, pharmacists’ expertise
can play a vital role in early detection
of unintended adverse effects. But
does that indicate drugs are unsafe? –
Definitely not. The intricacies of drugs
need to be considered as a concept, with
benefit-risk assessment applied to treat
patients through proven or commonly
agreed measures where benefits
outweigh risks. Unless otherwise
proven, mere existence of negative data
can never be conclusive or deemed
immaterial for further analysis. Numbers
speak volumes about ubiquity and are
never actual. A drug’s benefit-risk profile
is better derived from clinical judgement.
Ganesan Ramakrishnan
Dr J Vijay Venkatraman
Click here to go to Contents page
It is here that the role of pharmacists
assumes more significance, as it could
result in gradual accumulation of drug
safety information.
Drug Safety and The Pharmacist
The history of drug usage goes way
back to 5000 BC, with suggested use
of opium. But not until 1960s after
the thalidomide tragedy that it was
deemed necessary to closely control
the quality, efficacy, and safety of
medicines. This ultimately led to the
discipline called pharmacovigilance.
WHO defines pharmacovigilance as the
science and activities relating to the
detection, assessment, understanding
and prevention of adverse effects or any
other drug-related problem. It actively
contributes to the protection of patients’
and public health. It would be prudent
to say pharmacovigilance deals with
the collection of adverse drug reaction
(ADR) reports from various stakeholders
responsible for monitoring the safety
profile of drugs. An adverse drug
reaction is a noxious and unintended
response to the administration of a
medicinal product. It may arise from the
use of a product within or outside the
terms of its marketing authorisation,
and a pharmacist knows better on
why any drug is non-inclusive of its
safety profile in entirety before it
enters the market. Pharmacists have an
important contribution to make with
regard to post-marketing surveillance.
Whether it is a non-prescription drug
or a prescribed therapy, most drugs
accessible to the patients are made
available through the pharmacists. India
still has traditional pharmacy practice
where it sees more floating prescriptions
and over-the-counters (OTCs), which
remain a challenge.
A Step Beyond
So, how can pharmacists be proactively
involved? Well, the answer is simple. The
whole purpose of pharmacovigilance is
to minimise the potential for harm that
is associated with the drug. Pharmacists
form the core of the interdisciplinary
healthcare system where safety
monitoring is the integral part of clinical
practice. It would be a myth to consider
a drug entirely safe and a misperception
to consider it entirely harmful. From
a pharmacovigilance perspective,
healthcare professionals need both good clinical judgement of the adverse
drug reaction and sound insights on the
Click here to go to Contents page
effectiveness of a drug to arrive upon
the metacentre creating a relationship
between benefit and risk.
Safety as a Concept
Safety when defined can be “relative
absence of harm”. But that does not
mean safety is never doing anything
and hoping nothing has happened.
In pharmacovigilance, safety means
collection of reports of adverse effects of
drugs. Safety can mean generating data
and arriving upon a solution to decide
on further usage of drugs. Apart from
routinely reporting ADRs, a pharmacist
must also be involved in the collection of
data that might be useful in longitudinal
pharmacoepidemiological studies. There
is a trendy rule where manufacturers
deem their drugs as safe until proven
harmful, and the regulatory authorities
consider every drug might be harmful
until proven safe. As a matter of fact, the
pharmacists should consider both. Their
roles are not just confined to reporting
adverse events but there has to be a
proactive approach in preventing the
drug-related adverse events.
Staying Vigilant
One of the safety concerns is timely
identification of the early warnings of
adverse effects. The process is usually
dependent on doctors suspecting
something and trying to find an
association between the drug and the
disease. This gives an opportunity for
the pharmacists to step in and make a
difference by identifying the initial users
of new drugs through prescriptions and
to monitor them systematically rather
than waiting for someone to recognise
a possible adverse effect. This concept
is better known as prescription event
monitoring.
In addition to the pharmacist’s
responsibilities relating to the
reporting of adverse events, they
can also involve themselves in areas
such as record keeping, education
and monitoring the over-the-counter
drugs. A major step in empowering the
pharmacists is by providing access to
the medication records of the patient,
thereby maximising the benefit and
minimising the risks of medication use.
As a result, assessments of potential
drug interactions and any adverse
event are possible. In case of changes in
the labelling or when a drug has been
withdrawn from the market, it becomes
absolutely necessary for the pharmacist
to ensure that the patients get a
change in therapy and continue to take
medications for chronic conditions.
