Unused drugs: Take them back or throw away?
In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds. For 41 million Americans, it suggests water with something extra means more than just a slice of lemon, though the quantities of pharmaceutical compounds in the water are too small to constitute a medical dose, according to the report.
One reason why drugs are showing up in drinking water is because often when people take them, some pass through their bodies without being metabolized. But another reason is the habit many people have of flushing unused drugs down the toilet.
The Drug Enforcement Administration, working with local law enforcement agencies, has been arranging national drug take-back days every few months. The main purpose of the events is to keep drugs out of the hands of drug abusers, but sponsors of the events, including city governments and retailers, have touted their environmental benefits as well.
According to a new study by the University of Michigan, however, the best way to get rid of drugs in order to protect the environment may be to throw them in the garbage. The study, published in April in Environmental Science & Technology, measured the total emissions of active pharmaceutical ingredients and other water and air pollutants from three drug-disposal methods: taking them back to the pharmacy, throwing them in the trash and flushing them down the toilet.
The study found that if half of the estimated 200 million lbs. of unused drugs accumulated every year were thrown away and half were taken back, the amount of APIs in the environment would be reduced by 93%, while everybody throwing them in the trash would reduce the APIs by 88%. At the same time, however, the 5% difference would cost the economy possibly more than $1 billion per year and a 300% increase in emissions of greenhouse gases and smog-forming substances.
“National policy seems to be changing to support take-back programs, and we don’t know if that’s justified,” study author and University of Michigan Department of Civil and Environmental Engineering doctoral student Sherri Cook said.
To keep drug abusers from getting to prescription drugs, the study recommended mixing them in a sealed plastic bag with an unpalatable substance, such as coffee grounds.
Currently, the Food and Drug Administration and the DEA recommend throwing unused drugs away if patients don’t have access to take-back programs, such as those sponsored by pharmacy retailers like CVS and Giant-Carlisle. Supermarket chain Giant-Carlisle announced in May that it had collected nearly 3 tons of unused medications at 43 stores during a national take-back day. Meanwhile, the DEA regards take-backs as the best way to dispose of unused drugs.
“Unused drugs thrown in the trash in their bottles can be retrieved and abused or illegally sold,” a spokesman for the DEA’s Philadelphia division told Drug Store News, saying that the agency only recommends throwing drugs away if no take-back program is available. “Proper disposal of used prescription drugs can save lives.”
Legislative News — Chain Pharmacy, 6/25/12
WASHINGTON — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
News media reported last month that the bills, sponsored by Rep. Tim Murphy, R-Pa., would create an expedited FDA approval pathway for follow-on versions of biogenetic medications, such as vaccines and drugs made from human tissue and plasma. According to media reports, Murphy said the legislation would make the medications more affordable and accessible while ensuring that offshore drug makers are held to the same manufacturing standards as those based in the United States.
According to reports, the House Energy and Commerce Committee voted 46-0 to send the bill to the House floor.
MONTGOMERY, Ala. — A new law in Alabama will establish standards in the pharmacy audit process conducted by pharmacy benefit managers in the state. Last month, Alabama Gov. Robert Bentley signed SB 383, the Pharmacy Audit Integrity Act, which establishes uniform standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit. The law also requires audits that involve clinical or professional judgment be conducted in consultation with a pharmacist and establishes an appeals process.
The bill drew praise from the National Association of Chain Drug Stores, which has endorsed federal legislation that seeks to preserve pharmacy choice for patients and takes additional steps to prevent threats to pharmacy patient care. The bipartisan Pharmacy Competition and Consumer Choice Act — S. 1058 and H.R. 1971, sponsored by Sen. Mark Pryor, D-Ark., and Rep. Cathy McMorris Rodgers, R-Wash., respectively — includes provisions requiring transparency by PBMs in pharmacy audits.
MONTPELIER, Vt. — Vermont also enacted a PBM audit law, which drew praise from NACDS as well. S. 200, signed into law by Vermont Gov. Peter Shumlin, establishes consistent standards for the auditing of pharmacy records and includes requiring two weeks written notice of an audit; requires auditing records be provided to the pharmacy; sets a 60-day deadline for the preliminary audit report following completion of an audit; and establishes a written appeals process.
“We thank Gov. Shumlin for enacting this important pro-patient, pro-pharmacy legislation to curb practices used by some PBMs that jeopardize the role of community pharmacy in improving patient care and making healthcare delivery more efficient and cost-effective,” NACDS president and CEO Steve Anderson said. “We thank the Vermont Association of Chain Drug Stores for their leadership in helping to ensure transparency in the PBM audit process.”
PDUFA reauthorization moves toward resolution
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
On May 24, the Senate voted 96-1 to approve the reauthorization and modification of the user fee program, with Vermont independent Sen. Bernie Sanders casting the sole dissenting vote with the assertion that it wouldn’t do enough to bring down drug prices. The House followed suit, overwhelmingly approving its own version of PDUFA legislation May 30.
Both versions include new provisions that would create, for the first time, a user fee program for generic drug makers. The generic industry would pay $299 million a year in user fees for the next five years — beginning Oct. 1, 2012 — for new FDA staff, faster generic approvals that could help clear a backlog of some 2,500 applications and more inspections of manufacturers’ production plants.
In another key change, the PDUFA proposals would create a user fee program for makers of biosimilar drugs.
The House and Senate must still hammer out any differences in legislation. Some members of Congress predict that will happen before the July 4 recess.
Both the branded and generic drug industries hailed the moves in Congress. Ralph Neas, president and CEO of the Generic Pharmaceutical Association, said they’ll move Americans “one step closer to receiving faster access to … generic medicines.”
Said John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, “by casting a positive vote to reauthorize PDUFA, members of both the House and the Senate … have acted in the best interests of America’s patients.” The new funding, he added, also will “provide the FDA with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation.”
One provision of the Senate’s version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, did raise alarm bells among pharmacy groups, however. Five organizations — including the American Pharmacists Association, National Association of Chain Drug Stores and National Community Pharmacists Association — registered opposition to an amendment by Sen. Joe Manchin, D-W.Va.
Manchin’s proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone by raising them from schedule III to the more restrictive schedule II classification. The change would “result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” the pharmacy groups warned.