ORIGINALS

 

Medical professionals' perceptions regarding therapeutic adherence in patients with osteoporosis

Percepción de los profesionales médicos respecto la adherencia terapéutica de los pacientes con osteoporosis

 

 

Blanch J.¹, Casado E.², González J.³, Valdés C.⁴, Ruiz-Baena J.⁵, Palomino R.⁵ and Nogués X.⁶

¹ Servicio de Reumatología - Parque de Salud Mar - Instituto Hospital del Mar de Investigaciones Médicas (IMIM) - Barcelona (España)
² Servicio de Reumatología - Hospital Universitario Parque Taulí - Sabadell - Barcelona (España)
³ Unidad de Gestión Clínica Reumatología - Complejo Hospitalario Universitario de Granada - Granada (España)
⁴ Medicina Familiar y Comunitaria - Centro de Salud Fuencarral - Dirección Asistencial Norte - Servicio Madrileño de Salud (SERMAS) - Madrid (España)
⁵ GOC Networking - Barcelona (España)
⁶ Departamento de Medicina Interna - Parque de Salud Mar - Universidad Autónoma de Barcelona - Barcelona (España). Instituto Hospital del Mar de Investigaciones Médicas (IMIM) - Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad (RETICEF) - Instituto de Salud Carlos III FEDER - Barcelona (España)

The study has been funded with a grant from LACER, S.A., who was not involved at any point in the design, analysis, data interpretation, or writing of the final report published manuscript.

Correspondence

 

 

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SUMMARY

Introduction: Adherence to oral treatment of patients with osteoporosis is low, with a high dropout rate in the first year. The most noteworthy result is the lack of therapeutic response.
Objective: To ascertain the perception of physicians working with osteoporotic patients regarding adherence of these patients.
Methods: Cross-sectional study conducted by opinion survey aimed at primary care physicians and specialists involved in osteoporosis treatment. Participants were selected by purposive sampling.
Results: The questionnaire was answered by 235 specialists encompassing rheumatology (54.5%), orthopedics (10.6%) and primary care (18.7%). In 43.8% of participants, more than 25% of patients sometimes forget to take their treatment. According to 34.9%, more than 75% of patients are aware of treatment. Side effects and management complexity are the majority reasons that lead to a change in medication, mean value of 7.94±2.06 6±2.01 points respectively on a 0-10 scale.
Conclusions: Overall, medical specialists attributed low adherence to side effects, polypharmacy and lack of communication between professionals. Dosage and space use of soluble dosage forms may be options to facilitate patient adherence to treatment with oral bisphosphonates. Improved education concerning the importance of the disease or increased patient monitoring could foster adherence.

Key words: osteoporosis, surveys, bisphosphonates, therapeutic adherence, opinion.

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RESUMEN

Inroducción: La adherencia al tratamiento oral del paciente con osteoporosis es baja, con un alto porcentaje de abandonos durante el primer año. La consecuencia más notable es la falta de respuesta terapéutica.
Objetivo: Conocer la percepción de los facultativos involucrados en el abordaje del paciente osteoporótico en relación a la adherencia terapéutica de estos pacientes.
Material y métodos: Estudio descriptivo transversal realizado mediante una encuesta de opinión dirigida a médicos de Atención Primaria y Atención Especializada involucrados en el tratamiento de la osteoporosis. Los participantes fueron seleccionados mediante muestreo intencionado.
Resultados: El cuestionario fue contestado por 235 especialistas de Reumatología (54,5%), Traumatología (10,6%) y Atención Primaria (18,7%). En opinión del 43,8% de los encuentados, más de un 25% de los pacientes olvida alguna vez tomar el tratamiento. Según el 34,9%, más de 75% de los pacientes están concienciados con el tratamiento. Los efectos secundarios y la complejidad de la administración son las razones mayoritarias que propician un cambio de medicación, con una importancia media de 7,94±2,06 y 6±2,01 puntos respectivamente en una escala 0-10.
Conclusiones: Los facultativos percibieron baja adherencia terapéutica asociada fundamentalmente a los efectos secundarios, a la polimedicación y a la falta de comunicación entre profesionales. Espaciar la dosificación y el uso de formas galénicas solubles podrían ser opciones para facilitar la adherencia del paciente al tratamiento con bisfosfonatos orales. Mejorar la educación sobre la importancia de la enfermedad o aumentar el seguimiento del paciente serían algunos de los aspectos que podrían favorecer la adherencia terapéutica.

