Methods for assessing the quality of pharmacotherapy as tools for improving the effectiveness and safety of treatment interventions
https://doi.org/10.37489/2588-0519-2025-3-97-105
EDN: LYYFLW
Abstract
Introduction. Improving the efficiency and safety of pharmacotherapy in healthcare are priority tasks for healthcare systems. Irrational pharmacotherapy, polypharmacy, and adverse drug interactions typically lead to undesirable side effects, which not only reduces the efficacy and safety of treatment but also increases its cost. The selection of methods for assessing the quality of drug therapy prescribed to an individual patient, as well as the organization of quality control for pharmacotherapy in medical institutions, remain highly relevant.
Objective. To study the experience of using various methods for assessing the quality and safety of pharmacotherapy in the clinical practice of domestic and foreign healthcare systems.
Materials and methods. A review analysis of the use of methods for assessing the quality and safety of pharmacotherapy in domestic and international clinical practice was conducted based on a selection of publications identified through a keyword search. A list of the most frequently used methods for assessing the quality of pharmacotherapy was determined, including: the GTT method, Beers criteria, the GerontoNet scale, the STOPP/START criteria, and the Medication Appropriateness Index (MAI). Restrictive drug lists adopted in Sweden, France, Germany, and Turkey, which were developed using these methods to prevent the inappropriate use of medications, were also considered. Specialists widely use drug databases, such as Drug-drug interaction databases, to improve the quality of pharmacotherapy and prevent adverse drug interactions.
Conclusions. Currently, comprehensive approaches and methodologies for assessing the quality and safety of pharmacotherapy, suitable for regulatory purposes and widespread implementation, have not yet been fully established in many countries, including the domestic healthcare system. Previously, by Order of the Ministry of Health of Russia No. 494 dated October 22, 2003, "On Improving the Activities of Physicians — Clinical Pharmacologists," the "Form of Expert Assessment of the Quality of Pharmacotherapy" was adopted, which allows for an assessment of the quality of pharmacotherapy with a conclusion based on expert opinion. Modern evidence-based medicine approaches require a quantitative assessment of pharmacotherapy review results to enable an objective conclusion. In this regard, it is relevant to create an expert tool for assessing the quality and safety of pharmacotherapy based on the integrated use of existing assessment methods. This tool should be capable of determining compliance with: clinical guidelines, the clinical efficacy of drug therapy, rationality and safety indicators, including an assessment of the risks of adverse reactions.
About the Authors
T. I. KolesnikRussian Federation
Timofey I. Kolesnik — Intern researcher of the Department of process management in the field of healthcare and public health, clinical pharmacologist
Moscow
Competing Interests:
The authors declare no conflict of interest
L. A. Gabbasova
Russian Federation
Lyalya A. Gabbasova — Dr. Sci. (Med.), Associate professor, Head of the Department of process management in the field of healthcare and public health, Deputy director of the University Clinic, Professor of the Department of multidisciplinary clinical training FFM
Moscow
Competing Interests:
The authors declare no conflict of interest
E. P. Pavlikova
Russian Federation
Elena P. Pavlikova — Dr. Sci. (Med.), Associate professor, Head of the Scientific Department of Internal Diseases, Deputy Director for Medical Work-Chief Physician of the University Clinic, Professor of the Department of Internal medicine FFM
Moscow
Competing Interests:
The authors declare no conflict of interest
References
1. Martsevich S.Yu., Kutishenko N.P., Lukina Yu.V., et al. Main Approaches to Assessing the Quality of Drug Therapy in Cardiology. Rational Pharmacotherapy in Cardiology. 2018;14(4):558-566. (In Russ.).
2. Saraf AA, Petersen AW, Simmons SF, et al. Medications associated with geriatric syndromes and their prevalence in older hospitalized adults discharged to skilled nursing facilities. J Hosp Med. 2016 Oct;11(10):694- 700. doi: 10.1002/jhm.2614.
3. Troshina E.A., Barysheva V.O., Umarkhadzhieva Z.R. Polypragmasy and the basics of personalized rational pharmacotherapy selection in older patients with obesity and type 2 diabetes mellitus. Obesity and metabolism. 2023;20(4):275-282. (In Russ.).
4. Cherniaeva M.S., Rozhkova M.A., Kazakova M.V., et al. Experience of using Beers criteria in clinical practice (according to Russian literature). FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2024;17(3):384-395. (In Russ.).
