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PULMONARY PERSPECTIVES
CHEST P H YSICIAN • NOVEMBER 2007
The Perils of Pseudo-Compounded Medications
Physicians have a major responsibility to ensure submits an order for a nebulizer, the sup- Ǡ Receiving, storing, or using drug sub- plier will offer a free nebulizer if the pa- stances without first obtaining written as- the safety of their patients’ medications. tient gets his medication from the supplier, surance from the supplier that each lot of Recently, there has been a significant with ink that can leach into the solutions, un- plier bills the insurance company or FDA-registered facility.
Medicare, and the medication is virtually Ǡ Failing to conform to applicable state law labeling is embossed in the plastic, to avoid cost-free. This sounds like a good deal, ex- this problem. There are well-documented in- cept for the fact that the medications are stances of each of these problems where unreliable and can even be dangerous.
Special Risks of Pharmacy Compounding.
not well regulated. Many less heavily pub- drugs may also be obtained deceptively.
for patient advocacy groups and specialty Update, May 3, 2007: The Special Risks of frequently, the form does not make it clear that a substitution is being requested. In ad- cialize in respiratory diseases need to be especially vigilant, because many of these that pharmacies are not required to report PHYSICIANS WHO
other commonly “compounded” drugs.
events include: (1) three patients who died SPECIALIZE IN RESPIRATORY
of infections acquired by cardioplegic so- lutions during open-heart surgery; (2) two DISEASES NEED TO BE
ESPECIALLY VIGILANT,
response to a physician’s prescription, to fected solutions during cataract surgery; meet the needs of a specific patient. This (3) three patients who died of Serratia-in- BECAUSE MANY OF THESE
is an invaluable service rendered for pa- fested injectable beclomethasone; and (4) MEDICATIONS ARE USED IN
18 cases of Serratia marcescens in several tions that are not commercially available, NEBULIZERS.
people who may be allergic to inactive in- sulfate IV solution (Sunenshine et al. Clin Infect Dis 2007; 45:527). A particularly egre- unaware that they are signing off on drugs that are not FDA-approved and of inferior 4,000 L of respiratory solutions to be used quality. One could speculate that the “com- macies” exist that are engaged in the mass for nebulization and distributed them pounding” manufacturers and distributors manufacturing of drugs under the guise of nationwide to 18,000 patients. These med- are counting on physicians being too busy ications were contaminated with Pseudo- to scrutinize what they are signing.
produce millions of doses of their product Is there any peril to physicians if a pa- in anticipation of a physician’s order. The notified doctors or patients about the con- tient becomes ill as a result of taking such equipment companies is FDA-approved.
tamination and destroyed critical records.
a medicine? In fact, it is the physician who It was ultimately disciplined by the state becomes liable for the adverse events.
Board of Pharmacy, which, in Missouri, is Physicians have a major responsibility to process. Pharmacists running these opera- tion, the pharmacist preparing the drug is ensure the safety of their patients’ med- ications. They must read all their faxes for is supposed to be regulated at a state level prescriptions before they sign them. They by state pharmacy boards. Yet the FDA can protect patients and physicians from these also need to read the fine print to ensure intervene, and has intervened, when it can medications are the same as in their com- manufacturers claim that they have gener- ic versions of drugs, which are, in fact, not trigger its intervention. To the extent the that the medications they prescribe are dis- FDA can intervene with limited resources, pensed as written and their patients’ med- bling. States do not have the resources nec- available in this country. An example is the it has intervened. This list also is instruc- essary to inspect compounding pharmacies, tive in identifying the behaviors of these be aware that, if their patients are not and some states have only a handful of in- pharmacies that put them in conflict with spectors to cover the entire state, which al- proper manufacturing practices. These be- lows for some extremely shoddy practices by the “compounders.” The raw materials used that is aqueous-soluble. Budesonide is no- for their preparations are not FDA-approved, so it is impossible to determine their prove- “compounders” dissolve it in high con- were found to be unsafe or ineffective.
medication their patients inhale, ingest, or apply, it conforms to the highest pos- processes are often not sterile, and prepara- ly copies of a commercially available drug.
tions have been unevenly potent, causing the patients, including children, via nebuliza- “compounded” products are not surrep- tion. Ethanol is very irritating to the lungs ceiving prescriptions, except in very limit- tients. In addition, plastic ampules of drugs and, in these cases, is being given to pa- for nebulizer formulations have paper labels Dr. Gene L. Colice, FCCP
are deceptive to physicians and patients. In and Clinical Professor of Medicine

Source: http://aanma.org/pdf/CHEST_Physician_Nov2007.pdf