Palabras clave: osteoporosis, encuesta, bisfosfonatos, adherencia terapéutica, opinión.

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Introduction

Osteoporosis is a systemic skeletal disease characterized by low bone mass and altered bone microarchitecture causing increased fragility and consequently increased susceptibility to fractures [1]. According to the WHO diagnostic criteria, about 6% of men and 21% of women aged 50-84 years suffer osteoporosis [2]. At a European level, approximately 27.6 million men and women suffered from osteoporosis in 2010, of which 9% were Spanish. Osteoporosis is a major public health problem due to high predisposition to suffer bone fractures [3,4]. Osteoporosis causes more than 8.9 million fractures annually [5], with high healthcare costs [3,6] and a significant decline in the patient's quality of life [2].

The main objective in treating osteoporosis is to prevent fractures, improve patients' quality of life and ease the pain when it occurs. Most of the drugs available today obtain fracture risk reductions of 50-70% for vertebral fractures and 15-25% for the rest of vertebral fractures [2]; provided that the patient takes the medication continuously for the period of time that most baseline studies have shown effectiveness, between 3 and 5 years. Bisphosphonates are the most commonly used alternative therapy in the management of osteoporosis and are considered the first choice in our sector [7,8].

The term adherence encompasses the concepts of compliance and persistence. Compliance involves when and how the prescribed medication is taken, while persistence refers to how long the patient takes it. On the other hand, drug tolerability concerns the patient acceptance of the medication, based mainly on the perception and impact of the drug's unwanted side effects [9].

As osteoporosis is a silent disease, with no symptoms, even in the case of asymptomatic vertebral fractures, patients tend to think that drug treatment is not necessary. On the other hand, the lack of adherence and poor compliance are determined by other factors such as the drugs' side effects, advanced age of patients, polypharmacy or even fatigue patient to take medication on a long-term basis [10].

Adherence to treatment among patients with osteoporosis is low, with a high percentage of dropouts during the first year [11-15]. The most striking result is the lack of therapeutic response and the consequent increase in fracture. So proper adherence to treatment is not only beneficial to patients' health, but also effective in terms of cost-effectiveness [16-20].

This study aims to determine the perception of medical professionals involved in the treatment of osteoporosis concerning patient adherence to treatment in general and in particular regarding bisphosphonates, as well as analyze possible causes and solutions.

 

Material and methods

This cross-sectional surveyed primary care physicians (PCP) and specialized care professionals who treat patients with osteoporosis. The survey consisted of 13 questions on health professionals' perception regarding adherence of osteoporotic patients (Annex 1), and was completed through a website. Participants were selected through purposeful sampling and invited by the Spanish Society for Bone and Mineral Metabolism Research (SEIOMM) to which they were associated. To estimate the number of specialists participating in the survey, reference was made to a national population of about 20,000 PCP doctors, 5,000 primary care physicians and medical specialists were selected. According to the calculated sample size, made taking the scenario of worst participation ratio to an expected accuracy of 10% and a confidence level of 95% required a minimum of 200 participating physicians.

 

 

Statistical analysis was performed using SPSS version 23.0. (SPSS Inc. Chicago, Illinois, USA). The number and percentage of response was used for the description of categorical variables. The mean, standard deviation, median, minimum and maximum are used to describe continuous variables.

