noncompliance with antihypertensive therapy

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CURRENT OPINION PharmacoEconomics 1996 Jan; 9 (1): 1-4 1170-7690{96{OOOH1OO1{S02.oo{O © Adls International limited. All rights reserved. Noncompliance with Antihypertensive Therapy Economic Consequences Tracy L. Bkaer, David A. Belar and Linda M. Robison College of Pharmacy, Washington State University, Pullman, Washington, USA Hypertension is a silent disease state, the full seriousness of which becomes evident only when the sequelae of long-standing high blood pressure are manifest as congestive heart failure, angina, myo- cardial infarction, cerebral vascular accident and/or end-stage renal disease. II - 8 ] An estimated 60 million Americans have elevated blood pressure (systolic blood pressure Hg and/or diastolic blood pressure Hg) requiring nonpharmacologi- cal and/or pharmacological treatment. 19 - 11 ] The goal of antihypertensive therapy and/or lifestyle modi- fications is to achieve and maintain a reduced blood pressure «140/90mm Hg) with minimal, if any, ad- verse effects.l'2,13] A major barrier to the management of hyperten- sion is the extent to which patients comply with the treatment regimen. 114 ,15] An estimated 30 to 50% of hypertensive patients withdraw from their prescribed regimen within 1 year of diagnosis and, of the re- mainder, nearly 33% administer insufficient medi- cation to facilitate art adequate reduction in blood pressure.l'6,17] Noncompliance with antihypertensive pharmacotherapy has been associated with an in- crease in visits to the physician, hospital admis- sions, length of hospital stay and resulting health service expenditures.l'8,19] Hospital expenditures resulting from an interruption in, or termination of, an antihypertensive regimen have been estimated to exceed $US800 per episode (1988 dollars).120] A review of the medical literature reveals that no single intervention strategy will assure compli- ance with antihypertensive pharmacotherapy.l2 1 - 23 ] Barriers to compliance include:124-29] the patient's socioeconomic status access to medical care • understanding of hypertension and the role of pharmacotherapy the patient's locus of control • the adverse effect profile and administration schedule of the prescribed medication. Recent evidence suggests that a structured long- itudinal programme composed of educational modules, specialised prescription packaging, and scheduled consultation with healthcare providers may enhance the probability of long term adher- ence.l3°- 32 ] Given the estimated rate of noncompli- ance with antihypertensive pharmacotherapy and the magnitude of resulting health service expendi- tures, pharmaceutical manufacturers, health main- tenance organisations (HMOs) and government agencies have commenced the development· and implementation of disease state management pro- gramming. 133 ,34] While holding the promise of en- hanced patient outcomes, commercial sponsorship, whether that of a pharmaceutical firm or health in- surance scheme, may well result in the increased utilisation of either patent-protected medication or inexpensive alternatives, depending on the financial incentive of the benefactor. In either case, individ- ualisation of the treatment regimen may well be sacrificed. Vigilant oversight of programming initia- tives will be required as stakeholders pursue vested interests.

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Page 1: Noncompliance with Antihypertensive Therapy

CURRENT OPINION PharmacoEconomics 1996 Jan; 9 (1): 1-4 1170-7690{96{OOOH1OO1{S02.oo{O

© Adls International limited. All rights reserved.

Noncompliance with Antihypertensive Therapy Economic Consequences

Tracy L. Bkaer, David A. Belar and Linda M. Robison College of Pharmacy, Washington State University, Pullman, Washington, USA

Hypertension is a silent disease state, the full seriousness of which becomes evident only when the sequelae of long-standing high blood pressure are manifest as congestive heart failure, angina, myo­cardial infarction, cerebral vascular accident and/or end-stage renal disease. II-8] An estimated 60 million Americans have elevated blood pressure (systolic blood pressure ~140mrn Hg and/or diastolic blood pressure ~90mm Hg) requiring nonpharmacologi­cal and/or pharmacological treatment.19-11 ] The goal of antihypertensive therapy and/or lifestyle modi­fications is to achieve and maintain a reduced blood pressure «140/90mm Hg) with minimal, if any, ad­verse effects.l'2,13]

