Legal News

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

The Department of Health & Human Services approved foundation standards for electronic prescribing in January and is pushing hard for widespread adoption of e-prescribing. But across the Potomac River from HHS' downtown Washington headquarters, the Drug Enforcement Administration has serious fears about controlled substances being e-prescribed. It has indicated, for example, that further security measures may need to be in place before controlled-substance e-prescribing is allowed to go forward.

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.

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.