T H E O F F I C I A L J O U R N A L O F

INTERNATIONAL PHARMACY JOURNAL

VOL.33, NO.2 - JULY 2015

CROWD POWERbeing used in research

DATA REVOLUTION

Lab Boxes

BRINGING LEARNING TO LIFE

NEW SERVICES for MS and other complex patients

2 3INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

INTERNATIONAL PHARMACY JOURNAL

The International Pharmacy Journal is the official journal of the International

Pharmaceutical Federation (FIP) and began in 1912 as the Bulletin de la Fédération

Internationale Pharmaceutique. Subscription is a benefit to all members— individual

or otherwise — of FIP, with readership spanning 95 countries. The IPJ is published

electronically, three times a year. ISSN 2213-7890

SCOPE

The IPJ keeps its readership in touch with pharmacy around the world. The aim is to

communicate developments and work in pharmaceutical science, practice and

education & workforce in order to contribute to the mission of FIP: to improve global

health by advancing pharmacy practice and science to enable better discovery,

development, access to and safe use of appropriate, cost-effective, quality medicines

worldwide.

The IPJ reports on pharmacy matters affecting the global community or specific regions

or countries, offering in-depth coverage, summaries and unique content. The IPJ strives

to inform and inspire. It updates readers on FIP’s position and work on important

pharmacy issues as well as on relevant activities of FIP member organisations.

EDITORIAL POLICY

All articles published reflect the views of the authors and are not necessarily those of

FIP or the journal editors. The use of specific names of companies or products does

not imply endorsement or recommendation by FIP or the journal editors. Although all

reasonable efforts have been made to verify information, the publisher accepts no

responsibility for omissions or inaccuracies. In no event shall FIP be liable for any

damages arising as a result of interpretation and use of published information.

COPYRIGHT & PERMISSIONS

Copyright ©2015 by the International Pharmaceutical Federation, The Hague, the

Netherlands. All reproduction rights, including photocopying reserved. FIP members

may download or print one hard copy of the IPJ for personal non-commercial use or

study only. Permission to copy articles must be obtained from the Editorial Office.

EDITORS

Lowell Anderson, Lin-Nam Wang

EDITORIAL ADVISORY PANEL

Luc Besançon (Netherlands), Shazia Qasim Jamshed (Malaysia), Charles Alan Lyles

(USA), José Manuel Martinez Sesmero (Spain), Oliver van der Spek (Netherlands)

EDITORIAL OFFICE

Andries Bickerweg 5, 2517 JP The Hague, The Netherlands

T +31 70 302 1987

F +31 70 302 1999

E publications@fip.org

www.fip.org

ART DIRECTION/LAYOUT

NoSuchCompany, Rotterdam, The Netherlands

GUIDANCE FOR CONTRIBUTORS & ADVERTISEMENTS

Contact the Editorial Office.

News round-up 4Around the globe 10 Getting practical: the FIP project giving students much

needed lab experience 17Interview Marie Lindquist: Taking to song about

medicines safety 19Master your pharmacy information 24

Science

Crowd power being applied to research 26

Expert tips on communicating your research 30

Practice

New pharmacy services and better care for patients

with multiple sclerosis 32Pharmacy-generated record, public health resource 36How real-world data are improving access to medicines 38

Education & workforce

What might be the quickest path to equip hospital pharmacists

for the information age? 40What workforce data tell us 43

View from the USA Big data and the pharmacist —

caution advised 44View from the UK Community pharmacies deserve

a renaissance 46Panama Where pharmacy is on the rise 48Nine things About Middle East respiratory syndrome 51

In this issue

Did you know that when you opened this digital issue of the IPJ, your (anonymous) “click” was counted? We can track in which countries this issue was read, which articles and for how long. We use these data to make reader-driven improvements to the journal. All this is feasible because of technology.

Technological advancements have changed the ways in

which data are generated, gathered and analysed. They have

widened the range of data that is created. They have made it

so that data now exist in mammoth volumes and are

produced faster than ever before. They have made it possible

to trawl through existing data and conduct complex analysis

of new data, or of aggregates of old and new. This is the data

revolution: the world of crowd-sourced data, real-world and

real-time data, big data and data mining.

Around this time last year, the United Nations put together a

data revolution advisory group to inform the post-2015

Millennium Development Goals debate. The group’s work

culminated in a report, “A World that Counts”, which contains

examples of how the data revolution is already improving

general quality of life. One healthcare-related example is the

Mtrac programme in Uganda, which uses text message (SMS)

surveys completed by health workers to signal outbreaks of

malaria and let officials know how much medicine is

available. Since its start, the number of facilities out of stock

of artemisinin-based therapies has fallen dramatically from

80 to 15%. We commend this report to you as a

comprehensive overview. In particular, the advisory group

warns that major gaps are appearing between “data haves”

and “data have-nots”.

This issue of the IPJ, however, focuses on some of the

concepts of data revolution as they relate to pharmacy.

The UN group highlighted a need for standards, and a feature

(p12) reports on initiatives to ensure the integrity of health

The new medicines classed as

“ESSENTIAL”

7

Make PHARMACY count in the data revolution

data. Another article describes how scientific data are being

generated by crowd-sourcing in order to do things like

predict how cancer patients will respond to treatment (p26).

And we take a look at how data gathering is being used for

new pharmacy services (p32).

Of course, when pharmacists think of data, patient safety

will be high on the list. We took the opportunity to ask the

director of the Uppsala Monitoring Centre, which carries out

the WHO International Drug Monitoring Programme, about

the current extent of data mining in pharmacovigilance, the

difficulties and potentials. In the interview, you can also read

her view on Twitter as a way of monitoring adverse effects

and find out what she had to say about research on

thalidomide (p19).

At the very foundation of what we all do are data. These

numbers turn into information when given meaning and, at

the top of this pyramid (once the information is applied) is

knowledge. In other words, data and information are

fundamental to evidence-based practice.

To take full advantage of the data revolution, we need to be

aware of the changes taking place, to have an understanding

of the technology and to recognise and manage the potential

dangers.

Pharmacy counts. We hope this issue of the IPJ will prompt you to think about

how and why it counts.

news round-up

qualityaccountability

health

4 5INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

UNESCO RENEWS UNIQUE AGREEMENT TO DEVELOP PHARMACY EDUCATION WITH FIP

Development of pharmacy education around the world through a unique collaboration between

the International Pharmaceutical Federation (FIP), University College London School of Pharmacy

and the United Nations Educational, Scientific and Cultural Organization (UNESCO) is to continue

for a further four years.

The collaboration is a UNESCO-sponsored initiative known as the Global Pharmacy Education Development Network (GPhEd).

Launched in 2010, this was the first initiative for health professionals under UNESCO’s University Twinning and Networking

Programme (UNITWIN). This global network has brought together pharmacy schools and stakeholders from across the globe with

aims of synchronising powerful development in pharmacy and pharmaceutical sciences education, improving communication for

scientific innovation and healthcare outcomes and, ultimately, enabling attainment of Millennium Development Goals.

UNESCO has renewed the agreement with FIP “in light of the very good results achieved”. Major achievements of the network so

far have included the development a Global Pharmacy Workforce Observatory (which collates pharmacy workforce data with the

long-term aim of improving access to medicines and care; see p43) and the

creation of a Centre of Excellence across Africa (which currently works to

enhance professional education in pharmacy schools in Uganda, Ghana,

Nigeria, Zambia, Namibia and Malawi).

“Being reaccredited for a further four years shows that the network has

credibility and value for UNESCO and the wider development community, and

that our project goals continue to be relevant and successful,” said Jennifer

Marriot, director of the FIP UNESCO-UNITWIN collaboration.

“The renewal will support further work to enhance education, development

and workforce planning at global level, including a new venture with Monash

University, Australia, to develop a ‘global community of practice for pharmacy

educators’,” said GPhEd coordinator Ian Bates.

“Such projects make the future very exciting for our global network. Using the

UNITWIN banner we are able to provide better linkages with countries and

promote the whole initiative better at global level,” Professor Bates added.

FIP ANNUAL REPORT 2014 PUBLISHED“Together we are stronger” is the title of FIP’s annual report for 2014, published in May.

It reflects the fact that the number of FIP’s national member organisations grew to a

record number — 132 — last year. The report, which is now available online, shares

highlights from 2014 as well as giving an overview of the main issues FIP is currently

working on, such as green pharmacy and mental health.

“Outcomes of pharmacists working together, such as bringing about new laws,

clearly demonstrate strength in numbers. It could also be said that uniting over such

issues inspires pride in our profession,” says FIP President Carmen Peña in the report.

Stakeholders around the world have been brought

together for education

A roadmap for health measurement and accountability was

endorsed by global health leaders from governments,

academia, research institutions and civil society last month.

The endorsements were given at the “Measurement and

accountability for results in health” summit in Washington,

USA, organised by the World Health Organization, the World

Bank Group and the US Agency for International Development.

Explaining the importance of the summit, Ties Boerma,

director of the Department of Health Statistics and

Information Systems at the WHO, said: “Low-quality data are

being used to inform decisions on allocation of limited health

resources — undermining the quality of those decisions. There

is a lack of a coordinated global approach between countries

and development partners on what information countries

should collect to measure progress in health.”

Dr Boerma pointed out that health is a central component in

the new set of sustainable development goals (which will be

finalised later this year) and that every country needs robust

and reliable health information systems: “They need to be

able to generate their own data to monitor health

programmes and report on progress.”

Furthermore, he said that international partners and donors,

as well as domestic ministries of finance, are demanding

stronger evidence that investments in health are producing

results. However, “virtually all of the 80 low- and lower-middle-

income countries have major gaps in skills, tools and

resources to build quality health information systems.”

For several years, leaders from United Nations agencies and

global health partnerships have been “making increasingly

loud calls for more and better health data” and the summit

heralded a new approach to this, he said.

The health measurement and accountability roadmap

outlines investments and concrete actions and targets that

countries can adopt. Participants at the summit also agreed a

five-point call to action, including the more effective use of

data, openly sharing and standardising data, and promoting

accountability.

Work on establishing a global collaborative for measurement

and accountability is continuing, Dr Boerma added.

100 CORE HEALTH INDICATORS PUBLISHED

A global reference list of 100 core health

indicators was launched by the World

Health Organization last month.

Developed by a multi-agency working

group chaired by the WHO’s Director-

General over the past two years, the list

is intended to provide concise

information on health situations and

trends at national and global level. It is

hoped that this will serve as a global

standard, reducing the excessive and

duplicative reporting requirements that

currently burden countries, improving

harmonisation, and enhancing

efficiency and availability of data.

The list is divided into four main areas:

health status, risk factors, service

coverage and health systems. “It covers

the full spectrum of health priorities,

including maternal and child health,

infectious diseases and emerging

priorities such as non-communicable

diseases and universal health

coverage,” said Ties Boerma, director of

the WHO’s Department of Health

Statistics and Information Systems.

“All indicators were selected because

they are scientifically robust and have

a track record of being used for

measurement in countries. The list will

be a living document to be updated

periodically as new priorities emerge

and interventions change,” Dr Boerma

added.

The health measurement and accountability roadmap outlines concrete

actions and targets that countries can adopt

Indicators

selected for

scientific

robustness

HEALTH LEADERS COMMIT TO IMPROVING QUALITY AND SHARING DATA

news round-up

7VOL 33, NO.2 - JULY 2015

Five new direct-acting oral antivirals for hepatitis C, including

sofosbuvir and daclatasvir, are now listed, even though their

high prices mean they remain unaffordable for low-income

countries despite some efforts to reduce prices.

The WHO said that new breakthroughs made in cancer

treatment in recent years prompted it to revise the full cancer

segment of the Essential Medicines List: 52 products were

reviewed and 30 treatments confirmed, 16 being new

medicines. “Some of these medicines produce relevant

survival benefits for cancers with high incidence, such as

trastuzumab for breast cancer,” explained Kees De Joncheere,

WHO director of essential medicines. “Other treatment

regimens for rare cancers such as leukemia and lymphoma,

which can cure up to 90% of patients, were added to set a

global standard,” Dr De Joncheere said.

In addition, after about 45 years of scarce innovation for TB

medicines, five new products have now been included in the

list. Four of these, including bedaquiline and delamanid,

target multi-drug-resistant TB.

“When new effective medicines emerge to safely treat serious

and widespread diseases, it is vital to ensure that everyone

who needs them can obtain them,” said WHO director-

general, Margaret Chan. “Placing them on the WHO Essential

Medicines List is a first step in that direction.”

The WHO Expert Committee on the Selection and Use of

Essential Medicines has also recommended supporting

off-label uses in cases where there is clear evidence of major

health benefits but no licensed indication, such as for many

medicines for children.

Increasingly, governments and institutions around the world

are using the WHO list to guide the development of their own

essential medicines lists, because they know that every

medicine listed has been vetted for efficacy, safety and

quality, and that there has been a comparative cost-

effectiveness evaluation with other alternatives in the same

class of medicines, the WHO says.

In brief

ALERT ON FAKE MENINGITIS VACCINES ISSUED

As reports of 5,855 suspected cases of meningococcal

meningitis, including 406 deaths, come from Niger, the

WHO has issued an alert over fake meningitis vaccines.

It calls for increased vigilance with Mencevax ACW

(50 doses per vial), which may bear a genuine batch

number but false manufacturing and expiry dates.

Details.

RECORD HAUL OF ILLEGAL MEDICINES

Potentially dangerous medicines to the value of

US$81m were seized during the week of Operation

Pangea in June, according to Interpol. This year’s

Pangea VIII was the largest ever internet-focused

operation and saw 20.7 million illicit and counterfeit

medicines seized — more than twice the amount

confiscated during the 2013 operation. A total of 115

countries took part in Pangea VIII, resulting in 156

arrests worldwide, the suspension of 550 online

advertisements for illicit pharmaceuticals and 2,414

websites being taken offline. More.

NEW COUNTERFEIT MEDICINES HANDBOOK AVAILABLE

A handbook for healthcare professionals entitled “All

you need to know about spurious medicines” has been

developed by the World Health Professions Alliance,

under the lead of FIP, and in cooperation with the

Indian Pharmaceutical Association. It contains tips on

preventing and detecting counterfeit medicines as

well as advice on how to change behaviours.

GROUND-BREAKING MEDICINES CLASSED AS ESSENTIAL

New treatments for hepatitis C, a variety of cancers and multi-drug resistant tuberculosis appear in the latest Model List of Essential Medicines, published by the World Health Organization in May.

Sofosbuvir has

been placed on

the essential

medicines list

despite its

high price

© Serge001 |

Dreamstime.com

“PHARMACIST: YOUR PARTNER IN HEALTH”

news round-up

8 9INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

EXPLORE POOLED PROCUREMENT OF VACCINES, WHA SAYS

A resolution to improve access to sustainable supplies of

affordable vaccines — a key issue for low- and middle-income

countries — was an outcome of this year’s World Health

Assembly (WHA). The resolution urged member states to

increase transparency around vaccine pricing and explore

pooling the procurement of vaccines. It requested the WHO

Secretariat to report on barriers that may undermine robust

competition and barriers to enabling price reductions for new

vaccines. The resolution also recommended scaling up

advocacy efforts to improve understanding of the value of

vaccines and to allay fears leading to vaccine hesitancy.

Speaking at the WHA, FIP pointed out that the joint WHO-FIP

guidelines on good pharmacy practice emphasise that

pharmacists should be used to their full potential in

education to address vaccination hesitancy and resistance.

Full FIP statement on the Global Vaccines Action Plan.

DECADES OF PROGRESS IN TB WILL BE UNDONE UNLESS AMR IS ADDRESSED The billions of dollars invested in the Global Fund to Fight

AIDS, TB and Malaria by national governments will be under

threat unless urgent action is taken to address antimicrobial

resistance (AMR), Joanne Carter, vice-chair of the Stop TB

Partnership Coordinating Board said at the United Nations

in New York last month. Referring to a review on AMR

commissioned by the UK Prime Minister and published in May

(“Securing new drugs for future generations: the pipeline of

antibiotics”), Dr Carter said its findings “brought to light the

potentially massive scale and devastating impact of drug-

resistant TB and other AMR infections in both human and

economic terms. Decades of progress will be undone . . .

unless we address this challenge now.”

In April, a World Health Organization report revealed that only

a quarter of countries that responded to a survey on response

to AMR have national plans to preserve antimicrobial

medicines. The survey was part of a country situation analysis

(from 2013 to 2014) to determine the extent to which effective

practices and structures to address AMR have been put in place

and where gaps remain. The full report, “Worldwide country

situation analysis: Response to antimicrobial resistance”, is

available online.

