Barriers and facilitators to seniors - NCBI

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CONCEPTION Cette etude a fait appel 'a la methode qualitative des groupes de discussion. CONTEXTE ...... C) SmithKline Beecham Pharma Inc., 1996. |nA.
Barriers and facilitators to seniors' independence Perceptions of seniors, caregivers, and health care providers Judiffi Belle Brown, PHD Carol L. McWilliam, MSCN, EDD Verna Mai, MD, FRCPC OBJECTIVE To identify barriers and facilitators to independence as perceived by seniors with chronic health problems and their caregivers. In particular, researchers sought insights into seniors' experience of medical, home-based, and public health services. DESIGN This study used the qualitative method of focus groups. SETTING London, Ont, and surrounding area. PARTICIPANTS Seniors with chronic health problems and informal and formal caregivers were purposefully selected to participate. METHOD Seven focus groups composed of seniors, informal caregivers, and health care providers representing each of the three primary care areas (medical, home-based, and public health) explored the barriers and facilitators to seniors' independence. MAIN FINDINGS Four main themes characterized the barriers and facilitators to seniors' independence: attitudes and attributes, service accessibility, communication and coordination, and continuity of care. CONCLUSIONS Knowledge of barriers and facilitators to seniors' independence in the context of the health care system provides insight into how seniors can be empowered to remain independent. Health care providers need to communicate better, to foster more positive attitudes toward aging, and to participate in refining service access, coordination of services, and continuity of care. OBJECTIF A partir des perceptions de personnes agees atteintes de problemes chroniques de sante et de leurs soignants, identifier les obstacles et les facteurs qui favorisent l'autonomie. Les chercheurs visaient particulierement 'a mieux comprendre le vecu des personnes agees au niveau des services medicaux, des services a domicile et des services de sante publique. CONCEPTION Cette etude a fait appel 'a la methode qualitative des groupes de discussion. CONTEXTE London, Ontario, et les environs. PARTICIPANTS Selection deliberee de personnes agees atteintes de problemes chroniques et de soignants formels et informels. METHODE Sept groupes de discussion composes de personnes agees, de soignants informels et de dispensateurs de soins representant chacun des trois secteurs des soins de premiere ligne (soins medicaux, soins 'a domicile et sante publique) ont explore les obstacles et les facteurs qui favorisent l'autonomie des aines. PRINCIPAUX RESULTATS Quatre themes principaux ont caracterise les obstacles et les facteurs qui favorisent l'autonomie des personnes agees : attitudes et attributs, accessibilite aux services, communication et coordination, et continuite des soins. CONCLUSIONS Une meilleure connaissance des obstacles et des facteurs qui favorisent l'autonomie des aines dans le contexte du systeme de soins de sante nous eclaire sur la fa,on d'aider les personnes agees a demeurer autonomes. Les dispensateurs de soins doivent ameliorer la communication, entretenir des attitudes plus positives 'a l'egard du vieillissement et participer a ameliorer l'acces et la coordination des services ainsi que l'amelioration de la qualite des soins. Can Fam Physician 1997;43:469475. -*-

FOR PRESCRIBING INFORMATION SEE PAGE 557

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ostering independence in seniors with chronic health problems presents particular challenges for those involved in community-based care.1 Personal attributes rooted in the illness and impairment associated with old age often lead professionals to assume that seniors are dependent.2-10 Failure to recognize the concept of dependenceindependence as a relationship between an individual and caregivers" can create dependence.12"3 Functional disabilities and illnesses in old age are often managed as acute medical problems rather than as persistent life challenges calling for a continuous self-managed program that promotes health and prevents disease. Older people easily become "patients," dependent upon continuous professional management of care, a relationship that lowers their self-esteem and confidence. Ageism2 and asymmetrical power relations between seniors and their professional caregivers5""7 often contribute to seriously threatened autonomy.3'5 Physicians, particularly family physicians, can play an important role in promoting independence among seniors receiving care for chronic problems. This study aimed to identify barriers and facilitators to independence as experienced by seniors with chronic health problems as they interacted with medical, home-based, and public health services.

