This site is intended for health professionals only

Improving compliance/concordance with HRT

Nuttan Tanna
MRPharmS PhD ACPP
Specialist Pharmacist - Menopause and Osteoporosis

Associate Director
Pharmacy Practice
Northwick Park Menopause Clinical and Research Unit
NW London Hospitals NHS Trust
Harrow, Middlesex

Honorary Lecturer
MSc/Women's Healthcare Module
Department of Pharmacy
University of Cardiff
Wales
E:nuttan.tanna@nwlh.nhs.uk

The use of hormone replacement therapy (HRT) attracts a lot of attention. New evidence reported in mid-2002 shows that HRT should not be used for primary or secondary prevention of cardiovascular disease.(2-4) Patient information leaflets on the risks and benefits of using HRT, available from the Department of Health website,(5) are useful when a health professional wishes to provide further written, evidence-based information to women. When considering compliance to HRT, the importance of a holistic management plan for healthy postmenopausal life should be emphasised. Depending on the woman's views, this plan may or may not include taking HRT.
 
Compliance, adherence and concordance

Compliance
The term generally used for whether or not a person takes their medication is compliance. Compliance has been broadly defined as "the extent to which a patient's behaviour coincides with the medical or health advice given".(6) Here a patient with a medical problem approaches a health professional for advice. If there is a potentially helpful solution, a treatment will be proposed. The patient may be given a prescription, the terms of which they are expected to "comply" with.
 
Compliance is not guaranteed for HRT, as illustrated by the Massachusetts Women's Health Survey.(7) In this field study of 2,500 women aged between 45 and 55, only 40-50% of the patient cohort had taken treatment after receiving a HRT prescription; 20-30% did not have their prescription dispensed; while 10% took treatment intermittently; and 20% stopped treatment by nine months. The North American Menopause Society (NAMS) Consensus Statement Steering Group reported that most women who start HRT discontinue therapy by the end of the first or second year.(8) The studies they evaluated included women living mainly in the USA, who read and spoke English, were white and were well educated.

Within many general practices in London, the average length of HRT usage was 21 months, with a median duration of 11 months.(9) Uptake of HRT in the early 90s varied between 2% and 9% of the population at risk.(10) Barlow et al reported only 15% of their patient cohort continuing beyond two years.(11) Therefore compliance with HRT is generally low (see Table 1).

[[NIP10_table1_20]]

Adherence
The term "adherence", implying continuance with therapy, may to some extent explain why there is high compliance failure. With adherence, the health beliefs of the patient are considered when assessing treatment compliance. This provides more "real-life" naturalistic reasons for compliance failure. With the term "prescription adherence" there is an inherent "connotation of patient choice".(13) Numerous factors affect adherence.
 
Documented beliefs about HRT include patients seeing it as "medicalisation of life"(10) (eg, "the menopause should not be interfered with"(14)) or where HRT uptake is considered as going "against nature".(15,16) The menopause is a natural life event, preceding natural ageing processes. Therefore HRT could be regarded as going against nature. Use of HRT for cosmetic reasons by some patients will be seen by others as a trivial reason for taking HRT; this could be considered as "medicalising" life. The decision to comply with HRT will depend on the indication for use. The patient with osteoporosis may start HRT to reduce her future risk of fractures. The fact that the levels of hormones used in HRT regimens simulate physiological levels naturally circulating in the system before the woman went through the menopause means that women could regard HRT as taking "natural" therapy. The patient's health beliefs in each situation are different. Lack of adherence or continuance may indicate lack of belief in a diagnosis, lack of belief in the need for or efficacy of treatment, the need for personal control, lack of commitment, unwillingness to change one's lifestyle to accommodate treatment, or lack of organisation.(17)

There is evidence that women in the UK are less well informed about the menopause and its consequences, are less likely to consult their doctors about it, and when they do so are less likely to receive HRT than their European counterparts.(18) The patient may therefore not have had adequate explanation and may still be unsure as to the benefits. The benefits may be outweighed by factors such as the occurrence of withdrawal bleeding, fear of cancer, weight increase and other side-effects.(10,19,20) For example, the breast cancer risk, a highly emotive issue, may be categorised by patients as a high-risk element, but this may not actually be the case. In addition, the patient is more likely to get her information from the media and friends,(15,21) and this usually comprises reports of bad experiences with HRT.(12) These factors therefore help form some of the patient's often erroneous health beliefs. Table 2 presents the various factors that affect HRT treatment uptake and compliance.