GROWING FOCUS ON NEED TO IMPROVE HUMAN RESOURCES FOR HEALTH Calls to strengthen the health workforce

are growing, according to the Global

Health Workforce Alliance. At the World

Health Assembly (WHA) it was revealed

that a review of the WHA resolutions

made between 2000 and 2014 found that

many of the 374 resolutions on technical

themes generated by World Health

Organization member states contained

calls for the development of human

resources for health policy, data/

information and education/training of

individual health personnel for skills

enhancement.

Several of the agenda items tabled for

discussion at this year’s assembly,

including those on antimicrobial

resistance, Ebola, epilepsy, malaria,

nutrition, polio, public health, surgical

care and anaesthesia, and emergencies,

preparedness and surveillance, also had

health workforce implications. The WHO

Global Strategy on Human Resources for

Health is tabled for discussion by the next

WHA in May 2016.

FIP AT THE 2015 WORLD HEALTH ASSEMBLYINDICATION DETAILS WOULD HELP FIGHT AMR Putting indications on prescriptions would enable pharmacists to support

the responsible prescribing of antibiotics, said FIP during the World Health

Assembly discussion of antimicrobial resistance. The federation also

highlighted that diagnostic tools could easily be integrated into pharmacy

practice, citing as an example the UK National Chlamydia Screening

Programme, which helps to reach the at-risk population via point-of-care

testing in pharmacies. Similar models can be used for other infections,

such as syphilis, FIP said. Full statement.

PHARMACISTS SHOULD BE PARTNERS IN MENTAL HEALTH It is becoming more widely recognised that mental healthcare requires a

comprehensive approach with common services and resource

mobilisation, according to a statement submitted by FIP at the World

Health Assembly. The assembly was given two pharmacy examples of

moves in this direction, in the form of recent policies from Australia

(“A framework for pharmacists as partners in mental health care”) and

the USA (through the development of a pharmacy speciality of

psychopharmacology and behavioural health matters). Full statement.

INPUT ON PLAN TO COMBAT COUNTERFEITSRegulation of those who deal with raw materials in addition to active

pharmaceutical ingredient manufacturers is recommended, FIP said on

behalf of the World Health Professions Alliance during the World Health

Assembly. This is because we now have a highly fragmented supply chain

where overseeing reliable and complete traceability of the real sources of

raw materials is problematic. Full statement.

FIRST WHPA COLLABORATIVE PRACTICE AWARD WON BY ANTI-TOBACCO GROUPAn international award for bringing together several health

professions in a major collaborative project was won by the

Thai Health Professional Alliance Against Tobacco (THPAAT) in

May. The alliance, set up 10 years ago to increase the

awareness of tobacco hazards and to improve the health of

the people of Thailand, was presented with the award by the

World Health Professions Alliance at a ceremony in Geneva,

Switzerland. Accepting the award, THPAAT president Somsri

Pausawasdi said: “It was clear that the best way to

accomplish our goals was to create a collaborative

interprofessional team and so the medical association

collaborated with the Thai Health Foundation and recruited

four more organisations, including the pharmacy council, the

nurses’ association, the dental association and the public

health association, to join the team.”

FIP is a founding member of the WHPA.

NEW REPORT SHOWS 400 MILLION HAVE NO ACCESS TO ESSENTIAL HEALTH SERVICESFour hundred million people do not have access to

essential health services and 6% of people in low- and

middle-income countries are tipped into or pushed further

into extreme poverty because of health spending,

according to a report released by the World Health

Organization and the World Bank Group last month.

The report “Tracking universal health coverage” is the first

of its kind to measure health service coverage and financial

protection to assess countries’ progress towards universal

health coverage. It looked at global access to essential

health services, including family planning, antenatal care,

skilled birth attendance, child immunisation, antiretroviral

therapy, tuberculosis treatment, and access to clean water

and sanitation, in 2013.

“This report is a wake-up call: It shows that we’re a long

way from achieving universal health coverage. We must

expand access to health and protect the poorest from

health expenses that are causing them severe financial

hardship,” said Tim Evans, senior director of health,

nutrition and population at the World Bank.

The WHO and the World Bank recommend that countries

pursuing universal health coverage should aim to achieve a

minimum of 80% population coverage of essential health

services, and that everyone everywhere should be

protected from catastrophic and impoverishing health

payments. “Health policies and programmes should focus

on providing quality health services for the poorest people,

women and children, people living in rural areas and those

from minority groups,” said Marie-Paule Kieny, WHO

assistant director-general, health systems and innovation.

The report is the first in a series that the WHO and the

World Bank Group will produce on tracking progress

towards universal health coverage across countries.

The World Health Assembly took place in Geneva,

Switzerland, from 18 to 26 May 2015

Essential health services

include family planning,

child immunisation,

antiretroviral therapy and

tuberculosis treatment

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11VOL 33, NO.2 - JULY 2015INTERNATIONAL PHARMACY JOURNAL10

Community pharmacists in England are to get access to Summary Care

Records (SCRs; national electronic patient records) under new plans.

Around 96% of people have an SCR, which contains up-to-date clinical

information sourced from general practitioners. Following pilots across

140 sites, it was found that in 92% of cases where the SCR was accessed

by a pharmacist, patients did not need to be sent elsewhere in the

National Health Service, and in 18% of cases the risk of medication

errors was avoided. The UK Government plans to invest £7.5m in the

training and tools that community pharmacists will need to use SCRs.

FRANCE

PHARMACISTS RAISE ALARM THAT “PURPLE DRANK” HAS BECOME POPULAR WITH TEENS

A dangerous cocktail containing pharmacy medicines and

known as “purple drank” is becoming increasingly popular

with French teenagers, pharmacists in France report.

The practice of mixing cough linctus (usually containing codeine

and promethazine) with soft drinks is believed to originate from US

hip hop culture and has featured in a number of rap songs.

AUSTRALIA

GOVERNMENT STICKS BY RECOMMENDATION ON BIOLOGICAL SWITCHING

Following continued debate, the Australian Government has made a statement in support of the recent recommendation by the

Pharmaceutical Benefits Advisory Committee (PBAC) that doctors and pharmacists be able to substitute originator biologicals

with biosimilars. The Alliance for Safe Biologic Medicines, which represents originator companies, said that Australia “would

break with widely held international standards by becoming the first and only nation to allow pharmacy-level substitution of

biologic[al] medicines without physician involvement”. The PBAC maintains that if it recommends a biosimilar is substitutable

patients can be given the choice of taking the original biologic or the substitute biosimilar, just as they have a choice with

generic versions of synthetic molecule drugs.

ITALY

MEDICINES THEFT IS THE NEW PHARMACEUTICAL CRIME WAVE

An investigation of thefts of high-cost medicines from Italian hospitals has led to the

discovery of a vast transnational crime network. Medicines theft is emerging as the

new frontier of pharmaceutical crime, say the authors of a Transcrime report.

They found that, in Italy between 2006 and 2013, one in 10 hospitals reported thefts

of pharmaceuticals, suffering an average loss of €330,000 each time. The police

investigation revealed a complex mechanism of false invoicing that allowed stolen

medicines to re-enter the European market, with Eastern Europe and Greece appearing

to be popular destinations.

GLOBAL

ANOTHER GOOD REASON TO PROMOTE MEASLES VACCINATION

Vaccination against measles protects against other infectious and

potentially fatal diseases such as pneumonia and meningitis, scientists

say. The measles virus kills white blood cells that have a memory of past

infections, resulting in “immune amnesia”. It was previously thought that

this amnesia (ie, loss of immunity) was short but statistical analysis now

shows that it lasts, on average, 27 months. More.

SOUTH AFRICA

HOSPITALS EXPERIENCING SHORTAGES OF BASIC MEDICINES

Hospitals in KwaZulu-Natal province are running out of a wide range of medicines, including paracetamol. A health department

spokesman said that shortages are affecting both private and public sectors but the impact is being felt more in the public

sector because of the volumes involved. Manufacturer difficulties obtaining active pharmaceutical ingredients, quality

problems, and procurement and distribution issues have been blamed.

GERMANY

HEALTHCARE PROFESSIONS JOIN FORCES AGAINST INCLUSION OF HEALTH SECTOR IN TTIP

Five major healthcare professional

organisations in Germany, including

pharmacists, have jointly called for the

health sector to be excluded from the

Transatlantic Trade and Investment

Partnership (TTIP), the free trade

agreement being developed by the EU and

the USA. The organisations see a risk that

a market-oriented healthcare sector will

jeopardise the social principle that

characterises EU systems. In their joint

declaration, they say that health services

should not be equated with other

market-oriented services. Free trade

agreements explained.

SPAIN

PHARMACISTS DOUBLE ADHERENCE AND REDUCE MEDICINES PROBLEMS

Pharmacists’ interventions increased

adherence to treatment from 35% to 75.7%,

and reduced drug-related problems by

33.4%, according to the first results of the

ADHIERETE Programme. Findings also

indicated that participating in the

programme increased patient-perceived

quality of life by an average of 5.5 points.

The study was conducted at 51 pharmacies

with 114 elderly, non-adherent patients with

chronic conditions and multiple medicines.

GHANA

PHARMACISTS TO SIT ON COUNCIL OF NEW HEALTH FACILITIES REGULATOR

The Pharmaceutical Society of Ghana is to sit on the 10-member

council of Ghana’s newly established Health Facility Regulatory

Agency (HEFRA). The agency has been set up by the country’s Ministry

of Health to regulate public and private healthcare facilities.

Regulatory activities will focus on consumer protection in terms of

availability of human resources for health service delivery, availability

of appropriate health products, including pharmaceuticals, as well as

minimum standards for health facilities and services.

FINLAND

PHARMACY ADVICE SAVES €1BN A YEAR

Pharmacy advice significantly reduces the load on primary healthcare (GP and

emergency visits) and saves nearly €1bn each year, according to a

PricewaterhouseCoopers report commissioned by the Association of Finnish

Pharmacies. Most of the savings are generated by self-care management services in

minor ailments and advice on the responsible use of non-prescription medicines.

Pharmacy advice is also estimated to reduce visits to GPs by up to six million each year.

ENGLAND

COMMUNITY PHARMACISTS GET ACCESS TO PATIENT MEDICAL RECORDS

USA

NEW LAW ALLOWS PHARMACISTS TO ADMINISTER FLU VACCINE TO CHILDREN

Children as young as nine years of age can now

be immunised against influenza by their

community pharmacist under a new law in the

US state of Pennsylvania. The law aims to

boost vaccination rates and reduce influenza

cases by increasing access and convenience.

The Pennsylvania Department of State

estimates there are 8,816 licensed pharmacists

with the authority to administer the vaccines

with parental consent.

SWEDEN

PARACETAMOL BANNED FROM SUPERMARKETS

Sale of paracetamol tablets from

Swedish supermarkets is to cease

from 1 November, the country’s

medical products agency has

announced. The restriction of

paracetamol tablet sales to

pharmacies follows research

showing a 40% increase in

paracetamol-related poisoning,

since paracetamol tablets went

on general sale.

12 13INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

WHAT IS BIG DATA?The McKinsey Global Institute defines big data as

“datasets whose size is beyond the ability of typical

database software tools to capture, store, manage and

analyse.” What differentiates big data from previous

data is its three Vs: volume, variety and velocity.

The NIH is at the forefront of moves among policymakers and

research organisations to create an ethical and operational

framework for the collection, organisation, storage, and

analysis of big data. It is embarking on research projects that

bring together some of the major challenges posed. Last month,

the NIH revealed details of a research scheme on HIV prevention

which would explore “the potential for big data approaches and

methodology to address key questions” relating to gaps in HIV

knowledge. The scheme will involve investigation of social and

behavioural characteristics of population groups and networks,

gender and ethnic disparities in disease acquisition,

evolutionary relationships among groups of molecular

organisms, and ethical, legal and policy issues.

The research would be looking out for “unexpected

correlations through analysis of diverse data”. With the help

of big data approaches, these data may “reveal events that

are rare, unseen in traditional datasets and are transient”,

the NIH said in its announcement of the project. The

organisation wants to use big data science “technologies,

computing, informatics and analytics to address gaps in our

understanding of HIV transmission risks, social networks and

the HIV treatment continuum, including co-morbidities such

as cancer”, it says.

Thorny issue of privacyAlong with other leading research organisations, the NIH

has also been trying to tackle the thorny issue of privacy

with regard to personal data in big data research projects.

This means ensuring compliance with ethical norms and

legal rules at national and international levels. It also

involves taking a stance on the issue of whether complete

anonymity can be assured even after all evidence of personal

identity has been stripped out of data sources, as laid down

by legislation like the US Health Insurance Portability and

Accountability Act (HIPAA).

It has become clear that the process of de-identification can

be reversed so that anonymised data can be re-identified as

a result of advances in analytics and computer software.

Using only a computer, an internet connection and publicly

accessible online resources, researchers at the Whitehead

Institute for Biomedical Research, based at the

Massachusetts Institute of Technology (MIT), were able to

identify individuals who had anonymously submitted

personal genetic material in genomics studies. >>

By 2020 the amount of data being held globally is forecast to

be 44 times larger than it was in 2009. Big data (see Box) has

been predicted to radically raise efficiencies and quality of

healthcare, transform outcomes and improve research and

development of new drugs — all at a much lower cost. It is

also predicted to greatly accelerate the use of personalised

medicines.

It may eventually achieve some or all of these things. But it

will probably take longer than previously expected. “There

has been a lot of hype about it,” Martin Kohn, chief medical

scientist at Sentrian, Aliso Viejo, California, a pioneer in

remote monitoring of patients with chronic disease, said at a

conference on big data in London, UK, last month. “It’s not

the solution to all healthcare’s problems. On the other hand

it will certainly help to find answers.”

Today’s new technologies have resulted in a massive increase

in data being stored — data that are easily accessible and

that can be quickly distributed around the world. There are

already opportunities for health information exchanges

between different data points in the delivery of care,

according to IMS Health, the pharmaceuticals and healthcare

information services company. Among the new data sources

in medicine are electronic medical records (EMRs), insights

from social media, a wealth of real-world information on

treatment practices, patient compliance and health

outcomes, and data on what works and does not work with

individuals, the company says.

“Enormous amounts of data are now stored in data warehouses, data lakes and the cloud in a mix that has varied levels of quality.”

With biomedical data, the range of sources becomes more

varied, but this can make data collection and analysis more

difficult. The National Institutes of Health (NIH), part of the

US Department of Health and Human Sciences and the US

Government’s medical research agency, describes

biomedical big data sources as including “diverse, complex,

disorganised, massive and multimodal data being generated

by researchers, hospitals, and mobile devices around the

world”. More specifically, those data include “imaging,

phenotypic, molecular, exposure, health, behavioural and

many other types of data”, the NIH says. These data could be

used to discover new drugs or to determine the genetic and

environmental causes of human disease. Yet many barriers

need to be overcome before these objectives can be

achieved. These include, according to the NIH, “the unwieldly

amount of information, lack of organisation and access to

data and insufficient training in data science methods

[all of which] make it difficult for big data’s full powers to

be harnessed”.

BIG DATA: How far are we from the revolution in healthcare?

Big data has been widely touted to have the powers not only to revolutionise healthcare but science itself. Sean Milmo reports on the reality and recent developments.

BIGDATA

14 15INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

Since then the NIH has joined with the Broad Institute of MIT

and Harvard University and 140 other medical, research and

campaign organisations around the world to set up the Global

Alliance for Genomics and Health to enable the international

sharing of genomic and clinical data. It has already drawn up a

regulatory framework and technical guidelines.

The framework, which the alliance wants to become a global

standard, is guided by the United Nations 1948 Universal

Declaration of Human Rights, in particular the rights to

privacy and to “share in scientific advancement and its

benefits”. It applies to “the use of data that have been

consented to by donors (or their legal representatives) and/

or approved for use by competent bodies or institutions in

compliance with national and international laws, general

ethical principles, and best practice standards”, according to

the framework.

What about quality assurance?Together with privacy matters, another important issue with

big data is its quality. According to the Global Alliance, data

of acceptable quality would be “accurate, verifiable,

unbiased, proportionate and current so as to enhance

interoperability and replicability.”

