Substandard, non-approved drugs put patients at risk

and the subsequent deaths of 15 individuals—has renewed scrutiny on the contemporary practice of pharmacy compounding. The risks to patients, and associated liability risk to prescribing physicians, largely outweigh the benefits when the practice goes beyond the traditional, extemporaneous role, according to Sarah Sellers from q-Vigilance LLC and Wulf Utian from Case Western Reserve University in the US. Sellers and Utian's opinion piece appears online in the journal Drugs, published by Adis.

There is a place for traditional pharmacy compounding to fulfill medical needs of individuals that cannot be met with commercially available products. For example, a child who is unable to swallow tablets may be offered the liquid form of a , or a patient with a known allergy to an ingredient might be given alternatives. But formulations that are produced outside national regulatory frameworks lack studies to support their quality, safety and efficacy.

The authors explain, "FDA-approved products produced under federal Good Manufacturing Practice represent an essential standard of pharmaceutical care relied on by US citizens. Deviations from this standard of care should be made only under rare circumstances of medical necessity. Physicians should be cautious in their judgments regarding what circumstances would justify setting aside a federal standard for a professional one."

Under the traditional model of pharmacy compounding, non-FDA approved drugs are formulated to meet individual patient needs under the order of a physician. In contrast to this traditional role, compounding practices have emerged throughout the US and other countries, with direct marketing of formulations to both patients and prescribers. As a result, non-FDA approved, compounded drugs may be driven by largely unregulated pharmacy advertisements to physicians and patients, and they place prescribers in the backseat for decision making.

Sellers and Utian's paper outlines the essential differences between FDA-approved drugs and compounded drugs and reasserts the primary medical role of physicians when deciding what medical circumstances may necessitate treatment with non-FDA approved products. They also review the consequences of prescribing substandard drugs, including serious adverse events, and discuss the liability issues physicians need to consider when prescribing non-.

The authors conclude that it is in the interests of prescribers to remember that:

More information: Sellers S & Utian WH (2012). Pharmacy Compounding Primer for Physicians: Prescriber Beware. Drugs; DOI 10.2165/11640850-000000000-00000 , http://ow.ly/eqBPi

Provided by Springer Science+Business Media

not rated yet
add to favorites email to friend print save as pdf

Related Stories

CDC links eye infections to troubled Fla. pharmacy

May 03, 2012

(AP) -- Federal health officials confirmed 33 cases of a rare fungal eye infection across seven states on Thursday, stemming from products mixed in a Florida pharmacy that also mixed supplements that killed 21 elite polo ...

Off-label use: Oft not evidence based

Aug 21, 2009

In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief ...

Recommended for you

Novartis Japan admits concealing drug side effects

5 hours ago

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

Expression of privilege in vaccine refusal

Aug 27, 2014

Not all students returning to school this month will be up to date on their vaccinations. A new study conducted by Jennifer Reich, a researcher at the University of Colorado Denver, shows that the reasons why children may ...

User comments