Screening for maximum dosages

On the Docket

A recent case from New York reviewed the responsibility of pharmacists to recognize and address drug dosages that exceed the maximum dose listed in approved product labeling.

Background

A patient had been using multiple medications to treat obsessive–compulsive disorder. Her physician decided to initiate therapy with clomipramine and phoned the patient’s pharmacy. The physician claims to have ordered three 50-mg capsules daily. The pharmacy records indicate that a prescription for three 50-mg capsules twice daily was authorized. The patient alleged that this higher dose exceeded the 250-mg maximum daily dosage listed in the product labeling. The medication was dispensed at the 300-mg daily dosage. The pharmacist who received this telephone prescription could not recall the conversation with the physician.

Approximately 4 weeks later, the patient called the physician and described worsening symptoms. The physician again called the pharmacy. At this time, the physician claims to have prescribed four 50-mg capsules daily. The pharmacy records indicate that a prescription for four 50-mg capsules twice daily was received. Notes on this prescription indicated that the pharmacist informed the physician of the excessive dosage based on the product labeling and that the physician was aware of this fact. The medication was dispensed at the 400-mg daily dosage.


The patient allegedly suffered a seizure as a result of an excessive clomipramine dosage. She sued the physician and the pharmacy. The allegations against the pharmacy were that either the pharmacists transcribed the prescriptions incorrectly or, alternatively, that the dosage was transcribed accurately based on the physician’s order, and the pharmacists should have refused to fill the prescription because of its excessive dosage. The lawsuit also alleged a failure to counsel the patient on the excessive dosage.

The physician and the pharmacy filed a motion to dismiss the case.

Rationale

The court referred to the report of a pharmacist retained by the plaintiffs. This pharmacist opined that clomipramine prescriptions for 300 mg and 400 mg daily are “grossly excessive” and that “it was incumbent on the pharmacists to decline to fill a prescription that exceeded the daily maximum dosage by such a significant amount.” The expert also stated that “either the pharmacists did not properly transcribe [the physician’s] prescription, or they filled a prescription that they should not have filled.”

In reply, the pharmacy referred to a report submitted by a physician, who maintained that it is the pharmacist’s responsibility to inform the prescribing physician that a prescription exceeds the labeled dosage range, and that a daily dosage of clomipramine exceeding the labeled dosage range is still good medical practice.

The pharmacy contended that the lawsuit should be dismissed because the prescribed dosage of clomipramine was an appropriate dose, the pharmacy records indicated that a conversation about excessive dosages occurred between the second pharmacist and the physician, and a pharmacist does not have a duty to countermand the directives of a treating physician.

The court ruled that the case could not be dismissed as a matter of law, leaving it to a jury to determine whether a duty was breached by the pharmacists.

Discussion

Pharmacists who receive verbal orders for high dosages of medication are placed in a quandary when the prescriber verbally affirms the high dosage after a consultation from the pharmacist. Documentation of the conversation is certainly necessary, but it may not be sufficient. Insisting on a faxed written prescription, with justification for the high dosage, is a reasonable request. Patient counseling may also be an appropriate step to protect the patient and the pharmacy.

Based on: McGrath v Downer, 2014 N.Y.Misc. LEXIS 3020 (July 2, 2014)