In Clinical Practice
Pharmacists are one of the major
stakeholders along with the physicians,
patients and other healthcare
professionals. Pharmacists play a key
role in the management and prevention
of the adverse events associated with
the drug. Safety concerns are often
considered to be implied when drugs
are approved or authorized, but the
scope has widened now. It includes all
safety-related activity right from the
moment humans are first exposed to
the new drug. It should be noted that
the pharmacist has an added advantage
of getting in direct contact with the
patients who may not be involved in the
clinical trials for ethical reasons.
Safety when
defined can
be “relative
absence of
harm”. But
that does
not mean
safety is
never doing
anything
and hoping
nothing has
happened.
15
Making two factual considerations,
hospital pharmacists can play a major
role in drug safety. One, most serious
adverse drug events occur in hospitals;
two, adverse events account for a
significant percentage of all hospital
admissions. Pharmacists can actually
help in substantially reducing the
incidence of the adverse events by
recording as well as by ensuring timely
communication of adverse events
occurring in hospitals to further
control the harmful effects of these
events. This can be achieved through
direct involvement in patient care and
having a proper reporting system in
place. The adverse event information
obtained from hospitals can be quite
advantageous because of their highquality documentation. In fact, hospital
pharmacists have access to sophisticated
computer systems and databases which
augurs well for effective retrieval of
information.
Indian Framework
The Central Drugs Standard Control
Organisation (CDSCO), Directorate
General of Health Services under
the aegis of the Ministry of Health
and Family Welfare, Government of
India in collaboration with Indian
Pharmacopeia Commission (IPC),
Ghaziabad, has initiated a nation-wide
Pharmacovigilance Programme of
India (PvPI). The programme is being
coordinated by IPC as a National
Coordinating Centre (NCC). The centre
operates under the supervision of a
Steering Committee which has the Drug
Controller General of India (DCGI) as its
ex-officio chairman and the Officer-inCharge (New Drugs), CDSCO, New Delhi,
as its ex-officio Member Secretary. PvPI
currently has more than 150 functional
ADR monitoring centres (AMCs) across
the country. With increased nutritive
interest shown by government,
regulators, and industry, the numbers
are expected to soon increase involving
both private and government medical
colleges.
Accessibility
It is observed that underreporting
can be significantly reduced by
actively involving pharmacists in
the surveillance of drug safety. It is
highly recommended to increase the
participation of pharmacists especially
in a country like India, which cites
16
unawareness as primary reason for
underreporting. Negligence of reporting
is also considered to be a factor for the
steady dearth in reporting and seen as
a major setback amongst Indian HCPs.
The challenge now remains in creating
awareness.
Back in the olden days, information
about possible adverse effects of drugs
was spread through medical literature
which was then the available effective
way. Accessibility is far more accessible
now and the needed information just
a swipe away. Information technology
can be used constructively to improve
communication. Pharmacists have
quick access to a pool of information
on medication safety. India now has
a dedicated drug safety website with
a PvPI toolkit for the stakeholders.
PvPI recently launched a toll-free
helpline (1800-180-3024) to facilitate
reporting of adverse reactions. There are
various national level workshops held
providing training to the stakeholders
and generating awareness. Moreover,
it has become almost imperative for
pharmacists to use the Suspected
Adverse Drug Reaction Reporting
(SADRR) Forms to report suspected
adverse drug events. The interaction of
much of the stakeholders with the AMCs
is primarily through the SADRR forms.
This helps AMCs to maintain a database
of all the adverse events associate with a
drug. Suggestions are being proposed at
various levels to consider incorporation
of pharmacovigilance concepts in
education curriculum.
Take a Leap
Recently drug safety has earned
concerns by regulatory authorities
worldwide. Stringent laws are being
adopted. Global pharmaceutical
companies are looking at India for their
pharmacovigilance activities, which
is an added benefit to the existing
outsourcing hub. India now homes
leading PV service providers, clinical
research organisations, and IT majors.
India is one of the largest pharmaceutical
stations with many global players.
Pharmaceutical companies are now
setting up in-house PV units. With more
AMCs being added, medical colleges and
hospitals are in ardent need for trained
professionals.The industry is all set to see
much growth both in private as well as
in government sector. For aspirants who
wish to take up pharmacovigilance as
their career, this might be the right time
as future can see a demand in qualified
pharmacovigilance specialists.
Observation
A lifesaving drug today may receive
a ban tomorrow. It is very unlikely
that harm of medicines can always be
predicted and prevented but limiting
the numbers is surely attainable. A
pharmacist can perhaps be entrusted
as an effective messenger in collection
and reporting of ADRs as they are
present at all levels of medical care;
right from community pharmacy to
primary healthcare centres, government
hospitals to corporate hospitals.
