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Your health: The
custom-mixed meds
alternative
By R.J. Ignelzi
Tuesday, November 3,
2009 at midnight
Jerry
Greene, who
owns San
Diego
Compounding
Pharmacy in
Kearny Mesa,
says his lab
produces a
lot of
custom-tailored
pain
prescriptions
In this age of "have
it your way"
burgers, made-to-fit
jeans and
personalized ring
tones, it’s no
surprise that
prescription
medicine also can be
customized.
From converting
hard-to-swallow
pills into
easy-to-use
transdermal creams
for seniors, to
changing
bitter-tasting
medicine into
cherry-flavored
gummi bears for
children and
fish-flavored liquid
for finicky felines,
compounding
pharmacies create
medicines to meet
unique needs that
can’t be fulfilled
by mass-produced
drugs.
"Customized
medications offer
the patient more
options. We work
between the
physician and the
patient to tailor
doses, flavor and
consistency for the
specific
requirements of a
patient," says Sanam
Ansari,pharmacy
manager at Pharmaca
Integrative Pharmacy
in La Jolla, which
offers compounding
in addition to
traditional pharmacy
services.
Because many people
have allergies to
the preservatives,
dyes or yeast in
some commercial
medications,
compounding
pharmacists like
Jerry Greene remake
the medications
without these
fillers, just using
the active
ingredients.
"As a compounding
pharmacy, we’re
helping people who
need specialized
medicines," says
Greene, who owns San
Diego Compounding
Pharmacy in Kearny
Mesa. "We do a lot
of pain management
(prescriptions) such
topical analgesics
for people who don’t
want to take a lot
of NSAIDs (nonsteroidal
anti-inflammatory
drugs). We can make
seizure-control
medications in
suppository form and
specialized
wound-care
products."
The practice of
compounding is not
new. It actually
predates the mass
production of
medicine, which
didn’t come about
until the 1950s.
Compounding took a
back seat to quick
and easy
manufactured
medicine but has
recently seen a
resurgence via
modern technology
and innovative
techniques and
research.
All pharmacists and
pharmacies in
California are
authorized to
compound
medications, but not
all do. About a half
dozen pharmacies in
San Diego County
focus on
compounding, while
dozens of others
offer compounding as
one of many
services.
Compounding now
accounts for about 1
percent of all
prescriptions in the
United States, or
about 30 million
prescriptions
annually, generating
about $1 billion a
year in sales,
according to the
International
Academy of
Compounding
Pharmacists (IACP),
a professional group
of more than 2,000
compound
pharmacists, or
about half of those
in the United
States.
As with most things
custom made, you’ll
probably pay more
for a compounded
prescription than a
mass-produced one.
"(Compounders) have
to make it, so of
course it’s going to
cost more. It’s a
whole different
process. It’s
different from
pulling it off the
shelf and handing a
pre-made product to
the patient," says
Rod Shafer, CEO of
Houston-based IACP.
"A compound
pharmacist is not
only taking the time
and effort to make
it especially for
you, but they’re
also doing batch
testing for potency
and sterility.
There’s a lot more
involved than people
realize."
Getting health
insurers to pay for
compounded
medications "can be
a huge struggle,"
Shafer admits,
noting that
compounders have
recently been
notified that
Medicare will no
longer cover
compounded
medications.
Although specialized
medications are the
results of the
skills and training
of pharmacists, the
concept for the
unique drugs must
originate with the
doctor. Compounded
medications are
ordered via a
physician’s
prescription listing
proper dosage,
strength and any
recommended changes
in delivery, flavor,
etc.
"It’s imperative
that pharmacists,
especially compound
pharmacists, be part
of the triad between
the pharmacist,
physician and
patient," Ansari
says. "We talk to
the patient and can
give suggestions
about things that
will work, but
before we go ahead,
we talk to the
doctor. We need the
physician’s final
approval before we
go ahead with
(making) the
product."
Although compounding
pharmacies offer
consumers more
options, they also
require consumers to
take more
precautions, the
Food and Drug
Administration says.
While the
ingredients in
compounded
medications are
FDA-approved, the
final product is
not.
"There may be
unknown risks when
using a compound
(medication) since
they don’t go
through the same
approval process as
FDA-approved drugs
and there is no data
available," says
Kathleen Anderson,
deputy director of
the FDA’s Center for
Drug Evaluation and
Research in
Maryland.
Pharmacies,
including
compounding
pharmacies, are
regulated by state
boards, not the FDA,
which regulates drug
manufacturing.