Focus groups We used the qualitative method of focus groups,1&20 which has served effectively to elicit information in primary care settings.21-25 Focus groups in this study examined barriers and facilitators to seniors' independence from the perspective of seniors with chronic health problems, of informal caregivers, and of professional caregivers. Their experience with three major components of the primary care system (medical care, home-based care, and public health programs) was investigated. This study received ethics approval from the University of Western Ontario's Review Board for Health Sciences Research Involving Human Subjects. ...........*.........................* Dr Brown is an Assistant Professor and Dr McWilliam is an Associate Professor at the Centre for Studies in Family Medicine, Thames Valley Family Practice Research Unit, at the University of Western Ontario in London, Ont. Dr Mai is an Assistant Professor in the Department of Epidemiology and Biostatistics at the University of Western Ontario and is Associate Medical Officer ofHealth and Director of the Education and Research Division of the Middlesex-London Health Unit in London. ...........................

Participants were recruited from lists provided by the Middlesex-London Health Unit, the Oxford County Health Unit, and from selected family physicians in London. These sources were purposefully chosen to provide a sample with direct experience with the three health care components in both rural and urban settings.20 Each focus group recruited 10 to 15 participants to allow for drop-outs and cancellations. Seven focus groups, two comprising seniors, two representing informal caregivers, and one each of medical, public health, and home-care professionals, were conducted at the Thames Valley Family Practice Research Unit. The seniors were selected from those who had used the primary care services of interest. They were also selected to represent as broad an age range as possible. Of the 43 seniors recruited, 29 agreed. Refusal was primarily due to illness. Total attendance at the two focus groups of seniors was 24; the 16 women and eight men lived either with spouses (14) or alone (10). The average age of participants was 76 years (range 62 to 86 years). About 80% had one or more chronic health problems. Each of the two groups of informal caregivers was selected to represent a variety of caregiving relationships (ie, spouse, child, sibling) and a variety of caregiving commitments (ie, live-in, daily visits). Of the 23 caregivers approached, 17 agreed. Refusal was primarily due to their own illness or that of the senior for whom they cared. The final number of participants was 14 (eight women, six men) with an average age of 67 years (range 44 to 79). Despite attempts to have various caregivers represented, most (11) were spouses. Each of the three groups of professional caregivers comprised professionals from one of the three primary care components. From recruitment lists, eight of nine public health professionals, nine of 14 home-based professionals (nurses, occupational therapists, physiotherapists, social workers, homemakers), and 10 of 36 medical care providers (family practice nurses, family physicians, geriatricians) agreed to participate. The main reason for refusal to participate was prior commitments. Group moderators were highly involved,'18"9 guiding discussion with a semistructured framework of open-ended questions that had been pilot tested with seniors and informal and formal caregivers (Table 1). The investigator experienced in focus group methodology trained the other investigators in the process. Investigators then rotated the responsibility for moderating the groups, with two

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moderators always present at each focus group. After each group, moderators compared field notes and discussed the group process. Each approximately 2-hour focus group was audiotaped and transcribed verbatim. Initially, two investigators independently used basic content analysis techniques to identify the key words, phrases, and concepts222' emerging in each group. Transcripts were analyzed concurrently with data collection to promote saturation of themes. Cross-group analysis of similarities, contrasts, and potential connections among key words, phrases, and concepts within and among groups permitted reduction of the data and refinement of themes pertinent to all groups. Further analysis with all three investigators then led to clarification, confirmation, and consensus regarding themes. Phrases that most accurately illustrated the themes were identified. Peer review, using an advisory group comprised of seniors and informal and professional caregivers helped establish the credibility of the findings.

barriers: "But it's the fear of the unknown. Fear of the unknown is really something." Past experiences also affected seniors' readiness to trust. "[They] may have come from very persecuted backgrounds or concentration camps where this whole trust thing is part of it.... They also see the medical community as representing power and suppression, and so they don't utilize the services." Fear of declining health and the consequences of that was an additional barrier that often affected seniors. It led to interactions with professionals that Table 1. Focus group discussion guide FOR SENIORS

1. How does the health care system affect the independence of seniors with chronic health problems (eg, any gradation from high blood pressure to arthritis to more serious conditions of the heart)? 2. What things about the health care system have helped you to maintain independence, despite your health problems? 3. What things about the health care system have made it hard for you to maintain your independence, despite your health problems?