[[NIP10_table2_22]]

Concordance
Concordance is a concept that takes adherence one stage further. Its application should help to improve compliance and ongoing adherence to HRT. Here the patient and health professional negotiate the final prescription that the patient will be given. A "therapeutic alliance" is formed between them. Having taken the patient's agenda into consideration and addressed their concerns, the patient is more likely to adhere to therapy prescribed.(22) Inherent within the principle of concordance is the right of the patient to make an informed decision not to take therapy. For menopause patient management, the application of concordance is of paramount importance.
 
Indications for HRT include menopausal symptoms and preventive therapy for osteoporosis. Doctor-patient communication plays an important role in a woman's decision to take HRT, to fill her prescription and to adhere to the regimen.(23-25) The first visit for a HRT discussion is crucial for the establishment of an effective patient-doctor relationship. It has been suggested there should be at least 15 minutes, and preferably 45 minutes, reserved for this visit,(25) but due to time constraints the average length of time for this consultation is 8 minutes.(22) A practical way forward is to utilise the multidisciplinary team, including nurses, pharmacists and counsellors, to support and assist the formation of the "therapeutic alliance" between the patient and her doctor.(26) Where HRT treatment is indicated for the woman, optimal adherence or continuance will be the clinical goal,(8) and health professionals, with interdisciplinary liaison, can ensure that this objective is achieved.
 
Multidisciplinary teamworking has been shown to improve patient care.(10,28) Higher compliance figures for HRT have been reported for women attending a weekly health clinic at a surgery (25%) than for nonclinic attenders (10.8%).(10) Placing emphasis on education and lifestyle interventions, the practice nurse also offered screening support to the GP. A physiotherapist was employed to teach appropriate exercise routines to the patients. In this study, 78% of current HRT users had been on treatment for over a year and 15% for more than five years (current users=260).
 
Sethi's practice protocol focused on patient-led prescribing.(28) Offering structured care, patients alternated visits between the GP and the nurse, and use was made of the practice library where patient videos and information leaflets were available. A total of 28.7% of the patients, aged between 40 and 80 years, were HRT users. A compliance figure of 60% at five years and 19% at 10 years was reported for these patients from a retrospective analysis of patient records.(28)
 
Griffiths reported that women regard GPs and practice nurses as influencing their decision to take therapy.(29) Practice nurses can provide information about lifestyle and clinic facilities,((30) but present activity in this area varies between practices.(31) The involvement of nurse counsellors could help improve compliance, as suggested in one review article,(32) but their effect on patient compliance has not been formally evaluated.

Finally, GPs' attitudes can affect uptake of HRT by patients, with Isaacs et al reporting the prevalence and duration of use of HRT by menopausal women doctors to be higher than the background female population.(33) They rationalise that few women will be likely to take up HRT in the absence of a full evaluation of benefit and risk. It was suggested, quite reasonably, that the reason for higher uptake by the female doctors in this study was due to their ability to understand and make a risk-benefit HRT judgment for themselves.

Conclusion
In summary, to improve concordance, the following recommendations should be applied to achieve ongoing compliance with HRT:(8)

  • Involve the woman in the decision-making process.
  • Explain the benefits and risks with clarity and personalise them.
  • Clarify and discuss the woman's preferences and use these to modify the regimen.
  • Provide educational information that the woman can understand.
  • Help the woman to systemise medication taking.
  • Follow up.

All health professionals, including doctors, nurses and pharmacists,(34) approached by women seeking advice on HRT should be able to assist with the decision-making process and provision of information. It will be important to deal with side-effects and withdrawal bleeds, to ensure that the women have realistic expectations, to consider the ease and expense of treatment, and to monitor for ongoing compliance.