Enormous amounts of data are now stored in data

warehouses, data lakes and the cloud in a mix that has varied

levels of quality. “A large proportion of these data can be

flawed and it could take a long time to sort out what data are

flawed,” Dr Kohn said. For example, a lot of data from

laboratory studies will have been subject to the strict rules

of Good Laboratory Practice (GLP), a standard which was first

drawn up in the 1970s with its worldwide expansion since

becoming the responsibility of the Paris-based Organisation

for Economic Co-operation and Development. But there is

also much data from research laboratories, mainly in

universities and other academic institutions, which cannot

gain GLP status due to lack of equipment and manpower.

Academics have been in lengthy disputes with regulatory

authorities over the acceptability of the conclusions of their

non-GLP studies in areas like risks to human health and the

environment from certain industrial chemicals. This battle is

likely to intensify in the era of big data.

The different ways in which and the different purposes for

which data is collected may also pose problems. A working

group set up by the US National Heart, Lung and Blood

Institute to examine big data opportunities pointed out in a

report last year the challenges of dealing with data from

EMRs because they are designed for medical care rather than

clinical research. EMR data not only differ in quality from

data, for example, from carefully organised comparative

cohort studies, but they can be inconsistent because of the

contrasting ways in which EMR systems are organised and

physicians collect information. Mobile health devices, such

In a draft policy on sharing of genomic data issued last year

NIH stipulated that it expects researchers to obtain personal

consent for the use of data from de-identified clinical

specimens and cell lines. “Given growing concerns about

re-identification, it is no longer ethically tenable simply to

re-identify clinical specimens or derived cell lines to generate

data for research use without an individual’s consent,” the

NIH explained. Generally, individuals do not legally own the

data in their patient record or other data sources. But

acknowledgement that patients should give their consent to

the use of their genomic and other clinical data would seem

to override that.

“It has become clear that the process of de-identification can be reversed so that anonymised data can be re-identified as a result of advances in analytics and computer software.”

The NIH envisages that strict privacy rules will ultimately

benefit research rather than hinder it. “Obtaining consent for

broad future research uses will facilitate access to greater

volumes of data and ultimately will reduce the costs and

burdens associated with sharing research data,” it said.

In a White Paper issued two years ago, the NIH complained

that not only are the research and medical communities not

organised to seize the extraordinary opportunities of big

data but they are not on a path to do so. “If we remain on the

current path, the likely outcome will be a hodgepodge of

balkanised systems [inhibiting] learning and improving

healthcare.”

Mobile health devices are becoming another

large-scale source of data of variable quality

as watches that measure blood pressure, heart rates and

other health indicators, are becoming another large-scale

source of data of variable quality.

Initiatives are gradually being taken to standardise the

quality of data in major data sources, particularly in the way

they are collected and recorded. The European Medicines

Agency (EMA) has been issuing detailed guidelines to

pharmaceutical companies on the operation of an up-to-date

database on details of all authorised medicines on the

European market. The EMA wants to ensure that all the data

are entered in an accurate and standardised manner. The US

Government has introduced a scheme for giving incentives to

healthcare providers to make “meaningful use” of EMRs by

raising the quality of the data in the records so that they can

be shared and do more to improve outcomes for patients.

With regard to wearable medical devices, the Institute of

Electrical and Electronics Engineers (IEEE) has drawn up a

standard for blood pressure meters which do not depend on

the traditional blood pressure cuffs.

“With the availability of a standardised way to evaluate and

calibrate devices, the hope is that more manufacturers will

be encouraged to develop wearable, cuffless blood-pressure

monitors and more healthcare practitioners will be

encouraged to use them,” said Carole Carey, chair of IEEE’s

standards committee.

With more data sources becoming standardised, the quality

of the analysis of the information itself will become less of an

issue on the grounds that, generally, the results of analytics

are only as robust as the data. With big data the analytics are

centred on mathematical models and the algorithms into

which they are integrated to provide a set of step-by-step

operations for processing the data. In the financial world

faulty, hastily constructed algorithms are considered by

economists to be responsible for the 2008 crisis and the 2010

Flash Crash in which the US stock market plunged into the

steepest daily decline in its history. In healthcare and related

sectors, algorithms are worked out much more carefully with

some taking years to put together.

“With more data sources becoming standardised, the quality of the analysis of the information itself will become less of an issue.”

Once personalised medicine becomes a widespread

phenomenon the mass of algorithms for processing healthcare

data will have to be uniformly consistent and reliable. This will

raise the question of whether the main conventional method

of testing the quality, safety and efficacy of new drugs will

continue to be the randomised clinical trial based on a

comparison of evidence from a group of patients and a control

group. “With personalised medicines, a big weakness with

randomised clinical trials is that they cover groups of patients

not individuals,” said Dr Kohn.

It is likely that with the testing of drugs, randomised clinical

trials will continue to be applied to assess quality, safety and

efficacy — but with the help of big data. Mathematicians are

already claiming that they can draw up models that can

safely — at least theoretically — amalgamate data from

good laboratory practice and good clinical practice studies

with data from less closely controlled sources.

For that to become a reality, acceptable ways will have to be

established for verifying the qualities of a vast array of

different data sources, which would be a lengthy process.

16 17INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

GETTING PRACTICAL: the FIP project giving students

much needed lab experience

Chemistry is the backbone of pharmacy. It touches everything

from drug synthesis to identifying counterfeits. So most

people would agree that laboratory practice is an essential

component of pharmacy learning and few would imagine a

pharmacy school where the teaching is all theory and no

practice. But this was the case at the University of Malawi

Pharmacy Department until last year. A lack of simple

laboratory equipment meant that the students at the country’s

first ever pharmacy school were unable to gain necessary

hands-on laboratory experience. Under the auspices of the FIP

UNESCO-UNITWIN programme, however, a solution has been

provided: the Lab Box.

The Lab Box is simply a box containing enough basic

equipment to allow a student to conduct simple experiments

throughout the pharmacy curriculum. Jennifer Marriott,

director of the FIP UNESCO-UNITWIN programme explained

the concept: “Malawi needs pharmacists. In 2012 it had just 73

pharmacists and 174 pharmacy technicians for a population of

around 16 million. There has been progress in that the first

school of pharmacy opened in 2006 but a lack of resources has

hampered learning and the acquisition of skills. The need for

laboratory equipment was identified in 2014 during general

FIP UNESCO-UNITWIN discussions in Lusaka, and during a later

visit to Malawi, and we developed the Lab Box concept.”

Costs and other logistics had to be worked out: what exactly

should go into each box to improve educational outcomes in

an affordable way; who would be a suitable supplier; what

would be the best way to get them to their destination; and

where would the money come from?

The project brought together the University of Malawi

Pharmacy Department, FIP’s Academic Pharmacy Section and

the FIP UNESCO-UNITWIN collaboration. After much

deliberation, a list of contents — 24 different types of item

— was developed, a supplier was found and air freight was

selected. As for costs (each Lab Box cost US$99 plus US$44.66

for transport), these were met by the Academic Pharmacy

Section from project funds and a private donation.

In September 2014, 50 lab boxes were carefully packed into a

pallet and dispatched, arriving in Malawi just over three

weeks later. But this was not straightforward since, in many

developing countries, airfreighted foreign shipments are not

delivered to the recipient’s door, Lutz Heide, a visiting

professor at the university, told IPJ. Nor do airport or customs

offices automatically inform recipients of the arrival of

shipments. “One lesson was that the recipient needs to be

proactive and expedite customs clearance. This is important

since goods that remain too long in a port are at risk of

damage or pilferage,” he said.

News of a project that promises to make an impact on the future healthcare workforce in developing countries came out of Malawi last month. Lin-Nam Wang reports.

An experience, not just an experimentLast month, an FIP UNESCO-UNITWIN meeting in Malawi

provided an opportunity for FIPEd staff to see the Lab Boxes in

use and find out, first hand, just how valuable they have been.

Raymond Joso, senior lecturer in pharmaceutical chemistry at

the university, explained that, because of the Lab Boxes, his

students have been able to apply basic chemistry knowledge,

such as by making aspirin by esterification. They have also

been able to put analysis into practice, identifying drugs

through HPLC and TLC. He said the project has had a “huge

impact”, allowing students to graduate with laboratory skills

that could be used to deal with “big issues” such as

combatting counterfeiting and the discovery and

development of new drugs, and in the development of

government and industry protocols and policies. In addition,

he said that his work has been facilitated: the equipment

allows him to give demonstrations during class, keeping

learning from getting boring.

“The project has had a huge impact, allowing students to graduate with laboratory skills that could be used to deal with big issues such as combatting counterfeiting, in the discovery and development of new drugs and in the development of government and industry protocols and policies.”

The students were just as, if not more, enthusiastic. Third-

year student James Ng’ombe said that the Lab Boxes have

given him insight into what pharmaceutical analysis is all

about and what options he has: “[They] taught me how

pharmacy isn’t just about dispensing. It includes other areas,

such as quality assurance.” >>

Demonstrations during class keep learning from getting boring

Students explain how the Lab Boxes have been used in a video

interview

19VOL 33, NO.2 - JULY 201518 INTERNATIONAL PHARMACY JOURNAL

Next in line “Liberia and Sierra Leone have already contacted us with

requests for Lab Boxes,” Professor Marriott said. Not only

does Sierra Leone have a fragile healthcare system, figures

from the Pharmacy Board of Sierra Leone indicate that the

country had only 124 registered pharmacists for six million

people in 2014.

“Ultimately our work is all about helping to ensure sufficient

coverage of pharmacists around the world and there was no

better place to start than in Africa, where pharmacists are so

desperately needed. This is part of the general mission of FIP,”

she explained. The Lab Boxes are to enable laboratory classes

to support classroom teaching. Before they can be dispatched,

however, we need to ensure that they can be properly used.

This means knowing that a suitable laboratory is available,

laboratory manuals are in place, and that someone will be

responsible for their care and storage, she added.

“Feedback from students and staff of the University of

Malawi has been documented in a video that’s now available

online. I invite people to watch it so they can see for

themselves the big impact that these simple boxes have had,”

Professor Marriott said.

“[The Lab Boxes] are helpful because I’m a visual learner.

[They] helped me to understand the things I’ve been learning

in class,” he added.

Another student, Twambilire Mhango, said that the Lab Boxes

have made learning “more than an experiment”. Rather, they

have provided an experience.

Nettie Dzabala, head of the Pharmacy Department said: “[The

Lab Boxes have] motivated students. We see they are more

confident in chemistry. It is a dream come true for us. . . . I’m

very pleased about this development because we do need

pharmacists who are able and competent.”

A complete evaluation of the project is now planned. The Lab

Box contents will be reviewed but the students have already

made suggestions, such as for a mortar and pestle — “the

emblem of pharmacy” — and Petri dishes — “to protect any

drugs made from contamination” — to be included. Dr Joso

suggested that that the inclusion of retort stands and

burettes would allow students to conduct titrations. He also

said that the Lab Boxes could easily be tailored to enable

advanced chemistry practicals. A survey will be used to

measure relevance, improved learning outcomes and

satisfaction. And there are problems to be solved since the

supply of reagents is a continuing problem. But, perhaps most

importantly, replicability will be looked into.

The Uppsala Monitoring Centre (UMC) has provided scientific

leadership and operational support to the World Health

Organization’s International Drug Monitoring Programme

(WHO PIDM) since 1978. How would you describe the

programme?

The WHO PIDM brings almost 150 countries together in an

effort to improve patient safety. This global

pharmacovigilance network was started with the aim to

ensure that early signs of previously unknown medicine-

related safety problems would be identified and information

about them shared and acted on. Each country contributes

data from their post-marketing safety surveillance systems

to the WHO global database of suspected adverse drug

reactions, Vigibase, which is hosted by UMC. The aim of our

work is to enable patients and health professionals to make

wise decisions in their use of medicines.

What activities does the UMC carry out?

For almost 40 years we’ve supported existing national

pharmacovigilance centres and the establishment of

new national centres by our continued development

of core activities, such as data analysis. We also have a

responsibility to the pharmaceutical industry, academia

and professional organisations and networks, public

health programmes, and to a growing number of patient/

consumer organisations, all relying on the continued supply,

maintenance and development of our products and services.

We have pharmacists in every part of UMC, contributing

their specialist skills to research, data entry, database

management and production of output, data content

management, methodology and clinical research, technical

and scientific support, education, training and advocacy, and

sales and customer support. >>

“In all parts of the world, patient-reported harm or concerns about safety of medicines will increase exponentially as part of the big data and social media revolution.”

MARIE LINDQUIST: Taking to song about

medicines safety

Data are the bricks that build pharma-

covigilance but it’s knowing what to do with

the information that makes the difference.

IPJ talked challenges in pharmacovigilance,

roles for pharmacists and thalidomide with

Marie Lindquist, director of the Uppsala

Monitoring Centre in Sweden.

interview

20 21INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

Deciding if the risks of a medicine outweigh its benefits will

never be black and white. It’s about dealing with uncertainty,

trying to find the best balance between warning too early,

which could cause unnecessary panic and the withdrawal of

useful medicines; and too late, causing patient harm that

could have been avoided. Signal detection is not made more

difficult with the growing amount of data; in order to do our

job properly, we need more data, not less — the challenges

are to get good quality, relevant data, with as little delay as

possible, in a format that can be accessed and analysed

combining efficient IT technology, artificial and human

intelligence and experience.

Signal detection and analysis is a stepwise process. Once the

first suspicion of a possible drug-related problem has been

raised, we use different methods and data sources to build

knowledge gradually. It is important to keep in mind that a

signal is tentative and we, at the early stage, will not have

enough information to establish beyond doubt a causal

relationship between a medicine and a reported adverse effect.

A causal relationship of an adverse effect by a drug is always

a degree of probability. There are always other possible

causes that need to be considered in a single case or a study;

the competing probabilities need to be evaluated and made

transparent. Assessing the likelihood of causality is a

particular challenge if the suspected adverse reaction is a

common medical problem — a few case reports could be

nothing more than a chance finding.

There seems to be a trend in organisations applying data

mining to health. What’s the current extent of use of data

mining in pharmacovigilance, the difficulties and potentials?

I’m proud to say that we in the UMC pioneered the use of

data mining techniques to screen large healthcare data sets.

We started in the 90s developing our signal detection

process for the case reports in VigiBase to combine a first

screening using data mining and disproportionality analysis

with a subsequent manual clinical assessment of potential

signals, and then went on to apply the same technique to

find signals in electronic healthcare records. Nowadays most

major regulators and pharmaceutical companies use similar

techniques to ours to find new signals in their case report

databases. There are different formulas in use, but they are

all based on the same principle: looking at reporting

frequencies relative to a background of other reports to

identify associations that stand out. Using data mining to

recognise patterns is a way to help determine at-risk groups.

But automated screening is not going to do the trick on its

own — it can only generate potential signals — and has to be

combined with manual assessment and clinical judgement.

The main advantage is that by using computer technology to

do what it does well — sifting through huge amounts of data

— we can focus human effort to areas where it is best suited.

This issue of the IPJ focuses on data in health. How would you

sum up the use of data to create new knowledge and

evidence in pharmacovigilance?

The role of pharmacovigilance is to gather the best available

evidence on how medicines work in real life, in the most

cost-efficient and timely fashion. We need to systematically

collect data on possible adverse effects of medicines; and

then organise it and provide information in a way that is

valuable and relevant to improved patient safety.

After these first steps the information must be analysed,

interpreted and communicated; this is what builds the

knowledge base which will support good decision-making in

therapy. Data are the basis for all pharmacovigilance, but I

think the emphasis must move much more towards what we

make of the data, and how we ensure that it is transformed

to useful clinical information. A big challenge is that we have

to constantly re-examine our conclusions based on evolving

knowledge.

The WHO PIDM covers 95% of the world’s population.

What sorts of tools are used?

We obviously need to be effective both in our use of

technology and in the way we communicate to our audiences.

I think there has been too much emphasis on the former in

pharmacovigilance. IT tools are only the medium, not an end.

We have to focus more on how to reach the people we need

to reach, in a way that suits their needs, not ours.

“Today, open access to data is an important feature of the modern society where people expect to be included in decisions regarding their health.”

VigiBase holds information about 11 million individuals who

have been adversely affected by their use of medicines. It’s

our duty to make sure that this information is available so

that it can be used to prevent harm to future patients. For

many years we’ve developed search tools that we’ve made

available to all countries in the PIDM. But this is not enough.

Today, open access to data is an important feature of modern

society where people expect to be included in decisions

regarding their health. That’s why we’ve developed an

easy-to-use interface that can be accessed from a computer

or smartphone: VigiAccess.org allows anyone in the world

access to summarised information from VigiBase.

