Identical tablets from the same company – but different names and information

[email protected]

FIP, Cairo 2005

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)

Identical tablets from the same company –

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

Identical tablets from the same company –

• 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) •

Vioxx AC

brukes til å lindre akutt smerte eller til å behandle menstruasjons-smerter • (Pain and inflammation. Arthritis) • (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.

Triple medication

• ISMP www.ismp.org

report of a patient taking • Zyban

and

• Wellbutrin

and

• generic bupropion

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

finasteride (MSD)

- benign prostata hyperplasia Proscar 5mg - hair loss Propecia 1mg

duloksetin (Lilly)

• • - urge incontinence Yentreve 20mg and 40mg - antidepressivum Cymbalta 30mg and 60mg

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

thalidomide

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

•

misoprostol

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

rofecoxib (MSD)

• Arthritis • Acute pain • Colorectal cancer • Alzheimer • HIV • Vioxx • Vioxx AC • Brand Name 3 ?

• Brand Name 4 ? • Brand Name 5 ?

Atenolol

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

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

[email protected]

www.lyftingsmo.no