FINDINGS Four major themes characterized facilitators and barriers to seniors' independence: attitudes and attributes, service accessibility, communication and coordination, and continuity of care.

4. What things about people who provide you with care (eg, doctor, public health or home care or office nurse, homemaker, or relative) have helped you to maintain independence despite your health problems? .............................................................................................................

Attitudes and attributes. Participants identified attitudes and attributes as major contributors to seniors' independence, both as facilitators and barriers. Seniors spoke of how positive attitudes such as "having a bright outlook," "accepting one's limitations," and "caring for others" coupled with positive attributes such as "resourcefulness," "being active and involved," and "thinking ahead" promoted independence. As one senior observed, "As long as we can maintain our independence, that's fine and it's sheer determination. You can't give in." Caregivers and health care providers reinforced this view, describing characteristics such as "stubbornness," "willpower," "determination," and "a sense of humour": "Stubbornness. That's about the best word to use. The more you tell them they can't, the more they say, 'I can."' However, many of the seniors' attitudes and attributes, such as depression, loneliness, rigidity, lack of confidence, pride, boredom, loss of control, loss of hope, and their own age, served as barriers to independence. Past life events and fears and anxieties of the present and future further exacerbated these

5. What things about the people who provide you with care make it hard for you to maintain your independence, despite your health problems? .............................................................................................................

6. What part do you play in maintaining your own independence, despite your health problems?

FOR (AREGIVERS AND HEALTH CARE PROFESSIONAlS .............................................................................................................

1. How does the health care system affect the independence of seniors with chronic health problems (eg, any gradation from high blood pressure to arthritis to more serious conditions? .............................................................................................................

2. What things about the health care system have helped you to promote seniors' independence, despite their health problems? .............................................................................................................

3. What things about the health care system have made it hard for you to maintain seniors' independence, despite their health problems? .............................................................................................................

4. What things about seniors with chronic conditions have helped them to maintain their independence, despite their health problems? .............................................................................................................

5. What things about seniors with chronic conditions have made it hard for them to maintain their independence,

despite their health problems? .............................................................................................................

6. What part do you play in maintaining seniors' independence, despite their health problems?

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frequently were characterized by reluctance to seek help, lack of assertiveness, decline in communication, and deference to physicians. As one public health nurse observed, "Fear of acknowledging their declining health because of what that will mean in terms of where they will live and how they will live. Afraid to say that to their physician, to their family, or even to us sometimes." Many of these interconnected attitudes and attributes were accentuated by physical and cognitive limitations. Frustration with physical limitations often culminated in depression, limiting seniors' problemsolving abilities and coping skills and further diminishing independence. "My father, he is 85 and mentally he is fine, but he has lost his legs so he is in a wheelchair. He has always been an active man, and [now] he goes through bouts of depression and he's frustrated because he can't do what he did before." Participants spoke at length about the characteristics of both informal and formal caregivers that contributed to seniors' independence. These people were "helpful," "positive," "supportive," "responsive," "respectful," "accepting," "loving," and "listeners." Permitting seniors to take responsibility for their own care and involving them in decision making also facilitated independence. I have my 99-year-old mother at home. She suffers from dementia and incontinence, so she has very little control over her life in any way. The one thing she has control over is what she eats, or doesn't eat. It was hard for me to accept the fact that I had to totally give her control over how much she wanted and didn't want.