Most importantly, pharmacies work
as a department at affordable and
approachable locations. This serves as
best takeaway point as pharmacists
are actively involved in the final stages
of patient care. Pharmacists can create
a trusted environment by counselling
patients to reduce medication errors,
improve safety, and quality of care;
above all, it gets them all the attention a
pharmacist deserves.
Epilogue
Getting pharmacists recognised as
healthcare service providers would help
overcome the barriers in positioning
their role in a healthcare team. At the
same time, pharmacists should step
out; challenge themselves to take up
the responsibilities while working in
complex healthcare settings. They
should stay tuned, re-invent themselves
and be prepared. A budding pharmacist
should realise that clinical pharmacy
is not just drug-drug, drug-food
interaction, but a process involving
tracking adverse drug effects, reducing
medication errors, monitoring patients’
compliance and counselling patients.
Healthcare is all about collective
accomplishment and pharmacists do
deserve a little credit. A bit of us lies in
contributing back to society and if that
giving involves our profession too, what
better a service can it be?
For further information, please contact
Dr J Vijay Venkatraman at
[email protected]
Click here to go to Contents page
Meeting Customer
Expectations –
Is There An App For That?
Steve Hutson
Innovative technologies such as mobile websites and smartphone applications have
impacted many of our traditional businesses including high street banking, music, film
and retail and in some instances companies have failed. But for a new technology
to bring about a business failure it would need to be supported by other
factors e.g. a change in customer requirements and values.
A good example
of this occurred
in the mid 2000s
when mobile users
were beginning
to demand more
from their phones,
in particular
quick and easy
access to email
and the Internet
whilst on the move. Although existing
smartphones provided these capabilities
they were not easy to use. The launch
of Apple’s first iPhone in 2007 not only
satisfied the growing requirement for
email and Internet access, but also
delivered this capability through a multitouch interface and easy to use apps.
This innovative approach transformed
the iPhone into an intuitive hand held
computer that was easy to use whilst on
the move.
Giving your customers what they want
when they need it allows you to stay
ahead of the competition and potentially
expand your market at their expense, a
maxim that applies to the pharmaceutical
industry as much as any other. Today a
high percentage of pharma customers
e.g. healthcare professionals (HCPs)
and patients, own smartphones and
use apps in their day-to-day activities
and want to use this technology
when dealing with the industry. But is
pharma addressing this fundamental
change in its customer base?
In those areas where HCPs and
patients work closely with the industry,
Click here to go to Contents page
such as drug
development and
marketing, we
find the adoption
of mobile
technology
patchy. Marketing
are very active
in this field
and across the
industry there
are over 2000 smartphone apps for
customers, a marked contrast to drug
development, where only a few apps are
available.
There are a number of reasons why drug
development might want to address
this lack of mobile adoption. Firstly, as
already mentioned, many HCPs and
patients are mobile savvy and now
expect to use this technology at every
opportunity including reporting clinical
trial data for instance. Secondly, industry
regulators have picked up on this change
in customer expectations and have
begun to engage with them through
mobile technologies. For example, since
2012 the FDAs MedWatcher app has
been available for HCPs and the general
public to report adverse events directly
to the regulator. More recently the FDA
has made their adverse event reporting
system (FAERS) accessible to app
developers through the OpenFDA project.
These two projects demonstrate a
growing desire amongst HCPs and
patients to get involved in drug safety
and the FDA recognizes the potential
these initiatives have in helping
anticipate safety issues before they
become a problem.
yy A UK initiative, Care.data, has
similar potential. This project plans
to release anonymous patient
information from GP records and
when combined with similar data
from hospital records will create a
huge resource for medical research.
Such a dataset could, like the FAERS
data, be accessed using mobile apps.
yy Leading technology companies
also recognize the potential for
healthcare data. Apple, Google,
Samsung and IBM have already
developed tools that allow health
and fitness apps to work together
and pool results into big data sets
suitable for medical research. I’m
sure it will not be long before these
companies have mobile apps for
medical researchers to interrogate
these data.
For the pharmaceutical industry to catch
up with what the regulators, customer
groups and IT companies are already
doing with mobile technologies will
require considerable effort. However,
the recent announcement by Novartis
to explore the potential of Google’s
“smart lens” to address ocular conditions
suggests that the industry is waking up
to the potential of mobile technologies.
Steve Hutson
Co-founder, VirtualPV Ltd.
17
How Will The Change
in European Device
Regulations Affect
Vigilance Practises?
- A Future without Scandal
Matt Tutton, Senior Pharmacovigilance Scientist, Quanticate Limited.
