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Excerpted from USA Today- March 23, 2005
Millions of Americans rely on prescription medications for
their asthma and allergies. They inhale these medicines daily
with the help of a small, tabletop machine called a nebulizer.
Many of these patients do not know that they are using
respiratory drugs that are mixed together in pharmacies from
bulk-purchased ingredients. These pharmacies are called
compounding pharmacies. Medications compounded in pharmacies
are not approved by the Food and Drug Administration, and they
are made with far less oversight than drugs produced by
pharmaceutical companies. Compounding pharmacies make a wide
variety of drugs, from dermatological treatments to injectable
painkillers. While compounding technically violates federal drug
law because pharmacies produce drugs without FDA approval,
regulators have long allowed it because "the vast majority of
pharmacies ... provide a valuable medical service," Steven
Galson, the FDA's acting director for the Center for Drug
Evaluation and Research, told Congress in 2003.
But the agency has become increasingly concerned that some of
these pharmacies are acting as drug manufacturers, producing
millions of doses of medication, "which can expose large numbers
of patients to health risks associated with unsafe or
ineffective medications," Galson said. Respiratory
Medications Pharmacy-made respiratory drugs analyzed last
year by drugmaker AstraZeneca, which sells a product that is
often copied by pharmacies, found four of the five samples
failed potency tests. Officials at AstraZeneca declined to
comment on the internal analysis, but the company has launched a
doctor-education campaign about the differences between
pharmacy-made and brand-name drugs. All states and the FDA
allow the compounding of drugs. But FDA officials are concerned
that some pharmacies cannot match a manufacturer's ability to
make and package complex drugs properly.
The FDA is also concerned about the difficulty in making
sterile products in a pharmacy. Many respiratory drugs must be
sterile because they are used by the very young, the very old
and those with impaired lungs.
"Because of the requirements and nature of sterile products,
they are the most difficult to prepare, and the consequences of
error are most severe," says an FDA paper on compounding
pharmacies published in 2000. How Can Patients Ensure That
Their Medications are Safe?
Patients who are concerned about pharmacy manufacturing are
urged to speak to their physicians about this practice. If you
suspect that you or a family member may have received an
inappropriately pharmacy manufactured drug, you should
immediately go to your doctor’s office and show him/her the
product. |
