*** Amgen suit unveils industry 'overfilling' practices ***

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Amgen suit unveils industry 'overfilling' practices
By Allison Bruce

Tuesday, November 10, 2009

A lawsuit launched against Amgen Inc. on Oct. 30 raises important questions about what is accepted practice when it comes to manufacturing and administering certain drugs and whether the company encouraged the fraudulent sale of free drugs to increase their use.

The fifteen state attorneys general behind the suit allege that Amgen exceeded the amount of “overfill” necessary in its vials of anemia drug Aranesp and then its sales staff used that extra drug, placed in each vial so that a full dose can be extracted and administered with a needle, to encourage purchases and the false billing of Medicaid for the additional medicine.

This is in addition to charges against Amgen and other companies alleging kickbacks, weekend retreats and other incentives to get medical providers to buy Aranesp.

Amgen is being charged with violations of the federal anti-kickback statute and state false claims laws.

Amgen has called the allegations “without merit.”

Aranesp sales have declined because of safety concerns about the drug. Worldwide sales for Aranesp were $4.1 billion in 2006, $3.6 billion in 2007 and $3.1 billion in 2008.

Relating to the overfill allegations, the case deals with whether the company used the overfill amount as an added incentive to get doctors to buy and administer Aranesp. The allegation is that medical practitioners gave patients higher doses or pooled remaining overfill to yield a complete dose — then billed Medicaid for the dosage given using the free overfill amount.

Most, if not all, drug vials have overfill in them so patients can get the proper amount, said Gene Day, director of pharmacy for Community Memorial Hospital in Ventura.

“Generally, there’s not that much overfill to where you would have a significant amount of overfill to give to anyone else,” he said.

Of the different ways drugs are distributed — multi-use vials with multiple doses, single-use vials with a single dose and pre-filled syringes — single-use vials tend to require the most overfill. Overfill amounts can vary widely.

This can result in expensive waste or patient overdose.

An article from Pharmaceutical Commerce states manufacturers typically overfill vials by as much as 30 percent. A 2008 Genetic Engineering & Biotechnology News article said vials have to be overfilled by up to 18 percent.

By contrast, pre-filled syringes are usually overfilled by about 3 percent, the article stated.

The suit lays out the argument that Amgen’s launch of single-dose vials of Aranesp with 19 percent overfill, which declined in later years to 16.8 percent and then 13 percent, was more than was needed to get the right dosage and instead used as a free incentive.

It notes that the United States Pharmacopeia, which sets standards for prescription and over-the-counter medicines, recommended up to an additional .1 milliliter, a 10 percent overfill, for a 1.0 milliliter dose vial.

It went on to state that, around the time it launched Aranesp, Amgen started lowering the overfill amounts in Epogen, its earlier anemia drug, and Procrit, the competing anemia drug sold by Johnson & Johnson that Amgen manufactures. In 2002, the overfill for those drugs was reduced from 16.8 percent to 14.4 percent and then to 11.1 percent in 2004, the suit states.

Doctors and nurses have been known to give patients overfill amounts. In one case study on the USP Web site, it talks about a pharmacist mistakenly giving a nurse too little of a drug to administer to a patient in an emergency, but the nurse being able to use the overfill from the vials to give the patient enough of the drug without returning to the pharmacy.

It can raise issues as well.

In the case of Aranesp, the suit alleges that overfill usage resulted in patients receiving more than the recommended dose of the drug so medical practices could bill for the higher doses. This has stark implications because the FDA has determined in recent years that patients should receive as small a dose as possible of Aranesp because of safety concerns.

There also is worry about “pooling” the remaining overfill from several vials to create a single dose.

In a 2000 article in Nephrology Nursing Journal, a nephrology nurse mentioned surprise at seeing other nurses consolidate the overfill amounts over time — something that could be unsafe for patients.

A study published in the New England Journal of Medicine in 2001 found that cases of bloodstream infections in patients at a hemodialysis center in 1999 could be traced back to the repeated puncturing of single-use vials and pooling of the anemia drug overfill in an attempt to cut costs.

The Centers for Disease Control and Prevention recommends that single-use vials only be used once for one patient.

There’s finally the question of whether Amgen’s sales force was encouraging doctors to use the overfill and bill for it.

The California Medical Association has long-standing policies concerning the use of free samples. Spokeswoman Amber Beck said the association knows physicians want to keep costs down for patients, but also wants them to be mindful of where the drugs come from.

One policy supports requiring manufacturers to keep records of all samples distributed; prohibitions on the sale, purchase or trading of drug samples; and proposals for adequate disposal of outdated drug samples. Another supports legislation that would assure the right of physicians to dispense prepackaged samples without charge without inventory and labeling constraints. The common theme is using those samples to reduce patient cost.

Doctors and companies have run into trouble for selling free samples.

In 2003, AstraZeneca Pharmaceuticals agreed to pay a $355 million settlement for its marketing and drug pricing that provided doctors with free samples of Zoladex, a prostate cancer drug, that the doctors then billed government programs for giving to patients.

In 2001, TAP Pharmaceutical Products Inc. agreed to pay $875 million to resolve criminal charges and civil liabilities related to its drug pricing and marketing of Lupron, a drug for advanced prostate cancer, according to the U.S. Justice Department. Urologists and TAP managers were charged with conspiracy to defraud state Medicaid programs and causing free samples to be billed to Medicare, among other charges.

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