BACKGROUND: Generic drugs and generic substitution belong to the tools by which healthcare costs may be reduced. However, low awareness and reluctance among healthcare professionals towards generic drugs may negatively affect the rational use of generic substitution. METHODS: The study aimed to analyze opinions and attitudes towards generic drugs and generic substitution among Czech physicians including their understanding of generic substitution legislative rules and the physicians´ previous experience in this field. Using random allocation, 1551 physicians practicing in the Czech Republic were asked to participate in the sociological representative survey conducted from November to December 2016, through face-to-face structured interviews comprising 19 items. Factor analysis as well as reliability analysis of items focused on legal rules in the context of physicians' awareness were applied with p-value of < 0.05 as statistically significant. RESULTS: Of a total of 1237 (79.8%) physicians (43.7% males; mean age 47.5 ± 11.6 years, 46.3% general practitioners) 24.8% considered generic drugs to be less safe, especially those with specialized qualification (p < 0.01). However, only 4.4% of the physicians noticed any drug-related problems, including adverse drug reactions associated with generic substitution. The majority of physicians felt neutrally about performing generic substitution in pharmacies, nor they expressed any opinion on characteristics of generics, even though a better understanding of the legislation and higher need of accordance of substituted drugs were associated with more positive attitudes towards generic substitution (p < 0.05). Physicians showed low knowledge score of legislative rules (mean 3.9 ± 1.6 from maximum 9), nevertheless they overestimated the law, as they considered some rules valid, even if the law does not require them. Cronbach alpha of all legislative rules that regulate generic substitution increased from 0.318 to 0.553 if two optional rules (physician consent and strength equivalence) would be taken into account. CONCLUSIONS: There is no sufficient awareness of generic drugs and generic substitution related issues among Czech physicians, although a deeper knowledge of legislation improves their perception about providing generic substitution.

Faculty of Pharmacy in Hradec Kralove Czech Pharmaceutical Museum Charles University Akademika Heyrovskeho 1203 500 05 Hradec Kralove Czech Republic

Faculty of Pharmacy in Hradec Kralove Department of Social and Clinical Pharmacy Charles University Akademika Heyrovskeho 1203 500 05 Hradec Kralove Czech Republic

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European Medicines Agency. Generic and hybrid medicines. 2018. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000335.jsp&mid=WC0b01ac0580022717. Accessed 15 Aug 2018.

European Medicines Agency. Clinical efficacy and safety: clinical pharmacology and pharmacokinetics 2019. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf. Assessed 10 Apr 2019.

Maly J, Dosedel M, Kubena A, Vlcek J. Analysis of pharmacists' opinions, attitudes and experiences with generic drugs and generic substitution in the Czech Republic. Acta Pol Pharm. 2013;70:923–931. PubMed

Simoens S. A review of generic medicine pricing in Europe. GaBI Journal. 2012;1:8–12. doi: 10.5639/gabij.2012.0101.004. DOI

Dylst P, Vulto A, Godman B, Simoens S. Generic medicines: solutions for a sustainable drug market? Appl Health Econ Health Policy. 2013;11:437–443. doi: 10.1007/s40258-013-0043-z. PubMed DOI

Dylst P, Simoens S. Generic medicine pricing policies in Europe: current status and impact. Pharmaceuticals (Basel) 2010;3:471–481. doi: 10.3390/ph3030471. PubMed DOI PMC

Simoens S. Generic and therapeutic substitution: ethics meets health economics. Int J Clin Pharm. 2011;33:469–470. doi: 10.1007/s11096-011-9500-7. PubMed DOI

Garuolienė K, Godman B, Gulbinovič J, Schiffers K, Wettermark B. Differences in utilization rates between commercial and administrative databases: implications for future health-economic and cross-national studies. Expert Rev Pharmacoecon Outcomes Res. 2016;16:149–152. doi: 10.1586/14737167.2016.1158649. PubMed DOI

Wouters OJ, Kanavos PG, McKee M. Comparing generic drug Markets in Europe and the United States: prices, volumes, and spending. Milbank Q. 2017;95:554–601. doi: 10.1111/1468-0009.12279. PubMed DOI PMC

Organisation for Economic Co-operation and Development. Pharmaceutical Market. 2019. https://stats.oecd.org/Index.aspx?DataSetCode=HEALTH_PHMC. Assessed 10 Apr 2019.