In contrast, participants described barriers to independence as including professionals "with negative attitudes" or professionals and family members "who want to do too much." "It's the attitude that people want to do things for you instead of letting you do them yourself.... There are things that I can do, but somebody wants to do them for me."

Service accessibility. Lack of knowledge about services and resources available in the community and through the health care system was identified as a serious barrier to seniors' independence, resulting in confusion and frustration for both seniors and caregivers. This barrier was shared by many professionals, including family doctors. Physical barriers included transportation and buildings unequipped for wheelchair access. Rules, restricted hours, and types of services available often created barriers to access: 'We don't have a lot of different programs to choose from within the area.

Sometimes the populations just don't match what's being offered." Service delivery tended to focus on addressing medical problems rather than the everyday challenges experienced by seniors in their efforts to maintain independence. Participants noted that many services that might facilitate independence, such as grief counseling, were absent, and that health promotion and disease prevention programs were geared to younger people. System rigidity constituted a serious barrier, particularly in terms of eligibility criteria, as outlined in the following statement: 'They told me I wasn't bad enough. I could feed myself and dress myself. I mean, all I needed was somebody to help with heavy work in the house so I could keep, well, a little dignity." However, many services that enhanced seniors' independence, such as 911, Medic-Alert, and Lifeline programs, did exist. Most groups agreed that family doctors served as the central point through which seniors accessed care. Of greater importance was the knowledge that family doctors were available and prepared to make housecalls, if needed. As one participant explained, 'The doctor told us that any time we need help,... day or night, to call and he'll be right at our fingertips." Physicians concurred with the seniors, saying, "Doctors who do home visits are a really big plus in keeping people in the community.... It makes a really big difference." But access alone was not enough. Participants also viewed comprehensiveness of services (for example, home care services, respite care programs, alternative housing) as an important facilitator to seniors' independence. Communication and coordination. Participants viewed communication as a key factor in facilitating seniors' independence; in the absence of good communication, health care services were less accessible. Communication between seniors and their informal and formal caregivers was critical, as was communication among professionals from various health care services. Communication could be as simple as taking time to listen or providing information about medications. Inadequate or confusing information about medications was thought to be one of the biggest barriers to seniors' independence in managing their own care. Breakdowns in communication among specialists and between specialists and family physicians also contributed to management problems. As one family caregiver explained, "It's hard to get too much detail out of these specialists. You really have to have a family doctor."

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All the focus groups emphasized the need for a coordinated system of health care delivery. Seniors and caregivers identified family doctors as primary coordinators of care and advocates for seniors. But they also noted the need for a coordinated, centralized service: "There is a need for one central agency that you could go to... and say, 'Okay, I've got this problem, where do I go from here? How can you help me?"' Failure to have a coordinated, centralized service impeded access, leaving seniors frustrated and confused and with less confidence in using the health care system.

Continuity of care. Participants identified continuity of care as essential in promoting seniors' independence. Relationships with their family doctors and with home-care workers was highlighted: "It has nothing to do with trust of information; it's trust of the person, the continuity of that person, the consistency of the approach." Caregivers also expressed the importance of establishing long-term relationships with family doctors caring for their relatives: "You have a family doctor that you've gone to for a long time,... someone [who] understands the background... they know the

family." Establishing long-term relationships with seniors afforded health care professionals, most often family doctors and family practice nurses, with an opportunity to know patients better: "You get to know the person over a period of time and you know you can't do it all on the first visit." DISCUSSION The findings of this study provide several insights that merit consideration by family physicians providing primary care to seniors. More than 80% of people older than 65 have chronic health problems.26 Family physicians, through providing ongoing care, play an important role in either facilitating or impeding seniors' independence. Theorists surmise that personal control is both a cause and a consequence of health. Thus efforts to promote independence among seniors with chronic problems might improve not only their personal control but also, eventually, their overall health.2728 Strategies to increase seniors' participation in managing their health care are needed. Opportunities for independence in managing chronic conditions are missed frequently in a system that promotes learned helplessness and dependence among seniors using

