Main Approaches to Assessing the Quality of Drug Therapy in Cardiology

A competent choice of drug therapy in a specific clinical situation is a difficult and important task that a practical doctor must regularly solve in everyday practice, and the consequences of errors in this decision can be quite serious. Therefore, evaluation of the quality of the prescribed therapy is extremely important.

In the treatment of cardiovascular diseases, medicines that have a proven effect on the outcomes of the disease, primarily on mortality rates (so-called "life-saving drugs") acquire special significance. There are several classes of such drugs, and in different situations, their positive impact on the prognosis of the disease may be different. On the other hand, one should remember the so-called "drug-related problems" (DRP), which include contraindications to the prescription of certain drugs in a particular patient, the possibility of developing side effects of drug therapy, aggravated by polypharmacy, inter-drug interaction, improper dosage of drugs, etc.

In this publication, an attempt is made to identify the main components by which the quality of the prescribed therapy can be evaluated in the treatment of cardiovascular diseases: compliance of prescriptions with official instructions for preparations, modern clinical guidelines, adequate selection of a specific drug within the class, drug formulation, salt of the drug, evaluation of important safety parameters and efficacy of the prescribed drug. In addition, a review of the methods and scales of the composite evaluation of the quality of drug therapy developed to date has been conducted, as well as attempts to improve them and create new ones that continue to the present day. Nevertheless, none of the currently known methods for assessing the quality of therapy is not universal or devoid of shortcomings.

Most likely, a universal method of assessing the quality of the prescribed treatment may not exist. In its most general form, it can be said that treatment should be based on modern evidence-based medicine, which is usually reflected in the clinical guidelines, without contradicting the official instruction on the use of the drug, considering the presence of concomitant diseases, that are often the reasons of contraindications to prescribing those or other medicines.

1. Shareef J, Sandeep B, Shastry C. Assessment of Drug Related Problems in Patients with Cardiovascular Diseases in a Tertiary Care Teaching Hospital. Journal of Pharmaceutical Care. 2014;2(2):70-6. doi: 10.1186/1472-6823-13-2.

2. Al-Azzam SI, Alzoubi KH, AbuRuz S, Alefan Q. Drug-related problems in a sample of outpatients with chronic diseases: a cross-sectional study from Jordan. Ther Clin Risk Manag. 2016; 17;12:233-9. doi: 10.2147/TCRM.S98165.

3. Russian Federation Federal Law No. 323-FZ of November 21, 2011 (as amended on 07.03.2018) "On the fundamentals of protecting the health of citizens in the Russian Federation". [cited 2018 Aug 15. Available from: http://base.garant.ru/12191967/. (In Russ.)

4. Order of the Ministry of Health of the Russian Federation of July 15, 2016 No. 520n [cited 2018 Aug 15]. Available from: http://base.garant.ru/12191967/. (In Russ.)

5. Vilhelmsson A, Davis C, Mulinari S. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS Med. 2016;13(1):e1001945. doi: 10.1371/journal. pmed.1001945.

6. Bunyatyan ND, Krobov NV, Uteshev DB, Yavorsky AN. Some aspects of the prescription and promotion of medicines 'beyond the instructions'. Politika i Upravleniye v Zdravookhranenii. 2010;2:49-53. (In Russ)

7. Martsevich S.Y., Navasardjan A.R., Komkova N.A. Off-Label Prescribing. Possible Causes, Types and Consequences. Legal Regulation in the Russian Federation. Rational Pharmacotherapy in Cardiology. 2017;13(5):667-74. (In Russ.)

8. Noman A, Ang DS, Ogston S, et al. Effect of high-dose allopurinol on exercise in patients with chronic stable angina: a randomised, placebo controlled crossover trial. Lancet. 2010;375:2161-7. doi: 10.1016/S0140-6736(10)60391-1.

9. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013; 34(38):2949-3003. doi: 10.1093/eurheartj/eht296.