Matt Tutton
In October 2013 the European Parliament agreed to new proposals for regulation on medical devices and
in vitro diagnostic medical devices. Outdated legislation and high profile scandals have made changes
a necessity. This is despite disagreements between legislators and industry over the content of the new
legislation. But how will this impact vigilance procedure and will it stop medical device scandals from
ever happening again?
Before we look forward it is worth
looking back to the early 1990s. This was
a time before the internet had taken over
our lives. Politically and geographically
the fall of the Berlin Wall symbolised
the dawn of a new Europe at this time.
What has this got to do with Medical
Devices I dare you ask? It was around
the same time that the medical device
legislation was first drafted. These are
the same directives we work with today
(if you exclude numerous amendments).
This backdrop is significant because
the legislation was initially drafted at a
time when there were fewer EU Member
States and fewer advances in medical
device technology.
The three areas of current device
legislation are:
yy Medical Devices Directive (93/42/
EEC)
yy Active Implantable Medical Devices
Directive (90/385/EEC)
18
complete overhaul. Recent scandals
within the medical device industry,
most notably the Poly Implant Prothese
(PIP) breast implant scandal, have raised
public concerns and accelerated the
urgency for change. The new legislation
aims to toughen up the rules of the
industry and ensure mistakes and
misconduct are not likely to occur
Who will be affected by the changes?
The answer is really everyone who
is exposed to a medical device both
directly and indirectly, such as the
patients/consumers, healthcare
professionals and manufacturers. It is
important to note there is an acceptance
that change is necessary for reasons
already mentioned; however there are
objections from the industry to the
proposed changes in their entirety due
to factors such as cost and feasibility.
The proposed regulations are:
yy Medical Devices Regulation
yy In Vitro Diagnostic Medical Devices
Directive (98/79/EC)
yy In Vitro Diagnostic Medical Devices
Regulation
Fast forward a couple of decades and
proposals for the new legislation on
medical devices and in vitro diagnostic
medical devices were approved in
October 2013. Even more recently was
the passing of the first reading of the
proposals in April 2014. This is the first
time since the early 1990s that Medical
Device legislation has been given a
So what of the proposed changes?
The first change to note is that the
updated legislation documents have
been drafted as regulations rather than
directives. This leaves each member
state without the ability to interpret
legislation and then write them into
their own national law. The new
regulations are legally binding across all
…there is an
acceptance
that change
is necessary
for reasons
already
mentioned;
however there
are objections
from the
industry to
the proposed
changes…
Click here to go to Contents page
EU member states in a uniform manner.
From a device vigilance perspective
this will ensure that there are fewer
ambiguities between member states.
The main areas that will impact device
vigilance are:
yy Medical Devices Qualified Person
(QP)
yy Improved Market Surveillance and
Vigilance
yy Timeframe for reporting Adverse
Incidents
yy Centralised EU Device Reporting
Portal
Does the role “Qualified Person” sound
familiar? This is a role that is very
familiar to everyone associated with
authorised medicinal products in the
EU. This regulatory and compliance
role has now been adopted within the
proposed medical device regulations.
The manufacturer will be required to
employ an expert on Medical Devices.
Amongst a range of responsibilities
that the QP will have is the oversight
of vigilance reporting obligations
including the reporting of adverse
incidents. The QP will overlook the
manufacturer’s adherence to a new
15 day reporting timeframe signalling
a change to the current reporting
timeframes listed in MEDDEV 2.12/1
guidance. This timeframe applies
for reporting of incidents where
there is a causal relationship to the
device is a reasonably possibility.
The “Qualified Person” will be responsible
for oversight of an improved system of
vigilance on medical devices. One such
improvement will be the introduction
of an EU portal, or electronic system, to
quote the regulations. The manufacturer
will be required to submit serious
incidents and corrective actions via the
portal. This may not be an altogether
new idea as those of us who have
submitted incidents via the MHRA device
reporting portal; the Manufacturer’s
On-Line Environment (MORE), can
justify. The EU portal aims to go
further with its capabilities to include
automatic forwarding of reports to the
appropriate national authorities. This
will alleviate the administrative burden
of creating multiple submissions to
numerous authorities. In addition
it is hoped that authorities will be
Click here to go to Contents page
encouraged to have a greater level
of communication themselves.
So will these changes help to stave off
future scandals? That is certainly the
objective of legislators and politicians.
Tighter regulations will certainly make
it less likely. Notified bodies will be
under greater scrutiny to fulfil their
position. Manufacturers will potentially
have inspectors knocking at their door
unscheduled. This looks like good
news for the safety of patients who are
exposed to medical devices. Although
critics argue that prices may hike up the
costs of being able to implement these
regulations into everyday work.