health services.2'5 Family physicians must be leaders in addressing this issue. Findings of this study suggest specific clinical strategies for fostering positive attitudes and attributes that will facilitate seniors' independence. While ongoing support and encouragement do help seniors, family physicians should explore their senior patients' feelings of depression, loneliness, loss of control and hope, and boredom with life, and experience of ageism. We must confront the medical professions' public image of power and suppression by encouraging patients not to defer to professional authority.7 Seniors also require encouragement to make their own decisions about everyday issues and lifestyle preferences.29 Family physicians' counseling skills can be used to help seniors express and resolve negative attitudes, beliefs, and fears. Open discussion of fears related to declining health is critical. Exploring new activities to replace those lost due to physical limitations can help seniors retain a sense of purpose and meaning in life.30 Care for seniors' caregivers also has an indirect effect on seniors' independence. Staying healthy and feeling cared for enables family caregivers to remain supportive, accepting, and loving toward their senior relatives.3' As our participants indicated, caregiver attitudes can promote seniors' self-esteem and ability to remain independent. Our findings reveal that physician availability increases seniors' confidence to remain independent. Simply knowing that a physician will respond to immediate needs promotes seniors' independence. The importance of family physicians' role in facilitating coordination and comprehensiveness of health care services cannot be underestimated. Seniors are particularly vulnerable to losing their independence as a consequence of "falling through the cracks" of the health care system.3'5 As our findings suggest, family physicians can promote communication between seniors and the specialists involved in their care, clarify medical care plans, coordinate multiple services, and act as seniors' advocates with specialists.32 Family physicians should take the lead in refining services to ensure easy access, better coordination, and provision of programs geared to seniors' needs. Above all, patient-doctor communication and continuity of the relationship afford family physicians an opportunity to promote seniors' independence. Taking time to listen to seniors, to clarify their understanding of care, and to address miscommunications

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is critical.33 Family physicians should try to integrate family caregivers and seniors themselves into the team involved in managing care.

Limitations and future study Study findings must be considered in light of a sample that was primarily white, middle-class, English speaking, and exposed to health care in a mid-sized Ontario city and surrounding rural counties. Recognizing these limitations, we have used our findings to initiate a large survey to determine the prevalence of the identified barriers and facilitators to seniors' independence in the community at large. The insights gained from our current study have important implications for the practice of family medicine with this specific population.

Conclusion Focus group methods provided a venue for all key stakeholders to express their views on empowering seniors to remain independent or attain independence. Knowledge of the barriers and facilitators to seniors' independence in the context of the health care system provides insight into how seniors can remain independent. Health care providers should communicate and foster more positive attitudes toward aging and participate in improving service access, coordination, and continuity of care to maximize seniors' potential.

Acknowledgnent This study was funded by a grant from the National Health Research and Development Program (NHRDP). Dr McWilliam is funded by the Ontario Ministry of Health. The findings and conclusions are those of the authors and no endorsement by the funding bodies is intended or should be inferred.

Correspondence to: Dr J.B. Brown, Thames Valley Family Practice Research Unit, Gordon J. Mogenson Building, 100 Collip Circle, Suite 245, UWO Research Park, London, ON N6G 4X8; telephone (519) 858-5028, fax (519) 858-5029, e-mail [email protected] References 1. National Advisory Council on Aging. Understanding seniors' independence. Report #1: 7he barriers and suggestions for action. Ottawa: Supply and Services Canada, 1989. 2. Rodin J, Langer E. Aging labels: the decline of control and the fall of self-esteem.J Soc Issues 1980;36(2):12-29. 3. McWilliam CL. From hospital to home: the elderly's discharge experience. Fain Med 1991;24:247-68.