With the rapidly growing amount of data, is signal detection

getting more difficult?

Last year US researchers looked at Twitter as a way of

monitoring adverse effects. Could this or other social media

really be a viable pharmacovigilance approach?

I wouldn’t call social media a pharmacovigilance approach,

but it’s an untapped, and potentially useful source of data

and we should definitely embrace it. It will provide us with

better insight into problems with medicines, as perceived

by patients.

Until recently, much of our information of possible adverse

drug reactions (ADRs) has come from health professionals.

I’m excited about a new public-private partnership project

including UMC, WEB-RADR, investigating how we can make

the best use of mobile technology and patient-reported data

in social media.

The WHO PIDM was set up after the thalidomide disaster.

This old drug is now being used for new indications, such as

leprosy and multiple myeloma. What research and

monitoring is the UMC doing on this?

Thalidomide has shown to be useful for these new

indications, but we are concerned about reported harm to

fetuses, either during a clinically indicated use or by

accidental or off-label use. It could be that, in spite of strict

regulatory measures, the current controls are not

comprehensive enough to cover the vulnerabilities within

the entire supply and use chain. More research needs to be

done to fully understand the mechanism of thalidomide

embryopathy, and we need diagnostic criteria to establish

cases of fetal malformations with a reasonable level of

certainty. To address these issues a consensus meeting was

organised in 2014 by the UK Thalidomide Trust, and hosted by

WHO in Geneva. Several areas for research were outlined and

we are now developing methods for diagnosing

embryopathies, which could be extended to monitor the

effects of other medicines used during pregnancy.

Turning to new drugs, do biosimilars and biotech products

present any added challenges for pharmacovigilance?

Yes. Similar is not identical. Even slight differences between

molecules as a result of changed production processes may

be important both from the safety and effectiveness

perspective. Immunogenicity is a particular risk area for

biologicals, with the possibility of new reactions and

syndromes occurring.

Biologicals are often used for orphan diseases, and here we have

the problem of doing studies in small populations; we can’t

assemble enough controls to know if the treatment is effective,

and it will take a long time to establish the safety profile. >>

MARIE LINDQUIST QUICK FIREPharmacist Marie Lindquist became director of the

Uppsala Monitoring Centre in 2009. During her long

tenure at the centre Dr Lindquist has worked in data

management, research and IT development.

Significant milestones

Being part of the team that developed the first

routine signal detection process in

pharmacovigilance using data mining technology;

deciding I had the broad interests, skills and

determination needed to take on the challenge to

lead this unique organisation into the future.

Inspiration Being with thoughtful people who have

courage, integrity and a sense of humour, and who,

like me, want to do something important and useful

for this world.

Perfect weekend Lazy mornings with several cups of

tea, time to relax, think, go for walks or work in the

garden, and lively discussions and good food with

people that are close to me.

Visiting Uppsala? Don’t miss The Gustavianum

museum with its anatomical theatre and fika at Cafe

Guntherska by the River Fyris.

Swedish fika: coffee with something sweet and delicious

interview

22 23INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

Active risk planning and management is, therefore, critical when

these products are released for real-life clinical use.

We need to get much better at communicating and training

health professionals and patients to report more details for

these products. It’s not good enough to have ADR reporting

on the substance level — in the absence of an agreed precise

nomenclature allowing for a distinction between different

products, as a minimum requirement, the brand name must

be used.

Recent legislation requires the pharmaceutical industry to

develop risk management plans for new medicines. What’s

your opinion on this new application of post-marketing

pharmacovigilance?

Any serious pharmaceutical company and regulator will

always have done risk management as part of their safety

work; whether they called it “risk management” 20 years ago

is another question. I think it’s good that there’s now

legislative support for rigorous risk management practices

— but there’s a risk that the requirements related to the

production of the plans themselves become so detailed and

extensive that more effort is spent producing risk

management plans than doing the work. Risk management

planning per se is not changing our relations with industry.

“We now have a situation where medicines with limited safety profiles are made available to large populations in a short time, in places with little or no pharmacovigilance capacity.”

But the accelerated market entry of new medicines in low-

and middle-income countries will affect us directly, in that

we now have a situation where medicines with limited safety

profiles are made available to large populations in a short

time, in places with little or no pharmacovigilance capacity.

We will need real-life risk management in real time.

In its quest to increase reporting of side effects, the UMC

recently branched into the music world with its “Take & Tell”

song (see Box). But the lyrics only direct people to “Let your

doctor know”. What about pharmacists?

There’s a very simple reason for only including doctor in the

“Take & Tell” song: have you ever tried rhyming health

professional? Phar-ma-co-vigi-lance was bad enough, but we

felt it had to be included. On a more serious note, of course I

think that pharmacists have an important role in pharma-

covigilance — after all I’m a pharmacist myself! “Take & Tell”

is just a fun way of getting through the media noise of today

to be able to spread the serious and important message that

everyone can contribute to safer use of medicines.

“Pharmacists with their pharmacological and kinetic expertise have a unique contribution to make as part of the healthcare delivery team.”

Pharmacists with their pharmacological and kinetic expertise

have a unique contribution to make as part of the healthcare

delivery team. Also, pharmacists contribute to rational use of

medicines by keeping an eye on the risk of interactions and

suboptimal combination of drugs. As a pharmacist you’re

trained to be meticulous, and attention to detail is critical to

ensure that good quality data are collected and recorded

when an ADR, or any other problem in relation to medicines, is

suspected. When assessing new signals of possible ADRs,

pharmacists’ knowledge in pharmaceutics and pharmacology

is very important. So I’m not surprised that many national

pharmacovigilance centres are run by pharmacists.

What new types and applications of data do you predict in

the field of pharmacovigilance?

In all parts of the world, patient-reported harm or concerns

about safety of medicines will increase exponentially as part

CAMPAIGN

UMC’s Take & Tell campaign launched last month urges

people to be more active in pharmacovigilance.

A website explains side effects and what action to take,

an introduction to the WHO global database of suspected

adverse drug reactions, an application to allow people to

keep track of side effects and a campaign song.

of the data and social media revolution. The challenge for

pharmacovigilance here is to make use of diverse and

unstructured data in a way that helps other patients.

In low- and middle-income countries there will be much more

data coming from product-based surveillance projects done

as part of major roll-outs of donated medicines. In many of

these countries the resources and ability to do post-

marketing surveillance throughout the life cycle of all drugs

will likely continue to be limited. But things are changing,

and much needed efforts are now put into strengthening

overall regulatory systems and the harmonisation of

pharmacovigilance practices and processes across regions.

Perhaps most important is that there’s a new generation of

people now who are more than ready and able to apply agile

processes and the latest mobile technology which will

accelerate development.

The original aim of pharmacovigilance was to find new

suspected ADRs, mainly to new drugs. Only a broader look at

all the factors leading to adverse patient outcomes on

medication will reduce the burden of drug-induced morbidity

and mortality; including harm caused by sub-standard and

adulterated drugs, medication error and antibiotic

resistance. These are global problems, but posing particular

challenges in countries with limited regulatory and patient

safety systems.

“It does not make sense that hard pressed health professionals in poor countries should be asked to fill in many forms for the same patient, who happens to have several diseases, treated with medicines through different public health programmes.”

I’m pushing the principle that data collection should follow

the patient, not the drug. It does not make sense that

hard-pressed health professionals in poor countries should

be asked to fill in many forms for the same patient, who

happens to have several diseases, treated with medicines

through different public health programmes.

Safety assessment of new medicines in low- and middle-

income countries rely on the implementation of sustainable

pharmacovigilance processes and life-cycle management of

patient safety data; and robust and good quality data

collection and analytical tools. UMC will contribute actively

to these developments.

ABOUT THE UPPSALA MONITORING CENTRE

Uppsala Monitoring Centre (UMC) advances the

science of pharmacovigilance and inspires patient

safety initiatives all over the world. As an

independent, non-profit foundation, it engages

stakeholders who share its vision and collaborates to

build a global patient safety culture. As a leader in the

research and development of new scientific methods,

it explores the benefits and risks of medicines to help

minimise harm to patients, and offers products and

services used by health authorities and life-science

companies worldwide. For almost 40 years, it has

provided scientific leadership and operational

support to the WHO Programme for International

Drug Monitoring, expanding the global

pharmacovigilance network to reach more than 95%

of the world’s population.

25VOL 33, NO.2 - JULY 201524 INTERNATIONAL PHARMACY JOURNAL

Not-to-miss congress sessions

D5: INFORMATION MASTERY (Thursday 1 October; 09:00–12:00)

• Information mastery overview — Vimal Kishore (Xavier University of Louisiana, USA)

• Preparing a database to provide on-the-minute updated information about medicines/health products —

Sandra Lino (Associação Nacional das Farmácias, Portugal)

• Hands on demonstration of the use of high quality information mastery resources —

Timothy Chen (University of Sydney, Australia)

D6: EVIDENCE-BASED PRACTICE SKILLS (Thursday 1 October; 14:30–17:30)

• Barriers to EBP — Greg Duncan (Monash University, Australia)

• Techniques for empowering the pharmacist: skills to practise EBP — Safeera Hussainy (Monash University, Australia)

• Educational strategies to overcome barriers to EBP: model for an environment with limited resources —

P.T. Thomas (Taylor’s University, Malaysia)

B4: HOW TO USE SURVEYS TO GENERATE LOCALLY RELEVANT EVIDENCE THROUGH PRACTICE(Friday 2 October; 09:00–12:00)

• Survey research design: why survey designs matter — Parisa Aslani (University of Sydney, Australia)

• Survey studies: advantages and limitations — Carl Schneider (University of Sydney, Australia)

• Steps in survey research: developing and validating the survey instrument —

Anandi Law (Western University of Health Sciences, USA)

• Interactive workshop

Full congress programme.

Master your pharmacy information

The increasing use of medicines and expanding professional

roles mean pharmacists need to work smarter. Rapid changes,

such as mutations and resistance in infectious diseases and

emerging epidemics, make it imperative that they keep up

to date.

It is one thing to desire to use evidence-based practice (EBP),

but another to be able to use it routinely and effectively in

view of competing priorities in real practice environments,

says Vimal Kishore, professor of pharmacy at Xavier

University of Louisiana, USA.

So, how can EBP be ensured when pharmacists’ daily tasks

are growing? One solution is to become more efficient, and

one of the best ways to do this in time-constrained

environments is to exercise information mastery, he says.

Professor Kishore, an expert in research methods and

literature evaluation, explains that information mastery is

a tool: “an approach to quickly find pre-appraised and

summarised science-driven, relevant and high-quality

evidence”. And he believes that “its use applies to all

pharmacists, irrespective of their role”.

Professor Kishore will be giving an overview of this important

skill at this year’s FIP congress in Düsseldorf. In particular,

he will be explaining how information mastery (which is

time-efficient) differs from critical appraisal (which is time-

intensive). His presentation is part of two sessions (D5 and D6;

see Box) dedicated to using databases and ensuring EBP.

Session D5 will focus on information mastery and is not only

aimed at practitioners. One of the objectives of the session is

that participants learn how to incorporate this important

skill into curricula. “The teachings of EBP differ widely not

only across global regions but even within countries.

Information mastery as a formal required course is missing in

the majority of the pharmacy education system. It is

important to ensure that pharmacy students are exposed to

information mastery early on in their studies and throughout

their education,” Professor Kishore says.

Dealing with barriersSession D6 will help participants with further areas of EBP.

According to Professor Kishore, in order to adopt EBP

successfully, pharmacists have to be aware of the barriers and,

more importantly, how to overcome them. “Differences in

cultural, social, and religious attitudes towards modern

medicine serve as a major barrier to EBP around the world and

within regions of a given country. For example, herbal medicine

is revered in China, Ayurveda in India and homoeopathy in

other parts of the world, including Germany, although

acceptable evidence is not always available,” he says.

These sessions will also be relevant to pharmacists in

electronic-resource-poor practice environments. Professor

Kishore explains that information can be broken into three

categories: (1) electronic resources requiring paid

subscription; (2) credible electronic resources available

without subscription; and (3) non-electronic resources

generally produced as annual/semiannual reports available

free or at minimal cost. The plan is to make available a list of

such non-electronic resources based on various pharmacy

relevant classifications during sessions D5 and D6, he says.

With a wealth of rapidly evolving information at your fingertips, but little time to find — let alone analyse — what is most relevant to you, what can be done? Adian Magomedov reports.

Vimal Kishore

Contributing to the evidenceBesides being able to use information efficiently, pharmacists

themselves can generate valuable new evidence, Professor

Kishore says. For example, they can collect locally relevant

data by conducting survey studies through their own

pharmacies. But, he warns, “high quality surveys are not as

easy to design or conduct as people might think. A substantial

proportion of published pharmacy survey studies fail to meet

highest quality standards, primarily in robustness of design.”

To this end, he is chairing a session at the congress (B4) that

will concentrate on how to use surveys to generate locally

relevant evidence through practice, which will include an

interactive workshop.

The barriers to EBP and generating locally relevant

information are well known. The real question is what to do

about them. At these three congress sessions, you will be able

to find out.

“Information mastery as a formal required course is missing in the majority of the pharmacy education system.”

26 27INTERNATIONAL PHARMACY JOURNAL

science

VOL 33, NO.2 - JULY 2015

How crowd power is being applied to researchCrowd-based mentality has slowly been pervading our daily activities. Need a ride? Crowd-source it through Uber or numerous others. How about a place to stay? Find one through AirBnB. With the rise of on-demand access and technology, it may come as no surprise that science and research are also turning to crowd-sourcing. Timothy Dy Aungst finds about a landscape of citizen scientists, gamers and e-patients.

Crowd-sourcing data simply means collecting data from a

large group of people rather than from a more traditional

source. In health research, this could mean collecting data

from an online patient community rather than through a

clinical trial. The benefits of crowd-sourcing data include cost

reductions, overcoming logistical barriers and access to larger

datasets. The growing popularity of crowd-sourcing is due, in

part, to rapid advancements in technology, including

smartphones and their applications (apps), the internet and

social media.

Many organisations are looking for ways to integrate these

new technologies with medicine. For example, the charity

Cancer Research UK has recruited “citizen scientists” to help

with its projects, speeding up the identification of biomarkers

and the analysis of tumour samples. It has created a platform

— Cell Slider — to teach the public what to look for in images

of breast tumour samples, and to allow them to contribute to

image processing. Researchers can then look at what trends

are being spotted by these citizen scientists. One way in

which such information might be used is to predict how

patients will respond to treatment.

“With [our] first crowd-sourced citizen scientist project,

Cell Slider, it took just three months to score pathology

images which had taken researchers 18 months [previously],”

Hannah Keartland, Cancer Research UK’s citizen science

programme manager, told the IPJ. “Our absolute priority is

making sure that Cancer Research UK’s citizen science

products are genuinely useful to researchers. To do this, we

need to invest a lot of time in rigorous scientific validation.

We also recognise that this is crucial to convincing

researchers that they can trust our crowd-sourcing products,”

Ms Keartland added.

Gaming accelerating health researchCancer Research UK then expanded to other projects using

gaming to engage people and reward those who invest their

time. For instance, its “Genes in Space” game requires players

to pilot a spaceship collecting a fictional “element alpha”. But

they have to find the best space route and that means plotting

a course through real DNA microarray data and finding the

highly irregular bands medical researchers look for. By

crowd-sourcing players around the world through a game

available on smartphones, researchers have a large number of

people helping to peruse medical data faster than they could

alone. In another game, “Reverse the Odds”, players can help to

identify bladder cancer biomarkers though solving a puzzle.

Again, players spend time identifying patterns in real samples.

“Our two innovative mobile games have also attracted a lot of

attention globally which has helped raise awareness of Cancer

Research UK and of our citizen science activity. Over 50% of the

people playing our games are outside the UK,” Ms Keartland

said. Moreover, she said that “gamification” of research has

enabled the charity to tap into totally new audiences — people

who would not normally support it. However, she added: “This

is not without its challenges. We need to make sure that the

game-play element incentivises players to carry out accurate

analysis as that is what is most important to us.” She also

recognises that games have a limited shelf-life, and that

learning to increase the sustainability of these research games

is key to continual research benefits.

