Advertisement

Central European Journal of Medicine

, Volume 9, Issue 6, pp 830–838 | Cite as

Opinions of Czech general practitioners on generic drugs and substitution

  • Martin Dosedel
  • Josef Maly
  • Ales Kubena
  • Jiri Vlcek
Research Article

Abstract

The aim of the study was to map and analyze general practitioners` opinions of, attitudes towards and experiences with generic drugs and generic substitution (GS) in the Czech Republic. General practitioners (GPs) who took part in the annual and regional professional conferences of the Society of General Practice in the period from November 2008 until March 2009 were asked to complete the 28-item questionnaire concerning the issue of generic drugs and GS. Questions were organized in 5 sections aimed at assessing the attitude towards GS, understanding the legislation and opinions on statements related to GS. All data were analyzed using descriptive statistics and correlations were tested by selected parametric and non-parametric tests. Total of 263 completed questionnaires were returned (mean age of 52.2 years (SD=13.7), 177 (67.3%) females and 248 (94.3%) GPs having a practice specialization). 99 (37.6%) respondents have considered generic drugs to be bioequivalent to the respective brand name drugs. 121 (46.0%) respondents believed that generic drugs are of lower quality than brand name drugs. None of respondent showed acquaintance with all the legal rules for GS. Awareness of the legislation and attitude towards GS correlated with the age (p<0.001). In conclusion, distrust among GPs in generic drugs derives from poor knowledge and personal experiences.

