For centuries, physicians have prescribed medications for their patients. The pharmacist followed exactly the physician's specifications and meticulously formulated these prescriptions. As the science of medicine advanced, many of the standard prescriptions began to be formulated and manufactured by pharmaceutical manufacturers. Most phamacists welcomed the change, since this removed most of their physical hand labor. Now phamacists could concentrate on spending more time with the patients and the dispensing and counseling process.
However, physicians began to notice that not all patients responded to the standardized manufactured medicines. There was still a need to formulate or "compound" prescriptions to the individual needs of these patients. Many patients were sensitive to the various fillers, dyes and preservatives that were used in commercial medicines. A few pharmacists responded to theses special needs by continuing to carefully compound these prescriptions to the exact specifications ordered by the physician without the offending chemicals. Some medications have been discontinued by the manufacturers simply because it became unprofitable to manufacture them. This became a real problem for the patient who had responded well to these drugs. Where could this person obtain their needed medication? Again, the compounding pharmacist is usually able to meet this need.
The compounding pharmacist who is committed to the art and skill of prescription compounding has made a significant investment in obtaining pure drugs and chemicals along with highly specialized equipment in order to make these medications. The compounding pharmacist must be involved in obtaining extra education and training which is unique in the profession of pharmacy. Compounding laboratories and sterile environments are all part of the compounding pharmacy. Literature to verify and validate the use of unique compounded medications must be researched and distributed to the physicians who choose to treat the unique needs of their patients.
Frequently
Asked Questions about Compounding
(This comes from the International Academy of Compounding Pharmacists (IACP) www.iacprx.org)
What is pharmacy compounding?
In general, pharmacy
compounding is the customized preparation of a medicine that is not otherwise commercially available. These medications are prescribed by a physician,
veterinarian, or other prescribing
practitioner, and compounded by a state-licensed pharmacist. A growing number of people and animals have unique health needs that off-the-shelf, one- size-fits-all prescription medicines cannot meet. For them, customized medications are the only way
to better health.
Who are compounding
pharmacists?
Pharmacy compounding is a centuries-old, well-regulated and common
practice. Pharmacists are some of the most respected
and trusted professionals in the United States. In a recent survey, pharmacists ranked second (only behind nurses)
as the most trusted professionals in American society. Compounding has evolved into a specialty
practice within the pharmacy community today. New applications to meet today’s patient
needs require additional education, equipment, and processes that not all
pharmacies possess.
How are compounding pharmacies and pharmacists regulated? Should there be
increased federal oversight?
All pharmacies and pharmacists are licensed and strictly regulated at the state level. Compounding
is a
core component of pharmacy and has
always been regulated by state boards, which are constantly updating their standards
and regulations. In addition,
standards set by the United
States Pharmacopeia (USP) are integrated into the practice
of pharmacy compounding. The Pharmacy
Compounding Accreditation Board (PCAB) has developed national standards
to accredit pharmacies that perform a significant amount of compounding.
Does the FDA have the expertise and federal power
to regulate compounding pharmacies?
Why shouldn’t compounded medications, especially the most commonly used combinations, have to go through
FDA’s
established drug approval process?
The medical
profession, including the practice of pharmacy, has always been regulated by the states. State boards of pharmacy are in the best
position to inspect pharmacy operations, develop appropriate regulations, and respond to problems
or violations. The FDA does have an important
role to play in making
sure that ingredients used in compounding are safe and are manufactured by the FDA-registered and inspected facilities, but there is no such thing as an “FDA-approved” pharmacy.
The FDA’s drug approval
process takes years
and can cost hundreds of millions of dollars. Requiring this for individually
personalized medications that fulfill an individual doctor’s prescription is both impractical and contrary to the best interests
of patients requiring immediate
treatment.
What suppliers sell ingredients to compounding pharmacies? How are these suppliers regulated?
Just like big pharmaceutical
manufacturing companies, compounding pharmacies get their ingredients
for medications from the suppliers that are
registered and inspected by the FDA. Foreign suppliers are FDA-
registered facilities.
There are thousands
of FDA-approved drugs on the market for just
about any ailment. Why do we still
need compounded medications?
Some valuable medications and their different
delivery methods are only
available by compounding. Restricting a doctor’s access to compounded
medications would be a serious mistake.
Moreover, because of the economics of pharmaceutical manufacturing, FDA-approved drugs that serve a limited population are often discontinued by manufacturers. In most
of these cases the only option left for
doctors and their
patients is to have
a compounding pharmacist make the discontinued drug from scratch using pharmaceutical grade ingredients.
Are compounded
medications safe? How does one know
that the compounded medication they
are taking is safe and effective?
Compounded medications are similar to the so-called
off-label use of
FDA-approved drugs. When the FDA approves a specific drug as safe and
effective, this determination applies
only to the specific disease or
condition for which the drug was tested. But physicians and veterinarians
often prescribe medications for treatments for which they have not been
specifically approved. Medical professionals do this because,
in their judgment, the
treatment is in the best interest of the individual patient.
Similarly, medical professionals often prescribe compounded
medications because they believe
it is the best medical option for their
patients. It is estimated that one fifth of all prescriptions written
for FDA-approved drugs are for uses for which they were not specifically
approved.
Compounding Pharmacy :
There are compounding pharmacies in most large cities in the United States. However, not all are the same when it comes to pricing, customer service, and compliance to sterilization regulations. You should call them to compare prices and to provide your credit card and address
information. Prices for testosterone products (creams, injections, pellets), HCG, TRIMIX, clomiphene (Clomid), anastrazole (Arimidex), nandrolone, pain creams, Sermorelin, estrogen/progesterone creams, erectile dysfunction medications in sublingual and other fast acting formulations and other
compounded products can vary widely among compounding pharmacies. If your doctor uses only one compounding pharmacy, tell him or her that you will shop around before committing
to theirs as the main source of your products.
I highly recommend : APS Pharmacy due to their great prices, high safety and sterilization compliance (I have visited their facilities) and customer care. For more information, email Anthony at anthony@apsmeds.com
