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

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

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)

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

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 ?

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

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

“ ” 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

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

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.

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

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.

Two essential principles Measures have to be both: Effective Sustainable

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)

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) (8206409270)" 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.)

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.

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)

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)

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)

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 ?

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