This should make life easier from a
device vigilance perspective. Teething
problems are almost inevitable leading
up to the implementation of the new
regulations due in the next few years.
There were big changes in 2012 for
post-authorisation medicinal products in
Europe and the new device regulations
will have a comparable impact on the
medical device community in the next
few years. Emphasis on improved and
transparent vigilance procedures will
enable us to ensure patient safety is
paramount. After all, change is long
overdue as the landscape of 2014; with
technological advances and evolving
map of Europe, is a very different one to
that of 1990.
19
Risk Management:
How Well Are We Doing?
A report of a Datapharm Information Meeting held on
18th June 2014 at the Royal Society, London.
By Lawrence Berry, CEO Datapharm
Lawrence Berry
Representatives from 43 pharmaceutical companies attended Datapharm’s latest Information Mee
ting designed to provide pharmaceutical company members with essential information on medicines
information and risk management.
Capturing off-label use –
a presentation on the challenges
for industry
The challenges that companies face in
capturing off-label use of medicines
were addressed by Jayne Packham from
Jayne Packham Consultancy, a company
specialising in medical information for
the pharmaceutical industry.
Companies are obliged by law to
capture reports of off-label use. Jayne
therefore emphasised the importance
of a clear definition of “off-label”.
The legislation states that it refers to
medicines being “intentionally used”,
and “not in accordance with the
authorised product information”.
Different companies interpreted
the legislation in different ways, she
said, with some probing deeply to
ascertain off-label use in customer
interactions, and others capturing
information only if the customer
discusses actual off-label use.
One challenge for companies, said Jayne,
was training staff to recognise and
capture off-label use. Clear reporting
processes are needed for Sales staff to
ensure they don’t breach the ABPI Code
of Practice.
Working together on risk –
perspectives from industry
Speakers from major pharmaceutical
companies provided examples of
how their medical information,
pharmacovigilance and regulatory
20
departments address issues surrounding
risk.
Lorna Bailey, coordinator of risk
management plans at Roche Products
Ltd, explained that risk management
plans as specified in legislation
cover both routine and additional
pharmacovigilance and risk minimization
activities. Additional risk management
measures (RMMs) included activities
such as targeted education and
training programmes. At Roche, EMAapproved RMM materials go through
local adaptation and implementation
planning, and the adapted materials are
then submitted to the Medicines and
Healthcare Products Regulatory Agency
(MHRA) for approval. Once approved,
the materials are distributed to external
health care professionals.
Lorna said that one of the challenges was
to distribute materials effectively to the
right professionals. “And once they’re out
there, what are they doing with them?
Providing guidance through face-to-face
training is better than mass mailings, but
it is not always possible.”
Another question was whether
sales people should talk about risk
management materials: there was a
risk that it could be seen as promotion.
“Defining promotional versus nonpromotional purpose is all very well on
paper, but in practice clear definition
can sometimes be problematic” she
explained.
Another challenging area which
Lorna highlighted was around
…one of the
challenges
was to
distribute
materials
effectively
to the right
professionals.
“And once
they’re out
there, what
are they
doing with
them?
Click here to go to Contents page
measures of effectiveness. “We need
to measure the effectiveness of
RMMs. Some outcomes are easier
to measure than others.” she said.
Jacquie Warner, Operations Manager
at the Medical Collaboration Centre
of Novartis Pharmaceuticals UK,
explained the processes used by
Medical Information at her company
for reporting adverse events to their
Pharmacovigilance department.
Novartis is introducing electronic
reporting systems, she said, which will
link Medical Information systems directly
with the Pharmacovigilance systems.
There were many benefits of doing this,
including real time reporting, a simpler,
quicker process, reduced paperwork and
filing, but such systems took time to test
and develop.
“As yet, at Novartis, it’s early days in
terms of electronic reporting, but we’re
hoping to go live globally by the end of
this year.”
Demand for and supply of
medicines information is soaring
– the Datapharm experience
Demand for medicines information is
growing exponentially, with nearly 20
million visits to the eMC website during
the past year, compared with just over
five million five years ago.
Click here to go to Contents page
Lawrence Berry, Chief Executive of
Datapharm which provides the eMC,
explained that the growth was not just
down to increased internet use, but to
the growing amount of information now
available on the eMC. There are currently
more than 10,000 PILs and SPCs available
on the website, compared with around
half that number in 2006.
This was good news for pharmaceutical
companies that are members of
Datapharm – their subscription costs
had gone down 30% in real terms over a
period when the cost per document had
gone down by almost 50%.
