Issuu

Read E PIPELIN Online

rg aonline.o www.pip ournal -J /Pipeline

BREXIT and the QPPV An update

Alzheimer’s Disease The facts

The Future of Social Media in Pharmacovigilance A balancing act

The Fight Against Neglected Tropical Diseases The essential role of pharmaceutical companies

PIPA Conference 2018

Highlights and insights

Wednesday 3rd – Thursday 4th October 2018

£12.00 or Free for Members

Book Online: https://www.pipaonline.org/External-Events/PIPA-Conference-2018-Delegates/57214

CONTENTS 03

Letter From The Editors

Developmental Opportunities

The Future of Social Media in Pharmacovigilance

The Fight Against Neglected Tropical Diseases

Alzheimerâ€™s Disease: The Facts

Quality Management and Validation in Pharmacovigilance Software

Brexit and the QPPV, an update

The Chester Experience...The Journey Continues

The NHS Injectable Medicines Guide

PIPA Conference - Behind the Scenes

President's Reports - March 2018

New Members

PIPA Committee 2018

Pooja Shah & Salma Ibrahimo Jen Quinn

Tom Nichols

Dr Giuseppina Ortu Dr Doug Brown

Tessa Heffernan John Barber

Ammar Abbas

Christine Proudlove Christine Needham Sarah Hall

Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use. While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented. The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated. PIPELINE Editors: Pooja Shah and Salma Ibrahimo Designed by:

www.cascadestudio.co.uk

LETTER FROM THE EDITORS Welcome to our first official PIPELINE edition of 2018. By the time this edition reaches your desks, I expect only the wrappers from all the Easter eggs consumed over the long bank holiday weekend will be left! We hope the first third of 2018 has been everything you had wished for it to be, and that you continue on a positive journey throughout the remainder of the year. Talking about the year ahead, online bookings are now being taken for the eagerly awaited 2018 PIPA Conference at Legoland, Windsor on 3rd and 4th October 2018. Use this link to guarantee your place and for further information https://www.pipaonline.org/ExternalEvents/PIPA-Conference-2018-Delegates/57214. To give you an insight into what the committee does to organise and prepare for this event, Christine Needham (Vice President of PIPA) has written a short article snapshotting a behind-the-scenes view. Career progression and personal development is always on everyone’s mind and a big part of our role. So, in this edition of PIPELINE, read about Committee member Jen Quinn’s personal experience of her career progression, where she explains her motivations and drive in moving from Medical Information to a Medical Scientific Liaison role - and the reality of the new job. If you feel inspired, have a look at page 17 for the list of PIPA courses that we are offering in 2018 that could help your career and skills development.

hope you enjoy reading it as much as we have enjoyed putting it together. As always, we welcome your feedback and encourage you to interact with us and the other PIPA members via our online platforms. Until the next edition of PIPELINE in the summer, we wish you all to have a wonderful spring!

It has now been over a year since Article 50 was triggered, and the PIPA Committee is committed to staying on top of any developments and decisions around Brexit, so that we are able to keep our members informed. With this in mind, John Barber has contributed a summary of the latest developments for QPPVs in relation to Brexit.

If you want to make a contribution to PIPELINE, please feel free to contact us at journaleditor@pipaonline.org.

Tom Nichols, from Drive Phase PV, shares his thoughts on the future of social media in pharmacovigilance and the WEB-RADR project which started back in 2014. With social media being very much part of everyone’s future, this is an impactful read! We’ve listed here only a few of our many topical articles that we have managed to pack into this edition, and we

Pooja Shah 3

Salma Ibrahimo

DEVELOPMENTAL OPPORTUNITIES: Moving from Medical Information to Medical Scientific Liaison By Jen Quinn

From my motivations and drivers for seeking a new role, to the identification and development of the right skill set; my journey from Medical Information (MI) to Medical Scientific Liaison (MSL) and the reality of the new job.

you may have been in your job for many years; new projects arise, present challenges, and disappear. While the role is varied, the skill sets needed generally do not change much. After completing a project and returning to everyday MI life, I found myself desperately seeking ways to expand my repertoire of skills. The MSL role initially appealed to me as it would allow me to focus more on just one therapy area, meet leading specialists face-to-face and be involved in discussions that would be invigorating and more than simply an imparting of data. Sometimes in MI, I felt that I missed the bigger picture

What are the motivations for moving from MI to MSL? Motivations will always be individualised and for me the main driver was challenge. For many of you in MI, 4

as many Medical Education events and UK congresses as possible to meet customers face-to-face and work on answering questions “off-the-cuff”, without relying on the information at my fingertips. By the time an MSL role arose, I had enough experience to work with. What are the realities of the new role? People often say it takes a year to settle into a new job and that is certainly true of the MSL role. I did not imagine I would miss the 9-5 of working in MI, or the routine of regular meetings and telephone rotas. However, after months of a very variable diary, constant travel and unpredictable routine, I soon longed for the days when I didn’t wake up wondering what part of the country I was in. Change can be a difficult thing, but a new challenge is too exciting to turn down. Despite all this, perhaps the biggest shock to the system for me was moving from an office team to a virtual team. No longer could I just turn my chair around and bounce an idea off someone or let off steam after a particularly difficult caller. Needless to say, I’m sure my old team are much more productive without my distractions!

and a field-based role would allow me to learn about the NHS environment and find new ways to meet customer demand.

While most MSLs have metrics on the number of customer interactions to maintain, the idea that I had gained from working in MI that these are mainly reactive is far from the truth. Really, the MSL role is very proactive and to be truly effective and engage with leading specialists we must take the initiative to reach out wherever the Code of Practice allows us to do so. While this may sound simple, there is much ambiguity surrounding the compliance of these approaches and we often lack strong guidance on engaging in these types of interactions. Many of my interactions are positive and scientifically exciting but others make me feel like the value I added was very minimal. In this way, the job can be very polarised, as it can in MI.

Once you have your development goal, how can it be achieved? I examined the role profile for an MSL a couple of years ago and noted the skills I needed to work on. Some that struck me as particularly key were: • Deep scientific knowledge in the therapeutic area • Communication and presentation skills • Business acumen • Teamwork, leadership and influencing skills

The MSL role is a varied and exciting one, but I have found that it does not come without its difficulties. If you also find yourself looking for a change in role, I would suggest looking at what motivates and drives you the most, the activities you enjoy and dislike and what or how much of a challenge you are happy to find in your next role.

• Development and maintenance of networks The first and second of these points makes a relatively simple transition from MI to MSL. I had these in the bag. But what about the rest? Everything else needed some work. I met with my line manager to discuss my developmental goal and put a plan in place to develop the key skills I was missing. A role leading a work steam on a global digital project allowed me the opportunity to grow my leadership skills, and I enjoyed it immensely. It also gave me the chance to build and maintain networks of stakeholders. I became more heavily involved with PIPA, initially leading a face-to-face training course with the Training Working Party and then with the Committee, allowing me to hone my communication, networking and influencing skills. I shadowed other MSLs and went to

Jen Quinn Medical Scientific Liaison, Janssen

THE FUTURE OF SOCIAL MEDIA IN PHARMACOVIGILANCE By Tom Nichols

I will start by setting my stall out as being somewhat of a luddite when it comes to social media. I’m not on Twitter, Instagram or Snapchat. Beyond the inexplicable compulsion to check out the lives of people I haven’t seen or spoken to in years on Facebook (FB), I’ve remained pretty antisocial in my social media consumption.

there was also a workstream looking at “access to classified social media data via a visualisation platform for signal identification and confirmation”. The results of this give a strong starting point for any company looking for guidance on how to integrate social media mining into their PV system. As a highlevel conclusion, using Twitter and FB may have value as an independent source of data and for hypothesis generation, but they did not add value to ‘business as usual’ PV. In addition, only 17% of identified ADRs could be automatically mapped to MedDRA (although this was doubled if historic VigiBase1 mappings were used), demonstrating a significant element of manual effort in reviewing the posts. The introduction of Identification of Medicinal Products (IDMP) in the next couple of years will also require greater specification of what product was taken, which doesn’t lend itself to such freeform text, either. Patient forums performed better at identifying signals than Twitter or FB, although identification of these ‘signals’ often occurred later. The EMA representative at the WEB-RADR closing meeting stated that social media reports should be considered a secondary source. Companies should not have to plan any interaction with users (follow-up etc.) but should focus on best using the data collected for public health protection. There should be no expectation to report ADRs identified in social media as ICSRs, but companies could consider reporting them in periodic safety update reports (PSURs)/ Risk Management Plans (RMPs). Where used, such data should be clearly defined and documented.