Making use of online patient communities Beyond citizen science, several companies are using data

collected from e-patients (patients who are equipped, enabled,

empowered and engaged in their health and healthcare

decisions, especially through use of technology) and online

patient groups, through mobile apps and social media to

evaluate diseases and determine what treatments work. For

example, CureTogether is crowd-sourcing quantitative data

and patient responses to different treatments. It recently

announced the first results from its ongoing “study” of

arthritis treatments, evaluating the top 10 overall treatments

according to patients. It is also running similar “studies” on

treatments for Crohn’s disease, anxiety, bipolar disorder and

acid reflux. Scientists and health professionals at universities

and medical research companies across the USA are now

tapping into this patient-driven research initiative as a means

of evaluating ongoing or possible new treatments.

“Patients are equally likely to report issues with their medicines online as they are to share a picture of their latest meal.”

Walgreens, one of the largest retail pharmacy chains in the

USA, is also getting in on the action. It has partnered with

PatientsLikeMe to provide an online portal through which

patients who get prescriptions from Walgreens can access

collated data and compare their treatments with those of

other patients; what degree of success patients have

experienced and how long the medicine took to work.

Crowd-sourcing patient experiences with medical treatments

is quickly turning into a new realm of data acquisition

previously unattainable outside of clinical trials. Data

collected from patients’ experiences and their health journeys

may be especially useful for rare diseases where finding large

patient groups can be difficult.

Social media for pharmacovigilanceThrough Walgreens’s portal, patients can also find out about

the side effects experienced by others, illustrating how

platforms that serve as online communities could also be

used for pharmacovigilance. Patients’ experience data are

also actively being mined by government agencies as a new

source of information about adverse drug reactions. The US

Food and Drug Administration (FDA) traditionally relied on its

Adverse Event Reporting System (FAERS) and its MedWatch

programme for healthcare providers to identify and report

medical device and drug adverse events. But although this

system is recognised and used nationally, it can be

cumbersome and does not capture all data in the populace.

Taking that into consideration, attention turned to social

media as a potential resource to mine: researchers have

identified that patients are equally likely to report issues with

their medicines online as they are to share a picture of their

latest meal. In their Drug Safety paper “Digital drug safety

surveillance: Monitoring pharmaceutical products in Twitter”

(2014;37: 343–350), Freifeld et al evaluated over seven months,

Twitter posts that were related to 23 medical products.

They identified and analysed 4,401 Tweets related to adverse

events. Patients’ experiences with treatments on social media

may be an untapped resource that can be looked at as a future

means of pharmacovigilance and may offer an improvement

over current resources.

PatientsLikeMe recently announced a partnership with the

FDA to evaluate potential adverse events through its platform.

This may offer an advantage over Twitter (where only 140

characters can be communicated) in determining significance.

It remains to be seen whether such sources of data will be

beneficial to federal agencies and pharmaceutical industries.

Mobile data gathering to make predictionsThe widespread uptake of smartphones by a sizable portion

of the populace and the increased ability of these devices

to collect data from the environment (eg, accelerometer,

global positioning system [GPS], camera, microphone) poses

a new means of crowd-sourcing data. Take, for instance, the

HealthyDay app, which informs patients in real-time about

their risks for allergies, cold and influenza based on local data

(via built-in GPS). Other users in the same location manually

Quantitative data and

patient responses to

different treatments can

be crowd-sourced

28 INTERNATIONAL PHARMACY JOURNAL

science

medical research. Through collecting all kinds of data,

smartphones could also potentially reduce clinic visits and

other logistical barriers that researchers face.

Ethical conundrums and what the future may bringAlthough there are many examples of how crowd-sourcing is

disrupting the sphere of medical research, patient

engagement and healthcare advancement overall, there are

several limitations. Foremost is the ethical concern

regarding patient safety and confidentiality. Researchers

seeking to engage society as a means of crowd-sourced data

must ensure patients’ information is properly collected,

stored and protected from misuse. Other issues facing

researchers concern the accuracy and robustness of

crowd-sourced data that could either supplement or replace

traditional research methods. The medical community may

see itself having to adjust to new research parameters and

coming up with new methods to meet the potential data

overload that research may soon encounter.

Researchers and medical practitioners are now able to reach

and engage with a larger audience, enabling crowd-sourced

data collection to be a turning point in medical research.

Although these changes may prove beneficial, there are still

many unanswered questions. These include which

technology works, whether tapping into social media is a

worthwhile endeavor, and whether online patient groups will

really be a boon to expanding data sources. Rapid changes in

technology could also pose their own barriers, leaving

researchers and the field of medicine always trying to catch

up with the next big thing, never affirming the benefits or

harm of currently widespread accepted technological

advances. Other issues include competition by start-up

companies, pharmaceutical companies and even technology

powerhouses that have previously stayed away from

healthcare, all looking to delve into the realm of crowd-

sourced medical research to make the next big discovery or

possibly devise a means of monetising this potentially

limitless data source. Crowd-sourcing is here to stay. We will

be talking about it more in the next few years and it will most

definitely be a game changer in the way patients are treated.

or automatically feed in data when using the app to report

symptoms or vital statistics (eg, temperature). Other data such

as pollen count are also pulled and added to the information.

HealthyDay users can then compare themselves with other

members in their community and see if there has been any

increase in illnesses in their area. Health professionals

can also use these sorts of app to identify possible health

concerns arising in their area. However, the data gathering

is not without problems. Google Flu, for example, which has

tracked the spread of the influenza across parts of the world

based on browser search patterns, has been criticised for

failing to predict pandemics such as swine flu.

Crowd-sourcing data to plot out health patterns is in its

infancy but the reality is that with the growth and

capabilities of information analytics and mobile devices

real-time data could soon play a significant role in disease

control and patient care. This, in part, is highlighted by the

expansive role that Apple has entrusted in its smartphones

and its recently released ResearchKit platform, which will

allow medical researchers to crowd-source data from

iPhones. Users can choose to join clinical studies sponsored

by large academic institutions on a range of conditions such

as Parkinson’s disease and cardiac disease. This demonstrates

a paradigm shift in medical research. Pharmaceutical

companies are also taking an interest in exploiting

smartphones to broaden their patient engagement and

ABOUT THE AUTHORTimothy Dy Aungst is assistant professor at MCPHS

University, USA. He has provided consultancy services

to Iodine, Inc. He was previously an editor for

iMedicalApps, where he reviewed mobile medical

applications.

FUNDING THE NEXT MEDICAL BREAKTHROUGH

Crowd-sourced funding of medical research is here. Using

websites like KickStarter and Indiegogo, small companies

and individuals have seen success in their raising of funds

for their different products or business ventures.

Researchers have similarly turned an eye towards

crowd-funding as an alternative to traditional grants and

funding initiatives that have become much scarcer and

more competitive. Several online crowd-funding ventures

have come into being aimed at the scientific researching

community. Examples include Experiment, Walacea and

Consano. Here, scientists and researchers can pitch their

proposed research projects and receive funding from the

public, who can then see the research outcomes and the

results of their investments revealed in real-time. While

crowd-funding may be a potential option for researchers to

get help with their projects, currently there are limited

data to support the widespread use of these services or to

evaluate the overall impact of crowd-funded goals in the

wide scheme of medical research.

Systems approaches for better medicines and health

Join leading pharmaceutical scientists from around the world to discuss cutting-

edge research and up-and- coming developments at the Pharmaceutical Sciences

World Congress 2017 in Stockholm, Sweden.

THE SYSTEMS THERAPEUTICS APPROACH

Systems biology has emerged as a novel

scientifi c discipline, which focuses on the

analysis of biological networks as the basis

for the functioning of biological systems.

Systems analysis will revolutionise medicines

and health research.

This will impact on both the pharmaceutical

sciences and pharmacy practice, says

congress chairman Professor Meindert

Danhof.

In research, systems biology offers a novel

approach to:

i) Identifying pathways of disease;

ii) Discovering drug targets; and

iii) Discovering biomarkers (for monitoring

of the treatment response).

In practice, this will lead to the intro duction

of “systems therapeutics” interventions

which are:

i) Personalised (both with respect to the

selection of drug(s) and dosing regimens);

ii) Disease modifying (with emphasis on pre-

emptive and preventive treatments); and

iii) Complex (such as multi-target drugs,

rational drug-drug combinations,

drug-device combinations).

Pharmaceutical Sciences World Congress 2017Stockholm, Sweden21-24 May 2017

WHO NEEDS TO KNOW ABOUT IT?

The introduction of systems therapeutics will impact on the entire

chain, from drug discovery and design through to development,

regulation and use. This calls for a multi disciplinary approach with

contributions from the entire spectrum of subdisciplines in the

pharmaceutical sciences and pharmacy practice. We must join forces.

www.fi p.org/pswc2017

#FIPCongress

0091_PSWC2017_advert_v4.indd 1 31-03-15 11:34

www.fip.org/pswc2017

30 31INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

science

Expert tips on

COMMUNICATING your research

Research is about gathering data and analysing the information to turn it into knowledge. The next step is to get that knowledge communicated and, usually, that means publication. IPJ asked some of the distinguished scientists leading FIP’s special interest groups to share their tips for getting research published. Together they have over 550 published papers.

SELECTING A JOURNAL

WRITING YOUR PAPER

N Reading articles by top scientists

and analysing how they present their

data and put it in context can help you

write your paper.N Don’t try to convey too many messages in one

manuscript — keep things focused.

N After finishing your manuscript leave it for few days then read it

again critically.N Arrange scientific data into an attractive “story” rather than sequentially listing

results from experiments in the sequence they were performed. (But, at the same time,

the story must be scientifically sound — you may highlight elements but you should include

negative results in addition to positive ones, in order to avoid publication bias.)

N Display your research data in high quality figures or tables (including statistical evaluation) that clearly

support your conclusions.N Limit your discussion to a few topics that effectively enhance the reader’s understanding of your experimental

design, results and/or interpretation.N Make sure you understand your selected journal’s requirements for submission. These are usually available as “guidance for contributors” on the journal’s website.

N Ask an experienced scientist to read the draft you think is ready for submission.

N Look at the citations in

your paper. Which journals are these articles published in? They may

give you a good list of options for your submission. Use journal websites to judge

whether your paper fits the scope of the journal. N Consider the journal’s target audience and whether your work will be of interest to that audience. For

example, for more clinically oriented journals your results should be of clinical relevance. Ask: “Are there papers with comparable topics in that journal?” This can help you decide if the journal’s readers (and, therefore, the journal) will be interested. Other useful questions to ask

include: “Is the audience broad or a highly specialised interest group?” and “Does the journal tend to

publish substantially novel research findings or variations of a theme that merits

dissemination to the scientific community?”.

N Check the impact factor of your

target journal. It never hurts to aim a bit higher at first submission.

If your paper is not accepted you can always resubmit to a lower impact factor

journal. Established (higher impact) journals tend to focus on novel concepts that have not yet been

published.N Don’t disregard the newer digital journals, particularly if time to publication is relevant (eg, graduation require-

ment). Important selection criteria for newer online journals include whether they are indexed in a major data-

base (eg, PubMed, Scopus) and if there is a publication cost. Open access publication is important. However, the fact that

the researcher may be required to pay to publish in these journals is sometimes a problem if there’s no funding for this in the project.

N Newer journals with lower impact factors accept “variations on a theme” research that merits dissemination to the scientific community.

N Select a journal that has published similar work to yours but make sure your work contains clear progress from

previously published work.N Be flexible about choices — reaching the readers you

want may be more important than whether the journal is an e-journal or a standard journal. N Try to choose a journal with a good track record in

its reviewing process. It can be difficult to find information about time to publication but

through social media you can find and ask other researchers who have had a

paper published in the journal about their experiences.

Anke-Hilse Maitland-van der Zee, As-

sociate Professor of Precision Medicine at the University of

Utrecht, the NetherlandsResearch areas Precision medicine

in, among others, cardiovascular medicine, paediatrics (asthma, haematology, oncology)

and adverse drug reactions (drug induced liver injuries, myopathy, angioedema, hyper-

sensitivity reactions)Recent papers published in Clinical &

Experimental Allergy, Clinical Pharmacology & Therapeutics

and New England Journal of Medicine

Hanns-Christian Mahler, Head of

Product Development, Lonza AG, Basel, Switzerland

and Adjunct Faculty, Institute of Pharmacy, University of Frankfurt/MainResearch areas Protein formulation,

stabilisation, excipient degradation, aggre-gation, particles, product manufacturing

Recent papers published in Analytical Chemistry, Journal of Pharmaceutical

Sciences and Pharmaceutical Research (epub ahead of

print)

Jennifer Dressman, Professor

of Pharmaceutical Technology at Goethe

University, GermanyResearch area Prediction

of oral drug absorptionRecent papers published in European

Journal of Pharmaceutics and Biopharmaceutics, Journal of Pharmaceutical Sciences and

Journal of Pharmacy and Pharmacology

Giovanni M. Pau-letti, Associate Profes-sor of Biopharmaceutics & Pharmacokinetics at the

University of Cincinnati, USAResearch area Drug delivery and

membrane transportRecent papers published in

Advanced Materials, Lab on a Chip, and International Journal of

Pharmaceutical Sciences & Research

Masoud Jamei, Vice-President of R&D at Simcyp, UK

Research areas Physiologically based pharmacokinetics

modelling in virtual healthy and patient populations

Recent papers published in Toxicology in Vitro,

Frontiers in Immunology and Pharmaceutical

Research

Masaru Kato, Project Associate

Professor at the University of Tokyo, Japan

Research area Analytical chemistry

Recent papers published in Analytical Chemistry, Analyst and Chemical

Communications

32 33INTERNATIONAL PHARMACY JOURNAL VOL 33, NO.2 - JULY 2015

patient has reported as outcomes and barriers, pill box

opening and side effects. The web platform even has an

algorithm developed to detect macular oedema — if the

pharmacist selects certain combinations of side effects,

potential macular oedema is flagged. The platform also

allows free text entries. “But it’s not just about the data. It’s

about creating relationships,” Professor Bugnon stressed.

Furthermore, although one role of data is the feedback, a

second is to prove performance of the service: “Twenty years

ago we were paid only a margin on drugs, 10 years ago a fee

for service was paid. Now it’s about the effectiveness of the

service. If you want to prove this, you need the data.”

Outcomes and satisfaction“We have a high level of satisfaction. The neurologist is

happy with the work we are doing and to have contact with

the patient once or twice a year because she knows we are

following a process,” Professor Bugnon said.

He has presented preliminary data on the outcomes of this

project (see Box) but explained that his team were obliged to

allow a minimum follow-up time. In October they will have two

years’ worth of data from his first patient, and more analysis is

planned. Nevertheless, when it is estimated that 50% of

patients don’t take their medicines as prescribed,1 a pharmacy

service that produces 97–99% adherence is impressive. >>

practice

Complex treatments and complex patients are the markets of

the future. Prime examples where this applies are oncology

and HIV. Another such market is multiple sclerosis (MS), says

Olivier Bugnon, professor of clinical pharmacy practice at

Policlinique Médicale Universitaire, Lausanne, Switzerland.

In 2013, his community pharmacy, which is located in a

primary care centre, began a risk management service for

patients prescribed fingolimod, based on gathering data

from patient interviews and electronic pill boxes.

“In many instances the complex patient market does not

come to the community pharmacist. My idea was to prepare

pharmacists of the future for complex drugs. I believed we

could add more information on the use of drugs in routine

care. For example, effectiveness, side effects and barriers for

drug intake can be recorded,” Professor Bugnon said.

How it worksThe first dose of fingolimod must be taken in the neurologist’s

clinic, with close initial monitoring for at least six hours

(particularly to follow potential cardiovascular side effects),

and further monitoring after that. “The first two weeks is

really important because you have to be 100% adherent or

you have to start again,” Professor Bugnon explained.

Once the doctor and patient have taken the decision to begin

treatment, the pharmacist becomes involved, and explains

the pharmacy risk management programme to the patient

during the initial six-hour monitoring in hospital. The patient

is given a choice to receive care under the programme or to

follow the usual course of care (ie, no special service). Under

the programme, fingolimod is dispensed into an electronic

pill box that detects opening — an indication of adherence

— and at each refill, data are retrieved from the box, which

FIGURES AND FINDINGS

From October 2013 to October 2014, 72 patients

starting fingolimod were approached for inclusion in

the programme. Of these 61% (44) accepted, of which

32 patients were served by the Policlinique Médicale

Universitaire (PMU) pharmacy and 12 by other

accredited community pharmacies.

Of the PMU patients, 25% (8) left the programme (two

due to relocations, one due to a change in prescription,

one due to a loyalty conflict with his usual pharmacist

and four for other reasons).

Mean follow-up was 180 days per patient. Average

adherence according to pill count was 99%. Average

adherence according to electronic pill box data was 97%.

