Drugs are available over the counter (they are weaker than prescription,
cost less, and are available to everyone without ordering) and through
prescription (they are prescribed by the doctor, are expensive, and are
picked up at a pharmacy). It is important to illustrate this topic because
over the counter drugs and prescription drugs are different in ways that
they are not noticed. Patients pay less for drugs over the counter than
prescription, but the availability and risk of overdose is more common
on over the counter than prescription. Dr. Poes' insight (Click
Here to Listen) They can be changed, however, to suit the needs of
customers throughout theworld. (BMJ)
In
November 1999, the “Swedish Medical Products Agency” allowed
the switch of the drug Omeprazole to over-the-counter instead of prescription.
The drug is used for treating ulcers and gastro esophageal reflux disease.
In order to do this, they had to lessen the dosage from 20mg to 10mg;
more warning labels had to be placed onto the bottles of the pill to prevent
future over doses of patients who already take this drug. The reason the
agency made the switch was due to production cost. It was unusual for
the product to be in this predicament. It doesn’t really fit the
requirements for the drug to be considered over-the-counter. Also, the
switch was forced on the manufacturer of the drug because the patent was
about to expire. (BJM)
Loratadine
is another drug that was switched from prescription to over-the-counter
due to cost. (The FDA actually verified the switch in 1998, but their
regulations for switching drugs are different: the manufacturer has the
option of doing the switch. The regulations of the switch are not required,
even though the instruction was given by the FDA.) The manufacturer, Schering-Plough,
did agree to the switch because the patent (rights to the product) was
about to expire. The patent expired in 2002, and the switch of the antihistamine
to over the counter was made. What is ironic about the switch is that
the product is not as strong as the prescription one, even though it is
more readily available. It is actually the generic type. (BJM)
Switching prescription drugs to over the counter drugs has impediments
and benefits. The switch reduces the insurer’s drug cost but increases
the cost of the patients who want the drug itself. The insurer is the
one who covers the drug when it comes to cost and availability. The people
who usually want the drug but can’t are the ones who don’t
have health insurance. They can afford the drugs that used to be prescription
because the cost is more feasible for lower income customers to buy. However,
a drug company can fluctuate on whether or not they get more or lose more
money from the profits. That means the company can still make a profit,
but it cost money to keep the product running. The company can determine
on if they are making money, but it is a complicated system on doing so.
(BJM)
The
FDA has changed regulations when it comes to what kinds of drugs can be
over-the-counter vs. prescription. At times, the drug may be available
as over-the-counter in one place and available as a prescription in another
European country because most of the drugs come from Europe. The FDA now
requires studies on the comprehension of drug labels possible by consumers.
There is also a different way of prescribing medicine, behind the counter,
which is a prescription made by a pharmacist. This is actually considered
a lack for the U.S. due to safety concerns of over-the-counter drugs.
If the drug is available over-the-counter, then the customer buying the
drug is not under professional intermediary. A professional intermediary
is an experienced negotiator, one who can make sure that the customer
using the drug doesn’t abuse it. The FDA plans to increase the rate
of switching from prescriptions to over the counters by 50%. They will
specify drugs that they wish to switch by what they consider “suitable.”
(It is an example of exploring legal authority. They plan on trying out
5-10 drugs from European agencies that are over the counter in the U.S.
They plan on using a small portion of information from other European
counties to explain the idea of patients that understand the labeling
of drugs.) Some of these actions may help aid in the use of illegal drugs.
(BMJ)
Sources:
http://www.bmj.com/cgi/content/full/330/7481/39?maxtoshow=&HITS=
10&hits=10&RESULTFORMAT=&fulltext=
Omeprazole+as+over-the-counter&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT