Efecto de la intervención farmacéutica en la adherencia a la medicación y el control de la presión arterial en pacientes hipertensos tratadosjustificación, diseño y los métodos del estudio piloto AFenPA

  1. Fikri-Benbrahim, N.
  2. Sabater Hernández, D.
  3. Fikri Benbrahim, O.
  4. Faus, MJ.
  5. Martínez Martínez, F.
  6. González Segura Alsina, D.
Journal:
Ars pharmaceutica

ISSN: 2340-9894 0004-2927

Year of publication: 2011

Volume: 52

Issue: 4

Pages: 29-38

Type: Article

More publications in: Ars pharmaceutica

Abstract

Objective: To assess the effect of a protocol-based pharmacist intervention on blood pressure control and medication adherence among treated hypertensive patients who are users of community pharmacies. Methods: A quasi experimental study design with control group has been designed to compare the effect of pharmaceutical intervention (intervention group) versus the standard healthcare procedure (control group) on blood pressure and medication adherence among hypertensive patients receiving drug therapy in community pharmacies. The patients will be allocated evenly between the two groups (ncontrol = nintervention), with a 6-month follow-up. The pharmaceutical intervention program will comprise three main parts: 1) patient education / information on issues relating to hypertension and medication adherence; 2) self-monitoring of blood pressure; and 3) interaction with the physician through personalized reports when the mean blood pressure values recorded at home exceed the treatment goal according to the clinical condition of the patient. In order to evaluate the effect of the pharmaceutical intervention upon medication adherence and blood pressure, blood pressure recordings will be made in the pharmacy, while percent medication adherence will be established based on pill count in both groups at the start and end of the study. Discussion: To our knowledge, this is the first study in the community pharmacy setting in Spain to evaluate the effectiveness of pharmaceutical intervention in combination with home blood pressure monitoring on blood pressure control. In addition, the pharmaceutical intervention has been designed for inclusion as standard practice in the context of Pharmaceutical Care.