10. Vasiliev AN, Gavrishina EV, Niyazov RR, et al. The instruction on the use of the medicinal product is a key element of the registration dossier. Razrabotka i Registratsiya Lekarstvennykh Sredstv. 2013;5(5):142-9. (In Russ)

11. Greenspan AM, Kay HR, Berger BC, et al. Incidence of unwarranted implantation of permanent cardiac pacemakers in a large medical population. N Engl J Med. 1988;318:158-63. doi: 10.1056/NEJM198801213180306.

12. Field MJ, Lohr KN, eds. Clinical Practice Guidelines: Directions for a New Program, Institute of Medicine. Washington, DC: National Academy Press; 1990.

13. Suarez-Almazor M, Russell A. The art versus the science of medicine. Are clinical practice guidelines the answer? Ann Rheum Dis. 1998;57:67-9. doi: 10.1136/ard.57.2.67.

14. Culleton B. Development and limitations of clinical practice guidelines. In: Parfrey P, Barrett B. (eds.). Methods of Molecular Biology, Clinical Epidemiology. New York, NY: Humana Press; 2009:473.

15. Grimshaw J.M., Russel I.T. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet. 1993;342:1317-22. doi: 10.1016/0140-6736(93)92244-N.

16. Committee on Reviewing Evidence to Identify Highly Effective Clinical Services. Knowing what works in health care: a roadmap for the nation. Washington, DC: National Academies Press, 2008.

17. Eagle KA, Montoye CK, Riba AL, et al. Guideline-based standardized care is associated with substantially lower mortality in Medicare patients with acute myocardial infarction: the American College of Cardiology’s guidelines applied in practice (GAP) projects in Michigan. J Am Coll Cardiol. 2005;46:1242-8. doi: 10.1016/j.jacc.2004.12.083.

18. Tricoci P, Allen J, Kramer J, Califf R, Smith S. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;301:831-41. doi: 10.1001/jama.2009.205.

19. Grol R. Has guideline development gone astray? Yes. BMJ. 2010;340:c306. doi:10.1136/bmj.c306.

20. Wang Z., Norris S.L., Bero L. The advantages and limitations of guideline adaptation frameworks. Implementation Science. 2018;13:72. doi: 10/1186/s13012-018-0763-4.

21. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016;252:207-74. doi: 10.1016/j.atherosclerosis.2016.05.037.

22. National recommendations on the rational pharmacotherapy of patients with cardiovascular diseases. Cardiovascular Therapy and Prevention. 2009;8(6) S4:2-56. (In Russ.)

23. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013;31(7):1281-357. doi: 10.1097/01.hjh. 0000431740.32696.cc.

24. Turi Z.G., Braunwald E. The use of β-blockers afer myocardial infarction. JAMA. 1983;249:2512-6.

25. Soares I, Carneiro AV. Drug Class Effects: Definitions and Practical Applications. Rev Port Cardiol.2002;21(9):1031-42. doi:

26. Woolner D., Holford N. Class effects and the rational comparison of drugs. [cited 2018 Aug 15. Available from: http://holford.fmhs.auckland.ac.nz/docs/class-effects-article.pdf.

27. Guidance for Industry and Review Staff Labeling for Human Prescription Drug and Biological Products Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information Good Review Practice. [cited 2018 Aug 15. Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm186607.pdf.

28. Furberg CD. Class Effects and Evidence Based Medicine. Clinical Cardiology. 2000;23(Suppl. IV): 15-19.

29. Fox KM. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomized, double-blind, placebo-controlled, multicenter trial (the EUROPA study). Lancet. 2003;362(9386):782-8. doi: 10.1016/S0140-6736(03)14286-9.

30. Yusuf S, Sleight P, Pogue J. et al. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med. 2000; 342(3):145-53. doi: 10.1016/S1474-4422(03)00321-1

31. Gersh BJ. The PEACE trial: ACE inhibitors and coronary artery disease. Rev Cardiovasc Med. 2005;6(1):54-9.

32. McGill JB, Bakris GL, Fonseca V, et al. Beta-blocker use and diabetes symptom score: results from the GEMINI study. Diabetes Obes Metab. 2007;9(3):408-17. doi: 10.1111/j.1463-1326. 2006.00693.x.