 

Results

The questionnaire was answered by 235 physicians (63.4% male) with a mean age of 48.77±9.13 years. The most represented specialist areas were rheumatology (54.5%), orthopedics (10.6%) and Primary Care (18.7%). Respondents were from 15 different regional communities, with Andalusia (17.4%), Valencia (14.5%), Catalonia (14.5%) and Madrid (11.9%) showing a greater number of participants. 79.6% reported monthly visits to 100 patients for osteoporosis; the rest, 64.3% visited from 25 to 100 and 15.4% less than 25 patients.

Regarding the perception of physicians consulted on patient adherence to oral treatment for osteoporosis, 43.8% said that more than 25% of their patients sometimes forget to take treatment, although 80.4% reported that nearly half of patients do not take the medication at the recommended hours. 34.9% said that more than 75% of patients are conscious about the need for treatment. However, more than half of the patients stop taking it if they experience discomfort, according to 57.5% of the physicians surveyed (Figure 1).

 

 

Among the reasons that cause the lack of adherence, 83.0% of respondents felt that the poor coordination between levels of care is an important factor, mainly due to the lack of communication (41.3%), administrative barriers (15.3%), lack of training (14.0%) and applying different protocols (12.3%).

Regarding the causes for a change in treatment, the doctors surveyed reported that the side effects and management complexity are the main reasons, with an average value of 7.94±2.06 and 6±2.01 points respectively (scale of 1: did not motivate changes, 10: motivated major changes) (Figure 2). On the other hand, they indicated that more than half of patients (57%) were usually involved in the choice of treatment.

 

 

Regarding the most commonly used methods to assess adherence, 77.9% of respondents reported directly consulting the patient, while 10.2% said that the most common technique is to count the mismatch between the number of containers dispensed or requested by the patient and the amount prescribed. Other methods such as biochemical remodeling markers (4.7%), the Morisky-Green test (3.0%), clinical trial (2.6%) or Haynes-Sackett test (0,9%) were less frequent. Only 0.9% of respondents answered that they did not usually ask about compliance.

Regarding treatment with bisphosphonates, 51-75% of patients are treated and comply with such treatment in 63% and 60.9% of respondents, respectively. Furthermore, among patients who abandon treatment, 40% do so before six months, 29.4% between six and twelve months, and 30.6% after the first year.

According to the physicians surveyed, the main reasons for poor adherence to bisphosphonates are polypharmacy (7.37±1.9 points), side effects (7.34±1.93 points) and the few symptoms of the disease (6.58±2.24 points) (scale of 1: rare, 10: very common) (Figure 3). On the other hand, the restriction of eating and drinking before and after drug intake as instructed is more difficult to follow administration by patients (5.26±2.04 points) (scale of 1: easy to comply, 10: very difficult to enforce) (Figure 4).

 

 

 

As for the impact of various actions to facilitate treatment compliance to bisphosphonates, the most valued (scale of 1: no impact, 10: maximum impact) were: reducing the number of doses (7.57±1.88 points), providing patient with educational material about the disease and its treatment (7.25±1.89 points) and control of adherence in the first few weeks of its inception by nurses (7.12±2.21 points) (Figure 5). Finally, 88.9% of physicians surveyed believed that adherence to oral bisphosphonate treatments would improve greatly or rather a lot if it were administered in a soluble dosage.

 

 

Discussion

Regarding monthly care of 100 patients with osteoporosis (79.6% of respondents), and considering that 54.5% of respondents were rheumatology specialists, the results show that, in general, physicians perceive low patient adherence to oral treatment for osteoporosis. The figures concerning compliance and adherence of osteoporotic patients vary among different publications due to the calculation methods used in each. However, all agree that they could be improved [21-23].

