On The Docket
David B. Brushwood, BSPharm, JD
Dosing is a critical aspect of safe and effective drug therapy. Drug doses must be individualized for each patient, as a dose that is therapeutic for one patient may be toxic or subtherapeutic for another patient. As the University of Minnesota’s Robert Cipolle said, “Drugs don’t have doses—people have doses.” The 16th century Swiss pharmacist Paracelsus similarly said, “The dose makes the poison.” A pharmacist’s responsibility to screen each patient’s drug dosage was addressed in a recent Pennsylvania legal case.
Background
A patient was diagnosed with “chronic babesiosis” (a disease caused by a parasite that infects red blood cells). The patient’s physician prescribed antimicrobials and corticosteroid therapy. All of the patient’s prescriptions were processed accurately by the patient’s pharmacy.
On August 8, 2022, the pharmacy dispensed 500 tablets of prednisone 10 mg, with directions for the patient to take “up to 10 tabs po daily as directed.” On August 16, 2022, the pharmacy dispensed 200 tablets of dexamethasone 4 mg, with directions of “up to 10 tabs po as directed.” On October 4, 2022, the pharmacy dispensed another 200 tablets of dexamethasone 4 mg, with directions of “up to 10 tabs po as directed.”
The patient experienced progressively more severe abdominal pain. She was transported to a hospital emergency department, and she underwent surgery to repair GI perforations. She was told that the perforations were caused by the corticosteroids.
The patient sued the prescriber and the pharmacy. The patient alleged that the pharmacy had breached a duty to “remedy inadequacies on the face of the prescriptions.” The pharmacy insisted that there were no such inadequacies, and that “there is no upper limit for either medication.” The pharmacy moved for summary judgment to dismiss the lawsuit.
Rationale
The pharmacy contended that the phrase “as directed” established the facial adequacy of the prescriptions because the physician was communicating that he would monitor the patient’s use of the medication.
The court was “not persuaded that ‘as directed’ instructions or the lack of a specific ‘maximum dosage’ forecloses a finding of inadequacy.” Working through the double negative of this sentence, the court meant that simply adding the words “as directed” does not convey adequacy to a prescription’s otherwise inadequate directions for medication use.
The court reasoned that prior case law “does not appear to contemplate a duty which a pharmacist may automatically fulfill simply by instructing a patient to take prescribed medication ‘as directed.’” The court explained that “Such a protection would virtually absolve pharmacists from their duty entirely.”
The court referenced expert witness testimony that “the quantities/dosages prescribed and dispensed (which quantities and dosages are undisputed) posed a substantial risk of serious harm, and that pharmacists should have recognized that risk. A reasonable jury could determine that the prescriptions were inadequate on their face.”
The pharmacy’s motion to dismiss the case was denied.
Takeaways
While it may be true that there is no recognized ceiling dose for many drugs, it is also true that for each patient, there is a dosage of any drug that is more harmful than beneficial. The legal case reviewed here recognizes the responsibility of a pharmacist to consult with the prescriber concerning the appropriateness of drug dosing when there are obvious inadequacies on the face of a prescription.
The words “as directed” on the face of any prescription are a cause for concern about the adequacy of a patient’s understanding of the directions for medication use. Patients have a right to be given specific directions for use. The absence of a specific dose in a prescription is an obvious inadequacy.
This concern about dosage is particularly relevant when the indication for medication use is unusual. Consultation with the prescriber and/or the patient is an appropriate step to take under such circumstances, to ensure that adequate directions for use have been provided to the patient. ■