Identical tablets
from the same company –
but different names and
information
stein@lyftingsmo.no
FIP, Cairo 2005
Norway 25 years ago
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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
• Vioxx AC
• Symptomatisk
behandling
(treatment)
av artrose eller
reumatoid artritt.
• Lindring av akutt
smerte.
(Treatment of acute
pain)
Lindring av smerte
som skyldes primær
dysmenoré
Confusion
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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?
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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)
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- urge incontinence
Yentreve 20mg and 40mg
•
- antidepressivum
Cymbalta 30mg and 60mg
erythropoietin
epo
(old example)
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- anemia (in renal failure)
Epogen (Amgen)
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- anemia (in cancer)
Procrit (Ortho)
thalidomide
- leprosy
Thalomide (Celgene)
- tuberculosis
- cancer
- AIDS
Cellgene has patented distribution system
misoprostol
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- gastrointestinal ulceration
Cytotec (Searle, Pfizer)
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- gynecological use (main use)
No brand
No information
rofecoxib (MSD)
• Arthritis
• Acute pain
• Vioxx
• Vioxx AC
• Colorectal cancer
• Alzheimer
• HIV
• Brand Name 3 ?
• Brand Name 4 ?
• Brand Name 5 ?
Atenolol
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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
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:
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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
stein@lyftingsmo.no
www.lyftingsmo.no