Some medical errors are so egregious that lawmakers in four states now require hospitals to publicly report how often they occur, and to prove that they have taken corrective action. These "never events" laws adopted in Illinois, Minnesota, New Jersey, and Connecticut are based on criteria developed by the National Quality Forum (NQF).
Your chances of being audited "will likely double with Medicare Part D." This was the opening remark of H. Edward Heckman, R.Ph., president of PAAS National of Stoughton, Wis., a firm that provides consulting on third-party audits to pharmacists. Heckman was speaking at a pharmacy continuing education program sponsored by the Arnold & Marie Schwartz College of Pharmacy & Health Sciences and the New York City Pharmacists Society.
Supporters of the notion that apologies are better than malpractice lawsuits got a boost in late September. Sens. Hillary Rodham Clinton (D, N.Y.) and Barack Obama (D, Ill.) introduced the National Medical Error Disclosure and Compensation (MEDiC) Act to encourage hospitals to apologize after medical errors and negotiate fair compensation.
Medication therapy management (MTM) for Medicare patients is a first step that could transform the practice of pharmacy. The kinds of services the federal government requires under Medicare Part D beginning in January will spread into the commercial market. So will payment policies, procedures, and amounts.
Pharmacists are increasingly torn by conflicting state and federal regulations
Concerned about the potential impact that Medicaid budget cuts will have on health care, the National Association of Chain Drug Stores and the National Community Pharmacists Association have formed the Coalition for Meaningful Medicaid Reform (CMMR).
Fewer than a third of adults clean out their medicine cabinet annually—compared with 49% who update their wardrobe to reflect the current season.
Hospitals often take a financial beating when they do not get adequately reimbursed for certain high-priced, lifesaving drugs. But thanks to a new diagnostic code for stroke patients, which goes into effect on Oct. 1, 2005, reimbursement for critical clot-busting drugs (thrombolytics) will be more equitable.
Medication recycling is an idea whose time has not yet come. "We all recognize the absurdity of throwing away perfectly good and terribly expensive medications," said John Cronin, senior VP, California Pharmacists Association. California is one of several states debating legislation to allow the return and reuse of unused drugs. "The economic reality is that it is just not practical. There has got to be a way to do it, but nobody has figured out how to get it right yet."
Community pharmacists, beware. Congress is considering ways to reduce Medicaid spending. The goal is to save $10 billion over the next five years. Among the pharmacy product payment options Congress is evaluating are average selling price (ASP), average manufacturers' price (AMP), and wholesale acquisition cost (WAC) to replace average wholesale price (AWP), which many think has been responsible for Medicaid overpaying for Rx drugs.
The Food & Drug Administration approved another generic version of levothyroxine (Synthroid, Abbott) earlier this year. With a total of eight levothyroxine (T4) products on the market, generic manufacturers are happy, brand-name manufacturers unhappy, and endocrine physicians furious. The R.Ph. is caught between manufacturers, physicians, and the FDA.
Pharmacy is taking a wait-and-see attitude regarding the Food & Drug Administration's new risk management program designed to enhance the safe use of the drug isotretinoin (Accutane, Roche) during pregnancy. But not all pharmacists think the program is necessary.
When the Medicare Part D program starts up next year, one group that will be monitoring the quality of services provided by pharmacists is made up of the state-based quality improvement organizations (QIOs). So reported Karen Bell, M.D., M.S., division director of the Quality Improvement Group at the Centers for Medicare & Medicaid Services.
While the Medicare Part D drug benefit is still on track to begin on Jan. 1, 2006, another CMS program that was scheduled to kick off then—Medicare Part B's competitive acquisition program (CAP)—will now have a delayed start. Two days before all bids to the CAP program were due to the Centers for Medicare & Medicaid Services, as outlined in an interim rule published in the July 6 Federal Register, the agency announced that it's returning all the bids it has received and suspending the bidding process. CMS explained that it is setting back the program in order to make it more attractive and efficient.
An Institute of Medicine panel began a year-long investigation last month with hope of recommending fixes to the nation's foundering drug safety system. The panel was commissioned by Food & Drug Administration officials, who pledged to seek improvements to safety monitoring in the wake of highly publicized problems with COX-2 drugs, selective serotonin reupake inhibitor (SSR) antidepressants, and other products.