References

  1. Tanna N. NiP 2002;5:39-44.
  2. Writing group for the Women's Health Initiative Investigators. JAMA 2002;288:321-33.
  3. Grady D, et al. JAMA 2002;288:49-57.
  4. Beral V, et al. Lancet 2002;360:942-4.
  5. Patient Information Sheets. Available from URL: http://www.mca. gov.uk
  6. Griffith S. Br J Gen Pract 1990;40:114-16.
  7. MacKinley S, et al, cited in Ravniker VA. Am J Obstet Gynecol 1987;156:1332-4.
  8. NAMS. Menopause 1998;5:69-76.
  9. Spector TD. BMJ 1989;299:1434-5.
  10. Coope J, Marsh J. Maturitas 1992:15;151-8.
  11. Barlow DH, et al. Br J Obstet Gynaecol 1989;96:1192-7.
  12. Kenemans P, et al. Practical HRT. 2nd ed. The Netherlands: Medical Forum International; 1996.
  13. McGavock H. A review of the literature on drug adherence. Taking medicines to best effect. London: RPSGB & MSD; 1995.
  14. Mattson LA, et al. Eur J Obstet Gynecol Reprod Biol 1996;64:S3-5.
  15. Whitehead M, Godfree V. Hormone replacement therapy - your questions answered. Edinburgh: Churchill Livingstone; 1992.
  16. Hunter MS, et al. Soc Sci Med 1997;45:1541-8.
  17. Cramer JA. Am J Health-Syst Pharm 1995;52:S27-9.
  18. Oddens BJ, et al. Maturitas 1992;15:171-81.
  19. Hahn RG. Am J Obstet Gynecol 1989;161:1854-8.
  20. Draper J, Roland M. BMJ 1990;300:786-8.
  21. Roberts PJ. Br J Gen Pract 1991;41:421-4.
  22. From compliance to concordance. London: RPSGB; 1997.
  23. Leveille SG, et al. J Am Geriatr Soc 1007;45:1496-500.
  24. Semler J. Klinikartz 1997;26:175-80.
  25. Sarrel PM. Am J Obstet Gynecol 1999;180:337-40.
  26. Pitkin J. J Assoc Prim Care Groups Trusts 2002;Autumn:99-107.
  27. Roberts PJ. How can compliance be improved in a general practice setting? In: Wren BG, editor. Progress in the management of the menopause. Proceedings of the 8th International Congress on the Menopause, Sydney, Australia; 1996.
  28. Sethi K, Pitkin J. Eur Menop J 1995;2:33-4.
  29. Griffiths F. Br J Gen Pract 1995;45:477-80.
  30. Roberts PJ. Br J Gen Pract 1995;45:79-81.
  31. Jeffreys LA, et al. Br J Gen Pract 1995;45:415-8.
  32. Rozenberg S, et al. Int J Fertil Menop Stud 1995;40:23S-32.
  33. Isaacs AJ, et al. BMJ 1995;311:1399-401.
  34. Tanna N, Pitkin J. J Br Men Soc 1997;3(3):11-15.

Resources
British Menopause Society
T:01628 890199
W:www.the-bms.org

National Osteoporosis Society
T:01761 471771
Helpline:
01761 472721
F:01761 471104
W:www.nos.org.uk
E:info@nos.org.uk

The Northwick Park Menopause Clinical and Research Unit
Health Professional Linkline:
020 8869 2937
Patient Adviceline:020 8869 2877/3965

Osteoporosis 2000
47 Wilkinson St
Sheffield S10 2GB
Helpline:
0114 272 2000
F:0114 263 4420
E:anyone@osteoporosis2000.freeserve.co.uk

Amarant Trust
T:09068 660620
F:020 7490 2296

The Pennell Initiative
c/o JM Associates
13 Grove Street
Summertown Oxford OX2 7JT
T:01865 558000
Publications
orderline:
0800 550220
W:www.pennellwomenshealth.org