[Pharmwaste] Fw: Drug Recycling (a long way from ever becoming a widespread reality)
beling.christine@epamail.epa.gov
beling.christine@epamail.epa.gov
Thu, 19 May 2005 10:30:03 -0400
FYI
Christine Beling
USEPA-New England
Assistance and Pollution Prevention-SPP
One Congress Street
Boston, MA 02114
phone 617-918-1792
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----- Forwarded by Cynthia Greene/R1/USEPA/US on 05/18/2005 09:31 AM
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Christian
Daughton/LV/USEP
A/US To
Bobbye Smith/R9/USEPA/US@EPA,
05/18/2005 08:51 Cynthia Greene/R1/USEPA/US@EPA
AM cc
Subject
Drug Recycling (a long way from
ever becoming a widespread
reality)
http://www.nytimes.com/2005/05/18/health/18reuse.html
May 18, 2005
Old Pills Finding New Medicine Cabinets
By STEPHANIE STROM
As the cost of prescription drugs climbs, more of the nation's
officials and consumers are weighing how to salvage at least $1 billion
worth of unused drugs that are being flushed down the toilet each year.
Though the Food and Drug Administration generally forbids the
redistribution of prescription drugs once they are dispensed to
consumers, states are free to set their own policies for drugs
controlled by nursing homes, long-term-care centers and other
pharmacies.
"They seem content to let the states be laboratories, and that works
out rather well because the dollars the states are saving are in a lot
of cases federal dollars," said James Cooley, chief of staff for Diane
Delisi, a Texas state representative and the author of legislation to
expand Texas's limited drug recovery program, which may pass within a
week.
Several states, including Oklahoma, Louisiana and Ohio, have passed
legislation in the last few years allowing unused drugs to be recovered
from those organizations for distribution primarily to poor patients.
Nebraska even permits consumers to return unused drugs if they are in
tamper-resistant packaging, like the blister package most familiar in
over-the-counter medicines, skirting the F.D.A. prohibition.
Recovery has been modest, but California, Maine, Washington and other
states are pondering similar programs in hopes of lowering health care
costs, however marginally.
Other supporters are trying to push the idea further. An inventor in
Massachusetts is seeking a patent on a system that would knit together
existing technologies to address the myriad issues of drug
redistribution.
"We recycle newspapers, we recycle soda cans, we recycle plastic," said
Moshe Alamaro, the inventor, who is a visiting scientist at the
Massachusetts Institute of Technology. "It's ludicrous not to recycle
expensive drugs."
Mr. Alamaro added, "It should be criminal to throw these drugs away,
and instead it's required."
The concept has more skeptics than believers. The hurdles include
concerns about patient safety and privacy, the lack of an
infrastructure to process and redistribute drugs, and administrative
requirements.
"I don't want to sound overly negative, but there are lots of
obstacles," said Susan McCann, administrator of the Missouri Bureau of
Narcotics and Dangerous Drugs, which is struggling to begin the state's
redistribution program.
To sidestep the questions of recycling, Representative Tim Murphy, a
Republican who represents Pennsylvania in Congress, suggests that the
federal government take a different tack and make it easier for doctors
to prescribe small quantities of drugs initially to determine whether a
patient can use them.
Monthly or longer prescriptions, now encouraged and sometimes mandated
by states and insurers to hold down costs, lead to waste that could be
curbed through redistribution.
The amounts discarded are unknown. Though many states require nursing
homes, hospitals and consumers to follow specified procedures for drug
disposal, the rules add costs and are largely ignored, state health
officials and others say.
A study published in the Journal of Family Medicine in 2001 estimated
that $1 billion a year in drugs prescribed to the elderly are thrown
away, and Mr. Alamaro estimates that a more ambitious system for drug
recycling could recapture 5 percent of the nation's prescriptions, or
about $6 billion worth annually.
Existing programs are a long way from that, however. The prevailing
method of dispensing prescription medicine in bottles leaves it too
vulnerable to tampering and contamination for any chance of recovery.
Pharmacies, the most likely candidates for redistribution, have little
incentive to take on the administrative burdens and potential
liabilities.
And states have not committed to developing the databases and other
systems that would be needed, much less wrestled with how to ensure
adequate supplies of drugs for patients to continue a regimen.
