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Stein Lyftingsmo is a hospital
pharmacist from Elverum, Norway, and has a special interest in
packaging and medicines
information
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Before the medicine was withdrawn from the worldwide market in 2004, there were two MSD brands of rofecoxib on the market in Norway: Vioxx and Vioxx AC. The tablets had the same active ingredient, and the same shape, colour and excipients. The brands had different information. Vioxx was for arthritis and chronic pain, and Vioxx AC for acute pain. This difference was apparent both in the patient information and in the drug catalogue.
The situation was and is the same for bisprolol, which Merck markets
as Emconcor and as Emconcor CHF. Emconcor is marketed for hypertension
and prevention of angina, and Emconcor CHF for coronary heart failure.
Norway has a list of generic medicines that can be substituted. Emconcor
and Emconcor CHF are not on this list even though the tablets are identical.
But most physicians and pharmacists do not realise or ever think about
the difference between Emconcor and Emconcor CHF. We are used to generic
competition between companies. But to most people it is unexpected and
illogical that a company should appear to compete with itself.
Doctors are confused. I know this because I see their prescriptions.
Pharmacists are also confused. And having called the company for information,
I discovered that company staff themselves seem to be confused. Most
patients are not confused, but only because they do not know about it.
When I looked across the Atlantic I discovered other examples. Bupropion
from GlaxoSmithKline is marketed as Zyban for smoking cessation and as
Wellbutrin for depression. Fluoxetine from Lilly is the iconic brand
Prozac. Lilly also marketed fluoxetine as Sarafem (which has been licensed
to another company.). The colours here are not identical. Prozac is green
and cream. Sarafem, however, is pink, which may be considered a better
colour for a medicine for the treatment of premenstrual tension. Allowing
for different strengths, other dual brands are Yentreve and Cymbalta
(duloxetine), and Propecia and Proscar (finasteride).
Dual marketing (or brand splitting) increases the risk of double medication.
The US Institute for Safe Medication Practices (ISMP) has even reported
a case of triple dosage of bupropion: Zyban and Wellbutrin and generic
bupropion.
Brand splitting may increase total sale. But each brand will have reduced
turnover. Low-turnover packages are not kept in pharmacy stock, and the
patient may have to wait hours — even days in rural areas — for
his or her treatment. Brand splitting may give simpler and more case-specific
information for the different patient groups. But if a patient gets a
medicine that is intended for a different patient group, he or she will
also get information meant for that other group.
Brand splitting may reduce people being put off by a particular brand
name. If a brand name is strongly linked to a special use of a medicine,
this may affect other uses of the same medicine. Prozac is an example
of a brand with a very strong position in people’s minds, to the
extent that some patients will refuse to take it.
There is another substance that is old, but interesting in this connection:
thalidomide. Leprosy is the only indication approved by the US Food and
Drug Administration — but leprosy is not common in the US. The
main uses of thalidomide are off-label for tuberculosis, cancer and AIDS.
Thalidomide’s patent ran out long ago, but a company, Celgene,
has patented a thalidomide distribution system (as Pharmion has in some
European countries.) The information about thalidomide from Celgene does
not mention other uses. Information from Medmaster and USP DI (two American
organisations delivering information for dispensing from bulk) is more
generic and at least mentions other uses.
Another example of mainly off-label use is misoprostol (Cytotec). In
Norway, all information in the drug catalogue and patient leaflets is
about preventing gastrointestinal ulceration during treatment with non-steroidal
anti-inflammatory drugs. But almost all uses of the drug are for gynaecological
purposes (abortion, cervical priming, labour induction).
It is possible that if Vioxx had not been withdrawn there could have
been more chapters to its story. For example, there are patents and clinical
evidence for rofecoxib having an effect in preventing colorectal cancer,
in preventing Alzheimer’s disease and in the treatment of HIV.
MSD chose to use one brand name for chronic pain, and another for acute
pain. So it is not difficult to imagine another three brand names here.
Now look at an older substance: atenolol. The FDA has approved three
uses for atenolol; the Norwegian medicine authorities, another three.
There is good evidence for the use of atenolol for another five indications — altogether
11 different uses for one active substance. Imagine 11 brands, each packaged
with information for only one indication.
For patient packs the information in drug catalogues and package inserts
usually comes from the manufacturing company. There are several examples
of manufacturers claiming copyright on patient information. In the US
where most medicines are dispensed from bulk, the PILs mostly comes from
companies specialising in providing information.
Different patient groups need different information. How do we solve
this dilemma? Do we have one different brand for each indication or information
that covers all the different uses? Each solution has its advantages
and drawbacks. It is important that a risk analysis is made, since different
substances will present different risks.
Is it possible to differentiate information in generic packages? Perhaps
there should be two setss of PILs. Maybe there could be separate frames
or sections in the PIL for each patient group. Perhaps there are other
solutions.
Generally, brand building is the opposite of generic medicine; building
double brands certainly is. I believe that the issues around information
here are so confusing and obscure that it takes us back to the old days
of patent medicines and secret formulae.
I want regulatory restrictions to stop pharmaceutical companies using
more than one brand name on a medicine. But if companies are to be allowed
to continue to have more than one brand of the same drug, it should be
a requirement that the second brand name should be generic, and that
information in formularies and package inserts should not differ significantly. |
The
Pharmaceutical Journal