The perception of a portion of respondents (43.8%) is that adherence is low, considering that more than 25% of their patients forget to take their medication. These data are consistent with a recent study in primary care centers in the Canary Islands (Spain), where 24.1% of patients with fractures were not taking their prescribed medication [24]. Another retrospective study with similar characteristics performed in Spain showed that 29.5% of patients were not compliant with the proper drug treatments [25].

The efficacy of anti-osteoporotic drugs involves prolonged medication, which makes patient neglect of the drug quite common, thus reducing its effectiveness [26]. Clearly, proper adherence is beneficial to patient health [13,16,17,20].

In our study, one of the interesting aspects of the respondents' answers is that among the reasons for lack of adherence, poor coordination between levels of care and lack of communication. There may be communication problems between primary and specialized care, especially at the time of drug prescription, because in many cases the primary care physician is confronted with a medication prescribed by another physician without a specified report. Some studies have already shown that better communication can solve problems better and is a more efficient system [27].

According to respondents, and in line with other publications, other reasons for this lack of patient adherence are the medication's side effects and polypharmacy; which are also perceived as the most common reasons for a change in treatment with bisphosphonates [26,28-32].

Oral bisphosphonates have become the main drug treatment for osteoporosis [7]. This coincides with the perception of physicians consulted, since, in their view, between 2 or 3 out of 4 patients receiving this treatment present an average level of compliance. However, a high percentage (69.4%) of patients discontinue treatment within the first year, a figure somewhat higher than those reported in other publications [33,34]. In fact, these data reflect the reality of many studies that abandonment of drug treatments and bisphosphonates occurs in 53.9% of cases due to side effects [10].

In this study, polypharmacy and adverse effects seem the main causes of abandonment of oral bisphosphonates. In fact, osteoporosis patients are generally older, and co-morbidity because many of them have received multiple treatments, complicating good compliance and adherence to them. Furthermore, the main adverse effect described with oral bisphosphonates is poor gastrointestinal tolerance, mainly as reflux heartburn or epigastric pain which, as already described in the literature, is one of the main reasons for dropping out.

Assess adherence and treatment compliance require specific tools to ensure methodologic objectivity such as Haynes-Sackett or Morisky-Green tests [9,26]. However, in our study most respondents reported that they preferred direct patient consultation in clinical practice. This reflects the need to improve the query time in both primary care and specialized centers, so that physicians can use more proven methods than simple observation in daily practice.

In line with these study results, the reduced frequency of taking medication, patient education and monitoring of adherence have been proposed among the actions considered that could improve the taking of bisphosphonates [29,30,35-39].

Probably a combination of all these recommendations would be the best strategy to promote compliance and adherence. On the other hand, as most osteoporosis patients are elderly and may have difficulty swallowing, a soluble dosage form would improve the gastric tolerability of bisphosphonates, which would favor patients' treatment compliance, as noted by 88.9% of those physicians surveyed [40].

In conclusion, this survey shows that experts who manage osteoporosis perceived low patient adherence to oral treatment of disease. Poor adherence is mainly embodied by the abandonment of medication during the first year of therapy, and is mainly associated with the side effects, polypharmacy and lack of communication between professionals. Improved comfort by reducing the number of shots and using soluble dosage forms, improved education about the importance of the disease and improved patient follow-up, could foster adherence.

 

Conflict of interest

The authors declare no conflict of interest in this paper.

 

 

Correspondence:
Josep Blanch
Hospital del Mar
Paseo Marítimo, 25-29
08003 Barcelona (España)
Correo electrónico: 20143@parcdesalutmar.cat

Date of receipt: 08/10/2015
Date of acceptance: 27/11/2015

 

 

Bibliography

1. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. South Med J 2001;94:569-73.         [ Links ]

2. Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 2013;8:136.         [ Links ]

3. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007;22:465-75.         [ Links ]

4. Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int 2005;16(Suppl 2):S3-7.         [ Links ]

5. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-33.         [ Links ]