4. Rodin J, Langer E. Long-term effects of a control-relevant intervention among the institutionalized aged. JPers Soc Psychol 1977;35:897-902. 5. McW-illiam CL, Brown JB, Carmicheal JL, Lehman JM. A new perspective on threatened autonomy: the disempowering process. Soc Sci Med 1994;38(2):327-38. 6. Beisecker A. Aging and the desire for information and input in medical decisions: patient consumerism in medical encounters. Gerontologist 1988;28(3):330-5. 7. Beisecker A, Beisecker T. Patient information - seeking behaviours when communicating with doctors. Med Care 1990;28(1):19-28. 8. Langer E. Mindfulness. New York: Addison-Wesley, 1989. 9. Jagger C, Spiers N, Clarke M. Factors associated with decline in function, institutionalization and mortality of elderly people. Age Ageing 1993;22:190-7. 10. Jagger C, Clarke M. Mortality risks in the elderly: five year follow-up of a total population. IntJEpidemiol 1988;17:111-4. 11. George S. Measures of dependency: their use in assessing the need of residential care for the elderly.J Public Health Med

1991;13(3):178-81. 12. Estes CL, Swan JH. The long term care crisis: elders trapped in the no-care zone. Newbury Park, Calif: Sage Publications, 1993. 13. Lloyd PC. The empowerment of elderly people. JAging Stud 1991;5:125-35. 14. Estes CL. The aging enterprise. San Francisco: Jossey-Bass, 1979. 15. Estes CL. Construction of reality: problems of aging. JSoc Issues 1980;39(2):117-32. 16. Phillipson C, Walker A. Conclusion: alternative forms of policy and practice. In: Walker A, Phillipson C, editors. Ageing and social policy: a critical assessment. London: Gower, 1986:280-1. 17. Phillipson C. Challenging "the spectre of old age": community care for older people in the 1990s. In: Manning W, Page R, editors. Social policy yearbook. London: Social Policy Association, 1992:1-22. 18. Morgan DL. Focus groups as qualitative research. Newbury Park, Calif: Sage Publications, 1988. 19. Morgan DL. Successfulfocus groups: advancing the state of the art. Newbury Park, Calif: Sage Publications, 1993. 20. Patton M. Qualitative evaluation and research methods. 2nd ed. Newbury Park, Calif: Sage Publications, 1990. 21. Wood ML Focus group interview in family practice research. Can Fam Physician 1992;38:2821-7. 22. Wood ML Communication between cancer specialists and family doctors. Can Fam Physician 1993;39:49-57. 23. Brown JB, Lent B, Sas G. Identifying and treating wife abuse.JFam Pract 1993;36(2):185-91. 24. Brown JB, Sas G. Focus groups in family practice research: an example study of family physicians' approach to wife abuse. Fam Pract ResJ 1994;14(1):19-28.

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HEPATITIS A VACCINE (Inactivated) 25. Basch CE. Focus group interview: an underutilized research technique for improving theory and practice in health education. Health Educ Q 1987;14:411-48. 26. National Advisory Council on Aging. Aging vignettes. Ottawa: Government of Canada, 1993. 27. Peterson C, Stunkard A. Personal control and health promotion. Soc Sci Med 1989;28(8):819-28. 28. Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. In: Lohr KN, editor. Advances in health status assessment. Med Care 1989;27(Suppl 1):110-27. 29. McWilliam CL, Brown JB. Choices and chances - whose responsibility? Second case illustrating component 4: incorporating prevention and health promotion. In: Stewart M, Brown JB, Weston WW, McWhinney IR, McWllliam CL, Freeman TR Patient-centered medicine: transforming the clinical method. Thousand Oaks, Calif: Sage Publications, 1995:87-8. 30. McWilliam CL, Stewart M, Brown JB, Desai K, Coderre P. Creating health with chronic illness. Adv Nurs Sci 1996;18(3):1-15. 31. Theis SL, Moss JH, Pearson MA. Respite for caregivers: an evaluation study. J Community Health Nurs 1994;11(1):3144. 32. McWilliam CL, Brown JB. Show me the way to go home: case illustrating component 6: being realistic. In: Stewart M, Brown JB, Weston WW, McWhinney IR, McWllliam CL, Freeman TR Patient-centered medicine: transforming the clinical method. Thousand Oaks, Calif: Sage Publications, 1995:111-3. 33. McWilliam CL, Brown JB, Weston WW. A time to talk a time to listen: building a constructive doctor-patient relationship. Ont Med Rev 1995;62(1):63-4.