“With your help, we spend a lot of time
keeping the eMC up to date,” Lawrence
told the 80 pharmaceutical company
representatives at the meeting. “Without
that, the quality of the eMC would
disappear.”
He reported that 33% of all visits to
the eMC today are by mobile devices.
Datapharm’s iComply service, providing
tailored medicines information to
companies’ sales force, is now being used
by 800 company representatives in the
field – a figure expected to double by the
end of the year. “This compliance tool is
fast becoming the industry standard,” he
said.
Dr Peter Carroll, Datapharm’s Director
of Business Development, went on to
explain that 11 companies are now using
the eMC to host their risk management
materials (RMMs). “We think it makes
sense for companies to centralise their
assets on the eMC, and we’d like to
further develop this free service.”
Lawrence Berry also announced that
Datapharm will continue to be the
official provider of consumer medicines
information for the NHS Choices website.
This service will be funded by the NHS
rather than Datapharm’s members.
If you would like to contact
Datapharm to discuss your
company’s requirements or to
enquire about eMC membership,
please contact Rick Hindle on
01372 371407
21
DISCUSSION FORUMS
PIPA Discussion Forum
AE follow-up. Has anyone done a study
on how to increase the effectivness of AE
follow up? Do certain methods produce
better response rates than others?
From discussions with others in PV I get the impression that the response
rate to requests for follow up information to AE reports is very low. I was
wondering if anyone had any experience of looking into this and maybe
making changes to improve it.
Notification of SmPC & product updates
Which publications and relevant bodies do people notify when they
have SmPC updates / product changes such as supply issues and
discontinuations? Does anyone notify UKMI via the email mailing list you
can purchase for £100, how often do you obtain an updated mailing list?
How do you maintain your PV system master files? Is this done by PV or QA?
PSMF maintenance
My experience has been that while it is a PV document and is likely to
be written by someone with more of a PV background, many sections,
particularly some of the annexes (e.g system performance and that around
audit/inspection findings) are better handled by QA, or at least the person
responsible for PV compliance activities (e.g CAPA management).
Day zero - AIFA portal
In Italy, companies download regulatory authority ICSRs from a portal. I’d
like to know what people consider to be day zero for cases downloaded
from this portal - is it the day the MAH is aware of the valid case – i.e., the
day they search the database OR the day the case was available (e.g the day
it was uploaded to the portal by the authority).
Performance indicators
I would like to get some thoughts regarding Performance indicators
mentioned within the PSMF. At the moment we are considering: timeliness of ICSR reporting and PSUR Submission - timeliness of variation
implementation - adherence to RMP and safety commitments What other
indicators do you use?
Training MSLs and Sales to report off
label
Company staff are trained about reporting adverse events, but do
companies now routinely train MSLs and Sales and all staff for that matter,
and get them to report off label use (without an adverse event). I know that
an MHRA speaker suggested this at the last PIPA Conference. Are companies
doing this now? I assume that in VII.B.5.5.2, section 3 ‘other sources available
to the MA holder’ could include all company staff.
Data Protection responsibilities for PV
Service Providers
Is anyone able to provide advice/guidance regarding the data protection
responsibilities specifically for PV Service Providers? In particular, would PV
Service Providers be considered Data Controllers or Data Processors? Would
it be acceptable to assume that the client (MAH) is the data controller as
they are the organisation who has the legal basis for collection personal
data and that the PV Service Provider is the data processor?
Obtaining written or verbal consent
from HCPs for Reps to refer their
enquiry to Medical Information
Would anyone be willing to share whether their Reps obtain written consent
from a HCP (either by signing a form or using an app for example) for
referring their unsolicited enquiry to Medical Information to respond?
Medical Information requirements in
Europe
I would be interested to know the requirements for Medical Information in
Europe especially for France, Germany, Italy and Spain.
Do you happen to know the answers to these questions or experience of dealing with these from within your own company and
would li ke to share it with our readership?
Please email the editors at [email protected] and we will pass on your knowledge in our next edition of PIPELINE.
22
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FORUMS AND DIARY
Forums and Online Learning
PIPA has a long tradition of providing opportunities for members
to discuss hot topics, share best practice and learn from each
others experiences.
Each year we run a series of forums which combine formal presentations with
discussion and debate.
PIPA also holds an annual conference in order to allow members and non-members
to network and exchange ideas. The scientific programme runs over two days and
includes presentations, exhibitions and workshops.