Over my years in the industry, every now and then an article in my morning paper has told the story of an adverse drug reaction (ADR) involving a drug that the company I was working for couldn’t discount as its own. On it went to the safety database as an Individual Case Safety Report (ISCR), just like my pharmacovigilance (PV) training had taught me. But what was the value of this kind of report to the understanding of the safety profile of the product? It would contain the four minimum criteria and one would hope (in the days before a single online comment became known as a ‘Twitter-storm’), basic journalistic standards and competence would mean the events did take place. All in all, I always thought that it was a solid addition to our knowledge of the safety profile of the drug, even if it was inevitably an already well characterised reaction. Anyway, this kind of case was so few and far between, that they weren’t likely to clog up the database with low quality data. With over a quarter of the global population on FB alone, social media reports have the capacity to swamp PV departments, but there is little understanding of what the merits of this data may be. The area is currently a hotbed of confusion, with limited official guidance from regulators or thought leading opinion from industry.

There is no clear regulatory guidance on defining and documenting how social media data should be used. However, I don’t believe it should be over complicated. Start with deciding exactly how you want to use social media data (if you decide to use it at all), whether it be hypothesis generation or trying to integrate the data into signal validation activities, and work backwards on how to get the data you need. Mining these kinds of data sources is evidently as much a technology problem as a PV one, so may well be out of the reach of most small

The WEB-RADR (https://web-radr.eu/) project began in 2014, funded by the Innovative Medicines Initiative (IMI), a large-scale public-private partnership between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Reporting its results at the end of the project, in September 2017, it had had great success with the development of applications (apps) through which patients and healthcare professionals can report ADRs. Along with this, though, 6

and even medium sized companies to deal with in-house, whether that be for budgetary reasons, or lack of in-house expertise. There are increasing numbers of PV providers offering to monitor social media, but it’s crucial to know exactly what services they provide; from how the data is validated to what websites are being searched. In my opinion, it is important to clearly identify, up front, how such data will be used, which in turn will guide the optimal methods of collection. It’s certainly not something to jump into first, because it’s an exciting new world, expecting to work out how to use it further down the line.

Practice (GvP) Module won’t be seen as acceptable outside of the industry. It will be harder still if companies are perceived to be perfectly happy to market and advertise their products online, but not so willing to listen in return. Social media mining is not going to be the great panacea for pharmacovigilance companies, nor is it completely useless (and even if it were, it can’t just be ignored). The truth, as is always the way, lies somewhere in between. Indeed, the biggest impact social media may have on patient safety, in the short term, may well be the opportunities it affords for companies to develop innovative information delivery methods (Direct Healthcare Professional Communications), rather than on the receipt of information. Anything that can improve the relationship between the pharmaceutical industry and all stake-holders (patients, HCPs, regulators etc.) must be a good thing.

Social media is here to stay and ultimately patients have a right to expect that they are being listened to, however they have chosen to communicate. It will certainly be a difficult balancing act for the industry over the coming years. The value of the data will need to be continuously evaluated, perhaps through further collaborative WEB-RADR-like initiatives, so that the findings can inform the industry as a whole.

VigiBase is the World Health Organisation’s (WHO) ICSR database. Participating states contribute to what is the largest drug safety repository in the world.

However, that’s not to say that social media data should be ignored by individual companies until then. Reputationally, that’s not an option. In the event of a signal being detected, which is of such severity, or in such a widely used drug, that it is reported in the popular press, it’s inconceivable that there wouldn’t be attempts to uncover ‘reports’ of occurrences somewhere online. If and when that happens, there will need to be clear justification why such a report wasn’t immediately identified and acted upon. Whether or not it is specifically mandated in a Good Pharmcovigilance

Tom Nichols Director Drive Phase PV

THE FIGHT AGAINST NEGLECTED TROPICAL DISEASES The essential role of pharmaceutical companies By Dr Giuseppina Ortu

a battle that should be won on a daily basis and not only during treatment campaigns.

Neglected tropical diseases (NTDs) are a group of diseases that affect more than a billion people in the world, mainly on the African continent, and especially those that are the poorest, living in rural areas and unable to access adequate health care. The World Health Organization (WHO) has grouped these diseases into those that can be easily diagnosed and treated with a tablet (Preventive Chemotherapy and Transmission Control NTDs - PCT-NTDs) and those that require intense case by case management (Innovative and Intensified Disease Management NTDs - IDM-NTDs), for which cost-effective treatments and user-friendly diagnostic tests are not available.

Mass drug treatment campaigns are also very expensive. Their implementation requires not only considerable logistic support from the WHO in shipping donated drugs on time for these national campaigns, but also substantial international financial support to local Ministries of Health for delivering these treatments in rural areas. It is then important to assess whether continuing these campaigns in low endemic areas is still cost effective compared to treatment on a case-by-case basis. In mass treatment campaigns, everyone gets treated, independently from being infected or not; if disease prevalence is low (e.g. just 1-10% of the population is infected), continuing these campaigns is not cost effective anymore. Perhaps ensuring that free-of-charge drugs are available in PHC facilities, and slowly shifting mass drug administration campaigns into case-by-case treatment at the PHC level, may be a more cost-effective option.

Pharmaceutical companies have played a fundamental role in providing drugs free of charge for all the PCT-NTDs. Such drug donations have led to the introduction of national mass drug administration campaigns, in which entire populations at risk of PCT-NTDs receive treatment, once a year or as often as disease prevalence requires. PCT-NTD prevalence has dropped greatly in many countries where national drug administration campaigns have occurred, having a positive impact on millions of people.

Looking at the current efforts to fight IDM-NTDs, pharmaceutical companies have made some of the required treatments available free of charge. However, as these diseases are hard to detect due to the absence of adequate rapid diagnostic tests, such donated drugs are often not requested by PHC facilities as cases are not identified. Furthermore, if these diseases are detected, and donated drugs are available, PHC staff often do not have enough medical training to manage patients affected by these diseases, as treatments require monitoring potential severe side effects, making the management of individuals affected by IDM-NTD a real challenge. This challenge results in a substantial number of individuals being left without the treatment and care they require. Thus, the WHO Universal Health Coverage (UHC) agenda falls short of ensuring that all people obtain the health services they need.

Although these campaigns have had a huge positive impact, individuals that may be affected by these diseases, yet miss the opportunity to attend mass drug administration campaigns, do not receive free treatment if accessing the primary health care (PHC) system. This is because free drugs are available only during campaigns, and not routinely at the PHC level. The opportunity to access free drugs only during campaigns, and independently from when individuals are actually manifesting signs of these diseases, has led to PHC staff being unable to recognise these diseases. If symptoms are recognised, affected individuals may not get treatment as the necessary drugs are generally not available at the PHC level, or, if available, they are not free of charge. The need to ensure treatment on a routine basis in health facilities becomes an important aspect of the fight against NTDs,

WHOâ€™s appeal to eliminate at least some of these diseases in the next decade, as well as integrating NTDs in global 9

Although it seems a huge task, it is possible to start working towards a more equitable access to health: • By slowly directing drug donation to PHC facilities - international financial support from donors and philanthropic foundations could be partially redirected from the implementation of national campaigns to building knowledge of how and when to use these drugs in PHC facilities; • By promoting the development of new affordable diagnostic tests – it is possible to leverage current work done in other diseases, and produce affordable tests that not only would allow PHC staff to easily diagnose these diseases, but also benefit developed countries in the detection of these diseases in migrant populations; hence providing the opportunity to control the spread of these diseases;

health and development, clearly highlights the need to empower health facilities to manage these diseases. Access to appropriate diagnostic tools, a strengthened PHC structure in which the health staff are trained to recognise these diseases and manage them, and availability of the necessary drugs for routine care free of charge, are the key elements to ensure the patient is treated appropriately. This is the paradigm of the UHC – and we all have to put our efforts into achieving this.

• By developing new drugs. This may be the hardest part, as the journey from an initial potential compound to its routine use in patients may take up to 15 years. However, investigations into current treatments and how they could be improved could possibly be cheaper and less time consuming; leveraging on current R&D in other common infectious diseases could make this journey easy for the development of new and safer drugs for NTDs.

Keeping disease prevalence low, managing affected patients at the PHC level and establishing a surveillance system in countries where NTDs are a real burden, may have a positive impact on many developed countries. Recent global epidemiological reports have clearly shown that NTDs have started to impact the northern hemisphere; for example, schistosomiasis, leishmaniasis, dengue, chikungunya and Buruli ulcer have appeared in Europe, Australia and the United States. Migration, refugees, displaced populations, trade and tourism have all contributed to the spread of NTDs into countries that historically never had such diseases. We are now witnessing disease outbreaks, and we should start thinking about how best we can improve health and access to adequate health care in those countries where these diseases are endemic, to stop these emerging threats in new geographical areas.

