PSAIRISH PHARMACEUTICAL STUDENTS’ ASSOCIATION

May, 2015Issue 4

IN THIS EDITIONClinical Training and Cultural

Exchange in Tennessee

Internship in the EMA

Leonora O’Brien: founder of Pharmapod

SUMMER’S INEXAMS OUT Issue 4

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FOREWORDI would like to extend a personal congratulations to each and every one

of our undergraduate members on successfully completing their ex-ams. It has been a long, challenging and in some cases stressful and

hectic few weeks for us all and, at this stage, I am very happy to report that pharmacy students from all corners of the country have made it to the other side! Now that exams are over, we all deserve a well-earned rest. Some might also say we deserve a new issue of the IPSA Newsletter and so, here we are! First year or final year, with each year comes its own unique experiences and hopefully fond memories. From my own experience, there is nothing more rewarding than getting yourself involved and taking an active role in your world and most importantly, your own development and life.

Here at IPSA, our aim is to broaden the horizons of our members and in-spire them to aim higher, do more and reach their full potential. In this issue, we have excellent articles covering cultural/training exchanges in the United

States, an interesting internship experience with the European Medicines Agency and a very inspiring inter-view with the founder and owner of Pharmapod, Leonora O’Brien.

Mena Eskander,President

EDITOR

Kyle Malone

LAYOUT & DESIGN

Mena Eskander

CONTRIBUTORS

Amy Hsieh

Paul Dillon

Avril Burgess

SPECIAL THANKSLeonora O’Brien (Pharmapod)

This publication is the responsibility of the Irish Pharmaceutical Students’ Association.

PERSONNEL

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Clinical Training and Cultural Exchange in the USAAs part of our final year projects, my classmates,

Aishling and William, and I spent four weeks in Johnson City, Tennessee as part of an international ex-change programme between the School of Pharmacy, University College Cork (UCC) and the Bill Gatton College of Pharmacy, East Tennessee State Universi-ty (ETSU). This fantastic programme gives students from each school the opportunity to gain insight into pharmacy education, pharmacy practice, and health care delivery systems in other countries.

Clinical training is a major component of pharmacy education in the USA. The final year of the pharmacy program at ETSU consists of nine one-month clini-cal rotations in different practice settings: community pharmacies, hospitals and institutions, and primary care and ambulatory care settings. During our time there, we participated in clinical rotations with the final year students, spending time at different sites and experiencing what pharmacy is like in Tennessee. At each rotation site, we worked as part of the team, learned from the preceptor (supervising pharmacist), interacted with patients, and engaged in patient care activities. It was an incredible opportunity to under-stand and experience the roles and responsibilities of the pharmacist in different settings. It also gave us the chance to see how the pharmacy profession and scope of practice is developing and expanding in America.

The exchange programme is not just all about pharma-cy though. It is very much about cultural exchange as well. It was our first time in the Southern region of the

US, and we were struck by the warmth and strength of that renowned Southern hospitality. Everyone was extremely kind and welcoming. Outside of rotations, we got to know many of the students, staff, and fac-ulty at ETSU. We traded amusing and horror-filled pharmacy anecdotes like old battle stories over meals and drinks, all while our hosts heartily encouraged us to try the lovely local cuisine (think sweat tea, savoury biscuits and gravy, deep-fried okra, and de-licious Southern fried chicken). There were also fun activities and sightseeing trips. One weekend, some of our new friends took us skiing and snowboarding. On another occasion, we visited the impressive and historic Biltmore Estate, America’s largest home built on acres and acres of beautifully landscaped gardens and grounds. And, no trip to an American college is complete without watching and joining in on the ex-citement of an American college basketball game.