A major barrier to the management of hyperten­sion is the extent to which patients comply with the treatment regimen.114,15] An estimated 30 to 50% of hypertensive patients withdraw from their prescribed regimen within 1 year of diagnosis and, of the re­mainder, nearly 33% administer insufficient medi­cation to facilitate art adequate reduction in blood pressure.l'6,17] Noncompliance with antihypertensive pharmacotherapy has been associated with an in­crease in visits to the physician, hospital admis­sions, length of hospital stay and resulting health service expenditures.l'8,19] Hospital expenditures resulting from an interruption in, or termination of, an antihypertensive regimen have been estimated to exceed $US800 per episode (1988 dollars).120]

A review of the medical literature reveals that no single intervention strategy will assure compli-

ance with antihypertensive pharmacotherapy.l21-23] Barriers to compliance include:124-29] • the patient's socioeconomic status • access to medical care • understanding of hypertension and the role of

pharmacotherapy • the patient's locus of control • the adverse effect profile and administration

schedule of the prescribed medication. Recent evidence suggests that a structured long­

itudinal programme composed of educational modules, specialised prescription packaging, and scheduled consultation with healthcare providers may enhance the probability of long term adher­ence.l3°-32] Given the estimated rate of noncompli­ance with antihypertensive pharmacotherapy and the magnitude of resulting health service expendi­tures, pharmaceutical manufacturers, health main­tenance organisations (HMOs) and government agencies have commenced the development· and implementation of disease state management pro­gramming.133,34] While holding the promise of en­hanced patient outcomes, commercial sponsorship, whether that of a pharmaceutical firm or health in­surance scheme, may well result in the increased utilisation of either patent-protected medication or inexpensive alternatives, depending on the financial incentive of the benefactor. In either case, individ­ualisation of the treatment regimen may well be sacrificed. Vigilant oversight of programming initia­tives will be required as stakeholders pursue vested interests.

Page 2: Noncompliance with Antihypertensive Therapy

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Further complicating the prescribing of, and com­pliance with, antihypertensive pharmacotherapy are concerns regarding the magnitude of the patient's direct expenditure for the procurement of medica­tion.l35-37] Cardiovascular medicines are expen­sive.[38,39] As patients often present with more than one cardiovascular disease state, direct expenditures for pharmacotherapy may represent a significant barrier to regimen adherence. For example, an indi­vidual with coronary heart disease, hypertension, renal insufficiency and hypercholesterolaemia may well be prescribed a ~-blocker, an ACE inhib­itor, a diuretic and a cholesterol-lowering agent, thereby yielding a monthly expenditure for pharmaco­therapy in excess of $US150 (1989 dollars).[40]

The publication of the Joint National Commit­tee's fifth report on the treatment of hypertension has stimulated considerable debate as to the merits of issuing disease state management directives (i.e. guidelines).D 1,41] Many approach the treatment of hypertension as a means to reduce cardiovascular events, with the selection of pharmacotherapy predi­cated on the probability of prolonging both the quality and duration of life, rather than merely the potential to reduce millimetres of mercury.[42-47] Individualised treatment regimens may require in­creased expenditures for antihypertensive pharmaco­therapy; an exacting precursor to noncompliance. However, at present, there are insufficient clinical and/or economic data to assure formulary status for newer, more expensive therapeutic alternatives.[48-49] Randomised controlled trials, such as the Anti­hypertensive and Lipid-Lowering Treatment for Prevention of Heart Attack Trial organised by the US National Heart, Lung and Blood Institute, may assist in determining whether antihypertensive med­ications with demonstrable vasoprotective effects (e.g. ACE inhibitors or calcium antagonists) are to be preferred over diuretics and ~-blockers.l50]

At odds with scheduled events and outcomes associated with randomised controlled clinical trials are patient behaviours in the natural environ­ment.[51] Quality-of-life considerations are paramount if compliance with antihypertensive pharmaco­therapy is to be achieved.l52-57] Deterioration in

© Adls International Limited. All rtghts reserved.