By investing in NTDs we will all benefit. Alongside international donors, committed ministries of health and the WHO, pharmaceutical companies can have a pivotal role in alleviating the burden from the neediest populations, contain the spread of these diseases and, eventually, be instrumental in the elimination of NTDs. Giusi obtained an MSc in Biochemistry and her PhD supported positron emission tomography radiotracer development. Her passion for infectious diseases led to a career change and the achievement of an MSc in Control of Infectious Diseases at the London School of Hygiene and Tropical Medicine (LSHTM) in 2006. Since then Giusi has focused her work on prevention, control and surveillance of neglected tropical diseases in developing countries. Her main interest is to support integration of neglected tropical disease management into the primary health care systems in developing countries to ensure that individuals affected by these diseases receive adequate care. Defining approaches to strengthen the health system in vector control and disease surveillance are also part of Giusi’s scope of work.

Pharmaceutical companies potentially have an essential role in this fight against NTDs. Drug donation has greatly contributed to decreasing the burden of these diseases in the past decade. Now there is the need to address further challenges: • Availability of donated drugs at the PHC level, beyond mass drug campaigns;

Dr Giuseppina Ortu, MSc PhD

• Development of new rapid diagnostic tests, allowing easy detection of these diseases;

Senior Public Health Specialist – Neglected Tropical Diseases Malaria Consortium

• Investigation into new safe drugs for treatment of these diseases. 10

ALZHEIMER’S DISEASE: THE FACTS Dr Doug Brown

As part of our series of articles on health and wellbeing, Dr Doug Brown from the Alzheimer’s Society has provided a fascinating insight into Alzheimer’s, its associated risk factors, current treatments and steps you can take to try and avoid developing the disease. Summary Alzheimer’s disease, the most common form of dementia, affects more than 520,000 people in the UK. This article provides an overview of Alzheimer’s disease, its associated risk factors and what it’s like to live with the disease, before looking at the current treatments: memantine, acetylcholinesterase inhibitors and non-drug therapies.

Alzheimer’s is a progressive disease. Early brain damage occurs in the hippocampus, the area of the brain involved in day-to-day memory. Common early symptoms of Alzheimer’s include: • Memory lapses • Difficulty recalling recent events

Disease background Dementia describes a set of symptoms including memory loss and difficulties with thinking, problem solving or language. Symptoms occur when the brain is damaged by certain diseases like Alzheimer’s. During the disease, abnormal deposits of protein build up forming amyloid plaques and neurofibrillary tangles leading to loss of connection between, and the eventual death of, nerve cells and loss of brain tissue. Shortage of the neurotransmitter acetylcholine also impacts disease progression.

• Difficulty learning new information As the disease progresses, damage can spread to other brain areas and other symptoms may emerge, including difficulties with: • Communication • Perception • Reasoning

for them. Coping with the practical demands of caring and managing the emotional impact of the person’s dementia can be challenging. As dementia progresses, relationship dynamics may change. Though this can be a difficult transition, there are still many ways a person can live well with the condition. Activities for people with dementia can increasingly be found across the country, and support is available for carers, loved ones and people with dementia through Alzheimer’s Society.

These changes may result in anxiety, depression and loss of interest in activities previously enjoyed. Every person’s dementia journey is different, with disease progression and life expectancy varying greatly. On average, people with Alzheimer’s disease live for 8-10 years after the first symptoms appear but it should be emphasised that although this is an average, the range is significant. Causes The exact cause of Alzheimer’s disease is, as yet, unknown, but both genetics and lifestyle are thought to be involved.

Treatments available Available treatments for Alzheimer’s disease include drug and non-drug therapies. Current drug treatments can temporarily alleviate symptoms, but there is, as of yet, no treatment to slow disease progression as end stage trials have all been negative to date. There is a global research effort to identify a “disease-modifying treatment” that can slow or stop the disease by 2025. Alzheimer’s Society is at the centre of this – we have committed over £150m to dementia research over the next decade and are a founding funder of the UK Dementia Research Institute.

There are known “risk factors” increasing the chances of developing Alzheimer’s, which include: • Age: Increased age is the greatest risk factor. The majority of people affected by Alzheimer’s disease are over the age of 65. Above this age, the risk of development doubles every five years. However, 40,000 people in the UK are currently living with early onset dementia; this refers to those with the condition under the age of 65.

The two main medication types currently available include acetylcholinesterase inhibitors (namely donepezil, rivastigmine and galantamine) and NMDA (memantine) receptor antagonists. No new drug treatments have been licensed in the UK since memantine in 2002.

• Gender: Alzheimer’s disease is more common in women. This could be because of women’s increased life expectancy, or biological differences such as oestrogen depletion after menopause.

Acetylcholinesterase inhibitors function by increasing levels of the neurotransmitter acetylcholine in the brain. Falling acetylcholine levels in Alzheimer’s disease are linked to an increase in dementia symptoms. Using acetylcholinesterase inhibitors prevents acetylcholinesterase from carrying out its usual function of breaking down acetylcholine in the brain. This allows the concentration of acetylcholine to increase. In turn, this leads to improved communication between nerve cells, increasing alertness and providing temporary relief from some symptoms. These drugs are usually prescribed as soon as a person is diagnosed with dementia, but they do not work for people with mild cognitive impairment, a condition that can often precede dementia.

• Genetic inheritance: Over 30 genes have been associated with an increased risk of developing Alzheimer’s. Additionally, it is estimated that around 600 families worldwide have an inherited form of Alzheimer’s termed “familial Alzheimer’s”, which starts showing signs at a young age as the result of a rare mutation in one of three genes. People with Down’s syndrome also develop an inherited form of Alzheimer’s; they carry an extra copy of a gene that causes the characteristic build-up of amyloid plaques in the brain. Living with Alzheimer’s disease Alzheimer’s disease poses far more complex issues than just physical symptoms. Problems associated with memory and thinking have a significant psychological impact in terms of loss of confidence and self-esteem. Simple, everyday tasks become increasingly harder to carry out as the disease progresses, resulting in people with Alzheimer’s becoming more dependent on others for support. Relationships, the support received and the environment greatly influence how well someone is able to live with dementia.

Memantine is usually prescribed for people living in the moderate to severe stages of Alzheimer’s disease. It protects the brain cells by blocking the effects of excess glutamate, another neurotransmitter. In Alzheimer’s disease glutamate is released excessively, leading to excitotoxicity and cell death, a reaction similar to the neurodegeneration seen in Alzheimer’s disease. Blocking the effects of excess glutamate therefore helps prevent cell death.

Alzheimer’s disease not only impacts the person with the condition, but also family members and those who care 12

Possible side effects for acetylcholinesterase inihibitors may include:

impact of Alzheimer’s disease, in a way drug treatment alone cannot.

• Nausea

How to avoid Alzheimer’s There is no known way to prevent Alzheimer’s disease, but evidence indicates that living a healthy, active lifestyle can go some way to reduce the risk.

• Vomiting • Diarrhoea Possible memantine side effects may include:

Top tips include:

• Dizziness • Headaches

• Regular exercise – recommended 150 minutes a week

• Tiredness

• Eating a healthy, balanced diet

These are not exhaustive lists of possible side effects for these medications, but side effects associated with memantine or acetylcholinesterase inhibitors are rare. Medication is reviewed regularly and continued only as long as the benefits outweigh any side effects.

• Drinking alcohol in moderation • Maintaining a healthy weight • Keeping your brain active • Staying socially connected

Drug treatments are important but they should be coupled with the equally important non-drug treatments. Common non-drug treatments include:

For further information visit http://alzheimers.org.uk

• Talking therapies • Exercise

Doug Brown

• Reminiscence

Chief Policy and Research Officer at Alzheimer’s Society

As Alzheimer’s disease progresses, it is common for the person to become increasingly distressed. These therapies provide a useful tool for helping with the psychological

ESMS Global The UK’s Longest-Serving Medical Information Provider (formerly Guy’s Hospital Poisons Unit)

Ad-Hoc ! Out-of-Hours ! In-Hours ! 24hrs Language Services ! Medical Writing www.esmsglobal.com

(020) 7113 7878

commercial@esmsglobal.com

QUALITY MANAGEMENT AND VALIDATION IN PHARMACOVIGILANCE SOFTWARE Why it is critical for pharma companies to ensure their providers have an intimate understanding of drug safety regulations – and how they translate to software development By Tessa Heffernan

Quality Management and Validation in Pharmacovigilance Today, it is common for pharmaceutical companies to implement software solutions that simplify the workflow for pharmacovigilance. This software often aggregates and triages literature in a centralised location for the review and reporting of adverse events. However, despite stringent regulations that govern drug safety, many developers of pharmacovigilance software do not have any quality controls in place to ensure accuracy or precision. They leave these controls up to the pharmaceutical company.

