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Identical tablets from the same company – but different names and information FIP, Cairo 2005.

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Presentation on theme: "Identical tablets from the same company – but different names and information FIP, Cairo 2005."— Presentation transcript:

1 Identical tablets from the same company – but different names and information FIP, Cairo 2005

2 Norway 25 years ago Drug catalogue not publicly available No Patient Information Leaflet No Generic dispensing No Parallel import No dispensing from bulk (same today)

3 Identical tablets from the same company –

4 Identical tablets –Active ingredient –Shape –Colour –Excipients

5 Identical tablets from the same company –

6 Same company Vioxx MSD (Merck Sharp & Dohme) Emconcor Merck

7 Vioxx vs Vioxx AC Different name Norway: –Vioxx and Vioxx AC Sweden: –Vioxx and Vioxxakut Denmark: –Vioxx and Vioxxalt Germany: –Vioxx and Vioxxdolor

8 Emconcor vs Emconcor CHF Norway: –Emconcor and Emconcor CHF Sweden: –Emconcor and Emconcor CHF Denmark: –Emconcor and Cardicor Germany: –Concor and ConconCor

9 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)

10 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

11 Confusion Physicians Pharmacists Company Patients Regulatory authorities

12 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.

13 ISMP report of a patient taking Zyban and Wellbutrin and generic bupropion Triple medication

14 Possible consequences for the patient Duplicate medication Wrong information Delayed treatment More case specific info Simpler info Avoiding stigmatised brands

15 Possible consequences for society Better health? Health hazard? Confusing Expensive? Anti-Generic Patent medicine revisited?

16 Double (multiple) and selective brands is an increasing trend

17 finasteride (MSD) - benign prostata hyperplasia Proscar 5mg - hair loss Propecia 1mg

18 duloksetin (Lilly) - urge incontinence Yentreve 20mg and 40mg - antidepressivum Cymbalta 30mg and 60mg

19 erythropoietin epo (old example) - anemia (in renal failure) Epogen (Amgen) - anemia (in cancer) Procrit (Ortho)

20 thalidomide - leprosy Thalomide (Celgene) - tuberculosis - cancer - AIDS Cellgene has patented distribution system

21 misoprostol - gastrointestinal ulceration Cytotec (Searle, Pfizer) - gynecological use (main use) No brand No information

22 rofecoxib (MSD) Arthritis Acute pain Colorectal cancer Alzheimer HIV Vioxx Vioxx AC Brand Name 3 ? Brand Name 4 ? Brand Name 5 ?

23 Atenolol angina pectoris FDA + Norway approval hypertension FDA + Norway approval postmyocardial infarction FDA + Norway approval arrhytmias Norway approval migraine headache Norway approval thyreotoxicosis Norway approval anxiety (when giving presentations) documented effect congestive heart failure documented effect preeclampsia documented effect tremor documented effect alcohol withdrawal syndrome documented effect

24 Different patient groups need different information Different brands with different information? or Basic and differentiated information in all packages? Risk assessment for each substance

25 Different patient groups need different information Two sets of PILs? PILs start with targeted critical info? Other ways?

26 Manufacturers (or information making companies) claim copyright on medicine information.

27 Patent protection economical tool independant of medicine regulation

28 Patent protection of new use does NOT limit regulatory authority from approving the new indication for other manufacturers

29 Patent protection of new use does NOT prohibit the doctor in prescribing the old or generic medicine for the new indication/use

30 Patent protection of new use does NOT prohibit the pharmacy from dispensing the generic product on patented indications/uses

31 Medicine components: Active substance Pharmaceutical formulation Packaging material Information Information is also part of generic medicines

32 We need regulatory changes to ensure proper information about medicines for health workers and for patients

33 Recommendations for regulations Generic name should be prominent –Directly under product name –Fontsize half of product name

34 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

35


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