Diary
PIPA Conference 2014 Delegates
Thursday 6th & Friday 7th November 2014
Getting the Best Out of Searching: Optimise your Search Skills
Wednesday 8th October 2014
Chartridge Lodge, Chartridge Lane, Chesham, Buckinghamshire, HP5 2TU
If you’re looking to get the best out of searching and to optimise your search skills, this course is for you. With the increasing
amount of resources available on the internet, this course will enable you to choose the most valuable resources and will
also provide you with the skills and tips to be able to effectively search within these resources. The course will also provide
tips on the best ways to search for publications within PubMed.
This 1 day course is aimed at individuals who are new to Medical Information or a similar area, or would like up-to-date tips
on how to search for information. This course has been recently updated in light of feedback from previous delegates and
advancements in resources and searching technology.
Attending this course will enable delegates to:
•
•
•
•
•
•
•
Search the internet with confidence
Improve search accuracy
Identify resources and search tools
Identify reliable information
Assess the quality of internet sites
Learn more about literature searching (e.g. PubMed)
Have an increased awareness of servies such as electronic Medicines Compendium (eMC) and dictionary of medicines
and devices browser (dm+d)
• Keep abreast of social media channels and searching within these channels
Interactive workshops within a small group provide you with a good opportunity and forum for sharing experiences, best
practice and networking.
Click here to go to Contents page
23
Online Learning
Introduction to Pharmacovigilance for
non-Pharmacovigilance Personnel
Pharmaceutical companies are required, by law, to provide adequate training to their employees so that they are able to
identify and report adverse events.
While many companies will have a programme in place to facilitate this training, it may not always be possible to make this
immediately available to every new starter. Equally, the existing programme may be labour intensive to maintain or deliver.
PIPA has therefore developed a cost-effective generic online training course that provides the legally required level of
training for all employees working for a Pharmaceutical Company so that they are able to recognise and report adverse
events. It has been developed by senior Pharmacovigilance experts working within the Pharmaceutical Industry so you
can be confident of the quality and relevance of the training. It is up-to-date with current regulations and, once you
have passed the test at the end of the training course, a formal certificate is provided to confirm course completion and
understanding.
As a not-for-profit association, PIPA can only make this course available to members. However non-members may easily
access the course by becoming a ‘member for a month’* for a £15.00 supplement (£18.00 for overseas members) This fee
provides you with temporary PIPA membership for the month that you are completing the course
24
Click here to go to Contents page
NEW MEMBERS
Welcome to …
Mr William Ray
Pharmacovigilance Associate
Aptiv Solutions
2014153
Mr Mallesh Anemoni
2014156
Mrs Margaret Walters
Director, European Pharmacovigilance
and Deputy EU QPPV
Merck Sharp & Dohme Ltd.
2014157
Dr Samer Taslaq
PV officer
Fontus Health Ltd
2014159
Miss Holly Withers
Mr Venkatesh Sapavat
Miss Kru Doshi
Dr Christine Blanc Wilkinson
Dr Praful Bhooma
OBG Pharmaceuticals LTD
2014214
Central Medical Affairs Executive
Norgine Ltd.
2014183
UK Drug Safety & Quality
Assurance Assistant
Roche Products UK
2014188
Retinal Grader/Screener
Oxford University Hospitals NHS
2014189
Pharmacy consultant
Unik pharma services ltd.
2014209
Chief Medical Officer
PsiOxus Therapeutics Ltd
2014210
Dr John Paul Kinsey
Miss Kate Bowerman
Mr David Olatunya
Drug Safety Scientist
Janssen Cilag Ltd.
2014216
Mr David Olatunya
Medical information Officer
Genzyme Therapeutics
2014217
Medical Affairs Manager
Octapharma
2014167
Mr David Olatunya
Medical information Officer
Genzyme Therapeutics
2014217
Miss Sandra Wallik
Mr Sameer Wagle
Medicines Information Scientist
Merck Serono Limited
2014219
Ms Stephanie Duncan
Medical Information Officer
Janssen Cilag Ltd.
2014222
Miss Liesbeth Meulenberg
Pharmacovigilance/Regulatory
Affairs Officer (EU-QPPV)
Disphar International B.V.
2014164
Dr Paul Riley
2014170
Dr Alexandr Meszaros
Senior PV Manager
Acino
2014173
Mr Kurt Strittmatter
Associate Director Pharmacovigilance
& Risk Management
Shire Pharmaceuticals
2014176
Mr Florence Denance Habek
Marketing Manager
PrimeVigilance
2014177
Mr Daniel Houde
Director, R&D Quality Assurance
Ariad Pharmaceuticals, Inc.
2014178
Mr Stephen Ormesher
Reglatory Associate
Ayrton Saunders Limited
2014180
Click here to go to Contents page
Medinfo scientist
Gsk
2014190
Medical Information Assistant
Martindale Pharma
2014190
GlaxoSmithKline UK Ltd.