6. Nogués Solán X, Guerri R, Solé E, Díez-Pérez A. Impacto socioeconómico de la osteoporosis. Rev Osteoporos Metab Miner 2010;2:S8-S11.         [ Links ]

7. González-Macías J, Del Pino-Montes J, Olmos JM, Nogués X; en nombre de la Comisión de Redacción de las Guías de Osteoporosis de la SEIOMM. Guías de práctica clínica en la osteoporosis posmenopáusica, glucocorticoidea y del varón. Sociedad Española de Investigación ósea y Metabolismo Mineral (3^a versión actualizada 2014). Rev Clin Esp 2015;215:515-26.         [ Links ]

8. Sosa Henriquez M, Filgueira Rubio J, Lopez-Harce Cid JA, Diaz Curiel M, Lozano Tonkin C, del Castillo Rueda A, et al. What is the opinion of Spanish internists on osteoporosis?. Rev Clin Esp 2005;205:379-82.         [ Links ]

9. Nogués Solán X, Sorli Redó ML, Villar García J. Instrumentos de medida de adherencia al tratamiento. An Med Interna 2007;24:138-41.         [ Links ]

10. Clark EM, Gould VC, Tobias JH, Horne R. Natural history, reasons for, and impact of low/non-adherence to medications for osteoporosis in a cohort of community-dwelling older women already established on medication: a 2-year follow-up study. Osteoporos Int 2015 Aug 19. (Epub ahead of print).         [ Links ]

11. Rabenda V, Hiligsmann M, Reginster JY. Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence. Expert Opin Pharmacother 2009;10:2303-15.         [ Links ]

12. Rossini M, Bianchi G, Di Munno O, Giannini S, Minisola S, Sinigaglia L, et al. Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 2006;17:914-21.         [ Links ]

13. Papaioannou A, Kennedy CC, Dolovich L, Lau E, Adachi JD. Patient adherence to osteoporosis medications: problems, consequences and management strategies. Drugs Aging 2007;24:37-55.         [ Links ]

14. Gómez de Tejada Romero M. La adherencia en el tratamiento de la osteoporosis. Rev Osteoporos Metab Miner 2010;2:S10-S4.         [ Links ]

15. Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, et al. Early discontinuation of treatment for osteoporosis. Am J Med 2003;115:209-16.         [ Links ]

16. Imaz I, Zegarra P, Gonzalez-Enriquez J, Rubio B, Alcazar R, Amate JM. Poor bisphosphonate adherence for treatment of osteoporosis increases fracture risk: systematic review and meta-analysis. Osteoporos Int 2010;21:1943-51.         [ Links ]

17. Danese MD, Badamgarav E, Bauer DC. Effect of adherence on lifetime fractures in osteoporotic women treated with daily and weekly bisphosphonates. J Bone Miner Res 2009;24:1819-26.         [ Links ]

18. Fleurence RL, Iglesias CP, Johnson JM. The cost effectiveness of bisphosphonates for the prevention and treatment of osteoporosis: a structured review of the literature. Pharmacoeconomics 2007;25:913-33.         [ Links ]

19. Cotte FE, Fautrel B, De Pouvourville G. A Markov model simulation of the impact of treatment persistence in postmenopausal osteoporosis. Med Decis Making 2009;29:125-39.         [ Links ]

20. Siris ES, Selby PL, Saag KG, Borgstrom F, Herings RM, Silverman SL. Impact of osteoporosis treatment adherence on fracture rates in North America and Europe. Am J Med 2009;122(Suppl 2):S3-13.         [ Links ]

21. Turbi C, Herrero-Beaumont G, Acebes JC, Torrijos A, Grana J, Miguelez R, et al. Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: An open-label, prospective, nonrandomized, observational study. Clin Ther 2004;26:245-56.         [ Links ]

22. Ringe JD, Christodoulakos GE, Mellstrom D, Petto H, Nickelsen T, Marin F, et al. Patient compliance with alendronate, risedronate and raloxifene for the treatment of osteoporosis in postmenopausal women. Curr Med Res Opin 2007;23:2677-87.         [ Links ]