Our time at ETSU was unforgettable. It was an in-credible learning experience, and it was wonderful getting to know our American colleagues. Our cul-tures and accents might be a little different, but af-ter working and spending time together, we can say that pharmacists and future-pharmacists around the world are really quite similar. We look forward to col-laborating again in the future and hope that the rela-tionship between UCC and ETSU continues to grow and strengthen.

by Amy Hsieh, UCC

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My name is Paul Dillion and I am a Senior Demonstrator and PhD student in the School of Pharmacy RCSI. I am part of the

NPIP team and I assist in the continuous assessment of pharmacy interns. My research is focused on devel-oping an evidence base for enhanced clinical services in Irish community pharmacy. I am particularly inter-ested in the issue of poor adherence to blood pressure medication among older adults and how a pharmacist can identify patients with adherence issues and clini-cally intervene.

1. How did you hear about the internship?I became aware of the EMA traineeship during my six-month intern placement in the IMB (HPRA). A pharmacy intern from the year previously had been successful in applying to the traineeship, and the idea appealed to me to continue working in regulation at the end of my placement.

2. What was the interview and selection process like?Each year the European Medicines Agency (EMA) in London recruit around 40+ new graduates from all countries in the EU to participate in their trainee programme. Trainees are based in a specific unit or department for the duration of the traineeship (usu-ally 6 to 12 months). Approximately 1500 apply to the programme by submitting the application form which can be found on their website (http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000321.jsp&mid=WC-0b01ac0580029405). I applied specifically to the phar-macovigilance department. Following this I complet-ed two telephone interviews which included questions ranging from my knowledge on the new EU pharma-covigilance legislation and what information can be

found in the Martindale to my experience in working and studying in multicultural environments and my ability to speak a 2nd EU language (although thank-fully they didn’t assess!)

3. What tips would you give someone that wanted to put themselves forward for it? Do they require regu-latory experience? Is there only one candidate chosen or a few?The strength of my application was my experience in the IMB and I based my application on this. There were two more Irish pharmacists working with me in the traineeship. One guy had completed a six month placement in industry and applied for a similar role in the EMA to what he had been doing. The second guy applied to the veterinary medicine department and used his farming background to his advantage.

4. What was it like to travel to London? Were you ever there before or had you known friends there?London is a fantastic place to live and socialise but be wary it is very expensive particularly living on a sti-pend of £1350 that the trainees are paid. There is also great camaderie amongst the trainees and you get to meet so many people from different European coun-tries. Each cohort begin work at the same time, usual-ly at the beginning of October and many get to get to-gether to look for places to live. I stayed in a flat-share which I organised prior to starting the traineeship as my PRE was also at the start of October. Finding ac-commodation in London can be tough and expensive, and I didn’t want to combine that with the stress of finishing the MPharm. I took study leave during the second week of the traineeship to come home to study and complete the exam.

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5. How did you find the work itself i.e was it manageable or demanding?I worked within a team responsible for management of Eudravigilance, the system responsible for phar-macovigilance in the EU. Specifically I worked on the XEVMPD (medicinal product dictionary) which had particular importance under the new EU legislation. My projects were quite manageable but at times how-ever it could be boring as tasks are often not delegated to trainees and sometimes I wouldn’t have much to do! However it was great experience to see the EMA in action (CHMP, PRAC plenary sessions etc) and I attended many courses and received certification for activities such as ADR reporting to the EMA, and sig-nal detection for ADRs associated with a particular medicine.

6. What did you take and learn from the experience?

Towards the end of the traineeship I applied for a tem-porary contract at the EDQM in Strasbourg, France to cover a maternity leave. The EDQM are body es-tablished under the Council of Europe (a body sep-arate from the EU and which also incorporates the European Courts of Justice and Human Rights) and is responsible for the establishment and maintenance of monographs of the European Pharmacopoeia.

I worked within the certifications division reviewing dossiers from manufacturers of active pharmaceutical ingredients (APIs). APIs used in medicinal products to be marketed in the EU must comply with the Euro-pean Pharmacopoeia, and API manufacturers can ap-ply for certification (known as CEP) from the EDQM

which can then be used by final product manufactur-ers for their Product Authorisation.

The job was quite technical and I reviewed revisions to these dossiers usually concerning changes to man-ufacturing process, batch size, specifications and test procedures. I became very familiar with ICH quality guidelines as well as EMA and EDQM guidance as a result. For each application I assessed I would write a report and submit it to my supervisor for review.