5. Lukina Yu.V., Kutishenko N.P., Martsevich S.Yu., Drapkina O.M. Issues of concern and development of classifications of the main parameters of therapy quality and compliance. Part III: quality of pharmacotherapy. Cardiovascular Therapy and Prevention. 2024;23(12):4268. (In Russ.).
6. Polypharmacy in clinical practice: problems and solutions / edited by D. A. Sychev; scientific editor V. A. Otdelenov. — St. Petersburg: Center for Clinical Practice “Profession”, 2016. — 224 p. (In Russ.).
7. Gnjidic D, Hilmer SN, Blyth FM, et al. Polypharmacy cutoff and outcomes: five or more medicines were used to identify community-dwelling older men at risk of different adverse outcomes. J Clin Epidemiol. 2012 Sep;65(9):989-95. doi: 10.1016/j.jclinepi.2012.02.018.
8. Order of the Russian Ministry of Health dated November 2, 2012, No. 575n. "On approval of the procedure for providing medical care in the field of clinical pharmacology" (In Russ.).
9. Order of the Ministry of Health of Russia dated October 22, 2003 No. 494 "On improving the activities of physicians - clinical pharmacologists." (In Russ.).
10. Federal Law of November 21, 2011 No. 323-FZ "On the Fundamentals of Health Protection of Citizens in the Russian Federation". (In Russ.).
11. Federal Law of April 12, 2010 No. 61-FZ “On the circulation of medicines. (In Russ.).
12. Decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 88 “On approval of requirements for the instructions for medical use of a medicinal product and the general characteristics of a medicinal product for medical use” (with amendments and additions). (In Russ.).
13. Bunyatyan ND, Korobov NV, Uteshev DB, Yavorskii AN. Off-Label Drugs: Some Aspects of Their Use and Promotion. Medical Technologies. Assessment and Choice. 2010;2:49-53. (In Russ.).
14. Navasardyan A.R., Martsevich S.Yu., Gabay P.G. Prescribing Drugs not in Accordance with the Official Instructions for Medical Use (Off-label), Clinical Guidelines, Standards of Medical Care and Legal Regulation in the Russian Federation. Part 2. Rational Pharmacotherapy in Cardiology. 2021;17(2):286-293. (In Russ.).
15. Resolution of the Government of the Russian Federation of October 27, 2023 No. 1799 "On approval of requirements for a medicinal product registered in the Russian Federation, used in accordance with the indicators (characteristics) of the medicinal product that are not specified in the instructions for its use, the inclusion of which is permitted in the standards of medical care for children and clinical guidelines" (with amendments and additions). (In Russ.).
16. Fox KM; EURopean trial On reduction of cardiac events with Perindopril in stable coronary Artery disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet. 2003 Sep 6;362(9386):782-8. doi: 10.1016/s0140-6736(03)14286-9.
17. Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301. Erratum in: 2000 May 4;342(18):1376. Erratum in: N Engl J Med 2000 Mar 9;342(10):748.
18. Walckiers D, Van der Heyden J, Tafforeau J. Factors associated with excessive polypharmacy in older people. Arch Public Health. 2015 Nov 9;73:50. doi: 10.1186/s13690-015-0095-7.
19. Hovstadius B, Hovstadius K, Astrand B, Petersson G. Increasing polypharmacy - an individual-based study of the Swedish population 2005-2008. BMC Clin Pharmacol. 2010 Dec 2;10:16. doi: 10.1186/1472-6904-10-16.
20. Pirmohamed M, Park BK. Adverse drug reactions: back to the future. Br J Clin Pharmacol. 2003 May;55(5):486-92. doi: 10.1046/j.1365-2125.2003.01847.x.
21. Thong BY, Tan TC. Epidemiology and risk factors for drug allergy. Br J Clin Pharmacol. 2011 May;71(5):684-700. doi: 10.1111/j.1365-2125.2010.03774.x.
22. Metelitsa V. I. Handbook of Clinical Pharmacology of Cardiovascular Drugs / V. I. Metelitsa. - 3rd ed., revised and enlarged. - M.: Medical Information Agency (MIA), 2005. - 1536 p. (In Russ.).
23. Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016 May 3;353:i2139. doi: 10.1136/bmj.i2139.
24. Seddon ME, Jackson A, Cameron C, et al. The Adverse Drug Event Collaborative: a joint venture to measure medication-related patient harm. N Z Med J. 2012 Jan 25;126(1368):9-20.
25. Jha AK, Kuperman GJ, Teich JM, et al. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. J Am Med Inform Assoc. 1998 May-Jun;5(3):305-14. doi: 10.1136/jamia.1998.0050305.