Skaer et al.

quality of life as a result of prescribed medication is often cited by hypertensive patients as the basis for noncompliance with pharmacotherapy.l58] Con­temporary efforts to optimise antihypertensive pharmacotherapy need to focus on individualising treatment in accordance with the patient's age, gen­der and race, the presence of concomitant disease state processes and acceptable outcomes relative to quality of life.[59,60]

The ultimate value of antihypertensive pharma­cotherapy is its ability to reduce both the morbidity and mortality associated with cardiovascular dis­ease.[61,62] By focusing on expenditures for anti­hypertensive pharmacotherapy rather than expen­ditures for cardiovascular disease, government agencies, medical associations and health insurance schemes inadvertently enhance the probability of noncompliance by advocating the selection of medi­cines that need to be administered more than once per day and that are associated with bothersome adverse effects.l63,64] Where clinical and economic data justify it,first dollar coverage for individualised courses of antihypertensive pharmacotherapy, along with intensive programming on disease state man­agement, need to be considered in order to enhance compliance and reduce health service expendi­tures.l65,66]

References 1. Stamler 1, Stamler R, Neaton ID. Blood pressure, systolic and

diastolic, and cardiovascular risks: US population data. Arch Intern Med 1993; 153: 598-615

2. Sever P, Beevers G, Bulpitt C, et al. Management guidelines in essential hypertension: report of the Second Working Party of the British Hypertension Society. BMI 1993; 306: 983-7

3. Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. 1993 guidelines for the management of mild hypertension: memorandum from a World Health Orga­nizationllnternational Society of Hypertension meeting. Hy­pertension 1993; 22: 392-403

4. Myers MG, Carruthers SG, Leenen FHH, et aI. Recommenda­tions from the Canadian Hypertension Society Consensus Conference on the pharmacologic treatment of hypertension. Can Med Assoc 11989; 140: 1141-6

5. Hypertension Guidelines Committee, South Australian Faculty, Royal Australian College of General Practitioners. Hyperten­sion: diagnosis, treatment, and maintenance. Guidelines en­dorsed by the High Blood Pressure Research Council of Australia. Adelaide: South Australian Faculty, Royal Austra­lian College of General Practitioners, 1991

6. Mild hypertension: a summary of the 1993 World Health Orga­nizationllnternational Society of Hypertension (WHO/ISH)

PharmacoEconomics 1996 Jan; 9 (1)

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Noncompliance with Antihypertensives

guidelines for the management of mild hypertension. Memo­randum from a WHO/ISH meeting. J Intern Med 1994; 235: 21-9

7. Herbert PR, Moser M, Mayer J, et al. Recent evidence on drug therapy of mild to moderate hypertension and decreased risk of coronary heart disease. Arch Intern Med 1993; 153: 578-81

8. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. JAMA 1991; 265: 3255-64

9. Trials of Hypertension Prevention Collaborative Research Group. The effects of nonpharmacologic interventions of blood pressure of persons with high normal levels: results of the Trials of Hypertension Prevention, Phase I. JAMA 1992; 267: 1213-20

10. Treatment of Mild Hypertension Research Group. The treat­ment of mild hypertension study: a randomized, placebo­controlled trial of a nutritional-hygienic regimen along with various drug monotherapies. Arch Intern Med 1992; 152: 131-6

II. Joint National Committee on Detection, Evaluation, and Treat­ment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC-V). Arch Intern Med 1993; 153: 154-83

12. Pardell H, Armario P, Hernandez R. Progress in the 1980s and new directions in the 1990s with hypertension management: from the stepped-care approach to the individualised pro­gramme in hypertension treatment and control. Drugs 1992; 43 (I): 1-5

13. Alderman MH. Which antihypertensive drugs first - and why? JAMA 1992; 267: 2786-7

14. Stason WB. Opportunities to improve the cost-effectiveness of treatment for hypertension. Hypertension 1991; 18 Suppl. 3: 1161-6

15. Levine DM, Bone L. The impact of a planned health education approach on the control of hypertension in a high risk popu­lation. J Hum Hypertens 1990; 4: 317-21

16. Balazovjech I, Hnilica Jr P. Compliance with antihypertensive treatment in consultation rooms for hypertensive patients. J Hum Hypertens 1993; 7 (6): 581-3

