Legal News

A botanical garden offering self-guided tours, an auditorium, a library, and a terrace with a breathtaking view for parties that could accommodate 300 people ... Are these the amenities of a luxury resort? No, these facilities, along with office space and parking, will comprise the new American Pharmacists Association headquarters, now undergoing an extreme makeover.

Pharmacies across the country must better train employees and develop clear polices to avoid being investigated or prosecuted for fraud and abuse related to Medicare and Medicaid, said Don L. Bell II, general counsel of the National Association of Chain Drug Stores, at an NACDS Pharmacy & Technology Conference held recently in San Diego.

With conflicting statements from the Food & Drug Administration, Centers for Medicare & Medicaid Services, and a Federal District Court judge, the definition and legality of pharmacy compounding once again seems headed to the Supreme Court or Congress for sorting out.

A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.

Sometimes the best defense is a good offense. While many pharmacists have been vocal critics of the role of pharmacy benefit managers and the growing use of mail-order pharmacies, much of the focus has been on passing legislation to protect pharmacists or restrict PBMs. Taking a different approach, the Georgia Academy of Independent Pharmacy (AIP) has developed a multitiered plan to compete directly with the PBMs.

After 11 years in business on Main Street in Aspen, Colo., Rodney Diffendaffer, R.Ph., knows too well that the struggle between community pharmacists and the mail-order industry is heating up, with generics fueling the fire. "They get to sell three months of drugs at what comes close to my one-month price," he said. "I'm not allowed to sell a three-month supply. It's not a level playing field. Never has been."

Sometimes the best defense is a good offense. While many pharmacists have been vocal critics of the role of pharmacy benefit managers and the growing use of mail-order pharmacies, much of the focus has been on passing legislation to protect pharmacists or restrict PBMs. Taking a different approach, the Georgia Academy of Independent Pharmacy (AIP) has developed a multitiered plan to compete directly with the PBMs.

The Food & Drug Administration recently issued letters to three pharmacies warning them to "stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nationwide." The three named companies, RoTech Healthcare, CCS Medical, and Reliant Pharmacy Services, were all warned that if they did not comply, they risked injunctions and the possible seizure of their products in question.

How do I protect myself against liability for "incorrectly" filling transferred prescriptions?

Hospitals with large indigent patient populations have a new financial ally: the Medicare Part D outpatient pharmacy benefit.

The Institute of Medicine (IOM) recently released Preventing Medication Errors, a 544-page report that is the fourth in its Quality Chasm series. The authors concluded that medication errors harm at least 1.5 million people per year in the United States. In addition, the cost of treating drug-related injuries that occur in hospitals alone conservatively amounts to $3.5 billion per year, according to the Committee on Identifying and Preventing Medication Errors, which wrote the report. The report was funded by the Department of Health & Human Services and the Centers for Medicare & Medicaid Services.

It used to be that if pharmacists dispensed the right drug and right dose and gave the right directions to the right customer, we were free of liability. Thanks to the Omnibus Budget Reconciliation Act (OBRA), however, this is no longer the case. As a result of the OBRA counseling provisions, our profession has succeeded in tremendously increasing the risk of liability for frontline pharmacists. We now have to contend with aggressive lawyers who charge us with these three words: failure to warn.

How can pharmacy graduates obtain a better understanding of the role of pharmacy in the public process of legislation and regulation? How can they learn to advocate for the public good?

RxUSA Wholesale has filed a $1.8 billion lawsuit against 16 drug manufacturers, five drug wholesalers, and the Healthcare Distribution Management Association (HDMA). The New York-based distributor charged a conspiracy to boycott secondary wholesalers, eliminate competition, and maintain artificially high prices.

Washington State pharmacists are wondering if they are expected to be the penmanship police since a new law decrees that prescriptions in cursive handwriting are no longer considered to be legible.

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.