Compliance (medicine)

In medicine, compliance (also adherence, concordance, or capacitance) describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but may also mean use of medical appliances such as compression stockings, chronic wound care, self-directed physiotherapy exercises, or attending counseling or other courses of therapy. Both the patient and the health-care provider affect compliance, and a positive physician-patient relationship is the most important factor in improving compliance,^[1] although the high cost of prescription medication also plays a major role.^[2]

Non-compliance is a major obstacle to the effective delivery of health care. Estimates from the World Health Organization (2003) indicate that only about 50% of patients with chronic diseases living in developed countries follow treatment recommendations.^[1] In particular, low rates of adherence to therapies for asthma, diabetes, and hypertension are thought to contribute substantially to the human and economic burden of those conditions.^[1] Compliance rates may be overestimated in the medical literature, as compliance is often high in the setting of a formal clinical trial but drops off in a "real-world" setting.^[3]

Major barriers to compliance are thought to include the complexity of modern medication regimens, poor "health literacy" and lack of comprehension of treatment benefits, the occurrence of undiscussed side effects, the cost of prescription medicine, and poor communication or lack of trust between the patient and his or her health-care provider.^[4][5][6] Efforts to improve compliance have been aimed at simplifying medication packaging, providing effective medication reminders, improving patient education, and limiting the number of medications prescribed simultaneously.

Terminology

An estimated half of those for whom treatment regimens are prescribed do not follow them as directed.^[1] Until recently, this was termed "non-compliance", which was sometimes regarded as meaning that not following the directions for treatment was due to irrational behavior or willful ignoring of instructions. Today, health care professionals more commonly use the terms "adherence" to or "concordance" with a regimen rather than "compliance", because these terms are thought to more accurately reflect the diverse reasons for patients not following treatment directions in part or in full.^[7][5] However, the preferred terminology remains a matter of debate.^[8][9] In some cases, concordance is used to refer specifically to patient adherence to a treatment regimen that is designed collaboratively by the patient and physician, to differentiate it from adherence to a physician only prescribed treatment regimen.^[10][11] Despite the ongoing debate, adherence is the preferred term for the World Health Organization,^[1] The American Pharmacists Association,^[4] and the U.S. National Institutes of Health Adherence Research Network.^[12]

Concordance also refers to a current UK NHS initiative to involve the patient in the treatment process to improve compliance.^[13] In this context, the patient is informed about their condition and treatment options. They are involved with the treatment team in the decision as to which course of action to take, and partially responsible for monitoring and reporting back to the team. Compliance with treatment is improved by:

• Only recommending treatments that are effective in circumstances when they are required
• Selecting treatments with lower levels of side effect or fewer concerns for long-term use
• Prescribing the minimum number of different medications, e.g., prescribing a single antibiotic that addresses two concurrent infections (though risking contributing to antibiotic resistant species development)
• Simplifying dosage regimen by selecting a different drug or using a sustained release preparation that needs fewer doses during the day^[14]
• Discussing possible side effects, and whether it is important to continue medication regardless of those effects
• Advice on minimising or coping with side effects, e.g., whether to take a particular drug on an empty stomach or with food
• Developing trust so patients don't fear embarrassment or anger if unable to take a particular drug, allowing the doctor to try a better tolerated alternative

Societal impact

A WHO study estimates that only 50% of patients suffering from chronic diseases in developed countries follow treatment recommendations.^[1] This may affect patient health, and affect the wider society when it causes complications from chronic diseases, formation of resistant infections, or untreated psychiatric illness. Compliance rates during closely monitored studies are usually far higher than in later real-world situations. For example, one study reported a 97% compliance rate at the beginning of treatment with statins, but only about 50% of patients were still compliant after six months.^[3]

Compliance issues

Prescription fill rates

While a health care provider visit with a patient may result in the patient leaving with a prescription for medication, not all patients will fill the prescription at a pharmacy. In the U.S., 20-30% of prescriptions are never filled at the pharmacy.^[15][16] There are many reasons patients do not fill prescriptions including the cost of the medication^[4][2], doubting the need for medication, or preference for self-care measures other than medication.^[17][18] Cost may be a barrier to prescription drug adherence, but convenience, side effects and lack of demonstrated benefit are also significant factors to a complex situation. A US nationwide survey of 1,010 adults in 2001 found that 22% chose not to fill prescriptions because of the price, which is similar to the 20-30% overall rate of unfilled prescriptions. ^[2] However, analysis by health insurers suggest that patient co-payment requirements can be reduced to $0 with little or no improvement in long-term adherence rates.

Course completion

Once started, patients seldom follow treatment regimens as directed, and seldom complete the course of treatment.^[4][5] Cost and poor understanding of the directions for the treatment (referred to as 'health literacy') are major barriers to completing treatments.^[4][5][6] As mentioned previously, the World Health Organization (WHO) has estimates that only 50% of people complete long-term therapy for chronic illnesses as they were prescribed, which puts patient health at risk.^[1]

A wide variety of packaging approaches have been proposed to help patients complete prescribed treatments. These approaches include formats that increase the ease of remembering the dosage regimen as well as different labels for increasing patient understanding of directions. ^[19][20] For example, medications are sometimes packed with reminder systems for the day and/or time of the week to take the medicine.^[19] With the objective to support patient adherence to medicinal therapy, a not-for-profit organization (Healthcare Compliance Packaging Council of Europe/HCPC-Europe) [2] was set up between the pharmaceutical industry, the packaging industry and representatives of European patients organizations. The mission of HCPC-Europe is to assist and to educate the healthcare sector in the improvement of patient compliance through the use of packaging solutions. A variety of packaging solutions have been developed by this collaboration to aid in patient compliance.