Keywords

General practitioner Brand name drug Generic drug Generic substitution 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. [1]
    Shrank W.H., Choudhry N.K., Liberman J.N., Brennan T.A., The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money, Health Aff (Millwood)., 2011, 30, 1351–1357PubMedCrossRefGoogle Scholar
  2. [2]
    Pechlivanoglou P., van der Veen W.J., Bos J.H., Postma M.J., Analyzing generic and branded substitution patterns in the Netherlands using prescription data, BMC Health Serv Res., 2011, 11Google Scholar
  3. [3]
    Institute of Health Information and Statistics of the Czech Republic. Economic information on health care 2010 [online]. 2011 [cited 2012-5-25]. Available from http://www.uzis.cz/en/publications/economic-information-health-care-2010
  4. [4]
    Aalto-Setälä V., The impact of generic substitution on price competition in Finland, Eur J Health Econ., 2008, 9, 185–191PubMedCrossRefGoogle Scholar
  5. [5]
    Posner J., Griffin J.P., Generic substitution, Br J Clin Pharmacol., 2011, 72, 731–732PubMedCentralPubMedCrossRefGoogle Scholar
  6. [6]
    Dylst P., Simoens S., Generic Medicine Pricing Policies in Europe: Current Status and Impact, Pharmaceuticals., 2010, 3, 471–81PubMedCentralCrossRefGoogle Scholar
  7. [7]
    Czech Republic, Act No. 378/2007 on Pharmaceuticals, In: Catch III Registration of pharmaceuticals and steps related to their registration, Article 25, 2008, 115, 22–3, (in Czech)Google Scholar
  8. [8]
    State Institute for Drug Control, The physician’s and pharmacist’s roles derived from the new Act on Pharmaceuticals, Pharmacotherapeutic information 2/2008, A monthly for physicians and pharmacists, 2008, 2, 1–4, (in Czech)Google Scholar
  9. [9]
    Andersson K., Sonesson C., Petzold M., Carlsten A., Lönnroth K., What are the obstacles to generic substitution? An assessment of the behaviour of prescribers, patients and pharmacies during the first year of generic substitution in Sweden, Pharmacoepidemiol Drug Saf., 2005, 14, 341–348 ReferencesPubMedCrossRefGoogle Scholar
  10. [10]
    Mott D.A., Cline R.R., Exploring generic drug use behavior: the role of prescribers and pharmacists in the opportunity for generic drug use and generic substitution, Med Care., 2002, 40, 662–674PubMedCrossRefGoogle Scholar
  11. [11]
    Suh D.C., Trends of generic substitution in community pharmacies, Pharm World Sci., 1999, 21, 260–265PubMedCrossRefGoogle Scholar
  12. [12]
    Shrank W.H., Stedman M., Ettner S.L., DeLapp D., Dirstine J., Brookhart M.A., et al., Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use, J Gen Intern Med., 2007, 22, 1298–1304PubMedCentralPubMedCrossRefGoogle Scholar
  13. [13]
    Andersson K., Jörgensen T., Carlsten A., Physicians’ opinions and experiences of the Pharmaceutical Benefits Reform, Scand J Public Health., 2006, 34, 654–659PubMedCrossRefGoogle Scholar
  14. [14]
    Heikkilä R., Mäntyselkä P., Hartikainen-Herranen K., Ahonen R., Customers’ and physicians’ opinions of and experiences with generic substitution during the first year in Finland, Health Policy., 2007, 82, 366–374PubMedCrossRefGoogle Scholar
  15. [15]
    Lagarce L., Lusson-Brisset C., Bruhat C., Diquet B., Lainé-Cessac P., How practitioners view generic drugs: an opinion study from general practitioners in Maine-et-Loire (France), Therapie., 2005, 60, 67–74, (in French)PubMedCrossRefGoogle Scholar
  16. [16]
    Himmel W., Simmenroth-Nayda A., Niebling W., Ledig T., Jansen R.D., Kochen M.M., et al., What do primary care patients think about generic drugs?, Int J Clin Pharmacol Ther., 2005, 43, 472–479PubMedGoogle Scholar
  17. [17]
    Kersnik J., Peklar J., Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies, J Clin Pharm Ther., 2006, 31, 577–583PubMedCrossRefGoogle Scholar
  18. [18]
    García A.J., Martos F., Leiva F., Sánchez de la Cuesta F., Generic drugs: good or bad? Physician’s knowledge of generic drugs and prescribing habits, Gac Sanit., 2003, 17, 144–149, (in Spanish)PubMedCrossRefGoogle Scholar
  19. [19]
    Hassali M.A., Stewart K., Kong D.C., A national survey on knowledge and perceptions of senior medical students in Australia about generic medicines, Med J Aust., 2008, 188, 123–124PubMedGoogle Scholar
  20. [20]
    Institute of Health Information and Statistics of the Czech Republic, Physicians, Dentists and Pharmacists 2008 [online]. 2010 [cited 2012-5-25]. Available from www.uzis.cz/system/files/lekfar2008.pdf
  21. [21]
    Banahan B.F., III, Kolassa E.M., A physician survey on generic drugs and substitution of critical dose medications, Arch Intern Med., 1997, 157, 2080–2088PubMedCrossRefGoogle Scholar
  22. [22]
    European Medicines Agency, Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1/Corr ** [online]. 2010 [cited 2012-5-25]. Available from http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
  23. [23]
    Davit B.M., Nwakama P.E., Buehler G.J., Conner D.P., Haidar S.H., Patel D.T., et al., Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration, Ann Pharmacother., 2009, 43, 1583–1597PubMedCrossRefGoogle Scholar
  24. [24]
    Czech Republic, Act No. 48/1997 on public health insurance, In: Part VI Regulation of pricing and reimbursement of drugs and food for special medical purposes, Article 39, 1997, 16, 35–59, (in Czech)Google Scholar
  25. [25]
    Gomez Y., Adams E., Hoogmartens J., Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand, J Pharm Biomed Anal., 2004, 34, 341–348PubMedCrossRefGoogle Scholar
  26. [26]
    Reppe L.A., Stenberg-Nilsen H., Harg P., Hegge A.B., Lillefloth A.K., Buajordet I., Adverse events related to substitution of generic products in Norway 2005, Tidsskr Nor Laegeforen., 2008, 128, 2696–700, (in Norwegian)PubMedGoogle Scholar
  27. [27]
    Kopečná E., Deščíková V., Vlček J., Mladá J., Adverse drug reaction reporting in the Czech Republic 2005–2009, Int J Clin Pharm., 2011, 33, 683–689PubMedGoogle Scholar
  28. [28]
    Chandeclerc M.L., Tréchot P., Martin S., Weber-Muller F., Schmutz J.L., Barbaud A., Cutaneous adverse drug reaction induced by a generic substitute of Zyloric with a residual sensitization to allopurinol, Allergy., 2006, 61, 1492–1493PubMedCrossRefGoogle Scholar
  29. [29]
    Mumoli N., Cei M., Luschi R., Carmignani G., Camaiti A., Allergic reaction to Croscarmellose sodium used as excipient of a generic drug, QJM., 2011, 104, 709–710PubMedCrossRefGoogle Scholar
  30. [30]
    Kesselheim A.S., Stedman M.R., Bubrick E.J., Gagne J.J., Misono A.S., Lee J.L., et al., Seizure outcomes following the use of generic versus brand name antiepileptic drugs: a systematic review and meta-analysis, Drugs., 2010, 70, 605–621PubMedCentralPubMedCrossRefGoogle Scholar
  31. [31]
    Kesselheim A.S., Misono A.S., Lee J.L., Stedman M.R., Brookhart M.A., Choudhry N.K., Shrank W.H., Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis, JAMA., 2008, 300, 2514–2526PubMedCentralPubMedCrossRefGoogle Scholar
  32. [32]
    van der Meersch A., Dechartres A., Ravaud P., Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review, PLoS One., 2011, 6Google Scholar
  33. [33]
    Timonen J., Bengtström M., Karttunen P., Ahonen R., The impact of generic substitution on the activities of pharmaceutical companies — a survey from the companies’ perspective one year and five years after the introduction of generic substitution in Finland, BMC Clin Pharmacol., 2010, 10Google Scholar
  34. [34]
    Johnston A., Asmar R., Dahlöf B., Hill K., Jones D.A., Jordan J., et al., Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe, Br J Clin Pharmacol., 2011, 72, 727–730PubMedCentralPubMedCrossRefGoogle Scholar
  35. [35]
    Meredith P., Bioequivalence and other unresolved issues in generic drug substitution, Clin Ther., 2003, 25, 2875–2890PubMedCrossRefGoogle Scholar
  36. [36]
    Danish Health and Medicines Authority, Bioequivalence and labeling of medicines with regard to generic substitution [online]. Updated 2012-2 -07 [cited 2012-5-25]. Available from http://laegemiddelstyrelsen.dk/en/topics/authorisationand-supervision/licensing-of-medicines/marketingauthorisation/application-for-marketing-authorisation/bioequivalence-and-labelling-of-medicine-bstitution.aspx Google Scholar
  37. [37]
    Duerden M.G., Hughes D.A., Generic and therapeutic substitutions in the UK: are they a good thing?, Br J Clin Pharmacol., 2010, 70, 335–341PubMedCentralPubMedCrossRefGoogle Scholar
  38. [38]
    Simoens S., Generic and therapeutic substitution: ethics meets health economics, Int J Clin Pharm. 2011, 33, 469–470PubMedGoogle Scholar

Copyright information

© Versita Warsaw and Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Martin Dosedel
    • 1
  • Josef Maly
    • 1
  • Ales Kubena
    • 1
  • Jiri Vlcek
    • 1
  1. 1.Department of Social and Clinical PharmacyCharles University in Prague, Faculty of Pharmacy in Hradec KraloveHradec KraloveCzech Republic

Personalised recommendations