identical tablets from the same company – but different names and information...
TRANSCRIPT
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 ACDifferent 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 ACPatient 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 ACDrug 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 www.ismp.org
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
finasteride (MSD)
- benign prostata hyperplasia
Proscar 5mg
- hair loss
Propecia 1mg
duloksetin (Lilly)
• - urge incontinence
Yentreve 20mg and 40mg
• - antidepressivum
Cymbalta 30mg and 60mg
erythropoietinepo
(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 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 groupsneed
different information
• Different brands with different information?or
• Basic and differentiated information in all packages?
Risk assessment for each substance
Different patient groupsneed
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