PHARMACOLOGICAL CLASSIFICATION: Injectable vaccine for active immunization against infection by Hepatitis A virus. INDICATIONS AND CLINICAL USE: HAVRIX is indicated for active immunization against HAV infection in subjects at risk of exposure to HAV. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low and intermediate prevalence of hepatitis A, immunization with HAVRIX is particularly recommended in subjects who are, or will be, at increased risk of infection such as: Travelers: Persons traveling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. Armed Forces: Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Persons for whom Hepatitis A is an Occupational Hazard: These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and pediatric units, sewage workers, and food handlers, among others. Persons for whom there is an Increased Risk of Transmission of Hepatitis A: eg. homosexuals, persons with multiple sexual partners, abusers of injectable drugs, haemophiliac patients. Contacts of Infected Persons: Since virus shedding of infected persons may occur for a prolonged period, active immunization with concomitant administration of immune globulin (human) in close contacts may be considered. Specffic Population Groups known to have Higher Incidence of Hepatitis A: eg. North American Indians, Inuits, recognized community-wide HAV epidemics. CONTRAINDICATIONS: HAVRIX should not be administered to subjects with known hypersensitivity to any component of the vaccine preparation, or to subjects having shown signs of hypersensitivity after previous HAVRIX administration. As with other vaccines, the administration of HAVRIX should be postponed in subjects with severe febrile illness. The presence of a minor infection however, is not a contraindication. PRECAUTIONS: General: As with other injectable vaccines, appropriate medication (eg. adrenaline) should be readily available for immediate use in case of anaphylaxis or anaphylactoid reactions following administration of the vaccine. For this reason, the vaccinee should remain under medical supervision for 30 minutes after immunization. HAVRIX should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunization. It is not known whether HAVRIX will prevent hepatitis A in such cases. Use in Children: Clinical experience with HAVRIX 720 in children is limited. For children over one year of age who are likely to be at risk of exposure to HAV, one-half the adult dose (i.e. 360 ELISA Units) may be considered, used according to the recommended 0,1 month adult schedule with appropriate boosting between 6 and 12 months with 360 ELISA Units. HAVRIX 1440 is not recommended for use in children. Use in Pregnancy: The effect of HAVRIX on fetal development has not been assessed. However, as with all inactivated viral vaccines, the risks to the fetus are considered to be negligible. HAVRIX should be used during pregnancy only when clearly needed. Nursing Mothers: It is unknown whether HAVRIX is excreted in breast milk. Therefore, caution should be exercised if HAVRIX is to be administered to breast feeding women. Patients with Special Diseases and Conditions: As with other vaccines, hemodialysis patients and subjects with an impaired immune system may not obtain adequate antibody titres after the primary immunization course. Such patients may require administration of additional doses of HAVRIX. However, no specific dosing recommendations can be made at this time. Drug Interactions: The concomitant administration of HAVRIX and immune globulin (human) does not influence the seroconversion rate, but may result in a relatively lower anti-HAV antibody titre than when the vaccine is given alone. HAVRIX and immune globulin (human) should be administered at separate injection sites. Since HAVRIX is an inactivated vaccine, its concomitant use with other inactivated vaccines is unlikely to resuft in interference with immune responses. When concomitant administration of other vaccines is considered necessary, the vaccines must be given with different syringes and at different injection sites. Clinical experiences on the concomitant administration of HAVRIX and the recombinant hepatitis B virus vaccine, ENGERIX-B, have been satisfactory. No interference in the respective immune responses to either antigen has been observed. HAVRIX must not be mixed with other vaccines. ADVERSE REACTIONS: HAVRIX is well-tolerated. In controlled clinical studies, signs and symptoms were monitored in