Most people would agree that an amateur athlete with no clear understanding of the rules should never play in a world-championship match. That is like a pharmaceutical company employing a drug safety software vendor without a proper quality management system – one which includes documented validation activities and training on Good Practice (GxP) regulations – to provide software for pharmacovigilance.

Each year, regulatory authorities like the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issue hundreds of observations relating to IT software quality and validation management. Quality management, and specifically validation controls, in pharmacovigilance software development are critical – they allow for a repeatable and robust software development cycle in which a standardised approach is taken using standard operating procedures (SOPs), process flows and industry best practices (such as code reviews). These controls eliminate software bugs with documented “tried and true” methodology, rather than ad-hoc approaches to development. This is paramount in decreasing, and even eliminating, regulatory agency observations – and gives pharmaceutical companies peace of mind that the results of their searches and reviews are inclusive and accurate.

In both scenarios, a team effort is required to ensure that all regulations are met and, most importantly, harm is avoided.

However, there is much more to validated software than documenting and testing requirements. Without the quality management support structure for validation 15

activities, validation is simply an exercise in running test scripts. A pharmacovigilance software company should have implemented controls, processes and practices as defined by the multitude of health authority regulations which pertain to this space - from the 21 Code of Federal Regulations (CFR) documents* to GAMP** (Good Automated Manufacturing Practice) standards.

• Corrective and preventative actions (CAPAs) and support are properly mitigated based on risk to patient safety. To ensure a proper and defendable validation, controls must be in place to provide oversight and guidance of all validation activities, from defining user requirements all the way through to releasing the validation package to the customer. This provides traceability throughout the validation process which, in turn, provides a clear signal to regulators that a controlled phased-gate approach was followed to ensure validation, rather than the ad-hoc approach typical in Agile development methodologies which are based on iterative development, where requirements and solutions evolve through collaboration between self-organising cross-functional teams.

Most pharmacovigilance software companies perform validation activities as part of the ebb and flow of rolling out software, but lack a true understanding of why they are validating a product and, even more concerning, are unaware of the potential impact to patient safety that can result as part of a sub-par validation. The entire company, regardless of job title or role, should have a complete understanding of the why rather than just the how. What To Consider Before Choosing A Drug Literature Monitoring Software Provider

There is much more to selecting a pharmaceutical software vendor than reading “we offer validation services” printed in their brochure. It is critical to take a deep dive into the vendor’s quality management system to ensure appropriate controls are in place for each step in the development, rollout and support phase of a new project. Most important, specifically in literature monitoring software for pharmacovigilance, is patient safety. Any software deployed needs to work correctly 100% of the time due to the critical impact it could potentially have on patient safety. If the software is in a non-functional state, potential drug references could be missed and therefore not reported appropriately.

When considering a software provider, you should ensure: • The vendor speaks your “language,” allowing for easier understanding of requirements and expectations. • You won’t need to hire consultants to define your drug safety requirements. The vendor should have its own subject matter experts, which will aid in requirement gathering and documenting. • The vendor has a standardised and documented approach to software development, rollout and support, reducing the risk of bugs or issues.

* 21 CFR Part 11 is a section in the US Code of Federal Regulations that details the FDA’s guidelines on using electronic records and electronic signatures.

• All software vendor employees should be trained in health authority GxP regulations as they pertain to pharmacovigilance and software development.

** GAMP is a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide – “The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture” - describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process.

• Validation is performed per industry expectations: controlled, documented and supported. In other words: if it wasn’t documented, it didn’t happen. • All references must be imported and reviewed without delay or error. • The vendor must be able to not only provide support in a regulatory audit, but also act as a partner. An observation against you for a software deficiency will be an observation against the company as well. • The vendor has open communication channels. Getting in touch with your software provider should be more than sending an email to customer support and getting a response within 24-48 hours. Waiting any longer than eight hours for a response could have significant impacts not only on reporting timeframes, but patient safety.

Tessa Heffernan ProQuest Pharma Solutions Specialist

Pharmacovigilance and Medical Information Specialist Training Courses at Affordable Prices Developed by industry experts, these peer-reviewed, face-to-face and online training courses offer high quality for a low price. Each includes a test of your understanding and a formal certificate as evidence of your training.

Registration is easy via the Training section of the PIPA website http://www.pipaonline.org/Training/PIPA-Training-Programme

Join us on LinkedIn www.linkedin.com/ groups/3710679

PI PA On l i n e Tr ai ni n g C ou rs es GVP Module I - Pharmacovigilance Systems and their Quality Systems

£40 + VAT

GVP Module III - Pharmacovigilance Inspections

£40 + VAT

GVP Module IV - Pharmacovigilance Audits

£40 + VAT

GVP Module V - Risk Management Systems

£40 + VAT

GVP Module VI - Management and Reporting of Adverse

£40 + VAT

New online courses launching soon GVP Module IX - Signal Management

Reactions to Medicinal Products

GVP Module XV - Safety Communication

£40 + VAT

Introduction to Pharmacovigilance for non-Pharmacovigilance Personnel

£60 + VAT

How to Facilitate a Successful Product Launch

£40 + VAT

Data Protection

£40 + VAT

PI PA Face to Face Tr ai ni n g C ou rs es New face to face courses launching soon Copy Approval in Practice Medical Device Vigilance Regulatory Affairs for MI and PV

Foundation Skills in Medical Inform

Foundation Skills in Pharmacovigilance Advanced Pharmacovigilance Skills: Current Hot Topics Advanced Medical Information Skills Pharmacovigilance System Master File (PSMF) Analysis and Evaluation of Clinical Information (2 day course)

Image acknowledgement: “Business People Working In The Office With Digital Tablet” courtesy of nenetus at FreeDigitalPhotos.net

BREXIT AND THE QPPV -AN UPDATE By John Barber

Since I wrote my initial commentary last spring, what do we now know about Brexit and its impact upon the QPPV? There have, of course, been some significant developments and some clarifications. Firstly, we have confirmation of the numbers of UK-based EEA QPPVs. As of the end of May last year, the EMA stated that there were 1,358 registered QPPVs in the EEA, of which 153, just over 10%, were UK based1. Whether this number is still valid is open to question. There is anecdotal evidence of

some MAHs moving their EEA QPPV to an EU27 country. At the end of March last year, the UK government triggered Article 50; effectively giving two yearsâ€™ notice of its intention to leave the EU on 29 March 2019. The first wave of Brexit negotiations between the UK and the European Commission concluded at the end of 2017, with a transition period agreed to the end of 2020. This has now been confirmed in the draft Withdrawal Agreement 18

issued on the 19 March of this year2. This transition phase should be a period of ‘business as usual’. This has been interpreted as meaning that there is a stay of execution for the UK-based EEA QPPV to that date. This, however, is predicated on the negotiations scheduled for this year progressing harmoniously and the UK not crashing out of the EU on 29 March with a no-deal hard Brexit. With the very public disagreements on Brexit within the Conservative party and within the Cabinet, such an eventuality cannot be discounted.

much to the very public annoyance of Italy. The EMA will therefore be housed in temporary offices in Amsterdam pending the move to its final location. What this means for the EMA’s work programme is not clear. It has already issued a business continuity plan3 which clearly states that during the Brexit process, it may not be ‘business as usual’ and that the EMA must prioritise its activities. Furthermore, the plan states that a second business continuity plan will be required for the actual physical move. It is assumed that this is currently being prepared.

The draft Withdrawal Agreement also appears to indicate that unless otherwise agreed, the UK will not have access to any EU information systems and databases at the end of the transition period. This must be assumed to include EudraVigilance and the Article 57 database. In addition, the role of the MHRA in the EMA’s activities will be limited. It will be able to participate in discussions but will not be allowed to take a leading role in risk assessments, examinations or approvals. In view of the very active role that the MHRA has taken on developing and informing European pharmacovigilance systems and processes, it must be very frustrating for the MHRA that they may lose that influence.