23. Hazel-Fernandez L, Louder AM, Foster SA, Uribe CL, Burge RT. Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study. BMC Musculoskelet Disord 2013;14:4.         [ Links ]

24. Sosa Henríquez. M, Grupo de Trabajo en Osteoporosis Canario. Las mujeres osteoporóticas con fracturas muestran mayor cumplimiento terapéutico que las no fracturadas. Rev Osteoporos Metab Miner 2014;6:8-13.         [ Links ]

25. Diez A, Carbonell C, Calaf J, Caloto MT, Nocea G. Observational study of treatment compliance in women initiating antiresorptive therapy with or without calcium and vitamin D supplements in Spain. Menopause 2012;19:89-95.         [ Links ]

26. Cadarette SM, Burden AM. Measuring and improving adherence to osteoporosis pharmacotherapy. Curr Opin Rheumatol 2010;22:397-403.         [ Links ]

27. Biagetti B, Aulinas A, Dalama B, Nogues R, Zafon C, Mesa J. Communication between primary care and physician specialist: is it improving? Rev Calid Asist 2015;30:175-81.         [ Links ]

28. Carr AJ, Thompson PW, Cooper C. Factors associated with adherence and persistence to bisphosphonate therapy in osteoporosis: a cross-sectional survey. Osteoporos Int 2006;17:1638-44.         [ Links ]

29. Schousboe JT, Dowd BE, Davison ML, Kane RL. Association of medication attitudes with non-persistence and non-compliance with medication to prevent fractures. Osteoporos Int 2010;21:1899-909.         [ Links ]

30. Lau E, Papaioannou A, Dolovich L, Adachi J, Sawka AM, Burns S, et al. Patients' adherence to osteoporosis therapy: exploring the perceptions of postmenopausal women. Can Fam Physician 2008;54:394-402.         [ Links ]

31. Kamatari M, Koto S, Ozawa N, Urao C, Suzuki Y, Akasaka E, et al. Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate. J Bone Miner Metabol 2007;25:302-9.         [ Links ]

32. McHorney CA, Schousboe JT, Cline RR, Weiss TW. The impact of osteoporosis medication beliefs and side-effect experiences on non-adherence to oral bisphosphonates. Curr Med Res Opin 2007;23:3137-52.         [ Links ]

33. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:271-87.         [ Links ]

34. Rabenda V, Mertens R, Fabri V, Vanoverloop J, Sumkay F, Vannecke C, et al. Adherence to bisphosphonates therapy and hip fracture risk in osteoporotic women. Osteoporos Int 2008;19:811-8.         [ Links ]

35. Cramer JA, Gold DT, Silverman SL, Lewiecki EM. A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 2007;18:1023-31.         [ Links ]

36. Costa i Pagès J. Descanso en el tratamiento con bifosfonatos: quién, cuándo y por cuánto tiempo. Bulleti d'Informació Terapéutica 2014;25:29.         [ Links ]

37. Zolnierek KB, Dimatteo MR. Physician communication and patient adherence to treatment: a meta-analysis. Med Care 2009;47:826-34.         [ Links ]

38. Gleeson T, Iversen MD, Avorn J, Brookhart AM, Katz JN, Losina E, et al. Interventions to improve adherence and persistence with osteoporosis medications: a systematic literature review. Osteoporos Int 2009;20:2127-34.         [ Links ]

39. Schlenk EA, Bernardo LM, Organist LA, Klem ML, Engberg S. Optimizing medication adherence in older patients: a systematic review. J Clin Outcomes Manag 2008;15:595-606.         [ Links ]

40. Hodges LA, Connolly SM, Winter J, Schmidt T, Stevens HN, Hayward M, et al. Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate. Int J Pharm 2012;432:57-62.         [ Links ]