Plan to Reuse Prescription Drugs Stuck on Final Hurdles
Plan to Reuse Prescription Drugs Stuck on Final Hurdles [Chicago Tribune]
From Chicago Tribune (IL) (August 21, 2011)
Aug. 20--When people in Illinois die or just no longer needs their prescriptions, there's virtually no legal way to get them into the hands of other patients -- no matter how sick or needy they are.
Yet the practice of recycling sealed, unused medications occurs in dozens of other states. And proponents say the practice not only widens access to life-saving drugs for those who can't afford them but also prevents the medications from clogging up landfills or, worse, polluting the water supply.
"Given the obscene cost of so many drugs, it seems absurd to destroy otherwise usable medications," said Dr. Charles Schiffer, professor of medicine and oncology at Wayne State University School of Medicine in Detroit.
In Illinois, though, the movement to set up a clearinghouse for leftover pharmaceuticals has been hampered by concerns over safety and regulation, as well as legal liability.
Backers of a proposed drug reuse law are trying to broker a compromise between drug manufacturers who want to be protected from liability if something goes wrong and trial lawyers groups who argue that anyone harmed by taking reused drugs ought to be able to sue.
Nationwide, vast quantities of pharmaceuticals are thrown out every year: an estimated 250 million pounds by hospitals and health care centers alone, according to a 2009 Associated Press investigation that extrapolated that figure from a sampling of data. Some drugs end up in Chicago's drinking water, Tribune analyses have found, while patients who need prescription drugs but can't afford them go without.
Such findings have helped fuel momentum in Illinois for a proposed drug recycling law that has gained support from a wide variety of stakeholders, from patient advocates to doctors to pharmacists.
The movement comes as policymakers struggle to contain rising medical costs; the state can't pay its Medicaid bills on time and is slashing funding for a popular prescription drug program. A chief sponsor of the medications plan, Rep. Patricia Bellock, R-Hinsdale, suggests the measure could be on the verge of approval by lawmakers after years of getting stuck in committees. She hopes to see it called for a vote in the fall legislative session.
Yet re-prescribing drugs is not a simple matter, because the wrong drug or dose can be fatal, and some drugs must be kept refrigerated. Drug manufacturers and pharmacists must ensure the quality of what they sell, and once it goes to a consumer, it leaves that protective chain of custody. The Illinois Hospital Association has also raised concerns about how to make certain that medications are not tampered with and are correctly identified.
To answer these concerns, sponsors aim to establish tight controls. Only sealed vials and blister-packaged single dose containers would be accepted. An inspector would have to make sure each medication is labeled correctly. And only health care facilities could donate unused drugs -- not coroners offices that receive unused medications during death investigations, and not individuals.
That caveat is a disappointment to people such as Laura Redman, who quit her job to care for her mother when she was bedridden by Lou Gehrig's disease.
After her mother died, Redman was left with a drawerful of medications -- 13 vials containing hundreds of pills.
No stranger herself to the challenge of paying for pharmaceuticals -- she struggles to afford her $40-per-month hormone-replacement therapy -- Redman felt some small measure of her grief might be lessened if she knew the medications her mother left behind were helping someone else.
"It's a sin to see all this go to waste," said Redman, 56, who lives in the Will County community of Wilmington. "It hurts me, because other people could use it."
Despite the controversies and compromises of the proposed Illinois law, the idea behind it is not new. Hospital pharmacies already regularly re-prescribe sealed, unused drugs, as long as the hospital maintains control of them.
And, informally, some doctors have re-prescribed unused medications for years, but a formal program would help immensely, Schiffer said.
At least 38 states have such programs, according to the National Conference of State Legislatures, and the language of the Illinois legislation was modeled on at least 21 existing laws.
Specifically, the proposal would direct the Illinois Department of Public Health to create a drug repository that would take unused medications from health care providers such as nursing homes, rehabilitation facilities and hospices. The drugs would then be re-prescribed to needy patients.
As evidence that prescription drug recycling can work, supporters point to a similar program in Iowa.
Since it opened in 2007, the Iowa repository has grown steadily and reports serving 15,000 patients with medications valued at more than $3 million.
The two most frequently donated drugs have been anti-psychotics and anti-depressants, largely because of patients who changed treatments or didn't take their medications. Other drugs commonly processed by the clearinghouse are those that treat high blood pressure, cholesterol, asthma and seizures, most of it from long-term care facilities.
Iowa patients who are uninsured, underinsured or meet a poverty threshold can sign up to receive the recycled medications from participating pharmacies or medical facilities for only a service charge.
A nonprofit organization, the Iowa Prescription Drug Corporation, runs the program, which Executive Director Jon Rosmann suggests is the most extensive in the nation. Although the clearinghouse costs the state almost $400,000 to run annually, Rosmann feels it more than pays for itself.
For instance, he said, one patient in the program received the antibiotic Zyvox to treat a MRSA infection. Without the drug, the patient would have had to stay in a hospital for 10 days of IV treatment, at a cost of $41,000. With it, he was able to go home that day.
Other states have had trouble implementing their programs, Rosmann said. States with multiple local repositories rather than one central distribution center find it harder to coordinate, and retail pharmacies in some places have not participated because of concern about liability.
In Illinois, trial lawyers are unconvinced by programs elsewhere.
"If you knock out the immunities, this is a great program," Illinois Trial Lawyers Association President Jerry Latherow said. "But to provide civil and criminal immunity doesn't make sense. For a family that's lost a loved one to a drug, I don't see why they should be barred from seeking legal recourse."
The Iowa Association for Justice, which represents trial lawyers there, says there's a big distinction between the Iowa law and the Illinois proposal.
The Iowa law states that the repository and pharmaceutical companies can be liable if they don't act "reasonably and in good faith." The Illinois bill states that manufacturers must show "willful and wanton misconduct" in order for a patient to have grounds to sue -- a heightened standard that is very difficult to prove, said Lisa Davis-Cook, director of government affairs for the Iowa Association for Justice.
Dr. Wayne Polek, president of the Illinois State Medical Society, says immunity issues have been worked out previously on other matters without dire consequences, such as good Samaritan laws that allow doctors to help in emergencies or free clinics without fear of being sued.
Bellock, the bill's sponsor, hopes to negotiate a common ground between the desires of the trial lawyers and the Pharmaceutical Research and Manufacturers of America, which represents large drug manufacturers and wants even greater protections against lawsuits after drugs are out of their control.
The DuPage County Health Department is willing to test the concept with a pilot program. Maureen McHugh, executive director of the agency, said the county could look into either working with retail pharmacies, as it does with its flu shots, or with the county Convalescent Center, which has its own pharmacy.
The county's Access DuPage program, which provides medical services to the poor, spends 75 percent of its $2 million budget on prescription drugs. Any recycled drugs that could lower that cost would be well worth it to McHugh.
"That's not a cost," she said. "It's an investment."
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Posted: August 2011