Generic substitution refers to using a generic version of a drug that contains the same active ingredient as a brand name drug. While generics are typically much less expensive than brand name drugs, there are some concerns about their effectiveness and potential side effects compared to brand name drugs. Slovakia allows automatic generic substitution by pharmacists, which can save the government money but may disrupt patient-doctor relationships and reduce trust if not implemented carefully. Both benefits and risks of generic substitution are discussed.

1. Eva Kováčová, 22 VL 30.3.2011 GENERIC SUBSTITUTIONS USED IN PRESCRIPTION

2. What is generic substitution? a version of the drug with the same active ingredient It is not always identical 20 yrs after the original is on the market Strict observance of bioequivalence Might be less effective or experience different side-effects may disrupt the management of a chronic disease

3. Automatic generic substitution prescription only of active substance patient decides between various drugs with the same active ingredient prescription without branding part of a new deal on drug pricing

4. Example Klacid 500 (active substance: claritromycine) 14 pills cost 10,97 €. Generics for Klacid 500: Klaritromycin Mylan 500 mg 1,89 Clarithromycin-Teva 500 mg 1,99 Klabax 500 mg 1,99 € Klerimed 500 mg 2,01 € Fromilid 500 2,11 € Lekoklar 500 mg 2,11€ Clarithromycin - Ratiopharm 500 mg 2,29 8.68 €

5. Slovak legislative §38b; paragraph 6 , law no 140/1998 set of laws Generic can be subscribed with specifying: The route of administration Drug form and size Dosage This possibility is many times ignored. Change planned on Nov 2011

7. PROs typically 20% to 90% less expensive than the brand-name original App. 46 mil. € /year of savings for the Slovak goverment Bringing economic sense to pharmaceutical care In difficult cases can doctors prohibit the generic substitution

8. CONs For a patient: credibility and level of education of a doctor and pharmacist SLK (Slovak Medical Chamber) public discussion clearly defined liability Disturbment ofsensitive relationship between doctor and patient Trusting in the complex medical care

9. Statistics/facts In year 2009 any allergic reaction on excipient drug was reported The most trustworthy medical professions: pharmacist (85%), doctors (84%), nurses (82%) Pharmacology on medical faculties vs Pharmacology on pharmaceutical faculties Clinical pharmacology

10. Thought... According to the actual rating of clientelism is Slovakia on 138th place out of 139 evaluated countries. What is ours opinion?

11. Literature used http://www.genericsubstitution.com/ http://en.wikipedia.org/wiki/Automatic_Generic_Substitution http://www.health.gov.sk/?tlacove-spravy&sprava=efektivnost-v-liekovej-politike-zasadne-kroky-k-reforme-liekovej-politiky http://www.egagenerics.com/ http://www.slek.sk/ganet/slek/slek_portal.nsf/wdoc/d5abe3cc20bb4ec2c12577d7007343c0/$FILE/LL10_2010www.pdf http://www.sukl.sk/buxus/docs/Inspekcia/Legislativa/Zakon_140_oktober_2006.pdf http://www.generika.sk/statistika.htm

12. Thank you for your attention.  ewinka 2011