Eva Kováčová, 22 VL30.3.2011

GENERIC SUBSTITUTIONS USED IN PRESCRIPTION

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

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

ExampleKlacid 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 €

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

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

CONs• For a patient: – credibility and level of education of a doctor

and pharmacist• SLK (Slovak Medical Chamber)–public discussion– clearly defined liability–Disturbment of sensitive relationship

between doctor and patient– Trusting in the complex medical care

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

Thought...

According to the actual rating of clientelism is Slovakia on 138th place

out of 139 evaluated countries.

What is ours opinion?

Literature used

• http://www.genericsubstitution.com/• http://en.wikipedia.org/wiki/Automatic_Gene

ric_Substitution• http://www.health.gov.sk/?tlacove-spravy&sp

rava=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

THANK YOU FOR YOUR ATTENTION. ewinka 2011