1. Information about medicines – what does a patient really need?
Marco Greco, Ph.d.
EPF President
PRAC patient representative
Tallinn, 21 April 2016
Estonian Medicines Agency

2. Overview In general How patients perceive risk minimisation
How patient input contributes to good pharmacovigilance practice
Comments on available tools for risk minimisation
Health Literacy
Conclusions

3. Patients’ information needs
Information has to be “accurate, relevant, short, legible and understandable”
Offered verbally and in written form
Covers the basics, including:
diagnosis and the reasons for the prescribed treatment
what it is for (what it is supposed to do)
how likely it is that it will be effective
correct dosage and how to take it
possible interactions
does the course need to be completed
why is it important to adhere – especially if impact not immediate/noticeable
consequences of sub-optimal adherence
what adverse reactions can be expected and how to manage these
will further courses be needed
Why is Health Literacy low?
Health information is often inaccessible because the literacy demands of health systems and the literacy skills of average adults are mismatched:
Navigating increasingly complex health care systems is a major challenge for patients and their families.
Patients face multiple literacy requirements and increasingly difficult decisions
Health information materials are often poorly written and literacy demands are excessive
Health providers’ written and spoken communication has insufficient clarity and quality
What does low health literacy mean? (see slide)
EPF paper on adherence/concordance (2015)

4. In general Information about medicines must be: AVAILABLE
RELIABLE AND TRUSTABLE
UNDERSTANDABLE
WRITTEN HAVING PATIENTS IN MIND

5. AVAILABLE Patients requirements about information are simple:
Easy access
Easy to be found
Potential problem: nowadays an average citizen may potentially have access to infinte information through the web…how to choose ?

6. RELIABLE AND TRUSTABLE
It is essential to have access to the right information at the right moment
Information becomes “the right information” when is scientifically based
Agencies and patients organizations can make the difference
Potential problem: unnfortunately “junk science” is very often much easier to be understood than real science

7. This leads to a fundamental concept: health literacy
UNDERSTANDABLE and PATIENTS’ORIENTED
The best information is useless if written in a language that is not (fully) understandable
This leads to a fundamental concept: health literacy

8. “ ” Health Literacy More than info: skills and competences
People’s knowledge, motivation and competencies to access, understand, appraise, and apply health information in order to make judgments and take decisions in everyday life concerning healthcare, disease prevention and health promotion to maintain or improve quality of life during the life course.
(Sorensen and Brand, 2013) ”
More than info: skills and competences
Not (only) an individual problem
Institutions – such as regulators – need to address different levels of health literacy in their communication (WHO, 2013)
“Even highly educated individuals may find health systems too complicated to understand, especially when a health condition makes them more vulnerable.” (WHO, 2013)
Although there are different definitions of health literacy, common elements include skills, understanding, access, use of, information, knowledge, empowerment, decision-making.
1 - HL is different from “patient information”: it is the capacity to understand and use the information
2 - Need for a large range of competencies: from basic health knowledge to advocacy and activism
basic health knowledge, reading, comprehending and evaluating health information, application of health preventing, promoting and self-care behaviours, verbal communication with health professionals, health decision-making, health advocacy and activism
3 - The responsibility does not only lie with the patient: the healthcare system must be readable and easy to navigate in

9. OUTCOMES
The mentioned principles are basilar in different area of patients information
Please consider how relevant health literacy is in PhV and for minimizing risks

10. How do patients perceive risk ?
Full safety profile of a medicine can only be known after it has been used by many patients
Awareness of patients (and the public) that safety profile especially of newer medicines can change as more evidence is generated ?
Influence on adherence
Seek for “reliable” information
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.

11. Patient input contributes to good PhV
Patients as the end-users of products are in a unique position
Patient reports add value to pharmacovigilance:
Quality equal to HCP report
Patients can specify the circumstances
They often give much more detailed and nuanced descriptions
Patients report some different types of reactions
Often report earlier
Perceive impact and severity of reactions differently
Patients at EMA: PRAC, ad-hoc activities*
Review of information for the public: 110 package leaflets, 48 EPAR summaries, 39 safety communications
33 patients participated in SAG /ad-hoc meetings
28 patients participated in scientific advice / protocol assistance
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.
* 2013 data

12. Available tools for risk minimisation
For all products:
Packaging
Labelling
Patient information leaflet
For specific products:
Additional measures
E.g., specific educational tools, monitoring, patient selection
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.

