Legal News

Retailers who fail to comply with a new federal law on methamphetamine can be fined up to $25,000 and jailed for up to two years. Furthermore, if a state or local requirement conflicts with the federal requirement, retailers must comply with the most stringent version. So warned Kevin N. Nicholson, R.Ph., J.D., VP-pharmacy regulatory affairs, National Association of Chain Drug Stores, at the association's Marketplace Conference, held in San Diego recently.

Is technician training pharmacy's next divisive battle? It could be, if major retail employers and state pharmacy boards hold to their present courses.

The Florida Supreme Court recently added another brick to the increasingly solid legal wall of opinion that pharmacists have a duty to warn. The high court decision sent a lawsuit involving a drug overdose death against two pharmacies and a physician back to a lower court for trial.

The generic pharmaceutical industry has been at odds with the Food & Drug Administration over several key issues lately, including authorized generics, facilitating the development of more generic agents, and approving generic biopharmaceuticals. At a recent conference in New York City sponsored by the Pharmaceutical Care Management Association (PCMA), Scott Gottlieb, M.D., deputy commissioner for medical and scientific affairs at FDA, attempted to clarify the agency's position on several hot-button topics.

When the Governor signed the legislation in May, New Hampshire became, by at least one count, the 41st state to permit pharmacists to enter collaborative practice agreements with physicians. But no one knows for sure how many pharmacists are taking advantage of the professional privilege.

Can a pharmacist be liable for filling a prescription correctly?

Pharmacy may be at a moment of unaccustomed visibility just at a time when the nation's direction is in flux, political commentators told the several hundred pharmacists who went to lobby Washington during the National Community Pharmacists Association's legislative conference last month.

Oregon has joined Virginia in offering pharmacy technicians achoice of certification exams. The Oregon State Board of Pharmacyvoted in April to accept two exams to satisfy a new licensurerequirement. Oregon techs can pass either the Pharmacy TechnicianCertification Board (PTCB) exam or the Exam for the Certificationof Pharmacy Technicians (ExCPT), created by the Institute for theCertification of Pharmacy Technicians (ICPT).

Oregon has joined Virginia in offering pharmacy technicians achoice of certification exams. The Oregon State Board of Pharmacyvoted in April to accept two exams to satisfy a new licensurerequirement. Oregon techs can pass either the Pharmacy TechnicianCertification Board (PTCB) exam or the Exam for the Certificationof Pharmacy Technicians (ExCPT), created by the Institute for theCertification of Pharmacy Technicians (ICPT).

Two married pharmacists working for one of the largest PBMs,Caremark, filed a qui tam lawsuit in 2004 against their employer.They alleged Caremark had defrauded a Florida health plan forretired state workers by switching Rxs to higher-priced drugswithout permission and failing to give the health plan credit fordrugs that were returned unopened by customers.

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.