To the middle of 2017, the MHRA had stated in meetings with several UK trade associations that it would not require a UK QPPV. However, at the DIA QPPV Forum in October 2017, the opposite was stated4. The MHRA will now require a UK QPPV. The rationale is that an EEA QPPV will not be able to fulfil the requirements for UK inspection and supervision as, post-Brexit, they would have no legal obligation to deliver pharmacovigilance services for UK authorised products. The other (small) glimmer of hope for UK-based EEA QPPVs is that they may be able to assume the role of the deputy EEA QPPV. The concept of the deputy is not defined in the EU legislation, it is not described in either the Regulation or the Directive, nor is it described in the GVP modules. Clarification on this point has been requested from the EMA on behalf of the European trade associations.

The other significant event towards the end of last year was the announcement of the new home for the EMA from 30 March 2019. Amsterdam was chosen in preference to Milan on the toss of a coin. It has since transpired that the new location will not be ready in time for the relocation,

So how much has changed over the last 12 months? A bit, but the detail is still missing. And definitely not enough to enable QPPVs to start hardening up their Brexit preparedness planning. References 1.

Private communication. Email from EMA 22 May 2017

Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community. https://assets.publishing.service.gov.uk/government/uploads/ system/uploads/attachment_data/file/691366/20180319_DRAFT_ WITHDRAWAL_AGREEMENT.pdf 19 Mar 2018.

European Medicines Agency Brexit Preparedness Business Continuity Plan. EMA/196585/2017. 13 Oct 2017. EMA

Mick Foy. Brexit – the impact on EU pharmacovigilance activities. DIA QPPV Forum, 4 Oct 2017

The views expressed are personal and do not necessarily reflect those of PIPA, my employer or any other organisation with which I am affiliated.

John Barber Head of Pharmacovigilance – European Operations, and QPPV Dr. Reddy’s Laboratories

THE CHESTER EXPERIENCE… THE JOURNEY CONTINUES An intervention to improve Adverse Drug Reactions (ADRs) reporting at a district general hospital By Ammar Abbas

report ADRs faster at our local hospital - The Countess of Chester Hospital NHS Foundation Trust (CoCH).

Under-reporting of Adverse Drug Reactions (ADRs) is a major public health concern globally and is a major limitation of spontaneous reporting systems. The Yellow Card Scheme (YCS) is the UK’s principal system for reporting suspected ADRs. Studies estimate that no more than 6 –10 % of serious ADRs are reported through the YCS by healthcare professionals.1 It is also estimated that 6.5% of all acute hospital admissions in the UK are related to an ADR, accounting for approximately 4% of hospital bed capacity and resulting in a fatality incidence of 0.15%.2 The same study found that most recorded ADRs (70%) were considered possibly if not entirely preventable.2 Aside from the physical and psychological patient harm, the economic impact of ADRs on financial resources and operational capacity is significant and has been estimated to cost 79 billion Euros across the EU in 2012.3 Furthermore, there is evidence to show that approximately one fifth of patients readmitted to hospital within one year of discharge from their original admission were readmitted due to an ADR.4 Therefore, we aimed to raise awareness of healthcare professionals to suspect, identify, manage and

CoCH is a 600-bed district general hospital serving a population of 250,000 residents of Western Cheshire in the North West of England and adjacent regions of North Wales. Feedback on ADR reporting performance of CoCH healthcare professionals is communicated quarterly by Yellow Card Centre North West (YCCNW) using data provided by the Medicines and Healthcare Regulatory Agency (MHRA).5 Reports graphically display the total number of ADR reports, breakdowns of quantitative performance of different professional groups, comparative data between different quarters within a trust and with all other trusts in the North West.5 Baseline ADR reporting at CoCH was poor in 2012/2013 as shown in Figure 1 (ranking 18th out of 31 trusts) but improved consistently over the following 5 years after implementing a plan in January 2014, achieving top reporting trust in the North West of England in 2014-15 and again in 2016-17 as shown in Figure 2.

Figure 1: Number of YC reports submitted by hopsitals in the North West in 2012/2013 20

to Rheumatology, Gastroenterology and Accident & Emergency teams. An exploratory study looking into attitudes of Nurse-NMPs at CoCH towards reporting ADRs via the YCS was undertaken as part of an MSc dissertation. This helped identify some obstacles to reporting, namely, unsatisfactory knowledge of the YCS, challenges of identifying ADRs, remembering to report ADRs via the YCS, time pressure, extent of clinical complexity of presenting patient and difficulties with extracting ADR data from complex drug management systems. A 20 fold increase in total reporting compared to baseline was observed over a period of 5 years. The most significant effects were observed within pharmacy where individual reporting was monitored. Experience amongst the pharmacy team also showed that sharing observations about one type of ADR is likely to enhance the probability of detecting the same ADR by colleagues afterwards. For example, a case of Neuroleptic Malignant Syndrome (NMS) was identified by a pharmacist shortly after a patient was admitted. The pharmacist reflected that she was able to advise the team not to prescribe the suspect neuroleptic drugs following the weekly departmental circular detailing a similar case of NMS reported by a pharmacy colleague the week before. This mirrors the impact of a published example of a fatal ADR report submitted via the YCS involving a patient taking warfarin with cranberry juice. This report triggered an MHRA warning to avoid cranberry products in patients taking warfarin. Shortly afterwards, multiple warfarin / cranberry interaction reports were submitted, all of which were detected early enough not to cause harm. No further reports of this drug-food interaction have been received for some time after 2009.3 Concurrent use may have still continued to occur, but the evidence showed that awareness rose immediately after the warning and this helped potentially prevent harm.

Figure 2: Number of YC reports submitted by hopsitals in the North West in 2016/2017

The improvement in ADR reporting rates at CoCH was mainly due to reporting by the hospital pharmacy team as shown in Figure 3. A key performance indicator for the pharmacy department of 5 ADR reports per week was arbitrarily set as a starting point. An individual monthly reporting target of a minimum of 1 ADR report per pharmacist was also set. Initial promotional and collaborative focus was on areas likely to receive patients with ADRs as the cause of admission such as the Medical Admissions Unit and Accident & Emergency and to medical specialities (Rheumatology, Gastroenterology and Haematology) where drugs relevant to the MHRA current road map6 (biological agents, bio-similars and novel oral anticoagulants) are used. A campaign to highlight ADRs at ward rounds and train pharmacists, doctors and non-medical nurse prescribers (Nurse â€“ NMPs) in pharmacovigilance was implemented. This involved periodic lectures, online MHRA material and quarterly feedback on reporting performance received from the MHRA via YCCNW to pharmacists. A talk on pharmacovigilance was also incorporated into the educational curriculum of Foundation level (newly qualified) doctors and into pharmacy induction sessions of more senior doctors. Targeted sessions were delivered

Figure 3 : Number of YC reports submitted by the main profesionals groups at CoCH between 2012-2013 and 2016 - 2017 21

which were considered severe. Only 2% of submitted ADR reports involved a drug under the intensive monitoring list, highlighting the need for focused pharmacovigilance training.

Over the 5 years running to March 2017, a total of 1082 reports were submitted from CoCH, 27% of which involved drugs associated with a Commission of Human Medicines (CHM)/MHRA warning in the BNF and 25% of

Figure 4: 20 most frequently reported drugs suspected to cause ADRs from CoCH between April 2012 and March 2017

Figure 5: 20 most frequently reported suspected ADRs from CoCH between April 2012 and March 2017

In summary, improvement of ADR reporting activity needs a multi-faceted approach, in particular regular and targeted pharmacovigilance training. A multi-disciplinary approach incorporating the use of team champions, publicity campaigns, more efficient use of technology to enhance the reporting experience, periodical training and trust-wide feedback on ADR reporting performance may be the way forward. Increased ADR reporting reflects improved ADR identification which will ultimately reduce avoidable patient harm.

3. Griffiths R, Nurses Must Report Adverse Drug Reaction, British Journal of Nursing, 2013, Vol 22, No 8 4. Davies E; Green C & Pirmohamed M; Emergency re-admissions to hospital due adverse drug reactions within 1 year of the index admission. British Journal of Clinical Pharmacology (2010); 70:5; 749-755 5. Yellow Card Centre North West; http://www.yccnorthwest.nhs.uk/ accessed 01/03/18 6. 50th Anniversary Scientific Conference proceedings: New Era for The Yellow Card Scheme; A roadmap for the future; 20 March 2015 â€“ Roral College of Physicians Edinburgh

References

Ammar Abbas BPharm (Hons), Dip

1. Stewart D et al. Non-medical prescribers and pharmacovigilance: participation, competence and future needs. International Journal of Clinical Pharmacy 2013; 35: 268-274.

Pharm Practice, MSc in Clin. Pharm. Medicines Information / Medicines Management Pharmacist

2. Munir Pirmohamed, Sally James, Shaun Meakin, Chris Green, Andrew K; Adverse Reactions as a cause of admissions to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329: 15-19.