26. Ferranti J, Horvath MM, Cozart H, eta l. A multifaceted approach to safety: the synergistic detection of adverse drug events in adult inpatients. Journal of Patient Safety. 2008;4(3):184–190.
27. Hug BL, Keohane C, Seger DL, et al. The costs of adverse drug events in community hospitals. Jt Comm J Qual Patient Saf. 2012 Mar;38(3):120- 6. doi: 10.1016/s1553-7250(12)38016-1.
28. Williams D. Monitoring medicines use: the role of the clinical pharmacologist. Br J Clin Pharmacol. 2012 Oct;74(4):685-90. doi: 10.1111/j.1365-2125.2012.04316.x.
29. Barber N, Rawlins M, Dean Franklin B. Reducing prescribing error: competence, control, and culture. Qual Saf Health Care. 2003 Dec;12 Suppl 1(Suppl 1):i29-32. doi: 10.1136/qhc.12.suppl_1.i29.
30. Suvorov A.Yu., Martsevich S.Yu., 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):247-252. (In Russ.).
31. Federal Law of 21.11.11 No. 323-FZ (as amended on 11.06.22, as amended on 13.07.22) "On the Fundamentals of Health Protection of Citizens in the Russian Federation" (as amended and supplemented, entered into force on 29.06.22); Art. 37. (In Russ.).
32. Law of 21.11.11 No. 323-FZ (as amended on 11.06.22, as amended on 13.07.22) "On the Fundamentals of Health Protection of Citizens in the Russian Federation" (as amended and supplemented, entered into force on 29.06.22); Art. 79. (In Russ.).
33. Order of the Ministry of Health of the Russian Federation dated May 10, 2017 No. 203n "On approval of criteria for assessing the quality of medical care." (In Russ.).
34. Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. (Second Edition) / IHI Innovation Series white paper. Cambridge (MA): Institute for Healthcare Improvement, 2009. URL: www. IHI.org
35. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023 Jul;71(7):2052-2081. doi: 10.1111/jgs.18372.
36. Sychev D.A., Cherniaeva M.S., Rozhkova M.A., Vorobyova A.E. Potentially Inappropriate Medications for Use in Older Adults: Beers Criteria (2023 American Geriatrics Society Guidelines). Safety and Risk of Pharmacotherapy. 2024;12(3):253- 267. (In Russ.).
37. Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.
38. Gallagher P, Ryan C, Byrne S, et al. 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 Feb;46(2):72-83. doi: 10.5414/cpp46072.
39. O'Mahony D, Cherubini A, Guiteras AR, et al. STOPP/START criteria for potentially inappropriate prescribing in older people: version 3. Eur Geriatr Med. 2023 Aug;14(4):625-632. doi: 10.1007/s41999-023-00777-y. Epub 2023 May 31. Erratum in: Eur Geriatr Med. 2023 Aug;14(4):633. doi: 10.1007/s41999-023-00812-y.
40. Kotovskaya Yu.V., Tkacheva O.N., Runikhina N.K., et al. Enhanced STOPP/START Criteria: A Tool for Managing Polypharmacy in Older Population. Russian Journal of Geriatric Medicine. 2023;16(4):273-288. (In Russ.).
41. Samsa GP, Hanlon JT, Schmader KE, et al. A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994 Aug;47(8):891-6. doi: 10.1016/0895-4356(94)90192-9.
42. 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 Mar;32(3):189-99. doi: 10.1007/s40266-015-0242-4.
43. Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2.
44. Holt S, Schmiedl S, Thürmann PA. Potentially inappropriate medications in the elderly: the PRISCUS list. Dtsch Arztebl Int. 2010 Aug;107(31-32):543-51. doi: 10.3238/arztebl.2010.0543.
45. Bahat G, Erdogan T, Can B, et al. Cross-Cultural Adaptation and Clinical Validation of TIME Criteria to Detect Potentially Inappropriate Medication Use in Older Adults: Methodological Report from the TIME International Study Group. Drugs Aging. 2025 Jan;42(1):57-67. doi: 10.1007/s40266-024-01164-3.
Review
For citations:
Kolesnik T.I., Gabbasova L.A., Pavlikova E.P. Methods for assessing the quality of pharmacotherapy as tools for improving the effectiveness and safety of treatment interventions. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2025;(3):97-105. (In Russ.) https://doi.org/10.37489/2588-0519-2025-3-97-105. EDN: LYYFLW








