The failure to complete treatment regimens as prescribed has significant negative health impacts worldwide.^[1] Examples of the rate and consequences of non-compliance for selected medical disorders is as follows:

• Diabetes non-compliance (98% in US) is the principal cause of complications related to diabetes including nerve damage and kidney failure
• Hypertension non-compliance (93% in US, 70% in UK) is the main cause of uncontrolled hypertension-associated heart attack and stroke
• Asthma non-compliance (28-70% worldwide) increase the risk of severe asthma attacks requiring hospitalization

See also

• Polypharmacy and pill burden
• Withdrawal

References

1. ^ ^{a b c d e f g h} World Health Organization (2003) (PDF). Adherence to Long-Term Therapies: Evidence for Action. Geneva: World Health Organisation. ISBN 92-4-154599-2. http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf. 
2. ^ ^{a b c} Harris Interactive. Out-of-pocket costs may be a substantial barrier to prescription drug compliance. Available at: http://www.harrisinteractive.com/news/newsletters/healthnews/HI_HealthCareNews2001Vol1_iss32.pdf. Accessed May 12, 2010.
3. ^ ^{a b} "Patient Compliance with statins". Bandolier. 2004. http://medicine.ox.ac.uk/bandolier/booth/cardiac/patcomp.html. 
4. ^ ^{a b c d e} "Enhancing Patient Adherence: Proceedings of the Pinnacle Roundtable Discussion". APA Highlights Newsletter. October 2004. http://www.pharmacist.com/AM/Template.cfm?Section=Home2&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=11174. 
5. ^ ^{a b c d} Ngoh LN (2009). "Health literacy: a barrier to pharmacist-patient communication and medication adherence". J Am Pharm Assoc (2003) 49 (5): e132–46; quiz e147–9. doi:10.1331/JAPhA.2009.07075. PMID 19748861. 
6. ^ ^{a b} Elliott RA, Marriott JL (2009). "Standardised assessment of patients' capacity to manage medications: a systematic review of published instruments". BMC Geriatr 9: 27. doi:10.1186/1471-2318-9-27. PMC 2719637. PMID 19594913. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2719637. 
7. ^ Tilson HH (2004). "Adherence or compliance? Changes in terminology". Ann Pharmacother 38 (1): 161–2. doi:10.1345/aph.1D207. PMID 14742813. 
8. ^ Osterberg L, Blaschke T (2005). "Adherence to Medication". N Engl J Med 353 (5): 487–97. doi:10.1056/NEJMra050100. PMID 16079372. 
9. ^ Aronson JK (2007). "Compliance, concordance, adherence". Br J Clin Pharmacol 63 (4): 383–4. doi:10.1111/j.1365-2125.2007.02893.x. PMC 2203247. PMID 17378797. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2203247. 
10. ^ Bell JS, Airaksinen MS, Lyles A, Chen TF, Aslani P (2007). "Concordance is not synonymous with compliance or adherence". Br J Clin Pharmacol 64 (5): 710–1. doi:10.1111/j.1365-2125.2007.02971_1.x. PMC 2203263. PMID 17875196. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2203263. 
11. ^ US NIH Office of Behavior and Social Sciences Research (2008). "Framework for adherence research and translation: a blueprint for the next ten years". http://obssr.od.nih.gov/pdf/Workshop_final_report.pdf. 
12. ^ Office of Behavior and Social Sciences Research. "Adherence Research Network". U.S. National Institutes of Health. http://obssr.od.nih.gov/scientific_areas/health_behaviour/adherence/adherenceresearchnetwork.aspx. Retrieved 12 May 2010. 
13. ^ Marinker and Shaw (15 February 2003). "Not to be taken as directed - Putting concordance for taking medicines into practice". BMJ 326 (7385): 348–9. doi:10.1136/bmj.326.7385.348. 
14. ^ "Dosing and compliance?". Bandolier 117: Figure 1. November 2003. http://www.medicine.ox.ac.uk/bandolier/band117/b117-8.html. 
15. ^ Fischer MA, Stedman MR, Lii J, et al. (April 2010). "Primary medication non-adherence: analysis of 195,930 electronic prescriptions". J Gen Intern Med 25 (4): 284–90. doi:10.1007/s11606-010-1253-9. PMC 2842539. PMID 20131023. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2842539. 
16. ^ Norton M. (Reuters Health)Many patients may not fill their prescriptions. (2010), [1] Accessed May 12, 2010
17. ^ Shah NR, Hirsch AG, Zacker C, Taylor S, Wood GC, Stewart WF (February 2009). "Factors associated with first-fill adherence rates for diabetic medications: a cohort study". J Gen Intern Med 24 (2): 233–7. doi:10.1007/s11606-008-0870-z. PMC 2629003. PMID 19093157. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2629003. 
18. ^ Shah NR, Hirsch AG, Zacker C, et al. (April 2009). "Predictors of first-fill adherence for patients with hypertension". Am. J. Hypertens. 22 (4): 392–6. doi:10.1038/ajh.2008.367. PMC 2693322. PMID 19180061. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2693322. 
19. ^ ^{a b} Heneghan CJ, Glasziou P, Perera R (2006). Heneghan, Carl J. ed. "Reminder packaging for improving adherence to self-administered long-term medications". Cochrane Database Syst Rev (1): CD005025. doi:10.1002/14651858.CD005025.pub2. PMID 16437510. 
20. ^ Shrank W, Avorn J, Rolon C, Shekelle P (May 2007). "Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review". Ann Pharmacother 41 (5): 783–801. doi:10.1345/aph.1H582. PMID 17426075. 

External links

• Adherence to Long-Term Therapies, a report from the World Health Organization