Motivational interviews revealed that facilitators and

barriers to adherence were related to treatment

factors (eg, medication schedule, association with a

ritual), psycho-cognitive factors (eg, anxiety, existence

of treatment goals) and socio-economic factors (eg,

education, social support).

New pharmacy services and better care for patients with

MULTIPLE SCLEROSIS

the patient brings back to the pharmacy. On refill,

motivational interviews are conducted by the pharmacist,

who has been trained to provide the service. “We help

patients to find their own [adherence] solutions by

suggesting different strategies,” Professor Bugnon said.

Data are entered into a web platform and the pharmacist

submits a report of what was discussed to the doctor. “So we

have a complete collaboration system. The future of the

healthcare system has to be integrated,” he added. There are

criteria in place for referral back to the physician.

The web platform was developed by Professor Bugnon’s

team. It integrates the elements of the risk management plan

and guides the pharmacist’s consultation with the patient.

So, for example, the platform ensures that at three months

the patient is asked specifically about any skin complaints.

“The web platform ensures that the service is standardised

and that the pharmacist follows a process. Just as you buy

quality-assured aspirin in different pharmacies, so should

pharmacy services [in different pharmacies] be

standardised,” he told IPJ.

“It’s about the effectiveness of the service. If you want to prove this, you need the data.”

The data Patients using the service authorise the pharmacist and

doctor to share their data and use it for research. Data

collected include the severity of the MS, patient

expectations, the questions the patient has asked, what the

Collecting and sharing adherence and side-effect data from patients with multiple sclerosis is key to a new risk management service in Swiss pharmacies. Lin-Nam Wang reports.

34 INTERNATIONAL PHARMACY JOURNAL

practice

Finding remuneration“The fingolimod project development was funded by an

unrestricted grant from Novartis, but there has been interest

from other drug companies, especially because neurologists

are asking them to pay for the service. This is testament that

doctors recognise the benefits of the service,” Professor

Bugnon said.

A Novartis spokesman told the IPJ: “[We] considered the

integrated care programme for MS patients who were

starting treatment with an oral disease-modifying therapy

for the first time to be a very valuable project. In addition to

supporting patients with their new treatment, this project

assessed patient reported outcomes and treatment

adherence over time. In the past few years, several scientific

publications highlighted that drug adherence, especially for

oral formulations, is a critical success factor for the [efficacy]

of a drug, as medicines are only fully effective if they are

taken on a regular basis.”

The Swiss already have a pharmacy service for adherence that

is paid for through the health insurance system but Professor

Bugnon thinks a new source of funding could be found for

similar services and that this source should be the

pharmaceutical industry.

“Industry should pay because they now have to prove to

medicines authorities that the drug is effective and efficient,

beyond the clinical trial evidence required for licensing.

Moreover, the usual pharmacovigilance is for severe side

effects but we have no idea about minor side effects. We have

no idea about effectiveness. Without this you don’t know

anything about the real effectiveness of the drug and the

safety. The service could also be used to provide data to prove

the value of a medicine,” he said.

The programme highlights patients’ needs and brings new

data about safety and use of fingolimod in real life. “In real

life, we need to keep in mind three Es: efficacy, efficiency and

effectiveness. I have the feeling that community pharmacy is

the right place to prove this as a partner of industry,”

Professor Bugnon added.

Future directions“In Switzerland, the competition for fingolimod provision was

a mail order company. Pharmacy should want to keep

complex patients. This sort of programme is a good strategy,”

Professor Bugnon told IPJ.

Fingolimod must be taken once daily but there are other

medicines for which patients could benefit from similar

services: dimethyl fumarate is one since it has twice daily

dosing in MS. Professor Bugnon’s team has also tested

programmes for oncology and immunoglobulin self-infusion.

“I believed we could add more information on the use of drugs in routine care. For example, effectiveness, side effects and barriers for drug intake can be recorded.”

In addition, new regulations mean that the pharmaceutical

industry is responsible for following medicines post-launch

but this is difficult for it to do in primary care beyond the

number of boxes provided. Pharmacy adherence services

could offer a solution, Professor Bugnon believes. “If you

speak about adherence you have to collect a lot of data and

such a service could easily be adapted to provide post-

marketing surveillance,” he said.

He is now looking to talk to the pharmaceutical industry

about further funding but is wary that it can be sensitive over

the issue of side effects. There needs to be internal

commitment to side-effect notification within the company,

he said.

“A year ago I had no MS patients. Today I have 39 in my pharmacy.”

Professor Bugnon is a strong activist in finding new models of

care and remuneration for community pharmacy, and it

seems he is well on his way to achieving his goals: “A year ago I

had no MS patients. Today I have 39 in my pharmacy.”

REFERENCE

1. Brown MT, Bussell JK. Medication adherence: WHO cares?

Mayo Clin Proc 2011;86(4):304–14.

Olivier Bugnon

75thFIP WORLD

CONGRESS

The 2015 FIP congress is organised

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trade fair in Europe.

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Just what are the scope and limitations of

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B. PRACTICE THROUGH SCIENCE AND

ECITCARP HGUORHT ECNEICS

How do advances in science affect the

advice you give? And how can information

from practice make the knowledge we have

more powerful? It’s not only up to scientists

to gather the evidence! Among the topics in

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C.

WITH THE HUMAN TOUCH

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Can care in a world of innovation and

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What needs to be done to ensure

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Düsseldorf, Germany29 September - 3 October 2015

DUS_advert_IPJ_A4_v2.indd 1 23-10-14 13:37

36) DUS_advert_IPJ_A4_def.pdf 1 16-07-15 14:27

36 37INTERNATIONAL PHARMACY JOURNAL

practice

VOL 33, NO.2 - JULY 2015

Pharmacy-generated record,

public health resource In 2007, a shared electronic patient medicines record was established by law in France, the French Chamber of Pharmacists being in charge of its implementation. Isabelle Adenot and Olivier Porte give an update of how the system has expanded, and Jean-Charles Rochard gives an insight into demographic data gathered by the French Chamber.

The French pharmaceutical record (Dossier Pharmaceutique;

DP) is a shared electronic patient record aimed at securing the

safety of drug dispensing, by reducing drug interactions and

stopping medicines that are no longer required. A further aim is

to improve the coordination, continuity and thus quality of care.

The DP lists all the medicines dispensed to the patient in any

French community pharmacy in the preceding four months

(period extended to 21 years for vaccines and three years for

biological medicines). Prescription and over-the-counter

medicines are included. Since launch, the use of the DP has

security and confidentiality requirements. Being able to

monitor the dispensing of a particular medicine over the

territory in real time is an asset for those carrying out

epidemiological studies. French health authorities (eg, the

Medicines Agency, the Health Ministry and the Institute for

DEMOGRAPICS DATA TO PREPARE FOR THE FUTUREIn France, all practising pharmacists must be registered with the French Chamber of Pharmacists (74,492 pharmacists in

January 2015, including pharmacists working in clinical biology laboratories, industry and wholesalers). The register

allows us to have an exact picture of the demographic situation of the profession/workforce and of the range of

pharmacy establishments. This is a valuable tool for decision-makers when they discuss pharmacy issues. For 20 years,

we have published our data (available at www.ordre.pharmacien.fr) annually. To answer specific requests, we are also

able to cross-reference our data with other data, regarding doctors for instance.

As in previous years, our data show that community pharmacies are evenly spread over the French territory, including

rural areas. There are 22,510 community pharmacies in France (one per 2,936 inhabitants), one third of which are located

in towns with fewer than 5,000 inhabitants. We also notice that community pharmacists are increasingly joining forces

with each other to form partnerships for owning community pharmacies. — Jean-Charles Rochard

been gradually extended to hospitals, and new services are

being developed to allow the dissemination of health alerts,

batch recalls and drug shortage notifications. We are also

currently developing a new service using the DP infrastructure

for medicines verification.

By law, the French Chamber of Pharmacists (Ordre Nationale

des Pharmaciens), was charged with the responsibility of

developing the DP system. For community pharmacies,

implementation started in 2007 and 99.2% of French

community pharmacies are now involved. Some 38.1 million

patient records have been created, making the DP the second

largest patient record system in Europe after the summary

care record system in England (50 million patients; [see pXX

for news]). In terms of activity, the DP in community

pharmacies is the most widely used health record in Europe

with more than one million pieces of information shared

among French pharmacists every day (a total of 330 million

pieces of information in 2014).

On top of that, 195 hospitals are now involved. Hospital

pharmacists have been able to access the DP since October

2012. More recently, since spring 2013, a trial has been

ongoing to extend DP access to hospital physicians working

in emergency, anaesthetic and geriatric departments.

The first assessments have shown a major benefit regarding

medicines reconciliation (when a patient enters a hospital,

the DP allows the identification of 90% of the medicines the

patient is currenlty taking). A consequence is a reduction in

the number of patients requiring readmission to hospital on

account of drug problems.

Today, four billion dispensed medicines are recorded in our

statistical database. Data protection laws require all data to

be anonymised. And because of that the DP system has strict

Public Health Surveillance) have commissioned more than 20

such studies dealing with one particular medicinal product,

a group of medicines or a whole therapeutic class.

The  DP:  A  hub  now  providing  a  full  range  of  services    

PUBLIC HEALTH BODIES

DP SERVICES

HEALTHCARE PROFESSIONALS

•   Pharma  companies  •   Wholesalers  •   Pharmacists  

Public health nationwide statistics

Pharmacist software access

LE DOSSIER PHARMACEUTIQUE

Web access Healthcare alerts

Batch recalls, supply

shortage notification

•   Community  pharmacists  •   Hospital  pharmacists  •   Hospital  physicians  

Access  restricted  (to  dedicated  team  of  the  French  Chamber  of  

Pharmacists)  

DP FAST PASS

FAST : Fast Access Service to TreatmentsPASS : Portal for Alarms & Sanitary Security

THE DP: A hub now providing a full range of services

Since 2013, a trial has been ongoing to extend DP to emergency, anaesthetic and

geriatric hospital departments

38 39INTERNATIONAL PHARMACY JOURNAL

practice

VOL 33, NO.2 - JULY 2015

How REAL-WORLD DATA are improving access to medicines

Although randomised clinical trials (RCTs) are considered the

gold standard method for establishing efficacy, in general,

these use a standardised therapy in a selected group of

patients and are typically restricted to evaluating specific

discrete interventions one at a time. As such, RCTs fail to assess

complex interactions within a study arm, fail to establish

continuous relationship and fail to elucidate if the benefits/

harms of a treatment are drug-specific or mechanistic.

Traditional RCTs focus more on evaluating the efficacy of

simple therapies and less on the delivery of care, and it is said

that RCTs have internal validity but not external validity. For

assessing effectiveness of combinations and for evaluating

all these issues in RCTs, many study arms would be required.

For example, it would take 32 different study arms to examine

all the possible combinations of just five treatments, making

the costs of conducting RCTs that evaluate all these issues

prohibitive. This is where real-world data (RWD) have a role

to play.

The International Society for Pharmacoeconomics and

Outcome Research has defined RWD as everything that goes

beyond what is normally collected in the phase III clinical

trials programme in terms of efficacy. It is also conveniently

labelled as anything that is not interventional. Many

healthcare decision-makers are developing policies that

integrate evidence from different sources. Importantly, it is

being accepted that other sources of data can contribute to

the evidence base (eg, demonstrating how a drug works in

populations not studied in the trial, or relative to another

drug not included in the study).

In real-world studies, the actual care that patients receive in

clinics is recorded. Rather than having strict inclusion and

exclusion criteria, all patients — including those with

co-morbidities — have to be treated. Such studies generate

long-term efficacy and safety data along with economic

assessment under pragmatic conditions.

Data sources for RWD can be supplements to traditional

registration RCTs; large, simple trials known as pragmatic

clinical trials; registries; administrative data; health surveys;

and electronic health record and medical chart reviews.

Although some governments are making efforts to permit

patients and researchers greater access to data, most of the

health-related data are aggregated and curated by private

companies. In most cases, charging for access to such data is

integral to their business plans. In many cases, the data have

been transformed in some fashion by the company collecting

the data, and therefore considered as intellectual property.

Access may also be restricted to government-sponsored

datasets.

Improving access to medicineThe past few years have seen RWD being used to improve

access to medicines. For example, in July 2011, the

Pharmaceutical Benefits Advisory Committee in Australia

(PBAC) evaluated Yervoy (ipilimumab) for the treatment of

patients with stage III or IV malignant melanoma. The

submission presented a single phase III, randomised double-

blind trial. In the first two submissions, the PBAC did not

recommend the drug, noting that, although it demonstrated

In a paper published in Breathe recently (2015;11:26-38) a group of academics presented the importance of real-world research in respiratory medicine, such as exploring the links between asthma and obesity. But real-world data are also improving access to medicines. José Manuel Martínez Sesmero explains.

improved efficacy, it had an inferior safety profile and there

was considerable uncertainty regarding the eligible patient

population and costs associated with the treatment. On the

third submission in November 2012, the manufacturer

presented four new pieces of evidence related to the

durability of Yervoy’s effect and three new pieces of

information related to recent, real-world, post-registration

data. These new data demonstrated that the drug increased

survival (compared with gp100 peptide) and that there was

evidence of a plateau in effect. There was also evidence that

the effect was durable. Citing this new evidence (and a

decrease in price), the PBAC recommended the product.

Another example, from Scotland, is where RWD helped

demonstrate improvement in quality of life (QoL) with Zaltrap

(aflibercept). In June 2013, the Scottish Medicines Consortium

(SMC) reviewed Zaltrap in combination with FOLFIRI

chemotherapy for the treatment of adults with metastatic

colorectal cancer. The SMC evaluated one randomised,

placebo-controlled phase III study and, despite

demonstrating significantly longer overall survival, Zaltrap

was not recommended because of the lack of a sufficiently

robust economic analysis. In a February 2014 resubmission,

the licence holder included two open-label studies assessing

safety and quality of life. This RWE was used to revise the

utility values within the economic model. The SMC

recommended Zaltrap because the new data demonstrated a

substantial improvement in QoL. In addition, the licence

holder also presented a patient access scheme, which

improved the cost-effectiveness evaluation of Zaltrap.

A further example comes from France, where RWD helped

confirm the effectiveness of a drug for a rare inherited

disorder, Pompe disease. In 2006, Haute Autorité Santé (HAS)

reviewed Myozyme (alglucosidase alfa) for the treatment of

late-onset Pompe disease. The HAS evaluated interim analysis

from a non-comparative trial and observational data from an

expanded access programme. The HAS did not recommend

Myozyme because the efficacy/safety ratio was not well

established. In 2010, the HAS recommended the drug based

on newly submitted data: a larger randomised control trial, an

observational study of 44 patients, and data from the French

Pompe Disease registry. Data from the observational studies

confirmed that the drug improved the six-minute walk test

and seated vital capacity.

Important role, despite the issuesThere are a number of issues with collection of RWD, for

example: lack of good quality and sufficiently representative

databases in many countries; incomplete databases; the

presence of many asymptomatic cases (an issue with

retrospective observation of data); and more chances of bias

and confounding in prospective real-world studies (as it is

without randomisation). Yet RWD has an important role to

play in the evaluation of epidemiology and burden of disease,

treatment patterns, compliance, persistence, and health

outcomes of different treatments.

Health research, including health outcomes and comparative

effectiveness research, is on the cusp of a golden era of access

to digitised RWD that promises to transform the way in which

we understand and practise medicine and pharmacy. Part of

this transformation will be driven by the quantity of RWD that

will be generated as well as the broader interest in big data

(see pp 12). The era of digitised RWD and big data holds great

promise for the transformation of healthcare. Yet this promise

can only be fully realised if access to data is broadened, if

connectivity between datasets is improved, if the methods for

analysing large datasets are advanced, communication of

evidence is encouraged and put in the right context, and if

there are clear standards for how privacy can be maintained

that also recognise that no solution is entirely secure.

© D

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Colorectal cancer has been treated with medicine made accessible because of

real-world data

40 41INTERNATIONAL PHARMACY JOURNAL

education & workforce

VOL 33, NO.2 - JULY 2015

“Looking ahead to the next 50 years, it is not a stretch to imagine that the ability to manipulate and extract information from data will be as important as the ability to write.”

The information age is finally dawning for a hold-out sector in

the global economy: healthcare. This will likely produce

dramatic changes to the landscape of patient care, bringing

both opportunities and challenges to patients, providers and

payers. Looking ahead to the next 50 years, it is not a stretch

to imagine that the ability to manipulate and extract

information from data will be as important as the ability to

write. Leaders in the profession of pharmacy should realise

that this paradigm shift suggests that we should adopt new

skills and transform our practices accordingly. We need to

prioritise data manipulation and analysis skills in both the

pedagogical and practice settings.

