Viewpoint: OBRA has made you targets for lawyers

August 21, 2006

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.

Don't get me wrong-I am 100% in favor of counseling customers. But there's a caveat: Let's first figure out some way to fix the horrendous problem of understaffing in pharmacies that endangers the safety of our customers.

Have you noticed that the folks who advocate a greatly expanded cognitive role for pharmacists aren't themselves dispensing drugs in the trenches? Many pharmacists don't realize that the OBRA provisions were not pushed by the federal government but by our pharmacy leaders. Prior to the law, the federal government showed no interest in whether pharmacists counseled or not. Some pharmacy leaders felt that mandating counseling would give the profession more respect and help convince payers that pharmacists do much more than transfer pills from big bottles to little bottles. They believed that there was no future in dispensing because of mail-order mills and robotics. Therefore, pharmacists were told to embrace cognitive roles and to expect, with the assumption of more responsibilities, more liability as well.

Most pharmacists have time for, at best, a few sentences to customers, such as "Be careful. This may make you drowsy" or "Be sure to take this antibiotic till it's all gone." This level of communication is nowhere near being adequate in the eyes of aggressive lawyers. Legal experts say we need to give customers a list of every possible side effect, even rare ones. When consumers experience uncommon adverse drug consequences, pharmacists are sued for providing patient leaflets containing only the most common side effects.

For example, here's one of an endless number of nightmare scenarios that we can easily imagine: A customer with rheumatoid arthritis develops lymphoma from long-term use of methotrexate. A lawyer charges the pharmacist with negligence for continuing to fill methotrexate prescriptions long-term, in view of the fact that developing lymphoma is part of the black box warning on the labeling.

The implications of failure to warn are frightening: Two separate lawsuits against pharmacists have been based on failure to warn about the risk of priapism (an abnormally persistent erection) from two different drugs-Desyrel (trazodone HCl, Apothecon) and Caverject (alprostadil, Pfizer). Another lawsuit was based on the pharmacist's failure to warn about a very uncommon adverse reaction to desipramine in the death of a 14-year-old boy.

To make matters worse, most customers simply want to get their prescriptions filled as quickly as possible so they can go on their way. Many consumers don't want a lot of information about their drugs. We know that all too many customers throw away the drug leaflets we give them without reading a single word. On the other hand, finding out a drug's every side effect could frighten some consumers from getting their prescriptions filled.

The bottom line is that our profession's desire to expand from a distributive function has opened a Pandora's box of increased liability for rank-and-file pharmacists. We're caught between pharmacy leaders who advocate a greatly expanded cognitive role for pharmacists and employers who just want R.Ph.s who can dispense at lightning speed. To expect us to provide counseling when we don't have adequate staffing and thus open ourselves to potential litigation is a bullet I don't want to bite.

THE AUTHOR, a community pharmacist in Delray Beach, Fla., encourages feedback at dmiller1952@aol.com
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