Dunne SS, Dunne CP. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Med. 2015;13:173. doi: 10.1186/s12916-015-0415-3. PubMed DOI PMC

Patel A, Gauld R, Norris P, Rades T. Quality of generic medicines in South Africa: perceptions versus reality - a qualitative study. BMC Health Serv Res. 2012;12:297. doi: 10.1186/1472-6963-12-297. PubMed DOI PMC

Shrank WH, Liberman JN, Fischer MA, Girdish C, Brennan TA, Choudhry NK. Physician perceptions about generic drugs. Ann Pharmacother. 2011;45:31–38. doi: 10.1345/aph.1P389. PubMed DOI

Dunne S, Shannon B, Dunne C, Cullen W. Patient perceptions of generic medicines: a mixed-methods study. Patient. 2014;7:177–185. doi: 10.1007/s40271-013-0042-z. PubMed DOI

Howard JN, Harris I, Frank G, Kiptanui Z, Qian J, Hansen R. Influencers of generic drug utilization: a systematic review. Res Social Adm Pharm. 2018;14:619–627. doi: 10.1016/j.sapharm.2017.08.001. PubMed DOI PMC

Act on Pharmaceuticals, In: Catch III Registration of pharmaceuticals and steps related to their registration. In: 378/2007. Edited by Czech Republic, vol. 25; 2008: 22–3.

Kawalec P, Tesar T, Vostalova L, Draganic P, Manova M, Savova A, Petrova G, Rugaja Z, Männik A, Sowada C, Stawowczyk E, Harsanyi A, Inotai A, Turcu-Stiolica A, Gulbinovič J, Pilc A. Pharmaceutical regulation in central and eastern European countries: a current review. Front Pharmacol. 2017;8:892. doi: 10.3389/fphar.2017.00892. PubMed DOI PMC

State Institute for Drug Control. Regulation of prices and reimbursements for pharmaceuticals. 2019. http://www.sukl.eu/medicines/regulation-of-prices-and-reimbursements-for-pharmaceuticals. Accessed 31 Sep 2019.

Dosedel M, Maly J, Kubena A, Vlcek J. Opinions of Czech general practitioners on generic drugs and substitution. Cent Eur J Med. 2014;9:830–838.

Toverud EL, Hartmann K, Håkonsen H. A systematic review of Physicians' and Pharmacists' perspectives on generic drug use: what are the global challenges? Appl Health Econ Health Policy. 2015;13(Suppl 1):S35–S45. doi: 10.1007/s40258-014-0145-2. PubMed DOI PMC

ICC, ESOMAR. International code on market, opinion and social research and data analytics. In: ESOMAR. 2016. https://www.esomar.org/uploads/pdf/professional-standards/ICCESOMAR_Code_English_.pdf. Accessed 01 Sept 2018.

Physicians, Dentists and Pharmacists 2013. In: Physicians, Dentists and Pharmacists. Institute of Health Information and Statistics of the Czech Republic. 2014. http://www.uzis.cz/en/catalogue/physicians-dentists-and-pharmacists. Accessed 15 Aug 2018.

Irwing P, Booth T, Hughes DJ. The Wiley handbook of psychometric testing: a multidisciplinary reference on survey, scale and test development. John Wiley & Sons, 2018.

Tlusta E, Kubena A, Salek S, Vlcek J. Psychometric properties of the Czech version of the quality of life in epilepsy inventory (QOLIE-31) Epilepsy Behav. 2007;10:407–411. doi: 10.1016/j.yebeh.2007.01.002. PubMed DOI

Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. New York: Lawrence Erlbaum Associates; 1988.