7. Was there any language barrier and did you know any french before you left? Are there any upcoming positions for students to avail of? Moving to France was a bit tougher than London due to the language barrier; I speak very little French, however Strasbourg is a very multicultural city with many people also speaking English and I managed reasonably well. Strasbourg is also a beautiful city and due to its location in the heart of Europe I took the opportunity to travel to many other European cities.

The certification division recently advertised a posi-tion (https://www.coe-recruitment.com/JobDetails.aspx?vacancyID=988&Lang=En) and usually ad-vertise positions on a regular basis. My experience during the IMB working in quality assessment was a huge plus in applying this position; however similar experience on working with module 3 of the CTD or working in quality control testing (batch analyses) in a pharmaceutical company will be a big advantage.

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LEONORA O’BRIENAn interview with the founder of pharmapodInterview conducted by Avril Burgess, Secretary-General

A: Can you tell us about your current job, Leono-ra and what other interesting projects you’re involved in?

L: “My job today, as founder and CEO of Phar-mapod, a Global Incident Reporting and Learning System, is very varied which is what I love about it. As a founder, you wear lots of hats! I’m involved in the investment side of the business and in recruiting the right team and right talent, making sure we have the right competencies on board, and that the team is diverse. If you’re scaling a global product you need di-versity of thought and cultures – you need people who challenge each other and to be thinking along differ-ent lines, which is what we have now. It means we can identify with all the different types of customers out there and challenge our own strategy and tactics.”

“I’m also involved in liaising with our legal counsel which I like as well, making sure that we’re protecting the company each step of the way forward.”

“We have just signed a contract with the National Pharmacy Association (NPA) UK as supplier partners to the community pharmacy sector, but we still have to “on-board” all the pharmacies. We have a strate-gy to work with the independent sector, but we also have a strategy to work with the corporate groups; a key role for me is identifying what our strategy is,

as well as the tactics and the milestones and how we will achieve them, who will be responsible and how to track our progress over time.”

“I am involved in clinical discussions and governance and am the accountable person for accredited phar-macy training that we deliver. I also enjoy discussions with key stakeholders like the NHS on what data needs to be collected from pharmacies and what data is unnecessary.”

“I oversee the day-to-day management of the team and I’m responsible for leading the team”.

Major projects:“We are also working on localising our system for the Canadian, US and European markets but our sales ef-forts are laser focused on the UK right now.”

“I’m also one of the founding members of Health-2Dublin, a vibrant network which helps keep health-care professionals, tech people, designers and people interested in patient safety and public health, connect-ed to each other. The members meet monthly and it’s a great way of collaborating, identifying what prob-lems need to be solved in the healthcare system and harnessing technology and knowledge to implement change.”

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“Another project we have is adapting Pharmapod for the Kenyan market against counterfeit activity”.

A: Did your career path ever deviate from that which you had planned out?

L: [Laughs] “I had no plan, but I wouldn’t change anything; I didn’t need a plan, I simply followed my heart. You can have the best plan in the world but sometimes the reality just works out differently. If you follow your heart, you can’t really have any regrets, at least you’ve explored your interests. But it’s important to always challenge yourself. If you end up in a role that doesn’t challenge you, don’t be afraid to change it – there will always be work for pharmacists out there. I left jobs in the past against the advice of others and it all worked out perfectly fine”.

A: What have been the biggest defining moments for you that have shaped the professional you are to-day?

L: “I became the superintendent pharmacist for Unicare when the law requiring a superintendent was first passed, and no one knew what this involved, what the implications or repercussions were. So this was a steep learning curve, which was great, but being sud-denly accountable for other’s standards of practice was certainly a challenge. Overnight I became legal-ly responsible for over a hundred pharmacists, which required leadership skills and clinical governance ar-rangements. We had to quickly implement SOPs and procedures to protect the company, the patients and the pharmacists. I learned a lot about accountability which I believe is one of the most important things to come out of the Pharmacy Act.”

“I also worked across 8 European countries, which was very exciting! It really broadened my mind and I love traveling and seeing how others do things differ-ently. It’s so interesting to see how different cultures approach things differently.”