Countess of Chester Hospital NHS Foundation Trust

THE NHS INJECTABLE MEDICINES GUIDE Information support from the pharmaceutical industry is essential for this resource. By Christine Proudlove

Summary The Injectable Medicines Guide is widely used in the NHS as a point-of-care resource. Its content is reliant on information provided by the pharmaceutical industry in the form of Summaries of Product Characteristics and in response to specific requests to medical information departments.

The content of the IMG is co-ordinated by a small team based at Imperial Healthcare Trust and the website is hosted by NHS Wales Informatics Service. Monographs are written, and updated annually, by hospital pharmacists from around the UK. Monographs are brief, written in active language and highlight key points. They describe the presentation of the medicine, how it is reconstituted and/or diluted, how it is administered, and potential adverse effects. A risk rating relevant to these points, based on the NPSA tool for risk assessment, is included. Details are also given on storage requirements, product stability after preparation and whether natural rubber latex is a product component.

Introduction The 2007 National Patient Safety Agency (NPSA) Patient Safety Alert - Safer Use of Injectable Medicines in Near-Patient Areas recommended up-to-date guidance on preparing and administering injectable medicines be available to healthcare staff at the point of care, and suggested the NHS Injectable Medicines Guide (IMG, or Medusa) as a suitable source of this information. Today, most UK hospital trusts use the IMG website.

IV monographs include ‘technical’ information essential to minimise patient risk, including the pH and osmolarity of a preparation to inform the decision on the most appropriate venous access device, sodium content, and information on compatibility with a range of infusion fluids and with other medicines.

The website comprises around 400 individual monographs on medicines given by the following routes: • Intravenous (IV) injection/infusion. There are separate monographs for adult and paediatric practice.

To find out more about the IMG and to view sample monographs use the username - ivgdemo and password - bolus7 to access the website at www.injguide.nhs.uk

• Intramuscular (IM) injection.

The IMG, SmPCs and PILs Summaries of product characteristics (SmPCs) and patient information leaflets (PILs) are prime information resources for monograph authors. However, as a pointof-care resource, IMG monographs are shorter and much information contained in the SmPC is omitted. For example, only adverse effects that might be anticipated during or immediately after injectable administration are included. Where possible, content reflects current UK practice and recommendations may differ from those in SmPCs. In addition, monographs may cover unlicensed preparations, and unlicensed and off-label use and routes.

• Ocular injection.

Monographs hyperlink to SmPCs and PILs if they are available on the electronic Medicines Compendium (eMC). When not available on the eMC, links are made to SmPCs/PILs on company websites or pdf copies are 24

attached to the IMG monograph. These solutions lack the benefits of the eMC where links remain constant when documents are updated. The IMG and pharmaceutical manufacturers/ suppliers SmPCs and PILs often lack the ‘technical’ details needed to prepare a monograph and IMG authors may contact manufacturers/suppliers’ medical information departments for this information or to confirm information previously given is still current. Frequently requested information includes: • pH and osmolarity of the product. If the product is normally given by infusion, the pH and osmolarity of the product when diluted for infusion are more helpful than those for the undiluted solution.

Companies vary in how helpful they are in providing this information. Perhaps surprisingly, generic manufacturers/ suppliers are often more responsive than major pharmaceutical companies who may quote ‘commercial sensitivity’ as a reason for withholding information, or will provide the information only in response to a query about an individual patient. Where information is provided, a written response is preferred so it may be linked to the monograph for governance purposes. To comply with the usual conditions under which manufacturers/suppliers offer information, such links are only visible to IMG editors when the monograph is published and are not available to general users.

• The sodium content in mmol before reconstitution/ dilution. • The suitability of the following as diluents: sodium chloride 0.45% and 0.9%, glucose 5% and 10%, glucose/sodium chloride mixtures, sodium lactate, compound (Hartmann’s solution), Ringer’s Solution for injection, sodium chloride 0.9% and glucose 5% infusions containing 20mmol or 40mmol potassium chloride, and Plasmalyte 148. • The latex status of the preparation. The IMG uses two standard statements:

Manufacturers/suppliers are also asked to review draft monographs as part of the quality assurance process prior to publication. A website username/password specific to the company allows access to the draft. They are not asked to accept responsibility for the content of the monograph, but to comment on accuracy and check any linked SmPCs/PILs are current.

• Natural rubber latex is not used as a material in the manufacture of this product or in the container or packaging. Contact with latex during or after manufacture cannot be excluded. • This product contains natural rubber latex.

In conclusion, pharmaceutical industry support is essential to ensure content of the IMG is complete and accurate. All manufacturers/suppliers are encouraged to engage with the IMG in order to promote safe use of injectable medicines and minimise patient harm.

For some products, further information may be requested. For example, for products requiring reconstitution of a powder, the following information may be pertinent: • Does the vial contain an overage or, if not, what is the displacement value of the powder? When preparing a small dose for a child, part vials may be used, and neglecting to take these factors into account may be clinically significant.

For further information, please contact Christine Proudlove at christine.proudlove@rlbuht.nhs.uk

• If water for injections is recommended for reconstituting a medicine likely to be prepared in a closed-system infusion container, can sodium chloride 0.9% solution be used instead? If not, then reconstitution and dilution must be done as separate steps negating benefits offered by these containers.

Christine Proudlove Pharmacist, Injectable Medicine Guide Imperial Healthcare Trust/ North West Medicines Information Centre

PIPA Conference 2018 PIPA is delighted to announce that booking is now open for the 2018 PIPA Conference

We’re putting together an exciting and dynamic programme suitable for medical information and pharmacovigilance professionals of all levels – from new starters to experienced managers. This will include an update on the implications of Brexit by Dr Sheuli Porkess from the ABPI; Patrick Mitchell, Regional Director, NHS Health Education England will look at how the NHS's use of Digital Media will impact the Pharmaceutical Industry; a Code Compliance workshop run by Rina Newton, CompliMed; a PV audit and inspection hosting workshop; insights from Fiona Woods and Sarah Cavanagh from the UKMi; Sarah Dunnett will be delivering a workshop on launch excellence and Dr Dave Lewis will be returning to present a workshop on medication errors As in previous years, there will be a workstream dedicated to Managers where team and personal branding will be discussed, as well as an update on Data Protection post GDPR. We are still finalising the remainder of the programme, and new sessions will be added over the next few weeks. If there is a particular topic that you would like to see included, then please contact us via conference@pipaonline.org. You can view the programme via: https://www.pipaonline.org/Conference-Programme-2018

Date: Wednesday 3rd – Thursday 4th October 2018 Venue: Legoland Conference Centre, Windsor Booking: https://www.pipaonline.org/External-Events/PIPA-Conference-2018-Delegates/57214

PIPA CONFERENCE – BEHIND THE SCENES By Christine Needham

We start the planning process almost as soon as the previous conference is over. We aim to set a date and find a venue before Christmas. Anne and Sharon research all of the venues suggested by the PIPA membership and committee, and visit likely contenders. We also try and hold a committee meeting at the venue so the whole committee can view the facilities and see the rooms where the meeting and exhibition will take place. Location of the venue causes us lots of issues as we get many requests from PIPA members to hold the conference at a venue that is more convenient for them. London is a frequent request; however, the cost of a London hotel is prohibitive as we would have to pass these additional costs on to conference attendees. We are also aware that if we want to include speakers from organisations such the ABPI and the MHRA, we need to hold the event within reasonable travelling distance for them. We aim to choose a venue that ticks as many boxes as possible, whilst allowing us to keep our costs as low as possible to ensure that we can continue to offer competitive rates for attendance.

As many of you will be aware, we have just started taking bookings for PIPA’s 2018 Annual Conference. This year the conference will take place in the business suite at the Legoland Hotel, near Windsor, on the 3rd and 4th of October – so we are all very excited. When I first joined PIPA back in 2010, my first conference was held at a hotel somewhere in the Cotswolds and I was very impressed with the professionalism of the whole event. It was certainly presented at a level I had come to expect from much larger organisations. What I hadn’t realised then was that conference is put together by a team of people, many of whom also have a busy day job. The PIPA contractors, Anne, Sharon and Sarah, are of course the lynchpins in the planning process and they have all experienced many PIPA conferences in the past. Anne focuses on working with committee members to source a venue, pull together the programme and liaise with speakers. Sharon, who deals with all membership requests, works with Anne to organise the venue and deals with conference bookings and logistics such as dietary requirements. Sarah, who manages the PIPA accounts, keeps us all on track with the budget.