17. Col N, Fanale JE, Kronholm P. The role of medication noncom­pliance and adverse drug reactions in hospitalizations of the elderly. Arch Intern Med 1990; 150: 841-5

18. Sclar DA, Skaer TL, Chin A, et al. Utility of a transdermal delivery system for antihypertensive therapy: part II. Am J Med 1991; 91 Supp!. IA: 57S-60S

19. McCombs JS, Nichol MB, Newman CM, et a!. The costs of interrupting antihypertensive drug therapy in a medicaid pop­ulation. Med Care 1994; 32: 214-26

20. Office of National Cost Estimates. National health care expendi­tures, 1988 [summary J. Health Care Financ Rev 1990; II: 125

21. Carney S, Gillies A, Smith A, et al. Hypertension education: patient knowledge and satisfaction. J Hum Hypertens 1993; 7 (5): 505-8

22. Sharkness CM, Snow DA. The patient's view of hypertension and compliance. Am J Prev Med 1992; 8 (3): 141-6

23. Richardson MA, Simons-Morton B, Annegers JE Effect of per­ceived barriers on compliance with antihypertensive medica­tion. Health Educ Q 1993; 20 (4): 489-503

24. Eisen SA, Miller DK, Woodward RS, et al. The effect of pre­scribed daily dose frequency on patient medication compli­ance. Arch Intern Med 1990; 150: 1881-4

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25. Farquhar JW, Fortmann SP, Flora JA, et al. Effects of com­munitywide education on cardiovascular disease risk factors: the Stanford five-city project. JAMA 1990; 264: 359-65

26. Lefebvre RC, Lasater TM, Carleton RA, et al. Theory and de­livery of health programming in the community: the Paw­tucket Heart Health Program. Prev Med 1987; 16: 80-95

27. Sawicki PT, Muhlhauser I, Didjurgeit U, et al. Improvement of hypertension care by a structured treatment and teaching pro­gramme. J Hum Hypertens 1993; 7 (6): 571-3

28. Bittar N. Maintaining long-term control of blood pressure: the role of improved compliance. Clin Cardiol 1995; 18 Suppl. III: III 12-6

29. Sclar DA, Tessier GC, Skaer TL, et al. Effect of pharmaceutical formulation of diltiazem on medicaid and health maintenance organization services. Curr Ther Res 1994; 55 (10): 1136-49

30. Webber Gc. Patient education: a review of the issues. Med Care 1990; 28 (II): 1089-103

31. Skaer TL, Sclar DA, Markowski DJ, et al. Effect of value-added utilities on prescription refill compliance and health care ex­penditures for hypertension. J Hum Hypertens 1993; 7 (5): 515-8

32. Sclar DA, Skaer TL, Chin A, et al. Effect of health education on the utilization of HMO services: a prospective trial among patients with hypertension. Prim Cardiol 1992; 18 Supp!. I: 30-5

33. Vogel DP. Patient-focused care. Am J Hosp Pharm 1993; 50: 2321-9

34. Lathrop JP. Patient-focused care in theory and action. Am J Health Syst Pharm 1995; 52: 45-8

35. Shea S, Misra D, Enrlich MH, et al. Correlates of nonadherence to hypertension treatment in an inner-city minority popula­tion. Am J Public Health 1992; 82: 1607-12

36. Francis CK. Hypertension, cardiac disease, and compliance in minority patients. Am J Med 1991; 91 Suppl. IA: 29S-36S

37. Clark LT. Improving compliance and increasing control of blood hypertension: needs of special populations. Am Heart J 1991; 121: 664-9

38. Shea A, Misra D, Ehrlich MH, et al. Predisposing factors for severe, uncontrolled hypertension in an inner-city minority population. N Engl J Med 1992; 327: 776-81

39. Dustan HP, De Leon AC, Hill MN, et a!. Report of the task force on the availability of cardiovascular drugs to the medically indigent. Circulation 1992; 85 (2): 849-60

