Medicolegal Issues

Risky to Change Dosing "as a Favor"

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Julia Pallentino explains the risks inherent to trying to "help out" a patient, and cautions that clinicians must always take care to clarify instructions, particularly as they relate to medication use.


An Alabama woman with chronic asthma went to a pharmacy to pick up a refill of 10-mg warfarin tablets, prescribed by the defendant physician. She began to take the medication as prescribed, one tablet bid. Eleven days later, she was hospitalized with shortness of breath. A blood test revealed elevated warfarin levels.

The plaintiff alleged negligence on the part of the pharmacy, the physician, and the family practice with which the physician was associated. The plaintiff claimed that warfarin toxicity had exacerbated her asthma and that she should not have been taking more than one tablet per day. The plaintiff claimed that the prescription was inappropriate and that the pharmacy should have had some system in place to catch excessive prescription dosing.

The pharmacy was dismissed from the action.

The defendant physician claimed that the plaintiff had been given oral instructions regarding dosage, as the dosage had been modified based on blood testing, and the label on the prescription bottle did not reflect the dosage instructions given to the plaintiff. The defendant claimed that the prescription had been written to reduce the required number of trips to the pharmacy, to accommodate the plaintiff’s difficulty in arranging for transportation. The defendant also maintained that the episode had not impacted the plaintiff’s asthma.

According to a published report, a defense verdict was returned.

Here is a case in which doing a favor nearly turned into a malpractice judgment. Only the defense verdict saved this physician. Warfarin is a dangerous drug, as even a small change in dosing can cause a dramatic and deadly adverse effect. Warfarin level monitoring and subsequent dose modification present an especially rich opportunity for error.

In support of the need to provide clinical summaries of office visits to patients, the Health Resources and Services Administration cites research stating that 40% to 80% of medical information provided by practitioners “is forgotten immediately after a clinic visit.” Of the information that is remembered, almost one-half is remembered incorrectly. (See toolbox/MeaningfulUse/howdoiprovideclinicalsummaries.html). It is important to remember that an office visit may be a stressful event for a patient, and visual or auditory deficits may come into play as well. These deficits may not always be obvious to the provider.

At the very least, this means that a clearly written documentation of the correct dosage of the medication must be provided to the patient. This is especially true when there is an absence of written instructions on the medication bottle or if the instructions are eliminated from the prescription for any reason. The written instruction provided at the office may also act as a safety check for the patient that will confirm the accuracy of the prescription provided at the pharmacy.

How many times have health care providers written a script for a dose different from the dose that the patient was orally instructed to take? This may occur for many reasons, including (as happened in this case) saving the patient difficult trips to a pharmacy. Another reason might be to help a patient to save on copays when a greater number of doses of a medication fall within standard practice parameters. I have often seen prescriptions written with instructions “take as directed” when the dosing regimen might be too lengthy or require too many changes, such as tapering a dose of prednisone.

The need for written instructions also applies when giving medication samples to patients. Often samples do not come with patient instructions, and even if they do, the instructions may be separated from the sample provided. It may be difficult for the patient to find dosing information in a lengthy and dense product information guide, which may or may not be included in the sample package. This presents another situation in which great care is needed to prevent potential drug errors.

In addition to providing written instructions, the health care provider may use other precautions to prevent patients from misunderstanding or completely forgetting instructions. Examples include asking the patient to repeat the instructions before leaving the examining room, and using the opportunity to clarify any misunderstandings; or having the medical assistant recheck to be sure the patient does not have any questions about medications or other instructions before leaving the office. So many times I have had an assistant advise me that the patient is confused about instructions but did not want to “bother” me or take up my time with questions. And yet, this same patient was willing to tell the assistant that questions remained. The more opportunities that exist to clarify instructions, the better. —JP

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