The FDA also is
concerned with
compounders —
especially large
Internet pharmacies
— which produce and
stockpile mass
quantities of
compounded drugs and
make claims touting
the benefits of
their compounded
medicines over
manufactured drugs.
"There’s a blurry
line when
compounding crosses
from compounding for
an individual
patient to
compounding for the
general public, in
which case it
becomes
manufacturing," says
Virginia Herold,
executive officer
for the California
State Board of
Pharmacy in
Sacramento. "And,
when it becomes drug
manufacturing, it
then falls under the
FDA."
Critics accuse some
compounders of
acting like drug
manufacturers,
doctors or both, but
without the
appropriate
safeguards. However,
Herold expresses
confidence in most
compounding
pharmacies and
points out that
mass-produced drugs
have not been
without their own
serious problems
resulting in
worldwide product
recalls.
"If a compounding
pharmacy follows
proper procedure,
the consumer is no
more at risk using a
compound medication
than a manufactured
one," Herold says.
"But the consumer
must know what to
look for when
(getting) compounded
medicine.
Chemicals were
weighed at San Diego
Compounding Pharmacy
in Kearny Mesa,
where, for a premium
price, patients get
medicine compounds
adjusted to
preferences and
special needs. K.C.
Alfred/Union-Tribune
photos
Jerry Greene,owner
of San Diego
Compounding
Pharmacy, says his
lab produces a lot
of custom-tailored
pain prescriptions.
Consider the
following tips when
getting compounded
medicine:
•Ask your doctor to
recommend a
compounding
pharmacist. Look for
an experienced
compounding
pharmacist. Ask if
the pharmacist
regularly compounds
the drug you need.
If the answer is
"no," look for
another who does.
•Try to use a local
compounding
pharmacy, so you can
check it out in
person. "Take a
close look around.
Does the pharmacy
seem clean and well
organized and
professional? Or,
does it look crazy
and chaotic? If so,
you may want to go
to another
pharmacy," says
Virginia Herold,
executive officer
for the California
State Board of
Pharmacy in
Sacramento.
•Ask about the
pharmacy’s
quality-control
procedures. Look for
pharmacies that do
third-party testing
for sterility,
potency or
contaminants. "We
send out all
injectables, and we
randomly send out
creams and capsules
to an independent
third-party lab,"
says pharmacist
Jerry Greene, owner
of San Diego
Compounding
Pharmacy.
•Make sure the
pharmacists are
accessible. "It
shouldn’t take a
pharmacist three
days to return your
call. When you’re
dealing with
someone’s health,
it’s especially
important that a
pharmacist be
available," Greene
says.
•
Make sure you’re not
given a compounded
drug when the same
drug already exists
through an
FDA-approved
manufacturer. That’s
illegal.
•Check with your
doctor if your drug
label says it was
compounded and you
didn’t expect it to
be.
•
Think twice if
prescribed a
compounded version
of a drug no longer
on the market. Ask
why it was taken off
the market, and heed
any safety concerns.
•Be informed about
your drugs.
Compounded
medications may come
without warning
labels or
information about
side effects, but
that doesn’t make
them risk free. Ask
your doctor and
pharmacist how to
use, store and
discard medications
correctly. Check the
active ingredients
on Web sites such as
rxlist.com
•Pharmacists should
ask a patient
(particularly new
ones) about their
medical needs,
medical history and
all medications and
supplements they
use. "The pharmacist
should have an
in-depth
conversation with
you. However, if you
get an aggressive
sales pitch from a
pharmacist, beware,"
Herold says.
•Although no
compounding permit
is needed to
compound general
medications in
California,
pharmacists are
required to have a
special
accreditation if
they make injectable
drugs. If you’re
getting a compounded
injectable, make
sure your compounder
has this special
license.
•Check the
California State
Board of Pharmacy’s
Web site at
pharmacy.ca.gov to
make sure a pharmacy
is licensed and in
good standing. Check
to see if an
Internet pharmacy is
recommended by the
National Association
of Boards of
Pharmacy at
www.nabp.net. If
it’s on the "not
recommended site,"
don’t use it.
•Find out if the
pharmacy is
accredited by the
Pharmacy Compounding
Accreditation Board,
pcab.org, which
compounders
established to
certify pharmacies.
It’s not necessarily
a guarantee of
quality, but it’s
one indicator that
the company takes
compounding
seriously and
practices quality
control.
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