Bibliographic References

  • Agarwal R, Bills JE, Hecht TJ, Light RP: Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension. 2011; 57(1):29-38.
  • Banegas JR, Rodriguez-Artalejo F, Ruilope LM, Graciani A, Luque M, de la Cruz-Troca JJ, Garcia-Robles R, Tamargo J, Rey-Calero J: Hypertension magnitude and management in the elderly population of Spain. J Hypertens. 2002; 20(11):2157-2164.
  • Banegas JR, Segura J, Sobrino J, Rodriguez-Artalejo F, de la Sierra A, de la Cruz JJ, Gorostidi M, Sarria A, Ruilope LM: Effectiveness of blood pressure control outside the medical setting. Hypertension. 2007; 49(1):62-68.
  • Bonso E, Dorigatti F, Saladini F, Palatini P: Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol. Blood Press Monit. 2010; 15(1):63-66.
  • Borenstein JE, Graber G, Saltiel E, Wallace J, Ryu S, Archi J, Deutsch S, Weingarten SR: Physician-pharmacist comanagement of hypertension: a randomized, comparative trial. Pharmacotherapy. 2003; 23(2):209-216.
  • Cappuccio FP, Kerry SM, Forbes L, Donald A: Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004; 329(7458):145.
  • Carter BL, Elliott WJ: The role of pharmacists in the detection, management, and control of hypertension: a national call to action. Pharmacotherapy. 2000; 20(2):119-122.
  • Carter BL, Rogers M, Daly J, Zheng S, James PA: The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009; 169(19):1748-1755.
  • Carter BL, Zillich AJ: Pharmaceutical care services for patients with hypertension. Ann Pharmacother. 2003; 37(9):1335-1337.
  • Collins R, MacMahon S: Blood pressure, antihypertensive drug treatment and the risks of stroke and of coronary heart disease. Br Med Bull. 1994; 50(2):272-298.
  • Comité de Consenso. Foro de Atención Farmacéutica. Documento de Consenso. 2008.
  • de Castro MS, Fuchs FD, Santos MC, Maximiliano P, Gus M, Moreira LB, Ferreira MB: Pharmaceutical care program for patients with uncontrolled hypertension. Report of a double-blind clinical trial with ambulatory blood pressure monitoring. Am J Hypertens. 2006; 19(5):528-533.
  • Gil V, Muñoz C, Martínez JL, Belda J, Soriano JE, J. M: [Factors involved in the hypertensive patient non-compliance with treatment]. Med Clin (Barc). 1994; 102(2):50-53.
  • Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T: Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2010; (3):CD005182.
  • Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS: Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008; 299(24):2857-2867.
  • Grupo de Consenso. Documento de Consenso en Atención Farmacéutica. 2001; 42: 223-243. Ars Pharmaceutica. 2001; 42(3-4): 223-243.
  • Guidelines Subcommittee. 1999 World Health Organization- International Society of Hypertension. Guidelines for the Management of Hypertension. J Hypertens. 1999; 17(2):151-183.
  • Hackam DG, Khan NA, Hemmelgarn BR, Rabkin SW, Touyz RM, Campbell NR, Padwal R, Campbell TS, Lindsay MP, Hill MD et al: The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: part 2 - therapy. Can J Cardiol. 2010; 26(5):249-258.
  • Hepler CD, Strand LM: Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990; 47(3):533-543.
  • Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The Seventh Report oft the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. JAMA. 2003; 289:2560-2572.
  • Lai LL: Community pharmacy-based hypertension disease-management program in a Latino/Hispanic-American population. Consult Pharm. 2007; 22(5):411-416.
  • Lopez LM, Taylor JR: Home blood pressure monitoring: point-of-care testing. Ann Pharmacother. 2004; 38(5):868-873.
  • Machado M, Bajcar J, Guzzo GC, Einarson TR: Sensitivity of patient outcomes to pharmacist interventions. Part II: Systematic review and meta-analysis in hypertension management. Ann Pharmacother. 2007; 41(11):1770-1781.
  • Machin D, Campbell MJ: Statistical tables for design of clinical trials. Chapter 3. Comparing two binomials propotions. Offices Oshey Mead, Oxford OX2OEL edition; 1987.
  • Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A et al: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009, 27(11):2121-2158.
  • Matowe WC, Abahussain EA, Awad A, Capps PA: Self-monitoring of blood pressure and the role of community pharmacists in Kuwait. Med Princ Pract. 2008; 17(1):27-31.
  • McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P et al: Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010; 376(9736):163-172.
  • Morgado MP, Morgado SR, Mendes LC, Pereira LJ, Castelo-Branco M: Pharmacist interventions to enhance blood pressure control and adherence to antihypertensive therapy: Review and meta-analysis. Am J Health Syst Pharm. 2011; 68(3):241-253.
  • O’Brien E, Asmar R, Beilin L, Imai Y, Mancia G, Mengden T, Myers M, Padfield P, Palatini P, Parati G et al: Practice guidelines of the European Society of Hypertension for clinic, ambulatory and self blood pressure measurement. J Hypertens. 2005; 23(4):697-701.
  • Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T et al: European Society of Hypertension practice guidelines for home blood pressure monitoring. J Hum Hypertens. 2010; 24(12):779-785.
  • Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D: Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society Of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension. 2008; 52(1):10-29.
  • Piñeiro F, Gil V, Donis M, Orozco D, Pastor R, Merino J: Validez de 6 métodos indirectos para valorar el cumplimiento del tratamiento farmacológico en la hipertensión arterial. Aten Primaria. 1997; 19(7):372-376.
  • Prado JC, Jr., Kupek E, Mion D, Jr.: Validity of four indirect methods to measure adherence in primary care hypertensives. J Hum Hypertens. 2007; 21(7):579-584.
  • Simpson SH, Johnson JA, Biggs C, Biggs RS, Kuntz A, Semchuk W, Taylor JG, Farris KB, Tsuyuki RT: Practice-based research: lessons from community pharmacist participants. Pharmacotherapy. 2001; 21(6):731-739.
  • Sookaneknun P, Richards RM, Sanguansermsri J, Teerasut C: Pharmacist involvement in primary care improves hypertensive patient clinical outcomes. Ann Pharmacother. 2004; 38(12):2023-2028.
  • Stergiou G, Mengden T, Padfield PL, Parati G, O’Brien E: Self monitoring of blood pressure at home. BMJ. 2004; 329(7471):870-871.
  • Taylor CT, Byrd DC, Krueger K: Improving primary care in rural Alabama with a pharmacy initiative. Am J Health Syst Pharm. 2003; 60(11):1123-1129.
  • Tisdale JE: Role of the pharmacist in managing hypertension in patients with diabetes. Am J Health Syst Pharm. 2006; 63(12):1129.
  • Vivian EM: Improving blood pressure control in a pharmacist-managed hypertension clinic. Pharmacotherapy. 2002; 22(12):1533-1540.
  • Von Muenster SJ, Carter BL, Weber CA, Ernst ME, Milchak JL, Steffensmeier JJ, Xu Y: Description of pharmacist interventions during physician-pharmacist co-management of hypertension. Pharm World Sci. 2008; 30(1):128-135.
  • Zillich AJ, Sutherland JM, Kumbera PA, Carter BL: Hypertension outcomes through blood pressure monitoring and evaluation by pharmacists (HOME study). J Gen Intern Med. 2005; 20(12):1091-1096.