"It doesn't matter how safe the drugs are, how many of them there are
or how neat and crisp the records are, if there isn't a database to
tell patients what's available and where it is," Ms. McCann said.
So far, only one clinic has expressed interest in participating in the
Missouri program. Ohio has failed to get its program off the ground
more than two years after it was approved by the legislature because of
a lack of interest among nursing homes.
Among the handful of states pressing ahead, Louisiana is one of the
most advanced, with 12 pharmacies that distribute unused prescription
drugs. Expired drugs and controlled substances, those that are
potentially dangerous, are not accepted. As in other states, the drugs
are collected from nursing homes and assisted-living centers, which
have a carefully controlled storage and distribution system and use
blister packaging.
"We know those drugs are perfectly good," said William T. Winsley,
executive director of the Ohio State Board of Pharmacy. "They've been
under lock and key; they've been stored properly."
Nonetheless, concerns about safety and hygiene have dogged the
Louisiana program, said Malcolm J. Broussard, executive director of the
Louisiana Board of Pharmacy. "We run across the thought that these are
secondhand drugs, and 'don't poor people deserve the same drugs as
anyone else?' " he said.
Getting nursing homes to hand over unused drugs has also been a
challenge.
"For years, they've been under the impression that they had to waste
these medicines," Mr. Broussard said.
Louisiana's program intends to retrieve several million dollars' worth
of medicines each year, Mr. Broussard said, though it is too early to
gauge results.
The recovery and redistribution of unused medicines is handled by
charity pharmacies that cater to the working poor, thus avoiding thorny
questions of who gets reimbursed for returned medicines and how. Should
a patient get back part of the co-payment, for example?
"You need to reimburse the state or insurer or individual who paid for
the drug, and there's a big hassle in that paperwork," said Gay Dodson,
executive director of the Texas State Board of Pharmacy.
Mr. Alamaro is convinced that many problems can be resolved with
technology, greatly expanding the pool of retrievable medicines.
He and his partners want access to the shelved drugs in the medicine
chests of consumers like Florence Weisfeld of New York. Mrs. Weisfeld,
80, a former social worker, ached and had flulike symptoms when she
took Lipitor, the cholesterol-reducing medication. So her doctor
changed her prescription.
"I had 25 Lipitor tablets left in my medicine chest, and all I could do
with them was flush them down the toilet," Mrs. Weisfeld said. "Such a
waste."
Recycling Mrs. Weisfeld's Lipitor would require sweeping changes in the
way drugs are dispensed. Mr. Alamaro's plan contemplates replacing
bottles of pills with blister packaging or something like a high-tech
Pez dispenser.
Such packaging could be encoded with information about the drug and who
paid for it. That data would then be used to determine the drug's
integrity and reimbursement, which Mr. Alamaro envisions as a system of
credits. For instance, a consumer returning a drug to a pharmacy would
receive a credit toward a future co-payment.
Patients could return drugs by mail to a reprocessing center or deposit
them in a secure box at a pharmacy, which would then forward them to an
inspection center.
His own partners are the first to point out the challenges. "I'm
optimistic about the technology; I'm not optimistic about the economics
at present," said Mark G. Hodges, an environmental consultant who is
working with Mr. Alamaro.
The states that are trying drug redistribution have found novel ways to
overcome some of the problems. For instance, Oklahoma drafted a corps
of retired doctors to ferry drugs between donors and two participating
county pharmacies.
"There are always all kinds of reasons not to do things," said Paul
Patton, executive director of the Tulsa County Medical Society, the
doctors' group that led Oklahoma's efforts on drug recycling. "But this
makes so much sense that we've been able to convince a lot of people
that it's better to have this program and work to resolve the issues
than to not have it at all."
Proponents of drug recovery programs say the real test will come in
California, where the Senate is considering a bill to establish a drug
recycling program that was first advocated by five first-year medical
students at Stanford University.
"Throwing away valuable resources when there is already not enough to
go around is cavalier and unfeeling, not to mention poor public
policy," said Josemaria Paterno, one of the medical students.
The Stanford students estimate that a program to recover drugs from
nursing homes and long-term-care facilities would save the state $50
million to $100 million a year.