40. Haywood LJ. Hypertension in minority popUlations: access to care. Am J Med 1990; 88 Supp!. 3B: 17S-20S

41. Feder G. Which guidelines to follow? BMJ 1994; 308: 470-1 42. Menard J. Oil and water? Economic advantage and biomedical

progress do not mix well in a government guidelines commit­tee. Am J Hypertens 1994; 7: 877-85

43. Tobian L, Brunner HR, Cohn IN, et al. Modem strategies to prevent coronary sequelae and stroke in hypertensive patients differ from the JNC V consensus guidelines. Am J Hypertens 1994; 7: 859-72

44. Weber MA, Laragh JH. Hypertension: steps forward and steps backward. Arch Intern Med 1993; 153: 149-52

45. Gavras H, Gavras I. On the JNC V report: a different point of view. Am J Hypertens 1994; 7: 288-93

46. Swales JD. Guidelines on guidelines. J Hypertens 1993; II: 899-903

47. Swales JD. Guidelines for treating hypertension: improved care or retarded progress. Am J Hypertens 1994; 7: 873-6

48. Strasser T. Relative costs of antihypertensive drug treatment. J Hum Hypertens 1992; 6: 489-94

PharmacoEconomics 1996 Jan; 9 (1)

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49: Menard J, Cornu P, Day M. Cost of hypertension treatment and the cost of health. J Hum Hypertens 1992; 6: 447-58

50. Oparil S. Antihypertensive therapy: efficacy and quality of life [editorial). N Engl J Med 1993; 328 (13): 959-61

51. Cramer JA, Mattson RH, Prevey ML, et al. How oftenis med­ication taken as prescribed? A novel assessment technique. JAMA 1989; 261: 3273-7

52. Winklund I. Quality of life and cost-effectiveness in the treat­ment of hypertension. J Clin Pharm Ther 1994; 19 (2): 81-7

53. Testa MA, Anderson RB, Nackley JF, et al. Quality of life and antihypertensive therapy in men. N Engl J Med 1993; 328 (13): 907-13

54. Croog SH, Elias MF, Colton T, et al. Effects of antihypertensive medications on quality of lifein elderly hypertensive women. Am J Hypertens 1994; 7: 329-39

55. Applegate WB, Phillips HL, Schnaper H, et al. A randomized controlled trial of the effects of three antihypertensive agents on blood pressure control and quality of life in older women. Arch Intern Med.1991; 151 : 1817-23

56. Skaer TL. Applying pharmacoeconomic and quality-of-life measures to the formulary management process. Hosp Formul 1993;28(6): 577-84

57. Cramer MP, Saks SR. Translating safety, efficacy and compli­ance into economic value for controlled release dosage forms. PharmacoEconomics 1994; 5 (6): 482-504

58. Maxwell MH, Frishman WH, Kong BW. Quality-of-life consid­erations for first-line antihypertensive therapy. Cardiovasc Rev Rep 1994; 15: 17-22

Skaer et al.

59. Pool JL. Newer antihypertensive drugs: a glimpse into the fu­ture. CUff Opin Cardiol 1993; 8: 775-9

60. Weber MA. Clinical experience with the angiotensin II receptor antagonist losartan: a preliminary report. Am J Hypertens 1992; 5 (12 Pt 2): 247S-51S

61. Drummond M, Coyle D. Assessing the economic value of anti­hypertensive medicines. J Hum Hypertens 1992;6 (6): 495-501

62. Maynard A. The economics of hypertension control: some basic issues. J Hum Hypertens 1992; 6 (6): 417-20

63. Kozma CM, Reeder CE, Lingle EW. Expanding medicaid drug formulary coverage: effects on utilization of related services.

. Med Care 1990; 28 (10): 963-77 64. Sclar DA, SkaerTL. Pharmaceutical formulation and healthcare

expenditures. PharmacoEconomics 1992; 2 (4): 267-9 65. Vageloos PRo Are prescription drug prices high? Science 1991;

252: 1080-4 66. Shulman NB, Levinson RM, Dever GE, et al. Impact of cost

problems on morbidity in a hypertensive population. Am J Prev Med 1991; 7 (6): 374-8

Correspondence and reprints: Dr Tracy L. Skaer, College of Pharmacy, Washington State University, Pullman, WA 99164-6510, USA.

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