Last year we were fortunate to find the stunning venue of Wotton House near Dorking with its lovely façade and beautifully finished Old Library, which proved to be a truly majestic setting for the evening event. This year we are changing the theme completely and going with the energetic and colourful Legoland hotel near Windsor. Next in the planning process comes the programme. We always start with reviewing the feedback and suggestions you have provided from previous conferences. We also look at including relevant “hot topics”, reviews of any key regulatory changes and subjects of general interest. We plan the two days to provide a mixture of plenary items, which hopefully are of interest to all, along with breakout sessions and workshops which focus more on individual topics within PV and MI. The managers’ workstream has also become a popular session in recent years. We have become increasingly aware that MI and PV jobs are changing and broadening in aspect – so we are also attempting to broaden subjects to cover some wider aspects within medical affairs. Continuing Professional Development (CPD) points are awarded for attending conference – so it is vital that we provide content that both informs and educates.

The PIPA Annual General Meeting also takes place at conference. This short session allows the PIPA organisation to conduct its ‘business’. This includes electing the committee, making important decisions regarding the organisation, and informing the members of previous and future activities. Members also see PIPA financial account information for the past year and have the opportunity to ask any questions they may have about PIPA.

much more. With conference being held at Legoland this year, who knows what the committee will think of! So far so good – it all sounds relatively simple. Not so – we always have our fair share of dramas to contend with. One year we were let down by the venue about 3 months before conference – they had received a larger booking and could no longer honour our contract. We also had an issue with one venue when bedrooms were very inconsistent, some delegates had enormous rooms whilst others were given shoe boxes. Suffice to say we have not revisited either venue since. Then there are the simple logistical issues that occur throughout the conference: speakers running late, delegates who have neglected to inform us of their strict dietary requirements in advance, venues deciding to carry out key maintenance work during the conference etc. The team are excellent at dealing with all of these, but we are always relieved when we can all sit down at the end of another successful annual conference.

Like many conferences, we also have an exhibition and are fortunate to have exhibitors who return each year as well as some new faces who are keen to learn about PIPA and meet our members. The exhibition gives the conference delegates a good opportunity to chat with a variety of exhibitors and learn about a range of topics, such as what the British Library have to offer, the latest copyright rules and updates on industry-wide software. We also recognise that for our exhibitors, the conference is a big investment of time and money, but we couldn’t run conference without them.

Last, but not least, the most important part – the delegates – you! Come to conference, learn, enjoy the opportunity to meet new people and hear about how our industry is evolving. Early bird rates are available now until Friday 10th August via https://www.pipaonline.org/ External-Events/PIPA-Conference-2018-Delegates/57214.

Next comes all the finishing touches that make the conference complete. Choosing the evening event and menus always results in lots of discussion amongst the committee. We often choose a theme that goes with the venue. Last year’s beautiful old library was a perfect setting for a 1930’s murder mystery and back in 2012 the chapel at Beaumont Estate was a great backdrop for a twenties inspired evening, complete with Charleston dancers. We have also encouraged delegates to network by getting them involved in activities as well as the odd quiz. Over the past few years we have had an 80s night, a circus theme with a close-up magician and the opportunity to try various circus activities, a fencing demonstration and lesson, a Wild West evening with line dancing, a casino night and

I look forward to seeing you all at conference.

Christine Needham PIPA Vice President

PRESIDENT’S REPORT – MARCH 2018 Sarah Hall (PIPA President)

As I write this report, the country is coping with the ‘Beast from the East’ and ‘Storm Emma’. I hope that you and your families have kept yourselves safe and avoided the travel chaos. We spend a lot of time dealing with what life throws at us. Our ‘to do’ lists get longer and we have more and more plates spinning. At the end of last year I lost the friend and mentor who introduced me to Pharmacovigilance. He seemed to effortlessly juggle all his work commitments whilst unceasingly putting his family first. His loss, and a few other things going on at the moment, gave me pause for thought. It is so easy to get caught up in the chaos of life and forget what our true priorities are. I’ve taken 2018 as an opportunity to revisit my priorities.

Sometimes things in life happen that allow us to understand our priorities very clearly. Ultimately you can see those as gifts. - Mariska Hargitay With regards to PIPA, amid the post-conference activities and pre-Christmas rush, the Committee made the decision to send out the PIPA calendar before Christmas, but delay publishing the ‘December’ PIPELINE until the new year. It was a matter of deciding what was actually time sensitive and what could wait. At the time it was quite a difficult decision, but, looking back, it makes complete sense and gave our editors and contractors a bit of breathing space when they were dealing with so much. I hope you enjoyed reading all the articles and agree it was worth the wait. I especially hope you enjoyed learning about the 2017/2018 30

Pharmacovigilance diploma and MSc course. At the beginning of February, I had the pleasure of giving the PIPA lecture to the current intake. It was great to meet the students who had varied backgrounds and a shared passion for Pharmacovigilance. Most of them are completing their diploma or MSc whilst juggling their busy day jobs and home life. To me they are a great example of prioritising and I wish them all the best as they complete their studies.

Committee and can see what a great range of experience, knowledge and expertise the team has. One of the Committee activities at the end of 2017 was updating the PIPA UK Guidelines on Standards for Medical Information. You will have received a hard copy with the last edition of PIPELINE. They are also available on the PIPA website in the Medical Information section https://www.pipaonline.org/Medical-Information-MI-. The standards are up to date with current practice and in line with the changes to legislation and we are pleased to have received some great feedback already.

Life is short. Focus on what really matters most; you should change your priorities over time.

Along the same lines, the PIPA PV Compliance Workstream has been updating the PIPA UK Guidelines on Standards in Pharmacovigilance. Again, this is to bring them up to date with current practice and legislation. The changes also cover the impact of implementation of the General Data Protection Regulation (GDPR). We are also pleased that we continue to work closely with the ABPI PEN (Pharmacovigilance Expert Network). They have asked PIPA to take responsibility for the guidance notes on Data Privacy in Pharmacovigilance and bring them in line with the upcoming GDPR requirements so ‘watch this space’. Finally, with regards to Data Protection, we are updating the Data Protection online course and hope to launch it at about the same time as, or just before, implementation of the GDPR in May.

– Roy T. Bennett

We have made a good start creating the programme for the PIPA 2018 Conference, which will be held at Legoland on 3rd and 4th October. We have planned an exciting agenda with Sheuli Porkess (ABPI) returning to give us an update on Brexit, Patrick Mitchell (Regional Director, NHS Health Education England) talking about the impact on pharma of the NHS going digital as well returning favourites such as Dave Lewis, Rina Newton and the UKMi. By the time this edition hits your desks, registration will be open. You can find out more on the PIPA website https://www.pipaonline.org/ Conference-2018.

Decide what you want, decide what you are willing to exchange for it. Establish your priorities and go to work.

Hopefully 2018 has started well for you. The Committee and our contractors are juggling a lot of things in order to provide you, our PIPA family, the networking, knowledge, links and training opportunities you deserve. All our committee are volunteers working hard for the PIPA membership as well as dealing with busy working lives, families and other time pressures. We are always happy to hear from you if you have ideas on how we could support you even more and/or if you would like to be actively involved in one of our workstreams or other activities. Please get in touch via pipa@pipaonline.org or president@pipaonline.org. I hope to see and hear from many of you over the year and, in particular, I hope, like me, you are looking forward to our conference in October.

- H. L. Hunt For 2018, we are pleased to have established a joint venture with CompliMed to bring you the CompliMed PIPA Code Forums. An eNews with the 2018 Code Forum dates was sent out earlier this year. Please accept my apologies that the eNews didn’t refer to the name change. The CompliMed PIPA Code Forum will be chaired by Ros Henley (Managing Consultant, CompliMed and ex-member of the PMCPA Panel) and run at the CompliMed offices. The forum will continue to meet quarterly to discuss Code compliance matters, recent case rulings and sharing best practice among other things. If you missed the first forum of 2018, but want to attend the remaining three, you can book via the PIPA website https://www.pipaonline.org/ Events/2018-Code-Compliance-Forums-x-3/57394

The key is not to prioritize what's on your schedule, but to schedule your priorities. - Stephen Covey

Many of you will know that PIPA has a link with the University of Hertfordshire in the development of their 31

NEW MEMBERS Miss Oghenenyerhovwo Grace Olokpa Drug Safety Specialist Eisai Europe limited

Dr Liliana Cristina Hansen Senior Director, Head of Pharmacovigilance Zealand Pharma A/S

Miss Fahima Amin Medical Review and Information Specialist MSD

Dr Lay Ean Tan Medical Science Associate Kyowa Kirin Pharmaceutical Development Ltd.

