Download “ `Office use` means for use in the office or clinic, by or under the

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E D I T O R I A L
For Office Use: A Discussio
Discussion
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief, International Journal of Phar
Pharmaceutical Compounding
As most of us are aware, there have
been some tragic events related to
the prescribing for office use and
misuse
of
high-concentration
lidocaine gels. “Office use compounding is legal in many states and is very
appropriate. In fact, the US Food and
Drug Administration (FD A recog)
nizes the need for office use
compounding, as indicated during
the hearings on implementation of
C A S E
FDAMA97 and the FDA Compounding
Advisory Committee’s approval of some
bulk substances for office use only.
“ ‘Office use’ means for use
in the office or clinic, by or
under the supervision of
the health professional. ”
Continued on reverse
R E P O R T
2-deoxy-d-glucose Pluronic Lecithin Organ
Organogel for Treating Warts
Nat Jones,
nes, RPh
Suffolk, Virginia
At a compounding seminar last year, I
learned about a new active ingredient
in topical preparations used in the
treatment of warts and several new
recipes for such preparations. The
ingredient was 2-deoxy- d-glucose
(DDG), and some of the recipes also
included ibuprofen and/or cimetidine.
My 8-year-old son was the first patient
I treated with a DDG preparation. He
had eight or nine warts on his hands,
and application of acids and freezing
by the dermatologist had been unsuccessful; the warts has simply grown
back.
Upon my recommendation, the
dermatologist tried DDG 2% in
Pluronic lecithin organogel (PLO),
applied 3 times a day,
but after 30 days only
minimal improvement
had been achieved.
The formulation was
changed to include
ibuprofen 2% and
cimetidine 10%, and
this time, after 4
weeks of application 3 tim es a day, all
warts were gone, including a pe r s i s t e n
1 - c mwart at the nail bed on the index
finger that had been present for over 4
years.
The second patient treated was a teenaged
girl who had been diagnosed with lichen
sclerosis and genital and perianal warts.
Treatment was initiated with a topical
cream containing testosterone and triamcinolone, but results at 30 days were poor.
Continued on reverse
Types of Warts
EDITORIAL CONTINUED
Compounding standards for office use
are exactly the same as those for
individual patients;
the standards
described in United States Pharmacopeia (USP) Chapters <795> for nonsterile and <797> for sterile preparations
should be followed. The pharmacist’s
responsibilities include adhering to
state laws and regulations governing
compounding and to USP standards.
The compounded prescriptions should
be labeled “For Office Use Only” along
with appropriate beyond-use dates and
other information required by the
individual state.
These office use prescriptions, whether
lidocaine gel or any other preparation,
are NOT to be provided to patients for
their own administration. They are to be
used only in office, hence the name
“office use.” Prescriptions given to
patients for use outside the office
should be written as an individual
prescription for a specific patient along
with specific instructions.
CASE REPORT CONTINUED
The physician then focused treatment on
the warts, with topical imiquimod 5%
cream. Aft er o nl y one application the
patient was unable to continue therapy
owing to the side effects of the cream:
pain and extreme skin irritation.
Upon consultation, I recommended topical
DDG 2% in PLO, to be applied 3 times daily.
This was successful for several weeks, and a
laser procedure was performed to remove
all lesions. At a follow-up visit 80 days after
the laser procedure, all the patient’s symptoms had returned, including lesions in
greater numbers than before. Th e physician ordered interferon injections into each
lesion. While we were awaiting approval
from the patients insurance company, I
suggested trying the combination of DDG
2% and ibuprofen 2% and cimetidine 10%
in PLO, to be applied 3 times daily. When
the patient returned to get the injections,
after 4 weeks of this therapy, virtually all
lesions had healed. Impressed, the physician said that he was “amazed” at the
immune response.
There are four general types of warts: common, plantar (foot), flat, and genital.
Common warts usually grow around the nails, on the fingers, and on the
backs of the hands.
SAMPLE
Preparations compounded for off i ec
u s ed o n o tgenerally hav e specific
instructions since they are not
prescribed for individual patients and
their use may vary for each patient.
They do need to be labeled that they
are for office use. Some states are
requiring that “signup” sheets be sent
along with the compounded office use
preparation; each patient on whom the
preparation was used in the medical
office/clinic would be listed on the
sheet, which would then be returned to
the pharmacy.
Plantar
Pla
warts
arts (foot war
warts) occur on the soles
so of the feet. Plantar warts
create
crea the painful sensation
sensa
off having a pebble
pe
in the shoe.
Fla warts tend to occur in groups
Flat
oups of as ma
many as 20 to 100 at a time. They
appear smoother and flatter than the other types of warts and can occur
anywhere on the body. They usually occu
occur on the faces of children, on the
legs of adult women, and in the beard area of men (thought to be related
to irritation from shaving).
Genital warts (venereal warts,, condyloma
condylomas) are caused by the hum an
e become a ccommon and worrisome probpapillomavirus (HPV) and have
lem in adults. Of the 100 identified strains of HPV, more than 30 can infect
the genital tract; these often are transmitt
transmitted through sexual intercourse.
Suggested Reading
treatment of warts. IJPC 2004; 8(2): 126.
Allen LV Jr. Basics for compounding for the trea
Frequently Compou
Compounded Medications for Warts
Sal
Salicylic
acid 26%
6% and lactic acid 15% paste or gel: Apply to
wart after applying petroleum jelly to the skin around the
wart.
Trichloroacetic
acid
salicylic
chlor
cid 20% and
nd sal
lic acid 60% topical paste
(office use): Apply to wart after applying petroleum jelly to
the skin around the wart.
2-deoxy-d-glucose 0.2% and tea tree oil
Cimetidine 5% and 2-deoxy-d-glucos
ibuprofen 2% in Pluronic lecithin organogel: Apply
10% and ibuprof
to wart.
collected on many patients to verify
these results. But it is great to see
dramatic improvementt with a fast, well-tolerated, and noninvasive therapy for
these conditions, whose treatment is
often difficult and sometimes
es painful.
Plans are underway to collect data, hopefully for publication, as more patients are
treated. Obviously, information needs to be
RxTriad - A publication of the International Journal of Pharmaceutical Compounding. © 2005 IJPC. All rights reserved.
W
HO
gets warts?
Approximately 12% of the
population will have a wart at
some time in their life.
The incidence of warts in men
and women is the same.
Warts are more common in
European Americans than in
African Americans or Asian
Americans.
Warts can occur in any person of
any age, but they occur most
often in adolescents, especially
those aged 12 to 16 years.
Suggested Reading
Sug
Popovich NG, Newton GD. Minor foot
disorders. In: Allen LV, Berardi RR, DeSimone EM et al, eds. Handbook of Nonprescription Drugs. 12th ed. Washington, DC:
American Pharmaceutical Association;
2000: 781–818.