“Each role has had it’s own defining moments but nothing has impacted me more personally than start-ing Pharmapod. It has been the most exciting jour-ney of my career so far. Realising your own vision and contributing to the safety of patients is the best feel-ing; it’s very rewarding”.

“There are so many moments I could choose from!”

A: Where do you think the biggest area is where pharmacists could make a difference to public health, which isn’t yet optimised?

L: “There are patients being harmed all the time due to preventable errors that aren’t being addressed so I think there’s no point in coming up with some-thing new until we fix the current problems. These are not isolated incidents – there are a huge number of people dying from medication-related errors. It’s an epidemic, and we need to fix what’s broken first.”

“Pharmapod is developing the Pharmapod Pause Points, we call it the ‘treble P’. It involves identify the moments in the dispensing process where you can ac-tually catch an issue before it’s a danger and prompt an action to do something about it. Short, well re-searched checklists accompanied by memorable visu-al prompts. We first gather the objective analysis from our system to determine the root causes of problems in the dispensing processes then we analyse a series of SOPs already in place and identify where the weak-nesses are and devise the checklists and ‘Pause Points’ to intervene and actively prevent the risks occurring; for example at the point just before the pharmacist hands out medication to the patient, what do they need to pause and do as a final check? What do we need to prompt the patient to do? ‘Treble P’ provides visuals and alerts that are a constant reminder within the dispensary. We can also talk to the PMR suppliers and make sure that there are certain alerts in place to accompany the Pause Points making sure the dispens-ing process is as robust and safe as possible.”

“We also want to make communication packages pro-viding simple prompts for engagement for both the pharmacist and the patient, especially for the high-risk medicines, rather than patient information leaflets. There are only nine drug classes that are responsible for most medication-related deaths! Patients should be made aware that they are on one of these medica-tions – we need a new approach for their dispensing, especially with regards to the requirement for consul-tations. We want to come up with an improved system and provide dispensary excellence guidelines.”

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A: What have been the main misconceptions about pharmacy you’ve encountered and how did you dispel them?

L: “The public may not understand what you do as a pharmacist and often see pharmacists as re-tailers not healthcare professionals. The Pharmacy Act brought about a lot of badly needed change - it changed the terminology used by the Regulator and pharmacists, now we always discuss the “patient’s” needs as opposed to the “customer’s” needs, as it should be. All pharmacists have a responsibility to raise awareness for the benefits of our services. We’re not great as a profession at putting a value on our pro-fessional time and promoting our services amongst patients and payors. Quality costs. There’s a need for more collaboration among representative groups to set standards and fees charged for pharmacy services, rather than competing with each other and undercut-ting each other’s prices. When this happens it is a race to the bottom - the service is often offered at a loss which isn’t sustainable and is ultimately withdrawn”.

A: You are interested in starting pharmacy place-ments in Pharmapod in the near future – what would this unique opportunity entail and what would it offer the student?

L: “Yes, we currently have an opportunity for a student to become part of a dynamic and experienced team with leading pharmacists from diverse pharma-cy backgrounds and work in a progressive workplace. It’s a tech company so it’s fast moving and exciting and we have very strong tech networks – we’re always at tech or healthcare events, building our broader busi-ness network.”

“The student would need to have great communica-tion skills, be a positive ‘can do’ person, be good at working in a team and have an interest in patient safe-ty and in making a difference to patients.”

“They would be involved in a number of projects de-signed to drive dispensary standards and professional excellence; it will involve a certain amount of analy-sis of information about medication and weaknesses in systems that have impacted on patients. As well as SOP reviews, being part of focus groups, presenting information in an interesting, accessible way. An eye for design and an interest in technology would be helpful”.

If this sounds like an opportunity that interests you

get in touch with Pharmapod at 01 685 2242 or email lauren.oconnor@pharmapodhq.com

Check out Pharmapod here http://www.phar-mapodhq.com

IPSA Irish Pharmaceutical Students’ AssociationRoom 33, Goldsmith Hall, Trinity College,Dublin 2

Email: info@ipsa-online.com

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