Just because pharmacists or pharmacies don't know that certain actions are prohibited by the Healthcare Insurance Portability & Accountability Act doesn't mean they can't be brought up on criminal charges for violations, according to a ruling issued by the U.S. Department of Justice (DOJ).
As California and Florida gear up to implement new pedigree laws—legislation that requires a paper trail on prescription drugs to thwart counterfeiting—there are growing signs of resistance and complaints that it will be very costly to install a uniform tracking system.
Until now, all distributions of Schedules I and II controlled substances required the completion of the Drug Enforcement Administration's Form 222. As of May 31, DEA came out with an electronic alternative to the paper form. DEA says the system will "go live" soon, although it has not released a specific date.
A new patient enters a pharmacy with an Rx for OxyContin (oxycodone, Purdue). The patient seems nervous, the script is smudged, and there was a recent front-page news article about stolen Rx pads. What's the next step here?
T o counter the rise in drug counterfeiting, three states now have prescription drug pedigree laws on their books, another 15 have similar legislation in the pipeline, and the Food & Drug Administration is threatening to enforce its long- dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees by the end of 2006.
How do you know when a prescription is forged or when the prescription drug a customer refills at your pharmacy is being resold on the street? And when you have a suspicion about an Rx, what are the best courses of action to take?
How do you know when a prescription is forged or when the prescription drug a customer refills at your pharmacy is being resold on the street? And when you have a suspicion about an Rx, what are the best courses of action to take?
The Centers for Medicare & Medicaid Services is designing a comprehensive Medicare information Web site for pharmacists, as well as a pharmacy kit. The agency will also be sharing more information through continuing education and special pharmacist outreach events.
The administrator of the Centers for Medicare & Medicaid Services, Mark McClellan, is in a big hurry. A telltale sign is the rapid-fire way in which he spoke before pharmacists at the American Pharmacists Association annual meeting in Orlando last month. McClellan knows there are still many plans to be laid in the remaining months before Medicare Part D can be rolled out next January. But on schedule it will be, he vowed repeatedly at APhA's opening general session.
More and more hospitals are using specialty pharmacies as suppliers of injectable biotech therapies. For the most part, the drugs are shipped directly to the patients, physician offices, or home infusion vendors, but there are times when the drugs are delivered to a hospital to be given at an on-site infusion clinic or in hospital-based physician offices. Pharmacy directors may be wondering exactly where their responsibility for these drugs begins and ends.
Drug manufacturers breathed a collective sigh of relief last month after a Food & Drug Administration advisory panel concluded, at the end of three days of hearings, that COX-2 inhibitors should be allowed to stay on the market. The panel urged strict limits on the drugs as a condition of their continued sale, reflecting a sense of unease among experts and many patients over whether the benefits are worth the risks. The committee's narrow approval allowing Vioxx (rofecoxib, Merck) back on pharmacy shelves also reflected the public's willingness to accept the drug after widespread media coverage of its potential for cardiovascular harm.
A civilian pharmacist at a medical clinic tied to the U.S. Naval Hospital at Pensacola, Fla., was suspended for two weeks without pay last month for refusing to let a technician check prescriptions he had filled.
Medicare prescription rules are final, but we won't know how the system works until it is thrown into the real world, said a former Department of Health & Human Services policy official who did early work on the program. It is there that the drug plans will strategize to make money and the Centers for Medicare & Medicaid Services will attempt to maintain oversight.
Must pharmacies contact their state boards of pharmacy, DEA, OIG, and other agencies to see if a prospective staff R.Ph. has a license that's in order and has not been excluded from participation in Medicare and state healthcare programs?
State departments of health sometimes seek to circumvent their own procedural codes and avoid their legislatures by lowering Medicaid reimbursements and dispensing fees through emergency fiat. "They declare a state of budgetary emergency, then declare new rules and regulations," said Paul Baldwin, executive director of the Long Term Care Pharmacy Alliance (LTCPA) in Washington, D.C.