33. Sierra C, Coca A. The ACTION study: nifedipine in patients with symptomatic stable angina and hypertension. Expert Rev Cardiovasc Ther. 2008;6(8):1055-62. doi: 10.1586/14779072.6.8.1055.

34. Metelitsa VI. Handbook of Clinical Pharmacology of Cardiovascular Drugs. Moscow: OOO Meditsinskoye Informatsionnoye Agentstvo; 2005. (In Russ.)

35. Makary MA, Daniel M. Medical error the third leading cause of death in the US. BMJ. 2016; 353: i2139. doi: 10.1136/bmj.i2139.

36. Wester K, Jonsson AK, Spigset O, et al. Incidence of fatal adverse drug reactions: a population based study. Br J Clin Pharmacol. 2008;65:573-9. doi: 10.1111/j.1365-2125.2007.03064.x.

37. WHO The Pursuit of Responsible Use of Medicines: Sharing and Learning from Country Experiences. WHO/EMP/MAR/2012.3. [cited 2018 Aug 15. Available from: http://www.who.int/ medicines/publications/responsible_use/en/.

38. WHO Definition of rational use of medicines (1985). [cited 2018 Aug 15. Available from: http://apps.who.int/medicinedocs/en/d/Jh3011e/1.html.

39. Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D. STOPP (Screening Tool of Older Person’s Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther. 2008;46:72-83.

40. O’Mahony D., O’Sullivan D., Byrne S. et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015;44(2):213-8. doi: 10.1093/ageing/afu145.

41. Fastbom J, Johnell K. National indicators for quality of drug therapy in older persons: the Swedish experience from the first 10 years. Drugs Aging. 2015;32:189-99. doi: 10.1007/s40266-0150242-4.

42. Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007;63:725-31. doi: 10.1007/s00228-007-0324-2.

43. Holt S, Schmiedl S, Thurmann PA. Potentially inappropriate medications in the elderly: the PRISCUS list. Dtsch Arztebl Int. 2010;107:543-51. doi: 10.3238/arztebl.2010.0543.

44. Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med. 1991;151:1825-32. doi: 10.1001/archinte.1991.00400090107019.

45. American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Journal of the American Geriatrics Society. 2015;63(11):2227-46. doi: 10.1111/jgs.13702.

46. Samsa G.P., Hanlon J.T., Schmader K.E. et al. A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. Clin Epidemiol.1994;47(8):891-6.

47. Somers A., Mallet L., van der Cammen T. et al. Applicability of an adapted medication appropriateness index for detection of drug-related problems in geriatric inpatients. The American Journal of Geriatric Pharmacotherapy. 2012, 10(2):101-9. doi: 10.1016/j.amjopharm.2012.01.003.

48. Eapen ZJ, Fonarow GC, Dai D, et al. Comparison of composite measure methodologies for rewarding quality of care: an analysis from the American Heart Association's Get With The Guidelines program. Circulation Cardiovascular Quality and Outcomes. 2011;4(6):610-8. doi: 10.1161/CIRCOUTCOMES.111.961391..

49. Suvorov A.Y., Martsevich S.Y., Kutishenko N.P., et al. Evaluation of the conformity of cardiovascular therapy to current clinical guidelines in the improvement of outcomes in patients after stroke (according to the LIS-2 register). Rational Pharmacotherapy in Cardiology. 2015;11(3):247-52. (In Russ.)

50. Malyavin AG, Adasheva TV, Martynov AI, Volskaya EA. Development of an interactive system of expert support for medical solutions for rational prescribing of drugs in cases of comorbidity. Remedium. 2016;11:52-5. (In Russ.)

51. Garfinkel D, Mangin D. Feasibility Study of a Systematic Approach for Discontinuation of Multiple Medications in Older Adults Addressing Polypharmacy. Arch Intern Med. 2010;170:1648-54. doi: 10.1001/archinternmed.2010.355.

52. Pazan F, Weiss C, Wehling M. The FORTA (Fit fOR The Aged) List 2015: Update of a Validated Clinical Tool for Improved Pharmacotherapy in the Elderly. Drugs Aging. 2016; 33(6):447-449. doi: 10.1007/s40266-016-0371-4.