Several years ago, the FDA was going to ban all
compounding. At the last minute, they did not.
In recollecting my time as a retail pharmacist
and the little time I spent as an inpatient
pharmacist while in school, I can really find no
application for compounding at this time.
Most of the things I have made have
been "prescription cosmetics." An insurance plan
won't pay for Aquaphor for dry skin so a doctor
writes an RX for 30 grams of Hydrocortisone 2.5%
to be added to a pound (480 grams) of Aquaphor.
Is anybody out there doing this? When I was in
school many years ago, and I graduated pharmacy
school in 1976, the correct way to make this
would be to put 30 grams of hydrocortisone into
a mortar and pestle along with 30 grams of
Aquaphor. Then mix them so they are uniform.
Then add 60 grams of Aquaphor to that mixture
and stir again. Then add 120 grams of Aquaphor
and stir again. See the pattern? Has anyone
tried to stir Aquaphor? It is as thick as cold
tar.
How does it get made in reality? Someone (at
this point probably the lowest person on the
totem pole or the person assigned to it that
particular day) will take a 30 gram tube of
hydrocortisone 2.5% and and squeeze it out and
place it on the top of the Aquaphor while in the
1 pound jar and stir. Uniform mixture? I doubt
it. Anyone really care that the concentration of
Hydrocortisone if properly mixed would be
completely sub therapeutic?
How many times have I added hydrocortisone
powder to real cosmetics to get them covered by
insurance? Anyone care for the cost of health
care out there?
How about the time I made Tylenol 2-1/2. That's
right. I made a prescription with 22.5 mg of
codeine per capsule. What a waste of time.
Therapeutic innovation?
How about the time a doctor wanted liquid
erythromycin (a base) mixed with liquid aspirin
(an acid)? I got called by the patient's
insurance plan about that one because evidently
multiple pharmacies refused to make that
compound. By the way, there is no liquid aspirin
since aspirin is not stable in solution. It may
last 6 weeks. The only liquid aspirin is plain
Alka Seltzer and that is formed by the
bicarbonate in the tablet fizzing away to ionize
the aspirin. Again not a stable solution, that
is why it has to be taken immediately so the
ester bond is not broken turning the
acetylsalicylic acid (aspirin) into salicylic
acid and vinegar.
How about Supik's ointment? Any old pharmacists
out there from the Baltimore-Washington area?
This was an oldy but a goody from the 1930s I am
told. Dr. Supik made the following formula. 15
gram of anhydrous lanolin, 15 gram of
petrolatum, 2 grams of tannic acid, 0.6ml of
phenol (Astringent property) and what every
hemorrhoid needs 300mg of cocaine. Because of
this, every pharmacy in the Baltimore-Washington
area was stocking cocaine, and every pharmacy
was getting robbed because they stocked it. The
FDA actually did put a stop to that mixture
though I am not sure how.
When I was still in school compounding was
mandatory. Now it isn't. It is an elective and
not every pharmacist has even a clue how to
compound.
As a senior, we had to take a compounding
refresher course. One of the things the
insttructor had us make could not be made. That
was the point of the exercise. I don't remember
the ingredients but it was a water and oil
emulsion mixed up with other ingredients. The
added ingredients broke the emulsion and you
were left with gray colored water instead of a
white emulsion. I had a similar thing happen
about ten years ago trying to add a lot of urea
to an emulsion.
For the first product the PhD instructor with
years of experience couldn't figure out why.
Who knows about the second one. I was filling
in at the place and left them a note telling
them what happened.
I can't tell you what a compounding pharmacy has
in stock, but I know what hospitals and
community pharmacies have and it is the state
minimum. Nothing gets replaced unless broken or
missing and some of it darn hard to get replaced
since the wholesalers don't always stock the
mortar and pestles etc. How do they get
cleaned? Soap and water and usually a lot of
drying with paper towels to remove the residual
crud left inside. As clean as your dinner
plates? At the pharmacy school they called Roto
Rooter once a year for a week long clean out so
all of the drains in downtown Baltimore would
not back up from all the crap going down the
drain.
Preservatives? I only made one RX with
preservatives and that was in a hospital as a
student when I made 40 liters of Kayexelate for
enema use. The hospital actually did testing to
make sure no bacteria grew out. Why did I get to
make it? Because no one else wanted to and I was
the student. It was actually an interesting day
and it took all day to mix it, bottle it and
label it.
Any ingredient once approved by the FDA can be
used for any application though it can only be
advertised by the pharmaceutical company for its
FDA approved use. Do you really think the makers
of Ketamine can advertise it as a cream to be
applied for pain? But a compounding pharmacy can
essentially become a manufacturer and advertise
non FDA approved usages of the compound.
Our intact skin is a pretty good barrier to keep
things out. Do the drugs actually get to where
they say they are going? Who knows, no one tests
this. If you allow someone to put Ketamine over
abraded skin do they absorb too much? Is there
a warning about this? Topical fentanyl patches
say to keep away from pets and children because
the residual fentanyl can be toxic to them.
This to me is a similar situation that happened
within the past two years. The 2 megawatt
laser. My residents will already be laughing
since they have all heard this story if they
were not there when it actually happened. All
you need to say is the 2 megawatt laser. A rep
came in and wanted to show us his pain laser.
In consisted of a red laser like a laser
pointer. He told us it had 2 megawatts of
power. I let him slide figuring he made a
mistake. He talked about how wonderful it was
for pain and how he used it daily on himself for
back pain. He proceeded to rub my torn rotator
cuff with some lotion and pressed the laser
against my skin.
When he went on to explain for the second time
that afternoon how his laser was 2 megawatts, I
corrected him after the 2nd time. 2 megawatts
sounds really dramatic. By the way, it was
powered by 2 AA battereis. I corrected him at
this time stating his laser may be 2 milliwatts
(0.000002) but it could not be 2 megawatts.
The power companies say 1 megawatt can supply
the average electrical needs of 1,000 homes.
Politely we asked him to send in some additional
literature etc. Needless to say we never heard
from him again. The price for this toy? $1,800
plus the lotion. A good gig if you can get it.
I have heard another product misrepresented this
way at a national meeting and I did not correct
the speaker. His statement was about another
pain product that used electromagnetic energy to
treat pain. He explained that sound energy could
not be used for the same purpose because it is
way down on the electromagnetic spectrum. He
treated it later in his talks and it was
repeated again at another meeting by the same MD
speaker. It makes you not want to go to meetings
like this. I can't be the only one smart enough
to know sound energy is not on the
electromagnetic spectrum. Hopefully, I was not
the only one awake in the audience.
Yes, I understand it is expensive to get drugs
through the pipeline. Maybe we as podiatrists
need to have the highest standards and challenge
people when they make claims to prove them.
Telling me that someone at St. Elsewhere uses
XYZ product and they love it is not enough. You
haven't been a podiatrist long enough if you
have never overheard a rep telling someone else
that you love a product when the complete
opposite is true.
Jay Wenig, DPM, Dayton, OH, jaywenig@aol.com
