1. Patient Perspectives in Accessing Health Education, Skilled Treatment, and Safe Options for Incontinence: Meeting and Overcoming the Challenges and Obstacles ICS Workshop 52 30 September 2009 San Francisco

2. Goals of the Workshop 1.To identify issues from the patients’ perspectives for establishing common goals 2.To speak to the needs of people in all nations, both developed and emergent, large and small, recognizing not just the clinical or technology obstacles, but the political, economic, and cultural barriers as well 3.To engage the audience in discussion and exchange of ideas

3. Speaker: Tomasz Michalek The economic disparities to overcome because of difference among countries in coverage and reimbursement systems for treatment and care (aka the “financing” of healthcare) TOPIC I

4. Speaker: Lynne van Poelgeest The call for protection and optimization of patient safety, rights, and dignity - How lives are impacted - How misguided policies can jeopardize patient safety, rights, dignity, and quality of life Topic II

5. Speaker: Diaa Essam El-Din Rizk, MD Cultural and other social barriers preventing ease of access by patients within their own healthcare system or equality across borders Topic III

6. SELECTED COUNTRIES  Italy (EU member – Southern Europe)  The Netherlands (EU member – Western Europe)  Poland (new EU member – Eastern Europe)  Sweden (EU member – Northern Europe)  USA

7. DIFFERENCES  Level of GNP (per capita, per health care)  Policy (left, right, liberal, socialist, etc.)  Priorities (treatment, preventive treatment, prophylaxis)  Lobbies (pharma sector, medical devices, medical society)

8. SURGERY WITH TAPE USAGE Italy The NetherlandsPolandSwedenUSA Medical specialists authorised to direct patient for surgery treatment NO REIMBURSEMENT ??Gynaecologist, urologist Gynaecologist, urologist, other specialities, urotherapist, GP Gynaecologist, urologist, urogynecologist, physican, Medical specialists authorised to make surgery with tape usage NO REIMBURSEMENT ??Gynaecologist, urologist Gynaecologist, urologist, urogynecologist How often can reimbursement surgery with tape use can be done NO REIMBURSEMENT ??NO LIMIT Patient co-payment NO REIMBURSEMENT ??0% 20% OthersNO REIMBURSEMENT ??NOWaiting time might be long NO

9. PHARMACOLOGICAL TREATMENT - OAB REIMBURSEMENT Italy The Netherlands PolandSwedenUSA DrugsNO REIMBURSEMENT ???NO REIMBURSEMENT Tolterodine, Solifenacin, Fesoterodin, Darifenacin, Oxybutynin Trospium, Chloride, Tolterodine, Solifenacin, Fesoterodin, Darifenacin, Oxybutynin Patient co-payment NO REIMBURSEMENT ???NO REIMBURSEMENT Patient never have to pay more than 180 Euro for a year´s consumption of drugs Drug reimbursement varies between private and public insurance programs Prescribed byNO REIMBURSEMENT ???NO REIMBURSEMENT PhysicianPhysician, physicians’ assistant, nurse practictioners OthersNO REIMBURSEMENT ???NO REIMBURSEMENT NO

10. OTHER TREATMENTS - REIMBURSEMENT PELVIC FLOOR MUSCLE TRAINING Sweden, USA BLADDER TRAINING Sweden BIOFEEDBACK Sweden, USA

11. OTHER TREATMENTS - REIMBURSEMENT ELECTROSTIMULATION Sweden ACUPUNCTURE Sweden

12. ABSORPTION DEVICES - REIMBURSEMENT

13. Italy The NetherlandsPolandSwedenUSA Medical indications for conceding of reimbursement Urinary Incontinence Malignant diseases, mental retardation, certain types of dementia, nervous system's diseases, malformations Urinary Incontinence Patient co-payment 0% 30%0% Volume limit (pcs/month) 12015060NO LIMITS300 Types of absorption products Female pads, male pads, pants and underpads Price limit (EUR/month) NO LIMIT 17,5 EUR or 20,5 EUR (depending on medical indications) NO LIMITIn case of nursing home care and hospitalization this based on diagnosis. In case of home care this varies from state to state and may be as few as one case of product per week.

14. ABSORPTION DEVICES - REIMBURSEMENT Italy The Netherlands PolandSwedenUSA Classification (based on the level of incontinence) NOYESNOVary from county to county NO Prescribed byUrologist, gyneacologist, Doctors via a signed mandate Urologist, neurologist, surgeon, GP Urologist, gyneacologist, specislist nurses, urotherapist, GP In the case of institutional care (hospitals and nursing homes) the nursing protocol determines this DistributionMedical shops, chemistry, ALS Chemistry, via mail order company Medical shops, chemistry Delivered to patient’s home Delivered to patient’s home by the state agency

15. REIMBURSEMENT - CONCLUSIONS  Europe has one single economic regulations policy but no health policy  Each country has its own priorities  Restricted access to various methods of UI therapy (in most of the countries)  Limited access to information  Lack of international standards

16. REIMBURSEMENT - QUESTIONS  Do we need a golden standard for reimbursement?  Who should take responsibility to educate patients and medical society?  What about poor countries?

17. Discussion with Mr. Michalek What should the role be of the World Health Organization (or other similar group) with respect to standards for coverage of costs and patient access to technology and options? What should be the voice of patient advocacy groups like WFIP? Of professional societies such as ICS?

18. Obstacles Insufficient continence awareness worldwide Continence issues still TABOO Insufficient continence awareness worldwide Continence issues still TABOO Lack of access to treatment, quality information and support Lack of access to treatment, quality information and support Consequences Consequences – Negative effect on quality of life Action needed Action needed – New political priorities – Patiënts’ manifesto 16/07/09

19. Challenges (1)‏ Pharmaceutical industry Pharmaceutical industry – Safe innovative and accessible medicines – EU losing ground on innovation – Inequality of accessible information on medicines and treatment – eg. Reimbursement Ways of addressing problem: Ways of addressing problem: – Package (4 key goals) ‏ 16/07/09

20. Patient information: Key goals Recommendation: generate ‘safe’ information Recommendation: generate ‘safe’ information Exchange information for further collaboration – cross-border healthcare Exchange information for further collaboration – cross-border healthcare Ethical requirements: cultural differences Ethical requirements: cultural differences Raise visibility of existing (EU) partnerships Raise visibility of existing (EU) partnerships 16/07/09

21. Challenges (2)‏ Specific information on Specific information on – Diseases and treatment Keywords Keywords – Objective and up to date – Patient oriented – Evidence based – Reliable, accessible, relevant – Consistency 16/07/09

22. Political response (EU) Political response (EU) – Provision of information to patients – Accurate, substantiated by evidence, up-to- date and objective information on medicines – Need for reliable information on internet Patient information Patient information – Quality information – Increased active role in pharmaceutical area – More health conscious, increased awareness 16/07/09

23. Patient safety and information: EU actions Recommendations on access + dissemination Recommendations on access + dissemination – Review existing tools, awareness campaigns, promotion health education, promotion Information Communication Technology Effective communication format Effective communication format Identify and promote best practices Identify and promote best practices Further develop (EMEA) database on medicinal products authorised in the EU Further develop (EMEA) database on medicinal products authorised in the EU Evaluation Evaluation – review 2 years – co-operation and share experiences at EU level 16/07/09

24. Patient information: what is at stake? Multiple information Multiple information – Different providers – Diverging objectives – Quality and access Focus Focus – Disease and treatment information – Dissemination electronic and non-electronic information – Availability of ‘safe’ quality information 16/07/09

25. For stakeholders Map patient needs Map patient needs Promote best practices in healthcare settings Promote best practices in healthcare settings Promote multidisciplinary approaches among health professionals Promote multidisciplinary approaches among health professionals 16/07/09

26. Some general conclusions (1)‏ Challenge: to invest in high quality and accessible information: treatments and medicines Challenge: to invest in high quality and accessible information: treatments and medicines Recognition of role of national authorities, healthcare professionals and competent authorities Recognition of role of national authorities, healthcare professionals and competent authorities Benefit of mobilising knowledge and resources Benefit of mobilising knowledge and resources Consideration and adoption of national initiatives to promote cross-border healthcare in relation to continence issues Consideration and adoption of national initiatives to promote cross-border healthcare in relation to continence issues European information library European information library 16/07/09

27. Some general conclusions (2)‏ Development of coherent and unified strategy Development of coherent and unified strategy New approach stakeholders New approach stakeholders 16/07/09

28. Access and dissemination For EU Member States For EU Member States – Review existing tools, continence awareness campaigns, promotion health education and information communication technology For the Commission For the Commission – Support promotion, capacity building, exchange information For stakeholders For stakeholders – Education needs, promotion best practices and multidisciplinairy approach professionals 16/07/09

29. Core quality principles – Objective and up to date – Patient oriented – Evidence based – Reliable, accessible, relevant – Consistent 16/07/09

30. WFIP Charter of Patients ’ Rights 16/07/09 1. Receive treatment 2. Access to services without discrimination 3. Given a correct diagnosis 4. Obtain information 5. Given options 6. Participation in the decision process 7. Access to therapy 8. Access to public toilets 9. Provided check-ups and updates 10. Access to multidisciplinary care

31. Discussion with Ms. van Poelgeest-Pomfret How is the internet best used for issuing cross- border, timely, up-to-date public health educational content? Should ICS contribute to the EMEA database? Who should be the final authority on “evidence-based” choices?