Practice transformationAccomplishing this practice transformation will be more

difficult than agreeing with it in concept. The challenges are

many, starting with the fact that analytic skills are generally

lacking in pharmacy curricula both in the USA and

elsewhere.1–3 Accordingly, pharmacists around the world have

consistently voiced an appreciation of the value of analytic

endeavours, but at the same time feel ill-prepared to practise

them.4–7 These realities present significant obstacles toward

accomplishing the laudable goal recently upheld by the

editor-in-chief of the American Journal of Health-System

Pharmacy: to develop pharmacy residents as practice-based

researchers. Here, a classic “chicken or egg” paradox presents

itself. How are mentors and trainers to teach trainees these

analytic skills when the mentors and trainers feel inadequate

regarding these very skills?

One rather obvious answer to this dilemma is to increase

exposure to these topics within the pharmacy school

curricula.8 This could be accomplished through didactic

courses dedicated to health information technology, research

design, statistics and the like. It could be supplemented by

providing opportunities for students to gain practical

experience, either by conducting their own project work or by

assisting their school’s faculty. In any case, to prepare

pharmacists to succeed in the healthcare information age,

these efforts should include a sharp focus on manipulation

and analysis of large data sets. As our clinical information

systems evolve to provide access to richer, more complicated

data sets, the importance of mastering data manipulation

skills will increase. These skills have been somewhat

overlooked in favour of research design, analysis,

interpretation and communication.9 While these latter skills

What might be the quickest path to equip HOSPITAL PHARMACISTS for the information age?

Kenneth Shermock shares two US models that are helping pharmacists develop as practice-based researchers, able to manage data.

are undoubtedly essential, analysis and subsequent steps in

the research process presume that data have been properly

cleaned, manipulated and assembled into an analytic data set.

Viable strategiesEven in the best case scenario, where increased emphasis in

college of pharmacy curricula on research design, data

management and analysis happens quickly, there will still be

a substantial lag before these skills make it to the front lines

in the form of newly graduated pharmacists. Are there viable

strategies that pharmacy leaders can take to hasten the

arrival of these skills in their departments? There are two

successful examples that share a common element: they

involve hiring a formally trained pharmacist into a

department of pharmacy to lead the department’s efforts in

this regard. >>

1. TOPICS IN KAISER PERMANENTE

COLORADO’S PHARMACY INVESTIGATOR

TRAINING PROGRAMME

1 Introduction to the research process

2 Study objectives and design

3 Biostatistics, Health Insurance Portability and

Accountability Act and other regulatory issues

4 Data collection

5 Interpreting and presenting research findings

6 Manuscript preparation

2. TOPICS IN THE JOHNS HOPKINS

STATA TRAINING SESSIONS

Session 1 Introduction to Stata and basic data

management

Session 2 Intermediate data management

Session 3 Working with dates and string variables

Session 4 Analysis of categorical dependent variables

Session 5 Simple logistic regression

Session 6 Multivariable logistic regression

Session 7 Analysis of continuous dependent

variables, two groups

Session 8 Analysis of continuous dependent

variables, three or more groups

Session 9 Simple and multivariable linear regression

Session 10 Graphics

42 43INTERNATIONAL PHARMACY JOURNAL

education & workforce

VOL 33, NO.2 - JULY 2015

of pharmacists per 10,000 population over the period 2006–12

apart from South East Asia, which has seen a decline in

density, he explained.

The methodology used for the 2015 report is to identify

countries where data are available across at least two out of

three time points (2006, 2009 and 2012) and, for countries

where there is a gap in one data point, to undertake a

literature search to capture the missing data. The data will

then be plotted over the three time points so that trends can

be identified and discussed.

“This new report, however, will not only gather data but will also focus on identifying trends.”

As countries’ populations and economies change over the

years, will the pharmacy workforce density mirror the

changes? Will pharmacy be ready to meet the health demands

of the populations it serves? The data we collect will provide

the knowledge to answer such questions. However, “it is not

simply a matter of considering a head count of pharmacists

per country over time. Changing epidemiology and disease

burden at country level as well as population increases need

to be considered, and an assessment made as to whether the

development of pharmacy human resources has adapted and

made an impact over time,” Mr John said.

It is essential to monitor the global pharmacist workforce

trends at regular intervals so that decisions can be made as to

how countries can deploy their workforce. There is also an

increasing international transfer of healthcare professionals.

The WHO is rightly pushing for health equity as a global human

right and having access to a pharmacist is key to that because

medicines are one of the most important health interventions.

For almost a decade, the FIP Education Initiative has been gathering data about the pharmacy workforce from around the world. Its latest report is due to be published in October. Andreia Bruno explains the importance of these data and what they reveal

Many countries aspire to universal health coverage. To

achieve that, they need a health workforce — including

pharmacists — that can meet the health demand of the

population it serves. It is important, therefore, to monitor

trends in the workforce to see whether countries are

successfully approaching their health coverage goals.

In 2006, 2009 and 2012, FIP conducted pharmacy workforce

surveys, and analysed, monitored and reported on the status

of the pharmacy workforce at country level. The reach of the

surveys has grown each time, with 34 countries responding to

the 2006 survey, 56 in 2009 and 90 countries and territories in

2012, representing 2.5 million pharmacists and nearly one and

a half million technicians and support workers.

“The range of countries identified as having data for each of

the time points covered all the World Health Organization

regions, with Europe having the most countries with data

available and South East Asia the least,” said Christopher

John, the Global Workforce Observatory lead.

A key message from all three Global Pharmacy Workforce

Reports so far is that pharmacy workforce density varies

considerably between countries and WHO regions but

generally correlates with population numbers and country

level economic development indicators. “Those countries and

territories with lower economic indicators tended to have

relatively fewer pharmacists and pharmacy technicians,”

Mr John said.

Identifying important trendsThe fourth Global Pharmacy Workforce Report is in

preparation, with publication expected in October 2015. This

new report, however, will not only gather data but will also

focus on identifying trends, since there are now enough data

compiled over a long-enough period to begin to do this,

Mr John said. For example, after the 2012 report, we could see

that all WHO regions experienced an increase in the density

What WORKFORCE DATA tell us

At the first example, Kaiser Permanente Colorado, a clinical

pharmacy research team (CPRT) was assembled within the

department of pharmacy, led by a PhD-trained pharmacist

and including four staff members and two post-doctoral

fellows.10 The CPRT was established in 2004 to formally drive

the departmental research agenda, including resident trainee

research. Their approach involves review of potential resident

project ideas, using standardised criteria and oversight of the

project process. The CPRT also conducts a series of six classes

for their residents, offered at strategic times throughout the

residency year (see Box 1, p41). The percentage of resident

projects published in a peer-reviewed journal increased after

the CPRT was established from 47% to 86% (P=0.001). While

data management does not appear to be a primary focus,

their programme has achieved impressive results in terms of

publication rate.

“How are mentors and trainers to teach trainees these analytic skills when the mentors and trainers feel inadequate regarding these very skills?”

A second organisation, The Johns Hopkins Hospital, supports

the Center for Medication Quality and Outcomes (CMQO) within

their pharmacy department that is also led by a PhD-trained

pharmacist. The CMQO has three main missions: (1) to support

the department’s research enterprise, (2) to conduct quality

improvement and business intelligence assessments, and (3) to

manage the data infrastructure required to accomplish the first

two missions. Similar to Kaiser’s CPRT, the CMQO has a highly

structured process for reviewing and conducting residents’

projects. Additionally, the CMQO has developed a series of 10

classes to train clinical specialists and residents how to

manage and analyse data using Stata statistical software (see

Box 2). These 10 classes are offered multiple times during the

year. As clinical specialists become more proficient, they are

added to the roster of instructors in this curriculum. Using

these data management and analysis skills, the department has

published over 30 peer-reviewed publications in each of the

past four years. Moreover, these efforts have been used to

effect change within the organisation and have sent a strong

message that the department of pharmacy considers evidence-

based quality improvement as one of its core functions. To

support mission number 3, we are recruiting a data architect,

who will specialise in pulling data from disparate sources to

assemble data sets that will be used both for “one-off” research

purposes as well as for continuous quality improvement and

business intelligence.

Things in commonIt is notable that these two successful ventures have some

things in common and some differences. They share

dedicated personnel who are formally trained and are

responsible for promoting the research enterprise in their

departments. They also provide training programmes to

assist members of their departments to conduct practice-

based research. Interestingly, both the targets of and the

content in the training programmes differ. One is offered to

residents and focuses holistically on the research process,

but appears to de-emphasise data management. The other is

offered to both clinical pharmacy specialists and trainees,

but focuses on data management and analysis using

sophisticated software at the expense of other topics

relevant to conducting successful research. It is likely that a

hybrid model that trains clinical pharmacy specialists and

combines the two curricula might be the quickest path to

preparing our front-line pharmacists to take full advantage of

the increased access to data we are just beginning to see.

REFERENCES

1. Awaisu A, Alsalimy N. Pharmacists’ involvement in and

attitudes toward pharmacy practice research: a

systematic review of the literature. Res Social Adm Pharm

2015:1–24.

2. Fuji KT, Galt KA. Research skills training for the doctor of

pharmacy in US schools of pharmacy: a descriptive study.

Int J Clin Pharm 2009;17:115–21.

3. Phillips JA, Gabay MP, Ficzere C et al. Curriculum and

instructional methods for drug information, literature

evaluation, and biostatistics: survey of US pharmacy

schools. Ann Pharmacother 2012;46:793–801.

4. Awaisu A, Bakdach D, Elajez RH et al. Hospital

pharmacists’ self-evaluation of their competence and

confidence in conducting pharmacy practice research.

Saudi Pharm J 2014:1–9.

5. Elkassem W, Pallivalapila A, Hail MA et al. Advancing

pharmacy practice research agenda: views and

experiences of pharmacists in Qatar. Int J Clin Pharm

2013;35:692–6.

6. Kanjanarach T, Numchaitosapol S, Jaisa-ard R. Thai

pharmacists’ attitudes and experiences of research. Res

Social Adm Pharm 2012;8:58–9.

7. Perreault MM, Thiboutot Z, Burry LD et al. Canadian

survey of critical care pharmacists’ views and

involvement in clinical research. Ann Pharmacother

2012;46:1167–73.

8. Brazeau GA, Meyer SM, Belsey M et al. Preparing pharmacy

graduates for traditional and emerging career

opportunities. Am J Pharm Educ 2009;73:1–11.

9. Lee MW, Clay PG, Kennedy WK et al. The essential research

curriculum for doctor of pharmacy degree programs.

Pharmacotherapy 2010;30:966.

10. Olson KL, Irwin AN, Billups SJ et al. Impact of a clinical

pharmacy research team on pharmacy resident research.

Am J Health-Syst Pharm 2015;72:309–16.

opinion

44 INTERNATIONAL PHARMACY JOURNAL 45VOL 33, NO.2 - JULY 201544 INTERNATIONAL PHARMACY JOURNAL

Big data seems to be ubiquitous. Everywhere you look, there it is.

Big data is primarily a dynamic repository of clinical, social

and other personal information that can be used to have a

powerful and precise impact on targeted individuals, who

could be consumers of healthcare or other goods and services.

In 2011, US healthcare data alone reached 150 exabytes.

Those data include not only health records, and direct from

machine data, but also spoken words.1 Driven by current

policies, healthcare data are digitised and hold an

unprecedented potential to improve the quality of healthcare

delivery and reduce costs. Big data promises to support

healthcare functions such as clinical decision-making,

disease surveillance, and population health management.

There are reports of data-driven innovations that combine

Stories of the use of prescribing data to tailor advertising of medicines and the re-identification of anonymised data are coming out of the USA, which is among the front-runners in the big data revolution. Pharmacists know the ethical issues attached to handling patient data, but in the data revolution perhaps they need to think again.

By Fadia T. Shaya, Professor in Pharma-ceutical Health Services Research, and Priyanka Gaitonde, Research Associate, both at the University of Maryland School of Pharmacy, USA

BIG DATA and the pharmacist: caution advised

community settings. Pharmacists’ mastery in analytics of

medical data can foster partnerships with the physicians

where they would own the medication safety domain and help

physicians overcome barriers to medication safety, such as

time limitations and alert fatigue.7

In spite of its advantages, big data presents many opportunities

for inadvertent malpractice. Pharmacists need to rigorously

train and retrain periodically on patient confidentiality and

related legal requirements. They also need to remember that

data are only as good as the method used to collect them.

Considering that the field around big data is still evolving,

collection and reporting methods have not been yet

standardised. Therefore, despite what may be indicated

electronically, the pharmacist-patient-physician interaction in

a most HIPAA-compliant environment remains rudimentary,

and cannot be substituted by, but only be aided by big data.

REFERENCES

1. Institute of Health Technology Transformation.

Transforming health care through big data - Strategies for

leveraging big data in the health care industry. Updated

2013. Accessed July, 2015.

http://c4fd63cb482ce6861463-bc6183f1c18e748a49b87a259

11a0555.r93.cf2.rackcdn.com/iHT2_BigData_2013.pdf

2. Krisberg K. Big data key to improve healthcare. Updated

2014. Accessed July, 2015.

https://www.aamc.org/newsroom/reporter/

january2014/366338/big-data.html

3. Nikfarjam A, Sarker A, O’Connor K, et al. Pharmacovigilance

from social media: Mining adverse drug reaction mentions

using sequence labeling with word embedding cluster

features. Journal of the American Medical Information

Association. 2015;22(3):671–81. doi: 10.1093/jamia/ocu041

[doi].

4. Raghupathi W, Raghupathi V. Big data analytics in

healthcare: Promise and potential. Health Information

Science and Systems. 2014;2:3. eCollection 2014. doi:

10.1186/2047-2501-2-3 [doi].

5. National Institutes of Health (NIH). Data management

infrastructure for a national precision medicine cohort.

Updated 2015. Accessed July 2015.

http://www.nih.gov/precisionmedicine/workshop-

20150528-backgrounder.pdf

6. Robertson J, Pettypiece S. They know you buy Viagra and

they want to sell you more. Bloomberg. Updated 2014.

Accessed July, 2015.

http://www.bloomberg.com/news/articles/2014-12-10/

they-know-you-buy-viagra-and-they-want-to-sell-you-more

7. Wild D. Combing through big data yields big benefits.

Pharmacy Practice News. 2013. Accessed July, 2015.

electronic health records (EHRs) and geospatial software to

map geographical spikes in diseases such as influenza, or use

algorithms to help identify patients at risk for undiagnosed

conditions, provide data to physicians in real time and

provide precision in target care.2, 3

“Patients may be under a false sense of security.”

Many payers are deploying mobile apps to help patients

manage their care and coverage. Through analytics, payers can

monitor adherence to drug and treatment regimens and detect

trends that lead to individual and population wellness

benefits.4 The vision of precision medicine is to take the

revolution of big data further by building an evidence base

large enough to support pattern detection and correlations

among different types of data, including molecular level

genetic information to patients’ healthcare use, and make

treatment options patient-specific.5 The key to this vision is a

large national cohort of willing patients who would disclose

sensitive personal data thus making its security a high priority.

Potential vulnerabilitiesUS legislation (eg, the Health Insurance Portability and

Accountability Act; HIPAA) and healthcare providers’ (including

pharmacists) code of ethics cover the issue of patient

confidentiality, but it is not clear how much security belies

patients’ personal and medical data. Patients may be under a

false sense of security. Indeed, even with a process known as

“matchback”, which enables the tracking of patients’ drug use

and preferences via their prescription records, without their

names being exchanged, there is the potential for security

breaches. That fact exposes a potential vulnerability in the

system that claims privacy and security about the pharmacy

data.6 In the USA, the Health Information Technology for

Economic and Clinical Health (HITECH) Act has empowered

patients to view, download, and transmit their own health

records. But it has also made them targets of direct and

personalised advertising by pharmaceutical companies.

Marketing departments view this as a lucrative avenue to

promote products to patients, side-lining physicians,

pharmacists and insurers who previously stood between the

drug makers and consumers.

“In spite of its advantages, big data presents many opportunities for inadvertent malpractice.”

Use of big data in pharmacies happens at different levels.