all subjects for four days following administration of the vaccine. A checklist was used for this purpose. The vaccinees were also requested to report any clinical events occurring during the study period. The frequency of solicited adverse events tended to decrease with successive doses of HAVRIX 720. Most events reported were considered by the subjects as 'mild and did not last for more than 24 hours. The frequency of solicited adverse events reported following administration of HAVRIX is not different from the frequency of solicited adverse events reported following the administration of other aluminium adsorbed purified antigen vaccines. The most frequently occurring local adverse reaction, for both HAVRIX 720 and 1440, was injection site soreness and was reported as severe in less than 0.5% of the volunteers. Other local reactions reported were induration, redness and swelling, with a frequency varying between 4% and 7% of vaccinations. The systemic adverse events reported by the volunteers were essentially mild, and included headache, malaise, fatigue, fever, nausea, and loss of appetite. These events were reported with a frequency varying between 1% and 10% of vaccinations with HAVRIX 720. Systemic adverse events were similar for HAVRIX 1440, with headache being the most frequently reported symptom (13.9% of vaccinations). As with other vaccines, rare events, such as anaphylaxis, have been observed in temporal association with the administration of the vaccine (See Precautions). DOSAGE AND ADMINISTRATION Dosage: HAVRIX is available in two dosage forms which can be used for primary immunization and for booster. Primary Immunization HAVRIX 720 EL.U: Each aduit dose consists of a 1.0 mL sterile suspension, containing not less than 720 ELISA Units of inactivated hepatitis A antigen. The standard primary course of vaccination with HAVRIX consists of two doses, the first administered at the elected date, and the second, administered one month later. For more rapid protection from hepatitis A, the primary doses may be given two weeks apart. HAVRIX 1440 EL.U: Each adult dose consists of a 1.0 mL sterile suspension, containing not less than 1440 ELISA Units of inactivated hepatitis A antigen. A single dose ot HAVRIX 1440 Is used for primary Immunization: SEE CLINICAL PHARMACOLOGY. Booster Dose: For both HAVRIX 720 AND HAVRIX 1440, a booster dose is recommended at any time between 6 and 12 months after the initiation of the primary course in order to ensure long term antibody titres. Concomitant Administration with Immune Globulin (Human): Concomitant administration of HAVRIX (720 or 1440) and immune globulin (human) may be considered when a subject is at risk of being exposed to hepatitis A before adequate anti-HAV antibody titres can be reached. Method of Administration: Havrix should be injected INTRAMUSCULARLY in the deitoid region. The vaccine should not be administered intramuscularly in the gluteal region or subcutaneouslyfintradermally since administration by these routes may result in a less than optimal anti-HAV antibody response. As with all parenterals, vaccine products should be inspected visually for any foreign particulate matter or discolouration prior to administration. Before use of HAVRIX, the vial should be well shaken to obtain a slightly opaque, white suspension. Discard if the contents of the vial appear otherwise. The vaccine must be used as supplied. HAVRIX should never be administered Intravnously. Stability and Storage Recommendations: The Vaccine should not be used beyond the expiry date stamped on the vial or syringe. HAVRIX must be stored at 2AC to 8'C. DO NOT FREEZE: discard It vaccine has been frozen: Stability studies of HAVRIX show that the potency of unopened vaccine is not significantly affected after exposure at 37°C for up to 3 weeks. However, this is NOT a storage recommendation. AVAILABILITY OF DOSAGE FORMS: HAVRIX is available in two strengths - HAVRIX 720 (720 ELISA Units/mL) and HAVRIX 1440 (1440 ELISA Units/mL) in single dose 1 mL vials. Complete Product Monograph available on request. References:

1. World Health Organization. Intemational travel and health. vaccination requirements and health advice. Health risks and their avoidance. Geneva, Swizterland, 1994:61,80.

2. Product Monograph HAVRIX, SmthKline teecham vaccines.

S3hrUWne Bseechm C) SmithKline Beecham Pharma Inc., 1996 Oakville, Ontario L6H 5V2

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