32. Introducing Diaa E. E. Rizk, MSc, FRCOG, FRCS, MD Professor of Obstetrics & Gynaecology, Ain Shams University, Egypt U.K. postgraduate studies and fellowship >150 research articles and published abstracts Medical advisor to the WFIP Steering Committee

33. Introduction Pelvic floor health in women must be addressed from a broader outlook that falls in the health status/roles of women. The health status in any one society cannot be understood apart from the cultural factors that determine the individuals’ attitudes towards health matters and their behavior in seeking health care.

34. The Middle East is Peculiar Male-dominated culture- patriarchy- represents a strong factor in shaping the health behavior of women. Attitudes towards pregnancy, childbirth and women’s health are rooted in the broader milieu of culture. Formal health services may be bypassed and under- utilized, even when available.

35. The Middle East Paradox A pro-natal society with an average total fertility rate >4% and a female life expectancy at birth of >70 years. Urinary and fecal incontinence rates of 20.3 and 11.3 % were reported from the UAE. Incontinent women rarely seek medical help because of social traditions, cultural beliefs and inadequate public knowledge.

36. I- Cultural Beliefs It is common that incontinent women continue to live silently because of the embarrassment that a woman may feel in admitting incontinence even when she is aware that it may be related to childbirth.

37. II- Knowledge Barrier Urinary incontinence is perceived by the majority of women as a neurological or senile disorder rather than a gynecological condition caused by childbirth or menopause. Women’s knowledge level of the causes, diagnosis and available treatment options for urinary incontinence has a positive impact on health-care seeking behavior.

38. III- Religion The life style and social norms of women might be different and are principally dictated by their religious faith - Islam in the vast majority. Praying is a daily and ritually-prescribed activity in Moslem women that involves kneeling down during praying and requires absolution after urination or defecation for cleansing.

39. III- Religion Interference with praying ALONE can severely impair the quality of life of incontinent Middle Eastern Moslem women and highlights the cross-cultural and ethnic differences in women’s attitudes toward incontinence.

40. IV- Socialization of Health Role The intimate and sensitive nature of gynecologic diseases in a strict and conservative socio-religious environment significantly influences a preference for same gender physician. Most women thus feel more comfortable to consult a female gynecologist because of embarrassment during pelvic examination and reproductive counselling, religious beliefs and socio-cultural values.

41. V- Perceptions of Childbirth Popular beliefs consider pregnancy and childbirth as natural episodes in the female’s life. Cesarean delivery does not represent a socially accepted option based on this traditional perceptions. This observation has an important bearing on counseling of women about the benefit/risk ratio of elective cesarean delivery.

42. VI- External barriers to care Limited access to and/or inadequate health care facilities. Inconvenience of consultation because incontinence clinics are not clientele-friendly. Low expectations from health care. Fear of medical encounter. Incurred service cost.

43. Economic burden of UI Cost is associated with UI whether the woman is treated or NOT. If a woman is afraid to seek medical attention, then diagnostic and treatment costs will be zero. Costs are also incurred when UI is untreated. These include routine care costs (disposable garments and laundry), consequence costs (falls and hospital admissions), indirect costs (lost productivity) and intangible costs (pain, stress and suffering).

45. Recommendations Expert medical advice to women in the Middle East is necessary to correct the myth about incontinence being normal or untreatable. Education of more women and health professionals is required in the region about the process of micturition and defecation.

46. Recommendations A constructive way is needed to disseminate information to Middle Eastern women about incontinence because of its adverse effect on the quality of life. National health policies should be formulated to improve delivery of incontinence care and accessibility, cost and public image of incontinence services.

47. Audience Input to Discussion Further Suggestions/Recommendations to help these women? What are the best avenues for introducing public health education and objective information to improve quality of life of those with symptoms, while maintaining cultural sensitivity?

48. Take Away Messages 1.There is the need to build a consensus and work for common goals. This is best accomplished by first sharing experiences of everyday people. 2. Cross border healthcare must happen globally, not just in Europe. 3. We must recognize and accommodate differences among nations and cultures.

49. Take Away Messages (cont’d) 4.Interventions and solutions may differ among countries, but goals can be common and universal. 5.Patient advocacy groups should adopt a common charter of patients’ rights as guiding principles.