Same company Vioxx MSD (Merck Sharp & Dohme) Emconcor Merck
Vioxx vs Vioxx AC Different name Norway: –Vioxx and Vioxx AC Sweden: –Vioxx and Vioxxakut Denmark: –Vioxx and Vioxxalt Germany: –Vioxx and Vioxxdolor
Emconcor vs Emconcor CHF Norway: –Emconcor and Emconcor CHF Sweden: –Emconcor and Emconcor CHF Denmark: –Emconcor and Cardicor Germany: –Concor and ConconCor
Vioxx vs Vioxx AC Patient info Vioxx …… brukes for å redusere smerter og betennelse. ….. Vioxx brukes i behandlingen av artrose (en leddsykdom) (Pain and inflammation. Arthritis) Vioxx AC brukes til å lindre akutt smerte eller til å behandle menstruasjons-smerter (Acute pain)
Vioxx vs Vioxx AC Drug catalogue Vioxx Symptomatisk behandling (treatment) av artrose eller reumatoid artritt. Vioxx AC Lindring av akutt smerte. (Treatment of acute pain) Lindring av smerte som skyldes primær dysmenoré
Confusion Physicians Pharmacists Company Patients Regulatory authorities
Identical tablets from the same company – Bupropione (GSK) Zyban for smoking cessation Wellbutrin for depression. Fluoxetine (Lilly) Prozac for depression, panic, bulimia Sarafem for premenstrual dysforic syndrome.
ISMP report of a patient taking Zyban and Wellbutrin and generic bupropion Triple medication
Possible consequences for the patient Duplicate medication Wrong information Delayed treatment More case specific info Simpler info Avoiding stigmatised brands
Possible consequences for society Better health? Health hazard? Confusing Expensive? Anti-Generic Patent medicine revisited?
Double (multiple) and selective brands is an increasing trend
Different patient groups need different information Different brands with different information? or Basic and differentiated information in all packages? Risk assessment for each substance
Different patient groups need different information Two sets of PILs? PILs start with targeted critical info? Other ways?
Manufacturers (or information making companies) claim copyright on medicine information.
Patent protection economical tool independant of medicine regulation
Patent protection of new use does NOT limit regulatory authority from approving the new indication for other manufacturers
Patent protection of new use does NOT prohibit the doctor in prescribing the old or generic medicine for the new indication/use
Patent protection of new use does NOT prohibit the pharmacy from dispensing the generic product on patented indications/uses
Medicine components: Active substance Pharmaceutical formulation Packaging material Information Information is also part of generic medicines
We need regulatory changes to ensure proper information about medicines for health workers and for patients
Recommendations for regulations Generic name should be prominent –Directly under product name –Fontsize half of product name
Recommendations for regulations Double brands from the same company should be restricted Second brand name should be generic Information should not differ significantly Relevant information should be ensured