13. Two essential principles
Measures have to be both:
Effective
Sustainable

14. Packaging and labelling
Many patients experience difficulties with the packaging and/or labelling of their medicine*, including:
Too similar design
Information written too small
Information is difficult to comprehend
Too much information
Difficult names / too-similar names
Dose/strength not clearly differentiated
Visually bad design
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.
“Doctors prescribe different dosages and usages of medicine; the instructions can conflict with information on the packaging of PIL.”
* EPF survey (2009)

15. Patient information leaflet (PIL)
Despite incremental improvements and work (EMA), PIL still not regarded as patient-friendly
Tension between legal & information aspects
UK study (2012): 1/3 older adults had difficulties understanding instructions on a packet of aspirin
Poorer understanding was associated with higher mortality
2013: EC study on the shortcomings of the PIL: still not published
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.
"Drug Package Insert (FDA 115) ( )" by The U.S. Food and Drug Administration
(Bostock S and Steptoe A (2012) “Association between low functional health literacy and mortality in older adults: longitudinal cohort study.” BMJ 2012;344: e1602.)

16. Many Europeans have limited HL
European health literacy survey (HLS-EU, 2012) showed:
Average 47% of respondents with limited HL across 8 countries
Health Literacy is a problem for the general population at large, not just for particular “vulnerable” groups
* Austria, Bulgaria, Germany, Greece, Ireland, Netherlands, Poland and Spain
Recent research undertaken as part of the European Health Literacy Study has shown that limited health literacy is a challenge in several countries in Europe.
On average, 47% of respondents have limited health literacy across 8 countries (Austria, Bulgaria, Germany, Greece, Ireland, the Netherlands, Poland and Spain).
41% for health literacy related to healthcare
43% for health literacy related to disease prevention
51% for health literacy related to health promotion
The levels differ considerably between the countries surveyed
 This shows that health literacy is a problem not only for particular vulnerable groups, but also for the general population and society at large.

17. The Impact of Health Literacy
Low health literacy:
Reduced use of preventive services and management of chronic conditions
Higher mortality
Leads to medication errors, misdiagnosis due to poor communication between providers and patients
Low rates of treatment adherence
Hospital readmissions
And the reverse is also true.
Cost of low health literacy: 3-5 % of total healthcare costs at health system level
(“The Costs of limited health literacy: a systematic review”, Eichler K, Wieser S, Bruegger U, Int J Public Health, 2009; 54(5):313-24)
Why is Health Literacy low?
Health information is often inaccessible because the literacy demands of health systems and the literacy skills of average adults are mismatched:
Navigating increasingly complex health care systems is a major challenge for patients and their families.
Patients face multiple literacy requirements and increasingly difficult decisions
Health information materials are often poorly written and literacy demands are excessive
Health providers’ written and spoken communication has insufficient clarity and quality
What does low health literacy mean? (see slide)

18. Patient organisations can help
Divergent levels of interest – but some PO advocates very interested
Low level of PO engagement in Member States (EPF, 2013)
Need for simple information about “basics” – including roles of EMA vs MS authorities
Opportunity to raise awareness about medicines safety
Why is Health Literacy low?
Health information is often inaccessible because the literacy demands of health systems and the literacy skills of average adults are mismatched:
Navigating increasingly complex health care systems is a major challenge for patients and their families.
Patients face multiple literacy requirements and increasingly difficult decisions
Health information materials are often poorly written and literacy demands are excessive
Health providers’ written and spoken communication has insufficient clarity and quality
What does low health literacy mean? (see slide)

19. Patient organisations can help
EU level disease-specific organisations
15 national patients’ coalitions
Why is Health Literacy low?
Health information is often inaccessible because the literacy demands of health systems and the literacy skills of average adults are mismatched:
Navigating increasingly complex health care systems is a major challenge for patients and their families.
Patients face multiple literacy requirements and increasingly difficult decisions
Health information materials are often poorly written and literacy demands are excessive
Health providers’ written and spoken communication has insufficient clarity and quality
What does low health literacy mean? (see slide)

20. Conclusions
Is the patients’ role sufficiently used in risk management?
By the EMA? By Member States authorities? By industry?
Health literacy presents a systems’ challenge
Patients’ organisations can optimise reach-out …
but face resource-problems
and require “easy-use” reference materials they can customise
Patients need to be involved from the start in developing any risk-management plan  can we new and better solutions together that meet patients’ needs ?

21. Conclusions Often underestimated Underused
Patients Organizations skills:
Often underestimated
Underused
To be empowered => enourmous potential