2014190
Senior Medical Information Officer
Teva UK Ltd.
2014193
Senior Medical Affairs Associate
United Therapeutics Europe Ltd.
2014194
Mr Deepak Vyas
2014197
Ms Amy Walker
Medical Information Officer
Boehringer Ingelheim Ltd.
2014203
Miss Lauren Davis
Miss Lauren Davis
Miss Poonam Dhokia
Ms Jenny Lau
Miss Sophie Keddie
PV Consultant
Adamas Consulting
2014224
Miss Ella Jobson
Senior Consultant
Hobson Prior International Limited
2014229
Mr Om Prakash Maurya
asst. manager
in swift ltd
2014205
Mrs Sai Maneesha Chundi
Senior Associate Global Safety
Amgen Ltd
2014208
25
NOTICEBOARD
Contribute an Article to PIPELINE
Do you
enjoy
reading
the articles
and meeting
reports in
PIPELINE?
Then have you
ever considered
writing one
yourself?
We are committed to providing you with an excellent
range of topical articles from changes in the regulatory
environment, promotion of new initiatives to sharing best practices as just a
few examples and always welcome any contribution. There is also a reward
for your hard work as well as getting to see you words in print. PIPA will give
you a voucher for a well-known high street store; the value depends on
whether you have submitted an article or meeting review.
Also in recognition for not only attending our meetings and forums we can
also provide a subsidised or free place if you offer to write-up the session for
us. Just tell Sharon (PIPA administrator) when you book.
Interested? Then please contact us at
[email protected]
We look forward to hearing from you.
26
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COMMITTEE MEMBERS 2014
President
Vice President
Treasurer
Baxter Healthcare
Tel: 01635 206861
Email: [email protected]
Novarits Pharmaceuticals UK Ltd
Tel: 01276 698594
Email: [email protected]
Eusa Pharma
Tel: 07500 849613
Email: [email protected]
Vicki Page-Clark (HonMPIPA)
PIPA Administrative and Treasurer
Support
PIPELINE Co-editor
Sarah Dunnett (FPIPA)
Chair of Training and Development
Working Party
Sarah Hall (FPIPA)
Takeda UK Ltd
Tel: 01628 537966
Email: [email protected]
PIPA Membership and
Events Co-ordinator
Christine Needham (FPIPA)
PIPA Operations Manager
Anne Turnbull
Tel: 07531 899537
PO Box 254, Haslemere, Surrey GU27 9AF
Email: [email protected]
Archimedes
Tel: 0118 931 5092
Email: [email protected]
or [email protected]
Sanjay Motivaras (MPIPA)
Sarah Anthony
PIPELINE Co-editor
Committee Member
Committee Member
Baxter
Tel:
Email: [email protected]
Cancer Research UK
Tel: +44(0)20 3469 6905
Email: [email protected]
Amdipharm Mercury Company Ltd
Tel: +44 (0) 208 588 9048
Email: [email protected]
Tel: 07722 411409
Email: [email protected]
Tom Nichols
Committee Member
Committee Member
Committee Member
Napp Medical Information Manager
Tel:
Email:
Head of Pharmacovigilance for
Boehringer Ingelheim
Tel: 01344 741479
Email: [email protected]
Associate Safety Risk Lead
for Pfizer Limited
Tel: 01737 331386
Email: [email protected]
Phil Ball
Meetings Co-ordinator (PV)
Chair of Signal Detection Working Party
Tel: 07512 317656
Email: [email protected]
or [email protected]
Giulia Brichetto Graglia
Sharon Braithwaite
Emma Boulton (HonFPIPA)
Blessing Gombedza
Members of the PIPA Training Working Party
Sarah Hall
Avile Rodriguez
Elizabeth Gwynne
Manju Bhandari
Patricia Walcott
Jacquie Warner
Shirley-Ann van der Spuy
Alpa Shah
Jennifer Lean
Lisa Hughes
Click here to go to Contents page
Tel: 07773 818912
Email: [email protected]
Betty Mwesigwa
Ester Strachan
Members of the Benefit Risk Management
Working Party
Vicki Page-Clark, ProStrakan Group (Chair)
John Barber, Dr Reddy’s Laboratories
Jeff Guillon, Alliance Pharmaceuticals
Katerina Chinenyeze, Eisai
Bharat Amlani, Norgine
Sally Francis, Panacea Pharma Projects
Anne Lloyd, Sanofi-Aventis
Emily Barrett, Eli Lilly
Claire Longman, Pope Woodhead & Associates
27
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