Manzoli L, Flacco ME, Boccia S, D'Andrea E, Panic N, Marzuillo C, Siliquini R, Ricciardi W, Villari P, Ioannidis JP. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2016;31:351–368. doi: 10.1007/s10654-015-0104-8. PubMed DOI PMC

Ryu M, Kim J. Perception and attitude of Korean physicians towards generic drugs. BMC Health Serv Res. 2017;17:610. doi: 10.1186/s12913-017-2555-y. PubMed DOI PMC

Murshid MA, Mohaidin Z. Physicians’ perceptions towards brand medicine and its effect on prescribing: a narrative review. J Generic Med. 2017;13:157–183. doi: 10.1177/1741134317709509. DOI

Kumar R, Hassali MA, Saleem F, Alrasheedy AA, Kaur N, Wong ZY, Kader MA. Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia. J Pharm Policy Pract. 2015;8:11. doi: 10.1186/s40545-015-0031-9. PubMed DOI PMC

Fadare JO, Adeoti AO, Desalu OO, Enwere OO, Makusidi AM, Ogunleye O, Sunmonu TA, Truter I, Akunne OO, Godman B. The prescribing of generic medicines in Nigeria: knowledge, perceptions and attitudes of physicians. Expert Rev Pharmacoecon Outcomes Res. 2016;16:639–650. doi: 10.1586/14737167.2016.1120673. PubMed DOI

Hansen RN, Nguyen HP, Sullivan SD. Bioequivalent antiepileptic drug switching and the risk of seizure-related events. Epilepsy Res. 2013;106:237–243. doi: 10.1016/j.eplepsyres.2013.04.010. PubMed DOI

Duerden MG, Hughes DA. Generic and therapeutic substitutions in the UK: are they a good thing? Br J Clin Pharmacol. 2010;70:335–341. doi: 10.1111/j.1365-2125.2010.03718.x. PubMed DOI PMC

Čatić T, Avdagić L, Martinović I. Knowledge and attitudes of physicians and pharmacists towards the use of generic medicines in Bosnia and Herzegovina. Med Glas (Zenica) 2017;14:25–32. PubMed

Rathe J, Andersen M, Jarbøl DE, dePont Christensen R, Hallas J, Søndergaard J. Generic switching and non-persistence among medicine users: a combined population-based questionnaire and register study. PLoS One. 2015;10:e0119688. doi: 10.1371/journal.pone.0119688. PubMed DOI PMC

Trusell H, Sundell KA. Effects of generic substitution on refill adherence to statin therapy: a nationwide population-based study. BMC Health Serv Res. 2014;14:626. doi: 10.1186/s12913-014-0626-x. PubMed DOI PMC

Beauvais V, Marque A, Ferté G, Chrusciel J, Souille J, Nazeyrollas P, Sanchez S. Factors influencing the use of the "not for generic substitution" mention for prescriptions in primary care: a survey with general practitioners. BMC Health Serv Res. 2018;18:850. doi: 10.1186/s12913-018-3652-2. PubMed DOI PMC

Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, Al-Tamimi SK, Ibrahim MI, Aljadhey H. The experiences of implementing generic medicine policy in eight countries: a review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22:491–503. doi: 10.1016/j.jsps.2013.12.017. PubMed DOI PMC

Jamshed SQ, Ibrahim MI, Hassali MA, Masood I, Low BY, Shafie AA, Babar ZU. Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: a questionnaire based study. South Med Rev. 2012;5:22–30. PubMed PMC

Lewek P, Smigielski J, Kardas P. Factors affecting the opinions of family physicians regarding generic drugs--a questionnaire based study. Bosn J Basic Med Sci. 2014;15:45–50. doi: 10.17305/bjbms.2015.1.134. PubMed DOI PMC

Flood D, Mathieu I, Chary A, García P, Rohloff P. Perceptions and utilization of generic medicines in Guatemala: a mixed-methods study with physicians and pharmacy staff. BMC Health Serv Res. 2017;17:27. doi: 10.1186/s12913-017-1991-z. PubMed DOI PMC