One level is catering to the demands of the retail business

and analysing data to help provide a convenient shopping

experience while the other level is using the data to improve

and monitor medication adherence. However, pharmacists

have full access to sensitive personal medical information

conveyed to them by prescription records, by the patient

during counselling or via medical records if the pharmacy

partners with a healthcare organisation. Big data will thus help

pharmacists to better track patient behaviour, decisions and

rationale and provide patient-centric care efficiently. With

additional training, pharmacists can master the challenge of

data mining for insights from a healthcare data ecosystem that

includes prescription data, unstructured physician notes,

medical images, genomic data, and data from consumer’s

buying behaviour. This would put pharmacists on the forefront

of patient care, but at the same time provide a myriad of

opportunities to inadvertently violate confidentiality in

opinion

46 INTERNATIONAL PHARMACY JOURNAL 47VOL 33, NO.2 - JULY 201546 INTERNATIONAL PHARMACY JOURNAL

Thanks to worldwide action to make real the concept of

pharmaceutical care, today pharmacists in most countries are

looking forward to an expansion of their professional roles.

In many healthcare systems, there is a growing realisation

that pharmacists have much to offer and moves are being

made to put into place the leadership, the retraining and the

resources required to help them fulfil their potential, for the

benefit of patients.

In the drive to “reprofessionalise” pharmacists, there has

been less action on creating an equally promising future for

the community-based pharmacy. According to the thinkers

behind the concept of pharmaceutical care, the pharmacist

of the future will be less involved in dispensing, so little

Technology-enabled patients need technology-enabled health hubs. Could this be the future role of community pharmacies?

By Darrin Baines, Professor in Health Economics, Coventry University, UK

Community pharmacies deserve a renaissance

we can now scan our own groceries. In relation to pharmacy,

this direction suggests that community pharmacy shelves

should be cleared of commercial goods, turning the premises

into a hub for technology-enabled patients. I suggest the

following five steps for creating an innovative model of a

technology-enabled pharmacy:

1. Refit the “front of house” as a technology-hub that allows

patients to connect with the pharmacy, local doctors, the

healthcare system, pharmaceutical companies, charities,

other patients and the like

2. Exploit the time that patients wait for their prescriptions

by connecting them to a technology-enabled task, such as

reporting on their medicines use, watching an interactive

educational programme, completing a questionnaire, or

being an expert-patient in a study

3. Network the pharmacy hub into the wider healthcare

community, including providers, patient groups and

private companies — and by doing so become the port of

first call for patients — and coordinate their care through

the pharmacy’s technology enabled network

4. Retrain pharmacists in healthcare technology not just

medicines optimisation

5. Educate and enable the public to become technology-

enabled pharmacy users

The notion of a technology-enabled pharmacy must prove

itself in practice. However, the argument is clear: although

individual pharmacists are focusing on new roles for the craft

of pharmacy, there is now an urgent need to match this focus

with a technology-enabled new lease of life — a renaissance

— for the community pharmacy.

REFERENCES

1. Baines D. Dispensing: it’s time to let go. Pharmaceutical

Journal 2015;294:113–14.

2. Baines D. Pharmacists as dispensers and formation of the

PPA. Prescriber 2014;25:33–4.

3. Baines D. Has pharmacy run out of time? Pharmaceutical

Journal 2008;281:21.

attention need be placed on rejuvenating community

pharmacy premises because their importance will diminish

as the profession focuses on patients and not dispensing.

They believe the future of profession lies with the pharmacist

not the pharmacy.1

The demand for new roles for pharmacists against a

background of relative disinterest in pharmacies as

professional spaces is ironic: without local pharmacies, the

profession of pharmacy might not have thrived over the past

200-plus years. If the pharmacy had not been such an

important part of the landscape in our cities and towns,

dispensing might have been performed in-house by doctors

or vast publicly funded dispensaries might have become

popular. In other words, there is a strong argument that

suggests pharmacists only exist as a profession because of

their pharmacies.2 Therefore, today’s pharmacists walk away

from their professional “homes” at their professional peril.

From the perspective of pharmacists who have spent many

years dispensing medicines, the idea that there is a

professional life beyond the pharmacy is appealing. However,

the concept that the profession can en masse exist outside its

historical place of work is an unproven ideal. Given current

demand, a proportion of the profession could work with

patients on a regular basis, reviewing their medicines. But,

there is a limit to the number of pharmacists that are needed

to work as “knowledge managers” outside their traditional

homes. Moreover, if money is released from dispensing to

fund medicines optimisation and other activities for patients,

healthcare commissioners may decide that doctors or nurses

should be employed (instead of pharmacists) to do this work.

Could it be easier to train a doctor or nurse in pharmacology

and related skills than to train pharmacists in diagnosis,

medicines and all the other things they need to know to work

with patients safely and effectively?

Technology is everythingIn any profession, the exploration of new roles must always

be welcome. However, I suggest that an equal effort should be

put into finding new roles for pharmacies. Throughout

history, pharmacies have evolved in response to customer

demands and changes in technology, from new drugs to the

introduction of computers. The pharmacy profession should

now ask how pharmacies should evolve. Just because the

outside of a pharmacy remains the same, it does not mean

that the inside must do so. Instead of walking away from the

community pharmacy, there should be immediate action on

how best to transform its space into a technology hub ready

for the future. I will not expand fully on the technological

future of pharmacy here, as I have considered that subject

elsewhere,3 but the following trends are clear:

• Consumers will become more technology-enabled

• Healthcare will be built around the technology-enabled

patient

• Medicines will move away from compounded powders

into technology-assisted interventions (for example,

the future patient will used mobile technology to assist

in coordinating, receiving and reporting on their

prescribed care)

As patients will need somewhere to go if their technology

needs updating, reprogramming or fixing, perhaps the

pharmacy should become the healthcare technology shop of

the future. Think of banking and the grocery industry.

Big banking and supermarket chains are reducing workforces

in their local outlets and using technology instead. We can

now do our own banking, without a member of counter staff;

Darrin Baines

“Without local pharmacies the profession of pharmacy might not have thrived over the past 200-plus years.”

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48 INTERNATIONAL PHARMACY JOURNAL 49VOL 33, NO.2 - JULY 201548 INTERNATIONAL PHARMACY JOURNAL

Another challenge the country has had to face was a serious

counterfeiting situation in 2006 in which several people died.

The incident had a marked effect on general awareness of the

problems caused by counterfeit medicines and in the

development of policies and more stringent professional

practices to ensure the integrity and safety of drugs. Dr

Quintero said that the episode had forced the Panamanian

health authorities to instigate greater controls on the entry of

raw materials and medicines into the country. A national

pharmacovigilance centre has also been created.

Medicines shortages and new medicinesThe pharmaceutical industry in Panama manufactures about

10% of the drugs that reach the domestic market. Among the

drugs that the country exports are antibiotics, generally

presented as powders for reconstitution. Dr Quintero added

that in the Colón Free Trade Zone (a large entity near the

Atlantic entrance to the Panama Canal dedicated to re-

exporting a wide variety of merchandise to Latin America and

the Caribbean) there is a facility for the secondary packaging

of products so that they comply with the requirements of

other markets in South America. Panama is suffering from

drug shortages. There are several reasons for this, Dr Quintero

said. The high degree of regulation in the country means that

some manufacturers prefer not to register their products.

Tests to confirm medicines’ identity and concentration are

Pro mundi beneficio: for the benefit of the world. Panama’s motto seems particularly apt currently because the country’s benefit to the world will increase next year when the project to double the capacity of its famous canal will be completed. With the country set to leap on to the world stage and its national pharmacy organisation celebrating 10 years of FIP membership, Graeme Smith finds out from the President of the Colegio Nacional de Farmacéuticos de Panama how Panamanian pharmacy is living up to its country’s motto.

PANAMAWhere pharmacy is on the rise

Pharmacists in Panama are perceived as “consultants of the

community, counsellors of the people, the professional who

has more time than a doctor to give you healthcare or

recommend a good therapy”, said Nereida Quintero, President

of the Colegio Nacional de Farmacéuticos de Panama.

However, Dr Quintero also acknowledged the reality of a

World Health Organization report which pointed out that

indigenous and rural populations have limited access to

health services.

“Panama has adopted international standards proposed by the WHO and FIP for good pharmacy practice.”

The country’s capital, Panama City, is home to almost half of

the country's population of 3.6 million people and Dr Quintero

said that the health profile of Panamanian people is

characterised by the effects of demographic and

epidemiological polarisation. Communicable diseases remain

prevalent, especially among rural and poor people, and

pharmacists have to be familiar with tropical diseases typical

of the region, such as Chagas disease.

But such diseases coexist with the increasingly visible

chronic-degenerative conditions seen in ageing urban

populations. Dr Quintero added that a trend towards

urbanisation is seeing an emergence of problems such as

obesity, alcoholism and drug abuse, and “high incidences of

non-communicable diseases have forced the pharmaceutical

profession towards training in complex therapeutic regimens.”

In addition, her country’s pharmacists, as major participants

in the healthcare team, need to be aware of processes

surrounding how the country deals with natural disasters,

such as earthquakes, landslides and floods (and the

associated water-borne diseases). According to the World

Bank, Panama ranks 14th among countries most exposed to

multiple hazards based on land area.

The WHO has also said that Panama’s health code, which

dates from 1947, needs to be reformed. Dr Quintero agreed.

But she said it was important not to undermine what had

already been achieved. In particular, she said, the drugs

market was extremely important and there were forces that

wanted to ignore the many established controls in that

market. “We must always remember that medicines are a

social good and that the practice of pharmacy has always

been and will always be aimed at protecting public health.”

Panama has a fast growing economy and its greater exposure

to the world on account of the canal expansion project means

that “we have to strengthen health and put greater emphasis

on drug controls and the practice of the profession,” she said.

expensive. And drugs in Panama are generally more expensive

than in the rest of the region. Added to this is a shortage of

the raw materials required to produce drugs.

(For the benefit of countries, like Panama, that have

experienced medicines shortages, FIP has produced a report of

its International Summit on Medicines Shortages, held in

Toronto, Canada, in June 2013. Available in English and Spanish,

the document contains suggested solutions and recommen-

dations that may help alleviate the associated problems.)

“Scientists are investigating some types of fungi found in the fur of the three-toed sloth as a source of new anti-cancer, anti-parasitic and anti-bacterial compounds.”

Yet Panama may also be the source of new medicines. Some

40% of the country is covered by jungle that contains some

flora and fauna species found nowhere else in the world, and

teams of scientists are now investigating some types of fungi

found in the fur of the three-toed sloth (Bradypus variegatus)

as a source of new anti-cancer, anti-parasitic and anti-

bacterial compounds. >>

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51VOL 33, NO.2 - JULY 201550 INTERNATIONAL PHARMACY JOURNAL

Researcher Sarah Higginbotham and colleagues from the

Smithsonian Tropical Research Institute based in Panama

have described how they used a culture-based approach to

examine fungal communities associated with the coarse,

outer hair of this sloth (PLoS One 2014; 9[1]: e84549). They

isolated fungi with bioactivity against: Trypanosoma cruzi,

the causal agent of Chagas disease; Plasmodium falciparum,

the causal agent of malaria; the human breast cancer cell line

MCF-7; and a range of Gram-negative and Gram-positive

human pathogenic bacteria. Could Panama find itself a cradle

of new drug discovery? Watch this space!

A decade of FIP membershipThe Colegio Nacional de Farmacéuticos de Panama was

created in 1963 to regulate the functioning of pharmaceutical

establishments. Now celebrating 10 years of FIP membership,

the Colegio has over 2,600 pharmacists registered with it,

of whom around 60% are active. It promotes scientific

advancement, cooperates with universities in the training of

pharmacists, sees that those exercising the pharmaceutical

profession do so within the law, promotes and defends the

honour of the profession, and upholds ethical standards.

The IPJ asked Dr Quintero why it was important for the

Colegio to be a member of FIP. “It is important because you

have more access to better information strategies for

national pharmaceutical services,” she said.

Panama has adopted international standards proposed by

the WHO and FIP for good pharmacy practice, and is working

towards improving pharmaceutical care with respect to

access to medicines, the quality of medicines and the

responsible use of drugs.

“FIP membership: More access to better information strategies for national pharmaceutical services.”

Another outcome of the Colegio’s FIP membership is that its

country’s universities that teach pharmacy have begun to

mark World Pharmacists Day with special training sessions

and radio broadcasts, among other activities. (This year’s

World Pharmacists Day, on 25 September, will have the theme

“Pharmacist: your partner in health”).

Pharmacy in Panama is “on the rise” with much domestic and

foreign investment in it, Dr Quintero said. “Belonging to an

international organisation that brings together all the

thinking from the pharmaceutical world provides a window

of opportunity for Panamanian pharmacists to participate in

the updating, promotion and enhancement of the profession

through their awareness of global pharmaceutical activities.”

ABOUT MIDDLE EAST RESPIRATORY SYNDROME

Nine things...

As the IPJ went to press, 26 countries had reported cases of Middle East respiratory syndrome

(MERS). In the current outbreak Korea had 181 confirmed cases with 33 deaths. A suspected

MERS sufferer in Thailand had been declared disease-free and a case had been confirmed in

China. Here are nine things you should know about MERS.

PHARMACY AND HEALTH IN PANAMA

Panama’s oldest pharmacy school, at University of Panama

School of Pharmacy, was founded in 1920 and has produced

more than 2,000 graduates.

Currently around 916 pharmacists work for the state; the

remainder work on boards, non-governmental organisations

or for private companies.

Since January 2001, a qualified pharmacist must be present in

any pharmaceutical establishment.

Medical doctors may not own a pharmacy in Panama but

pharmacies may be owned by anyone else as long as a

registered pharmacist is employed.

The health of most of the Panamanian population is covered

by the public sector through the Ministry of Health and

funded through a system of social security. Those who can

afford to pay use services provided by the private sector.

“Pharmacists in Panama are perceived as consultants of the community, counsellors of the people.”

She concluded: “Panama has become a centre of world trade

and has good things and new technologies. We also have new

threats and we must learn to anticipate advances in our field

to ensure the health of our nationals and visitors. . . . We learn

from the experiences of other countries and we can share our

knowledge and experience and so contribute to the world.”

ACKNOWLEDGEMENT

With thanks to Gonçalo Sousa Pinto and Margareth Charry for

translations.

Nereida Quintero

1.Middle East respiratory syndrome (MERS) is a viral

respiratory illness caused by a novel coronavirus that

was first reported in Saudi Arabia in 2012. The source is

unknown, but it is thought the disease may have

arisen through human contact with camels.

5.Since 2013, cases of MERS have

arisen across the world. Most cases

outside the Arabian peninsula have

been associated with contact with

infected individuals who have

travelled from that area. Countries

affected outside Arabia include

China, France, Germany, Thailand,

the UK and the USA. A cluster of

cases in South Korea, where the

original case does not appear to

have had any contact with camels

or the Arabian peninsula, has been

concerning.

6.A World Health Organization

Emergency Committee met in June to

discuss the situation in Korea.

It concluded that the country’s lack of

awareness about MERS and suboptimal

infection prevention and control

measures in its hospital had

contributed to the outbreak. The

committee has issued advice to

affected countries.

7.There is no vaccine against

MERS, although the possibility of

developing one is being explored.

Advice on prevention is the same as

for other respiratory diseases and

includes rigorous hand-washing, use

and disposal of tissues, avoiding

personal contact with sick people,

and cleaning and disinfection of

surfaces and objects like door

handles, for instance.

2.Symptoms are similar to those of other respiratory illnesses and

include cough, shortness of breath and fever. Gastrointestinal

symptoms have also been reported. More severe complications can

develop, such as pneumonia and kidney failure. However some

infected people have displayed no symptoms at all.

8.Currently there is no

recommendation that anyone

need change their travel plans on

account of MERS.

9.The WHO recently issued a statement

on best practices for naming new

human infectious diseases (such as

MERS). It recommends against using

geographical locations in names

because this is unscientific and has the

potential seriously to affect people’s

lives and livelihoods.

4.Presence of the disease is confirmed by

laboratory testing. High quality supportive

care is the keystone of patient management.

Convalescent plasma, interferon and lopinavir

may be considered for specific treatment

(Public Health England). The WHO has interim

guidance on the clinical management of severe

acute respiratory infections when novel

coronavirus is suspected.

3.MERS kills three to four out of every 10

people infected. However most of those who

die usually have underlying medical

conditions, such as diabetes or cancer.

Healthcare workers in contact with MERS

patients are particularly at risk of infection.

For others, the risk is generally low since there

is no indication of sustained transmission

from person to person in the community.