Mrs Tahsina Choudhury Medical Information and Patient Safety Executive AstraZeneca UK Ltd

Dr Manoj Prabu Janaki Ponnusamy Director/ Trainee RP Blumont Pharma Ltd.

Miss Nitasha Vekaria Medical Review And Information Specialist MSD

Mr Inam Hassan Drug Safety Coordinator Reckitt Benckiser Healthcare International Ltd.

Miss Simran Marway Medical Information Officer Ethypharm UK Ltd and Martindale Pharma

Miss Dania Shamil Senior Pharmacovigilance Regulation Specialist Vertex

Mrs Amirah Panhwar Senior Manager INC Research UK Limited

Mr Jay Borkhataria Medical Information Specialist Novo Nordisk Ltd.

Mrs Karen Foster Kyowa Kirin Pharmaceutical Development Ltd.

Dr Timothy Fish Director Sarepta Therapeutics

Dr Maryam Habibzay Senior Scientific Information Officer SanofI

Mr Harminder Mudhar Safety Evaluation Scientist Eisai Europe Ltd.

Mr Ashish Vyas Pharmacovigilance Manager Healthcare at Home

Mrs Chibundo Binitie Medical Affairs Officer Chiesi Ltd.

Dr Anton Dimitrov Safety Physician INC Research UK Limited

Miss Emma Howard Medical Information Specialist Roche Products UK

Mrs Yasmin Choudhry Regulatory Affairs Wise Pharmaceuticals Ltd

Miss Natalia Mele Pharmacist Moonlight Pharmacy

Dr Olayinka Omisore Clinical Research Physician Watershoray Limited

Mr Mohammed Hanslot Medical Affairs Officer Chiesi

Mr David Lough Pharmacovigilance Officer JensonR+ Ltd.

Miss Lorraine Anderson Senior Pharmacovigilance Writer Kinapse Ltd.

Mr Mohammed Hanslot Pharmacist Well Pharmacy

Mr Raphael Otubu EMEA PV Compliance Manager Eisai Europe limited

Dr Ajit Gurjar Drug Safety Manager ICON Clinical Research UK Ltd.

Mrs Dovile Mandeikiene Pharmacovigilance Manager Sanoswiss

Dr Akiko Onishi Quality Strategy Lead Merck KGaA

Mrs Fiona Syndercombe Medical Manager Biogen Idec Ltd.

Mrs Hetal Parmar-Hughes Medical Information Officer Ashfield In2focus

Dr Nicholas Flinn

Miss Nirosha Paramalingam

Mrs Arpitaa Injamuri

Mr Sushil Sangar Pharmacist Boots UK Ltd.

Mr Krishan Mistry Medical Affairs Officer Chiesi Ltd.

Ms Jacqueline Flounders Shire Pharmaceuticals Ltd

Miss Martyna Myka Beiersdorf UK Ltd.

Ms T Mason Harefield Pharmacovigilance Ltd.

Dr Michaela Polakova Ewopharma International, s.r.o

Ms Ana Sousa Eisai Europe Ltd.

Mr Brad Read Johnson & Johnson Ltd.

Retirement - And we say goodbye to Ros O’Callaghan After a total career in Medical Information of 40 years, 26 of these at Bristol-Myers Squibb, I will be retiring.

enthused by the development of Medical Information initatives over the decades.

I have been a member of PIPA and previously AIOPI since 1978, and a highlight for me was organising the Cross Company training courses for 8 years where companies invited teams of new entrants to Medical and Scientific Information to their sites to share best practices on a variety of topics, from literature searching, to compliance to medical writing. Through this I created a large network of MI folks who I am still in touch with.

I wish you all the greatest success in your future careers. My personal email is below and I am on LinkedIn. Ros O’Callaghan` Ros.ocallagan@btopenworld.com Former Lead for Medical Capabilities, European Markets, Australia and Canada, Bristol-Myers Squibb (until 1st March 2018)

I have always treasured the rich dialogue and discussions facilitated by PIPA amongst its members, and been so

PIPA COMMITTEE 2018 Who are we? The PIPA committee is the backbone of the association; and this page features all the current contact details. The Committee is supported by 3 part-time contractors, whose details are also included on this page.

Sarah Hall

Christine Needham

President

Vice President & Honorary Secretary Freelance Consultant

Email: president@pipaonline.org

Email: vicepresident@pipaonline.org

Role: Leadership - strategy & committee / KOL liaison / PIPA representation

Role: Correspondence / Membership matters / Constitution compliance / AGM leadership / Consultation responses

Tracy Crooks

Jen Quinn

Treasurer Reckitt Benckiser

Co-Treasurer Janssen Cilag Ltd

E-mail: treasurer@pipaonline.org

Role: Financial lead / Audit & compliance / Invoice payment

Shirely-Ann Van Der Spuy

Izzy Whitehead Training Workstream Co-Chair; Communications & Profile Janssen Cilag Ltd

Training Workstream Co-Chair RedLine Pharmacovigilance E-mail: training@pipaonline.org

E-mail: training@pipaonline.org; internet@pipaonline.org

Role: Co-ordinating face to face training courses for the PIPA membership.

Role: Co-ordinating face to face training courses for the PIPA membership. Raising awareness & engagement within & beyond PIPA

Esther Straghan

Zaiba Malek

Training Workstream Co-Chair Pfizer Ltd

Training Workstream Co-Chair Bayer

E-mail: training@pipaonline.org

Role: Co-ordinating online training courses for the PIPA membership.

Bisola Idris

Janine Gavin-Poulter Code Co-ordinator; Conference Co-organiser Sobi

Code Co-ordinator E-mail: code@pipaonline.org

E-mail: code@pipaonline.org; conference@pipaonline.org

Role: Providing a PIPA lead on Code-related topics.

Role: Assisting with organisation of PIPA Code Forums; assisting with PIPA Conference preparation and delivery.

Pooja Shah

Salma Ibrahimo

PIPELINE Co-Editor; Conference Co-organiser Cancer Research UK

PIPELINE Co-Editor Amgen E-mail: journaleditor@pipaonline.org

E-mail: journaleditor@pipaonline.org conference@pipaonline.org

Role: Preparation and proof-reading of PIPA's journal, PIPELINE.

Role: Preparation and proof-reading of PIPA's journal, PIPELINE; assisting with PIPA Conference preparation and delivery.

Ejaz Butt

Dora Amene Communications & Profile; Conference Co-Organiser Zigzag Associates Ltd

PV Compliance Reckitt Benckiser E-mail: pv-liaison@pipaonline.org

E-mail: conference@pipaonline.org; internet@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance.

Role: Raising awareness & engagement within & beyond PIPA; assisting with PIPA Conference preparation and delivery.

Anne Lloyd

Sarah Anthony

PV Compliance; Conference Co-organiser Ethypharm UK & Martindale Pharma

Administrative and Treasurer's Support (Contractor)

E-mail: pv-liaison@pipaonline.org; conference@pipaonline.org

PO Box 254, Haslemere, Surrey, GU27 9AF E-mail: sarah.anthony@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance; assisting with PIPA Conference preparation and delivery.

Sharon Braithwaite

Anne Turnbull

Membership and Events Co-ordinator (Contractor)

Operations Manager (Contractor) PO Box 254, Haslemere, Surrey, GU27 9AF

PO Box 254, Haslemere, Surrey, GU27 9AF

Tel: 07904 164812

Tel: 07340 519234

E-mail: anne.turnbull@pipaonline.org

E-mail: sharon.braithwaite@pipaonline.org

Contribute an article to Pipeline or register as a contributor Could you impart knowledge that you have gained recently through work or training, which you feel the membership would find useful? We are always looking for new authors and are committed to providing you with an excellent range of topical articles from changes in the regulatory environment, promotion of new initiatives and sharing best practices. Articles can be 250 - 1500 words long. Please contact the editorial team with your ideas or article, or to register your expertise in a specific field so we can invite you to write on a specific topic our members would like to see in the next edition: journaleditor@pipaonline.org

ADVERTISE IN PIPELINE PIPA is an association of around 700 professionals who are employed in the Pharmaceutical Industry, predominantly in the fields of Medical Information, Pharmacovigilance and Compliance. Advertising to members can be undertaken via our journal, PIPELINE, which is published 3 times a year, a paper mailing or on the PIPA website. The PIPA membership list is confidential and is not made available to advertisers and non-members of the association. We also accept advertorials. Please let us know if you would like to write an advertorial rather than including a simple advert in the next or subsequent editions of PIPELINE. External agencies who wish to advertise with PIPA must have PIPA member representation within their organisation, and may only advertise services that are of benefit to the PIPA membership. For further information, advertising rates and/or membership details please contact: anne.turnbull@pipaonline.org